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Background: For many patients, sudden cardiac arrest (SCA) risk is elevated temporarily. Wearable cardioverter-defibrillators (WCDs) can monitor and treat SCA during these temporary periods. Traditional WCDs can be uncomfortable, require frequent maintenance, and cannot be used when showering, resulting in poor compliance and avoidable SCA deaths. The Jewel is a novel, water-resistant patch-wearable cardioverter-defibrillator (P-WCD) with a machine learning detection algorithm designed to improve compliance and protection against SCA., Objectives: This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD., Methods: The Jewel IDE Study, a prospective, single-arm study conducted at 30 U.S. sites, enrolled patients at SCA risk due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator. The primary safety endpoint was <15% patients with clinically significant cutaneous adverse device effects and the primary effectiveness endpoint was <2 inappropriate shocks/100 patient-months. Secondary endpoints were ≥1 successful ventricular tachycardia/ventricular fibrillation conversion and wear time compliance of >14.1 h/d., Results: A total of 305 patients (mean age: 57.9 years; 30.2% female, 27.9% non-White) were enrolled, of which 290 had available device data. The clinically significant cutaneous adverse device effect rate was 2.30% (upper 1-sided 98% CI: 4.80); none were severe. No device-related deaths or serious adverse events were reported. The inappropriate shock rate was 0.36/100 patient-months (upper 1-sided 98% CI: 1.53). Of 11 shocks in 9 patients, 9 shocks were adjudicated to be appropriate. Eight of 9 shocks were successful with a single shock. Median wear time compliance was 23.5 (20.7-23.9) h/d., Conclusions: The novel P-WCD is a safe and effective WCD with high patient compliance. There were no deaths due to noncompliance and a high number of successful conversions (Jewel IDE study [A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest]; NCT05201495)., Competing Interests: Funding Support and Author Disclosures The Jewel IDE trial was conducted with support from Element Science, Inc. The sponsor was responsible for site selection, data monitoring, and overall clinical trial management. All statistical analyses were performed by an independent statistician. Dr Hummel has received consulting fees from Medtronic, Volta Medical, S4 Medical, Abbott Medical, and Element Science. Dr Houmsse has received speaker fees from Zoll. Dr Tomassoni has received speaker fees from Zoll. Ms Mathews and Drs Eapen and Kumar are employed by and stockholders of Element Science, Inc. Dr Thakkar was a Clinical Affairs Fellow at Element Science, Inc. Dr Kumar is a stockholder of iRhythm Technologies. Dr Mehran has received institutional research payments from Abbott, Abiomed, Affluent Medical, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, AtriCure Inc, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, CardiaWave, CeloNova, CERC, Chiesi, Concept Medical, Cytosorbents, Daiichi-Sankyo, Duke, Element Science, Essential Medical, Faraday, Idorsia Pharmaceuticals, Janssen, MedAlliance, Mediasphere, Medtelligence, Medtronic, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Population Health Research Institute, Protembis, RecCor Medical Inc, RenalPro, RM Global, Sanofi, Shockwave, Vivasure, and Zoll; and has received personal fees from Cardiovascular Research Foundation (CRF), Cordis, Daiichi-Sankyo Brasil, E.R. Squibb & Sons, Esperion, Europa Group, Gaffney Events, Educational Trust, Henry Ford Health Cardiology, Ionis Pharmaceuticals, MedCon International, Novartis, NovoNordisk, PeerView Institute for Medical Education, TERUMO Europe N.V., Vectura, VoxMedia, WebMD, IQVIA, Radcliffe, and TARSUS Cardiology. Dr Butler has received consulting fees from Abbott, American Regent, Amgen, Applied Therapeutic, AskBio, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiac Dimension, Cardiocell, Cardior, CSL Bearing, CVRx, Cytokinetics, Daxor, Edwards, Element Science, Faraday, Foundry, G3P, Innolife, Impulse Dynamics, Imbria, Inventiva, Ionis, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Pfizer, Prolaio, Regeneron, Renibus, Roche, Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, and Zoll. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Wearable cardioverter-defibrillators (WCDs) are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating ventricular tachycardia/ventricular fibrillation (VT/VF) with a single shock. The aim was to evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD., Methods and Results: This was a first-in-human, prospective, single-arm, single-centre study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150 J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events., Conclusion: This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF., Clinical Trial Registration: URL: https://clinicaltrials.gov/; Unique identifier: NCT05490459., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background Evidence-based therapies are generally underused for cardiovascular risk reduction; however, less is known about contemporary patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. Methods and Results Pharmacy and medical claims data from within Anthem were queried for patients with established atherosclerotic cardiovascular disease and type 2 diabetes mellitus. Using an index date of April 18, 2018, we evaluated the proportion of patients with a prescription claim for any of the 3 evidence-based therapies on, or covering, the index date ±30 days: high-intensity statin, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and sodium glucose cotransporter-2 inhibitor or glucagon-like peptide-1 receptor agonist. The potential benefit of achieving 100% adoption of all 3 evidence-based therapies was simulated using pooled treatment estimates from clinical trials. Of the 155 958 patients in the sample, 24.7% were using a high-intensity statin, 53.1% were using an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and 9.9% were using either an sodium glucose cotransporter-2 inhibitor or glucagon-like peptide-1 receptor agonists. Overall, only 2.7% of the population were covered by prescriptions for all 3 evidence-based therapies, and 37.4% were on none of them. Over a 12-month period, 70.6% of patients saw a cardiologist, while only 18% saw an endocrinologist. Increasing the use of evidence-based therapies to 100% over 3 years of treatment could be expected to reduce 4546 major atherosclerotic cardiovascular events (myocardial infarction, stroke, or cardiovascular death) in eligible but untreated patients. Conclusions Alarming gaps exist in the contemporary use of evidence-based therapies in this large population of insured patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. These data provide a call to action for patients, providers, industry, regulators, professional societies, and payers to close these gaps in care.

