Hydroxychloroquine use is associated with reduced mortality risk in older adults with rheumatoid arthritis.

BACKGROUND: There is little robust data about the cardiovascular safety of hydroxychloroquine in patients with rheumatoid arthritis (RA), who often have cardiovascular comorbidities. We examined the association between use of hydroxychloroquine (HCQ) in patients with RA and major adverse cardiovascular events (MACE). METHODS: In a retrospective cohort of Medicare beneficiaries aged ≥ 65 years with RA, we identified patients who initiated HCQ (users) and who did not initiate HCQ (non-users) between January 2015-June 2017. Each HCQ user was matched to 2 non-users of HCQ using propensity score derived from patient baseline characteristics. The primary outcome was the occurrence of MACE, defined as acute admissions for stroke, myocardial infarction, or heart failure. Secondary outcomes included all-cause mortality and the composite of MACE and all-cause mortality. Cox proportional hazards model was used to compare outcomes between HCQ users to non-users. RESULTS: The study included 2380 RA patients with incident HCQ use and matched 4633 HCQ non-users over the study period. The mean follow-up duration was 1.67 and 1.63 years in HCQ non-users and users, respectively. In multivariable models, use of HCQ was not associated with the risk of MACE (hazard ratio 1.1; 95% CI: 0.832-1.33). However, use of HCQ was associated with a lower risk of all-cause mortality (HR: 0.54; 95% CI: 0.45-0.64) and the composite of all-cause mortality and MACE (HR 0.67; 95% CI: 0.58-0.78). CONCLUSION: HCQ use was independently associated with a lower risk of mortality in older adults with RA but not with incidence of MACE events. Key Points • Using an incident user design (to avoid the biases of a prevalent user design) and a population-based approach, we examined the effect of hydroxychloroquine (HCQ) on the risk of major cardiovascular events (MACE) in older patients with RA. • We did not find an association between HCQ use and incident MACE. We did, however, find a significant association with the composite outcome (MACE and all-cause mortality) driven by a significant reduction in all-cause mortality with HCQ use.

Mortality Among US Veterans Admitted to Community vs Veterans Health Administration Hospitals for COVID-19.

Importance: Veterans Health Administration (VHA) enrollees receive care for COVID-19 in both VHA and non-VHA (ie, community) hospitals, but little is known about the frequency or outcomes of care for veterans with COVID-19 in VHA vs community hospitals. Objective: To compare outcomes among veterans admitted for COVID-19 in VHA vs community hospitals. Design, Setting, and Participants: This retrospective cohort study used VHA and Medicare data from March 1, 2020, to December 31, 2021, on hospitalizations for COVID-19 in 121 VHA and 4369 community hospitals in the US among a national cohort of veterans (aged ≥65 years) enrolled in both the VHA and Medicare with VHA care in the year prior to hospitalization for COVID-19 based on the primary diagnosis code. Exposure: Admission to VHA vs community hospitals. Main Outcomes and Measures: The main outcomes were 30-day mortality and 30-day readmission. Inverse probability of treatment weighting was used to balance observable patient characteristics (eg, demographic characteristics, comorbidity, mechanical ventilation on admission, area-level social vulnerability, distance to VHA vs community hospitals, and date of admission) between VHA and community hospitals. Results: The cohort included 64 856 veterans (mean [SD] age, 77.6 [8.0] years; 63 562 men [98.0%]) dually enrolled in the VHA and Medicare who were hospitalized for COVID-19. Most (47 821 [73.7%]) were admitted to community hospitals (36 362 [56.1%] admitted to community hospitals via Medicare, 11 459 [17.7%] admitted to community hospitals reimbursed via VHA's Care in the Community program, and 17 035 [26.3%] admitted to VHA hospitals). Admission to community hospitals was associated with higher unadjusted and risk-adjusted 30-day mortality compared with admission to VHA hospitals (crude mortality, 12 951 of 47 821 [27.1%] vs 3021 of 17 035 [17.7%]; P < .001; risk-adjusted odds ratio, 1.37 [95% CI, 1.21-1.55]; P < .001). Readmission within 30 days was less common after admission to community compared with VHA hospitals (4898 of 38 576 [12.7%] vs 2006 of 14 357 [14.0%]; risk-adjusted hazard ratio, 0.89 [95% CI, 0.86-0.92]; P < .001). Conclusions and Relevance: This study found that most hospitalizations for COVID-19 among VHA enrollees aged 65 years or older were in community hospitals and that veterans experienced higher mortality in community hospitals than in VHA hospitals. The VHA must understand the sources of the mortality difference to plan care for VHA enrollees during future COVID-19 surges and the next pandemic.

Association of Rapid Response Teams With Hospital Mortality in Medicare Patients.

BACKGROUND: Although rapid response teams have been widely promoted as a strategy to reduce unexpected hospital deaths, most studies of rapid response teams have not adjusted for secular trends in mortality before their implementation. We examined whether implementation of a rapid response team was associated with a reduction in hospital mortality after accounting for preimplementation mortality trends. METHODS: Among 56 hospitals in Get With The Guidelines-Resuscitation linked to Medicare, we calculated the annual rates of case mix-adjusted mortality for each hospital during 2000 to 2014. We constructed a hierarchical log-binomial regression model of mortality over time (calendar-year), incorporating terms to capture the effect of rapid response teams, to determine whether implementation of rapid response teams was associated with reduction in hospital mortality that was larger than expected based on preimplementation trends, while adjusting for hospital case mix index. RESULTS: The median annual number of Medicare admissions was 5214 (range, 408-18 398). The median duration of preimplementation and postimplementation period was 7.6 years (≈2.5 million admissions) and 7.2 years (≈2.6 million admissions), respectively. Hospital mortality was decreasing by 2.7% annually during the preimplementation period. Implementation of rapid response teams was not associated with a change in mortality during the initial year (relative risk for model intercept, 0.98 [95% CI, 0.94-1.02]; P=0.30) or in the mortality trend (relative risk for model slope, 1.01 per year [95% CI, 0.99-1.02]; P=0.30). Among individual hospitals, implementation of a rapid response team was associated with a lower-than-expected mortality at only 4 (7.1%) and higher-than-expected mortality at 2 (3.7%) hospitals. CONCLUSIONS: Among a large and diverse sample of US hospitals, we did not find implementation of rapid response teams to be associated with reduction in hospital mortality. Studies are needed to understand best practices for rapid response team implementation, to ensure that hospital investment in these teams improves patient outcomes.

Diffusion of Percutaneous Ventricular Assist Devices in US Markets.

BACKGROUND: Percutaneous ventricular assist devices (PVADs) have been replacing intra-aortic balloon pumps for hemodynamic support during percutaneous coronary intervention (PCI), even though data supporting a benefit for hard clinical end points remain limited. We evaluated diffusion of PVADs across US markets and examined the association of market utilization of PVAD with mortality and cost. METHODS: Using the 2013 to 2019 Medicare data, we identified all patients aged ≥65 years who underwent PCI with either a PVAD or intra-aortic balloon pump. We used hospital referral region to define regional health care markets and categorized them in quartiles based on the proportional use of PVADs during PCI. Multilevel models were constructed to determine the association of patient, hospital, and market factors with utilization of PVADs and the association of PVAD utilization with 30-day mortality and cost. RESULTS: A total of 79 176 patients underwent PCI with either intra-aortic balloon pump (47 514 [60.0%]) or PVAD (31 662 [40.0%]). The proportion of PCI procedures with PVAD increased over time (17% in 2013 to 57% in 2019; P for trend, <0.001), such that PVADs overtook intra-aortic balloon pump for hemodynamic support during PCI in 2018. There was a large variation in PVAD utilization across markets (range, 0%-85%), which remained unchanged after adjustment of patient characteristics (median odds ratio, 2.05 [95% CI, 1.91-2.17]). The presence of acute myocardial infarction, cardiogenic shock, and emergent status was associated with a 45% to 50% lower odds of PVAD use suggesting that PVADs were less likely to be used in the sickest patients. Greater utilization of PVAD at the market level was not associated with lower risk mortality but was associated with higher cost. CONCLUSIONS: Although utilization of PVADs for PCI continues to increase, there is large variation in PVAD utilization across markets. Greater market utilization of PVADs was not associated with lower mortality but was associated with higher cost.

Risk from delayed or missed care and non-COVID-19 outcomes for older patients with chronic conditions during the pandemic.

BACKGROUND: During the COVID-19 pandemic, patients with chronic illnesses avoided regular medical care, raising concerns about long-term complications. Our objective was to identify a population of older patients with chronic conditions who may be at risk from delayed or missed care (DMC) and follow their non-COVID outcomes during the pandemic. METHODS: We used a retrospective matched cohort design using Medicare claims and electronic health records at a large health system with community and academic clinics. Participants included 14,406 patients over 65 years old with two or more chronic conditions who had 1 year of baseline data and up to 9 months of postpandemic follow-up from March 1, 2019 to December 31, 2020; and 14,406 matched comparison patients from 1 year prior. Risk from DMC was defined by 13 indicators, including chronic conditions, frailty, disability affecting the use of telehealth, recent unplanned acute care, prior missed outpatient care, and social determinants of health. Outcomes included mortality, inpatient events, Medicare payments, and primary care and specialty care visits (in-person and telehealth). RESULTS: A total of 25% of patients had four or more indicators for risk from DMC. Per 1000 patients annually, those with four or more indicators had increased mortality of 19 patients (95% confidence interval, 4 to 32) and decreased utilization, including unplanned events (-496 events, -611 to -381) and primary care visits (-1578 visits, -1793 to -1401). CONCLUSIONS: Older patients who had four or more indicators for risk from DMC had higher mortality and steep declines in inpatient and outpatient utilization during the pandemic.

Community-Level Economic Distress, Race, and Risk of Adverse Outcomes After Heart Failure Hospitalization Among Medicare Beneficiaries.

