Achieving Equity in Hospital Performance Assessments Using Composite Race-Specific Measures of Risk-Standardized Readmission and Mortality Rates for Heart Failure.

BACKGROUND: The contemporary measures of hospital performance for heart failure hospitalization and 30-day risk-standardized readmission rate (RSRR) and risk-standardized mortality rate (RSMR) are estimated using the same risk adjustment model and overall event rate for all patients. Thus, these measures are mainly driven by the care quality and outcomes for the majority racial and ethnic group, and may not adequately represent the hospital performance for patients of Black and other races. METHODS: Fee-for-service Medicare beneficiaries from January 2014 to December 2019 hospitalized with heart failure were identified. Hospital-level 30-day RSRR and RSMR were estimated using the traditional race-agnostic models and the race-specific approach. The composite race-specific performance metric was calculated as the average of the RSRR/RMSR measures derived separately for each race and ethnicity group. Correlation and concordance in hospital performance for all patients and patients of Black and other races were assessed using the composite race-specific and race-agnostic metrics. RESULTS: The study included 1 903 232 patients (75.7% White [n=1 439 958]; 14.5% Black [n=276 684]; and 9.8% other races [n=186 590]) with heart failure from 1860 hospitals. There was a modest correlation between hospital-level 30-day performance metrics for patients of White versus Black race (Pearson correlation coefficient: RSRR=0.42; RSMR=0.26). Compared with the race-agnostic RSRR and RSMR, composite race-specific metrics for all patients demonstrated stronger correlation with RSRR (correlation coefficient: 0.60 versus 0.74) and RSMR (correlation coefficient: 0.44 versus 0.51) for Black patients. Concordance in hospital performance for all patients and patients of Black race was also higher with race-specific (versus race-agnostic) metrics (RSRR=64% versus 53% concordantly high-performing; 61% versus 51% concordantly low-performing). Race-specific RSRR and RSMR metrics (versus race-agnostic) led to reclassification in performance ranking of 35.8% and 39.2% of hospitals, respectively, with better 30-day and 1-year outcomes for patients of all race groups at hospitals reclassified as high-performing. CONCLUSIONS: Among patients hospitalized with heart failure, race-specific 30-day RSMR and RSRR are more equitable in representing hospital performance for patients of Black and other races.

Historical Redlining, Socioeconomic Distress, and Risk of Heart Failure Among Medicare Beneficiaries.

BACKGROUND: The association of historical redlining policies, a marker of structural racism, with contemporary heart failure (HF) risk among White and Black individuals is not well established. METHODS: We aimed to evaluate the association of redlining with the risk of HF among White and Black Medicare beneficiaries. Zip code-level redlining was determined by the proportion of historically redlined areas using the Mapping Inequality Project within each zip code. The association between higher zip code redlining proportion (quartile 4 versus quartiles 1-3) and HF risk were assessed separately among White and Black Medicare beneficiaries using generalized linear mixed models adjusted for potential confounders, including measures of the zip code-level Social Deprivation Index. RESULTS: A total of 2 388 955 Medicare beneficiaries (Black n=801 452; White n=1 587 503; mean age, 71 years; men, 44.6%) were included. Among Black beneficiaries, living in zip codes with higher redlining proportion (quartile 4 versus quartiles 1-3) was associated with increased risk of HF after adjusting for age, sex, and comorbidities (risk ratio, 1.08 [95% CI, 1.04-1.12]; P<0.001). This association remained significant after further adjustment for area-level Social Deprivation Index (risk ratio, 1.04 [95% CI, 1.002-1.08]; P=0.04). A significant interaction was observed between redlining proportion and Social Deprivation Index (Pinteraction<0.01) such that higher redlining proportion was significantly associated with HF risk only among socioeconomically distressed regions (above the median Social Deprivation Index). Among White beneficiaries, redlining was associated with a lower risk of HF after adjustment for age, sex, and comorbidities (risk ratio, 0.94 [95% CI, 0.89-0.99]; P=0.02). CONCLUSIONS: Historical redlining is associated with an increased risk of HF among Black patients. Contemporary zip code-level social determinants of health modify the relationship between redlining and HF risk, with the strongest relationship between redlining and HF observed in the most socioeconomically disadvantaged communities.

