Leadless vs. Conventional Transvenous Pacemakers in Valve Intervention Patients: A Systematic Review & Meta-Analysis

Management of structural heart diseases (SHD) with either transcatheter or surgical valve interventions has led to a growing number of patients requiring post-procedural permanent pacemaker implantation,(PPI) with rates of implantation reaching as high as 37.7% after transcatheter aortic valve replacement (TAVR). Transvenous pacemakers (TVP) have been the standard of care for such cases, although they carry the risk of numerous complications, such as surgical pocket and lead infections. Leadless pacemakers (LP) were introduced as an alternative to minimize these risks. This study aims to compare the outcomes of leadless versus TVP implantation in patients undergoing valve intervention during the peri-procedural duration.

We conducted a systematic review and meta-analysis of studies identified through a comprehensive search of the PubMed, Scopus, Web of Science, and Cochrane Library databases, performed in accordance with the Cochrane Handbook, to compare leadless and TVP in valve intervention patients during the peri-procedural period. Data analysis was performed using Comprehensive Meta-analysis (CMA, version 3.7.107). Primary outcomes included mortality, rehospitalization, and device- or procedure-related complications. Risk ratios (RRs) and mean differences (MDs) were calculated for dichotomous and continuous outcomes, respectively, both with 95% confidence intervals (CIs). The protocol was prospectively registered (PROSPERO: CRD420251150891).

The meta-analysis included 5 cohort studies comprising 10,494 participants. 794 patients received LP and 9,700 received conventional TVP. LP patients had a significantly higher mortality risk (RR = 1.85; 95% CI, 1.06-3.20; p = 0.029), longer hospital stay (MD = 0.67; 95% CI, 0.43-0.90; p < 0.001) and lower ventricular pacing burden (MD = -11.39; 95% CI, -18.98 to -3.80; p = 0.003) compared to patients with conventional TVP. There was no statistically significant difference between the two groups regarding rehospitalization, pocket infection, lead/device dislodgement, and vascular complications.

In this meta-analysis, LP implantation was associated with reduced ventricular pacing burden, but at the expense of a longer hospital stay and increased mortality risk compared with conventional TVP. No significant differences were observed between the two modalities in terms of rehospitalization, pocket infection, lead/device dislodgement, and vascular complications. These findings suggest that although LP were associated with higher observed mortality, this association is likely driven by selection bias, as leadless devices are preferentially implanted in patients with higher baseline risk and greater comorbidity burden. Randomized controlled trials are needed to clarify the comparative safety of leadless versus TVP while minimizing confounding by indication.

The study protocol was prospectively registered in PROSPERO (CRD420251150891).