bluuebunny/crossref_metadata_2025 huggingface dataset:
Abstract 031: Determination of Drivers of Cost Variation in Aortic Valve Replacement; a Case Costing Approach
Authors: Warren Claire E , Hirsch Gregory M
Published: June 2021

Objective:
We sought to establish the cost of an aortic valve replacement (AVR) in a single, tertiary cardiac centre through a detailed case costing approach, and to identify the cost drivers of AVR.

Methods:
Intra-operative consumables were collected directly from the operating room during the procedure while indirect costs were calculated after the procedure had been finished using time based calculations and straight line depreciation. Costs were divided into four departments: Pharmacy costs, including all drugs and fibrinogen, Perfusion costs, including all required blood products and cardiopulmonary bypass consumables excluding cannulas, Cardiac Surgery costs, including valves, cannulas and catheters opened for each case, and Anesthesia costs, including rotational thromboelastometry (ROTEM) test, central monitoring cannulas, endotracheal tubes and monitoring disposables.

Results:
We were able to calculate costs for 24 patients undergoing isolated AVR between June and August, 2016.. The average intra-operating room per-patient costs were $8,629.70 with a standard deviation of $1,623.74. Backwards-stepwise linear regression showed that perfusion (beta coefficient 0.332; p = 0.002), pharmacy (beta coefficient 0.425; p < 0.001) and cardiac surgery (beta coefficient 0.587; p < 0.001) were all significant sources of cost variability between cases. In Pharmacy, the largest driver of cost was the use of fibrinogen. In Perfusion, the largest driver of cost was blood product use. . In Cardiac Surgery, the largest driver of cost was the selection of prosthesis by the surgeon. Although anesthesia costs did not significantly affect cost variation, interestingly there was a negative beta coefficient (beta coefficient -.063. Where the ROTEM test was the single largest cost contributor to anesthesia costs this suggests the ROTEM may be ultimately cost savings.

Conclusion:
We demonstrate that there is significant cost variation in AVR, and that the major drivers are the use of fibrinogen; the use of blood products; and the choice of valve prosthesis. These costs are arguably both patient and practitioner driven. Interestingly the use of diagnostic ROTEM tests may mitigate costs through more directed strategies toward controlling bleeding. Identification of drivers of cost variation may allow for future cost reduction.
Abstract 038: American Heart Association Mission: Lifeline Breakthrough Series Collaborative Improving the Survival Rates for Out of Hospital Cardiac Arrest by Focusing on Early CPR With an Emphasis on Chest Compressions
Authors: Siegel Charles R , Chakrabarti Anjan , Siegel Lewis , Winslow Forrest , Hall Thomas
Published: June 2021

Introduction:
Out-of-hospital cardiac arrest (OHCA) remains a highly morbid public health problem. Despite improving practices and clear guidelines, mortality from this condition remains high at 90%, with survivors often suffering from poor neurologic outcomes. To determine the feasibility of quality improvement collaboratives to narrow gaps between evidence-based practice and patient care for OHCA, we conducted a pilot study of the AHA Resuscitation Collaborative.

Methods:
Eight emergency medical service agencies participated in the quality improvement collaborative pilot project. We identified several OHCA performance measures to assess the quality of care, guide collaborative activities, and monitor change in performance over time. Over the course of four learning sessions, participants were trained in quality improvement and performance measurement, analyzed performance measure results, and shared successes and challenges.

Results:
Five remaining agencies underwent the process outlined in Figure 1. Adherence to performance measures, including compression rate compliance (Figure 2), improved over the course of the collaborative. Compression rate compliance in Figure 2 corresponds to the process improvement efforts of the Chesapeake Fire Department with achievement of goals for optimal range of chest compression rate between 100 and 120 compressions per minute during resuscitations.

Conclusion:
As demonstrated in Virginia, the collaborative approach was an effective framework to improve OHCA care. Improvement in performance measures, the evident commitment of dedicated peers and colleagues, consistent collaboration, and the effective diffusion of best practices all support the continued use of this model.
Abstract 039: Comparison of Costs & Outcomes of Dapagliflozin With Dipeptidyl Peptidase-4 Inhibitors Added to Metformin Using a Short-term Cost-effectiveness Model
Authors: Chakravarty Abhiroop , Rastogi Mohini , Dhankhar Praveen , Bell Kelly
Published: June 2021

Background:
Several long-term models have been developed to compare the economic impact of alternative anti-diabetic treatments. However short-term models, based on actual trial data, might give more accurate results and be preferable over long-term models for estimating costs and benefits in short term.

Objective:
To assess the economic impact of the antidiabetic drug dapagliflozin (DAPA), a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, and dipeptidyl peptidase-4 inhibitors (DPP-4i) combined with metformin in the treatment of T2D.

Methods:
A short-term decision-analytic model with one year time horizon was developed using a payer’s perspective for United States (US). Costs and benefits associated with four clinical end points (glycated hemoglobin [HbA1c], body weight, systolic blood pressure (SBP), and risk of hypoglycemia) were evaluated in the analysis. A network meta-analysis was utilized to evaluate the impact of DAPA vs. DPP-4i on these clinical end points. Data for costs and QALYs associated with a per unit change in these clinical end points was taken from published literature. Drug prices were taken from annual wholesale price list. All costs were inflation-adjusted to 2016 costs using the medical care component of the consumer price index. Total costs (medical and drug), total QALYs, and incremental cost effectiveness ratios (ICERs) were estimated. Sensitivity analyses were performed as well. Results from the short-term model were compared with long term models published for these treatments.