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.

Ninety-Day Risk-Standardized Home Time as a Performance Metric for Cardiac Surgery Hospitals in the United States.

BACKGROUND: Assessing hospital performance for cardiac surgery necessitates consistent and valid care quality metrics. The association of hospital-level risk-standardized home time for cardiac surgeries with other performance metrics such as mortality rate, readmission rate, and annual surgical volume has not been evaluated previously. METHODS: The study included Medicare beneficiaries who underwent isolated or concomitant coronary artery bypass graft, aortic valve, or mitral valve surgery from January 1, 2013, to October 1, 2019. Hospital-level performance metrics of annual surgical volume, 90-day risk-standardized mortality rate, 90-day risk-standardized readmission rate, and 90-day risk-standardized home time were estimated starting from the day of surgery using generalized linear mixed models with a random intercept for the hospital. Correlations between the performance metrics were assessed using the Pearson correlation coefficient. Patient-level clinical outcomes were also compared across hospital quartiles by 90-day risk-standardized home time. Last, the temporal stability of performance metrics for each hospital during the study years was also assessed. RESULTS: Overall, 919 698 patients (age 74.2±5.8 years, 32% women) were included from 1179 hospitals. Median 90-day risk-standardized home time was 71.2 days (25th-75th percentile, 66.5-75.6), 90-day risk-standardized readmission rate was 26.0% (19.5%-35.7%), and 90-day risk-standardized mortality rate was 6.0% (4.0%-8.8%). Across 90-day home time quartiles, a graded decline was observed in the rates of in-hospital, 90-day, and 1-year mortality, and 90-day and 1-year readmission. Ninety-day home time had a significant positive correlation with annual surgical volume (r=0.31; P<0.001) and inverse correlation with 90-day risk-standardized readmission rate (r=-0.40; P <0.001) and 90-day risk-standardized mortality rate (r=-0.60; P <0.001). Use of 90-day home time as a performance metric resulted in a meaningful reclassification in performance ranking of 22.8% hospitals compared with annual surgical volume, 11.6% compared with 90-day risk-standardized mortality rate, and 19.9% compared with 90-day risk-standardized readmission rate. Across the 7 years of the study period, 90-day home time demonstrated the most temporal stability of the hospital performance metrics. CONCLUSIONS: Ninety-day risk-standardized home time is a feasible, comprehensive, patient-centered metric to assess hospital-level performance in cardiac surgery with greater temporal stability than mortality and readmission measures.

Early versus late discharge after transcatheter aortic valve replacement and readmissions for permanent pacemaker implantation.

OBJECTIVE: To examine the rate of readmission for permanent pacemaker (PPM) implantation with early versus late discharge after transcatheter aortic valve replacement (TAVR). BACKGROUND: There is a current trend toward early discharge after TAVR. However, paucity of data exists on the impact of such practice on readmissions for PPM implantation. METHODS: The Nationwide Readmission Database 2016-2018 was queried for all hospitalizations where patients underwent TAVR. Hospitalizations were stratified into early (Days 0 and 1) versus late (≥Day 2) discharge groups. Observations in which PPM was required in the index admission were excluded. Multivariable regression analyses involving patient- and hospital-related variables were utilized. The primary outcome was 90-day readmission for PPM implantation. RESULTS: The final analysis included 68,482 TAVR hospitalizations, 20,261 (29.6%) with early versus 48,221 (70.4%) with late discharge. Early discharge after TAVR increased over the study period (16.2% in 2016 vs. 37.9% in 2018, Ptrend < 0.01). Nevertheless, 90-day readmission for PPM implantation remained stable (1.8% in 2016 vs. 2.0% in 2018, Ptrend = 0.32). The 90-day readmission rate for PPM implantation (2.0% vs. 1.8%; adjusted odds ratio: 1.15; 95% confidence interval: 0.95-1.39; p = 0.15) and median time-to-readmission (5 days [interquartile range, IQR 3-9] vs. 5 days [IQR 3-14], p = 0.92) were similar with early versus late discharge. Similar rates were observed regardless of whether readmission was elective versus not. Early discharge was associated with lower hospitalization cost ($39,990 ± $13,681 vs. $46,750 ± $18,218, p < 0.01) compared with late discharge. CONCLUSION: In patients who did not require PPM during the index TAVR hospitalization, the rate of readmission for PPM implantation was similar with early versus late discharge.

