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, Peter Kan

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

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. 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. 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.

Original languageEnglish (US)
Pages (from-to)275-282
Number of pages8
JournalNeurosurgery
Volume89
Issue number2
DOIs
StatePublished - Aug 1 2021

Keywords

  • Brain aneurysm
  • Intrasaccular flow disruption
  • WEB

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Fingerprint

Dive into the research topics of 'Postmarket American Experience with Woven EndoBridge Device: Adjudicated Multicenter Case Series'. Together they form a unique fingerprint.

Cite this