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

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.

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.

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.

AVEIR AR was associated with fewer long-term complications and reinterventions compared with DCTV and RATV, while 1-year mortality remained similar.