Mikhael El-Chami1, Robert C Kowal2, Kyoko Soejima3, Philippe Ritter4, Gabor Z Duray5, Petr Neuzil6, Lluis Mont7, Alexander Kypta8, Venkata Sagi9, John Harrison Hudnall2, Kurt Stromberg2, Dwight Reynolds10. 1. Division of Cardiology, Section of Electrophysiology, Department of Medicine, Emory University, Atlanta, Georgia. 2. Medtronic plc, Mounds View, Minnesota. 3. Department of Cardiology, Kyorin University Hospital, Tokyo, Japan. 4. 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. 5. Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. 6. Homolka Hospital, Prague, Czech Republic. 7. Hospital Clínic, Universitat de Barcelona, Barcelona, Spain. 8. Department of Cardiology, Linz General Hospital, Johannes Kepler University School of Medicine, Linz, Austria. 9. Baptist Heart Specialists, Jacksonville, Florida. 10. Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City, Oklahoma.
Abstract
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.
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.
Authors: Moghniuddin Mohammed; Juwairiya Arshi; Brian M Ramza; Alan P Wimmer; Daniel A Steinhaus; Michael J Giocondo; Sanjaya K Gupta; Omair K Yousuf Journal: Indian Pacing Electrophysiol J Date: 2020-03-04
Authors: Fleur V Y Tjong; Niek E G Beurskens; Petr Neuzil; Pascal Defaye; Peter-Paul Delnoy; John Ip; Juan Jose Garcia Guerrero; Mayer Rashtian; Rajesh Banker; Vivek Reddy; Derek Exner; Johannes Sperzel; Reinoud E Knops Journal: J Interv Card Electrophysiol Date: 2018-08-13 Impact factor: 1.900