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OBJECTIVE: The objective of this study was to investigate variations across hospitals in infection rates and associated costs, the latter reflected in 90-day Medicare payments. Despite high rates and expenditures of healthcare-associated infections associated with durable ventricular assist device implant, few studies have examined inter-hospital variation and associated costs. METHODS: Clinical data on 8688 patients who received primary durable ventricular assist devices from July 2008 to July 2017 from The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) hospitals (n=120) were merged with post-implant 90-day Medicare claims. Terciles of hospital-specific, risk-adjusted infection rates per 100 patient-months were estimated using Intermacs and associated with Medicare payments (among 5440 Medicare beneficiaries). Primary outcomes included infections within 90 days of implant and Medicare payments. RESULTS: There were 3982 infections identified among 27.8% (2,417/8,688) of patients developing an infection. The median (25(th), 75(th) percentile) adjusted incidence of infections (per 100 patient-months) across hospitals was 14.3 (9.3, 19.5) and varied by hospital (range 0.0 – 35.6). Total Medicare payments from implant to 90-days were 9.0% (absolute difference: $13,652) greater in high versus low infection tercile hospitals, p

Prior work has established that high socioeconomic deprivation is associated with worse short- and long-term outcomes for patients undergoing coronary artery bypass grafting (CABG). The relationship between socioeconomic status and 90-day episode spending is poorly understood. In this observational cohort analysis, we evaluated whether socioeconomically disadvantaged patients were associated with higher expenditures during 90-day episodes of care after isolated CABG.We linked clinical registry data from 8728 isolated CABG procedures from January 1, 2012, to December 31, 2018, to Medicare fee-for-service claims data. Our primary exposure variable was patients in the top decile of the Area Deprivation Index. Linear regression was used to compare risk-adjusted, price-standardized 90-day episode spending for deprived against nondeprived patients as well as component spending categories: index hospitalization, professional services, post acute care, and readmissions.A total of 872 patients were categorized as being in the top decile. Mean 90-day episode spending for the 8728 patients in the sample was $55 258 (SD, $26 252). Socioeconomically deprived patients had higher overall 90-day spending compared with nondeprived patients ($61 579 vs $54 557; difference, $3003; P = .001). Spending was higher in socioeconomically deprived patients for index hospitalizations (difference, $1284; P = .005), professional services (difference, $379; P = .002), and readmissions (difference, $1188; P = .008). Inpatient rehabilitation was the only significant difference in post-acute care spending (difference, $469; P = .011).Medicare spending was higher for socioeconomically deprived CABG in Michigan, indicating systemic disparities over and above patient demographic factors.

Regional quality improvement collaboratives may provide one solution to improving cardiac rehabilitation (CR) participation through performance benchmarking and provider engagement. The objective of this study was to evaluate the feasibility of the Michigan Cardiac Rehab Network to improve CR participation.Multipayer claims data from the Michigan Value Collaborative were used to identify hospitals and CR facilities and assemble a multidisciplinary advisory group. Univariate analyses described participating hospital characteristics and hospital-level rates of CR performance across eligible conditions including enrollment within 1 yr, mean days to first CR visit, and mean number of CR visits within 1 yr. Three diverse CR facilities were chosen for virtual site visits to identify areas of success and barriers to improvement.A total of 95 hospitals and 84 CR facilities were identified, with 48 hospitals (51%) providing interventional cardiology services and 33 (35%) providing cardiac surgical services. A 17-member multidisciplinary advisory group was assembled representing 13 institutions and diverse roles. Statewide CR enrollment across eligible admissions was 33.4%, with wide variation in CR performance measures across participating hospitals and eligible admissions. Virtual site visits revealed individual successes in improving CR participation but a variety of barriers to participation related to referrals, capacity and staffing constraints, and geographic and financial barriers.This study demonstrated the feasibility of creating a statewide collaboration of hospitals and CR facilities centered around the goal of equitably improving CR enrollment for all eligible patients in Michigan that is supported by a multidisciplinary advisory group and performance benchmarking.

BACKGROUND The United States National Organ Procurement Transplant Network (OPTN) implemented changes to the adult heart allocation system to reduce waitlist mortality by improving access for those at greater risk of pre-transplant death, including patients on short-term mechanical circulatory support (sMCS). While sMCS increased, it is unknown whether the increase occurred equitably across centers. METHODS The OPTN database was used to assess changes in use of sMCS at time of transplant in the 12 months before (pre-change) and after (post-change) implementation of the allocation system in October 2018 among 5,477 heart transplant recipients. An interrupted time series analysis comparing use of bridging therapies pre- and post-change was performed. Variability in the proportion of sMCS use at the center level pre- and post-change was determined. RESULTS In the month pre-change, 9.7% of patients were transplanted with sMCS. There was an immediate increase in sMCS transplant the following month to 32.4% - an absolute and relative increase of 22.7% and 312% (p < 0.001). While sMCS use was stable pre-change (monthly change 0.0%, 95% CI [-0.1%,0.1%]), there was a continuous 1.2%/month increase post-change ([0.6%,1.8%], p < 0.001). Center-level variation in sMCS use increased substantially after implementation, from a median (interquartile range) of 3.85% (10%) pre-change to 35.7% (30.6%) post-change (p < 0.001). CONCLUSIONS Use of sMCS at time of transplant increased immediately and continued to expand following heart allocation policy changes. Center-level variation in use of sMCS at the time of transplant increased compared to pre-change, which may have negatively impacted equitable access to heart transplantation.

Objective Our objective was to evaluate changes in elective surgical volume in Michigan while an Executive Order (EO) was in place curtailing elective surgery during the COVID-19 pandemic. Summary background data Many state governors enacted EOs curtailing elective surgery to protect scare resources and generate hospital capacity for patients with COVID-19. Little is known of the effectiveness of an EO on achieving a sustained reduction in elective surgery. Methods This retrospective cohort study of data from a statewide claims-based registry in Michigan includes claims from the largest private payer in the state for a representative set of elective operations on adult patients from February 2 through August 1, 2020. We reported trends in surgical volume over the period the EO was in place. Estimated backlogs in elective surgery were calculated using case counts from the same period in 2019. Results Hospitals achieved an 91.7% reduction in case volume before the EO was introduced. By the time the order was rescinded, hospitals were already performing elective surgery at 60.1% of pre-pandemic case rates. We estimate that a backlog of 6,419 operations was created while the EO was in effect. Had hospitals ceased elective surgery during this period, an additional 18% of patients would have experienced a delay in surgical care. Conclusions Both the introduction and removal of Michigan's EO lagged behind the observed ramp-down and ramp-up in elective surgical volume. These data suggest that EOs may not effectively modulate surgical care and could also contribute to unnecessary delays in surgical care.