BACKGROUND: Socioeconomic disadvantage is a strong determinant of adverse outcomes in patients with heart failure. However, the contribution of community-level economic distress to adverse outcomes in heart failure may differ across races and ethnicities. METHODS: Patients of self-reported Black, White, and Hispanic race and ethnicity hospitalized with heart failure between 2014 and 2019 were identified from the Medicare MedPAR Part A 100% Files. We used patient-level residential ZIP code to quantify community-level economic distress on the basis of the Distressed Community Index (quintile 5: economically distressed versus quintiles 1-4: nondistressed). The association of continuous and categorical measures (distressed versus nondistressed) of Distressed Community Index with 30-day, 6-month, and 1-year risk-adjusted mortality, readmission burden, and home time were assessed separately by race and ethnicity groups. RESULTS: The study included 1 611 586 White (13.2% economically distressed), 205 840 Black (50.6% economically distressed), and 89 199 Hispanic (27.3% economically distressed) patients. Among White patients, living in economically distressed (versus nondistressed) communities was significantly associated with a higher risk of adverse outcomes at 30-day and 1-year follow-up. Among Black and Hispanic patients, the risk of adverse outcomes associated with living in distressed versus nondistressed communities was not meaningfully different at 30 days and became more prominent by 1-year follow-up. Similarly, in the restricted cubic spline analysis, a stronger and more graded association was observed between Distressed Community Index score and risk of adverse outcomes in White patients (versus Black and Hispanic patients). Furthermore, the association between community-level economic distress and risk of adverse outcomes for Black patients differed in rural versus urban areas. Living in economically distressed communities was significantly associated with a higher risk of mortality and lower home time at 1-year follow-up in rural areas but not urban areas. CONCLUSIONS: The association between community-level economic distress and risk of adverse outcomes differs across race and ethnic groups, with a stronger association noted in White patients at short- and long-term follow-up. Among Black patients, the association of community-level economic distress with a higher risk of adverse outcomes is less evident in the short term and is more robust and significant in the long-term follow-up and rural areas.

Racial and Sex Disparities in Anticoagulation After Electrical Cardioversion for Atrial Fibrillation and Flutter.

Background Anticoagulation is indicated for 4 weeks after cardioversion in patients with atrial fibrillation/flutter. We sought to examine whether there is evidence of sex or racial disparity in anticoagulant prescription following cardioversion, and whether postcardioversion anticoagulation affects outcomes. Methods and Results We identified a representative sample of Medicare patients who underwent elective electric cardioversion in an outpatient setting from 2015 to 2017. We identified patients who had an anticoagulant prescription for 3 months after the cardioversion date. Multivariable logistic regression was used to assess factors associated with a prescription of an anticoagulant after cardioversion. Cox regression analysis was used to test association of anticoagulation with a composite end point of 90-day mortality, ischemic stroke, or arterial embolism. The final study cohort included 7860 patients. Overall, 5510 patients (70.1%) received any anticoagulation following cardioversion, while 2350 (29.9%) did not. Patients who did not receive anticoagulation were younger, with a lower burden of most comorbidities. Patients were less likely to receive anticoagulation if they had dementia or atrial flutter, while patients with valvular heart disease, obesity, heart failure, peripheral vascular or coronary disease, or hypertension were more likely to receive anticoagulation. Female sex (adjusted odds ratio, 0.84; 95% CI, 0.75-0.92; P<0.001), Black and Hispanic race (adjusted odds ratio, 0.50; 95% CI, 0.38-0.65; and odds ratio, 0.56; 95% CI, 0.41-0.75, respectively; P<0.001) were independently associated with lower probability of anticoagulant prescription. Postcardioversion anticoagulation was associated with lower risk of the composite end point (adjusted hazard ratio, 0.38; 95% CI, 0.27-0.52; P<0.001). Conclusions Racial and sex disparities exist in anticoagulant prescription after outpatient elective cardioversion for atrial fibrillation.

Risk-Standardized Home Time as a Novel Hospital Performance Metric for Pneumonia Hospitalization Among Medicare Beneficiaries: a Retrospective Cohort Study.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) use hospital readmissions as a performance metric to incentivize hospital care for acute conditions including pneumonia. However, there are limitations to using readmission alone as a hospital performance metric. OBJECTIVE: To characterize 30-day risk-standardized home time (RSHT), a novel patient-centered post-discharge performance metric for acute pneumonia hospitalizations in Medicare patients, and compare hospital rankings based on this metric with mortality and readmissions. STUDY DESIGN: Retrospective, cohort study. PARTICIPANTS: A cohort of Medicare fee-for-service beneficiaries admitted between January 01, 2015 and November 30, 2017. INTERVENTIONS: None. MAIN MEASURES: Risk-standardized hospital-level home time within 30 days of discharge was evaluated as a novel performance metric. Multilevel regression models were used to calculate hospital-level estimates and rank hospitals based on RSHT, readmission rate (RSRR), and mortality rate (RSMR). KEY RESULTS: A total of 1.7 million pneumonia admissions admitted to one of the 3116 hospitals were eligible for inclusion. The median 30-day RSHT was 20.5 days (interquartile range: 18.9-21.9 days; range: 5-29 days). Hospital-level characteristics such as case volume, bed size, for-profit ownership, rural location of the hospital, teaching status, and participation in the bundled payment program were significantly associated with home time. We found a modest, inverse correlation of RSHT with RSRR (rho: -0.233, p< 0.0001) and RSMR (rho: -0.223, p< 0.0001) for pneumonia. About 1/3rd of hospitals were reclassified as high performers based on their RSHT metric compared with the rank on their RSRR and RSMR metrics. CONCLUSION: Home time is a novel, patient-centered, hospital-level metric that can be easily calculated using claims data and accounts for mortality, readmission to an acute care facility, and admission to a skilled nursing facility or long-term care facility after discharge. Utilization of this patient-centered metric could have policy implications in assessing hospital performance on delivery of healthcare to pneumonia patients.

