Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series
| Autor: | Ramesh Grandhi, Jeremiah N. Johnson, Stephen R. Chen, Kunal Vakharia, Peter Kan, Frank C. Tong, Visish M Srinivasan, Bradley A. Gross, Matthew D Alexander, C. Michael Cawley, Elad I. Levy, Ajit S. Puri, Sheila R. Eshraghi, Brian M. Howard, Jan-Karl Burkhardt, Jacob Cherian |
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| Rok vydání: | 2020 |
| Předmět: |
Brain aneurysm
medicine.medical_specialty Ruptured aneurysms Context (language use) 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Aneurysm Modified Rankin Scale Occlusion Medical imaging Medicine Humans Prospective Studies Prospective cohort study Retrospective Studies business.industry Endovascular Procedures Intracranial Aneurysm medicine.disease Embolization Therapeutic United States Surgery Treatment Outcome Neurology (clinical) business 030217 neurology & neurosurgery |
| Zdroj: | Neurosurgery. 89(2) |
| ISSN: | 1524-4040 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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