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ImportanceGuideline-directed medical therapy (GDMT) remains underutilized on a global level, with significant disparities in access to treatment worldwide. The potential global benefits of quadruple therapy on patients with heart failure with reduced ejection fraction (HFrEF) have not yet been estimated.ObjectiveTo assess the projected population-level benefit of optimal GDMT use globally among patients with HFrEF.Design, setting, and participantsEstimates for HFrEF prevalence, contraindications to GDMT, treatment rates, and the number needed to treat for all-cause mortality at 12 months were derived from previously published sources. Potential lives saved from optimal implementation of quadruple therapy among patients with HFrEF was calculated globally and a sensitivity analysis was conducted to account for uncertainty in the existing data.Main outcomes and measuresAll-cause mortality.ResultsOf an estimated 28.89 million people with HFrEF worldwide, there were 8 235 063 (95% CI, 6 296 020-10 762 972) potentially eligible for but not receiving β-blockers, 20 387 000 (95% CI, 15 867 004-26 184 996) eligible for but not receiving angiotensin receptor-neprilysin inhibitors, 12 223 700 (95% CI, 9 376 895-15 924 973) eligible for but not receiving mineralocorticoid receptor antagonists, and 21 229 170 (95% CI, 16 537 400-27 242 688) eligible for but not receiving sodium glucose cotransporter-2 inhibitors. Optimal implementation of quadruple GDMT could potentially prevent 1 188 277 (95% CI, 767 933-1 914 561) deaths over 12 months. A large proportion of deaths averted were projected in Southeast Asia, Eastern Mediterranean and Africa, and the Western Pacific regions.Conclusions and relevanceImprovement in use of GDMT could result in substantial mortality benefits on a global scale. Significant heterogeneity also exists across regions, which warrants additional study with interventions tailored to country-level differences for optimization of GDMT worldwide.

Advances in cancer therapeutics have revolutionized survival outcomes in patients with cancer. However, cardiovascular toxicities associated with specific cancer therapeutics adversely affect the outcomes of patients with cancer. Recent studies have uncovered excess risks of these cardiotoxic events, especially in traditionally underrepresented populations. Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations. Previously decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigation, and potential optimal strategies to address disparate cardiotoxicity in contemporary cancer care (eg, with immunotherapy, biologic, or cytotoxic therapies) settings. This scientific statement aims to define the current state of evidence for disparate cardiotoxicity while proposing uniform and novel methodological approaches to inform the identification and mitigation of disparate cardio-oncology outcomes in future clinical trials, registries, and daily clinical care settings. We also propose an evidence-based integrated approach to identify and mitigate disparities in the routine clinical setting. This consensus scientific statement summarizes and clarifies available evidence while providing guidance on addressing inequities in the era of emerging anticancer therapies.

Background Many patients with heart failure (HF) have severely reduced ejection fraction but do not meet threshold for consideration of advanced therapies (ie, stage D HF). The clinical profile and health care costs associated with these patients in US practice is not well described. Methods and Results We examined patients hospitalized for worsening chronic heart failure with reduced ejection fraction ≤40% from 2014 to 2019 in the GWTG-HF (Get With The Guidelines-Heart Failure) registry, who did not receive advanced HF therapies or have end-stage kidney disease. Patients with severely reduced EF defined as EF ≤30% were compared with those with EF 31% to 40% in terms of clinical profile and guideline-directed medical therapy. Among Medicare beneficiaries, postdischarge outcomes and health care expenditure were compared. Among 113 348 patients with EF ≤40%, 69% (78 589) had an EF ≤30%. Patients with severely reduced EF ≤30% tended to be younger and were more likely to be Black. Patients with EF ≤30% also tended to have fewer comorbidities and were more likely to be prescribed guideline-directed medical therapy ("triple therapy" 28.3% versus 18.2%, P

AimsTo assess heart failure (HF) in-hospital quality of care and outcomes before and during the COVID-19 pandemic.Methods and resultsPatients hospitalized for HF with ejection fraction (EF)

Breast cancer and heart failure share several known clinical cardiovascular risk factors, including age, obesity, glucose dysregulation, cholesterol dysregulation, hypertension, atrial fibrillation and inflammation. However, to fully comprehend the complex interplay between risk of breast cancer and heart failure, factors attributed to both biological and social determinants of health must be explored in risk-assessment. There are several social factors that impede implementation of prevention strategies and treatment for breast cancer and heart failure prevention, including socioeconomic status, neighborhood disadvantage, food insecurity, access to healthcare, and social isolation. A comprehensive approach to prevention of both breast cancer and heart failure must include assessment for both traditional clinical risk factors and social determinants of health in patients to address root causes of lifestyle and modifiable risk factors. In this review, we examine clinical and social determinants of health in breast cancer and heart failure that are necessary to consider in the design and implementation of effective prevention strategies that altogether reduce the risk of both chronic diseases.

BackgroundUninsurance is a known contributor to racial/ethnic health inequities. Insurance is often needed for prescriptions and follow-up appointments. Therefore, we determined whether the Affordable Care Act(ACA) Medicaid Expansion was associated with increased receipt of guideline-directed medical treatment(GDMT) at discharge among patients hospitalized with heart failure(HF) by race/ethnicity.MethodsUsing Get With The Guidelines-HF registry, logistic regression was used to assess odds of receiving GDMT(HF medications; education; follow-up appointment) in early vs non-adopter states before(2012 - 2013) and after ACA Medicaid Expansion(2014 - 2019) within each race/ethnicity, accounting for patient-level covariates and within-hospital clustering. We tested for an interaction(p-int) between GDMT and pre/post Medicaid Expansion time periods.ResultsAmong 271,606 patients(57.5% early adopter, 42.5% non-adopter), 65.5% were White, 22.8% African American, 8.9% Hispanic, and 2.9% Asian race/ethnicity. Independent of ACA timing, Hispanic patients were more likely to receive all GDMT for residing in early adopter states compared to non-adopter states (P

BackgroundSouth Asian Americans experience disproportionately high burden of cardiovascular diseases. Estimating predicted heart failure (HF) risk distribution may facilitate targeted prevention. We estimated the distribution of 10-year predicted risk of incident HF in South Asian Americans and evaluated the associations with social determinants of health and clinical risk factors.Methods and resultsIn the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study, we calculated 10-year predicted HF risk using the Pooled Cohort Equations to Prevent Heart Failure multivariable model. Distributions of low (

Background Sacubitril/Valsartan has been highly efficacious in randomized trials of heart failure with reduced ejection fraction (HFrEF). However, the effectiveness of sacubitril/valsartan in older patients hospitalized for HFrEF in real-world US practice is unclear. Methods and Results This study included Medicare beneficiaries age ≥65 years who were hospitalized for HFrEF ≤40% in the Get With The Guidelines-Heart Failure registry between October 2015 and December 2018, and eligible for sacubitril/valsartan. Associations between discharge prescription of sacubitril/valsartan and clinical outcomes were assessed after inverse probability of treatment weighting and adjustment for other HFrEF medications. Overall, 1551 (10.9%) patients were discharged on sacubitril/valsartan. Of those not prescribed sacubitril/valsartan, 7857 (62.0%) were prescribed an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker. Over 12-month follow-up, compared with a discharge prescription of angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker, sacubitril/valsartan was independently associated with lower all-cause mortality (adjusted hazard ratio [HR], 0.82; 95% CI, 0.72-0.94; P=0.004) but not all-cause hospitalization (adjusted HR, 0.97; 95% CI, 0.89-1.07; P=0.55) or heart failure hospitalization (adjusted HR, 1.04; 95% CI, 0.91-1.18; P=0.59). Patients prescribed sacubitril/valsartan versus those without a prescription had lower risk of all-cause mortality (adjusted HR, 0.69; 95% CI, 0.60-0.79; P