Evaluation of Risk-Adjusted Home Time After Hospitalization for Heart Failure as a Potential Hospital Performance Metric.

Importance: Thirty-day home time, defined as time spent alive and out of a hospital or facility, is a novel, patient-centered performance metric that incorporates readmission and mortality. Objectives: To characterize risk-adjusted 30-day home time in patients discharged with heart failure (HF) as a hospital-level quality metric and evaluate its association with the 30-day risk-standardized readmission rate (RSRR), 30-day risk-standardized mortality rate (RSMR), and 1-year RSMR. Design, Setting, and Participants: This hospital-level cohort study retrospectively analyzed 100% of Medicare claims data from 2 968 341 patients from 3134 facilities from January 1, 2012, to November 30, 2017. Exposures: Home time, defined as time spent alive and out of a short-term hospital, skilled nursing facility, or intermediate/long-term facility 30 days after discharge. Main Outcomes and Measures: For each hospital, a risk-adjusted 30-day home time for HF was calculated similar to the Centers for Medicare & Medicaid Services risk-adjustment models for 30-day RSRR and RSMR. Hospitals were categorized into quartiles (lowest to highest risk-adjusted home time). The correlations between hospital rates of risk-adjusted 30-day home time and 30-day RSRR, 30-day RSMR, and 1-year RSMR were estimated using the Pearson correlation coefficient. Distribution of days lost from a perfect 30-day home time were calculated. Reclassification of hospital performance using 30-day home time vs 30-day RSRR was also evaluated. Results: Overall, 2 968 341 patients (mean [SD] age, 81.0 [8.3] years; 53.6% female) from 3134 hospitals were included in this study. The median hospital risk-adjusted 30-day home time for patients with HF was 21.77 days (range, 8.22-28.41 days). Hospitals in the highest quartile of risk-adjusted 30-day home time (best-performing hospitals) were larger (mean [SD] number of beds, 285 [275]), with a higher volume of patients with HF (median, 797 patients; interquartile range, 395-1484) and were more likely academic hospitals (59.9%) with availability of cardiac surgery (51.1%) and cardiac rehabilitation (68.8%). A total of 72% of home time lost was attributable to stays in an intermediate- or long-term care facility (mean [SD], 2.65 [6.44] days) or skilled nursing facility (mean [SD], 3.96 [9.04] days), 13% was attributable to short-term readmissions (mean [SD], 1.25 [3.25] days), and 15% was attributable to death (mean [SD], 1.37 [6.04] days). Among 30-day outcomes, the 30-day RSRR and 30-day RSMR decreased in a graded fashion across increasing 30-day home time categories (correlation coefficients: 30-day RSRR and 30-day home time, -0.23, P < .001; 30-day RSMR and 30-day home time, -0.31, P < .001). Similar patterns of association were also noted for 1-year RSMR and 30-day home time (correlation coefficient, -0.35, P < .001). Thirty-day home time meaningfully reclassified hospital performance in 30% of the hospitals compared with 30-day RSRR and in 25% of hospitals compared with 30-day RSMR. Conclusions and Relevance: In this study, 30-day home time among patients discharged after a hospitalization for HF was objectively assessed as a hospital-level quality metric using Medicare claims data and was associated with readmission and mortality outcomes and with reclassification of hospital performance compared with 30-day RSRR and 30-day RSMR.

Trends, Perioperative Adverse Events, and Survival of Patients With Left Ventricular Assist Devices Undergoing Noncardiac Surgery.