Results:
Total annual medical cost for DAPA was $1,119 less than that for DPP-4i, with the difference mainly attributable to cost associated with weight change ($860). Treatment with DAPA resulted in an average QALY gain of 0.0587 per treated patient compared to DPP-4i. DAPA was cost-saving when compared to DPP-4i. Among all the four clinical end points, change in weight had the greatest impact on total annual costs and ICERs. Probabilistic sensitivity analysis demonstrated that total annual cost for DAPA was less than that for DPP-4i in more than 97% of simulations and DAPA had a 97% probability of being cost-saving compared with DPP-4i. Results from the short-term model were similar to published long term models.

Conclusions:
Our analysis showed that DAPA was cost saving when compared with DPP-4i in the US setting. Furthermore, the results suggest that among the four composite clinical endpoints, change in weight had greater impact on cost-effectiveness results. In addition, our short-term model provides results similar to published long term models.
Abstract 041: Trends in Publication and Methodological Quality of Major Non-inferiority Cardiovascular Trials From 1990-2016: a Systematic Review
Authors: Welsh John W , Bikdeli Behnood , Akram Yasir , Lee Ike , Desai Nihar R , Stone Gregg W , Ross Joseph S , Krumholz Harlan M
Published: June 2021

Introduction:
Randomized controlled trials (RCTs) designed to demonstrate non-inferiority of an intervention compared with control have become increasingly common in cardiovascular medicine. Such RCTs may be biased toward null findings through low enrollment, post-randomization exclusions, loss to follow-up, or wide inferiority margins. We characterized the features of non-inferiority cardiovascular RCTs published in high-impact journals that could lead to bias.

Methods:
We searched PubMed for non-inferiority cardiovascular RCTs published between January 1, 1990 and August 11, 2016 in
The New England Journal of Medicine, Lancet
, and
JAMA
. We reviewed methodological characteristics, including sample size, power estimates, selected non-inferiority margin, and success of studies in achieving non-inferiority.

Results:
Of 3,689 screened studies, we identified 104 non-inferiority RCTs. Publication increased over time (P<0.001), as more than 50% (n=53) were published since 2010. Of 101 trials with eligible data, 80 (77%) trials claimed non-inferiority (19 of which also demonstrated superiority), whereas 21 (20%) did not (including 7 which showed worse outcomes with the tested intervention, and 14 that had inconclusive results, Figure). Only 1 study had >10% of participants lost to follow-up. Of 75 studies with available data, 14 reported >10% post-randomization exclusions. Of 89 studies with available information, 10 analyzed a cohort >20% smaller than their calculated sample size. Only 55 studies (53%) reported all the randomized patients in the primary endpoint analyses. Only 52 trials (50%) reported analyses from both the intention-to-treat and per-protocol cohorts, of which 2 found a discrepancy in analyses. Treatment adherence was reported in 18 trials (34%). Pre-specified non-inferiority margins ranged widely, with absolute differences between 0.4-14%, hazard ratios between 1.05-2.85, odds ratios between 1.1-2.0, and relative risks between 1.1-2.0. Only 9 studies (8.7%) used a placebo or no-intervention arm.

Conclusion:
Non-inferiority designed RCTs in cardiovascular medicine are increasingly published in high-impact journals, commonly conclude non-inferiority of the new intervention, and frequently have design features that might bias the studies toward non-inferiority.
Abstract 043: Health Insurance and the Risk of Incident Cardiovascular Disease in the Multi-Ethnic Study of Atherosclerosis
Authors: Crim Matthew T , Xie Joe X , Ko Yi-An , Blumenthal Roger S , Blaha Michael J , Nasir Khurram , Budoff Matthew J , Shaw Leslee J
Published: June 2021

Background:
Health insurance plays an important role in access to medical care and is the focus of extensive policy efforts. We examined the association of health insurance with cardiovascular disease (CVD) incidence.

Methods and Results:
The Multi-Ethnic Study of Atherosclerosis, sponsored by the National Heart, Lung and Blood Institute of the NIH, followed a US cohort, aged 45-84 without clinical CVD at baseline, for a median of 12.2 years; 788 events occurred among 6,674 individuals. Data were stratified by baseline health insurance status. Kaplan-Meier survival and Cox regression analyses were used to assess the association between health insurance and incident CVD (myocardial infarction, resuscitated cardiac arrest, stroke, CVD death, and angina), adjusting for biomedical CVD risk (traditional risk factors, including age and race/ethnicity, and markers of subclinical atherosclerosis) and socioeconomic status (SES). The majority of individuals had private insurance (51%). Uninsured individuals (9%) were more likely to have untreated hypertension and diabetes, less likely to be on lipid-lowering therapy, and more likely to receive care in an Emergency Department (p < 0.0001). Income, 10-year CVD risk, and 10-year event-free survival varied across insurance groups (
Table
). After adjustment for biomedical CVD risk, individuals with health insurance had a lower risk of incident CVD compared to the uninsured (HR 0.72, p=0.03). However, with additional adjustment for SES (income, education, and employment), insurance was no longer associated with incident CVD (HR 0.78, p=0.12). Among the insurance groups, those with private insurance had a lower risk of incident CVD after adjustment for both biomedical CVD risk and SES (HR 0.70, p=0.03). Medicare and Medicaid coverage were not associated with incident CVD. The military/VA group had a lower risk of incident CVD with adjustment for biomedical CVD risk (HR 0.57, p=0.02) that was no longer significant after adjustment for SES (HR 0.66, p=0.09).

