Evidence Report/Technology Assessment 

Number 144 

Comparison of Endovascular and Open Surgical 

Repairs for Abdominal Aortic Aneurysm 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. 290-02-0009 

Prepared by: 

University of Minnesota Evidence-based Practice Center, Minneapolis, Minnesota 

Investigators

Timothy J. Wilt, M.D., M.P.H. 

Frank A. Lederle, M.D. 

Roderick MacDonald, M.S. 

Yvonne C. Jonk, Ph.D. 

Thomas S. Rector, Ph.D. 

Robert L. Kane, M.D. 

AHRQ Publication No. 06-E017 

August 2006
This report is based on research conducted by the Minnesota Evidence-based Practice Center 

(EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD 

(Contract No. 290-02-0009). The findings and conclusions in this document are those of the 

author(s) who are responsible for its contents; the findings and conclusions do not necessarily 

represent the views of AHRQ. Therefore, no statement in this article should be construed as an 

official position of the Agency for Healthcare Research and Quality or of the U.S. Department of 

Health and Human Services. 

The information in this report is intended to help clinicians, employers, policymakers, and others 

make informed decisions about the provision of health care services. This report is intended as a 

reference and not as a substitute for clinical judgment. 

This report may be used, in whole or in part, as the basis for development of clinical practice 

guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 
ii 

This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

Wilt TJ, Lederle FA, MacDonald R, Jonk YC, Rector TS, Kane RL. Comparison of 

Endovascular and Open Surgical Repairs for Abdominal Aortic Aneurysm. Evidence 

Report/Technology Assessment No. 144. (Prepared by the University of Minnesota Evidencebased Practice Center under Contract No. 290-02-0009.) AHRQ Publication No. 06-E017. 

Rockville, MD. Agency for Healthcare Research and Quality. August 2006. 

None of the investigators has any affiliations or financial involvement that conflicts 

with the material presented in this report. 
iii 

Preface 

 The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. The reports and assessments provide organizations 

with comprehensive, science-based information on common, costly medical conditions, and new 

health care technologies. The EPCs systematically review the relevant scientific literature on 

topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to 

developing their reports and assessments. 

 To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

 AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

 We welcome written comments on this evidence report. They may be sent to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by email to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. 

Director Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality 

 

Beth Collins Sharp, Ph.D., R.N. 

Director, EPC Program 

Agency for Healthcare Research and Quality 

Gurvaneet Randhawa, M.D., M.P.H 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 
iv 

Acknowledgments 

 We would like to thank Andrea Cutting, Heidi O'Connor, and James Tacklind for their 

assistance with data extraction and table preparation; Indulus Rutks for literature search and 

retrieval; and Marilyn Eells for editing and formatting this report. 
v 

Structured Abstract 

Objectives: Evaluate treatment options for nonruptured abdominal aortic aneurysms (AAA); the 

relationship of hospital and physician volume to outcomes for endovascular repair (EVAR); 

affect of patient and AAA factors on outcomes; cost-benefits of treatments. 

Data sources: PubMed®, Cochrane Library, FDA, and other electronic websites until May 

2006. Reference lists and content experts were used to identify additional reports. 

Review Methods: Randomized controlled trials (RCT) of open surgical repair (OSR), EVAR, or 

active surveillance, systematic reviews, nonrandomized U.S. trials, and national registries were 

used to assess clinical outcomes. Volume-outcome articles published after 2000 were reviewed if 

they reported the relationship between U.S. hospital or physician volume and outcomes, were 

population-based, and the analysis was adjusted for risk factors. Cost studies included at least 50 

EVAR and provided data on costs or charges, and cost-effectiveness analyses.

Results: Initial or attained diameter is the strongest known predictor of rupture. The annual risk 

of rupture is below 1 percent for AAA <5.5 cm in diameter. Among medically ill patients unfit 

for OSR with AAA ≥5.5 cm, the risk of rupture may be as high as 10 percent per year. 

Early/immediate OSR of AAA <5.5 cm (two trials n=2,226) did not reduce all-cause mortality 

compared with surveillance and delayed OSR. Results did not differ according to age, gender, 

baseline AAA diameter, or creatinine concentration. Two RCT with followup of at least 2 years 

compared EVAR to OSR for AAA ≥5.5 cm. EVAR reduced postoperative 30-day mortality 

compared to OSR (1.6 percent EVAR vs. 4.7 percent OSR, RR = 0.34 [0.17 to 0.65]). Early 

reduction in all-cause mortality with EVAR disappeared before 2 years. Post-operative 

complications and reinterventions were higher with EVAR. Quality of life differences were 

small and disappeared after 3-6 months. One RCT of patients with AAA ≥5.5 cm judged 

medically unfit for OSR (n=338), reported no difference in all-cause mortality or AAA mortality 

between EVAR and no intervention (HR = 1.21; 95 percent CI 0.87 to 1.69). Forty-eight 

nonrandomized reports evaluated EVAR. Patient, AAA characteristics, and outcomes were 

similar to RCT comparing EVAR to OSR. A volume outcome relationship has been shown for 

OSR, but there are no data adequate to estimate the effect of hospital or physician volume on 

EVAR outcomes or to identify a volume threshold for policymakers. Immediate OSR for AAA 

<5.5 cm costs more and does not improve long-term survival compared to active surveillance 

and delayed OSR. The cost effectiveness of EVAR relative to OSR is difficult to determine. 

However, compared to OSR for AAA ≥5.5 cm, EVAR has greater in-hospital costs primarily due 

to the cost of the prosthesis. EVAR has shorter length of stay, lower 30-day morbidity and 

mortality but does not improve quality of life beyond 3 months or survival beyond 2 years, and is 

associated with complications, need for reintervention, long-term monitoring, and higher longterm costs. Compared to no intervention in patients medically unfit for OSR, EVAR costs more 

and does not improve survival or quality of life. 

Conclusions: For AAA <5.5 cm in diameter, active surveillance with delayed OSR results in 

equivalent mortality but lesser morbidity and operative costs due to fewer interventions 

compared to immediate OSR. For AAA ≥5.5 cm, EVAR has not been shown to improve longterm survival or health status over OSR though peri-operative outcomes are improved. EVAR 
vi 

does not improve survival in patients who are medically unfit for OSR. EVAR is associated with 

more complications, need for reintervention, monitoring, and costs compared to OSR or no 

intervention. U.S. RCT are needed using approved EVAR devices to evaluate patient outcomes. 
vii

Contents 

Executive Summary.................................................................................................................... 1 

Evidence Report........................................................................................................................ 11 

Chapter 1. Introduction .............................................................................................................. 13 

 Overview .............................................................................................................................. 13 

 Background........................................................................................................................... 13 

Chapter 2. Methods.................................................................................................................... 17 

 Topic Assessment and Refinement and Literature Review.................................................. 17 

 Analytic Framework ............................................................................................................. 17 

 Question 1.......................................................................................................................... 17 

 Literature Search and Review Strategy .......................................................................... 20 

 Study Eligibility and Extract Data.................................................................................. 20 

 Outcomes........................................................................................................................ 20 

 Question 2.......................................................................................................................... 21 

 Search Strategy for Pertinent Publications..................................................................... 25 

 Study Inclusion and Exclusion Criteria.......................................................................... 25 

 Data Extraction............................................................................................................... 26 

 Data Analysis.................................................................................................................. 26 

 Question 3.......................................................................................................................... 26 

 Literature Search Strategy and Eligibility Criteria......................................................... 26 

 Outcomes........................................................................................................................ 26 

 Question 4.......................................................................................................................... 27 

 Search Strategy Methods................................................................................................ 28 

Chapter 3. Results ...................................................................................................................... 33 

 Question 1................................................................................................................................ 33 

 Natural History of AAA ....................................................................................................... 33 

 Elective Immediate OSR Versus Active Surveillance for Small Aneurysms (4.0 

to 5.5 cm)........................................................................................................................... 35 

 Baseline Characteristics.................................................................................................. 35

 Followup and Treatment ................................................................................................ 36 

 Results .................................................................................................................................. 36 

 Mortality......................................................................................................................... 36 

 Complications of OSR.................................................................................................... 38 

 Rupture and Enlargement of Small Aneurysms in Patients Kept Under 

Ultrasound Surveillance .............................................................................................. 38 

 Quality of Life ................................................................................................................ 39 

 Large Aneurysm (≥5.5 cm) Randomized Controlled Trials........................................... 39 

 EVAR Versus OSR Patients Who are Medically Fit for OSR....................................... 40 

 Short-Term Mortality and Morbidity ............................................................................. 40 

 Endoleaks and Secondary Interventions......................................................................... 41 

 Midterm Mortality and Morbidity.................................................................................. 41 
viii

 Midterm Endoleaks and Secondary Interventions.......................................................... 41 

 Health Related Quality of Life ....................................................................................... 42 

 EVAR versus No Intervention for AAA ≥5.5 cm in Patients Judged 

Medically Unfit for OSR............................................................................................. 42 

 Overall and AAA Related Mortality .............................................................................. 43 

 Evidence from Nonrandomized Controlled Trials, Registries, Case Series, and 

Comparative Studies Evaluating EVAR ........................................................................... 55 

 Study and Patient Characteristics ................................................................................... 55 

 Results .................................................................................................................................. 56 

 Mortality......................................................................................................................... 56 

 Early and Delayed Aneurysm Rupture........................................................................... 56 

 Primary and Delayed Conversion to OSR...................................................................... 56 

 Secondary Intervention Following EVAR ..................................................................... 57 

 Additional Outcomes...................................................................................................... 57 

 Endoleaks and Complications ........................................................................................ 58 

 Question 2................................................................................................................................ 60 

 Results .................................................................................................................................. 60 

 EVAR of AAA ............................................................................................................... 60

 OSR of AAA .................................................................................................................. 60 

 Summary of Results ....................................................................................................... 61 

 Question 3................................................................................................................................ 65 

 Aneurysm Location and Morphology................................................................................... 69 

 Aneurysm Size (Small AAA)......................................................................................... 69 

 Large AAA ..................................................................................................................... 70 

 High Surgical Risk Patients............................................................................................ 71 

 Device-Specific Results from FDA Reports and Lifeline Registry ............................... 72 

 Device-Specific Results from Published Nonrandomized Studies ................................ 73 

 Question 4................................................................................................................................ 77 

 Results .................................................................................................................................. 77 

 EVAR Prosthesis............................................................................................................ 79 

 Reimbursement Issues.................................................................................................... 79 

 Measures of Effectiveness.............................................................................................. 79 

 Cost-Effectiveness Analyses Using Markov Methodologies......................................... 80 

Chapter 4. Discussion ................................................................................................................ 97 

 Recommendations for Future Research................................................................................ 100 

 Conclusions .......................................................................................................................... 102 

References and Included Studies ................................................................................................ 103 

List of Acronyms/Abbreviations................................................................................................. 113 
ix

Tables

Table 1. Classification of Endoleak ....................................................................................... 20 

Table 2. Subgroup Mortality for Early/Immediate Elective Repair Versus 

Surveillance of AAA Randomized Controlled Trials .............................................. 45 

Table 3. All-Cause and Aneurysm-Related Mortality for Early/Immediate Elective 

Repair Versus Surveillance of AAA Randomized Controlled Trials ...................... 46 

Table 4. Mortality for EVAR Versus OSR of AAA Randomized Controlled Trials............. 47 

Table 5. Complications and Endoleaks for EVAR Versus OSR of AAA Randomized 

Controlled Trials ...................................................................................................... 48 

Table 6. Mortality for the EVAR-2 Trial (N=338), EVAR Versus No Intervention 

(NI) of AAA............................................................................................................. 50 

Table 7. Kaplan-Meier Estimates of Mortality and Complications According to 

Treatment Arm for EVAR Versus No Intervention of AAA: EVAR-2 

Randomized Controlled Trial................................................................................... 51 

Table 8: Summary of Studies of Relationships Between Hospital and Surgeon 

Volume and Mortality of OSR of Unruptured AAA in the 1990s........................... 63 

Table 9: LIFELINE, FDA, and RCT Data for Patients Undergoing EVAR for AAA .......... 74 

Table 10: Summaries of LIFELINE, FDA Data, and RCT Data for Patients Undergoing 

OSR (or no Intervention) for AAA .......................................................................... 76 

Table 11: Overview of Studies................................................................................................. 83 

Table 12: Studies Excluded from Systematic Review ............................................................. 84 

Table 13: Cost Analysis and Findings...................................................................................... 85 

Table 14: Short-term Mortality, Hospital, and Intensive Care Unit (ICU) Length of Stay ..... 92 

Table 15: Markov Models ........................................................................................................ 94 

Figures

Figure 1. Flow Chart: Question 1—RCTs............................................................................... 29 

Figure 2. Flow Chart: Question 2—Volume ........................................................................... 30 

Figure 3. Flow Chart: Question 3—nonRCTs......................................................................... 31 

Figure 4. Flow Chart: Question 4—Cost................................................................................. 32 

Figure 5: Endovascular Repair Versus Open Repair: 30-day Mortality.................................. 52 

Figure 6: Endovascular Repair Versus Open Repair: Midterm All-Cause Mortality.............. 53 

Figure 7: Endovascular Repair Versus Open Repair: Aneurysm-Related Mortality............... 54 

Appendixes 

Appendix A: Technical Expert Panel Members and Areas of Expertise 

Appendix B: Exact Search Strings 

Appendix C: List of Excluded Studies 

Appendix D: Data Extraction Forms 

Appendix E: Evidence Tables and Figures 

Appendix and Evidence Tables for this report are provided electronically at 

http://www.ahrq.gov/clinic/tp/aaareptp.htm
1 

Executive Summary 

Introduction 

 An abnormal bulging of the abdominal aorta, called an abdominal aortic aneurysm (AAA) is 

a potentially serious condition that can lead to death if it ruptures. An AAA is considered present 

when the maximum diameter of the aorta below the renal arteries (infrarenal AAA) expands to 

exceed 3.0 cm. In the United States, rupture of AAA accounts for approximately 9,000 deaths 

annually.1 Another 30,000-40,000 patients undergo elective surgical repair of asymptomatic 

AAA to prevent rupture, with perioperative mortality ranging from 2-8 percent.2,3 Death due to 

AAA rupture or repair is the thirteenth leading cause of death in the United States and tenth 

among older men.4,5 

 The majority of AAAs remain asymptomatic for years, though the risk of rupture increases 

with AAA size. Immediate death can result, and mortality remains between 40 and 60 percent, 

even when emergency care and repair are undertaken. Management options are primarily based 

on patient’s life expectancy and AAA size and include no treatment, active surveillance and 

delayed repair, immediate open surgical repair (OSR), and endovascular aneurysm repair 

(EVAR). 

 Recent recommendations for AAA screening in high-risk populations along with emerging 

endovascular methods for repair have led to increased interest in evaluating the effectiveness and 

adverse effects of treatment options for patients with AAA. 

Objectives and Key Questions 

 

 The Minnesota Evidence-based Practice Center (EPC) was asked to answer the following 

questions related to elective treatment of nonruptured AAA that were nominated by America’s 

Health Insurance Plans (AHIP). 

1. What are the comparative effectiveness and adverse effects of treatment options of AAA 

including active surveillance, open repair, and endovascular repair? 

2. What is the relationship of volume, both hospital and physician, to the benefits and harms 

of endovascular procedures to repair AAA? 

3. How do the characteristics of the aneurysm (size/location/shape) and the patient 

(age/gender) affect the benefits and harms of endovascular and open-surgical repair? 

4. What are the costs-benefits for each of the procedures? 

Methods 

Literature Search 

 

 For questions 1 and 3 we searched PubMed®, Cochrane Library, Food and Drug 

Administration (FDA), and other electronic websites from 1990 to October 2005. The following 

terms were included: abdominal aortic aneurysm, endovascular repair, surveillance, and surgery. 

Titles and abstracts of identified references were reviewed. For question 2, MEDLINE® was 

searched for publications about volume-outcome relationships for procedures to repair AAA 
2 

published after 1990. Key words included abdominal aortic aneurysm, volume, outcome, and 

process assessment of health care. For question 4 we used the terms abdominal aortic aneurysm 

combined with economics, nursing economics, pharmaceutical economics, cost, 

pharmacoeconomics, cost analysis, cost allocation, cost-benefit analysis, cost control, cost 

savings, cost of illness, cost sharing, “deductibles and coinsurance,” medical savings accounts, 

health care costs, direct service costs, drug costs, employer health costs, hospital costs, health 

expenditures, capital expenditures, hospital economics, hospital charges, hospital costs, medical 

economics, or medical fees. Reference lists and contacts with content experts were used to 

identify additional reports. 

Study Selection Extract Data 

 For questions 1 and 3, studies were eligible if they were randomized controlled trials or 

multivariate natural history studies involving AAA, open repair, endovascular repair, or active 

surveillance and reported clinical outcomes. We included and updated a systematic review of 

EVAR vs. open repair published by the U.K. National Institute of Clinical Excellence (NICE) as 

well as nonrandomized U.S. trials or national registries.6

 To assess volume-outcome relations 

(question 2), articles that met the following criteria were reviewed. The report had to be an 

original analysis of U.S. data representing repair of unruptured AAA beginning in 1990; the 

sample had to represent variation between hospitals or surgeons in a community or larger 

geographic area and present sample statistics representing the relationship between a measure of 

hospital or physician volume and a beneficial or harmful outcome of AAA repair; the analysis 

had to attempt to make adjustments for other known risk factors. For question 4, studies had to 

include at least 50 AAA procedures in each arm, provide data on costs, charges, or 

reimbursement rates, or be a cost-effectiveness analysis. 

Quality Assessment and Strength of Evidence 

 The methods of Schulz et al. were used to assess the quality of randomized controlled trials 

(RCT).7 We determined whether intention-to-treat analysis was utilized and whether published 

RCT used EVAR devices similar to those available in the United States. We evaluated whether 

effectiveness of interventions varied according to patient, aneurysm, or device characteristics 

including: age, race, gender, EVAR device manufacturer, or aneurysm size (small [<5.5 cm] vs. 

large aneurysm). Data from nonrandomized studies were included to assess relevance and 

consistency to practice in the United States. Analyses of administrative databases to examine 

relationships between provider volume and outcomes were evaluated by their ability to represent 

current practices in the United States, the reliability and validity of ‘volume’ and outcome 

measures, and the thoroughness of the regression analyses, including control of key risk factors. 

Quality of cost studies were based on whether they included relevant costs, used appropriate time 

frame, and evidence of effectiveness and adverse effects from randomized controlled trials.

Data Extraction 

 

 Data regarding study, patient, and device characteristics as well as outcomes were extracted. 

Outcomes were described as effectiveness (initial clinical success ≤30 days or during initial 
3 

hospitalization; short-term (30 days to 6 months), midterm (6 months to 5 years), and long-term 

>5 years) and adverse effects based on recommendations for reporting of outcomes for open and 

EVAR by the Society for Vascular Surgery.8 The primary outcome was midterm all-cause 

mortality. Additional outcomes included initial all-cause mortality, AAA mortality, AAA 

rupture, quality of life, and technical measures of EVAR and OSR success. Adverse events and 

complications included treatment-related mortality and morbidity such as endoleaks, graft 

rupture, migration, kinking, and need for additional interventions, including OSR. 

 For question 2 the main outcome that has been studied in relation to provider volume is 

short-term mortality. All published analyses used regression models of this outcome on 

retrospectively defined volume measures. Information was abstracted to characterize (1) the 

study population, (2) volume measures, (3) outcome measures, (4) regression model including 

covariates used for risk adjustment and handling of clustering of patients within hospitals or 

surgeons, and (5) adjusted and unadjusted estimates of volume effects. For question 4 we 

assessed charges, costs, reimbursement rates, hospital and intensive care unit length of stay, 

incremental cost effectiveness ratios, and quality adjusted life years. 

Data Analysis 

 Descriptive characteristics of patient populations were presented. For results from RCTs we 

calculated odds ratios (ORs) for categorical variables and weighted risk differences for 

continuous variables with the corresponding 95 percent confidence intervals. Because of the 

paucity of RCT, results from each study were evaluated and described and the corresponding 

statistical parameters for effect size and significance were described. We reported on tests of 

interaction for predefined subgroups. The preponderance of evidence for relationships between 

the volume of procedures performed by hospitals and physicians to repair AAA and outcomes 

has been obtained by secondary regression analysis of administrative databases. Methodological 

differences, including the definition of volume and outcomes measures, make it difficult to 

compare results from the different studies. Use of variables to control for pre-procedure risk 

(case-mix), physician training, and health care system attributes varied. Analytical methods 

varied as well. Therefore, we did not attempt to do a meta-analysis to combine estimates from 

different retrospective observational studies. The summary of studies of the volume-outcome 

relationship was limited to tabulation of individual study characteristics and results. Cost 

analysis was limited to a review of published findings and discussion of study limitations and 

strengths. 

Results 

Comparative Effectiveness of Treatment Options 

 The strongest known predictor of rupture is AAA diameter. AAA enlargement rate is not 

consistently independently associated with rupture rate. The annual rate of rupture for AAA <5.5 

cm is 1 percent or less. Among individuals refusing or medically unfit for surgical intervention, 

the 1 year rupture risk may exceed 10 percent in AAA >6 cm and for AAA of >8 cm, the risk 

may exceed 25 percent at 6 months. 
4 

 For patients with small AAA (<5.5 cm), two high-quality RCT (n=2,226), the Aneurysm 

Detection and Management study (ADAM)9 and the United Kingdom Small Aneurysm Trial 

(UKSAT)10 demonstrated that early/immediate OSR of AAA did not reduce all-cause mortality 

compared with active surveillance and delayed OSR. After a mean followup of approximately 5 

years, the overall relative risk (RR) and hazard ratio (HR) for all-cause mortality for ADAM and 

UKSAT were 1.21 [95 percent confidence interval (CI) 0.95 to 1.54] and 0.94 [95 percent CI 

0.75 to 1.17, p=0.56], respectively. Outcomes did not differ between treatment groups according 

to age, gender, or AAA diameter at baseline. After a mean followup of 8 years in the UKSAT 

study, no significant difference in mean survival was found between groups (6.5 years for 

surveillance versus 6.7 for early surgery, p=0.29) although total mortality was lower in the 

early/immediate OSR (adjusted HR was 0.83 [95 percent CI 0.69 to 1.00, p=0.05]). AAA related 

mortality was not reduced by early/immediate OSR in the ADAM study (3.3 percent vs. 3.4 

percent). In the UKSAT trial, AAA-related deaths (combined ruptured AAA, secondary AAA 

rupture, and AAA repair deaths) accounted for 19 percent of all deaths in the surveillance group 

compared to 15 percent for the early OSR group at a mean followup of 8 years. Differences in 

quality of life measures, when they existed, were small. 

 Three high-quality multicenter trials compared the outcomes of EVAR with OSR of large 

AAA (≥5.5 cm) (n = 1,489) in patients judged medically fit for OSR.11-13 Two trials provided 

data at 2 years or longer (n = 1,413).12,13 None of the studies were conducted in the United 

States. All began recruitment prior to 2000 and some EVAR devices used may not be currently 

available in the United States EVAR reduced postoperative 30-day mortality compared to OSR 

(EVAR = 1.6 percent vs. OSR = 4.7 percent RR = 0.34 [95 percent CI 0.17 to 0.65]) and hospital 

length of stay. Reduction in all-cause mortality seen with EVAR disappeared by 2 years. There 

was a persistent 3 percent reduction in AAA-related mortality. Outcomes did not differ 

significantly by treatment for either all-cause or AAA mortality according to age, gender, 

aneurysm diameter, or renal function though few women were enrolled. In EVAR-1, 

postoperative complications, included primarily EVAR graft related ruptures, infections, 

endoleaks, thrombosis, or other surgery required and re-exploration of OSR. These were five 

times more common with EVAR as with OSR (17.6 vs. 3.3 per 100 person years). The Dutch 

Randomized Endovascular Aneurysm Management (DREAM) trial reported nearly identical 

rates of severe (systemic, local-vascular/graft complications or local nonvascular complications) 

adverse event-free survival in the two groups (16.9 percent [EVAR] versus 19.4 percent [OSR] 

at year 2). The rate of survival free of moderate or severe complications was similar at two years 

(65.6 percent for EVAR and 65.9 percent for OSR). In EVAR-1, reinterventions occurred three 

times as often in the EVAR group, exceeding 20 percent at 4 years. DREAM showed a similar 

pattern in the first 9 months but then reintervention rates were roughly parallel. 

 DREAM study data on quality of life and sexual functioning favored EVAR in the early 

postoperative period, but by 6 months, scores in the OSR group equaled or surpassed those in the 

EVAR group. In EVAR-1, physical component summary scores in the Short Form-36 (SF-36) 

were lower with OSR to 3 months, with no differences thereafter. There were no differences at 

any point in the mental component summary scores. Differences at 3 months did not achieve a 

level previously determined detectable by patients. EVAR costs were higher than OSR. 

 The British EVAR-2 study was a methodologically high-quality study and the only RCT that 

evaluated EVAR versus no intervention for patients with large AAA (≥5.5 cm) and deemed 

medically unfit for OSR (n = 338). There was a 6 percent higher all-cause mortality in patients 

receiving EVAR compared with no intervention that did not achieve statistical significance (45 
5 

percent vs. 39 percent; HR = 1.21; [95 percent CI 0.87 to 1.69]). AAA rupture occurred in 4 

percent of EVAR patients and 12 percent of individuals in the no intervention group (rupture rate 

in the no intervention group = 9 per 100 person years.) There was no difference in AAA related 

mortality (12 vs. 13 percent) (HR = 1.01 [0.55 to 1.84]), although nine ruptures and six AAA 

deaths occurred in the EVAR group prior to elective repair (median time from randomization to 

EVAR = 57 days). There were no significant differences in mortality for EVAR compared with 

no intervention according to age, sex, aneurysm diameter, or renal function. The 30-day EVAR 

mortality was higher in the sicker EVAR-2 patients than those receiving EVAR who were judged 

medically fit for surgery in EVAR-1 (9 percent versus 2 percent; p <0.0001). If only elective 

EVAR cases were considered in EVAR-2 the 30-day EVAR mortality was 7 percent. Compared 

to EVAR-1 patients, there was a greater need for internal iliac artery embolization, blood 

products, renal dialysis, and longer hospital stay. 

 Approximately 55 percent of individuals with large AAA screened for trial enrollment in 

EVAR-1 and 2 were judged to be anatomically suitable for EVAR. The most commonly used 

EVAR devices in these two trials were Zenith (33-59 percent of devices) and Talent (21 to 33 

percent). Over 90 percent of EVAR devices used in these trials were aortobiiliac device systems 

commercially available in the U.K. at the time of the RCT. Aorto-aortic (tube) grafts were used 

in the majority of OSR. Selection for EVAR and OSR grafts was based on the discretion of the 

surgical team. There are no data to determine whether outcomes varied according to device type. 

The exact make and model of EVAR devices used is not known, and some may not be approved 

for use or currently available in the United States. Refinements in device, delivery systems, and 

provider experience may be associated with different outcomes in the United States than reported 

in these RCTs. 

 Forty-eight reports of lower methodologic quality than RCT (case series, nonrandomized 

controlled studies, national registries, and U.S. FDA reports) assessed clinical outcomes of 

EVAR. While it is not possible to make direct comparisons with RCT, most reports explicitly 

stated patients were candidates for OSR. Baseline patient characteristics, AAA diameter, 30 day 

and 2 year overall, and AAA mortality as well as EVAR conversion rates and secondary 

interventions for included patients were similar to those from EVAR-1 and DREAM. None of 

these reports assessed EVAR in patients with AAA ≥5.5 cm and considered “medically unfit for 

OSR” and direct comparisons cannot be made with EVAR-2. One report evaluated outcomes of 

EVAR and OSR in a “high surgical risk” subgroup of patients entered into any of five 

nonrandomized multicenter Investigational Device Exemption (IDE) studies leading to U.S. 

FDA approval of EVAR devices. Patients with AAA ≥5.5 cm were retrospectively categorized 

as “high surgical risk” based on age >60 years and having at least one cardiac, pulmonary, or 

renal comorbidity. Inclusion criteria for the IDE studies required that patients were candidates 

for OSR, though in one study patients were prospectively defined as being poor candidates for 

OSR or at high risk due to pathophysiologic conditions including creatinine >2.0 mg/dL, 

disabling COPD, ejection fraction <25 percent, stroke with residual deficit, or myocardial 

infarction within the past 6 months. Three-quarters of “high-risk” patients had only one 

comorbid category and less than one percent had all three categories.14 After 4 years, deaths 

categorized as due to AAA were similar between EVAR and OSR patients (4.2 percent and 5.1 

percent respectively (p = 0.58). Overall-survival in EVAR treated patients was 10 percent lower 

compared to OSR (56 percent vs. 66 percent) though this difference was not statistically 

significant (p = 0.23). 
6 

 Patient treatment preference according to AAA size and medical fitness for surgical 

intervention is difficult to ascertain. How the results from published RCTs influence future 

patient and provider treatment preferences in the United States is not known. 

Volume Outcomes 

 Our search did not find any adequate published studies of the relationship between hospital 

or physician volume and any outcome of EVAR. 

 There were several historical studies of the relationship between the volume of OSR done by 

hospitals and physicians to repair AAA and short-term mortality. Many of these studies 

represented practices in the 1990s when endovascular repair procedures were being developed 

and later tested in randomized controlled trials. Studies of the volume-outcome relationship for 

OSR have not been reported since the widespread adoption of EVAR in the United States. 

Nevertheless, historical studies of OSR of AAA can serve to inform the design of future studies 

of EVAR. Studies of OSR have not determined why hospital volume appears to be related to 

short-term mortality. Surgeon volume and surgeon specialty may explain a large portion of the 

commonly observed inverse relationship between the volume of OSR done by hospitals and 

short-term mortality. Very low-volume hospitals often appear to have higher mortality; however, 

data from low-volume providers is highly variable and statistically imprecise. No previous study 

carefully controlled all the key risk factors that might confound these observational studies, 

especially the characteristics of the aneurysms that will be important in studies of EVAR. The 

type of endograft might be another important factor in studies of EVAR outcomes. The one study 

of OSR that was able to control for preoperative clinical measures did not find a significant 

association between hospital volume and mortality. Very low-volume hospitals often appear to 

have higher mortality; however, data from low-volume providers is highly variable and 

statistically imprecise. Thus, future studies of EVAR volume in relation to outcomes must strive 

to take all important covariates into account, and consider the imprecision of outcome data for 

low-volume providers. Two studies suggested that the volume effect for OSR was relatively 

consistent in subgroups of patients with different preoperative risks of death.15,16 However, 

studies of EVAR should not assume that any volume-outcome relationship will be constant 

across subgroups of patients. Arbitrary cutpoints for hospital volume that were associated with 

lower adjusted mortality ranged from 17 to 100 AAA repairs per year in studies of OSR. 

Investigators used a variety of measures of volume and mortality and did not attempt to analyze 

their data to find a threshold(s) for the volume effect. If studies of volume-outcome relationships 

for EVAR are going to be used by payers or policymakers to define volume thresholds for 

preferential referral, studies should be designed with standardized measures of volume and 

outcomes, and the nature of relationships between hospital and physician volume and outcomes 

needs to be characterized more completely. 

Costs 

 Case series focusing on hospital costs generally found that EVAR costs more to perform than 

OSR, primarily due to the cost of the prosthesis. The high cost of the EVAR prosthesis is 

partially offset by reduced hospital and intensive care unit length of stay, operating time, and 

necessity for blood transfusion relative to open surgery. More comprehensive cost analyses noted 

the higher follow-up costs for EVAR. 
7 

 None of the Markov cost effectiveness models had accurate data on the complication and 

reintervention rates associated with EVAR. Although the Michaels et al. study is based on the 

literature published through September 2004, several case series have come out since then, and 

data from midterm results of RCTs were not included.17 Results from ongoing RCTs, comparing 

EVAR and OSR for large AAA and EVAR versus surveillance for small AAA conducted in the 

United States have not yet been published. 

Data from RCTs demonstrate that for small AAA (<5.5 cm) immediate OSR costs more and 

does not improve survival compared to active surveillance and delayed elective intervention. For 

large AAA (≥5.5 cm) among patients unfit for OSR, EVAR has both greater short- and longterm costs, does not improve overall survival or quality of life beyond 1 year, and is associated 

with complications, need for reintervention, and long-term monitoring compared to OSR or no 

intervention. EVAR is associated with shorter hospital and intensive care unit length of stay, 

reduced AAA mortality, and lower 30-day morbidity and mortality, compared to OSR. 

 The cost effectiveness of EVAR relative to OSR varies by whether an institutional or societal 

perspective was taken. Third party payers and hospitals each formulate their own institutional 

perspective on costs and effectiveness that depends on the extent and duration of their 

responsibility for the financing and/or provision of the patient’s health care needs. For third party 

payers such as Medicare, hospital reimbursement levels are determined by a DRG that does not 

vary by the type of inpatient procedure (EVAR or OSR) or the cost of the prosthesis. 

Conclusions 

 AAA are associated with considerable morbidity, mortality, and health-care costs. Patients 

with AAA <5.5 cm have an annual risk of rupture of approximately 1 percent. For AAA <5.5 cm 

in diameter high-quality RCT results demonstrate that active surveillance with ultrasound and 

delayed OSR (if AAA attains a diameter of ≥5.5 cm or the patient develops aneurysm related 

symptoms) results in equivalent mortality but lesser morbidity and operative costs due to fewer 

interventions compared to immediate OSR. There are no RCTs evaluating EVAR in these 

patients. 

 Among individuals refusing or medically unfit for OSR the 1-year rupture risk may exceed 

10 percent in AAA >6 cm and for AAA of >8 cm, the risk may exceed 25 percent at 6 months. 

For AAA ≥5.5 cm and suitable for EVAR, high-quality RCTs have been conducted outside the 

United States and may have used some EVAR devices that are not approved for use in the 

United States. Their results demonstrate that, compared to OSR, EVAR is associated with lower 

perioperative morbidity and mortality and persistent reduction in AAA-defined mortality to 4 

years, though the latter may be due, at least in part, to ascertainment bias for later term cause of 

death. EVAR did not improve longer term overall survival or health status and was associated 

with greater complications, need for reintervention, long-term monitoring, and costs. 

 For the minority of patients with AAA ≥5.5 cm and judged medically unfit for OSR, one 

high-quality RCT conducted in the U.K. and with EVAR devices that may not be approved for 

use in the United States demonstrated that EVAR did not improve survival or health status and 

costs more than no intervention. 

 There are no data adequate to estimate the effect of hospital or physician volume on EVAR 

outcomes and identify a volume threshold for policymakers. A volume outcome relationship for 

OSR has been shown for surgery prior to the introduction of EVAR, but none since. 
8 

 The long-term cost effectiveness of EVAR relative to OSR is difficult to determine because 

there are no long term (>4 year) outcome data from RCT of EVAR versus OSR conducted in the 

United States using devices approved by the FDA. 

Future Research 

• Results from nonrandomized trials, case-series, or FDA reports are inadequate to 

accurately assess the relative effectiveness and safety of treatments for AAA. The highest 

priority for future research to guide clinical care is to conduct long-term RCTs in the 

United States to assess whether RCT results of EVAR conducted in Europe apply to U.S. 

settings. These include EVAR vs. OSR for AAA >5.5 cm, EVAR versus active 

surveillance for AAA <5.5 cm, and EVAR versus no intervention for AAA >5.5 cm in 

patients medically unfit for OSR. 

• Effective strategies are required to disseminate and implement the findings from 

published high-quality RCTs to patients, providers, health-care organizations, and payers. 

• Additional information on the benefits and risks of treatments in women is needed. 

• Refinements in EVAR devices, technique, and interventionist team are required to reduce 

complications and need for long-term followup. 

• Consistent/validated definitions of outcomes including AAA mortality, complications, 

and need for reintervention are required to assist clinicians, investigators, policymakers, 

and patients to evaluate relative safety and effectiveness of treatment options. In 

particular, cause of death ascertainment beyond 30 days or the initial hospitalization is 

problematic. Reducing ascertainment bias likely requires rigorous adjudication of all 

death, including use of autopsy and/or post-mortem imaging. 

• Conduct RCTs to determine whether medical therapy slows AAA enlargement or rupture. 

• Improve data submission, followup, and cause of death ascertainment in registries. 

• Improved medical management is needed for patients with large AAA considered as 

unacceptable surgical risks. 

• Specific studies of EVAR are needed to characterize the hospital and physician volumeoutcome relationship, if any. The validity of methods used to identify and count EVAR 

procedures should be examined and reported. Studies should measure volume in a 

consistent manner and focus on outcomes defined in reporting standards including 

clinical success, continuing success, complications, and return to preprocedure activity 

levels. Risk adjustment should include patient demographics, comorbidity, morphology 

of the aneurysm and access vessels, device characteristics, and any other variables that 

could have a substantial influence on the outcomes under investigation. Rigorously 

developed and tested regression models and examination of the sensitivity of results to 

the method of analysis would be useful. Most likely, representative prospective registries 

will be needed to perform a proper indepth analysis to determine whether and how the 

volume of endovascular procedures done by hospitals or physicians to repair AAA relate 

to beneficial or adverse outcomes. Ideally, future studies would strive to characterize the 

functional form of volume-outcome relationships and explain why they exist. The 

volume-mortality relationship for OSR of AAA needs to be reexamined in the EVAR era. 

• Future cost analyses studies should include short- and long-term followup data, either 

collected prospectively on all patients or incorporated from RCTs into Markov models. 
9 

• A standardized approach to analyzing costs and effectiveness associated with the two 

procedures is recommended. Studies should explicitly describe the methods used to 

calculate costs and should include the following categories: direct medical care costs, 

institutional overhead costs, patient travel costs, and patients’ time and/or lost earnings. 

The collection of these costs should be carefully itemized and described. 

• Studies conducting prospective data collection in the United States taking a societal 

perspective are needed. Where appropriate, data on the patient’s time taken off work or 

other activities to travel and attend medical appointments, whether on an inpatient or 

outpatient basis, and to obtain prescriptions are needed. 

• Data on United States patient’s Quality of Life (QOL), where the treatment of the QOL 

associated with lost earnings and death is explicitly stated, should also be collected. 
Evidence Report

13 

Chapter 1. Introduction 

Overview 

 An abnormal bulging of the abdominal aorta, called an abdominal aortic aneurysm (AAA) is 

a potentially serious condition that can lead to death if it ruptures. An AAA is considered present 

when the maximum diameter of the aorta below the renal arteries (infrarenal AAA) expands to 

exceed 3.0 cm. In the United States rupture of AAA accounts for approximately 9,000 deaths 

annually.1 Another 30,000-40,000 patients undergo elective surgical repair of asymptomatic 

AAA to prevent rupture, with perioperative mortality ranging from 2-8 percent.2,3 Death due to 

AAA rupture or repair is the thirteenth leading cause of death in the U.S. and tenth among older 

men.4,5 

 The majority of AAAs remain asymptomatic for years, though the risk of rupture increases 

with AAA size. Immediate death can result and mortality remains between 40 and 60 percent, 

even when emergency care and repair are undertaken. Management options are primarily based 

on patient’s life expectancy and AAA size and include no treatment, active surveillance and 

delayed repair, immediate open surgical repair (OSR), and endovascular repair (EVAR). 

 Recent recommendations for AAA screening in high-risk populations along with emerging 

endovascular methods for repair have led to increased interest in evaluating the effectiveness and 

adverse effects of treatment options for patients with AAA. 

Question 1: What are the comparative effectiveness and adverse effects of treatment options of 

AAA including active surveillance, open repair, and endovascular repair? 

Question 2: What is the relationship of volume, both hospital and physician, to the benefits and 

harms of endovascular procedures to repair AAA? 

Question 3: How do the characteristics of the AAA (size/location/shape) and the patient 

(age/gender) affect the benefits and harms of EVAR and OSR? 

Question 4: What are the costs-benefits for each of the procedures? 

Background 

 The prevalence of AAA found in population-based ultrasound screening studies ranges from 

4.2-8.8 percent in men and 0.6-1.4 percent in women.18 Risk factors for AAA include age, 

history of regular smoking, family history of AAA, coronary artery disease, hypertension, 

hypercholesterolemia, and cerebrovascular disease. The overall prevalence of AAA greater than 

3.0 cm in “never smokers” ranges from less than 0.2 percent in ages 50-54 to nearly 3 percent in 

ages 75-79. For “ever smokers” the prevalence ranges from approximately 1 percent to 7 percent 

across these age groups. Smoking status is also a risk factor for AAA mortality. Negative risk 

factors for AAA prevalence include female gender, diabetes, and black race. 

 In a study of 73,451 mostly male U.S. veterans ages 50-79 who did not have a history of 

AAA, 7.1 percent had an AAA defined as an infrarenal aortic diameter of ≥3.0 cm on ultrasound. 

More than 90 percent of AAA were considered small (<5.5 cm) and only 0.4 percent were ≥6.0 

cm. With each 1 cm decrease in diameter, the number of AAA of that diameter or larger more 

than doubled.19 Most aneurysms noted at autopsy were small and asymptomatic and therefore did 
14 

not require intervention during the patient’s lifetime. However, the natural history of AAA is 

progressive enlargement. Non-invasive prevention of growth and rupture is primarily limited to 

smoking cessation and blood pressure control, though the use of aneurysmal pharmacotherapy 

has recently received attention.20 Because as many as one in three AAA eventually rupture if left 

untreated18 and only 10 to 25 percent of individuals with ruptured AAAs survive through repair, 

diagnostic and treatment goals are to identify individuals with AAA and target effective 

treatments possessing low interventional morbidity towards individuals at high risk of rupture. 

 A recent report from the U.S. Preventive Services Task Force (USPSTF) addressed screening 

for AAA.18 The review identified four good or fair quality population-based AAA screening 

trials; all conducted outside of the U.S. All trials had ORs favoring an association between an 

invitation to attend screening and a reduction in AAA-related deaths. Pooled analysis of trials 

showed a reduction for men in AAA-related mortality (OR, 0.57 [CI 0.45 to 0.74]). The 5-year 

outcomes of AAA screening by smoking history in a cohort of 100,000 men 65-74 years of age 

demonstrated that 155 AAA deaths could be prevented by screening and elective OSR 138 (89 

percent) in “ever smokers.” Meta-analysis of the trials demonstrated a nonsignificant reduction 

in all-cause mortality (OR, 0.98 [95 percent CI 0.95, 1.02]). The evidence report and the 

USPSTF concluded that “population screening for AAA in men ages 65-74 years appears to 

reduce AAA-related mortality. Treatment is associated with significant risks for operative deaths 

and complications. These risks, however, may be acceptable to men with AAAs greater than 5.5 

cm.”18,21 Additionally, the USPSTF review of four relevant cost-effectiveness studies of AAA 

screening yielded an estimated cost-effectiveness ratio of population-based screening compared 

with no screening that was in the range of other cost effective preventive services.22

Recommendations for selected screening are likely to lead to increased AAA detection and 

intervention, particularly of the more prevalent small AAA. Management of AAA will therefore 

take on increased importance in the future. 

 The total volume of elective AAA repairs has increased for both OSR and EVAR.23 Vascular 

surgeons who repair AAA utilizing both endovascular and open techniques have experienced an 

increase in aneurysm referrals, while those who have not adopted endovascular skills have seen a 

decline.24 Practitioners in interventional radiology, cardiovascular surgery, general surgery, and 

peripheral vascular surgery are receiving training and purchasing the equipment specifically 

required to perform AAA endografting. These can include attending 1-3 month training courses 

at a cost of $30,000 and purchasing portable fluoroscopy units that cost approximately 

$250,000.24

 Because the risk of rupture is strongly related to AAA size, management options are 

generally based on AAA size (small <5.5 cm vs. large ≥5.5 cm) and patient’s operative risk 

(medically fit for OSR versus medically unfit) determined by age and comorbidities. OSR has 

been considered the gold-standard for prevention of AAA rupture and death. However, it has the 

mortality risk of major vascular surgery with perioperative complications of about 32 percent 

including myocardial ischemia, respiratory failure, renal failure, ischemic colitis, spinal cord 

ischemia and prosthetic graft infection, as well as the cost of this procedure.22 Therefore, 

management options that would be equally effective in preventing AAA rupture and prolonging 

survival, with lower morbidity and similar or reduced health care costs, have been sought. 

 There are no established criteria for determining acceptable medical fitness for OSR. 

Because risk factors for AAA include smoking, advanced age, and hypertension, individuals 

considered candidates for OSR frequently are elderly and have multiple comorbidities including 

cardiac, pulmonary, or renal disease. Decisions about whether a patient is an acceptable OSR or 
15 

EVAR candidate are determined by the perioperative team and incorporate the severity as well as 

the presence of comorbidities, AAA morphology, the individual surgeon/medical center 

threshold for acceptable medical fitness and assessment of whether outcomes vary according to 

gender, AAA, or device characteristics. 

 As reviewed by others,25-27 several studies have observed that, on average, in-hospital 

mortality was inversely associated with the number (volume) of AAA OSR procedures done by 

hospitals. The mortality appeared to be particularly high for very low volume providers 

decreasing and eventually leveling off as volume increased. Despite substantial improvement in 

survival, volume continued to be inversely associated with short-term mortality. In-hospital case 

fatality rates for OSR in Michigan were reduced from 13.6 percent in 1980 to 5.6 percent in 

1990.28 In California, the in-hospital mortality rate decreased from 11.9 percent to 4.5 percent 

from 1982 to 1994.29 Nevertheless, the volume of procedures done in hospitals continued to be 

inversely associated with mortality in these studies as was originally observed by Luft et al, who 

analyzed hospital discharge data from 1974-1975.30

 Given repeated findings of a relationship between volume and mortality for OSR, one might 

hypothesize that a volume-outcome relationship exists for EVAR as well. Like OSR, EVAR is a 

technically demanding procedure with inherent risks. However, volume-outcome relationships 

vary by type of procedure and are not found for all procedures.30,31 Patient selection criteria, 

technology, operator skills, and processes of care for endovascular repair differ from open 

surgical procedures and continue to evolve. Different types of physicians, including 

interventional radiologists with different training and experience, may be involved in 

endovascular repairs. As demonstrated elsewhere in this report, short-term mortality is less with 

EVAR compared to OSR.6,32,33 Indeed, the 30-day mortality after EVAR now might be less than 

2 percent, making it more difficult to detect relationships to hospital or operator volume. 

 Discussions about cost effectiveness usually begin with a belief that a given approach confers 

a benefit. The question then is how the cost of achieving that benefit compares to other effects 

that a similar investment could pay for. Some of the benefits of EVAR appear to occur early in 

the care process, e.g., fewer complications, reduced hospital length of stay (LOS), etc. Hence 

they have value primarily where early return to work is crucial. These outcome measures are 

typically presented as the cost per quality adjusted life year (QALY). 

 The costs of AAA repair include preoperative costs, hospitalization costs associated with the 

initial procedure, the costs of the EVAR prosthesis (i.e., graft), and subsequent post operative 

surveillance, interventions, hospitalizations, and drug treatment. EVAR requires longer term and 

more intensive monitoring than open repair. OSR of AAA incurs the costs of the surgical team as 

well as perioperative hospital care. OSR is considered to have greater and more severe early 

morbidity than EVAR. OSR could result in a longer and more costly length of hospital stay and 

subsequent greater duration of impaired functional status and quality of life. However, late 

complications, including rupture, have been rare after open repair. Thus, radiologic, laboratory, 

and clinician evaluation and costs beyond the perioperative period (approximately 3 months) in 

the absence of symptoms are minimal. 

 The main questions in the elective management of AAA are: (1) at what diameter to offer 

elective repair and (2) do EVAR devices provide a safe and effective treatment option. 

Additional questions relate to whether outcomes are associated with surgical or medical center 

volume or OSR or EVAR performed and the relative cost and cost-effectiveness of various 

options. 

17 

Chapter 2. Methods 

Topic Assessment and Refinement and Literature Review 

 We began the review process conferencing with the Agency for Healthcare Research and 

Quality (AHRQ) and the nominee partner (AHIP) to clarify the project scope and background 

information. Clinical experts representing areas of vascular surgery, internal medicine, AAA 

epidemiology, diagnosis and treatment, and systematic review methodology served as members 

of a technical expert panel (TEP) (Appendix A∗

.) TEP comments and suggestions clarified the 

conceptual framework and refined study questions used for the project. Based on our initial 

conference calls, we developed a comprehensive work plan that covered an assessment and 

refinement of study questions and proposed literature search and review, inclusion/exclusion 

criteria, and methods for evaluating the quality of studies and reporting the evidence. 

Analytic Framework 

 An analytic framework was developed that assessed the key questions. The framework 

describes the logic chain that should be supported by evidence linking management options for 

AAA to improved outcomes. It takes the perspective of adults presenting with an asymptomatic 

AAA based on AAA size (small [<5.5 cm] vs. large [≥5.5 cm]) and patient operative risk 

(medically fit for surgery vs. medically unfit for surgery). 

Question 1. What are the comparative effectiveness and adverse effects of treatment options of 

AAA including active surveillance, open repair, and endovascular repair?

 Periodic surveillance, typically with abdominal ultrasound, has been considered reasonable 

for those with abdominal aortas measuring 3.0-3.9 cm because their risk of rupture is considered 

very low. For AAA 4.0-5.4 cm in diameter (small AAA) the question existed of whether 

immediate OSR, compared to ultrasound surveillance with delayed OSR, improves AAA-related 

mortality and all-cause mortality. For individuals with an AAA >5.5 cm, immediate OSR has 

been recommended, provided the patient is considered medically fit for OSR.34 

 In 1997, prior to widespread adoption of EVAR, there were an estimated 37,000 OSRs of 

intact AAA in the United States.35 During OSR, a vascular graft, comprised of a non-textile 

synthetic material or a woven synthetic textile that is usually sealed with collagen, gelatin, or 

albumin is sutured into the aorta. The proximal anastomosis is an end-to-end type and the distal 

anastomosis is located on the aortic bifuracation, the iliac bifurcations, or the common femoral 

arteries. Results from several long-term followup studies of individuals undergoing elective OSR 

for AAA have indicated that the risk of late complications, including secondary rupture, is quite 

low. In the absence of symptoms, additional evaluation of patients who received OSR is not 

typically performed. 

 However, in-hospital mortality rate for repair of intact AAA found in the National Inpatient 

Sample of community hospitals was 4.2 percent.4

 In-hospital plus 30-day mortality associated 

with AAA repairs in the elderly fee-for-service Medicare population was estimated to be 5.6 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
18 

percent in 1999. Because of perioperative mortality and morbidity (which are likely higher in 

older/sicker patients), individuals who were considered medically unfit for OSR due to 

comorbidities and/or advanced age previously underwent no attempt to repair the aneurysm. 

However, the risk of rupture can be as high as 25 percent per year for AAA with diameters 

greater than 6 cm.36

 EVAR consists of the placement of a graft across the aneurysm and fixation to the normal 

aortic and iliac wall with stents at both ends. Endovascular access is via a transfemoral or 

transiliac artery approach with the aim of excluding the aneurysm by this graft. The theoretic 

benefit of EVAR versus OSR is based on the belief that EVAR has lower early morbidity, length 

of hospital stay, and mortality. Additionally, EVAR may provide long-term effective prevention 

of AAA rupture, equivalent or increased overall survival, and improved quality of life compared 

to OSR. These potential benefits of EVAR must be balanced with the need for periodic longterm followup, later-term device failures or complication, need for reinterventions, and costs. 