While left ventricular assist devices (LVADs) increase survival for patients with advanced heart failure (HF), racial and sex access and outcome inequities remain and are poorly understood.To assess risk-adjusted inequities in access and outcomes for both Black and female patients and to examine heterogeneity in treatment decisions among patients for whom clinician discretion has a more prominent role.This retrospective cohort study of 12 310 Medicare beneficiaries used 100% Medicare Fee-for-Service administrative claims. Included patients had been admitted for heart failure from 2008 to 2014. Data were collected from July 2007 to December 2015 and analyzed from August 23, 2020, to May 15, 2022.Beneficiary race and sex.The propensity for LVAD implantation was based on clinical risk factors from the 6 months preceding HF admission using XGBoost and the synthetic minority oversampling technique. Beneficiaries with a 5% or greater probability of receiving an LVAD were included. Logistic regression models were estimated to measure associations of race and sex with LVAD receipt adjusting for clinical characteristics and social determinants of health (eg, distance from LVAD center, Medicare low-income subsidy, neighborhood deprivation). Next, 1-year mortality after LVAD was examined.The analytic sample included 12 310 beneficiaries, of whom 22.9% (n = 2819) were Black and 23.7% (n = 2920) were women. In multivariable models, Black beneficiaries were 3.0% (0.2% to 5.8%) less likely to receive LVAD than White beneficiaries, and women were 7.9% (5.6% to 10.2%) less likely to receive LVAD than men. Individual poverty and worse neighborhood deprivation were associated with reduced use, 2.9% (0.4% to 5.3%) and 6.7% (2.9% to 10.5%), respectively, but these measures did little to explain observed disparities. The racial disparity was concentrated among patients with a low propensity score (propensity score0.52). One-year survival by race and sex were similar on average, but Black patients with a low propensity score experienced improved survival (7.2% [95% CI, 0.9% to 13.5%]).In this cohort study of Medicare beneficiaries hospitalized for HF, disparities in LVAD use by race and sex existed and were not explained by clinical characteristics or social determinants of health. The treatment and post-LVAD survival by race were equivalent among the most obvious LVAD candidates. However, there was differential use and outcomes among less clear-cut LVAD candidates, with lower use but improved survival among Black patients. Inequity in LVAD access may have resulted from differences in clinician decision-making because of systemic racism and discrimination, implicit bias, or patient preference.

Failure to rescue (FTR), defined as death after a complication, is recognized as a principal driver of variation in mortality among hospitals. We evaluated FTR as a quality metric in patients who received durable left ventricular assist devices (LVADs) using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support.Data on 13,617 patients who received primary durable LVADs from April 2012 to October 2017 at 131 hospitals that performed at least 20 implants were analyzed from the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support. Rates of major complications and FTR were compared across risk-adjusted in-hospital mortality terciles (low, medium, high) and hospital volume. Logistic regression was used to estimate expected FTR rates on the basis of patient factors for each major complication.The overall unadjusted in-hospital mortality rate was 6.96%. Risk-adjusted in-hospital mortality rates varied 3.1-fold across terciles (low, 3.3%; high, 10.3%; P trend.001). Rates of major complications varied 1.1-fold (low, 34.0%; high, 38.8%; P .0001). Among patients with a major complication, 854 died in-hospital for an FTR rate of 17.7%, with 2.8-fold variation across mortality terciles (low, 8.5%; high, 23.9%; P .0001). FTR rates were highest for renal dysfunction requiring dialysis (45.3%) and stroke (36.5%). Higher average annual LVAD volume was associated with higher rates of major complications (10 per year, 26.7%; 10-20 per year, 34.0%; 20-30 per year, 34.0%;30 per year, 40.1%; P trend.0001) whereas hospitals implanting10 per year had the highest FTR rate (10 per year, 23.5%; 10-20 per year, 16.5%; 20-30 per year, 17.0%;30 per year, 17.9%; P = .03).FTR might serve as an important quality metric for durable LVAD implant procedures, and identifying strategies for successful rescue after complications might reduce hospital variations in mortality.

Racial disparities in health care have come to the forefront. We hypothesized that Black race was associated with worse preoperative risk, lower repair rates, and worse outcomes among patients who underwent mitral valve surgery.All patients who underwent mitral valve repair or replacement with or without coronary artery bypass grafting from 2011 to 2020 in a statewide collaborative database were stratified into 3 racial groups, White, Black, and other. Preoperative characteristics, procedure type, and outcomes were evaluated.A total of 9074 mitral valve operations were performed at 33 centers (Black 1009 [11.1%], White 7862 [86.6%]). Preoperative combined Society of Thoracic Surgeons morbidity and mortality was higher for Black patients (Black 32%, White 22%, other 23%, [P .001]) because of a greater proportion of diabetes, hypertension, and chronic lung disease. White patients were more likely to undergo mitral repair (White 66%, Black 53.3%, other 57%; P .001). Operative mortality was similar across racial groups (White 3.7%, Black 4.6%, other 4.5%; P = .36). After adjusting for preoperative factors, mitral etiology, and hospitals, race was not associated with mitral valve repair, complications, or mortality, but Black patients had higher odds of extended care facility utilization and readmission.Contrary to our hypothesis, there was no difference in the odds of repair or operative mortality across races after accounting for risk and etiology. However, Black patients were more likely to be readmitted after discharge. These findings support a greater focus on reducing disparities in mitral valve surgery.

