ZOLL Medical Corp., manufacturer of medical devices and related software, reported that patients experience a high one-year survival rate following use of the LifeVest Wearable Defibrillator. Results form the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry) were presented during a clinical trials session in Europe.
The WEARIT-II prospective registry includes more than 2,000 patients prescribed the LifeVest Wearable Defibrillator with U.S. enrollment completed in 2015. One-year survival following use of the LifeVest across all patients was high at 97 percent.
One-year survival for patients who experienced VT/VF during use of the LifeVest was also high at 92 percent. There was no difference in survival between patients with ischemic or non-ischemic cardiomyopathy, according to the company.
Previously reported results from the WEARIT-II registry demonstrated a high sustained VT/VF event rate, with 22 events per 100 patient-years — 2.1 percent of patients had a VT/VF event. One in 14 patients experienced a clinically meaningful arrhythmia requiring intervention while wearing the LifeVest.
The wearable defibrillator is 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.
The LifeVest is used for a range of patient conditions or situations, including following a myocardial infarction, before or after coronary revascularization, and for those with cardiomyopathy or congestive heart failure that places them at particular risk. The LifeVest gives physicians time to optimize medical therapy and assess a patient’s long-term risk for sudden death.
The LifeVest is lightweight, allowing patients to return to their common activities of daily living, while having peace of mind, according to the company. It continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.
ZOLL Medical Corp. is an Asahi Kasei Group company.