Objectives: This study sought to better understand the discrepant results of 2 trials of serelaxin on acute heart failure (AHF) and short-term mortality after AHF by analyzing causes of death of patients in the RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF-2) trial., Background: Patients with AHF continue to suffer significant short-term mortality, but limited systematic analyses of causes of death in this patient population are available., Methods: Adjudicated cause of death of patients in RELAX-AHF-2, a randomized, double-blind, placebo-controlled trial of serelaxin in patients with AHF across the spectrum of ejection fraction (EF), was analyzed., Results: By 180 days of follow-up, 11.5% of patients in RELAX-AHF-2 died, primarily due to heart failure (HF) (38% of all deaths). Unlike RELAX-AHF, there was no apparent effect of treatment with serelaxin on any category of cause of death. Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and noncardiovascular (CV) death (27% vs. 19%) compared to younger patients. Patients with preserved EF (≥50%) had lower rates of HF-related mortality (30% vs. 40%) but higher non-CV mortality (36% vs. 20%) compared to patients with reduced EF., Conclusions: Despite previous data suggesting benefit of serelaxin in AHF, treatment with serelaxin was not found to improve overall mortality or have an effect on any category of cause of death in RELAX-AHF-2. Careful adjudication of events in the serelaxin trials showed that older patients and those with preserved EF had fewer deaths from HF or sudden death and more deaths from other CV causes and from noncardiac causes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778)., Competing Interests: Author Disclosures The RELAX-AHF-2 trial was funded by Novartis. Dr. Loungani receives research support from Pfizer and Boston Scientific. Dr. Teerlink has received research grants and/or consulting fees from Abbott, AbbVie, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Cytokinetics, EBR Systems, Medtronic, Merck, and Novartis. Dr. Metra has received consulting honoraria as a member of trials’ committees or advisory boards from Abbott Vascular, Amgen, Bayer, Edwards Therapeutics, and Vifor Pharma. Dr. Allen has received research grants from National Heart, Lung, and Blood Institute (NHLBI), PCORI, and American Heart Association; and has acted as a consultant to Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. Dr. Butler serves as a consultant for Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, InnoLife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, V-Wave Limited, and Vifor. Dr. Carson has received honoraria as a CEC member from Novartis. Drs. Chen, Gimpelewicz, and Holbro are all employees and shareholders of Novartis Pharma AG. Drs. Cotter and Davison received research grants and personal fees from Novartis during the trials’ conduct; and grants from Abbott Laboratories, Amgen, Celyad, Cirius Therapeutics, Roche Diagnostics, Sanofi, and Windtree Therapeutics. Dr. Filippatos has participated in committees of trials and registries sponsored by Novartis, Servier, Medtronic, Vifor, BI, and Bayer. Dr. Greenberg has received research support from the AHA, NIH, and Rocket Pharma; and serves as a consultant for ACI, Actelion, Akcea, Amgen, EBR Systems, Ionis, Janssen, Merck, MyoKardia, Novartis, Sanofi, Viking, Zensun, and Zoll. Dr. Januzzi is a Trustee of the American College of Cardiology; has received grant support from Novartis Pharmaceuticals and Abbott Diagnostics, and consulting income from Abbott, Janssen, Novartis, MyoKardia, and Roche Diagnostics; and participates in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Amgen, CVRx, Janssen, and Takeda. Dr. Lanfear has received research grants from NHLBI, Amgen, Bayer, and Janssen; and has acted as a consultant for Amgen, Janssen, Ortho Diagnostics, and Novartis. Dr. Pang has served as a consultant for Baxter, Bristol Myers Squibb, and Merck; and has received research or other support from Bristol Myers Squibb, Roche, Novartis, PCORI, AHA, NHLBI, AHRQ, OrthoDiagnostics, and Abbott. Dr. Piña is an Advisory Board member of Relypsa and Vifor. Dr. Ponikowski receives consulting fees and speaker honoraria from Vifor Pharma, Amgen, Servier, Novartis, Berlin Chemie, Bayer, Pfizer, Cibiem, Impulse Dynamics, Renal Guard Solutions, Boehringer Ingelheim, and AstraZeneca, and research grants from Vifor Pharma. Dr. Miller serves as a consultant for Abbott, Boehringer, CVRx, Pfizer, Novartis, and Respicardia; and receives research support from Merck. Dr. Voors has received consultancy fees and/or grant support from Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim, Cytokinetics, MyoKardia, Novo Nordisk, Novartis, Roche Diagnostics, Servier, and Vifor Pharma. Dr. Felker has received research grants from NHLBI, American Heart Association, Amgen, Bayer Merck, Cytokinetics, and Roche Diagnostics; and has acted as a consultant to Novartis, Amgen, Bristol Myers Squibb, Cytokinetics, Medtronic, Cardionomic, V-Wave, MyoKardia, InnoLife, EBR Systems, Arena, Abbott, Roche Diagnostics, Alnylam, LivaNova, Rocket Pharma, Reprieve, and SC Pharma. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

As we enter the information age of health care, digital health technologies offer significant opportunities to optimize both clinical care delivery and clinical research. Despite their potential, the use of such information technologies in clinical care and research faces major data quality, privacy, and regulatory concerns. In hopes of addressing both the promise and challenges facing digital health technologies in the transformation of health care, we convened a think tank meeting with academic, industry, and regulatory representatives in December 2016 in Washington, DC. In this paper, we summarize the proceedings of the think tank meeting and aim to delineate a framework for appropriately using digital health technologies in healthcare delivery and research., (Copyright © 2018 American College of Cardiology Foundation. All rights reserved.)

Given the high prevalence of heart failure (HF) and the profound impact on morbid, mortality, and health care costs, strategies to improve outcomes and reduce cost have become progressively more attractive. Reducing HF hospitalizations as a study outcome has gained traction in recent years. The basic hypothesis of these investigations is that HF hospitalizations are preventable and harmful. This article examines advancements in pharmacotherapy, medical devices, and health care delivery techniques targeting reductions in HF hospitalizations and evaluates the role and implications of hospitalization in the natural history of HF., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Behavioral challenges are often present in human illness, so behavioral economics is increasingly being applied in healthcare settings to better understand why patients choose healthy or unhealthy behaviors. The application of behavioral economics to healthcare settings parallels recent shifts in policy and reimbursement structures that hold providers accountable for outcomes that are dependent on patient behaviors. Numerous studies have examined the application of behavioral economics principles to policy making and health behaviors, but there are limited data on applying these concepts to the management of chronic conditions, such as heart failure (HF). Given its increasing prevalence and high associated cost of care, HF is a paradigm case for studying novel approaches to improve health care; therefore, if we can better understand why patients with HF make the choices they do, then we may be more poised to help them manage their medications, influence daily behaviors, and encourage healthy decision making. In this article, we will give a brief explanation of the core behavioral economics concepts that apply to patients with HF. We will also examine how to craft these concepts into tools such as financial incentives and social networks that may improve the management of patients with HF. We believe that behavioral economics can help us understand barriers to change, encourage positive behaviors, and offer additional approaches to improving the outcomes of patients with HF., (© 2017 American Heart Association, Inc.)

Acute heart failure (HF) is a major public health problem with substantial associated economic costs. Because most patients who present to hospitals are admitted irrespective of their level of risk, novel approaches to manage acute HF are needed, such as the use of same-day access clinics for outpatient diuresis and observation units from the emergency department. Current published data lacks a comprehensive overview of the present state of acute HF management in various clinical settings. This review summarizes the strengths and limitations of acute HF care in the outpatient and emergency department settings. Finally, a variety of innovative technologies that have the potential to improve acute HF management are discussed., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Telehealth offers an innovative approach to improve heart failure care that expands beyond traditional management strategies. Yet the use of telehealth in heart failure is infrequent because of several obstacles. Fundamentally, the evidence is inconsistent across studies of telehealth interventions in heart failure, which limits the ability of cardiologists to make general conclusions. Where encouraging evidence exists, there are logistical challenges to broad-scale implementation as a result of insufficient understanding of how to transform telemedicine strategies into clinical practice effectively. Ultimately, when implementation is reasonable, the application of these efforts remains hampered by regulatory, reimbursement, and other policy issues. The primary aim of this paper is to describe these challenges and to outline a path forward to apply telehealth approaches to heart failure in conjunction with payment reform and pragmatic research study design., (Copyright © 2017. Published by Elsevier Inc.)