IntroductionAt the start of the COVID-19 public health emergency, the federal government made temporary Medicare policy changes to expand telehealth coverage, resulting in a surge in telehealth use. As federal and state policymakers currently consider permanent telehealth policy options, it is important to understand the trends in telehealth use during 2021 and whether telehealth has led to an increase in the overall volume of healthcare services.MethodsOur analysis was conducted using Part B claims for 100% of Medicare fee-for-service beneficiaries. We identified all outpatient evaluation and management (E&M) services received by beneficiaries from January 1, 2019 through December 31, 2021. We then calculated the monthly proportion of outpatient E&M services that were performed in-person and through telehealth.ResultsThe total number of all outpatient E&M services was 289.0 million in 2019, 255.2 million in 2020 (11.7% lower than 2019), and 260.7 million in 2021 (9.8% lower than 2019). Monthly telehealth services peaked at 7.2 million (or 50.7% of monthly E&M services) in April 2020, followed by a slow decline through the end of 2021. During the second half of 2021, telehealth services made up 8.5-9.5% of monthly E&M services.ConclusionFrom April 2020 through December 2021, the monthly volume of telehealth services slowly declined and has plateaued between 8.5-9.5% of all outpatient E&M services received by Medicare fee-for-service beneficiaries. Importantly, the total volume of outpatient E&M services was lower in 2020 and 2021, suggesting that the COVID-19 telehealth flexibilities have not increased the overall volume of outpatient E&M services received by Medicare beneficiaries. These findings should mitigate some concerns about the impact of telehealth on overall healthcare utilization.At the start of the COVID-19 public health emergency, the federal government made temporary Medicare policy changes to expand telehealth coverage, resulting in a surge in telehealth use.1,2 While telehealth was a necessary substitute for in-person care during first few months of the pandemic, there was a decline in the use of telehealth during the second half of 2020.3 As federal and state policymakers currently consider permanent telehealth policy options, it is important to understand the trends in telehealth use during 2021 and whether telehealth has led to an increase in the overall volume of healthcare services.

Background: Despite reported benefit in the setting of aortic valve replacement (AVR), cardiac rehabilitation (CR) utilization remains low, with few studies evaluating hospital and patient-level variation in CR participation. We explored determinants of CR variability during AVR episodes of care: transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Methods: A cohort of 10 124 AVR episodes of care (TAVR n=5121 from 24 hospitals; SAVR n=5003 from 32 hospitals) were identified from the Michigan Value Collaborative statewide multipayer registry (2015–2019). CR enrollment was defined as the presence of a single professional or facility claim within 90 days of discharge: 93 797, 93 798, G0422, G0423. Annual trends and hospital variation in CR were described for TAVR, SAVR, and all AVR. Multilevel logistic regression was used to estimate effects of predictors and hospital risk-adjusted rates of CR enrollment. Results: Overall, 4027 (39.8%) patients enrolled in CR, with significant differences by treatment strategy: SAVR=50.9%, TAVR=28.9% ( P P P r =0.56, P Conclusions: Substantial variation exists in CR participation during AVR episodes of care across hospitals. However, within-hospital CR participation rates were significantly correlated across treatment strategies. These findings suggest that CR participation is the product of hospital-specific practice patterns. Identifying hospital practices associated with higher CR participation can help assist future quality improvement efforts to increase CR use after AVR.

Importance While telehealth use in surgery has shown to be feasible, telehealth became a major modality of health care delivery during the COVID-19 pandemic. Objective To assess patterns of telehealth use across surgical specialties before and during the COVID-19 pandemic. Design, Setting, and Participants Insurance claims from a Michigan statewide commercial payer for new patient visits with a surgeon from 1 of 9 surgical specialties during one of the following periods: prior to the COVID-19 pandemic (period 1: January 5 to March 7, 2020), early pandemic (period 2: March 8 to June 6, 2020), and late pandemic (period 3: June 7 to September 5, 2020). Exposures Telehealth implementation owing to the COVID-19 pandemic in March 2020. Main Outcomes and Measures (1) Conversion rate defined as the rate of weekly new patient telehealth visits divided by mean weekly number of total new patient visits in 2019. This outcome adjusts for a substantial decrease in outpatient care during the pandemic. (2) Weekly number of new patient telehealth visits divided by weekly number of total new patient visits. Results Among 4405 surgeons in the cohort, 2588 (58.8%) performed telehealth in any patient care context. Specifically for new patient visits, 1182 surgeons (26.8%) used telehealth. A total of 109 610 surgical new outpatient visits were identified during the pandemic. The median (interquartile range) age of telehealth patients was 46.8 (34.1-58.4) years compared with 52.6 (38.3-62.3) years for patients who received care in-person. Prior to March 2020, less than 1% (8 of 173 939) of new patient visits were conducted through telehealth. Telehealth use peaked in April 2020 (week 14) and facilitated 34.6% (479 of 1383) of all new patient visits during that week. The telehealth conversion rate peaked in April 2020 (week 15) and was equal to 8.2% of the 2019 mean weekly new patient visit volume. During period 2, a mean (SD) of 16.6% (12.0%) of all new patient surgical visits were conducted via telehealth (conversion rate of 5.1% of 2019 mean weekly new patient visit volumes). During period 3, 3.0% (2168 of 71 819) of all new patient surgical visits were conducted via telehealth (conversion rate of 2.5% of 2019 new patient visit volumes). Mean (SD) telehealth conversion rates varied by specialty with urology being the highest (14.3% [7.7%]). Conclusions and Relevance Results from this study showed that telehealth use grew across all surgical specialties in Michigan in response to the COVID-19 pandemic. While rates of telehealth use have declined as in-person care has resumed, telehealth use remains substantially higher across all surgical specialties than it was prior to the pandemic.

Background Pneumonia is the most prevalent healthcare-associated infection after coronary artery bypass grafting (CABG), but the relative effectiveness of strategies to reduce its incidence remains unclear. We evaluated the relationship between healthcare-associated infection recommendations and risk of pneumonia after CABG. Methods Pneumonia prevention practice recommendations were developed based on literature review and analysis of semistructured interviews with key health care personnel across centers with low ( 6.1%) rates of pneumonia. These practices were implemented among 2482 patients undergoing CABG from 2016 to 2017 across 18 centers. The independent effect of each practice in reducing pneumonia was assessed using multivariable logistic regression, adjusting for baseline risk and center. A composite (bundle) score was calculated as the number of practices (0 to 4) each patient received. Results Recommended pneumonia prevention practices included lung protective ventilation management, early extubation, progressive ambulation, and avoidance of postoperative bronchodilator therapy. Pneumonia occurred in 2.4% of patients. Lung protective ventilation (adjusted odds ratio [ORadj], 0.45; 95% confidence interval [CI], 0.22-0.92), ambulation (ORadj, 0.08; 95% CI, 0.04-0.17), and postoperative ventilation of less than 6 hours (ORadj, 0.47; 95% CI, 0.26-0.87) were significantly associated with lower odds of pneumonia. Postoperative bronchodilator therapy (ORadj, 4.83; 95% CI, 2.20-10.7) was significantly associated with higher odds. Risk-adjusted rates of pneumonia, operative mortality, and intensive care unit length of stay were lower in patients with higher bundle scores (all P-trend Conclusions These pneumonia prevention recommendations may serve as effective targets for avoiding postoperative healthcare-associated infections.