The safety of Bruton's tyrosine kinase inhibitors in B-cell malignancies: A systematic review.

B-cell malignancies, most notably lymphomas, make up most of the non-Hodgkin lymphomas in the United States. There are limited randomized data comparing first- and second-generation Bruton tyrosine kinase (BTK) inhibitors. Our aim was to compare the safety profiles of first versus second-generation BTK inhibitors. A systematic search was performed from database inception to January 13, 2020. Studies with BTK inhibitor monotherapy for the treatment of B-cell malignancies in the adult population (>18 years old) were utilized and the adverse events (AEs) were extracted. Fifty-five studies that met the inclusion criteria were included in the systematic review with 41 studies with first generation and 14 studies with second generation. The review included both clinical trials and retrospective studies with average time of follow-up of 2 years for the first-generation group and 18 months for the second-generation group. We found that the incidence of cardiovascular AEs was significantly higher in the first-generation group (20.8%) as compared to the second-generation group (6.3%). However, there was a higher incidence of hematologic/oncologic and gastrointestinal side effects in the second-generation group compared to the first (62.3% compared to 39.2% and 36.9% compared to 28.9%). The number of Grade 5 cardiovascular events (death) was same in the first-generation group compared to the second generation. Further research is needed to develop highly selective BTK inhibitors to avoid unwanted AEs by minimizing off-targets.

Comparison of risk scores for predicting outcomes after isolated tricuspid valve surgery.

BACKGROUND: Risk models play important roles in stratification and decision-making towards cardiac surgery. Isolated tricuspid valve surgery is a high risk but increasingly performed the operation, however, the performance of risk models has not been externally evaluated in these patients. We compared the prognostic utility of contemporary risk scores for isolated tricuspid valve surgery. METHODS: Consecutive patients undergoing isolated tricuspid valve surgery at Cleveland Clinic during 2004-2018 were evaluated in this cohort study. EuroSCORE II, Society of Thoracic Surgeon's tricuspid (STS-TVS) score, and the Model for End-stage Liver Disease (MELD) score were retrospectively calculated, and their performance for predicting operative mortality, postoperative complications, and mortality during follow-up was assessed. RESULTS: Amongst 207 patients studied, the mean age was 54.1 ± 17.9 years, 116 (56.0%) were female, 92 (44.4%) had secondary tricuspid regurgitation, and 151 (72.9%) had a surgical repair. Mean EuroSCORE II, STS-TVS, and MELD scores were 6.3 ± 6.6%, 5.5 ± 6.2%, and 9.8 ± 4.7, respectively. C-statistics (95% confidence intervals) for operative mortality were 0.83 (0.74-0.93) for EuroSCORE II, 0.60 (0.45-0.75) for STS-TVS score, and 0.74 (0.58-0.89) for MELD score, while observed/expected ratios were 0.78 and 0.89 for the first two scores. All three scores were associated with mortality during follow-up and discriminated most postoperative complications. CONCLUSION: EuroSCORE II was superior to STS-tricuspid score for isolated TVS risk assessment. Although surgical risk scores traditionally underestimated operative mortality after isolated tricuspid valve surgery, they did not in our cohort, reflecting the excellent surgical results. The simple MELD score performed similarly to the EuroSCORE II, especially for discriminating morbidities.

Expansion of transcatheter aortic valve replacement in the United States.

