Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study

Mikhael El-Chami, Robert C. Kowal, Kyoko Soejima, Philippe Ritter, G. Duray, Petr Neuzil, Lluis Mont, Alexander Kypta, Venkata Sagi, John Harrison Hudnall, Kurt Stromberg, Dwight Reynolds

Research output: Article

9 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)834-842
Number of pages9
JournalPACE - Pacing and Clinical Electrophysiology
Volume40
Issue number7
DOIs
Publication statusPublished - júl. 1 2017

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Fluoroscopy
Safety
Pericardial Effusion
Cadaver
Teaching
Catheters
Animal Models
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Impact of operator experience and training strategy on procedural outcomes with leadless pacing : Insights from the Micra Transcatheter Pacing Study. / El-Chami, Mikhael; Kowal, Robert C.; Soejima, Kyoko; Ritter, Philippe; Duray, G.; Neuzil, Petr; Mont, Lluis; Kypta, Alexander; Sagi, Venkata; Hudnall, John Harrison; Stromberg, Kurt; Reynolds, Dwight.

In: PACE - Pacing and Clinical Electrophysiology, Vol. 40, No. 7, 01.07.2017, p. 834-842.

Research output: Article

El-Chami, M, Kowal, RC, Soejima, K, Ritter, P, Duray, G, Neuzil, P, Mont, L, Kypta, A, Sagi, V, Hudnall, JH, Stromberg, K & Reynolds, D 2017, 'Impact of operator experience and training strategy on procedural outcomes with leadless pacing: Insights from the Micra Transcatheter Pacing Study', PACE - Pacing and Clinical Electrophysiology, vol. 40, no. 7, pp. 834-842. https://doi.org/10.1111/pace.13094
El-Chami, Mikhael ; Kowal, Robert C. ; Soejima, Kyoko ; Ritter, Philippe ; Duray, G. ; Neuzil, Petr ; Mont, Lluis ; Kypta, Alexander ; Sagi, Venkata ; Hudnall, John Harrison ; Stromberg, Kurt ; Reynolds, Dwight. / Impact of operator experience and training strategy on procedural outcomes with leadless pacing : Insights from the Micra Transcatheter Pacing Study. In: PACE - Pacing and Clinical Electrophysiology. 2017 ; Vol. 40, No. 7. pp. 834-842.
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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.",
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T1 - Impact of operator experience and training strategy on procedural outcomes with leadless pacing

T2 - Insights from the Micra Transcatheter Pacing Study

AU - El-Chami, Mikhael

AU - Kowal, Robert C.

AU - Soejima, Kyoko

AU - Ritter, Philippe

AU - Duray, G.

AU - Neuzil, Petr

AU - Mont, Lluis

AU - Kypta, Alexander

AU - Sagi, Venkata

AU - Hudnall, John Harrison

AU - Stromberg, Kurt

AU - Reynolds, Dwight

PY - 2017/7/1

Y1 - 2017/7/1

N2 - 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.

AB - 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.

KW - clinical trial

KW - leadless pacemaker

KW - learning curve

KW - outcomes

KW - procedure training

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