Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.
Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.
Heart Rhythm. 2023 Jul;20(7):970-975. doi: 10.1016/j.hrthm.2023.03.1604. Epub 2023 May 19.
The LifeVest® wearable cardioverter-defibrillator (WCD) prevents sudden cardiac death in at-risk patients who are not candidates for an implantable defibrillator. The safety and efficacy of the WCD may be impacted by inappropriate shocks (IAS).
The purpose of this study was to assess the causes and clinical consequences of WCD IAS in survivors of IAS events.
The Food and Drug Administration's Manufacturers and User Facility Device Experience database was searched for IAS adverse events (AE) that were reported during 2021 and 2022.
A total of 2568 IAS-AE were found (average number of IAS per event: 1.5 ± 1.9; range 1-48). IAS were caused by tachycardias (1255 [48.9%]), motion artifacts (840 [32.7%]), and oversensing (OS) of low-level electrical signals (473 [18.4%]) (P <.001). Tachycardias included atrial fibrillation (AF) (828 [32.2%]), supraventricular tachycardia (SVT) (333 [13.0%]), and nonsustained ventricular tachycardia/fibrillation (NSVT/VF) (87 [3.4%]). Activities responsible for motion-induced IAS included riding a motorcycle, lawnmower, or tractor (n = 128). In 19 patients, IAS induced sustained ventricular tachycardia or ventricular fibrillation that subsequently were terminated by appropriate WCD shocks. Thirty patients fell and suffered physical injuries. Conscious patients (n = 1905) did not use the response buttons to abort shocks (47.9%) or used them improperly (20.2%). IAS resulted in 1190 emergency room visits or hospitalizations, and 17.3% of patients (421/2440) discontinued the WCD after experiencing IAS, especially multiple IAS.
The LifeVest WCD may deliver IAS caused by AF, SVT, NSVT/VF, motion artifacts, and oversensing of electrical signals. These shocks may be arrhythmogenic, result in injuries, precipitate WCD discontinuation, and consume medical resources. Improved WCD sensing, rhythm discrimination, and methods to abort IAS are needed.
LifeVest®可穿戴除颤器（WCD）可预防不适合植入式除颤器的高危患者发生心源性猝死。WCD 的安全性和有效性可能会受到不适当电击（IAS）的影响。
本研究旨在评估 IAS 事件幸存者中 WCD IAS 的原因和临床后果。
检索美国食品和药物管理局的制造商和用户设施设备经验数据库，以查找 2021 年和 2022 年报告的 IAS 不良事件（AE）。
共发现 2568 例 IAS-AE（平均每个事件的 IAS 数为 1.5±1.9；范围 1-48）。IAS 是由心动过速（1255 例[48.9%]）、运动伪影（840 例[32.7%]）和低水平电信号的过感知（OS）（473 例[18.4%]）引起的（P<.001）。心动过速包括心房颤动（AF）（828 例[32.2%]）、室上性心动过速（SVT）（333 例[13.0%]）和非持续性室性心动过速/颤动（NSVT/VF）（87 例[3.4%]）。导致运动引起的 IAS 的活动包括骑摩托车、割草机或拖拉机（n=128）。在 19 名患者中，IAS 引发了持续的室性心动过速或心室颤动，随后被适当的 WCD 电击终止。30 名患者摔倒并受伤。有意识的患者（n=1905）未使用响应按钮中断电击（47.9%）或使用不当（20.2%）。IAS 导致 1190 次急诊就诊或住院治疗，17.3%的患者（421/2440）在经历 IAS 后停止使用 WCD，尤其是多次 IAS。
LifeVest WCD 可能会引发由 AF、SVT、NSVT/VF、运动伪影和电信号过感知引起的 IAS。这些电击可能具有致心律失常性，导致受伤，促使 WCD 停用，并消耗医疗资源。需要改进 WCD 感知、节律识别和中止 IAS 的方法。
