Duncker, David and Marijon, Eloi and Metra, Marco and Piot, Olivier and Fudim, Marat and Siebert, Uwe and Frey, Norbert and Maier, Lars Siegfried and Bauersachs, Johann (2025) Sudden cardiac death in newly diagnosed non-ischaemic or ischaemic cardiomyopathy assessed with a wearable cardioverter-defibrillator: the German nationwide SCD-PROTECT study. EUROPEAN HEART JOURNAL, 46 (43). pp. 4597-4606. ISSN 0195-668X, 1522-9645
Full text not available from this repository. (Request a copy)Abstract
Background and Aims Patients with newly diagnosed non-ischaemic cardiomyopathy (NICM) or myocardial infarction/coronary artery disease (MI/CAD) face an increased risk of sudden cardiac death (SCD) during the early phase of guideline-recommended medical therapy initiation and up-titration. Aim is to evaluate the risk in this population by assessing sudden cardiac arrest (SCA) due to ventricular tachycardia/ventricular fibrillation (VT/VF). Methods All patients in Germany who received a wearable cardioverter-defibrillator (WCD) between December 2021 and May 2023 were enrolled in the observational multicentre SCD-PROTECT study (NCT06883383). The primary outcome was the incidence of SCA due to sustained VT/VF, measured by appropriate WCD-delivered treatments, and reported as events per 100 patient-years with 95% confidence intervals (CI). Secondary outcomes included inappropriate WCD treatments, all-cause mortality, adverse events, adherence to WCD use, and heart failure medication patterns. Results In this cohort of 19 598 patients, the mean age (+/- standard deviation) was 58.6 +/- 13.7 years for those with NICM and 64.2 +/- 10.6 years for patients with MI/CAD. Female patients accounted for 23.8% of the NICM and 16.3% of the MI/CAD group. Left ventricular ejection fraction (LVEF) at study start was 26.9 +/- 10.3% for NICM and 28.4 +/- 8.0% for MI/CAD patients. The incidence rate of first appropriate treatment by WCD in NICM patients and MI/CAD patients was 6.10 (95% CI 5.31-7.00) and 8.64 (95% CI 7.41-10.05) events per 100 patient-years, respectively. Overall incidence density for all appropriate treatments was 8.53 (95% CI 7.36-9.88) and 14.98 (95% CI 12.69-17.65) per 100 patient-years in the respective groups. Improvement in LVEF to >35% was observed in 53.5% of NICM patients and 51.7% of MI/CAD patients over a mean of 65.9 +/- 43.8 days. 36.2% of patients were implanted with a cardioverter-defibrillator at the end of WCD use. Total mortality was 0.8%. Inappropriate shocks occurred in 0.5% of patients. Conclusions The SCD-PROTECT study highlights a substantial risk of SCA due to VT/VF during the early phase of guideline-recommended medical therapy optimization in patients with newly diagnosed reduced LVEF, regardless of ischaemic or non-ischaemic origin. The WCD provided SCD protection, the LVEF could improve to >35% in the majority of these patients and can therefore serve as risk stratification across both aetiologies. [GRAPHICS]
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | MYOCARDIAL-INFARCTION; RISK; TECHNOLOGY; Sudden cardiac arrest; NICM; Myocardial infarction; Coronary artery disease; Incidence; Dilated cardiomyopathy |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Apr 2026 05:34 |
| Last Modified: | 01 Apr 2026 05:34 |
| URI: | https://pred.uni-regensburg.de/id/eprint/67783 |
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