BACKGROUND: Patterns of diffusion of TAVR in the United States (U.S.) and its relation to racial disparities in TAVR utilization remain unknown. METHODS: We identified TAVR hospitals in the continental U.S. from 2012-2017 using Medicare database and mapped them to Hospital Referral Regions (HRR). We calculated driving distance from each residential ZIP code to the nearest TAVR hospital and calculated the proportion of the U.S. population, in general and by race, that lived <100 miles driving distance from the nearest TAVR center. Using a discrete time hazard logistic regression model, we examined the association of hospital and HRR variables with the opening of a TAVR program. RESULTS: The number of TAVR hospitals increased from 230 in 2012 to 540 in 2017. The proportion of the U.S. population living <100 miles from nearest TAVR hospital increased from 89.3% in 2012 to 94.5% in 2017. Geographic access improved for all racial and ethnic subgroups: Whites (84.1%-93.6%), Blacks (90.0%- 97.4%), and Hispanics (84.9%-93.7%). Within a HRR, the odds of opening a new TAVR program were higher among teaching hospitals (OR 1.48, 95% CI 1.16-1.88) and hospital bed size (OR 1.44, 95% CI 1.37-1.52). Market-level factors associated with new TAVR programs were proportion of Black (per 1%, OR 0.78, 95% CI 0.69-0.89) and Hispanic (per 1%, OR 0.82, 95% CI 0.75-0.90) residents, the proportion of hospitals within the HRR that already had a TAVR program (per 10%, OR 1.07, 95% CI 1.03-1.11), P <.01 for all. CONCLUSION: The expansion of TAVR programs in the U.S. has been accompanied by an increase in geographic coverage for all racial subgroups. Further study is needed to determine reasons for TAVR underutilization in Blacks and Hispanics.

Initial experience with regadenoson stress positron emission tomography in patients with left bundle branch block: Low prevalence of septal defects and high accuracy for obstructive coronary artery disease.

BACKGROUND: Assessing for coronary artery disease (CAD) in patients with left bundle branch block (LBBB) is difficult with noninvasive cardiac imaging. Few studies report the prevalence of LBBB associated septal-apical perfusion defects using regadenoson stress on Positron Electron Tomography (PET) imaging. METHODS AND RESULTS: We identified 101 consecutive patients with baseline LBBB, and without known CAD, who underwent rest-stress regadenoson PET. Investigators have the ability to prospectively identify studies, whose quality is limited by LBBB artifact. With the infusion of regadenoson, resting to peak stress heart rate rose from a median of 78 to 93 BPM. Despite this, LBBB perfusion artifacts were not identified in any studies. 10 individuals had both regadenoson SPECT and PET within 1 year. 3 of the 10 SPECT studies had LBBB artifacts, all of which were not seen on subsequent PET. 21 patients with PET had subsequent coronary angiography. Of these, 9 PETs were without significant inducible ischemia, and angiogram was without flow-limiting disease. 3 PETs identified inducible ischemia, but did not have flow-limiting disease on angiogram. 9 PETs identified inducible ischemia and had flow-limiting disease on angiogram. CONCLUSIONS: In patients with LBBB undergoing regadenoson PET stress imaging, artifactual septal perfusion defects are rare.

Temporal trends and outcomes of critical limb ischemia among patients with chronic kidney disease.

