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. 2023 Oct;16(10):e012232.
doi: 10.1161/CIRCEP.123.012232. Epub 2023 Sep 28.

Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model

Rajesh S Banker  1 , Marian K Rippy  2 , Nicole Cooper  3 , Petr Neužil  4 , Derek V Exner  5 , Devi G Nair  6 , Daniel F Booth  3 , David Ligon  3 , Nima Badie  3 , Mark Krans  3 , Kenji Ando  7 , Reinoud E Knops  8 , James E Ip  9 , Rahul N Doshi  10 , Mayer Rashtian  11 , Vivek Y Reddy  4   12
Affiliations
Free article

Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model

Rajesh S Banker et al. Circ Arrhythm Electrophysiol. 2023 Oct.
Free article

Abstract

Background: The clinical utilization of leadless pacemakers (LPs) as an alternative to traditional transvenous pacemakers is likely to increase with the advent of dual-chamber LP systems. Since device retrieval to allow LP upgrade or replacement will become an important capability, the first such dual-chamber, helix-fixation LP system (Aveir DR; Abbott, Abbott Park, IL) was specifically designed to allow catheter-based retrieval. In this study, the preclinical performance and safety of retrieving chronically implanted dual-chamber LPs was evaluated.

Methods: Atrial and ventricular LPs were implanted in the right atrial appendage and right ventricular apex of 9 healthy ovine subjects. After ≈2 years, the LPs were retrieved using a dedicated transvenous retrieval catheter (Aveir Retrieval Catheter; Abbott) by snaring, docking, and unscrewing from the myocardium. Comprehensive necropsy/histopathology studies were conducted to evaluate device- and procedure-related outcomes.

Results: At a median of 1.9 years postimplant (range, 1.8-2.6), all 18 of 18 (100%) LPs were retrieved from 9 ovine subjects without complications. The median retrieval procedure duration for both LPs, from first-catheter-in to last-catheter-out, was 13.3 minutes (range, 2.5-36.4). Postretrieval, all right atrial, and right ventricular implant sites demonstrated minimal tissue disruption, with intact fibrous tissue limited to the distal device body. No significant device-related trauma, perforation, pericardial effusion, right heart or tricuspid valve injury, or chronic pulmonary thromboembolism were observed at necropsy.

Conclusions: This preclinical study demonstrated the safe and effective retrieval of chronically implanted, helix-fixation, dual-chamber LP systems, paving the way for clinical studies of LP retrieval.

Keywords: cardiac pacemaker, artificial; feasibility study; intracardiac catheters; preclinical; right atrium; right ventricle.

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Conflict of interest statement

Disclosures Dr Banker reports consulting fees and research support from Abbott, Boston Scientific, and Medtronic. Dr Rippy reports consulting fees from Abbott. Dr Neužil reports consulting fees from Abbott. Dr Exner reports consulting fees and research grants from Abbott, Boston Scientific, and Medtronic. Dr Nair reports consulting fees, honoraria, research grants and support from and serving on advisory boards for Abbott, Adagio Medical, Biosense Webster, Boston Scientific, and Medtronic. Dr Knops reports consulting fees, research grants, and honoraria from Abbott, Boston Scientific, and Medtronic. Dr Ip reports honoraria, serving as a consultant and on a steering committee for Abbott; and consulting fees and honoraria for Medtronic; and serving on a data safety monitoring committee for Boston Scientific. Dr Doshi reports consulting fees and fellowship support from Abbott, Boston Scientific, and Medtronic. Dr Rashtian reports consulting fees and research grants from Abbott. Dr Reddy has served as a consultant to Abbott; in addition, unrelated to this article, Dr Reddy has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, 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 Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. N. Cooper, D.F. Booth, D. Ligon, Dr Badie, and M. Krans are all employees of Abbott. The other author report no conflicts.

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