Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker

• Type of Material: Article
• Authors: Mikhael El Chami, Emory University; Timothy Shinn, Michigan Heart; Sundeep Bansal, Lancaster Gen Hlth; Jose L Martinez-Sande, University Clinical Hospital of Santiago de Compostela; Nicolas Clementy, Centre Hospitalier Régional Universitaire de Tours; Ralph Augostini, Ohio State University; Bipin Ravindran, Michigan Heart; Venkata Sagi, Baptist Medical Center, Jacksonville Florida; Hemanth Ramanna, Haga Teaching Hospital; Christophe Garweg, University Hospital Leuven; Paul R Roberts, Univ Hosp Southampton NHS Fdn Trust; Kyoko Soejima, Kyorin University; Kurt Stromberg, Medtronic Inc; Dedra H Fagan, Medtronic Inc; Nicky Zuniga, Medtronic Inc; Jonathan P Piccini, Duke University
• Language: English
• Date: 2021-01-23
• Publisher: WILEY
• Publication Version: Final Published Version
• Copyright Statement: © 2021 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals LLC
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1111/jce.14881
• Title of Journal or Parent Work: JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY
• Volume: 32
• Issue: 3
• Start Page: 832
• End Page: 841
• Grant/Funding Information: The Micra Post‐Approval Registry (ClinicalTrials.gov identifier: NCT02536118), Micra Continued Access Study (ClinicalTrials.gov identifier: NCT02488681), and Micra Transcatheter Pacing Study (ClinicalTrials.gov identifier: NCT02004873) are funded by Medtronic, Inc
• Keywords: Cardiac & Cardiovascular Systems; Cardiovascular System & Cardiology; Life Sciences & Biomedicine; leadless pacemaker; Science & Technology; AV node ablation; Micra
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

Background: The feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA. Methods: Patients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA. Baseline characteristics, acute and follow-up outcomes, and electrical performance were compared between patients with and without AVNA during the follow-up period. Results: A total of 192 patients (mean age 77.4 ± 8.9 years, 72% female) underwent AVNA at the time of Micra implant and were followed for 20.4 ± 15.6 months. AVNA patients were older, more frequently female, and tended to have more co-morbid conditions compared with non-AVNA patients (N = 2616). Implant was successful in 191 of 192 patients (99.5%). The mean pacing threshold at implant was 0.58 ± 0.35 V and remained stable during follow-up. Major complications within 30 days occurred more frequently in AVNA patients than non-AVNA patients (7.3% vs. 2.0%, p <.001). The risk of major complications through 36-months was higher in AVNA patients (hazard ratio: 3.81, 95% confidence interval: 2.33–6.23, p <.001). Intermittent loss of capture occurred in three AVNA patients (1.6%), all were within 30 days of implant and required system revision. There were no device macrodislodgements or unexpected device malfunctions. Conclusion: Concomitant AVN ablation and leadless pacemaker implant is feasible. Pacing thresholds are stable over time. However, patient comorbidities and the risk of major complications are higher in patients undergoing AVNA.