Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series
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Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. / 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; Spelle, Laurent.
In: J NEUROINTERV SURG, Vol. 10, No. 6, 06.2018, p. 553-559.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series
AU - Pierot, Laurent
AU - Moret, Jacques
AU - Barreau, Xavier
AU - Szikora, Istvan
AU - Herbreteau, Denis
AU - Turjman, Francis
AU - Holtmannspötter, Markus
AU - Januel, Anne-Christine
AU - Costalat, Vincent
AU - Fiehler, Jens
AU - Klisch, Joachim
AU - Gauvrit, Jean-Yves
AU - Weber, Werner
AU - Desal, Hubert
AU - Velasco, Stéphane
AU - Liebig, Thomas
AU - Stockx, Luc
AU - Berkefeld, Joachim
AU - Molyneux, Andrew
AU - Byrne, James
AU - Spelle, Laurent
N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
PY - 2018/6
Y1 - 2018/6
N2 - 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).
AB - 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).
KW - Journal Article
U2 - 10.1136/neurintsurg-2017-013448
DO - 10.1136/neurintsurg-2017-013448
M3 - SCORING: Journal article
C2 - 28965106
VL - 10
SP - 553
EP - 559
JO - J NEUROINTERV SURG
JF - J NEUROINTERV SURG
SN - 1759-8478
IS - 6
ER -