Study of Zoll’s wearable defibrillator misses primary endpoint
The first randomized, controlled trial evaluating Zoll Medical‘s wearable cardioverter defibrillator, LifeVest, missed its primary endpoint of sudden death mortality.
The study did show that the device reduced total mortality by 36% in the 90 days following a heart attack for patients with reduced heart function, according to Zoll.
The trial enrolled 2,302 patients who had recently suffered a heart attack and randomized them to receive the LifeVest WCD and guideline directed medical therapy or just guideline directed medical therapy for 90 days.
The rate of sudden death at 90 days was 1.6% among patients treated with Zoll’s LifeVest WCD, compared to 2.4% of patients in the control group. The rate of all-cause death was 3.2% in the defibrillator group versus 4.9% in the control group. The system was associated with a relative risk reduction of 35.5% and an absolutely risk reduction of 1.7% compared to just medical therapy.
“While the Vest Trial did not meet the endpoint of sudden death mortality, the ability to determine the cause of death as sudden when unwitnessed is difficult and could result in misclassification. These meaningful total mortality results add large randomized controlled trial data to an already large body of clinical evidence in support of the 2017 AHA/ACC/HRS Guideline recommendations for WCD use in patients at risk of sudden cardiac death,” co-principal investigator and professor of cardiology at the University of California San Francisco, Dr. Jeffrey Olgin, said in prepared remarks.
“The results of the Vest Trial show that, in addition to the current best practices in medicine which includes GDMT, use of the LifeVest WCD can further reduce mortality in patients with a low EF,” Dr. Kent Volosin, Zoll’s VP of medical & clinical affairs, said. “The totality of clinical evidence supporting use of the WCD, along with AHA/ACC/HRS Guideline recommendations, underscore the need to evaluate all patients for sudden cardiac death risk and discuss WCD therapy with patients and their families through a shared decision-making approach.”
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