Dual-Chamber Leadless Pacemaker Implant Procedure Outcomes: Insights from the AVEIR DR i2i Study.

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 (RA) and ventricular (RV) LPs delivering atrioventricular synchronous pacing.

Objective: Evaluate procedural outcomes and learning curve for de novo implantation of the dual-chamber LP (AVEIR DR™, Abbott).

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

Results: De novo dual-chamber LPs were successfully implanted in 446/452 (98.7%) patients by 126 physicians. Mean procedural duration metrics included 90±37 min introducer sheath insertion-to-removal time, 74±32 min dual-chamber procedure, 26±17 min RV LP procedure, 42±24 min RA LP procedure, and 20±13 min fluoroscopy use; between initial vs. advanced implant experience, there were reductions of 19-36% (P<0.05) in these duration metrics. There were 62 procedural complications in 50/452 (11.1%) patients (i.e., 88.9% complication free), predominantly involving cardiac arrhythmias (i.e., atrial fibrillation/flutter or complete atrioventricular block; 16/452, 3.5%). Freedom from complication significantly improved from 88.5% to 97.6% of patients (P<0.05) when comparing initial vs. advanced implant experience.

Conclusions: In a pivotal investigational study, implantation of a dual-chamber LP system was successful in 98.7% of patients. Advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion-to-removal, dual-chamber procedure, VLP and ALP procedures, and fluoroscopy) and improved freedom from complication.