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Wearable Defibrillator for Sudden Cardiac Arrest Risk
Quick Takes
- P-WCD, an adhesive-based wearable defibrillator, successfully met the prespecified primary and secondary endpoints for safety and effectiveness with no deaths due to noncompliance.
- These data suggest that the P-WCD may be a viable alternative for patients indicated for WCD therapy.
- Additional prospective studies to validate these data would be helpful.
Study Questions:
What is the safety and clinical effectiveness of a novel patch–wearable cardioverter-defibrillator (P-WCD)?
Methods:
The investigators conducted the Jewel IDE study (A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest), a prospective, single-arm study conducted at 30 US sites. The study enrolled patients at risk of sudden cardiac arrest (SCA) due to ventricular tachycardia/fibrillation (VT/VF) who were not candidates for or refused an implantable defibrillator. The primary safety endpoint was <5% of patients with clinically significant cutaneous adverse device effects (ADEs) and the primary effectiveness endpoint was <2 inappropriate shocks/100 patient-months. Secondary endpoints were ≥1 successful VT/VF conversion and wear time compliance of >14.1 hours/day.
Results:
A total of 305 patients (mean age 57.9 years; 30.2% female, 27.9% non-white) were enrolled, of which 290 had available device data. The clinically significant cutaneous ADE rate was 2.30% (upper one-sided 98% confidence interval [CI], 4.80); none were severe. No device-related deaths or serious adverse events were reported. The inappropriate shock rate was 0.36/100 patient-months (upper 98% CI, 1.53). Of 11 shocks in nine patients, nine shocks were adjudicated to be appropriate. Eight of nine shocks were successful with a single shock. Median wear time compliance was 23.5 (20.7, 23.9) hours/day.
Conclusions:
The authors report that the novel P-WCD is a safe and effective WCD with high patient compliance.
Perspective:
This study reports that a novel P-WCD, an adhesive-based wearable defibrillator, successfully met the prespecified primary and secondary endpoints for safety and effectiveness with no deaths due to noncompliance. The Jewel is a novel, water-resistant P-WCD designed to enhance compliance by reducing maintenance and allowing use during most activities, including showering, sleeping, and moderate exercise. These data suggest that the P-WCD may be a viable alternative for patients indicated for WCD therapy. Additional prospective studies to validate these data would be helpful.
Clinical Topics: Arrhythmias and Clinical EP, SCD/Ventricular Arrhythmias
Keywords: Death, Sudden, Cardiac, Wearable Electronic Devices
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