Leadless pacemaker in atrioventricular block patients with specific indications: a systematic review

Leadless cardiac pacemakers are becoming a viable alternative to traditional intravenous pacemakers. This study aims to systematically evaluate the safety of using leadless pacemakers in patients with atrioventricular block (AVB) who meet specific indications, based on existing published research.

A comprehensive literature search was conducted in PubMed, Web of Science, CNKI, Embase, Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) and Wanfang Database for clinical studies on leadless pacemaker treatment for atrioventricular block. Data analysis was conducted using RevMan and R software. Relative risk (RR) with 95% confidence interval (CI) was calculated. Heterogeneity was assessed using the I² statistic.

A total of 60 studies were ultimately included, with AVB patients accounting for 6% to 100% of the implanted population. The overall incidence of adverse events in patients receiving leadless pacemakers was low. Among these, 16 studies provided complication data for the AVB subgroup and were included in the meta-analysis. The results showed that, compared with the control group, leadless pacemakers did not significantly reduce the risk of adverse events in AVB patients (RR = 1.41, 95% CI: 0.43-4.60, P = 0.57). Subgroup analysis by device type demonstrated no statistically significant differences in adverse event risks compared to traditional pacemakers for either single-chamber ventricular leadless pacemakers (RR = 0.26, 95% CI: 0.03-2.01, P = 0.20) or AV-synchronous/dual-chamber leadless pacemakers (RR = 2.16, 95% CI: 0.76-6.17, P = 0.15), with no significant interaction between subgroups. In the single-arm rate analysis, five cohort studies reported an adverse event rate of 14% (95% CI: 0.04-0.24); after applying the Freeman-Tukey transformation to eleven single-arm studies, the adverse event rate was 1.15% (95% CI: 0.26%-2.67%).

In patients with atrioventricular block, leadless pacemakers demonstrate no significant difference in the risk of adverse events compared with conventional pacemakers, with lower complication rates and favorable clinical feasibility.