Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study
- PMID: 28814528
- DOI: 10.1136/neurintsurg-2017-013310
Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study
Abstract
Introduction: The WEB Intra-saccular Therapy (WEB-IT) trial is an investigational device exemption study to demonstrate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. The neurovascular replicator (Vascular Simulations, Stony Brook, New York, USA) creates a physical environment that replicates patient-specific neurovascular anatomy and hemodynamic physiology, and allows devices to be implanted under fluoroscopic guidance.
Objective: To report the results of a unique neurovascular replicator-based training program, which was incorporated into the WEB-IT study to optimize technical performance and patient safety.
Methods: US investigators participated in a new training program that incorporated full surgical rehearsals on a neurovascular replicator. No roll-in cases were permitted within the trial. Custom replicas of patient-specific neurovascular anatomy were created for the initial cases treated at each center, as well as for cases expected to be challenging. On-site surgical rehearsals were performed before these procedures.
Results: A total of 48 participating investigators at 25 US centers trained using the replicator. Sessions included centralized introductory training, on-site training, and patient-specific full surgical rehearsal. Fluoroscopy and procedure times in the WEB-IT study were not significantly different from those seen in two European trials where participating physicians had significant WEB procedure experience before study initiation.
Conclusions: A new program of neurovascular-replicator-based physician training was employed within the WEB-IT study. This represents a new methodology for education and training that may be an effective means to optimize technical success and patient safety during the introduction of a new technology.
Keywords: aneurysm; blood flow; stroke.
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Conflict of interest statement
Competing interests: The primary Investigators for the WEB-IT trial received institutional salary support for study-related activities. Investigators in the WEB-IT trial also received payment for proctoring cases within the context of the trial. AA received personal fees from Sequent during the conduct of the study; is a consultant for Leica, Medtronic, Microvention, Penumbra, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Serenity, and Synchron outside of the submitted work. DH received personal fees from Sequent during the conduct of the study; and serves as a consultant for Covidien outside of the submitted work. AC received personal fees from Sequent during the conduct of the study; and serves as a consultant for Medtronic, Microvention, and Stryker Neurovascular outside of the submitted work. JDA received personal fees from Sequent during the conduct of the study; and serves as consultant for Medtronic, Penumbra, and Sequent outside of the submitted work. LE received personal fees from Sequent during the conduct of the study; and serves as a consultant for Codman Neurovascular, Medtronic, MicroVention, Penumbra, Sequent, and Stryker outside of the submitted work. SC received personal fees from Sequent during the conduct of the study; and serves as consultant for Medtronic, MicroVention, Sequent outside of the submitted work. DF received personal fees from Sequent during the conduct of the study; and is a consultant for Medtronic, Stryker, Microvention, Penumbra, and Codman; receives research support from Medtronic, Microvention, Penumbra, and royalties from Codman; and is a stockholder for Vascular Simulations outside of the submitted work.
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