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Commercial Implant Experience of a Helix-Fixation Dual-Chamber Leadless Pacemaker
Cyrus A Hadadi1, Ken W Lee2, Monica Lo3
1MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, D.C., USA.
Journal of Cardiovascular Electrophysiology
|May 10, 2025
Summary
The AVEIR DR leadless pacemaker system demonstrated safe and efficient implantation in its initial commercial use. This dual-chamber system showed clinically acceptable electrical metrics and minimal complications in early patient experiences.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Electrophysiology
Background:
- The AVEIR DR is a dual-chamber leadless pacemaker (LP) system using wireless communication for atrioventricular synchrony.
- It features right atrial and right ventricular helix-fixation LPs (ALP, VLP).
- The initial commercial implant experience of this system required evaluation.
Purpose of the Study:
- To evaluate the initial, multi-center commercial implant experience of the AVEIR DR dual-chamber leadless pacemaker system.
- To assess procedural characteristics, electrical parameters, and acute complications.
Main Methods:
- Consecutive patients indicated for dual-chamber pacing were included post-US commercial release.
- Implant procedural characteristics and electrical parameters were measured.
- Acute complications within 30 days were recorded.
Main Results:
- 175 patients were implanted; ALPs in the right atrial appendage (82%), VLPs in the right ventricular septum (94%).
- Successful implantation with minimal repositioning needed (95%).
- Procedure duration averaged 64±33 min; fluoroscopy 13±8 min. Electrical parameters improved significantly, with 99% of patients complication-free at 30 days.
Conclusions:
- The initial commercial experience confirms safe and efficient implantation of the helix-fixation, dual-chamber LP system.
- Clinically acceptable electrical metrics and minimal acute complications were observed.
- This study supports the feasibility of the AVEIR DR system in clinical practice.