Importance: Information regarding the performance and outcomes of noncardiac surgery (NCS) in patients with left ventricular assist devices (LVADs) is scarce, with limited longitudinal follow-up data that are mostly limited to single-center reports. Objective: To examine the trends, patient characteristics, and outcomes associated with NCS among patients with LVAD. Design, Setting, and Participants: This cohort study examined patients enrolled in Medicare undergoing durable LVAD implantation from January 2012 to November 2017 with follow-up through December 2017. The study included all Medicare Provider and Analysis Review Part A files for the years 2012 to 2017. Patients identified by International Classification of Diseases, Ninth Revision Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision (ICD-10) procedure codes for new LVAD implantation were included. Data analysis was performed from November 2019 to February 2020. Exposures: NCS procedures were identified using the ICD-9-CM and ICD-10 procedural codes and divided into elective and urgent or emergent. Main Outcomes and Measures: The primary outcome was major adverse cardiovascular events (MACEs), defined as in-hospital or 30-day all-cause mortality, ischemic stroke, or intracerebral hemorrhage after NCS. Early (<60 days after NCS) and late (≥60 days after NCS) mortality after NCS were analyzed in both subgroups using time-varying covariate and landmark analysis using patients who did not undergo NCS as reference. Results: Of the 8118 patients with LVAD (mean [SD] age, 63.4 [10.8] years; 6484 men [79.9%]), 1326 (16.3%, or approximately 1 in 6) underwent NCS, of which 1000 procedures (75.4%) were emergent or urgent and 326 (24.6%) were elective. There was no difference in age between patients who underwent NCS and patients who did not (mean [SD] age, 63.6 [10.6] vs 63.4 [10.9] years). The number of NCS procedures among patients with LVAD increased from 64 in 2012 to 304 in 2017. The median (interquartile range) time from LVAD implantation to NCS was 309 (133-606) days. The most frequent type of NCS was general (613 abdominal, pelvic, and gastrointestinal procedures [46.2%]). Perioperative MACEs occurred in 169 patients (16.9%) undergoing emergent or urgent NCS and 23 patients (7.1%) undergoing elective NCS. Urgent or emergent NCS was associated with higher mortality early (adjusted hazard ratio [aHR], 8.78; 95% CI, 7.20-10.72; P < .001) and late (aHR, 1.71; 95% CI, 1.53-1.90; P < .001) after NCS compared with patients with LVAD who did not undergo NCS. Elective NCS was also associated with higher mortality early (aHR, 2.65; 95% CI, 1.74-4.03; P < .001) and late (aHR, 1.29; 95% CI, 1.07-1.56; P = .008) after NCS. Conclusions and Relevance: One of 6 patients with LVAD underwent NCS. Perioperative MACEs were frequent. Higher mortality risk transcended the early postoperative period in urgent or emergent and elective surgical procedures.

Sex Differences in Management and Outcomes of Critical Limb Ischemia in the Medicare Population.

BACKGROUND: Evidence about sex differences in management and outcomes of critical limb ischemia (CLI) is conflicting. METHODS: We identified Fee-For-Service Medicare patients within the 5% enhanced sample file who were diagnosed with new incident CLI between 2015 and 2017. For each beneficiary, we identified all hospital admissions, outpatient encounters and procedures, and pharmacy prescriptions. Outcomes included 90-day mortality and major amputation. RESULTS: Incidence of CLI declined from 2.80 (95% CI, 2.72-2.88) to 2.47 (95% CI, 2.40-2.54) per 1000 person from 2015 to 2017, P<0.01. Incidence was lower in women compared with men (2.19 versus 3.11 per 1000) but declined in both groups. Women had a lower prevalence of prescription of any statin (48.4% versus 52.9%, P<0.001) or high-intensity statins (15.3% versus 19.8%, P<0.01) compared with men. Overall, 90-day revascularization rate was 52%, and women were less likely to undergo revascularization (50.1% versus 53.6%, P<0.01) compared with men. Women had a similar unadjusted (9.9% versus 10.3%, P=0.5) and adjusted 90-day mortality (adjusted rate ratio, 0.98 [95% CI, 0.85-1.12], P=0.7) compared with men. Over the study period, unadjusted 90-day mortality remained unchanged for men (10.4% in 2015 to 9.9% in 2017, Pfor trend=0.3), and women (9.5% in 2015 to 10.6% in 2017, Pfor trend=0.2). Men had higher unadjusted (12.9% versus 8.9%, P<0.001) and adjusted risk of 90-day major amputation (adjusted rate ratio, 1.30 [95% CI, 1.14-1.48], P<0.001). One-third of patients with CLI underwent major amputation without a diagnostic angiogram or trial of revascularization in the preceding 90 days regardless of the sex. CONCLUSIONS: Women with new incident CLI are less likely to receive statin or undergo revascularization at 90 days compared with men. However, the differences were small. There was no difference in risk of 90-day mortality between both sexes. Graphic Abstract: A graphic abstract is available for this article.

Management of Aortic Stenosis in Patients With End-Stage Renal Disease on Hemodialysis.

BACKGROUND: Patients with end-stage renal disease on hemodialysis (ESRD-HD) and aortic stenosis have poor prognosis. The role of transcatheter aortic valve replacement (TAVR) in this high-risk population is debated. METHODS: We compared the outcomes among ESRD-HD Medicare beneficiaries who were managed with TAVR, surgical AVR (SAVR), or conservative management for aortic stenosis between 2015 and 2017, using overlap propensity score weighting analysis to control for differences in treatment assignment. The primary outcome was all-cause mortality and was compared between treatment groups as well as to age-sex matched mortality for ESRD-HD in the US population. Secondary outcomes included trend of heart failure hospitalizations. RESULTS: A total of 8107 ESRD-HD patients with aortic stenosis were included, 4130 (50%) underwent TAVR, 2565 (31.6%) underwent SAVR, and 1412 (17.4%) were managed conservatively. TAVR patients had more comorbidities and higher frailty compared with the other 2 groups. Thirty-day mortality was lower with TAVR compared with SAVR (4.6% versus 12.8%, P<0.01). After a median follow-up of 465 days (interquartile range, 261-759), on overlap propensity score weighting analysis, there was no difference in mortality between TAVR and SAVR (adjusted hazard ratio, 1.02 [95% CI, 0.91-1.15], P=0.7), and mortality was lower with TAVR compared with conservative management (adjusted hazard ratio, 0.53 [95% CI, 0.47-0.60], P<0.001). Standardized mortality ratios with TAVR, SAVR, and conservative management compared with age-sex matched ESRD-HD US population were 1.24, 1.27, and 1.83, respectively. The rate of heart failure admissions declined after TAVR (incidence rate ratio, 0.55 [95% CI, 0.48-0.62], P<0.001) and SAVR (incidence rate ratio, 0.76 [95% CI, 0.65-0.88], P<0.001). CONCLUSIONS: In ESRD-HD patients with aortic stenosis, mortality was lower in the short-term with TAVR compared with SAVR but comparable in the mid-term. AVR is associated with an improvement in survival and reduction in heart failure hospitalizations compared with conservative management.

