Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. Mostly, ventricular tachycardia (VT) and ventricular fibrillation (VF) are the underlying aetiology of SCA, which is claimed to be successfully treated by a novel therapy, a wearable cardioverter defibrillator (WCD, LifeVest®).

The assessment, performed within the European Network for HTA (EUnetHTA), aimed to provide valid data on clinical effectiveness and safety of the WCD. Furthermore, the project intended to elicit patients views on aspects regarding their cardiac disease and the WCD therapy as well as to identify neglected outcomes.

A synthesis of evidence on the basis of a systematic literature search in Medline via Ovid, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination (CRD) databases was performed. The search was complemented by citation tracking and handsearch.

A face-to-face semi-structured focus group interview was performed with five cardiac disease patients in the scoping phase.

Since no prospective controlled trials were found, no assessment of effectiveness could be performed. With regard to safety, five prospective studies were included, but the quality of the body of evidence was very low. Adverse events (AEs) reported were skin rash/itching (6 percent), false alarms (14 percent), palpitations/lightheadedness/fainting (9 percent) and discontinuation due to comfort/lifestyle issues (16-22 percent). Serious adverse events (SAEs) were inappropriate shocks (0-2 percent) and unsuccessful shocks (0-.7 percent). Frequency of SAEs leading to death was 0-.3 percent.

Patients of the focus group reported that experiencing a sense of security was crucial to them. The WCD therapy was not considered an option for weeks or months, due to expected restrictions in living a ‘normal’ and secure life.

No statement can be made about the device effectiveness – further research is needed. More data and more adequate reporting of AEs and SAEs are needed in order to establish the device safety. In particular, more data is needed for risk stratification of high risk patients in order to further narrow down the wide range of indications for the WCD use.