The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Baptist Health Lexington, Lexington, Kentucky, USA.
J Am Coll Cardiol. 2024 Aug 6;84(6):525-536. doi: 10.1016/j.jacc.2024.04.063.
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.
This study aims to demonstrate the safety and clinical effectiveness of a novel P-WCD.
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.
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.
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).
对于许多患者来说，心搏骤停（SCA）风险是暂时升高的。可穿戴式除颤器（WCD）可在这些临时期间监测和治疗 SCA。传统的 WCD 可能会引起不适，需要频繁维护，并且在洗澡时无法使用，从而导致依从性差和可避免的 SCA 死亡。Jewel 是一种新型的防水贴片式除颤器（P-WCD），具有机器学习检测算法，旨在提高依从性并预防 SCA。
本研究旨在证明新型 P-WCD 的安全性和临床有效性。
Jewel IDE 研究是一项在美国 30 个地点进行的前瞻性、单臂研究，招募了因室性心动过速/室颤而处于 SCA 风险中的患者，这些患者不适合或拒绝植入式除颤器。主要安全性终点为<15%的患者出现临床意义重大的皮肤不良设备影响，主要有效性终点为<2 次不适当的电击/100 患者月。次要终点为≥1 次成功的室性心动过速/室颤转换和>14.1 小时/天的佩戴时间依从性。
共纳入 305 例患者（平均年龄：57.9 岁；30.2%为女性，27.9%为非白人），其中 290 例有可用的设备数据。临床意义重大的皮肤不良设备影响发生率为 2.30%（单侧上限 98%CI：4.80）；均不严重。未报告与设备相关的死亡或严重不良事件。不适当的电击率为 0.36/100 患者月（单侧上限 98%CI：1.53）。在 9 例患者的 11 次电击中，9 次电击被判定为适当。9 次电击中的 8 次单次电击成功。中位佩戴时间依从性为 23.5（20.7-23.9）小时/天。
新型 P-WCD 是一种安全有效的 WCD，患者依从性高。由于不依从导致的死亡为零，且成功转换的次数很多（Jewel IDE 研究[NCT05201495]）。