 The first report of endoluminal treatment of AAAs in a clinical setting was in 1990.37 By 

2001 the estimated number of EVAR in the United States each year exceeded 12,000.38 An 

estimated 40-80 percent of AAA could be amenable to endovascular grafting based on aneurysm 

size, morphology, and patient surgical risk characteristics.39,40

 EVAR has involved at least 16 different devices, but only four gained FDA approval and are 

currently in use in the United States: Cook Incorporated (Zenith); Gore (Excluder); Medtronic 

(AneuRx); and Endologix (Powerlink). A fifth device, Guidant (Ancure) is no longer available 

but was used in published reports that are included in this report. Others are, or will soon be, 

applying for FDA approval including (Talent, Quantum, ENOVUS (formerly Trivascular), and 

Anaconda).41 Each device has specific criteria and recommendations regarding the anatomic 

suitability of an individual patient for a particular graft type. However, one published accepted 

contraindication to EVAR is a proximal infranal neck either shorter than 15 mm or absent. Other 

anatomic features include excessive vascular tortuosity or angulation, calcification, or 

circumferential thrombus. None of these criteria are fixed and often vary by center, 

interventionalist, and device. There are numerous design and delivery issues unique to each 

device. The details, available on the FDA websites: (Gore Excluder: www.fda.gov/cdrh/mda/ 

docs/P020004.html; Cook Zenith: www.fda.gov/cdrh/MDA/DOCS/p020018.html; Guidant 

Ancure: www.fda.gov/cdrh/mda/docs/ p990017s030.html; Endologix PowerLink: www.fda.gov/ 

cdrh/mda/docs/p040002.html, and Medtronic AneuRx: www.fda.gov/cdrh/pdf/p990020.html), 

are beyond the scope of this project. However, because certain aneurysm characteristics may be 

associated with additional patient factors, device selection, and clinical outcomes, it is difficult to 

accurately assess differential rates of outcomes among graft types. 

 Typically, EVAR devices are modular and allow modification (including selection of size 

and configuration) by the surgeon or radiologist at the time of placement based on patient, 

provider, and aneurysm criteria. The most common configurations of endovascular devices now 

used in the treatment for AAA are the aortobiiliac and aortouniilliac devices. Early developed 

aorto-tube grafts are no longer marketed in the United States. The endograft is radio-opaque with 

prespecified markers to aid positioning under fluoroscopic guidance and subsequent radiologic 

monitoring. It is composed of fabric or expended polytetrafluroethylene, and metal stents and 

comes loaded in a delivery system. Under fluoroscopic guidance, this introducer system is fed 

through the iliac arteries by means of catheters and guidewires until the endograft is positioned 

correctly at the top and bottom of the aneurysmal segment. Removal of the introducer system 

allows the fixing devices to attach with hooks, radial force/friction, column stiffness, or other 
19 

anchors to the aortic wall and hold the graft in place, excluding blood flow from the aneurysm 

sac and removing pressure from the aneurysm wall. 

 Imaging guidelines for AAA repair with endovascular stent grafts have been published.42

These include preprocedural, intraprocedural, and postprocedural imaging and are more 

extensive than recommended for OSR. The details are beyond the scope of this report. However, 

two imaging modalities have been recommended no more than 6 months prior to the planned 

procedure in order to 1) detect or confirm, 2) measure AAA, or 3) evaluate the suitability of the 

patient for EVAR. Additionally, preoperative evaluation is required because during the 

procedure it may be determined that EVAR is not possible or complications may result, 

necessitating OSR. 

 Recommended preprocedure imaging modalities consist of Thin-Cut Helical/Spiral CT 

Arteriography (CTA) with multiplanar reconstruction and catheter angiography. The goals of 

intraprocedural imaging are: (1) to guide and document the appropriate placement of the 

endovascular stent graft and (2) to evaluate the effectiveness of the stent graft in excluding the 

AAA. Fluoroscopy and catheter angiography have been considered necessary and sufficient in 

the vast majority of cases. The goals of postprocedural imaging are to (1) confirm and 

redocument the appropriate placement status of the stent graft, (2) better assess the effectiveness 

of the stent graft in initially excluding the AAA (detecting flow in the sac), (3) follow the longterm fate and size of the AAA sac and ensure its stability, (4) detect stent graft failure, and (5) 

better characterize and follow patients with endoleaks. Current imaging modalities include plain 

films of the abdomen, CTA, and catheter angiography. The first two have been recommended 

every 6 months for at least 2 years and CTA annually thereafter (or more frequently if symptoms 

or device related problems develop). Catheter angiography is not recommended if CTA findings 

are satisfactory. Excellent technical results are initially characterized by a perfectly canalized 

blood flow and later by a completely retracted aneurysm wall around the endograft. EVAR use 

has increased, in part because it is postulated to be less invasive than open repair, results in 

reduced procedural morbidity, mortality, and hospital and other health care costs, while 

improving health related quality of life and providing equivalent long-term disease-specific and 

overall survival to OSR. 

 Additionally, EVAR may alter the threshold for intervention among individuals because 

EVAR may be considered an effective and relatively safe option compared to (1) surveillance 

among individuals with small (≥5.5 cm) AAA in whom the risk of rupture was previously 

considered too low to justify the morbidity of OSR and (2) no treatment for individuals with 

large AAA who are judged unfit for surgery due to advanced age or coexisting medical 

conditions and thus have a risk of rupture-related death that is relatively low compared to 

mortality from OSR. 

 EVAR has been associated with unique complications not associated with OSR. These can be 

related to the device, patient, AAA morphology, or interventionalist. Complications unique to 

EVAR include stent migration, stent wire fracture, metal fatigue, and endoleak. Because of the 

potential for these complications to arise and cause serious medical problems or require 

reintervention, long-term monitoring, following EVAR with CTA, is currently standard practice. 

 Endoleak is defined by the persistence of blood flow outside the lumen of the endoluminal 

graft but within the aneurysm sac as determined by an imaging study. An endoleak is evidence of 

incomplete exclusion of the aneurysm from the circulation. While causes and classifications 

vary, they may result from an incomplete seal between the endograft and the wall of the blood 
20 

vessel, an inadequate connection between stent components, fabric defects, or porosity or 

retrograde blood flow from patent aortic side branches.8 Some endoleaks may resolve 

spontaneously. However, some persistent endoleaks are capable of repressurizing the aneurysm 

sac and have been associated with late rupture and need for subsequent interventions. Ruptures 

have been observed in the absence of endoleak. This concept of elevated pressure within the 

aneurysm sac has been called endotension. Table 1 provides a classification of endoleak. 

Table 1. Classification of endoleak43

Type Cause of Perigraft Flow 

I a) Inadequate seal at proximal end of endograft 

b) Inadequate seal at distal end of endograft 

c) Inadequate seal at iliac occluder plug 

II Flow from visceral vessel (lumbar, IMA, accessory renal, hypogastric) without 

attachment site connection 

III a) Flow from module disconnection 

b) Flow from fabric disruption 

 Minor (<2 mm) 

 Major (≥2 mm) 

IV Flow from porous fabric (<30 days after graft placement) 

Endoleak of undefined origin Flow visualized but source identified 

Literature Search and Review Strategy 

 

 A literature search was conducted using PubMed®, Cochrane Library, FDA, and other 

electronic websites from 1990 to October 2005, as well as handsearching of references from 

retrieved articles and contact with content experts. The following terms were included: 

abdominal aortic aneurysm, endovascular repair, surveillance, and surgery. Titles and abstracts 

of identified references were reviewed using standardized data abstraction sheets. The number of 

excluded studies and reasons for exclusion were noted. Studies meeting preliminary eligibility 

criteria were retrieved in full for further assessment and data extraction. (See Appendix B∗

 for 

Exact Search Strings and Appendix C for Lists of Excluded References.) Data extraction forms 

included information related to study and patient characteristics, interventions, and outcomes. 

Study Eligibility and Extract Data 

 

 Studies were eligible if they were randomized controlled trials or natural history studies 

involving AAA, open repair, endovascular repair, or active surveillance and reported clinically 

relevant outcomes (Figures 1 and 3 on pages 27 and 29). We also included and updated a 

systematic review of evidence of EVAR vs. open repair for AAA published online and in 

manuscript form by the U.K. National Institute of Clinical Excellence (NICE). Data from 

nonrandomized studies and device-specific data available on the FDA website as submitted by 

manufacturers to the FDA were included to assess relevance and consistency to the United 

States. This included a report submitted by the Society for Vascular Surgery and published 

online in April 2006.14

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
21 

Outcomes 

 Outcomes were described as effectiveness (initial clinical success ≤30 days or during initial 

hospitalization), short-term (30 days to 6 months), midterm (6 months to 5 years), long term (>5 

years), and adverse effects. These were based on recommendations for reporting of outcomes for 

open and EVAR by the Society for Vascular Surgery.8 The primary outcome was midterm allcause mortality. Additional clinical outcomes included initial all-cause mortality, AAA 

mortality, AAA rupture, quality of life, and technical measures of EVAR and OSR success. 

Adverse events included treatment related mortality and morbidity (graft rupture, migration, and 

kinking) and need for additional interventions (including OSR). Incidences of endoleaks were 

also noted. Because data from RCT represent level one evidence, their results were emphasized 

and reported separately from reports using other study designs. Results from the United States 

that evaluated EVAR approved and available in the United States were highlighted for nonRCT 

data. 

 Quality of studies, reduction of bias, and strength of evidence. The methods of Schulz et 

al. were used to assess the quality of randomized controlled trials (RCT).7

 We determined 

whether intention-to-treat analysis was utilized, whether results varied by intention-to-treat or per 

protocol analysis, and whether published RCT used EVAR devices similar to those approved and 

available in the United States. We evaluated whether effectiveness of interventions varied 

according to patient, aneurysm, or device characteristics including age, race, gender, EVAR 

device manufacturer and characteristics (name, tubular, mono or bi-iliac), aneurysm size (small 

[<5-5.5 cm] vs. large aneurysm) or medical fitness for OSR. Data from nonrandomized studies 

were included to assess relevance and consistency to practice in the United States. All data were 

extracted by trained data extractors onto standardized, piloted forms (Appendix D∗

). 

Question 2. What is the relationship of volume, both hospital and physician, to the benefits 

and harms of endovascular procedures to repair AAA?

History of the relationship between hospital volume and operative mortality for OSR. 

 Volume is believed to be a proxy for one or more structures or processes of care that 

influence outcomes. However, the structure and processes of care responsible for the volumeoutcome relationship in cases of OSR of AAA have not been firmly established. Experience and 

greater availability of resources in higher volume hospitals could lead to better structure, patient 

selection, and pre-, intra-, and post-operative processes of care as well as more capable surgeons 

and support staff. The relationship between hospital volume and survival after OSR of AAA also 

might depend, in part, on surgeon volume and the type of surgeon (vascular, cardiothoracic, 

general). Some low-volume providers could perform operations only as necessary or in 

emergency situations that increase the risk, and a single death could greatly influence the 

mortality rate of low volume providers. 

 Conversely, hospitals that somehow achieve better outcomes or those that have a surgeon 

who specializes in vascular surgery could get more referrals. High volume itself might generate 

more referrals because information about volume may be more readily available to the 

community than outcome information. Some providers might be associated with a poor outcome 

and get fewer referrals. Thus, to some extent, outcome could drive volume rather than vice 

versa.44,45 Selective referrals could be augmented by recent policies of purchasers such as the 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
22 

Leapfrog Group who encouraged preferred use of hospitals in urban areas that perform more 

than 30 repairs of AAA per year in an effort to improve outcomes.46 

 Policymakers have already used studies of the volume-outcome relationship to set thresholds 

for preferential referral for OSR. The Leapfrog definition of ‘high’ volume was based on an 

investigation that was judged to be the single best report in the literature at the time.47 This 

investigation analyzed 3,419 repairs of unruptured AAA done in 116 Veterans Affairs (VA) 

hospitals (>99 percent male patients) from 1991-1993.48 Repairs of intact AAA were identified 

by Patient Management Category algorithms applied to ICD-9-CM codes recorded on discharge 

abstracts. The validity of this method of case identification wasn’t reported. Unadjusted inhospital mortality was 4.2 ± 3.5 percent in hospitals that performed 32 or more repairs versus 6.7 

± 7.8 percent in hospitals performing fewer than 32 repairs. The basis for selecting 32 as a cutoff 

was not reported, although it was the mean hospital volume. However, 22 so-called low-volume 

hospitals had zero mortality in 267 patients. In addition, the published report does not clearly 

state whether the volume categories were per annum as defined by Leapfrog or over the entire 3-

year period of study. Furthermore, many of the operations might have been performed by 

surgical residents in training. Given these limitations, this study is not adequate for defining a 

hospital volume threshold for the United States. Investigators only recently demonstrated that 

hospital volume measured in one time period is related to outcomes in a subsequent period of 

time.49 The Leapfrog criterion for a high volume hospital has been increased to 50 or more 

procedures per year.50 It is not clear whether this count includes endovascular procedures to 

repair of AAA or whether the data used to define this threshold represent a period of time before 

FDA approval and widespread use of endovascular devices. 

 Adoption of endovascular procedures to repair AAA. The FDA approved the first devices 

for EVAR in September 1999. A separate International Classification of Diseases procedure 

code for EVAR was issued in October 2000. By 2001 approximately 36 percent of the repairs of 

intact AAA were coded as EVAR procedures in the National Inpatient Sample of 986 nonfederal community hospitals in 33 states.51 Those undergoing EVAR rather than OSR tended to 

be older males with higher prevalence of hypertension and ischemic heart disease and less renal 

insufficiency or peripheral artery disease.52 Between May 2001 and September 2003 

approximately 38 percent of AAA repairs were coded as endovascular procedures in the VA 

medical centers. Discharge data from 234 accredited hospitals in Illinois indicated that EVAR 

was used in approximately 32 percent of all (unruptured and ruptured) AAA cases in 2002.53 The 

proportion of AAA repairs done by EVAR was less in women than men. In-hospital mortality for 

elective EVAR was 2.3 percent in this series of cases from 1995 to 2003, and higher in women 

than men (5.1 percent vs. 1.7 percent unadjusted for risk or length of stay). 

 Hospital discharge data representing non-federal hospitals in New York indicated that 40 

percent of all repairs of intact AAA in 2001 were EVAR, increasing to more than 50 percent in 

2002.54 There was a corresponding increase of more than 20 percent in the number of hospitals 

performing EVAR. Compared to patients undergoing OSR, patients having EVAR were older 

and more likely to have coronary artery disease, hypertension, hyperlipidemia, and diabetes 

mellitus. In 2002, 60 hospitals in New York performed EVAR. Nearly half did five or fewer 

procedures, while 12 hospitals did 30 or more. In-hospital mortality rates were 1.9 percent and 

0.8 percent respectively. This small difference in mortality was not statistically significant given 

the relatively small number of hospitals. Furthermore, risk adjustment was not done because the 

database did not contain patient or physician identifiers, information about the severity of comorbidities, or information about the aneurysms that were repaired. 
23 

Rationale for a volume-outcome relationship for endovascular repair of AAA. There is 

some evidence of a learning curve for EVAR of AAA. One practice at a tertiary facility analyzed 

277 consecutive cases treated from 1994 to 1998 and estimated that approximately 55 cases were 

required before their technical success rate leveled off at 88 percent.55 Custom-made endografts 

were used in two-thirds of these procedures prior to the availability of commercial bifurcated 

modular endografts for investigational use in 1997. The surgical team and patient selection 

criteria remained stable during the period of observation, although it is likely they were not 

trained to perform EVAR and learned as they were developing new procedures and devices. 

Thus, their experience should not be extrapolated to current EVAR practices where trained 

physicians use approved devices with less problematic designs. The same referral practice 

compared 30 procedures done as part of a clinical trial to 230 cases done after FDA approval of 

the device. Technical success was achieved in 97 percent and 98 percent of these cases. 

However, procedural complications such as endoleaks, contrast-induced azotemia, access site 

hematoma, and limb occlusions increased from 11 percent to 18 percent. The increase in 

complications was attributed not to poorer proficiency over time, but rather to a greater degree of 

anatomical and morphological difficulty of the cases being referred and treated after FDA 

approval.56

 European registry data were grouped according to cumulative experience in 93 hospitals 

from 1994 to 2000. The EVAR procedures (n=2,863) were grouped as the first 11 performed at a 

center, cases 12-37, 38-91, and 92 and higher. Unadjusted mortality after 30 days was the same 

(3-4 percent) in all four groups.57 There were differences in smoking status, vascular 

morphology, and types of devices used in the four groups with initial patients appearing to have 

greater risk. Co-morbidity was not reported. The adjusted hazard of death during continued 

followup was lower in quartiles three and four (i.e., after 38 cases) compared to first quartile 

representing early experience. The adjusted hazard ratio for secondary interventions for 

endoleaks, migration, kinking, thrombosis, stenosis, and rupture was lower in all other quartiles 

compared to the most inexperienced case quartile. The amount of bias present in these 

comparisons due to differences in patient selection and censoring (initial cases followed much 

longer) is not clear. A more recent report based on this registry suggested that devices for earlier 

EVAR procedures might explain the influence of experience on midterm outcomes.58 This 

observation highlights the importance of analyzing data that represent current devices and 

clinical practices in the United States rather than foreign data on devices that are not being used 

in the United States. 

 One should not assume there would be a relationship between EVAR volume and outcome 

just because there is a learning curve. When development of a new technique is fairly complete, 

teachers can greatly facilitate learning by experience. Measures of hospital and physician volume 

typically used in studies are not cumulative counts beginning with initial experience. In fact, 

volume is often measured during a specified time period ignoring prior experience. Therefore, 

typical volume measures may reflect a provider’s ability to maintain rather than learn skills and 

effective processes of care. The volume needed to maintain processes of care, skills, and optimal 

outcomes after a learning curve levels off is not known. 

 Several randomized controlled trials have required that a certain number of EVAR be done 

by investigators prior to enrolling patients, but the threshold definitions vary. The EVAR trials 

required investigator centers to perform at least 20 AAA repair procedures before enrolling 

patients, whereas investigator teams in the DREAM trial had to have done at least five 

procedures.12,59 The Veterans Administration Open Versus Endovascular Repair (OVER) trial 
24 

requires a vascular surgeon or interventional radiologist who has performed at least 12 

endovascular procedures.60 Thus, investigator experience required for participation in clinical 

trials has varied. The bases for these volume criteria were not reported. 

Analytical issues. Outcome measures that are based on a smaller number of cases (i.e., low 

volume) exhibit greater random variation. One is less confident that the outcome measured for 

low volume providers represents their true or long-term performance. A minimum number of 

cases per provider is sometimes required to help assure the outcome measurements aren’t too 

unreliable. Regression analyses that weight data points by their variance can help avoid placing 

undue emphasis on outcomes measured in low-volume providers. Regression analyses generally 

assume that the variation in outcome measures is homogeneous across all levels of a predictor, 

which is generally not true when volume is used to predict outcomes. Data transformation, such 

as taking the logarithm of outcome measures, might make this assumption more tenable. 

Furthermore, the influence of each hospital or physician on the estimated volume-outcome 

relationship estimated by regression analysis should be examined. 

 Patients treated at the same hospital or by the same surgeon may be more likely to have 

similar outcomes than if the patients were treated by different providers. Thus, outcomes might 

not be truly independent of each other as is assumed by regression analyses that use the patient 

as the unit of analysis. This so-called clustering with hospitals and physicians reduces variation 

in outcomes compared to what would be observed with truly independent measurements. 

 General estimating equations can be used to calculate confidence intervals and p-values that 

take clustering into account.61 This analytical approach is difficult when the outcome data are 

clustered within more than one variable, e.g., hospital and surgeon volume, and when the size of 

the clusters, i.e., volume, is correlated with the outcome. In addition, the resulting estimate of 

relative effects such as an odds ratio is an aggregate or population averaged estimate specific to 

the mix of clusters in the analysis. Alternatively, random-effects regression models that consider 

clusters, i.e., hospitals or surgeons, as random variables can account for clustering in the data. 

Small clusters (low-volume providers) can complicate this approach. Clustering within surgeons 

and hospitals could be analyzed by hierarchical random-effects models if surgeons don’t operate 

at more than one hospital. If a surgeon(s) represents most of the volume at a hospital, the surgeon 

and hospital volume will be redundant measures, making it difficult to estimate their separate 

effects on outcomes. Thus, different methods of analysis of the same data might not produce the 

same estimate of the effects of volume on outcomes. The method of analysis is an important 

consideration when comparing studies. Multiple methods of analysis could be employed to see if 

the results are sensitive to the method of analysis. 

 The adequacy of risk adjustment is questionable in retrospective studies of databases that did 

not prospectively collect data on known risk factors. Known risk factors for operative mortality 

for AAA repairs include the urgency of the operation, presence and severity of renal dysfunction, 

ischemic heart disease and its treatment with beta-adrenergic blockers and statins, heart failure 

and chronic obstructive pulmonary disease, advanced age, being female, and several 

characteristics of the aneurysm such as its diameter and juxtarenal position.52,62 Unmeasured risk 

factors could be particularly important for low-volume providers. One unrecognized high risk 

case can greatly affect the outcomes, and if the variable that made the case high risk wasn’t 

measured, the increased risk would not be controlled. Omission of influential covariates can bias 

estimates of volume-outcome relationships even if they are balanced across groups. Thus, it is 

important to examine the risk factors that were taken into consideration in analyses. 
25 

 All studies of the relationship between provider volumes and outcomes used regression 

models to analyze the data. Therefore, it is important to know how well the model fits the data 

and how well the model discriminated the outcomes, such as death or survival. A model with 

poor discrimination suggests that key risk factors were not measured, hence controlled, in the 

analysis. The c-statistic is commonly used to examine model discrimination. A c-statistic equal 

to 1 indicates perfect discrimination whereas a value of 0.5 indicates the model was no better 

than random predictions of outcomes. 

Search Strategy for Pertinent Publications 

The MEDLINE® database was searched for publications about volume-outcome 

relationships for procedures to repair AAA that were published after 1990 when endovascular 

procedures for repair of AAA became available, at least to investigators. Key words included 

abdominal aortic aneurysm, volume, outcome, and process assessment health care. Reference 

lists were searched for additional reports (Figure 2 on page 28). 

Study Inclusion and Exclusion Criteria 

Articles that met the following criteria were reviewed to summarize study methods and 

characterize volume-outcome relationships. 

• The report had to be an original analysis of data representing repair of unruptured AAA 

in the endovascular era beginning in 1990. 

• The report had to represent practices in the United States. 

• The sample had to represent variation between hospitals or surgeons in a community or 

larger geographic area, thereby excluding single site cases series. 

• The report had to present sample statistics (e.g., percentages, odds ratios) representing the 

relationship between a measure of hospital or physician volume and any good or bad 

outcome associated with AAA repair. 

• The analysis had to attempt to make adjustments for known risk factors in an effort to 

reduce bias. 

 Health care systems, physician training, clinical care processes, and procedures to repair 

AAA have evolved, thus older and foreign data might not represent current practices or 

outcomes in the United States. Since health care practices including patient selection criteria, 

referral patterns, and types of devices sold outside the United States could differ from the U.S. in 

important ways, this review was restricted to studies within the U.S. This restriction corresponds 

with the presumed interests of U.S. insurance companies that requested this evidence review. 

Furthermore, inclusion of foreign studies would not address the limitations of U.S. studies, 

would create concern about extrapolating foreign results to the United States, and would not alter 

the conclusions of this review. More recent recommendations in the United States to seek out 

higher volume hospitals could be altering the volume-outcome relationships. In addition, 

adoption of EVAR in recent years most likely has altered the characteristics of cases being 

surgically repaired, and perhaps the volume-outcome relationship. This review focused on 

available data that represented practices and outcomes in the United States in the 1990s and 

beyond. 
26 

Data Extraction 

 All published analyses regressed an outcome of AAA on retrospectively defined volume 

measures. A single unblinded reviewer abstracted information from each study to characterize 

(1) the study population including the time period and geographical region, (2) volume measures, 

(3) outcome measures, (4) regression model including covariates used for risk adjustment and 

handling of clustering of patients within hospitals or surgeons, and (5) adjusted and unadjusted 

estimates of volume effects. 

Data Analysis 

The preponderance of evidence for relationships between the volume of procedures 

performed by hospitals and physicians to repair AAA and outcomes has been obtained by 

secondary regression analysis of administrative databases. Methodological differences make it 

difficult to compare results from the different studies. For example, investigators defined hospital 

and physician volume in a variety of ways, often using arbitrary categorizations with varying 

reference groups. Use of variables to control for pre-procedure risk (case-mix), physician 

training, and health care system attributes varied. Analytical methods varied as well. Therefore, 

we did not attempt to do a meta-analysis to combine estimates from different studies. This 

review was limited to tabulation of individual study characteristics and results. 

Question 3: How do the characteristics of the aneurysm (size/location/shape) and the patient 

(age/gender) affect the benefits and harms of endovascular and open-surgical repair? 

 It is not known whether patient, aneurysm, provider, or device characteristics differentially 

affect treatment success rates. As discussed above, patient factors including age, gender, and 

comorbidities may not only affect the prevalence and size of AAA but also the risk of AAA 

rupture and/or operative/EVAR related complications. As noted in Question 1, AAA 

morphology including size, vascular angulation, size of the aortic neck, and/or involvement of 

renal or iliac vessels may alter the feasibility of repair options and influence outcomes. 

Literature Search Strategy and Eligibility Criteria 

A literature search strategy was conducted similar to question 1 (Figures 1 and 3 on pages 27 

and 29). Emphasis was placed on studies that provided comparative effectiveness of one 

treatment strategy versus another (especially RCT), conducted in the United States, used devices 

currently available in the United States, and provided information on clinical outcomes 

according to AAA size, location, shape, patient age, gender, or race. We updated a systematic 

review by NICE63 with emphasis on results from RCTs or studies conducted in the United States. 

Outcomes 

Data regarding study, patient, and device characteristics, as well as outcomes, were extracted. 

Outcomes were described as effectiveness (initial clinical success ≤30 days or during initial 

hospitalization); short-term (30 days to 6 months), midterm (6 months to 5 years), and long-term 
27 

(>5 years); and adverse effects based on recommendations for reporting of outcomes for open 

and EVAR by the Society for Vascular Surgery.8 The primary outcome was midterm all-cause 

mortality. Additional outcomes included initial all-cause mortality, AAA mortality, AAA 

rupture, quality of life, and technical measures of EVAR, and OSR success. Adverse events 

included treatment related mortality and morbidity including endoleaks, graft rupture, migration, 

kinking, and need for additional interventions, including OSR. Specific characteristics of AAA 

and patient included: 1) AAA size (small <5.5 cm; large ≥5.5 cm), shape (sacular vs. fusiform), 

extension (into iliacs); 2) patient age (<65 vs. ≥65), race (White, Black, Hispanic, other); gender; 

and 3) device manufacturer and type. 

Quality of studies, reduction of bias, and strength of evidence. We used the methods of 

Schulz et al. to assess the quality of RCT.7

 We attempted to assess whether the effectiveness of 

interventions varied according to patient, aneurysm, or device characteristics including age, race, 

gender, EVAR device manufacturer, aneurysm size (<5.5 cm vs. ≥5.5 cm), or aneurysm location. 

No study quality measures were used for manufacturer submitted data available on the FDA 

website. We described how patients, AAA, EVAR characteristics, and outcomes compare with 

those from RCT. 

Question 4: What are the costs-benefits for each of the procedures? 

 From the perspective of cost, different audiences have different concerns. Traditional 

economic analysis focuses on the cost to the economy of delivering each element of service. 

However, policy makers may be more interested in the payments they must underwrite than in 

the economic cost of a procedure. These costs vary somewhat depending on the health care 

system. For example, in the United States, where Medicare pays for hospital care using a DRG 

payment approach, differences in the costs of the prosthesis/graft or even in lengths of stay are 

irrelevant for Medicare because they are all folded into the overall rate paid. However, those 

differences are very salient to hospitals that must bear them. Likewise in the United Kingdom, 

working under the National Health System, issues of hospital efficiency are quite important. 

 The analysis becomes even more complex if a differential survival rate exists across 

treatments. Unless the results can be expressed in terms like QALYs, which capture both quality 

of life and survival, the estimated benefit may be exaggerated by comparing quality of life only 

among survivors. 

 The classic approach would be to estimate the difference in outcomes across treatments and 

then divide that by the difference in costs. However, in the case of AAA repair, the outcomes 

seem to be generally equivalent over the long term. The real difference lies in the short term. 

 EVAR is considered less invasive and may result in shorter in-hospital and intensive care 

unit length of stay compared with open repair. However, there are additional costs associated 

with EVAR. These include the high costs the stent device (which has accounted for over 50 

percent of the total in hospital EVAR costs in one analysis) diagnostic cost, primarily because of 

increased imaging costs with EVAR, and professional fees.64 Pre and intraprocedural imaging 

are more extensive with EVAR than open repair. Because of the concern related to EVAR 

complications or failures, long term radiologic monitoring is required. The complexities of and 

recommendations for conducting cost-effectiveness analyses comparing treatment options for 

AAA have been described.22,65 
28 

Search Strategy Methods 

We adopted the search strategy used by the AHRQ report on AAA screening.22 Our search 

was conducted within MEDLINE®. Key search terms included abdominal aortic aneurysm 

combined with economics, nursing economics, pharmaceutical economics, cost, 

pharmacoeconomics, cost analysis, cost allocation, cost-benefit analysis, cost control, cost 

savings, cost of illness, cost sharing, “deductibles and coinsurance,” medical savings accounts, 

health care costs, direct service costs, drug costs, employer health costs, hospital costs, health 

expenditures, capital expenditures, hospital economics, hospital charges, hospital costs, medical 

economics, or medical fees. We focused on studies reporting on the cost associated with either 

procedure, EVAR, OSR, or both. This strategy yielded 27 articles published between 2000 and 

2005. Six of these studies were eliminated from the analyses as they contained less than 50 

patients in either arm of the study (i.e., EVAR or OSR).66-71 Of the remaining 21 articles, 12 

reported on a comparative analysis of EVAR and OSR, two reported on EVAR and Conservative 

Management (CM) (one of which also reported on EVAR and OSR), three on EVAR only, two 

on OSR and CM, and three on OSR only (Figure 4 on page 30). 
29 

Search results = 247 references 

241 references remaining for 

abstract checking 

Excluded: duplicate citations = 6 

references 

16 references (6 studies) included

DREAM = 5 references 

UKSAT = 4 references 

ADAM = 3 references 

EVAR1 = 2 references 

EVAR2 = 1 reference 

Cuypers = 1 reference 

Excluded: 

Not RCTs = 95 references 

Not EVAR vs open or 

surveillance trials = 108 

references 

Not English language = 21 

references 

No outcomes of interest = 1 

reference 

Figure 1. Flow Chart: Question 1—RCTs 
30 

Figure 2. Flow Chart: Question 2—Volume 

Search results = 25 references 

6 references remaining for 

inclusion 

Excluded (from information in 

abstract or title) = 19 

references 

9 references (8 studies) 

included 

Additional references for 

inclusion (from other sources) 

= 3 references 
31 

Figure 3. Flow Chart: Question 3—nonRCTs 

Selected from Drury review = 47 

references 

60 references included 

Additional references for 

inclusion from other sources 

[Lifeline and RETA registries, 

FDA information, updates of 

earlier studies] = 13 

references
32 

Search results = 150 references 

17 references remaining for 

inclusion 

Excluded (from information in 

abstract or title) = 133 

references 

21 references included

EVAR vs open = 11 references 

EVAR vs surveillance = 1 

reference 

EVAR only = 3 references 

Open vs surveillance = 2 

references 

Open surgery only = 3 

references 

EVAR vs open and EVAR vs 

surveillance = 1 reference 

Additional references for 

inclusion (from other 

sources) = 4 references 

Figure 4. Flow Chart: Question 4—Cost 
33 

Chapter 3. Results 

Question 1: What are the comparative effectiveness and adverse effects of treatment options of 

AAA including active surveillance, open repair, and endovascular repair? 

Natural History of AAA 

 Observational studies have assessed the rupture rate of AAA according to diameter and other 

risk factors among patients followed by surveillance. The results of seven recent studies that 

assessed the average rate of enlargement and risk of rupture of AAA according to initial or 

attained size are summarized. Studies were selected, in part, because they represent patients with 

AAA size or medical conditions where the decision for early intervention is controversial (e.g., 

small AAA (<5.5 cm) or patients with large AAA (≥5.5) but considered medically unfit for 

OSR). For individuals with large AAA that are considered OSR candidates, the more relevant 

question is not based on rupture rate in the absence of intervention but rather on the comparative 

effectiveness of EVAR vs. OSR. Estimates for AAA rupture or enlargement in an individual may 

be more variable than the average estimates obtained from these studies. 

 A population-based study of residents of Rochester, Minnesota, with AAA documented by 

ultrasound reported on enlargement rate and risk of rupture. Of 181 patients, 103 had more than 

one ultrasound. The diameter of the AAA increased by a median of 0.21 cm/year. The risk of 

rupture over 5 years was 0 percent for the 130 patients with an initial AAA <5 cm in diameter 

and 25 percent for the 46 patients with AAA ≥5 cm.72 Among variables examined, including age 

and sex, only the size of the AAA at initial ultrasound was associated with subsequent rupture. A 

1 cm larger initial diameter was associated with an approximately 50 percent increase in the 

adjusted rupture risk. There was no significant association with risk of rupture in relation to the 

rate of change in size, though the confidence intervals were wide. 

 An evaluation of 166 patients with small AAA detected by screening reported an annual 

rupture rate of 0.7 percent for AAA of 3.0 to 4.4 cm and 1.7 percent for AAA 4.5 to 4.9 cm. 73

When patients who underwent elective OSR due to growth rate or attained size were included, 

the risk of rupture or elective OSR was 2.1 percent and 10.2 percent respectively. An additional 

report demonstrated that the risk of rupture was very low (2 of 256 patients per year) for AAA 

<5 cm, even if they grew 1.0 cm or greater per year.74

 Three studies9,75,76 used results from patients recruited for RCTs of immediate OSR versus 

active surveillance and delayed OSR of small AAA to determine the rate of, and risk factors for, 

rupture of AAA under surveillance. A cohort of 2,257 adults was comprised of patients enrolled 

in the UKSAT and the associated study for patients ineligible or refusing randomization. After 3 

years the annual rate of AAA rupture was 2.2 percent. The risk of rupture was associated with 

female gender, larger AAA diameter, mean blood pressure, and current smoking. Additional 

analyses assessed the risk of rupture and last known or estimated AAA diameter categorized as 

≤3.9 cm, 4.0 to 4.9 cm, 5.0 to 5.9 cm and ≥6.0 cm. The number of ruptures per 100 patient-years 

increased from 0.3 for AAA <3.9 cm to 1.5 for AAA 4.0 to 4.9 cm and 6.5 for AAA 5.0 to 5.9 

cm. Individuals with AAA ≥6.0 had few person-years of followup because most underwent OSR. 

The mean diameter preceding rupture was smaller in women (5.0 ± 0.8 cm) than men (6.0 ± 1.4 

cm; p = 0.001). In the surveillance group of UKSAT, the median aneurysm growth rate was 0.33 

cm per year (Inter Quartile Range of 0.20-0.53). 
34 

 In the surveillance arm of the ADAM trial, the rate of rupture was 0.7 percent per year. Of 

these ruptures, two were incidental findings at the time of elective repair. Median rate of increase 

in diameter according to first and last Computed Tomography (CT) readings was 0.32 cm per 

year (interquartile range = 0.16 to 0.42 cm). The only significant predictor of increased rate of 

enlargement was a larger initial diameter and the absence of diabetes.9

 The expansion rates and outcomes for men with very small AAA (3.0 cm to 3.9 cm) found 

by ultrasound scanning were assessed at five VA Medical Centers participating in the ADAM 

trial.76 More than 90 days after the initial screening 790 men had AAA meeting the eligibility 

diameter and had at least one repeat ultrasound scan. The average followup period was 3.9 years, 

mean AAA size = 3.3 cm and the median expansion rate = 0.11 cm/year. No expansion was 

observed in 25 percent of patients and moderate expansion (defined as >0.4 cm/year) was noted 

in 8.9 percent of the overall group. There were no reported AAA ruptures during the study 

period. However, the cause of death was available in only 43 percent of patients. Therefore, 

misclassification or lack of assessment could lead to underreporting of AAA rupture and death. 

In patients with initial AAA of 3.0 to 3.4 cm, only 23 of 578 (4 percent) had expansion to ≥5 cm 

and 1.2 percent had OSR. Among 212 men with an AAA of 3.5 to 3.9 cm, 14 percent had 

expansion to ≥5 cm and 6.6 percent had OSR. 

 The risk of rupture of large AAA has been poorly understood because most patients with AAA 

≥5.5 cm undergo early elective repair. Three studies provided information on patients with large 

AAA who were considered unfit for OSR or refused OSR. In 1998 Jones reported on rupture rates 

in a cohort of patients with a large AAA considered unfit for OSR.77 The annual rupture rate was 

12 percent for AAA of 5.0 to 5.9 cm and 14 percent for AAA ≥6 cm. 

 Lederle and colleagues reported on the rupture rate of large AAA (mean = 6.6 cm) in a 

cohort of 198 veterans who refused or were considered unfit for elective OSR.36 Outcome 

ascertainment was complete for all patients (almost all men) with a 46 percent autopsy rate 

among the 112 patients who died; 40.2 percent had a probable AAA rupture. The 1-year 

incidence of probable rupture by initial AAA diameter was 9.4 percent for AAA of 5.5 to 5.9 cm, 

10.2 percent for AAA of 6.0 to 6.9 cm, and 32.5 percent for AAA ≥7.0 cm. Among patients who 

attained an AAA diameter exceeding 8.0 cm, 25.7 percent ruptured within 6 months. In 

multivariate analysis diameter of the AAA was the strongest predictor of rupture (RR = 1.39 per 

1 cm). The median rate of change in AAA diameter was 0.43 cm per year. In multivariate models 

the rate of change was a nearly significant predictor of probable rupture when last measurement 

of AAA diameter was also included (RR per 0.1 cm per year = 1.07; 95 percent CI, 0.99-1.15). 

 The EVAR-2 study was a RCT comparing EVAR to no intervention in 338 patients ≥60 

years of age with AAA >5.5 cm and considered medically unfit for OSR. Patients enrolled in the 

no intervention arm (n=172, though 27 percent underwent intervention to exclude the AAA, 

including 12 cases of OSR) provide information regarding rupture rates in medically unfit 

patients at a median followup of 2.4 years. Mean AAA diameter was 6.3 cm. Crude rupture rate 

in the no intervention group was 9.0 per 100 person years (95 percent CI 6.0-13.5) with a median 

time to rupture of 98 days. The rupture rate was lower than in the report by Lederle.36 Overall, 33 

percent of patients died, with mortality attributed to AAA rupture occurring in 12 percent. 

 In summary, the strongest known predictor of rupture is initial or attained AAA diameter. 

The rate of enlargement has not been consistently independently associated with rupture rates. 

Evaluating rupture rates based on size or enlargement is complicated by the fact that many 

patients with larger or more rapidly enlarging AAA receive elective intervention in the absence 

of symptoms due to concern of rupture and subsequent poor outcomes. 
35 

 The annual risk of rupture is 1 percent or lower for AAA less than 5.5 cm. These individuals 

are very unlikely to benefit from elective interventions even if there is low operative morbidity. 

The 1-year risk of rupture increases with AAA size and may exceed 10 percent in individuals 

with AAA >6 cm who are judged medically unfit for OSR. AAA of this diameter comprise fewer 

than 1 percent of AAA detected in screening programs. For AAA that attain a size of >8.0 cm, 

the risk may exceed 25 percent at 6 months. Based on estimates of rupture risk in the absence of 

intervention, the potential risks and benefits of early OSR or EVAR can be weighed. 

Elective Immediate OSR Versus Active Surveillance for Small 

Aneurysms (4.0 to 5.5 cm) 

 Two randomized trials (n=2,226), one in the United States and the other in the United 

Kingdom, assessed whether immediate elective OSR decreases AAA and overall mortality for 

patients with small AAA (4.0-5.5 cm), compared to active surveillance with OSR delayed for 

prespecified AAA conditions: ADAM9 and the UKSAT.10 Both studies had similar eligibility 

requirements and criteria for intervention in the active surveillance group. An RCT conducted in 

Canada was ended prematurely due to inadequate recruitment and reported no outcomes. 

 Two trials evaluating early EVAR compared with surveillance have begun recruitment. The 

Positive Impact of endoVascular Options for Treating Aneurysms earLy (PIVOTAL), a multicenter randomized trial, is scheduled to enroll 1,700 patients with AAA 5.0 cm or less in 

diameter.78 The Comparison of surveillance versus Aortic Endografting for Small Aneurysm 

Repair (CAESAR) trial has a target enrollment of 740 patients with AAA between 4.1 and 5.4 

cm.79

Baseline Characteristics (Appendix E∗, Table E1) 

 Baseline characteristics and a description of the study protocol are shown in Appendix E, 

Table E1. ADAM randomized 1,136 patients fit for elective OSR with an AAA between 4.0 to 

5.4 cm in diameter out of a total of 5,038 patients screened and referred for recruitment. The 

majority of patients excluded had AAA outside the eligible parameters, severe comorbid 

conditions, or were judged to be unlikely to adhere to the study protocol. Patients were 

randomized to immediate OSR (n=569) or to undergo surveillance (n=567) by ultrasonography 

or computed tomography (CT) every 6 months. Patients in the surveillance group were followed 

without repair until: 1) AAA reached 5.5 cm in diameter; 2) enlargement of AAA by at least 0.7 

cm in six months or 1.0 cm in 1 year; or 3) the development of symptoms attributable to the 

AAA by the attending vascular surgeon. 

 Enrolled patients were ages 50 to 79 years with a mean age of 68 and a baseline mean AAA 

diameter by CT scan of 4.7 cm. Comorbid conditions included hypertension (56 percent), 

coronary artery disease (42 percent), and diabetes (10 percent). Past or current smoking status 

was greater than 90 percent. Patients were overwhelmingly male and white race. 

 UKSAT randomized 1,090 out of 1,276 eligible patients with non-tender infrarenal AAA 

between 4.0 to 5.5 cm. Patients fit for elective OSR were randomly assigned to early OSR 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
36 

(n=563) or ultrasonographic surveillance (n=527). OSR in the surveillance group was 

recommended if patients met the following criteria: (1) AAA exceeded 5.5 cm in diameter; (2) 

enlargement of AAA >1.0 cm per year; (3) AAA became tender; or (4) iliac or thoracic repair of 

an aneurysm was needed. Patients had a mean age of 69 years (range 60 to 76) and a mean AAA 

diameter of 4.6 cm. The majority of patients were male (83 percent) and 37 percent were current 

smokers. Hypertension was prevalent in 38 percent, ischemic heart disease in 40 percent. Over 

90 percent of patients had a history of tobacco use with 37 percent still smoking. 

Followup and Treatment 

 The mean duration of followup was 4.9 years for ADAM and 4.6 years for the initial report 

of the UKSAT. Additional analysis of the UKSAT provided results at a mean followup duration 

of 8 years (range 6-10). In both trials approximately 60 percent of patients randomized to active 

surveillance underwent OSR sometime during the trial. The vast majority of delayed OSR were 

because AAA achieved predetermined criteria; typically AAA size >5.5 cm. In ADAM, AAA 

repair was performed in 93 percent of patients in the immediate OSR group, 72 percent within 6 

weeks after randomization. In the active surveillance group, 62 percent of patients in the 

surveillance group had undergone AAA OSR by the end of the trial, and 9 percent were 

performed despite the fact that participants did not meet study criteria for OSR. Rate of repair in 

the surveillance group increased with the size of the aneurysm at baseline. Four years after 

randomization, 27 percent of AAA that had measured 4.0 to 4.4 cm at baseline had OSR as 

compared with 81 percent of those with baseline AAA 5.0 to 5.4 cm. 

 In UKSAT, 92 percent assigned to early repair had undergone OSR by the end of the trial 

and 87 percent within 5 months of randomization. Within the surveillance group, 62 percent had 

undergone repair, (82 percent of all delayed OSR were done according to protocol). The median 

time to surgery was 2.9 years. At the 8 year mean followup period, an additional 1 percent in the 

early repair group and 12 percent in the surveillance group had AAA repair. Treatment between 

the initial and longer followup report did not necessarily adhere to protocol. Approximately one 

of five patients in the surveillance group (105 of 527) died without undergoing AAA repair. 

Results 

Mortality (Tables 2 and 3 on pages 42 and 43 and Appendix E∗, Table E2) 

All-cause mortality. Early/immediate OSR of AAA did not significantly reduce all-cause 

mortality compared with surveillance in either trial. After a mean followup of approximately 5 

years, 27 percent of patients randomized to early OSR had died compared with 25 percent of the 

surveillance and delayed OSR group. Comparing immediate OSR to surveillance, the RR of 

death in the ADAM trial was 1.21 [95 percent CI 0.95 to 1.54] and the HR for the UKSAT was 

0.94 [95 percent CI 0.75 to 1.17, p=0.56]. After a mean followup of 8 years, the adjusted hazard 

ratio was 0.83 [95 percent CI 0.69 to 1.00; p <0.05] with an estimated 7.1 and 8.3 deaths per 100 

patient years for the early repair and surveillance groups, respectively. 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
37 

 In UKSAT (but not ADAM) mortality within the first 6 months of randomization was 

significantly higher in the early repair group compared with patients in the surveillance group 

(HR of 2.52 [95 percent CI 1.20 to 5.33] and absolute risk difference of 3 percent) (Appendix E∗

, 

Table E2). The 30-day mortality rate was approximately 6 percent for patients who underwent 

elective OSR and did not vary by time of repair. After 3 years, mortality was higher in the 

surveillance group in UKSAT but not ADAM. At the 8 year followup period, the mean duration 

of survival in the early OSR group was 6.7 years compared to 6.5 years for the surveillance 

group. Despite a mortality of 2.7 percent within 30 days of surgery or during hospitalization, the 

immediate OSR group of ADAM had lower cumulative survival compared to the surveillance 

and delayed OSR throughout the followup period. Independent predictors of death included 

higher serum creatinine level, lower weight, diagnosis of Chronic Obstructive Pulmonary 

Disease (COPD) or diabetes, larger AAA diameter, lower forced expiratory volume in one 

second, and nonuse of a beta-blocker. 

Aneurysm-related mortality and rupture. (Table 2 on page 42) Aneurysm-related 

mortality was not reduced by early/immediate repair in the ADAM study (3.3 percent vs. 3.4 

percent) but as defined differently in UKSAT was lower in the long-term followup report (7.5 

percent vs. 11.4 percent. 

 In ADAM, 0.4 percent in the immediate OSR group and 1.9 percent in the surveillance group 

had AAA rupture. UKSAT assessed AAA rupture and death from OSR. The latter was defined 

as occurring within 14 days of OSR. The total rupture rate was 1.6 percent per year in the first 5 

years of followup and 3.2 percent per year in the subsequent 3 years. Four percent of patients (8 

percent of all deaths) in the surveillance group study died due to ruptured AAA compared to 1.8 

percent (4 percent of all deaths) in the early OSR group after 8 years of followup. 

 Aneurysm related mortality in UKSAT, defined as deaths due to ruptured AAA, secondary 

AAA rupture, or AAA repair accounted for 19.3 percent vs. 15.3 percent of all deaths in the 

surveillance and early OSR groups respectively. Death associated with aneurysm-related 

disorders following OSR occurred in 19 patients, 15 in the surveillance group compared to four 

in the early repair group (p <0.001). Of these 19 deaths, three resulted from secondary AAA 

rupture, four from aortoduodenal fistula, and 12 from a ruptured thoracic aortic aneurysm. The 

risk of rupture was four times as high among women as among men. Additionally, fatal ruptures 

were more common in women than men; resulting in 14 percent of deaths for women versus 5 

percent of deaths for men (p = 0.001). However, deaths for women from any cause were similar 

in the two treatment groups (8.4 percent versus 7.3 percent respectively; p = 0.99). 

 All-cause mortality according to diameter of aneurysm, age, gender, and smoking 

status. (Table 3 on page 43) Both trials reported no benefit from early OSR of AAA <5.5 cm in 

diameter or in any subgroup of patients defined by aneurysm diameter at entry. In UKSAT the 

reported test of interaction was not significant (p = 0.28) across AAA size or age (p = 0.18) or 

gender (p = 0.40). Calculated risk differences, reported relative risks and tests for interaction 

from ADAM were not significant and had point estimates favoring surveillance. In UKSAT, the 

overall death rate for patients who continued to smoke was 12.0 per 100 patient-years compared 

to 3.8 per 100 patient-years for patients who no longer smoked. However, these results were not 

reported according to randomized treatment assignment. 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
38 

 Operative and in-hospital mortality. The age and sex adjusted 30-day and in-hospital 

operative mortality did not differ in either the UKSAT or ADAM trial between patients receiving 

immediate OSR or those initially managed with surveillance but receiving delayed OSR. In 

UKSAT the 30 day operative mortality was 5.8 percent in the early repair group versus 7.1 

percent in the group initially managed with surveillance (p = 0.30). In-hospital mortality was 5.8 

percent and 7.2 percent respectively. Direct comparisons of these percents should be done 

cautiously because of differences between groups at the time of surgery in terms of age, 

aneurysm size, and number of tender or ruptured AAA at the time of OSR. In the ADAM study 

both the 30-day and in-hospital mortality were below 3 percent in the immediate OSR group and 

the surveillance group. Thus the finding in ADAM of no survival benefit with early OSR was 

found despite a low total operate mortality in the immediate repair group. 

Complications of OSR (Appendix E∗, Table E3) 

 AAA-related hospitalizations (besides those for the elective OSR) occurred more than twice 

as often for patients undergoing immediate OSR (44.8 percent) versus those randomized to 

surveillance (22.7 percent). Major complications of OSR with no operative death of unruptured 

AAA occurred in 4.5 percent of immediate repair patients and 7.6 percent of patients in 

surveillance who underwent delayed OSR. More than 50 percent of patients in either group who 

underwent OSR experienced “any complication.” Rehospitalizations for complications were 

slightly higher for early OSR versus surveillance (20.5 percent versus 16.5 percent). Late graft 

failure occurred in less than 0.5 percent of patients in either arm. 

Rupture and Enlargement of Small Aneurysms in Patients Kept Under 

Ultrasound Surveillance 

 After nearly 5 years of followup, there were 25 and 14 total ruptures in UKSAT and ADAM, 

respectively. In ADAM, there were 12 ruptures in the surveillance group, resulting in eight 

deaths, yielding a rupture rate of 0.7 percent per year of followup of unrepaired aneurysms. The 

mean risk of rupture in the UKSAT study was 1.0 percent per year. The rate of aneurysm 

enlargement was 0.32 cm (interquartile range (IQR) 0.16 to 0.42) and 0.33 cm (IQR 0.20 to 0.53) 

per year for the ADAM and UKSAT surveillance groups, respectively. After 8 years of 

followup, UKSAT assessed total rupture rates (including AAA ≥5.5 cm and non-fatal ruptures) 

for two time periods. The total rupture up to the end of the trial was 1.6 percent per year and 

during the final 3 years of followup the rate was 3.2 percent per year (p = 0.008). 

