WEB Treatment of Intracranial Aneurysms: Clinical and Anatomic Results in the French Observatory.
Pierot L., Moret J., Turjman F., Herbreteau D., Raoult H., Barreau X., Velasco S., Desal H., Januel AC., Courtheoux P., Gauvrit JY., Cognard C., Molyneux A., Byrne J., Spelle L.
BACKGROUND AND PURPOSE: Flow disruption with the WEB device is a new technique for the endovascular treatment of wide-neck bifurcation aneurysms. To obtain precise data regarding the safety and efficacy of this treatment with high-quality methodology, the prospective French Observatory study was conducted. Analysis of these data is presented, including 1-year follow-up. MATERIALS AND METHODS: Patients with bifurcation aneurysms for which WEB treatment was indicated were included in this prospective, multicenter Good Clinical Practice study. Clinical data, including adverse events and clinical status at 1 month and 1 year, were collected and independently analyzed by a medical monitor. An independent core laboratory evaluated the anatomic results at 1 year following the procedure. RESULTS: Ten French neurointerventional centers included 62 patients (39 women), 33-74 years of age (mean, 56.6 ± 9.80 years) with 63 aneurysms. Aneurysm locations were the middle cerebral artery in 32 aneurysms (50.8%), anterior communicating artery in 16 (25.4%), basilar artery in 9 (14.3%), and internal carotid artery terminus in 6 (9.5%). Morbidity and mortality at 1 month were, respectively, 3.2% (2/62 patients) and 0.0% (0/62). Morbidity and mortality (unrelated to the treatment) at 1 year were, respectively, 0.0% (0/59) and 3.4% (2/59 patients). At 1 year, complete occlusion was observed in 30/58 aneurysms (51.7%); neck remnant, in 16/58 aneurysms (27.6%); and aneurysm remnant, in 12/58 aneurysms (20.7%). CONCLUSIONS: This prospective French Observatory study showed very good safety of aneurysm treatment with the WEB, with a high rate of adequate aneurysm occlusion at 1 year (79.3%).