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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.
- aneurysm
- blood flow
- stroke
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Footnotes
Contributors All authors of this work met ICMJE criteria for authorship and made substantial contributions to the conception and design, acquisition of data, analysis and interpretation of data, drafting, critical revising, and final approval of this manuscript.
Funding The WEB-IT study was supported by Sequent Medical Inc.
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.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement There are no additional data to share.
Collaborators Methodist University Hospital Neuroscience Institute & Cancer Center, Memphis, TN (21), PI: Adam Arthur, MD, Sub-I: Daniel Hoit, MD, Lucas Elijovich, MD; Stony Brook University Medical Center, Stony Brook, NY (12), PI: David Fiorella, MD, Sub-I: Henry Woo, MD; The Johns Hopkins Hospital, Baltimore, MD (12) PI: Alexander Coon, MD Sub-I: Geoffrey Colby, MD; Koru Hospital, Ankara, Turkey (11) PI: Isil Saatci, MD, Sub-I: Saruhan Cekirge, MD; National Institute of Neurosciences, Budapest, Hungary (10) PI: Istvàn Szikora, MD; Marmara University Faculty of Medicine Pendik Training and Research Hospital, Istanbul, Turkey (9) PI: Feyyaz Baltacioğlu, MD, Sub-I: Ruslan Asadov, MD; Brigham and Women’s Hospital, Boston, MA (8), PI: Ali Sultan, MD Sub-I: Ram Chavali, MD, Kai Frerich, MD; Abbott Northwestern Hospital, Minneapolis, MN (7), PI: Josser Delgado, MD Sub-I: Yasha Kayan, MD; Lyerly Neurosurgery, Baptist Medical Center, Jacksonville, FL (7), PI: Ricardo Hanel, MD Sub-I: Eric Sauvageau, MD; Medical University of South Carolina, Charleston, SC (7), PI: Raymond Turner, MD, Sub-I: Imran Chaudry, MD, Alejandro Spiotta, MD, Aquila Turk, MD; West Virginia University Medical Center, Morgantown, VA (6) PI: Ansaar Rai, MD, Sub-I: Jeffrey Carpenter, MD, Sohyun Boo, MD; Thomas Jefferson University Hospital, Philadelphia, PA (6), PI: Pascal Jabbour, MD, Sub-I Stavropoula Tjoumakaris, MD, Robert Rosenwasser, MD; Fort Sanders Regional Medical Center, Knoxville, TN (5), PI: Keith Woodward; Albany Medical Center, Albany, NY (4) PI: Alan Boulos, MD, Sub-I: John Dalfino, MD, Junichi Yamamoto,MD; Riverside Methodist Hospital, Columbus, OH (4) PI: Nirav Vora, Sub-I: Ronald Budzik,MD. Peter Pema, MD, Thomas Davis, DO; Baptist Memorial Hospital, Memphis, TN (3), PI:Daniel Hoit, MD, Sub-I: Adam Arthur, MD, Lucas Elijovich, MD; Mayo Clinic, Rochester, MN,(3): PI: David Kallmes, MD, Sub-I: Giuseppe Lanzino, MD, Harry Cloft, MD; University at Buffalo Medical Center, Buffalo, NY (2), PI: Adnan Siddiqui, MD, Sub-I: Elad Levy, MD,Kenneth Snyder, MD; Rush University Medical Center, Chicago, IL (2), PI: Demetrius Lopes,MD Sub-I: Michael Chen, MD; Mount Sinai Roosevelt Hospital, New York, NY (2) PI: JDMocco, MD, Sub- I: Johanna Fifi, MD; University of Texas Medical School, Houston, TX (2) PI:Peng Roc Chen; Royal University Hospital, Saskatoon Canada, (2), PI: Michael Kelly, MD, Sub- I: Lissa Peeling, MD; Swedish Medical Center, Englewood, CO (1) PI: Don Frei, MD, Sub-I: Daniel Huddle, DO, Richard Bellon, MD, David Loy, MD; Barrow Neurological Institute, St. Joseph’s Hospital and Medical Center, Phoenix, AZ (1) PI: Felipe Albuquerque, MD Sub-I: Andrew Ducruet, MD; Righospitalet, University of Copenhagen, Copenhagen, Denmark (1), PI: Marcus Holtmannspötter; University of Louisville Hospital, Louisville, KY (1), PI: Robert James, MD, Sub-I: Wei Liu, MD; Helios General Hospital, Erfurt, Germany (1) PI: Joachim Klisch, MD, Sub-I: Christoph Strasilla, MD, Christin Clajus, MD.