bluuebunny/crossref_metadata_2025 huggingface dataset:
Abstract 9: Alirocumab Prior Authorization Approval and Prescription Fill Rates Among Medicare Advantage Patients in a Large US Managed Care Plan
Authors: Dacus Kelley C , Horter Libby , Hayden Jennifer , Harvey Raymond A , Thompson Stephen , Gervasio Joseph
Published: July 2021

Introduction:
Alirocumab is a proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitor approved as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol. Barriers to possession, including therapy cost and cost-sharing implications, may contribute to low utilization of this therapy.

Objective:
To explore differences in demographic and clinical characteristics between patients with prior authorization (PA) approvals or denials for alirocumab as evidenced through filled alirocumab prescription claims.

Methods:
A retrospective claims-based database analysis of patients with a Medicare Advantage Prescription Drug (MAPD) plan was conducted to identify patients with evidence of a PA approval for alirocumab. Among the group of patients with a PA for alirocumab, the pharmacy claims database was searched for evidence of a corresponding prescription claim within 30 days following the first PA request (index date). The analysis was stratified by evidence of Federal low income subsidy (LIS) support, a program that provides extra assistance with prescription drug costs for eligible individuals whose income and resources are limited, and/ or dual eligibility (DE) status, eligible for Medicare and Medicaid, (LIS/DE) at index.

Results:
A total of 2,098 MAPD patients meeting study inclusion/exclusion criteria and with a PA for alirocumab were identified between March 1, 2016 and February 28, 2017. Non-LIS/DE patients comprised approximately 82% of the eligible population (n=1,730). There were several notable differences in baseline demographics between the non-LIS/DE vs. the LIS/DE cohorts with an approved PA claim, including Deyo-Charlson Comorbidity Index (2.2 vs. 3.0), prevalence of diabetes mellitus (39.2% vs. 54.7%), and prevalence of HeFH (11.8% vs. 15.6%). While the percentage of patients with an approved PA was similar between the LIS/DE and non-LIS/DE cohorts, 88.9% and 91.2%, respectively, substantially more patients in the LIS/DE cohort had evidence of alirocumab possession based on a paid claim (60.6%) vs. those in the non-LIS/DE cohort (17.3%).

Conclusion:
Although a high percentage of MAPD patients had evidence of an approved PA, there were notable differences in clinical and demographic characteristics between those with and without LIS/ DE status. Further, the proportion of patients with an approved PA and a paid prescription claim differed markedly amongst MAPD patients with and without LIS/DE status, suggesting further research is needed to understand potential barriers to obtaining PCSK9i therapy.
Abstract 1: Impact of Predicted Bleeding Risk on the Cost-Effectiveness of Direct Thrombin Inhibition vs. Heparin Monotherapy for Patients Undergoing PCI
Authors: Amin Amit P , Marso Steven P , Rao Sunil V , Messenger John , House John , Kennedy Kevin , Robertus Katherine , Cohen David J , Mahoney Elizabeth
Published: July 2021

Introduction
Direct thrombin inhibitors (DTI) reduce bleeding and are cost-saving in patients (pts) undergoing PCI when compared to unfractionated heparin (UFH) plus routine glycoprotein IIb/IIIa inhibition (GPI). Little is known about the cost-effectiveness of DTI alone vs. UFH alone, however.

Methods
We combined data on patient-level bleeding risk with several external data sources to estimate the economic impact of substituting DTI for UFH among unselected PCI patients. We used a validated model to predict the risk of major bleeding for 81,628 NCDR® CathPCI Registry® patients who received UFH only in 2004-06. DTI costs were estimated based on current FDA dosing guidelines and acquisition costs. The cost of major bleeding ($8722) was estimated based on data from the Mid America Heart Institute. The benefit of DTI vs. UFH alone was based on bleeding risk reduction from ISAR-REACT 3. A Markov model based on published data was used to estimate the loss in life expectancy associated with major bleeding.

Results
The overall rate of major bleeding in the reference population was 2.2%, the estimated cost of a major bleed was $8722, projected DTI costs were $641/pt and heparin costs were negligible ($4). Assuming that DTI use reduces the risk of bleeding by 33%, use of DTI for all patients was estimated to increase costs by $573/patient and was cost saving only for patients with a predicted risk of major bleeding >20% (0.16% of the overall population). When life years lost due to bleeding were included, at willingness-to-pay thresholds of $50K and $100K per life year gained, DTI was cost effective for patients with a bleeding risk ≥8% (2.5% patients) and ≥5% (7.9% of patients), respectively.

Conclusions
For patients undergoing PCI, substitution of DTI for UFH monotherapy is projected to increase costs for virtually all patients, but may be reasonably cost-effective for patients with a high predicted risk (≥5%) of bleeding.
Abstract 5: Do Stroke Centers Reduce Mortality for Patients with Acute Ischemic Stroke? An Instrumental Variable Analysis
Authors: Xian Ying , Holloway Robert G , Noyes Katia , Shah Manish N , Friedman Bruce
Published: July 2021

Background:
Although the establishment of stroke centers based on the Brain Attack Coalition recommendations has great potential to improve quality of stroke care, little is known about whether stroke centers improve health outcomes such as mortality.

Methods:
Using 2005-2006 New York State Statewide Planning and Research Cooperative System data, we identified 32,783 hospitalized patients age 18+ with a principal diagnosis of acute ischemic stroke (ICD-9 433.x1, 434.x1 and 436). We compared in-hospital mortality and up to one year all-cause mortality between New York State Designated Stroke Centers and non-stroke center hospitals. Because patients were not randomly assigned to hospitals, stroke centers might treat different types of patients than other hospitals (a selection effect). We used a “natural randomization” approach, instrumental variable analysis (differential distance was the instrument), to control for this selection effect. To determine whether the mortality difference was specific to stroke care, we repeated the analysis using a different group of patients with gastrointestinal (GI) hemorrhage (N=53,077).

