Abstract 14167: Safety Profile of Leadless Pacemaker in Comparison to Conventional Transvenous Pacemaker: A Systemic Review and Meta-Analysis

Introduction: Recently, there has been a dramatic surge of interest in leadless pacemakers (LP). Although benefits of LP versus transvenous pacemakers (TVP) have been reported in small institutional and some registry-based studies, the systematic comparison and pooling of data remain limited. Therefore, we sought to meta-analyze the safety and benefit of leadless pacemakers over conventional transvenous pacemaker systems. Method: We followed PRISMA guidelines to conduct the study. The study protocol has been registered in the PROSPERO (CRD42022325376). Databases were searched for published literature from inception to April 12, 2022. Comparative studies on TVP with LP reporting device-related, cardiac, vascular, thoracic complications, and infection were included. Studies were analyzed using RevMan 5.4.1 with odds ratios (OR) to assess overall complications, device dislodgement, reintervention, and other complications. The I-squared (I 2 ) test was used to assess the heterogeneity. Result Total 879 studies were imported from databases. After the removal of 265 duplicates, 614 papers were screened for eligibility. Among 41 papers screened for full text, 17 meet the inclusion criteria. There were 50% lower odds of overall complications in the LP group (OR 0.50, 95% CI 0.32 to 0.78; n = 20825). Similarly, 73% lower odds of device dislodgment (OR 0.27, 95% CI 0.14 to 0.50; n = 6897), 46% lower odds of re-intervention (OR 0.54, 95% CI 0.45 to 0.64; n= 17009), 87% lower odds of pneumothorax (OR 0.13, 95% CI 0.03 to 0.57; n = 4261), however 2.08 higher odds of pericardial effusion (OR 2.08, 95% CI 1.04 to 4.16; n = 4842) observed in LP group. Conclusion Meta-analysis of observational studies suggests that LP demonstrates a more favorable complication profile than TVP, although with higher rates of pericardial effusion. However, patient selection was not uniform between studies, and inferences remain limited.