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

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 defibrillator 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.

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Publication Details

Journal
Expert Review of Medical Devices
Published
2026-06-18
DOI
https://doi.org/10.1080/17434440.2026.2693099
Primary Topic
Cardiac pacing and defibrillation studies
Type
article
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article

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

Amgad N. Makaryus, Eugene Kim, Dhir Gala
Expert Review of Medical Devices
Cardiac pacing and defibrillation studies
article

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

Amgad N. Makaryus, Eugene Kim, Dhir Gala
article en

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 defibrillator 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.

Expert Review of Medical Devices
Rutgers, The State University of New Jersey (US), Northwell Health (US), Donald & Barbara Zucker School of Medicine at Hofstra/Northwell (US), Rutgers New Jersey Medical School (US)
Good health and well-being
Openalex Percentile: Top 7%
Cardiac pacing and defibrillation studies
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