1. Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular Therapy study (WEB-IT).
- Author
-
Fiorella, David, Molyneux, Andy, Coon, Alex, Szikora, Istvan, Saatci, Isil, Baltacioglu, Feyyaz, Aziz-Sultan, Mohammad A., Hoit, Daniel, Delgado Almandoz, Josser E., Elijovich, Lucas, Cekirge, H. Saruhan, Byrne, James, Klisch, Joachim, and Arthur, Adam S.
- Subjects
PATIENT aftercare ,CLINICAL trials ,THERAPEUTIC embolization ,TREATMENT effectiveness ,DIAGNOSTIC imaging ,REOPERATION ,DESCRIPTIVE statistics ,RESEARCH funding ,ADVERSE health care events ,PATIENT safety ,INTRACRANIAL aneurysms ,LONGITUDINAL method ,EVALUATION - Abstract
Introduction The US Woven EndoBridge Intra-saccular Therapy (WEB-IT) study is a pivotal, prospective, single arm, investigational device exemption study to evaluate the safety and effectiveness of the WEB device for the treatment of wide neck bifurcation aneurysms (WNBAs). We present complete 5 year data for the cohort of 150 patients. Methods 150 patients with WNBAs were enrolled at 21 US and six international centers. Imaging from the index procedure, 6 month, 1 year, 3 year, and 5 year follow-up were reviewed by a core laboratory. Adverse events were reviewed and adjudicated by a clinical events adjudicator. Results 83 patients had 5 year follow-up imaging and 123 had clinical follow-up. No ruptured (0/9) or unruptured aneurysm (0/141) rebled or bled during follow-up. No new device or procedure related adverse events or serious adverse events were reported after 1 year. At 5 years, using the LOCF method, complete occlusion was observed in 58.1% and adequate occlusion in 87.2% of patients. For patients with both 1 year and 5 year occlusion statuses available, 76.8% (63/82) of aneurysms remained stable or improved with no retreatment. After 1 year, 18 aneurysms were retreated, 11 of which were adequately occluded at 1 year, and 15 of which were retreated in the absence of any deterioration in occlusion grade. Conclusions Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF