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皮下植入式心律转复除颤器的真实世界疗效与安全性:来自GASP注册研究的见解

Real-World Efficacy and Safety of the Subcutaneous Implantable Cardioverter Defibrillator: Insights from the GASP Registry.

作者信息

Milaras Nikias, Oikonomou Evangelos, Letsas Konstantinos P, Ktenopoulos Nikolaos, Xydonas Sotirios, Korantzopoulos Panagiotis, Leventopoulos Georgios, Dourvas Panagiotis, Archontakis Stefanos, Batsouli Athena, Mililis Panagiotis, Saplaouras Athanasios, Kanoupakis Emmanuel, Toutouzas Konstantinos, Paraskevaidis Stylianos, Efremidis Michalis, Sideris Skevos

机构信息

Cardiology Department, General Hospital of Athens Ippokrateion, Vasilissis Sofias 114, 11527 Athens, Greece.

Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece.

出版信息

Biomedicines. 2025 Jun 20;13(7):1510. doi: 10.3390/biomedicines13071510.

DOI:10.3390/biomedicines13071510
PMID:40722586
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12292647/
Abstract

The advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) marked a significant milestone in the course of cardiac rhythm devices, particularly for patients who are deemed at high risk for ventricular arrhythmias and sudden cardiac death. This extracardiac approach makes the S-ICD an especially valuable option for young patients, those with difficult venous access, or those at high risk of infection. Although the S-ICD does not provide pacing for bradycardia or heart failure, it has shown efficacy in treating ventricular arrhythmias while minimizing complications associated with transvenous systems. : The purpose of this multicenter retrospective analysis was to assess the real-world efficacy and safety of the S-ICD in a heterogeneous population. : The GASP registry consisted of 114 patients, 68% male, aged 41 ± 15 years, with a mean LVEF of 50%. In the follow-up of 35 months, inappropriate shocks occurred in 7% while appropriate shocks occurred in 6.2%. The most common reasons for inappropriate shocks were myopotentials and atrial tachyarrhythmias. Thirty-day complication-free rates were 97.3%, with the majority of patients requiring device extraction due to infection. Over the longer term, four patients required re-intervention due to local discomfort, while one device was extracted for infection. In a multivariate analysis, complications were not significantly higher in the sicker population, such as those with diabetes, kidney disease requiring dialysis, or heart failure. : These findings support the growing role of the S-ICD as an alternative to the TV-ICD, especially in patients without pacing indications.

摘要

皮下植入式心律转复除颤器(S-ICD)的出现标志着心律装置发展历程中的一个重要里程碑,对于那些被认为有室性心律失常和心源性猝死高风险的患者而言尤为如此。这种心外膜途径使得S-ICD对于年轻患者、静脉通路困难的患者或感染高风险患者成为一个特别有价值的选择。尽管S-ICD不能为心动过缓或心力衰竭提供起搏治疗,但它在治疗室性心律失常方面已显示出疗效,同时将与经静脉系统相关的并发症降至最低。本多中心回顾性分析的目的是评估S-ICD在异质性人群中的实际疗效和安全性。GASP注册研究纳入了114例患者,男性占68%,年龄41±15岁,平均左心室射血分数(LVEF)为50%。在35个月的随访中,7%的患者发生不适当电击,6.2%的患者发生适当电击。不适当电击最常见的原因是肌电位和房性快速性心律失常。30天无并发症发生率为97.3%,大多数患者因感染需要取出装置。从长期来看,4例患者因局部不适需要再次干预,1例装置因感染被取出。在多变量分析中,病情较重的人群,如患有糖尿病、需要透析的肾病或心力衰竭患者,并发症并没有显著更高。这些发现支持S-ICD作为经静脉植入式心律转复除颤器(TV-ICD)替代方案的作用日益增加,尤其是在没有起搏指征的患者中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fab/12292647/e9c8de9ca773/biomedicines-13-01510-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fab/12292647/e332f82e1567/biomedicines-13-01510-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fab/12292647/c4ea84d21f02/biomedicines-13-01510-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fab/12292647/e9c8de9ca773/biomedicines-13-01510-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fab/12292647/e332f82e1567/biomedicines-13-01510-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fab/12292647/c4ea84d21f02/biomedicines-13-01510-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fab/12292647/e9c8de9ca773/biomedicines-13-01510-g003.jpg

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本文引用的文献

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Pacing Clin Electrophysiol. 2025 Apr;48(4):443-446. doi: 10.1111/pace.15173. Epub 2025 Mar 13.
2
A Modular Communicative Leadless Pacing-Defibrillator System.一种模块化的通讯型无导线起搏除颤器系统。
N Engl J Med. 2024 Oct 17;391(15):1402-1412. doi: 10.1056/NEJMoa2401807. Epub 2024 May 18.
3
Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial.
皮下与经静脉植入式心脏复律除颤器植入术的围手术期安全性和早期患者与器械结局:一项随机、多中心试验。
Ann Intern Med. 2022 Dec;175(12):1658-1665. doi: 10.7326/M22-1566. Epub 2022 Nov 8.
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2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death.2022年欧洲心脏病学会室性心律失常患者管理和心脏性猝死预防指南
Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262.
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Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study.皮下植入式心脏除颤器:EFFORTLESS 研究的长期结果。
Eur Heart J. 2022 Jun 1;43(21):2037-2050. doi: 10.1093/eurheartj/ehab921.
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Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial.经静脉和皮下植入式除颤器中适当电击和抗心动过速起搏的疗效和安全性:PRAETORIAN 试验中所有适当治疗的分析。
Circulation. 2022 Feb;145(5):321-329. doi: 10.1161/CIRCULATIONAHA.121.057816. Epub 2021 Nov 14.
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