Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study

Adam Arthur, Daniel Hoit, Alexander Coon, Josser E.Delgado Almandoz, Lucas Elijovich, Saruhan Cekirge, David Fiorella

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)507-511
Number of pages5
JournalJournal of neurointerventional surgery
Volume10
Issue number5
DOIs
StatePublished - Jan 1 2018

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Physicians
Patient Safety
Education
Equipment and Supplies
Anatomy
Research Personnel
Therapeutics
Fluoroscopy
Aneurysm
Blood Vessels
Neck
Hemodynamics
Technology
Safety

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

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Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study. / Arthur, Adam; Hoit, Daniel; Coon, Alexander; Almandoz, Josser E.Delgado; Elijovich, Lucas; Cekirge, Saruhan; Fiorella, David.

In: Journal of neurointerventional surgery, Vol. 10, No. 5, 01.01.2018, p. 507-511.

Research output: Contribution to journalArticle

Arthur, Adam ; Hoit, Daniel ; Coon, Alexander ; Almandoz, Josser E.Delgado ; Elijovich, Lucas ; Cekirge, Saruhan ; Fiorella, David. / Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study. In: Journal of neurointerventional surgery. 2018 ; Vol. 10, No. 5. pp. 507-511.
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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.",
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