Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series

Abstract

BackgroundFlow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy.PurposeTo report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2.MethodsWEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.ResultsThe cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%.ConclusionsThis series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment.Clinical trial registrationFrench Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

An Update on the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction Trial: 1-Year Safety and Angiographic Results

“…Aneurysm occlusion rates in patients treated with the Pul-seRider and evaluated by core lab adjudication were 53% at time of initial treatment and progressed to 67% and 90% for complete and adequate occlusion, respectively. These occlusion rates at 1 year compare favorably with the pooled data from 3 prospective trials using the Woven EndoBridge device (WEB; Sequent Medical, Aliso Viejo, California), 30 which demonstrated complete aneurysm occlusion in 52.9%, Raymond-Roy II in 26.1%, and Raymond-Roy III in 20.9%. These angiographic outcomes demonstrate the immediate utility of the PulseRider as an adjunct to coil embolization of these wide-neck aneurysms arising at the basilar apex and carotid terminus, as well as the stability (no recanalizations were observed) and modest degree of flow diversion afforded as reflected in the progressive occlusion at both 6-and 12-month follow-up.…”

Treatment strategies for recurrent and residual aneurysms after Woven Endobridge implantation

“…In the cumulative population of the three prospective studies WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), WEBCAST-2, and French Observatory, complete and adequate occlusion at 1-year follow-up was observed in 52.9% and 79%, respectively, and retreatment was performed in 6.9% 4. In our series, similar angiographic results were obtained.…”

Factors that determine aneurysm occlusion after embolization with the Woven EndoBridge (WEB)

“…Mid-term adequate occlusion rates in Good Clinical Practice trials have been shown to exceed those of conventional coiling or stent-assisted coiling in similar subsets of aneurysms 9. However, aneurysm recurrence may occur 10.…”