Conclusions:
The association of health insurance with CVD incidence varied by insurance group, and private insurance was associated with a lower risk of incident CVD. Further exploration of the features of health insurance coverage that impact CVD incidence may facilitate improvements in the primary prevention of CVD.
Abstract 045: Incremental Medical Expenditures Attributable to Hypertension in China’s Middle-aged and Elderly Population
Authors: Zhang Donglan , Li Shukai
Published: June 2021

Background:
Hypertension is a prevalent and costly health condition in China. We sought to estimate the inpatient and outpatient expenditures attributable to hypertension among China’s middle-aged and elderly population.

Methods:
Data for this study was from the China Health and Retirement Longitudinal Survey (CHARLS) 2011 and 2013, a comprehensive and nationally representative survey of Chinese residents aged 45 and older. We selected our study sample among respondents who had complete information on biomarker blood pressure measures and had not developed hypertension in 2011. Hypertension in 2013 was identified in the following steps: (a) He/she had an average systolic blood pressure of ≥ 140 mmHg, and/or an average diastolic blood pressure of ≥ 90 mmHg and/or (b) He/she was currently taking anti-hypertensive medications. The outcome measures were total inpatient expenditures in the past year and outpatient expenditures in the last month. We used a difference-in-difference approach, by classifying those with hypertension as treatment group, and those without hypertension as control group. A propensity score weighting approach was applied to balance out the population characteristics between the treatment and control groups. Linear regression was used to examine the incremental medical expenditures attributable to hypertension.

Results:
The final sample contained 7827 observations. For those who developed hypertension between 2011 and 2013, their inpatient expenditure increased faster and on average, the hypertension-attributable inpatient expenditures were¥129.5 ($20.9) per person in a year. When we restricted the sample to those with only positive inpatient expenditures, the incremental expenditure reached ¥1526.2 ($246.2) a year. On average, the hypertension-attributable outpatient expenditures were ¥31.0 ($5) per person each month. When we only considered the sample with positive outpatient expenditures, the incremental outpatient expenditures reached ¥276.1 ($44.5) in a month.

Conclusions:
Having hypertension was associated with substantially higher medical expenditures for both inpatient and outpatient care services. Given that the prevalence of hypertension among adults aged 45 and older was 33% (180 million) in China), the estimated national medical expenditures attributable to hypertension would be as high as ¥90.3 billion ($14.6 billion) per year.
Abstract 061: Sex-specific Trends in Acute Myocardial Infarction Hospitalization, 2000 to 2014
Authors: Reading Stephanie R , Reynolds Kristi , Li Bonnie H , Qian Lei X , Ryan Denison S , Harrison Teresa N , Scott Ronald D , Cavendish Jeffrey J , Jacobsen Steven J , Kanter Michael H
Published: June 2021

Objectives:
Age and sex-specific differences exist in acute myocardial infarction (AMI) prevalence, morbidity and mortality. Thus, within a diverse integrated health care delivery system of over 4 million members, we examined how sex-specific temporal trends in AMI incidence may have contributed to these differences and reflect evolving changes in AMI prevention efforts.

Methods:
We identified all Kaiser Permanente Southern California members (aged ≥35 years) with a primary ICD-9-CM hospital discharge diagnosis of AMI between January 1, 2000 and December 31, 2014. Incident AMI hospitalization was defined as the first event documented in the electronic health record between 2000 and 2014, with no prior AMI hospitalization. Incident ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) were identified similarly. Age-standardized (using U.S. 2010 Census data) and age-specific incidence rates by sex were calculated separately for AMI, STEMI and NSTEMI events for each calendar year. Average annual percent change and 95% confidence intervals (CIs) were estimated using log-linear Poisson models.

Results:
A total of 45,331 AMI, 16,524 STEMI and 32,552 NSTEMI incident events were identified between 2000 and 2014. Age-standardized incidence rates (per 100,000 person years) of AMI declined an average of 4.7%/year (95% CI [4.4, 4.9]) for men from 441.9 in 2000 to 223.6 in 2014 and 3.9%/year (95% CI [3.6, 4.2]) for women from 246.5 in 2000 to 146.4 in 2014. NSTEMIs declined an average of 2.8%/year (95% CI [2.5, 3.2]) for men from 268.2 in 2000 to 170.2 in 2014 and 1.9%/year (95% CI [1.5, 2.3]) for women from 156.1 in 2000 to 121.8 in 2014. Although STEMI incidence rates declined substantially from 2000 to 2014, sex differences were minimal, with an average decline of 8.0%/year (95% CI [7.6, 8.4]) for men from 205.9 in 2000 to 67.5 in 2014 and 8.9%/year (95% CI [8.3, 9.5]) for women from 107.2 in 2000 to 32.3 in 2014. Comparing 2000 to 2014, age-specific incidence rates of AMI, NSTEMI and STEMI declined in both men and women across all age groups (
Table
).