Evaluation of Risk-Adjusted Home Time After Acute Myocardial Infarction as a Novel Hospital-Level Performance Metric for Medicare Beneficiaries.

BACKGROUND: The utility of 30-day risk-standardized readmission rate (RSRR) as a hospital performance metric has been a matter of debate. Home time is a patient-centered outcome measure that accounts for rehospitalization, mortality, and postdischarge care. We aim to characterize risk-adjusted 30-day home time in patients with acute myocardial infarction (AMI) as a hospital-level performance metric and to evaluate associations with 30-day RSRR, 30-day risk-standardized mortality rate (RSMR), and 1-year RSMR. METHODS: The study included 984 612 patients with AMI hospitalization across 2379 hospitals between 2009 and 2015 derived from 100% Medicare claims data. Home time was defined as the number of days alive and spent outside of a hospital, skilled nursing facility, or intermediate-/long-term acute care facility 30 days after discharge. Correlations between hospital-level risk-adjusted 30-day home time and 30-day RSRR, 30-day RSMR, and 1-year RSMR were estimated with the Pearson correlation. Reclassification in hospital performance using 30-day home time versus 30-day RSRR and 30-day RSMR was also evaluated. RESULTS: Median hospital-level risk-adjusted 30-day home time was 24.0 days (range, 15.3-29.0 days). Hospitals with higher home time were more commonly academic centers, had available cardiac surgery and rehabilitation services, and had higher AMI volume and percutaneous coronary intervention use during the AMI hospitalization. Of the mean 30-day home time days lost, 58% were to intermediate-/long-term care or skilled nursing facility stays (4.7 days), 30% to death (2.5 days), and 12% to readmission (1.0 days). Hospital-level risk-adjusted 30-day home time was inversely correlated with 30-day RSMR (r=-0.22, P<0.0001) and 30-day RSRR (r=-0.25, P<0.0001). Patients admitted to hospitals with higher risk-adjusted 30-day home time had lower 30-day readmission (quartile 1 versus 4, 21% versus 17%), 30-day mortality rate (5% versus 3%), and 1-year mortality rate (18% versus 12%). Furthermore, 30-day home time reclassified hospital performance status in ≈30% of hospitals versus 30-day RSRR and 30-day RSMR. CONCLUSIONS: Thirty-day home time for patients with AMI can be assessed as a hospital-level performance metric with the use of Medicare claims data. It varies across hospitals, is associated with postdischarge readmission and mortality outcomes, and meaningfully reclassifies hospital performance compared with the 30-day RSRR and 30-day RSMR metrics.

Potentially harmful drug prescription in elderly patients with heart failure with reduced ejection fraction.

AIMS: This study aimed to evaluate the prescription frequency of potentially harmful prescription drugs as defined in current heart failure guidelines among elderly patients with a diagnosis of heart failure with reduced ejection fraction and their association with clinical outcomes. METHODS AND RESULTS: We used the Centers for Medicare & Medicaid Services data from a nationally representative 5% sample for the years 2014-2016 to identify patients admitted to acute care hospitals with a primary diagnosis of heart failure with reduced ejection fraction. The primary exposure was filling a prescription for a potentially harmful drug. Potentially harmful drug fills were treated as a time-dependent covariate to examine their association on readmission and mortality. A total of 8993 patients met study criteria. Potentially harmful drugs were prescribed in 1077 (11.9%) patients within 90 days of discharge from the heart failure hospitalization. Non-steroidal anti-inflammatory agents were the most frequently prescribed potentially harmful drug (6.7%) followed by calcium channel blockers (4.7%), thiazolidinedione (0.59%), and select antiarrhythmic (0.33%). Factors independently associated with potentially harmful drug prescription were female gender, Hispanic ethnicity, severe obesity, among others. In the multivariable Cox model, the prescription of a potentially harmful drug was associated with an increased risk of readmission (hazard ratio 1.14; 95% confidence interval 1.05-1.23, P < 0.001). Among drug subgroups, only calcium channel blockers were associated with an increased risk of readmission (hazard ratio 1.225; 95% confidence interval 1.085-1.382, P = 0.0011). CONCLUSIONS: In elderly patients discharged with a primary diagnosis of heart failure with reduced ejection fraction on guideline-directed medical therapy, prescription of a potentially harmful drug was frequent. Calcium channel blockers were associated with an increased risk of readmission.

Characteristics and outcomes in patients with atrial fibrillation receiving direct oral anticoagulants in off-label doses.

