Leadless pacemaker versus transvenous single-chamber pacemaker therapy: A propensity score-matched analysis

Background: The recent introduction of leadless pacemakers (PMs) was aimed to eliminate transvenous lead- and pocket-related complications. While the initial results with the leadless PMs seem promising, the nonrandomized nature, limited implant experience of operators, and short follow-up period of these studies preclude a simple comparison to transvenous PMs. Objectives: The objective of this study was to provide a balanced comparison of leadless and transvenous single-chamber PM therapies through a propensity score-matched analysis. Methods: Leadless patients from 3 experienced leadless implant centers were propensity score-matched to VVI-R patients from a contemporary prospective multicenter transvenous PM registry. The primary outcome was device-related complications that required invasive intervention during mid-term follow-up. Separate analyses including and excluding PM advisory–related complications were performed. Results: A total of 635 patients were match-eligible (leadless: n = 254; transvenous: n = 381), of whom 440 patients (median age 78 years; interquartile range 70–84 years; 61% men) were successfully matched (leadless: n = 220 vs transvenous: n = 220). The complication rate at 800 days of follow-up was 0.9% (95% confidence interval [CI] 0%–2.2%) in the leadless group vs 4.7% (95% CI 1.8%–7.6%) in the transvenous group when excluding PM advisory–related complications (P =.02). When including these PM advisory–related complications, the complication rate at 800 days increased to 10.9% (95% CI 4.8%–16.5%) in the leadless group vs 4.7% (95% CI 1.8%–7.6%) in the transvenous group (P =.063). Conclusion: This study reveals favorable complication rates for leadless compared to transvenous single-chamber pacing therapy at mid-term follow-up in a propensity score-matched cohort. When including PM advisory–related complications, this advantage is no longer observed.