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Clinical Trial
. 2016 Jan;78(1):133-41.
doi: 10.1227/NEU.0000000000001106.

Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory)

Laurent Pierot  1 , Laurent Spelle, Andrew Molyneux, James Byrne; WEBCAST and French Observatory Investigators
Affiliations
Clinical Trial

Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory)

Laurent Pierot et al. Neurosurgery. 2016 Jan.

Abstract

Background: Flow disruption with WEB is an innovative endovascular approach for wide-neck bifurcation aneurysms. Initial series have shown a low complication rate with good efficacy.

Objective: To report clinical and anatomical results of the WEB treatment in the cumulated population of WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm) and French Observatory series.

Methods: WEBCAST and French Observatory are single-arm, prospective, multicenter, Good Clinical Practice studies dedicated to the evaluation of WEB treatment. Ruptured and unruptured bifurcation aneurysms located in the basilar artery, middle cerebral artery, anterior communicating artery, and internal carotid artery terminus were included in both studies. Clinical data were independently evaluated. Postoperative, 6-month (in WEBCAST), and 1-year aneurysm occlusion was independently evaluated with a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.

Results: The cumulated population was 113 patients (74 female, 65.5%) 33 to 74 years of age with 114 aneurysms with a mean neck size of 5.6 mm. There was no mortality at 1 month, and morbidity was 2.7%. A statistically significant difference in the rate of occurrence of thromboembolic events was observed between the use of any antiplatelet agent and the use of no antiplatelet agent (P < .001). At 1 year, complete aneurysm occlusion was observed in 56.0%, neck remnant in 26.0%, and aneurysm remnant in 18.0%. Worsening of aneurysm occlusion between the procedure and 12 months was observed in 2.0% and between 6 months and 1 year in 7.1%.

Conclusion: The analysis in this large cumulated population of studies confirms favorable safety and efficacy of WEB treatment.

Trial registration: ClinicalTrials.gov NCT01778322.

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References

    1. Cognard C, Pierot L, Anxionnat R, Ricolfi F. Clarity Study Group. Results of embolization used as the first treatment choice in a consecutive nonselected population of ruptured aneurysms: clinical results of the Clarity GDC study. Neurosurgery. 2011;69(4):837–841. - PubMed
    1. Pierot L, Spelle L, Vitry F. ATENA Investigators. Clinical outcome of patients harbouring unruptured intracranial aneurysms treated by endovascular approach: results of the ATENA trial. Stroke. 2008;39(9):2497–2504. - PubMed
    1. Pierot L, Cognard C, Spelle L, Moret J. Safety and efficacy of balloon remodeling technique during endovascular treatment of intracranial aneurysms: critical review of the literature. AJNR Am J Neuroradiol. 2012;33(1):12–15. - PMC - PubMed
    1. Pierot L, Spelle L, Leclerc X, Cognard C, Bonafé A, Moret J. Endovascular treatment of unruptured intracranial aneurysms: comparison of safety of remodeling technique and standard treatment with coils. Radiology. 2009;251(3):846–855. - PubMed
    1. Pierot L, Cognard C, Anxionnat R, Ricolfi F. CLARITY Investigators. Remodeling technique for endovascular treatment of ruptured intracranial aneurysms had a higher rate of adequate postoperative occlusion than did conventional coil embolization with comparable safety. Radiology. 2011;258(2):546–553. - PubMed

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