Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. In Europe, there are about 350 000 out of hospital SCAs per year. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA. The wearable cardioverter defibrillator (WCD) –a novel defibrillation therapy– claims to prevent sudden cardiac deaths that may result from SCA. To date, it is unclear whether the plausible and promising theoretical benefits can be translated into clinically relevant benefits.

Therefore, the project at hand aimed at synthesising the current available evidence regarding the use of the WCD: A systematic review regarding the effectiveness and safety of the WCD was hereby performed. In total, 11 studies were identified: 1 RCT was eligible for the evidence synthesis of the effectiveness of the WCD and further 10 observational studies were additionally included for the evaluation of safety of the device. The scientific evidence from 1 RCT indicates the WCD in combination with guideline-directed medical therapy (GDMT) is not proven to be more effective than GDMT alone based on the endpoint arrhythmic mortality. The studies included in the evaluation of safety of the device suggest that the WCD could be a relatively safe device.

To date, the comparative effectiveness of the WCD was not established. Further research is needed in this context. This document is the German summary of a collaborative assessment due to be published in early 2019.