BackgroundFew contemporary data exist evaluating care patterns and outcomes in heart failure (HF) across the spectrum of kidney function.ObjectivesThis study sought to characterize differences in quality of care and outcomes in patients hospitalized for HF by degree of kidney dysfunction.MethodsGuideline-directed medical therapies were evaluated among patients hospitalized with HF at 418 sites in the GWTG-HF (Get With The Guidelines-Heart Failure) registry from 2014 to 2019 by discharge CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)-derived estimated glomerular filtration rate (eGFR). We additionally evaluated the risk-adjusted association of admission eGFR with in-hospital mortality.ResultsAmong 365,494 hospitalizations (age 72 ± 15 years, left ventricular ejection fraction [EF]: 43 ± 17%), median discharge eGFR was 51 ml/min/1.73 m2 (interquartile range: 34 to 72 ml/min/1.73 m2), 234,332 (64%) had eGFR

ImportanceThe Centers for Medicare & Medicaid Services uses a new peer group-based payment system to compare hospital performance as part of its Hospital Readmissions Reduction Program, which classifies hospitals into quintiles based on their share of dual-eligible beneficiaries for Medicare and Medicaid. However, little is known about the association of a hospital's share of dual-eligible beneficiaries with the quality of care and outcomes for patients with heart failure (HF).ObjectiveTo evaluate the association between a hospital's proportion of patients with dual eligibility for Medicare and Medicaid and HF quality of care and outcomes.Design, setting, and participantsThis retrospective cohort study evaluated 436 196 patients hospitalized for HF using the Get With The Guidelines-Heart Failure registry from January 1, 2010, to December 31, 2017. The analysis included patients 65 years or older with available data on dual-eligibility status. Hospitals were divided into quintiles based on their share of dual-eligible patients. Quality and outcomes were analyzed using unadjusted and adjusted multivariable logistic regression models. Data analysis was performed from April 1, 2020, to January 1, 2021.Main outcomes and measuresThe primary outcome was 30-day all-cause readmission. The secondary outcomes included in-hospital mortality, 30-day HF readmissions, 30-day all-cause mortality, and HF process of care measures.ResultsA total of 436 196 hospitalized HF patients 65 years or older from 535 hospital sites were identified, with 258 995 hospitalized patients (median age, 81 years; interquartile range, 74-87 years) at 455 sites meeting the study criteria and included in the primary analysis. A total of 258 995 HF hospitalizations from 455 sites were included in the primary analysis of the study. Hospitals in the highest dual-eligibility quintile (quintile 5) tended to care for patients who were younger, were more likely to be female, belonged to racial minority groups, or were located in rural areas compared with quintile 1 sites. After multivariable adjustment, hospitals with the highest quintile of dual eligibility were associated with lower rates of key process measures, including evidence-based β-blocker prescription, measure of left ventricular function, and anticoagulation for atrial fibrillation or atrial flutter. Differences in clinical outcomes were seen with higher 30-day all-cause (adjusted odds ratio, 1.24; 95% CI, 1.14-1.35) and HF (adjusted odds ratio, 1.14; 95% CI, 1.03-1.27) readmissions in higher dual-eligible quintile 5 sites compared with quintile 1 sites. Risk-adjusted in-hospital and 30-day mortality did not significantly differ in quintile 1 vs quintile 5 hospitals.Conclusions and relevanceIn this cohort study, hospitals with a higher share of dual-eligible patients provided care with lower rates of some of the key HF quality of care process measures and with higher 30-day all-cause or HF readmissions compared with lower dual-eligibility quintile hospitals.

Background Regional patient characteristics, care quality, and outcomes may differ based on a variety of factors among patients hospitalized for heart failure (HF). Regional disparities in outcomes of cardiovascular disease have been suggested across various regions in the United States. This study examined whether there are significant differences by region in quality of care and short-term outcomes of hospitalized patients with HF across the United States. Methods and Results We examined regional demographics, quality measures, and short-term outcomes across 4 US Census Bureau regions in patients hospitalized with HF and enrolled in the GWTG-HF (Get With The Guidelines-Heart Failure) registry from 2010 to 2016. Differences in length of stay and mortality by region were examined with multivariable logistic regression. The study included 423 333 patients hospitalized for HF in 488 hospitals. Patients in the Northeast were significantly older. Completion of achievement measures, with few exceptions, were met with similar frequency across regions. Multivariable analysis demonstrated significantly lower in-hospital mortality in the Midwest compared with the Northeast (hazard ratio, 0.64; 95% CI, 0.51-0.8; P

BackgroundPostdischarge mortality following hospitalization for heart failure with reduced ejection fraction (HFrEF) has remained high and unchanged over the past 2 decades, despite effective therapies for HFrEF. We aimed to explore whether these patterns could in part be explained by changes in longitudinal risk profile and HF severity over time.MethodsAmong patients hospitalized for HF in the GWTG-HF registry from January 2005 to December 2018 with available data, we evaluated GWTG-HF and ADHERE risk scores, observing in-hospital mortality per-year. The risk profiles and outcomes were described overall and by subgroups based on ejection fraction (EF), diabetes mellitus (DM), sex, and age.ResultsOverall, 335,735 patients were included (50% HFrEF, 46% DM, 48% female, mean age 74 years). In-hospital mortality increased by 2.0% per year from 2005 to 2018. There was no significant change in mean GWTG-HF risk score overall or when stratified by EF groups (P = 0.46 HFrEF, p = 0.26 HF mid-range EF [HFmrEF], and P = 0.72 HF preserved EF [HFpEF]), age, sex, or presence of DM. The observed/expected ratio based on the GWTG-HF risk score was 0.93 (0.91-0.96), 0.83 (0.77-0.90), 0.92 (0.89-95) for HFrEF, HFmrEF, and HFpEF, respectively. Similar findings were seen when risk was assessed using ADHERE risk score.ConclusionsThere were no significant changes in average risk profiles among hospitalized HF patients over the study duration. These data do not support the notion that worsening risk profile explains the lack of improved outcomes despite therapeutic advances, underscoring the importance of aggressive implementation of guideline-recommended therapies and investigation of novel treatments.