BACKGROUND: We evaluated adherence to dosing criteria for patients with atrial fibrillation (AF) taking dabigatran or rivaroxaban and the impact of off-label dosing on thromboembolic and bleeding risk. METHODS: We used data for a retrospective cohort from a large U.S. health plan for Medicare beneficiaries age > =65 years with AF who initiated dabigatran or rivaroxaban during 2010-2016. Stroke and major bleeding were quantified in patients who were eligible for low dose but received standard dose, and in patients who were eligible for standard dose but received low dose. RESULTS: We identified 8035 and 19,712 patients who initiated dabigatran or rivaroxaban, respectively. Overall, 1401 (17.4%) and 7820 (39.7%) patients who received dabigatran and rivaroxaban met criteria for low dose, respectively. Of those, 959 (68.5%) and 3904 (49.9%) received standard dose. In contrast, 1013 (15.3%) and 2551 (21.5%) of patients eligible for standard dose dabigatran and rivaroxaban received low dose. Mean follow-up for patients eligible for low and standard dose dabigatran and rivaroxaban were 13.9, 15.1, 10.1, and 12.3 months, respectively. In unadjusted analyses, patients eligible for low or standard dose dabigatran and rivaroxaban but receiving off-label dose, had no differences in the rates of ischemic stroke. Among patients who met criteria for standard dose direct oral anticoagulants (DOAC), use of low dose was associated with significantly higher risk of any major bleeding (Dabigatran: HR = 1.44; 95% CI 1.14-1.8, P = 0.002, Rivaroxaban HR 1.34, 95% CI 1.11-1.6, P = 0.002) and gastrointestinal bleeding (Dabigatran: HR = 1.48; 95% CI 1.08-2, P = 0.016). In patients who met criteria for low dose DOACs, there was lower risk of major bleeding (Dabigatran: HR = 0.59; 95% CI 0.43-0.8, P < 0.001), gastrointestinal (Rivaroxaban: HR 0.79; 95% CI 0.64-0.98, P = 0.03) and intracranial bleeding (Dabigatran: HR = 0.33; 95% CI 0.12-0.9, P = 0.001) with standard dosing. After propensity matching, use of off-label doses was not associated with stroke, major, gastrointestinal or intracranial bleeding for either dabigatran or rivaroxaban. CONCLUSIONS: While a significant number of patients receive higher or lower dose of dabigatran and rivaroxaban than recommended, we found no evidence of significant impact on thromboembolic or hemorrhagic outcomes.

Incidence and Outcomes of Acute Coronary Syndrome After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to address a knowledge gap by examining the incidence, timing, and predictors of acute coronary syndrome (ACS) after transcatheter aortic valve replacement (TAVR) in Medicare beneficiaries. BACKGROUND: Evidence about incidence and outcomes of ACS after TAVR is scarce. METHODS: We identified Medicare patients who underwent TAVR from 2012 to 2017 and were admitted with ACS during follow-up. We compared outcomes based on the type of ACS: ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina. In patients with non-ST-segment elevation ACS, we compared outcomes based on the treatment strategy (invasive vs. conservative) using inverse probability weighting analysis. RESULTS: Out of 142,845 patients with TAVR, 6,741 patients (4.7%) were admitted with ACS after a median time of 297 days (interquartile range: 85 to 662 days), with 48% of admissions occurring within 6 months. The most common presentation was NSTEMI. Predictors of ACS were history of coronary artery disease, prior revascularization, diabetes, valve-in-TAVR, and acute kidney injury. STEMI was associated with higher 30-day and 1-year mortality compared with NSTEMI (31.4% vs. 15.5% and 51.2% vs. 41.3%, respectively; p < 0.01). Overall, 30.3% of patients with non-ST-segment elevation ACS were treated with invasive approach. On inverse probability weighting analysis, invasive approach was associated with lower adjusted long-term mortality (adjusted hazard ratio: 0.69; 95% confidence interval: 0.66 to 0.73; p < 0.01) and higher risk of repeat revascularization (adjusted hazard ratio: 1.29; 95% confidence interval: 1.16 to 1.43; p < 0.001). CONCLUSIONS: After TAVR, ACS is infrequent (<5%), and the most common presentation is NSTEMI. Occurrence of STEMI after TAVR is associated with a high mortality with nearly one-third of patients dying within 30 days. Optimization of care is needed for post-TAVR ACS patients and if feasible, invasive approach should be considered in these high-risk patients.

Effect of travel distance and rurality of residence on initial surveillance for hepatocellular carcinoma in VA primary care patient with cirrhosis.

OBJECTIVE: To determine the relationship between travel distance and surveillance for hepatocellular carcinoma among veterans with cirrhosis. DATA SOURCES: Veterans Health Administration (VHA) inpatient and outpatient administrative data were linked to geocoded enrollee files. CMS-VHA merged data were used to assess receipt of Medicare-financed non-VA imaging. STUDY DESIGN: A retrospective cohort of US veterans diagnosed with cirrhosis between 2009 and 2015 was examined. First available abdominal imaging following the diagnosis of cirrhosis was analyzed separately as a function of travel distance to the nearest VA medical center (VAMC) and to the patient's assigned VA primary care provider. Veterans with dual use of Medicare and VA services were also examined for receipt of imaging outside of the VA. PRINCIPAL FINDINGS: Veterans who resided more than 30 miles from the nearest VAMC were less likely to receive any imaging for HCC surveillance. Among dual users, increased travel distance between the patient's residence and nearest VAMC was associated with an increased likelihood of receiving any abdominal imaging at non-VA facilities. CONCLUSION: Increased travel distance to the nearest VA medical center reduces the likelihood of receiving imaging for HCC surveillance in cirrhotic veterans. Future efforts should focus on reducing geographic barriers to HCC surveillance.