Patients undergoing left ventricular assist device (LVAD) implantation are at risk for death and postoperative adverse outcomes. Interhospital variability and concordance of quality metrics were assessed using the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs).A total of 22 173 patients underwent primary, durable LVAD implantation across 160 hospitals from 2012 to 2020, excluding hospitals performing10 implant procedures. Observed and risk-adjusted operative mortality rates were calculated for each hospital. Outcomes included operative and 90-day mortality, a composite of adverse events (operative mortality, bleeding, stroke, device malfunction, renal dysfunction, respiratory failure), and secondarily failure to rescue. Rates are presented as median (interquartile range [IQR]). Hospital performance was evaluated using observed-to-expected (O/E) ratios for mortality and the composite outcome.Interhospital variability existed in observed (median, 7.2% [IQR, 5.1%-9.6%]) mortality. The rates of adverse events varied across hospitals: major bleeding, 15.6% (IQR, 11.4%-22.4%); stroke, 3.1% (IQR, 1.6%-4.7%); device malfunction, 2.4% (IQR, 0.8%-3.7%); respiratory failure, 10.5% (IQR, 4.6%-15.7%); and renal dysfunction, 6.4% (IQR, 3.2%-9.6%). The O/E ratio for operative mortality varied from 0.0 to 6.1, whereas the O/E ratio for the composite outcome varied from 0.28 to 1.99. Hospital operative mortality O/E ratios were more closely correlated with the 90-day mortality O/E ratio (r = 0.74) than with the composite O/E ratio (r = 0.12).This study reported substantial interhospital variability in performance for hospitals implanting durable LVADs. These findings support the need to (1) report hospital-level performance (mortality, composite) and (2) undertake benchmarking activities to reduce unwarranted variability in outcomes.

Objective We evaluated whether interhospital variation in mortality rates for coronary artery bypass grafting was driven by complications and failure to rescue. Methods An observational study was conducted among 83,747 patients undergoing isolated coronary artery bypass grafting between July 2011 and June 2017 across 90 hospitals. Failure to rescue was defined as operative mortality among patients developing complications. Complications included the Society of Thoracic Surgeons 5 major complications (stroke, surgical reexploration, deep sternal wound infection, renal failure, prolonged intubation) and a broader set of 19 overall complications. After creating terciles of hospital performance (based on observed:expected mortality), each tercile was compared on the basis of crude rates of (1) major and overall complications, (2) operative mortality, and (3) failure to rescue (among major and overall complications). The correlation between hospital observed and expected (to address confounding) failure to rescue rates was assessed. Results Median Society of Thoracic Surgeons predicted mortality risk was similar across hospital observed:expected mortality terciles (P = .831). Mortality rates significantly increased across terciles (low tercile: 1.4%, high tercile: 2.8%). Although small in magnitude, rates of major (low tercile: 11.1%, high tercile: 12.2%) and overall (low tercile: 36.6%, high tercile: 35.3%) complications significantly differed across terciles. Nonetheless, failure to rescue rates increased substantially across terciles among patients with major (low tercile: 9.1%, high tercile: 14.3%) and overall (low tercile: 3.3%, high tercile: 6.8%) complications. Hospital observed and expected failure to rescue rates were positively correlated among patients with major (R2 = 0.14) and overall (R2 = 0.51) complications. Conclusions The reported interhospital variability in successful rescue after coronary artery bypass grafting supports the importance of identifying best practices at high-performing hospitals, including early recognition and management of complications.

Background Public reporting of transcatheter aortic valve replacement (TAVR) claims–based outcome measures is used to identify high‐ and low‐performing centers. Whether claims‐based TAVR outcomes can reliably be used for center‐level comparisons is unknown. In this study, we sought to evaluate center variability in claims‐based TAVR outcomes used in public reporting. Methods and Results The study sample included 119 554 Medicare beneficiaries undergoing TAVR between January 2014 and October 2018 based on procedure codes in 100% Medicare inpatient claims. Multivariable hierarchical logistic regression was used to estimate center‐specific adjusted rates and reliability (R) of 30‐day mortality, discharge not to home/self‐care, 30‐day stroke, and 30‐day readmission. Reliability was defined as the ratio of between‐hospital variation to the sum of the between‐ and within‐hospital variation. The median (interquartile range [IQR]) center‐level adjusted outcome rates were 3.1% (2.9%–3.4%) for 30‐day mortality, 41.4% (31.3%–53.4%) for discharge not to home, 2.5% (2.3%–2.7%) for 30‐day stroke, and 14.9% (14.4%–15.5%) for 30‐day readmission. Median reliability was highest for the discharge not to home measure (R=0.95; IQR, 0.94–0.97), followed by the 30‐day stroke (R=0.92; IQR, 0.87–0.94), 30‐day mortality (R=0.86; IQR, 0.81–0.91), and 30‐day readmission measures (R=0.42; IQR, 0.35–0.51). Across outcomes, there was an inverse relationship between center volume and measure reliability. Conclusions Claims‐based TAVR outcome measures for mortality, discharge not to home, and stroke were reliable measures for center‐level comparisons, but readmission measures were unreliable. Stakeholders should consider these findings when evaluating claims‐based measures to compare center‐level TAVR performance.

Background:Despite its established benefit and strong endorsement in international guidelines, cardiac rehabilitation (CR) use remains low. Identifying determinants of CR referral and use may help develop targeted policies and quality improvement efforts. We evaluated the variation in CR referral and use across percutaneous coronary intervention (PCI) hospitals and operators.Methods:We performed a retrospective observational cohort study of all patients who underwent PCI at 48 nonfederal Michigan hospitals between January 1, 2012 and March 31, 2018 and who had their PCI clinical registry record linked to administrative claims data. The primary outcomes included in-hospital CR referral and CR participation, defined as at least one outpatient CR visit within 90 days of discharge. Bayesian hierarchical regression models were fit to evaluate the association between PCI hospital and operator with CR referral and use after adjusting for patient characteristics.Results:Among 54 217 patients who underwent PCI, 76.3% received an in-hospital referral for CR, and 27.1% attended CR within 90 days after discharge. There was significant hospital and operator level variation in in-hospital CR referral with median odds ratios of 3.88 (95% credible interval [CI], 3.06–5.42) and 1.64 (95% CI, 1.55–1.75), respectively, and in CR participation with median odds ratios of 1.83 (95% CI, 1.63–2.15) and 1.40 (95% CI, 1.35–1.47), respectively. In-hospital CR referral was significantly associated with an increased likelihood of CR participation (adjusted odds ratio, 1.75 [95% CI, 1.52–2.01]), and this association varied by treating PCI hospital (odds ratio range, 0.92–3.75) and operator (odds ratio range, 1.26–2.82).Conclusions:In-hospital CR referral and 90-day CR use after PCI varied significantly by hospital and operator. The association of in-hospital CR referral with downstream CR use also varied across hospitals and less so across operators suggesting that specific hospitals and operators may more effectively translate CR referrals into downstream use. Understanding the factors that explain this variation will be critical to developing strategies to improve CR participation overall.

