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1.
Europace ; 26(7)2024 Jul 02.
Article in English | MEDLINE | ID: mdl-39001864

ABSTRACT

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.


Subject(s)
Defibrillators , Electric Countershock , Tachycardia, Ventricular , Ventricular Fibrillation , Wearable Electronic Devices , Humans , Male , Female , Ventricular Fibrillation/therapy , Ventricular Fibrillation/diagnosis , Electric Countershock/instrumentation , Electric Countershock/adverse effects , Middle Aged , Tachycardia, Ventricular/therapy , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/physiopathology , Prospective Studies , Treatment Outcome , Aged , Equipment Design , Adult , Death, Sudden, Cardiac/prevention & control
2.
J Am Coll Cardiol ; 84(6): 525-536, 2024 Aug 06.
Article in English | MEDLINE | ID: mdl-39084827

ABSTRACT

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).


Subject(s)
Death, Sudden, Cardiac , Defibrillators , Wearable Electronic Devices , Humans , Death, Sudden, Cardiac/prevention & control , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/etiology , Female , Male , Middle Aged , Prospective Studies , Aged , Tachycardia, Ventricular/therapy , Ventricular Fibrillation/therapy , Equipment Design , Adult , Patient Compliance
3.
J Am Heart Assoc ; 10(2): e016835, 2021 01 19.
Article in English | MEDLINE | ID: mdl-33432843

ABSTRACT

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.


Subject(s)
Cardiovascular Agents , Coronary Artery Disease , Diabetes Mellitus, Type 2 , Health Services Misuse , Hypoglycemic Agents , Professional Practice Gaps , Cardiovascular Agents/classification , Cardiovascular Agents/therapeutic use , Comorbidity , Coronary Artery Disease/complications , Coronary Artery Disease/mortality , Coronary Artery Disease/therapy , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/therapy , Drug Utilization Review/methods , Drug Utilization Review/statistics & numerical data , Female , Health Services Misuse/prevention & control , Health Services Misuse/statistics & numerical data , Health Services Needs and Demand , Humans , Hypoglycemic Agents/classification , Hypoglycemic Agents/therapeutic use , Male , Middle Aged , Professional Practice Gaps/standards , Professional Practice Gaps/statistics & numerical data , Referral and Consultation/statistics & numerical data , United States/epidemiology
4.
JACC Heart Fail ; 8(12): 999-1008, 2020 12.
Article in English | MEDLINE | ID: mdl-33189635

ABSTRACT

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).


Subject(s)
Heart Failure , Relaxin , Acute Disease , Cause of Death , Heart Failure/drug therapy , Humans , Recombinant Proteins , Treatment Outcome
5.
J Am Coll Cardiol ; 71(23): 2680-2690, 2018 06 12.
Article in English | MEDLINE | ID: mdl-29880129

ABSTRACT

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.


Subject(s)
Biomedical Technology/methods , Congresses as Topic , Delivery of Health Care/methods , Evidence-Based Medicine/methods , Telemedicine/methods , Biomedical Technology/trends , Clinical Trials as Topic/methods , Congresses as Topic/trends , Delivery of Health Care/trends , District of Columbia , Evidence-Based Medicine/trends , Humans , Telemedicine/trends
6.
Circulation ; 136(8): 765-772, 2017 Aug 22.
Article in English | MEDLINE | ID: mdl-28827221

ABSTRACT

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.


Subject(s)
Delivery of Health Care/methods , Economics, Behavioral , Health Behavior , Heart Failure/therapy , Delivery of Health Care/economics , Delivery of Health Care/trends , Economics, Behavioral/trends , Heart Failure/economics , Humans , Treatment Outcome
7.
Prog Cardiovasc Dis ; 60(2): 171-177, 2017.
Article in English | MEDLINE | ID: mdl-28733079

ABSTRACT

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.


Subject(s)
Delivery of Health Care , Heart Failure/therapy , Patient Admission , Delivery of Health Care/economics , Health Care Costs , Heart Failure/diagnosis , Heart Failure/economics , Heart Failure/physiopathology , Humans , Insurance, Health, Reimbursement , Patient Admission/economics , Patient Readmission , Patient Transfer , Risk Factors , Treatment Outcome
8.
JACC Heart Fail ; 5(5): 329-336, 2017 05.
Article in English | MEDLINE | ID: mdl-28285117

ABSTRACT

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.


Subject(s)
Ambulatory Care/statistics & numerical data , Emergency Service, Hospital/statistics & numerical data , Heart Failure/therapy , Hospitalization/statistics & numerical data , Outcome Assessment, Health Care , Telemedicine/statistics & numerical data , Acute Disease , Adult , Aged , Cause of Death , Disease Management , Female , Heart Failure/diagnosis , Heart Failure/mortality , Humans , Male , Middle Aged , Public Health , Risk Assessment , Survival Analysis , United States
9.
JACC Heart Fail ; 5(4): 297-304, 2017 04.
Article in English | MEDLINE | ID: mdl-28189579

ABSTRACT

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.


Subject(s)
Cardiology/methods , Heart Failure/therapy , Telemedicine/methods , Cardiology/economics , Cardiology/legislation & jurisprudence , Disease Management , Evidence-Based Medicine , Fee-for-Service Plans , Health Policy , Humans , Medicare , Medicare Access and CHIP Reauthorization Act of 2015 , Organization and Administration , Reimbursement Mechanisms , Reimbursement, Incentive , Telemedicine/economics , Telemedicine/legislation & jurisprudence , United States
10.
BMJ Open ; 6(10): e012723, 2016 10 17.
Article in English | MEDLINE | ID: mdl-27798018

ABSTRACT

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.


