Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study
| Autor: | David Fiorella, Saruhan Cekirge, Daniel Hoit, Adam S Arthur, Josser E Delgado Almandoz, Alexander L. Coon, Lucas Elijovich |
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| Rok vydání: | 2017 |
| Předmět: |
Technical success
Investigational device exemption 030218 nuclear medicine & medical imaging World Wide Web 03 medical and health sciences Patient safety 0302 clinical medicine Physicians Humans Medicine Fluoroscopy Protocol (science) medicine.diagnostic_test business.industry Endovascular Procedures Intracranial Aneurysm Prostheses and Implants General Medicine Neurovascular bundle Embolization Therapeutic Technical performance Treatment Outcome Surgery Clinical Competence Patient Safety Neurology (clinical) business Training program 030217 neurology & neurosurgery |
| Zdroj: | Journal of NeuroInterventional Surgery. 10:500-504 |
| ISSN: | 1759-8486 1759-8478 |
| Popis: | IntroductionThe 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.ObjectiveTo 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.MethodsUS 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.ResultsA 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.ConclusionsA 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. |
| Databáze: | OpenAIRE |
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