Su Li, Guo Jia, Hao Yingqun, Tan Hong
The First Department of Gerontology, 960th Hospital of the People's Liberation Army, Jinan, 250001, China.
Department of Cardiology, 960th Hospital of the People's Liberation Army, No. 25 Shifan Road, Jinan, 250001, China.
J Interv Card Electrophysiol. 2021 Apr;60(3):355-363. doi: 10.1007/s10840-020-00929-1. Epub 2021 Jan 11.
The use of transvenous implantable cardioverter defibrillators (TV-ICDs) is associated with multiple risks related to the presence of the defibrillator leads within the venous system and right side of the heart, including endocarditis, venous occlusion, tricuspid regurgitation, and potential lead failure. The emergence of subcutaneous ICDs (S-ICDs) may potentially overcome the aforementioned disadvantages. However, evidence validating the safety of S-ICDs relative to TV-ICDs is limited. The present study aimed to synthesize and analyze available data from published studies to comprehensively compare transvenous and subcutaneous ICDs.
Different databases were searched for full-text publications with a direct comparison of TV- and S-ICDs. Fixed effect models were applied to pooled data, and no study-to-study heterogeneity was detected.
Data from 7 studies totaling 1666 patients were pooled together. Compared to S-ICDs, the risk of suffering device-related complications was higher in patients with TV-ICDs (OR = 1.71; 95% CI: 1.23-2.38). The number of patients with an S-ICD who suffered inappropriate shocks (IS) was not significantly different than patients with a TV-ICD (OR = 0.92; 95% CI: 0.65-1.30). Subgroup analysis indicated that the TV-ICD group had a higher risk of IS due to supraventricular oversensing (OR = 3.29; 95% CI: 1.92-5.63) while T-wave oversensing tending to cause IS in the S-ICD group (OR = 0.09; 95% CI: 0.03-0.23). The risk of device-related infection in the S-ICD group was not any lower than that in the TV-ICD group (OR = 1.57; 95% CI: 0.67-3.68). The survival rate without any complications during a 1-year follow-up period was similar between the 2 groups (HR = 1.23; 95% CI: 0.81-1.86), although it was assumed that the trend leaned toward more complications in patients with a TV-ICD.
The present study verified the safety of S-ICDs based on pooled data. Although there were no differences between TV- and S-ICDs in the short term, fewer adverse events were found in patients with S-ICDs during long-term follow-up.
经静脉植入式心脏复律除颤器（TV-ICD）的使用与多种风险相关，这些风险与除颤器导线在静脉系统和心脏右侧的存在有关，包括心内膜炎、静脉阻塞、三尖瓣反流以及潜在的导线故障。皮下植入式心脏复律除颤器（S-ICD）的出现可能会克服上述缺点。然而，验证S-ICD相对于TV-ICD安全性的证据有限。本研究旨在综合和分析已发表研究中的可用数据，以全面比较经静脉和皮下植入式心脏复律除颤器。
检索不同数据库以获取对TV-ICD和S-ICD进行直接比较的全文出版物。将固定效应模型应用于汇总数据，未检测到研究间的异质性。
汇总了7项研究共1666例患者的数据。与S-ICD相比，TV-ICD患者发生与设备相关并发症的风险更高（OR = 1.71；95%CI：1.23 - 2.38）。发生不适当电击（IS）的S-ICD患者数量与TV-ICD患者无显著差异（OR = 0.92；95%CI：0.65 - 1.30）。亚组分析表明，TV-ICD组因室上性感知过度导致IS的风险更高（OR = 3.29；95%CI：1.92 - 5.63），而T波感知过度在S-ICD组中倾向于导致IS（OR = 0.09；95%CI：0.03 - 0.23）。S-ICD组与设备相关感染的风险并不低于TV-ICD组（OR = 1.57；95%CI：0.67 - 3.68）。两组在1年随访期内无任何并发症的生存率相似（HR = 1.23；95%CI：0.81 - 1.86），尽管据推测TV-ICD患者有更多并发症的趋势。
本研究基于汇总数据验证了S-ICD的安全性。虽然TV-ICD和S-ICD在短期内无差异，但在长期随访中S-ICD患者的不良事件较少。
