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

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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.

Graphical abstract

Helix-fixation single-chamber ventricular leadless pacemakers were implanted in 167 patients, with a median procedure time of 25.5 minutes, 98.8% implant success, and 98.2% freedom from acute adverse events.

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Funding

No funds, grants, or other support was received. Data analysis and manuscript preparation supported by Abbott.

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Authors and Affiliations

  1. Bernards Healthcare, Jonesboro, AR, USA

    Devi G. Nair, Bridget Lee & Brandon Doty

  2. Libin Cardiovascular Institute, Calgary, Canada

    Derek V. Exner

  3. Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Vivek Y. Reddy & Marc A. Miller

  4. Abbott, Sunnyvale, CA, USA

    Nima Badie & David Ligon

  5. MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC, USA

    Athanasios Thomaides, Zayd Eldadah, Malick Islam & Cyrus Hadadi

  6. Arrhythmia Research Group, Jonesboro, AR, USA

    Devi G. Nair

Authors
  1. Devi G. Nair
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  2. Derek V. Exner
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  3. Vivek Y. Reddy
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  4. Nima Badie
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  5. David Ligon
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  6. Marc A. Miller
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  7. Bridget Lee
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  8. Brandon Doty
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  9. Athanasios Thomaides
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  10. Zayd Eldadah
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  11. Malick Islam
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  12. Cyrus Hadadi
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Corresponding author

Correspondence to Devi G. Nair.

Ethics declarations

Research involving human participants and/or animals

This retrospective study was performed according to the principles outlined in the Declaration of Helsinki and the Good Clinical Practice guidelines of the European Commission and was approved by the local ethics committee.

Informed consent

All patients provided written informed consent.

Conflict of interest

DGN has served on the advisory board, served as a consultant, or received honoraria, research grants, or support from Medtronic Inc., Boston Scientific Corporation, Abbott, Biosense Webster, and Adagio Medical. DVE has served as a consultant and received honoraria and research grants from Abbott; and unrelated to this manuscript, serves as a consultant for Boston Scientific, Medtronic, and GE Healthcare and has equity in Clarius, CorVista eMurmur, HelpWear, and ProtonIntel. VYR has served as a consultant to Abbott; and unrelated to this manuscript, he serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. NB and DL are employees of Abbott. ZE received consulting honoraria from AtriCure. MI received honoraria from Boston Scientific and Biosense Webster. CH served as a consultant or received honoraria, research grants, or support from Abbott and Biotronik. NB and DL are employees of Abbott.

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Nair, D.G., Exner, D.V., Reddy, V.Y. et al. Early real-world implant experience with a helix-fixation ventricular leadless pacemaker. J Interv Card Electrophysiol (2024). https://doi.org/10.1007/s10840-024-01791-1

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  • DOI: https://doi.org/10.1007/s10840-024-01791-1

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