Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study
Rahul N. Doshi, James E. Ip, Pascal Defaye, Vivek Y. Reddy, Derek V. Exner, Robert C. Canby, Morio Shoda, Maria Grazia Bongiorni, Gerhard Hindricks, Petr Neužil, Thomas Callahan, Sri Sundaram, Daniel Booth, Louis‐Philippe Richer, Nima Badie, Reinoud E. Knops
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.