Highlights • Post-TAVR HRQOL shows more rapid short-term improvement than SAVR within trials. • Higher TAVR use requires better real-world TAVR/SAVR cost-effectiveness comparisons. • Wearable devices should be used in real-world settings to compare TAVR/SAVR HRQOL., Background Aortic stenosis is a prevalent valvular heart disease that is treated primarily by surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR), which are common treatments for addressing symptoms secondary to valvular heart disease. This narrative review article focuses on the existing literature comparing recovery and cost-effectiveness for SAVR and TAVR. Methods Major databases were searched for relevant literature discussing HRQOL and cost-effectiveness of TAVR and SAVR. We also searched for studies analyzing the use of wearable devices to monitor post-discharge recovery patterns. Results The literature focusing on quality-of-life following TAVR and SAVR has been limited primarily to single-center observational studies and randomized controlled trials. Studies focused on TAVR report consistent and rapid improvement relative to baseline status. Common HRQOL instruments (SF-36, EQ-5D, KCCQ, MLHFQ) have been used to document that TF-TAVR is advantageous over SAVR at 1-month follow-up, with the benefits leveling off following 1 year. TF-TAVR is economically favorable relative to SAVR, with estimated incremental cost-effectiveness ratio values ranging from $50,000 to $63,000/QALY gained. TA-TAVR has not been reported to be advantageous from an HRQOL or cost-effectiveness perspective. Conclusions While real-world experiences are less described, large-scale trials have advanced our understanding of recovery and cost-effectiveness of aortic valve replacement treatment strategies. Future work should focus on scalable wearable device technology, such as smartwatches and heart-rate monitors, to facilitate real-world evaluation of TAVR and SAVR to support clinical decision-making and outcomes ascertainment.

As surgical mortality decreases and endovascular utilization increases, it is unknown whether volume-outcome relationships exist in thoracic aortic dissection repair. We characterized volume-outcome relationships for surgical and endovascular management of thoracic aortic dissection.Patients aged more than 18 years undergoing repair of thoracic aortic dissection in the United States between 2010 and 2014 were identified in seven all-payer state inpatient administrative databases. Patients were divided into groups based on type of repair: surgical repair of type A dissection (TAAD), surgical repair of type B dissection (TBAD), and endovascular repair (TEVAR). Hierarchical logistic regression models evaluated the association between hospital volume and in-hospital mortality.Overall in-hospital mortality rate was 13.4% (890 of 6650), highest after TAAD (463 of 2918, 15.9%), followed by TBAD (270 of 1934, 14.0%) and TEVAR (157 of 1798, 8.7%). Volume-outcome relationships for adjusted in-hospital mortality were demonstrated for TAAD and TBAD (P-trend.001), but not TEVAR (P-trend = .11). Adjusted in-hospital mortality differed most for TAAD (fewer than 3 cases per year: 21%, 95% confidence interval, 18% to 24%; vs 11 or more cases per year: 12%, 95% confidence interval, 8% to 16%; P.001) and TBAD (fewer than 2 cases per year: 18%, 95% confidence interval, 15% to 22%; vs 11 or more cases per year: 9%, 95% confidence interval, 5% to 12%; P.001), whereas TEVAR did not differ between quartiles. Adjusted mortality was lower at centers with 26 or more overall annual thoracic dissection repairs, compared with any of the three lower-volume quartiles (P.001).This study demonstrated lower mortality at high-volume hospitals for overall repair of aortic dissection, persisting separately for surgical repair of TAAD and TBAD, but not TEVAR. As endovascular technology advances and practice patterns consequently change, analyses should focus on understanding the balance between procedural volume, mortality, and access to care for thoracic aortic dissection.

Although the current wide-scale adoption of the HeartMate 3 left ventricular assist device can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of left ventricular assist device clinical trial outcomes and evaluated the prognostic value of specific inclusion and exclusion criteria.The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) who underwent HeartMate 3 implantation (n = 4610) between August 2017 and March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models.Indications for HeartMate 3 implant included destination therapy (n = 2827, 61%), bridge to candidacy (n = 969, 21%), and bridge to transplant (n = 702, 15%). A total of 1941 recipients (42%) were trial-ineligible, with 1245 (27%) meeting one ineligibility criterion, 470 (10%) meeting two, and 226 (5%) meeting three or more. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17% ± 1% vs 10% ± 1%, P.001). Compared with trial-eligible patients, 1-year mortality was incrementally higher for patients meeting one ineligibility criterion (15% ± 1%), two criteria (16% ± 2%), and three or more criteria (30% ± 3%). Thrombocytopenia and elevated creatinine, bilirubin, and international normalized ratio in trial-ineligible patients were independently associated with increased mortality.Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded.

Introduction: Endovascular therapy (EVT) and tissue plasminogen activator (tPA) are highly effective treatments but little is published on their impact on health care utilization and payments. We analyzed of data from the Michigan Value Collaborative (MVC) registry to compare 90-day episode payments for EVT and tPA treatments acute ischemic stroke patients. Methods: The MVC registry uses claims data from Michigan residents insured by Medicare fee-for-service and Blue Cross Blue Shield, to construct risk-adjusted and price-standardized payments for 90-day episodes of care. Total payments are categorized into index hospitalization, professional services, readmissions, and post-acute care. All ischemic stroke admissions between January 2014 and June 2019 were identified and then categorized using a combination of diagnosis and procedure codes into 3 mutually exclusive treatment groups: EVT (with and without tPA), IV or IA tPA only, and all other ischemic strokes (non EVT-tPA). We compared 90-day episode payments between the 3 groups using analysis of variance and Tukey’s pairwise comparisons. Results: We identified 47,235 acute ischemic stroke patients admitted to 83 Michigan hospitals, 1,775 (3.8%), 4,889 (10.3%), and 40,571 (85.9%) received EVT, tPA only, or neither, respectively. Statistically significant differences were observed across the 3 treatment groups in all payment categories. EVT treated patients had the highest 90-day mean payments in all categories, but particularly for readmissions and post-acute care (Table). tPA treated patients had significantly higher costs than the non EVT-tPA group for total payments, professional and hospitalization fees. Conclusions: EVT and tPA treatments significantly affect 90-day episode payments - primarily due to higher hospitalization and professional payments. Higher readmission and post-acute cost in EVT treated patients reflect higher readmission rates and use of in-patient rehabilitation.

