SCD-PROTECTLifeVest® Wearable Defibrillator Monitoring for Sudden Cardiac Arrest in Cardiomyopathy and Coronary Artery Disease

This study, SCD-PROTECT, focuses on understanding the risk of sudden cardiac arrest (SCA) or sudden cardiac death (SCD) in individuals with a newly diagnosed heart condition. Specifically, it looks at those with non-ischemic cardiomyopathy (NICM) or myocardial infarction/coronary artery disease (MI/CAD). These patients often have a reduced heart pumping efficiency and may be at a higher risk for SCA/SCD, especially in the early stages of their treatment. To manage this risk, a wearable cardioverter defibrillator (WCD), like the LifeVest®, can be used. This device monitors the heart's rhythm, detects life-threatening irregular heartbeats, and can deliver an automatic shock to restore a normal rhythm. The study aims to gather more detailed data on the risk of SCA/SCD in these patients during the early phase of their disease, as current information is limited. The SCD-PROTECT study involves analyzing data from at least 18,000 patients in Germany who used a WCD between December 2021 and May 2023. The observation period starts with the first heart rhythm recording by the WCD and ends when the patient stops using the device. The main goal is to measure the incidence of SCA/SCD by counting the percentage of patients who received at least one appropriate shock from the WCD. The study also calculates the incidence density of appropriate shocks per 100 patient years. Secondary objectives include assessing inappropriate WCD treatments, mortality, and side effects during WCD use. Exploratory objectives involve studying the change in heart pumping efficiency, compliance with WCD use, time to the first appropriate shock, and incidence of appropriate shocks by the specific type of NICM or MI/CAD.