Conclusions:
Despite absolute differences, both men and women have experienced similar declines in hospitalized AMI, STEMI and NSTEMI incidence rates, presumably due to increased efforts in both primary and secondary AMI prevention.
Abstract 062: Physiological and Psychological Stress Response are Related to QOL and Functional Status Among People Living With a Left Ventricular Assist Device
Authors: Abshire Martha , Page Gayle G , Budhathoki Chakra , Davidson Patricia M , Russell Stuart D , Han Haera , Desai Shashank , Dennison Himmelfarb Cheryl
Published: June 2021

Background:
Advanced heart failure patients with left ventricular assist device (LVAD) have experienced emotional distress and psychological sequelae following implant. However, few studies have examined stress among patients with LVAD. The purpose of this study was to describe physiological and psychological stress response and then to examine relationships between physiological and psychological stress response and outcomes (quality of life (QOL), functional status and healthcare utilization) in patients with LVAD.

Design:
A descriptive observational study design was used to examine physiological and psychological stress response among LVAD patients.

Methods:
Data was collected for patients more than 3 months post-LVAD implantation (N = 44). Relationships among indicators of physiological (salivary cortisol, sleep quality) and psychological stress, (perceived stress, depression and fatigue) and outcomes (quality of life, functional status as measured by Six Minute Walk Test (6MWT) and healthcare utilization, using hospitalization rate) were examined using descriptive statistics and logistic regression models.

Results:
The sample was average age 57.7 years, mostly male (73%), married (70.5%) and racially diverse (white 46%, black 43%, other 11%). Median LVAD support was 18.2 months. Normal cortisol awakening response was seen in most participants (61%). LVAD patients reported moderate levels of psychological stress and sleep quality and enjoy a good quality of life (73 out of 100, SD ± 13.5). At the bivariate level, normal cortisol awakening response was correlated with low depressive symptoms (p< 0.02). Poor sleep quality was correlated with increased psychological stress response and QOL (p< 0.01). Perceived stress was positively associated with healthcare utilization (p<0.01). In multivariate analysis, cortisol and sleep quality were independent predictors of 6MWT > 300 meters (R
2
= 0.33, chi
2
= 0.002), but not for QOL and healthcare utilization when controlling for psychological stress.

Conclusions:
This is the first report of salivary cortisol and perceived stress in outpatients with LVAD. Associations were seen between sleep quality, psychological stress response and QOL. Cortisol and sleep quality were predictive of functional status among patients with LVAD. Future research should explore if those with a higher stress profile (abnormal cortisol awakening response, worse sleep quality, perceived stress, depression, fatigue) would benefit from tailored supportive interventions to lower perceived stress, improve sleep quality and improve QOL.
Abstract 068: High Sensitivity C-reactive Protein Levels Among Patients With Myocardial Infarction: Insights From Triumph
Authors: Qintar Mohammed , Sharma Puza P , Pokharel Yashashwi , Tang Yuanyuan , Jones Philip , Dreyer Rachel , Spertus John
Published: June 2021

Background:
Elevated hs-CRP has been shown to correlate with adverse outcomes in patients with coronary disease, however, little is known about the patterns of hs-CRP levels at the time of, and following, AMI. We sought to describe these patterns and patient characteristics associated with persistently elevated hs-CRP.

Methods:
TRIUMPH was a prospective observational AMI registry that assessed hs-CRP levels at baseline, 1 and 6 months after AMI. Patients were divided into groups based on their hs-CRP levels at baseline and follow up (1 and 6 months) with elevated hs-CRP defined as ≥ 2 mg/L.

Results:
Among patients with available baseline and 1 month hs-CRP (n=801), 753 (94%) of patients had hs-CRP ≥2 at baseline, of which 427 (56.7%) still had hs-CRP ≥2 at 1 month (Figure). Of 48 patients with hs-CRP <2 at baseline, only 12 (25%) had elevated hs-CRP at 1 month. Among 434 patients with baseline and 6 months hs-CRP, 407 (93%) had elevated hs-CRP at baseline of which 195 (45%) still had elevated hs-CRP at 6 months. There were 247 patients with persistent elevation of hs-CRP at both1 and 6 months. Patients with elevated hsCRP at 1 month were more likely to be female, non-white, obese, smokers, with diabetes, hypertension, prior MI and with multi-vessel disease.

Conclusions:
Approximately half of patients with elevated hs-CRP at the time of an AMI have persistently elevated hs-CRP at 1 and 6 months. Further investigation is needed to better illuminate the optimal risk reduction strategies for this higher-risk cohort.
Abstract 073: Maximizing Sacubitril/Valsartan Clinical Benefit Under Budget Constraints
Authors: Arbel Ronen , Hammerman Ariel , Triki Noa , Weinstein Jean Marc , Grrenberg Dan
Published: June 2021

Background:
The angiotensin receptor-neprilysin inhibitor sacubitril/valsartan has been shown in the PARADIGM-HF trial to be superior to enalapril in reducing the risks of cardiovascular (CV) deaths and hospitalizations in heart failure (HF) patients. Although several studies suggested that sacubitril/valsartan is a cost-effective therapy, budget constraints may limit its use. Our objective was to characterize HF sub-populations in which cost per CV death/hospitalization prevented are excessively high in order to assist in treatment prioritization decisions.

Methods:
Outcome data were retrieved from the published PARADIGM-HF trial reports. Costs were calculated based on current United States prices of sacubitril/valsartan.

