Leadless Versus Transvenous Pacing: Propensity‐Matched 12‐Month Outcomes

ABSTRACT Background Leadless pacemakers avoid the subcutaneous pocket and transvenous lead required for conventional pacing, but comparative real‐world evidence in patients at high cardiorenal risk remains limited. Methods We conducted a single‐center retrospective cohort study of de novo permanent pacemaker recipients between January 2021 and December 2024. The source cohort comprised 150 leadless and 410 transvenous pacemaker recipients. After 1:2 propensity score matching, 150 and 300 patients, respectively, were analyzed. The primary endpoint was the first occurrence of a prespecified 12‐month device‐related complication composite. A prespecified analysis evaluated patients aged 65 years or older with type 2 diabetes mellitus and chronic kidney disease. Results The primary endpoint occurred in 6.7% of leadless and 14.0% of transvenous recipients (risk ratio, 0.48; 95% confidence interval, 0.25–0.92; p = 0.028), an absolute difference of 7.3 percentage points (95% confidence interval, 1.1–12.6). The time‐to‐event association was similar (hazard ratio, 0.45; 95% confidence interval, 0.23–0.90; p = 0.024) and remained consistent after parsimonious adjustment and competing‐risk analysis. The difference was mainly driven by pocket‐, lead‐, and thoracic access‐related events. After pocket‐ and lead‐specific events were excluded, serious complication rates were 5.3% in both groups. Findings in the older diabetes plus chronic kidney disease subgroup were directionally consistent but imprecise. Conclusions The observed advantage of leadless pacing was primarily structural, reflecting avoidance of complications inherent to the transvenous pocket‐and‐lead system. Non‐pocket/non‐lead serious complications were similar between groups.