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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 [ABSTRACT FROM AUTHOR]

BackgroundTimely 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 resultsWe 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

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

BackgroundGuidelines 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 resultsWe 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).ConclusionsA 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.

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

BackgroundWhether 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 resultsWe 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

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.

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.

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. This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD. 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. 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. 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) [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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.)