Photo Credit: Omelchenko Andrii
The patch wearable cardioverter defibrillator named ‘JEWEL’ appeared safe and effective in patients with a risk of sudden cardiac arrest.
The patch wearable cardioverter defibrillator named ‘JEWEL’ appeared safe and effective in patients with a risk of sudden cardiac arrest who were indicated for a wearable cardioverter defibrillator. With a high number of patient saves, a low number of inappropriate shocks, no deaths or serious adverse events, and high patient compliance rates, JEWEL met the clinical trial’s endpoints.
The multicentre, prospective, single-arm JEWEL IDE study (NCT05201495) evaluated the safety and efficacy of JEWEL in 290 patients at risk for sudden cardiac arrest with an indication for a wearable cardioverter defibrillator. The primary efficacy endpoint was “fewer than 2 inappropriate shocks per 100 patient months,’ whereas the primary safety endpoint was ‘fewer than 15% of patients with clinically significant cutaneous adverse device effects (ADEs).” John Hummel, MD (Ohio State University), presented the key results at AHA Scientific Sessions 2023.1
The observed inappropriate shock rate was low, at 0.36 per 100 patient-months (upper 98% CI 1.53). Sinus tachycardia and supraventricular tachycardia with underlying left bundle branch block were reported as the causes for inappropriate shocks. Next, the clinically significant ADE rate was 2.30% (upper one-sided 98% CI 4.80), meeting the primary safety endpoint. “Importantly, the median wear time of JEWEL was 23.5 hours, indicating that JEWEL is comfortable enough to wear for most patients,” argued Dr Hummel.
Medical writing support was provided by Robert van den Heuvel.
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