Background: Cardiac rehabilitation (CR) is associated with improved outcomes for patients with coronary artery disease (CAD). However, CR enrollment remains low and there is a dearth of real-world data on hospital-level variation in CR enrollment. We sought to explore determinants of hospital variability in CR enrollment during CAD episodes of care: medical management of acute myocardial infarction (AMI-MM), percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). Methods: A cohort of 71 703 CAD episodes of care were identified from 33 hospitals in the Michigan Value Collaborative statewide multipayer registry (2015 to 2018). CR enrollment was defined using professional and facility claims and compared across treatment strategies: AMI-MM (n=18 678), PCI (n=41 986), and CABG (n=11 039). Hierarchical logistic regression was used to estimate effects of predictors and hospital risk-adjusted rates of CR enrollment. Results: Overall, 20 613 (28.8%) patients enrolled in CR, with significant differences by treatment strategy: AMI-MM=13.4%, PCI=29.0%, CABG=53.8% ( P 2 =0.72), followed by PCI versus CABG (R 2 =0.51) and AMI-MM versus CABG (R 2 =0.46, all P Conclusions: Substantial variation exists in CR enrollment during CAD episodes of care across hospitals. However, within-hospital CR enrollment rates were significantly correlated across all treatment strategies. These findings suggest that CR enrollment during CAD episodes of care is the product of hospital-specific rather than treatment-specific practice patterns.

Background Cardiovascular outcomes are worse among individuals from areas with limited socioeconomic resources. This study evaluated the relationship between high socioeconomic deprivation and isolated coronary artery bypass grafting (CABG) outcomes. Methods We linked statewide Society of Thoracic Surgeons Adult Cardiac Surgery Database data to Medicare fee-for-service records for 10,423 Michigan residents undergoing isolated CABG between 01/2012-12/2018. High socioeconomic deprivation was defined as residing in the highest decile of zip code-level area deprivation index (ADI). Multivariable logistic regression estimated the relationship between top ADI decile and major morbidity, in-hospital mortality, and operative mortality. Survival analyses evaluated long-term survival comparing patients in the top versus not in the top ADI decile. Results A total of 1,036 patients were in the top decile of ADI (ADI>82.4), and were more likely to be female, black, and have a higher predicted risk of mortality. Patients in the top ADI decile had significantly higher rates of major morbidity (17.4% versus 11.4%, adjusted odds ratio =1.26, 95% CI: 1.04-1.54, p=0.021) and in-hospital mortality (3.2% versus 1.3%, adjusted odds ratio=1.84, 95% CI: 1.18-2.86, p=0.007), but not operative mortality. The adjusted hazard of mortality was 16% higher for patients residing in the top ADI decile (95% CI: 1.01-1.33, p=0.032). Conclusions Isolated CABG patients residing in the highest areas of socioeconomic deprivation differed with respect to demographic and clinical characteristics, and experienced worse short and long-term outcomes compared with those not in the top ADI decile.

Introduction: Research suggests that neighborhood-level factors are associated with long-term health; however, there is a dearth of research evaluating this association among patients (pts) undergoing percutaneous coronary intervention (PCI), a population that is usually optimally treated with respect to long-term risk management. Hypothesis: We hypothesize that pts living in the most disadvantaged areas have a higher risk of post-discharge mortality after PCI compared with pts not living in the most disadvantaged areas. Methods: Using a clinical registry of pts with valid zip codes who underwent PCI between 1/2013 - 3/2018 at 47 Michigan hospitals linked to Medicare claims, we compared long-term outcomes between pts in the highest ADI decile (i.e. most disadvantaged) with the remainder. The Area Deprivation Index (ADI) is a zip-code-level composite measure of neighborhood disadvantage. Unadjusted mortality was depicted on a Kaplan-Meier plot. We used a Cox model to assess the association between the ADI and mortality after adjusting for pt factors. Results: Among 26,164 pts, 9.9% lived in the most disadvantaged zip codes and were more likely to be younger, of black race, have both Medicare and Medicaid insurance, and have more cardiovascular comorbidities. Unadjusted rates of mortality were higher among pts living in the most disadvantaged areas compared with the remainder (5-yr mortality: 64.5% vs 70.9%; Fig). After adjusting for pt factors, those living in the most disadvantaged areas had a significantly increased risk of long-term mortality (HR 1.16; 95% CI 1.08 - 1.25), a risk equivalent to an 8% reduction in one’s ejection fraction (HR for 8% EF reduction: 1.16; 95% CI 1.14 - 1.17). Conclusions: Medicare pts living in the most disadvantaged areas have a higher risk of post-PCI long-term mortality compared with the remainder. Policies targeting the deleterious health effects of neighborhood disadvantage and social risk are needed to improve survival after PCI.

Introduction: Despite its proven benefits, cardiac rehabilitation (CR) use remains low. Identifying the sources of variation in CR referral and downstream use may help direct policies and quality improvement efforts. Objectives: We sought to quantify the magnitude of hospital and operator-level variation in CR referral and utilization after percutaneous coronary intervention (PCI). Methods: We used clinical registry data from patients (pts) discharged after PCI between 1/2012 and 10/2016 at 32 Michigan hospitals performing at least 100 PCIs linked to Blue Cross Blue Shield or Medicare claims. Registry and claims data were used to identify (i) CR referral prior to discharge and (ii) any CR use within 90 days after discharge. We calculated hospital-level risk and reliability adjusted rates of CR referral and utilization with Bayesian hierarchical regression models adjusted for patient characteristics and clustering by hospital and operator. Median odds ratios (MORs) with 95% credible intervals (CI) measured variation attributable to hospitals and operators. Results: Among 33,593 pts with a valid zip code and discharged home after PCI, 76.4% received an in-hospital referral for CR. Overall CR use was 26.7% and 31.3% among those who received an in-hospital referral. Adjusted rates of CR referral and use across hospitals ranged from 1.0%-100% and 14.9%-73.9%, respectively (Fig). After adjusting for pt factors, there was significant hospital and operator-level variation in CR referral with MORs of 5.91 (95% CI 4.02-9.34) and 1.71 (95% CI 1.60-1.85), respectively. There was also significant hospital and operator-level variation in CR use with MORs of 1.99 (95% CI 1.67 - 2.46) and 1.36 (95% CI 1.29 - 1.44), respectively. Conclusions: We found significant hospital and operator-level variation not only in post-PCI CR referral, but also CR utilization. Multi-faceted interventions targeting hospitals and PCI operators are needed to improve CR use after PCI.

