University of Washington, Seattle, Washington, USA.
Washington University in St. Louis, St. Louis, Missouri, USA.
J Cardiovasc Electrophysiol. 2022 May;33(5):831-842. doi: 10.1111/jce.15417. Epub 2022 Feb 28.
A wearable cardioverter defibrillator (WCD) is indicated in appropriate patients to reduce the risk for sudden cardiac death. Challenges for patients wearing a WCD have been frequent false shock alarms primarily due to electrocardiogram noise and wear discomfort. The objective of this study was to test a contemporary WCD designed for reduced false shock alarms and improved comfort.
One hundred and thirty patients with left ventricular ejection fraction ≤40% and an active implantable cardioverter defibrillator (ICD) were fitted with the ASSURE WCD (Kestra Medical Technologies) and followed for 30 days. WCD detection was enabled and shock alarm markers recorded, but shocks and shock alarms were disabled. All WCD episodes and ICD ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were adjudicated. The primary endpoint was the false-positive shock alarm rate with a performance goal of 1 every 3.4 days (0.29 per patient-day).
Of 163 WCD episodes, 4 were VT/VF and 159 non-VT/VF (121 rhythms with noise, 32 uncertain with noise, 6 atrial flutter without noise). Only three false-positive shock alarm markers were recorded; one false-positive shock alarm every 1333 patient-days (0.00075 per patient-day, 95% confidence interval: 0.00015-0.00361; p < .001). No ICD recorded VT/VF episodes meeting WCD detection criteria (≥170 bpm for ≥20 s) were missed by the WCD during 3501 patient-days of use. Median wear was 31.0 days (interquartile range [IQR] 2.0) and median daily use 23.0 h (IQR 1.7). Adverse events were mostly mild: skin irritation (19.4%) and musculoskeletal discomfort (8.5%).
The ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.
可穿戴式除颤器 (WCD) 适用于特定患者，可降低心源性猝死的风险。佩戴 WCD 的患者面临的挑战是频繁出现虚假电击警报，主要是由于心电图噪声和佩戴不适。本研究的目的是测试一种新设计的 WCD，旨在减少误报和提高舒适度。
130 名左心室射血分数≤40%且有活动植入式心脏复律除颤器 (ICD) 的患者配备 ASSURE WCD（Kestra Medical Technologies）并随访 30 天。启用 WCD 检测并记录电击警报标记，但禁用电击和电击警报。所有 WCD 事件和 ICD 室性心动过速/心室颤动 (VT/VF) 事件均进行裁决。主要终点是每 3.4 天出现 1 次假阳性电击警报率（0.29 次/患者天）。
163 次 WCD 事件中，4 次为 VT/VF，159 次为非 VT/VF（121 次为噪声节律，32 次为噪声不确定节律，6 次为无噪声心房扑动）。仅记录到 3 个假阳性电击警报标记；每 1333 个患者天出现 1 次假阳性电击警报（0.00075 次/患者天，95%置信区间：0.00015-0.00361；p<.001）。在 3501 个患者天的使用期间，WCD 未错过 ICD 记录的满足 WCD 检测标准（≥170 bpm 持续≥20 s）的 VT/VF 事件。中位佩戴时间为 31.0 天（四分位距 [IQR] 2.0），中位每日使用时间为 23.0 h（IQR 1.7）。不良事件主要为轻度：皮肤刺激（19.4%）和肌肉骨骼不适（8.5%）。
ASSURE WCD 显示出较低的假阳性电击警报率、较低的患者报告不适和无严重不良事件。