There is a paucity of data on the outcomes and revascularization strategies for critical limb ischemia (CLI) among patients with chronic kidney disease (CKD). Hence, we conducted a nationwide analysis to evaluate the trends and outcomes of hospitalizations for CLI with CKD. The National Inpatient Sample database (2002-2015) was queried for hospitalizations for CLI. The trends of hospitalizations for CLI with CKD were reported, and endovascular versus surgical revascularization strategies for CLI with CKD were compared. The main study outcome was in-hospital mortality. The analysis included 2,139,640 hospitalizations for CLI, of which 484,224 (22.6%) had CKD. There was an increase in hospitalizations for CLI with CKD (Ptrend = 0.01), but a reduction in hospitalizations for CLI without CKD (Ptrend = 0.01). Patients with CLI and CKD were less likely to undergo revascularization compared with patients without CKD. CLI with CKD had higher rates of in-hospital mortality (4.8% vs 2.5%, adjusted odds ratio (OR) 2.01; 95% CI 1.93-2.11) and major amputation compared with no CKD. Revascularization for CLI with CKD was associated with lower rates of mortality (3.7% vs 5.3%, adjusted-OR 0.78; 95% CI 0.72-0.84) and major amputation compared with no revascularization. Compared with endovascular revascularization, surgical revascularization for CLI with CKD was associated with higher rates of in-hospital mortality (4.7% vs 2.7%, adjusted-OR 1.67; 95% CI 1.43-1.94). In conclusion, this contemporary observational analysis showed an increase in hospitalizations for CLI among patients with CKD. CLI with CKD was associated with higher in-hospital mortality compared with no CKD. Compared with endovascular therapy, surgical revascularization for CLI with CKD was associated with higher in-hospital mortality.

Comparative Effectiveness and Safety of Direct Oral Anticoagulants in Obese Patients with Atrial Fibrillation.

BACKGROUND: Unlike warfarin direct oral anticoagulants (DOACs) are administered in fixed doses, which raises concerns of its effectiveness on larger patients. Data from randomized trials are limited on the safety and efficacy of DOACs in morbidly obese individuals with atrial fibrillation (AF). METHODS: We analyzed a cohort of obese (≥ 120 kg) and morbidly obese (BMI > 40 kg/m2) patients from the Veterans Health Administration system with AF who initiated apixaban, rivaroxaban, dabigatran, or warfarin between years 2012 and 2018. We used inverse probability of treatment weighting (IPTW) and Cox proportional hazards regression models to evaluate the relative hazard of death, myocardial infarction (MI), ischemic stroke, heart failure (HF), and bleeding events between oral anticoagulant (OAC) groups while censoring for medication cessation. RESULTS: We identified 6052 obese patients on apixaban, 4233 on dabigatran, 4309 on rivaroxaban, and 13,417 on warfarin (mean age 66.7 years, 91% males, 80.4% whites). At baseline patients on apixaban had the lowest glomerular filtration rate and highest rates of previous stroke and MI compared to other OACs. Among patients with weight ≥ 120 kg and those with BMI > 40 kg/m2, all DOACs were associated with lower risk of any hemorrhage, hemorrhagic stroke, and gastrointestinal (GI) bleeding. Patients with BMI > 40 kg/m2 treated with DOACs had similar ischemic stroke risk with those on warfarin. CONCLUSIONS: In this large cohort of obese Veterans Health Administration system patients, the use of DOACs resulted in lower hemorrhagic complications than warfarin while maintaining efficacy on ischemic stroke prevention.

Comparative Effectiveness of Rivaroxaban, Apixaban, and Warfarin in Atrial Fibrillation Patients With Polypharmacy.

BACKGROUND AND PURPOSE: Comparative effectiveness and safety of oral anticoagulants in patients with atrial fibrillation and high polypharmacy are unknown. METHODS: We used Medicare administrative data to evaluate patients with new atrial fibrillation diagnosis from 2015 to 2017, who initiated an oral anticoagulant within 90 days of diagnosis. Patients taking ≤3, 4 to 8, or ≥9 other prescription medications were categorized as having low, moderate, or high polypharmacy, respectively. Within polypharmacy categories, patients receiving apixaban 5 mg twice daily, rivaroxaban 20 mg once daily, or warfarin were matched using a 3-way propensity score matching. Study outcomes included ischemic stroke, bleeding, and all-cause mortality. RESULTS: The study cohort included 6985 patients using apixaban, 3838 using rivaroxaban, and 6639 using warfarin. In the propensity-matched cohorts there was no difference in risk of ischemic stroke between the 3 drugs in patients with low and moderate polypharmacy. However, among patients with high polypharmacy, the risk of ischemic stroke was higher with apixaban compared with warfarin (adjusted hazard ratio 2.34 [95% CI, 1.01-5.42]; P=0.05) and similar to rivaroxaban (adjusted hazard ratio, 1.38 [95% CI, 0.67-2.84]; P=0.4). There was no difference in risk of death between the 3 drugs in patients with low and moderate polypharmacy, but apixaban was associated with a higher risk of death compared with rivaroxaban (adjusted hazard ratio, 2.03 [95% CI, 1.01-4.08]; P=0.05) in the high polypharmacy group. Apixaban had lower bleeding risk compared with warfarin in the low polypharmacy group (adjusted hazard ratio, 0.54 [95% CI, 0.32-0.90]; P=0.02), but there was no difference in bleeding between the 3 drugs in the moderate and high polypharmacy groups. CONCLUSIONS: Our study suggests that among patients with significant polypharmacy (>8 drugs), there may be a higher stroke and mortality risk with apixaban compared with warfarin and rivaroxaban. However, differences were of borderline significance.

