Abstract 4369298: Feasibility, Safety and Intraprocedural Device Outcomes of Dual-Chamber Leadless Pacemakers: A Systematic Review and Single-Arm Meta-Analysis

Abstract

Introduction: Dual-chamber leadless pacemakers (dcLP) represent an innovative advancement in cardiac pacing, aiming to provide atrioventricular (AV) synchronous pacing without the complications associated with transvenous leads and surgical pockets. Early clinical studies have demonstrated promising procedural success and safety profiles, but comprehensive synthesis of available data is lacking. Hypothesis: dcLP can be a safe alternative in patients requiring AV pacing. Aims: To assess the feasibility, safety and intraprocedural device outcomes associated with dcLP. Methods: We performed a single-arm meta-analysis of randomized controlled trial and observational studies reporting outcomes of dcLP implantation. PubMed, Embase and Cochrane databases were searched up to May 2025. Outcomes included procedural success and efficiency (procedural success rate, procedure and fluoroscopy time), procedural complications (vascular, pericardial effusion, intra and post lead dislodgement) and device function (atrial and ventricular lead impedance, capture threshold, sensing amplitude and AV synchrony). Random-effects models were used to pool event rates, means and proportions with 95% confidence intervals (CIs) using R software (version 4.4.1), following PRISMA guidelines. Results: This meta-analysis included 6 studies comprising 730 patients with a mean age of 71,6 years, of whom 59% were male. DcLP were associated with high procedural success rates 98.65% (95% CI, 97.32-99.32%), along with short procedure durations mean 69.78 (95% CI, 44.44-95.12min) and fluoroscopy times mean 15.96 (95% CI, 8.99-22.93min). Access site bleeding and pericardial effusion were infrequent, occurring at rates of 2.75% (95% CI, 0.22-26.92%) and 1.20% (95% CI, 0.52-2.73%), respectively. Intra and post lead dislodgement were reported at frequencies of 1.87% (95% CI, 1.04-3.35%) and 1.52% (95% CI, 0.79-2.9%). Device parameters demonstrated stable atrial and ventricular lead impedance mean 359.12Ω (95% CI, 92.30-625.95Ω)/714.02Ω (95% CI, 40.59-1387.44Ω), pacing capture thresholds (0.4-ms pulse width) 1.80V (95% CI, -5.82-9.42V)/0.80V (95% CI, 0.80-0.80V) and sensing amplitudes 1.94mV (95% CI, 0.04-3.85mV)/9.12mV (95% CI, 4.69-13.54mV). AV synchrony reported rate was 87.1% (95% CI, 58.6-97.0%). Conclusion: dcLP demonstrates favorable feasibility and safety in patients requiring AV-synchronous pacing, though long-term data remain necessary to confirm durability and sustained clinical outcomes.