Introduction: Volume-outcome relationships are well defined in transcatheter aortic valve replacement (TAVR), but little is known about how hospital experience in aortic valve replacement (AVR) informs processes of care to rescue patients once a complication occurs after TAVR. Hypothesis: Increasing AVR experience improves post-TAVR rates of failure to rescue (FTR) - defined as in-hospital mortality after major treatable post-procedural complications. Methods: Statewide Inpatient Databases from seven diverse states were queried from 2011 to 2017 for patients who underwent TAVR. Hospitals were stratified as low vs high-volume by mean annualized SAVR and TAVR volume using the median as cutoff: SAVR = 43 cases/year, TAVR = 28 cases/year. Crude rates of complications, in-hospital mortality, and FTR were estimated for the overall sample and stratified by SAVR and TAVR volume (low vs high). Logistic regression was used to estimate the adjusted odds ratio of SAVR and TAVR volume, independently, on the outcomes above, adjusting for patient demographics and comorbid conditions. Results: A total of 42,025 TAVR patients were identified and categorized as low (N = 2,946) or high-volume (N = 39,079) SAVR centers, and low (N = 7,183) or high-volume (N = 34,842) TAVR centers. Within the high-volume SAVR centers, 84.8% were also high-volume TAVR centers. Low SAVR or TAVR volume was associated with a marginal increase in the risk of developing complications after TAVR (OR 1.26; P < 0.001 and OR 1.14; P < 0.001) as show in Table 1. There was no statistically significant difference in risk-adjusted in-hospital mortality rates (OR 1.10; P = 0.499 and OR 1.10; P = 0.273) or FTR rates (OR 0.97; P = 0.816 and OR 1.03; P = 0.732) after TAVR between low- and high-volume SAVR or TAVR centers, respectively. Conclusion: Undergoing TAVR at a high-volume SAVR or TAVR center was associated with lower rates of complications, but volume was not an independent predictor of in-hospital mortality or FTR.

Background: Postacute care is a major driver of cardiac surgical episode spending, but the sources of variation in spending have not been explored. The objective of this study was to identify sources of variation in postacute care spending within 90-days of discharge following coronary artery bypass grafting (CABG) and aortic valve replacement (AVR) and the relationship between postacute care spending and other postdischarge utilization. Methods and Results: A retrospective analysis was conducted of public and private administrative claims for Michigan residents insured by Medicare fee-for-service and Blue Cross Blue Shield of Michigan/Blue Care Network commercial and Medicare Advantage plans undergoing CABG (n=11 208) or AVR (n=6122) in 33 nonfederal acute care Michigan hospitals between January 1, 2015 and December 31, 2018. Postacute care use was present in 9662 (86.2%) CABG episodes and 4242 (69.3%) AVR episodes, with respective mean (SD) 90-day spending of $4398±$6124 and $3465±$5759. Across hospitals, mean postacute care spending ranged from $3280 to $8186 for CABG and $2246 to $7710 for AVR. Inpatient rehabilitation and skilled nursing facility care accounted for over 80% of the variation spending between low and high postacute care spending hospitals. At the hospital-level, postacute care spending was modestly correlated across procedures and payers. Spending associated with readmissions, emergency department visits, and outpatient facility care was significantly different between low and high postacute care spending hospitals in CABG and AVR episodes. Conclusions: There was wide hospital variation in postacute care spending after cardiac surgery, which was primarily driven by differential use and intensity in facility-based postacute care. Optimizing facility-based postacute care after cardiac surgery offers unique opportunities to reduce potentially unwarranted care variation.

Background Over 180 000 coronary artery bypass grafting (CABG) procedures are performed annually, accounting for $7 to $10 billion in episode expenditures. Assessing tradeoffs between spending and quality contributing to value during 90-day episodes has not been conducted but is essential for success in bundled reimbursement models. We, therefore, identified determinants of variability in hospital 90-day episode value for CABG. Methods Medicare and private payor admissions for isolated CABG from 2014 to 2016 were retrospectively linked to clinical registry data for 33 nonfederal hospitals in Michigan. Hospital composite risk-adjusted complication rates (≥1 National Quality Forum-endorsed, Society of Thoracic Surgeons measure: deep sternal wound infection, renal failure, prolonged ventilation >24 hours, stroke, re-exploration, and operative mortality) and 90-day risk-adjusted, price-standardized episode payments were used to categorize hospitals by value by defining the intersection between complications and spending. Results Among 2573 total patients, those at low- versus high-value hospitals had a higher percentage of prolonged length of stay >14 days (9.3% versus 2.4%, P =0.006), prolonged ventilation (17.6% versus 4.8%, P P =0.001). Mean total episode payments were $51 509 at low-compared with $45 526 at high-value hospitals ( P P =0.005), professional ($7462 versus $6090, P P =0.031), and index hospitalization payments ($33 474 versus $30 800, P P P P =0.016) and emergency department services (13% versus 17%, P =0.034). Conclusions To succeed in emerging bundled reimbursement programs for CABG, hospitals and physicians should identify strategies to minimize complications while optimizing inpatient evaluation and management spending and use of inpatient rehabilitation, home health, and emergency department services.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has increased in volume as an alternative to surgical aortic valve replacement (SAVR). Comparisons of total episode expenditures, while largely ignored thus far, will be key to the value proposition for payers. METHODS: We evaluated 6,359 Blue Cross Blue Shield of Michigan and Medicare fee-for-service beneficiaries undergoing TAVR (17 hospitals, n=1,655) or SAVR (33 hospitals, n=4,704) in Michigan between 2012 and 2016. Payments through 90 post-discharge days between TAVR and SAVR were price-standardized and risk-adjusted. Centers were divided into terciles of procedural volume separately for TAVR and SAVR, and payments were compared between lowest and highest terciles. RESULTS: Payments (± standard deviation) were higher for TAVR than SAVR ($69,388 ± $22,259 vs. $66,683 ± $27,377, p

