Randomized Control Trial of ZOLL LifeVest Use for Patients with a Reduced Heart Function Following a Heart Attack: Results Coming March 2018
ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today that findings from the “Vest Prevention of Early Sudden Death Trial” (VEST Trial) on use of the ZOLL LifeVest® wearable cardioverter defibrillator (WCD) will be presented as a Late-Breaking Clinical Trial at the American College of Cardiology’s 67th Annual Scientific Session on Saturday, March 10, 2018 in Orlando, Florida. Results will be presented by Jeffrey E. Olgin, MD, FACC, co-principal investigator, Professor and Chief of Cardiology, University of California San Francisco Heart and Vascular Center.
The VEST Trial studied the use of the LifeVest WCD for patients who had recently suffered a heart attack (clinically known as a myocardial infarction or “MI”) and had a reduced heart function (defined as a low-ejection fraction or “EF” of 35 percent or less). The trial enrolled 2,300 low-EF, post-MI patients, with or without revascularization (such as a stent placement or bypass procedure), age 18 or older across more than 100 trial sites in four countries. Patients were randomized to receive the LifeVest WCD with medications or medications alone for 90 days to determine the potential mortality benefit of the LifeVest WCD.
The VEST Trial results will be presented and discussed during the following sessions:
The LifeVest WCD is prescribed for patients at risk of sudden cardiac death (SCD), including patients with a low-EF who have recently suffered a heart attack or have a new diagnosis of heart failure. Ejection fraction, a measure of the heart’s pumping ability, is the most powerful predictor of long-term mortality.1 Numerous clinical studies demonstrate the risk of mortality in low-EF patients is highest in the first 90 days for following a cardiac event, such as a heart attack or a new diagnosis of heart failure, including high mortality from SCD.1,2,3,4,5,6
The LifeVest WCD 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. LifeVest gives physicians time to optimize medical therapy and assess a patient’s long-term risk for sudden death. LifeVest allows patients to return to their common activities of daily living, while having the peace of mind they are protected from SCD.
The 2017 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death includes recommended use of the WCD for a wide range of patients at risk of SCD, including those who have a low-EF following a heart attack or a new diagnosis of heart failure.
LifeVest will be showcased in Booth 1801 in the West Concourse, along with additional products from ZOLL including the ZOLL R Series® Monitor Defibrillator, AutoPulse® Resuscitation System, and the Hospital Wearable Defibrillator.
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/.
1Halkin A et al. Prediction of mortality after primary
percutaneous coronary intervention for acute myocardial infarction:
CADILLAC risk score. J Am Coll Cardiol. 2005;45:1397–1405.
2Solomon
SD et al. Sudden death in patients with myocardial infarction and left
ventricular dysfunction, heart failure, or both. NEJM. 2005;352:2581–2588.
3Adabag
AS et al. Sudden death after myocardial infarction. JAMA. 2008;300(17):2022–2029.
4Zishiri
ET et al. Early risk of mortality after coronary artery
revascularization in patients with left ventricular dysfunction and
potential role of the wearable cardioverter defibrillator. Circ
Arrhythm Electrophysiol. 2013;6:117–128.
5Weintraub
W et al. Prediction of long-term mortality after percutaneous coronary
intervention in older adults: Results from the National Cardiovascular
Data Registry. Circulation. 2012;125:1501–1510.
6Packer
M et al. The effect of carvedilol on morbidity and mortality in patients
with chronic heart failure. NEJM. 1996;334(21):1349–1355.
7Kutyifa
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.
Copyright © 2018 ZOLL Medical Corporation. All rights reserved. LifeVest and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180301005914/en/
ZOLL Medical Corporation
Diane Egan, +1 978-421-9637
degan@zoll.com
