Leadless or Transvenous pacemakers following TAVR: A systematic review and meta-analysis.

INTRODUCTION

Transcatheter aortic valve replacement (TAVR) is frequently associated with conduction disturbances and arrhythmias, often requiring permanent pacemaker (PPM) implantation in an elderly, high-bleeding-risk population. Leadless pacemakers (LPMs) reduce pocket and lead-related complications and have demonstrated noninferior safety compared with transvenous pacemakers (TVP) in non-TAVR populations. However, comparative data in the post-TAVR setting are lacking.

METHODS

We systematically searched Pubmed, Cochrane, Embase, Web of Sciences and Scopus for studies comparing LPM vs. TVP following TAVR. Random effects models were used to calculate risk ratios (RRs) with 95% confidence intervals (CIs) for all-cause mortality, device-related complications, re-hospitalization and vascular access site complications. Statistical analysis was performed with R software, version 4.2.3.

RESULTS

Six retrospective studies comprising 10,681 patients were included, of whom 874 (7.56%) underwent LPM implantation. Compared with TVP, LPM was associated with a significant reduction in device related complications (RR 0.46; 95% 0.25-0.83; p < 0.011) and vascular access site complications (RR 0.15; 95% CI 0.03-0.68; p = 0.011). There was no significant difference in re-hospitalization (RR 0.82; 95% CI 0.23-3.12; p = 0.76). LPM was associated with a higher risk of all-cause mortality (RR 1.61; 95% CI 1.01-2.57; p = 0.047).

CONCLUSIONS

Among these six retrospective studies, LPM use following TAVR was associated with fewer device-related and vascular access complications compared with TVP, albeit with a higher risk of all-cause mortality at 2 years. However, this finding likely reflects a selection bias in non-adjusted baseline characteristics rather than device inferiority. No significant differences were observed in re-hospitalization between the two strategies. Prospective studies are required to confirm or refute these findings.