Leadless and extracardiac cardiac rhythm management systems: the next generation of pacing and defibrillation.

IF 2.7
Expert review of medical devices Pub Date : 2026-08-01 Epub Date: 2026-06-29 DOI:10.1080/17434440.2026.2693099
Dhir Gala, Eugene Kim, Amgad N Makaryus
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Abstract

Introduction: The complications associated with the use of transvenous leads and device pockets have been a major drawback in the use of traditional cardiac implantable electronic devices. Infections, venous obstruction, and problems in device extraction have been some of the issues. Leadless pacing systems and extravascular implantable cardioverter defibrillators have been developed to overcome some of the issues.

Areas covered: A narrative literature review was performed on the available literature using the PubMed/MEDLINE, Embase, and Google Scholar databases to search for relevant studies published between January 2000 and January 2026. Clinical trials, registries, and observational studies assessing the performance, complications, and patient selection for these devices were reviewed. The current literature shows high success rates of implantation, low infection risk, and efficacy of defibrillation and pacing with these devices, although challenges exist in the form of battery life, incomplete cardiac resynchronization, and the strategy of device succession.

Expert opinion: Leadless and extravascular cardiac rhythm management systems are a significant move toward reducing complications associated with leads and maintaining vascular access. The future use of these systems will depend on advancements in device longevity, pacing functions, cost effectiveness, lifetime device management, and evidence that reductions in lead and pocket-related morbidity are not offset by new long-term management burdens.

无导线和心外心律管理系统:新一代起搏和除颤。
导语:使用经静脉导联和设备口袋相关的并发症是传统心脏植入式电子设备使用的主要缺点。感染、静脉阻塞和器械取出中的问题是其中的一些问题。无铅起搏系统和血管外植入式心律转复除颤器的发展已经克服了一些问题。覆盖领域:使用PubMed/MEDLINE、Embase和谷歌Scholar数据库对现有文献进行叙述性文献综述,搜索2000年1月至2026年1月间发表的相关研究。临床试验、注册和观察性研究评估了这些装置的性能、并发症和患者选择。目前的文献显示,这些装置的植入成功率高,感染风险低,除颤和起搏效果好,尽管存在电池寿命、心脏再同步不完全和装置接续策略等方面的挑战。专家意见:无导联和血管外心律管理系统是减少导联相关并发症和维持血管通路的重要举措。这些系统的未来使用将取决于设备寿命、起搏功能、成本效益、设备寿命管理方面的进步,以及新的长期管理负担不会抵消铅和口袋相关发病率减少的证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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