Feldman Arthur M, Klein Helmut, Tchou Patrick, Murali Srinivas, Hall W Jackson, Mancini Donna, Boehmer John, Harvey Mark, Heilman M Stephen, Szymkiewicz Steven J, Moss Arthur J
Department of Medicine, Jefferson Medical College, Philadelphia, Pennsylvania 19107-5083, USA.
Pacing Clin Electrophysiol. 2004 Jan;27(1):4-9. doi: 10.1111/j.1540-8159.2004.00378.x.
The automatic ICD improves survival in patients with a history of sudden cardiac arrest. However, some patients do not meet the guidelines for ICD implantation or are unable to receive an implantable device. This study tested the hypothesis that these patients could benefit from a wearable cardioverter defibrillator. Patients with symptomatic heart failure and an ejection fraction of <0.30 (WEARIT Study) or patients having complications associated with high risk for sudden death after a myocardial infarction or bypass surgery not receiving an ICD for up to 4 months (BIROAD Study) were enrolled into two studies. After a total of 289 patients had been enrolled in the trial (177 in WEARIT and 112 in BIROAD), prespecified safety and effectiveness guidelines had been met. Six (75%) of eight defibrillation attempts were successful. Six inappropriate shock episodes occurred during 901 months of patient use (0.67% unnecessary shocks per month of use). Twelve deaths occurred during the study 6 sudden deaths: 5 not wearing and 1 incorrectly wearing the device). Most patients tolerated the device although 68 patients quit due to comfort issues or adverse reactions. The results of the present study suggest that a wearable defibrillator is beneficial in detecting and effectively treating ventricular tachyarrhythmias in patients at high risk for sudden death who are not clear candidates for an ICD and may be useful as a bridge to transplantation or ICD in some patients.
自动植入式心律转复除颤器（ICD）可提高心脏骤停病史患者的生存率。然而，一些患者不符合ICD植入指南，或无法接受植入式设备。本研究检验了这样一种假设，即这些患者可从可穿戴式心律转复除颤器中获益。有症状性心力衰竭且射血分数<0.30的患者（WEARIT研究），或心肌梗死或搭桥手术后有与猝死高风险相关并发症且长达4个月未接受ICD的患者（BIROAD研究）被纳入两项研究。在该试验共纳入289例患者后（WEARIT研究177例，BIROAD研究112例），预设的安全性和有效性指南得到满足。8次除颤尝试中有6次（75%）成功。在患者使用的901个月期间发生了6次不适当电击事件（每月使用的不必要电击率为0.67%）。研究期间发生了12例死亡（6例猝死：5例未佩戴设备和1例佩戴设备不正确）。尽管有68例患者因舒适度问题或不良反应退出，但大多数患者耐受该设备。本研究结果表明，可穿戴式除颤器对于检测和有效治疗猝死高风险且不适合植入ICD的患者的室性快速心律失常有益，并且在某些患者中可能作为移植或ICD的过渡手段。