Introduction: Text message interventions have been shown to be effective in prevention and management of several non-communicable disease risk factors. However, the extent to which their effects might vary in different participants and settings is uncertain. We aim to conduct a systematic review and individual participant data (IPD) meta-analysis of randomised clinical trials examining text message interventions aimed to prevent cardiovascular diseases (CVD) through modification of cardiovascular risk factors (CVRFs)., Methods and Analysis: Systematic review and IPD meta-analysis will be conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis of IPD (PRISMA-IPD) guidelines. Electronic database of published studies (MEDLINE, EMBASE, PsycINFO and Cochrane Library) and international trial registries will be searched to identify relevant randomised clinical trials. Authors of studies meeting the inclusion criteria will be invited to join the IPD meta-analysis group and contribute study data to the common database. The primary outcome will be the difference between intervention and control groups in blood pressure at 6-month follow-up. Key secondary outcomes include effects on lipid parameters, body mass index, smoking levels and self-reported quality of life. If sufficient data is available, we will also analyse blood pressure and other secondary outcomes at 12 months. IPD meta-analysis will be performed using a one-step approach and modelling data simultaneously while accounting for the clustering of the participants within studies. This study will use the existing data to assess the effectiveness of text message-based interventions on CVRFs, the consistency of any effects by participant subgroups and across different healthcare settings., Ethics and Dissemination: Ethical approval was obtained for the individual studies by the trial investigators from relevant local ethics committees. This study will include anonymised data for secondary analysis and investigators will be asked to check that this is consistent with their existing approvals. Results will be disseminated via scientific forums including peer-reviewed publications and presentations at international conferences., Trial Registration Number: CRD42016033236., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Background: Timely reperfusion after ST-elevation myocardial infarction (STEMI) improves survival. Guidelines recommend primary percutaneous coronary intervention (PPCI) within 90 minutes of arrival at a PCI-capable hospital. The alternative is fibrinolysis within 30 minutes for those in those for whom timely transfer to a PCI-capable hospital is not feasible., Methods and Results: We identified STEMI patients receiving reperfusion therapy at 229 hospitals participating in the Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) database (January 1, 2003 through December 31, 2008). Temporal trends in the use of fibrinolysis and PPCI, its timeliness, and in-hospital mortality outcomes were assessed. We also assessed predictors of fibrinolysis versus PPCI and compliance with performance measures. Defect-free care was defined as 100% compliance with all performance measures. We identified 29 190 STEMI patients, of whom 2441 (8.4%) received fibrinolysis; 38.2% of these patients achieved door-to-needle times ≤30 minutes. Median door-to-needle times increased from 36 to 60 minutes (P=0.005) over the study period. Among PPCI patients, median door-to-balloon times decreased from 94 to 64 minutes (P<0.0001) over the same period. In-hospital mortality was higher with fibrinolysis than with PPCI (4.6% vs 3.3%, P=0.001) and did not change significantly over time. Patients receiving fibrinolysis were less likely to receive defect-free care compared with their PPCI counterparts., Conclusions: Use of fibrinolysis for STEMI has decreased over time with concomitant worsening of door-to-needle times. Over the same time period, use of PPCI increased with improvement in door-to-balloon times. In-hospital mortality was higher with fibrinolysis than with PPCI. As reperfusion for STEMI continues to shift from fibrinolysis to PPCI, it will be critical to ensure that door-to-needle times and outcomes do not worsen., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: Higher rates of obesity and heart failure have been observed in African Americans, but associations with mortality are not well-described. We examined intermediate and long-term clinical implications of obesity in African Americans and associations between obesity and all-cause mortality, heart failure, and heart failure hospitalization., Methods and Results: We conducted a retrospective analysis of a community sample of 5292 African Americans participating in the Jackson Heart Study between September 2000 and January 2013. The main outcomes were associations between body mass index (BMI) and all-cause mortality at 9 years and heart failure hospitalization at 7 years using Cox proportional hazards models and interval development of heart failure (median 8 years' follow-up) using a modified Poisson model. At baseline, 1406 (27%) participants were obese and 1416 (27%) were morbidly obese. With increasing BMI, the cumulative incidence of mortality decreased (P= .007), whereas heart failure increased (P < .001). Heart failure hospitalization was more common among morbidly obese participants (9.0%; 95% confidence interval [CI] 7.6-11.7) than among normal-weight patients (6.3%; 95% CI 4.7-8.4). After risk adjustment, BMI was not associated with mortality. Each 1-point increase in BMI was associated with a 5% increase in the risk of heart failure (hazard ratio 1.05; 95% CI 1.03-1.06; P < .001) and the risk of heart failure hospitalization for BMI greater than 32 kg/m(2) (hazard ratio 1.05; 95% CI 1.03-1.07; P < .001)., Conclusions: Obesity and morbid obesity were common in a community sample of African Americans, and both were associated with increased heart failure and heart failure hospitalization., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: This study assessed the comparative frequency of precipitating clinical factors leading to hospitalization among heart failure (HF) patients with reduced, borderline, and preserved ejection fraction (EF) BACKGROUND: There are few data assessing the comparative frequency of clinical factors leading to HF among hospitalized among patients with reduced, borderline, and preserved EF., Methods: We analyzed the factors potentially contributing to HF hospitalization among 99,825 HF admissions from 305 hospitals in the Get With The Guidelines-HF (GWTG-HF) database between January 2005 and September 2013 and assessed their association with length of stay and in-hospital mortality., Results: Mean patient age was 72.6 ± 14.2 years, 49% were female, and mean EF was 39.3 ± 17.2%. Common factors included pneumonia/respiratory process (28.2%), arrhythmia (21.7%), medication noncompliance (15.8%), worsening renal failure (14.7%), and uncontrolled hypertension (14.5%). In patients with borderline EF (EF 40% to 49%), pneumonia was associated with longer hospital stay, whereas dietary and medication noncompliance were associated with reduced length of stay. In patients with preserved EF (EF ≥50% or qualitative assessment of normal or mild dysfunction), pneumonia, weight gain, and worsening renal function were independently associated with longer lengths of stay. Worsening renal function and pneumonia were independently associated with higher in-hospital mortality in all HF groups, and acute pulmonary edema was associated with higher mortality in reduced EF. Dietary noncompliance (14.7%) was associated with reduced mortality for all groups but reached statistical significance in the subgroups of reduced (odds ratio [OR]: 0.65; 95% confidence interval [CI]: 0.46 to 0.91) and preserved systolic function (OR: 0.52; 95% CI: 0.33 to 0.83). Patients presenting with ischemia had a higher mortality rate (OR: 1.31; 95% CI: 1.02 to 1.69; and 1.72; 95% CI: 1.27 to 2.33, respectively, in the 2 groups)., Conclusions: Potential precipitating factors among patients hospitalized with HF vary by EF group and are independently associated with clinical outcomes., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In 2009, the Centers for Medicare & Medicaid Services (CMS) began publicly reporting 30-day hospital readmission rates for patients discharged with acute myocardial infarction (MI), heart failure (HF), or pneumonia., Objectives: This study assessed trends of 30-day readmission rates and post-discharge care since the implementation of CMS public reporting., Methods: We analyzed Medicare claims data from 2006 to 2012 for patients discharged after a hospitalization for MI, HF, or pneumonia. For each diagnosis, we estimated trends in 30-day all-cause readmissions and post-discharge care (emergency department visits and observation stays) by using hospitalization-level regression models. We modeled adjusted trends before and after the implementation of public reporting. To assess for a change in trend, we tested the difference between the slope before implementation and the slope after implementation., Results: We analyzed 37,829 hospitalizations for MI, 100,189 for HF, and 79,076 for pneumonia from >4,100 hospitals. When considering only recent trends (i.e., since 2009), we found improvements in adjusted readmission rates for MI (-2.3%), HF (-1.8%), and pneumonia (-2.0%), but when comparing the trend before public reporting with the trend after reporting, there was no difference for MI (p = 0.72), HF (p = 0.19), or pneumonia (p = 0.21). There were no changes in trends for 30-day post-discharge care for MI or pneumonia; however, the trend decreased for HF emergency department visits from 2.3% to -0.8% (p = 0.007) and for observation stays from 15.1% to 4.1% (p = 0.04)., Conclusions: The release of the CMS public reporting of hospital readmission rates was not associated with any measurable change in 30-day readmission trends for MI, HF, or pneumonia, but it was associated with less hospital-based acute care for HF., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In 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 Results: Using 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., Conclusions: Guideline-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., (© 2016 American Heart Association, Inc.)

Background: Previous data demonstrate early follow-up (ie, within 7 days of discharge) after a hospitalization for heart failure is associated with a lower risk of readmission, yet is uncommon and varies widely across hospitals. Limited data exist on whether the use of early follow-up after discharge has improved over time., Methods and Results: We used data from Get With The Guidelines-Heart Failure (GWTG-HF) linked to Medicare claims to examine temporal trends in early follow-up and to assess for patient and hospital characteristics associated with early scheduled follow-up. In the overall GWTG-HF cohort, we studied 52,438 patients discharged from 239 hospitals from 2009 to 2012. Scheduled early follow-up at the time of hospital discharge rose from 51% to 65% over time (P<0.001). After multivariable adjustment, patients with older age (odds ratio, 1.04; 95% confidence interval, 1.01-1.07), certain comorbidities (anemia, diabetes mellitus, and chronic kidney disease), and the use of anticoagulation at discharge (odds ratio, 1.16; 95% confidence interval, 1.11-1.22) were associated with greater likelihood for early scheduled follow-up. Patients treated in hospitals located in the Midwest (odds ratio, 0.67; 95% confidence interval, 0.50-0.91) were less likely to have early scheduled follow-up. In a subset of patients with linked Medicare claims, we observed smaller improvements in actual early follow-up visits over time from 26% to 30% (P=0.005)., Conclusions: From 2009 to 2012, there was improvement in early scheduled outpatient follow-up and, in the subset analyzed, improvement in actual early follow-up visits for hospitalized patients with heart failure. However, substantial opportunities remain for improving heart failure transitional care., (© 2016 American Heart Association, Inc.)

Objectives: The authors sought to describe characteristics, treatments, and in-hospital outcomes of hospitalized heart failure (HF) patients stratified by etiology., Background: Whether characteristics and outcomes of HF patients differ by cardiomyopathy etiology is unknown., Methods: The authors analyzed data on 156,013 hospitalized HF patients from 319 U.S. hospitals participating in Get With The Guidelines-HF between 2005 and 2013. Characteristics, treatments, and in-hospital outcomes were assessed by HF etiology. Standard regression techniques adjusted for site and patient-level characteristics were used to examine association between HF etiology and in-hospital outcomes., Results: Median age was 75 years, 69.2% were white, and 49.5% were women. Overall, 92,361 patients (59.2%) had ischemic cardiomyopathy and 63,652 patients (40.8%) had nonischemic cardiomyopathy (NICM). Hypertensive (n = 28,141; 48.5%) and idiopathic (n = 17,808; 30.7%) cardiomyopathies accounted for the vast majority of NICM patients. Post-partum (n = 209; 0.4%), viral (n = 447; 0.8%), chemotherapy (n = 721; 1.2%), substance abuse (n = 2,653; 4.6%), familial (n = 556; 1.0%), and other (n = 7,523; 13.0%) etiologies were far less frequent. There were significant differences in baseline characteristics between those with ischemic cardiomyopathy compared with NICM with respect to age (76 years vs. 72 years), sex (44.4% vs. 56.9% women), and ejection fraction (38% vs. 45%). Risk-adjusted quality of care provided to eligible patients varied minimally by etiology. Similarly, in-hospital mortality did not differ among ischemic compared with NICM patients. However, among NICM patients, only hypertensive cardiomyopathy had a lower mortality rate compared with idiopathic NICM (adjusted odds ratio: 0.83; 95% confidence interval: 0.71 to 0.97)., Conclusions: Characteristics of hospitalized HF patients vary by etiology. Both risk-adjusted quality of care and in-hospital outcomes did not differ by etiology., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Guidelines for heart failure (HF) recommend prescription of guideline-directed medical therapy before hospital discharge; some of these therapies are included in publicly reported performance measures. The burden of new medications for individual patients has not been described., Methods and Results: We used Get With The Guidelines-HF registry data from 2008 to 2013 to characterize prescribing, indications, and contraindications for angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, aldosterone antagonists, hydralazine/isosorbide dinitrate, and anticoagulants. The difference between a patient's medication regimen at hospital admission and that recommended by HF quality measures at discharge was calculated. Among 158 922 patients from 271 hospitals with a primary discharge diagnosis of HF, initiation of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was indicated in 18.1% of all patients (55.5% of those eligible at discharge were not receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers at admission), β-blockers in 20.3% (50.5% of eligible), aldosterone antagonists in 24.1% (87.4% of eligible), hydralazine/isosorbide dinitrate in 8.6% (93.1% of eligible), and anticoagulants in 18.0% (58.0% of eligible). Cumulatively, 0.4% of patients were eligible for 5 new medication groups, 4.1% for 4 new medication groups, 9.4% for 3 new medication groups, 10.1% for 2 new medication groups, and 22.7% for 1 new medication group; 15.0% were not eligible for new medications because of adequate prescribing at admission; and 38.4% were not eligible for any medications recommended by HF quality measures. Compared with newly indicated medications (mean, 1.45 ± 1.23), actual new prescriptions were lower (mean, 1.16 ± 1.00)., Conclusions: A quarter of patients hospitalized with HF need to start >1 medication to meet HF quality measures. Systems for addressing medication initiation and managing polypharmacy are central to HF transitional care., (© 2015 American Heart Association, Inc.)

The management of acute heart failure is shifting toward treatment approaches outside of a traditional hospital setting. Many heart failure providers are now treating patients in less familiar health care settings, such as acute care clinics, emergency departments, and skilled nursing facilities. In this review we describe the current pressures driving change in the delivery of acute heart failure and summarize the evidence regarding treatments for acute heart failure outside of the inpatient setting. We also provide considerations for the design of future treatment strategies to be implemented in alternative care settings., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: There is significant variation in the delivery of evidence-based care for patients with heart failure (HF), but there is limited evidence defining the best methods to improve the quality of care., Methods and Results: We performed a cluster-randomized trial of personalized site performance feedback at 147 hospitals participating in the Get With The Guidelines-Heart Failure quality improvement program from October 2009 to March 2011. The intervention provided sites with specific data on their heart failure achievement and quality measures in addition to the usual Get With The Guidelines-Heart Failure tools. The primary outcome for our trial was improvement in site composite quality of care score. Overall, 73 hospitals (n=33 886 patients) received the intervention, whereas 74 hospitals (n=37 943 patients) did not. One year after the intervention, both the intervention and control arms had a similar mean change in percentage points in their composite quality score (absolute change, +0.31 [SE, 1.51] versus +3.18 [SE, 1.68] in control; P=0.21). Similarly, none of the individual achievement measures or quality measures improved more at intervention versus control hospitals., Conclusions: Our site-based intervention, which included personalized site feedback on adherence to quality metrics, was not able to elicit more quality improvement beyond that already associated with participation in the Get With The Guidelines-Heart Failure program., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00979264., (© 2015 American Heart Association, Inc.)