 UKSAT investigators assessed risk factors associated with AAA rupture in 2,257 patients 

enrolled in the UKSAT or an associated study who were kept under ultrasound surveillance (data 

not shown in tables).75 In addition to UKSAT participants, eligible patients analyzed had aortic 

diameter <4.0 cm (n=507), or ≥5.5 cm (n=100), refused randomization (n=122), were considered 

unfit for surgery (n=340), or other reasons (n=98). Ninety-eight percent of patients had initial 

aneurysm diameters between 3-6 cm. Three-quarters of the ruptures occurred in patients with 

AAA ≥5 cm in diameter. After 3 years of followup, the annual rate of AAA rupture was 2.2 

percent (95 percent CI = 1.7 to 2.8). The risk of rupture was associated with female sex, larger 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
39 

initial aneurysm diameter, current smoking, and higher mean blood pressure. Women had a 

threefold higher risk of aneurysm rupture than men. Crude rupture rate in women was 4.6 per 

100 person years vs. 2.0 per 1,000 person years in men. 

Quality of Life (Appendix E∗, Figures E1-E3 and Appendix E, Table E4) 

 Any differences in quality of life between treatment groups were small. ADAM utilized the 

Short Form-36 (SF-36) health status questionnaire in addition to measuring impotence and 

maximal activity level. The SF-36 scores for the physical and mental subscales are shown in 

Appendix E, Figure E1. There were no significant differences in any of the subscales between 

the immediate OSR and surveillance group with the exception of general health. All subscales 

showed a significant decrease throughout the followup period regardless of treatment group. The 

general health score was higher (p <0.001) at individual time points from 6 months to 2 years for 

the immediate OSR group. There were sporadic time point comparisons in other subscales that 

were significant, mental health at 6 months favoring immediate OSR and physical function at 5 

years and role-physical at 6.5 years favoring the surveillance group. These should be interpreted 

cautiously due to the large number of comparisons. The baseline value for physical functioning 

was determined to be an independent predictor of mortality during the study duration. 

 The prevalence of impotence by treatment arm over the study duration is shown in Appendix 

E, Figure E2. Approximately 40 percent of all patients were impotent before OSR. Following 

randomization, impotence increased in the immediate OSR group between 18 months to 4 years 

(p <0.03), with the exception of 12 months. Maximum activity level did not significantly differ 

between the study groups. A significant interaction between treatment and followup (p <0.02) 

indicated a greater decline in maximum activity level over time in the immediate repair group. 

 Health-related quality of life status for UKSAT was assessed by the Medical Outcomes 

Study short-form 20-item questionnaire. There were no significant differences between groups in 

the mean change in scores from baseline at 12 months after randomization with the exception in 

current health perceptions subscale which favored the early repair group. The weighted mean 

difference in the mean change of scores from baseline between early repair and surveillance was 

6.70 [95 percent CI 3.45 to 9.95] (Appendix E, Table E4, Appendix E, Figure E3). Within the 

surveillance group, mean score changes between baseline and 12 months after randomization for 

physical functioning, role functioning, social functioning, and bodily pain subscales decreased. 

In the early OSR group only physical functioning decreased significantly, but the health 

perceptions subscale improved significantly. 

Large Aneurysm (≥5.5 cm) Randomized Controlled Trials 

 Three RCTs that enrolled patients with AAA >5.5 cm and considered medically fit for OSR 

have been completed.11-13 None were conducted in the United States. EVAR devices used may 

not have been approved for, or are currently in use, in the U.S. Two of the trials, British 

Endovascular Aneurysm Repair-1 (EVAR-1) and DREAM, recently published midterm (2-4 

year) results. EVAR-1 and DREAM report on procedures performed from 1999-2003. The 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
40 

Cuyper’s trial objective was to compare cardiac response after EVAR and OSR. Cardiac 

complications in both groups were assessed up to 1 month postoperatively, and no long-term 

outcomes were reported. Two additional trials are undergoing recruitment, the Open Versus 

Endovascular Repair (OVER) in the U.S. and the AnEVARysme de l’aorte abdominal: Chirurgie 

versus Endoprothese (ACE) project in France. OVER has a recruitment goal of 900 and ACE is 

planning on enrolling 600 patients. The VA OVER trial will compare procedures done from 

2002 to 2007. OVER is unique in that the specific device the patient will receive if randomized 

to EVAR will be recorded before randomization, thus allowing for subgroup analysis by EVAR 

compared with randomized controls for that graft. OVER will include a cost-effectiveness 

analysis of U.S. utilization and costs. 

EVAR Versus OSR Patients Who Are Medically Fit for OSR 

 Study and patient characteristics. (Appendix E∗, Table E5). Three trials comparing EVAR 

with OSR randomized a total of 1,489 patients11-13 In the largest of the three trials, EVAR-1, 

2,068 patients were anatomically eligible for EVAR, of which 52 percent gave consent and were 

randomized. Reasons for exclusion included: 1) refusal of further assessment following initial 

screen (n=327); 2) deemed unfit for OSR after local fitness assessment and offered EVAR-2 

(n=399); and 3) refusal to participate (n=260). 

 Eligible patients had to be candidates for either OSR or EVAR based on aneurysm size (at 

least 5.0 cm) and anatomy as well as surgical risk. Over 90 percent of enrollees were male with 

an average age of approximately 70 years. Mean AAA diameter ranged from 5.4 cm in the small 

study by Cuypers to 6.5 cm in EVAR-1. More than 40 percent had a history of cardiac disease, 

10-16 percent had diabetes, and the majority a history of tobacco use. All studies reported 

analyses comparing groups by intention-to-treat. EVAR-1 reported “per protocol” results. 

Short-Term Mortality and Morbidity (Table 4 on page 44, Figure 5 on page 49, and 

Appendix E, Table E6) 

 EVAR resulted in a lower postoperative 30-day mortality compared to OSR. Pooled 30-day 

mortality was 1.6 percent for EVAR compared with 4.7 percent for OSR (Risk Difference [RD] = 

-3, 95 percent CI -5 to -1; RR = 0.34, 95 percent CI 0.17 to 0.65) (Table 4 and Figure 5). Inhospital mortality was similar, 1.9 percent for EVAR vs. 5.8 percent for OSR (RR = 0.32 [0.17 to 

0.59]). Of the nine deaths within 30 days in the EVAR group reported in EVAR-1, one occurred 

after emergency OSR for AAA rupture and one after from rupture following elective OSR. In the 

OSR group, there was one death after AAA rupture and emergency repair within 30 days. 

 DREAM reported more severe or moderate systemic operative complications for the OSR 

group, 26.4 percent versus 11.7 percent for EVAR, an absolute risk reduction of 15 percent [95 

percent CI -23 to -7]. A higher rate of pulmonary complications in the OSR group accounted for 

the majority of this difference. There were significantly more local vascular or implant related 

complications in the EVAR group, 16.4 percent compared with 8.6 percent for the OSR group 

(RR = 1.90, 95 percent CI 1.05 to 3.43). In addition, there were three conversions to OSR. 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
41 

Endoleaks and Secondary Interventions (Table 5 on pages 45-46 and Appendix 

E∗, Table E6) 

 Secondary intervention occurred in 9.8 percent of the EVAR group during primary admission 

in EVAR-1, including ten conversions to OSR and 18 endoleak corrections. The OSR group had 

5.8 percent secondary interventions during initial admission, half for re-exploration of OSR. 

Midterm Mortality and Morbidity (Table 4 on page 44, Figures 6 and 7 on pages 50 

and 51, and Appendix E, Table E6) 

 In both EVAR-1 and DREAM, reduction in all-cause mortality seen with EVAR at 30 days 

had disappeared after 2 years (Table 4 and Figure 6). Pooled all-cause mortality was similar 

between EVAR and OSR groups, 12.7 percent versus 13.2 percent (ARR = -1. 95 percent CI -4 

to 3), respectively (DREAM, EVAR-1). It is unclear whether this was just the endovascular 

group catching up on delayed deaths, or if late mortality will continue to increase with EVAR 

due to complications or failure to prevent rupture. Both studies reported some advantage for 

EVAR in aneurysm-related deaths at 2 years (Figure 7), but this may be because all early postoperative deaths (mostly open) are classified as aneurysm-related, whereas late aneurysm-related 

deaths (mostly EVAR) may be easily misclassified as something else (Table 4 and Figure 6). 

Overall, 2.5 percent of EVAR deaths were classified as aneurysm-related compared with 5.6 

percent for the OSR control, risk reduction of 3 percent [95 percent CI -5 to -1]. The EVAR-1 

trial presented results at 4 years after randomization. All-cause mortality was similar between 

EVAR and OSR, but aneurysm-related mortality continued to be significantly lower in the 

EVAR group, 3.5 percent versus 6.3 percent (ARR = -3, 95 percent CI -5 to 0). No significant 

interactions were reported for all-cause or AAA-related mortality with age, sex, AAA diameter, 

or creatinine concentration subgroups. 

 In DREAM the rate of survival free of moderate or severe complications was similar in the 

two groups at two years (65.6 percent [EVAR] versus 65.9 percent [OSR]). No details on 

specific adverse events, including graft complications were reported. No documented 

postoperative AAA ruptures were reported, although there was one possible but unconfirmed 

case.

12 

Midterm Endoleaks and Secondary Interventions (Table 5 on pages 45-46, 

and Appendix E, Table E6) 

 At 4 years after randomization, the overall rate of complications in EVAR-1 was five times 

as common with EVAR compared with OSR, 17.6 vs. 3.3 per 100 person years. However, a 

large percentage of these complications included radiographic detected endoleaks which are 

often asymptomatic and do not require a reintervention. Complications occurred in 35 percent of 

successfully completed EVAR procedures compared to 8.4 percent of OSRs completed [absolute 

risk difference of 27 percent; 95 percent CI 22 to 31] (Table 5). The most frequent complications 

were endoleak type 2 (42 percent), endoleak type 1 (15 percent), graft migration (6 percent) and 

graft thrombosis (6 percent). Reinterventions occurred three times as often in the EVAR group, 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
42 

exceeding 20 percent at 4 years in contrast to 6 percent for the OSR group. In DREAM the rate 

of reintervention after EVAR was almost three times the rate after OSR during the first nine 

months of followup. Thereafter, reintervention rates similar (Appendix E∗

, Table E6). Most 

reinterventions reported in EVAR-1 were endovascular, primarily repairing endoleaks. In the 

OSR group, reexploration of OSR was the most common re-intervention (44 percent of 

reinterventions). Overall, 14 EVAR patients required conversion to OSR, including eight 

completed after initial discharge from the hospital. 

Health Related Quality of Life (Appendix E, Figures E4-E8) 

 The DREAM study reported on quality of life (Appendix E, Figures E4 and E5) and sexual 

function from the first 153 patients who underwent randomization. The preoperative scores were 

comparable to the general population of similar age. The physical function but not mental health 

scores of the SF-36 favored the EVAR group in the early postoperative period, but by six 

months, scores in the OSR group equaled or surpassed those in the EVAR group.80,81 Similar 

findings were reported for sexual function. 

 In EVAR-1, EQ5D and SF-36 physical component summary scores were lower with OSR to 

3 months, with no differences after or at any point in the SF-36 mental component summary 

scores (Appendix E, Figures E6-E8). 

EVAR Versus No Intervention for AAA ≥5.5 cm in Patients Judged 

Medically Unfit for OSR (Appendix E, Table E7) 

Study and patient characteristics. The EVAR-2 study is the only RCT that has evaluated 

EVAR versus no intervention for AAA ≥5.5 cm among individuals judged to be medically unfit 

for OSR (Appendix E, Table E7). This study was conducted at the same clinical centers and in 

parallel with EVAR-1. It enrolled 338 patients at 31 hospitals in the United Kingdom. Each 

center had to have performed and submitted to the RETA registry at least 20 EVAR procedures. 

Patients ≥60 years of age, with AAA diameter ≥5.5 cm were considered for participation in the 

EVAR-1 trial. If they had suitable vascular anatomy for EVAR and were judged medically unfit 

for major surgery as determined locally by surgeon, radiologist, anesthesiologist, and 

cardiologist they were offered randomization to EVAR or no intervention. In general, 

unacceptable surgical risk was due to severe cardiopulmonary conditions. Nearly 90 percent of 

enrollees were men. The mean age was 76.4 years and mean AAA diameter = 6.3 cm. Local 

centers could select the graft. Zenith grafts were inserted in 59 percent of patients, Talent in 21 

percent, Excluder in 7 percent, and Aneurex in 6 percent. Bifurcated grafts were used in 87 

percent of patients. Further description of the grafts was not provided. The mean duration of 

followup was 3.3 years. One subject randomized to receive EVAR declined and 47 patients 

randomized to no intervention received treatment with EVAR (35) or OSR (12). The stated 

reason (n) for repair included rupture (2); tender AAA (11), fast AAA growth (5), became fit for 

OSR (1), patient preference (14); unknown (14). 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
43 

Overall and AAA Related Mortality (Tables 6 and 7 on pages 47 and 48 and 

Appendix E∗

, Tables E8 and E9) 

 All-cause mortality was higher in patients receiving EVAR compared to no intervention 

though not statistically so (44.6 percent vs. 39.5 percent; HR = 1.21; [95 percent CI 0.87 to 1.69; 

p = 0.25]) (Table 6). Overall mortality at 4 years for both groups combined was 64 percent 

according to Kaplan-Meier estimates (Table 7). AAA rupture occurred in 3.9 percent EVAR 

patients and 12.2 percent in the no intervention group (rupture rate in the no intervention group = 

9.0 per 100 person years.) AAA specific mortality was similar between groups (12 vs. 13 

percent) (HR = 1.01 [0.55 to 1.84]). 

 30-day mortality and treatment-related complications. Mortality within 30 days of the 

primary procedure occurred in 8.7 percent of patients assigned to EVAR and 2.1 percent among 

the 47 patients in the no intervention group who subsequently underwent either EVAR or OSR 

(Table 6, and Appendix E, Table E8). 

 Among patients having a successful EVAR (including the 12 randomized to no intervention) 

32.6 percent had a study defined post-intervention complication and 18 percent required 

reintervention (Tables 6-7 and Appendix E, Table E8). Endoleaks occurred in 18 percent of 

patients, and there was one graft rupture. The most common reason for reintervention was for 

repair of endoleaks (mostly type 1). Four-year point estimates for complications were 43 percent 

vs. 18 percent; EVAR vs. no intervention; for reintervention: 26 percent and 4 percent. 

Complications following EVAR were comparable in EVAR-1 vs. EVAR-2 patients (43 percent 

vs. 41 percent). However, the reintervention rate was higher in unacceptable surgical risk EVAR2 patients (11.5 per 100 person years) compared to EVAR-1 (6.9 per 100 person years). 

Health related quality of life. Baseline quality of life scores were lower in EVAR-2 

participants compared to EVAR-1 enrollees. There were no differences in quality of life or 

health status scores between patients assigned to EVAR versus no intervention as measured by 

the EuroQol 5-D and SF-36 questionnaires (physical and mental components) at any time point 

among patients who were still alive and completed forms. (Appendix E, Table E9). The authors 

state that because their results demonstrate that “compared to no intervention EVAR did not 

show a survival benefit, had little effect on Health Related Quality of Life, was more costly, and 

involves a continuing need for surveillance and reintervention, they did not see a need to pursue 

cost-effectiveness modeling at this time (i.e., no intervention was a dominant strategy). 

Continued monitoring of patients for an additional 6 years is planned.” 

Patient preferences. There are few data to accurately determine patient treatment 

preferences according to age, race, AAA size, and comorbid conditions. Determining patient 

preference by rates or volume of a given procedure is subject to influences by provider or 

industry. We looked at registries of patients screened for participation in RCTs of OSR versus 

surveillance and delayed OSR for AAA <5.5 cm, EVAR versus OSR for patients judged 

medically fit for OSR who have AAA ≥5.5 cm, and EVAR versus no intervention among 

individuals judged medically unfit for OSR who have AAA ≥5.5 cm. Estimating preferences by 

these methods is difficult because preferences are not known among patients refusing to be 

considered for enrollment. Additionally, in the two countries conducting EVAR trials, EVAR 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
44 

outside the RCT setting was limited. Patient willingness to participate in and receive EVAR may 

have been influenced by the opportunity to be treated with otherwise unavailable technology. 

 Among patients with small AAA and eligible for UKSAT randomization to early OSR or 

ultrasonographic surveillance, 14 percent refused randomization (reasons not stated). Among 

those randomized to early OSR 2.3 percent refused surgery. Among those randomized to 

ultrasonographic screening and delayed OSR 7.2 percent had OSR against protocol. In the 

ADAM study 2 percent eligible patients refused randomization. In the surveillance group, 9 

percent had procedures performed despite the fact that the AAA did not meet criteria for OSR 

 In DREAM, one percent declined to undergo AAA repair. One patient assigned to OSR 

crossed over to EVAR. In EVAR-1, 24 percent eligible and offered randomization refused 

randomization. Stated treatment preferences among those refusing included EVAR (32 percent), 

OSR (60 percent), no intervention (8 percent), and unknown (2 percent). 

 Patients who were eligible but refused entry into EVAR-2 were evenly divided between 

preference for EVAR and no intervention. Eight percent assigned to no intervention 

subsequently received intervention due to patient preference. Only one patient assigned to EVAR 

refused. How RCT results will influence preferences in the U.S. is not known. 
45

Table 2. Subgroup mortality for early/immediate elective repair versus surveillance of AAA randomized controlled trials 

Outcome, Trials Early/Immediate Repair, 

n / N (%) 

Surveillance Events, 

n / N (%) 

Death Rate per 100 

Patient-Year 

Mortality according to baseline aneurysm diameter: Tertile Group 1 (diameter 4.0 to 4.4 cm) 

ADAM,9 mean followup 4.9 years 37 / 174 (21.5) 32 / 197 (16.2) NR UKSAT,82 mean followup 4.6 years 63 / 214 (29.4) 53 / 213 (24.9) 7.4 ER; 6.5 S UKSAT,82 mean followup 8 years 91 / 214 (42.5) 93 / 213 (43.7) 7.1 ER; 7.4 S Mortality according to baseline aneurysm diameter: Tertile Group 2 (diameter 4.5 to 4.8 cm (UKSAT) / 4.9 cm (ADAM))ADAM,9 mean followup 4.9 years 46 / 205 (22.4) 33 / 188 (17.6) NR UKSAT,82 mean followup 4.6 years 45 / 175 (25.7) 45 / 169 (26.6) 6.3 ER; 6.8 S UKSAT,82 mean followup 8 years 73 / 175 (41.7) 78 / 169 (46.2) 6.7 ER; 7.9 S Mortality according to baseline aneurysm diameter: Tertile Group 3 (diameter 4.9 cm (UKSAT) / 5.0 cm (ADAM) to 5.4 cm (ADAMADAM,9 mean followup 4.9 years 60 / 190 (31.6) 57 / 182 (31.3) NR UKSAT,82 mean followup 4.6 years 51 / 174 (29.3) 52 / 145 (35.9) 7.4 ER; 9.5 S UKSAT,82 mean followup 8 years 78/174 (44.8) 83/145 (57.2) 7.5 ER; 10.4 S Mortality according to gender UKSAT,82 Men, mean followup 8 

years 

201 / 468 (42.9) 210 / 434 (48.4) 7.1 ER; 8.3 S 

UKSAT,82 Women, mean followup 8 

years 

41 / 95 (43.1) 44 / 93 (47.3) 7.3 ER; 8.4 S 

Mortality according to age subgroups, ADAM Age 50 to 59 years, mean followup 

4.9 years 

8 / 47 (17.0) 8 / 51 (15.7) NR 

Age 60 to 69 years, mean followup 

4.9 years 

61 / 251 (24.3) 55 / 279 (19.7) NR 

Age 70 to 79 years, mean followup 

4.9 years 

74 / 271 (27.3) 59 / 237 (24.9) NR 

Mortality according to age subgroups, UKSATAge 60 to 66 years, mean followup 8 

years 

56 / 183 (30.6) 68 / 181 (37.6) 4.7 ER; 6.1 S 

Age 67 to 71 years, mean followup 8 

years 

76 / 183 (41.5) 94 / 180 (52.2) 6.7 ER; 9.5 S 

Age 72 to 76 years, mean followup 8 

years 

110 / 197 (55.8) 92 / 166 (55.4) 10.0 ER; 9.8 S 

NR = Not reported
46

Table 3. All-cause and aneurysm-related mortality for early/immediate elective repair versus surveillance of AAA randomized c

Outcome, Trials, 

Followup Period 

Early/Immediate Repair (ER) 

Events, n / N (%) 

Surveillance Events, 

n / N (%) 

Death Rate per 100 

Patient-Year 

All-cause mortality 

ADAM,9 mean followup 4.9 

years 

143 / 569 (25.1) 122 / 567 (21.5) NR 

UKSAT,10 mean followup 4.6 

years 

159 / 563 (28.2) 150 / 527 (28.5) 7.0 ER; 7.4 S 

UKSAT,82 mean followup 8 

years

242 / 563 (43.0) 254 / 527 (48.2) 7.1 ER; 8.3 S 

Aneurysm-related mortality, ADAMAAA-related 19 / 569 (3.3) 19 / 567 (3.4) NR Thoracic aneurysm-related 2 / 569 (<1) 0 Aneurysm-related mortality, UKSAT (combined ruptured AAA, secondary AAA rupture, and AAA repair considered underlying cause o

14 days after AAA surgery)

Mean followup 8 years 37 / 242 deaths (15.3) 49 / 254 deaths (19.3) NR Mortality according to time period, UKSAT Months 0 to 6 31 / 563 (5.5) 12 / 527 (2.3) 11.4 ER; 4.6 S Months >6, mean followup 8 

years 

211 / 532 (39.7) 242 / 515 (47.0) 6.4 ER; 7.8 S 

* Repair considered underlying cause of death NR = Not reported
47

Table 4. Mortality for EVAR versus OSR of AAA randomized controlled trials 

Outcome, Trials EVAR Events, 

n / N (%) 

OSR Events, 

n / N (%) 

Risk Difference, % 

[95% CI] 

Re

Postoperative 30-day mortality Patient denominators exclude subject deaths, refusals or postponements prior to surgery. DREAM, 6 p

included in intention-to-treat populations (OSR – 1 death (prior to surgery), 3 refusals; EVAR – 1 death, 1 refusal). EVAR Trial 1, 35 patie

intention-to-treat populations (OSR – 14 deaths, 7 refusals, 2 postponed; EVAR – 1 death, 1 refusal, 1 postponed) 

Cuypers11 1 / 57 (1.8) 1 / 19 (5.3) -4 [-14 to 7] 0.33 DREAM81 2 / 171 (1.2) 8 / 174 (4.6) -3 [-7 to 0] 0.25 EVAR-113 9 / 531 (1.7) 24 / 516 (4.7) -3 [-5 to -1] 0.36 Totals 12 / 759 (1.6) 33 / 709 (4.7) -3 [-5 to -1] 0.34 

In-hospital mortality

DREAM81 2 / 171 (1.2) 8 / 174 (4.6) -3 [-7 to 0] 0.25 EVAR-113 11 / 531 (2.1) 32 / 516 (6.2) -4 [-7 to -2] 0.33 Totals 13 / 702 (1.9) 40 / 690 (5.8) -4 [-6 to -2] 0.32 

Mortality <30 days after primary operation, AAA procedure-related (elective) 

EVAR-113 7 / 532 (1.3) 23 / 518 (4.2) -3 [-5 to -1] 0.30 

Mid term (2-year) all-cause mortality

DREAM81 20 / 173 (11.6) 18 / 178 (10.1) 1 [-5 to 8] 1.14 EVAR-113 71 / 543 (13.1) 77 / 539 (14.2) -1 [-5 to 3] 0.92 Totals 91 / 716 (12.7) 95 / 717 (13.2) -1 [-4 to 3] 0.96 

Mid term (4-year) all-cause mortality

EVAR-113 100 / 543 (18.4) 109 / 539 (20.2) -2 [-7 to 3] 0.91 

Mid term (2-year) aneurysm-related mortality

DREAM81 2 / 173 (1.2) 8 / 178 (4.5) -3 [-7 to 0] 0.26 EVAR-113 16 / 543 (2.9) 32 / 539 (5.9) -3 [-5 to -1] 0.50 Totals 18 / 716 (2.5) 40 / 717 (5.6) -3 [-5 to -1] 0.45 

Mid term (4-year) aneurysm-related mortality

EVAR-113 19 / 543 (3.5) 34 / 539 (6.3) -3 [-5 to 0] 0.55 

Mid term (2-year) mortality after discharge 

DREAM81 17 / 169 (10.1) 9 / 166 (5.4) 5 [-1 to 10] 1.86 

Mid term (4-year) mortality >30 days after primary operation

EVAR-113 81 / 523 (15.5) 71 / 493 (14.4) 1 [-3 to 5] 1.08 
48

Table 5. Complications and endoleaks for EVAR versus OSR of AAA randomized controlled trials 

Outcome, Trials EVAR Events, 

n / N (%) 

OSR Events, 

n / N (%) 

Risk Difference, 

% [95% CI] 

Number of patients with postoperative 30-day mortality and severe complications (based on standards of the Society of Vascular Society for Cardiovascular Surgery) 

DREAM81 8 / 171 (4.7) 17 / 174 (9.8) -5 [-11 to 0] 

Number of patients with postoperative 30-day mortality and moderate or severe complications

DREAM81 31 / 171 (18.1) 41 / 174 (23.6) -5 [-14 to 3] Systemic complications, 

moderate/severe 

20 / 171 (11.7) 46 / 174 (26.4) -15 [-23 to -7] 

Systemic complications, 

severe 

6 / 171 (3.5) 19 / 174 (10.9) -7 [-13 to -2] 

Vascular/implant-related 

complications, moderate/ severe 

28 / 171 (16.4) 15 / 174 (8.6) 8 [1 to 15] 

Vascular/implant-related 

complications, severe 

7 / 171 (4.1) 9 / 174 (5.2) -1 [-6 to 3] 

Correction of endoleak 2 /171 (1.2) 0 / 174 Arterial/graft obstruction 11 / 171 (6.4) 5 / 174 (2.9) 4 [-1 to 8] 

Number of patients with a conversion to OSR 

EVAR-113 – Secondary 

intervention during 30 days or 

primary admission 

10 / 531 (1.9) NA 

DREAM81 3 / 171 (1.7) NA 

Number of patients with secondary interventions (during 30 days or during primary admission) 

EVAR-113 52 / 531 (9.8) 30 / 516 (5.8) 4 [1 to 7] Correction of endoleak 18 / 531 (3.4) 1 / 516 (< 1) Re-exploration of OSR NA 15 / 516 (2.9) 

Number of patients with endoleaks and postoperative complications (categories with ≥5 patients): after discharge (4 years)

EVAR-113 186 / 529* (35.1) 44 / 519* (8.5) 27 [22 to 31] Endoleak, type 1 27 / 529 (5.1) NA Endoleak, type 2 79 / 529 (14.9) NA Endoleak, type 3 8/ 529 (1.5) NAGraft rupture 9 / 529 (1.7) 0 / 519 Graft migration 12 / 529 (2.3) NA Graft kinking or endotension 12 / 529 (2.3) NA Re-exploration of OSR NA 16 / 519 (3.1) Other surgery required 13 / 529 (2.5) 16 / 519 (3.1) -1 [-3 to 1] 

Number of patients with reintervention: after discharge (4 years) 

EVAR-113 81 / 529* (15.3) 36 / 519* (6.9) 8 [5 to 12] 

Number of patients with endoleaks and postoperative complications with reintervention: after discharge (4 years)

Endoleak, type 1 17 / 529 (3.2) NA 
Table 5. Complications and endoleaks for EVAR versus OSR of AAA randomized controlled trials (continued) 

49

Outcome, Trials EVAR Events, 

n / N (%) 

OSR Events, 

n / N (%) 

Risk Difference, 

% [95% CI] 

Endoleak, type 2 17 / 529 (3.2) NA Endoleak, type 3 4/ 529 (<1) NAGraft rupture 3 / 529 (<1) 0 / 519 Graft migration 7 / 529 (1.3) NA Graft kinking or endotension 2/ 529 (<1) NA Re-exploration of OSR NA 16 / 519 (3.1) Other surgery required 13 / 529 (2.5) 16 / 519 (3.1) -1 [-3 to 1] 

* Based on the number of successful EVARs and OSRs completed NA = Not applicable 
50

Table 6. Mortality for the EVAR-2 Trial (N=338), EVAR versus no intervention (NI) of AAA 

Outcome EVAR Events, 

n / N (%) 

NI Events, 

n / N (%) 

Hazar

[95

All-cause mortality 74 / 166 (44.6) 68 / 172 (39.5) 1.21 [0.8Aneurysm-related mortality 20 / 166 (12.0) 22 / 172 (12.8) 1.01 [0.5Mortality prior to operation 14 / 166 (8.4) 57 / 172 (33.1) Mortality <30 days after primary operation. Of the 172 patients in the no intervention group, 125 had no intervention at followup and 47 had AAA repair (35 EVAR and 12 OSR) 

13 / 150 (8.7) 1 / 47 (2.1) 

Mortality <30 days after primary operation, AAA procedure-related (elective) 

13 / 150 

9% [95%CI 5 to 15] 

1 / 47 (2.1) 

Mortality >30 days after primary operation 47 / 137 (34.3) 10 / 46 (21.7) Total number of patients with complications 58 / 178 

33% [95%CI 26 to 40] 

NA 

Type of complication Endoleak, type 1 10 / 178 (5.6) Endoleak, type 2 17 / 178 (9.6) Endoleak, type 3 5 / 178 (2.8) Graft rupture 1 / 178 (<1) Graft migration 2 / 178 (1.1) Graft thrombosis 7 / 178 (3.9) Other surgery required 8 / 178 (4.5) *Total number of patients with reintervention 32 / 178* (18.0) 

18% [95%CI 13 to 24] 

Reason for reintervention Endoleak, type 1 8 / 178 (4.5)Endoleak, type 2 3 / 178 (1.7)Endoleak, type 3 3 / 178 (1.7)Graft rupture 1 / 178 (<1)Graft migration 0 Graft thrombosis 5 / 178 (2.8)Other surgery required 8 / 178 (4.5)* Includes 12 patients randomized to No Intervention NA = Not applicable 
51 

Table 7. Kaplan-Meier estimates of mortality and complications according to treatment arm for EVAR versus 

no intervention of AAA: EVAR-2 randomized controlled trial 

1. All-cause mortality (extracted from graph)

Group Year 1 Year 2 Year 3 Year 4 

EVAR Proportion dying 20% 37% 52% 66% 

(n=166) Number at risk 129 58 23 6 

No intervention Proportion dying 16% 30% 47% 62% 

(n=172) Number at risk 139 71 29 9 

2. Aneurysm-related mortality (extracted from graph)

Group Year 1 Year 2 Year 3 Year 4 

EVAR Proportion dying 10% 11% 14% 14% 

(n=166) Number at risk 129 58 23 6 

No intervention Proportion dying 8% 10% 19% 19% 

(n=172) Number at risk 139 71 29 9 

3. Complications (extracted from graph): (defined as graft rupture, graft infection, graft migration, endoleaks, graft 

thrombosis, graft stenosis, renal infarction, anastomotic aneurysm, iliac dilation, technical problem of graft insertion, 

other surgery required)

Group Year 1 Year 2 Year 3 Year 4 

Proportion with 

complications EVAR 24% 30% 37% 43% 

(n=166) Number at risk 105 47 14 5 

Proportion with 

complications No Intervention 4% 7% 11% 18% 

(n=172) Number at risk 137 69 26 7 

4. Reinterventions (extracted from graph)

Group Year 1 Year 2 Year 3 Year 4 

Proportion with 

reinterventions EVAR 16% 18% 21% 26% 

(n=166) Number at risk 115 55 20 7 

Proportion with 

reinterventions No Intervention 2% 4% 4% 4% 

(n=172) Number at risk 137 70 29 9 
52

Figure 5. Endovascular repair versus open repair: 30-day mortality 
53

Figure 6. Endovascular repair versus open repair: Midterm all-cause mortality 
54

Figure 7. Endovascular repair versus open repair: Aneurysm-related mortality 
55 

Evidence from Nonrandomized Controlled Trials, Registries, 

Case Series, and Comparative Studies Evaluating EVAR 

Study and Patient Characteristics 

 The evidence of the effectiveness and adverse effects of EVAR from sources other than RCTs 

is based primarily on an update of a recently published systematic review by Drury 

(http://www.nice.org.uk/pdf/ip/AAA%20stent%20review%20body%20report% 

20for%20web.pdf.6 The authors included 47 studies published between 2000 and early 2004 

(n=19,160, ranging from 46 to 4,613), including one RCT,11 nine nonrandomized controlled trials 

(NRCTs) in comparison to OSR,54,83-90 16 comparative (two or more subgroups undergoing 

EVAR) observational studies,56,91-105 and 21 case series.57,106-125 Studies were excluded if they were 

case series with fewer than 50 patients, not primary studies, assessed ruptured AAA, had 

insufficient outcomes of interest, or more recent or relevant publications were available. We 

verified or corrected results from their included studies, summarized findings, updated with data 

from two recently published national registries, Lifeline (conducted in the U.S., n=2,664)126 and 

RETA (n=1,000)127 and information available on the FDA website from device-specific data. 

Additionally, we provide information from a post-hoc defined “high-risk subgroup” of patients 

enrolled in these five mutlicenter investigational device exemption clinical trials leading to FDA 

approval.14 Discussion of results from this report are provided under Key Question 3. 

 Studies were included if the intervention was EVAR, included adults with asymptomatic 

infrarenal AAA undergoing elective intervention, and assessed clinical outcomes related to 

efficacy/safety of EVAR. Patients with thoracic and thoraco-abdominal aneurysms and 

symptomatic or ruptured aneurysms were excluded. Main clinical outcomes included EVAR 

deployment success, primary and 30-day technical success, aneurysm rupture following 

successful EVAR, conversion rates (primary and secondary), and secondary interventions. 

Complications of EVAR were assessed by the frequency of technical problems (stent/graft 

complications and endoleaks) and major adverse events including 30-day mortality. 

 Mean ages of the study participants ranged from 65 to 76 years and mean followup times 

ranged from 7 to 36 months for the studies reporting these variables. AAA diameter ranged from 

5 to 7 cm with a mean of 5.8 cm. The average AAA size would be classified as “large.” Over 70 

percent of studies had a mean followup of at least 12 months, seven with 24 months. Mean 

followup was not reported in 12 studies. Nearly 90 percent of patients were men. Most had 

coexisting medical conditions including diabetes (14 percent), hypertension (54 percent), 

coronary artery disease (59 percent), tobacco use (67 percent), and chronic obstructive 

pulmonary disease (35 percent). 

 The methodological quality of included studies reported varied considerably. Reported 

limitations included lack of detail regarding inclusion/exclusion of study participants, description 

of dropouts or patients lost to followup, operator experience, and blinding of outcomes assessors. 

Furthermore, because these studies were not randomized trials, it is not possible to make 

definitive statements about the relative effectiveness or adverse effects of different endografts. 

Generally, statistical analyses of study outcomes were not adjusted for confounding factors. The 

majority of the included studies did not provide a source of funding. Funding was provided by 

device manufacturers (eight studies),87,94,95,99,104,105,108,123 and the U.S. government in one.116 
56 

Results 

Mortality 

 30-day mortality. Fourteen case-control reports, including registries or nonrandomized but 

controlled trials, compared 30-day mortality of EVAR to OSR.51,54,84-88,90,126,128-132 There was a 

higher 30-day mortality in the OSR group, 3.8 percent versus 1.5 percent for EVAR (absolute 

risk reduction of 2 percent [95 percent CI 2 to 3] favoring EVAR). Incidence and risk reduction 

in mortality for EVAR were similar to results reported from RCT (Appendix E∗, Table E10). The 

pooled 30-day mortality rate for non-device specific EVAR as reported from both case series and 

comparative studies was slightly higher than either the RCT or the comparative studies (2.6 

percent) and ranged from 0 to 8.4 percent (Appendix E, Table E11). 

All-cause and AAA-related mortality. All-cause and AAA-related deaths from reports 

limited to registries and device-specific studies are shown in Appendix E, Table E12. Mean 

followup times varied widely or were not reported, limiting interpretation of the results. In the 

pooled Lifeline registry comprised of device trials conducted in the U.S., 23 percent of patients 

had died at a mean followup of 34 months, nearly 2 percent due to AAA-defined cause.126 In 

data not shown, the overall incidence of AAA-related death was 3.0 percent (range 1.3 percent to 

6.8 percent) in three studies (n=1,171) with followup periods ranging from 21 to 36 months. 

Non-AAA mortality was assessed in eight studies (n=1,228), including one nonRCT. In the 

nonRCT, using the Talent device, mortality not related to AAA following EVAR was 8.3 percent 

versus 4.8 percent for OSR at a mean followup of 13 months.87 

Early and Delayed Aneurysm Rupture (Appendix E, Table E13) 

 Nine studies (n=8,772) including the four clinical trials comprising Lifeline, reported 

incidence of early AAA rupture, defined as occurring within 30 days or less following EVAR. 

The rupture rate was 0.2 percent (16 events) and ranged from 0 percent to 1.6 percent. Delayed 

rupture, occurring after 30 days postoperatively, was reported in 18 studies (n=9,720). The 

percent of delayed rupture following EVAR was 0.5 percent during mean followup times ranging 

from 7 to 72 months. In the device-specific studies, early and late ruptures were reported only for 

AneuRx device, three (0.3 percent) and ten (0.84 percent), respectively.124 

Primary and Delayed Conversion to OSR (Appendix E, Table E14) 

 Primary conversion is defined as conversion to OSR immediately after a failed EVAR 

procedure. Primary conversion results were reported in 18 studies (n=10,832) including the four 

clinical trials comprising Lifeline. The overall percentage of patients converting to OSR was 2.2 

percent and ranged from 0 to 10 percent. In the device-specific trials, primary conversion ranged 

from 0 percent for the Excluder device up to 9.7 percent for the EGS.89,133 In a sub-study of the 

AneuRx clinical trial, Shames compared EVAR outcomes between men (n=203) and women 

(n=42) (data not shown).104 Six women (14 percent) required conversion to OSR compared to 

one man. Two studies compared early to late experience in performing EVAR. Conversion to 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
57 

OSR for “early experience” was 27 percent and 8.9 percent compared to 4.5 percent and 0 

percent for “late experience” in the Flora and Resch studies, respectively.93,117 

 A delayed conversion to OSR was considered to be a conversion after a successful EVAR 

procedure. The pooled percentage occurrence of delayed conversions from 18 studies (n=10,141) 

was 1.8 percent with mean followup times ranging from 7 to 72 months. In the device-specific 

trials, delayed conversion was reported for 38 patients receiving AneuRx (3.2 percent)124 Only 

one study had occurrences of delayed conversion greater than 5 percent.93

Secondary Intervention Following EVAR (Appendix E∗, Table E15) 

 Secondary intervention was defined by Drury as any surgical or radiological procedure 

following EVAR that was conducted to maintain exclusion of the aneurysm sac from the 

circulation or to maintain graft patency. The number and percentage of secondary interventions 

for 22 studies (n=10,793) are shown in Appendix E, Table E15. Overall, 15.3 percent (range 3.8 

to 55.5 percent) of analyzed patients required a secondary procedure within mean followup times 

ranging from 6 to 72 months. In the device-specific studies, secondary interventions were 

undertaken for 12 and 13 percent of patients receiving Powerlink and Excluder devices after 

approximately 2 years, respectively.133,134 For patients receiving Ancure and EGS devices, 37 

percent followed for 5 years required a secondary procedure.89 

Additional Outcomes 

 The Drury review assessed clinical outcomes not examined further in our report. These 

include: (1) deployment success; (2) primary and 30-day technical success; (3) change in aneurysm 

size during followup; (4) procedural blood loss; (5) length of intensive care unit (ICU) stay; and 

(6) length of hospital stay. The results are summarized: 

(http://www.nice.org.uk/pdf/ip/AAA%20stent%20review%20body%20report%20for%20web.pdf). 

 Successful EVAR deployment, defined as EVAR placement in the correct position without 

surgical intervention or OSR conversion, was reported in 13 studies 

(n=5,480).56,87,89,99,102,103,106,108-110,114,115,120,121,125 Deployment success rate was 97 percent. In two 

device-specific nonRCTs, success for Ancure/EGS and Talent was 93 percent and 99 percent, 

respectively.87,89 

 Primary technical success was reported in 11 studies 

(n=4,998).56,87,89,92,99,102,103,108,109,112,116,120-122,125 The majority of studies defined this outcome as 

the successful placement of the endoluminal-stent with complete exclusion of the aneurysm from 

the circulation.87,92,99,109,125 

 Three studies provided an alternative definition56,103,116 and four studies102,108,112,120 provided 

no definition. Success was verified with either angiogram upon completion or pre-discharge 

angiograms. Primary technical success varied widely, from 61 to 91 percent, (80 percent 

overall). One nonRCT (Talent) reported a success of 70 percent.87 Thirty-day technical success 

was defined as successful placement of the graft resulting in complete exclusion of the AAA, 

with or without prior secondary intervention. Overall success was 91 percent in eight studies 

(n=1,493) and ranged from 77 to 100 percent. Success for the Talent study was 86 percent.87 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
58 

 Increase in AAA size was reported in 14 studies (n=2,509)83,87,95,96,108-113,121,122,124,135 and ten 

(n=2,065) reported reduction in AAA83,95,96,108,110,112,113,121,124,135 following EVAR. Eight studies 

reported significant change as an increase or decrease of greater than 5 mm.87,95,110-112,122,124,135

One study defined decrease as a change over 10 mm and increase as a change over 5 mm from 

preoperative size.83 The range of increase in the included studies was 0 - 27 percent with an 

overall average of 7.7 percent. Approximately 44 percent of patients experienced a decrease in 

AAA (range 11 - 82.5 percent). 

 Overall procedural blood loss following EVAR was 397 ml, reported in 12 studies 

(n=2,594).56,84,85,87-89,96,106,108,110,116,121 Mean blood loss was less for EVAR (414 ml, range 96-

783) compared to OSR (1,329 ml range 451-1,800). Mean length of ICU stay with EVAR was 

less than one-half of OSR (0.7 vs. 1.6 days).11,84,86-89 The mean length of hospital stay for EVAR 

from nine nonRCT was also less than one-half that of OSR (4.2 days vs. 9.9 days). 

Endoleaks and Complications 

 

 Safety of EVAR was assessed according to the incidence of EVAR device-related adverse 

events, or technical complications. Endoleaks are included in this section although they are not 

classified as a complication. Endoleaks, detected and classified through radiographic imaging, 

are often asymptomatic and do not require a reintervention. Complications included stent 

migrations, fractures, graft-limb thrombosis, graft stenosis, and access artery injury. 

 Endoleaks (Appendix E∗

, Tables E16-E18)

 Any endoleaks. The incidence of any EVAR endoleaks is shown in (Appendix E, Table E16). 

Data were extracted from two registries, RETA and Lifeline with additional data from the four 

clinical trials comprising Lifeline. Within 30 days postoperatively, any endoleaks occurred in 

nearly one-quarter in the U.S. Lifeline series126 and 14.6 percent in the European RETA 

database.127 For the individual devices, incidences ranged from 13.9 percent AneuRx124 to 22.7 

percent for Powerlink.134 The incidence was two to three fold as high (42.2 percent) at discharge 

for combined Ancure and EGS bifurcated devices.89

 Type I endoleaks. Ten studies (n=2,617) reported occurrences of Type I endoleaks within 30 

days following EVAR (Appendix E, Table E17). The overall incidence was 4.2 percent. In the 

device-specific studies this ranged from 0.9 percent (Powerlink and AneuRx) to 5.8 percent for 

Talent.134 87,124 The overall incidence was 3.5 percent (range from 0-14 percent) after one year in 

13 studies (n=2,544) reporting. The incidence of Type 1 endoleaks beyond 1 year was 6.7 

percent (range 0 to 21.5 percent) for 18 studies reporting (n=7,848). 

Type II endoleaks. Eleven studies (n=2,712) reported occurrences of Type II endoleaks 

within 30 days following EVAR (Appendix E, Table E18). The overall incidence was 10.5 

percent with a wide range (1.4-31.2 percent). The percentage of events for the device-specific 

studies was 1.4 to 19.3 percent for 2 AneuRx studies 102,124 11.7 percent for Excluder, 133 and 20 

percent for Powerlink.134 The highest number of events occurred in the combined Ancure and 

EGS study,89 although this event was reported for bifurcated grafts only. At one year, 14.7 

percent of individuals had a Type II endoleak. For the device-specific studies, the 1-year range 

was 5.4 percent (Talent) up to 21.8 percent (combined Ancure and EGS, bifurcated grafts 

only).87,89 After 1 year the percent of events was still 10.2 percent (range 1.0-20.8 percent; 14 

studies; n=7,066). 

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
59 

Type III endoleaks. Type III endoleaks were infrequent. Three studies (n=1,290) reported 30 

day outcomes. All 15 events occurred in the RETA registry.127,133,134 Overall, 4.0 percent had a 

Type III endoleak after 1 year (nine studies, n=6,599). The majority were from Eurostar.119 Of 

the device-specific studies, only AneuRx reported events (8 of 383, 2.1 percent).124

Technical complications. (Appendix E∗

, Table E19). The outcome “any technical 

complication” for the duration of postoperative hospitalization was reported by the RETA 

registry.127 There were 55 events in 976 patients (5.6 percent). Stent migration was defined as 

caudal displacement greater than 10 mm. Stent migration within 30 days following EVAR or up 

to discharge occurred in less than 1 percent of patients in the two registries, Lifeline and Eurostar 

providing data.120,126 The one year stent migration rate was less than 1 percent for three studies 

reporting (n=1,599). After 1 year, 4.4 percent had stent migration with a wide range in results 

(1.7-18.9 percent, eight studies, n=7,027). Stent migration occurred in over 6 percent of patients 

in the AneuRx device study.124 

 No stent fractures were reported in the 47 included studies by Drury. Stent wire fractures can 

occur without a full stent fracture and are typically detected by followup x-rays or CT scans. 

Stent-wire fractures were reported in three studies, two device-specific.87,108,134 Overall, 17 

events in 659 patients occurred (2.6 percent). The Powerlink study reported no stent wire 

fractures while the Talent reported an incidence of 4.6 percent.87,134 

 Graft-limb thrombosis was reported in five studies (n=659) within 30 days following EVAR 

(2.4 percent, range 0.7 to 6.3 percent). Incidences for the two device-specific studies were 

comparable. The overall percentage was similar at 1 year, 2.5, with a range of 0 to 11 percent (11 

studies, n=1,657). After 1 year, the incidence increased to 3.8 percent (range 1.9 to 6.1 percent, 

eight studies, n=6,602). The 1-year incidence for device-specific Powerlink and combined 

Ancure and EGS reports were 2.1 and 5.4 percent, respectively.89,134 

 Graft stenosis was reported by four studies. Only Eurostar provided data within 30 days 

(n=2,862) and greater than 1 year (n=4,613) following EVAR (0.3 percent and 1.4 percent 

respectively). Up to 1 year, the overall incidence of graft stenosis was 2.7 percent in three studies 

reporting (n=365), including one device-specific study (Powerlink), which reported three events 

in 192 patients.134 In data not shown, access artery injury was reported in seven studies (n=2,561) 

with an overall incidence of 4.8 percent (range 1.4-12.9 percent).89,92,102-104,109,118,121

 

∗ Appendixes and Evidence Tables for this report are provided electronically at http://www.ahrq.gov/clinic/tp/aaareptp.htm
60 

Question 2. What is the relationship of volume, both hospital and physician, to the benefits 

and harms of endovascular procedures to repair of AAA? 

Results 

EVAR of AAA 

 The literature search did not find any qualifying studies of the association between the 

volume of endovascular AAA repairs done by hospitals or physicians and any beneficial or 

harmful outcome. 

 The only report from the U.S. was based on a statewide discharge database in New York that 

compared hospitals that did fewer than five EVAR to repair AAA to hospitals doing 30 or 

more.54 The crude in-patient mortality rates of 1.9 percent versus 0.8 percent did not differ 

significantly in this small sample. Investigators were not able to make adjustments for potential 

differences in risk due to patient, physician, or hospital characteristics. 

 Analysis of data in a European registry did not find a relationship between 30-day mortality in 

the first 11 cases versus subsequent cases treated at a medical center.57 Midterm outcomes were 

related to center experience. However, methodological issues discussed in the Background 

section, including use of withdrawn devices that are not used in the U.S. in earlier cases, make it 

difficult to determine whether these observations would apply to contemporary practice in the 

U.S.58

OSR of AAA 

 Previous studies of the relationship between hospital and surgeon volume of OSRs and 

outcomes were reviewed to inform future studies of EVAR. Table 8 on pages 59-64 summarizes 

studies of relationships between the volume of OSRs of AAA and outcomes in the United States 

in the 1990s. Endovascular repair was primarily an investigational procedure during this time, 

and these findings should not be extrapolated to current practice where endovascular procedures 

are being used to repair a substantial select fraction of the AAA. 

 Five studies of OSR of AAA used a national sample of hospital discharges, discharges of 

elderly Medicare enrollees, or operations in VA medical centers.15,16,136-139 Three investigations 

analyzed hospital discharges in Maryland, Florida, or New York.140-142 All studies were 

retrospective analyses of available databases. The VA study was the only one that had 

prospectively collected preoperative data including clinical variables.139 Corresponding with the 

incidence of AAA, all samples were predominantly elderly males, and data for females is sparse. 

 Death was the primary outcome in all analyses. In-hospital death was analyzed in five of the 

eight reports16,138,140-142 Others included deaths within 30-days to avoid bias that can be introduced 

by differences in hospital length of stay.143 Hospital volume was analyzed in all studies. Two 

studies of Medicare data attempted to estimate each hospital’s total volume, not just operations 

covered by Medicare.15,136,137 Volume measures reflected periods of time that varied from 1 to 6 

years. Some were analyzed as average annual volume, while others reported total volume during 

the period of study. Half of the studies included a measure of surgeon volume. Only one examined 

the surgeon’s specialty.138 All studies ignored procedures that were done prior to the period of 

study as well as the surgeon’s experience doing other types of vascular operations. 
61 

 All studies employed logistic regression models with patients as the unit of analysis. Four 

studies did not report adjustments for clustering of patients within hospitals (or surgeons).16,140-

142 Two studies utilized hierarchical regression models with hospitals and or surgeons as random 

effects.137,139 Age and sex were used as covariates in all analyses except the VA study that was 

nearly 100 percent male. Race (white versus non-white) was included in six studies.15,16,136-

138,141,142 Two studies did not attempt to include co-morbidities because of concerns about 

completeness of diagnoses listed on discharge abstracts and the inability to differentiate 

postoperative complications from preexisting conditions.141,142 Admission acuity was a covariate 

in all studies except one that excluded urgent and emergency admissions. Most excluded hospital 

transfers. Other covariates used by some, but not all, included year to control for time trends, 

estimated patient income or type of insurance, service intensity of DRGs, hospital length of stay, 

and characteristics such as bed size, ownership, being a teaching facility for physicians, and 

urban location. Information about aneurysm characteristics was not available for risk adjustment 

in any of the eight investigations. Another analysis of the data in Nationwide Inpatient Sample 

from 1998 to 2001 found that use of low volume hospitals (<10 AAA repairs/year) was 

associated with race/ethnicity, geographic region, rural setting, Medicaid, and lack of insurance 

and non-elective admissions.144 If these variables are also associated with outcomes, they need to 

be controlled when estimating the effects of volume. Only two studies reported how well their 

regression model fit the data and three reported how well their model discriminated deaths. 

Reported c-statistics were modest, ranging from 0.68 to 0.75. 

