Yong Loo Lin School of MedicineNational University of Singapore Singapore.
Department of Cardiology Changi General Hospital Singapore.
J Am Heart Assoc. 2022 Jun 7;11(11):e024756. doi: 10.1161/JAHA.121.024756. Epub 2022 Jun 3.
Background Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have been of great interest as an alternative to transvenous implantable cardioverter-defibrillators (TV-ICDs). No meta-analyses synthesizing data from high-quality studies have yet been published. Methods and Results An electronic literature search was conducted to retrieve randomized controlled trials or propensity score-matched studies comparing S-ICD against TV-ICD in patients with an implantable cardioverter-defibrillator indication. The primary outcomes were device-related complications and lead-related complications. Secondary outcomes were inappropriate shocks, appropriate shock, all-cause mortality, and infection. All outcomes were pooled under random-effects meta-analyses and reported as risk ratios (RRs) and 95% CIs. Kaplan-Meier curves of device-related complications were digitized to retrieve individual patient data and pooled under a 1-stage meta-analysis using Cox models to determine hazard ratios (HRs) of patients undergoing S-ICD versus TV-ICD. A total of 5 studies (2387 patients) were retrieved. S-ICD had a similar rate of device-related complications compared with TV-ICD (RR, 0.59 [95% CI, 0.33-1.04]; =0.070), but a significantly lower lead-related complication rate (RR, 0.14 [95% CI, 0.07-0.29]; <0.0001). The individual patient data-based 1-stage stratified Cox model for device-related complications across 4 studies yielded no significant difference (shared-frailty HR, 0.82 [95% CI, 0.61-1.09]; =0.167), but visual inspection of pooled Kaplan-Meier curves suggested a divergence favoring S-ICD. Secondary outcomes did not differ significantly between both modalities. Conclusions S-ICD is clinically superior to TV-ICD in terms of lead-related complications while demonstrating comparable efficacy and safety. For device-related complications, S-ICD may be beneficial over TV-ICD in the long term. These indicate that S-ICD is likely a suitable substitute for TV-ICD in patients requiring implantable cardioverter-defibrillator implantation without a pacing indication.
皮下植入式心律转复除颤器（S-ICD）作为经静脉植入式心律转复除颤器（TV-ICD）的替代方案，引起了广泛关注。目前尚未发表过荟萃分析综合高质量研究数据的文章。
本研究通过电子文献检索，检索了比较 S-ICD 与 TV-ICD 用于有植入式心律转复除颤器指征患者的随机对照试验或倾向评分匹配研究。主要结局为器械相关并发症和导线相关并发症。次要结局为不恰当电击、恰当电击、全因死亡率和感染。所有结局均采用随机效应荟萃分析进行汇总，并报告为风险比（RR）和 95%置信区间（CI）。通过数字化器械相关并发症的 Kaplan-Meier 曲线，获取个体患者数据，并采用 Cox 模型进行 1 期荟萃分析，以确定 S-ICD 与 TV-ICD 患者的危险比（HR）。共检索到 5 项研究（2387 例患者）。S-ICD 的器械相关并发症发生率与 TV-ICD 相似（RR，0.59 [95%CI，0.33-1.04]；=0.070），但导线相关并发症发生率显著降低（RR，0.14 [95%CI，0.07-0.29]；<0.0001）。4 项研究基于个体患者数据的 1 期分层 Cox 模型对器械相关并发症进行分析，结果无显著差异（共享脆弱性 HR，0.82 [95%CI，0.61-1.09]；=0.167），但汇总 Kaplan-Meier 曲线的直观检查提示 S-ICD 存在优势。两种治疗方式的次要结局无显著差异。
在导线相关并发症方面，S-ICD 优于 TV-ICD，而在疗效和安全性方面，两种治疗方式相当。就器械相关并发症而言，S-ICD 可能在长期随访中优于 TV-ICD。这些结果表明，在无起搏指征需要植入式心律转复除颤器的患者中，S-ICD 可能是 TV-ICD 的合适替代方案。