Heart failure (HF) with reduced left ventricular function inflicts a large and growing burden of morbidity and mortality in the US and across the globe. One source of this burden is stroke. While it appears that HF itself may impose some risk of stroke, it is in the presence of other risk factors, like atrial fibrillation, that the greatest risks are observed. Therapeutic anticoagulation is the mainstay of risk reduction strategies in this population. While warfarin was the only available therapy for anticoagulation for many decades, there are now four direct oral anticoagulants available. In three of these four, outcomes in the specific subgroup of patients with heart failure have been examined. In this review, we provide some pathophysiologic basis for the risk of stroke in heart failure. In addition, the available therapeutic options for stroke risk prevention in heart failure are described in detail including how these options are incorporated into relevant professional society guidelines.

Background: Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years by improving cardiovascular prevention. An important tool in the success of programs like Million Hearts is public ranking on the quality of practices, yet different measures may provide different rankings, so the true quality of practices is difficult to discern. We evaluated the quality of ambulatory cardiology care using performance measure metrics., Methods: We compared rankings of practices participating in the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence Registry using measures from (1) the physician quality reporting system and (2) the American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement. We compared achievement rates for measures between the 2 frameworks and determined correlations in rankings using Spearman correlation coefficients., Results: From January 1, 2008 to December 31, 2012, there were 1,711,326 patients enrolled from 111 US practices. Among eligible patients, the physician quality reporting system and American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement measures were achieved in 76.1% versus 77.4% for antiplatelet prescription (P < .001), 68.3% versus 90.8% for blood pressure control (P < .001), 26.9% versus 43.4% for cholesterol control (P < .001), and 37.4% versus 40.6% for smoking cessation (P = .383). Practice rankings were strongly correlated for antiplatelet prescription (correlation coefficient 0.98) and cholesterol control (0.92) but poorly correlated for blood pressure control (0.39) and smoking cessation (0.22)., Conclusions: Evaluation of preventive care and individual practice rankings vary significantly depending on how measures are defined. Publicly reported measures need to be validly associated with outcomes to avoid incorrectly evaluating practice performance and failing to achieve public health goals., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: An 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 Results: We 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., Conclusions: County-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., (© 2015 American Heart Association, Inc.)

Background: Whether heart rate upon discharge following hospitalization for heart failure is associated with long-term adverse outcomes and whether this association differs between patients with sinus rhythm (SR) and atrial fibrillation (AF) have not been well studied., Methods and Results: We conducted a retrospective cohort study from clinical registry data linked to Medicare claims for 46 217 patients participating in Get With The Guidelines(®)-Heart Failure. Cox proportional-hazards models were used to estimate the association between discharge heart rate and all-cause mortality, all-cause readmission, and the composite outcome of mortality/readmission through 1 year. For SR and AF patients with heart rate ≥75, the association between heart rate and mortality (expressed as hazard ratio [HR] per 10 beats-per-minute increment) was significant at 0 to 30 days (SR: HR 1.30, 95% CI 1.22 to 1.39; AF: HR 1.23, 95% CI 1.16 to 1.29) and 31 to 365 days (SR: HR 1.15, 95% CI 1.12 to 1.20; AF: HR 1.05, 95% CI 1.01 to 1.08). Similar associations between heart rate and all-cause readmission and the composite outcome were obtained for SR and AF patients from 0 to 30 days but only in the composite outcome for SR patients over the longer term. The HR from 0 to 30 days exceeded that from 31 to 365 days for both SR and AF patients. At heart rates <75, an association was significant for mortality only for both SR and AF patients., Conclusions: Among older patients hospitalized with heart failure, higher discharge heart rate was associated with increased risks of death and rehospitalization, with higher risk in the first 30 days and for SR compared with AF., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: QRS prolongation is associated with adverse outcomes in mostly white populations, but its clinical significance is not well established for other groups. We investigated the association between QRS duration and mortality in African Americans., Methods and Results: We analyzed data from 5146 African Americans in the Jackson Heart Study stratified by QRS duration on baseline 12-lead ECG. We defined QRS prolongation as QRS≥100 ms. We assessed the association between QRS duration and all-cause mortality using Cox proportional hazards models and reported the cumulative incidence of heart failure hospitalization. We identified factors associated with the development of QRS prolongation in patients with normal baseline QRS. At baseline, 30% (n=1528) of participants had QRS prolongation. The cumulative incidences of mortality and heart failure hospitalization were greater with versus without baseline QRS prolongation: 12.6% (95% confidence interval [CI], 11.0-14.4) versus 7.1% (95% CI, 6.3-8.0) and 8.2% (95% CI, 6.9-9.7) versus 4.4% (95% CI, 3.7-5.1), respectively. After risk adjustment, QRS prolongation was associated with increased mortality (hazard ratio, 1.27; 95% CI, 1.03-1.56; P=0.02). There was a linear relationship between QRS duration and mortality (hazard ratio per 10 ms increase, 1.06; 95% CI, 1.01-1.12). Older age, male sex, prior myocardial infarction, lower ejection fraction, left ventricular hypertrophy, and left ventricular dilatation were associated with the development of QRS prolongation., Conclusions: QRS prolongation in African Americans was associated with increased mortality and heart failure hospitalization. Factors associated with developing QRS prolongation included age, male sex, prior myocardial infarction, and left ventricular structural abnormalities., (© 2015 American Heart Association, Inc.)