 Overall mortality in the studies ranged from 3.5 percent to 5.7 percent. Seven of eight studies 

reported that significantly lower adjusted mortality was associated with higher volume hospitals. 

Two studies suggested that the volume effect was relatively consistent in patient subgroups with 

different preoperative risks of death.15,16 Cutpoints for hospital volume that were associated with 

lower adjusted mortality ranged from 17 to 100 AAA OSR per year. These cutpoints were 

arbitrary and studies did not report analyses specifically to determine a volume threshold(s). The 

highest volume in the VA study that did not find an association between hospital volume and 

mortality was 32 procedures per year. This was the only study that prospectively collected and 

incorporated numerous preoperative clinical variables for risk adjustment. A summary plot of 

mortality versus volume from all studies was not possible given varying measures of mortality 

and volume and broad volume categorizations. Some studies only reported risk-adjusted results 

for volume analyzed as a logarithm-transformed continuous variable. 

 All three studies that analyzed surgeon volume reported that surgeon volume had an effect 

that was independent of hospital volume.137,138,140 One study that reported how surgeon volume 

altered the effect of hospital volume indicated that the addition of surgeon volume to the 

regression model greatly reduced, but did not eliminate, the effect of hospital volume.137 Surgeon 

volume was inversely related to mortality when surgeon specialty was taken into account in the 

two studies.138,142 These studies did not identify a volume cutpoint that could be used to identify 

surgeons who perform enough AAA repairs to maintain optimal outcomes. 

Summary of Results 

 Adequate studies of the relationship between the volume of EVAR procedures done by 

hospitals and physicians in the United States have not been reported to date. Most previously 

published studies of OSRs of AAA done by hospitals and surgeons suggest that there is an 

inverse relationship between volume and short-term mortality. Whether or not a similar inverse 
62 

relationship exists between the volume of EVAR procedures done by hospitals or physicians and 

mortality or any other outcome has not been established. The poorly defined relationship 

between the volume of OSR and short-term mortality should not be extrapolated to EVAR. 

Studies specific to EVAR that address important limitations of previous volume-outcome studies 

discussed in the Background section are needed to guide policy. 
63

Table 8. Summary of studies of relationships between hospital and surgeon volume and mortality of OSR of unruptured AAA i

Reference(s) 

[Period of Study] 

Population 

Outcome Volume Analysis Risk Adjustment Volume 

Groups 

(n) 

Unadjusted 

Mortality 

(%) 

Birkmeyer136 Goodney15 [1994-1999] All fee-for-service Medicare enrollees over 65 years old who were discharged from a hospital. Mean Age: NR Male: 76% 

Death before discharge or within 30 days 

Estimated average annual number of AAA repairs over 6 years 

Logistic regression with patients as unit of analysis adjusted for clustering Goodness-of-fit: NR Discrimination: NR 

Age, sex, race, income, year, acuity of admission, Charlson comorbidity score (19 conditions excluding the indication for surgery and complications) 

Overall Annual hospital volume <17 (1900) 17-30 (426) 31-49 (257) 50-79 (156) >79 (80) Subgroups Low predicted risk  Hospital volume <17  Hospital volume >79 High predicted risk  Hospital volume <17  Hospital volume >79 

5.7 7.8 5.9 5.2 5.3 4.4 5.6 3.3 

12.4 

7.4 

Birkmeyer137 [1998-1999] All fee-for-service Medicare enrollees over 65 years old who were discharged from a hospital. Mean Age: NR Male: 77% 

Death before discharge or within 30 days 

Estimated average annual number of AAA repairs over 2 years 

Logistic regression with patients as unit of analysis adjusted for clustering within surgeon and hospital via hierarchical mixed models; surgeon and hospital volume tested in separate and combined models Goodness-of-fit: NR Discrimination: NR 

Age, sex, race, income, year, acuity of admission, Charlson comorbidity score (19 conditions excluding the indication for surgery and complications), hospital ownership, teaching status and urban location 

Overall Surgeon volume  Low <8/year (NR)  Med 8-17.5/year (NR)  High >17.5/year (NR)  Low volume surgeon  High volume surgeon Hospital volume <27.5/yr Low surgeon (3279)  Medium surgeon (800) High surgeon (218) Hospital volume 27.5-

60.5/year 

 Low surgeon (1333)  Medium surgeon (642)  High surgeon (282) 

NR 
Table 8. Summary of studies of relationships between hospital and surgeon volume and mortality of OSR of unruptured AAA i

64

Reference(s) 

[Period of Study] 

Population 

Outcome Volume Analysis Risk Adjustment Volume 

Groups 

(n) 

Unadjusted 

Mortality 

(%) 

Hospital volume >60.5/yr Low surgeon (795)  Medium surgeon (379) High surgeon (310) Controlling for hospital 

volume 

 Low volume surgeon  High volume surgeon Hospital volume  Low <50/year (NR)  High >50/year (NR)  Low <50/year  High >50/year Controlling for surgeon 

volume 

 Low volume hospital  High volume hospital 
Table 8. Summary of studies of relationships between hospital and surgeon volume and mortality of OSR of unruptured AAA i

65

Reference(s) 

[Period of Study] 

Population 

Outcome Volume Analysis Risk Adjustment Volume 

Groups 

(n) 

Unadjusted 

Mortality 

(%) 

Dimick16[1996 & 1997] National Inpatient Sample (stratified random sample of 20% of all discharges from nonfederal hospitals Mean Age: 72 ± 8.1 yrs Male: 79% 

In-hospital death 

AAA repair procedures done in sample hospitals each year 

Logistic regression with patients as unit of analysis not adjusted for clustering. Goodness-of-fit: NR Discrimination: NR 

Age, sex, race, acuity of admission, 10 comorbid conditions (Charlson index as modified by Romano). No mention of excluding conditions that might have been complications. 

Overall Hospital volume 

≤30/year (76 & 91) 

 >30/year (431 & 445) Subgroups Age <65  Hospital ≤30/year 

 Hospital >30/year Age <65 & male  Hospital ≤30/year 

 Hospital >30/year Age <65 & female  Hospital ≤30/year 

 Hospital >30/year Age >65  Hospital ≤30/year 

 Hospital >30/year Age >65 & male  Hospital ≤30/year 

 Hospital >30/year Age >65 & female  Hospital ≤30/year 

 Hospital >30/year 

3.8 4.7 3.1 

2.7 1.0 2.5 0.8 3.9 1.9 5.2 3.5 4.6 3.2 

7.1 4.4 
Table 8. Summary of studies of relationships between hospital and surgeon volume and mortality of OSR of unruptured AAA i

66

Reference(s) 

[Period of Study] 

Population 

Outcome Volume Analysis Risk Adjustment Volume 

Groups 

(n) 

Unadjusted 

Mortality 

(%) 

Dimick138

[1997] 60% of National Inpatient Sample that had surgeon identifiers Mean Age: 72±8 years Male: 79% 

In-hospital death 

AAA repair procedures done in sample hospitals. AAA repairs done by surgeon in all hospitals in sample. 

Logistic regression with patients as unit of analysis adjusted for clustering by hospital. Goodness-of-fit: OK Discrimination: c-statistic 0.71 

Age, sex, race, acuity of admission, type of procedure code (resection vs. bypass), 10 comorbid conditions (Charlson index as modified by Romano). No mention of excluding conditions that might have been complications. 

Overall Hospital volume  Low <35  High ≥35 

Surgeon volume  <10 

≥10 

Surgeon specialty  General  Cardiac  Vascular Low volume hospital  Low volume surgeon  High volume surgeon  General surgeon  Cardiac surgeon  Vascular surgeon High volume hospital  Low volume surgeon  High volume surgeon  General surgeon  Cardiac surgeon  Vascular surgeon 

4.2 5.5 3.0 5.6 2.5 5.5 4.0 2.2 6.5 3.2 6.3 5.9 2.7 

4.2 2.4 4.4 2.5 1.9 
Table 8. Summary of studies of relationships between hospital and surgeon volume and mortality of OSR of unruptured AAA i

67

Reference(s) 

[Period of Study] 

Population 

Outcome Volume Analysis Risk Adjustment Volume 

Groups 

(n) 

Unadjusted 

Mortality 

(%) 

Khuri139

[1991-1997; fiscal years that begin in October] Veterans Affairs medical centers in the prospective National Surgical Risk Study or Surgical Quality Improvement Program Mean Age: 69±6.9 Male: 99% 

30-day postoperative mortality 

Annual volume per hospital derived as total number of AAA repairs done in a hospital / years hospital contributed to database 

Logistic regression with patient as unit of analysis to derive expected number of deaths per hospital, and estimate expected (risk adjusted) mortality Goodness-of-fit: NR C-statistic: 0.75 Mixed effects hierarchical logistic regression; level 1 regression of death on patient characteristics; level 2 regression of hospital volume on risk adjusted mortality 

Age, emergency procedure, American Society Anesthesia class, weight loss, albumin, white blood cell count, blood urea nitrogen plus 60 other insignificant factors 

Overall Hospital volume  0-3/year (26)  4-6/year (26)  7-10/year (26)  11-32/year (26) 

4.7 

8.2±17.3 

5.3±5.6 4.4±3.0 4.6±2.7 

Dardik140[1990-1995] Discharges from nonfederal, acute care hospitals in Maryland excluding urgent and emergent admissions Mean Age: 70±7.5 years Male: 78% 

In-hospital death 

Total number of elective AAA repairs done by hospitals and surgeons operating in sample hospitals over 6-year period 

Logistic regression presumably with patient as unit of analysis, adjustments for clustering not reported Goodness-of-fit: NR Discrimination: NR 

Age, sex, race, Medicaid, hypertension, diabetes, chronic obstructive pulmonary disease, cardiac disease, renal disease, smoking history 

Overall Hospital volume  <50 (30)  50-99 (9)  100 or more (7) Surgeon volume  1 (71)  2-9 (83)  10-49 (56)  50-99 (6)  100 or more (3) 

3.5 

4.3±0.8 4.2±0.8 2.5±0.5 9.9±3.6 4.9±1.1 2.8±0.5 2.9±0.9 3.8±1.0 
Table 8. Summary of studies of relationships between hospital and surgeon volume and mortality of OSR of unruptured AAA i

68

Reference(s) 

[Period of Study] 

Population 

Outcome Volume Analysis Risk Adjustment Volume 

Groups 

(n) 

Unadjusted 

Mortality 

(%) 

Sollano141

[1990-1995] Discharges from nonfederal, acute care hospitals in New York excluding emergency repairs Age: NR Male: NR 

In-hospital death 

Total number of nonruptured AAA repairs done in hospitals over 6-year period 

Logistic regression with patients as unit of analysis not adjusted for clustering Goodness-of-fit: OK C-statistic: 0.68 

Age, sex, race, admission acuity, transfer admission, payer, service intensity weights based on DRG cost ratings were tested 

Hospital volume per 

100 cases (9,847) 

Average of hospital 

volumes 

 15 (131)  62 (33)  105 (13)  171 (5)  193 (3)  260 (2)  292 (5)  334 (1)  433 (1) 

5.5 8.2 5.8 5.5 3.3 4.8 5.4 4.7 3.3 2.6 

Pearce142 

[1992-1996] Discharges from nonfederal, acute care hospitals in Florida Median [IQR] Age: 72 [67-77] Male: 81% 

In-hospital death 

Annual hospital and surgeon AAA repairs done in sample hospitals 

Logistics regression using logarithm of volume measures not adjusted for clustering although presumably patients were the unit of analysis Goodness-of-fit: NR C-statistic: NR 

Age, sex, emergency admission, length of stay, year, hospital bed size, teaching status and ownership 

Overall Median hospital 

volume/year 

 32 [18, 46] (162) Median surgeon 

volume/year 

 9 [5, 15] (609) Vascular certification  18% of repairs (62) 

5.7 

NR = not reported. CI = confidence interval. RR = relative risk. O/E = observed/expected. IQR = interquartile range. 
69 

Question 3: How do the characteristics of the aneurysm (size/location/shape) and the patient 

(age/gender) affect the benefits and harms of endovascular and open-surgical repair? 

Aneurysm Location and Morphology 

 Only elective repair for asymptomatic AAA are considered. Patients enrolled in RCT all had 

infrarenal AAA. There are no outcomes data based on AAA morphology or classification. The 

following information is provided to summarize the epidemiology of AAA enrolled in RCTs to 

serve as a benchmark for estimating relevance to future study design or practice. 

 In the small aneurysm trials of OSR versus active surveillance, patients were ineligible if 

they had suprarenal or juxtarenal aneurysm (defined by an anticipated need for reimplantation of 

a main renal artery). RCT results have not provided outcomes according to AAA morphology 

class (i.e., whether the aneurysm was confined to the aorta, involved the aortic bifurcation, 

proximal common iliac arteries, or extended into one or both of the iliac bifurcations). There are 

no data based on whether AAAs were considered “sacular” versus “fusiform.” DREAM provides 

extensive information on AAA morphology. Nearly 70 percent had cylindrical or fusiform AAA, 

approximately 60 percent of AAA were considered to involve the aortic bifurcation and have 

normal iliac arteries, and 18 percent extended into one or both iliac arteries. “Unfavorable 

features” of the infrarenal neck as defined by an angulation of more than 90 degrees, diameter of 

more than 18 mm, and a diameter of less than 6 mm or more than 50 percent stenosis was 

reported in about one-half, while extensive iliac calcification was reported in 70 percent. 

 Among patients assigned to OSR, nearly 60 percent received a conventional aortoaortic tube 

graft, while one-third received an aortobiliac (bifurcated graft). Among EVAR patients, more 

than 90 percent received aortobiiliac EVAR. Parlani evaluated patients with iliac aneurysms 

versus those without iliac aneurysms and noted no differences in mortality, complications, or 

need for reinterventions after EVAR.96

Aneurysm Size (Small AAA) 

Natural History: AAA initial or attained diameter is the biggest known predictor of rupture 

risk. AAA typically have been classified as small (<5.5 cm) or large. These classifications have 

been used for inclusion criteria in RCTs and clinical decision making. 

 The annual rupture rate for AAA <5.5 cm was less than 1 percent in patients enrolled in the 

active surveillance arm of ADAM and UKSAT. A cohort of 2,257 adults was comprised of 

patients enrolled in the UKSAT trial and the associated study for patients’ ineligible or refusing 

randomization. After 3 years the annual rate of AAA rupture was 2.2 percent. Additional 

analyses assessed the risk of rupture and last known or estimated AAA diameter categorized as 

≤3.9 cm, 4.0 to 4.9 cm, 5.0 to 5.9 cm, and ≥6.0 cm. The number of ruptures per 100 patient years 

increased from 0.3 for AAA <3.9 cm to 1.5 and 6.5 for patients with AAAs 4.0 to 4.9 cm and 5.0 

to 5.9 cm respectively. A Mayo Clinic study suggested that a 1 cm larger initial diameter was 

associated with an approximately 50 percent increase in the adjusted rupture risk. 

OSR. As noted previously (Question 1) both ADAM and UKSAT analyzed mortality 

according to treatment arm (early OSR versus surveillance) and age or aneurysm diameter at 

baseline, based on tertile groups. The adjusted hazard ratio at 8 years followup in UKSAT tended 

toward a greater benefit of early OSR among younger patients, men, and those with larger 
70 

aneurysms. However, neither study demonstrated a significant interaction between treatment 

group and age baseline, AAA diameter, or gender. The reported test of interaction was not 

significant across AAA size (p = 0.28) or age (p = 0.18). Calculated risk differences, reported 

relative risks, and tests for interaction from ADAM were not significant and had point estimates 

favoring surveillance. In UKSAT, the overall death rate for patients who continued to smoke was 

12.0 per 100 patient years compared to 3.8 per 100 patient years for patients who no longer 

smoked. Results were not reported according to randomized treatment assignment. Results from 

ADAM demonstrated that independent predictors of death among all enrollees included higher 

serum creatinine level, lower weight, diagnosis of COPD or diabetes, larger AAA diameter, 

lower forced expiratory volume in one second, and nonuse of a beta-blocker. There were few 

women enrolled in either trial. The test for interaction with gender was not significant in UKSAT 

(p = 0.40). However, fatal ruptures were nearly three times more common in women than men 

and the risk of AAA rupture was four times higher among women. Greater than 90 percent of 

enrollees were of white race, and no outcomes according to race were provided. 

EVAR. Despite an RCT that reported no benefit in survival or quality of life with immediate 

OSR versus active surveillance in patients with AAA <5.5 cm there is a possibility that some of 

these patients might benefit from EVAR, especially if EVAR morbidity is very low. One study 

recently began recruitment to evaluate EVAR versus surveillance for small AAA. The estimated 

rupture rate for the surveillance group used in sample size calculations for this trial are higher 

than reported in the two trials of OSR versus surveillance. 

Large AAA 

 

No intervention. The rupture rate for large AAA in patients judged fit for OSR is difficult to 

determine because most undergo early AAA repair. Lederle reported that the 1-year incidence of 

probable rupture by initial AAA diameter in those refusing or judged medically unfit for OSR. 

Rupture rates were 9.4 percent for AAA of 5.5 to 5.9 cm, 10.2 percent for AAA of 6.0 to 6.9 cm, 

and 32.5 percent for AAA ≥7.0 cm. Among patients who attained an AAA diameter exceeding 

8.0 cm, 25.7 percent ruptured within 6 months.36 The rupture rate among the no intervention 

group in EVAR-2 was lower than that reported by Lederle. In EVAR-2, (mean AAA = 6.3 cm) 

AAA rupture occurred in 12.2 percent of individuals in the no intervention group (rupture rate in 

the no intervention group = 9.0 per 100 person years). 

EVAR versus OSR or no intervention. Outcomes of EVAR from randomized controlled 

trials for large AAA were assessed relative to OSR or no intervention based on whether patients 

were considered medically fit for OSR. Enrolled patients were all considered candidates for 

EVAR. However, the proportion of patients with large AAA (i.e., ≥5.5 cm) who might be 

eligible for EVAR in clinical settings was estimated from the EVAR-1 and 2 trial registries as 54 

percent.13 This is consistent with other reports from EVAR utilization patterns in the U.S. where 

an estimated 40-80 percent of AAA could be amenable to EVAR based on aneurysm size, 

morphology, and patient surgical risk characteristics.39,40 Data from the EVAR-2 trial suggests 

that approximately one-fifth of patients with large AAA who are EVAR candidates are judged 

medically unfit for OSR.145

Patient characteristics. In trials of EVAR vs. OSR over 90 percent of enrollees were male 

with an average age of 70 years. Almost all were white. The mean AAA diameter ranged from 

approximately 5.4 cm in the small study by Cuypers to 6.5 cm in EVAR-1. More than 40 percent 
71 

of patients had a history of cardiac disease, 10-16 percent diabetes, and the majority were current 

or past smokers. No outcomes by race or these selected comorbidities were reported. 

 Detailed findings from RCTs of EVAR versus OSR or no intervention are described in 

Question 1. In the DREAM trial the perioperative survival advantage with EVAR as compared 

with OSR was not sustained after the first postoperative year. In the early postoperative period 

there was a small quality of life advantage for EVAR. At 6 months and beyond QOL was better 

after OSR. In the larger EVAR-1 trial, compared with OSR, EVAR offered no advantage in allcause mortality and health related quality of life, was more expensive, and was associated with a 

greater number of complications and reinterventions. There was a 3 percent better AAA-related 

survival with EVAR, though it is possible that cause of death ascertainment was biased against 

later AAA related deaths in the EVAR group. There were no significant interactions for all-cause 

or AAA-related mortality with age, sex, aneurysm diameter, or creatinine concentration. 

Followup time period suggested that hazard ratios for AAA-related mortality, total mortality, 

complications, and need for intervention began to favor OSR after 6 months. 

 Patients in EVAR-2 were considered medically unfit for OSR and had large AAA (mean 

AAA diameter = 6.4 cm; range = 6.0-7.4).145 Patients were older (76 vs. 70 years) and had worse 

pulmonary function based on spirometry (FEV1: 1.6 vs. 2.1L) than patients enrolled in EVAR-1. 

Baseline blood pressure, serum creatinine, and cholesterol levels as well as the percent males or 

individuals with diabetes, smoking, or cardiac history appeared similar. The severity or duration 

of these comorbidities was not described in detail, but 2 year mortality in the no intervention 

group was greater than 60 percent. In the EVAR-2 trial, EVAR resulted in a 30-day operative 

mortality of 9 percent in patients unfit for OSR. EVAR did not improve overall or AAA related 

mortality or quality of life over no intervention and was associated with a need for continued 

surveillance and reinterventions at increased cost. 

 There were no significant interactions for the effect of EVAR with age, sex, aneurysm 

diameter, or creatinine concentration. The 30-day EVAR mortality was higher in the sicker 

EVAR-2 patients than those receiving endovascular repair who were judged fit for surgery in 

EVAR-1 (9 percent and versus 1.7 percent; p <0.0001). Additionally, compared to healthy 

EVAR-1 patients, there was a greater need for internal iliac artery embolization, blood products, 

renal dialysis, length of hospital stay (and a trend for overall reintervention rate). 

 A wide range of EVAR devices was used in these trials. Over 90 percent of EVAR 

procedures used commercially available aortobiiliac device systems while aorto-aortic (tube) 

grafts were used in the majority of OSRs. Selection for both EVAR and OSR was based on the 

discretion of the surgical team. The most commonly used EVAR devices were Zenith (33-59 

percent of devices) and Talent (27 to 33 percent). Additional description of the devices was not 

provided. Prior to participating, investigators were required to submit data related to at least 20 

completed EVAR procedures. 

High Surgical Risk Patients 

 No randomized trials of EVAR versus OSR have specifically limited recruitment to patients 

judged to be at high surgical risk due to age, medical comorbidities, or abdominal anatomy (e.g., 

horseshoe kidney, abdominal adhesions, etc.). As noted previously, patients enrolled in the 

EVAR and OSR trials were elderly and had numerous comorbid conditions that would result in a 

limited life expectancy and a relatively high surgical risk. One report enrolled 100 patients 

believed to be at high risk for complications from OSR and subsequently treated them with the 
72 

Zenith AAA EVAR.131 Pathophysiologic conditions used to determine high risk status included 

age >80 years, creatinine >2.0 mg/dL, disabling COPD, ejection fraction <25 percent, stroke 

with residual deficit, medically intractable hypertension, previous renal bypass surgery, or 

myocardial infarction within the past 6 months. Mean baseline AAA and patient characteristics 

were not reported and it is not clear how many, if any, of these patients were considered 

“medically unfit” for OSR. Based on Kaplan-Meir plot estimates, overall survival at 1 year was 

92 percent and at 2 years was 78 percent (number at risk not provided). AAA reported survival 

was estimated at 94 percent for both 1 and 2 year. An additional report evaluated outcomes of 

EVAR and OSR in a “high surgical risk” subgroup of patients entered into any of five 

nonrandomized multicenter IDE studies leading to FDA approval of EVAR devices.14 Patients 

with AAA ≥5.5 cm were retrospectively categorized as “high surgical risk” based on age >60 

years and having at least one cardiac, pulmonary, or renal comorbidity. Inclusion, criteria for the 

IDE studies required that patients were candidates for OSR, though in one study patients were 

prospectively defined as being at high risk for OSR complications as noted above. Three-quarters 

of “high-risk” patients had only one comorbid category and <1 percent had all three categories. 

There were 14.2 percent endoleaks reported at 30 days, 17.5 percent at 1 year, and 18.9 percent 

at 4 years. Endograft migration occurred in 2.7 percent at 4 years. Major complications were not 

reported. After 4 years, deaths categorized as due to AAA were similar between EVAR and OSR 

patients (4.2 percent and 5.1 percent respectively (p = 0.58). Overall-survival in EVAR treated 

patients was 10 percent lower compared to OSR (56 percent vs. 66 percent), though this 

difference was not statistically significant (p = 0.23). 

Device-Specific Results from FDA Reports and Lifeline Registry (Tables 

9 and 10 on pages 70-72) 

 Few studies provided an evaluation according to device or patient characteristics. We 

previously described results from nonrandomized studies of EVAR with description of devicespecific results (key question 1 results from nonrandomized trials). A summary of some of these 

findings is also provided here with attention to reports from the United States (Tables 9 and 10). 

Pooled results from EVAR devices (n = 3,016) included in the published Lifeline report (Ancure, 

AneuRx, Excluder, and Powerlink) as well as FDA data related to the Cook-Zenith device and 

corresponding OSR controls (n = 414) are provided. Information from manufacture/device 

specific FDA reports is summarized. None represent direct comparisons from randomized trials. 

Patient or aneurysm factors could influence outcomes. Therefore, it is hazardous to make 

definitive statements regarding relative safety or effectiveness. 

 Compared to RCT enrollees, patients receiving EVAR included in these reports had smaller 

AAA (mean = 5.6 cm). Compared to the listed OSR controls, EVAR patients had slightly 

smaller AAA (5.6 vs. 5.8 cm), were older (73 vs. 70 years), more frequently male (89 vs. 81 

percent), and have a history of coronary artery disease (79 versus 53 percent). Across devices 

there were no large differences in mean age, AAA diameter, gender, or comorbid conditions. 

 The number of EVAR devices submitted for FDA review ranged from 121 for Ancure to 416 

for AneuRx. The pooled results as well as device-specific data obtained separately from FDA 

websites indicates that 30-day mortality rates with different devices ranged from 1 percent with 

Gore Excluder to 4.2 percent with Guidant Ancure. EVAR and OSR 30-day mortality rates were 

1.6 and 1.4 percent respectively. Major complications or adverse events within 30 days were not
73 

provided in the Lifeline report but ranged from 13.6 percent in FDA reports with Gore Excluder 

to 35.6 percent with Guidant Ancure. 

Device-Specific Results from Published Nonrandomized Studies 

 The mean AAA diameter was ≥5 cm in patients included in the nonrandomized-EVAR 

reports, and available outcomes would be considered related to large AAA. However, three 

reports describe outcomes of EVAR for small versus large AAA.94,100,146 Arko reported no 

significant difference in endoleaks between small, medium, or large AAA (p = 0.41). Ouriel 

reported that in a cohort of 700 patients treated with EVAR, overall survival, AAA related death, 

conversion, and Type 1 endoleaks were worse in large (≥5.5 cm) versus small AAA. Similar 

results from the Eurostar registry were noted by Peppelenbosch. 

 In the device-specific published studies (which often included additional patients and 

outcomes data compared to the FDA reports), early and late ruptures were reported only for 

AneuRx device and were 0.3 and 0.8 percent respectively.124 Primary conversion ranged from 0 

percent for the Excluder device up to 9.7 percent for the EGS. In a sub study of the AneuRx 

clinical trial, Shames compared EVAR outcomes between men (n = 203) and women (n = 42) 

(data not shown).104 Six women (14 percent) required conversion to OSR compared to one man. 

The incidence of delayed conversions for 18 studies (n = 10,141) was 1.8 percent with mean 

followup times ranging from 7 to 72 months. 

 In device-specific trials delayed conversion was reported for 3.2 percent of patients receiving 

AneuRx. Secondary interventions were undertaken for 12 percent, and 13 percent of patients 

receiving Powerlink and Excluder devices after approximately 2 years. For patients receiving 

Ancure and EGS devices, 37 percent followed for 5 years required a secondary procedure. 

 The incidence of any EVAR endoleaks is shown in Table 9. Data were extracted from two 

registries, RETA and Lifeline, with additional data from four clinical trials comprising Lifeline. 

Within 30 days postoperatively, the percentage of any endoleaks for the two registries was 24.7 

percent for Lifeline and 14.6 percent for RETA. For the individual devices, incidences ranged 

from 13.9 percent AneuRx to 22.7 percent for Powerlink. Incidence was 42.2 percent at 

discharge for combined Ancure and EGS devices. This included only bifurcated grafts. 

 The overall incidence of Type I endoleaks within 30 days following EVAR was 4.2 percent 

and ranged from 0.9 percent to 11 percent. The percentage of events in the device-specific 

studies ranged from 0.9 percent (Powerlink and AneuRx) to 5.8 percent for Talent. Overall 

incidence of Type III endoleaks within 30 days following EVAR was 1.2 percent in three 

reports, including Powerlink and Excluder. Powerlink and Excluder reported no Type III 

endoleaks at any followup period. 

 There was a wide range in the percentage of Type II endoleaks within 30 days following 

EVAR (1.4 percent to 19.3 percent in two AneuRx studies, 11.7 percent for Excluder and 20 

percent for Powerlink). The highest number of events occurred in the combined Ancure and EGS 

study, although this event was reported for bifurcated grafts only. In 12 studies (n = 2,598) 14.7 

percent had events at 1 year. The range was 5.4 percent (Talent) to 21.8 percent (combined 

Ancure and EGS, bifurcated grafts only). The Powerlink study reported no stent fractures. 

 Graft-limb thrombosis was reported in five studies (n = 659) within 30 days following EVAR 

with an overall incidence of 2.4 percent (range 0.7 percent to 6.3 percent). Incidences for the two 

device-specific studies were comparable. The 1 year incidence for device-specific Powerlink and 

combined Ancure and EGS NRCTs were 2.1 percent and 5.4 percent, respectively. Up to 1 year, 

the overall incidence of graft stenosis was 2.7 percent in three studies reporting, including one 

device-specific study Powerlink which reported events in 1.6 percent of patients. 
74

Table 9. LIFELINE, FDA, and RCT data for patients undergoing EVAR for AAA 

Pooled 

LIFELINE* 

and FDA 

Cook 

Zenith 

(n=3,016) 

SVS 

Outcomes 

Database 

“High 

Risk” 

(n=565) 

FDA 

Guidant 

ANCURE 

(n=121) 

FDA 

Medtronic 

ANEURX 

(n=416) 

FDA Gore 

EXCLUDER 

(n=235) 

FDA 

Endologix 

POWERLINK 

(n=192) 

FDA Cook 

ZENITH 

(n=352**) 

DREAM 

RCT 

(n=173) 

Demographics/comorbiditiesMean age (range) 

73 75.7 ± 7.0 73.2 ± 7.1 73 (45-93) 73 (48-91) 73.2 ± 7.0 73.1 ± 7.0 70.7 ± 6.6 

Mean preop AAA diameter 

5.6 6.4 ± 0.8 5.8† 5.7† 5.6† 5.2† 5.7† 6.1 ± 0.9 

Male (%) 89 89.2 92.6 89 87 88.5 92.6 93 CHD (%) 78.6 69.5 65.3 11 62 45.8 36.8 (MI) 40.9 HTN (%) 64 66.9 62.8 64 NR 63.9 65.2 57.9 DM (%) 12.3 13.8 12.4 12 NR 13.1 13.8 9.9 COPD (%) 28.3 60.5 39.7 24 26 31.8 23.9 27.5 Smoking Hx (%) 86.5 84.9 90.8 86 89 82.8 86.7 64.9 Outcomes Mortality ≤30 days (%) 

1.6 2.8 crude; 

2.9‡ 

4.2 1.7 1.3 1 1.1 1.2 

Mortality 2 years (%) 

13.0 24.6; 

26‡ 

NR NR 12.8; 

13.0‡ 

NR 8.5†† 11.6; 

10.3‡ 

AAA-related Mortality 2 years (%) 

2.0 3.5; 

3.8‡ 

NR NR 1.7; 

2.0‡ 

NR 1.0†† 1.2; 2.1 

cumulative 

rate 

Mortality 4 years (%) 

19.9 36.1; 

44.0‡ 

NR NR 22.1; 

23.0‡ 

NR NR NR 

AAA-Mortality 4 years (%) 

2.1 3.7; 

 4.2‡ 

NR NR 2.6 NR NR NR 

Major complications/ adverse events (AEs) ≤30 days (%) 

NR NR 35.6 NR 13.6 

Major AEs 

18.8 

Serious AEs 

24.4 

AEs 

11.7 

systemic; 

16.4 loca

Major complications/AEs >30 days (%) 

NR NR NR NR 46.8 at 2 

years 

Major AEs 

34.9 at 1 year 

Serious AEs 

32.4 at 1 

year 

AEs 

16.9 at 2 

years 

Primary conversion (%) 

2.3 NR 5.8 1.7 0 1.6 0 1.7 
Table 9. LIFELINE, FDA, and RCT data for patients undergoing EVAR for AAA (continued) 

75

Pooled 

LIFELINE* 

and FDA 

Cook 

Zenith 

(n=3,016) 

SVS 

Outcomes 

Database 

“High 

Risk” 

(n=565) 

FDA 

Guidant 

ANCURE 

(n=121) 

FDA 

Medtronic 

ANEURX 

(n=416) 

FDA Gore 

EXCLUDER 

(n=235) 

FDA 

Endologix 

POWERLINK 

(n=192) 

FDA Cook 

ZENITH 

(n=352**) 

DREAM 

RCT 

(n=173) 

Conversions ≤12 

months (%) 

2.5 

(75/3015) 

28 post 6 

months 

NR 7.4 1.9 0 

10 post 24 

months 

2.1 0.85; 

2 post 12 

months 

NR 

Secondary interventions ≤30 days (%) 

15.6 

(415/2664) 

LIFELINE 

NR NR NR NR NR NR Reported 

for 2 

endoleaks 

Secondary interventions ≤12 months (%) 

15.4 

(464/3015) 

NR NR 6.7 6.4‡‡ 9.9 10.3 NR 

Secondary intervention >12 months (%) 

83, 81,73 

reintervention 

free: 2, 4, 6 

years 

NR NR NR 5.9‡‡: 12-24 

months 

NR 3.4 12.5 at 2 

years 

Aneurysm rupture ≤12 months (%) 

0.17; 14 

post 12 months 

<1; 2 at 1 

year 

5 post 12 

months 

0 0.2 0 0 0.28 None 

(considere

in 2 

patients) 

Endoleaks ≤30 days (%) 

NR 14.2 51.8 46.6 21.7 22.7 16.8 2 reinterventio

Endoleaks ≤12 months (%) 

NR 17.5 33 17.4 17.3 14.1 3 NR 

* N=2,664; Pooled clinical trial data for ANCURE, ANEURX, EXCLUDER and POWERLINK ** EVAR group comprised of Standard Risk (SR) group (n=200), High Risk group (n=100) and Roll-in group (n=52) † Based on median of diameter ranges (Interquartile range if provided) †† SR group only ‡ Estimated from Kaplan-Meier analysis ‡‡ For endoleak and aneurysm size increases NR Not reported 
76

Table 10. Summaries of LIFELINE, FDA data, and RCT data for patients undergoing OSR (or no intervention) for AAA 

Pooled 

LIFELINE* 

and FDA 

Cook 

Zenith 

(n=414) 

SVS 

Outcomes 

Database 

“High 

Risk” 

(n=61) 

FDA 

Guidant 

ANCURE 

(n=111) 

FDA 

Medtronic 

ANEURX 

(n=66) 

FDA Gore 

EXCLUDER 

(n=99) 

FDA 

Endologix 

POWERLINK 

(n=66) 

FDA Cook 

ZENITH 

(n=80) 

DREAM 

RCT 

(n=174) 

Demographics/comorbiditiesMean age (range) 69.8 74.2 71.6 ± 7.0 69 (49-85) 70 (51-87) 69.7 ± 7.9 69 ± 7.0 69.5 ± 6.8 Mean preop AAA diameter 

5.8 6.6 ± 1.0 5.6** 6.0** 6.0** 5.9** 6.4** 6.0 

± 0.9 

Male gender (%) 81 67.2 76.6 85 74 86.4 88.6 90.2 CHD (%) 53.4 67.3 61.3 8 54 59.4 28.8 (MI) 46.6 HTN (%) 69.8 72.1 71.2 56 NR 69.7 83.3 54.0 DM (%) 13 16.4 9.9 9 NR 18.2 15.2 9.8 COPD (%) 26.6 70.5 29.7 36 25 24.2 17.9 17.8 Smoking Hx (%) 87.8 77.1 90.1 82 85 85.7 95 54.0 Outcomes Mortality ≤30 days (%) 

1.4 4.9 crude; 

5.1† 

2.7 0 0 6.1 2.5 4.6 

Mortality 2 years (%) 

7.8 13.1; 

14† 

NR NR 6.1; 

7.0† 

NR NR 10.1; 

10.4† 

AAA-related Mortality 2 years (%) 

1.2 at 1 

year 

4.9; 

5.2† 

NR NR 2.0; 

2.0† 

NR NR 4.5; 5.7 

cumulative 

rate 

Mortality 4 years (%) 

12.6 24.6; 

44.0† 

NR NR 12.1; 

15.0† 

NR NR NR 

AAA-related Mortality, 4 years (%) 

NR 4.9; 

5.2%† 

NR NR 2.0 NR NR NR 

Major complications/adverse events (AEs) ≤30 days (%) 

NR NR 44.1 NR 57.0 34.9 

Serious AEs 

42.5 

AEs 

26.4 

Systemic; 

8.6 Local 

Major complications/AEs >30 days (%) 

NR NR NR NR 66.0 45.5 

Serious AEs 

51.0 

AEs 

19.4† at 2 

years 

AAA rupture ≤12 months (%) 

NR 0 NR NR 0 NR NR 0 

* Pooled trial data for ANCURE, ANEURX, EXCLUDER and POWERLINK; ** Based on median of diameter ranges; † Estimated from Ka

NR = Not reported
77 

Question 4: What are the costs-benefits for each of the procedures?

 Aside from studies developing Markov models to estimate lifetime costs and the cost 

effectiveness of EVAR and OSR, the majority of studies reviewed for the economic analysis 

report either on the costs associated with the initial elective procedure (EVAR, OSR, or both) or 

on costs of followup care for EVAR. If studies reporting on cost also include measures of 

effectiveness, we report those findings as well as conclusions regarding cost effectiveness. 

 The results of the two EVAR RCTs for AAA ≥5.5 cm (EVAR vs. OSR and EVAR vs. no 

intervention) were used as the basis for a cost-effectiveness modeling. With those two 

exceptions, most of the data on costs or effectiveness (rarely both) come from observational 

studies, some of which are simply case series with no comparative analysis. 

 All of the retrospective reviews and prospective case series included in our analyses have 

taken an institutional perspective and report only the costs incurred by the hospital(s) and/or 

clinics. None take the societal perspective of including the cost or quality of life associated with 

the patient’s or caregiver’s time lost from work or other activities while hospitalized, traveling, 

or attending followup visits. 

 Table 11 on page 79 presents an overview of the included studies. These studies vary not 

only by type (i.e., RCTs, systematic reviews, Markov models, retrospective reviews, and 

prospective case series), but also along several substantive dimensions including country, 

population, time horizon, type of grafts, patient selection criteria, and economic perspective 

(societal or institutional). A few studies report on hospital incentives supporting the use of these 

two procedures within the context of their profitability relative to Medicare reimbursement rates 

for DRGs 110 and 111 (AAA repair with and without complications, respectively). 

 The costs reported within the studies reviewed also vary by whether they considered direct, 

indirect, variable, and/or fixed costs. As individual hospital accounting systems do not 

necessarily follow a standardized approach to allocating costs across departments, the costs 

reported within this systematic review reflect a variety of costing methodologies. Despite these 

qualifications, we found a general consensus in the relative costs of EVAR and OSR within each 

of these studies regardless of the time frame considered. 

Results 

 UKSAT measured and valued direct health service costs for use of UK National Health 

Service (NHS) resources for participants in their trial. The mean cost of treatment in the earlyOSR group was significantly higher than that for ultrasonographic surveillance (£ = 4,978 vs. 

£3,924; difference = £1,064, CI 799-1,328).147 It is not clear how these costs would directly 

relate to U.S. settings. Trials conducted outside the U.S. do not reflect U.S. norms associated 

with resource valuation, utilization of health care resources, practice variation, and U.S. health 

care expertise. One cost-effectiveness report used UKSAT data and concluded that despite the 

negative conclusions of the UK trial, early OSR may be modestly cost effective for patients with 

small AAAs, particularly younger patients (<72 years of age).148 Given the higher cost associated 

with early OSR and the lack of effectiveness regarding survival and quality of life from the 

UKSAT and ADAM studies (published subsequent to the above cost-effectiveness analysis), it is 

difficult to accurately conclude that early OSR is cost-effective compared to surveillance with 

delayed OSR. Although they used different data bases, included different cost elements, were 

based in different countries with differing health care and payment systems, and focused on 
78 

elective and ruptured AAAs, both studies of OSR cost-effectiveness came up with similar 

findings, an Incremental Cost Effectiveness Ratio (ICER) of about $11,000 per QALY.142, 155

 With regard to the main comparison of EVAR and OSR, our analyses begins with a 

discussion of the overall results of the 12 studies providing cost data comparing EVAR and OSR, 

and then a discussion of the studies reporting on the costs associated with either procedure. 

Studies include one RCT,13 one systematic review,33 seven retrospective reviews, and three 

Markov models,17,149,150 one of which is based on the results of one of the other studies. 

 Regardless of time frame, all studies comparing EVAR and OSR report higher costs 

associated with EVAR compared to OSR (Table 11 on page 79). Studies relying on Markov 

models to estimate long-term followup report that the relative cost of EVAR and OSR is very 

sensitive to the cost of the graft (production costs versus commercial pricing) as well as the need 

for followup care associated with monitoring, complications, and reinterventions. 

 Of the 15 studies reporting cost data, four reported on the direct variable costs,64,147,151,152

excluding the indirect costs that take into account overhead (e.g., utilities) and fixed costs (e.g., 

new hospital equipment, training). Six of the studies included both direct and indirect costs;153-158

the remaining five were unclear.4,51,145,159 Excluded studies are shown in Table 12 on page 80. 

 Summarizing or comparing the studies reporting on costs is complicated by the variety of 

approaches taken to calculate costs. Each study includes different elements and combines them 

differently. Table 13 on pages 81-87 displays what elements were addressed in each of the 

studies considered, as well as the degree to which the papers fully enumerated what was included 

in their cost analysis. For example, the vague descriptor “hospital care” included distinctly 

different subcategories of services from one hospital to another. The majority of the studies did 

not include pre- or post-operative costs and did not include surgeon fees within the cost of the 

hospitalization for the initial procedure nor in their total cost estimates. Studies from other 

countries are hard to translate into the U.S. context. Not only do hospital costs differ, but the 

basis for the costs is often different. For example, LOS has a different effect on costs in the 

context of DRGs; it is a cost to the hospital but not to the payer. Focusing on studies reporting 

hospitalization costs (as opposed to charges, which tend to be higher), EVAR hospitalization 

costs for the initial procedure ranged from a low of $16,700 reported by Dryjski et al.156 to a high 

of $23,000 in Bertges et al.153 Although the cost of the EVAR graft reported within Dryjski et 

al.156 was among the highest reported in all of the studies, a number of items were explicitly 

excluded from the cost analysis that led to a relatively low hospitalization cost estimate. These 

items are anesthesia, respiratory care, pharmacy, radiology, and laboratory tests. Bertges et al., 

on the other hand, included a very comprehensive itemized list of categories of care in their 

analyses and thus report higher hospitalization costs of $23,000.153

 Studies reporting OSR hospitalization costs for the initial procedure ranged from a low of 

$9,000 reported by Dryjski et al.156 to a high of $18,500 in Bosch et al.154 This difference is again 

due in part to Dryjski’s explicit exclusion of a number of categories of care as listed above. 

 Studies reporting hospital charges are generally higher than costs, ranging from $45,000 64 to 

$50,00051 for EVAR hospitalizations and $31,000 64 to $47,00051 for OSR hospitalizations. The 

Australian study is on the low end of the scale, reporting costs of approximately $16,000 and 

$13,400 for EVAR and OSR respectively.157 

 None of the studies reported on the cost of acquiring new equipment or the training required 

by surgeons to perform EVAR. Both of these items can be quite costly. 
79 

EVAR Prosthesis 

 

 Since the cohort year also represents the year that the grafts were used, it represents the stage 

of the technology and to some extent the learning curve associated with the procedure. The 

majority of the EVAR grafts reported on in these studies received FDA approval in 1999.67 The 

cost of some of these grafts may have been discounted or paid for based on production costs at 

the time the studies were underway. Once grafts became commercially available, they became 

more expensive. As the driving force behind the majority of the cost of EVAR is the cost of the 

graft, associated supplies/equipment, and the degree of complications associated with followup, 

the cohort year relative to the year the grafts became commercially available is important. 

 Cost estimates for the EVAR graft range from a low of $7,000 reported for a 1997-1999 

patient cohort154 to $13,000 reported for a 2000 patient cohort.156 The graft accounts for a range 

of 34 percent to 78 percent of the total hospitalization costs reported in these two studies 

respectively, with the differences in percentages largely a reflection of how comprehensively the 

authors itemized costs. Bosch et al. relied on graft costs reported in the literature near the time of 

commercialization and estimated a relatively low price for the graft relative to the cost of the 

hospitalization, thus contributing to underestimating the total hospitalization costs for EVAR, 

underestimating the difference in the cost of EVAR relative to OSR, and underestimating the 

percent of total hospitalization costs attributable to the graft.154 In contrast, Dryjski et al. 

underestimated the cost of the hospitalization relative to the graft by excluding a number of 

categories of necessary hospital services from the cost estimate.156 

Reimbursement Issues 

 The adequacy of Medicare reimbursement for either procedure varies by type of hospital, 

geographic region, and type of grafts used primarily for EVAR. Several studies report that from 

a hospital's perspective, reimbursement may not be sufficient to cover the cost of EVAR 

hospitalization, primarily because the DRG rates were set before EVAR procedure was 

introduced, thus not taking into account the cost of the prosthesis (graft). Studies published in the 

late 1990s rely on production costs associated with grafts. Once grafts obtained FDA approval 

and became commercially available, grafts essentially doubled in price, making it more difficult 

for hospitals to break even based on Medicare reimbursement rates for AAA repair. As Medicare 

reimbursement rates for AAA repair do not differentiate between EVAR and OSR, they do not 

reflect the high cost of the EVAR grafts or differences in length of stay. Hospitals may thus be 

trading off savings from reduced length of stay against the cost of the EVAR prosthesis. 

Measures of Effectiveness (Table 14 on pages 88-89) 

 Measures of effectiveness include the LOS associated with the initial hospitalization, ICU 

time, mortality (in-hospital, 30 day) and morbidity, complication, and reintervention rates. 

EVAR has a shorter LOS associated with the initial hospitalization, range 2.0 days,151 to 10 

days13 includes preoperative assessments) compared to OSR, range 7.3 days151 to 15.7 days.13

The longer length of hospital and ICU length of stay are based on the randomized trials that were 

conducted in Europe and thus may not be comparable to U.S. settings. Less ICU time is 

associated with EVAR’s initial hospitalization, range 0.6 days152 to 1.4 days,156 compared to 
80 

OSR, range 2 days64 to 3.5 days.151 Thus, EVAR is associated with less resource use in terms of 

a patient’s time spent in the hospital as well as use of the ICU. Because hospital beds are 

expensive and essentially define the hospital’s capacity/ability to serve patients, from the 

hospital’s perspective, EVAR may represent a more efficient use of hospital resources than OSR. 

 Short-term benefits associated with EVAR include reduced LOS, reduced use of ICU, 

reduced operative, and 30-day mortality and morbidity. However, results of two RCT comparing 

EVAR with OSR have provided additional midterm outcome data after 2-4 years of followup. 

The results from these studies (which were not conducted in the U.S.) indicate that compared to 

OSR, EVAR reduces AAA related mortality by 3 percent. However, after 2 years there was no 

difference in overall survival. Differences in health related quality of life were small, may not be 

clinically noticeable, and disappeared after 3 months. EVAR costs were higher than OSR and 

were associated with more complications, need for reinterventions, and continued monitoring. 

Cost Effectiveness Analyses Using Markov Methodologies (Table 15 on 

pages 90-92) 

 Table 15 summarizes three studies that utilized Markov methodologies to analyze differences 

in the cost and effectiveness of EVAR and OSR over a patient’s lifetime17,149,150 and two studies 

that compared OSR to conservative treatment. All three of the former found that EVAR was 

more expensive. Two of the studies were conducted in the U.S. and report that a higher quality of 

life was associated with EVAR and that the ICERs were $9,905 per QALY and $22,826 per 

QALY respectively.149,150 While Bosh, Patel, and Michaels use differing baseline operative 

mortality rates and QOL measures, they all use 70 year olds with aneurysms between 5 and 6 cm 

as their baseline reference case. The Patel study used assumptions of effectiveness based on case 

series data. They conclude that the benefits were worth the cost with the qualification that their 

results were highly dependent on their assumptions regarding mortality and morbidity. Patel et 

al. reported that EVAR may be more cost effective than OSR if operative mortality rates were 

<1.2 percent and the surgical mortality rates were >1.7 percent.150 However, if the combined 

mortality and long term morbidity rate of open surgery decreased from 9.1 percent to 4.7 percent, 

the authors concluded that EVAR may not be cost effective. Bosch et al. also used case series 

data as the basis for their model; they report the sensitivity of their conclusions to EVAR graft 

performance in terms of long term failure and rupture rates.149 They fail, however, to explicitly 

account for the cost of the EVAR prosthesis by using Medicare reimbursement rates for DRG 

codes 110 and 111 (AAA repair with and without complications, respectively) to estimate the 

cost of the initial AAA repair. These DRG codes do not distinguish differences in the cost of 

AAA repair by procedure (i.e., by EVAR and OSR), and do not include the cost of the EVR 

prosthesis. Thus, Bosch et al. underestimate the cost of the EVAR initial hospitalization costs 

relative to OSR and report a conservative estimate of the costs in the cost effectiveness ratio. On 

the other hand, Bosch includes patients’ time lost from work in terms of lost wages in the costs 

associated with each procedure. As they also estimate the impact of the procedures on the 

patients’ quality of life and include this in the denominator of the cost effectiveness ratio, they 

have essentially double counted the impact of AAA repair from the patient’s perspective. 

 Although Bosch and Patel varied their analytical assumptions and conducted sensitivity 

analyses, they did not vary their assumptions simultaneously by employing probabilistic 

sensitivity analyses to fully test the robustness of their findings as recommended by the U.S. 

Panel on Cost Effectiveness in Health and Medicine.160-162
81 

 In a more recent, rigorous approach to Markov modeling, Michaels et al.17 used data from the 

EVAR trials and concluded that EVAR was NOT cost effective, in that the extra cost was not 

worth the gain in QALYs.17 Their ICER was ₤110,000 per QALY, which is well above accepted 

norms for cost effective procedures.65,160 Michaels et al.17 found that the cost effectiveness of 

EVAR and OSR is sensitive to assumptions regarding lower early morbidity for EVAR, higher 

operative mortality rate for OSR, higher need for followup care for EVAR, higher reintervention/ 

complication rates for EVAR, e.g., 25-30 percent for EVAR versus 0 percent for OSR, and 

higher costs associated with care provided to EVAR patients, regardless of time frame. 

 Michaels et al. point out that there is a time dependent effect.17 Studies conducted within a 

relatively short timeframe fail to adequately address the long-term benefits, harm, or costs 

associated with EVAR. Decreased operative mortality rates associated with EVAR may be offset 

by higher complication rates later in life. If followup costs associated with complications and 

reinterventions for EVAR are ignored, then EVAR’s low operative mortality rates favor EVAR 

and may lead to the premature conclusion that EVAR is a cost effective alternative to OSR. This 

assumption is particularly relevant given the midterm results from RCTs demonstrating that 

compared with OSR, EVAR offered no advantage in all-cause mortality or health related quality 

of life and led to a greater number of complications and reinterventions. 

