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Multicenter Study
. 2025 Sep;22(9):2391-2400.
doi: 10.1016/j.hrthm.2025.03.1941. Epub 2025 Mar 13.

Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study

Rahul N Doshi  1 , James E Ip  2 , Pascal Defaye  3 , Vivek Y Reddy  4 , Derek V Exner  5 , Robert Canby  6 , Morio Shoda  7 , Maria Grazia Bongiorni  8 , Gerhard Hindricks  9 , Petr Neuzil  10 , Thomas Callahan  11 , Sri Sundaram  12 , Daniel F Booth  13 , Louis-Philippe Richer  13 , Nima Badie  13 , Reinoud E Knops  14
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Free article
Multicenter Study

Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study

Rahul N Doshi et al. Heart Rhythm. 2025 Sep.
Free article

Abstract

Background: Initial results were recently reported for the AVEIR DR i2i study, which involved the percutaneous implantation of a novel dual-chamber leadless pacemaker (LP) system, with right atrial and right ventricular LPs delivering atrioventricular synchronous pacing.

Objective: The purpose of this study was to evaluate procedural outcomes and learning curve for de novo implantation of the dual-chamber LP (AVEIR DR, Abbott, Abbott Park, IL).

Methods: Implant procedure metrics collected during the study were analyzed, including procedural complications within 30 days of implantation. Procedural outcomes were evaluated according to implanter experience: 1-4 vs 9+ dual-chamber LP implant procedures (ie, initial vs advanced implant experience).

Results: De novo dual-chamber LPs were successfully implanted in 446 of 452 patients (99%) by 126 physicians. Mean procedural duration metrics included 90±37 minutes of introducer sheath insertion-to-removal time, 74±32 minutes of dual-chamber procedure duration, 26±17 minutes of right ventricular LP procedure duration, 42±24 minutes of right atrial LP procedure duration, and 20±13 minutes of fluoroscopy duration; between initial and advanced implant experience, there were reductions of 19%-36% (P<.05) in these duration metrics. There were 62 procedural complications in 50 of 452 patients (11.1%) (ie, 88.9% complication free), predominantly involving cardiac arrhythmias (ie, atrial fibrillation/flutter or complete atrioventricular block; 16 of 452 [3.5%]). Freedom from complications significantly improved from 89% to 98% of patients (P<.05) when comparing initial and advanced implant experience.

Conclusion: In a pivotal investigational study, implantation of a dual-chamber LP system was successful in 99% of patients. Advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion to removal, dual-chamber procedure, ventricular LP and atrial LP procedures, and fluoroscopy) and improved freedom from complications.

Trial registration: ClinicalTrials.gov identifier: NCT05252702.

Keywords: AVEIR DR; Dual-chamber leadless pacemaker; Implanter experience; Learning curve; Percutaneous implant procedure.

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Conflict of interest statement

Disclosures Drs Doshi, Ip, Reddy, Exner, Neuzil, Callahan, Sundaram, and Knops report consulting fees from Abbott. Drs Defaye, Exner, and Knops report research grants from Abbott. Drs Exner, Callahan, and Sundaram report honoraria from Abbott. Drs Doshi, Ip, Shoda, Bongiorni, Hindricks, and Knops serve as steering committee members of Abbott. Mr Booth, Dr Richer, and Dr Badie are employees of Abbott. Dr Canby reports no conflicts of interest. Additional Disclosures unrelated to this manuscript are as follows: Dr Doshi serves as a steering committee member of Boston Scientific, Kestra Medical, and Zoll Medical and reports consulting fees from Boston Scientific, Impulse Dynamics, Kestra Medical, and Zoll Medical. Dr Ip reports consulting fees from Medtronic and serves as a data safety monitoring committee member of Boston Scientific. Dr Reddy serves 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, CardioFocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EP Frontiers, Farapulse, Field Medical, Focused Therapeutics, HRT, InterShunt, Javelin, Kardium, Keystone Heart, Laminar Medical, LuxMed, MedLumics, NeuTrace, NuVera–Biosense Webster, Oracle Health, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath, and Valcare; he has served as a consultant for Adagio Medical, Append Medical, AtriAN, BioTel Heart, Biosense Webster, Biotronik, Boston Scientific, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, and Philips; and he has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, NewPace, Nyra Medical, SoundCath, sureCor, and VizaraMed. Dr Canby reports consulting fees from Medtronic. Dr Callahan reports speaking and consulting fees from Medtronic, Philips, Boston Scientific, and ShockWave. Dr Sundaram holds an unrelated patent with Abbott. Dr Knops reports research grants, consulting fees, and serves as a steering committee member of Boston Scientific and reports speaking fees from Medtronic.

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