Impact of Pre-Existing and New-Onset Atrial Fibrillation on Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to evaluate impact of new-onset and pre-existing atrial fibrillation (AF) on transcatheter aortic valve replacement (TAVR) long-term outcomes compared with patients without AF. BACKGROUND: Pre-existing and new-onset AF in patients undergoing TAVR are associated with poor outcomes. METHODS: The study identified 72,660 patients ≥65 years of age who underwent nonapical TAVR between 2014 and 2016 using Medicare inpatient claims. History of AF was defined by diagnoses on claims during the 3 years preceding the TAVR, and new-onset AF was defined as occurrence of AF during the TAVR admission or within 30 days after TAVR in a patient without prior history of AF. Outcomes included all-cause mortality, and readmission for bleeding, stroke, and heart failure (HF). RESULTS: Overall, 40.7% had pre-existing AF (n = 29,563) and 6.8% experienced new-onset AF (n = 2,948) after TAVR. Mean age was 81.3, 82.4, and 83.8 years in patients with no AF, pre-existing, and new-onset AF, respectively. Pre-existing AF patients had the highest burden of comorbidities. After follow-up of 73,732 person-years, mortality was higher with new-onset AF compared with pre-existing and no AF (29.7, 22.6, and 12.8 per 100 person-years, respectively; p < 0.001). After adjusting for patient characteristics and hospital TAVR volume, new-onset AF remained associated with higher mortality compared with no AF (adjusted hazard ratio: 2.068, 95% confidence interval [CI]: 1.92 to 2.20; p < 0.01) and pre-existing AF (adjusted hazard ratio: 1.35; 95% CI: 1.26 to 1.45; p < 0.01). In competing risk analysis, new-onset AF was associated with higher risk of bleeding (subdistribution hazard ratio [sHR]: 1.66; 95% CI: 1.48 to 1.86; p < 0.01), stroke (sHR: 1.92; 95% CI: 1.63 to 2.26; p < 0.01), and HF (sHR: 1.98; 95% CI: 1.81 to 2.16; p < 0.01) compared with pre-existing AF. CONCLUSIONS: In patients undergoing TAVR, new-onset AF is associated with increased risk of mortality and bleeding, stroke, and HF hospitalizations compared with pre-existing AF or no AF.

Clinical Outcomes of Mortality, Readmissions, and Ischemic Stroke Among Medicare Patients Undergoing Left Atrial Appendage Closure via Implanted Device.

Importance: Left atrial appendage closure (LAAC) has emerged as a nonpharmacological alternative for stroke prevention in patients with nonvalvular atrial fibrillation. Contemporary data regarding the characteristics and outcomes of patients undergoing this procedure are limited. Objective: To determine the characteristics, postprocedural mortality rate, and rates of readmission and ischemic stroke among Medicare beneficiaries who underwent LAAC via implanted device. Design, Setting, and Participants: This population-based cohort study used Medicare inpatient claims from January 2015 to December 2017 for 13 627 patients aged older than 65 years with a diagnosis of atrial fibrillation who underwent LAAC with an implanted device from January 2015 to November 2017. Data analyses were conducted from January through August 2019. Exposure: Left atrial appendage closure. Main Outcomes and Measures: Mortality rates during the index admission and for 1 year after LAAC were assessed. The 30-day readmission rate and the primary reasons for readmission were also examined. In addition, the likelihood of hospitalization for ischemic stroke within 180 days among 9231 patients for whom 6 months of follow-up data were available was evaluated. Results: Among the 13 627 patients undergoing LAAC, the mean (SD) age was 78.0 (6.3) years, 9406 (69.0%) were older than 75 years, 11 980 (87.9%) were white, and 5630 (41.3%) were women. The mean (SD) CHA2DS2-VASc score was 4.3 (1.4). Twenty-eight patients (0.2%) died during the index admission. Mortality rates were 0.6% (80 patients) at 30 days, 1.9% (262 patients) at 90 days, 4.0% (547 patients) at 180 days, and 7.5% (1027 patients) at 365 days. The 30-day readmission rate among 13 599 patients discharged alive was 9.4% (1284 patients). Among 9231 patients with 6 months of follow-up data, 111 (1.2%) experienced readmission for ischemic stroke or transient ischemic attack within 180 days of discharge. Conclusions and Relevance: In this cohort study of patients older than 65 years with atrial fibrillation who underwent LAAC with an implanted device, readmission rates for ischemic strokes over the course of 6 months were lower than expected given the patients' CHA2DS2-VASc scores in the absence of anticoagulation therapy. Mortality at 1 year was higher than that reported in previous randomized clinical trials, likely because the patients in the present study were older, had a higher number of comorbidities, and were ineligible to receive warfarin.