ObjectivesThis study compared the characteristics of Medicare beneficiaries who were hospitalized for heart failure (HF) and then discharged home who received home health care (HHC) to the characteristics of those who did not, and examined associations among HHC and readmission and mortality rates.BackgroundAfter hospitalization for HF, some patients receive HHC. However, the use of HHC over time, the factors associated with its use, and the post-discharge outcomes after receiving it are not well studied.MethodsThis study used Get With The Guidelines-HF data, merged with Medicare fee-for-service claims. Propensity score matching and Cox proportional hazards models were used to evaluate the associations between HHC and post-discharge outcomes.ResultsFrom 2005 to 2015, 95,531 patients were admitted for HF, and 32,697 (34.2%) received HHC after discharge. The rate of HHC increased over time from 31.4% to 36.1% (p

ImportanceSodium-glucose cotransporter 2 inhibitor (SGLT2-i) therapy provided incremental survival benefit to patients with heart failure and reduced ejection fraction (HFrEF) who received guideline-directed medical therapy regardless of type 2 diabetes status in a recent clinical trial. To date, estimation of the potential benefits that could be gained from optimal implementation of SGLT2-i therapy at the population level has not been quantified.ObjectiveTo quantify the projected gains for deaths prevented or postponed with comprehensive implementation of SGLT2-i therapy for patients with HFrEF in the United States.Design, setting, and participantsThis decision analytical model, performed from September 25 to October 20, 2019, used published sources to estimate the US population of patients with HFrEF eligible for SGLT2-i therapy and the numbers needed to treat to prevent or postpone overt death. Sensitivity analyses were performed to account for the range of potential benefits.Main outcomes and measuresAll-cause mortality.ResultsOf the 3.1 million patients with HFrEF in the United States, 2 132 800 (69%) were projected to be candidates for SGLT2-i therapy. Optimal implementation of SGLT2-i therapy was empirically estimated to prevent up to 34 125 deaths per year (range 21 840-49 140 deaths per year). A secondary analysis excluding patients on the basis of N-terminal-pro brain natriuretic peptide levels and other trial entry criteria would yield a potential benefit of 25 594 deaths per year prevented (range, 16 380-36 855 deaths per year prevented).Conclusions and relevanceThis study suggests that a substantial number of deaths in the United States could be prevented by optimal implementation of SGLT2-i therapy. These data support implementation of the current evidence into practice in a timely manner to achieve important public health benefits and to reduce the mortality burden of HFrEF.

BackgroundIn PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-pro BNP in Patients Stabilized From an Acute Heart Failure Episode), the in-hospital initiation of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure (ADHF) was well-tolerated and led to improved outcomes. We aim to determine the representativeness of the PIONEER-HF trial among patients hospitalized for ADHF using real-world data.MethodsThe study population was derived from all patients discharged alive for ADHF in the Get With The Guidelines-HF registry from 2006 to 2018 with HF with reduced ejection fraction (HFrEF; all HFrEF with ADHF). We then determined the proportion of patients meeting PIONEER-HF eligibility criteria (PIONEER-HF eligible) and those meeting a set of limited eligibility criteria (actionable cohort). Rates of HF readmissions and all-cause mortality were then compared between the all HFrEF with ADHF, PIONEER-HF eligible, and actionable cohorts using linked Medicare claims data.ResultsA total of 99 767 patients with HFrEF in Get With The Guidelines-HF were hospitalized for ADHF. PIONEER-HF inclusion criteria were met by 71 633 (71.8%) patients, and both inclusion and exclusion criteria were met by 20 704 (20.8%) patients. Further, 68 739 (68.9%) patients met the criteria for the actionable cohort. Among the Centers for Medicare and Medicaid-linked patients, the HF rehospitalization rate at 1 year was 35.1% (95% CI, 34.5-35.8) for all HFrEF with ADHF patients, 32.6% (95% CI, 31.3-33.9) for the PIONEER-HF eligible cohort, and 33.1% (95% CI, 32.3-33.9) for the actionable cohort. The 1-year all-cause mortality was 36.7% (95% CI, 36.1-7.4) for all HFrEF with ADHF patients, 31.6% (95% CI, 30.3-32.9) for the PIONEER-HF eligible cohort, and 32.2% (95% CI, 31.4-33.0) for the actionable cohort.ConclusionsPatient characteristics and clinical outcomes for patients eligible for PIONEER-HF only modestly differ when compared with those encountered in routine practice, suggesting that the in-hospital initiation of sacubitril/valsartan should be routinely considered for patients with HFrEF hospitalized for ADHF.

Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Background Limited data exist to guide treatment for patients with heart failure with preserved ejection fraction and atrial fibrillation, including the important decision regarding rate versus rhythm control. Methods and Results We analyzed the Get With The Guidelines-Heart Failure (GWTG-HF) registry linked to Medicare claims data from 2008 to 2014 to describe current treatments for rate versus rhythm control and subsequent outcomes in patients with heart failure with preserved ejection fraction and atrial fibrillation using inverse probability weighted analysis. Rhythm control was defined as use of an antiarrhythmic medication, cardioversion, or AF ablation or surgery. Rate control was defined as use of any combination of β-blocker, calcium channel blocker, and digoxin without evidence of rhythm control. Among 15 682 fee-for-service Medicare patients, at the time of discharge, 1857 were treated with rhythm control and 13 825 with rate control, with minimal differences in baseline characteristics between groups. There was higher all-cause death at 1 year in the rate control compared with the rhythm control group (37.5% and 30.8%, respectively, P

ObjectivesThis study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.BackgroundBlack patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.MethodsThe ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.ResultsAmong 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p

BackgroundDiabetes mellitus is an increasingly prevalent condition among heart failure (HF) patients. The long-term morbidity and mortality among patients with and without diabetes with HF with reduced (HFrEF), borderline (HFbEF), and preserved ejection fraction (HFpEF) are not well described.MethodsUsing the Get With The Guidelines (GWTG)-HF Registry linked to Centers for Medicare & Medicaid Services claims data, we evaluated differences between HF patients with and without diabetes. Adjusted Cox proportional-hazard models controlling for patient and hospital characteristics were used to evaluate mortality and readmission outcomes.ResultsA cohort of 86,659 HF patients aged ≥65 years was followed for 3 years from discharge. Unadjusted all-cause mortality was between 4.4% and 5.5% and all-cause hospitalization was between 19.4% and 22.6% for all groups at 30 days. For all-cause mortality at 3 years from hospital discharge, diabetes was associated with an adjusted hazard ratio of 1.27 (95% CI 1.07-1.49, P = .0051) for HFrEF, 0.95 (95% CI 0.55-1.65, P = .8536) for HFbEF, 1.02 (95% CI 0.87-1.19, P = .8551) for HFpEF. For all-cause readmission, diabetes was associated with an adjusted hazard ratio of 1.06 (95% CI 0.87-1.29, P = .5585) for HFrEF, 1.48 (95% CI 1.15-1.90, P = .0023) for HFbEF, and 1.06 (95% CI 0.91-1.22, P = .4747) for HFpEF.ConclusionsHFrEF and HFbEF patients with diabetes are at increased risk for mortality and rehospitalization after hospitalization for HF, independent of other patient and hospital characteristics. Among HFpEF patients, diabetes does not appear to be independently associated with significant additional risks.

BackgroundWhen used in appropriately selected heart failure (HF) patients, cardiac resynchronization therapy (CRT) reduces mortality and hospitalization. It is not understood whether CRT implantation during hospitalization for HF is associated with similar benefits.HypothesisTiming of CRT implantation relative to hospitalization for HF is associated with clinical outcomes.MethodsThis analysis included patients eligible for CRT and discharged alive between January 2005 and December 2012 from 388 hospitals in Get With The Guidelines-HF. Participants were linked with Centers for Medicare and Medicaid Services data to evaluate outcomes of all-cause mortality and HF re-hospitalization based on CRT status (present on admission, placed during hospitalization, and prescribed at discharge; reference = no CRT).ResultsOf 15 619 CRT-eligible HF patients, 2408 (15%) had CRT on admission, 1269 (8%) underwent CRT implantation during hospitalization and 643 (4%) had CRT prescribed at discharge. Compared with patients without CRT, mortality was lower in those who received CRT implantation during HF hospitalization (adjusted hazard ratio [HR] 0.63; P < 0.0001) and those prescribed CRT at discharge (adjusted HR 0.78; P = 0.048). A reduction in HF re-hospitalization was observed in patients with CRT implanted during hospitalization (adjusted HR 0.64; P < 0.0001), but not in those who were prescribed CRT at discharge (adjusted HR 1.02; P = 0.77).ConclusionCRT implantation during HF hospitalization was associated with lower rates of mortality and HF re-hospitalization. These data suggest that a CRT utilization strategy that does not delay implantation to the post-discharge period may be appropriate. Randomized data are needed to definitively identify optimal timing of CRT implantation.