Previous work identified a direct relationship between frailty and adverse outcomes in cardiac surgery, but assessment of the effect across subgroups of patients has largely been ignored. This study identified whether the association of frailty (measured by gait speed) with adverse outcomes differed across subgroups of patients.The study evaluated 53,932 patients who underwent cardiac operations between 2011 and 2016 across 33 Michigan institutions. Five-meter gait speed (in seconds) was divided into groups: faster (5.0 seconds), intermediate (5.0 to 5.99 seconds), and slower (≥6.0 seconds). The study used mixed logistic regression to estimate the relationship between increasing gait speed time and a patient's odds of major morbidity or mortality, by adjusting for patient-related demographics, disease characteristics, surgeon, and hospital. Effect modification by subgroup of patients and gait speed test time was tested with interaction terms. The study's secondary end point was an analysis of discharge disposition.Nearly one fourth (22.7%) of patients had at least one gait speed test. Slower (34% of patients) versus faster (28%) patients were older (72.5 years vs 62.6 years), had more comorbidities, and had the primary outcome (16.6% vs 9.5%) (p0.0001). Significant interactions with gait speed existed for patients' comorbidities (chronic lung disease, atrial fibrillation, p0.05), although marginal interactions existed for patients' age (p = 0.059) and diabetes (p = 0.063). Slower patients were more often discharged to a facility rather than home.Slower gait speed was associated with increased odds of major morbidity or mortality. This effect was amplified among patients with preexisting comorbidities. Future studies should evaluate the impact of preprocedural interventions on frailty, including those aimed at addressing comorbidities.

Background A central objective of recent U.S. healthcare policy reform, most notably the Affordable Care Act’s (ACA) Health Insurance Marketplace, has been to increase access to stable, affordable health insurance. However, changing market dynamics (rising premiums, changes in issuer participation and plan availability) raise significant concerns about the marketplaces’ ability to provide a stable source of healthcare for Americans that rely on them. By looking at the effect of instability on changes in the consumer choice set, we can analyze potential incentives to switch plans among price-sensitive enrollees, which can then be used to inform policy going forward. Methods Data on health plan features for non-tobacco users in 2512 counties in 34 states participating in federally-facilitated exchanges from 2014 to 2016 was obtained from the Centers for Medicaid & Medicare Services. We examined how changes in individual plan features, including premiums, deductibles, issuers, and plan types, impact consumers who had purchased the lowest-cost silver or bronze plan in their county the previous year. We calculated the cost of staying in the same plan versus switching to another plan the following year, and analyzed how costs vary across geographic regions. Results In most counties in 2015 and 2016 (53.7 and 68.2%, respectively), the lowest-cost silver plan from the previous year was still available, but was no longer the cheapest plan. In these counties, consumers who switched to the new lowest-cost plan would pay less in monthly premiums on average, by $51.48 and $55.01, respectively, compared to staying in the same plan. Despite potential premium savings from switching, however, the majority would still pay higher average premiums compared to the previous year, and most would face higher deductibles and an increased probability of having to change provider networks. Conclusion While the ACA has shown promise in expanding healthcare access, continued changes in the availability and affordability of health plans are likely to result in churning and switching among enrollees, which may have negative ramifications for their health going forward. Future healthcare policy reform should aim to stabilize marketplace dynamics in order to encourage greater care continuity and limit churning.

Purpose Heart failure (HF) disproportionally affects racial minorities and disparities in access to therapies exist. Recent work suggests greater use of left ventricular assist devices (LVAD) among African American (AA) patients compared to white patients that likely remains disparate due to a higher prevalence of HF in AA. We sought to understand disparities in LVAD use by race among a cohort of patients with similar HF severity and explore the impact of socioeconomic disadvantage. Methods We analyzed fee-for-service Medicare claims among 311,265 beneficiaries admitted with a principal diagnosis of systolic HF between 2008-2014. Inpatient and outpatient claims in prior 6 months used to estimate propensity for LVAD treatment using synthetic minority over-sampling, a machine learning method. Beneficiaries with ≥70% predicted probability of receiving an LVAD were included. These results were applied to model disparities using logistic regression with LVAD use and 1-year survival with and without LVAD among AA and white recipients as the dependent variables. Model covariates included race, clinical characteristics, distance from LVAD center, and year. After confirming a disparity, the Medicare low-income subsidy included to explore impact of socioeconomic disadvantage. Results The sample included 15,406 observations, of whom 45.2% (n=6,967) received an LVAD. AA were 23.6% (n=3,648) of the population and 21.8% (n=1,520) of LVAD recipients. One-year survival was 73% with LVAD and 62% without. Compared to white patients, AA patients matched for the propensity to receive an LVAD were 4.0% less likely to receive the therapy (95% CI -5.1 to -1.7; p Conclusion Disparities in the use of LVAD for AA Medicare beneficiaries with HF exist that are not entirely explained by socioeconomic disadvantage. These data suggest that other factors are impacting the application of LVAD therapy in AA patients. Potential explanations include racial biases or systemic racism that influence clinician decision-making or patient preferences.

Purpose Clinical trials assessing durable LVAD therapy have demonstrated survival benefits that have increased adoption. However, highly selected trial populations may not reflect the real-world setting. We assessed the generalizability of LVAD clinical trial findings by comparing mortality between LVAD recipients meeting current trial eligibility criteria to those ineligible. Methods Patients undergoing LVAD implantation between 2012-2017 were identified in INTERMACS (n=15,077). MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy with HeartMate 3) trial inclusion/exclusion criteria were mapped to INTERMACS variables to categorize patients as trial eligible or ineligible and by number of exclusion criteria present: 0, 1, 2, and ≥3. Kaplan-Meier analyses were used to compare cumulative mortality by trial eligibility and number of exclusion criteria. Multivariable Cox models were used to report risk-adjusted mortality with hazard ratios (HR) and 95% confidence intervals (CI). Results A total of 6728 (44.6%) LVAD recipients were trial ineligible, of which 4331 (28.7%) had 1 exclusion, 1517 (10.1%) had 2, and 880 (5.8%) had ≥3. Mortality for trial ineligible recipients (1-year: 26±1%; 3-year: 44±2%) was higher than for trial eligible recipients (1-year: 16±1%; 3-year: 37±1%; p Conclusion Nearly half of real-world LVAD recipients do not meet current clinical trial criteria, and these trial ineligible recipients demonstrated higher mortality. Providers should incorporate trial criteria when assessing LVAD candidate outcomes.