 In terms of the cost effectiveness of the two procedures, Michaels et al. found that OSR 

dominates if operative mortality rates are less than 3 percent.17 OSR is preferred if EVAR’s 

cost/QALY is greater than $30,000 and if operative mortality rates for OSR are between 3 

percent and 11 percent. EVAR dominates if operative mortality rates are greater than 40 percent. 

If EVAR costs are similar to OSR, and/or if EVAR reintervention rates are cut by 50 percent, 

then EVAR is preferred over OSR. If operative mortality rates are between 11 percent and 40 

percent, Michaels et al. report that the outcome of whether EVAR is a cost-effective alternative 

to OSR is uncertain.17 Again, this cost effectiveness analysis did not include the midterm results 

from RCT. 

 Although Michaels takes the most rigorous approach employing probabilistic sensitivity 

analyses, they do not explicitly state their assumptions regarding what cost categories they 

considered for the initial procedure, nor for the cost of the EVAR prosthesis. The authors state 

that this new technology comes at a considerable price, yet no explicit monetary value was 

reported, nor was any sensitivity analyses on the cost of the graft and its effect on the cost 

effectiveness of EVAR relative to OSR conducted. 

 Michaels also reported that EVAR was cost effective compared to no intervention in 

individuals with large AAA who were judged medically unfit for OSR.17 However, they did not 

use results from EVAR-2 that directly compared EVAR with no intervention.145 The findings 

from this RCT demonstrated that EVAR had a considerable 30-day operative mortality in 

patients already medically unfit for OSR. EVAR did not improve survival compared to no 

intervention, had little effect on health-related quality of life, and was associated with a need for 

continued surveillance and reinterventions, at substantially increased cost. Therefore, the authors 

of EVAR-2 concluded that they saw no reason to pursue cost-effectiveness modeling. 

 As shown in Table 15, each of these cost-effectiveness models used different levels of 

specificity when describing how the costs of treatment were calculated. The Michaels study 

provided almost no guidance about just what went into their calculations. 

 None of these Markov studies analyzing the cost effectiveness of AAA repair included the 

less favorable midterm results regarding quality of life, survival, complications, or need for 

reintervention described above from recently reported RCTs of EVAR versus OSR. Furthermore, 
82 

as no RCT studies have been completed within the U.S., the relevance of the cost data 

incorporated within these Markov studies from other countries is questionable. 

 Although none of the studies give confidence intervals around the cost effectiveness ratios, 

the use of probabilistic sensitivity analyses (PSA) and the percent of simulations falling below 

the reference threshold addresses this issue. However, for those studies not using PSA, because 

of the large observed variability in operative mortality, EVAR complication rates and the need 

for reintervention, confidence intervals would help clarify the significance of the point estimate, 

and the comparability of the reported cost effectiveness ratios. For all of the reasons mentioned 

above, the cost effectiveness of EVAR versus OSR remains unclear, particularly for specific 

patient cohorts defined by age, aneurysm size, and comorbidity. 
83

Table 11. Overview of studies 

Procedures Authors 

(Reference) 

Study Type Publication 

Year 

Cohort Year Country Sample Size Timefram

EVAR, OSR Bosch149 Markov CEA 2002 Not applicable USA Not applicable lifetime 

Patel150 Markov CEA 1999 Not applicable USA Not applicable lifetime Michaels17 Markov CEA 2005 Not applicable UK Not applicable 10 years EVAR-113 RCT 2005 1999 UK 543, 539 4 years Angle151 Retrospective 

review 

2004 2000-2001 USA 55, 64 Hospital 

Bosch154 Retrospective 

review 

2001 1997-1999 USA 181, 273 Hospital 

Clair152 Retrospective 

review 

2000 1998 USA 45, 94 Hospital 

Dryjski156 Retrospective 

review 

2003 2000 USA 73, 57 Hospital 

Hayter157 Retrospective 

review 

2005 1995-2004 Australia 55, 140 Hospital + 1 ye

followup 

Lee51 Retrospective 

review 

2004 2001 USA 2565, 4607 Hospital 

Sternbergh64 Retrospective 

review 

2000 1996-1997 USA 131, 49 Hospital 

Maher33 Systematic 

review 

2003 Not applicable Not applicable Not applicable Not applicable 

EVAR, CM Michaels17 Markov CEA 2005 Not applicable UK Not applicable 10 years 

EVAR-2145 RCT 2005 1999 UK 166, 172 4 years 

EVAR only Prinssen159 Prospective 

review 

2004 1994-2000 Netherlands 77 Followup 

surveillance 

Bertges 153 Retrospective 

review 

2003 2000-2001 USA 221 Hospital 

Lester158 Retrospective 

review 

2001 1994-1999 USA 91 Hospital 

OSR, CM UKSAT147 RCT 1998 1991-1995 

UKSAT 

UK 563, 527 18 months pos

randomization 

Schermerhorn148 Markov CEA 2000 Not applicable UK Not applicable Lifetime 

OSR only Brox155 Retrospective 

review 

2003 1997-2000 USA/Canada 505(US), 

552(Canada) 

Hospital 

Huber4 Retrospective 

review 

2001 1994-1996 USA 16,450 Hospital 

Patel163 Markov CEA 2000 Not applicable USA Not applicable 

CM – Conservative Management, EVARh and OSRh = cost associated with initial hospitalization for EVAR and OSR respectively. 
84

Table 12. Studies excluded from systematic review 

Exclusion 

rationale 

Authors 

(reference) 

Study type Publication 

year 

Cohort year Sample size Timeframe 

Aquino66 Prospective 2001 1997-1999 25, 26 Hospital + 1 year 

followup 

N

Berman67 Prospective 2002 1999-2000 9, 11 Hospital $

$

Birch68 Retrospective 

review 

2000 1996-1999 31, 31 Hospital, pred 

lifetime 

$

Forbes69 Retrospective 

review 

2002 1998 7, 31 Hospital +1 year 

followup 

$

Lottman70 RCT 2004 1996-1999 57, 19 Preop, 1 and 3 

months postop 

N

<50 in either arm 

Rosenberg71 Retrospective 

review 

2005 2002-2003 34, 54 Hospital $

$

No cost information 

Drury6 Systematic 

review 

2005 Not applicable Not applicable Not applicable N

EVARh and OSRh = cost associated with initial hospitalization for EVAR and OSR respectively
85

Table 13. Cost analyses and findings 

 EVAR-1 0513 Angle 04151 Bosch 01154 Cla

 Type of cost data (source) Hospital costs (UK 

National Health 

Service) 

Hospital costs 

(unspecified) 

Hospital costs (TSI) Hospita

 Type of study RCT Retrospective review Retrospective review Retrospe Direct only or direct AND 

indirect 

Unclear Direct only Direct and indirect Dire

 Currency UK pound U.S. dollar U.S. dollar, 1999 U.S Cohort 1999-2003, UK 2000-2001 1997-1999 1

EVAR OSR EVAR OSR EVAR OSR EVAR 

Ancure, Guidant (Menlo Park, CA) 

- 9 "majority" 9 - 

AneuRx, Medtronic (Santa Rosa, CA) 

9 4% 9 "rest" - 9 100%

Excluder, Gore (Flagstaff, AZ) 9 7% - 9 - Talent, Medtronic (Minneapolis, MN; Santa Rosa, CA) 

9 33% - - - 

Vanguard, Boston Scientific (Wayne, NJ) 

- - 9 - 

Zenith, Cook (Bloomington, IN; Denmark) 

9 51% - - - 

Other commercial grafts 9 5% - - - Custom-made stents - - 9 43% - Straight, tube type 9 10% 9 17% 57% 9 8%Bifurcated type 9 90% 9 83% 43% 9 64%

------ GRAFTS USED ----- 

Other  9 27%

 

Ancillary supplies included in graft costs 

--- not specified not specified 

EVAR OSR EVAR OSR EVAR OSR EVAR 

 Initial ER evaluation - - ?  Preop / preop diagnostics - - ?  Total preop - - ?  Commercial graft / prosthetic 

device 

9 9 $7,000 $600 $8,976 

 % hospital costs accounted for 

by graft 

 58% 34% 3% 

 Operating room 9 9 9  Surgeon fees ? ? -  Nursing ? 9 9  Anesthesia ? ? 9 
Table 13. Cost analyses and findings (continued) 

86

 EVAR-1 0513 Angle 04151 Bosch 01154 Cla

 Medical/surgical supplies ? 9 9  Respiratory services/ventilation ? 9 ?  Pharmacy ? 9 ?  Radiology ? 9 9  Blood/transfusion 9 ? ?  Laboratory ? 9 ?  Postop ICU 9 9 9  Postop ward 9 9 9  Post diagnostic ? - ?  Allied health, therapy, etc. ? - ?  "Procedure" 9 9 9  "Hospital," "inpatient 

hospitalization" 

9 9 9 

 Patient costs (time, travel, 

morbidity). 

- - - 

 "Other" 9 ? ?  Total hospitalization ₤10,819 ₤9,204 EVAR =1.74*OSR $20,716 $18, 484 EVAR =  Total preop + hospitalization - - -  Radiology: imaging followup 9 - -  Endoleak repair 9 - -  Conversion to OSR 9 - -  "Adverse events" 9 - -  Patient costs (time, morbidity) 9 - -  Total followup ₤2,439 ₤741 - -  GRAND TOTAL ₤13,258- 

4 years 

₤9,945-

4 years 

- - 

 Dryjski 03156 Hayter 05157 Lee 04

 Type of cost data (source) Hospital costs (unspecified) Hospital costs (Medicare 

benefits schedule, MBS) 

Hospital charge

Inpatient Samp

 Type of study Retrospective review Retrospective review Retrospective  Direct only or direct AND indirect Direct and indirect Direct and indirect Direct and i Currency U.S. dollar AU converted U.S. dollar, 

2003/04 

U.S. dollars

 Cohort 2000 1995-2004 2001 
Table 13. Cost analyses and findings (continued) 

87

 Dryjski 03156 Hayter 05157 Lee 04

EVAR OSR EVAR OSR EVAR 

Ancure, Guidant (Menlo Park, CA) 9 91% - AneuRx, Medtronic (Santa Rosa, CA) 9 9% - Excluder, Gore (Flagstaff, AZ) - 9 25% All availaTalent, Medtronic (Minneapolis, MN; 

Santa Rosa, CA) 

- 9 2% (National data

Vanguard, Boston Scientific (Wayne, NJ) - - Zenith, Cook (Bloomington, IN; 

Denmark) 

- 9 73%

Other commercial grafts - - Custom-made stents - - Straight, tube type ? 66% 9 Bifurcated type 9 9 100% 34% 9 

------ GRAFTS USED ----- 

Other 

 Ancillary supplies included in graft costs? yes yes Not spec

 Initial ER evaluation - - -  Preop / preop diagnostics - 9 - 

Total preop - $733 $663 - 

 Commercial graft / prosthetic device $12,974 $750 $7,765 $363 $10-$12,000  % hosp costs accounted for by graft 78% 8% 49% 3%  Operating room 9 9 ?  Surgeon fees - 9 ?  Nursing 9 9 ?  Anesthesia - 9 ?  Medical/surgical supplies ? 9 ?  Respiratory services/ventilation - 9 ?  Pharmacy - 9 ?  Radiology - 9 ?  Blood/transfusion ? ? ?  Laboratory - ? ?  Postop ICU 9 9 ?  Postop ward 9 9 ?  Post diagnostic ? 9 ?  Allied health, therapy, etc. ? 9 ?  "Procedure" ? 9 ?  "Hospital," "inpatient hospitalization" ? 9 9 Patient costs (time, travel, morbidity). - - -  "Other" ? ? - 
Table 13. Cost analyses and findings (continued) 

88

 Dryjski 03156 Hayter 05157 Lee 04

Total hospitalization $16,731 $9,042 $15,898 $13,400 $50,346 Total preop + hospitalization - $16,631 $14,063 - 

 Radiology: imaging followup - 9 -  Endoleak repair - 9 -  Conversion to OSR - None needed -  "Adverse events" - 9 -  Patient costs (time, morbidity) - 9 - 

Total followup - $2,013 $59 - GRAND TOTAL - $18,644 

at 2 years 

$14,122 

at 2 years 

- 

 Sternbergh 0064 EVAR2 05145 Prinssen 04159 Bertg

 Type of cost data (source) Hospital costs 

(unspecified) 

Hospital costs (UK 

National Health Services) 

Hospital costs Hospita

ch

 Type of study Retrospective review RCT Prospective review Retrospe Direct only or direct AND indirect Direct only Unclear Direct and indirect Direct a Currency U.S. dollar UK pound U.S. dollar U.S Cohort 1996-1997 1999-2003, UK 1994-2000 200

 EVAR OSR EVAR CM EVAR E

Ancure, Guidant (Menlo Park, CA) 

- - 9 97% 9 

AneuRx, Medtronic (Santa Rosa, CA) 

9 100% 9 6% - 9 

Excluder, Gore (Flagstaff, AZ) - 9 7% 9 3% Talent, Medtronic (Minneapolis, MN; Santa Rosa, CA) 

- 9 21% - 

Vanguard, Boston Scientific (Wayne, NJ) 

- - - 

Zenith, Cook (Bloomington, IN; Denmark) 

- 9 59% - 

Other commercial grafts - 9 7% - Custom-made stents - - - Straight, tube type ? 9 13% 9 17%Bifurcated type ? 9 87% 9 52%Other 9 21%

------ GRAFTS USED -----

Ancillary supplies included in graft costs? 

Not specified --- --- 
Table 13. Cost analyses and findings (continued) 

89

 Sternbergh 0064 EVAR2 05145 Prinssen 04159 Bertg

 Initial ER evaluation ? - -  Preop / preop diagnostics 9 - -  Total preop $1,100 $644 - -  Commercial graft / prosthetic 

device 

$10,200 $653 9 - $1

 % hospital costs accounted for 

by graft 

51% 6% - 

 Operating room  Surgeon fees - ? -  Nursing ? ? -  Anesthesia 9 ? -  Medical/surgical supplies 9 ? -  Respiratory services/ventilation ? ? -  Pharmacy 9 ? -  Radiology ? ? -  Blood/transfusion 9 9 -  Laboratory ? ? -  Postop ICU 9 9 -  Postop ward 9 9 -  Post diagnostic 9 ? -  Allied health, therapy, etc. ? ? -  "Procedure" 9 9 -  Hospital," "inpatient 

hospitalization" 

9 9 - 

 Patient costs (time, travel, 

morbidity) 

- - - 

 "Other" ? 9 - 

Total hospitalization $20,150 $11,698 ₤11,016 ₤3,518 $2

 U.S. dollars $17,626 $5,629  Total preop + hospitalization $21,250 $12,342 - -  Radiology: imaging followup - 9 9  Endoleak repair - 9 9  Conversion to OSR - 9 9  "Adverse events" - 9 ?  Patient costs (time, morbidity) - 9 - 

Total followup ₤2,616 ₤1,465 $9,729 (5 years) GRAND TOTAL ₤13,632-

4 years 

₤4,983- 

4 years 
Table 13. Cost analyses and findings (continued) 

90

 Lester 01158 Brox 03155 Forbes 98147 Hu

 Type of cost data (source) Hospital costs (TSI) Hospital costs (TSI) Hospital cost (UK 

National Health Service) 

Hospit

 Type of study Retrospective review Retrospective review RCT Retrospe Direct only or direct AND 

indirect 

Direct and indirect Direct and indirect Direct only Direct a

 Currency U.S. dollar U.S. dollar, 2000 UK pound U.S. do Cohort 1994-1999 1997-2000 ? 199

Treatment EVAR OSR-USA OSR-Canada CM OSR O

Ancure, Guidant (Menlo Park, CA) 

9 

AneuRx, Medtronic (Santa Rosa, CA) 

- 

Excluder, Gore (Flagstaff, AZ) 9 Not applicable Not applicable Not aTalent, Medtronic (Minneapolis, MN; Santa Rosa, CA) 

- 

Vanguard, Boston Scientific (Wayne, NJ) 

9 

Zenith, Cook (Bloomington, IN; Denmark) 

- 

Other commercial grafts - Custom-made stents - Straight, tube type 9 21%Bifurcated type 9 79%

------ GRAFTS USED ----- 

Other 

 

Ancillary supplies included in graft costs? 

Not specified --- --- 

 Initial ER evaluation 9 ? ?  Preop / preop diagnostics ? ? ?  Total preop ? ? ?  Commercial graft / prosthetic 

device 

- 9 ? 

 % hospital costs accounted for 

by graft 

 Operating room 9 9 ?  Surgeon fees - - ?  Nursing 9 9 ?  Anesthesia 9 9 ?  Medical/surgical supplies 9 9 ?  Respiratory services/ventilation ? 9 ? 
Table 13. Cost analyses and findings (continued) 

91

 Lester 01158 Brox 03155 Forbes 98147 Hu

 Pharmacy 9 9 ?  Radiology 9 9 9  Blood/transfusion 9 9 ?  Laboratory 9 9 ?  Postop ICU 9 9 ?  Postop ward 9 9 9  Post diagnostic 9 9 ?  Allied health, therapy, etc. 9 ? ?  "Procedure" 9 9 9  "Hospital," "inpatient 

hospitalization" 

9 9 9 

 Patient costs (time, travel, 

morbidity) 

- - - 

 "Other" 9 ? 9  Total hospitalization 9 $19,000 $16,000 ₤3,914 ₤4,978 $3 Total preop + hospitalization $11,842 ? ?  Radiology: imaging followup - ? ?  Endoleak repair - ? ?  Conversion to OSR - ? ?  "Adverse events" - ? ?  Patient costs (time, morbidity) - ? ?  Total followup - ? ?  GRAND TOTAL - ? ? 

Key: explicitly included cost (); explicitly excluded cost (-); cost not mentioned or inclusion/exclusion uncertain (?). 
92

Table 14. Short-term mortality, hospital, and intensive care unit (ICU) length of stay 

Sternbergh 0064 Clair 00152 Angle 04151 Hayter 05157 Lester 01158

EVAR OSR EVAR OSR EVAR OSR EVAR OSR EVAR 

Total N per treatment arm 131 49 45 94 55 64 55 140 91 30-day mortality, n NR NR see notes 2 1 1 2 NR 30-day mortality, % 3.6 1.5 1.8 1.4 In-hospital mortality, n NR NR 0 1 NR NR NR NR 1 In-hospital mortality, % NR NR 0% 1.0% 1% Hospital LOS, days (mean) 3.9 8 3.2 9.7 1.96 

(1 median)

7.3 

(6 median)

6* 10* 3.5 

Hospital LOS, range or SD 3.6* 5.8* 1.4* 4.8* 1.5* 8.3* 4 to 24 6 to 46 2.3* ICU LOS, days (mean) 1.1 2 0.06 2.97 0.09 3.5 0* 1* ICU LOS, range or SD 2.0* 2.3* 0.25* 3.02* 0.29* 7.36* 0 to 3 1 to 19 Notes: *SD *SD unless 

specifically reported as 30-day mortality is assumed to be “in-hospital 

*SD *Median *SD 

 Bosch 01154 Dryjski 03156 Bertges 03153 EVAR1 0513 EVAR2 05145 Brox 031

 EVAR OSR EVAR OSR EVAR EVAR OSR EVAR AS OSR-U.S.

O

C

Total N per treatment arm 181 273 73 57 221 543 539 166 172 2.97* 30-day mortality, n NR NR NR NR NR 9/532 25/518 13/150 1/47 NR 30-day mortality, % 1.7 4.8 8.7 2.1 In-hospital mortality, n 2 8 3 0 NR NR NR NR NR In-hospital mortality, % 1.1% 2.9% 4 5.2% Hospital LOS, days (mean) Postop LOS only 4.9 12.6 2.4 10.3 15.7 NR NR NR Hospital LOS, range or SD 13.4* 14.8* 17.8* 16.9* ICU LOS, days (mean) 1.2* (1 

median) 

2.3* (1 

median) 

1.4 5 NR 0.7 2.4 NR NR NR 

ICU LOS, range or SD 0.4** 

1 to 2 

2.1** 

1 to 12 

7.1* 6.1* 3.8* 5.9* 

Notes: * Includes only 

patients staying 1 day or longer *SD 

*SD *SD * sample size f

elective surgeronly 
Table 14. Short-term mortality, hospital, and intensive care unit (ICU) length of stay (continued) 

93

 Bosch 02149 Huber 014 Lee 0451 Michaels 0517 

EVAR OSR OSR EVAR OSR RC1-

EVAR 

RC1-

OSR 

RC2-

Nothing 

Total N per treatment arm 16450 2565 4607 30-day mortality, n NR NR NR NR NR NR 30-day mortality, % In-hospital mortality, n NR NR 691 (est) 33 176 1.85* 5.8* In-hospital mortality, % 4.2 1.3 3.8 Hospital LOS, days (mean) NR NR 10 

(8 median) 

3.6 

(2 median)

8.8 

(7 median)

NR NR 

Hospital LOS, range or SD 8.1* 5.9* 7.8* ICU LOS, days (mean) NR NR NR NR NR NR NR ICU LOS, range or SD Notes: Markov decision 

model 

*SD *SD Markov decision model 

*Probabilities, presumed postoperative, from RCTs 

M

 UKSAT147 Patel 99150 Prinssen 04159

 AS OSR EVAR OSR EVAR Only 

Total N per treatment arm 527 563 77 30-day mortality, n 4.8* 1.2* NR 30-day mortality, % 7.1% 5.8% In-hospital mortality, n 0 In-hospital mortality, % 7.2% 5.8% 4.8 1.2 Hospital LOS, days (mean) NR NR NR NR NR Hospital LOS, range or SD ICU LOS, days (mean) NR NR NR NR NR ICU LOS, range or SD Notes: *Probability 

AS = Active Surveillance
94

Table 15. Markov models Source of Costs Bosch 2002149 Patel 1999150 Michaels 200517 Schermerhorn 2000148 Direct only or direct AND indirect currency 

Hospital costs, 

Medicare 

reimbursement for 

DRGs 110 & 111 

physician CPT codes 

Direct and indirect 

U.S. dollar, 2000 

Hospital cost 

accounting system, 

Medicare 

reimbursement rates for 

physician CPT codes 

Direct and indirect 

U.S. dollar, 1997 

National Health Service 

(NHS), Sheffield Teaching 

Hospitals, NHS Trust 

Unclear 

UK £, 2003-2004 

Hospital costs (UK NHS), 

UKSAT 

Direct 

UK £ * 1.6 = U.S. $ 

1996-97 

 EVAR OSR EVAR OSR RC1-EVAR RC2-

Surveillance 

OSR CM 

Reference case 70 years old 70 years old 70 years old 80 years old 60-76 years old AAA diameter 5-6 cm 5 cm 5.5 cm 6.5 cm 4-5.5 cm Risk group (fit or unfit for OSR) 

Fit for either procedure Fit for either procedure Fit for either Unfit for 

OSR 

Fit for OSR 

Time horizon lifetime lifetime 10 years 6 years (UK trial) & lifetime Discount rate 3% 3% 3.50% 3% Consumer Price Index (CPI) for inflation 

CPI medical care CPI medical care ? ? 

Baseline operative mortality rate 

3% 4% 1.2% 4.80% EVAR: 1-

85%, OSR: 

5-80% 

Range 5-

80% 

5.8% elective 

Quality of Life (QOL) scores 

-10% for 

30 days 

-30% for 

60 days 

QALY – 

11 days 

QALY – 

47 days 

QOL=0.8 each arm; EVAR: 

QALY – 30 days; OSR: 

QALY – 14 days 

QOL = 0.86 for each arm 

QOL adjustment for complications (Y/N) 

Yes Yes ? Yes 

Software DATA 3.5 (TreeAge) SMLTREE v2.9 TreeAge Pro DATA 3.0 (TreeAge) Probabilistic sensitivity analyses (SA) (Y/N) 

No. one & multiple way 

SA 

No. one & multiple way 

SA 

Yes No. one way SA 

Initial ER evaluation - - ? - Preop / preop diagnostics 

- - ? - 

Total preop - - ? - Graft / prosthetic device 

- - $8,000 $650 ? ? ? 

Type of graft / prosthetic device 

- - Tube 10% 

bifurc 90% 

? ? ? ? ? 
Table 15. Markov models (continued) 

95

Source of Costs Bosch 2002149 Patel 1999150 Michaels 200517 Schermerhorn 2000148 Direct only or direct AND indirect currency 

Hospital costs, 

Medicare 

reimbursement for 

DRGs 110 & 111 

physician CPT codes 

Direct and indirect 

U.S. dollar, 2000 

Hospital cost 

accounting system, 

Medicare 

reimbursement rates for 

physician CPT codes 

Direct and indirect 

U.S. dollar, 1997 

National Health Service 

(NHS), Sheffield Teaching 

Hospitals, NHS Trust 

Unclear 

UK £, 2003-2004 

Hospital costs (UK NHS), 

UKSAT 

Direct 

UK £ * 1.6 = U.S. $ 

1996-97 

% TC accounted for by graft 

 40% 4% ? ? ? 

Operating room ? 9 ? ? 9 Surgeon fees 9 9 ? ? ? Nursing ? ? ? ? ? Anesthesia ? 9 ? ? ? Medical/surgical supplies 

? 9 ? ? ? 

Respiratory services/ ventilation 

? ? ? ? ? 

Pharmacy ? ? ? ? ? Radiology ? 9 ? ? 9 Blood/transfusion ? 9 ? ? ? Laboratory ? 9 ? ? ? Postop ICU ? 9 ? ? ? Postop ward ? 9 ? ? ? Post diagnostic ? 9 ? ? ? “Procedure” 9 9 ? ? 9 “Hospital,” “inpatient hospitalization” 

9 9 ? ? ? 

Patient costs (time, travel, morbidity 

9 9 ? ? ? 

Other ? ? ? ? ? Total hospitalization $19,642 $23,484 $20,083 $16,016 £? £? ? Total preop + hospitalization 

- - - - ? 

Imaging followup 9 9 9 9 9 9 ? Total followup 9 9 9 9 ? GRAND TOTAL $39,785 

lifetime 

$37,606 

lifetime 

$28,901 

lifetime 

$19,314 

lifetime 

? ? $8,000 

lifetime 

$6,490 

lifetime 

Net cost $2,179 more for EVAR $9,587 more for EVAR 11,449 

more for 

EVAR 

14,077 more 

for EVAR 

$1,510 more for early 

surgery* 
Table 15. Markov models (continued) 

96

Source of Costs Bosch 2002149 Patel 1999150 Michaels 200517 Schermerhorn 2000148 Direct only or direct AND indirect currency 

Hospital costs, 

Medicare 

reimbursement for 

DRGs 110 & 111 

physician CPT codes 

Direct and indirect 

U.S. dollar, 2000 

Hospital cost 

accounting system, 

Medicare 

reimbursement rates for 

physician CPT codes 

Direct and indirect 

U.S. dollar, 1997 

National Health Service 

(NHS), Sheffield Teaching 

Hospitals, NHS Trust 

Unclear 

UK £, 2003-2004 

Hospital costs (UK NHS), 

UKSAT 

Direct 

UK £ * 1.6 = U.S. $ 

1996-97 

Net benefit QALYs >0.22 for EVAR QALYs >0.42 for EVAR QALYs 

>0.1 for 

EVAR 

QALYs 

>1.64 for 

EVAR 

QALYs >0.14 for early 

surgery 

Incremental Cost Effectiveness Ratio (ICER) 

$9,905/QALY using 

Medicare 

reimbursement rates 

$22,826 / QALY £100,000 / 

QALY 

£8,579 / 

QALY 

$10,800 / QALY 

Cost calculation based only on simple conversion from British pounds to U.S. dollars using £1.6 = $1 
97

Chapter 4. Discussion 

 AAA are associated with considerable morbidity, mortality and health-care costs. Elective 

OSR has traditionally been considered the intervention of choice to reduce the risk of AAA 

rupture and improve survival in individuals at high risk of rupture. However, EVAR has become 

widely used based on belief that it may provide long-term prevention of ruptures with low 

intervention morbidity and mortality and improved length and quality of life. Approximately 

one-half of large AAA might be anatomically suitable for EVAR. Results from this systematic 

review provide the most up-to-date evidence related to the natural history, treatment, and costs 

associated with asymptomatic nonruptured infrarenal AAA. This report also evaluates evidence 

related to the relationship of surgical and hospital volume on outcomes for both OSR and EVAR. 

 AAA is predominantly a condition of older men with a much lower prevalence in younger 

persons and women. The strongest known predictor of AAA rupture is initial or attained size. 

Patients with AAA <5.5 cm have an annual risk of rupture of approximately 1 percent. For AAA 

<5.5 cm in diameter, high-quality RCT results demonstrate that active surveillance with 

ultrasound and delayed OSR (if AAA attains a diameter of ≥5.5 cm or the patient develops 

aneurysm related symptoms) results in equivalent mortality but lesser morbidity and operative 

costs due to fewer interventions compared to immediate OSR. Therefore, for AAA <5.5 cm, 

active surveillance and delayed OSR if AAA diameter exceed 5.5 cm (or in those that develop 

symptoms consistent with impending rupture) results in comparable long-term survival and 

quality of life, fewer OSR, and lower costs than immediate OSR regardless of age or gender. 

There are no RCT evaluating EVAR in these patients. 

 Among individuals with large AAA and refusing or medically unfit for OSR, the 1 year 

rupture risk may exceed 10 percent in AAA >6 cm and for AAA of >8 cm, the risk may exceed 

25 percent at 6 months. For AAA ≥5.5 cm and suitable for EVAR, high-quality RCTs have been 

conducted outside the U.S. and may have used some EVAR devices that are not approved for use 

in the U.S. Their results demonstrate that compared to OSR for medically fit patients, EVAR is 

associated with lower perioperative morbidity and mortality and persistent reduction in AAAdefined mortality to 4 years, though the latter may be due, at least in part, to ascertainment bias 

for later term cause of death. EVAR did not improve longer term overall survival or health status 

and was associated with greater complications, need for reintervention, long-term monitoring, 

and costs. Because decisions regarding the risks and benefits of AAA treatments should 

incorporate a long-term time frame, additional followup information beyond 4 years is needed. 

There are insufficient data to determine whether outcomes varied according to device type. 

 For the minority of patients with AAA ≥5.5 cm judged medically unfit for OSR, one highquality RCT conducted in the U.K. with EVAR devices that may not be approved for U.S. use 

demonstrated that EVAR did not improve survival at 3 years or health status and costs more than 

no intervention. More than 60 percent of the no intervention group died indicating that longer 

followup was unlikely to alter results. Refinements in EVAR devices or provider experience may 

result in different outcomes. Therefore a RCT conducted in the U.S. with currently approved 

EVAR devices in these patients is indicated. However, unless results from such a RCT refute 

findings from EVAR-2, the RCT data provide the highest quality evidence available for 

treatment decision making and do not support the widespread practice of using EVAR to treat 

AAA in patients judged to be too sick for OSR. Patient treatment preference is difficult to 
98

ascertain. How the results of RCT influence patient and provider treatment preference in the U.S. 

is not known. 

 Data from nonRCT are limited by lack of randomization as well as incomplete followup 

reporting of entered patients. They cannot be used as substitutes for RCT to evaluate the 

comparative effectiveness and adverse effects of AAA treatment options. Few studies provided 

an evaluation according to device or patient characteristics. None represent head to head 

comparisons from RCT. Furthermore, patient or aneurysm factors could influence outcomes. 

Therefore, it is hazardous to make definitive statements regarding relative safety or effectiveness. 

While it is not possible to make direct comparisons with RCT, most reports explicitly stated 

patients were candidates for OSR. Baseline patient characteristics, AAA diameter, 30 day and 2 

year overall, and AAA mortality as well as EVAR conversion rates and secondary interventions 

for included patients were similar to those from EVAR-1 and DREAM. None of these reports 

assessed EVAR in patients with AAA ≥5.5 cm and considered “medically unfit for OSR.” One 

report evaluated outcomes of EVAR and OSR in a retrospectively defined “high surgical risk” 

subgroup of patients entered into any of five nonrandomized multicenter IDE studies leading to 

FDA approval of EVAR devices. Inclusion criteria for the IDE studies required that patients 

were candidates for OSR, though in one study patients were prospectively defined as being at 

high risk for OSR due to age >80 years or other pathophysiologic conditions. It is not known 

whether any were judged medically unfit for OSR. After 4 years, deaths categorized as due to 

AAA were similar between EVAR and OSR patients. Overall-survival in EVAR treated patients 

was 10 percent lower compared to OSR, though this difference was not statistically significant. 

 Because of the relatively low 30-day procedure related morbidity and mortality, treatment 

with EVAR of patients with smaller AAA has occurred. Therefore, while the total number of 

interventions for AAA has remained relatively constant over time, the proportion of patients 

treated with EVAR has increased. There are no published investigations of relationships between 

hospital or physician volume and any outcome of EVAR of AAA. Published and ongoing EVAR 

RCT have required that investigators and their facilities have experience in use of this procedure. 

The threshold for permitting participation varies from 5 to 20 and were not based on evidence. 

 The volume of OSR procedures done by hospitals and physicians to repair unruptured AAA 

was inversely associated with short-term mortality in the 1990s when EVAR procedures were 

being investigated. Surgeon volume may explain a large portion of the effect of hospital volume, 

although hospital volume appears to have an effect that is not related to surgeon volume or 

surgeon specialty. Uncontrolled risk factors might account for some of the volume effects. The 

one study that was able to control for preoperative clinical measures did not find a significant 

association between hospital volume and mortality.139 Otherwise, the reasons for the observed 

relationships between the volume of procedures done by hospitals or surgeons over a period of 

time and short-term mortality have not been clearly established. The imprecision inherent in 

measuring outcomes of very low-volume providers isn’t always taken into account and may 

unduly influence estimates in some studies. Even though policymakers such as the Leapfrog 

group have somewhat arbitrarily selected cutoffs to define preferred ‘high’ volume hospitals for 

OSR of AAA, investigators have not identified optimal thresholds for grouping providers by 

volume in an effort to improve outcomes. Furthermore, this question needs to be revisited since 

EVAR has replaced OSR in a substantial percentage of AAA. 

 The cost effectiveness of EVAR relative to OSR is difficult to determine for several reasons: 

there are no long term (>4 year) outcome data from RCT of EVAR versus OSR; evolving EVAR 

technological refinements and provider experience may push EVAR towards being an effective 
99

and cost-effective alternative to OSR; it is difficult to extrapolate the cost experience in one 

country to that in another with a different health care and payment system; the perspective of the 

concerned party is critical in such analyses. 

 Case series focusing on hospital costs generally found that EVAR costs more to perform than 

OSR, primarily due to the cost of the prosthesis. The high cost of the EVAR prosthesis is 

partially offset by reduced hospital and intensive care unit length of stay, operating time, and 

necessity for blood transfusion relative to OSR. More comprehensive cost analyses noted the 

higher followup costs for EVAR. 

 None of the Markov cost effectiveness models had accurate data on the complication and 

reintervention rates associated with EVAR. Although the Michaels et al. study is based on the 

literature published through September 2004, several case series have come out since then, and 

data from midterm results of RCTs were not included.17 

 Results from additional RCTs, comparing EVAR and OSR for large AAA and EVAR versus 

surveillance for small AAA conducted in the U.S. have not yet been published. It is not clear 

how these costs would directly relate to U.S. settings. Trials conducted outside the U.S. do not 

reflect U.S. norms associated with resource valuation, utilization of health care resources, 

practice variation, and U.S. health care expertise. Decisions based on costs may differ with the 

locus. For example, hospitals may be willing to consider trading higher procedural costs for 

shorter lengths of stay. 

Data from RCTs demonstrate that for small AAA (<5.5 cm) immediate OSR costs more and 

does not improve survival compared to active surveillance and delayed elective intervention. For 

large AAA (≥5.5 cm) among patients fit for OSR, EVAR has greater short- and long-term costs, 

does not improve overall survival or quality of life beyond 1 year, and is associated with greater 

long-term complications, need for reintervention, and long-term monitoring compared to OSR. 

EVAR is associated with shorter hospital and intensive care unit length of stay, reduced AAA 

mortality, and lower 30-day morbidity and mortality, compared with OSR. In patients with AAA 

≥5.5 cm and judged medically unfit for OSR, EVAR did not improve survival or quality of life 

among those who were alive and was associated with higher costs compared to no intervention. 

 The analyses conducted in the UK reflect concerns relevant to the NHS that may not be as 

important in a U.S. context. For example, whereas EVAR’s potential to free up hospital beds 

may be important to NHS hospitals pressed for space, in the American context this aspect of 

EVAR has more salience for hospitals trading off LOS for a more expensive EVAR prosthesis 

under a fixed payment DRG reimbursement approach. 

 Other issues regarding the published data used in the Markov models include the 

transferability of results found in case series studies to different patient populations, e.g., of 

different aneurysm size. As new clinical devices are continually being introduced in the market, 

technological improvements may change the mortality and morbidity rates associated with 

EVAR in particular. The evidence of a learning curve or improvements in device manufacturing 

associated with EVAR may be associated with a lower long-term mortality, morbidity, and need 

for monitoring and reintervention that might someday demonstrate that EVAR is a cost effective 

alternative to OSR. Finally, because the 30-day mortality rates associated with OSR are variable, 

the significance of the differences in mortality rates between EVAR and OSR is obscured. The 

variability associated with operative mortality translates to greater uncertainty and higher risk to 

patients considering OSR. If improvements in long-term morbidity and mortality with EVAR are 

demonstrated in the future, this may make EVAR a favorable alternative to OSR from the 

patient’s perspective. 
100

 When conducting CEA, a common concern among researchers is that one needs to account 

for the fact that patients who die cost less in terms of health care expenditures than patients who 

live longer. The treatment arm that results in higher mortality rates would thus have lower costs 

reflected in the numerator of the cost effectiveness ratio. The standard approach to adjusting the 

cost effectiveness ratio for deaths is to assume that the QOL associated with death is zero in the 

denominator.160 The assumption is that QOL takes into account the disutility associated with 

morbidity/mortality. As long as the QOL scale also reflects the disutility of lost earnings, solely 

relying on the QOL to account for deaths in the denominator is permissible. If the QOL scale 

does not reflect lost earnings, then the numerator must reflect the patients’ lost earnings as part 

of the cost associated with each treatment. Although some might attribute the QOL associated 

with death as zero, others may think of death as having a higher QOL than other outcomes, such 

as living with pain. 

 Different components of cost may have different salience in different national health 

contexts. When comparing results of economic analyses across countries, there is currently no 

consensus or standard on how to do this. Simply factoring in the foreign exchange rate, for 

example, overlooks the variance in utilization and cost estimates across countries due to 

differences in physician practice patterns, resource valuation, and resource use. Reed et al. 

discuss the strengths and weaknesses of various methods used to pool cost estimates across 

countries.164 Methods are differentiated according to whether measures of effectiveness, resource 

utilization, and cost are derived from one or multiple countries. Strengths and weaknesses are 

based on balancing concerns about generalizability, transparency, and statistical power. 

Tradeoffs exist between trying to keep things simple enough for other researchers to implement 

(e.g., a one-country costing approach) and losing internal validity associated with a multinational 

costing approach. One-country costing disrupts the theoretical relationship between relative costs 

and resource use. Reed et al. note that using relatively high U.S. unit costs overestimates total 

costs as well as the absolute difference in costs between treatment groups, inflating the 

numerator of an ICER.164

Recommendations for Future Research 

 • Results from nonrandomized trials, case-series, or FDA reports are inadequate to 

accurately assess the relative effectiveness and safety of treatments for AAA. The 

highest priority for future research to guide clinical care is to conduct long-term RCTs 

in the U.S. to assess whether RCT results of EVAR conducted in Europe apply to U.S. 

settings. These include EVAR vs. OSR for AAA ≥5.5 cm in patients judged medically 

fit for OSR (analysis of results according preplanned categories of AAA, operative risk, 

gender, and device characteristics appears warranted), EVAR versus active surveillance 

for AAA <5.5 cm, and EVAR versus no intervention for AAA ≥5.5 cm in patients 

medically unfit for OSR. 

• Effective strategies are required to disseminate and implement the findings from 

published high-quality RCTs to patients, providers, health-care organizations, and 

payers. 

• Additional information on the benefits and risks of treatments in women are needed. 

• Refinements in EVAR devices, technique, and interventionist team are required to 

reduce complications and need for long-term followup. 
101

• Although studies cannot avoid measurement error associated with outcomes resulting 

from incorporating new devices into them, more research is needed to identify whether 

outcomes for EVAR vary according to device manufacturer or type and patient or 

aneurysm characteristics. Ideally, these would be obtained by conducting direct 

comparison RCTs. 

• Consistent/validated definitions of outcomes including AAA mortality; complications, 

and need for reintervention are required to assist clinicians, investigators, policy 

makers, and patients to evaluate relative safety and effectiveness of treatment options. 

In particular, cause of death ascertainment beyond 30 days or the initial hospitalization 

is problematic. Reducing ascertainment bias likely requires rigorous adjudication of all 

deaths including use of autopsy and/or post-mortem imaging. 

• Conduct RCTs to determine whether medical therapy slows AAA enlargement or 

rupture. Previous trials were inadequately powered to provide clinically meaningful 

results. 

• Improve data submission, followup, and cause of death ascertainment in registries. 

• Improvement in medical management of patients with large AAA considered 

unacceptable for OSR is needed. 

• Specific studies of EVAR are needed to characterize the hospital and physician 

volume-outcome relationship, if any. The validity of methods used to identify and 

count EVAR procedures should be examined and reported. Studies should measure 

volume in a consistent manner and focus on outcomes defined in reporting standards 

including clinical success, continuing success, complications, and return to 

preprocedure activity levels. Risk adjustment should include patient demographics, 

comorbidity, morphology of the aneurysm and access vessels, device characteristics, 

and any other variables that could have a substantial influence on the outcomes under 

investigation. Rigorously developed and tested regression models and examination of 

the sensitivity of results to the method of analysis would be useful. Most likely, 

representative prospective registries will be needed to perform a proper indepth analysis 

to determine whether and how the volume of endovascular procedures done by 

hospitals or physicians to repair AAA relate to beneficial or adverse outcomes. Ideally, 

future studies would strive to characterize the functional form of volume-outcome 

relationships and explain why they exist. The volume-mortality relationship for OSR of 

AAA needs to be reexamined in the EVAR era. 

• Future cost analyses studies should include short- and long-term followup data, either 

collected prospectively on all patients or incorporated from RCTs into Markov models. 

• Studies should follow a standardized approach to analyzing costs and effectiveness 

associated with the two procedures. Studies should explicitly describe the methods used 

to calculate costs and should include the following categories: direct medical care costs, 

institutional overhead costs, patient travel costs, and patients’ time and/or lost earnings. 

The collection of these costs should be carefully itemized and described. 

• Studies conducting prospective data collection in the United States taking a societal 

perspective are needed. Where appropriate, data should be collected on the patient’s 

time taken off work or other activities to travel and attend medical appointments, 

whether on an inpatient or outpatient basis, and to obtain prescriptions. 

• Data on United States patient’s QOL, where the treatment of the QOL associated with 

lost earnings and death is explicitly stated, should also be collected. 
102

Conclusions 

 AAA are associated with considerable morbidity, mortality and health-care costs. Patients 

with AAA <5.5 cm have an annual risk of rupture of approximately 1 percent. For AAA <5.5 cm 

in diameter high-quality RCT results demonstrate that active surveillance with ultrasound and 

delayed OSR (if AAA attains a diameter of ≥5.5 cm or the patient develops aneurysm related 

symptoms) results in comparable long-term survival and quality of life, fewer OSR, and lower 

costs than immediate OSR regardless of age or gender. There are no RCTs evaluating EVAR in 

these patients. 

 Among individuals refusing or medically unfit for OSR the 1-year rupture risk may exceed 

10 percent in AAA >6 cm and for AAA of >8 cm, the risk may exceed 25 percent at 6 months. 

For AAA ≥5.5 cm and suitable for EVAR, high-quality RCTs have been conducted outside the 

U.S. and may have used some EVAR devices that are not approved for use in the U.S. Their 

results demonstrate that, compared to OSR, EVAR is associated with lower perioperative 

morbidity and mortality and persistent reduction in AAA-defined mortality to 4 years, though the 

latter may be due, at least in part, to ascertainment bias for later term cause of death. EVAR did 

not improve longer term overall survival or health status and was associated with greater 

complications, need for reintervention, long-term monitoring, and costs. 

 For the minority of patients with AAA ≥5.5 cm and judged medically unfit for OSR, one 

high-quality RCT conducted in the U.K. and with EVAR devices that may not be approved for 

use in the U.S. demonstrated that EVAR did not improve survival or health status and costs more 

than no intervention. 

 There are no data adequate to estimate the effect of hospital or physician volume on EVAR 

outcomes and identify a volume threshold for policymakers. A volume outcome relationship for 

OSR has been shown for surgery prior to the introduction of EVAR, but none since. 

 The cost effectiveness of EVAR relative to OSR is difficult to determine for several reasons: 

there are no long term (>4 year) outcome data from RCT of EVAR versus OSR; evolving EVAR 

technological refinements and provider experience may push EVAR towards being an effective 

and cost-effective alternative to OSR; it is difficult to extrapolate the cost experience in one 

country to that in another with a different health care and payment system; and the perspective of 

the concerned party is critical in such analyses.
103

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List of Acronyms/Abbreviations 

AAA Abdominal Aortic Aneurysm 

ACE AnEVARysme de l’aorte abdominal: Chirurgie versus Endoprothese 

ADAM Aneurysm Detection and Management 

AHIP America’s Health Insurance Plans 

AHQR Agency for Healthcare Research and Policy 

ARR Absolute Risk Reduction 

CAESAR Comparison of surveillance versus Aortic Endografting for Small Aneurysm Repair 

CI Confidence Interval 

CM Conservative Management 

COPD Chronic Obstructive Pulmonary Disease 

CT Computed Tomography 

CTA Thin-Cut Helical/Spiral CT Arteriography 

DREAM Dutch Randomized Endovascular Aneurysm Management 

DRG Diagnosis Related Group 

EGS Endovascular Aortoiliac Grafting System 

EPC Evidence-based Practice Center 

EVAR Endovascular Repair 

FDA Food and Drug Administration 

FEV1 Forced Expiratory Volume in 1 second 

HR Hazard Ratio 

ICD-9-CM International Classification of Diseases, 9th Revision, Clinical Modification 

ICER Incremental Cost Effectiveness Ratio 

ICU Intensive Care Unit 

IDE Investigational Device Exemption 

IQR Interquartile Range 

LOS Length of Stay 

NHS National Health Service 

NICE National Institute of Clinical Excellence 

NRCTs Nonrandomized Controlled Trials 

OSR Open Surgical Repair 

OVER Open Versus Endovascular Repair 

PIVOTAL Positive Impact of endovascular Options for Treating Aneurysms 

PSA Probabilistic Sensitivity Analysis 

QALY Quality Adjusted Life Years 

QOL Quality of Life 

RCT Randomized Controlled Trials 

RD Risk Difference 

RR Relative Risk 

SF-36 Short Form-36 

TEP Technical Expert Panel 

UKSAT United Kingdom Small Aneurysm Trial 

USPSTF U.S. Preventive Services Task Force 

VA Veterans Administration 
Appendixes 

to 

“Comparison of Endovascular and Open Surgical Repairs for 

Abdominal Aortic Aneurysm” 

Prepared by the Minnesota Evidence-based Practice Center 

(Contract # 290-02-0009) 

Appendix A: Technical Expert Panel Members and Areas of Expertise 

Appendix B: Exact Search Strings 

Appendix C: List of Excluded Studies 

Appendix D: Data Extraction Forms 

Appendix E: Evidence Tables and Figures 
A-1 

Appendix A: Technical Expert Panel Members and Areas of 

Expertise 

TEP Member Area of Expertise 

R. Clement Darling, III, MD Vascular surgery 

Russell Harris, MD, MPH Internal medicine 

Wayne Johnston, MD, FRCSC, FACS Vascular surgery 

Jon S. Matsumura, MD Vascular surgery 
B-1 

Appendix B: Exact Search Strings 

Question 1 (RCTs)

 The literature search was done on MEDLINE (via OVID) using the following combination 

of MeSH headings, keywords, and publication types (search results were limited to clinical trials, 

clinical trials phase I, clinical trials phase II, clinical trials phase III, clinical trials phase IV, 

controlled clinical trials, meta analyses, or randomized controlled trials): 

(aortic aneurysm/ OR 

aortic aneurysm, abdominal/) 

AND 

((Blood Vessel Prosthesis/ OR 

Blood Vessel Prosthesis Implantation/ OR 

(endovascular repair.mp. OR 

evar.mp. OR 

Stents/) OR 

(vascular surgical procedures/ OR 

open surgery.mp.)) 

Question 2 (Volume)

 The literature search was done on MEDLINE (via OVID) using the following combination 

of MeSH headings, keywords, and publication types (search results were limited to humans, 

English language, and years 2000-2005): 

((hospital.tw. AND 

volume.tw.) AND 

((outcome.mp. AND 

process assessment health care.sh.) OR 

outcome.tw. OR 

(mortality.tw. OR 

risk.tw. OR 

quality.tw.))) 

AND 

(Aortic Aneurysm, Abdominal/) 
B-2 

Question 4 (Cost)

 The literature search (taken from Meenan 2005 [AHRQ report])17 was done on MEDLINE 

(via OVID) using the following combination of MeSH headings and keywords (search results 

were limited to English language, and years 2000-2005): 

(aortic aneurysm, abdominal/ OR 

(aortic and aneurysm$ and abdom$).ti,ab.) 

AND 

(ECONOMICS/ OR 

economics, nursing/ OR 

economics, pharmaceutical/ OR 

ec.fs. OR 

(econom$ or cost or costs or costing or pharmacoeconomic$).ti,ab. OR 

(expenditure$ not energy).ti,ab. OR 

"costs and cost analysis"/ OR 

cost allocation/ OR 

cost-benefit analysis/ OR 

cost control/ OR 

cost savings/ OR 

cost of illness/ OR 

cost sharing/ OR 

"deductibles and coinsurance"/ OR 

medical savings accounts/ OR 

health care costs/ OR 

direct service costs/ OR 

drug costs/ OR 

employer health costs/ OR 

hospital costs/ OR 

health expenditures/ OR 

capital expenditures/ OR 

economics, hospital/ OR 

hospital charges/ OR 

hospital costs/ OR 

economics, medical/ OR 

fees, medical/) 
C-1 

Appendix C: List of Excluded Studies

Question 1: RCTs (reason for exclusion is provided in italics following each reference)

Adachi H, Ino T, Mizuhara A, et al. [Clinical significance 

of selective cerebral perfusion with cold blood on the brain 

protection]. Nippon Kyobu Geka Gakkai Zasshi 1995 Sep; 

43(9):1605-10. (Jap) Not AAA; not English language 

Adiseshiah M, Bray AJ, Bergeron P, et al. Endoluminal 

repair of large abdominal aortic aneurysms using PTFE: a 

feasibility study. J Endovasc Surg 1997 Aug; 4(3):286-9. 

Not RCT 

Adriaensen ME, Bosch JL, Halpern EF, et al. Elective 

endovascular versus open surgical repair of abdominal 

aortic aneurysms: systematic review of short-term results. 

Radiology 2002 Sep; 224(3):739-47. Not RCT 

Alimi YS, Hartung O, Cavalero C, et al. Intestinal retractor 

for transperitoneal laparoscopic aortoiliac reconstruction: 

experimental study on human cadavers and initial clinical 

experience. Surg Endosc 2000 Oct; 14(10):915-9. Not RCT 

Allen BT, Hovsepian DM, Reilly JM, et al. Endovascular 

stent grafts for aneurysmal and occlusive vascular disease. 