Background: Because little was previously known about Asian-American patients with heart failure (HF), we compared clinical profiles, quality of care, and outcomes between Asian-American and non-Hispanic white HF patients using data from the American Heart Association Get With The Guidelines-Heart Failure (GWTG-HF) program., Methods: We analyzed 153,023 HF patients (149,249 whites, 97.5%; 3774 Asian-Americans, 2.5%) from 356 U.S. centers participating in the GWTG-HF program (2005-2012). Baseline characteristics, quality of care metrics, in-hospital mortality, discharge to home, and length of stay were examined., Results: Relative to white patients, Asian-American HF patients were younger, more likely to be male, uninsured or covered by Medicaid, and recruited in the western region. They had higher prevalence of diabetes, hypertension, and renal insufficiency, but similar ejection fraction. Overall, Asian-American HF patients had comparable quality of care except that they were less likely to receive aldosterone antagonists at discharge (relative risk , 0.88; 95% confidence interval , 0.78-0.99), and anticoagulation for atrial fibrillation (RR, 0.91; 95% CI, 0.85-0.97) even after risk adjustment. Compared with white patients, Asian-American patients had comparable risk adjusted in-hospital mortality (RR, 1.11; 95% CI, 0.91-1.35), length of stay>4 days (RR, 1.01; 95% CI, 0.95-1.08), and were more likely to be discharged to home (RR, 1.08; 95% CI, 1.06-1.11)., Conclusions: Despite some differences in clinical profiles, Asian-American patients hospitalized with HF receive very similar quality of care and have comparable health outcomes to their white counterparts., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Little is known about global patterns of critical care unit (CCU) care and the relationship with outcomes in patients with acute decompensated heart failure (ADHF). Whether a ward or a CCU admission is associated with better outcomes is unclear., Methods: Patients in the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) trial were initially hospitalized in a ward or CCU (coronary or intensive care unit). Sites were geographically classified: Asia-Pacific (AP), Central Europe (CE), Latin America (LA), North America (NA), and Western-Europe (WE). The primary outcome of 30-day all-cause mortality or all-cause hospital readmission was adjusted using a two-stage multivariable logistic regression model with a generalized estimated equation that took sites within each country as a nested random factor., Results: Overall, 1944 (38.2%) patients were admitted to a CCU and 3150 (61.8%) to a ward, and this varied by region: 50.6% AP, 63.3% CE, 60.7% WE, 22.1% LA, and 28.6% NA. The 30-day death or readmission rate was 15.2% in ward patients and 17.0% in CCU patients (risk-adjusted Odds Ratio [OR] 1.44: 95% CI, 1.14-1.82). Compared with CCU patients in NA (24.1% 30-day event rate), the primary outcomes were: AP (10.4%, Odds Ratio [OR] 0.63; 95% confidence Interval [CI], 0.35 to 1.15), CE (10.4%, OR 0.56: 95% CI, 0.31 to 1.02), LA (22.4%, OR 0.60: 95% CI, 0.11 to 3.32), and WE (11.2%, OR 0.63, 95% CI, 0.25 to 1.56). No regional differences in 30-day mortality were observed; however, 30-day readmission rates were highest in NA sites., Conclusions: Management of patients with ADHF varies significantly, and after adjustment, CCU care was associated with higher risk of early mortality, not explained by international differences. These findings may help to improve the early decisions regarding risk stratification of patients hospitalized with ADHF., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: Studies on outcomes among patients with heart failure (HF) with preserved left ventricular ejection fraction (HFpEF), borderline left ventricular ejection fraction (HFbEF), and reduced left ventricular ejection fraction (HFrEF) remain limited. We sought to characterize mortality and readmission in patients with HF in the contemporary era., Methods: Get With The Guidelines-HF was linked to Medicare data for longitudinal follow-up. Patients were grouped into HFpEF (left ventricular ejection fraction [EF] ≥ 50%), HFbEF (40% ≤ EF < 50%), and HFrEF (EF < 40%). Multivariable models were constructed to examine the relationship between EF and outcomes at 30 days and 1 year and to study trends over time., Results: A total of 40,239 patients from 220 hospitals between 2005 and 2011 were included in the study: 18,897 (47%) had HFpEF, 5,626 (14%) had HFbEF, and 15,716 (39%) had HFrEF. In crude survival analysis, patients with HFrEF had slightly increased mortality compared with HFbEF and HFpEF. After risk adjustment, mortality at 1 year was not significantly different for HFrEF, HFbEF, and HFpEF (HFrEF vs HFpEF, hazard ratio [HR] 1.040 [95% CI 0.998-1.084], and HFbEF vs HFpEF, HR 0.967 [95% CI 0.917-1.020]). Patients with HFpEF had increased risk of all-cause readmission compared with HFrEF. Conversely, risk of cardiovascular and HF readmissions were higher in HFrEF and HFbEF compared with HFpEF., Conclusions: Among patients hospitalized with HF, patients with HFpEF and HFbEF had slightly lower mortality and higher all-cause readmission risk than patients with HFrEF, although the mortality differences did not persist after risk adjustment. Irrespective of EF, these patients experience substantial mortality and readmission highlighting the need for new therapeutic strategies., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: The 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 Results: Using 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., Conclusions: Among 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., (© 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years. The degree to which outpatient providers are controlling risk factors has not been fully described., Methods: We examined adherence to the Million Hearts clinical quality measures using The Guideline Advantage, a nationwide quality improvement program for outpatient care. Specifically, we determined the proportion of patients with (1) ischemic vascular disease who were prescribed an antiplatelet drug; (2) hypertension whose blood pressure was controlled; (3) diabetes mellitus whose most recent low-density lipoprotein cholesterol level was <100 mg/dL; and 4) a tobacco use screening and who received a smoking cessation intervention as needed., Results: From January 1, 2010, to March 31, 2012, there were 147,038 patients enrolled from 25 US practices. At the practice level, antiplatelet prescription ranged from 50.0% to 82.3% (median 71.9%, interquartile range [IQR] 66.7-82.1), hypertension control ranged from 48.6% to 75.3% (median 66.6%, IQR 60.1-70.9), hyperlipidemia control among patients with diabetes mellitus ranged from 53.3% to 100.0% (median 75.8%, IQR 65.8-83.0), and tobacco use screening and intervention ranged from 31.0% to 98.8% (median 79.8%, IQR 72.0-83.2). Black and people of color races were associated with a lower likelihood of blood pressure control and cholesterol control. Female gender was associated with a lower likelihood of antiplatelet prescription and cholesterol control., Conclusions: Compliance with quality measures for the Million Hearts initiative varies widely and is notable for racial and gender disparities. Our findings identify multiple opportunities to improve the quality of cardiovascular prevention., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: The rapid growth in the number of mobile health applications could have profound significance in the prevention of disease or in the treatment of patients with chronic disease such as diabetes., Objective: The objective of this study was to describe the characteristics of the most common mobile health care applications available in the Apple iTunes marketplace., Methods: We undertook a descriptive analysis of a sample of applications in the "health and wellness" category of the Apple iTunes Store. We characterized each application in terms of its health factor and primary method of user engagement. The main outcome measures of the analysis were price, health factors, and methods of user engagement., Results: Among the 400 applications that met the inclusion criteria, the mean price of the most frequently downloaded paid applications was US $2.24 (SD $1.30), and the mean price of the most currently available paid applications was US $2.27 (SD $1.60). Fitness/training applications were the most popular (43.5%, 174/400). The next two most common categories were health resource (15.0%, 60/400) and diet/caloric intake (14.3%, 57/400). Applications in the health resource category constituted 5.5% (22/400) of the applications reviewed. Self-monitoring was the most common primary user engagement method (74.8%, 299/400). A total of 20.8% (83/400) of the applications used two or more user engagement approaches, with self-monitoring and progress tracking being the most frequent., Conclusions: Most of the popular mobile health applications focus on fitness and self-monitoring. The approaches to user engagement utilized by these applications are limited and present an opportunity to improve the effectiveness of the technology.