Results:
Of the 32,783 stroke patients, nearly 50% (16,258) were admitted to stroke centers. Stroke centers had lower unadjusted in-hospital mortality and 30-, 90-, 180-, and 365-day all-cause mortality than non-stroke centers (7.0% vs. 7.8%, 10.0% vs. 12.6%, 14.6% vs. 17.5%, 18.0% vs. 21.0%, 22.4% vs. 26.2%, respectively). After adjusting for patient and hospital characteristics, comorbidities, and the patient selection effect, stroke centers were associated with significantly lower all-cause mortality. The adjusted differences were -2.6%, -2.7%, -1.8%, and -2.3% for 30-, 90-, 180- and 365-day mortality (all p<0.05). The adjusted difference in in-hospital mortality was -0.8% but was not statistically significant. In a specificity analysis of patients with GI hemorrhage, stroke centers had slightly higher mortality.

Conclusions:
Hospitals that are Designated Stroke Centers had lower mortality for acute ischemic stroke than non-stroke center hospitals. The mortality benefit was specific to stroke and was not observed for GI hemorrhage. Providing stroke centers nationwide has the potential to reduce mortality.
Abstract P109: Patterns of Statin Prescription Among Privately Insured Commercial and Medicare Patients
Authors: Bae Jay P , Peng Xiaomei , Zhao Zhenxiang , Zagar Anthony , LeNarz LeRoy
Published: July 2021

Background:
Statins are considered to play an important role in reducing coronary heart disease (CHD) risk. There are currently 6 statins available in the U.S. market and more than 193 million statin prescriptions were written in 2008. We sought to examine the prescription patterns of statins among privately insured commercial and Medicare patients in the U.S.

Methods:
A retrospective analysis was performed using MarketScan Commercial and Medicare data from Jan. 2008 to Dec. 2008. Two cohorts were created: 1) the commercial cohort (CC) and 2) the Medicare cohort (MC). Statin scripts of minimum 30 day supply were extracted from the pharmacy claims data and individual demographic and clinical information were linked from their medical and administrative records. Prescription patterns of 6 statins were examined and additional analyses by age and gender were performed.

Results:
There were 18 million and 9.8 million statin prescriptions filled by the CC and MC, respectively. In both cohorts, simvastatin accounted for the largest share of statin prescriptions (MC: 44%; CC: 44%), followed by atorvastatin (MC: 32%; CCl: 31%), rosuvastatin (MC: 7.8%; CC: 11.2%), pravastatin (MC: 8.1%; CC: 6.5%), lovastatin (MC: 7.4%; CC: 6.6%) and fluvastatin (MC: 0.9%; CC: 0.6%). The majority of statin prescriptions were for generics (MC: 60%; CC: 57%). For patients with at least one fill, the average number of statin prescription per year was 9.3 for the MC and 7.6 for the CC. In the CC, 58% of prescriptions were filled by male, while 50% of prescriptions were filled by male in the MC. Commercial patients aged 55-65 filled 56% of statin prescriptions, followed by 33% filled by patients aged 45-54, and 11% filled by patients aged < 45. In the MC, patients aged 65-75 filled 54% of statin prescriptions and the rest 46% of the prescriptions were filled by patients aged>75. Diabetic patients accounted for 35.2% of prescriptions in the MC, and 26.8% in the CC.

Conclusions:
This claims data analysis suggests different statin use patterns by age, gender, and insurance. Further research is warranted to understand appropriateness of statin use in the population.
Abstract P120: Application of Variable Life Adjusted Displays (VLAD) on Isolated Coronary Artery Bypass From Australian Society of Cardiac and Thoracic Surgeons (ASCTS) Database
Authors: Andrianopoulos Nick , Dinh Diem , Shardey Gil , Smith Julian , Cameron Peter , Reid Chris
Published: July 2021

Objective:
To investigate the implementation and appropriateness of VLAD as a quality control procedure to monitor “in-control” versus “out-of-control” states in hospitals and surgeons performing isolated coronary bypass surgery.

Methods:
We obtained isolated coronary artery bypass procedural data from the ASCTS database for 2005-8. The VLAD is a plot of a cumulative sum of the difference in expected outcome (range 0-1) and observed outcome (0 or 1) for sequential procedures. This is a simple but clinically appealing measure of quality. The outcome of interest was 30-day mortality following surgery. The previously validated AusScore was used to determine a realistic measure of expected mortality. VLAD were plotted for the years 2005-8, by the 10 hospitals and 53 surgeons (all de-identified) associated with the procedures. Signalling limits for 30%, 50% and 75%, risk decrease and risk increase were determined and plotted for each VLAD utilizing risk-adjusted CumulativeSUM (CUSUM) techniques. This is a likelihood-ratio test statistic for signalling. If the VLAD signalled by intersecting with a limit, the limit was reset.

Results:
There were n=6880 consecutive procedures recorded in the database. Median(IQR) expected mortality was 1.29%(0.78% to 2.49%). Overall observed mortality was 1.66% (114 of 6880). The number of procedures per hospital ranged from 362 to 1155 with a mean(SD) of 688(222). Observed mortality ranged from 0.61% (7 of 1155) to 2.89% (21 of 726). The number of procedures per surgeon ranged from 1 to 459 with a mean(SD) of 130(106). Sixteen had no observed mortality, with the number of procedures ranging from 1 to 158. Of those with more than one case of mortality, the highest observed rate was 4.88% (8 of 164). No VLAD signalled for risk decrease or increase.

Conclusions:
VLAD intersecting with limits to signal potential “out-of-control” states, may be an appropriate technique to help hospitals assess quality control. Relevant signals could be used to investigate why a system is potentially performing better than or worse than expected. For 30-day mortality following isolated coronary artery bypass surgery the system appears to be “in-control”.
Abstract P126: Can a Structured Quality Improvement Initiative Reduce Elective Cardioversion Patient Waiting Times?
Authors: Cowie Kathleen P , Cecchin Serina , Soon Kean
Published: July 2021

Background:
Current guidelines recommend anticoagulation with a documented international normalised ratio of 2-3 for 3 weeks prior to an elective cardioversion (ECV). At Western Health multiple stakeholders were involved in the pre-procedural care of the ECV patient (cardiologists, general physicians, outpatient clinics and pathology service providers) with varying adherence to the anticoagulation guidelines. Inadequate patient anticoagulation identified at the time of procedure or inadequate hospital resources (CCU bed or anaesthetic personnel) led to cancellations and re-booking of the procedure. ECV cancellations led to prolonged waiting times to the procedure and consequently patients remaining in atrial fibrillation longer.

Objective:
Decrease waiting times from referral to the ECV procedure by improving guideline compliance.

Method:
The ECV procedure was re-designed by incorporating the ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation into the written clinical procedure and clinical pathway. Coordination of the ECV was assigned to the cardiology preadmission clinic (PAC) and all patients attend a PAC appointment prior to ECV being scheduled. The role of PAC was to manage clinical risk factors and patient preparation. Resource alignment and bed modelling resulted in structured twice-weekly ECV sessions. A combined transoesophageal echocardiogram /ECV procedure was introduced as per guideline recommendations to specifically manage the ‘difficult to anticoagulate’ patient subgroup. Effectiveness of the process improvement was performed by comparing mean waiting time from referral to ECV before the change (2008) and after (2009).

Results:
Following process improvement, mean waiting times to ECV procedure decreased from 12 weeks to 5 weeks (p < 0.001). The patient subgroup ‘difficult to anticoagulate’ achieved the greatest reduction in mean waiting time, from 22 weeks to 8 weeks (p < 0.001).

Conclusion:
Introducing a guideline driven policy and procedure for ECV has led to a significant reduction in waiting times from referral to ECV. Goals of anticoagulation therapy are clearly articulated and the preadmission clinic provides a coordinating role amongst the multiple stakeholders involved.
Abstract P164: Health Status Outcomes in Patients With Non-Obstructive Coronary Artery Disease
Authors: Tavella Rosanna , Cutri Natalie , Beltrame John F
Published: July 2021

BACKGROUND.
Approximately 20-30% of coronary angiograms undertaken for the investigation of chest pain show non-obstructive coronary artery disease (NoCAD). These patients receive little attention compared to their counterparts with obstructive coronary artery disease (CAD). The current study assessed the health outcomes of patients with NoCAD as compared with CAD over 12 months.

METHOD.
Consecutive patients undergoing angiography for the investigation of chest pain were recruited prior to the procedure. The following health outcomes were evaluated at baseline, 1, 6 and 12 months: (a) chest pain, (b) Seattle Angina Questionnaire (SAQ), and (c) Short-Form 36 (SF-36).

RESULTS.
Of the 1148 patients with chest pain recruited, 320 (28%) had NoCAD. Compared with CAD, these patients were younger (62 11 vs 57 12 years, respectively, p <0.001) and following age-adjusted analysis, were more likely to be female (29 vs 58%, respectively, p < 0.001). Baseline SF-36 and SAQ scores were similar for the two groups. Over 12 months, both patient groups showed an improvement in SF36 and SAQ scores. However, the change in SF-36 Physical Summary Score at 12 months compared to baseline was significantly lower in NoCAD patients (see plot). No longitudinal differences were seen in SAQ domain scores. Self reported chest pain was lower in the CAD patients compared with NoCAD at 1 (64% vs 68%, p>0.05), 6 (46% vs 61%, p <0 .001) and 12 months (40% vs 48%, p>0.05).

CONCLUSION.
Patients with NoCAD are younger and more likely to be female. After adjusting for age, they are more likely to have ongoing chest pain and impaired quality of life as assessed by the SF-36.
Abstract P171: Etiologies of Syncope in 325 Consecutive Patients Hospitalized for Syncope
Authors: sule sachin S , Palaniswamy Chandrasekar , Aronow Wilbert S , Peterson Stephen J , Ahn Chul , Adapa Sreedhar , Mudambi Lakshmi
Published: July 2021

Purpose:
To investigate the etiologies of syncope in patients hospitalized for syncope.

Methods:
We investigated the etiologies of syncope in 325 consecutive patients, mean age 66 ± 17 years, hospitalized for syncope. All patients had Doppler echocardiograms and electrocardiographic monitoring by telemetry for arrhythmias during hospitalization.

Results:
Of the 325 patients, the causes of syncope were vasovagal syncope in 58 patients (18%), volume depletion including acute blood loss and dehydration in 39 patients (12%), orthostatic hypotension in 8 patients (3%), bradyarrhythmias in 28 patients (18 with sick sinus syndrome and 10 with advanced second-degree or third-degree atrioventricular block) (9%), 36 with tachyarrhythmias (20 with ventricular tachycardia or ventricular fibrillation, 15 with supraventricular tachyarrhythmias, and 1 with pacemaker-mediated tachycardia) (11%), cardiomyopathy requiring insertion of an implantable cardioverter-defibrillator in 7 patients (2%), acute coronary syndromes in 23 patients (7%), aortic stenosis in 8 patients (3%), hypertrophic obstructive cardiomyopathy in 4 patients (1%), hypersensitive carotid sinus in 7 patients (2%), cerebral hemorrhage, ischemic stroke, or brain tumor documented by computed tomographic brain scans in 5 patients (2%), anaphylaxis in 2 patients (1%), sedative overdose in 5 patients (2%), hypoglycemia in 3 patients (1%), pulmonary embolism documented by contrast-enhanced spiral computed tomographic scans in 2 patients (1%), primary pulmonary hypertension in 2 patients (1%), micturition syncope in 2 patients (1%), heat stroke in 1 patient (<1%), cardiac tamponade in 1 patient (<1%), and undetermined etiology in 84 patients (26%).

Conclusions:
Of 325 consecutive patients hospitalized for syncope, the cause of syncope was diagnosed in 241 patients (74%).
Abstract P180: Comparison of the Framingham Risk Score With Coronary Artery Disease Burden in Hispanics
Authors: Marzouka George R , Tamariz Leonardo , Palacio Ana , Florez Hermes , Seo David , Dresen William , Schmidt Kevin
Published: July 2021

Background:
The Framingham risk score (FRS) predicts the 10-year risk of having a myocardial infarction (MI). However, the accuracy of the FRS in hispanics has not been throughly evaluated. We compared coronary artery disease (CAD) severity with FRS by ethnic groups in patients undergoing cardiac catheterization.

Methods:
We performed a cross-sectional analysis of 178 consecutive patients who were referred for elective coronary angiography at Jackson Memorial Hospital in Miami. We measured the components of the FRS and evaluated ethnicity by self-report. We evaluated CAD severity based on the coronary angiography results. We defined severe CAD if the patients had >= 70% luminal obstruction in a vessel or >=50% in the left main coronary artery. We also evalauted severity as a continuos score of the number of vessels with narrowings>=50%. We calculated the median and interquartile range (IQR) of FRS and correlated with the CAD severity and the p-value for trend as well as analysis of variance to determine if FRS differed by ethnicity adjusted for confounders.

Results:
We identified 110 patients who identified as Hispanic and 68 patients identified as non-hispanics. At baseline, Hispanics had a mean FRS of 10.0±3.8 and non-Hispanics had a mean FRS of 10.3±5.9 (p=0.70). In Hispanics the median FRS for patients with >= 70% stenosis was 10% (IQR 8.5-13) compared to <70% stenosis 9 % (IQR 5-13). In non-Hispanics with >= 70% stenosis the median FRS was 12.5% (IQR 10-16) compared to those with <70% stenosis 8 % (IQR 4-11). The same differences were seen when using >=50% stenosis (table).

Conclusions:
The FRS does not correlate with coronary artery disease severity in Hispanics but does correlate with CAD severity in non-Hispanics.

Median and IQR of FRS by degree of stenosis and ethnicity

Severity of stenosis
*

Hispanics
Non-Hispanics

>=70%
10 (8.5-13)
12.5 (10-16)

>=60%
9 (5-13)
8 (4-11)

>=50%
10 (9-13)
12 (9-15)

<50%
9 (6-13)
8 (5-14)

*

p<0.01 for comparisons between severe CAD and non-severe CAD by ethnicity
Abstract P186: Extent of Myocardium at Risk in Women, but Not in Men, is Associated With Major Adverse Cardiac Events Following Coronary Artery Bypass Grafting
Authors: Buth Karen J , Currie Maria E , Yip Alexandra M , Hirsch Gregory M
Published: July 2021

Objective:
Many studies have reported higher rates of adverse outcomes in women than men following CABG surgery. To date, the mechanism has not been elucidated. We studied a large group of CABG patients for whom detailed angiographic data were available and investigated the impact of myocardium at risk (MAR) on major adverse cardiac events (MACE) in men and women post-CABG.

Methods:
For patients undergoing isolated primary CABG, a Duke Index score was calculated from angiographic data. Duke Index is a validated score that quantifies MAR using distribution and severity of coronary artery disease. Categories of MAR were defined as Low, Moderate and High based on number of diseased vessels as well as location of disease, with proximal lesions conferring a higher weight than distal stenoses. The post-CABG outcome was in-hospital MACE (1 or more of mortality, low cardiac output, stroke, MI, sepsis, deep sternal wound infection, ventilation >48 hrs or return to ICU). Logistic regression was used to examine the impact of MAR as a predictor of MACE in women and in men, after adjusting for clinical comorbidities.

Results:
Of 3744 CABG patients, 70% (2614) had complete angiographic data and were included in the analysis; 23% (607 of 2614) were women. Compared with men, women undergoing CABG had similar Duke Index scores but were older and more likely to have diabetes, hypertension, vascular disease, disabling angina, and require urgent surgery. Completeness of revascularization did not differ between men and women. Prevalence of MACE was higher in women than in men: 19.9% (121 of 607) versus 13.0% (262 of 2007), p=0.0001. In a logistic regression model fully adjusted for comorbidities, there was a significant interaction between female sex and increased MAR as predictors of MACE. In separate logistic regression models for each sex, increasing MAR was an independent predictor of MACE for women (High MAR: OR 3.2, 95% CI 1.4-7.6, Moderate MAR: OR 2.5, 95% CI 1.0-6.2), but not for men (High MAR: OR 1.0, 95% CI 0.6-1.7, Moderate MAR: OR 1.1, 95% CI 0.6-1.8).

Conclusions:
Myocardium at risk impacts post-CABG outcome differently for women than for men. This novel finding suggests that CABG surgery may not provide the same potential for recovery of ischemic myocardium for women compared with men.
Abstract P194: A Prospective Study of the Association of Flushing Bother, Impact, Treatment Satisfaction and Discontinuation of Niacin Therapy
Authors: Norquist Josephine M , Liao Jane , Miller Tiffany B , Bash Lori D , Watson Douglas J , Rhodes Thomas
Published: July 2021

Background:
Niacin has proven lipid-modifying efficacy and cardiovascular benefit. Previous cross-sectional and retrospective studies have suggested that niacin-induced flushing (NIF) significantly limits patient adherence to therapy. We conducted a one-year ‘real-world’ prospective observational study to characterize the impact and severity of NIF symptoms in subjects newly prescribed extended-release (ER) niacin.

Methods:
Subjects were surveyed daily during week 1 of therapy and thereafter via telephone at weeks 5, 9, 13 and months 6, 9 and 13. Surveys included the Global Flushing Symptom Score (GFSS), Flushing Impact Questionnaire (FIQ), and Treatment Satisfaction Questionnaire for Medication (TSQM).

Results:
A total of 306 subjects were recruited of which 43.5% (n=133) discontinued ER niacin by the end the study. Among those who discontinued, the median duration of ER niacin use was 95 days (range 2-402 days). At discontinuation, 3 (2.3%) subjects were on 250mg, 71 (54%) on 500mg, 1 (0.8%) on 750mg, 27 (20.3%) on 1000mg, 6 (4.5%) on 1500mg, and 4 (3.1%) on 2000mg. Dose was not available for 21 subjects. Over half of the discontinuers experienced flushing symptoms; 82% reported moderate to extreme flushing (GFSS≥4) and 68% reported severe to extreme (GFSS≥7) prior to discontinuation. About 74% of the discontinuers reported that moderate was the greatest degree of flushing they could tolerate before discontinuation. Those who discontinued and reported experiencing flushing side effects reported high degrees of impact in the FIQ Irritation/Frustration domain: mean (SD) 3.0 (1.3) (0=not at all, 4=extremely) and high dissatisfaction due to side effects as measured by the TSQM Side Effect domain: mean (SD) 63.3 (33.8) (0=extremely dissatisfied, 100=extremely satisfied). In addition, subjects who reported moderate or greater flushing bother during week 1 were 3.3 times more likely to discontinue due to flushing than those who reported less bother (95% CI: 1.01-10, p<0.05).

Conclusion:
Results from this study suggest that in a “real-world” setting, flushing side effects are bothersome and have an impact on continuation of ER niacin therapy. Further research is needed into alternative methods for increasing ER niacin acceptability.
Abstract P203: The Effect of Combination Evidence-Based Medical Therapy on Six-Month Mortality in Elderly Patients with ACS
Authors: Zacharias Sibin , Howe Michael , Montgomery Dan , Jackson Elizabeth A
Published: July 2021

Background
Beta-blockers, anti-platelet agents, ACE-inhibitors, and lipid-lowering agents have been shown to reduce mortality in patients with acute coronary syndromes (ACS). Elderly patients often do not receive these medications due to provider concerns regarding potential for adverse events. We compared three age groups for receipt of cardiac medications after ACS and associated outcomes at six months.

Methods
Data on demographics, comorbidities, and management was collected on ACS patients discharged between January 1999 and December 2006. A composite appropriateness score, defined as the number of evidence-based medications received divided by the number indicated, was calculated for each patient. Patients were grouped by age. The primary outcome was six-month mortality across appropriateness level, after adjustment for the GRACE risk score.

Results
Of 3,058 patients followed, 175 died at six-months. Older age was associated with lower receipt of indicated medications upon discharge as compared to younger patients, identified by an appropriateness score of 0, 1, or 2 (p<0.0001). After adjustment for the GRACE risk score, ACS patients 65 years or greater who received appropriate cardiac medications had similar risk reductions to those less than 65. (Figure)

Conclusions
Older patients without contraindications to cardiac medications have similar survival benefits to younger patients. Efforts to improve compliance with current ACS guidelines for all patients including the elderly are warranted.
Abstract P205: Anticoagulation Volume Does Not Predict Facility Performance of Time in Therapeutic INR Range of Patients With Atrial Fibrillation: A National VA Study
Authors: Turakhia Mintu P , Phibbs Ciaran , Schmitt Susan , Heidenreich Paul , Frayne Susan
Published: July 2021

Introduction:
Effectiveness of warfarin for stroke prevention in atrial fibrillation (AF) is proportional to the time in INR therapeutic range of 2.0-3.0. Time in therapeutic range (TTR) ≥ 58% is a validated threshold at which warfarin has benefit over aspirin, while TTR < 40% may cause net harm due to hemorrhage. Variation of TTR across facilities may be due to systematic or facility-based factors, including patient volume. We evaluated the relationship of anticoagulation facility patient volume and TTR.

Methods:
We performed a national cohort study of Veterans Health Administration data using centralized medical and administrative records. We identified 48,192 patients with at least two outpatient ICD-9 diagnoses of AF who were prescribed warfarin from 94 VA anticoagulation facilities in FY 2003-04. The primary outcome was facility TTR, which was mean TTR calculated for FY04 from all patient-level TTRs of that facility. Patient-level TTR was calculated using the modified Rosendaal method, using linear imputation of INR values up to a maximum of 56 days.

Results:
Excluding two outliers with TTR < 1%, the mean TTR across 92 facilities was 54.6% ± 6.1% (95% CI 43.7%-63.0%). Only 30 of 92 facilities (33%) had a mean TTR ≥ 58%, and 2 (2.2%) had a mean TTR < 40%. Facility volume, as measured by the number of identified patients per facility, was not related to TTR (R-squared 2.6%) although facility INR test frequency was related to TTR (R-squared 29%). After multivariate adjustment for facility volume and facility prevalence of diabetes, heart failure, hypertension, coronary disease, stroke/TIA, and mean patient age, INR test frequency was significantly associated with TTR ≥ 58% (p < 0.001), while facility volume remained insignificant (p=0.55). For every three additional INR tests per month, the adjusted odds of achieving TTR ≥ 58% increased 5.33 (p < 0.001).

Conclusions:
We found systematic variation of facility TTR in a national health care system. Facility volume did not predict quality of anticoagulation. However, the facility's mean INR frequency is strongly associated with its overall quality of anticoagulation of patients with AF. Standardization and improvement of warfarin management across facilities may improve quality and prevent adverse outcomes.
Abstract P207: What is More Important in Cardiologists' Decision Making Around Implantable-Cardioverter Defibrillators (ICD), Mortality Data or Patient Preferences?
Authors: Matlock Dan D , Masoudi Frederick A , Emsermann Caroline , Al-Khatib Sana , Sanders Gillian D , Rumsfeld John S , Dickinson L M , Kutner Jean S
Published: July 2021

Introduction:
The Institute of Medicine has identified ‘patient-centeredness’ as one of the six pillars of quality health care. Because ICD therapy is associated with important complications after implantation and because ICD shocks may influence quality of life, patient-preferences for this therapy are of paramount importance. The objective of this study was to determine cardiologists' thoughts on the relative importance of patient preferences for ICD therapy.

Methods:
A total of 1210 members of the American College of Cardiology (ACC) from a national sample of 10,080 responded to a survey regarding physician attitudes and recommendations towards ICDs. There were no differences between responders and non-responders with respect to physician demographics. The survey contained a list of factors including patient's preference and mortality data and asked: “To what extent does each of the following factors affect your recommendations regarding ICDs for primary prevention of sudden cardiac death?” with responses on a 5 point Likert scale ranging from “not at all” to “a great deal.” A total of 1124 respondents were used in the analysis after excluding pediatric cardiologists and cardiologists not implanting/referring ICDs in the past 12 months. Respondents were divided into two groups, one rating mortality data higher than patient preferences and another rating patient preferences equal to or greater than mortality data. Pearson's Chi-squared test of association was used to determine general associations.

Results:
Mortality data were considered more important than patient preferences by 628 (56%) ACC members. Physicians rating mortality data as more important than patient preferences were more likely to assert that ICDs make patients live longer (96.3% vs 93.7%, P=0.0440) but also more likely to disagree that ICDs decrease a patient's quality of life (51.6% vs. 40.2%, P=0,0001) or that the financial costs of ICDs are not worth the benefit (75.6% vs 63.6 %, P<0.0001).

Conclusions:
Approximately half of the respondents in this survey rated patient preferences lower than mortality data. These respondents tended to have more positive attitudes towards ICDs. The effect of these attitudes on the overall ‘patient-centeredness’ of care calls for further study.
Abstract P224: Completeness of Revascularization Predicts Long-Term Survival Benefit in CABG Surgery
Authors: Kelly Ryan P , Buth Karen J , Legare Jean-Francois
Published: July 2021

Objectives:
The primary objective of this study was to examine the effect of complete vs. incomplete revascularization in CABG surgery on long-term mortality. The secondary objective of this study was to examine the effect of variable grafting strategies on long-term mortality.

Methods:
All consecutive CABG surgeries performed at a single tertiary care center between 1995-2007 were reviewed. Long-term survival rates were compared among patients based on completeness of revascularization, the use of no arterial graft (all saphenous vein), single arterial graft, and multiple arterial grafts. Groups were also stratified based on the type of arterial grafts used (bilateral internal mammary arteries (BIMA) vs. multiple arterial grafts with only one IMA). Cox proportional Hazards ratio models were generated to adjust for differences in clinical presentation between the CABG groups.

Results:
A total of 8977 isolated CABG operations were preformed at our institution during that period. These patients were followed for a median time of 3.5 years (IQR=1.1-6.4). In this patient population, incomplete revascularization predicted an increased risk of mortality (HR=1.25; CI=1.12-1.39). A single arterial graft was performed in the majority of patients (63%; n=5637) with 28% of patients (n=2532) receiving multiple arterial grafts. Patients who received multiple arterial grafts were more likely to be younger, male, and undergo non-urgent surgery. After adjusting for these differences, patients who received an arterial graft (LIMA, RIMA, or radial) were shown to have improved survival when compared to patients who did not (HR=0.74; CI=0.65-0.83). Among patients who received multiple arterial grafts, percent survival for patients with BIMA grafts at 10 years was 70.4% compared to 66.1% for patients with single arterial grafts. Furthermore, patients who received BIMA grafts had the lowest predicted mortality among arterial graft patients when compared to patients who did not receive an arterial graft (HR=0.63; CI=0.51-0.77).

Conclusions:
We were able to show that after adjusting for differences in clinical presentation, both completeness of revascularization and BIMA grafting are strong independent predictors of long-term survival among CABG patients.
Abstract P270: Automating Processes to Expedite Medical Record Review in Research
Authors: Reeder K M , Ellerbeck Edward , Werkowitch Marilyn , Nazir N. , Waltrip B. , Smith C. E
Published: July 2021

Problem.
Heart failure (HF) clinical trials often use medical record review data to determine HF related hospital events, such as emergency room visits and readmissions. However, reviewing medical records for each hospital event can be daunting. The
purpose
of this project was to expedite medical record review processes using an automated method for identifying potential HF related hospital events.

