Evidence-based Synthesis Program Department of Veterans Affairs

Health Services Research & Development Service

Prepared for:

Department of Veterans Affairs

Veterans Health Administration

Quality Enhancement Research Initiative

Health Services Research & Development Service

Washington, DC 20420

Prepared by:

Evidence-based Synthesis Program (ESP) Center

Minneapolis VA Medical Center

Minneapolis, MN

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

Investigators:

Principal Investigators: 

Thomas S. Rector, Ph.D. 

Brent C. Taylor, Ph.D., M.P.H.

Research Associates:

Nancy Greer, Ph.D.

Indulis Rutks, B.S.

Use of Left Ventricular Assist Devices 

as Destination Therapy in

End-Stage Congestive Heart Failure: 

A Systematic Review

May 2012
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

PREFACE

Quality Enhancement Research Initiative’s (QUERI) Evidence-based Synthesis Program 

(ESP) was established to provide timely and accurate syntheses of targeted healthcare topics 

of particular importance to Veterans Affairs (VA) managers and policymakers, as they work to 

improve the health and healthcare of Veterans. The ESP disseminates these reports throughout 

VA.

QUERI provides funding for four ESP Centers and each Center has an active VA affiliation. The 

ESP Centers generate evidence syntheses on important clinical practice topics, and these reports 

help:

• develop clinical policies informed by evidence,

• guide the implementation of effective services to improve patient 

outcomes and to support VA clinical practice guidelines and 

performance measures, and 

• set the direction for future research to address gaps in clinical 

knowledge.

In 2009, the ESP Coordinating Center was created to expand the capacity of QUERI Central 

Office and the four ESP sites by developing and maintaining program processes. In addition, 

the Center established a Steering Committee comprised of QUERI field-based investigators, 

VA Patient Care Services, Office of Quality and Performance, and Veterans Integrated Service 

Networks (VISN) Clinical Management Officers. The Steering Committee provides program 

oversight, guides strategic planning, coordinates dissemination activities, and develops 

collaborations with VA leadership to identify new ESP topics of importance to Veterans and the 

VA healthcare system.

Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP 

Coordinating Center Program Manager, at nicole.floyd@va.gov.

Recommended citation: Rector TS, Taylor BC, Greer N, Rutks I, and Wilt TJ. Use of Left 

Ventricular Assist Devices as Destination Therapy in End-Stage Congestive Heart Failure: A 

Systematic Review. VA-ESP Project #09-009; 2012.

This report is based on research conducted by the Evidence-based Synthesis Program 

(ESP) Center located at the Minneapolis VA Medical Center, Minneapolis, MN funded 

by the Department of Veterans Affairs, Veterans Health Administration, Office of 

Research and Development, Quality Enhancement Research Initiative. 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 

the Department of Veterans Affairs or the United States government. Therefore, no 

statement in this article should be construed as an official position of the Department 

of Veterans Affairs. No investigators have any affiliations or financial involvement (e.g., 

employment, consultancies, honoraria, stock ownership or options, expert testimony, 

grants or patents received or pending, or royalties) that conflict with material presented 

in the report.
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

TABLE OF CONTENTS

EXECUTIVE SUMMARY

Background.................................................................................................................................................... 1

Methods......................................................................................................................................................... 1

Data Synthesis............................................................................................................................................... 2

Peer Review................................................................................................................................................... 2

Results ........................................................................................................................................................... 2

Recommendations for Future Research......................................................................................................... 4

INTRODUCTION............................................................................................................................................... 5

Ventricular Assist Devices Approved for Use as Destination Therapy ......................................................... 6

Centers for Medicare and Medicaid Services (CMS) Coverage ................................................................... 6

Registry of Ventricular Assist Devices Used as Destination Therapy........................................................... 7

Guideline Recommendations......................................................................................................................... 7

METHODS

Topic Development........................................................................................................................................ 9

Search Strategy.............................................................................................................................................. 9

Study Selection............................................................................................................................................ 10

Data Abstraction .......................................................................................................................................... 12

Quality Assessment ..................................................................................................................................... 12

Rating the Body of Evidence....................................................................................................................... 13

Data Synthesis............................................................................................................................................. 14

Peer Review................................................................................................................................................. 14

RESULTS

Literature Search ......................................................................................................................................... 15

Key Question #1. How does use of an FDA-approved, current generation LVAD as destination 

therapy (i.e., the HeartMate II left ventricular assist device) effect patient outcomes? .............................. 15

Key Question #2. What patient or site characteristics have been associated with patient benefits 

or harms when the FDA-approved, current generation LVAD is used as destination therapy? .................. 17

Key Question #3. What is the range of cost-effectiveness estimates of using the FDA-approved, 

current generation LVAD as destination therapy in end-stage heart failure and what explains 

variation in these estimates?........................................................................................................................ 19

SUMMARY AND DISCUSSION

Summary Points........................................................................................................................................... 21

Limitations................................................................................................................................................... 21

Recommendations for Future Research....................................................................................................... 21

Conclusions ................................................................................................................................................. 23

REFERENCES ................................................................................................................................................... 24
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

FIGURES

Figure 1. Analytic Framework................................................................................................................. 10

Figure 2. Literature Flow Diagram.......................................................................................................... 15

APPENDIX A. Technical Expert Panel Members............................................................................ 27

APPENDIX B. Search Strategy............................................................................................................... 28

APPENDIX C. Peer Review Comments/Author Responses .......................................................... 29

APPENDIX D. Evidence Tables

Table 1. Key Question #1: Effects on Patient Outcomes...................................................................... 34

Table 2. Key Question #2: Patient Selection......................................................................................... 38

Table 3. Key Question #3: Cost-effectiveness...................................................................................... 41
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

EVIDENCE REPORT

INTRODUCTION

Several common chronic conditions such as atherosclerotic heart disease and hypertension as 

well as other diseases can result in heart failure, a reduced ability of the heart to pump blood 

and maintain normal bodily functions. The prevalence of chronic heart failure increases with 

age to over 10% in the elderly population.7

 More than 100,000 people in the United States 

with progressive heart failure are refractory to available treatments and have high rates of 

hospitalization and mortality and a poor quality of life due to limited physical and social 

activities and psychological stress. Heart transplantation is currently the preferred treatment 

for end-stage heart failure. Unfortunately, the supply of donor hearts is far less than needed 

and many patients do not meet the criteria for heart transplantation primarily due to old age 

and comorbidities such as diabetes with damage to vital organs, pulmonary hypertension, renal 

insufficiency, malignancies and morbid obesity. 

Implantable mechanical pumps that assist the circulation of blood by one or both ventricles 

of the heart have evolved over several decades. Typically blood flows from the native left 

ventricle of the heart into the surgically implanted assist device and is pumped out into the 

aorta via an implanted conduit. The design of the mechanical pump varies (pulsatile fill and 

pump designs similar to a normal heart and continuous flow rotary pumps). Currently, longterm implantable left ventricular assist devices require an external source of power and control 

module. 

Surgical placement of a left ventricular assist device is increasingly done as a last resort for 

patients with refractory heart failure who are not eligible for heart transplantation, so called 

destination therapy.8

 Some patients may improve after they receive a ventricular assist device 

as destination therapy and become eligible for heart transplantation even though this was not 

the initial therapeutic goal. A limited number may recover enough heart function to not need 

a heart transplant or mechanical assist device. Although survival with a newer generation 

continuous flow ventricular assist device is approaching that of a heart transplant, long-term 

use of the device by patients who are eligible for a heart transplant is not currently accepted 

practice.9

 Conversely, many patients that receive a ventricular assist device as a bridge to 

transplant use the device for increasingly prolonged periods while waiting for a donated heart 

and some may become ineligible for a heart transplant. 

The purpose of this report is to review the scientific evidence for use of ventricular assist 

devices as destination therapy for patients with severe, refractory heart failure who are not 

eligible for heart transplantation at the time the device is implanted. Although many patients 

receive the same types of ventricular assist devices as a bridge to heart transplantation 

or recovery, the characteristics, hence risk profiles, of patients receiving bridge therapy 

are different from patients selected to receive a device as permanent destination therapy. 

Furthermore many bridged patients do receive a heart transplant that alters patient outcomes. 

Thus, this review focused on evidence about patient outcomes, patient selection and cost 
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

effectiveness of ventricular assist devices specifically intended as destination therapy. The 

primary goals of destination therapy are to:

• prolong survival, 

• improve daily function and health-related quality of life, 

• minimize harms including infection, major bleeding episodes, thromboembolic events 

including strokes and device malfunction or failure especially those that require hospital 

care.

Ventricular Assist Devices Approved for Use as

Destination Therapy

The first randomized controlled clinical trial of a ventricular assist device as destination therapy 

compared an early generation device (a ventilated electric pulsatile pump, HeartMate VE) to 

optimal medical therapy.2 This device significantly improved survival to 52% versus 25% at 1 

year and 23% versus 8% after 2 years. Unfortunately, 35% of the surgically implanted devices 

failed within 2 years, and 17% of the deaths were attributed to failure of the device. The overall 

effect of the device, including serious complications on the subjects’ functional status and healthrelated quality of life, was difficult to assess due to the high, differential mortality rates and lack 

of assessments during early follow-up. Comparisons of the subjects that survived for one year 

indicated physical and emotional status were better in the group treated with the ventricular assist 

device. This pivotal trial led to approval by the U.S. Food and Drug Administration (FDA) in 

November 2002 of the left ventricular assist device (modified and now known as the HeartMate 

XVE) for use as destination therapy.10 The approved indication included patients that were not 

eligible for heart transplantation who have New York Heart Association (NYHA) class IV heart 

failure (shortness of breath and/or fatigue during minimal physical activity or at rest) for at least 

60 of the last 90 days despite optimal medical therapy, an unassisted left ventricular ejection 

fraction less than 25%, and a peak oxygen consumption less than 12 ml/kg/min during an 

exercise stress test or continued need for an intravenous inotrope. Furthermore, the estimated life 

expectancy without the ventricular assist device should be less than 2 years, similar to patients 

that participated in the clinical trial. After FDA approval, clinical use of the HeartMate XVE was 

associated with a similar 56% 1-year survival, but unfavorable rates of surgical complications 

including sepsis, multi-organ failure, right heart failure, prolonged hospitalization and a 90-day 

in-hospital mortality of 27%.11 Within 2 years, 73% needed device replacement or experienced a 

fatal device failure.

In January 2010, a newer generation, rotary continuous flow ventricular assist device (HeartMate 

II) was approved by the FDA for destination therapy based on a clinical trial that compared the 

new ventricular assist device, the HeartMate II, to the HeartMate XVE. 

CENTERS for MEdiCARE AND MEDICAID SERVICES (CMS) 

COVERAGE

In October 2003, the Centers for Medicare and Medicaid Services (CMS) decided to cover use 

of FDA-approved ventricular assist devices as destination therapy when provided by a Medicare-
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

approved heart transplantation center.12 The clinical center needed to have the staff and processes 

to fully inform prospective recipients about the potential benefits, risks and required followup care. Furthermore, the center was required to report case information to a national audited 

registry from the date of device implantation until death. In March 2007, the facility criteria 

were modified to require a board-certified cardiovascular surgeon that has implanted at least 10 

ventricular assist devices during the past 3 years (at least one in past 18 months) and facility 

certification by the Disease-Specific Care Certification Program for Ventricular Assist Device 

developed by the Joint Commission on Accreditation of Healthcare Organizations.

After FDA approval of the HeartMate II device for destination therapy, CMS eligibility 

requirements were changed to include patients that are refractory to optimal medical 

management for at least 45 of the past 60 days or dependent on an intra-aortic balloon pump 

for 7 days or an intravenous inotrope for 14 days. The peak oxygen requirement was increased 

to 14 ml/kg/min or less unless the patient was physically unable to do an exercise test or was 

dependent on a balloon pump or intravenous inotrope.

