Procedural Outcomes of Leadless Pacemaker Extraction and Retrieval: A Systematic Review and Meta-Analysis With Descriptive Synthesis of Post-Implant Management.

Abstract

Introduction: Leadless pacemakers reduce lead- and pocket-related complications, but pooled evidence on the procedural outcomes of their extraction and retrieval remains limited.

Methods and results: A systematic review and meta-analysis (PROSPERO CRD420261397097) evaluated leadless pacemaker extraction or retrieval. The primary analysis pooled independent full-text studies reporting at least three attempted removals using a random-effects binomial-normal generalized linear mixed model. Outcomes were procedural success and major retrieval-related procedural events. Eight studies contributed 303 removal attempts to the primary success analysis, and six studies contributed 293 subjects or procedures to the safety analysis. Pooled procedural success was 89.1% (95% CI, 85.1% to 92.2%), and major retrieval-related procedural events occurred in 3.8% (95% CI, 2.1% to 6.7%); between-study heterogeneity was not detected for either outcome. Sensitivity estimates for major events ranged from 3.3% to 4.1%. Reported dwell time before removal ranged from intraprocedural retrieval to 9 years. A secondary descriptive synthesis of 96 clinical publications and five cohorts with complete denominators characterized post-implant management without cross-study pooling.

Conclusion: Leadless pacemaker removal was successful in approximately nine of 10 attempts, while qualifying major retrieval-related events occurred in approximately four of 100 safety denominators. The certainty of evidence was very low. Post-implant management patterns varied across cohorts and could not be pooled.