Key result
Leadless pacemakers cut lead dislodgement ~79% vs transvenous pacemakers but increase access site complications.
Why the study?
Leadless pacemakers eliminate leads and pockets to reduce complications, but their comparative safety and efficacy versus traditional transvenous pacemakers required evaluation.
Do leadless pacemakers improve safety and efficacy compared to traditional transvenous pacemakers in patients with brady-arrhythmias?
Meta-Analysis (n=286,349)
Do leadless pacemakers improve safety and efficacy compared to traditional transvenous pacemakers in patients with brady-arrhythmias?
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
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.
LPs reduce pneumothorax and dislodgement risks versus TVPs but raise tamponade and access complications; extends comparative safety data for device selection.
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.
No takes yet. Share an insight, caveat, or question.
Soleimani et al. (2025) 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.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: