Setting the Pace with
AVEIR™ Leadless Pacemakers
Single and Dual Chamber Leadless Pacemakers (LP), only from Abbott
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Clinical Evidence
Leadless pacemakers represent a significant advancement in cardiac pacing technology, offering a promising alternative to traditional transvenous pacemakers.
The key findings of clinical studies outlined here have contributed to our understanding of the safety and efficacy profile of leadless pacemakers. The studies have demonstrated potential to mitigate many of the complications associated with conventional pacing systems, making leadless pacemakers a compelling option for patients requiring cardiac pacing therapy.
In this study, early real-world implantation of the AVEIR AR2 atrial leadless pacemaker in 70 patients demonstrated 100% procedural success, no device-related complications, and improved electrical performance at follow-up. The procedure was efficient, with an average duration of ~12.5 minutes. Projected battery longevity reached ~12.9 years in AAI(R) and AAI(R)+VVI modes, representing a substantial improvement over prior device.
This real-world analysis compared AVEIR DR LP System with dual chamber transvenous pacemakers in de novo patients. At 6 months, AVEIR DR LP System significantly reduced overall complications (4.1% vs 6.9%; HR 0.59), device-related complications (2.8% vs 5.9%; HR 0.48), and reinterventions (2.1% vs 4.3%; HR 0.49), with no difference in mortality or heart failure hospitalizations.
This real-world analysis compared AVEIR AR Atrial LP with dual chamber and right-atrial transvenous pacemakers in sinus node dysfunction patients. Compared with dual chamber transvenous pacemakers, AVEIR AR Atrial LP demonstrated lower 30-day complications (6.7% vs 9.4%; OR 0.7) and significantly lower 1-year overall complications (3.6% vs 8.5%; HR 0.4), with similar mortality. AVEIR AR Atrial LP also reduced device-related complications and device reinterventions versus dual chamber transvenous systems.
This article presents a real-world comparative analysis evaluating the safety of AVEIR VR Ventricular LP vs single chamber transvenous ventricular pacemakers following FDA approval. Compared with transvenous VVI systems, AVEIR VR Ventricular LP demonstrated fewer acute device-related complications (1.4% vs 2.8%, p=0.002), similar overall 30-day complications (6.5% vs 6.8%) and cardiac effusion/perforation rates (0.4% vs 0.3%), and comparable 30-day mortality. At 12 months, AVEIR VR Ventricular LP was associated with a 30% lower overall complication rate (4.1% vs 5.7%, p=0.02), 47% fewer device-related complications (2.8% vs 5.2%, p=0.0002), 61% fewer reinterventions (1.2% vs 3.2%, p<0.0001), and lower all-cause mortality (17.0% vs 18.2%, p=0.02) compared with transvenous ventricular pacing.
View APHRS 2025 Presentations
Commercial Implant Experience of a Helix-Fixation Dual Chamber Leadless Pacemaker (2025)
In this commercial experience of the AVEIR™ DR dual-chamber leadless pacemaker, 175 patients across 8 centers underwent implantation with 99% complication-free outcomes at 30 days. Pre-fixation mapping eliminated repositioning in 95% of atrial and ventricular implants. The mean procedure time was 64 ± 33 minutes with fluoroscopy time of 13 ± 8 minutes. At discharge, electrical performance showed improved capture thresholds and sensed amplitudes. These findings confirm safe, efficient implantation and excellent early performance for the dual-chamber leadless pacing system in real-world practice.
In this AVEIR™ DR i2i study, AVEIR DR system was successfully implanted in 446 patients by 126 physicians. Mean procedure times were 90 ± 37 min (sheath insertion–removal), 74 ± 32 min (dual-chamber procedure), and 20 ± 13 min (fluoroscopy). With increased implant experience (≥9 procedures), procedural times reduced by 19–36% (P<.05), and freedom from complications improved from 89% to 98%. The findings demonstrate a high implant success rate and a clear learning curve, leading to greater procedural efficiency and safety over time.
Early Real‑World Implant Experience with a Helix‑Fixation Ventricular Leadless Pacemaker (2024)
In this multicenter real-world study of 167 patients, implantation of the helix-fixation AVEIR™ Ventricular Leadless Pacemaker was successful in 98.8% of cases across 4 centers. Pre-fixation mapping eliminated the need for repositioning in 95.7% of implants, with median procedure and fluoroscopy times of 25.5 and 5.7 minutes, respectively. 98.2% of patients were free from acute adverse events. These results demonstrate a safe, efficient implant procedure with excellent electrical performance and low complication rates for the helix-fixation leadless system.
Atrioventricular Synchrony Delivered by a Dual Chamber Leadless Pacemaker System (2024)
In this multicenter trial of 464 patients, the AVEIR™ Dual Chamber Leadless Pacemaker System demonstrated exceptional performance in maintaining atrioventricular (AV) synchrony. 98% AV synchrony was achieved across all postures and activities at 3 months post-implant, surpassing both atrial-to-ventricular and ventricular-to-atrial i2i communication success rates (94%). The findings confirm robust, beat-to-beat AV synchrony and reliable wireless communication in real-world physiologic conditions.
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