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

Autor: Pierot, Laurent, Moret, Jacques, Barreau, Xavier, Szikora, Istvan, Herbreteau, Denis, Turjman, Francis, Holtmannspötter, Markus, Januel, Anne-Christine, Costalat, Vincent, Fiehler, Jens, Klisch, Joachim, Gauvrit, Jean-Yves, Weber, Werner, Desal, Hubert, Velasco, Stéphane, Liebig, Thomas, Stockx, Luc, Berkefeld, Joachim, Molyneux, Andrew, Byrne, James
Předmět:
Zdroj: Journal of NeuroInterventional Surgery; Jun2018, Vol. 10 Issue 6, p556-562, 7p, 3 Color Photographs, 1 Diagram, 4 Charts
Abstrakt: 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. Clinical Trial Registration French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322). [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index