Early real-world implant experience with a helix-fixation ventricular leadless pacemaker

Devi G Nair; Derek V Exner; Vivek Y Reddy; Nima Badie; David Ligon; Marc A Miller; Bridget Lee; Brandon Doty; Athanasios Thomaides; Zayd Eldadah; Malick Islam; Cyrus Hadadi

doi:10.1007/s10840-024-01791-1

Early real-world implant experience with a helix-fixation ventricular leadless pacemaker

J Interv Card Electrophysiol. 2024 Mar 20. doi: 10.1007/s10840-024-01791-1. Online ahead of print.

Authors

Devi G Nair^{1

2}, Derek V Exner³, Vivek Y Reddy⁴, Nima Badie⁵, David Ligon⁵, Marc A Miller⁴, Bridget Lee⁶, Brandon Doty⁶, Athanasios Thomaides⁷, Zayd Eldadah⁷, Malick Islam⁷, Cyrus Hadadi⁷

Affiliations

¹ Bernards Healthcare, Jonesboro, AR, USA. drdevignair@gmail.com.
² Arrhythmia Research Group, Jonesboro, AR, USA. drdevignair@gmail.com.
³ Libin Cardiovascular Institute, Calgary, Canada.
⁴ Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁵ , Abbott, Sunnyvale, CA, USA.
⁶ Bernards Healthcare, Jonesboro, AR, USA.
⁷ MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC, USA.

PMID: 38509402
DOI: 10.1007/s10840-024-01791-1

Abstract

Background: Roughly one in six patients receiving conventional transvenous pacemaker systems experience significant complications within 1 year of implant, mainly due to the transvenous lead and subcutaneous pocket. A new helix-fixation single-chamber ventricular leadless pacemaker (LP) system capable of pre-deployment exploratory electrical mapping is commercially available. Such an LP may mitigate complications while streamlining the implantation. In this study, the initial real-world implant experience of the helix-fixation LP was evaluated following its commercial release.

Methods: In patients indicated for single-chamber right ventricular pacing, helix-fixation Aveir VR LPs (Abbott, Abbott Park, IL) were implanted using the dedicated loading tool, introducer, and delivery catheter. Implant procedural characteristics, electrical parameters, and any 30-day procedure-related adverse events of consecutive implant attempts were retrospectively evaluated.

Results: A total of 167 patients with Class I indication for permanent pacing received implants in four North American centers (57% male, 70 years old). Pre-fixation electrical mapping of potential sites allowed repositioning to be avoided in 95.7% of patients. Median [interquartile range] LP procedure and fluoroscopy durations were 25.5 min [20.0, 35.0] and 5.7 min [4.0, 9.2], respectively. Pacing capture threshold, sensed R-wave amplitude, and impedance were 0.8 V [0.5, 1.3], 9.0 mV [6.0, 12.0], and 705 Ω [550, 910], respectively. Implantation was successful in 98.8% of patients, with 98.2% free from acute adverse events.

Conclusions: The initial, real-world experience of the helix-fixation ventricular leadless pacemaker demonstrated safe and efficient implantation with minimal repositioning, viable electrical metrics, and limited acute complications.

Keywords: Aveir; Helix fixation; Implant procedure; Leadless pacemaker; Pacemaker complications; Single-chamber pacemaker.