Trends and In-Hospital Outcomes of Conventional Transvenous Pacemaker vs. Leadless Pacemaker　― Nationwide Matched Control Study Using the JROAD-DPC Database ―

Background: Nationwide data on in-hospital deaths and complications between leadless pacemakers (LPMs) and transvenous pacemakers (TVPMs) in Japan remain limited. Methods and Results: Using a nationwide database, we identified adults who underwent TVPM or LPM implantation between 2017 and 2023. LPM implantation increased from 0.5% to 25% (P for trend <0.001). LPMs were selected more often as patient age increased and those undergoing dialysis or with dementia and atrial fibrillation (P<0.001). After propensity score matching (12,599 per group), composite outcomes (in-hospital deaths and all complications) were comparable between the LPM and TVPM groups (5.41% vs. 5.59%, respectively; P=0.44; odds ratio [OR] 0.95; 95% confidence interval [CI] 0.84–1.07). All-cause in-hospital death did not differ between groups (LPM, 1.09%; TVPM, 1.05%; P=0.55; OR 1.07; 95% CI 0.83–1.38), whereas all-cause death within 7 days after implantation was higher in the LPM group (0.58% vs. 0.33%; P=0.003; OR 1.80; 95% CI 1.21–2.67). All complications was comparable between the LPM and TVPM groups (LPM, 4.78%; TVPM, 4.82%; P=0.59; OR 0.96; 95% CI 0.85–1.09), but cardiac tamponade was more frequent in the LPM group (0.29% vs. 0.06%; P<0.001; OR 5.42; 95% CI 2.38–12.32). Conclusions: Composite outcomes were comparable between the LPM and TVPM groups, but the rates of cardiac tamponade and all-cause death within 7 days after implantation were higher in the LPM group.