Impact of COVID-19 pandemic on patients with ST-segment elevation myocardial infarction: Insights from a British cardiac center.

The current study aimed to examine the impact of COVID-19 pandemic on patient-related delay with ST-segment elevation myocardial infarction (STEMI) at a tertiary center in the United Kingdom. The study demonstrated a significant delay in symptom-to-first medical contact and a higher cardiac troponin-I level on admission in patients with STEMI during the COVID-19 pandemic versus the pre-COVID era.

Outcomes of urgent versus nonurgent transcatheter aortic valve replacement.

BACKGROUND: There is a paucity of data regarding the outcomes of transcatheter valve replacement (TAVR) performed in an urgent clinical setting. METHODS: The Nationwide Inpatient Sample (NIS) database years 2011-2014 was used to identify hospitalizations for TAVR in the urgent setting. Using propensity score matching, we compared patients who underwent TAVR in nonurgent versus urgent settings. RESULTS: Among 42,154 hospitalizations in which TAVR was performed, 10,114 (24%) underwent urgent TAVR. There was an uptrend in the rate of urgent TAVR procedures (p = .001). The rates of in-hospital mortality among this group did not change during the study period (p = .713). Nonurgent TAVR was associated with lower mortality (odds ratio [OR] = 0.78; 95% confidence interval [CI]: 0.69-0.89, p < .001) compared with urgent TAVR. Nonurgent TAVR was associated with lower incidence of cardiogenic shock (OR = 0.46; 95%CI: 0.40-0.53 p < .001), use of mechanical circulatory support devices (OR = 0.69; 95%CI: 0.59-0.82, p < .001), AKI (OR = 0.60; 95%CI: 0.56-0.64 p < .001), hemodialysis (OR = 0.67; 95%CI: 0.56-0.80 p < .001), major bleeding (OR = 0.94; 95%CI: 0.89-0.99 p = .045) and shorter length of stay (7.08 ± 6.317 vs. 12.39 ± 9.737 days, p < .001). There was no difference in acute stroke (OR = 0.96; 95%CI: 0.81-1.14, p = .636), vascular complications (OR = 1.07; 95%CI: 0.89-1.29, p = .492), and pacemaker insertions (OR = 0.92; 95%CI: 0.84-1.01, p = .067) between both groups. Among those undergoing urgent TAVR, subgroup analysis showed higher mortality in patients ≤80 years (p = .033), women (p < .001), chronic kidney disease (p = .001), heart failure (p < .001), and liver disease (p = .003). CONCLUSION: In this large nationwide analysis, almost a quarter of TAVR procedures were performed in the urgent settings. Although urgent TAVR was associated with higher mortality and increased complications compared with nonurgent TAVR, the absolute difference in in-hospital mortality was not remarkably higher. Thus, urgent TAVR can be considered as a reasonable approach when indicated.

Role of diabetes and insulin use in the risk of stroke and acute myocardial infarction in patients with atrial fibrillation: A Medicare analysis.

