WEBCAST 2 confirms the high safety and efficacy of WEB aneurysm treatment demonstrated in the WEBCAST and French Observatory studies.

BACKGROUND AND PURPOSE:Endoluminal reconstruction with flow-diverting stents represents a widely accepted technique for the treatment of complex intracranial aneurysms. This European registry study analyzed the initial experience of 15 neurovascular centers with the Flow-Redirection Intraluminal Device (FRED) system.

BackgroundWEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2).MethodsAneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.ResultsThe safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%.ConclusionsThis analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms.Clinical trial registrationURL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

IntroductionMechanical thrombectomy (MT) has transformed the treatment of ischemic stroke. However, patient access to MT may be limited due to a shortage of doctors specifically trained to perform MT. The studies reported here were done to (1) develop, operationally define, and seek consensus from procedure experts on the metrics which best characterize a reference procedure for the performance of an MT for ischemic stroke and (2) evaluate their construct validity when implemented in a virtual reality (VR) simulation.MethodsIn study 1, the metrics for a reference approach to an MT procedure for ischemic stroke of 10 phases, 46 steps, and 56 errors and critical errors, were presented to an international Delphi panel of 21 consultant level interventional neuroradiologists (INRs). In study 2, the metrics were used to assess 8 expert and 10 novice INRs performing a VR simulated routine MT procedure.ResultsIn study 1, the Delphi panel reached consensus on the appropriateness of the procedure metrics for a reference approach to MT in ischemic stroke. Group differences in median scores in study 2 demonstrated that experienced INRs performed the case 19% faster (P=0.029), completed 40% more procedure phases (P=0.009), 20% more steps (P=0.012), and made 42% fewer errors (P=0.016) than the novice group.ConclusionsThe international Delphi panel agreed metrics implemented in a VR simulation of MT distinguished between the computer scored procedure performance of INR experts and novices. The studies reported here support the demonstration of face, content, and construct validity of the MT metrics.