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ZOLL LifeVest Wearable Defibrillator

ZOLL Medical Corporation, a manufacturer of resuscitation devices and related software solutions, announced that the ZOLL LifeVest® Wearable Defibrillator is now covered by Medical Assistance (MA), Minnesota's Medicaid program. The WCD (LifeVest®, ZOLL, Pittsburgh, PA) was FDA-approved in 2001 as an outpatient device after a clinical trial involving 285 out-of-hospital patients 16 WCDs are intended for use in adult patients that have an increased risk of SCD if an ICD is not warranted.
The only randomised controlled trial investigating its use to date is the VEST trial 6 It failed to show a significant reduction LifeVest Wearable Defibrillator in arrhythmic death in patients with severely reduced EF during the early post-myocardial infarction phase with use of the WCD.

Four adverse events were potentially related to the wearable cardioverter-defibrillator (Table S13 in the Supplementary Appendix ). Three were hospitalizations (two for aborted shocks and one for an inappropriate shock), and one was a death while the participant was wearing the device, which was deemed likely to not be an arrhythmic death (no tachyarrhythmia was recorded by the device and emergency medical technicians noted pulseless electrical activity on arrival).
Dr. Werner Jung, Schwarzwald-Baar Kliniken, Villingen Schwenningen, Germany, and PD Dr. Christian Veltmann, Medizinische Hochschule, Hannover, Germany, will present a symposium entitled New Onset Heart Failure Patients are Different: A Strategy for Managing SCD Risk During Medical Optimization,” Monday, 1 September, 1:00-1:45 p.m., Reykjavik, Village 6, Session #3783.

The Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST) study was negative for the reduction of sudden cardiac death (SCD) in the postmyocardial-infarction waiting” period, but was likely underpowered and had a protracted enrollment period, during which time, the enrollment target was reduced.
When focusing only on studies that involved patients with ischaemic cardiomyopathy, they found the incidence of appropriate WCD therapy to be much lower in the VEST trial at only 1 per 100 people over 3 months (95% CI: 1.0 to 2.0) than in the observational studies, which had an incidence of 11 per 100 people over 3 months (95% CI: 11.0 to 20.0; I2=93%).

The FDA believes that the new, more prominent and persistent patient alert for Message Code 102” will help increase awareness of the potential hazard and increase the likelihood of a patient contacting Zoll immediately for a replacement device after the alert appears on the device screen.
47. Future Research Needs  Most promising study is VEST trial  Study of the Wearable Defibrillator in Heart-Failure Patients (SWIFT) is an observational study to evaluate rates of defibrillation in 4 important subgroups: advanced heart failure, LVEF ≤0.35 with revascularization or heart failure diagnosis within 90 days, Killip class III to IV AMI, and those awaiting ICD reimplantation.

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