BackgroundHigher fibroblast growth factor-23 (FGF23) concentrations have been found to be associated with incident heart failure (HF). Experimental data suggest FGF23 directly stimulates myocardial hypertrophy. FGF23 may also enhance renin-angiotensin-aldosterone system activity. Whether FGF23 is associated with increased HF risk in populations with hypertension and whether this association is weaker in the presence of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) therapy is unknown.MethodsWe studied 2,858 adults with hypertension free of cardiovascular disease at baseline (65.6 ± 9.5 years, 46.2% male) participating in the Multi-Ethnic Study of Atherosclerosis (MESA). We investigated the association of baseline serum intact FGF23 with incident HF over a 14-year median follow-up and whether ACEI/ARB therapy modified this risk. We also investigated the relationship of FGF23 with aldosterone and plasma renin activity in a random subgroup of the entire MESA cohort with available assays (N = 1,642).ResultsIn adjusted Cox regression models, higher FGF23 was associated with a 63% greater hazard of incident HF (hazard ratio: 1.63, 95% confidence interval: [1.13-2.36] per 1-unit increase in log-transformed FGF23), which persisted after exclusion of participants with chronic kidney disease (hazard ratio: 1.94 [1.10-3.43]). There was no heterogeneity by ACEI/ARB use (Pinteraction = 0.438). FGF23 improved model fit over covariables (likelihood ratio χ2 = 6.67, P = 0.010). In multivariable linear regression models, there was no association between FGF23 and aldosterone or plasma renin activity.ConclusionsHigher FGF23 concentrations are associated with a significantly increased risk of HF in hypertension but this risk did not differ by ACEI/ARB treatment status. FGF23 may be a useful biomarker for HF risk in hypertensive populations.

BackgroundHeart failure (HF) is the leading cause of morbidity and mortality in the United States. Despite advancement in the management of HF, outcomes remain suboptimal, particularly among the uninsured. In 2014, the Affordable Care Act expanded Medicaid eligibility, and millions of low-income adults gained insurance. Little is known about Medicaid expansion's effect on inpatient HF care.Methods and resultsWe used the American Heart Association's Get With The Guidelines-Heart Failure registry to assess changes in inpatient care quality and outcomes among low-income patients (

BackgroundSurveys of patients with cardiovascular disease have suggested that "home-time"-being alive and out of any health care institution-is a prioritized outcome. This novel measure has not been studied among patients with heart failure (HF).ObjectivesThis study sought to characterize home-time following hospitalization for HF and assess its relationship with patient characteristics and traditionally reported clinical outcomes.MethodsUsing GWTG-HF (Get With The Guidelines-Heart Failure) registry data, patients discharged alive from an HF hospitalization between 2011 and 2014 and ≥65 years of age were identified. Using Medicare claims, post-discharge home-time over 30-day and 1-year follow-up was calculated for each patient as the number of days alive and spent outside of a hospital, skilled nursing facility (SNF), or rehabilitation facility.ResultsAmong 59,736 patients, 57,992 (97.1%) and 42,153 (70.6%) had complete follow-up for home-time calculation through 30 days and 1 year, respectively. The mean home-time was 21.6 ± 11.7 days at 30 days and 243.9 ± 137.6 days at 1 year. Contributions to reduced home-time varied by follow-up period, with days spent in SNF being the largest contributor though 30 days and death being the largest contributor through 1 year. Over 1 year, 2,044 (4.8%) patients had no home-time following index hospitalization discharge, whereas 8,194 (19.4%) had 365 days of home-time. In regression models, several conditions were associated with substantially reduced home-time, including chronic obstructive pulmonary disease, renal insufficiency, and dementia. Through 1 year, home-time was highly correlated with time-to-event endpoints of death (tau = 0.72) and the composite of death or HF readmission (tau = 0.59).ConclusionsHome-time, which can be readily calculated from administrative claims data, is substantially reduced for many patients following hospitalization for HF and is highly correlated with traditional time-to-event mortality and hospitalization outcomes. Home-time represents a novel, easily measured, patient-centered endpoint that may reflect effectiveness of interventions in future HF studies.

ObjectivesThe purpose of this study was to analyze cumulative Medicare expenditures at index admission and after discharge by race or ethnicity.BackgroundHeart failure with preserved ejection fraction (HFpEF) is a growing proportion of heart failure (HF) admissions. Research on health care expenditures for patients with HFpEF is limited.MethodsRecords of patients discharged from the Get With The Guidelines-Heart Failure registry between 2006 and 2014 were linked to Medicare data. The primary outcome was unadjusted payments for acute care services. Comparisons between race/ethnic groups were made using generalized linear mixed models. Cost ratios were reported by race/ethnicity, and adjustments were made sequentially for patient characteristics, hospital factors, and regional socioeconomic status.ResultsMedian Medicare costs for index hospitalizations were $7,241 for the entire cohort, $7,049 for whites, $8,269 for blacks, $8,808 for Hispanics, $8,477 for Asians, and $8,963 for other races. Median costs at 30 days for readmitted patients were $9,803 and $17,456 for the entire cohort at 1-year. No significant differences were seen in index admission cost ratios by race/ethnicity. At 30 days among readmitted patients, costs were 9% higher (95% confidence interval [CI]: 1% to 17%; p = 0.020) for blacks in the fully adjusted model than whites. At 1 year, costs were 14% higher (95% CI: 9% to 18%; p < 0.001) for blacks, 7% higher (95% CI: 0% to 14%; p = 0.041) for Hispanics, and 24% higher (95% CI: 8% to 42%; p = 0.003) for patients of other races. No significant differences between white and Asian expenditures were noted.ConclusionsMinority patients with HFpEF have greater acute care service costs. Further research of improving care delivery is needed to reduce acute care use for vulnerable populations.

Adoption of electronic health record (EHR) systems has increased significantly across the nation. Whether EHR use has translated into improved quality of care and outcomes in heart failure (HF) is not well studied. We examined participants from the Get With The Guidelines-HF registry who were admitted with HF in 2008 (N=21 222), using various degrees of EHR implementation (no EHR, partial EHR, and full EHR). We performed multivariable logistic regression to determine the relation between EHR status and several in-hospital quality metrics and outcomes. In a substudy of Medicare participants (N=8421), we assessed the relation between EHR status and rates of 30-day mortality, readmission, and a composite outcome. In the cohort, the mean age was 71±15 years, 49% were women, and 64% were white. The mean ejection fraction was 39±17%. Participants were admitted to hospitals with no EHR (N=1484), partial EHR (N=13 473), and full EHR (N=6265). There was no association between EHR status and several quality metrics (aside from β blocker at discharge) or in-hospital outcomes on multivariable adjusted logistic regression (P>0.05 for all comparisons). In the Medicare cohort, there was no association between EHR status and 30-day mortality, readmission, or the combined outcome. In a large registry of hospitalized patients with HF, there was no association between degrees of EHR implementation and several quality metrics and 30-day postdischarge death or readmission. Our results suggest that EHR may not be sufficient to improve HF quality or related outcomes.

