Commercial Implant Experience of a Helix-Fixation Dual-Chamber Leadless Pacemaker.

Abstract

Introduction: The AVEIR DR pacemaker (Abbott) is a dual-chamber leadless pacemaker (LP) system that includes right atrial and right ventricular helix-fixation LPs (ALP, VLP), with atrioventricular synchrony maintained via wireless communication between the two devices. The initial, multi-center commercial implant experience of the AVEIR DR dual-chamber LP system has yet to be evaluated.

Methods: Patients indicated for dual-chamber pacing after US commercial release were consecutively included. Implant procedural characteristics were evaluated, and electrical parameters were measured during pre-fixation mapping, post-fixation tether mode, after LP release, and before patient discharge. Any acute procedure- or device-related complications within 30 days were noted.

Results: Patients were implanted with AVEIR DR per standard practice (N = 175 at 8 centers; 72 ± 11 years; 60% male; 62% sinus node dysfunction, 37% AV block; 83% de novo implants). ALPs were implanted predominantly in the base of the right atrial appendage (82%), VLPs in the mid-to-apical right ventricular septum (94%). Pre-fixation mapping allowed repositioning to be avoided in 95% of ALPs and VLPs. The total procedure duration was 64 ± 33 min, from initial incision to final suture, with a cumulative fluoroscopy duration of 13 ± 8 min. In both LPs, capture thresholds and sensed amplitudes improved significantly before patient discharge (ALP 1.2 ± 1.0 V, 2.1 ± 1.1 mV; VLP 0.8 ± 0.6 V, 9.5 ± 3.8 mV). At 30 days post-implant, 99% of patients were complication-free.

Conclusion: The initial commercial experience of the helix-fixation, dual-chamber LP system demonstrated safe and efficient implantation with clinically acceptable electrical metrics and minimal acute complications.