Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis Publisher



Soleimani H ; Dastjerdi P ; Hosseini Mohammadi NS ; Najdaghi S ; Shayesteh H ; Narimani Davani D ; Yarmohammadi H ; Eslami M ; Mollazadeh R
Source: Heart Rhythm O2 Published:2026

Abstract

Background Leadless pacemakers (LPs) are emerging as a transformative alternative to traditional transvenous pacemakers (TVPs) for managing brady-arrhythmias. Unlike TVPs, LPs eliminate the need for leads and subcutaneous generator pockets, addressing complications. Objective This meta-analysis aimed to evaluate the safety and efficacy of LPs, including Micra (Medtronic) and Aveir VR (Abbott) devices, in comparison to TVPs. Method A systematic review and meta-analysis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Overall, 55 studies involving 286,349 patients met the inclusion criteria. Results LPs demonstrated significantly lower risks of pneumothorax (relative risk [RR], 0.29; P = .019, event rate: 0.14% [LP] vs 0.93% [TVP], number needed to treat [NNT] = 128) and lead dislodgement (RR, 0.21; 95% confidence interval, 0.16–0.28; P < .0001, event rate: 0.36% [LP] vs 2.29% [TVP], NNT = 52) compared with TVPs, with negligible infection rates. However, LPs were associated with higher risks of cardiac tamponade (RR, 2.36; P = .007, event rate: 0.84% [LP] vs 0.46% [TVP], number needed to harm [NNH] = 265) and access site complications (RR, 2.82; P < .0001, event rate: 2.03% [LP] vs 0.62% [TVP], NNH = 71). Conclusion LPs offer distinct advantages over TVPs, including reduced risks of certain complications and improved procedural efficiency. © 2025 Heart Rhythm Society.