Medication adherence improves outcomes for patients with heart failure, but adherence rates remain low. We examined the association between earlier postdischarge follow-up and medication adherence. We performed a retrospective cohort study of patients ≥65 years who were hospitalized for heart failure, covered by Medicare Part D, and discharged alive from April 2006 to October 2012 using the Get With The Guidelines-Heart Failure Registry linked to Medicare claims. Patients were categorized into 4 groups by timing of first postdischarge follow-up visit: ≤1, 1 to 2, 2 to 6, and >6 weeks. Medication adherence was defined by proportion of days covered of >80% at 90 days and 1-year posthospital discharge to 5 guideline-directed medical therapies (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, evidence-based β-blocker, aldosterone antagonist, hydralazine/isosorbide dinitrate, and anticoagulation for atrial fibrillation). Among 9878 patients with heart failure, 73% had left ventricular ejection fraction ≤40%, median age was 78 years (25th-75th percentile, 71-84), and 48% were male. Overall, 30% had a follow-up appointment within 1-week postdischarge and 25% >6 weeks. At 1 year, medication adherence was 53% for evidence-based β-blockers, 48% for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and 8% for hydralazine/isosorbide dinitrate. We found no significant association between timing of first follow-up visit and medication adherence at 1 year (1.04, 0.92-1.17) when comparing follow-up visits >6 weeks to the earliest ones. Posthospital heart failure discharge, overall adherence to medical therapies in Medicare beneficiaries was low. Early follow-up was not associated with increased medication adherence to guideline-directed medical therapy in the short or long term.

Cardiovascular, respiratory, and related disorders (CVRDs) are the leading causes of adult death worldwide, and substantial inequalities in care of patients with CVRDs exist between countries of high income and countries of low and middle income. Based on current trends, the UN Sustainable Development Goal to reduce premature mortality due to CVRDs by a third by 2030 will be challenging for many countries of low and middle income. We did systematic literature reviews of effectiveness and cost-effectiveness to identify priority interventions. We summarise the key findings and present a costed essential package of interventions to reduce risk of and manage CVRDs. On a population level, we recommend tobacco taxation, bans on trans fats, and compulsory reduction of salt in manufactured food products. We suggest primary health services be strengthened through the establishment of locally endorsed guidelines and ensured availability of essential medications. The policy interventions and health service delivery package we suggest could serve as the cornerstone for the management of CVRDs, and afford substantial financial risk protection for vulnerable households. We estimate that full implementation of the essential package would cost an additional US$21 per person in the average low-income country and $24 in the average lower-middle-income country. The essential package we describe could be a starting place for low-income and middle-income countries developing universal health coverage packages. Interventions could be rolled out as disease burden demands and budgets allow. Our outlined interventions provide a pathway for countries attempting to convert the UN Sustainable Development Goal commitments into tangible action.

BackgroundSharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials.MethodsWe extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies.ResultsFrom January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement.ConclusionsDespite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication.

ImportancePublic reporting of hospitals' 30-day risk-standardized readmission rates following heart failure hospitalization and the financial penalization of hospitals with higher rates have been associated with a reduction in 30-day readmissions but have raised concerns regarding the potential for unintended consequences.ObjectiveTo examine the association of the Hospital Readmissions Reduction Program (HRRP) with readmission and mortality outcomes among patients hospitalized with heart failure within a prospective clinical registry that allows for detailed risk adjustment.Design, setting, and participantsInterrupted time-series and survival analyses of index heart failure hospitalizations were conducted from January 1, 2006, to December 31, 2014. This study included 115 245 fee-for-service Medicare beneficiaries across 416 US hospital sites participating in the American Heart Association Get With The Guidelines-Heart Failure registry. Data analysis took place from January 1, 2017, to June 8, 2017.ExposuresTime intervals related to the HRRP were before the HRRP implementation (January 1, 2006, to March 31, 2010), during the HRRP implementation (April 1, 2010, to September 30, 2012), and after the HRRP penalties went into effect (October 1, 2012, to December 31, 2014).Main outcomes and measuresRisk-adjusted 30-day and 1-year all-cause readmission and mortality rates.ResultsThe mean (SD) age of the study population (n = 115 245) was 80.5 (8.4) years, 62 927 (54.6%) were women, and 91 996 (81.3%) were white and 11 037 (9.7%) were black. The 30-day risk-adjusted readmission rate declined from 20.0% before the HRRP implementation to 18.4% in the HRRP penalties phase (hazard ratio (HR) after vs before the HRRP implementation, 0.91; 95% CI, 0.87-0.95; P

BACKGROUND:Perceived risks of hyperkalemia and acute renal insufficiency may limit use of mineralocorticoid receptor antagonist (MRA) therapy in patients with heart failure, especially those with diabetes mellitus or chronic kidney disease. METHODS AND RESULTS:Using clinical registry data linked to Medicare claims, we analyzed patients hospitalized with heart failure between 2005 and 2013 with a history of diabetes mellitus or chronic kidney disease. We stratified patients by MRA use at discharge. We used inverse probability-weighted proportional hazards models to assess associations between MRA therapy and 30-day, 1-year, and 3-year mortality, all-cause readmission, and readmission for heart failure, hyperkalemia, and acute renal insufficiency. We performed interaction analyses for differential effects on 3-year outcomes for reduced, borderline, and preserved ejection fraction. Of 16 848 patients, 12.3% received MRA therapy at discharge. Higher serum creatinine was associated with lower odds of MRA use (odds ratio, 0.66; 95% confidence interval, 0.61-0.71); serum potassium was not (odds ratio, 1.00; 95% confidence interval, 0.90-1.11). There was no mortality difference between groups. MRA therapy was associated with greater risks of readmission for hyperkalemia and acute renal insufficiency and lower risks of long-term all-cause readmission. Patients on MRA therapy with borderline or preserved ejection fraction had greater risks of readmission for hyperkalemia (P=0.02) and acute renal insufficiency (P

ObjectivesThis study analyzed HFpEF patient characteristics and clinical outcomes according to race/ethnicity and adjusted for patient and hospital characteristics along with socioeconomic status (SES).BackgroundThe proportion of hospitalizations for heart failure with preserved ejection fraction (HFpEF) has increased over the last decade. Whether the short- and long-term outcomes differ between racial/ethnic groups is not well described.MethodsThe Get With The Guidelines-Heart Failure registry was linked to Medicare administrative data to identify hospitalized patients with HFpEF ≥65 years of age with left ventricular ejection fraction ≥50% between 2006 and 2014. Cox proportional hazards models were used to report hazard ratios (HRs) for 30-day and 1-year readmission and mortality rates with sequential adjustments for patient characteristics, hospital characteristics, and SES.ResultsThe final cohort included 53,065 patients with HFpEF. Overall 30-day mortality was 5.87%; at 1 year, it was 33.1%. The 30-day all-cause readmission rate was 22.2%, and it was 67.0% at 1 year. After adjusting for patient characteristics, hospital characteristics, and SES, 30-day mortality was lower for black patients (HR: 0.84; 95% confidence interval [CI]: 0.71 to 0.98; p = 0.031) and Hispanic patients (HR: 0.78; 95% CI: 0.64 to 0.96; p = 0.017) compared with white patients. One-year mortality was lower for black patients (HR: 0.93; 95% CI: 0.87 to 0.99; p = 0.031), Hispanic patients (HR: 0.83; 95% CI: 0.75 to 0.91; p < 0.001), and Asian patients (HR: 0.76; 95% CI: 0.66 to 0.88; p < 0.001) compared with white patients. Black patients had a higher risk of readmission at 30 days (HR: 1.09; 95% CI: 1.02 to 1.16; p = 0.012) and 1 year (HR: 1.14; 95% CI: 1.09 to 1.20; p < 0.001) compared with white patients.ConclusionsBlack, Hispanic, and Asian patients had a lower mortality risk after a hospitalization for HFpEF compared with white patients; black patients had higher readmission rates. These differences in mortality and readmission risk according to race/ethnicity persisted after adjusting for patient characteristics, SES, and hospital factors.

Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) reduce mortality in many patients with heart failure (HF), but the current use and effectiveness of ICD/CRT in patients with chronic kidney disease (CKD) are uncertain. We examined associations between kidney function and guideline-recommended prescription of ICD/CRT in the Get With The Guidelines-Heart Failure registry, a performance improvement program for hospitalized patients with HF. We compared differences in ICD and CRT prescription between the following categories of estimated glomerular filtration rate (eGFR; mL/min/1.73 m2): ≥60, 59 to 30,

BackgroundGuidelines recommend continuation or initiation of guideline-directed medical therapy, including angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARB), in hospitalized patients with heart failure with reduced ejection fraction.Methods and resultsUsing the Get With The Guidelines-Heart Failure Registry, we linked clinical data from 16 052 heart failure with reduced ejection fraction (ejection fraction ≤40%) patients with Medicare claims data. We divided ACEi/ARB-eligible patients into 4 categories based on admission and discharge ACEi/ARB use: continued (reference group), started, discontinued, or not started on therapy. A multivariable Cox proportional hazard model was used to determine the association between ACEi/ARB category and outcomes. Most, 90.5%, were discharged on ACEi/ARB (59.6% continued and 30.9% newly started). Of those discharged without ACEi/ARB, 1.9% were discontinued, and 7.5% were eligible but not started. Thirty-day mortality was 3.5% for patients continued and 4.1% for patients started on ACEi/ARB. In contrast, 30-day mortality was 8.8% for patients discontinued (adjusted hazard ratio [HRadj] 1.92; 95% CI 1.32-2.81; P

Diabetes mellitus, heart failure (HF), and chronic kidney disease are common comorbidities, but overall use and safety of antihyperglycemic medications (AHMs) among patients with these comorbidities are poorly understood. Using Get With the Guidelines-Heart Failure and linked Medicare Part D data, we assessed AHM use within 90 days of hospital discharge among HF patients with diabetes mellitus discharged from Get With the Guidelines-Heart Failure hospitals between January 1, 2006, and October 1, 2011. We further summarized use by renal function and assessed renal contraindicated AHM use for patients with estimated glomerular filtration rate

Reducing hospital readmissions for patients with heart failure is a national priority, and quality improvement campaigns are targeting reductions of ≥20%. However, there are limited data on whether such targets have been met. We analyzed data from the American Heart Association's Get With The Guidelines-Heart Failure registry linked to Medicare claims between 2009 and 2012 to describe trends and relative reduction of rates of 30-day all-cause readmission among patients with heart failure. A total of 21,264 patients with heart failure were included from 70 US sites from January 2009 to October 2012. Overall hospital-level, risk-adjusted, 30-day all-cause readmission rates declined slightly, from 20.0% (SD, 1.3%) in 2009 to 19.0% (SD, 1.2%) in 2012 (P=0.001). Only 1 in 70 (1.4%) hospitals achieved the 20% relative reduction in 30-day risk-adjusted readmission rates. A multivariable linear regression model was used to determine hospital-level factors associated with relative improvements in 30-day risk-adjusted readmissions between 2009 and 2012. Teaching hospitals had higher relative readmission rates as compared with their peers, and hospitals that used postdischarge heart failure disease management programs had lower relative readmission rates. Although there has been slight improvement in 30-day all-cause readmission rates during the past 4 years in patients with heart failure, few hospitals have seen large success.

ImportanceGene transfer has rarely been tested in randomized clinical trials.ObjectiveTo evaluate the safety and efficacy of intracoronary delivery of adenovirus 5 encoding adenylyl cyclase 6 (Ad5.hAC6) in heart failure.Design, setting, and participantsA randomized, double-blind, placebo-controlled, phase 2 clinical trial was conducted in US medical centers (randomization occurred from July 19, 2010, to October 30, 2014). Participants 18 to 80 years with symptomatic heart failure (ischemic and nonischemic) and an ejection fraction (EF) of 40% or less were screened; 86 individuals were enrolled, and 56 were randomized. Data analysis was of the intention-to-treat population. Participants underwent exercise testing and measurement of left ventricular EF (echocardiography) and then cardiac catheterization, where left ventricular pressure development (+dP/dt) and decline (-dP/dt) were recorded. Participants were randomized (3:1 ratio) to receive 1 of 5 doses of intracoronary Ad5.hAC6 or placebo. Participants underwent a second catheterization 4 weeks later for measurement of dP/dt. Exercise testing and EF were assessed 4 and 12 weeks after randomization.InterventionsIntracoronary administration of Ad5.hAC6 (3.2 × 109 to 1012 virus particles) or placebo.Main outcomes and measuresPrimary end points included exercise duration and EF before and 4 and 12 weeks after randomization and peak rates of +dP/dt and -dP/dt before and 4 weeks after randomization. Fourteen placebo participants were compared (intention to treat) with 24 Ad5.hAC6 participants receiving the highest 2 doses (D4 + 5).ResultsFifty-six individuals were randomized and monitored for up to 1 year. Forty-two participants (75%) received Ad5.hAC6 (mean [SE] age, 63 [1] years; EF, 30% [1%]), and 14 individuals (25%) received placebo (age, 62 [1] years; EF, 30% [2%]). Exercise duration showed no significant group differences (4 weeks, P = .27; 12 weeks, P = .47, respectively). The D4 + 5 participants had increased EF at 4 weeks (+6.0 [1.7] EF units; n = 21; P

BackgroundIn clinical trials, hydralazine-isosorbide dinitrate (H-ISDN) for heart failure with reduced ejection fraction reduced morbidity and mortality among black patients and patients with intolerance to angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers. The effectiveness of H-ISDN in clinical practice is unknown.Methods and resultsUsing data from a clinical registry linked with Medicare claims, we examined the use and outcomes of H-ISDN between 2005 and 2011 among older patients hospitalized with heart failure and reduced ejection fraction. We adjusted for demographic and clinical characteristics using Cox proportional hazards models and inverse probability weighting. Among 4663 eligible patients, 22.7% of black patients and 18.2% of patients not on an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker were newly prescribed H-ISDN therapy at discharge. By 3 years, the cumulative incidence rates of mortality and readmission were similar between treated and untreated patients. After multivariable adjustment, 3-year outcomes remained similar for mortality [black patients: hazard ratio (HR), 0.92; 95% confidence interval (CI), 0.75-1.13; other patients: HR, 0.93; 95% CI, 0.79-1.09], all-cause readmission (black patients: HR, 0.98; 95% CI, 0.84-1.13; other patients: HR, 1.02; 95% CI, 0.90-1.17), and cardiovascular readmission (black patients: HR, 0.99; 95% CI, 0.82-1.19; other patients: HR, 0.94; 95% CI, 0.81-1.09). A post hoc analysis of Medicare Part D data revealed low postdischarge adherence to therapy.ConclusionsGuideline-recommended initiation of H-ISDN therapy at hospital discharge was uncommon, and adherence was low. For both black patients and patients of other races, there were no differences in outcomes between those treated and untreated at discharge.

