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. 2024 Oct;21(10):1929-1938.
doi: 10.1016/j.hrthm.2024.04.091. Epub 2024 Apr 30.

Six-month electrical performance of the first dual-chamber leadless pacemaker

Gerhard Hindricks  1 , Rahul Doshi  2 , Pascal Defaye  3 , Derek V Exner  4 , Vivek Y Reddy  5 , Reinoud E Knops  6 , Robert Canby  7 , Morio Shoda  8 , Maria Grazia Bongiorni  9 , Petr Neužil  10 , Thomas Callahan  11 , Sri Sundaram  12 , Nima Badie  13 , James E Ip  14
Affiliations
Free article

Six-month electrical performance of the first dual-chamber leadless pacemaker

Gerhard Hindricks et al. Heart Rhythm. 2024 Oct.
Free article

Abstract

Background: The first dual-chamber leadless pacemaker (DC-LP) system consists of 2 separate atrial and ventricular devices that communicate to maintain synchronous atrioventricular pacing and sensing. The initial safety and efficacy were previously reported.

Objective: The purpose of this study was to evaluate the chronic electrical performance of the DC-LP system.

Methods: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with the DC-LP system (Aveir DR, Abbott), including right atrial and ventricular helix-fixation LPs (atrial leadless pacemaker [ALP], ventricular leadless pacemaker [VLP]). Pacing capture threshold, sensed amplitude, and pacing impedance were collected using the device programmer at prespecified timepoints from 0-6 months postimplant.

Results: De novo devices were successfully implanted in 381 patients with complete 6-month data (62% male; age 69 ± 14 years; weight 82 ± 20 kg; 65% sinus nodal dysfunction, 30% atrioventricular block). ALPs were implanted predominantly in the right atrial appendage anterior base and VLPs primarily at the mid-to-apical right ventricular septum. From implant to 1 month, pacing capture thresholds (0.4-ms pulse width) improved in both ALPs (2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.001) and VLPs (0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.001). Sensed amplitudes improved in both ALPs (1.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001) and VLPs (8.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001). Impedances were stable in ALPs (334 ± 68 Ω to 329 ± 52 Ω; P = .17) and reduced in VLPs (789 ± 351 Ω to 646 ± 190 Ω; P <.001). Electrical measurements remained relatively stable from 1-6 months postimplant. No differences in electrical metrics were observed among ALP or VLP implant locations.

Conclusion: This first in-human evaluation of the new dual-chamber leadless pacemaker system demonstrated reliable electrical performance throughout the initial 6-month evaluation period.

Keywords: Aveir DR; Chronic pacing; Dual chamber; Helix fixation; Leadless pacemaker; Pacing capture threshold; Sensed amplitude.

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Conflict of interest statement

Disclosures Dr Rahul Doshi, Dr Derek V. Exner, Dr Vivek Y. Reddy, Dr Reinoud E. Knops, Dr Petr Neužil, Dr Thomas Callahan, Dr Sri Sundaram, and Dr James E. Ip report Abbott consulting fees. Dr Pascal Defaye, Dr Derek V. Exner, and Dr Reinoud E. Knops report Abbott research grants. Dr Derek V. Exner, Dr Thomas Callahan, and Dr Sri Sundaram report Abbott honoraria. Dr Gerhard Hindricks, Dr Rahul Doshi, Dr Reinoud E. Knops, Dr Morio Shoda, Dr Maria Grazia Bongiorni, and Dr James E. Ip serve as Abbott steering committee members. Dr Nima Badie is an Abbott employee. Additional Disclosures unrelated to this manuscript: Dr Petr Neužil reports research grants from Boston Scientific and Medtronic. Dr Derek V. Exner serves as a consultant for Boston Scientific, Medtronic, and GE Healthcare; and has equity in Clarius, CorVista eMurmur, HelpWear, and ProtonIntel. Dr Vivek Y. Reddy 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, Laminar Medical, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare. Dr Vivek Y. Reddy has served as a consultant for Adagio Medical, 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. Dr Reinoud E. Knops reports research grants, consulting fees, and serves as a steering committee member of Boston Scientific; and reports speaking fees from Medtronic. Dr Robert Canby reports consulting fees from Medtronic. Dr Thomas Callahan reports speaking and consulting feeds from Medtronic, Philips, Boston Scientific, and ShockWave. Dr Sri Sundaram holds an unrelated patent with Abbott. Dr James E. Ip reports consulting fees from Medtronic and serves as a data safety monitoring committee member of Boston Scientific. All other authors have no conflicts of interest to disclose.

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