Results:
In the PARADIGM-HF trial, treatment of 4,187 patients with sacubitril/valsartan resulted in prevention of 203 CV deaths or HF hospitalizations (135 CV deaths) during a total of 9,396 patient-years. The estimated additional cost of sacubitril/valsartan during the trial’s follow-up period would have reached $42,089,220. Therefore, the cost of preventing one HF hospitalization or CV death would have been $207,336 and the cost of preventing one CV death would have been $311,772. This figure is significantly higher in sub-groups that presented a lower risk-reduction, as in patients with an ejection fraction >35% ($674,831) and in patients without prior use of HF medical therapy ($2,024,494).

Conclusions:
In healthcare settings under budget constraints, payers can maximize clinical outcomes in HF patients, by prioritizing sacubitril/valsartan therapy to sub-populations that have demonstrated higher benefit in the PARADIGM-HF trial. Advocating the reduction of sacubitril/valsartan prices could enable wider populations to benefit from this promising therapy.
Abstract 084: Avoiding Heart Failure Readmissions
Authors: Abdallah Houda , McMahon Colin , Krallman Rachel , Koelling Todd , Rubenfire Melvyn , Kline-Rogers Eva , Bumpus Sherry M
Published: June 2021

Background:
Heart failure (HF) has high in-hospital mortality and is associated with high readmission rates. Reasons for and ways to avoid HF readmissions are unclear. We explored readmission diagnoses and guideline adherence, as a proxy for avoidability, among patients readmitted after index hospitalization for HF.

Method:
From 2008-2014, 3381 patients were referred to the BRIDGE transitional care clinic. Retrospective data was derived for 64 of the 154 HF patients who were readmitted within 30 days. Patients were assigned cohorts by readmission diagnosis: “HF or HF related,” “non-HF related other cardiac,” or “non-cardiac, non-HF related.” Patient and provider adherence to ACCF/AHA HF guidelines, including sodium and fluid restrictions, weight monitoring, outpatient follow-up, and medication, were assessed to determine readmission avoidability.

Results:
Data were collected for 64 pts of whom 62 had complete data. The mean age was 70.3±10.3 years; the majority were male (n=40, 64.5%) and white (n=54, 87.1%). HF diagnoses accounted for 58.1% (n=36) of readmissions; 19.4% (n=12) were for non-HF cardiac diagnoses and 22.6% (n=14) were for non-cardiac diagnoses. Overall provider guideline adherence at discharge was high (82.3%). Providers frequently documented providing education on sodium (77.4%) and fluid restrictions (54.8%), as well as daily weights (88.7%). Patients reported compliance with sodium (94.2%) and fluid restrictions (89.2%), daily weights (96.5%), and medications (96.7%). Patients readmitted for HF had lower guideline adherence than non-HF cardiac or non-cardiac diagnoses for both provider (n=26, 72.7%; p=.046) and patient (n=28, 77.8%, p=.248). HF was also the most frequent readmission diagnoses when provider guidelines were not adhered (n=10, 90.9%).

Conclusion:
Over 40% of HF readmissions within 30 days of discharge were non-HF related, half of which were also non-cardiac. Overall adherence to guidelines for both patients and providers was high, suggesting that many readmissions post-index hospitalization for HF may be unavoidable. When guidelines were not adhered to, patients were more likely to be readmitted for HF related diagnoses. Further research is needed to discern whether further reductions in readmission rates can be achieved through improved guideline adherence.
Abstract 089: Can Medical Claims Accurately Assess Cardiovascular and Bleeding Events in an All-Aged Post-Myocardial Infarction Population? Insights Fom the TRANSLATE-ACS Study
Authors: Guimaraes Patricia O , Krishnamoorthy Arun , Kaltenbach Lisa A , Anstrom Kevin J , Effron Mark B , Mark Daniel B , McCollam Patrick L , Davidson-Ray Linda , Peterson Eric D , Wang Tracy Y
Published: June 2021

Background:
Pragmatic clinical trial designs have proposed the use of claims data to ascertain clinical events. However, little is known about the accuracy of medical claims diagnosis in identifying events.

Methods:
Administrative claims were obtained for all rehospitalizations occurring within 12 months of index acute myocardial infarction (MI) in those enrolled in the TRANSLATE-ACS study. Outcome events (recurrent myocardial infarction [MI], stroke, and hospitalized bleeding) were identified based on all diagnosis and procedure codes in these claims. These clinical events were also independently adjudicated by physicians based on medical record review. The cumulative 1-year incidences for each outcome were compared when identified by administrative claims vs. physician adjudication. Kappa statistics assessed the accuracy of claims-identified events using physician adjudication as the gold standard.

Results:
Among 12,351 MI patients, the cumulative 1-year incidence of events identified by administrative claims were 4.3% for MI, 0.9% for stroke, and 5.0% for bleeding. Incidence rates based on physician adjudication of medical records were 4.7% for MI, 0.9% for stroke, and 5.4% for bleeding. Agreement between claims-identified and physician-adjudicated events was modest for MI and stroke events: kappa=0.76 and 0.55, respectively. In contrast, agreement was poor between claims-identified and physician-adjudicated bleeding events: kappa=0.24 for any hospitalized bleeding event and 0.15 for GUSTO moderate-severe bleeding.