BackgroundClinical trials of implantable cardioverter defibrillators (ICDs) for primary prevention enrolled a limited number of women. We sought to examine clinical practice data to compare survival rates among women with heart failure with or without a primary prevention ICD.Methods and resultsWe linked data from 264 US hospitals included in the Get With The Guidelines for Heart Failure registry with data from the Centers for Medicare and Medicaid Services. From these sources, we propensity score matched 430 women with heart failure who received a primary prevention ICD to 430 women who did not; we further adjusted using a Cox proportional hazards model. Median follow-up was 3.4 and 3.0 years. For comparison, we matched 859 men receiving an ICD with 859 who did not; median follow-up was 3.9 versus 2.9 years. In the matched cohorts, an ICD was associated with similarly better survival in women (hazard ratio, 0.78; 95% confidence interval, 0.66-0.92; P=0.003) and men (hazard ratio, 0.76; 95% confidence interval, 0.67-0.87 P

BackgroundImplantable cardioverter-defibrillator (ICD) therapy is associated with improved outcomes in patients with heart failure (HF), but whether this association holds among older patients with multiple comorbid illnesses and worse HF burden remains unclear.Methods and resultsUsing the National Cardiovascular Data Registry's ICD Registry and the Get With The Guidelines-Heart Failure (GWTG-HF) registry linked with Medicare claims, we examined outcomes associated with primary-prevention ICD versus no ICD among HF patients aged ≥65 years in clinical practice. We included patients with an ejection fraction ≤35% who received (ICD Registry) and who did not receive (GWTG-HF) an ICD. Compared with patients with an ICD, patients in the non-ICD group were older and more likely to be female and white. In matched cohorts, the 3-year adjusted mortality rate was lower in the ICD group versus the non-ICD group (46.7% versus 55.8%; adjusted hazard ratio [HR] 0.76; 95% CI 0.69 to 0.83). There was no associated difference in all-cause readmission (HR 0.99; 95% CI 0.92 to 1.08) but a lower risk of HF readmission (HR 0.88; 95% CI 0.80 to 0.97). When compared with no ICD, ICDs were also associated with better survival in patients with ≤3 comorbidities (HR 0.77; 95% CI 0.69 to 0.87) and >3 comorbidities (HR 0.77; 95% CI 0.64 to 0.93) and in patients with no hospitalization for HF (HR 0.75; 95% CI 0.65 to 0.86) and at least 1 prior HF hospitalization (HR 0.69; 95% CI 0.58 to 0.82). In subgroup analyses, there were no interactions between ICD and mortality risk for comorbidity burden (P=0.95) and for prior HF hospitalization (P=0.46).ConclusionAmong older HF patients, ICDs for primary prevention were associated with lower risk of mortality even among those with high comorbid illness burden and prior HF hospitalization.

BackgroundAn individual's socioeconomic status (SES) is associated with health outcomes and mortality, yet it is unknown whether accounting for SES can improve risk-adjustment models for 30-day outcomes among Centers for Medicare & Medicaid Services beneficiaries hospitalized with heart failure.Methods and resultsWe linked clinical data on hospitalized patients with heart failure in the Get With The Guidelines-Heart Failure database (January 2005 to December 2011) with Centers for Medicare & Medicaid Services claims and county-level SES data from the 2012 Area Health Resources Files. We compared the discriminatory capabilities of multivariable models that adjusted for SES, patient, and hospital characteristics to determine whether county-level SES data improved prediction or changed hospital rankings for 30-day all-cause mortality and rehospitalization. After adjusting for patient and hospital characteristics, median household income (per $5000 increase) was inversely associated with odds of 30-day mortality (odds ratio, 0.97; 95% confidence interval, 0.95-1.00; P=0.032) and the percentage of people with at least a high school diploma (per 5 U increase) was associated with lower odds of 30-day rehospitalization (odds ratio, 0.95; 95% confidence interval, 0.91-0.99). After adjustment for county-level SES data, relative to whites, Hispanic ethnicity (odds ratio, 0.70; 95% confidence interval, 0.58-0.83) and black race (odds ratio, 0.57; 95% confidence interval, 0.50-0.65) remained significantly associated with lower 30-day mortality, but had similar 30-day rehospitalization. County-level SES did not improve risk adjustment or change hospital rankings for 30-day mortality or rehospitalization.ConclusionsCounty-level SES data are modestly associated with 30-day outcomes for Centers for Medicare & Medicaid Services beneficiaries hospitalized with heart failure, but do not improve risk adjustment models based on patient characteristics alone.

BackgroundRacial and ethnic minorities are under-represented in clinical trials of primary prevention implantable cardioverter-defibrillators (ICDs). This analysis investigates the association between primary prevention ICDs and mortality among Medicare, racial/ethnic minority patients.Methods and resultsData from Get With The Guidelines-Heart Failure Registry and National Cardiovascular Data Registry's ICD Registry were used to perform an adjusted comparative effectiveness analysis of primary prevention ICDs in Medicare, racial/ethnic minority patients (nonwhite race or Hispanic ethnicity). Mortality data were obtained from the Medicare denominator file. The relationship of ICD with survival was compared between minority and white non-Hispanic patients. Our analysis included 852 minority patients, 426 ICD and 426 matched non-ICD patients, and 2070 white non-Hispanic patients (1035 ICD and 1035 matched non-ICD patients). Median follow-up was 3.1 years. Median age was 73 years, and median ejection fraction was 23%. Adjusted 3-year mortality rates for minority ICD and non-ICD patients were 44.9% (95% confidence interval [CI], 44.2%-45.7%) and 54.3% (95% CI, 53.4%-55.1%), respectively (adjusted hazard ratio, 0.79; 95% CI, 0.63-0.98; P=0.034). White non-Hispanic patients receiving an ICD had lower adjusted 3-year mortality rates of 47.8% (95% CI, 47.3%-48.3%) compared with 57.3% (95% CI, 56.8%-57.9%) for those with no ICD (adjusted hazard ratio, 0.75; 95% CI, 0.67%-0.83%; P

BackgroundHeart failure with preserved ejection fraction (HFpEF) is a heterogeneous clinical syndrome in need of improved phenotypic classification. We sought to evaluate whether unbiased clustering analysis using dense phenotypic data (phenomapping) could identify phenotypically distinct HFpEF categories.Methods and resultsWe prospectively studied 397 patients with HFpEF and performed detailed clinical, laboratory, ECG, and echocardiographic phenotyping of the study participants. We used several statistical learning algorithms, including unbiased hierarchical cluster analysis of phenotypic data (67 continuous variables) and penalized model-based clustering, to define and characterize mutually exclusive groups making up a novel classification of HFpEF. All phenomapping analyses were performed by investigators blinded to clinical outcomes, and Cox regression was used to demonstrate the clinical validity of phenomapping. The mean age was 65±12 years; 62% were female; 39% were black; and comorbidities were common. Although all patients met published criteria for the diagnosis of HFpEF, phenomapping analysis classified study participants into 3 distinct groups that differed markedly in clinical characteristics, cardiac structure/function, invasive hemodynamics, and outcomes (eg, phenogroup 3 had an increased risk of HF hospitalization [hazard ratio, 4.2; 95% confidence interval, 2.0-9.1] even after adjustment for traditional risk factors [P

