https://doi.org/10.55788/0d23d7ad
“Patients who actually wear their wearable cardioverter defibrillator have a survival benefit,” stated Dr John Hummel (Ohio State University, OH, USA) [1]. Thus, a wearable with a high adherence rate may be a fruitful solution for patients at risk for sudden cardiac death. The multicentre, prospective, single-arm Jewel IDE study (NCT05201495) evaluated the safety and efficacy of JEWEL in 290 participants 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 participants with clinically significant cutaneous adverse device effects. Dr Hummel presented the key results.
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 adverse device effect 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.
“The key statistic of this trial is the median wear time of 23.5 hours,” expressed Dr Gregory Marcus (University of California San Francisco, CA, USA). He further raised some considerations: “Would some of the observed ventricular tachyarrhythmias have spontaneously terminated? And do we need randomised trials for specific populations to prove superiority in mortality?”
- Hummel JD, et al. Safety and efficacy of the JEWEL, a novel patch wearable cardioverter defibrillator: results from the JEWEL IDE study. FS06, AHA Scientific Sessions 2023, 11–13 November, Philadelphia, USA.
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Table of Contents: AHA 2023
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