Background Flow 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.
Purpose To 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.
Methods WEBCAST, 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.
Results The 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%.
Conclusions This 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.
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Contributors All authors have provided a substantial contribution to the conception and design of the studies and/or the acquisition and/or the analysis of the data and/or the interpretation of the data; drafted the work or revised it for significant intellectual content; approved the final version of the manuscript; agree to be accountable for all aspects of the work, including its accuracy and integrity.
Funding WEBCAST, WEBCAST-2, and French Observatory have been funded by Sequent.
Competing interests LP: consultant for Balt, Microvention, Neuravi, and Penumbra. JM: consultant for Medtronic, Microvention, Stryker, and Balt. XB: consultant for Microvention and Stryker. ISI: consultant for Codman, Medtronic, Sequent, and Stryker. VC: consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker. JF: has received fees as consultant or lecturer from Acandis, Bayer, Boehringer-Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker; his institution received funding from MicroVention, Medtronic, BMBF, BMWi, DFG, EU. JK: consultant for Microvention/Sequent. WW: consultant for Microvention, Phenox, and Medtronic. TL: consultant for Medtronic, Mentice, Microvention, and Route92. AM: consultant for Microvention/Sequent and Cerus Endovascular. JB: consultant and shareholder for Oxford Endovascular Ltd; his institution received funding from MicroVention. LS: consultant for Stryker, MicroVention, Medtronic, Balt. J-YG, HD, and SV have no disclosures.
Patient consent Obtained.
Ethics approval Reims institutional review board.
Provenance and peer review Not commissioned; externally peer reviewed.
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