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Randomized Controlled Trial
. 2024 Aug 30;26(9):euae229.
doi: 10.1093/europace/euae229.

Surgical skill simulation training to proficiency reduces procedural errors among novice cardiac device implanters: a randomized study

Jorio Mascheroni  1   2 , Martin Stockburger  3   4 , Ashish Patwala  5 , Lluís Mont  6   7   8 , Archana Rao  9 , Hartwig Retzlaff  10 , Christophe Garweg  1   11 , Anthony G Gallagher  12   13   14 , Tom Verbelen  1   15
Affiliations
Randomized Controlled Trial

Surgical skill simulation training to proficiency reduces procedural errors among novice cardiac device implanters: a randomized study

Jorio Mascheroni et al. Europace. .

Abstract

Aims: In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications. We investigated how novel proficiency-based progression (PBP) simulation training impacts the surgical quality of implantations, compared to traditional simulation (SIM) training.

Methods and results: In this international prospective study, novice implanters were randomized (blinded) 1:1 to participate in a simulation-based procedure training curriculum, with proficiency demonstration requirements for advancing (PBP approach) or without (SIM). Ultimately, trainees performed the surgical tasks of an implant on a porcine tissue that was video-recorded and then scored by two independent assessors (blinded to group), using previously validated performance metrics. Primary outcomes were the number of procedural Steps Completed, Critical Errors, Errors (non-critical), and All Errors Combined. Thirty novice implanters from 10 countries participated. Baseline experiences were similar between groups. Compared to SIM-trained, the PBP-trained group completed on average 11% more procedural Steps (P < 0.001) and made 61.2% fewer Critical Errors (P < 0.001), 57.1% fewer Errors (P = 0.140), and 60.7% fewer All Errors Combined (P = 0.001); 11/15 (73%) PBP trainees demonstrated the predefined target performance level vs. 3/15 SIM trainees (20%) in the video-recorded performance.

Conclusion: Proficiency-based progression training produces superior objectively assessed novice operators' surgical performance in device implantation compared with traditional (simulation) training. Systematic PBP incorporation into formal academic surgical skills training is recommended before in vivo device practice. Future studies will quantify PBP training's effect on surgery-related device complications.

Keywords: CIED implant; Cardiac resynchronization therapy; Pacing; Proficiency-based progression; Surgical skill; Training.

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Conflict of interest statement

Conflict of interest: J.M. conducted the present research project as part of his PhD studies at KU Leuven, Belgium. J.M. is also an employee of Medtronic. M.S. reports personal fees (honoraria for educational activity) from Medtronic during the conduct of the project and personal fees from Biotronik outside the submitted work; A.P. reports personal fees (honoraria for educational activity) from Medtronic during the conduct of the project; L.M. reports grants and personal fees (support for Fellowship programme, research grants, consulting honoraria) from Medtronic, Abbott, and Boston Scientific during the conduct of the project; A.R. reports teaching honoraria from Medtronic outside the submitted work; H.R. reports personal fees (honoraria for educational activity) from Medtronic during the conduct of the project and outside the submitted work; C.G. reports research funding from Abbott, Biotronik, and Medtronic, and speaker/consultancy fees from Medtronic, Biotronik, and Abbott outside the submitted work; A.G.G. reports personal fees (consulting) from Medtronic during the conduct of the project; T.V. reports personal fees (lectures honoraria) from Medtronic outside the submitted work.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
Figure 1
Study/training flowchart.
Figure 2
Figure 2
Skills training for the surgical CIED procedure on porcine tissue. Tasks illustrated: (A) lead fixation; (B) leads-device connection; (C) system insertion into pocket; (D) wound closure. CIED, cardiac implantable electronic device.
Figure 3
Figure 3
Study flow diagram.
Figure 4
Figure 4
Primary study outcomes from the surgical CIED performance videos. Median, 25th, and 75th rank scores of the objectively assessed performance Metrics in the surgical CIED procedure videos: number of Steps Completed, Critical Errors, Errors (non-critical), All Errors Combined (Errors + Critical Errors). The boxes indicate medians (central line) and 75% and 25% quartiles (upper and lower ends); whiskers represent maximum and minimum values (without outliers); and circles represent outliers. CIED, cardiac implantable electronic device; PBP, proficiency-based progression simulation training group; SIM, traditional simulation training group.
See this image and copyright information in PMC

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