Am J Surg 1998 Dec; 176(6):574-80. Not RCT 

Almgren B, Cars O, Eriksson I, Erlendsdottir H. 

Pharmacokinetics of dicloxacillin in serum and aortic wall 

during aneurysmal surgery. Acta Chir Scand 1986 Jan; 

152:19-21. Not EVAR vs open or surveillance trial 

Alric P, Hinchliffe RJ, Wenham PW, et al. Lessons learned 

from the long-term follow-up of a first-generation aortic 

stent graft. J Vasc Surg 2003 Feb; 37(2):367-73. Not RCT 

Amesur NB, Zajko AB, Orons PD, et al. Embolotherapy of 

persistent endoleaks after endovascular repair of abdominal 

aortic aneurysm with the ancure-endovascular technologies 

endograft system. J Vasc Interv Radiol 1999 Oct; 

10(9):1175-82. Not RCT 

Amesur NB, Zajko AB, Orons PD, et al. Endovascular 

treatment of iliac limb stenoses or occlusions in 31 patients 

treated with the ancure endograft. J Vasc Interv Radiol 

2000 Apr; 11(4):421-8. Not RCT 

Ariyoshi H, Okuyama M, Okahara K, et al. Expanded 

polytetrafluoroethylene (ePTFE) vascular graft loses its 

thrombogenicity six months after implantation. Throm Res 

1997 Dec 1; 88(5):427-33. Not RCT 

Ashoke R, Brown LC, Rodway A, et al. Color duplex 

ultrasonography is insensitive for the detection of endoleak 

after aortic endografting: a systematic review. J Endovasc 

Ther 2005 Jun; 12(3):297-305. Not EVAR vs open or 

surveillance trial 

Axelrod DJ, Lookstein RA, Guller J, et al. Inferior 

mesenteric artery embolization before endovascular 

aneurysm repair: technique and initial results. J Vasc Interv 

Radiol 2004 Nov; 15(11):1263-7. Not EVAR vs open or 

surveillance trial 

Ayuso JR, de Caralt TM, Pages M, et al. MRA is useful as 

a follow-up technique after endovascular repair of aortic 

aneurysms with nitinol endoprostheses. J Magn Reson 

Imaging 2004 Nov; 20(5):803-10. Not EVAR vs open or 

surveillance trial 

Balm R, Eikelboom BC, May J, et al. Early experience with 

transfemoral endovascular aneurysm management (TEAM) 

in the treatment of aortic aneurysms. Eur J Vasc Endovasc 

Surg 1996 Feb; 11(2):214-20. Not RCT 

Barnes RW, Baker WH, Shanik G, et al. Value of 

concomitant sympathectomy in aortoiliac reconstruction. 

Results of a prospective, randomized study. Arch Surg 

1977 Nov; 112(11):1325-30. Not EVAR vs open or 

surveillance trial 

Batt M, Magne JL, Alric P, et al. In situ revascularization 

with silver-coated polyester grafts to treat aortic infection: 

early and midterm results. J Vasc Surg 2003 Nov; 

38(5):983-9. Not EVAR vs open or surveillance trial 

Baum RA, Shetty SK, Carpenter JP, et al. Limb kinking in 

supported and unsupported abdominal aortic stent-grafts. J 

Vasc Interv Radiol 2000 Oct; 11(9):1165-71. Not EVAR vs 

open or surveillance trial 

Baxendale BR, Baker DM, Hutchinson A, et al. 

Haemodynamic and metabolic response to endovascular 

repair of infra-renal aortic aneurysms. Br J Anaesth 1996 

Nov; 77(5):581-5. Not RCT 

Becquemin JP, Haiduc F, Cavillon A. Thrombogenicity of 

an elastomer-coated aortofemoral Dacron prosthetic graft in 

humans. Ann Vasc Surg 1994 Sep; 8(5):443-51. Not EVAR 

vs open or surveillance trial 

Becquemin JP, Lapie V, Favre JP, et al. Mid-term results of 

a second generation bifurcated endovascular graft for 

abdominal aortic aneurysm repair: the French Vanguard 

trial. J Vasc Surg 1999 Aug; 30(2):209-18. Not RCT 

Beebe HG, Cronenwett JL, Katzen BT, et al. Results of an 

aortic endograft trial: impact of device failure beyond 12 

months. J Vasc Surg 2001 Feb; 33(2 Suppl):S55-63. Not 

RCT 

Bertrand M, Godet G, Koskas F, et al. Endovascular 

treatment of abdominal aortic aneurysms: is there a benefit 

regarding postoperative outcome? Eur J Anaesth 2001 Apr; 

18(4):245-50. Not RCT 
C-2 

Biasi GM, Piglionica MR, Meregaglia D, et al. European 

multicentre experience with modular device (Medtronic 

AneuRx) for the endoluminal repair of infrarenal 

abdominal aortic aneurysms. J Mal Vasc 1998 Dec; 

23(5):374-80. Not RCT 

Blankensteijn JD. Mortality and morbidity rates after 

conventional abdominal aortic aneurysm repair. Semin 

Interv Cardiol 2000 Mar; 5(1):7-13. Not RCT 

Blum U, Voshage G, Beyersdorf F, et al. Two-center 

German experience with aortic endografting. J Endovasc 

Surg 1997 May; 4(2):137-46. Not RCT 

Blum U, Voshage G, Lammer J, et al. Endoluminal stentgrafts for infrarenal abdominal aortic aneurysms. N Engl J 

Med 1997 Jan 2; 336(1):13-20. Not EVAR vs open or 

surveillance trial 

Bolke E, Jehle PM, Storck M, et al. Endovascular stentgraft placement versus conventional open surgery in 

infrarenal aortic aneurysm: a prospective study on acute 

phase response and clinical outcome. Clin Chim Acta 2001 

Dec; 314(1-2):203-7. Not RCT 

Bonazzi M, Gentile F, Biasi GM, et al. Impact of 

perioperative haemodynamic monitoring on cardiac 

morbidity after major vascular surgery in low risk patients. 

A randomised pilot trial. Eur J Vasc Endovasc Surg 2002 

May; 23(5):445-51. Not EVAR vs open or surveillance trial 

Borner G, Ivancev K, Sonesson B, et al. Percutaneous 

AAA repair: is it safe? J Endovasc Ther 2004 Dec; 

11(6):621-6. Not RCT 

Bove PG, Long GW, Shanley CJ, et al. Transrenal fixation 

of endovascular stent-grafts for infrarenal aortic aneurysm 

repair: mid-term results. J Vasc Surg 2003 May; 37(5):938-

42. Not RCT 

Brener BJ, Faries P, Connelly T, et al. An in situ adjustable 

endovascular graft for the treatment of abdominal aortic 

aneurysms. J Vasc Surg 2002 Jan; 35(1):114-9. Not RCT 

Broeders IA, Blankensteijn JD, Gvakharia A, et al. The 

efficacy of transfemoral endovascular aneurysm 

management: a study on size changes of the abdominal 

aorta during mid-term follow-up. Eur J Vasc Endovasc 

Surg 1997 Aug; 14(2):84-90. Not RCT 

Broeders IA, Blankensteijn JD, Wever JJ, et al. Mid-term 

fixation stability of the EndoVascular Technologies 

endograft. EVT Investigators. Eur J Vasc Endovasc Surg 

1999, Oct; 18(4):300-7. Not RCT 

Brustia P, Renghi A, Gramaglia L, et al. Mininvasive 

abdominal aortic surgery. Early recovery and reduced 

hospitalization after multidisciplinary approach. J 

Cardiovasc Surg 2003 Oct; 44(5):629-35. Not RCT 

Burtoft JN, Robicsek F, Daugherty HK, et al. Comparative 

analysis of thrombogenicity and clinical patency between 

woven and knitted aorto-iliac and aorto-femoral prostheses. 

ASAIO Trans 1987 Jul-Sep; 33(3):207-11. Not RCT 

Bush RL, Najibi S, Lin PH, et al. Early experience with the 

bifurcated Excluder endoprosthesis for treatment of the 

abdominal aortic aneurysm. J Vasc Surg 2001 Sep; 

34(3):497-502. Not RCT 

Buth J, van Marrewijk CJ, Harris PL, et al. Outcome of 

endovascular abdominal aortic aneurysm repair in patients 

with conditions considered unfit for an open procedure: a 

report on the EUROSTAR experience. J Vasc Surg 2002 

Feb; 35(2):211-21. Not RCT 

Carpenter JP, Anderson WN, Brewster DC, et al. 

Multicenter pivotal trial results of the Lifepath System for 

endovascular aortic aneurysm repair. J Vasc Surg 2004 Jan; 

39(1):34-43. Not RCT 

Carpenter JP, Endologix Investigators. Midterm results of 

the multicenter trial of the powerlink bifurcated system for 

endovascular aortic aneurysm repair. J Vasc Surg 2004 

Nov; 40(5):849-59. Not RCT 

Carpenter JP, Endologix Investigators. Multicenter trial of 

the PowerLink bifurcated system for endovascular aortic 

aneurysm repair. J Vasc Surg 2002 Dec; 36(6):1129-37. 

Not RCT 

Cartes-Zumelzu F, Lammer J, Hoelzenbein T, et al. 

Endovascular placement of a nitinol-ePTFE stent-graft for 

abdominal aortic aneurysms: initial and midterm results. J 

Vasc Interv Radiol 2002 May; 13(5):465-73. Not RCT 

Castronuovo JJ Jr, James KV, Resnikoff M, et al. 

Laparoscopic-assisted abdominal aortic aneurysmectomy. J 

Vasc Surg 2000 Aug; 32(2):224-33. Not RCT 

Chavan A, Cohnert TU, Heine J, Dresler C, Leuwer M, 

Harringer W, et al. Endoluminal grafting of abdominal 

aortic aneurysms: experience with the Talent endoluminal 

stent graft. Eur Radiol 2000; 10(4):636-41. Not RCT 

Christ F, Gamble J, Raithel P, Steckmeier B, Messmer K. 

[Preoperative changes in fluid filtration capacity in patients 

undergoing vascular surgery]. Anaesthesist 1999 Jan; 

48(1):9-18. (Ger) Not RCT; not English language 

Chuter TA, Wendt G, Hopkinson BR, et al. Transfemoral 

insertion of a bifurcated endovascular graft for aortic 

aneurysm repair: the first 22 patients. Cardiovasc Surg 

1995, Apr; 3(2):121-8. Not RCT 

Cina CS, Abouzahr L, Arena GO, et al. Cerebrospinal fluid 

drainage to prevent paraplegia during thoracic and 

thoracoabdominal aortic aneurysm surgery: a systematic 

review and meta-analysis. J Vasc Surg 2004 Jul; 40(1):36-

44. Not EVAR vs open or surveillance trial 
C-3 

Conners MS 3rd, Tonnessen BH, Sternbergh WC 3rd, et al. 

Does ASA classification impact success rates of 

endovascular aneurysm repairs? Ann Vasc Surg 2002 Sep; 

16(5):550-5. Not RCT 

Coppi G, Moratto R, Silingardi R, et al. The Italian trial of 

endovascular AAA exclusion using the Parodi endograft. J 

Endovasc Surg 1997 Aug; 4(3):299-306. Not EVAR vs open 

or surveillance trial 

Coppi G, Pacchioni R, Moratto R, et al. Experience with 

the Stentor endograft at four Italian centers. J Endovasc 

Surg 1998 Aug; 5(3):206-15. Not RCT 

Courbier R, Ferdani M, Jausseran JM, et al. The role of 

omentopexy in the prevention of femoral anastomotic 

aneurysm. J Cardiovasc Surg 1992 Mar-Apr; 33(2):149-53. 

Not RCT 

Criado FJ, Clark NS, McKendrick C, et al. Update on the 

Talent LPS AAA stent graft: results with "enhanced talent". 

Semin Vasc Surg 2003 Jun; 16(2):158-65. Not RCT 

Criado FJ, Fairman RM, Becker GJ, et al. Talent LPS AAA 

stent graft: results of a pivotal clinical trial. J Vasc Surg 

2003 Apr; 37(4):709-15. Not RCT 

Criado FJ, Fry PD, Machan LS, et al. The talent 

endoluminal AAA stent-graft system. Report of the phase I 

USA trial, and summary of worldwide experience. J Mal 

Vasc 1998 Dec; 23(5):371-3. Not RCT 

Criado FJ, Wilson EP, Abul-Khoudoud O, et al. Brachial 

artery catheterization to facilitate endovascular grafting of 

abdominal aortic aneurysm: safety and rationale. J Vasc 

Surg 2000 Dec; 32(6):1137-41. Not RCT 

Criado FJ, Wilson EP, Wellons E, et al. Early experience 

with the Talent stent-graft system for endoluminal repair of 

abdominal aortic aneurysms. Tex Heart Inst J 2000; 

27(2):128-35. Not RCT 

d'Audiffret A, Santilli S, Tretinyak A, et al. Fate of the 

ectatic infrarenal aorta: expansion rates and outcomes. Ann 

Vasc Surg 2002 Sep; 16(5):534-6. Not EVAR vs open or 

surveillance trial 

Dake MD, Kato N, Mitchell RS, et al. Endovascular stentgraft placement for the treatment of acute aortic dissection. 

N Engl J Med 1999 May 20; 340(20):1546-52. Not EVAR 

vs open or surveillance trial 

Darling RC 3rd, Cordero JA Jr, Chang BB, et al. Advances 

in the surgical repair of ruptured abdominal aortic 

aneurysms. Cardiovasc Surg 1996 Dec; 4(6):720-3. Not 

RCT 

Darling RC 3rd, Shah DM, McClellan WR, et al. 

Decreased morbidity associated with retroperitoneal 

exclusion treatment for abdominal aortic aneurysm. J 

Cardiovasc Surg 1992 Jan-Feb; 33(1):65-9. Not EVAR vs 

open or surveillance trial

De Mol Van Otterloo JC, Van Bockel JH, Ponfoort ED, et 

al. Systemic effects of collagen-impregnated aortoiliac 

Dacron vascular prostheses on platelet activation and fibrin 

formation. J Vasc Surg 1991 Jul; 14(1):59-66. Not EVAR vs 

open or surveillance trial 

Deaton DH, Balch D, Kesler C, et al. Telemedicine and 

endovascular aortic grafting. Am J Surg 1999 Jan; 

177(1):75-7. Not EVAR vs open or surveillance trial 

Deaton DH, Bogey WM, Chiang K, et al. Bifurcated 

endovascular grafting for abdominal aortic aneurysm. Ann 

Vasc Surg 1999 Jan; 13(1):23-31. Not RCT 

Deleersnijder R, Daenens K, Fourneau I, et al. 

Endovascular repair of inflammatory abdominal aortic 

aneurysms with special reference to concomitant ureteric 

obstruction. Eur J Vasc Endovasc Surg 2002 Aug; 

24(2):146-9. Not EVAR vs open or surveillance trial 

Donati A, Cornacchini O, Loggi S, et al. A comparison 

among portal lactate, intramucosal sigmoid Ph, and 

deltaCO2 (PaCO2 - regional Pco2) as indices of 

complications in patients undergoing abdominal aortic 

aneurysm surgery. Anesth Analg 2004 Oct; 99(4):1024-31. 

Not EVAR vs open or surveillance trial 

Dorman BH, Elliott BM, Spinale FG, et al. Protamine use 

during peripheral vascular surgery: a prospective 

randomized trial. J Vasc Surg 1995 Sep; 22(3):248-55. Not 

EVAR vs open or surveillance trial 

Duda D, Lorenz W, Celik I. Histamine release in 

mesenteric traction syndrome during abdominal aortic 

aneurysm surgery: prophylaxis with H1 and H2 

antihistamines. Inflamm Res 2002 Oct; 51(10):495-9. Not 

EVAR vs open or surveillance trial 

Duda D, Lorenz W, Celik I. [Mesenteric traction syndrome 

during the operation of aneurysms of the abdominal aorta--

histamine release and prophylaxis with antihistaminics]. 

Anaesthesiol Reanim 2003; 28(4):97-103. (Ger) Not EVAR 

vs open or surveillance trial 

Ebaugh JL, Matsumura JS, Morasch MD, et al. 

Morphometric analysis of the popliteal artery for 

endovascular treatment. Vasc Endovasc Surg 2003 JanFeb; 37(1):23-6. Not EVAR vs open or surveillance trial 

Edwards WH Jr, Naslund TC, Edwards WH Sr, et al. 

Endovascular grafting of abdominal aortic aneurysms. A 

preliminary study. Ann Surg 1996 May; 223(5):568-73. 

Not RCT 

Ellozy SH, Carroccio A, Lookstein RA, et al. First 

experience in human beings with a permanently 

implantable intrasac pressure transducer for monitoring 

endovascular repair of abdominal aortic aneurysms. J Vasc 

Surg 2004 Sep; 40(3):405-12. Not RCT 
C-4 

Engellau L, Olsrud J, Brockstedt S, et al. MR evaluation ex 

vivo and in vivo of a covered stent-graft for abdominal 

aortic aneurysms: ferromagnetism, heating, artifacts, and 

velocity mapping. J Magn Reson Imaging 2000 Jul; 

12(1):112-21. Not RCT 

Ersoy H, Jacobs P, Kent CK, et al. Blood pool MR 

angiography of aortic stent-graft endoleak. AJR Am J 

Roentgenol 2004 May; 182(5):1181-6. Not EVAR vs open 

or surveillance trial

Eyraud D, Bertrand M, Fleron MH, et al. [Risk factors for 

mortality in abdominal aortic surgery]. Ann Fr Anesth 

Reanim 2000 Jun; 19(6):452-8. (Fre) Not RCT 

Fairman RM, Velazquez O, Baum R, et al. Endovascular 

repair of aortic aneurysms: critical events and adjunctive 

procedures. J Vasc Surg 2001 Jun; 33(6):1226-32. Not RCT 

Falk V, Vettelschoss M, Walther T, et al. Surgical 

treatment of abdominal aortic aneurysms of octogenarians. 

Cardiovasc Surg 1996 Dec; 4(6):727-31. Not RCT 

Fanti L, Masci E, Mariani A, et al. Is endoscopy useful for 

early diagnosis of ischaemic colitis after aortic surgery? 

Results of a prospective trial. Ital J Gastroenterol Hepatol 

1997 Aug; 29(4):357-60. Not RCT 

Faries PL, Brener BJ, Connelly TL, et al. A multicenter 

experience with the Talent endovascular graft for the 

treatment of abdominal aortic aneurysms. J Vasc Surg 2002 

Jun; 35(6):1123-8. Not RCT 

Fiane AE, Videm V, Lingaas PS, et al. Mechanism of 

complement activation and its role in the inflammatory 

response after thoracoabdominal aortic aneurysm repair. 

Circulation 2003 Aug 19; 108(7):849-56. Not RCT 

Fisher JB, Dennis RC, Valeri CR, et al. Effect of graft 

material on loss of erythrocytes after aortic operations. 

Surg Gynecol Obstet 1991 Aug; 173(2):131-6. Not EVAR 

vs open or surveillance trial

Friedman SG, Sowerby SA, Del Pin CA, et al. A 

prospective randomized study of abdominal aortic surgery 

without postoperative nasogastric decompression. 

Cardiovasc Surg 1996 Aug; 4(4):492-4. Not EVAR vs open 

or surveillance trial

Fujii H, Ujiie T, Ariizumi K, et al. [Surgical treatment of 

acute aortic dissections--a clinical study using a ringed 

intraluminal graft]. Nippon Kyobu Geka Gakkai Zasshi 

1995 Sep; 43(9):1611-6. (Jap) Not EVAR vs open or 

surveillance trial; not English language

Furunaga A, Tsuboi H, Katoh T, et al. [Clinical analysis of 

the surgical therapy of DeBakey type I acute aortic 

dissection]. Kyobu Geka 1995 Apr; 48(4):306-8. (Jap) Not 

EVAR vs open or surveillance trial; not English language

Godet G, Canessa R, Arock M, et al. [Effects of plateletrich plasma on hemostasis and transfusion requirement in 

vascular surgery]. Ann Fr Anesth Reanim 1995; 14(3):265-

70. (Fre) Not EVAR vs open or surveillance trial; not 

English language

Goeau-Brissonniere OA, Qanadli SD, Ippoliti A, et al. Can 

knitting structure affect dilation of polyester bifurcated 

prostheses? A randomized study with the use of helical 

computed tomography scanning. J Vasc Surg 2000 Jan; 

31(1 Pt 1):157-63. Not EVAR vs open or surveillance trial

Goueffic Y, Becquemin JP, Desgranges P, et al. Midterm 

survival after endovascular versus open repair of infrarenal 

aortic aneurysms. J Endovasc Ther 2005 Feb; 12(1):47-57. 

Not RCT 

Grabowska-Gawel A, Wisniewski J. [Effectiveness of 

extrameningeally administered opioids in patients with 

aortic prosthesis]. Pol Merkuriusz Lek 2004 Jun; 

16(96):516-8. (Pol) Not EVAR vs open or surveillance 

trial; not English language

Greenberg R, Zenith Investigators. The Zenith AAA 

endovascular graft for abdominal aortic aneurysms: clinical 

update. Semin Vasc Surg 2003 Jun; 16(2):151-7. Not RCT 

Greenberg RK, Chuter TA, Lawrence-Brown M, et al. 

Analysis of renal function after aneurysm repair with a 

device using suprarenal fixation (Zenith AAA 

Endovascular Graft) in contrast to open surgical repair. J 

Vasc Surg 2004 Jun; 39(6):1219-28. Not RCT 

Greenberg RK, Chuter TA, Sternbergh WC 3rd, et al. 

Zenith AAA endovascular graft: intermediate-term results 

of the US multicenter trial. J Vasc Surg 2004 Jun; 

39(6):1209-18. Not RCT 

Greenberg RK, Lawrence-Brown M, Bhandari G, et al. An 

update of the Zenith endovascular graft for abdominal 

aortic aneurysms: initial implantation and mid-term followup data. J Vasc Surg 2001 Feb; 33(2 Suppl):S157-64. Not 

RCT 

Guo W, Ge L, Zhang G, Liang F, et al. [Endovascular 

treatment for abdominal aortic aneurysm, a primary study]. 

Chung-Hua i Hsueh Tsa Chih 2002 Mar; 82(5):291-3. (Chi) 

Not RCT 

Hagberg RC, Safi HJ, Sabik J, et al. Improved 

intraoperative management of anastomotic bleeding during 

aortic reconstruction: results of a randomized controlled 

trial. Am Surg 2004 Apr; 70(4):307-11. Not EVAR vs open 

or surveillance trial

Hankeln K, Senker R, Beez M. [Comparative study of the 

intraoperative effectiveness of 5% human albumin or 10% 

hydroxyethyl starch (HAES-steril) on hemodynamics and 

oxygen transport in 40 patients]. Infusionstherapie (Basel) 

1990 Jun; 17(3):135-40. (Ger) Not EVAR vs open or 

surveillance trial, not English language
C-5 

Hansen CJ, Aziz I, Kim BB, et al. Results from the 

Endologix PowerLink multicenter trial. Semin Vasc Surg 

2003 Jun; 16(2):166-70. Not RCT 

Harafuji K, Chikamori T, Kawaguchi S, et al. Preoperative 

risk stratification for endovascular surgery using 

pharmacologic stress myocardial imaging. Am J Cardiol 

2004 Dec 1; 94(11):1471-4. Not RCT 

Hausegger KA, Mendel H, Tiessenhausen K, et al. 

Endoluminal treatment of infrarenal aortic aneurysms: 

clinical experience with the Talent stent-graft system. J 

Vasc Interv Radiol 1999 Mar; 10(3):267-74. Not RCT 

Hessmann M, Dossche K, Wellens F, et al. Surgical 

treatment of thoracic aneurysm: a 5-year experience. 

Cardiovasc Surg 1995 Feb; 3(1):19-25. Not RCT 

Houweling PL, Ionescu TI, Leguit P, et al. Comparison of 

the cardiovascular effects of intravenous, epidural and 

intrathecal sufentanil analgesia as a supplement to general 

anaesthesia for abdominal aortic aneurysm surgery. Eur J 

Anaesthesiol 1993 Nov; 10(6):403-11. Not EVAR vs open 

or surveillance trial

Hovsepian DM, Siegel BA, Kimbiris G, et al. Tc-99m 

sulfur colloid scintigraphy for detecting perigraft flow 

following endovascular aortic aneurysm repair: A 

feasibility study. Cardiovasc Interv Radiol 1999 Nov-Dec; 

22(6):447-51. Not EVAR vs open or surveillance trial

Howell M, Doughtery K, Strickman N, et al. Percutaneous 

repair of abdominal aortic aneurysms using the AneuRx 

stent graft and the percutaneous vascular surgery device. 

Catheter Cardiovasc Interv 2002 Mar; 55(3):281-7. Not 

EVAR vs open or surveillance trial

Howell MH, Zaqqa M, Villareal RP, et al. Endovascular 

exclusion of abdominal aortic aneurysms: initial experience 

with stent-grafts in cardiology practice. Tex Heart Inst J 

2000; 27(2):136-45. Not RCT 

Ince H, Petzsch M, Rehders T, et al. Percutaneous 

endovascular repair of aneurysm after previous coarctation 

surgery. Circulation 2003 Dec 16; 108(24):2967-70. Not 

RCT 

Jones K, Powell J, Brown L, et al. The influence of 4G/5G 

polymorphism in the plasminogen activator inhibitor-1 

gene promoter on the incidence, growth and operative risk 

of abdominal aortic aneurysm. Eur J Vasc Endovasc Surg 

2002 May; 23(5):421-5. Not EVAR vs open or surveillance 

trial

Karch LA, Henretta JP, Hodgson KJ, et al. Algorithm for 

the diagnosis and treatment of endoleaks. Am J Surg 1999 

Sep; 178(3):225-31. Not EVAR vs open or surveillance trial

Karner J, Schemper M, Teleky B, et al. Aorto-Ybifurcation graft: Dacron versus PTFE. Preliminary results 

of a randomized prospective study. Int Surg 1988 Oct-Dec; 

73(4):218-20. Not EVAR vs open or surveillance trial

Kazui T, Komatsu S. [Selection of surgical treatment for 

aortic dissection on the basis of pathophysiology]. Jpn Circ 

J, 1993; 57 Suppl 4:1313-6. (Jap) Not RCT; not English 

language 

Kelley-Patteson C, Ammar AD, Kelley H. Should the Cell 

Saver Autotransfusion Device be used routinely in all 

infrarenal abdominal aortic bypass operations? J Vasc Surg, 

1993 Aug; 18(2):261-5. Not EVAR vs open or surveillance 

trial

Kibbe MR, Matsumura JS, Excluder Investigators. The 

Gore Excluder US multi-center trial: analysis of adverse 

events at 2 years. Semin Vasc Surg, 2003 Jun; 16(2):144-

50. Not RCT 

Kieffer E, Maraval M, Natali J. [Cure of abdominal aortic 

aneurysm at the origin of the renal arteries]. Nouv Presse 

Med, 1974 Mar 30; 3(13):807-8. (Fre) Not EVAR vs open 

or surveillance trial; not English language

Kindgen-Milles D, Muller E, Buhl R, et al. Nasalcontinuous positive airway pressure reduces pulmonary 

morbidity and length of hospital stay following 

thoracoabdominal aortic surgery. Chest, 2005 Aug; 

128(2):821-8. Not EVAR vs open or surveillance trial

Kinney EV, Kaebnick HW, Mitchell RA, et al. Minimally 

invasive aortic surgery: endovascular stent-graft repair of 

abdominal aortic aneurysm. J Ky Med Assoc 1999 Nov; 

97(11):518-24. 

Not RCT 

Kolvenbach R. Hand-assisted laparoscopic abdominal 

aortic aneurysm repair. Semin Laparosc Surg, 2001 Jun; 

8(2):168-77. Not EVAR vs open or surveillance trial

Kolvenbach R, Da Silva L, Deling O, et al. Video-assisted 

aortic surgery. J Am Coll Surg, 2000 Apr; 190(4):451-7. 

Not RCT 

Kolvenbach R, Pinter L, Raghunandan M, et al. 

Laparoscopic remodeling of abdominal aortic aneurysms 

after endovascular exclusion: a technical description. J 

Vasc Surg, 2002 Dec; 36(6):1267-70. Not RCT 

Komori K, Ishida M, Matsumoto T, et al. Cytokine patterns 

and the effects of a preoperative steroid treatment in the 

patients with abdominal aortic aneurysms. Int Angiol, 1999 

Sep; 18(3):193-7. Not EVAR vs open or surveillance trial

Koschyk DH, Meinertz T, Hofmann T, et al. Value of 

intravascular ultrasound for endovascular stent-graft 

placement in aortic dissection and aneurysm. J Card Surg, 

2003 Sep-Oct; 18(5):471-7. Not RCT 

Koskas F, Cluzel P, Kieffer E, et al. [Tailored 

endoprostheses for the endovascular treatment of aorto-iliac 

aneurysms: current features and perspectives]. Bull Acad 

Natl Med, 2002; 186(2):393-408. (Fre) Not RCT; not 

English language 
C-6 

Kotake Y, Moriyama K, Innami Y, et al. Performance of 

noninvasive partial CO2 rebreathing cardiac output and 

continuous thermodilution cardiac output in patients 

undergoing aortic reconstruction surgery. Anesthesiology, 

2003 Aug; 99(2):283-8. Not EVAR vs open or surveillance 

trial

Kovalenko VI. [Disorder of the rheological properties of 

the blood as a risk factor in interventions on the abdominal 

aorta and its branches]. Vestn Khir Im I I Grek, 1979 Mar; 

122(3):82-7. (Rus) Not EVAR vs open or surveillance trial; 

not English language

Kritpracha B, Beebe HG, Criado FJ, et al. Post-endograft 

abdominal aortic aneurysm shrinkage varies among 

hospitals: observations from multicenter trials. J Endovasc 

Ther, 2004 Aug; 11(4):454-9. Not EVAR vs open or 

surveillance trial

Lachat ML, Pfammatter T, Witzke HJ, et al. Endovascular 

repair with bifurcated stent-grafts under local anaesthesia to 

improve outcome of ruptured aortoiliac aneurysms. Eur J 

Vasc Endovasc Surg, 2002 Jun; 23(6):528-36. Not EVAR vs 

open or surveillance trial

Laohapensang K, Rerkasem K, Chotirosniramit N. Left 

retroperitoneal versus midline transperitoneal approach for 

abdominal aortic aneurysms (AAAs) repair. J Med Assoc 

Thai, 2005 May; 88(5):601-6. Not EVAR vs open or 

surveillance trial

Larsen KE, Justesen P, Rohr N. [Endovascular treatment of 

abdominal aortic aneurysms]. Ugeskr Laeger, 2002 Apr 22; 

164(17):2288-91. (Dan) Not EVAR vs open or surveillance 

trial

Lau LL, Gardiner KR, Martin L, et al. Extraperitoneal 

approach reduces neutrophil activation, systemic 

inflammatory response and organ dysfunctionin aortic 

aneurysm surgery. Eur J Vasc Endovasc Surgm 2001 Apr; 

21(4):326-33. Not EVAR vs open or surveillance trial

Lau LL, Halliday MI, Lee B, et al. Intestinal manipulation 

during elective aortic aneurysm surgery leads to portal 

endotoxaemia and mucosal barrier dysfunction. Eur J Vasc 

Endovasc Surg, 2000 Jun; 19(6):619-24. Not EVAR vs open 

or surveillance trial

Lee AM, Rockman CB, Riles TS, et al. Report of a singleinstitution experience using the EVT endovascular 

abdominal aortic aneurysm graft in 25 patients. Ann Vasc 

Surg, 1999 Jan; 13(1):60-6. Not EVAR vs open or 

surveillance trial

Lethagen S, Rugarn P, Bergqvist D. Blood loss and safety 

with desmopressin or placebo during aorto-iliac graft 

surgery. Eur J Vasc Surg, 1991 Apr; 5(2):173-8. Not EVAR 

vs open or surveillance trial

Leyh RG, Fischer S, Kallenbach K, et al. High failure rate 

after valve-sparing aortic root replacement using the 

"remodeling technique" in acute type A aortic dissection. 

Circulation 2002 Sep 24; 106(12 Suppl 1):I229-33. Not 

EVAR vs open or surveillance trial

Lifeline Registry of Endovascular Aneurysm Repair 

Steering Committee. Lifeline Registry of Endovascular 

Aneurysm Repair: Registry data report. J Vasc Surg 2002 

Mar; 35(3):616-20. Not RCT 

Lloyd WE, Paty PS, Darling RC 3rd, et al. Results of 1000 

consecutive elective abdominal aortic aneurysm repairs. 

Cardiovasc Surg 1996 Dec; 4(6):724-6. Not EVAR vs open 

or surveillance trial

Lottman PE, Laheij RJ, Cuypers PW, et al. Health-related 

quality of life outcomes following elective open or 

endovascular AAA repair: a randomized controlled trial. J 

Endovasc Ther 2004 Jun; 11(3):323-9. No clinical 

outcomes of interest 

Lyden SP, Sternbach Y, Waldman DL, et al. Clinical 

implications of internal iliac artery embolization in 

endovascular repair of aortoiliac aneurysms. Ann Vasc 

Surg 2001 Sep; 15(5):539-43. Not EVAR vs open or 

surveillance trial

Makaroun M, Zajko A, Orons P, et al. The experience of an 

academic medical center with endovascular treatment of 

abdominal aortic aneurysms. Am J Surg 1998 Aug; 

176(2):198-202. Not EVAR vs open or surveillance trial

Makaroun M, Zajko A, Sugimoto H, et al. Fate of 

endoleaks after endoluminal repair of abdominal aortic 

aneurysms with the EVT device. Eur J Vasc Endovasc Surg 

1999 Sep; 18(3):185-90. Not EVAR vs open or surveillance 

trial

Makaroun MS, Chaikof E, Naslund T, et al. Efficacy of a 

bifurcated endograft versus open repair of abdominal aortic 

aneurysms: a reappraisal. J Vasc Surg 2002 Feb; 35(2):203-

10. Not RCT 

Makaroun MS, Deaton DH. Is proximal aortic neck 

dilatation after endovascular aneurysm exclusion a cause 

for concern? J Vasc Surg 2001 Feb; 33(2 Suppl):S39-45. 

Not EVAR vs open or surveillance trial

Malina M, Nilsson M, Brunkwall J, et al. Quality of life 

before and after endovascular and open repair of 

asymptomatic AAAs: a prospective study. J Endovasc Ther 

2000 Oct; 7(5):372-9. Not RCT 

Matsumoto M, Hata T, Tsushima Y, et al. Minimally 

invasive vascular surgery for repair of infrarenal abdominal 

aortic aneurysm with iliac involvement. J Vasc Surg 2002 

Apr; 35(4):654-60. Not RCT 
C-7 

Matsumura JS, Brewster DC, Makaroun MS, et al. A 

multicenter controlled clinical trial of open versus 

endovascular treatment of abdominal aortic aneurysm. J 

Vasc Surg 2003 Feb; 37(2):262-71. Not RCT 

Matsumura JS, Chaikof EL. Continued expansion of aortic 

necks after endovascular repair of abdominal aortic 

aneurysms. EVT Investigators. EndoVascular 

Technologies, Inc. J Vasc Surg 1998 Sep; 28(3):422-30. 

Not EVAR vs open or surveillance trial

Matsumura JS, Katzen BT, Hollier LH, et al. Update on the 

bifurcated EXCLUDER endoprosthesis: phase I results. J 

Vasc Surg 2001 Feb; 33(2 Suppl):S150-3. Not EVAR vs 

open or surveillance trial

Matsumura JS, Moore WS. Clinical consequences of 

periprosthetic leak after endovascular repair of abdominal 

aortic aneurysm. Endovascular Technologies Investigators. 

J Vasc Surg 1998 Apr; 27(4):606-13. Not EVAR vs open or 

surveillance trial

May J, White GH, Yu W, et al. Concurrent comparison of 

endoluminal repair vs. no treatment for small abdominal 

aortic aneurysms. Eur J Vasc Endovasc Surg 1997 May; 

13(5):472-6. Not RCT 

May J, White GH, Yu W, et al. Endovascular grafting for 

abdominal aortic aneurysms: changing incidence and 

indication for conversion to open operation. Cardiovasc 

Surg 1998 Apr; 6(2):194-7. Not RCT 

McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery 

revascularization before elective major vascular surgery. N 

Engl J Med 2004 Dec 30; 351(27):2795-804. Not EVAR vs 

open or surveillance trial

McGahan TJ, Berry GA, McGahan SL, et al. Results of 

autopsy 7 months after successful endoluminal treatment of 

an infrarenal abdominal aortic aneurysm. J Endovasc Surg 

1995 Nov; 2(4):348-55. Not EVAR vs open or surveillance 

trial

Meierhenrich R, Gauss A, Anhaeupl T, et al. Analysis of 

diastolic function in patients undergoing aortic aneurysm 

repair and impact on hemodynamic response to aortic 

cross-clamping. J Cardiothorac Vasc Anesth 2005 Apr; 

19(2):165-72. Not EVAR vs open or surveillance trial

Milne AA, Murphy WG, Reading SJ, et al. A randomised 

trial of fibrin sealant in peripheral vascular surgery. Vox 

Sang 1996; 70(4):210-2. Not EVAR vs open or surveillance 

trial

Mocini D, Uguccioni M, Galli C, et al. Dipyridamole 

echocardiography and 99mTc-MIBI spect dipyridamole 

scintigraphy for cardiac evaluation prior to peripheral 

vascular surgery. Minerva Cardioangiol 1995 May; 

43(5):185-90. Not EVAR vs open or surveillance trial

Moore WS. The Guidant Ancure bifurcation endograft: 

five-year follow-up. Semin Vasc Surg 2003 Jun; 16(2):139-

43. Not RCT 

Moore WS. The role of endovascular grafting technique in 

the treatment of infrarenal abdominal aortic aneurysm. 

Cardiovasc Surg 1995 Apr; 3(2):109-14. Not RCT 

Moore WS, Brewster DC, Bernhard VM. Aorto-uni-iliac 

endograft for complex aortoiliac aneurysms compared with 

tube/bifurcation endografts: results of the EVT/Guidant 

trials. J Vasc Surg 2001 Feb; 33(2 Suppl):S11-20. Not RCT 

Moore WS, Matsumura JS, Makaroun MS, et al. Five-year 

interim comparison of the Guidant bifurcated endograft 

with open repair of abdominal aortic aneurysm. J Vasc 

Surg 2003 Jul; 38(1):46-55. Not RCT 

Moore WS, Rutherford RB. Transfemoral endovascular 

repair of abdominal aortic aneurysm: results of the North 

American EVT phase 1 trial. EVT Investigators. J Vasc 

Surg 1996 Apr; 23(4):543-53. Not EVAR vs open or 

surveillance trial

Nakajima T, Kawazoe K, Komoda K, et al. Midline 

retroperitoneal versus midline transperitoneal approach for 

abdominal aortic aneurysm repair. J Vasc Surg 2000 Aug; 

32(2):219-23. Not EVAR vs open or surveillance trial

Nakayama S, Yamazato A, Hanada M, et al. [Results of 

surgical treatment of aortic dissections]. Nippon Geka 

Hokan 1994 May 1; 63(3):99-103. (Jap) Not RCT 

Nakayama Y, Sakata R, Umebayashi Y, et al. [An 

evaluation of aortic root reconstruction using Carrel patch 

method with coronary anastomosis]. Kyobu Geka 1996 

Jun; 49(6):452-5. (Jap) Not EVAR vs open or surveillance 

trial

Naslund TC, Edwards WH Jr, Neuzil DF, et al. Technical 

complications of endovascular abdominal aortic aneurysm 

repair. J Vasc Surg 1997 Sep; 26(3):502-9. Not EVAR vs 

open or surveillance trial

Neimark MI, Merkulov IV, Flat MK. [Renal protective 

function in surgical treatment for chronic infrarenal aortic 

aneurysms]. Anesteziol Reanimatol 2005 Jul-Aug; (4):18-

22. (Rus) Not EVAR vs open or surveillance trial

Nienaber CA, Ince H, Weber F, et al. Emergency stentgraft placement in thoracic aortic dissection and evolving 

rupture. J Card Surg 2003 Sep-Oct; 18(5):464-70. Not 

EVAR vs open or surveillance trial

Norgren L, Holtas S, Persson G, et al. Immune response to 

collagen impregnated Dacron double velour grafts for 

aortic and aorto-femoral reconstructions. Eur J Vasc Surg 

1990 Aug; 4(4):379-84. Not EVAR vs open or surveillance 

trial
C-8 

Ohkado A, Shiina Y, Nakajima T, et al. Evaluation of 

effect and distribution of heparin administered in vascular 

reconstructive surgery. Panminerva Med 1999 Mar; 

41(1):18-21. Not EVAR vs open or surveillance trial

Ohmi M, Ito T, Niibori K, et al. [Separate perfusion of 

upper and lower body under mild hypothermia during 

operation on the thoracoabdominal aorta]. Kyobu Geka 

1995 Aug; 48(9):725-9. (Jap) Not EVAR vs open or 

surveillance trial; not English language

Orend KH, Pamler R, Goerich J, et al. [Value of stentassisted aneurysm treatment]. Langenbecks Arch Chir 

Suppl Kongressbd 1998; 115:1234-6. (Ger) Not English 

language 

Ouriel K, Clair DG, Greenberg RK, et al. Endovascular 

repair of abdominal aortic aneurysms: device-specific 

outcome. J Vasc Surg 2003 May; 37(5):991-8. Not EVAR 

vs open or surveillance trial

Paaske WP, Laustsen J. Early results of 132 aortic or aortoiliac arterial reconstructions with the new Stretch ePTFE 

vascular prosthesis. Int Angiol 1994 Dec; 13(4):296-9. Not 

EVAR vs open or surveillance trial

Parra JR, Crabtree T, McLafferty RB, et al. Anesthesia 

technique and outcomes of endovascular aneurysm repair. 

Ann Vasc Surg 2005 Jan; 19(1):123-9. Not EVAR vs open 

or surveillance trial

Patra P, Chaillou P, Bizouarn P. Intraoperative 

autotransfusion for repair of unruptured aneurysms of the 

infrarenal abdominal aorta. A multicenter study of 203 

patients. Association Universitaire de Recherche en 

Chirurgie (AURC). J Cardiovasc Surg 2000 Jun; 41(3):407-

13. Not EVAR vs open or surveillance trial

Paty PS, Darling RC 3rd, Chang BB, et al. A prospective 

randomized study comparing exclusion technique and 

endoaneurysmorrhaphy for treatment of infrarenal aortic 

aneurysm. J Vasc Surg 1997 Mar; 25(3):442-5. Not EVAR 

vs open or surveillance trial

Pevec WC, Holcroft JW, Blaisdell FW. Ligation and 

extraanatomic arterial reconstruction for the treatment of 

aneurysms of the abdominal aorta. [Review]. J Vasc Surg 

1994 Oct; 20(4):629-36. Not RCT 

Piquet P, Amabile P, Rollet G. Minimally invasive 

retroperitoneal approach for the treatment of infrarenal 

aortic disease. J Vasc Surg 2004 Sep; 40(3):455-62. Not 

EVAR vs open or surveillance trial

Quarmby JW, Burnand KG, Lockhart SJ, et al. Prospective 

randomized trial of woven versus collagen-impregnated 

knitted prosthetic Dacron grafts in aortoiliac surgery. Br J 

Surg 1998 Jun; 85(6):775-7. Not EVAR vs open or 

surveillance trial

Raman KG, Missig-Carroll N, Richardson T, et al. Colorflow duplex ultrasound scan versus computed tomographic 

scan in the surveillance of endovascular aneurysm repair. J 

Vasc Surg 2003 Oct; 38(4):645-51. Not EVAR vs open or 

surveillance trial

Rapp HJ, Rabethge S, Luiz T, et al. Perioperative STsegment depression and troponin T release. Identification 

of patients with highest risk for myocardial damage. Acta 

Anaesthesiol Scand 1999 Feb; 43(2):124-9. Not EVAR vs 

open or surveillance trial

Robbins M, Kritpracha B, Beebe HG, et al. Suprarenal 

endograft fixation avoids adverse outcomes associated with 

aortic neck angulation. Ann Vasc Surg 2005 Mar; 

19(2):172-7. Not EVAR vs open or surveillance trial

Sadahiro M, Sakurai M, Hata M, et al. [Open distal 

anastomosis or aortic balloon occlusion technique during 

complete aortic arch replacement]. Jpn J Thorac Cardiovasc 

Surg 1998 Jul; 46(7):610-5. (Jap) Not EVAR vs open or 

surveillance trial; not English language

Sadahiro M, Tabayashi K, Ohmi M, et al. [Surgical 

treatment of type A aortic dissection based on the location 

of the entry]. Nippon Kyobu Geka Gakkai Zasshi 1995 

Mar; 43(3):306-12. (Jap) Not EVAR vs open or surveillance 

trial; not English language

Sampram ES, Karafa MT, Mascha EJ, et al. Nature, 

frequency, and predictors of secondary procedures after 

endovascular repair of abdominal aortic aneurysm. J Vasc 

Surg 2003 May; 37(5):930-7. Not EVAR vs open or 

surveillance trial

Sangiorgi G, D'Averio R, Mauriello A, et al. Plasma levels 

of metalloproteinases-3 and -9 as markers of successful 

abdominal aortic aneurysm exclusion after endovascular 

graft treatment. Circulation 2001 Sep 18; 104(12 Suppl 

1):I288-95. Not EVAR vs open or surveillance trial

Sato DT, Goff CD, Gregory RT, et al. Endoleak after aortic 

stent graft repair: diagnosis by color duplex ultrasound scan 

versus computed tomography scan. J Vasc Surg 1998 Oct; 

28(4):657-63. Not EVAR vs open or surveillance trial

Schepens MA, Dekker E, Hamerlijnck RP, et al. Survival 

and aortic events after graft replacement for 

thoracoabdominal aortic aneurysm. Cardiovasc Surg 1996 

Dec; 4(6):713-9. Not EVAR vs open or surveillance trial

Schurink GW, Aarts NJ, van Bockel JH. Endoleak after 

stent-graft treatment of abdominal aortic aneurysm: a metaanalysis of clinical studies. Br J Surg 1999 May; 86(5):581-

7. Not RCT 

Shah DM, Darling RC 3rd, Chang BB, et al. Access to the 

right renal artery from the left retroperitoneal approach. 

Cardiovasc Surg 1996 Dec; 4(6):763-5. Not EVAR vs open 

or surveillance trial
C-9 

Shah DM, Darling RC 3rd, Kreienberg PB, et al. A critical 

approach for longitudinal clinical trial of stretch PTFE 

aortic grafts. Cardiovasc Surg 1997 Aug; 5(4):414-8. Not 

EVAR vs open or surveillance trial

Skora J, Janczak D, Szyber P, et al. [Radioisotopic 

diagnosis of infected anastomotic groin aneurysms after 

complications with aorto-bifemoral vascular prosthesis]. 

Wiad Lek 1997; 50(Suppl 1 Pt 2):23-6. (Pol) Not EVAR vs 

open or surveillance trial

Speziale F, Zaccaria A, Rizzo L, et al. [Use of 

endoprosthesis in aortoiliac aneurysms]. Minerva 

Cardioangiol 1999 Dec; 47(12):565-6. (Ita) Not EVAR vs 

open or surveillance trial

Sprouse LR 2nd, Meier GH 3rd, Parent FN, et al. Is threedimensional computed tomography reconstruction justified 

before endovascular aortic aneurysm repair? J Vasc Surg 

2004 Sep; 40(3):443-7. Not EVAR vs open or surveillance 

trial

Sternbergh WC 3rd, Money SR. Hospital cost of 

endovascular versus open repair of abdominal aortic 

aneurysms: a multicenter study. J Vasc Surg 2000 Feb; 

31(2):237-44. Not RCT 

Stratton JR, Ritchie JL. Effect of suloctidil on 

tomographically quantitated platelet accumulation in 

Dacron aortic grafts. Am J Cardiol 1986 Jul 1; 58(1):152-6. 

Not EVAR vs open or surveillance trial

Sueda T, Morita S, Okada K, et al. Selective intercostal 

arterial perfusion during thoracoabdominal aortic aneurysm 

surgery. Ann Thorac Surg 2000 Jul; 70(1):44-7. Not EVAR 

vs open or surveillance trial

Teufelsbauer H, Prusa AM, Wolff K, et al. Endovascular 

stent grafting versus open surgical operation in patients 

with infrarenal aortic aneurysms: a propensity scoreadjusted analysis. Circulation 2002 Aug 13; 106(7):782-7. 

Not RCT 

Thompson JP, Boyle JR, Thompson MM, et al. Nocturnal 

hypoxaemia and respiratory function after endovascular 

and conventional abdominal aortic aneurysm repair. Br J 

Anaesth 1999 Jan; 82(1):129-31. Not RCT 

Torsello GB, Kasprzak B, Klenk E, et al. Endovascular 

suture versus cutdown for endovascular aneurysm repair: a 

prospective randomized pilot study. J Vasc Surg 2003 Jul; 

38(1):78-82. Not EVAR vs open or surveillance trial

Treiman GS, Lawrence PF, Edwards WH Jr, et al. An 

assessment of the current applicability of the EVT 

endovascular graft for treatment of patients with an 

infrarenal abdominal aortic aneurysm. J Vasc Surg 1999 

Jul; 30(1):68-75. Not EVAR vs open or surveillance trial

Turnipseed WD, Carr SC, Hoch JR, et al. Minimal incision 

aortic surgery (MIAS). Ann Vasc Surg 2003 Mar; 

17(2):180-4. Not EVAR vs open or surveillance trial

Ueki M, Yokono S, Nogaya J, et al. [Effects of ulinastatin 

on renal function after subrenal aortic cross-clamping]. 

Masui 1995 Mar 3; 44(3):357-61. (Jap) Not EVAR vs open 

or surveillance trial; not English language

Utoh J, Goto H, Hirata T, et al. Postoperative inflammatory 

reactions to sealed Dracon prostheses: a comparison of 

Gelseal and Hemashield. J Cardiovasc Surg 1997 Jun; 

38(3):287-90. Not EVAR vs open or surveillance trial

Utoh J, Miyauchi Y, Goto H, et al. Inflammatory reactions 

after vascular prosthesis implantation: a comparison of 

gelatin-sealed and unsealed Dacron prostheses. Surg Today 

1996; 26(4):258-61. Not EVAR vs open or surveillance trial

Valdes F, Seitz J, Fava M, et al. [Endovascular treatment of 

abdominal aortic aneurysm. Initial experience]. Rev Med 

Chil 1998 Oct; 126(10):1206-15. (Spa) Not EVAR vs open 

or surveillance trial

Valentine RJ, Duke ML, Inman MH, et al. Effectiveness of 

pulmonary artery catheters in aortic surgery: a randomized 

trial. J Vasc Surg 1998 Feb; 27(2):203-11. Not EVAR vs 

open or surveillance trial

Vallabhaneni SR, Gilling-Smith GL, How TV, et al. Aortic 

side branch perfusion alone does not account for high intrasac pressure after endovascular repair (EVAR) in the 

absence of graft-related endoleak. Eur J Vasc Endovasc 

Surg 2003 Apr; 25(4):354-9. Not EVAR vs open or 

surveillance trial

van Marrewijk C, Buth J, Harris PL, et al. Significance of 

endoleaks after endovascular repair of abdominal aortic 

aneurysms: The EUROSTAR experience. J Vasc Surg 2002 

Mar; 35(3):461-73. Not RCT

Velazquez OC, Carpenter JP, Baum RA, et al. Perigraft air, 

fever, and leukocytosis after endovascular repair of 

abdominal aortic aneurysms. Am J Surg 1999 Sep; 

178(3):185-9. Not EVAR vs open or surveillance trial

Villareal RP, Kar B, Howell MH, et al. Bare metal stents 

with or without coil embolization for abdominal aortic 

aneurysm exclusion in high-risk patients. Catheter 

Cardiovasc Interv 2001 Sep; 54(1):12-8. Not EVAR vs open 

or surveillance trial

Volta CA, Ferri E, Marangoni E, et al. Respiratory 

function after aortic aneurysm repair: a comparison 

between retroperitoneal and transperitoneal approaches. 