Conclusion:
Event rates at 1 year were lower for MI, stroke and bleeding when using administrative claims to identify events in comparison with physician adjudication. Administrative claims diagnoses are modestly accurate in identifying recurrent MI and stroke admissions but have limited accuracy in identifying bleeding events, which suggests that an alternative approach is needed to ensure good safety surveillance in cardiovascular studies.
Abstract 096: Association of Body Mass Index With Bleeding in Patients Taking Warfarin for Atrial Fibrillation or Venous Thromboembolism
Authors: Stahlbaum Kyle , Kline-Rogers Eva , Kong Xiaowen , Barnes Geoffrey D , Haymart Brian , Kozlowski Jay H , Almany Steven L , Kaatz Scott , Krol Gregory D , Shah Vinay , McNamara Michael W , Froehlich James B
Published: June 2021

Background:
Most patients taking warfarin for atrial fibrillation (AF) and venous thromboembolism (VTE) have a target International Normalized Ratio (INR) between 2-3 to reduce risk of bleeding and thromboembolic events. Body Mass Index (BMI) is not included in traditional bleed risk scores, but may be an indicator of bleeding risk in warfarin patients.

Methods:
Using data from the multi-site Michigan Anticoagulation Quality Improvement Initiative (MAQI
2
) Registry, we identified all AF/VTE patients , separated them into three cohorts: BMI < 20 (underweight), BMI 20-25 (normal weight) and BMI >25 (overweight). Bleeding events in these cohorts were identified and stratified into severity according to International Society of Thrombosis and Hemostasis criteria.

Results:
Of 6,054 patients, 4,766 (78.7%) had a BMI of > 25. These patients were generally younger, with higher prevalence of hypertension. The HAS-BLED scores were slightly lower in overweight AF patients (2.6 vs 2.8; p=0.04); otherwise no difference between groups. The overall minor, major, and life threatening bleeding rates were 22.8/27.7; 4.3/3.7; and 1.2/0.7 (per 100 patient years) in AF and VTE patients, respectively. A higher proportion of females were underweight for both indications, and AF patients were older. More underweight and normal weight AF and VTE patients had a bleeding history compared to overweight patients. Bleeding outcomes are listed in Table. Comparisons were made with Poisson regression analysis.

Conclusion:
In a large, unselected cohort of warfarin treated patient from a multi-site registry, minor bleeding was more common in underweight and normal weight AF patients; major and life-threatening bleeding was more common in underweight and normal weight VTE patients. Since the majority of patients were overweight, further studies are needed to determine if reasons for bleeding differ between patients based on BMI in order to guide quality improvement efforts.
Abstract 105: Racial Differences in Health Status, Clinical Characteristics and Treatment Patterns Among Patients With Peripheral Artery Disease: Insights From the PORTRAIT Registry
Authors: Jelani Qurat-ul-ain , Smolderen Kim , Spertus John A , Jingyan Wang , Tuohy Edward R , Zarich Stuart , Jones Phil , Graham Garth , Dreyer Rachel P
Published: June 2021

Background:
Despite the higher prevalence and excess morbidity associated with peripheral arterial disease (PAD) in blacks, as compared with whites, little is known about racial differences in clinical characteristics, treatment referral and health status outcomes (symptoms, functioning, quality of life) at the time of PAD presentation.

Methods:
We used data from the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease Investigating Trajectories (PORTRAIT) registry, a multicenter, international prospective study of patients with new or worsening PAD symptoms consulting specialty care (2011-2015). Clinical and treatment characteristics were abstracted from medical records and health status was collected via patient interviews at presentation using the Peripheral Artery Questionnaire (PAQ). We calculated summary statistics using t-test/chi-square analyses and examined mean differences in the PAQ summary score at baseline between blacks and whites.

Results:
The final cohort consisted of 760 patients (N=183 blacks; 24%). Compared with whites, blacks were younger (66±9.8 vs 70±9.2; P=< 0.001), more likely to be female (58% vs. 37%, P= <0.001), non-married (40% vs. 59% P=<0.001), and had a higher prevalence of hypertension (94.5% vs. 86.3%, P=0.002), diabetes (47.5% vs. 34.8%, P= 0.002), chronic kidney disease (23.5% vs. 12.7%, P=<0.001), current smoking (38.8% vs. 25.5%, P=0.002) and lower ankle brachial index values (0.6 vs. 0.7, P=0.034). Blacks were also less likely to have had prior percutaneous coronary intervention (22.4% vs. 29.3%, P= 0.07) or coronary artery bypass grafting (13.7% vs. 28.4%, P=< 0.001), but had similar rates of non-healing ulcers (2.2% vs. 1.4%, P=0.50) or amputation (2.7% vs. 1.0%, P=0.146). Black and white patients had similar mean PAQ summary scores at presentation (46.8±22.4 vs. 47.6±21.8; P=0.669) and were equally likely to be referred for revascularization (30.1% vs. 36.9 %, P=0.09)

Conclusion:
Despite excess prevalence of adverse risk factors including diabetes, hypertension, and smoking, black patients presenting with PAD have similar health status outcomes and invasive treatment strategies when compared with whites. Follow-up studies are needed to determine if these observations persist after adjustment for covariates and if there are differences in health status recovery over time.
Abstract 139: Comparison of Access to Care and Quality of Care in Veterans versus Non-veterans With Cardiovascular Disease
Authors: Srivastava Pallavi , Lacey Matthew , Butler Javed , Shroyer A. Laurie , Parikh Puja B
Published: June 2021

Background:
Improved access to care and quality of care can mitigate population level risk of heart disease and improve health outcomes. We sought to compare access to care in veterans versus non-veterans with cardiovascular disease (CVD) in the U.S.

