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- This single-arm multicenter study assessed the safety and effectiveness of a novel patch-wearable cardioverter-defibrillator designed to improve compliance and enhance protection against sudden cardiac arrest (SCA) among 305 patients at a risk for SCA due to ventricular tachycardia/fibrillation who were unsuitable for or refused an ICD. The results showed low rates of clinically significant cutaneous adverse effects (2.30%) and inappropriate shocks (0.36/100 patient-months). The device demonstrated high patient compliance, with a median wear time of 23.5 hours per day, and achieved successful conversion of ventricular arrhythmias in most patients.
- These findings suggest that the novel patch-wearable cardioverter-defibrillator may offer a safe and effective alternative for protection against SCA in high-risk patients.
abstract
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BACKGROUND
For many patients, sudden cardiac arrest (SCA) risk is elevated temporarily. Wearable cardioverter-defibrillators (WCDs) can monitor and treat SCA during these temporary periods. Traditional WCDs can be uncomfortable, require frequent maintenance, and cannot be used when showering, resulting in poor compliance and avoidable SCA deaths. The Jewel is a novel, water-resistant patch-wearable cardioverter-defibrillator (P-WCD) with a machine learning detection algorithm designed to improve compliance and protection against SCA.
OBJECTIVES
This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD.
METHODS
The Jewel IDE Study, a prospective, single-arm study conducted at 30 U.S. sites, enrolled patients at SCA risk due to ventricular tachycardia/ventricular fibrillation who were not candidates for or refused an implantable defibrillator. The primary safety endpoint was <15% patients with clinically significant cutaneous adverse device effects and the primary effectiveness endpoint was <2 inappropriate shocks/100 patient-months. Secondary endpoints were ≥1 successful ventricular tachycardia/ventricular fibrillation conversion and wear time compliance of >14.1 h/d.
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 adverse device effect rate was 2.30% (upper 1-sided 98% 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 1-sided 98% CI: 1.53). Of 11 shocks in 9 patients, 9 shocks were adjudicated to be appropriate. Eight of 9 shocks were successful with a single shock. Median wear time compliance was 23.5 (20.7-23.9) h/d.
CONCLUSIONS
The novel P-WCD is a safe and effective WCD with high patient compliance. There were no deaths due to noncompliance and a high number of successful conversions (Jewel IDE study [A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest]; NCT05201495).
A wearable cardioverter-defibrillator (WCD) offers a temporary bridge therapy for patients at an increased risk for sudden cardiac arrest (SCA) owing to ventricular arrhythmias but do not meet the criteria for ICDs. Studies such as the Vest Prevention of Early Sudden Death Trial and ASSURE WCD Clinical Evaluation—Detection and Safety Study have shown that the greatest limitation to the effectiveness of traditional garment-based WCDs was patient compliance.
The Jewel — a novel water-resistant patch-WCD (P-WCD) — comprises two main adhesive patches: the upper adhered to the right anterior chest wall and the lower to the left lateral torso. Unlike garment-based WCDs, the P-WCD can be worn continuously for up to a week, including during activities and showering. This study assessed whether this difference improved patient compliance while meeting the safety and effectiveness endpoints.
This was a prospective single-arm study conducted at 30 US cities, enrolling 305 patients at a risk for SCA. Notable findings include a median wear time of 23.5 hours per day and a clinically significant cutaneous adverse device effect rate of only 2.3%, meeting the primary safety endpoint. Of 11 shocks, 9 were deemed appropriate, with an inappropriate shock rate of 0.36 per 100 patient-months, which was well below the primary effectiveness endpoint goal of 2 per 100 patient-months.
The JEWEL IDE study provides evidence that the Jewel P-WCD is a safe and effective viable alternative to garment-based devices owing to its ease of use. One of the most striking findings is the improved wear time as 64% of the arrhythmic deaths in the Vest Prevention of Early Sudden Death Trial occurred in patients who were not wearing the garment WCD. The device delivers multiple escalating shock energies, provides warning prompts to bystanders, and allows patients the ability to defer shocks. Clinicians now appear to have a WCD that may allow improved compliance to protect patients susceptible to SCA.