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Leadless Atrial Pacing: Real-World Evidence of Safety, Efficiency, and the Potential Shift Away from Transvenous Systems

Abbott Cardiac Rhythm Management | July 14, 2025

Multiple presentations at HRS 2025 emphasized the growing role of leadless atrial pacing as a safe, efficient, and clinically effective alternative to traditional transvenous systems—particularly for patients with sinus node dysfunction and intact atrioventricular (AV) conduction. Here are a few highlights to note.

Dr. Cyrus Hadadi of the MedStar Heart & Vascular Institute in Washington DC shared real-world multicenter data on the AVEIR™ AR Atrial Leadless Pacemaker (LP), which included 75 patients across three centers. The study reported:

100% implant success rate with no complications within 30 days post-implantation.

Pre-fixation mapping proved highly effective with 95% of implants requiring no repositioning.

Procedurally, the average total duration for the implant was 36 ± 33 minutes with an average implant time of 21 ± 14 minutes and fluoroscopy time of 7 ± 8 minutes. Electrical performance demonstrated significant improvements in pacing thresholds and sensed P-wave amplitudes by discharge, while impedance values remained stable, highlighting both procedural efficiency and clinical safety and efficacy.

To complement this data, a real-world comparison of AVEIR AR Atrial LP with traditional transvenous atrial pacemakers (TVAP) in Medicare patients further underscored the advantages of leadless pacing. The analysis included 125 AVEIR AR Atrial LP patients and 1,079 TVAP patients. At 30 days, complication rates were lower for AVEIR AR Atrial LP, especially in terms of device-related issues.

At the three month mark:

AVEIR AR Atrial LP continued to show favorable outcomes with a 0% reintervention rate compared to 4.6% for TVAP.

A trend was shown toward fewer overall and device-related complications with AVEIR AR Atrial LP, 0.9% vs 4.8%.

Adjusted three-month mortality was significantly lower in the AVEIR AR Atrial LP group at 2.7% compared to 5.3% for the transvenous group.

Dr. Roderick Tung of the University of Arizona College of Medicine reinforced these findings in his presentation by addressing the anatomical and procedural limitations of both transvenous and left bundle branch area pacing (LBBAP) systems. These include risks such as tricuspid regurgitation, vascular complications, and infection. He emphasized that the AVEIR AR Atrial LP offers a safer, less invasive alternative that avoids chest scars and lead-related issues. Although technical challenges persist—especially in patients with complex anatomy—early clinical results remain encouraging. Dr. Tung advocated for minimizing unnecessary ventricular pacing with leadless AAI pacing as a safer approach to Sinus Node Dysfunction patient management.

Dr. Devi Nair of St. Bernard’s Heart and Vascular Center in Arkansas offered a forward-looking view of a fully modular leadless system during her presentation. Through case studies, she demonstrated how the AVEIR™ DR Dual Chamber LP System allows tailored therapy and adaptability over time with implant-to-implant (i2i™) communication. Her insights support the broader movement toward a modular and upgradeable approach to cardiac rhythm management—one that is increasingly patient-specific, future-ready, and minimally invasive.

All this data signals a potential shift in the field of electrophysiology, positioning leadless atrial pacing not just as a viable alternative, but as a frontrunner in the evolution of bradycardia therapy.

View all three presentations or visit the AVEIR AR Atrial LP page to find case studies and more.

For more on the exciting developments that occurred at HRS 2025, read about Mode Optimization in Leadless Pacing: Unlocking Battery Longevity and Tailored Therapy.