BACKGROUND: Atrial fibrillation (AF) is associated with elevated risk for ischemic stroke and myocardial infarction (MI). The aim of the study is to assess the role of insulin use on the risk of stroke and MI in AF patients with diabetes. METHODS: We identified Medicare beneficiaries with new AF in 2011 to 2013. Primary outcomes were ischemic stroke and MI. Multivariate Cox regression models were used to assess the association between AF and time to stroke and MI. We adjusted for anticoagulant as a time-dependent covariate. RESULTS: Out of 798,592 AF patients, 53,212 (6.7%) were insulin-requiring diabetics (IRD), 250,214 (31.3%) were non-insulin requiring diabetics (NIRD) and 495,166 (62%) were non-diabetics (ND). IRD had a higher risk of stroke when compared to NIRD (adjusted HR: 1.15, 95% CI 1.10-1.21) and ND (aHR 1.24, 95% CI 1.18-1.31) (P < .01 for both). The risk of stroke was higher in NIRD compared to ND (aHR 1.08, 95% CI 1.05-1.12). For the outcome of MI, IRD had a higher risk compared to NIRD (aHR 1.24, 95% CI 1.18-1.31) and ND (aHR 1.46, 95% CI 1.38-1.54)]. NIRD had a higher risk compared to ND (aHR 1.17, 95% CI 1.13-1.22). Anticoagulation were most effective at preventing stroke in ND [0.72 (0.69-0.75)], and NIRD [0.88 (0.85-0.92)], but were not associated with significant reduction in stroke in IRD [0.96 (0.89-1.04)]. CONCLUSION: There is an incremental risk of ischemic stroke and MI from non-diabetics to non-insulin diabetics with the highest risk in insulin users. Protective effect of anticoagulation is attenuated with insulin use.

National trends and outcomes for extra-corporeal membrane oxygenation use in high-risk pulmonary embolism.

Little is known about the temporal trends and outcomes for extra-corporeal membrane oxygenation (ECMO) in patients with high-risk pulmonary embolism (PE) in the United States. We queried the National Inpatient Sample (NIS) database from 2005 to 2013 to identify patients admitted with high-risk PE. Our objective was to determine trends for ECMO use in patients with high-risk PE. We also assessed in-hospital outcomes among patients with high-risk PE receiving ECMO. We evaluated 77,809 hospitalizations for high-risk PE. There was an upward trend in the utilization of ECMO from 0.07% in 2005 to 1.1% in 2013 ( p = 0.015). ECMO was utilized more in urban teaching hospitals and large hospitals. ECMO use was associated with lower mortality in patients with massive PE ( p < 0.001). In-hospital mortality for patients receiving ECMO was 61.6%, with no change over the observational period ( p = 0.68). Our investigation revealed several independent predictors of increased mortality in patients with high-risk PE using ECMO as hemodynamic support, including: age, female sex, obesity, congestive heart failure, and chronic pulmonary disease. ECMO, therefore, as a rescue strategy or bridge to definitive treatment, may be effective in the management of high-risk PE when selecting patients with favorable clinical characteristics.

National Trends and Outcomes of Endomyocardial Biopsy for Patients With Myocarditis: From the National Inpatient Sample Database.

BACKGROUND: The utility of endomyocardial biopsy (EMB) in the management of myocarditis in the era of advanced cardiac imaging has been challenged. METHODS AND RESULTS: The Nationwide Inpatient Sample Database (years 1998-2013) was queried to identify hospitalization records with a primary diagnosis of myocarditis, and underwent EMB procedure. We identified 22,299 hospitalization records with a diagnosis of myocarditis during the study period. Of those, 798 (3.6%) underwent EMB procedures. There was an average decrease in the incidence of EMB for myocarditis by 0.15% (P < .01) over the study period. Younger patients, women, and those with chronic kidney disease were more likely to undergo EMB. On multivariate analysis, patients with myocarditis who underwent EMB had higher in-hospital mortality (hazard ratio [HR] 1.97, 95% confidence interval [CI] 1.41-2.74) and longer median hospital stay (9 days vs 3 days; P < .001). EMB was associated with a higher incidence of cardiac tamponade (odds ratio [OR] 5.21, 95% CI 2.76-9.82), cardiogenic shock (OR 4.66, 95% CI 3.75-5.78), need for intra-aortic balloon pump (OR 3.52, 95% CI 2.49-4.97), and need for extracorporeal membrane oxygenation (OR 4.26, 95% CI 2.78-6.53). CONCLUSIONS: The use of EMB in hospitalizations with myocarditis has decreased over time. The use of EMB was associated with a higher likelihood of in-hospital mortality and morbidity. Whether these findings represent a causative association from the procedure or a consequence of more severe disease in this group could not be confirmed in this study.

