von Alvensleben Johannes C, Dechert Brynn, Bradley David J, Fish Frank A, Moore Jeremy P, Pilcher Thomas A, Escudero Carolina, Ceresnak Scott R, Kwok Sit Yee, Balaji Seshadri, Aziz Peter F, Papagiannis John, Cortez Daniel, Garnreiter Jason, Kean Adam, Schäfer Michal, Collins Kathryn K
Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado, USA.
Mott Children's Hospital, University of Michigan Medical School, Ann Arbor, Michigan, USA.
JACC Clin Electrophysiol. 2020 Dec;6(14):1752-1761. doi: 10.1016/j.jacep.2020.07.010. Epub 2020 Oct 28.
The primary goal of this study was to evaluate the implant experience and midterm results of subcutaneous implantable cardioverter-defibrillators (S-ICDs) in pediatric patients and those with congenital heart disease.
The S-ICD was developed to avoid the lead-related complications associated with transvenous systems. The absence of intravascular or intracardiac components offers potential advantages to pediatric patients and those with congenital heart disease.
This international, multicenter, retrospective, standard-of-care study was conducted through the Pediatric & Congenital Electrophysiology Society. Complications at 30 and 360 days, inappropriate shocks, and delivery of appropriate therapy were assessed.
The study included 115 patients with a median follow-up of 32 (19 to 52) months. Median age was 16.7 years (14.8 to 19.3 years), 29% were female, and 55% had a primary prevention indication. Underlying disease substrate was cardiomyopathy (40%), structural heart disease (32%), idiopathic ventricular fibrillation (16%), and channelopathy (13%). The complication rate was 7.8% at 30 days and 14.7% at 360 days. Overall, inappropriate shocks occurred in 15.6% of patients, with no single clinical characteristic reaching statistical significance. At implant, 97.9% of patients had successful first shock conversion with 96% requiring ≤65 J. Appropriate therapy was delivered to 11.2% of patients with an annual incidence of 3.9% and an acute first shock conversion success rate of 92.5%.
This study found that in a heterogeneous population of pediatric patients and those with congenital heart disease, the S-ICD had comparable rates of complications, inappropriate shocks, and conversion efficacy compared with previously published studies on transvenous systems in similar populations.
本研究的主要目标是评估皮下植入式心律转复除颤器（S-ICD）在儿科患者和先天性心脏病患者中的植入体验及中期结果。
研发S-ICD是为了避免与经静脉系统相关的导线相关并发症。不存在血管内或心内组件为儿科患者和先天性心脏病患者提供了潜在优势。
这项国际性、多中心、回顾性、标准治疗研究是通过儿科与先天性电生理学协会开展的。评估了30天和360天时的并发症、不适当电击以及恰当治疗的实施情况。
该研究纳入了115例患者，中位随访时间为32（19至52）个月。中位年龄为16.7岁（14.8至19.3岁），29%为女性，55%有一级预防指征。基础疾病类型为心肌病（40%）、结构性心脏病（32%）、特发性室颤（16%）和离子通道病（13%）。30天时的并发症发生率为7.8%，360天时为14.7%。总体而言，15.6%的患者发生了不适当电击，没有单一临床特征具有统计学意义。植入时，97.9%的患者首次电击转复成功，96%的患者所需能量≤65焦耳。11.2%的患者接受了恰当治疗，年发生率为3.9%，急性首次电击转复成功率为92.5%。
本研究发现，在儿科患者和先天性心脏病患者这一异质性群体中，与之前发表的关于类似群体经静脉系统的研究相比，S-ICD的并发症、不适当电击和转复疗效发生率相当。