Intensive Care Med 2003 Aug; 29(8):1258-64. 

Not EVAR vs open or surveillance trial

von Segesser LK, Lorenzetti E, Lachat M, et al. Aortic 

valve preservation in acute type A dissection: is it sound? J 

Thorac Cardiovasc Surg 1996 Feb; 111(2):381-90. Not 

EVAR vs open or surveillance trial

Wagar D. Gadolinium CT aortography in stent-graft repair 

of abdominal aortic aneurysms. Acad Radiol, 2002 May; 9 

(Suppl 1):S220-2. Not EVAR vs open or surveillance trial 
C-10 

Wakefield TW, Shulkin BL, Fellows EP, et al. Platelet 

reactivity in human aortic grafts: a prospective, randomized 

midterm study of platelet adherence and release products in 

Dacron and polytetrafluoroethylene conduits. J Vasc Sur, 

1989 Feb; 9(2):234-43. Not EVAR vs open or surveillance 

trial

Walschot LH, Laheij RJ, Verbeek AL. Outcome after 

endovascular abdominal aortic aneurysm repair: a metaanalysis. J Endovasc The, 2002 Feb; 9(1):82-9. Not RCT 

Waters JH, Gottlieb A, Schoenwald P, et al. Normal saline 

versus lactated Ringer's solution for intraoperative fluid 

management in patients undergoing abdominal aortic 

aneurysm repair: an outcome study. Anesth Anal, 2001 

Oct; 93(4):817-22. Not EVAR vs open or surveillance trial

Webster SE, Smith J, Thompson MM, et al. Does the 

sequence of clamp application during open abdominal 

aortic aneurysm surgery influence distal embolisation? Eur 

J Vasc Endovasc Sur, 2004 Jan; 27(1):61-4. Not EVAR vs 

open or surveillance trial

Wenk H, Shekarriz H, Bruch HP. [Choice of vascular 

prosthesis material in treatment of infrarenal abdominal 

aortic aneurysms--initial results of a prospective 

randomized study]. Zentralbl Chir 1997; 122(9):743-6. 

(Ger) Not EVAR vs open or surveillance trial; not English 

language

White RA, Donayre CE, Walot I, et al. Modular bifurcation 

endoprosthesis for treatment of abdominal aortic 

aneurysms. Ann Surg 1997 Sep; 226(3):381-9. Not EVAR 

vs open or surveillance trial

Wijnen MH, Roumen RM, Vader HL, et al. A 

multiantioxidant supplementation reduces damage from 

ischaemia reperfusion in patients after lower torso 

ischaemia. A randomised trial. Eur J Vasc Endovasc Surg 

2002 Jun; 23(6):486-90. Not EVAR vs open or surveillance 

trial

Wilson NV, Melissari E, Standfield NJ, et al. Intraoperative antithrombotic therapy with low molecular 

weight heparin in aortic surgery. How should heparin be 

administered? Eur J Vasc Surg 1991 Oct; 5(5):565-9. Not 

EVAR vs open or surveillance trial

Wolowczyk L, Nevin M, Day A, et al. The effect of acute 

normovolaemic haemodilution on the inflammatory 

response and clinical outcome in abdominal aortic 

aneurysm repair--results of a pilot trial. Eur J Vasc 

Endovasc Surg 2005 Jul; 30(1):12-9. Not EVAR vs open or 

surveillance trial

Yamasaki R, Komori K, Mori E, et al. [Usefulness of 

endovascular grafting for abdominal aortic aneurysm]. 

Fukuoka Igaku Zasshi 1999 Jul; 90(7):318-23. (Jap) Not 

RCT 

Yasuhara H, Shigematsu H, Muto T. Advantages of straight 

graft for abdominal aortic aneurysm repair. Panminerva 

Med 1998 Sep; 40(3):199-203. Not EVAR vs open or 

surveillance trial

Zannetti S, De Rango P, Parente B, et al. Role of duplex 

scan in endoleak detection after endoluminal abdominal 

aortic aneurysm repair. Eur J Vasc Endovasc Surg 2000 

May; 19(5):531-5. Not EVAR vs open or surveillance trial

Zarins CK, AneuRx Clinical Investigators. The US 

AneuRx Clinical Trial: 6-year clinical update 2002. J Vasc 

Surg 2003 Apr; 37(4):904-8. Not RCT 

Zarins CK, Bloch DA, Crabtree T, et al. Aneurysm 

enlargement following endovascular aneurysm repair: 

AneuRx clinical trial. J Vasc Surg 2004 Jan; 39(1):109-17. 

Not RCT 

Zarins CK, Bloch DA, Crabtree T, et al. Stent graft 

migration after endovascular aneurysm repair: importance 

of proximal fixation. J Vasc Surg 2003 Dec; 38(6):1264-72. 

Not RCT 

Zarins CK, Crabtree T, Arko FR, et al. Endovascular repair 

or surveillance of patients with small AAA. Eur J Vasc 

Endovasc Surg 2005 May; 29(5):496-503. Not RCT 

Zarins CK, White RA, Schwarten D, et al. AneuRx stent 

graft versus open surgical repair of abdominal aortic 

aneurysms: multicenter prospective clinical trial. J Vasc 

Surg 1999 Feb; 29(2):292-305. Not RCT 

Zimmer S, Heiss MM, Schardey HM, et al. [Inflammatory 

syndrome after endovascular implantation of an aortic 

stent--a comparative study]. Langenbecks Arch Chir Suppl 

Kongressbd 1998; 115(Suppl I):13-7. (Ger) Not RCT 
C-11 

Question 2: Volume (reason for exclusion is provided in italics following each reference)

Albertini JN, Branchereau A, Hopkinson B, et al. Mortality 

and morbidity following endovascular repair of abdominal 

aortic aneurysms: analysis of two single centre experiences. 

Eur J Vasc Endovasc Surg 2001 Nov; 22(5):429-35. No 

volumes data 

Bastounis E, Filis K, Georgopoulos S, et al. Selective use 

of the intensive care unit after elective infrarenal abdominal 

aortic aneurysm repair. Int Angiol 2003 Sep; 22(3):308-16. 

No volumes data 

Carpenter JP, Endologix Investigators. Midterm results of 

the multicenter trial of the powerlink bifurcated system for 

endovascular aortic aneurysm repair. J Vasc Surg 2004 

Nov; 40(5):849-59. No volumes data

Cheng SW, Ting AC, Tsang SH. Epidemiology and 

outcome of aortic aneurysms in Hong Kong. World J Surg 

2003 Feb; 27(2):241-5. No volumes data

Cowan JA Jr, Dimick JB, Henke PK, et al. Surgical 

treatment of intact thoracoabdominal aortic aneurysms in 

the United States: hospital and surgeon volume-related 

outcomes. J Vasc Surg 2003 Jun; 37(6):1169-74. Not 

unruptured AAA treatment

Cowan JA Jr, Dimick JB, Wainess RM, et al. Ruptured 

thoracoabdominal aortic aneurysm treatment in the United 

States: 1988 to 1998. J Vasc Surg 2003 Aug; 38(2):319-22. 

Not unruptured AAA treatment

de Donato G, Sarradon P, Weber G, et al. Current role of 

the minimally invasive direct aortic surgery for 3-A repair 

(MIDAS-3A). [Review]. Chir Ital 2003 Sep-Oct; 

55(5):625-36. No volumes data 

Dimick JB, Pronovost PJ, Cowan JA, et al. The volumeoutcome effect for abdominal aortic surgery: differences in 

case-mix or complications? Arch Surg 2002 Jul; 

137(7):828-32. Data previously reported 

Dimick JB, Pronovost PJ, Cowan JA Jr, et al. Should older 

patients be selectively referred to high-volume centers for 

abdominal aortic surgery? Vascular 2004 Jan; 12(1):51-6. 

Data previously reported 

Dimick JB, Upchurch GR Jr. The quality of care for 

patients with abdominal aortic aneurysms. [Review]. 

Cardiovasc Surg 2003 Oct; 11(5):331-6. Data previously 

reported 

Dueck AD, Johnston KW, Alter D, et al. Predictors of 

repair and effect of gender on treatment of ruptured 

abdominal aortic aneurysm. J Vasc Surg 2004 Apr; 

39(4):784-7. Not unruptured AAA treatment

Dueck AD, Kucey DS, Johnston KW, et al. Survival after 

ruptured abdominal aortic aneurysm: effect of patient, 

surgeon, and hospital factors. J Vasc Surg 2004 Jun; 

39(6):1253-60. Not unruptured AAA treatment

Forbes TL, De Rose G, Harris KA. A CUSUM analysis of 

ruptured abdominal aortic aneurysm repair. Ann Vasc Surg 

2002 Sep; 16(5):527-33. Not unruptured AAA treatment

Huber TS, Seeger JM. Dartmouth Atlas of Vascular Health 

Care review: impact of hospital volume, surgeon volume, 

and training on outcome. J Vasc Surg 2001 Oct; 34(4):751-

6. Review 

Shaw PM, Veith FJ, Lipsitz EC, et al. Open aneurysm 

repair at an endovascular center: value of a modified 

retroperitoneal approach in patients at high risk with 

difficult aneurysms. J Vasc Surg 2003 Sep; 38(3):504-10. 

No volumes data 

Tu JV, Austin PC, Johnston KW. The influence of surgical 

specialty training on the outcomes of elective abdominal 

aortic aneurysm surgery. J Vasc Surg 2001 Mar; 33(3):447-

52. No volumes data 

Urbach DR, Baxter NN. Does it matter what a hospital is 

"high volume" for? Specificity of hospital volume-outcome 

associations for surgical procedures: analysis of 

administrative data. Qual Saf Health Care 2004 Oct; 

13(5):379-83. Not US study 

Waters JH, Gottlieb A, Schoenwald P, et al. Normal saline 

versus lactated Ringer's solution for intraoperative fluid 

management in patients undergoing abdominal aortic 

aneurysm repair: an outcome study. Anesth Analg 2001 

Oct; 93(4):817-22. No volumes data

Wong JC, Torella F, Haynes SL, et al. Autologous versus 

allogeneic transfusion in aortic surgery: a multicenter 

randomized clinical trial. Ann Surg 2002 Jan; 235(1):145-

51. No volumes data
C-12 

Question 4: Cost (reason for exclusion is provided in italics following each reference) 

Abularrage CJ, Sheridan MJ, Mukherjee D. Endovascular 

versus "fast-track'' abdominal aortic aneurysm repair. Vasc 

Endovasc Sur, 2005 May-Jun; 39(3):229-36. Less than 50 

patients / treatment arm 

Adachi K, Iwasawa T, Ono T. Screening for abdominal 

aortic aneurysms during a basic medical checkup in 

residents of a Japanese rural community. Surg Today 2000; 

30(7):594-9. Not AAA EVAR/open treatment trial 

Anonymous. Screening for abdominal aortic aneurysms. 

Health News 2003 Oct; 9(10):10. Not AAA EVAR/open 

treatment trial 

Anonymous. Socioeconomic tips of the month. Coding for 

endovascular abdominal aortic aneurysm repair. Bull Am 

Coll Surg 2001 Mar; 86(3):44-5. No cost data 

Anonymous. Stemming losses from AAA endografts. OR 

Manager 2003 Jun; 19(6):26. No cost data 

Arko FR, Filis KA, Heikkinen MA, et al. Duplex scanning 

after endovascular aneurysm repair: an alternative to 

computed tomography. [Review]. Semin Vasc Surg 2004 

Jun; 17(2):161-5. Not AAA EVAR/open treatment trial 

Aune S, Laxdal E, Pedersen G, et al. Lifetime gain related 

to cost of repair of ruptured abdominal aortic aneurysm in 

octogenarians. Eur J Vasc Endovasc Surg 2004 Mar; 

27(3):299-304. No data of interest 

Axelrod DA, Diwan A, Stanley JC, et al. Cost of routine 

screening for carotid and lower extremity occlusive disease 

in patients with abdominal aortic aneurysms. J Vasc Surg 

2002 Apr; 35(4):754-8. Not AAA EVAR/open treatment 

trial 

Bader RS, Goldberg L, Sahn DJ. Risk of sudden cardiac 

death in young athletes: which screening strategies are 

appropriate?. [Review]. Pediatr Clin North Am 2004 Oct; 

51(5):1421-41. Not AAA EVAR/open treatment trial 

Ballard DJ, Fowkes FG, Powell JT. Surgery for small 

asymptomatic abdominal aortic aneurysms. [Review]. 

Cochrane Database Syst Rev 2000; (2):CD001835. Review 

Ballard JL, Abou-Zamzam AM, Teruya TH, et al. Quality 

of life before and after endovascular and retroperitoneal 

abdominal aortic aneurysm repair. J Vasc Surg 2004 Apr; 

39(4):797-803. Less than 50 patients in treatment arm 

Ballard JL, Yonemoto H, Killeen JD. Cost-effective aortic 

exposure: a retroperitoneal experience. Ann Vasc Surg 

2000 Jan; 14(1):1-5. Less than 50 patients / treatment arm 

Barone JE, Tucker JB, Bull SM. The Leapfrog Initiative: a 

potential threat to surgical education. Curr Surg 2003 MarApr; 60(2):218-21. No cost data 

Beard JD. Screening for abdominal aortic aneurysm. Br J 

Surg 2003 May; 90(5):515-6. Not AAA EVAR/open 

treatment trial 

Becker C. Stealth fighter. Abdominal aortic aneurysms can 

kill quickly and silently. Some say the best prevention is 

increased screening and surgery to implant sophisticated 

grafts. Mod Healthc 2005 Feb 14; 35(7):52, 56. Not AAA 

EVAR/open treatment trial 

Bein B, Turowski P, Renner J, et al. Comparison of xenonbased anaesthesia compared with total intravenous 

anaesthesia in high risk surgical patients. Anaesthesia 2005 

Oct; 60(10):960-7. Not AAA EVAR/open treatment trial 

Beinfeld MT, Wittenberg E, Gazelle GS. Cost-effectiveness 

of whole-body CT screening. Radiology 2005 Feb; 

234(2):415-22. Not AAA EVAR/open treatment trial 

Bell PR. Endovascular repair of abdominal aortic 

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Bensenor IM. Screening for abdominal aortic 

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on abdominal aortic aneurysm in men aged 60 to 65 years 

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trial 

Bonamigo TP, Siqueira I. Screening for abdominal aortic 

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Brown LC, Epstein D, Manca A, et al. The UK 

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C-13 

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2001 Apr; 94(4):411-6. Not AAA EVAR/open treatment 

trial 

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2002 Oct; 236(4):471-9. No AAA repair cost data 

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management of abdominal aortic aneurysm: a costeffectiveness analysis. Clin Invest Med 2002 Aug; 

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AAA EVAR/open treatment trial 

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AAA EVAR/open treatment trial 

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AAA EVAR/open treatment trial 

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Not AAA EVAR/open treatment trial 

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AAA EVAR/open treatment trial 
C-14 

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Not AAA EVAR/open treatment trial 

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Haulon S, Tyazi A, Willoteaux S, et al. Embolization of 

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EVAR/open treatment trial 

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AAA EVAR/open treatment trial 

Ishikawa S, Takahashi T, Sato Y, et al. Screening cost for 

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treatment trial 

Johnson BL, Dalman RL. Duplex surveillance of 

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2001 Sep; 14(3):227-32. Not AAA EVAR/open treatment 

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Kan CB, Wang JS, Yu TJ, et al. Is combined abdominal 

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EVAR/open treatment trial 

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EVAR/open treatment trial 

Kedjanyi WK, Gupta D. Near total transection of the 

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R Coll Surg Edinb 2001 Aug; 46(4):242-3. Not AAA 

EVAR/open treatment trial 

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Kim LG, Scott RA, Thompson SG, et al. Implications of 

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EVAR/open treatment trial 

Krupski WC. Con: Endovascular stent repair for aortic 

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199(6):946-60. Review 

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Thai 2005 May; 88(5):601-6. Less than 50 patients / arm 

Lederle FA. Ultrasonographic screening for abdominal 

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Lee TY, Korn P, Heller JA, et al. The cost-effectiveness of 

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Surgery 2002 Aug; 132(2):399-407. Not AAA EVAR/open 

treatment trial 

Leshno M, Levy H. Stochastic dominance and medical 

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C-15 

Liapis C, Kakisis J, Kaperonis E, et al. Changes of the 

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Lindholt JS, Juul S, Fasting H, et al. Hospital costs and 

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Vasc Endovasc Surg 2002 Jan; 23(1):55-60. Not AAA 

EVAR/open treatment trial 

Lippmann M, Lingam K, Rubin Set al. Anesthesia for 

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trial 

Lippmann M, Rubin S, Ginsburg R, et al. An alternative 

anesthetic technique for the morbidly obese patient 

undergoing endovascular repair of an abdominal aortic 

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EVAR/open treatment trial 

Lipsitz EC, Ohki T, Veith FJ, et al. Limited role for IVUS 

in the endovascular repair of aortoiliac aneurysms. J 

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EVAR/open treatment trial 

Longo C, Upchurch GR Jr. Abdominal aortic aneurysm 

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EVAR/open treatment trial 

Malinzak LE, Long GW, Bove PG, Brown OW, Romano 

W, Shanley CJ, et al. Gastrointestinal complications 

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Vascular & Endovascular Surgery 2004 Mar-Apr; 

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Maloney JD, Hoch JR, Carr SC, et al. Preliminary experience 

with minilaparotomy aortic surgery. Ann Vasc Surg 2000 Jan; 

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Matsumoto K, Murayama T, Nagasaki K, et al. One-stage 

surgical management of concomitant abdominal aortic 

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2002 Apr; 26(4):434-7. Less than 50 patients / arm

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trial 

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one-stage coronary artery bypass grafting on the beating 

heart and abdominal aortic aneurysm repair. Ann Thorac 

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EVAR/open treatment trial 

Morishita K, Kawaharada N, Fukada J, et al. Can 

minilaparotomy abdominal aortic aneurysm repair be 

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Surgery 2003 Apr; 133(4):390-5. Not AAA EVAR/open 

treatment trial 

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doxycycline to decrease the growth rate of abdominal aortic 

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pilot study. J Vasc Surg 2001 Oct; 34(4):606-10. Not AAA 

EVAR/open treatment trial 

Muir Gray JA. Screening for abdominal aortic aneurysm. 

Br J Surg 2003 Sep; 90(9):1165 Not AAA EVAR/open 

treatment trial 

Multicentre Aneurysm Screening Study Group. Multicentre 

aneurysm screening study (MASS): cost effectiveness 

analysis of screening for abdominal aortic aneurysms based 

on four year results from randomised controlled trial. BMJ 

2002 Nov 16; 325(7373):1135. Not AAA EVAR/open 

treatment trial 

Myers KA. Endoluminal grafting for abdominal aortic 

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J Surg 2000 Nov; 70(11):767-8. Not AAA EVAR/open 

treatment trial 

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Thorac Surg 2000 Dec; 70(6):2171-2. Not AAA EVAR/open 

treatment trial 

Patra P, Chaillou P, Bizouarn P. Intraoperative 

autotransfusion for repair of unruptured aneurysms of the 

infrarenal abdominal aorta. A multicenter study of 203 

patients. Association Universitaire de Recherche en 

Chirurgie (AURC). J Cardiovasc Surg 2000 Jun; 41(3):407-

13. Not AAA EVAR/open treatment trial

Pentikainen TJ, Sipila T, Rissanen P, et al. Costeffectiveness of targeted screening for abdominal aortic 

aneurysm. Monte Carlo-based estimates. Int J Technol 

Assess Health Care 2000; 16(1):22-34. Not AAA 

EVAR/open treatment trial

Post PN, Kievit J, van Bockel JH. Optimal follow-up 

strategies after aorto-iliac prosthetic reconstruction: a 

decision analysis and cost-effectiveness analysis. Eur J 

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EVAR/open treatment trial

Powell JT, Brady AR. Detection, management, and prospects 

for the medical treatment of small abdominal aortic 

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Feb; 24(2):241-5. Not AAA EVAR/open treatment trial
C-16 

Prinssen M, Buskens E, Blankensteijn JD. The Dutch 

Randomised Endovascular Aneurysm Management 

(DREAM) trial. Background, design and methods. J 

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Pronovost P, Garrett E, Dorman T, et al. Variations in 

complication rates and opportunities for improvement in 

quality of care for patients having abdominal aortic 

surgery. Langenbecks Arch Surg 2001 Jul; 386(4):249-56. 

Not AAA EVAR/open treatment trial

Prytherch DR, Ridler BM, Ashley S, et al. Risk-adjusted 

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Puech-Leao P. Screening for abdominal aortic aneurysms: 

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Paulo 2003 Mar-Apr; 58(2):61-2. Not AAA EVAR/open 

treatment trial

Ravhon R, Adam D, Zelmanovitch L. Validation of 

ultrasonic image boundary recognition in abdominal aortic 

aneurysm. IEEE Trans Med Imaging 2001 Aug; 20(8):751-

63. Not AAA EVAR/open treatment trial

Rigberg DA, Dorafshar A, Sridhar A, et al. Abdominal 

aortic aneursym: stent graft vs clinical pathway for direct 

retroperitoneal repair. Arch Surg 2004 Sep; 139(9):941-4. 

Not AAA EVAR/open treatment trial

Rosenberg BL, Comstock MC, Butz DA, et al. 

Endovascular abdominal aortic aneurysm repair is more 

profitable than open repair based on contribution margin 

per day. Surgery 2005 Mar; 137(3):285-92. No cost data 

Rubin GD, Armerding MD, Dake MD, et al. Cost 

identification of abdominal aortic aneurysm imaging by 

using time and motion analyses. Radiology 2000 Apr; 

215(1):63-70. Not AAA EVAR/open treatment trial 

Rutherford RB. Structural failures in abdominal aortic 

aneurysm stentgrafts: Threat to durability and challenge to 

technology. [Review]. Semin Vasc Surg 2004 Dec; 

17(4):294-7. Not AAA EVAR/open treatment trial

Rutherford RB, Krupski WC. Current status of open versus 

endovascular stent-graft repair of abdominal aortic 

aneurysm. [Review]. J Vasc Surg 2004 May; 39(5):1129-

39. Review 

Saket RR, Razavi MK, Padidar A, et al. Novel 

intravascular ultrasound-guided method to create 

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peripheral occlusive disease and aortic dissection. J 

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EVAR/open treatment trial

Scott RA, Bridgewater SG, Ashton HA. Randomized 

clinical trial of screening for abdominal aortic aneurysm in 

women. Br J Surg 2002 Mar; 89(3):283-5. Not AAA 

EVAR/open treatment trial

Shuhaiber JH, Whitehead SM. The impact of introducing an 

autologous intraoperative transfusion device to a community 

hospital. Ann Vasc Surg 2003 Jul; 17(4):424-9. Not AAA 

EVAR/open treatment trial

Siepel T, Clifford DS, James PA, et al. The ultrasoundassisted physical examination in the periodic health 

evaluation of the elderly. J Fam Pract 2000 Jul; 49(7):628-

32. Not AAA EVAR/open treatment trial

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aneurysms. Vasa 2001 Nov; 30(4):262-70. Not AAA 

EVAR/open treatment trial

Sparks AR, Johnson PL, Meyer MC. Imaging of abdominal 

aortic aneurysms. [Review]. Am Fam Physician 2002 Apr 

15; 65(8):1565-70. Not AAA EVAR/open treatment trial

Steinmetz E, Rubin BG, Sanchez LA, et al. Type II 

endoleak after endovascular abdominal aortic aneurysm 

repair: a conservative approach with selective intervention 

is safe and cost-effective. J Vasc Surg 2004 Feb; 39(2):306-

13. Not AAA EVAR/open treatment trial

Sternbergh WC. The costs of endovascular versus 

transabdominal abdominal aortic aneurysm (AAA) 

repair.[comment]. Ann Surg 2000 Nov; 232(5):725-6. 

Commentary 

Sweeney AB, Flora HS, Chaloner EJ, et al. Integrated care 

pathways for vascular surgery: an analysis of the first 18 

months. Postgrad Med J 2002 Mar; 78(917):175-7. Not 

AAA EVAR/open treatment trial

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surgery for ruptured abdominal aortic aneurysm. Eur J 

Vasc Endovasc Surg 2003 Sep; 26(3):299-302. Not AAA 

EVAR/open treatment trial

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endoleaks. [Review]. Radiol Clin North Am 2002 Jul; 

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suture versus cutdown for endovascular aneurysm repair: a 

prospective randomized pilot study. J Vasc Surg 2003 Jul; 

38(1):78-82. Less than 50 patients / treatment arm 

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technology assessment. The PATHS model: methods and 

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incision aortic surgery with endovascular aortic repair. Am 

J Surg 2003 Sep; 186(3):287-91. Review 

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aortic surgery (MIAS). Ann Vasc Surg 2003 Mar; 

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C-17 

Turnipseed WD, Carr SC, Tefera G, et al. Minimal incision 

aortic surgery. J Vasc Surg 2001 Jul; 34(1):47-53. Less 

than 50 patients / treatment arm 

Urban BA, Fishman EK. Tailored helical CT evaluation of 

acute abdomen. [Review]. Radiographics 2000 May-Jun; 

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of iliac extensions and reduced graft junctions with 

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endograft components for endovascular aneurysm repair. J 

Vasc Surg 2004 Aug; 40(2):222-7. Not AAA EVAR/open 

treatment trial

Vogel TR, Nackman GB, Brevetti LS, et al. Resource 

utilization and outcomes: effect of transfer on patients with 

ruptured abdominal aortic aneurysms. Ann Vasc Surg 2005 

Mar; 19(2):149-53. Not AAA EVAR/open treatment trial

Wanhainen A, Lundkvist J, Bergqvist D, et al. Costeffectiveness of different screening strategies for abdominal 

aortic aneurysm. J Vasc Surg 2005 May; 41(5):741-51. Not 

AAA EVAR/open treatment trial

Wieslander CK, Huang CC, Omura MC, et al. 

Endovascular workforce for peripheral vascular disease: 

current and future needs. J Vasc Surg 2002 Jun; 

35(6):1218-25. Not AAA EVAR/open treatment trial

Wilmink AB, Quick CR, Hubbard CS, et al. Effectiveness 

and cost of screening for abdominal aortic aneurysm: 

results of a population screening program. J Vasc Surg 

2003 Jul; 38(1):72-7. Not AAA EVAR/open treatment trial

Wilson KA, Lee AJ, Lee AJ, et al. The relationship 

between aortic wall distensibility and rupture of infrarenal 

abdominal aortic aneurysm. J Vasc Surg 2003 Jan; 

37(1):112-7. Not AAA EVAR/open treatment trial

Wolff KS, Prusa AM, Polterauer P, et al. Endografting 

increases total volume of AAA repairs but not at the 

expense of open surgery: experience in more than 1000 

patients. J Endovasc Ther 2005 Jun; 12(3):274-9. Not AAA 

EVAR/open treatment trial

Wong JC, Torella F, Haynes SL, et al. Autologous versus 

allogeneic transfusion in aortic surgery: a multicenter 

randomized clinical trial. Ann Surg 2002 Jan; 235(1):145-

51. Not AAA EVAR/open treatment trial

Wong JG. Appropriate abdominal aortic aneurysm 

screening.[comment]. Postgrad Med 2000 Mar; 107(3):21-2. 

Not AAA EVAR/open treatment trial

Zierler BK, Gray DT. The principles of cost-effectiveness 

analysis and their application. [Review]. J Vasc Surg 2003 

Jan; 37(1):226-34. Not AAA EVAR/open treatment trial
D-1 

Appendix D: Data Extraction Forms 

Abdominal Aortic Aneurysm (AAA): Surveillance Article Abstraction Form (pages D-2 – D-9) 

Abdominal Aortic Aneurysm (AAA): Open vs. Endovascular Repair RCT Article Abstraction 

Form (pages D-10 – D-16) 

Abdominal Aortic Aneurysm (AAA): Hospital/Surgeon Volumes Abstraction Form (pages D17 – D 27)
UNIQUE IDENTIFIER #________________

D-2 

ABDOMINAL AORTIC ANEURYSM (AAA): 

Surveillance Article Abstraction Form: 

Author (first): ____________________________________________________ 

Journal: _________________________________________________________ 

Year Publication: _______________ Country (ies): __________________________________ 

 (where study was conducted) 

 

Data Abstractor: _________________________ 

Case-series Yes No Unclear

IF YES, STOP 

Open study Yes No Unclear 

Epidemiologic cohort study Yes No Unclear 

RCT: Subjects randomly assigned Yes No Unclear 

Study duration > 1 month Yes No Unclear 

 

 

METHODS 

Study Design and Conduct

Intention-to-treat analysis Yes No Unclear 

Repairs performed by surgical 

 teams with experience (i.e > 5 repairs) Yes No Unclear 

ASSESSMENT OF STUDY QUALITY 

1. RCT - RANDOMIZATION ALLOCATION CONCEALMENT METHOD (circle one) 

Clearly adequate: Centralized randomization by telephone, randomization scheme controlled by 

pharmacy, numbered or coded identical containers administered sequentially, on site computer system 

which can only be accessed after entering the characteristics of an enrolled participant, sequentially 

numbered sealed opaque envelopes. 

Clearly Inadequate: Alternation (odd-even, etc..), date of birth, date of week 

Unclear: Sealed envelopes but not sequentially numbered or opaque, other, list of random numbers read 

by someone entering patient into trial (open list) or study noted to be random or “randomization” or 

“random allocation” but no details provided.
UNIQUE IDENTIFIER #________________

D-3 

2. OBSERVATIONAL STUDIES, OTHER (based on “Systems to Rate the Strength Of Scientific 

Evidence, AHRQ Publication No. 02-E016, April 2002) 

Score each domain on a scale of 0 (poor, not defined) to 5 (excellent, clearly defined) 

Observational Studies Quality Domains/Elements Score 

Study question clearly focused and appropriate 

Notes:

Description of Study Population 

Notes: 

Clear definition of intervention 

Notes:

Primary/secondary outcomes defined 

Notes: 

Statistical Analysis: Assessment of confounding attempted Did the analysis 

adjust for or examine the effects of various factors (i.e., population baseline 

characteristics, characteristics of surgeons, training, surgical procedures, types of 

prostheses mentioned/ incorporated into the analyses) 

Notes:

Statistical methods used to take into account the effect of more than one variable 

on the outcome such as multiple regression, multivariate analysis, regression 

modeling -see methods in paper 

Notes: 

Measure of effect for outcomes and appropriate measure of precision 

Notes:

Conclusions supported by results with possible bias and limitations taken into 

consideration 

Notes: 

Single versus Multi-site study (note one of the other) 

Notes:

Patients evaluated with radiographs for outcomes 

Notes:

Comorbidities mentioned 

Notes:

Comorbidities incorporated in the analyses 

Notes: 

Attrition accounted for 

Notes: 

Death rates recorded 

Notes:
UNIQUE IDENTIFIER #________________

D-4 

SUBJECTS 

Multi-center or single site (circle one) 

Total # subjects randomized/enrolled ______________ 

Surveillance Surgery (if applicable) 

# Subjects: 

Mean age 

Men: 

n / N and % (if provided) 

 

Women: 

n / N and % 

 

Age < 65* 

n / N and % 

 

Age > 65 

n / N and % 

 

Race: white 

n / N and % 

 

Race: black 

n / N and % 

 

Race: Other 

n/N and % 

 

Coronary Disease 

n/N and % 

 

Cerebrovascular Disease 

n/N and % 

 

Hypertension 

n/N and % 

 

Diabetes 

n/N and % 

 

COPD 

n/N and % 

 

Current smoker 

n/N and % 

 

Ever smoked 

n/N and % 

 

Blood pressure (mm Hg) 

 Systolic 

 Diastolic 

Cholesterol, total (mg/dl) 

 LDL, (mg/dl) 

 HDL, (mg/dl) 

Other 

n/N and % 

Other 

n/N and % 

 
UNIQUE IDENTIFIER #________________

D-5 

INCLUSION CRITERIA (write in) 

___________________________________________________________________________ 

___________________________________________________________________________ 

___________________________________________________________________________ 

ABDOMINAL AORTIC ANEURYSM 

 Surveillance Surgery (if applicable) 

Diameter (cm), mean 

Diameter (cm), median 

Diameter (cm), range 

Diameter subgroups (N) 

(write in) 

Family History 

n/N and % 

 

Other 

DROPOUTS PRIOR TO REPAIR 

Did not 

undergo 

repair 

Reason: 

Declined 

Reason: 

Died 

Reason: Other 

Surveillance 

Surgery (if 

applicable) 

 

Notes: 
UNIQUE IDENTIFIER #________________

D-6 

PRIMARY/CLINICAL OUTCOMES 

(provide SDs, SEs, p-values and confidence intervals when appropriate) 

 Surveillance Surgery (if applicable) 

Mortality, all-cause, Total

n/N and % 

 

Diameter subgroup 

(write in) 

 

AAA-related, Total

n/N and % (write in diameter) 

 

Mean/Median rate of AAA 

change 

 

Rupture of AAA 

n/N and %

 

Attained Rupture rate 

Repair of AAA (all) 

n/N and % 

 

Other (write in) 

Other 

n/N and % 

 

Other 

n/N and % 

 
UNIQUE IDENTIFIER #________________

D-7 

STATUS OF SURVIVING PATIENTS AT END OF STUDY 

(provide SDs, SEs, p-values and confidence intervals when appropriate) 

Surveillance Surgery (if applicable) 

Unrepaired AAA 

n/N and % 

Repaired AAA, exit CT 

performed n/N and % 

Proximal AAA > 4 cm, 

n/N and % 

Iliac artery aneurysm > 2.5 cm, 

n/N and % 

Any aneurysm 

n/N and % 

COMPLICATIONS 

(provide SDs, SEs, p-values and confidence intervals when appropriate) 

Surveillance Surgery (if applicable) 

Major complication with no 

operative death n/N and % 

 

Reoperation required 

n/N and %

 

Myocardial infarction 

n/N and % 

 

Amputation 

n/N and % 

 

Paraplegia 

n/N and % 

 

Stroke 

n/N and % 

 

Renal dialysis 

n/N and % 

 

Pulmonary embolism 

n/N and % 

 

Other (write in) 

Other (write in) 
UNIQUE IDENTIFIER #________________

D-8 

SURVIVAL DATA (from survival curves i.e. Kaplan Meier) 

Write in outcome (all-cause mortality, etc.)________________________ 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Write in outcome (all-cause mortality, etc.)________________________ 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Write in outcome (all-cause mortality, etc.)________________________ 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Write in outcome (all-cause mortality, etc.)________________________ 
UNIQUE IDENTIFIER #________________

D-9 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Quality of Life 

Measure:____________________________________________________ 
UNIQUE IDENTIFIER #________________

D-10 

ABDOMINAL AORTIC ANEURYSM (AAA): 

Open vs. Endovascular Repair RCT 

Article Abstraction Form: 

Author (first): ____________________________________________________ 

Journal: _________________________________________________________ 

Year Publication: _______________ Country (ies): __________________________________ 

 (where study was conducted) 

 

Data Abstractor: _________________________ 

VERIFICATION/SELECTION OF STUDY ELIGIBILITY

Subjects randomly assigned Yes No Unclear 

Study duration > 1 month Yes No Unclear 

Primary/Clinical outcomes of interest Yes No Unclear 

 (all-cause/operative mortality; severe complications (systemic complications, hemorrhage, graft 

complications/infection, thromboembolic complications, obstruction – graft or arterial, QoL measures) 

 

Stop if any of the above is “NO” 

METHODS 

Study Design and Conduct

Outcome adjudication blinded Yes No Unclear 

Intention-to-treat analysis Yes No Unclear 

Repairs performed by surgical 

 teams with experience (i.e > 5 repairs) Yes No Unclear 

 write in mimimum #_______ 

Sponsor’s role___________________________________________________________________ 

RANDOMIZATION ALLOCATION CONCEALMENT METHOD (circle one) 

Clearly adequate: Centralized randomization by telephone, randomization scheme controlled by 

pharmacy, numbered or coded identical containers administered sequentially, on site computer system 

which can only be accessed after entering the characteristics of an enrolled participant, sequentially 

numbered sealed opaque envelopes. 

Clearly Inadequate: Alternation (odd-even, etc..), date of birth, date of week 

Unclear: Sealed envelopes but not sequentially numbered or opaque, other, list of random 

numbers read by someone entering patient into trial (open list) or study noted to be random or 

“randomization” or “random allocation” but no details provided.
UNIQUE IDENTIFIER #________________

D-11 

PARTICIPANTS 

Multi-center or single site (circle one) 

Total # subjects randomized ______________ 

Period of enrollment _______________________ 

Open Repair Group Endovascular Repair 

Group 

# Subjects: 

Mean age 

Men: 

n / N and % (if provided) 

 

Women: 

n / N and % 

 

Age < 65* 

n / N and % 

 

Age > 65 

n / N and % 

 

Race: white 

n / N and % 

 

Race: black 

n / N and % 

 

Race: Other 

n/N and % 

 

Coronary Disease 

n/N and % 

 

Cerebrovascular Disease 

n/N and % 

 

Hypertension 

n/N and % 

 

Diabetes 

n/N and % 

 

COPD 

n/N and % 

 

Current smoker 

n/N and % 

 

Ever smoked 

n/N and % 

 

Other 

n/N and % 

 

Other 

n/N and % 

 
UNIQUE IDENTIFIER #________________

D-12 

ABDOMINAL AORTIC ANEURYSM 

 Open Repair Group Endovascular Repair 

Group 

Diameter (cm), mean 

Diameter (cm), median 

Diameter (cm), range 

Diameter subgroups 

(write in) 

 

 

 

Family History 

n/N and % 

 

Definition arterial candidate

(write in) 

INCLUSION CRITERIA (write in) 

___________________________________________________________________________ 

___________________________________________________________________________ 

___________________________________________________________________________ 

DROPOUTS PRIOR TO REPAIR

Did not 

undergo repair 

(postponed) 

Reason: 

Declined/ 

refused 

Reason: Died 

Before 

surgery 

Reason: Other 

Open Repair 

Group

 

Endovascular 

Repair Group

 

Notes: 
UNIQUE IDENTIFIER #________________

D-13 

CLINICAL OUTCOMES (provide SDs, SEs, p-values and confidence intervals when 

appropriate) 

 Open Repair Group Endovascular Repair 

Group 

Mortality 

Mortality, all-cause 

n/N and % 

 

AAA-related 

n/N and % 

 

Operative Mortality 

n/N and % 

 

AAA Complications 

Operative mortality and severe 

complications: n/N and % 

 

Rupture of AAA 

n/N and % 

 

Repair of AAA (all) 

n/N and % 

 

Crossover to open repair 

n/N and % 

 

Other (write in) 

n/N and % 

 

Other (write in) 

n/N and % 

 

COMPLICATIONS 

(provide SDs, SEs, p-values and confidence intervals when appropriate) 

Open Repair Group Endovascular Repair 

Group 

Systemic, total

n/N and % 

 

Cardiac 

n/N and % 

 

Pulmonary 

n/N and % 

 

Renal 

n/N and % 

 

Cerebrovascular/Spinal cord 

n/N and % 

 

Bowel ischemia 

n/N and % 

 
UNIQUE IDENTIFIER #________________

D-14 

Other 

n/N and % 

 

Local – vascular or implant

related, total; n/N and % 

 

Hemorrhage 

n/N and % 

 

Graft complications 

n/N and % 

 

Graft infection 

n/N and % 

 

Arterial or graft obstruction 

n/N and % 

 

Endovascular leak 

n/N and % 

 

Thromboembolic complications 

n/N and % 

 

Local – nonvascular, total:

n/N and % 

 

Wound complications 

n/N and % 

 

Iatrogenic bowel perforation 

n/N and % 

 

Impotence 

n/N and % 

 

Claudication 

n/N and % 

 

Amputation 

n/N and % 

 

Secondary Procedures (write in) 

Other (write in) 

Other (write in) 
UNIQUE IDENTIFIER #________________

D-15 

HOSPITALIZATION FOR STUDY PROCEDURES 

(provide SDs, SEs, p-values and confidence intervals when appropriate 

Duration of hospitalization 

(days) 

Mean 

Median 

Range 

 

Duration of ICU stay (hrs) 

Mean 

Median 

Range 

 

Post-op mechanical ventilation 

n/N and % 

 

Duration of Post-op mechanical 

ventilation (hrs) 

Mean 

Median 

Range 

 

SURVIVAL DATA (from survival curves i.e. Kaplan Meier) 

Write in outcome (all-cause mortality, etc.)________________________ 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 
UNIQUE IDENTIFIER #________________

D-16 

Write in outcome (all-cause mortality, etc.)________________________ 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Write in outcome (all-cause mortality, etc.)________________________ 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Write in outcome (all-cause mortality, etc.)________________________ 

Group (write in)_________________________ 

Year 1 

% = 

n = N = 

Year 2 

% 

n = N = 

Year 3 

% 

n = N = 

Year 4 

% 

n = N = 

Year 4 

% 

n = N = 

Year 5 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 

Year _____ 

% 

n = N = 
Unique ID: ____________________ 

D-17

ABDOMINAL AORTIC ANEURYSM (AAA) 

Hospital/Surgeon Volumes Abstraction Form 

Title: ___________________________________________________________________ 

First Author: _____________________________________________________________ 

Journal: _________________________________________________________________ 

Year of Publication: _______________ Description of Database: ___________________ 

________________________________________________________________________ 

Abstractor: ______________________________ 
Unique ID: ____________________ 

D-18

Reference: _____________________________________ Group #: _____ 

Patient Demographics 

Number of patients (n,N,%): ______ ______ ______ 

Age (years,%): ______ ______ Mean: ______ Min: ______ Max: _____ ±SD: ______ 

±SE: ______ 

Sex (n,%) Males: ______ ______ Females: ______ ______ Mixed: ______ ______ 

Unknown: ______ ______ 

Race (n,%) White: ______ ______ African-American: ______ ______ 

Other: ______ ______ Describe: _______________________________________ 

Smoking Status: (n,%) ______ ______ 

Hypertension: (n,%)______ ______ 

Diabetes: (n,%)______ ______ 

Comments 

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________ 

Patient Inclusion Criteria: __________________________________________________ 

________________________________________________________________________ 

Patient Exclusion Criteria: __________________________________________________ 

________________________________________________________________________ 

Surgeon Inclusion Criteria: _________________________________________________ 

________________________________________________________________________ 

Surgeon Exclusion Criteria: _________________________________________________ 

________________________________________________________________________ 
Unique ID: ____________________ 

D-19

Reference: _____________________________________ Group #: _____ 

Group/Sub-Group Definitions 

Group ID Patients (n) Define 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Unique ID: ____________________ 

D-20

Reference: _____________________________________ Group #: _____ 

Type of Volume 

Hospital Volume

1. Number of patients: ______ 

2. Number of hospitals: ______ 

(e.g., low, medium, high) 

3. Description: _____________________________________________ 

(AAA repair/yr) 

4. Define: __________ 

5. Mean: ______ 

1. Number of patients: ______ 

2. Number of hospitals: ______ 

(e.g., low, medium, high) 

3. Description: _____________________________________________ 

(AAA repair/yr) 

4. Define: __________ 

5. Mean: ______ 

Comments 

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________ 
Unique ID: ____________________ 

D-21

Reference: _____________________________________ Group #: _____ 

1. Number of patients: ______ 

2. Number of hospitals: ______ 

(e.g., low, medium, high) 

3. Description: _____________________________________________ 

(AAA repair/yr) 

4. Define: __________ 

5. Mean: ______ 

1. Number of patients: ______ 

2. Number of hospitals: ______ 

(e.g., low, medium, high) 

3. Description: _____________________________________________ 

(AAA repair/yr) 

4. Define: __________ 

5. Mean: ______ 

1. Number of patients: ______ 

2. Number of hospitals: ______ 

(e.g., low, medium, high) 

3. Description: _______________________________________________ 

(AAA repair/yr) 

4. Define: __________ 

5. Mean: ______ 

Comments 

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________ 
Unique ID: ____________________ 

D-22

Reference: _____________________________________ Group #: _____ 

Surgeon Volume

Surgeon Demographics 

_____ Vascular: (n,%) ______ ______Define: __________________________________ 

_____ Cardiothoracic: (n,%) ______ ______ Define: _____________________________ 

_____ General: (n,%) ______ ______ Define: __________________________________ 

_____ Other: (n,%) ______ ______ Define: ____________________________________ 

_____ Other: (n,%) ______ ______ Define: ____________________________________ 

1. Number of patients: ______ 

(e.g., low, medium, high) 

2. Description: _______________________________________________________ 

(AAA repair/yr) 

3. Define: _______________ 

Mean: ______ 

Median: ______ 

1. Number of patients: ______ 

(e.g., low, medium, high) 

2. Description: _______________________________________________________ 

(AAA repair/yr) 

3. Define: _______________ 

Mean: ______ 

Median: ______ 
Unique ID: ____________________ 

D-23

Reference: _____________________________________ Group #: _____ 

1. Number of patients: ______ 

(e.g., low, medium, high) 

2. Description: _______________________________________________________ 

(AAA repair/yr) 

3. Define: _______________ 

Mean: ______ 

Median: ______ 

1. Number of patients: ______ 

(e.g., low, medium, high) 

2. Description: _______________________________________________________ 

(AAA repair/yr) 

3. Define: _______________ 

Mean: ______ 

Median: ______ 

1. Number of patients: ______ 

(e.g., low, medium, high) 

2. Description: _______________________________________________________ 

(AAA repair/yr) 

3. Define: _______________ 

Mean: ______ 

Median: ______ 
Unique ID: ____________________ 

D-24

Reference: _____________________________________ Group #: _____ 

Intervention 

√ % x 

Open 

EVAR* 

Not Designated 

Other (define): 

*Kind of EVAR: ___________________________________________________ 
Unique ID: ____________________ 

D-25

Reference: _____________________________________ Group #: _____ 

Complications 

(provide SDs, SEs, p-values and confidence intervals when appropriate) 

Open Repair Group Endovascular Repair Group 

Systemic, total 

n/N and % 

 

Cardiac 

n/N and % 

 

Pulmonary 

n/N and % 

 

Renal 

n/N and % 

 

Cerebrovascular/Spinal cord 

n/N and % 

 

Bowel ischemia 

n/N and % 

 

Other 

n/N and % 

 

Local – vascular or implant 

related, total; n/N and % 

 

Hemorrhage 

n/N and % 

 

Graft complications 

n/N and % 

 

Graft infection 

n/N and % 

 

Arterial or graft obstruction 

n/N and % 

 

Endovascular leak 

n/N and % 

 

Thromboembolic complications 

n/N and % 

 

Local – nonvascular, total: 

n/N and % 

 

Wound complications 

n/N and % 

 

Iatrogenic bowel perforation 

n/N and % 

 

Impotence 

n/N and % 

 

Claudication 

n/N and % 

 

Amputation 

n/N and % 

 

Secondary Procedures (write 

in) 

 
Unique ID: ____________________ 

D-26

Reference: _____________________________________ Group #: _____ 

Outcomes 

Number of patients: ______ 

Time (days): ______ 

Define: ______________________________________________________________ 

_____________________________________________________________________ 

 % ±SD ±SE P-Value 95% CI 

Overall Mortality 

AAA-Specific Mortality 

Adjusted OR* 

Unadjusted OR 

Adjusted RR* 

Unadjusted RR 

Risk Reduction 

Other (define): 

____________________ 

____________________ 

____________________ 

*Adjusted by: _________________________________________________________ 

_____________________________________________________________________ 
Unique ID: ____________________ 

D-27

Reference: _____________________________________ Group #: _____ 

Outcomes 

Type of mortality (define): _______________________________________________ 

 

 

 

 

Comments: ___________________________________________________________ 

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________ 
E-1 

Appendix E: Evidence Tables and Figures 

Table E1. Characteristics of elective early/immediate repair versus surveillance of 

abdominal aortic aneurysm (AAA) randomized controlled trials....................... E-3 

Table E2. Cumulative survival according to treatment arm for surveillance versus 

elective early/immediate repair of abdominal aortic aneurysm (AAA) 

randomized controlled trials................................................................................ E-4 

Table E3. Outcomes and complications for the ADAM, an early/immediate elective 

repair versus surveillance of abdominal aortic aneurysm (AAA) 

randomized controlled trial ................................................................................. E-5 

Table E4. Health-related quality of life measures for elective early/immediate repair 

versus surveillance of abdominal aortic aneurysm (AAA) randomized 

controlled trials.................................................................................................... E-6 

Table E5. Characteristics of endovascular repair (EVAR) versus OSR of abdominal 

aortic aneurysm (AAA) randomized controlled trials......................................... E-8 

Table E6. Kaplan-Meier estimates of mortality and complications or severe events 

according to treatment arm for endovascular repair (EVAR) versus OSR of 

abdominal aortic aneurysm (AAA) randomized controlled trials....................... E-11 

Table E7. Characteristics of the EVAR 2 Trial (n=338), endovascular repair (EVAR) 

versus no intervention of abdominal aortic aneurysm (AAA) ............................ E-13 

Table E8. Complications for EVAR-2 trial (n=338), endovascular repair (EVAR) 

versus no intervention of abdominal aortic aneurysm (AAA) ............................ E-14 

Table E9. Health-related quality of life measures for the EVAR-2 trial (n=338),, 

endovascular (EVAR) versus no intervention of abdominal aortic aneurysm 

(AAA) ................................................................................................................. E-15 

Table E10. Postoperative 30-day mortality for endovascular (EVAR) versus open 

repair of abdominal aortic aneurysm (AAA) nonrandomized controlled 

trials, and registries ............................................................................................ E-16 

Table E11. Mortality following EVAR: Data from nonrandomized clinical trials (nondevice specific), case series and comparative studies........................................ E-17 

Table E12. Mortality following EVAR: Data from registries and device-specific nonrandomized clinical trials (NRCTs) ................................................................... E-18 

Table E13. Early (<30 days post-procedure) and delayed (>30 days post-procedure) 

aneurysm rupture following EVAR: Data from registries, nonrandomized 

studies, case series, and comparative studies ..................................................... E-20 

Table E14. Primary (immediately following a failed EVAR or <30 days postprocedure) and delayed (secondary or >30 days post-procedure) conversion 

to OSR following EVAR: Data from registries, nonrandomized studies, 

case series, and comparative studies .................................................................. E-21 

Table E15. Secondary intervention following EVAR: Data from registries, 

nonrandomized studies, case series, and comparative studies ........................... E-22 

Table E16. Incidence of any EVAR endoleaks: Data from registries, nonrandomized 

studies, case series, and comparative studies ..................................................... E-23 

Table E17. Incidence of EVAR type I endoleaks: Data from registries, nonrandomized 

studies, case series, and comparative studies ..................................................... E-24 
E-2 

Table E18. Incidence of EVAR type II and III endoleaks: Data from registries, nonrandomized studies, case series and comparative studies .................................. E-26 