Epidemiology of lower extremity peripheral artery disease in veterans.

OBJECTIVE: The objective of this study was to describe the epidemiology, clinical features, outcomes, and predictors of mortality in veterans with peripheral artery disease (PAD). METHODS: We used national data from the Veterans Health Administration from fiscal years 2009 to 2011 to identify patients with a new diagnosis of PAD. Within this cohort, we describe characteristics of the patients, use of recommended medications, and clinical outcomes during a 3-year follow-up (fiscal year 2014). We used Cox proportional hazards regression to examine predictors of mortality and adverse limb outcomes (amputation and hospitalization for critical limb ischemia [CLI]) during follow-up. RESULTS: A total of 175,865 patients with a new diagnosis of PAD were included. The mean age was 69.9 years; 97.8% were male, and 67.7% were white. Nearly 77% of patients had hypertension, 46.5% had diabetes, 23% had chronic obstructive pulmonary disease, and 12.9% had renal failure. A prescription for statins was filled by 60.8%, and 34.9% received high-intensity statins within 90 days of PAD diagnosis. At 1 year, 2.6% underwent revascularization, 1.3% developed CLI, and 1.1% underwent amputation. During a median follow-up of 3.8 years, a total of 28.6% patients died (6.7% at 1 year), and 3.7% developed a limb outcome (2.0% at 1 year). Predictors of mortality included advanced age, comorbidities, and CLI or amputation at presentation. In contrast, prescription with statins was associated with lower mortality. Similar findings were present with regard to predictors of adverse limb outcomes, except that older age was associated with a lower risk of amputation or CLI. CONCLUSIONS: We found that veterans with PAD have a high prevalence of comorbid conditions and have a significant risk of mortality and limb loss. A substantial proportion of veterans with PAD are not prescribed recommended medications, especially statin therapy. Our data highlight important opportunities for improving care of veterans with PAD.

Deferred or immediate stent implantation for primary percutaneous coronary intervention: A meta-analysis of randomized trials.

OBJECTIVES: To perform a meta-analysis of randomized trials comparing a deferred versus immediate stenting strategy for primary percutaneous coronary intervention (PCI). BACKGROUND: Deferred stent implantation has emerged as a potential strategy aiming to reduce the thrombus burden and improve micro-vascular reperfusion during primary PCI. METHODS: Electronic databases were searched for randomized trials that compared a deferred stent implantation versus immediate stent implantation strategy in patients undergoing primary PCI. Random effects risk ratios (RR) were estimated for the outcomes of interest. RESULTS: Four trials with 1,570 patients were included. A deferred stent implantation strategy was associated with a lower incidence of no-/slow reflow (RR 0.49, 95% confidence interval [CI] 0.24-0.96), and improved myocardial blush grade 3 (RR 1.42, 95% CI 1.14-1.77). At a mean follow up of 34 ± 15 months, both strategies were associated with a similar risk of all-cause mortality (RR 0.85, 95% CI 0.58-1.24), cardiovascular mortality (RR 0.84, 95% CI 0.48-1.45), reinfarction (RR 1.54, 95% CI 0.43-5.49), and stent thrombosis (RR = 0.35, 95% CI 0.04-3.35, P = 0.36). CONCLUSION: In patients undergoing primary PCI, deferred stent implantation is associated with improvement in surrogate outcomes, but does not appear to improve clinical outcomes. Future randomized trials are encouraged to identify the patient population who might benefit from a deferred stent implantation strategy (e.g., high thrombus burden).