BACKGROUND: Leadless pacemaker systems have been designed to avoid the need for a pocket and transvenous lead. However, delivery of this therapy requires a new catheter-based procedure. This study evaluates the role of operator experience and different training strategies on procedural outcomes. METHODS: A total of 726 patients underwent implant attempt with the Micra transcatheter pacing system (TPS; Medtronic, Minneapolis, MN, USA) by 94 operators trained in a teaching laboratory using a simulator, cadaver, and large animal models (lab training) or locally at the hospital with simulator/demo model and proctorship (hospital training). Procedure success, procedure duration, fluoroscopy time, and safety outcomes were compared between training methods and experience (implant case number). RESULTS: The Micra TPS procedure was successful in 99.2% of attempts and did not differ between the 55 operators trained in the lab setting and the 39 operators trained locally at the hospital (P = 0.189). Implant case number was also not a determinant of procedural success (P = 0.456). Each operator performed between one and 55 procedures. Procedure time and fluoroscopy duration decreased by 2.0% (P = 0.002) and 3.2% (P < 0.001) compared to the previous case. Major complication rate and pericardial effusion rate were not associated with case number (P = 0.755 and P = 0.620, respectively). There were no differences in the safety outcomes by training method. CONCLUSIONS: Among a large group of operators, implantation success was high regardless of experience. While procedure duration and fluoroscopy times decreased with implant number, complications were low and not associated with case number. Procedure and safety outcomes were similar between distinct training methodologies.

Baptist Heart Specialists Jacksonville Florida

Cardiovascular Section University of Oklahoma Health Sciences Center OU Medical Center Oklahoma City Oklahoma

Clinical Electrophysiology Department of Cardiology Medical Centre Hungarian Defence Forces Budapest Hungary

Department of Cardiac Pacing and Electrophysiology CHU Université de Bordeaux Pessac France and L'Institut de Rythmologie et de Modélisation Cardiaque LIRYC CHU Université de Bordeaux INSERM U1045 Pessac France

Department of Cardiology Kyorin University Hospital Tokyo Japan

Department of Cardiology Linz General Hospital Johannes Kepler University School of Medicine Linz Austria

Division of Cardiology Section of Electrophysiology Department of Medicine Emory University Atlanta Georgia

Homolka Hospital Prague Czech Republic

Hospital Clínic Universitat de Barcelona Barcelona Spain

Medtronic plc Mounds View Minnesota

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The learning curve associated with the implantation of the Nanostim leadless pacemaker