Safety and efficacy of leadless pacemakers: A systematic review and meta-analysis

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.