Methods:
The 2013 Centers for Disease Control’s Behavioral Risk Factor Surveillance Survey was utilized to identify a cohort of 57,171 adults with CVD. Presence of CVD was noted with a single affirmative response to the following questions: “Has a health care professional ever told you that you had any of the following:” (1) a heart attack or myocardial infarction, (2) angina or coronary heart disease, (3) a stroke? Demographic data, clinical history and medication use were recorded in these patients. Access to care variables included report of financial barriers to medical care and/or prescription drug costs and report of delay in receiving medical care. Quality of care variables included annual blood cholesterol check, blood sugar testing, flu shot administration, antihypertensive use, and aspirin use.

Results:
Among 57,171 adults with CVD studied, 13,205 (23.1%) were veterans while 43,966 (76.9%) were non-veterans. Veterans with CVD tended to be older (p<0.0001), male (95.6% vs 33.0%, p<0.0001), white (84.8% vs 76.6%, p<0.0001), married (57.3% vs 40.8%, p<0.0001), college-educated (60.9% vs 47.7%, p<0.0001), homeowners (81.1% vs 70.1%, p<0.0001), and with higher annual income. Veterans with CVD were more likely to be taking antihypertensive medications (93.3% vs 91.7%, p<0.0001) and have lower rates of current smoking (15.1% vs 18.9%, p<0.0001), chronic obstructive pulmonary disease (21.5% vs 23.1%, p=0.0003), asthma (12.7% vs 21.4%, p<0.0001), obesity (32.0% vs 36.9%, p<0.0001), physical inactivity (37.1% vs 44.3%, p<0.0001), and depressive disorders (22.0% vs 31.0%, p<0.0001). Veterans with CVD were less likely to report financial barriers to medical care (7.5% vs 15.6%, p<0.0001) and to medication costs (6.1% vs 14.7%, p<0.0001) and had higher rates of blood sugar testing (77.2% vs 72.2%, p<0.0001), blood cholesterol testing (98.2% vs 96.5%, p<0.0001), flu shot administration (64.2% vs 56.6%, p<0.0001), and annual check-up by a health care provider (88.7% vs 84.9%, p<0.0001). Veterans with CVD were more likely to be taking aspirin (77.1% vs 70.0%, p<0.0001). In multivariate analysis, being a veteran was associated with decreased odds of financial barriers to care (OR,0.82; 95% CI 0.73-0.92) and financial barriers to medication cost (OR,0.56; 95% CI 0.48-0.64). Compared to non-veterans, veterans had increased odds of medical checkup in past year (OR,1.25; 95% CI 1.13-1.38), cholesterol check in past year (OR, 1.21; 95% CI 1.07-1.37), and flu shot (OR,1.22; 95% CI 1.14-1.30).

Conclusion:
Veterans with CVD receive improved access to care and quality of care compared to their non-veteran counterparts.
Abstract 142: Increasing Appropriate Statin Use in the Primary Care Clinic
Authors: Khetan Aditya K , Khan Omer , Rashid Umar , Pleyer Christopher , Singh Mamta
Published: June 2021

Background:
In 2013, ACC/AHA released new guidelines for cholesterol management. Historically, new guidelines can take up to a decade to diffuse into clinical practice, leading to suboptimal patient management. We hypothesized that systematic identification of barriers, and targeted interventions can improve management of cholesterol.

Objectives:
To increase appropriate intensity statin prescription, as enumerated in the 2013 ACC/AHA guidelines, in all primary care clinic patients with atherosclerotic cardiovascular disease (ASCVD) or diabetes mellitus (DM), with an aim to make a 25% relative improvement from baseline (Dec’14) to Dec’ 15.

Methods:
Information regarding statin use was obtained from the primary care clinic database. MD, NP and PharmD providers in the clinic were surveyed with an aim to understand the barriers to prescribing statins. A series of tailored interventions was subsequently deployed through multiple PDSA cycles, including pocket cards on statin guidelines, education sessions and EMR generated lists of patients who were not on a statin as per guidelines.

Result:
Baseline data showed that 59.7% (238 of 398) patients with ASCVD were on an appropriate dose statin, while 70.7% (619 of 875) patients with DM were on an appropriate dose statin. Post intervention results after 12 months showed a 8.4% relative increase (258 of 398) in appropriate dose statin use amongst patients with ASCVD and a 2.1% relative increase (632 of 875) in patients with DM.

Conclusions and implication:
A targeted strategy of PDSA cycles can increase the rates of statin usage, and lead to quicker uptake of ACC/AHA guidelines on cholesterol management.
Abstract 145: Use of Bromocriptine in the Management of Peripartum Cardiomyopathy: A Systematic Review
Authors: Saint Croix Garly Rushler , Ibrahim Michel , Chaparro Sandra
Published: June 2021

Background:
Prolactin metabolites have been shown to possibly be cardio-toxic in humans and play a role in the pathogenesis of Peripartum Cardiomyopathy (PPCM). Some studies have demonstrated medical treatment with bromocriptine, a dopamine agonist able to inhibit prolactin, associated with standard therapy to be beneficial not only in managing symptomatology but also in the reversal of disease process. The present study was performed to systematically review the PPCM literature and determine the therapeutic effect of bromocriptine on left ventricular function and clinical outcomes.

Methods:
We performed a literature review to identify randomized, nonrandomized clinical studies, case series and case reports that reported the use of bromocriptine in the management of PPCM. A total of 9 databases including MEDLINE, Embase, Cochrane, DARE and Scopus containing articles from January 1, 1945 to July 31, 2016 were analyzed.

