Purpose: WEB Flow disruption is an innovative endovascular treatment for wide-neck bifurcation aneurysms. Safety and efficacy are analyzed in the cumulated population of 3 prospective multicenter GCP (Good Clinical Practice) studies conducted in Europe (WEBCAST, French Observatory, WEBCAST2).
Methods: Patients with wide neck bifurcation aneurysms were included in these 3 studies. An independent medical monitor independently analyzed adverse events. An independent expert in Interventional Neuroradiology evaluated anatomical results at 12 months using the 3 grades scale: complete occlusion, neck remnant, and aneurysm remnant.
Results: A total of 168 patients with 169 aneurysms including 14 ruptured (8.3%) were included in the 3 studies. Eighty-six out 169 aneurysms were located at middle cerebral artery (50.9%), 36/169 at anterior communicating artery (21.3%), 30/169 at basilar artery (17.8%), and 17/169 at internal carotid artery terminus (10.1%). Placement of the WEB device was feasible in 163/169 aneurysms (96.4%). Morbidity and mortality at one month were reported in 4/168 patients (2.4%) and 0/168 patients (0.0%), respectively. Anatomical results at 12 months were complete aneurysm occlusion in 82/149 aneurysms (55.0%), neck remnant in 38/149 aneurysms (25.5%), and aneurysm remnant in 29/149 aneurysms (19.5%).
Conclusion: This analysis in the large cumulated population of 3 GCP studies confirms the high safety of WEB treatment with low morbidity and mortality. At 12 months, adequate occlusion (complete occlusion and neck remnant) was obtained in a high percentage of aneurysms (80.5%).