可穿戴式除颤器中国多中心临床观察性研究

Wearable cardioveter-defibrillator in China:from multicenter experience

目的分析中国人应用可穿戴式除颤器(WCD)的临床特点和随访资料,了解WCD在中国应用的初步情况。方法本研究为多中心临床观察性研究,国内共5家医学中心参与该研究。入选2018年6月至2019年10月接受WCD并完成随访的患者共54例。收集患者的基线资料,随访穿戴依从性、反馈的问题、除颤治疗效果等。结果接受WCD治疗的患者男47例(87.0%),年龄(55.2±17.6)岁。其中冠心病患者31例(57.4%),持续室性心动过速(室速)/心室颤动(室颤)发作患者19例(35.2%)。使用WCD的主要适应证为急性心肌梗死早期(40 d内)伴左心室射血分数≤35%18例(35.2%),其次为等待心脏移植且具有心脏性猝死(SCD)发生风险患者9例(16.7%)。患者平均穿戴天数为(51±34)d,最长145 d。18例患者随访3个月期间内坚持穿戴超过1个月。穿戴过程中感觉不适主要为除颤背心影响睡眠和无故报警。1例患者随访过程中监测到13次室颤发生,均予1次除颤治疗成功转复。无1例患者发生误放电。6例患者植入了植入型心律转复除颤器(ICD)结论WCD的中国临床观察性研究较为系统地介绍了中国人应用WCD的临床特点和使用情况,为进一步改善患者SCD的预防、加强公众对WCD的认识提供了经验。

Objective The purpose of this study was to know the clinical characteristics and preliminary application of wearable cardioverter-defibrillator(WCD)in China.Methods This multicenter,observational study was performed by five medical centers from China.A total of 54 consecutive patients received WCD from June 2018 to October 2019 were analyzed.Clinical features,WCD compliance,feedbacks and treatment effects were collected from all patients.Results The mean age of WCD patients was at(55.2±17.6)years with 87.0%male.There were 31(57.4%)patients with coronary artery disease,19(35.2%)with sustained ventricular tachycardia/ventricular fibrillation.The major prescription indications was the acute myocardial infarction with left ventricular ejection fraction≤35%within 40 days(35.2%),following the high risk of sudden cardiac death(SCD)during pre-cardiac transplantation(16.7%).The mean wear time was(51±34)days,and the maximum time was 145 days while the minimum was only one day.Only 18 patients continuously wear WCD over 1 month during three-month follow-up.Two major feedbacks were insomnia and device alarming without causes.Only one patient was recorded ventricular fibrillation for 13 times and successfully cardioverted by WCD.Six patients received implantable cardioverter defibrillation Conclusion This multicenter experience from China WCD observational study initially demonstrates the clinical characteristics and preliminary application in patients with WCD,which further contributes to improving SCD prevention and enhancing the public awareness of WCD.