BackgroundThe degree to which outcomes following hospitalization for acute heart failure (HF) vary by racial and ethnic groups is poorly characterized. We sought to compare 30-day and 1-year rehospitalization and mortality rates for HF among 4 race/ethnic groups.Methods and resultsUsing the Get With The Guidelines-HF registry linked with Medicare data, we compared 30-day and 1-year outcomes between racial/ethnic groups by using a multivariable Cox proportional hazards model adjusting for clinical, hospital, and socioeconomic status characteristics. We analyzed 47 149 Medicare patients aged ≥65 years who had been discharged for HF between 2005 and 2011: there were 39 213 whites (83.2%), 4946 blacks (10.5%), 2347 Hispanics (5.0%), and 643 Asians/Pacific Islanders (1.4%). Relative to whites, blacks and Hispanics had higher 30-day and 1-year unadjusted readmission rates but lower 30-day and 1-year mortality; Asians had similar 30-day readmission rates but lower 1-year mortality. After risk adjustment, blacks had higher 30-day and 1-year CV readmission than whites but modestly lower short- and long-term mortality; Hispanics had higher 30-day and 1-year readmission rates and similar 1-year mortality than whites, while Asians had similar outcomes. When socioeconomic status data were added to the model, the majority of associations persisted, but the difference in 30-day and 1-year readmission rates between white and Hispanic patients became nonsignificant.ConclusionsAmong Medicare patients hospitalized with HF, short- and long-term readmission rates and mortality differed among the 4 major racial/ethnic populations and persisted even after controlling for clinical, hospital, and socioeconomic status variables.

BackgroundIn 2009, the Get With The Guidelines-Heart Failure program enhanced the standard recognition of hospitals by offering additional recognition if hospitals performed well on certain quality measures. We sought to determine whether initiation of this enhanced recognition opportunity led to acceleration in quality of care for all hospitals participating in the program.Methods and resultsWe examined hospital-level performance on 9 quality-of-care (process) measures that were added to an existing recognition program (based on existing published performance measures). The rate of increase in use over time 6 months to 2 years after the start of the program was compared with the rate of increase in use for the measures during the 18-month period prior to the start of the program. Use increased for all 9 new quality measures from 2008 to 2011. Among 4 measures with baseline use near or lower than 50%, a statistically significant greater increase in use during the program was seen for implantable cardioverter defibrillator use (program versus preprogram use: odds ratio 1.14, 95% CI 1.06 to 1.23). Among the 5 measures for which baseline use was 50% or higher, the increase in influenza vaccination rates actually slowed. There was no evidence of adverse impact on the 4 established quality measures, a composite of which actually increased faster during the expanded program (adjusted odds ratio 1.08, 95% CI 1.01 to 1.15).ConclusionsA program providing expanded hospital recognition for heart failure had mixed results in accelerating the use of 9 quality measures.

BackgroundClinical trials have demonstrated benefit for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) therapies in patients with heart failure with reduced ejection fraction (HFrEF); yet, questions have been raised with regard to the benefit of device therapy for minorities.ObjectivesThe purpose of this study was to determine the clinical effectiveness of CRT and ICD therapies as a function of race/ethnicity in outpatients with HFrEF (ejection fraction ≤35%).MethodsData from IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) were analyzed by device status and race/ethnicity among guideline-eligible patients for mortality at 24 months. Multivariate Generalized Estimating Equations analyses were conducted, adjusting for patient and practice characteristics.ResultsThe ICD/cardiac resynchronization defibrillator (CRT-D)-eligible cohort (n = 7,748) included 3,391 (44%) non-Hispanic white, 719 (9%) non-Hispanic black, and 3,638 (47%) other racial/ethnic minorities or race-not-documented patients. The cardiac resynchronization pacemaker (CRT-P)/CRT-D-eligible cohort (n = 1,188) included 596 (50%) non-Hispanic white, 99 (8%) non-Hispanic black, and 493 (41%) other/not-documented patients. There was clinical benefit associated with ICD/CRT-D therapy (adjusted odds ratio: 0.64, 95% confidence interval: 0.52 to 0.79, p = 0.0002 for 24-month mortality), which was of similar proportion in white, black, and other minority/not-documented patients (device-race/ethnicity interaction p = 0.7861). For CRT-P/CRT-D therapy, there were also associated mortality benefits (adjusted odds ratio: 0.55, 95% confidence interval: 0.33 to 0.91, p = 0.0222), and the device-race/ethnicity interaction was not significant (p = 0.5413).ConclusionsThe use of guideline-directed CRT and ICD therapy was associated with reduced 24-month mortality without significant interaction by racial/ethnic group. Device therapies should be offered to eligible heart failure patients, without modification based on race/ethnicity.

BackgroundHeart failure is the leading cause for hospital readmission, the reduction of which is a priority under the Affordable Care Act. Digoxin reduces 30-day all-cause hospital admission in chronic systolic heart failure. Whether digoxin is effective in reducing readmission after hospitalization for acute decompensation remains unknown.MethodsOf the 5153 Medicare beneficiaries hospitalized for acute heart failure and not receiving digoxin, 1054 (20%) received new discharge prescriptions for digoxin. Propensity scores for digoxin use, estimated for each of the 5153 patients, were used to assemble a matched cohort of 1842 (921 pairs) patients (mean age, 76 years; 56% women; 25% African American) receiving and not receiving digoxin, who were balanced on 55 baseline characteristics.ResultsThirty-day all-cause readmission occurred in 17% and 22% of matched patients receiving and not receiving digoxin, respectively (hazard ratio [HR] for digoxin, 0.77; 95% confidence interval [CI], 0.63-0.95). This beneficial association was observed only in those with ejection fraction

BackgroundThe intersection of heart failure (HF) and atrial fibrillation (AF) is common, but the burden of AF among black patients with HF is poorly characterized. We sought to determine the prevalence of AF, characteristics, in-hospital outcomes, and warfarin use associated with AF in patients hospitalized with HF as a function of race.Methods and resultsWe analyzed data on 135 494 hospitalizations from January 2006 through January 2012 at 276 hospitals participating in the American Heart Association's Get With The Guidelines HF Program. Multivariable logistic regression models using generalized estimating equations approach for risk-adjusted comparison of AF prevalence, in-hospital outcomes, and warfarin use. In this HF population, 53 389 (39.4%) had AF. Black patients had markedly less AF than white patients (20.8% versus 44.8%, P < 0.001). Adjusting for risk factors and hospital characteristics, black race was associated with significantly lower odds of AF (adjusted odds ratio 0.52, 95% CI 0.48 to 0.55, P < 0.0001). There were no racial differences in in-hospital mortality; however, black patients had a longer length of stay relative to white patients. Black patients compared with white patients with AF were less likely to be discharged on warfarin (adjusted odds ratio 0.76, 95% CI 0.69 to 0.85, P < 0.001).ConclusionsDespite having many risk factors for AF, black patients, relative to white patients hospitalized for HF, had a lower prevalence of AF and lower prescription of guideline-recommended warfarin therapy.

BackgroundHydralazine-isosorbide dinitrate (H-ISDN) therapy is recommended for African American patients with moderate to severe heart failure with reduced ejection fraction (