da Silva Menezes Júnior Antônio, Oliveira Izadora Caiado, de Sousa André Maroccolo, Paro Piai Ricardo Figueiredo, Oliveira Vinícius Martins Rodrigues
Department of Medicine, Federal University of Goiás, Goiânia, GO, Brazil.
Internal Medicine Department, Pontifical Catholic University of Goiás, Goiânia, GO, Brazil.
Cardiovasc Diagn Ther. 2024 Jun 30;14(3):318-327. doi: 10.21037/cdt-24-15. Epub 2024 Jun 27.
A subcutaneous implantable cardioverter-defibrillator (S-ICD) is an alternative to a transvenous implantable cardio defibrillator (TV-ICD). An S-ICD reduces the risk of transvenous lead placement. However, further research is required to determine how S-ICDs affect patients with hypertrophic cardiomyopathy (HCM). In this study, we investigated the comparative efficacy and safety of S-ICDs versus TV-ICDs in HCM.
On December 6, 2023, we performed a comprehensive search of the PubMed, Embase, Scopus, and Cochrane databases to identify randomized clinical trials (RCTs) and observational studies comparing S-ICDs with TV-ICDs in HCM patients published from 2004 until 2023. No language restrictions were applied. The primary outcome was appropriate shocks (AS), with inappropriate shocks (IAS), and device-related complications considered as secondary outcomes. Odds ratios (ORs) and 95% confidence intervals (CIs) were pooled using a random effects model. The ROBINS-I tool was used to assess the risk of bias of the studies.
The search yielded 1,114 records. Seven studies comprising 4,347 HCM patients were included, of whom 3,325 (76.0%) had TV-ICDs, and 1,022 (22.6%) had S-ICDs. There were 2,564 males (58.9%). The age range was from 39.1 to 49.4 years. Compared with the TV-ICD group, the S-ICD cohort had a significantly lower incidence of device-related complications (OR 0.52; 95% CI: 0.30-0.89; P=0.02; I=4%). Contrastingly, there were no statistically significant differences in the occurrences of AS (OR 0.49; 95% CI: 0.22-1.08; P=0.08; I=75%) and IAS (OR 1.03; 95% CI: 0.57-1.84; P=0.93; I=65%) between the two device modalities. In the analysis of the overall risk of bias in the studies, we found 42% of them with several, 28% with moderate, and 14% with low risk of bias.
In HCM patients, S-ICDs were associated with a lower incidence of device-associated problems than TV-ICDs. AS and IAS incidence rates were similar between groups. These findings may assist clinicians in determining the most suitable device for treating patients with HCM.
皮下植入式心律转复除颤器（S-ICD）是经静脉植入式心律转复除颤器（TV-ICD）的一种替代方案。S-ICD可降低经静脉植入导线的风险。然而，需要进一步研究以确定S-ICD对肥厚型心肌病（HCM）患者的影响。在本研究中，我们调查了S-ICD与TV-ICD在HCM中的相对疗效和安全性。
2023年12月6日，我们全面检索了PubMed、Embase、Scopus和Cochrane数据库，以识别2004年至2023年发表的比较HCM患者中S-ICD与TV-ICD的随机临床试验（RCT）和观察性研究。不设语言限制。主要结局为恰当电击（AS），不恰当电击（IAS）和与设备相关的并发症被视为次要结局。使用随机效应模型汇总比值比（OR）和95%置信区间（CI）。使用ROBINS-I工具评估研究的偏倚风险。
检索共获得1114条记录。纳入了7项研究，共4347例HCM患者，其中3325例（76.0%）植入TV-ICD，1022例（22.6%）植入S-ICD。男性有2564例（58.9%）。年龄范围为39.1至49.4岁。与TV-ICD组相比，S-ICD队列中与设备相关并发症的发生率显著更低（OR 0.52；95% CI：0.30 - 0.89；P = 0.02；I² = 4%）。相反，两种设备类型在AS（OR 0.49；95% CI：0.22 - 1.08；P = 0.08；I² = 75%）和IAS（OR 1.03；95% CI：0.57 - 1.84；P = 0.93；I² = 65%）的发生方面无统计学显著差异。在分析研究的总体偏倚风险时，我们发现其中42%存在若干偏倚风险，28%为中度偏倚风险，14%为低偏倚风险。
在HCM患者中，S-ICD与TV-ICD相比，与设备相关问题的发生率更低。两组间AS和IAS的发生率相似。这些发现可能有助于临床医生确定治疗HCM患者的最合适设备。
