Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series
Department of Radiology
Cardiovascular Diseases | Nervous System Diseases | Neurosurgery | Radiology
BACKGROUND: The 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.
OBJECTIVE: To review early as-practiced clinical experience with the WEB device in the United States.
METHODS: Retrospective 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.
RESULTS: The 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. Adequate 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.
CONCLUSION: Immediate 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.
Brain aneurysm, Intrasaccular flow disruption, WEB
DOI of Published Version
Cherian J, Chen SR, Puri A, Vakharia K, Levy E, Eshraghi S, Howard BM, Tong FC, Cawley CM, Gross B, Alexander MD, Grandhi R, Srinivasan VM, Burkhardt JK, Johnson JN, Kan P. Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series. Neurosurgery. 2021 May 14:nyab158. doi: 10.1093/neuros/nyab158. Epub ahead of print. PMID: 33989398. Link to article on publisher's site
Cherian J, Chen SR, Puri AS, Vakharia K, Levy E, Eshraghi S, Howard BM, Tong FC, Cawley CM, Gross B, Alexander MD, Grandhi R, Srinivasan VM, Burkhardt J, Johnson JN, Kan P. (2021). Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series. Radiology Publications. https://doi.org/10.1093/neuros/nyab158. Retrieved from https://escholarship.umassmed.edu/radiology_pubs/632