Objectives: This study sought to examine trends in mortality, readmission, and costs among Medicare beneficiaries receiving ventricular assist devices (VADs) and associations between hospital-level procedure volume and outcomes., Background: VADs are an option for patients with advanced heart failure, but temporal changes in outcomes and associations between facility-level volume and outcomes are poorly understood., Methods: This is a population-based, retrospective cohort study of all fee-for-service Medicare beneficiaries with heart failure who received an implantable VAD between 2006 and 2011. We used Cox proportional hazards models to examine temporal changes in mortality, readmission, and hospital-level procedure volume., Results: Among 2,507 patients who received a VAD at 103 centers during the study period, the in-hospital mortality decreased from 30% to 10% (p < 0.001), the 1-year mortality decreased from 42% to 26% (p < 0.001), and the all-cause readmission was frequent (82% and 81%; p = 0.70). After covariate adjustment, in-hospital and 1-year mortality decreased (p < 0.001 for both), but the all-cause readmission did not change (p = 0.82). Hospitals with a low procedure volume had higher risks of in-hospital mortality (risk ratio: 1.72; 95% confidence interval [CI]: 1.28 to 2.33) and 1-year mortality (risk ratio: 1.55; 95% CI: 1.24 to 1.93) than high-volume hospitals. Procedure volume was not associated with risk of readmission. The greatest cost was from the index hospitalization and remained unchanged ($204,020 in 2006 and $201,026 in 2011; p = 0.21)., Conclusions: Short- and long-term mortality after VAD implantation among Medicare beneficiaries improved, but readmission remained similar over time. A higher volume of VAD implants was associated with lower risk of mortality but not readmission. Costs to Medicare have not changed in recent years., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The relative impact of atrial fibrillation on early outcomes of patients with heart failure with reduced or preserved ejection fraction (EF) is unknown., Methods: We conducted a retrospective cohort study of clinical registry data linked to Medicare claims for patients with heart failure with reduced or preserved EF stratified by presence of atrial fibrillation at admission. Outcomes of interest were all-cause mortality and readmission at 30days. We used Kaplan-Meier methods to estimate mortality and calculated cumulative incidence estimates of readmission. We used Cox proportional hazards models to examine associations between atrial fibrillation and 30-day outcomes., Results: Among 66,357 patients admitted to 283 hospitals between January 2001 and March 2006, 46% had atrial fibrillation (44% of patients with reduced EF and 48% of patients with preserved EF). After adjustment for other patient characteristics, atrial fibrillation was associated with a modestly higher risk of 30-day mortality (HR, 1.08; 95% CI, 1.03-1.14) and readmission (HR, 1.06; 95% CI, 1.02-1.11). In subgroup analyses, atrial fibrillation was associated with a higher risk of 30-day mortality (HR, 1.16; 95% CI, 1.08-1.25) among patients with preserved EF but not among patients with reduced EF. The association of atrial fibrillation with readmission did not differ by heart failure type (P=.37 for the interaction)., Conclusions: Atrial fibrillation was associated with higher 30-day mortality among patients with heart failure with preserved EF but not reduced EF. The association of atrial fibrillation with 30-day readmission was modest and did not differ by heart failure type., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: Postdischarge adherence and long-term persistence in the use of warfarin among patients with heart failure and atrial fibrillation without contraindications have not been fully described., Methods and Results: We identified patients with heart failure and atrial fibrillation who were ≥ 65 years old, eligible for warfarin, and discharged home from hospitals in the Get With the Guidelines-Heart Failure registry from January 1, 2006, to December 31, 2009. We used linked Medicare prescription drug event data to measure adherence and persistence. The main outcome measures were rates of prescription at discharge, outpatient dispensing, discontinuation, and adherence as measured by the medication possession ratio. We hypothesized that adherence to warfarin would differ according to whether patients received the prescription at discharge. Among 2,691 eligible patients, 1,856 (69.0%) were prescribed warfarin at discharge. Patients prescribed warfarin at discharge had significantly higher prescription fill rates within 90 days (84.5% vs 12.3%; P < .001) and 1 year (91.6% vs 16.8%; P < .001) and significantly higher medication possession ratios (0.78 vs 0.63; P < .001). Among both previous nonusers and existing users, fill rates at 90 days and 1 year and possession ratios were significantly higher among those prescribed warfarin at discharge., Conclusions: One-third of eligible patients with heart failure and atrial fibrillation were not prescribed warfarin at discharge from a heart failure hospitalization, and few started therapy as outpatients. In contrast, most patients who were prescribed warfarin at discharge filled the prescription within 90 days and remained on therapy at 1 year., (Copyright © 2014 Elsevier Inc. All rights reserved.)

The risks and benefits of anticoagulation for patients with both heart failure and atrial fibrillation are unclear. We hypothesized that anticoagulation was associated with improved clinical outcomes of heart failure patients with atrial fibrillation independent of other risk factors. We conducted a retrospective cohort study of clinical registry data linked to Medicare claims for new users of oral anticoagulation (warfarin) without contraindications, discharged home alive, and stratified by CHADS 2 score. Outcomes of interest were propensity score-adjusted estimates of the effects of warfarin at discharge on all-cause mortality, thromboembolic events, major adverse cardiovascular events, and bleeding events. Among 10,494 patients with heart failure and atrial fibrillation, the 2249 patients newly treated with warfarin had lower 1-year mortality (27.7% vs 39.3% for CHADS 2 score ≤ 3 [P > .001]; 31.6% vs 41.8% for CHADS 2 score > 3 [P > .001]) than patients not treated with warfarin. There was no significant difference in thromboembolic events, major adverse cardiovascular events, or bleeding events at 1 year. After multivariate adjustment, exposed individuals in both CHADS 2 subgroups had lower adjusted 1-year mortality (CHADS 2 ≤ 3: hazard ratio, 0.78 [95% confidence interval, 0.69-0.89]; CHADS 2 >3: 0.78 [0.66-0.93]). In conclusion, warfarin use in heart failure patients with atrial fibrillation was associated with improved survival at 1 year independent of baseline CHADS 2 score. However, there was no significant reduction in clinical events, such as thromboembolic or major adverse cardiovascular events at 1 year that might simply explain the survival benefit associated with warfarin.

Background: Effective warfarin thromboprophylaxis requires maintaining anticoagulation within the recommended international normalized ratio (INR) range. INR testing rates and associations between testing and outcomes are not well understood., Hypothesis: INR testing rates after hospitalization for acute decompensated heart failure are suboptimal, and testing is associated with lower risks of mortality and adverse clinical events., Methods: We conducted a retrospective cohort study of patients who were long-term warfarin users and were hospitalized for heart failure, had a medical history of atrial fibrillation or valvular heart disease, and were enrolled in fee-for-service Medicare. INR testing was defined as ≥1 outpatient INR test within 45 days after discharge. Using Cox proportional hazards models, we examined associations between testing and all-cause mortality, all-cause readmission, and adverse clinical events at 1 year., Results: Among 8558 patients, 7722 (90.2%) were tested. After 1 year, tested patients had lower all-cause mortality (23.5% vs 32.6%; P < 0.001) and fewer myocardial infarctions (2.0% vs 3.3%; P = 0.02). These differences remained significant after multivariable adjustment with hazard ratios of 0.72 (95% confidence interval [CI]: 0.63-0.84; P < 0.001) and 0.58 (95% CI: 0.41-0.83; P = 0.003), respectively. Differences in all-cause readmission, thromboembolic events, ischemic stroke, and bleeding events were not statistically significant., Conclusions: Postdischarge outpatient INR testing in patients with heart failure complicated by atrial fibrillation or valvular heart disease was high. INR testing was associated with improved survival and fewer myocardial infarctions at 1 year but was not independently associated with other adverse clinical events., (© 2013 Wiley Periodicals, Inc.)