Registry of Ventricular Assist Devices Used as

Destination Therapy

An Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) was 

created with support from the National Heart, Lung and Blood Institute, FDA, CMS, the device 

industry and health care providers. In June 2006, this registry began to collect information 

about patients, devices and outcomes including adverse events. The registry is focused on use 

of FDA-approved ventricular assist devices including destination therapy. The registry meets 

the CMS mandate that all hospitals in the United States that provide mechanical circulatory 

support as destination therapy enter their cases into a national audited registry.3 During the 

6-month period from January to June 2010 (shortly after FDA approval of the new continuous 

flow device, HeartMate II), there was nearly a 10-fold increase in the number of registered 

uses for destination therapy. All registered cases during this period received the newer FDAapproved HeartMate II ventricular assist device. As of June 30, 2011, 126 medical centers had 

registered patients of which 101 centers were approved by CMS to provide destination therapy.13

A total of 847 patients treated with destination therapy had been registered and all recent cases 

employed the FDA approved continuous flow ventricular assist device, presumably HeartMate 

II. No VA Medical Centers were listed by the registry as of March 5, 2012 (see www.intermacs.

org/membership). Patients receiving a continuous device as destination therapy had significantly 

worse survival than those receiving a continuous device as a bridge to transplant.

Guideline Recommendations

A 2009 update of the 2005 American College of Cardiology Foundation/American Heart 

Association Task Force on Practice Guidelines for the Diagnosis and Management of Heart 

Failure in Adults did not modify their previous recommendation concerning destination therapy 

for patients with refractory end-stage heart failure (stage D).14 Consideration of a permanent left 

ventricular assist device continued to be considered reasonable for highly selected (undefined) 

patients that have estimated 1-year mortality with optimal medical therapy over 50%. This 
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

recommendation was developed in collaboration with International Society for Heart Lung 

Transplantation.

Guidelines issued by the Heart Failure Society of America in 2010 recommend that permanent 

mechanical assistance may be considered in highly selected patients with severe heart failure 

refractory to conventional therapy who are not candidates for heart transplantation, particularly 

those who cannot be weaned from inotropic support by an experienced heart failure center.15

The 2011 Canadian Cardiovascular Society Heart Failure Guidelines recommend that permanent 

mechanical circulatory support be considered for highly selected patients who are ineligible 

for heart transplantation.16 This was considered to be a ‘weak’ recommendation because of the 

uncertainty about the balance of benefits and risk given currently available evidence. Eligible 

candidates would have severe symptoms of advanced heart failure despite optimal treatment and 

meet at least two of the following criteria: 1) a left ventricle ejection fraction less than 25% and, 

if exercise stress test is done, a peak oxygen consumption less than 14 ml/kg/min, 2) progressive 

organ dysfunction due to hypoperfusion, 3) need to reduce standard therapies for heart failure 

due to symptomatic hypotension or worsening renal function, 4) more than 3 hospital admissions 

for refractory heart failure during the previous year or 5) unable to wean from inotropic support. 

Informed patient preferences were a very important component of the recommendation as was 

a medical center that has a multidisciplinary team with expertise in surgical implantation and 

follow-up of patients with ventricular assist devices. 
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

METHODS

TOPIC DEVELOPMENT

This project was nominated by Dr. Chester Good, Chief, Section of General Medicine. The key 

questions were developed with input from a technical expert panel (see Appendix A).

The final key questions were:

Key Question #1. How does use of an FDA-approved, current generation LVAD as destination 

therapy (i.e., the HeartMate II left ventricular assist device) effect patient outcomes?

Key Question #2. What patient or site characteristics have been associated with patient benefits 

or harms when the FDA-approved, current generation LVAD is used as destination therapy?

Key Question #3. What is the range of cost-effectiveness estimates of using the FDA-approved, 

current generation LVAD as destination therapy in end-stage heart failure and what explains 

variation in these estimates?

Figure 1 depicts the analytic framework for these questions. 

SEARCH STRATEGY

We searched MEDLINE (OVID) for studies that reported patient outcomes, articles about patient 

selection or prediction of patient outcomes, systematic reviews or cost-effectiveness analyses 

from 1995 to October 2011 using standard search terms. The 1995 start date is well before the 

first randomized clinical trial that used a left ventricular assist device for destination therapy. The 

search was limited to articles involving human subjects and published in the English language. 

Search terms included: heart-assist devices, heart failure and ventricular dysfunction (See 

Appendix B for the MEDLINE search strategy). We also examined reference lists to identify 

other pertinent publications and asked our panel of experts to identify additional reports. 

Other searches included the Cochrane Database of Systematic Reviews, the Translating Research 

into Practice (TRIP) database for systematic reviews and technology assessments, the Center for 

Medicare and Medicaid Services (CMS) Web site and the NIH Clinical Trials Web site. 
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

Figure 1. Analytic Framework

KQ1 Patient Outcomes:

Benefits

Prolonged survival

Days lived outside of a 

hospital

Reduced symptoms of 

heart failure 

Reduced functional 

limitations

Improved health-related 

quality of life

Device removal after 

recovery or a heart 

transplantation

Harms

Device failure

Surgical/device-related 

complications including 

infections, major bleeding, 

thromboembolic events, 

right heart, pulmonary or 

renal failure

KQ2 Patient 

Selection Factors: 

Patient /site 

characteristics that 

might be used to 

accurately predict 

patient outcomes 

(benefits or harms)

KQ3 Cost-Effectiveness Estimates

Adults with 

refractory, endstage heart failure 

receiving an FDAapproved, newer 

generation left 

ventricular assist 

device as destination 

therapy

STUDY SELECTION

Generally, abstracts and full text articles were excluded whenever

1. The report did not provide data about the only continuous flow device currently approved 

by FDA for destination therapy, the HeartMate II ventricular assist device.

2. The report did not provide data about use of the device as destination therapy. Short-term 

use of the device as a bridge to transplant was excluded.

3. The report did not provide data about patient outcomes of interest such as survival, hospitalizations, daily function, health-related quality of life or harms.

4. The report did not provide data about adults defined as age 18 years or older.

The following discusses more specific study selection criteria for each key question.
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

Key Question #1 – Patient Outcomes

Randomized controlled trials were sought as the highest quality of evidence for the first 

key question about patient outcomes. At a minimum, randomization helps assure unbiased 

allocation of subjects to the groups being compared. However, the number of patients currently 

eligible for destination device therapy is limited and randomization might not balance baseline 

characteristics in small studies. Subjects that withdraw from the study after randomization or 

crossover to the comparison group may also bias the comparison, particularly if any changes 

in treatment were related to study outcomes. Obviously a comparison of a surgically implanted 

device to continuation of optimal medical therapy can’t be blinded, and endpoint assessments, 

especially subjective assessments and device-related harms, may be biased as a result. However, 

more objective endpoints such as maximal exercise tests are affected by patient effort and 

difficult to interpret in terms of how they translate into affects on patients’ lives. Given the high 

morbidity and mortality of patients with refractory end-stage heart failure, randomization to 

continuation of non-surgical therapies might not be acceptable to patients and providers who 

believe a ventricular assist device is a reasonable alternative. Therefore, randomized clinical 

trials are being designed as a non-inferiority comparison of a new ventricular assist device to an 

approved device.17,18 Non-inferiority studies introduce additional concerns that the characteristics 

of the enrolled subjects, including how they were treated, might not be similar to previous 

studies that demonstrated the ‘control’ device is effective with acceptable risks.19 Furthermore, 

the magnitude of the differences between devices excluded by the statistical analysis of 

non-inferiority needs to be small enough to rule out clinically important differences. Since 

high quality evidence from randomized clinical trials of the FDA-approved continuous flow 

ventricular assist device for destination therapy is very limited, we did not restrict our review to 

randomized controlled trials, and considered cohort studies that could provide estimates of the 

likelihood of patient outcomes. 

Key Question #2 – Patient Selection

Given numerous differences in outcomes including device malfunction between the two 

ventricular assist devices currently approved for use as destination therapy, the HeartMate 

XVE and HeartMate II, and the current exclusive use of the HeartMate II device for destination 

therapy in the INTERMACS registry, our search for the second key question concerning 

selection of patients sought specific analyses about the HeartMate II ventricular assist device. 

As previously mentioned, we also focused on selection of patients for destination therapy 

rather than bridge therapy because the criteria and outcomes including competing risks such as 

heart transplantation are not the same. Thus, studies were selected if they provided evidence 

specifically or predominantly about the selection of patients for use of the HeartMate II device 

as destination therapy. Subgroup analyses that focused on this specific therapy were considered 

including regression analysis that included variables indicating the type of ventricular assist 

device and/or therapy.

Patient selection criteria for destination therapy are based primarily on the selection criteria used 

in the studies that supported FDA approval and therefore define patients eligible for the approved 

indication. However, regression or subgroup analyses are often conducted using study data or 

other patient cohorts in an effort to better define which patients are more likely to benefit or 

be harmed. Studies were sought that provided statistical evidence for significant differences in 
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

patient outcomes between groups defined by preoperative patient characteristics. Expert reviews 

of patient selection criteria were read in search of additional scientific evidence about patient 

selection criteria. Because estimates of patient survival without the ventricular assist device are 

used to select patients, we also included studies that evaluated survival prediction models in a 

sample of patients eligible for destination therapy.

Key Question #3 – Cost Effectiveness

We included studies that provided cost-effectiveness estimates for the use of HeartMate II 

ventricular assist device as destination therapy.

DATA ABSTRACTION

For reports that provided pertinent evidence about patient outcomes and selection (Key 

Questions #1 and #2), we extracted information about the study sites and sponsor, subject 

inclusion and exclusion criteria, sample characteristics, intervention(s) including the comparison 

group(s), if any, length of follow-up, patient outcome(s) of interest and quality of the evidence. 

For reports that provided pertinent evidence about cost effectiveness (Key Question #3), we 

extracted information about the overall estimate of cost effectiveness, the uncertainty in the cost 

effectiveness estimate, the base case assumptions for the cost effectiveness model and the results 

of sensitivity analyses that varied the assumptions in the base case model. 

QUALITY ASSESSMENT

Key Question #1 – Patient Outcomes

The quality of clinical trials was judged based on the potential for bias in the estimates of 

treatment effects according to the following criteria: 1) random assignment to treatment with 

adequate concealment of assignment, 2) blinding of key study personnel (i.e., providers, study 

personnel and/or patients) who determined outcomes to assigned treatment, 3) analysis by 

intention-to-treat (i.e., all subjects counted in group to which they were randomized in the 

analysis of outcomes), 4) reporting of number of withdrawals/dropouts by group assignment 

along with reasons for any losses to follow-up that may be related to beneficial or adverse 

treatment effects and 5) the size of the treatment effects (larger effects are less likely to be 

explained by baseline differences between treatment groups or differential losses to follow-up).20

Studies were rated as good, fair, or poor quality. A rating of ‘good quality’ generally required that 

the investigators randomly assigned patients to treatments and reported adequate concealment of 

assignments, blinded or objective outcome assessments, an intent-to-treat analysis, an adequate 

description of reasons for dropouts/attrition and a sizable treatment effect. The quality of a study 

was generally considered poor if the method of allocation concealment was inadequate or not 

defined, blinding was not reported or possible, analysis by intent-to-treat was not reported and 

reasons for dropouts/attrition were not reported and/or there was a high rate of attrition or the 

estimated treatment effect was small.
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

Key Question #2 – Patient Selection

Criteria to assess the quality of evidence concerning variables and multivariable models to 

predict patient outcomes have not been firmly established. We relied on our, as yet unpublished, 

guidance for conducting systematic reviews of prognostic tests commissioned by the Agency 

for Healthcare Research and Quality (Rector TS, Taylor BG, Wilt TJ. Chapter 12: Systematic 

Reviews of Prognostic Tests in Methods Guide for Comparative Effectiveness Reviews). Specific 

criteria: 1) were patients in the analysis similar to those who would receive an FDA-approved 

ventricular assist device as destination therapy?, 2) were the variables used to make outcome 

predictions measured shortly before implantation of the device and not affected by the procedure, 

subsequent care or knowledge of the outcome being predicted?, 3) were the measurements of 

the potential predictor variables and outcomes reliable, valid and routinely available in clinical 

practice?, 4) did losses to follow-up bias the assessment of outcomes?, 5) was the duration 

of follow-up adequate?, 6) were the number of patients that had the outcome being predicted 

adequate for the number of predictors tested?, 7) were predicted outcome probabilities reported 

for patient subgroups that would be included or excluded from destination therapy?, 8) how 

closely did outcome predictions agree with the observed outcomes?, 9) were the outcome 

prediction somehow validated? and 10) did the analysis demonstrate that the outcome predictions 

could be used to improve patient outcomes? 

Key Question #3 – Cost Effectiveness

There are no well-accepted criteria for evaluating the quality of cost-effectiveness analyses, 

however, there are long lists of factors related to the analytical model and assumptions that can 

be considered.21 In order to assess quality we extracted information on the cost-effectiveness 

model structure and assumptions.

RATING THE BODY OF EVIDENCE

The overall evidence for a key question was graded using the method proposed by Owens et al.23

using the following criteria:

• High grade evidence: Further research is very unlikely to change the confidence in the 

estimated treatment effect on patient outcomes. Generally, a high grade requires more 

than one good quality study and consistent estimates with statistical confidence intervals 

that exclude clinically meaningful differences. 

• Moderate grade evidence: Further research may change the estimate of the size of the 

effect or the level of uncertainty.

• Low grade evidence: Further research is likely to change the estimate of the size of the 

effect and or the confidence interval.

• Insufficient evidence: Sufficient evidence was not found to answer the question.
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

DATA SYNTHESIS

We constructed evidence tables for Key Questions #1, #2 and #3, and drew our conclusions 

based on a qualitative synthesis of the evidence available to answer each key question. Not 

finding several reports that provided independent estimates of patient outcomes, relationships 

between baseline variables and patient outcomes or cost effectiveness, we did not do any metaanalyses to pool evidence from different studies. 

PEER REVIEW

A draft version of this report was reviewed by clinical experts including the Technical Expert 

Panel. Their comments are presented in Appendix C as are our responses to any suggestions to 

modify the report itself.
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Use of Left Ventricular Assist Devices as Destination Therapy 

in End-Stage Congestive Heart Failure: A Systematic Review Evidence-based Synthesis Program

RESULTS

LITERATURE SEARCH

Figure 2 summarizes the literature search. We reviewed 1,637 titles and abstracts from the 

electronic search. After applying inclusion/exclusion criteria, 1,491 references were excluded. 

We retrieved 146 full-text articles for further review and 140 were excluded. We identified 1 

additional reference by hand-searching references lists and 2 articles that were published after 

our search date. There were a total of 4 articles (3 from the literature search) for Key Question 

#1; only one was a randomized controlled trial. There were 4 articles included for Key Question 

#2 (3 from the literature search); 3 examined prediction models and 1 was a subgroup analysis. 

For Key Question #3, 1 article was included that was published after the initial literature search. 

Figure 2. Literature Flow Diagram

1637 Abstracts from 

MEDLINE search

146 Articles pulled for 

3 Articles full text review

added from 

references and 

more recent 

publications

1491 Abstracts 

excluded

140 Articles 

excluded

KQ3: 

1 Article

KQ2: 

4 Articles

KQ1: 

4 Articles

KEY QUESTION #1. How does use of an FDA-approved, current 

generation LVAD as destination therapy (i.e., the HeartMate II left 

ventricular assist device) effect patient outcomes?

We found one good quality randomized clinical trial of the HeartMate II left ventricular assist 

device employed as destination therapy.1 Patients enrolled in this study generally met the current 

criteria for destination therapy that were based on a previous study of an older generation device2

including being ineligible for a heart transplant, most being in NYHA association class IV heart 

failure that was refractory to optimized therapies, a left ventricular ejection fraction less than 

25% and very limited ability to exercise. The subjects’ (n=200) mean age was 62 years and 84% 

were males. Compared to the older generation HeartMate XVE left ventricular assist device, 

use of the HeartMate II provided superior patient outcomes (See Appendix D, Table 1). After 24 

months, the primary endpoint of survival free of disabling stroke or reoperation to remove the 

device was 46% versus 11%, respectively (p < 0.0001). Survival in the HeartMate II group was 
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Use of Left Ventricular Assist Devices as Destination Therapy 

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significantly better (58% versus 24% after 2 years) and subjects spent a greater percentage of 

their follow-up time outside of a hospital (88% versus 74%) largely due to a lower readmission 

rate. During follow-up, survivors with the HeartMate II also had fewer limitations due to heart 

failure as measured by the NYHA class, Minnesota Living with Heart Failure Questionnaire and 

clinical component of the Kansas City Cardiomyopathy Questionnaire. The incidences of several 

adverse events were lower as well including right heart failure, cardiac arrhythmias, devicerelated infections, sepsis, respiratory failure, renal failure and device replacement. None of the 

adverse events rates were higher in the HeartMate II group including major bleeding and strokes. 

This study provides moderate quality evidence that numerous patient outcomes in patients 

treated with the HeartMate II are better than the HeartMate XVE when used for destination 

therapy. Since patient characteristics and outcomes in the HeartMate XVE arm of this study were 

similar to those in the previous clinical trial that demonstrated the HeartMate XVE provided 

superior outcomes compared to optimal medical therapy,2

 one might infer that the HeartMate II 

would also be superior to optimal medical therapy. 

A recent fair quality report23 compared outcomes of patients enrolled in a continued access 

protocol to those who received the HeartMate II in the above randomized clinical trial (Appendix 

D, Table 1). Patient selection criteria and baseline characteristics in the continued access 

protocol were essentially the same as the randomized controlled trial. The patients enrolled in the 

continued access protocol had as good or better outcomes. After 24 months, the primary endpoint 

of survival free of disabling stroke or reoperation to remove the device was 50% in the group 

assigned to the HeartMate II in the randomized controlled trial versus 59% in the continued 

access protocol (p=0.07). Survival for 2 years was also similar 58% versus 63%, respectively. 

During follow-up survivors also had similar improvements in symptoms and related quality of 

life as measured by the NYHA class, Minnesota Living with Heart Failure Questionnaire and 

the Kansas City Cardiomyopathy Questionnaire. The incidences of hemorrhagic stroke, bleeding 

treated with packed red blood cells, sepsis and device-related infection were significantly lower 

in the group enrolled in the continued access protocol. The reduction in bleeding events was 

attributed to changes in the postoperative use of less aggressive anticoagulation regimens. There 

were no differences in the incidences of other adverse effects. 

Two reports of case series3,24 provided survival estimates for patients receiving the Heart Mate 

II as destination therapy (Appendix D, Table 1). Although these reports provided lower quality 

evidence, survival at one year in these cases series was similar to the 68% 1-year survival in the 

HeartMate II group in the randomized clinical trial. More recent survival estimates without heart 

transplantation or heart recovery from the INTERMACS registry that are based on 740 cases 

were 74% and approximately 60% after 1 and 2 years, respectively.13 The available survival 

estimates are remarkably consistent with each other.

Summary of Findings for Key Question #1

A single good quality study provided evidence that use of the newer, continuous flow HeartMate 

II ventricular assist device for destination therapy provides better patient outcomes than the 

older, pulsatile flow HeartMate XVE device. A fair quality continued access protocol for use of 

the HeartMate II indicated that all of the reported patient outcomes continue to be as good as 

those seen in the randomized controlled trial or better including significantly fewer hemorrhagic 
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Use of Left Ventricular Assist Devices as Destination Therapy 

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strokes, major bleeding episodes and infections. Case series have also reported similar survival 

when the HeartMate II was used as destination therapy. 

Clinical trials of other continuous flow devices for destination therapy such as a HeartWare 

device with a different continuous flow design are ongoing,4,5,25 however results are not expected 

for several years. 

KEY QUESTION #2. What patient or site characteristics have been 

associated with patient benefits or harms when the FDA-approved, 

current generation LVAD is used as destination therapy?

Based on the approved FDA indication and clinical trials, CMS has determined that the evidence 

is adequate to conclude that implantation of a left ventricular assist device approved by the 

FDA for destination therapy is reasonable and necessary for Medicare beneficiaries who have 

chronic end-stage heart failure, are not candidates for heart transplantation, and meet all of the 

following conditions: 1) NYHA Class IV symptoms of heart failure that have not responded 

to optimal medical management including dietary salt restriction, diuretics, digitalis, betablockers and angiotensin converting enzyme inhibitors (if not tolerated, presumably angiotensin 

receptor blockers would be an acceptable alternative) for at least 45 of the last 60 days or 

have been balloon pump dependent for 7 days, or IV inotrope dependent for 14 days (cardiac 

resynchronization therapy and an implantable cardiac defibrillator are not listed although they 

have become standards of care when clinically indicated for patients with heart failure), 2) a left 

ventricular ejection fraction less than 25%, 3) demonstrated functional limitation with a peak 

oxygen consumption of 14 ml/kg/min or less unless the patients is balloon pump or inotrope 

dependent or physically unable to perform an exercise test and 4) appropriate body size for the 

device.12

In addition, CMS determined that destination therapy is reasonable and necessary only when 

the procedure is performed in a facility approved under the Disease-Specific Care Certification 

Program for Ventricular Assist Device developed by the Joint Commission on Accreditation 

of Healthcare Organizations.26 Facility staff must have implanted at least 10 ventricular assist 

devices or total artificial hearts as a bridge to transplant or as destination therapy during the 

past 36 months with at least one procedure within the past 18 months. The facility also must 

have in place staff and processes that assure that prospective recipients receive all information

necessary to assist them in giving informed consent for the procedure, and so that they and their 

families are fully aware of the aftercare requirements and potential limitations as well as benefits. 

We found only one study of patient preferences related to use of ventricular assist devices that 

explored a few hypothetical situations describing life expectancy and daily function without the 

device.27

The CMS criteria also state that the facility must be an active, continuous member of a national, 

audited registry that requires submission of data on all destination therapy patients from the date 

of implantation throughout the remainder of the recipient’s lives. The INTERMACS registry 

satisfies this CMS reporting requirement. 
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More detailed patient inclusion and exclusion criteria have been used in clinical trials 

of ventricular assist devices as destination therapy and are recommended by clinical 

experts.28,29,30,31,32

Since outcomes among patients meeting current selection criteria do vary, selection of patients 

could be refined using strong predictors of patient outcomes. Clearly, there is little or no 

benefit to patients that don’t recover from the operation to implant a ventricular assist device. 

A validated method to determine which eligible patients have unacceptably high (not defined) 

operative risk might improve patient selection and outcomes. A report of INTERMACS 

data summarized in Appendix D, Table 2 indicated that the presence of cardiogenic shock, 

concomitant surgery and poorer renal function as indicated by higher blood urea nitrogen were 

associated with higher mortality within 30 days of the operation.3

 This analysis focused on use 

of ventricular devices as destination therapy but included many cases that received the obsolete 

HeartMate XVE. Interactions between the type of device and operative risk factors were not 

reported to determine whether the prognostic information depended on the type of device. More 

importantly, the risk factors were not used to identify patients that have an unacceptably high 

operative risk, and the confidence one would have in selecting patients based on the predicted 

probabilities of operative mortality risk was not reported. 

Lietz et al. analyzed data in the manufacturer’s registry of HeartMate XVE use post-FDA 

approval to develop a risk model of 90-day in hospital mortality.11 The risk model incorporated 

several preoperative variables as summarized in Appendix D, Table 2. The risk score derived 

from this model discriminated the two outcome groups and could place patients into risk groups 

that had substantially different levels of risk. However, the difference in predicted and observed 

outcomes was substantial in some risk groups and the precision of the estimates was inadequate 

in the smaller risk groups. Furthermore, there was no consensus about which, if any, risk groups 

should be excluded from treatment due to high risk. We found no reports that tried to validate or 

update this risk model for current practices that use the HeartMate II device. 

Current criteria for use of a ventricular assist device as destination therapy include an estimated 

1-year survival without the device of less than 50%14 or an overall life expectancy of less 

than 2 years.10,12 A validated method for making these predictions has not been established. 

As summarized in Appendix D, Table 2, Levy et al. adapted and evaluated the Seattle Heart 

Failure Model to predict survival of the patients in the optimal medical therapy arm of the 

initial clinical trial of the HeartMate VE.33 There was good agreement between the observed 

and predicted 1-year survival (28% versus 30%), and 81% met the guideline criterion of less 

than 50% predicted probability of survival for one year without a ventricular assist device. No 

further studies were found that indicated use of this prediction model would improve selection of 

patients for destination therapy or patient outcomes.

