LifeVest Clinical Outcomes SCD-PROTECT

Sudden cardiac death in newly diagnosed non-ischaemic or ischaemic cardiomyopathy assessed with a wearable cardioverter-defibrillator: the German nationwide SCD-PROTECT study

David Duncker¹, Eloi Marijon^2,3, Marco Metra⁴, Oliver Piot⁵, Marat Fudim^6,7, Uwe Siebert^8,9,10, Norbert Frey¹¹, Lars Siegfried Maier¹², and Johann Bauersachs¹

Objectives

The SCD-PROTECT study was an analysis of >19,500 consecutive patients in Germany with non-ischemic cardiomyopathy (NICM) or myocardial infarction/coronary artery disease (MI/CAD) and reduced left ventricular ejection fraction (LVEF), using a LifeVest® wearable cardioverter defibrillator (WCD) to evaluate the current SCA/SCD risk in this early phase.
Primary outcome was SCA/SCD incidence, measured by appropriate treatments delivered and automatically recorded by the LifeVest WCD.

Methods

Epidemiological, observational, multicenter study
Nationwide analysis of all patients between December 2021 and May 2023 who wore a LifeVest WCD
Consecutive cohort of 19,598 patients
The outcome is presented as cumulative incidence per 100 patient-years, respectively

Chart showing medical therapy rates at discharge

Patient Characteristics and Indications

WCD start was associated with high utilization of contemporary GDMT at hospital discharge in both NICM and MI/CAD (see table).
Patients: n=19,598
- Male: 79.3% (n=15,545)
- Female: 20.7% (n=4,053)
Age:
- NICM: 58.6 (+/- 13.7)
- MI/CAD: 64.2 (+/- 10.6)
Indications:
- NICM: n=11,449
- MI/CAD: n=8,149
LVEF at Baseline:
- NICM: 26.9%
- MI/CAD: 28.4%

Cumulative SCA/SCD incidence per 100 patient-years graph

Clinical Results

Despite wide overall use of GDMT in both NICM and MI/CAD, incidence of appropriate LifeVest treatments was high.
Cumulative incidence of SCA/SCD in 100 patient-years:
- 6.10 in NICM
- 8.64 in MI/CAD
Median LifeVest Wear Time® per day was 23.4 and 23.5 hours in NICM and MI/CAD patients, respectively.
Inappropriate treatments were rare with an overall rate of 0.5%.
Mean LVEF at baseline was 26.9 (+/- 10.3) for NICM and 28.4 (+/- 8.0) for MI patients and improved to above 35% in both groups (38.9% (+/- 10.8) and 38.3% (+/- 9.9)).

“There is a high risk of SCA or SCD within the first month after diagnosis of reduced LVEF, despite the fact that there was broad use of the fantastic four.”

-Johann Bauersachs, SCD-PROTECT investigator, discusses results with Radcliffe Cardiology

Conclusions

The German nationwide SCD-PROTECT study is the largest WCD study to date.
Despite wide utilization of GDMT, the risk of SCA/SCD is high during the early medical therapy optimization for reduced LVEF in patients with NICM and MI/CAD patient groups.
The incidence of SCA/SCD per 100 patient-years was considerably higher than seen in ICD trials in chronic HFrEF patients.
The majority of patients' LVEF improved beyond 35%.

READ THE FULL PUBLICATION

Source: David Duncker, Eloi Marijon, Marco Metra, Olivier Piot, Marat Fudim, Uwe Siebert, Norbert Frey, Lars Siegfried Maier, Johann Bauersachs, 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, 2025;, ehaf668, https://doi.org/10.1093/eurheartj/ehaf668

¹Hannover Heart Rhythm Center, Department of Cardiology and Angiology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
²Division of Cardiology, European Georges Pompidou Hospital, Paris, France
³Université Paris Cité, PARCC, INSERM U970, Paris, France
4 Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy
5 Department of Cardiology 2, Centre Cardiologique du Nord, Saint-Denis, France
⁶Cardiology, Duke University, Durham, NC, USA
⁷Duke Clinical Research Institute, Durham, NC, USA
⁸UMIT TIROL—University for Health Sciences and Technology, Department of Public Health, Health Services Research and Health Technology Assessment, Hall in Tirol, Austria
⁹Center for Health Decision Science, Departments of Epidemiology and Health Policy & Management, Harvard T.H. Chan School of Public Health, Boston, MA, USA
¹⁰Program on Cardiovascular Research, Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
¹¹Department of Cardiology, Angiology, Pneumology, University Hospital Heidelberg, Heidelberg, Germany
¹² Internal Medicine II, University Hospital Regensburg, Regensburg, Germany

Clinical Outcomes: SCD-PROTECT