Leadless atrial versus transvenous pacing for sinus node dysfunction: 1-year outcomes from the leadless ARRIVE real-world study

BACKGROUND AND AIMS: Leadless pacing was developed to avoid complications inherent to transvenous (TV) pacemakers. Among patients with sinus node dysfunction (SND) without atrioventricular block (AVB), TV systems remain standard therapy. Real-world data have shown favourable safety profiles for leadless vs. TV pacemakers. This study aimed to compare 30-day complications and 1-year outcomes-including complications, device-reinterventions, and all-cause mortality-between AVEIR AR leadless pacemakers (LP) and dual-chamber (DCTV) or right-atrial (RATV) TV pacemakers. METHODS: Medicare fee-for-service claims were analysed to identify patients undergoing de novo AVEIR AR LP or TV pacemaker implantation from January 2024 to March 2025, with ≥1 year of prior and ≥30 days of post-implant continuous enrolment. The DCTV cohort included patients with SND without permanent atrial fibrillation or AVB; the RATV and LP cohorts included all respective recipients. Outcomes included 30-day and 1-year complications, device-reinterventions, and mortality. Comparisons were adjusted using propensity score derived overlap weights. RESULTS: A total of 428 AVEIR AR, 39 881 DCTV, and 389 RATV patients were included. Thirty-day complications were lower with AVEIR AR compared with DCTV (adjusted 6.7% vs. 9.4%; OR = 0.7) and similar to RATV (6.9% vs. 6.7%). At 1 year, overall complications remained lower in AVEIR AR than DCTV (3.6% vs. 8.5%; HR = 0.4) and RATV (3.3% vs. 7.5%; HR = 0.4) cohorts. Device-related complications were reduced vs. DCTV, and reinterventions were reduced vs. both DCTV and RATV. Mortality was comparable across all groups. CONCLUSION: AVEIR AR was associated with fewer long-term complications and reinterventions compared with DCTV and RATV, while 1-year mortality remained similar.