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

Laurent Pierot (1) , Jacques Moret (2, 3) , Xavier Barreau (4) , Istvan Szikora (5) , Denis Herbreteau (6) , Francis Turjman (7) , Markus Holtmannspötter (8) , Anne-Christine Januel (9) , Vincent Costalat (10, 11) , Jens Fiehler (12) , Joachim Klisch (13) , Jean-Yves Gauvrit (14, 15) , Werner Weber (16) , Hubert Desal (17) , Stéphane Velasco (18) , Thomas Liebig (19) , Luc Stockx (20) , Joachim Berkefeld (21) , Andrew Molyneux (22) , James Byrne (22) , Laurent Spelle (3)

1 Hôpital Maison Blanche
2 MECADEV - Mécanismes Adaptatifs et Evolution
3 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
4 CHU de Bordeaux Pellegrin [Bordeaux]
5 NICN - National Institute of Clinical Neurosciences [Budapest]
6 CHU Trousseau [Tours]
7 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
8 Rigshospitalet [Copenhagen]
9 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
10 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
11 IGF - Institut de Génomique Fonctionnelle
12 UKE - Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg]
13 Helios Klinikum [Erfurt]
14 VisAGeS - Vision, Action et Gestion d'informations en Santé
15 Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes]
16 Universitätsklinikum Knappschaftskrankenhaus = University Hospital Knappschaftskrankenhaus [Bochum]
17 CHU Nantes - Centre Hospitalier Universitaire de Nantes
18 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
19 Uniklinik Köln - Universitätsklinikum Köln
20 ZOL - Ziekenhuis Oost-Limburg
21 Universitätsklinikum Frankfurt
22 University of Oxford

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\textpm10.2 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. CLINICAL TRIAL REGISTRATION: French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

Mots clés: Aneurysm

Domaines: Sciences du Vivant [q-bio]

Laurent Pierot, Jacques Moret, Xavier Barreau, Istvan Szikora, Denis Herbreteau, et al.. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. Journal of Neurointerventional Surgery, 2018, 10 (6), pp.553-559. ⟨10.1136/neurintsurg-2017-013448⟩. ⟨hal-01743902⟩