Zoll Medical has announced that results from the largest German registry of patients who were prescribed the company’s LifeVest wearable defibrillator reaffirm that the device is safe and effective for the prevention of sudden cardiac death. Results have been published in the Circulation.
In the study, investigators evaluated the use of the device in more than 6,000 patients from 404 clinical centres across all 16 German states—representing the largest LifeVest patient registry in Europe. They demonstrated that risk for sudden cardiac death was high in the early period following an acute cardiac event. Seventy per cent of treated patients received therapy in the first 40 days and 89% in the first 90 days of LifeVest use. Treated patients demonstrated a 93% event survival. Additionally, overall survival among all patients prescribed the LifeVest was 99.9% at the end of LifeVest use.
Ruth Strasser, University of Dresden, Germany, comments: “This study clearly demonstrates that the wearable defibrillator is reliable and can save lives in patients at high risk for sudden death. It also reinforces the clinical advantage across a variety of indicators and strongly suggests that guideline recommendations should be expanded.”
According to a press release, the wearable defibrillator was included in the 2015 European Society of Cardiology Guidelines for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death and has received formal recommendations in the 2016 American Heart Association Science Advisory for the Wearable Cardioverter Defibrillator, with endorsement from the Heart Rhythm Society.