The Effectiveness and Safety of Leadless Pacemakers: An Updated Meta-Analysis

Leadless pacemakers (LPs) are promising alternatives to traditional transvenous pacemakers (TVPs), but their comparative effectiveness and safety in clinical outcomes remain uncertain.

We systematically searched PubMed, Embase, Scopus, Cochrane, and ClinicalTrials.gov for studies comparing LPs and TVPs. A restricted maximum likelihood random-effects model was used for all outcomes. Heterogeneity was assessed using I² statistics. We performed a subgroup analysis with studies with multivariate-adjusted data.

We included 21 studies involving 47,229 patients, of whom 12,199 (25.8%) underwent LP implantation. Compared with TVPs, LPs were associated with a significantly lower risk of overall complications (OR 0.61; 95% CI 0.45–0.81; p < 0.01), dislodgement (OR 0.34; 95% CI 0.20–0.56; p < 0.01), and pneumothorax (OR 0.27; 95% CI 0.16–0.46; p < 0.01). No significant difference in all-cause mortality was observed in the overall analysis (OR 1.43; 95% CI 0.65–3.15; p = 0.35) and in studies with multivariate-adjusted data (OR 1.34; 95% CI 0.65–2.78; p = 0.43). However, LPs were associated with a higher risk of pericardial effusion (OR 2.47; 95% CI 1.39–4.38; p < 0.01) and cardiac tamponade (OR 3.75; 95% CI 2.41–5.83; p < 0.01). LPs also demonstrated a lower pacing capture threshold (MD -0.19 V; 95% CI [-0.23 V]-[-0.16 V]; p < 0.01), but no significant difference in impedance (MD 32.63 ohms; 95% CI [-22.50 ohms]-[87.76 ohms]; p = 0.25).

These findings suggest that LPs were associated with lower overall complication rates and similar effectiveness to TVPs. However, randomized controlled trials are warranted to validate these results.