Leadless Pacemakers After Transcatheter Aortic Valve Replacement: A Meta-analysis With Time-to-Event Analysis.

Abstract

Background: Permanent pacemaker implantation is a common complication after transcatheter aortic valve replacement (TAVR). Leadless pacemakers (LPs) may reduce lead- and pocket-related complications, but their clinical outcomes after TAVR remain uncertain. This systematic review and meta-analysis evaluated the safety and effectiveness of LPs compared with transvenous pacemakers (TVPs).

Methods: PubMed, Scopus, and ScienceDirect were searched from inception to June 10, 2026. Randomized and observational studies were included. Random-effects meta-analyses pooled proportions, risk ratios (RRs), and mean differences (MDs). Reconstructed Kaplan-Meier data were used to estimate hazard ratios (HRs).

Results: Ten studies involving 10,809 patients (1030 LP and 9779 TVP recipients) were included. The pooled procedural success rate of LP implantation was 98% (95% CI 95%-99%). Implantation success was comparable between LP and TVP (RR 1.00, 95% CI 0.98-1.02). Sensitivity analysis demonstrated a shorter hospital stay with LP (MD -1.37 days, 95% CI -2.33 to -0.41) and a lower risk of heart failure hospitalization (RR 0.37, 95% CI 0.14-0.96). Overall survival did not differ between groups (HR 1.05, 95% CI 0.44-1.23), although reconstructed survival curves showed late separation favoring LP. Device-related and vascular complications were comparable between LP and TVP.

Conclusions: LP implantation after TAVR demonstrates excellent procedural success and clinical outcomes comparable to TVPs. LPs may reduce hospital stay and heart failure hospitalization, supporting their use as an alternative pacing strategy in appropriately selected patients.