97% One-Year Survival for Patients at High Risk of Sudden Cardiac Death Prescribed the ZOLL LifeVest Wearable Defibrillator

New results from the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry) were presented today by Valentina Kutyifa, MD, PhD, University of Rochester Medical Center, during the Late-Breaking Clinical Trials session at CARDIOSTIM/EUROPACE 2016.

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%.1 Notably, one-year survival for patients who experienced VT/VF during use of the LifeVest was also high at 92%.1 There was no difference in survival between patients with ischemic or non-ischemic cardiomyopathy.1

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% of patients had a VT/VF event.2 One in 14 patients experienced a clinically meaningful arrhythmia requiring intervention while wearing the LifeVest.2

“These national study results demonstrate excellent one-year survival for patients prescribed with the LifeVest Wearable Defibrillator after an acute cardiac event like a heart attack or decompensation due to heart failure,” said Jason T. Whiting, President of ZOLL LifeVest. “These data are made even more powerful by the fact that patients in the study used the LifeVest for a median of 90 days and only 40% received an implantable defibrillator following LifeVest use, still survival was high even approximately nine months after ending use of the LifeVest. These new data clearly serve to further strengthen the clinical evidence supporting the guidelines and recommendations published within the last year for wearable defibrillator use.”

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.

On any given day, tens of thousands of people around the world are protected from sudden cardiac death (SCD) by the LifeVest Wearable Defibrillator. The LifeVest is used for a wide 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 and easy to wear, allowing patients to return to their common activities of daily living, while having the peace of mind that they are protected from SCD. The LifeVest 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.

About ZOLL Medical Corporation
ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com.

About Asahi Kasei
The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.

1Kutyifa V, et al. One-Year Follow-Up of the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II Registry), presented as Late-Breaking Clinical Trial at CARDIOSTIM/EUROPACE 2016, June 10, 2016.
2Kutyifa V, et al. Use of the Wearable Cardioverter Defibrillator in High-Risk Cardiac Patients: Data from the Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator (WEARIT-II Registry). Circulation. 2015;132(17):1613-1619.

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Diane Egan, +1-978-421-9637