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

<h2>Abstract</h2><h3>Background</h3> 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. <h3>Objective</h3> This meta-analysis aimed to evaluate the safety and efficacy of LPs, including Micra (Medtronic) and Aveir VR (Abbott) devices, in comparison to TVPs. <h3>Method</h3> A systematic review and meta-analysis were conducted following PRISMA guidelines. Fifty-five studies involving 286,349 patients met the inclusion criteria. <h3>Result</h3> LPs demonstrated significantly lower risks of pneumothorax (Relative risk (RR): 0.29, p=0.019, event rate: 0.14% (LP) vs. 0.93% (TVP), Number Needed to Treat (NNT) = 128) and lead dislodgement (RR: 0.21, 95% CI: 0.16–0.28, p < 0.0001, event rate: 0.36% (LP) vs. 2.29% (TVP), NNT=52) compared to TVPs, with negligible infection rates. However, LPs were associated with higher risks of cardiac tamponade (RR: 2.36, p=0.007, event rate: 0.84% (LP) vs. 0.46% (TVP), Number Needed to Harm (NNH) = 265) and access site complications (RR: 2.82, p < 0.0001, event rate: 2.03% (LP) vs. 0.62% (TVP), NNH=71). <h3>Conclusion</h3> LPs offer distinct advantages over TVPs, including reduced risks of certain complications and improved procedural efficiency.