Leadless pacemakers following TAVR significantly reduced device-related complications compared to transvenous pacemakers (RR 0.46; 95% CI 0.25-0.83; p<0.011).
Meta-Analysis (n=10,681)
Does leadless pacemaker implantation reduce complications or mortality compared to transvenous pacemakers in patients requiring pacing after TAVR?
Following TAVR, leadless pacemakers are associated with fewer device and access-site complications compared to transvenous pacemakers, though unadjusted data show higher all-cause mortality likely driven by selection bias.
Effect estimate: RR 0.46 (95% CI 0.25-0.83)
p-value: p=<0.011
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.
Suruagy-Motta et al. (Sun,) conducted a meta-analysis in Conduction disturbances requiring permanent pacemaker following TAVR (n=10,681). Leadless pacemaker (LPM) vs. Transvenous pacemaker (TVP) was evaluated on Device-related complications (RR 0.46, 95% CI 0.25-0.83, p=<0.011). Leadless pacemakers following TAVR significantly reduced device-related complications compared to transvenous pacemakers (RR 0.46; 95% CI 0.25-0.83; p<0.011).