BACKGROUND: Aveir DR (Abbott, Abbott Park, IL) is a dual-chamber leadless pacemaker (LP) system with distinct atrial and ventricular LPs (ALP, VLP) that communicate wirelessly to deliver atrioventricular synchronous pacing. Success rates of these implant-to-implant (i2i) transmissions have not been systematically evaluated. OBJECTIVE: This study aims to evaluate chronic i2i success rates in a clinical setting. METHODS: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with dual-chamber LP systems as part of a prospective international clinical trial (Aveir DR i2i Study). The percent of successful i2i transmissions from ALP-to-VLP (A-to-V) and VLP-to-ALP (V-to-A) were interrogated from LPs in de novo patients using the device programmer at implant, discharge, and at 1, 3, and 6 months postimplant (1M, 3M, 6M). RESULTS: A total of 399 patients completed device implant and i2i diagnostic interrogation (62% male; age 69 years; 65% sinus node dysfunction, 32% atrioventricular [AV] block). Median A-to-V and V-to-A i2i success rates exceeded 90% of beats at all time-points from implant to 6M. The minority of patients with A-to-V or V-to-A i2i success in <70% of beats at implant (A-to-V: 19% of patients, V-to-A: 31% of patients) showed roughly 40% improvement by 1M, with this minority dropping to roughly 5% of patients by 6M. Improvement in i2i communication success may be attributed to reprogramming of i2i setting levels, natural changes in dominant posture, and device stabilization. CONCLUSION: Wireless implant-to-implant communication in the new dual-chamber leadless pacemaker system demonstrated successful transmissions in >90% of beats throughout the 6-month evaluation period. Communication success improved significantly over time postimplant for specific subgroups. CLINICAL TRIAL REGISTRATION: Aveir DR i2i Study, ClinicalTrials.gov ID NCT05252702.

Abbott Sunnyvale California

Amsterdam UMC Amsterdam The Netherlands

CHRU Albert Michallon Grenoble France

Cleveland Clinic Foundation Cleveland Ohio

Foothills Medical Centre Calgary Alberta Canada

Heart Center Leipzig GmbH Leipzig Germany

HonorHealth Cardiac Arrhythmia Group Scottsdale Arizona

Mount Sinai Fuster Heart Hospital New York New York

Na Homolce Hospital Prague Czech Republic

San Rossore Private Hospital and Medical Center Pisa Italy

Texas Cardiac Arrhythmia Institute Austin Texas

Tokyo Women's Medical University Tokyo Japan

Weill Cornell Medicine New York Presbyterian Hospital New York New York

Citace poskytuje Crossref.org

Battery longevity of a helix-fixation dual-chamber leadless pacemaker: results from the AVEIR DR i2i Study

Zobrazit více v PubMed

ClinicalTrials.gov
NCT05252702