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]; )

中文翻译：

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适用于有心脏骤停风险的患者的贴片可穿戴心脏复律除颤器


对于许多患者来说，心脏骤停 (SCA) 的风险暂时升高。可穿戴式心律转复除颤器 (WCD) 可以在这些临时时期监测和治疗 SCA。传统的 WCD 可能会不舒服，需要频繁维护，并且不能在淋浴时使用，导致依从性差并导致 SCA 死亡。 Jewel 是一款新型防水贴片可穿戴心脏复律除颤器 (P-WCD)，具有机器学习检测算法，旨在提高依从性和针对 SCA 的防护。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，纳入了因室性心动过速/心室颤动而存在 SCA 风险的患者，这些患者不适合或拒绝植入式除颤器。主要安全终点为<15 id=0>14.1 小时/天。共有 305 名患者（平均年龄：57.9 岁；30.2% 为女性，27.9% 非白人）参与研究，其中 290 名患者拥有可用的设备数据。具有临床意义的皮肤装置不良反应率为 2.30%（上 1 侧 98% CI：4.80）；没有一个是严重的。没有报告与设备相关的死亡或严重不良事件。不适当的休克率为 0.36/100 患者月（上 1 侧 98% CI：1.53）。在对 9 名患者进行的 11 次电击中，有 9 次被判定为适当电击。 9 次电击中有 8 次通过一次电击成功。中位佩戴时间合规性为 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。没有因不依从而导致死亡，并且有大量成功转换（Jewel IDE 研究 [A Clinical Prediction of the Jewel P-WCD in High Risk for Cardiac Arrest]；）