Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Xietu Road, 1069, Shanghai, China.
National Clinical Research Center for Interventional Medicine, Shanghai Clinical Research Center for Interventional Medicine, Shanghai, China.
Herz. 2023 Dec;48(6):462-469. doi: 10.1007/s00059-023-05192-4. Epub 2023 Aug 4.
Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have been shown to be non-inferior to transvenous ICDs in the prevention of sudden cardiac death (SCD), but there is still a lack of evidence from clinical trials in China. We investigated whether S‑ICD implantation in the Chinese population is safe and feasible and should be promoted in the future.
Consecutive patients undergoing S‑ICD implantation at our center were enrolled in this retrospective study. Data were collected within the median follow-up period of 554 days. Data concerning patient selection, implantation procedures, complications, and episodes of shock were analyzed.
In total, 70.2% of all 47 patients (median age = 39 years) were included for secondary prevention of SCD with different etiologies. Vector screening showed that 98% of patients were with > 1 appropriate vector in all postures. An intraoperative defibrillation test was not performed on six patients because of the high risk of disease deterioration, while all episodes of ventricular fibrillation induced post implantation were terminated by one shock. As expected, no severe complications (e.g., infection and device-related complications) were observed, except for one case of delayed healing of the incision. Overall, 15 patients (31.9%) experienced appropriate shocks (AS) with all episodes terminated by one shock. Two patients (4.3%) experienced inappropriate shocks (IAS) due to noise oversensing, resulting in a high Kaplan-Meier IAS-free rate of 95.7%.
Based on appropriate patient selection and standardized implantation procedures, this real-world study confirmed the safety and efficacy of S‑ICD in Chinese patients, indicating that it may help to promote the prevention of SCD in China.
皮下植入式心律转复除颤器（S-ICD）在预防心源性猝死（SCD）方面已被证明不劣于经静脉植入式心律转复除颤器（ICD），但中国仍缺乏临床试验证据。我们研究了 S-ICD 在中国人群中的植入是否安全可行，以及将来是否应该推广。
本回顾性研究纳入了在我院行 S-ICD 植入术的连续患者。中位随访时间为 554 天，收集了患者选择、植入程序、并发症和电击事件的数据。
共有 47 例患者（中位年龄 39 岁）符合纳入标准，其中 70.2%为 SCD 二级预防，病因各异。向量筛查显示，98%的患者在所有体位下均有>1 个合适的向量。由于疾病恶化风险高，有 6 例患者未行术中除颤测试，而所有植入后诱发的室颤均经一次电击终止。不出所料，除 1 例切口愈合延迟外，未观察到严重并发症（如感染和器械相关并发症）。总体而言，15 例（31.9%）患者发生了适当的电击（AS），所有电击均由一次电击终止。2 例（4.3%）患者因噪声过感知发生了不适当的电击（IAS），Kaplan-Meier 无 IAS 率高达 95.7%。
基于合适的患者选择和标准化的植入程序，本真实世界研究证实了 S-ICD 在我国患者中的安全性和有效性，表明它可能有助于促进我国 SCD 的预防。
