Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series
Authors
Cherian, JacobChen, Stephen R.
Puri, Ajit S.
Vakharia, Kunal
Levy, Elad
Eshraghi, Sheila
Howard, Brian M.
Tong, Frank C.
Cawley, C. Michael
Gross, Bradley
Alexander, Matthew D.
Grandhi, Ramesh
Srinivasan, Visish M.
Burkhardt, Jan-Karl
Johnson, Jeremiah N.
Kan, Peter
UMass Chan Affiliations
Department of RadiologyDocument Type
Journal ArticlePublication Date
2021-05-14Keywords
Brain aneurysmIntrasaccular flow disruption
WEB
Cardiovascular Diseases
Nervous System Diseases
Neurosurgery
Radiology
Metadata
Show full item recordAbstract
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.Source
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
DOI
10.1093/neuros/nyab158Permanent Link to this Item
http://hdl.handle.net/20.500.14038/48532PubMed ID
33989398Notes
Full author list omitted for brevity. For the full list of authors, see article.
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10.1093/neuros/nyab158