A secondary analysis of clinical trial data collected at a single center suggested that 

carefully selected patients that were 70 years old or older (a commonly used cutoff for heart 

transplantation) had similar outcomes to those less than 70 years old.34 However as summarized 

in Appendix D, Table 2, there were only a small number of patients in this comparison and there 

were no adjustments for preoperative differences. 
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Use of Left Ventricular Assist Devices as Destination Therapy 

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Summary of Findings for Key Question #2

The scientific evidence concerning use of newer generation, continuous flow FDA-approved 

ventricular assist devices, i.e., the HeartMate II, is insufficient to refine patient selection criteria 

for destination therapy beyond the current criteria used to enroll patients in the pivotal clinical 

trials and determine eligibility for CMS coverage. 

A few studies have identified risk factors for mortality and developed or applied prediction 

models to this particular patient population. Further studies are needed to validate the use of 

different criteria to select patients and improve patient outcomes. An ongoing clinical trial is 

selecting less severely ill patients and may expand the criteria for use of a newer generation 

continuous flow devices as destination therapy.4,5 In the meantime, the approved FDA indication 

and CMS criteria for coverage are available. 

KEY QUESTION #3. What is the range of cost-effectiveness estimates 

of using the FDA-approved, current generation LVAD as destination 

therapy in end-stage heart failure and what explains variation in these 

estimates?

As reported in the results for Key Question #1, we identified one randomized trial comparing 

a current generation continuous flow ventricular assist device (HeartMate II) to the older 

generation (HeartMate XVE) ventricular assist device.1

 There was also one prior trial comparing 

an older generation HeartMate VE device to optimal medical management.2 There have been 

no studies that directly compared a current generation device to optimal medical management. 

We found only one analysis of cost-effectiveness that used data from these two prior trials to 

indirectly estimate the cost-effectiveness of using the HeartMate II ventricular assist device for 

destination therapy compared to optimal medical management.35

Rogers et al. estimated that the continuous-flow device would have an incremental cost 

effectiveness ratio (ICER) of $198,184 per quality-adjusted life year and $167,208 per overall 

life years not adjusted for in the patients’ quality of life.35 Estimates of confidence intervals 

around these cost-effectiveness ratios were not reported. The analysis was funded by the maker 

of the device and the costs were assessed from the perspective of a third-party payer, not 

necessarily the VA. Details of this analysis related to the key model components, source data, 

and the effect sensitivity analyses are summarized in Appendix D, Table 3. The ICER estimates 

used “base case” assumptions regarding: survival that included the 24-month estimates from the 

clinical trials with extrapolation of survival thereafter, costs related to the initial implantation of 

the ventricular assist device, costs of medical management, re-hospitalization rates and costs, 

device replacement costs, outpatient care costs, end-of-life costs and estimates of quality of 

life (utility) for each of the four NYHA classes of limitations due to symptoms of heart failure 

that patients may fall in after implantation of the device. The quality of life assessment did not 

incorporate other medical conditions including the impact of device complications. Limited 

sensitivity analyses that changed one model component at a time suggested that the variation in 

the cost-effectiveness estimates were most dependent on the extrapolated estimates of survival 

from 24 to 60 months and the costs of the initial implantation of the ventricular assist device and 

subsequent re-hospitalizations for complications. Plausible changes to any of these individual 
20

Use of Left Ventricular Assist Devices as Destination Therapy 

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assumptions resulted in estimates of cost-effectiveness ranging from $150,000 to $300,000 per 

quality-adjusted life year.

Prior analyses that compared use of the older generation ventricular assist device (HeartMate 

VE) to optimized medical management reported a cost-effectiveness ratio of $802,700 per 

quality-adjusted life year.36 Rogers’ adaptation of this model for the HeartMate II appeared to 

show a significant improvement in the cost-effectiveness. The main drivers of the improvement 

in cost-effectiveness were not well established, however, Rogers et al. state that the improvement 

was largely due to better survival, reductions in implant costs and better quality of life of 

surviving patients that received the device.35 Nevertheless, destination therapy remains among 

the least cost-effective interventions covered by Medicare.6

Summary of Findings for Key Question #3

The estimated cost-effectiveness of using the HeartMate II as destination therapy for patients 

with end-stage heart failure was approximately $200,000 per quality-adjusted life year. The 

cost-effectiveness estimates did not drop below $150,000 even with more favorable assumptions 

regarding the outcomes or costs of using the HeartMate II ventricular assist device as destination 

therapy. 
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Use of Left Ventricular Assist Devices as Destination Therapy 

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SUMMARY AND DISCUSSION

SUMMARY POINTS 

• Only one good quality randomized trial of a newer generation continuous flow ventricular 

assist device as destination therapy has been reported to date. This study found that patients 

who received the HeartMate II had better survival, fewer major complications, spent less time 

in the hospital, and that their heart failure had substantially less adverse impact on their quality 

of life than those who received the older generation pulsatile flow HeartMate XVE device. 

• Currently, selection of patients for destination therapy is based on the FDA approved 

indication and CMS criteria for coverage of Medicare beneficiaries that are based on 

enrollment criteria used by pivotal randomized controlled clinical trials. Studies have not 

validated use of other preoperative variables to further refine patient selection and thereby 

improve patient outcomes. 

• Only one industry-funded cost-effectiveness analysis has been reported to date. This 

analysis reported costs from a third payer perspective and found that the incremental cost 

effective ratio was approximately $200,000 per quality-adjusted life year compared to 

optimal medical management. 

LIMITATIONS

At this time there is limited, but encouraging, data to support use of the FDA approved continuous 

flow ventricular assist device as destination therapy. Only one randomized clinical trial has been 

completed. Patients enrolled in the clinical trial were carefully selected thereby limiting the ability 

to generalize the results. Outcomes continue to improve with experience in selecting patients, 

surgical procedures to implant ventricular assist devices and postoperative patient care.