Results:
We were able to identify and screen 410 potentially eligible publications through the databases. Based on our exclusion criterias, 8 studies were selected: one randomized control trial (RCT), two case control studies and five case reports. We found that Bromocriptine improved left ventricular ejection fraction (LVEF) and clinical outcomes in women with acute severe PPCM and no thrombotic event was reported. The RCT (n = 20) showed an improvement of composite end point of death, NYHA Class III/IV and LVEF < 35% (35 of 100) at 6 months. LVEF went from 27% (27 of 100) to 58% (58 of 100) in the group taking bromocriptine vs 36% (36 of 100) in the other group . One of the case controls (n = 51) showed LVEF improvement of 85% (43 of 51) and full recovery in 47% (24 of 51) after 6 months +/- 3 of treatment. The other case control study (n = 115) failed to suggest a beneficial effect of bromocriptine. However, all the five case reports (n = 7) showed LV improvement.

Conclusion:
Peripartum Cardiomyopathy is a rare but serious condition that affects childbearing women. Targeted therapies like bromocriptine have shown promising results but a large multicenter RCT is needed to evaluate furthermore the benefits and harms of bromocriptine before it can be adopted in routine clinical use.
Abstract 151: Patient Decision Support in Implanted Defibrillator Care: A Human Rights-Based Assessment Model
Authors: Henry Ian , Knoepke Christopher
Published: June 2021

Background:
Shared decision making (SDM) is a mainstream component of cardiovascular disease care in the US. This is particularly true in light of support for SDM from the IOM, the ACA, the FDA 1-3, several professional societies, and Cochrane Review findings of improved patient-centered outcomes4. Given the complex nature of advanced CV therapies - characterized by the IOM as having “more to do, more to manage, and more people involved than ever before”5 - SDM programs are critical to patient-centered assessment of quality of care in CV.

Human rights-based approaches (HRBAs)6-7 are common in evaluations of programs targeting communicable disease in developing countries, but are underutilized in CVD care in the US. HRBAs ground assessment in international human rights law, and provide a normative framework for the design, implementation, monitoring and evaluation of interventions, policy, and programs. An HRBA to health aims to realize the right to the “highest attainable standard of health”—including the availability, accessibility, acceptability, and quality of health facilities, information, goods, and services—and other health-related human rights (including autonomy and full and informed decisionmaking, the right to participation, and accountability).8-12

Approach:
Using decision support regarding ICDs as a model, we created a conceptual framework highlighting synergies between HRBAs and SDM. This model of HRBA assessment of SDM programs covers four stages of design/deployment of decision aids (design of tools; implementation; use of PtDAs with patients; monitoring, evaluation and accountability), with accompanying rights-based considerations for each. The model is replicable across decision support related to other complex therapies with preference-sensitive trade-offs.

Results & Implications:
There is considerable synergy between HRBAs and SDM. Both empower patients, emphasize autonomy, and have potential to improve processes and outcomes. This model offers legal grounding and a normative framework through which one can evaluate SDM programming, improving decisionmaking processes and better aligning outcomes with patients’ values and goals. Research into the use of HRBA assessment of SDM is warranted; the goal being to respect, protect, and fulfill human rights obligations.
Abstract 152: Adherence to Rivaroxaban versus Apixaban Among Patients With Atrial Fibrillation: Analysis of Overall Population and Subgroups of Prior Oral Anticoagulant Users
Authors: McHorney Colleen A , Crivera Concetta , Laliberté François , Germain Guillaume , Wynant Willy , Lefebvre Patrick
Published: June 2021

Background:
Medication nonadherence predicts poor outcomes among patients with non-valvular atrial fibrillation (NVAF). Understanding differences in adherence rates among non-vitamin K oral anticoagulants (NOACs) could guide treatment decisions, promote adherence and improve clinical outcomes.

Objective:
To compare adherence to rivaroxaban and apixaban among the overall NVAF population and subgroups at higher risk for adverse clinical outcomes (e.g., prior OAC use, multiple comorbidities, and with risk factors for nonadherence).

Methods:
Using healthcare claims from the Truven Health Analytics MarketScan database from 7/2012-7/2015, adult patients with 2 dispensings of rivaroxaban or apixaban at least 180 days apart, with > 60 days of supply, ≥ 6 months of pre- and post-index eligibility, ≥ 2 atrial fibrillation diagnoses pre- or post-index, and without valvular involvement were identified. Propensity score methods were used to create matched cohorts of rivaroxaban and apixaban patients, adjusting for demographics, risk factors for nonadherence (e.g., bipolar, anxiety), previous OAC use, and clinical characteristics. Adherence was assessed using the percentage of patients with proportion of days covered ≥0.8 at 6 months. Subgroups of patients with prior OAC use, prior OAC use and a Quan-Charlson Comorbidity index ≥2, and prior OAC use with/without nonadherence risk factors were evaluated.

Results:
14,635 NVAF subjects were included in each of 2 matched cohorts. All baseline characteristics were balanced between cohorts. At 6 months, significantly more rivaroxaban users were adherent to treatment as compared to apixaban users (82.4% vs 78.5%; absolute difference of 3.9%; P<0.01). Rivaroxaban users had significantly higher adherence rates in all subgroups examined with prior OAC agents (Figure).

Conclusion:
Rivaroxaban users had consistently higher adherence rates than apixaban users overall and among all NVAF subgroups examined.