Subject(s)
Cardiovascular Diseases/prevention & control , Cell Phone , Text Messaging , Cardiovascular Diseases/psychology , Humans , Randomized Controlled Trials as Topic , Reminder Systems , Risk Reduction Behavior , Self Care , Systematic Reviews as Topic
11.
J Am Heart Assoc ; 5(10)2016 10 06.
Article in English | MEDLINE | ID: mdl-27792640

ABSTRACT

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.


Subject(s)
Fibrinolytic Agents/therapeutic use , Percutaneous Coronary Intervention/trends , Registries , ST Elevation Myocardial Infarction/therapy , Thrombolytic Therapy/trends , Time-to-Treatment/trends , Aged , Cohort Studies , Databases, Factual , Female , Guideline Adherence , Hospital Mortality , Humans , Male , Middle Aged , Outcome and Process Assessment, Health Care , Practice Guidelines as Topic
14.
JACC Heart Fail ; 4(6): 464-72, 2016 06.
Article in English | MEDLINE | ID: mdl-27256749

ABSTRACT

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.


Subject(s)
Heart Failure/physiopathology , Hospital Mortality , Hospitalization , Length of Stay , Stroke Volume , Aged , Aged, 80 and over , Arrhythmias, Cardiac/epidemiology , Female , Heart Failure/epidemiology , Humans , Kidney Diseases/epidemiology , Male , Medication Adherence/statistics & numerical data , Middle Aged , Pneumonia/epidemiology , Precipitating Factors , Weight Gain
15.
J Card Fail ; 22(8): 589-97, 2016 Aug.
Article in English | MEDLINE | ID: mdl-26975941

ABSTRACT

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.


Subject(s)
Black or African American , Body Mass Index , Healthcare Disparities , Heart Failure/ethnology , Hospitalization/trends , Obesity, Morbid/ethnology , Risk Assessment , Adult , Aged , Cause of Death/trends , Female , Follow-Up Studies , Heart Failure/complications , Heart Failure/therapy , Humans , Male , Middle Aged , North Carolina/epidemiology , Obesity, Morbid/complications , Proportional Hazards Models , Prospective Studies , Risk Factors , Survival Rate/trends
16.
J Am Coll Cardiol ; 67(8): 963-972, 2016 Mar 01.
Article in English | MEDLINE | ID: mdl-26916487

ABSTRACT

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.


Subject(s)
Heart Failure/therapy , Hospitals/standards , Insurance Claim Reporting/statistics & numerical data , Medicare/statistics & numerical data , Myocardial Infarction/therapy , Patient Readmission/statistics & numerical data , Pneumonia/therapy , Cause of Death/trends , Follow-Up Studies , Heart Failure/epidemiology , Humans , Incidence , Myocardial Infarction/epidemiology , Pneumonia/epidemiology , Quality Indicators, Health Care , Retrospective Studies , Survival Rate/trends , United States/epidemiology
17.
Circ Heart Fail ; 9(2): e002444, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26867758

ABSTRACT

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.


Subject(s)
Guideline Adherence/standards , Heart Failure/drug therapy , Hydralazine/therapeutic use , Isosorbide Dinitrate/therapeutic use , Practice Guidelines as Topic/standards , Practice Patterns, Physicians'/standards , Stroke Volume/drug effects , Aged , Aged, 80 and over , Chi-Square Distribution , Disease Progression , Drug Combinations , Female , Heart Failure/diagnosis , Heart Failure/mortality , Heart Failure/physiopathology , Humans , Hydralazine/adverse effects , Isosorbide Dinitrate/adverse effects , Kaplan-Meier Estimate , Logistic Models , Male , Medicare Part D , Patient Discharge , Patient Readmission , Proportional Hazards Models , Registries , Risk Factors , Time Factors , Treatment Outcome , United States
18.
Circ Heart Fail ; 9(1)2016 Jan.
Article in English | MEDLINE | ID: mdl-26754624

ABSTRACT

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.


Subject(s)
Ambulatory Care/trends , Appointments and Schedules , Guideline Adherence/trends , Heart Failure/therapy , Patient Discharge/trends , Practice Guidelines as Topic , Practice Patterns, Physicians'/trends , Transitional Care/trends , Aged , Aged, 80 and over , Catchment Area, Health , Chi-Square Distribution , Female , Healthcare Disparities/trends , Heart Failure/diagnosis , Humans , Male , Medicare , Middle Aged , Multivariate Analysis , Odds Ratio , Quality Indicators, Health Care/trends , Registries , Residence Characteristics , Time Factors , United States
20.
JACC Heart Fail ; 3(11): 906-16, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26454848

ABSTRACT

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.


Subject(s)
Cardiomyopathies/complications , Cardiomyopathies/therapy , Heart Failure/etiology , Heart Failure/therapy , Inpatients , Myocardial Ischemia/etiology , Myocardial Ischemia/therapy , Aged , Aged, 80 and over , Cardiomyopathies/diagnosis , Cardiomyopathies/etiology , Cardiomyopathies/mortality , Female , Heart Failure/diagnosis , Heart Failure/mortality , Heart Transplantation/mortality , Heart Transplantation/statistics & numerical data , Humans , Male , Middle Aged , Myocardial Ischemia/diagnosis , Myocardial Ischemia/mortality , Prevalence , Prospective Studies , Risk Assessment , Risk Factors , Survival Analysis , Treatment Outcome , United States/epidemiology
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