The reviewed literature did not identify any VA medical center that has enrolled patients in a 

clinical trial or the national INTERMACS registry. The number of veterans who would meet 

the current selection criteria for using a left ventricular assist device as destination therapy is 

not known. Additional data and analyses are needed to estimate the costs the Veterans Health 

Administration would incur to provide this highly-specialized care.

RECOMMENDATIONS FOR FUTURE RESEARCH

Additional high-quality data are needed to inform clinical practices and policies regarding the use 

of ventricular assist devices to treat patients with end-stage heart failure who are not eligible for a 

heart transplant. Investigators suggest the following recommendations regarding future research:

• Create or participate in a registry of all Veterans that receive an LVAD 

as destination therapy, and support enrollment of Veterans in ongoing, 

randomized controlled clinical trials. 

Given the small number of patients who have received destination therapy and the rapidly 

evolving devices and practices, it is imperative to learn as much as possible from patients 
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Use of Left Ventricular Assist Devices as Destination Therapy 

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who undergo this procedure. All Veterans that receive destination therapy approved by the 

Veterans Health Administration should be entered into a national registry in a way that will 

allow separate analyses and comparisons of patient characteristics and outcomes. In addition, 

enrollment of patients into randomized controlled clinical trials should be encouraged. For 

example, a study comparing a third generation ventricular assist device to FDA-approved 

devices is currently trying to enroll up to 450 patients who, for the most part, meet current 

criteria for destination therapy.25 As ventricular assist devices become more durable with 

fewer complications they are also being tested in patients with less severe heart failure given 

concerns that the operative risk of many patients who meet the current criteria for destination 

therapy is too high, and patients with a less dire prognosis without a device may benefit 

from increasingly reliable devices.4,5 Permission to enroll patients in this study of a currently 

unapproved use of a newer device (HeartWare) should be considered to increase patient 

access to destination therapy.

• Validate and, if necessary, update prediction models especially for early postoperative mortality.

Patients who die in the hospital soon after implantation of a ventricular assist device do not 

benefit. A validated prediction model for early/postoperative mortality could be applied to 

avoid high risk and costly attempts to use ventricular assist devices as destination therapy. 

Ideally clinical trials would be done to show that use of an outcome prediction model improves patient outcomes. This review did not find any established or proposed threshold for 

predicted risk of post operative mortality that would preclude use of destination therapy or 

generally be acceptable to patients and health care providers.

• Develop decision aids to help providers share information about the benefits, 

risks and care needed when using an approved ventriclualr assist device as 

destination therapy and to help them make decisions that are consistent with 

the informed patient’s values and preferences. 

The difficult decision to employ a ventricular assist device as destination therapy typically 

is made when patients are in poor health and have a very limited life expectancy without 

the device. A number of benefits and risks need to be explained in ways patients can understand including the uncertainty inherent in the outcomes data. Patients need to understand 

the follow-up care that will be required. Future states of health when the patient might want 

the device to be turned off need to be anticipated and discussed. Decisions aids can enhance 

provider-patient communication and increase patients’ knowledge and participation and acceptance of the decision.37

• Update the cost-effectiveness model as more data become available and incorporate a probabilistic sensitivity analysis. 

There have been large improvements in the cost-effectiveness of destination therapy during 

the past decade.35,36 It will be important to keep updating the cost-effectiveness models as the 

devices and related procedures improve. This is particularly important for the model parameters that appear to be most influential i.e., long-term survival both on the device and with optimal medical management, cost of the device, cost of initial hospitalization, rehospitalization 
23

Use of Left Ventricular Assist Devices as Destination Therapy 

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rate and utility estimates based on measures of health-related quality of life. Additionally, 

adding probabilistic sensitivity modeling would help decision makers better understand the 

uncertainty of the estimates in the model by estimating confidence intervals around the incremental cost-effectiveness estimates. This can be done by using distributions of the model 

parameters with Monte Carlo simulation to assess the probability the incremental cost effectieness ratio will be less than or greater than various dollar amounts. Probabilistic sensitivity 

analyses that took the UK National Health Service payer perspective have been completed 

for the cost-effectiveness of continous flow LVAD as a bridge to transplant providing a good 

example of what could be done for destination therapy.38

• Conduct a budget impact analysis.

Cost-effectiveness analyses provide general estimates from a societal perspective or the 

perspective of a generic third party payer, however, additional budget impact analyses would 

be useful to help the Veterans Health Administration understand the potential impact of 

different strategies and policies for providing destination therapy. For example, it would be 

important to know how many veterans would be eligible and interested in the treatment and 

what the options would be in terms of how and where this therapy would be provided. 

CONCLUSIONS

Key Question #1 

Use of the FDA-approved HeartMate II rather than the HeartMate XVE left ventricular assist 

device results in superior patient outcomes (better survival and daily existence, fewer harmful 

complications). [moderate strength evidence]

Key Question #2 

Preoperative correlates of patient outcomes have not been established as patient selection criteria 

that can lead to better patient outcomes. [insufficient evidence]

Key Question #3 

The cost-effectiveness of HeartMate II ventricular assist device for destination therapy has been 

estimated to be approximately $200,000 per quality-adjusted life year when compared to optimal 

medical management. [low strength evidence]
24

Use of Left Ventricular Assist Devices as Destination Therapy 

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32. Wilson SR, Mudge GH, Stewart GC, Givertz MM. Evaluation for a ventricular assist 

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34. Adamson RM, Stahovich M, Chillcott S, et al. Clinical strategies and outcomes in 

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APPENDIX A. Technical Expert Panel Members

Inder Anand, MD, FRCP, DPhil

Director, Heart Failure Program

University of Minnesota Medical School

William Gunnar, MD, JD

National Director of Surgery

Department of Veterans Affairs

William Holman, MD

Chief, Surgical Services

Birmingham VA Medical Center

Gundars Katlaps, MD

Chief, Section of Cardiothoracic Surgery

Surgical Director, Programs of Heart Transplantation and Mechanical Assist Devices

Richmond McGuire VA Medical Center

Richard Schofield, MD, FACC

Chairman of Medicine

Malcolm Randal VA Medical Center

Chief, Medical Service

North Florida/South Georgia Veterans Health System

Josef Stehlik, MD

Director, VAMC Cardiac Transplant Program

VA Salt Lake City Health Care System