• Neurosurgery · Jul 2021

    Multicenter Study

    Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series.

    • Jacob Cherian, Stephen R Chen, Ajit Puri, Kunal Vakharia, Elad Levy, Sheila Eshraghi, Brian M Howard, Frank C Tong, C Michael Cawley, Bradley Gross, Matthew D Alexander, Ramesh Grandhi, Visish M Srinivasan, Jan-Karl Burkhardt, Jeremiah N Johnson, and Peter Kan.
    • Department of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland, USA.
    • Neurosurgery. 2021 Jul 15; 89 (2): 275-282.

    BackgroundThe Woven EndoBridge (WEB) device was granted premarket approval in the United States following results of the Woven EndoBridge Intrasaccular Therapy (WEB-IT) study. WEB-IT reported excellent adequate angiographic occlusion of treated aneurysms with a high safety profile. These results were achieved, however, in the context of a prospective study with strict inclusion criteria and rigorous training support.ObjectiveTo review early as-practiced clinical experience with the WEB device in the United States.MethodsRetrospective review across 6 institutions identified 91 patients undergoing 92 treatment sessions for WEB device placement in treatment of 91 intracranial aneurysms. Details regarding demographics, aneurysm characteristics, treatment considerations, clinical outcomes, and aneurysm occlusion were obtained and analyzed in a multicenter database. Angiograms from the index procedure and follow-up studies were reviewed by a blinded and independent adjudicator.ResultsThe middle cerebral, anterior communicating, and basilar artery complexes were the commonly treated locations. Eight patients presented with ruptured aneurysms. A mean of 1.2 devices were introduced per case. Technical failure without deployment of a WEB device occurred in 2% (2/92) of sessions. Complete aneurysm occlusion for patients with imaging follow-up was 49% (mean follow-up of 8 mo). Four aneurysms were retreated. 90% of patients had modified Rankin Scale ≤ 2 at last clinical follow-up with no mortalities.ConclusionImmediate postmarket experience with the WEB device, newly introduced at American centers, confirms safe procedural use, but long-term efficacy remains unclear. Early challenges include accurate sizing and device selection.© Congress of Neurological Surgeons 2021.

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