Methods.
A stepwise procedure was developed for obtaining electronic information of all consented HF clinical trial participants' hospital events. First, an electronic list of all study participants was generated from a study data base and electronically sent to the Medical Records department each month. Next, a list of all emergency room visits and hospitalizations, including admission and discharge dates, discharge disposition, and diagnosis and procedure codes was electronically generated by the Medical Records department. A trained cardiovascular research nurse reviewed the abstracted coding and billing data for each hospital event and identified specific codes potentially related to HF. Last, hospital events identified as meeting specific criteria were included in the medical record review.

Results.
Using the automated system, a total of 294 hospital events for 125 subjects were obtained from the Medical Records department during the initial 2 years of the clinical trial. Of these, 85 (29%) hospital events were identified as needing to undergo chart review. Thirty-three (39%) of the 85 charts that underwent blinded review were identified as being HF related hospital events.

Conclusions.
Automating procedures for obtaining hospital event information expedited both the systematic data review and chart review processes. In this study, combined use of automated processes for obtaining hospital event data and nurse review reduced the number of charts requiring blinded review by nearly 60%.
Abstract P305: Assessing the Feasibility of Implementing a Clinical Decision Support Tool in the Office-Based Setting: Experiences From the American College of Cardiology's Improving Continuous Cardiac Care (IC3) Pilot Program
Authors: Kehoe Katie , Mitchell Kristi , Fiocchi Fran , Elma Mary Anne , Breeding Tracie , Thrutchley Duane , Spertus John A
Published: July 2021

BACKGROUND:
Clinical decision support tools have been used to improve guideline adherence amidst challenges during implementation in the office-based setting. As such, these tools require pilot testing to assess feasibility and ease of use.

METHODS:
The IC
3
Program, now known as the PINNACLE Registry, is a prospective, practice-based QI program designed to capture and report outpatient performance measures (PM) and provide decision support tools to optimize the quality of care delivered to outpatient cardiac patients. ACC/AHA guidelines and PMs for CAD, atrial fibrillation, heart failure and hypertension were translated into key data elements collected systematically via a paper-based data collection form (DCF). In September 2008, four offices participated in a 2-week pilot to assess the feasibility of implementing the DCF. A self-reported survey was administered, followed by a phone interview with participants.

RESULTS:
Results of the implementation pilot found that all respondents agreed with the overall layout of the DCF and that the data collected were typical of that routinely collected during a patient encounter. Physicians completed the DCFs more often( 57.1%) than other staff in the office. However, nurses or other staff(80%) were more likely to fax the data into the ACC. DCFs were faxed generally at the end of the week (66.7%). Most practices entered data both during and after the patient encounter (60%). Time for data entry ranged from 10-20 minutes. Roughly, half of the participants found data collection easy and others found it time consuming. One physician suggested making changes in the office work flow for future data collection.

CONCLUSION:
The pilot of the DCF provided valuable insight regarding the feasibility of collecting and reporting data, as well as the usability of a paper-based DCF in the outpatient setting. Although challenging, implementation of a paper-based decision support tool in practices can be successful. These findings demonstrate that it takes a team effort with clear delineation of roles and responsibilities to insure practice-wide adoption of a systematic QI process for accurately collecting and reporting clinical data.
Abstract P322: Health Status of Stable Patients With Obstructive or Non-Obstructive Coronary Artery Disease Compared With Healthy Controls
Authors: Tavella Rosanna , Cutri Natalie , Beltrame John F
Published: July 2021

BACKGROUND.
Patients with chest pain and no evidence of obstructive coronary artery disease on angiography (NoCAD) are frequently considered not to have significant pathology and their symptoms trivialized. This study compared the health status of patients with NoCAD, obstructive coronary artery disease (CAD) and healthy subjects.

METHOD.
Patients undergoing angiography within the preceding 12 months for the investigation of chest pain were categorized as NoCAD or CAD on the basis of the angiographic findings and completed a health-related quality of life instrument, the Short Form-36 (SF-36). These were compared with a ‘healthy control’ group that were randomly selected from the electronic white pages and recruited if they had no self-reported history of cardiovascular disease. Cross sectional comparisons between the three groups were age adjusted and performed using liner regression.

RESULTS.
As shown in the
table
below, the healthy controls were significantly younger and therefore comparison of SF36 scores were age adjusted. All SF-36 sub-scales (except for bodily pain) and summary scores (see
table
), were significantly lower in the CAD and NoCAD groups compared to the healthy controls. There were no differences in SF-36 scores between NoCAD and CAD.

CONCLUSION.
Compared with a healthy population, patients with stable CAD and NoCAD have significantly poorer quality of life asF-36. Future management strategies need to address the health outcomes in these patients.

Healthy Controls (n = 3168)
NoCAD (n = 320)
CAD (n = 828)

Age

52 ± 15

57 ± 12
*

62 ± 11

#

SF-36: Physical Summary Score
49 ± 10

41 ± 11
*

41 ± 11

#

SF-36: Mental Summary Score
51 ± 10

46 ± 11
*

46 ± 11

#

*

p
<0.01 for healthy controls vs NoCAD,

#

p
<0.01 for healthy controls vs CAD
Abstract P336: LDL Density and Cardiovascular Profile Among Patients With an Incident Myocardial Infarction: Results in 1,975 Patients in the TRIUMPH Registry
Authors: Mathews Robin , Gosch Kensey , Blazing Michael , Kulkarni Krishnaji , Peterson Eric D , Alexander Karen P , Spertus John
Published: July 2021

Background:
Recent evidence suggests that LDL levels alone may be an incomplete assessment of cardiovascular risk, given the emerging importance of LDL density. Specifically, an excess of low-density LDL (Pattern B vs. A/B or A) has been shown in primary prevention cohorts to be particularly atherogenic. To date, however, the prevalence of Pattern B profiles among patients presenting with an MI has not been described.

Methods:
The TRIUMPH registry enrolled acute MI patients from 24 US centers between 4/05 and 12/08. We excluded patients with prior MI or missing LDL levels; leaving 1,975 patients for analysis. Patients were stratified by LDL patterns, using the VAP method, to compare their demographic and clinical characteristics. As a secondary analysis, we examined changes in LDL pattern from baseline in patients newly on statins at 6 months.

Results:
Pattern B LDL profiles were present in 644 (32.6%) of patients. These patients were younger and more likely to be male, obese, have larger waist circumferences, higher triglycerides, and lower HDL levels (
Table
). Blood pressure, fasting glucose, and Lp-a levels did not differ across groups. Among 311 MI patients started on a statin, their LDL patterns became more atherogenic in 99 (31.8%) and less atherogenic in 43 (13.8%), suggesting little improvement with statins. Of the 113 patients with Pattern B at baseline, 84 (74.3%) patients did not improve, while the remaining 29 (25.7%) changed to a more favorable pattern.

Conclusion:
Patients with LDL Pattern B were younger and had more risk factors for metabolic syndrome. Statins did not markedly improve particle size patterns over time, suggesting that other approaches may be needed to further modify risk.

Patient characteristics and 6-month LDL patterns according to LDL Density Pattern at baseline

Patient characteristics and 6 month LDL patterns

Variable
Pattern A (n=777)
Pattern A/B (n=554)
Pattern B (n=644)
p-value

Age (yrs.)
59.9 ± 12.8
58.2 ± 12.1
55.3 ± 10.7
<0.001

Male
473 (60.9%)
383 (69.1%)
482 (74.8%)
<0.001

Caucasian
475 (61.3%)
378 (68.2%)
495 (77.1%)
<0.001

MI type:

<0.001

STEMI
303 (39.0%)
275 (49.6%)
326 (50.6%)

NSTEMI
468 (60.2%)
273 (49.3%)
315 (48.9%)

DM
224 (28.8%)
175 (31.6%)
180 (28.0%)
0.359

LDL-C (mg/dL)
94.4 ± 32.2
95.8 ± 31.7
100.0 ± 31.9
0.004

Triglycerides (mg/dL)
132.4 ± 65.2
133.8 ± 60.3
200.1 ± 149.0
<0.001

HDL (mg/dL)
42.6 ± 11.4
40.9 ± 10.3
36.6 ± 8.1
<0.001

BMI (kg/m
2
)

28.5 ± 6.1
29.9 ± 6.7
30.8 ± 6.6
< 0.001

Waist circumference (in)
37.6 ± 5.6
38.9 ± 5.7
39.3 ± 5.3
< 0.001

hsCRP (mg/L)
4.2 ± 6.0
3.7 ± 4.6
3.2 ± 4.0
<0.001

Home statin use (%)
191(24.6%)
165(29.8%)
218(33.9%)
<0.001

Initial systolic BP (mmHg)
141.9 ± 31.7
143.1 ± 27.3
144.9 ± 29.1
0.171
Abstract P338: Adverse Outcomes Following Percutaneous Coronary Intervention in Insulin Dependent and Non-Insulin Dependent Diabetes Mellitus
Authors: Scholfield Michael S , Murthy Ragu , Mohamedali Burhan , McGraw Sloane , Shivaraju Anupama , Shroff Adhir
Published: July 2021

Background:
ACC guidelines suggests late outcomes in diabetic patients after percutaneous coronary intervention (PCI) are similar to non-diabetics if the hgbA1C can be maintained less than 7.0%. To achieve this level of glycemic control many patients require the addition of insulin. The differences in outcomes amongst insulin dependent (IDDM) and non-insulin dependent (NIDDM) patients are not well known. We wish to analyze the cardiovascular (CV) outcomes and glycemic control of diabetic patients 6 months post PCI stratified by insulin usage.

Methods:
We conducted a retrospective cohort study investigating the impact of DM on clinical outcomes in patients who underwent a PCI at a Veterans Health Institution from September 2004 to March 2009. Adverse cardiovascular outcomes (death, myocardial infarct, revascularization, cardiac hospitalization, and combined outcomes) six months post-PCI were recorded and compared in IDDM and NIDDM patients. Data pertaining to glucose levels, HgbA1C, lipids, and blood pressure were also collected.

Results:
Of the 771 unique patients in our analysis, 302 had DM of which, 132(44%) were on insulin and 169(56%) were on oral medications. Although not statistically significant, in IDDM patients there was an increased rate of death, MI, cardiac hospitalization, and combined outcomes. HgbA1C and glucose values in IDDM were significantly higher pre and post-PCI.

Conclusion:
Our study suggested that both IDDM and NIDDM groups had poor glycemic control, however, IDDM patients were less controlled. Although lack of power in our study may have led to our inability to detect statistically significant differences in adverse CV outcomes we can see a trend toward worse outcomes in the IDDM group. Increased attention to promote tighter glycemic control particularly among IDDM veterans is warranted. We can conclude that more attention needs to be paid to diabetics patients, especially IDDM patients, to maintain a tighter glycemic control and hence reduce adverse cardiovascular outcomes post PCI.