Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device
Open Access
- 1 January 2016
- journal article
- clinical trial
- Published by Ovid Technologies (Wolters Kluwer Health) in Neurosurgery
- Vol. 78 (1), 133-141
- https://doi.org/10.1227/neu.0000000000001106
Abstract
Flow disruption with WEB is an innovative endovascular approach for wide-neck bifurcation aneurysms. Initial series have shown a low complication rate with good efficacy. To report clinical and anatomical results of the WEB treatment in the cumulated population of WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm) and French Observatory series. WEBCAST and French Observatory are single-arm, prospective, multicenter, Good Clinical Practice studies dedicated to the evaluation of WEB treatment. Ruptured and unruptured bifurcation aneurysms located in the basilar artery, middle cerebral artery, anterior communicating artery, and internal carotid artery terminus were included in both studies. Clinical data were independently evaluated. Postoperative, 6-month (in WEBCAST), and 1-year aneurysm occlusion was independently evaluated with a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. The cumulated population was 113 patients (74 female, 65.5%) 33 to 74 years of age with 114 aneurysms with a mean neck size of 5.6 mm. There was no mortality at 1 month, and morbidity was 2.7%. A statistically significant difference in the rate of occurrence of thromboembolic events was observed between the use of any antiplatelet agent and the use of no antiplatelet agent (P < .001). At 1 year, complete aneurysm occlusion was observed in 56.0%, neck remnant in 26.0%, and aneurysm remnant in 18.0%. Worsening of aneurysm occlusion between the procedure and 12 months was observed in 2.0% and between 6 months and 1 year in 7.1%. The analysis in this large cumulated population of studies confirms favorable safety and efficacy of WEB treatment.Keywords
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