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

Area of Science:

• Cardiology
• Medical Devices
• Health Outcomes

Background:

• Transvenous (TV) pacemakers carry inherent complications.
• Leadless pacemakers (LP) offer a potential alternative to reduce these risks.
• Current standard therapy for sinus node dysfunction (SND) without atrioventricular block (AVB) uses TV systems.

Purpose of the Study:

• To compare 30-day complications and 1-year outcomes between AVEIR AR leadless pacemakers and dual-chamber (DCTV) or right-atrial (RATV) transvenous pacemakers.
• To evaluate device-reinterventions and all-cause mortality in patients with SND without AVB.
• To assess the real-world safety and efficacy of leadless pacing technology.

Main Methods:

• Analysis of Medicare fee-for-service claims data for de novo pacemaker implantations (January 2024-March 2025).
• Inclusion of patients with at least 1 year of prior and 30 days of post-implant continuous enrollment.
• Propensity score derived overlap weights were used for adjusted comparisons of outcomes, including 30-day and 1-year complications, device-reinterventions, and mortality.

Main Results:

• A total of 428 AVEIR AR, 39,881 DCTV, and 389 RATV patients were analyzed.
• Thirty-day complications were lower for AVEIR AR compared to DCTV (6.7% vs. 9.4%) and similar to RATV (6.9% vs. 6.7%).
• At 1 year, overall complications were significantly lower for AVEIR AR versus DCTV (3.6% vs. 8.5%) and RATV (3.3% vs. 7.5%), with reduced device-related complications and reinterventions.

Conclusions:

• The AVEIR AR leadless pacemaker is associated with fewer long-term complications and reinterventions compared to DCTV and RATV transvenous pacemakers.
• One-year mortality rates were comparable across all pacemaker groups studied.
• Leadless pacing demonstrates a favorable safety profile for patients with SND without AVB.