Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2024 Oct;67(7):1539-1545.
doi: 10.1007/s10840-024-01791-1. Epub 2024 Mar 20.

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

Devi G Nair  1   2 , Derek V Exner  3 , Vivek Y Reddy  4 , Nima Badie  5 , David Ligon  5 , Marc A Miller  4 , Bridget Lee  6 , Brandon Doty  6 , Athanasios Thomaides  7 , Zayd Eldadah  7 , Malick Islam  7 , Cyrus Hadadi  7
Affiliations
Multicenter Study

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

Devi G Nair et al. J Interv Card Electrophysiol. 2024 Oct.

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.

PubMed Disclaimer

References

    1. Cantillon DJ, et al. Complications and health care costs associated with transvenous cardiac pacemakers in a nationwide assessment. JACC: Clinical Electrophysiology. 2017;3(11):1296–305. - PubMed
    1. Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014;35(18):1186–94. - DOI - PubMed
    1. Udo EO, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012;9(5):728–35. - DOI - PubMed
    1. Tobin K, Stewart J, Westveer D, Frumin H. Acute complications of permanent pacemaker implantation: their financial implication and relation to volume and operator experience. Am J Cardiol. 2000;85(6):774–6. - DOI - PubMed
    1. Sattar Y, et al. Complications of leadless vs conventional (lead) artificial pacemakers – a retrospective review. J Community Hosp Intern Med Perspect. 2020;10(4):328–33. - DOI - PubMed - PMC

Publication types

LinkOut - more resources