Table E19. Incidence of common technical complications of EVAR: Data from 

registries, nonrandomized studies, case series, and comparative studies........... E-28 

Figure E1. ADAM trial: Mean SF-36 scores by treatment group......................................... E-30 

Figure E2. ADAM trial: Prevalence of impotence by treatment group ................................ E-31 

Figure E3. Immediate open repair of small aneurysms (4.0 to 5.5 cm) vs. surveillance: 

UKSAT mean change in SF-20 scores from baseline at 12 months ................... E-32 

Figure E4. DREAM trial (n = 153): Changes in Short Form-36: Physical function 

domain over time: Endovascular repair (EVAR) vs. open repair (OR).............. E-33 

Figure E5. DREAM trial (n = 153): Changes in Short Form-36: Domain of mental 

health, over time: Endovascular repair (EVAR) vs. open repair (OR) ............... E-34 

Figure E6. EVAR1 trial: Euro QoL 5-D (EQSD): Endovascular repair (EVAR) vs. 

open repair (OR) ................................................................................................. E-35 

Figure E7. EVAR1 trial: Short Form-36 physical component: Endovascular repair 

(EVAR) vs. open repair (OR) ............................................................................. E-36 

Figure E8. EVAR1 trial: Short Form-36 mental component: Endovascular repair 

(EVAR) vs. open repair (OR) ............................................................................. E-37 

References for Evidence Tables............................................................................................. E-38 
E-3

Table E1. Characteristics of elective early/immediate repair versus surveillance of abdominal aortic aneurysm (AAA) randomiz

Study (Year) / Country 

Repair Groups 

(# Randomized) 

Mean 

Study 

Followup 

Methodologic Characteristics Description of Su

ADAM (2004)1 / 

United States 1. Surveillance (n = 567) 2. Immediate surgery (n = 

569) 

4.9 years Randomization: adequate (Schultz) 

Criteria for surveillance: ultrasonography or 

computed tomography every 6 months 

Criteria for surgery in open group: AAA that 

became symptomatic or reached ≥5.5 cm 

Type of graft used: not defined Intention-to-treat analysis: yes (patients were 

not excluded after randomization) 

1,136 subjects fit for elective surgery we

considered for randomization, 46% exthan 5.4 or severe comorbidities, 23% ages 50 to 79 years old, with AAA 4.0 age was 68; male 99%; white race 944.7 cm; family history of AAA was 13%diabetes 10%; history of cardiac diseaever smoked 94%; tobacco use, curre

UK Small Aneurysm Trial (1998)2 / United Kingdom 1. Surveillance (n = 527) 2. Early surgery (n = 563) 

4.6 years Randomization: adequate (Schultz) 

Criteria for surveillance: ultrasonography or 

computed tomography for AAA 4.0 to 4.9 every 6 months, for AAA 5.0 to 5.5 every 3 months 

Criteria for surgery in open group: AAA that 

became symptomatic or reached ≥5.5 cm 

Type of graft used: prosthetic inlay (92%). Intention-to-treat analysis: yes 

1,090 subjects with asymptomatic AAA 

for elective surgery were randomized randomization, 15% refused). Subjecyears old, with AAA 4.0 to 5.5 cm. Pamale 83%; mean AAA diameter 4.6 c38%; diabetes 3%; ischemic heart disever smoked 94%; tobacco use, curre

Canadian Trial No details, trial ended prematurely due to 

inadequate recruitment 

107 subjects were randomized 
E-4

Table E2. Cumulative survival according to treatment arm for surveillance versus elective early/immediate repair of abdominal 

randomized controlled trials ADAM (extracted from graph, estimated by product-limit method)

Group Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Ye

Survival 99% 95% 91% 87% 82% 75% 72

Surveillance (n=567) Number at 

risk 552 530 513 393 274 183 7

Immediate Survival 96% 93% 88% 83% 78% 73% 6repair (n=569) Number at risk 545 526 502 383 264 172 6UK Small Aneurysm Trial (extracted from graph, estimated by Kaplan-Meier method)

Survival up to time of surgery 

Group Year 0.5 Year 1 Year 2 Year 3 Year 4 Year 5 

Survival 99% 95% 90% 84% 76% 70% Surveillance 

(n=527) Number at 

risk 484 409 292 197 77 29 

Immediate Survival 99% 90% 86% 78% 63% - repair (n=563) Number at risk 91 54 38 32 14 9 UK Small Aneurysm Trial (extracted from graph, estimated by Kaplan-Meier method) Survival after surgery 

Group Year 1 Year 2 Year 3 Year 4 Year 5 

Survival 90% 84% 79% 70% 68% Surveillance 

(n=527) Number at 

risk 241 182 117 60 28 

Immediate Survival 91% 87% 83% 77% 73% repair (n=563) Number at risk 471 448 385 263 149 
E-5 

Table E3. Outcomes and complications for the ADAM, an early/immediate elective repair versus surveillance 

of abdominal aortic aneurysm (AAA) randomized controlled trial

Outcome Early/Immediate Repair, 

n / N (%) 

Surveillance Events, 

n / N (%) 

Rupture, repair, and hospitalization outcomes 

Repair of AAA, ruptured and unruptured 527 / 569 (92.6) 349 / 567 (61.6) 

Rupture of AAA 2 / 569 (<1) 11 / 567 (1.9) 

Other AAA hospitalizations, no. 255 129 

Complications of repair or unruptured AAA: mean followup 4.9 years

Operative death within 30 days 11 / 526 (2.1) 6 / 340 (1.8) 

Operative death within 30 days or 

hospitalization 

14 / 526 (2.7) 7 / 340 (2.1) 

Number of patients with any complication 275 / 526 (52.3) 193 / 340 (56.8) 

Rehospitalization for complications 108 / 526 (20.5) 56 / 340 (16.5) 

Late graft failure 2 / 526 (0.4) 1 / 340 (0.3) 

Reoperation required 9 / 526 (1.7) 4 / 340 (1.2) 
E-6

Table E4. Health-related quality of life measures for elective early/immediate repair versus surveillance of abdominal aortic ane

randomized controlled trials UK Small Aneurysm Trial 

Outcome Surveillance 

(n=480), 

Baseline Mean (SD) 

Surveillance (n=399), 

Mean Score Change 

12 Months After 

Randomization (SD) 

(p vs. baseline) 

Early Surgery 

(n=512), 

Baseline Mean (SD) 

Early Surgery 

(n=391), 

Mean Score Change 

12 Months After 

Randomization (SD) 

(p vs. baseline) 

Early 

Su

Mean Ch

from 

Weighted 

Short Form 20 Health Survey (SF-20) (subscales 0-100, higher score indicates better quality of life) Physical functioning 66.5 (29.3) -6.2 (25.5)* 

(<0.05) 

64.2 (30.7) -3.5 (27.2)* 

(<0.05) 

2.70 [

Role functioning 76.7 (37.6) -4.9 (39.7)* 

(<0.05) 

71.9 (39.5) -3.9 (36.3)* 1.00 [

Social functioning 89.8 (20.4) -2.2 (20.4)* 

(<0.05) 

89.2 (20.8) -1.0 (21.2)* 1.20 [

Mental health 79.5 (17.0) 0.0 (15.3)* 80.2 (17.2) 0.0 (18.2)* 0.00 [Health perceptions 62.4 (24.6) -1.0 (22.4)* 62.4 (24.3) 5.7 (24.2)* 6.70 Bodily pain 64.3 (32.1) -4.7 (36.7)* 

(<0.05) 

64.1 (31.5) -1.0 (35.3)* 3.70 [

*estimated from confidence intervals ADAM Trial, Maximum activity, Surveillance (SURV) vs. Early Repair (ER) 

Time Interval, 

Years After 

Randomization 

Surveillance, 

%* Vigorous 

(# Patients)

Surveillance, 

%* Moderate 

(# Patients)

Surveillance, 

%* Mild 

(# Patients)

Surveillance, 

%* Sedentary 

(# Patients)

Early Repair, 

%* Vigorous 

(# Patients)

Early Repair, 

%* Moderate 

(# Patients)

Early Repair

%* Mild 

(# Patients)

Baseline SURV n=566 ER n=568 

14 50 34 2 11 50 36 

1 year SURV n=521 ER n=492 

11 44 37 8 12 43 39 

2 years SURV n=483 ER n=458 

13 42 34 11 10 41 41 

3 years SURV n=446 ER n=423 

8 39 44 9 8 39 44 
Table E4. Health-related quality of life measures for elective early/immediate repair versus surveillance of abdominal aortic ane

randomized controlled trials (continued) 

E-7

Time Interval, 

Years After 

Randomization 

Surveillance, 

%* Vigorous 

(# Patients)

Surveillance, 

%* Moderate 

(# Patients)

Surveillance, 

%* Mild 

(# Patients)

Surveillance, 

%* Sedentary 

(# Patients)

Early Repair, 

%* Vigorous 

(# Patients)

Early Repair, 

%* Moderate 

(# Patients)

Early Repair

%* Mild 

(# Patients)

4 years SURV n=333 ER n=317 

5 41 42 12 7 38 45 

5 years SURV n=223 ER n=208 

8 39 43 10 5 35 47 

6 years SURV n=149 ER n=132 

4 36 43 17 2 30 44 

7 years SURV n=60 ER n=55 

2 34 47 17 3 20 54 

7.5 years ** 11 26 52 11 4 25 50 Maximum activity level did not differ significantly between treatment groups at repeated measure analysis. There was a significant intera

treatment and followup time (p <0.02) indicating that worsening of maximum activity was greater in the early repair group. 

*estimated from graph **final assessment 
E-8

Table E5. Characteristics of endovascular repair (EVAR) versus OSR of abdominal aortic aneurysm (AAA) randomized control

Study (Year) / Country 

Repair Groups 

(# Randomized) 

Study 

Outcome 

Interval 

Methodologic Characteristics Inclusion Criteria and Descri

DREAM (2004)3 / 

Netherlands and Belgium 1. EVAR (n = 173) 2. Open repair (n = 178) 

30 days and 2 years 

Randomization: adequate (Schultz)4 – 

computer-generated permuted block sequence 

Experience: Surgeons and radiologists at each 

center were required to have performed ≥20 EVAR procedures (fewer than 20 required presence of experienced proctor) complying with guidelines issued by Endovascular Safety Committee of the Dutch Society for Vascular Surgery and Dutch Society for Radiology 

Intention-to-treat analysis: yes Sponsor’s role in study: none Grafts used: Zenith 33%; Talent 27%; Excluder 

22%; Others 18% 

351 subjects anatomically suitable (non

AAA ≥5.0 cm) for EVAR were randomto-treat (ITT) subjects were included in 2 died prior to AAA repair. 

Patients had adequate infrarenal neck a

anatomical configuration suitable for Eexpectancy ≥2 years 

Exclusion criteria included juxtarenal or 

inflammatory AAA (more than wall thicretroperitoneal incision required, sacriarties, various anatomical variations (iarteries requiring reimplantation), patielaparotomy 

Characteristics: 92% men; mean age 70

(mean 6.0), range was 5.4 to 6.5 cm; hypertension 56%; cardiac disease 4414%; hyperlipidemia 50%; tobacco us

EVAR-1 (2005)5 / 

United Kingdom (34 hospitals) 1. EVAR (n = 543) 2. Open repair (n = 539) 

30 days and 4 years 

Randomization: adequate (Schultz)4 - 50:50 

ratio randomly permuted block sizes constructed by STATA package 

Experience: Each participating center must 

have performed ≥20 EVAR procedures according to the UK registry for endovascular treatment of aneurysms (RETA) 

Intention-to-treat analysis: yes Sponsor’s role in study: none Grafts used: Zenith 51%; Talent 33%; Others 

16%. Participating centers were free to choose which commercial or in-house devices to use. Use of commercially available devices having undergone certain safety checks was favored. 90% were tubular or bifurcated and the remainder were aortouniiliac 

1,082 subjects, ≥60 years age, with an A

anatomically suitable for EVAR were ITT subjects were included in the anapostponed surgery and 24 died prior t

Recommended guidelines for patient fit

suitability for EVAR-1 or 2 were defineonset of angina ≤3 months, unstable severe valve disease, significant arrhCHF 

Open repair would not be recommended 

following: unable to walk flight of stairbreath; FEV1 <1.0 L; PO2 < 8.0 KPa; P

200μmol/L 

Characteristics: 91% men; mean age 74

(mean 6.5); BMI 26.4; diabetes 10%; 43%; current smokers 21%; ever smo53%; statin use 33% 
Table E5. Characteristics of endovascular repair (EVAR) versus OSR of abdominal aortic aneurysm (AAA) randomized control

E-9

Study (Year) / Country 

Repair Groups 

(# Randomized) 

Study 

Outcome 

Interval 

Methodologic Characteristics Inclusion Criteria and Descri

Cuypers (2001)6 / Netherlands 1. EVAR (n = 57) 2. Open repair (n = 19) Note: Study’s objective was to compare cardiac response between EVAR and OR. Cardiac complications were assessed at 1 hour, day 1, day 7, and day 30 after procedure. Outcome assessor was blinded to treatment allocation. 

30 days Randomization: treatment allocation 

concealment unclear. A 3:1 ratio for EVAR and OSR was used to increase the experience of the team involved with EVAR and it was also expected that this randomization scheme would increase enrollment to the trial with the greater probability of being allocated to EVAR. 

Experience: Unclear/not discussed Intention-to-treat analysis: yes Sponsor’s role in study: unclear Grafts used: AneuRx (Medtronic) 

76 subjects with anatomically suitable A

were randomized. 

Exclusion criteria included subjects with 

morphology for EVAR, a contrast alleconditions precluding open surgery. 

Characteristics: 92% men; mean age 69 

mean 5.5, (mean for EVAR was 5.6 (for OSR (range 4.0 to 6.1)); diabetes coronary artery disease 46%; history 33%; previous CABG 24%; previous 

OVER (Frank Lederle, Personal communication) United States (40 centers) 1. EVAR 2. Open repair 

Up to 8 years 

Randomization: adequate (Schultz)4 - computer 

generated random numbers 

Experience: participating investigators must 

have expertise in open surgery and EVAR and be approved by a study review committee 

Intention-to-treat analysis: yes Sponsor’s role in study: solely funded by the 

Department of Veterans Affairs Cooperative Studies Program 

Grafts used: FDA-approved EVAR systems, 

including ANCURE (Guidant) and AneuRx (Medtronic). Choice of graft to be used will be made prior to randomization by the individual investigator based on that physician's assessment of what graft would be optimal for that patient. 

Male and female patients (n=1,260 estim

abdominal aortic aneurysms will be emeet each of the following inclusion c2) an iliac aneurysm (associated with external diameter in any plane of ≥3.

the AAA: a) has increased by 0.7 cm 1.0 cm in 12 months, as measured fro(ultrasound, CT scan, or MRI) within tthe later one within 6 months of rando(i.e., a portion of the circumference of the aneurysm is considered normal bor c) is associated with distal embolis

Patients with any of the following will be 

1) previous abdominal aortic surgery; test, of AAA rupture; 3) AAA repair is emergent operation, usually due to suinability or unwillingness to give informstudy protocol 
Table E5. Characteristics of endovascular repair (EVAR) versus OSR of abdominal aortic aneurysm (AAA) randomized control

E-10

Study (Year) / Country 

Repair Groups 

(# Randomized) 

Study 

Outcome 

Interval 

Methodologic Characteristics Inclusion Criteria and Descri

ACE France (32 centers to date) Randomization started 01/2003 1. EVAR 2. Open repair 

Up to 5 years 

Randomization: unclear Experience: Surgeons and radiologists at each 

center were required to have performed ≥10 EVARs 

Intention-to-treat analysis: yes Sponsor’s role in study: unclear (sponsored by 

the Programme Hopitalier de Recherche Clinique, section of the Ministry of Health) 

Grafts used: commercially available devices 

having undergone certain safety checks were favored 

Male and female patients (n=600 estima

years of age with abdominal aortic an

meeting the following anatomical criteaneurysmal neck ≥1.5 cm; 2) end of t≥1.5 cm proximal to one of the commsignificant superior mesenteric artery or equal to 80% of the iliac arteries anexternal iliac arteries greater than 6 m

Patients with severely angulated, heavy 

aneurysmal upper neck and with anehypogastric arteries will be excluded 
E-11

Table E6. Kaplan-Meier estimates of mortality and complications or severe events according to treatment arm for endovasculaOSR of abdominal aortic aneurysm (AAA) randomized controlled trials 1. All-cause mortality EVAR-1 (extracted from graph)

Group Year 1 Year 2 Year 3 Year 4 

Proportion dying 8% 15% 22% 26% EVAR (n=543) Number at risk 503 316 187 94 Proportion dying 10% 16% 22% 29% OSR (n=539) Number at risk 484 314 195 88 

DREAM (extracted from graph)

Group Year 1 Year 2 Year 3 Year 4 

Proportion dying 3.5% 10.3% NR NR EVAR (n=171) Number at risk 163 98 Proportion dying 7% 10.4% NR NR OSR (n=174) Number at risk 160 97 

2. Aneurysm-related mortality EVAR-1 (extracted from graph): (defined as death within 30 days of any surgery for AAA unless overruled by post-mortem findings or if a (unrelated to the aneurysm) took place between aneurysm and death and was attributed as the death. Death with underlying cause attrib1713-19 were also classified as aneurysm-related) 

Group Year 1 Year 2 Year 3 Year 4 

Proportion dying 2% 3% 4% 4% EVAR (n=543) Number at risk 503 316 187 94 Proportion dying 6% 6% 7% 7% OSR (n=539) Number at risk 484 314 195 88 

3. Complications / severe events EVAR-1 (extracted from graph): Complications (C): Included primarily graft ruptures, graft infections, endoleaks (EVAR specific), graft th

required, re-exploration of open repair 

Group Year 1 Year 2 Year 3 Year 4 

Proportion with C 25% 30% 36% 41% EVAR (n=543) Number at risk 386 235 134 67 Proportion with C 5% 5% 7% 9% OSR (n=539) Number at risk 466 301 182 82 
Table E6. Kaplan-Meier estimates of mortality and complications or severe events according to treatment arm for endovascula

OSR of abdominal aortic aneurysm (AAA) randomized controlled trials (continued) 

EE-12

DREAM (extracted from graph): Severe events (SE): not defined, classified and graded according to the reporting standards of the Ad HStandardized Reporting Practices in Vascular Surgery/International Society for Cardiovascular Surgery 

Group Year 1 Year 2 Year 3 Year 4 

Proportion with SE 12% 16.9% NR NR EVAR (n=171) Number at risk 151 91 Proportion with SE 15% 19.4% NR NR OSR (n=174) Number at risk 146 89 
E-13

Table E7. Characteristics of the EVAR 2 Trial (n=338), endovascular repair (EVAR) versus no intervention of abdominal aortic a

Study (Year) / Country 

Repair Groups 

(# Randomized) 

Study 

Outcome 

Interval 

Methodologic Characteristics Inclusion Criteria and Descrip

EVAR-2 (2005)7 / 

United Kingdom (31 hospitals) 1. EVAR (n = 166) 2. No Intervention (n = 172) 

30 days Randomization: adequate (Schultz).4 50:50 ratio 

randomly permuted block sizes constructed by STATA package 

Experience: Each participating center must have 

performed ≥20 EVAR procedures according to the UK registry for endovascular treatment of aneurysms (RETA) 

Intention-to-treat analysis: yes Sponsor’s role in study: none Grafts used: Zenith 59%; Talent 21%; Excluder 

7%; AneuRx 6%; Others 7%. Participating centers were free to choose which commercial or in-house devices to use. Use of commercially available devices having undergone certain safety checks was favored. 87% bifurcated systems. 

338 subjects, ≥60 years age, with AAA 

considered unfit (determined locally by anesthesiologist, and cardiologist) for randomized. Recommended guidelineopen repair and unsuitability for EVAR ≤3 months; onset angina ≤3 months; unight/at rest; severe valve disease; siguncontrolled CHF. In addition, open rebe recommended for subjects with the flight of stairs without shortness of bre

<8.0 KPa; PCO2 >6.5 KPa; creatinine 

group 1 subject declined, 1 was deemdied prior to AAA repair. No subjects wthe No Intervention group, 1 subject w

Characteristics: 85% men; mean age 76

6.3 [IQR* 6 to 7.4]; AAA tender at randdiabetes 14%; history of cardiac disea17%; ever smoked 93%; aspirin use 5

*IQR = Interquartile range 
E-14 

Table E8. Complications for EVAR-2 trial (n=338), endovascular repair (EVAR) versus no intervention of 

abdominal aortic aneurysm (AAA) 

Outcome Events, n / N % 

Number of patients with postoperative complications 

All subjects having a successful EVAR* 58 / 178 32.6 

Endoleak, type 1 10 / 178 5.6 

Endoleak, type 2 17 / 178 9.6 

Endoleak, type 3 5 / 178 2.8 

Graft rupture 1 / 178 < 1 

Graft migration 2 / 178 1.1 

Graft thrombosis 7 / 178 3.9 

Other surgery required 8 / 178 4.5 

Number of patients with reintervention

All subjects having a successful EVAR* 32 / 178 18.0

Endoleak, type 1 8 / 178 4.5 

Endoleak, type 2 3 / 178 1.7 

Endoleak, type 3 3 / 178 1.7 

Graft rupture 1 / 178 < 1 

Graft migration 0 0 

Graft thrombosis 5 / 178 2.8 

Other surgery required 8 / 178 4.5 

* Includes 12 subjects randomized to no intervention 
E-15

Table E9. Health-related quality of life measures for the EVAR-2 trial (n=338), endovascular (EVAR) versus no intervention of aaneurysm (AAA) 

Outcome EVAR, 

Mean (SD) 

(number of patients) 

No Intervention, 

Mean (SD) 

(number of patients) 

Weighted Mean Difference 

[95% CI] 

Differ

Baselin

(nu

EQ5D weighted index score (higher score indicates better quality of life)Baseline 0.58 (0.31) (164) 0.63 (0.28) (171) -0.05 (SE 0.03) Crude difference 0-3 months 0.57 (0.28) (48) 0.56 (0.29) (92) 0.01 [-0.09 to 0.11] 03-12 months 0.64 (0.28) (122) 0.60 (0.26) (120) 0.04 [-0.03 to 0.11] 012-24 months 0.65 (0.24) (88) 0.60 (0.30) (68) 0.05 [-0.04 to 0.14] 0SF-36: Physical component summary (higher score indicates better quality of life) Baseline 35.47 (6.63) (160) 35.12 (6.23) (171) 0.35 (SE 0.71) Crude difference 0-3 months 33.96 (5.13) (46) 35.60 (5.70) (89) -1.64 [-3.54 to 0.26] -13-12 months 34.33 (6.10) (116) 35.12 (6.42) (111) -0.79 [-2.42 to 0.84] -112-24 months 34.54 (5.89) (71) 36.01 (6.92) (60) -1.47 [-3.69 to 0.75] -0SF-36: Mental component summary (higher score indicates better quality of life) Baseline 45.13 (7.92) (160) 46.31 (6.97) (171) -1.18 (SE 0.82) Crude difference 0-3 months 45.76 (8.65) (46) 44.03 (7.78) (89) 1.73 [-1.25 to 4.71] 23-12 months 44.76 (7.21) (116) 44.84 (7.85) (111) -0.08 [-2.04 to 1.88] 012-24 months 45.36 (7.20) (71) 44.67 (7.93) (60) 0.69 [-1.92 to 3.30] 0
E-16

Table E10. Postoperative 30-day mortality for endovascular (EVAR) versus open surgical repair (OSR) of abdominal aortic ane

nonrandomized controlled trials, and registries 

Trials EVAR Events, 

n / N (%) 

OSR Events, 

n / N (%) 

Risk Difference, 

% [95% CI] 

Anderson/SPARCS*8 19 / 1706 (1.1) 121 / 3063 (4.0) -3 [-4 to -2] Becquemin9 2 / 73 (2.7) 2 / 107 (1.9) 1 [-4 to 5] Bertrand10 6 / 193 (3.1) 12 / 193 (6.2) -3 [-7 to 1] Bolke11 0 / 20 1 / 20 (5.0) -5 [-18 to 8] Criado12 1 / 240 (< 1) 0 / 126 0 [-1 to 2] Elkouri13 0 / 94 3 / 261 (1.1) -1 [-3 to 1] Garcia-Madrid14 2 / 53 (3.8) 2 / 30 (6.7) -3 [-13 to 7] Greenberg15 1 / 200 (<1) 2 / 80 (2.5) -2 [-6 to 2] Hansman16 1 / 50 (2.0) 0 / 50 2 [-3 to 7] Jordan17 6 / 259 (2.3) 12 / 145 (8.3) -6 [-11 to -1] Lee**18 33 / 2565 (1.3) 176 / 4607 (3.8) -3 [-3 to -2] LIFELINE Registry†19 45 / 2664 (1.7) 4 / 334 (1.2) 0 [-1 to 2] Teufelsbauer20 7 / 275 (2.5) 23 / 481 (4.8) -2 [-5 to 0] Zeebregts21 1 / 92 (1.1) 15 / 194 (7.7) -7 [-11 to -2] 

Totals 124 / 8484 (1.5) 383 / 9691 (3.8) -2 [-3 to -2] * Data from discharge dataset: New York State-Statewide Planning and Research Cooperative System (SPARCS) ** Data from National Inpatient Sample (NIS) database, representing 20% of all-payer stratified sample of nonfederal U.S. hospitals † Clinical data from four Investigational Device Exemption clinical trials including Carpenter22 (Matsamura23 and Moore24 studies) 
E-17

Table E11. Mortality following EVAR: Data from nonrandomized clinical trials (non-device specific), case series, and comparat

Author Number of Patients 

(Reference) Undergoing EVAR Number of Deaths (%) 30-Day Deaths* (%) AAA-Related Deaths (%) 

Resch 200225 164 NR 7 (4.3) NR Haulon 200326 96 13 (13.5) 2 (2.1) 0 Burks 200227 95 2 (2.1) 2 (2.1) 0 Cartes 200228 72 1 (1.4) 1 (1.4) 1 (1.4) Alric 200229 88 24 (27.3) 3 (3.4) 6 (6.8) Flora 200330 108 11 (10.2) 9 (8.3) 2 (peri-op) + 2 after OSR García-Madrid** 200414 53 5 (9.4) 2 (3.8) 0 Zeebregts 2004**21 93 11 (11.8) at 2 years 1 (1.1) 0 Gilling-Smith 200031 55 8 (14.5) NR 2 graft -related Ohki 200132 239 Unclear 

(53 of unrelated causes) 

20 (8.4) Unclear 

(3 after second intervention) 

Parlani 200233 336 NR 4 (1.2) 0 (peri-op) Faries 200234 65 11 (16.9) 0 0 Tutein Nolthenius 200135 77 15 (19.5) 4 (5.2) 0 Carpenter 200422 227 15 (6.6) 3 (1.3) 1 Ricco 200336 1012 47 (4.6) 27 (2.7) NR Becquemin 2000**9 73 7 (9.6) 2 (2.7) 2 possibly graft-related May 200037 266 NR NR NR Blum 200138 298 3 (1.0) 2 (<1) 2 (<1) Albertini 200139 185 12 (6.5) 12 (6.5) 6 (3.2) Bertrand 2001**10 193 6 (3.1) 6 (3.1) Unclear Bölke 2001**11 20 0 0 0 Elkouri 2004**13 94 NR 0 NR Ouriel 200340 704 20% men 

22% women at 24 months 

11 (1.6) 3.1% men 

1.8% women at 24 months 

Teufelsbauer 2003**20 275 NR 7 (2.5) NR 

Total 4,888 125 (2.6) 0 to 6.8 * ≤30 days after procedure ** 30-day mortality versus control (open repair) in Appendix E, Table E10 NR = Not reported 
E-18

Table E12. Mortality following EVAR: Data from registries and device-specific non-randomized clinical trials (NRCTs) 

Author Number of Patients 

(Reference) Undergoing EVAR Number of Deaths (%) 30-Day Deaths* (%) AAA-Related Deaths (%) 

RETA database (n=1,000) Thomas 200541 1,000 11% year 1 (post-procedure) 

10% year 2 

7% year 3 

10% year 4 

8% year 5 

57 / 989 (5.8) 6 deaths year 1 

(post-procedure) 

Lifeline database (n=2,664): Pooled data from 4 NRCTs Lifeline 2005†19 2,664 603 (22.6) up to 6 years 45 

(1.7) 

56 

(2.1) 

Powerlink Carpenter 200422 192 20 (10.4) 2 (1.0) 1 (<1) Excluder Matsumura23 235 33 (14.0) 2 (1.0) 0 from AAA rupture Ancure (n=305) and EGS (n=268); Moore 200324

573 73 / 319 (22.9) 

Subjects selected for longterm followup** 

10 (1.7) 

Ancure 3/305 (1.0%) 

EGS 7/268 (2.6%) 

0 / 319 

AneuRx Zarins 200342 1,193 250 (21.0) 22 (1.8) 30 (2.5) Eurostar database (n=4,613): No mortality data in most recent publication43Laheij 200244 2,863 257 

(9.0) 

85 

(3.0) 

0 

Laheij 200044 2442, 245 unfit for 

surgery and 97 unfit for 

general anesthesia (GA)

56 unfit for surgery and GA 

died during followup vs. 157 

fit 

78 (3.2), 15 unfit for 

surgery (6%) and 4 unfit 

for GA (4%) 

1 rupture death (unclear if 

patient was fit or unfit) 

Data from discharge dataset: New York State-Statewide Planning and Research Cooperative System (SPARCS) Anderson 2004†8 1,706 NR 19 

(1.1) 

NR 

Data from National Inpatient Sample (NIS) database, representing 20% of all-payer stratified sample of non-federal U.S. hospitaLee 2004†18 2,565 33 

(1.3) 

33 

(1.3) 

NR 

Data from University of Alabama-Birmingham vascular registry, “high” vs. “low” risk subjects Jordan 2003†17 259 

130 high 

129 low 

NR 6 (2.3) high 

0 low 

0 

AneuRx Clinical Trial (n=1,193): Data from 19 investigational centers Zarins 200342 See Lifeline above for data on all subjects 
Table E12. Mortality following EVAR: Data from registries and device-specific non-randomized clinical trials (NRCTs) (continue

E-19

Author Number of Patients 

(Reference) Undergoing EVAR Number of Deaths (%) 30-Day Deaths* (%) AAA-Related Deaths (%) 

Zenith Clinical Trial (n=200) Greenberg 2004†15 200 7 (3.5) at 12 months 1 (0.5) 1 (0.5) at 12 months Talent Clinical Trial (n=471) Criado 2001†45 471 8 / 462 (1.7) 8 / 462 (1.7) 1 reported * ≤30 days after procedure ** Based on implantation date; i.e., the earliest implantations were followed for 5 years. † 30-day mortality versus control (open repair) in Appendix E, Table E-10 NR = Not reported 
E-20

Table E13. Early (<30 days post-procedure) and delayed (>30 days post-procedure) aneurysm rupture following EVAR: Data fro

nonrandomized studies, case series, and comparative studies 

Author Number of Patients Followup (Mont

(Reference) Undergoing EVAR With Early Rupture (%) With Delayed Rupture (%) Mean 

RETA 

Thomas 200541 1,000 2 (0.2) 6 deaths year 1 post- procedure (0.6) At year 1 

LIFELINE 200519

4 NRCTs (below) 

2,664 3 (0.1) 15 (0.6) 72* 

Powerlink Carpenter 200422

192 0 0 22 

Excluder Matsumura 200323 235 0 0 2-year update Ancure (n=305) and 

EGS (n=268) 

Moore 200324

319 0 0 5-year update 

AneuRx Zarins 200342 1,193 3 (0.3 15 (1.3) 6-year update 

Eurostar 

Laheij 200244

2,863 1 / 2,442 

(Laheij 2000) 

16 (0.6) NR 

Talent 

Criado 200312

190 NR 0 13 

Albertini 200139 185 3 (1.6) NR Alric 200229 88 NR 2 (2.2) 21 Becquemin 20009 73 NR 0 7 Blum 200138 298 1 (0.3) 4 (1.3) 35 Burks 200227 95 NR 0 25 Carpenter 200446 227 2 (0.9) NR Cartes 200228 72 NR 0 22 Elkouri 200347 100 NR 1 (1) 7 Faries 200234 74 0 0 13 Flora 200330 108 NR 0 20 Gilling-Smith 200031 55 NR 1 (1.8) 18 Moore 200324 684 NR 0 NR Tutein Nolthenius 200135 77 NR 0 12 Ohki 200132 239 NR 2 (0.8) 16 Ouriel 200340 704 1 (0.1) 3 (0.4) NR Parlani 200233 336 see Zannetti 2 (0.6) 14 Ricco 200336 1,012 2 (0.1) NR Zannetti 200148 240 1 (0.4) NR 

Total (%) 16 / 8,772 (0.2) 52 / 9,720 (0.5) 7 to 72 * Unclear, studies were to have a minimum of 5-year followup. Kaplan-Meier analyses were done at 6 years NR = Not reported
E-21

Table E14. Primary (immediately following a failed EVAR or <30 days post-procedure) and delayed (secondary or >30 days pos

to OSR following EVAR: Data from registries, nonrandomized studies, case series, and comparative studies 

Author Conversions Followup (M

(Reference) 

Total Number of 

EVAR Primary n (%) Delayed n (%) Mean 

RETA 

Thomas 200541 1,000 33 / 996 (3.3) 23 (2.3) 36 

Lifeline 200519 2,664 68 (2.6) 28 / 2524 (1.1) 72* 

Powerlink Carpenter 200422 192 3 (1.6) 1 / 190 (0.5) 22 Excluder Matsumura 200323 235 0 3 (1.3) 2-year update 

Ancure (n=305) and EGS 

(n=268); Moore 200324 573 42 (7.3) 16 Ancure (5.2) 26 EGS (9.7) 8 / 319 (2.5) 5-year update 

AneuRx Zarins 200342 1,193 11 (0.9) 38 (3.2) 6-year update 

Eurostar 

Vallabhaneni 200149 2,862 47 (1.6) 41 (1.4) 12 

Talent 

Criado 200312 240 NR 5 (2.1) 13 

Albertini 200139 185 2 (1.1) NR Alric 200229 88 1 (1.1) 3 (3.4) 21 Becquemin 20009 73 NR 3 (4.1) 7 Bertrand 200110 193 6 (3.1) NR Blum 200138 298 5 (0.8) 8 (2.7) 35 Carpenter 200446 227 3 (1.3) 2 (0.9) 11 Elkouri 200347 100 3 (3.0) 1 (1) 7 Faries 200234 65 NR 2 (3.1) 13 Flora 200330

2 groups (early vs. late) 

108 

26 early / 82 late 

11 (10.0) 

7 (27.0) / 4 (4.5) 

3 (2.8) 20 

Gilling-Smith 200031 55 NR 1 (1.8) 18 Hansman 200316 50 0 1 (2) NR May 200037 266 17 (6.4) NR Tutein Nolthenius 200135 77 2 (2.6) NR Ohki 200132 239 NR 5 (2.1) 16 Ouriel 200340 700 3 (0.4) 29 (4.1) 12 Parlani 200233 336 6 (1.8) 4 (1.2) 14 Resch 2001502 groups (early vs. late) 

164 

90 early / 68 late 

8 (4.9) 

8 (8.9) / 0 

15 (9.1) 39 

Ricco 200336 1,012 11 (1.1) 4 (0.4) 11 Zannetti 200148 266 6 (2.3) NR 

Total 233 / 10,832 (2.2) 178 / 10,141 (1.8) 7 to 72 * Unclear, studies were to have a minimum of 5-year followup. Kaplan-Meier analyses were done at 6 years NR = Not reported
E-22

Table E15. Secondary intervention following EVAR: Data from registries, nonrandomized studies, case series, and comparativ

Author Secondary Interventions Followup (M

(Reference) 

Total Number of EVAR 

Number % Mean 

RETA  Thomas 200541 996 110 (Short-term) 11.0 36 Lifeline 200519 2,664 487 (415 early) 18.3 72** 

Powerlink Carpenter 200422 192 23 (6 early) 12.0 22 Excluder Matsumura 200323 235 31 13.2 2-year update Ancure (n=305) and EGS 

(n=268); 

Moore 200324

319 212 37.0 5-year update 

AneuRx Zarins 200342 1,193 NR NR 6-year update 

Eurostar 

Laheij 200244

2,863 410 14.3 NR 

Talent 

Criado 200312

240 9 3.8 13 

Alric 200229 88 6 6.8 21 Becquemin 20009 73 16 21.9 7 Blum 200138 298 24 8.1 35 Carpenter 200446 227 17 7.5 11 Cartes 200228 72 10 13.9 22 Elkouri 200347 100 29 29.0 7 Faries 200234 65 17 26 13 Flora 200330 108 28 26.2 20 Gilling-Smith 200031 55 11 20.0 18 Hansman 200316 50 6 12.0 NR Haulon 200326 96 38 39.6 27 May 200037 266 43 16.2 6 Tutein Nolthenius 200135 77 22 28.6 12 Ohki 200132 239 23 9.6 16 Ouriel 200340 704 173 24.7 NR Parlani 200233 336 19 5.7 14 Resch 200150 164 91 55.5 39 Ricco 200336 1,012 67 6.6 11 

Total 10,793 1,656 15.3 6 to 72 * Unclear, studies were to have a minimum of 5-year followup. Kaplan-Meier analyses were done at 6 years NR = Not reported
E-23 

Table E16. Incidence of any EVAR endoleaks: Data from registries, nonrandomized studies, case series, and 

comparative studies 

Time Point Author 

(Reference) 

Number 

of Subjects 

Number 

of Cases 

% 

<30 days RETA 

Thomas 200541 1,000 146 14.6 

<30 days 1,646 407 24.7 

 2,646 553 20.9 

At discharge 1,589 451 28.4 

3 months 441 90 20.4 

6 months 1,403 327 23.3 

12 months 1,309 222 17.0 

24 months 926 198 21.4 

36 months 415 61 14.7 

48 months 

Lifeline 200251

Total 

77 16 20.8 

≤30 days 110 25 22.7 

6 months 101 13 12.9 

12 months 128 18 14.1 

24 months 

Powerlink 

Carpenter 200422

78 5 6.8 

≤30 days 180 39 21.7 

12 months 156 27 17.3 

24 months 

Excluder 

Matsumura 200323

119 24 20.2 

Discharge 308* 130 42.2 

12 months 262* 79 30.3 

24 months 225* 55 24.4 

36 months 175* 32 18.3 

48 months 101* 15 14.9 

60 months 

Ancure (n=305) and EGS 

(n=268); Moore 200324

43* 7 16.3 

Predischarge 1,103 306 27.7 

≤30 days 1,056 147 13.9 

6 months 987 135 13.7 

12 months 951 132 13.9 

24 months 772 129 16.7 

36 months 451 63 14.0 

48 months 

AneuRx 

Zarins 200342

137 19 13.9 

* Bifurcated only
E-24 

Table E17. Incidence of EVAR type I endoleaks: Data from registries, nonrandomized studies, case series, 

and comparative studies 

Time Point Author 

(Reference) 

Number 

of Subjects 

Number 

of Cases 

% 

RETA 

Thomas 200541 1,000 54 5.4 

Powerlink

Carpenter 200422 110 1 0.9 

Excluder 

Matsumura 200323 180 7 3.9 

Ancure (n=305) and EGS

(n=268); Moore 200324 308 12 3.9 

AneuRx 

Howell 200052 215 2 0.9 

AneuRx 

Lee 200253 150 5 3.3 

Talent

Criado 200312 190 11 5.8 

Gilling-Smith 200031 55 6 10.9 

Becquemin 20009 73 8 11.0 

Parlani 200233 336 3 1.2 

<30 days 

Total 2,617 109 4.2 

Powerlink 

Carpenter 200422 128 0 0 

Excluder 

Matsumura 200323 156 2 1.3 

Ancure (n=305) and EGS

(n=268); Moore 200324 262 9 3.4 

AneuRx 

Howell 200052 84 2 2.4 

Talent

Criado 200312 159 7 4.4 

Albertini 200139 185 16 8.6 

Blum 200138 298 6 2.0 

Carpenter 200446 227 7 3.1 

Cartes 200228 72 3 4.2 

Hansman 200316 50 1 2.0 

Haulon 200326 91 13 14.3 

Tutein Nolthenius 200135 128 4 3.1 

Ouriel 200340 704 18 2.6 

Up to 1 year 

Total 2,544 88 3.5 

Powerlink 

Carpenter 200422 78 0 0 

Excluder 

Matsumura 200323 119 3 2.5 

Ancure(n=305) and EGS

(n=268); Moore 200324 225 4 1.8 

AneuRx 

Howell 200052 132 6 4.5 

AneuRx 

Wolf 200254 189 13 6.9 

AneuRx 

Zarins 200342 383 10 2.6 

Talent

Criado 200312 179 8 4.5 

Alric 200229 88 3 3.4 

Burks 200227 95 0 0.0 

>1 year 

Faries 200234 65 14 21.5 
Table E17. Incidence of EVAR type I endoleaks: Data from registries, nonrandomized studies, case series, 

and comparative studies (continued) 

E-25 

Time Point Author 

(Reference) 

Number 

of Subjects 

Number 

of Cases 

% 

Flora 200330 108 12 11.1 

Fransen 200343 4,613 375 8.1 

Haulon 200326 77 2 2.6 

May 200037 266 21 7.9 

Tutein Nolthenius 200135 128 2 1.6 

Ohki 200132 239 7 2.9 

Ouriel 200340 700 25 3.6 

Resch 200150 164 20 12.2 

Total 7,848 525 6.7 
E-26 

Table E18. Incidence of EVAR type II and III endoleaks: Data from registries, non-randomized studies, case 

series and comparative studies 

Time Point Author 

(Reference) 

Number 

of Subjects 

Number 

of Cases 

% 

Type II endoleak 

RETA 

Thomas 200541 1,000 44 4.4 

Powerlink

Carpenter 200422 110 22 20 

Excluder 

Matsumura 200323 180 21 11.7 

Ancure (n=305) and EGS

(n=268); Moore 200324 308 96 31.2 

AneuRx 

Howell 200052 215 3 1.4 

AneuRx 

Lee 200253 150 29 19.3 

Talent

Criado 200312 190 16 8.4 

Becquemin 20009 73 9 12.3 

Burks 200227 95 19 20.0 

Gilling-Smith 200031 55 5 9.1 

Parlani 200233 336 22 6.5 

<30 days 

Total 2,712 286 10.5 

Powerlink

Carpenter 200422 128 16 12.5 

Excluder 

Matsumura 200323 156 19 12.2 

Ancure (n=305) and EGS

(n=268); Moore 200324 262 57 21.8 

AneuRx 

Howell 200052 84 8 9.5 

AneuRx 

Zarins 200342 383 55 14.4 

Talent

Criado 200312 185 10 5.4 

Blum 200138 298 9 3.0 

Carpenter 200446 227 18 7.9 

Cartes 200228 30 1 3.3 

Hansman 200316 50 7 14.0 

Haulon 200326 91 9 9.9 

Ouriel 200340 704 173 24.6 

Up to 1 year 

Total 2,598 382 14.7 

Eurostar 

Fransen 200343 4,613 485 10.5 

Powerlink

Carpenter 200422 78 3 4.1 

Excluder 

Matsumura 200323 119 16 13.4 

Ancure (n=305) and EGS

(n=268); Moore 200324 225 38 16.9 

AneuRx 

Arko 200355 206 40 19.4 

AneuRx 

Zarins 200342 573 61 10.6 

Alric 200229 88 5 5.7 

Faries 200234 65 3 4.6 

>1 year 

Flora 200330 108 9 8.3 
Table E18. Incidence of EVAR type II and III endoleaks: Data from registries, non-randomized studies, case 

series and comparative studies (continued) 

E-27 

Time Point Author 

(Reference) 

Number 

of Subjects 

Number 

of Cases 

% 

Haulon 200326 77 16 20.8 

May 200037 383 4 1.0 

Tutein Nolthenius 200135 128 8 6.3 

Ohki 200132 239 13 5.4 

Resch 200150 164 23 14.0 

Total 7,066 724 10.2 

Type III endoleak

RETA database 

Thomas 200541 1000 15 1.5 

Powerlink

Carpenter 200422 110 0 0 

Excluder 

Matsumura 200323 180 0 0 

<30 days 

Total 1,290 15 1.2 

Powerlink

Carpenter 200422 128 0 0 

Excluder 

Matsumura 200323 156 0 0 

Up to 1 year 

Total 284 0 0 

Eurostar 

Fransen 200343 4,613 225 4.9 

Powerlink

Carpenter 200422 78 0 0 

Excluder 

Matsumura 200323 119 0 0 

AneuRx 

Zarins 200342 383 8 2.1 

Alric 200229 88 1 1.1 

Blum 200138 298 5 1.7 

Tutein Nolthenius 200135 77 4 2.3 

Ohki 200132 239 1 0.4 

Ouriel 200340 704 23 3.3 

>1 year 

Total 6,599 267 4.0 
E-28 

Table E19. Incidence of common technical complications of EVAR: Data from registries, nonrandomized 

studies, case series, and comparative studies 

Time Point Author 

(Reference) 

Number of 

Subjects 

Number of 

Cases 

% 

Technical complications, any 

In-hospital RETA 

Thomas 200541 976 55 5.6 

Stent migration 

At discharge Lifeline 200251 1,589 9 0.6 

Eurostar 

Villabhaneni 200149 <30 days 2,862 39 1.4 

Total 4,451 40 0.90 

3 months 441 2 0.4 

6 months 

Lifeline 200251

1,403 11 0.8 

Lifeline 200251 1,309 2 0.2 

Talent Criado 200312 240 3 1.3 

Hansman 200316 50 1 2.0 

<1 year 

Total 1,599 6 0.4 

Lifeline 200251 926 48 5.2 

Eurostar 

Fransen 200343

4,613 156 3.4 

AneuRx 

Zarins 200342 383 13 6.3 

Blum 200138 298 5 1.7 

Flora 200330 108 2 1.9 

Tutein Nolthenius 200135 77 6 8.2 

Ouriel 200340 704 51 7.2 

Resch 200150 164 31 18.9 

>1 year 

Total 7,027 312 4.4 

36 months Lifeline 200251 415 30 7.2

48 months 77 7 9

Stent wire fracture 

Powerlink

Carpenter 200422 192 0 0 

Talent

Criado 200312 240 11 4.6 

Carpenter 200446 227 6 2.6 

Up to 1 year 

Total 659 17 2.6 

Graft limb thrombosis 

Ancure (n=305) and EGS

(n=268); Moore 200324 573 17 3.0 

AneuRx 

Howell 200052 215 5 2.3 

Burks 200227 95 6 6.3 

Lee 200253 150 1 0.7 

Parlani 200233 336 4 1.2 

<30 days 

Total 1,369 33 2.4 

AneuRx 

Shames 200356 241 10 4.1 

AneuRx 

Zarins 200057 149 1 0.7 

Albertini 200139 135 2 1.5 

<1 year 

Alric 200229 88 3 3.4 
Table E19. Incidence of common technical complications of EVAR: Data from registries, nonrandomized 

studies, case series, and comparative studies (continued) 

E-29 

Time Point Author 

(Reference) 

Number of 

Subjects 

Number of 

Cases 

% 

Arko 200355 200 1 0.5 

Ayerdi 200358 96 2 2.1 

Becquemin 20009 73 8 11.0 

Blum 200138 298 4 1.3 

Carpenter 200446 227 0 0.0 

Elkouri 200347 100 4 4.0 

Hansman 200316 50 2 4.0 

Total 1,657 41 2.5 

Eurostar 

Fransen 200343 4613 152 3.3 

Powerlink

Carpenter 200422 192 4 2.1 

Ancure (n=305) and EGS

(n=268); Moore 200324 573 31 5.4 

Flora 200330 108 2 1.9 

Haulon 200326 96 8 8.3 

Tutein Nolthenius 200135 77 3 2.3 

Ohki 200132 239 7 2.9 

Ouriel 200340 704 43 6.1 

>1 year 

Total 6,602 250 3.8 

Graft stenosis 

<30 days Eurostar 

Villabhaneni 200149 2862 10 0.3 

Powerlink

Carpenter 200422 192 3 1.6 

Becquemin 20009 73 4 5.5 

Elkouri 200347 100 3 3.0 

<1 year 

Total 365 10 2.7 

>1 year Eurostar 

Fransen 200343 4,613 66 1.4 
E-30 

Figure E1. ADAM trial: Mean SF-36 scores by treatment group 

All scores are 0 to 100, with 100 representing better health. Asterisks for individual time points are for p <.05. 

Physical Component Summary 

30

35

40

45

0

YEARS OF FOLLOW-UP

012345678

I

S

N=568

N=567

506

536

471

495

442

461

323

344

215

230

132

155

57

60

IMMEDIATE

SURVEILLANCE

Mental Component Summary 

45

50

55

60

0

YEARS OF FOLLOW-UP

012345678

I

S

N=568

N=567

506

536

471

495

442

461

323

344

215

230

132

155

57

60

Reprinted from Journal of Vascular Surgery, Volume 38, Number 4, Lederle FA, GR Johnson, SE Wilson, CW Archer, 

DJ Ballard, FN Littooy, and LM Messina for the Aneurysm Detection and Management Veterans Affairs Cooperative 

Study, Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of 

small abdominal aortic aneurysm pages 745-752 (2003), with permission from the Society for Vascular Surgery.
E-31 

Figure E2. ADAM trial: Prevalence of impotence by treatment group 

Overall, by repeated measures analysis, impotence was significantly increased after randomization in the 

immediate repair group (p <.03) PERCENT OF PATIENTS

0

5

10

15

20

25

30

35

40

45

50

55

60

65

70

75

80

YEARS OF FOLLOW-UP

012345678

IMMED

SURV

566

564

492

519

458

484

422

444

316

332

207

223

132

150

55

60

Reprinted from Journal of Vascular Surgery, Volume 38, Number 4, Lederle FA, GR Johnson, SE Wilson, CW Archer, 

DJ Ballard, FN Littooy, and LM Messina for the Aneurysm Detection and Management Veterans Affairs Cooperative 

Study, Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of 

small abdominal aortic aneurysm pages 745-752 (2003), with permission from the Society for Vascular Surgery. 
E-32 

Figure E3. Immediate open repair of small aneurysms (4.0 to 5.5 cm) vs. surveillance: UKSAT mean change in SF-20 scores fro
E-33 

Figure E4. DREAM trial (n = 153): Changes in Short Form-36: Physical function domain over time: 

Endovascular repair (EVAR) vs. open repair (OR) 

0

10

20

30

40

50

60

70

80

90

Preop 3W

postop

6W

postop

3M

postop

6M

postop

12M

postop

EVAR

OR
E-34 

Figure E5. DREAM trial (n = 153): Changes in Short Form-36: Domain of mental health, over time: 

Endovascular repair (EVAR) vs. open repair (OR) 

60

65

70

75

80

85

Preop 3W

postop

6W

postop

3M

postop

6M

postop

12M

postop

EVAR

OR
E-35

Figure E6. EVAR1 trial: Euro QoL 5-D (EQSD): Endovascular repair (EVAR) vs. open repair (OR) 
E-36

Figure E7. EVAR1 trial: Short Form-36 physical component: Endovascular repair (EVAR) vs. open repair (OR) 
E-37

Figure E8. EVAR1 trial: Short Form-36 mental component: Endovascular repair (EVAR) vs. open repair (OR) 
E-38 

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E-40 

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