Mp-453087-1 initial commercial experience of a single-chamber helix-fixation leadless pacemaker

Approximately 1 in 6 conventional, transvenous pacemaker patients experience complications in the first 3 years of implant. The Aveir™ VR pacemaker (Abbott, Abbott Park, IL) is a newly released, single-chamber, ventricular leadless pacemaker (LP), featuring a helix-based fixation mechanism and pre-fixation exploratory electrical mapping capability. By eliminating the lead and subcutaneous pocket, this alternative to transvenous pacemakers may mitigate some related complications while streamlining the implant procedure. Evaluate the initial, multi-center commercial implant experience of the Aveir VR single-chamber, ventricular LP. Patients implanted with an Aveir VR device after commercial release in the United States were consecutively included in this evaluation. Implant procedural characteristics were evaluated, electrical parameters were measured, and any acute procedure-related complications were noted. Patients in 3 centers (N=94, 59% male) were implanted with an Aveir VR LP per standard practice (see representative workflow in figure). The median [interquartile range] total procedure duration was 36.0 [20.0-90.0] min, with a fluoroscopy duration of 6.0 [4.1-10.3] min. For the 79/94 patient subpopulation with procedures limited to an Aveir VR implant (e.g., not concurrent with a lead extraction, ablation, etc.), the total procedure duration was 23.0 [19.0-33.0] min, with a fluoroscopy duration of 5.5 [4.0-9.0] min. Leveraging the Aveir pre-fixation electrical mapping capability (1 site mapped in 67% of patients, 2 sites in 27%, 3-5 sites in 6%), post-fixation repositioning that could increase the risk of clinical complications was avoided in 94% of all patients. LPs were implanted in the low septum (87%), mid septum (10%), and apex (3%) of the right ventricle. Pacing capture threshold @ 0.4 ms, R-wave amplitude, and pacing impedance were 0.8 [0.5-1.3] V, 9.5 [7.5-12.0] mV, and 750 [560-960] Ω. Acute complications were avoided in 99% of all patients; intraprocedural retrieval and repositioning occurred in 1 device to address an acutely elevated capture threshold. The initial, real-world experience of Aveir VR leadless pacemakers with mapping capability demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and minimal acute complications.