Leadless pacemakers significantly reduced the risk of lead dislodgement compared to transvenous pacemakers (RR 0.21; 95% CI 0.16-0.28; p<0.0001), but increased access site complications.
Meta-Analysis (n=286,349)
Do leadless pacemakers improve safety and efficacy compared to traditional transvenous pacemakers in patients with brady-arrhythmias?
Leadless pacemakers significantly reduce the risk of pneumothorax and lead dislodgement compared to transvenous pacemakers, but are associated with increased risks of cardiac tamponade and access site complications.
Relative Risk: 0.21 (95% CI 0.16–0.28)
Absolute Event Rate: 0.36% vs 2.29%
Number Needed to Treat: 52
p-value: p=< 0.0001
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 PRISMA guidelines. Fifty-five studies involving 286,349 patients met the inclusion criteria. Result 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). Conclusion LPs offer distinct advantages over TVPs, including reduced risks of certain complications and improved procedural efficiency.
Soleimani et al. (Tue,) conducted a meta-analysis in Brady-arrhythmias (n=286,349). Leadless pacemakers (LPs) vs. Traditional transvenous pacemakers (TVPs) was evaluated on Lead dislodgement (RR 0.21, 95% CI 0.16-0.28, p=< 0.0001). Leadless pacemakers significantly reduced the risk of lead dislodgement compared to transvenous pacemakers (RR 0.21; 95% CI 0.16-0.28; p<0.0001), but increased access site complications.