The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

Abstract

IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.MethodsOne-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.ResultsOne-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.ConclusionsThe prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.Trial registration number NCT02191618

What is the hemodynamic effect of the Woven EndoBridge? An in vivo quantification using time-density curve analysis

“…This is of special concern in ruptured aneurysms, and in principle it could mean that some aneurysms, especially acutely ruptured, might not be adequately protected in the short term due to persisting aneurysmal wall stress. This hypothesis might be a possible explanation for the re-rupture of WEB-treated aneurysms [16,18] or the occurrence of delayed ipsilateral parenchymal hemorrhage [19]. This hypothesis is further substantiated from our data with one case of delayed rupture of an unruptured aneurysm after WEB deployment.…”

How to WEB: a practical review of methodology for the use of the Woven EndoBridge

“…In the WEB-IT study, only two patients suffered from periprocedural subarachnoid hemorrhage and neither experienced any permanent clinical sequel (figure 12). 15 16…”

Endovascular treatment of basilar tip aneurysms in the era of endosaccular flow disruption: a comparative study

“…The WEB and Contour devices represent a completely different concept: different from stents and intraluminal flow diverter stents, these dense-meshed devices are placed completely in the aneurysm sac and aim to disrupt the blood flow entering and exiting the sac at the level of the neck in order to promote stagnation and thrombus formation. The WEB device proved efficacy and safety in multiple prospective and retrospective multi-centred studies, especially in the treatment of ruptured and wide-necked aneurysms [3][4][5][6][7].…”