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Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series
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 populatio...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5969386/ https://www.ncbi.nlm.nih.gov/pubmed/28965106 http://dx.doi.org/10.1136/neurintsurg-2017-013448 |
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author | 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 |
author_facet | 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 |
author_sort | Pierot, Laurent |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-5969386 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-59693862018-06-01 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 J Neurointerv Surg Hemorrhagic Stroke 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). BMJ Publishing Group 2018-06 2017-09-30 /pmc/articles/PMC5969386/ /pubmed/28965106 http://dx.doi.org/10.1136/neurintsurg-2017-013448 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Hemorrhagic Stroke 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 Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series |
title | Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series |
title_full | Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series |
title_fullStr | Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series |
title_full_unstemmed | Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series |
title_short | Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series |
title_sort | safety and efficacy of aneurysm treatment with web in the cumulative population of three prospective, multicenter series |
topic | Hemorrhagic Stroke |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5969386/ https://www.ncbi.nlm.nih.gov/pubmed/28965106 http://dx.doi.org/10.1136/neurintsurg-2017-013448 |
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