Journal of the American College of Cardiology (JACC)Wearable Defibrillator for Sudden Cardiac Arrest Risk

Novel Adhesive-Based Wearable Defibrillator Shows Promise in High-Risk Sudden Cardiac Arrest Patients

A recent study evaluates the safety and effectiveness of a new patch-wearable cardioverter-defibrillator (P-WCD) for patients at risk of sudden cardiac arrest. The Jewel IDE study, conducted across 30 US sites, enrolled 305 patients who were not candidates for or refused an implantable defibrillator. The novel P-WCD demonstrated high compliance rates and met prespecified safety and effectiveness endpoints, potentially offering a viable alternative for patients indicated for WCD therapy.

Key Points:

• Study design: Prospective, single-arm study involving 305 patients (mean age 57.9 years; 30.2% female, 27.9% non-white)
• Primary safety endpoint: <5% of patients with clinically significant cutaneous adverse device effects (ADEs)
• Primary effectiveness endpoint: <2 inappropriate shocks/100 patient-months
• Secondary endpoints: ≥1 successful VT/VF conversion and wear time compliance of >14.1 hours/day
• Results:
  • Clinically significant cutaneous ADE rate: 2.30% (upper one-sided 98% CI, 4.80)
  • No severe ADEs, device-related deaths, or serious adverse events reported
  • Inappropriate shock rate: 0.36/100 patient-months (upper 98% CI, 1.53)
  • 11 shocks in nine patients; 9 shocks adjudicated as appropriate
  • 8 out of 9 appropriate shocks were successful with a single shock
  • Median wear time compliance: 23.5 (20.7, 23.9) hours/day
• The Jewel P-WCD is water-resistant, allowing use during showering, sleeping, and moderate exercise
• The device aims to enhance compliance by reducing maintenance requirements
• Additional prospective studies are needed to validate these findings

There were 1,040,308 deaths in North America attributed to cardiovascular diseases in 2023. (AHA)

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