Comparative assessment of safety with leadless pacemakers compared to transvenous pacemakers: a systemic review and meta-analysis

Abstract

Background: Leadless pacemakers (LP) and transvenous pacemakers (TVP) are two stable pacing platforms currently available in clinical practice. Observational data show mixed results with regards to their comparative safety. This meta-analysis was aimed to evaluate the comparative safety of LP over TVP.

Methods: The study protocol was registered in PROSPERO registry (CRD42022325376). Six databases were searched for published literature from inception to April 12, 2022. RevMan 5.4.1 was used for statistical analysis. Odds ratio (OR) and mean difference were used to estimate the outcome with a 95% confidence interval (CI).

Results: A total of 879 studies were imported from the databases. Among these, 41 papers were screened for full text and 17 meet the inclusion criteria. Among them, pooled results showed 42% lower odds of occurrence of complications in the LP group (OR 0.58, CI 0.42-0.80) compared to TVP group. Notably, 70% lower odds of device dislodgment (OR 0.30, CI 0.21-0.43), 46% lower odds of re-intervention (OR 0.54, CI 0.45-0.64), 87% lower odds of pneumothorax (OR 0.13, CI 0.03-0.57), albeit, 2.65 times higher odds of pericardial effusion (OR 2.65, CI 1.49-4.70) were observed in the LP group.

Conclusions: This meta-analysis showed LP to be a significantly safer modality compared to TVP, in terms of re-intervention, device dislodgment, pneumothoraxes, and overall complications. However, there were higher rates of pericardial effusion in the LP group. There was a diverse number of patients included, and all studies were observational. Randomized trials are needed to validate our findings.

Keywords: Leadless pacemakers; Meta-analysis; Safety; Transvenous pacemaker.