Background: In heart failure (HF), there are known differences in plasma B-type natriuretic peptide (BNP) levels between reduced and preserved ejection fraction (EF), but few HF studies have explored sex differences. We sought to evaluate the relationship between sex, EF, and BNP in HF patients and determine prognostic significance of BNP as it relates to sex and EF., Methods: We included hospitals in Get With The Guidelines-Heart Failure that admitted 99,930 HF patients with reduced (EF <40%), borderline (EF 40%-49%), or preserved (EF ≥50%) EF. The primary end point was inhospital mortality. Multivariate models were used to compute odds ratios while accounting for hospital clustering., Results: There were 47,025 patients with reduced (37% female), 13,950 with borderline (48% female), and 38,955 with preserved (65% female) EF. Women compared with men had higher admission median BNP levels with the greatest difference among reduced EF and smallest difference among preserved EF (median BNP in women vs men: EF reduced 1,259 vs 1,113 pg/mL, borderline 821 vs 732 pg/mL, and preserved 559 vs 540 pg/mL; P < .001 all comparisons). Ejection fraction and sex were independently associated with BNP. Inhospital mortality was 2.7%, and patients above the median BNP level had higher mortality than those below. After adjusting for over 20 clinical variables, the ability of BNP to predict inhospital mortality was similar among all subgroups (P for heterogeneity = .47)., Conclusions: In a large registry, we found that despite sex/EF differences in BNP values, there was no significant difference in the ability of BNP to predict inhospital mortality among these subgroups., (© 2013.)

Background: Dispensing data from Medicare Part D standalone prescription drug plans are now available, but characteristics of enrollees with heart failure have not been well described., Methods and Results: We identified 81 874 patients with prevalent heart failure as of January 1, 2010, in a nationally representative 5% sample of Medicare beneficiaries. We classified patients according to enrollment in a Medicare Part D plan as of January 1, 2010. Demographic characteristics, comorbid conditions, and prescriptions were compared by enrollment status. A total of 49 252 (60.2%) were enrolled in a Medicare Part D plan as of January 1. Enrollees were more often women, black, and of lower socioeconomic status. Enrollees with heart failure more often filled prescriptions for loop diuretics than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, or aldosterone antagonists. During the first 4 months of 2010, 5444 (12.3%) reached the coverage gap, and 566 (1.3%) required catastrophic coverage beyond the gap., Conclusions: Medicare beneficiaries with heart failure differ significantly according to enrollment in Part D prescription drug plans and represent a population underrepresented in clinical efficacy trials. Many face the coverage gap, and few select Medicare Part D plans that provide coverage during the gap. Linking Medicare Part D event data with clinical registries could help to determine whether eligible enrollees are undertreated for heart failure.

Background: The Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) randomly assigned 7,141 participants to nesiritide or placebo. Dyspnea improvement was more often reported in the nesiritide group, but there were no differences in 30-day all-cause mortality or heart failure readmission rates. We compared medical resource use, costs, and health utilities between the treatment groups., Methods and Results: There were no significant differences in inpatient days, procedures, and emergency department visits reported for the first 30 days or for readmissions to day 180. EQ-5D health utilities and visual analog scale ratings were similar at 24 hours, discharge, and 30 days. Billing data and regression models were used to generate inpatient costs. Mean length of stay from randomization to discharge was 8.5 days in the nesiritide group and 8.6 days in the placebo group (P = .33). Cumulative mean costs at 30 days were $16,922 (SD $16,191) for nesiritide and $16,063 (SD $15,572) for placebo (P = .03). At 180 days, cumulative costs were $25,590 (SD $30,344) for nesiritide and $25,339 (SD $29,613) for placebo (P = .58)., Conclusions: The addition of nesiritide contributed to higher short-term costs and did not significantly influence medical resource use or health utilities compared with standard care alone., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Hospital readmission is an important clinical outcome of patients with heart failure. Its relation to length of stay for the initial hospitalization is not clear., Methods and Results: We used hierarchical modeling of data from a clinical trial to examine variations in length of stay across countries and across hospitals in the United States and its association with readmission within 30 days of randomization. Main outcomes included associations between country-level length of stay and readmission rates, after adjustment for patient-level case mix; and associations between length of stay and readmission rates across sites in the United States. Across 27 countries with 389 sites and 6848 patients, mean length of stay ranged from 4.9 to 14.6 days (6.1 days in the United States). Rates of all-cause readmission ranged from 2.5% to 25.0% (17.8% in the United States). There was an inverse correlation between country-level mean length of stay and readmission (r=-0.52; P<0.01). After multivariable adjustment, each additional inpatient day across countries was associated with significantly lower risk of all-cause readmission (odds ratio, 0.86; 95% confidence interval, 0.75-0.98; P=0.02) and heart failure readmission (odds ratio, 0.79; 95% confidence interval, 0.69-0.99; P=0.03). Similar trends were observed across US study sites concerning readmission for any cause (odds ratio, 0.92; 95% confidence interval, 0.85-1.00; P=0.06) and readmission for heart failure (odds ratio, 0.90; 95% confidence interval, 0.80-1.01; P=0.07). Across countries and across US sites, longer median length of stay was independently associated with lower risk of readmission., Conclusions: Countries with longer length of stay for heart failure hospitalizations had significantly lower rates of readmission within 30 days of randomization. These findings may have implications for developing strategies to prevent readmission, defining quality measures, and designing clinical trials in acute heart failure., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.

Background: Patients with heart failure are at higher risk for thromboembolic events, even in the absence of atrial fibrillation, but the effect of anticoagulation therapy on outcomes is uncertain., Methods and Results: With data from a clinical registry linked to Medicare claims, we estimated the adjusted associations between anticoagulation and 1-year outcomes with the use of inverse probability of treatment weighting. Eligible patients had an ejection fraction ≤35%, had no concurrent atrial fibrillation, were alive at discharge, and had not received anticoagulation therapy before admission. Of 13,217 patients in 276 hospitals, 1,140 (8.6%) received anticoagulation therapy at discharge. Unadjusted rates of thromboembolic events and major adverse cardiovascular events did not differ by receipt of anticoagulation therapy. Patients discharged on anticoagulation therapy had lower unadjusted rates of all-cause mortality (27.2% vs 32.3%; P < .001) and readmission for heart failure (29.4% vs 35.4%; P < .001) and higher rates of bleeding events (5.2% vs 2.8%; P < .001). After adjustment for probability of treatment and discharge medications, there were no differences in all-cause mortality (hazard ratio 0.92; 95% confidence interval 0.80-1.06) or readmission for heart failure (0.91, 0.81-1.02), but patients receiving anticoagulation therapy were at higher risk for bleeding events (2.09, 1.47-2.97)., Conclusions: Anticoagulation therapy at discharge is infrequent among older patients with heart failure and without atrial fibrillation. There were no statistically significant propensity-weighted associations between anticoagulation therapy and 1-year outcomes, except for a higher risk of bleeding., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Sudden cardiac arrest (SCA) is one of the most impactful public health problems in the United States. Despite the progress made in reducing the number of cardiac deaths, the incidence of sudden cardiac death remains high. Studies of life-saving interventions for prevention and treatment of SCA, like β-blockers, aldosterone antagonists, implantable cardioverter defibrillator therapy, automated external defibrillators, and cardiopulmonary resuscitation, have brought to light substantial underutilization, variations in care, and disparities. Thus, a comprehensive systems-based approach to addressing these gaps in care should be implemented. In addition to educating stakeholders about SCA and its prevention and developing tools that could help physicians identify patients who could benefit from primary prevention of SCA, robust performance measures with strong, evidence-based association between process performance and patient outcomes are needed. In this article, we review the burden of SCA and highlight the need to develop performance measures related to the prevention and treatment of SCA., (Copyright © 2013 Mosby, Inc. All rights reserved.)