1. Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort study.
- Author
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Forestier G, Piotin M, Chau Y, Derelle AL, Brunel H, Aggour M, Saleme S, Levrier O, Pierot L, Barreau X, Boubagra K, Janot K, Barbier C, Clarençon F, Chabert E, Spelle L, Arteaga C, Consoli A, Machi P, Blanc R, Rodesch G, Cortese J, Sourour N, Herbreteau D, Heck O, Soize S, Marnat G, Rouchaud A, Anxionnat R, Sedat J, and Mounayer C
- Subjects
- Humans, Female, Male, Middle Aged, Prospective Studies, Treatment Outcome, Aged, Endovascular Procedures instrumentation, Endovascular Procedures methods, Adult, Aneurysm, Ruptured therapy, Aneurysm, Ruptured diagnostic imaging, Intracranial Aneurysm therapy, Intracranial Aneurysm diagnostic imaging, Stents
- Abstract
Background: The Low profile visualized intraluminal support (LVIS)/LVIS Jr is a self-expanding braiding stent for the treatment of intracranial aneurysm. This study is to determine the safety and effectiveness of the LVIS/LVIS Jr for the treatment of intracranial aneurysms in a real-world setting., Methods: This prospective, observational, multicenter study enrolled patients with unruptured, ruptured and recanalized intracranial aneurysms treated with the LVIS stents, between February 2018 to December 2019. Primary endpoint was the cumulative morbidity and mortality rate (CMMR) assessed at 12 months follow-up (FU)., Results: A total of 130 patients were included (62.3 % women, mean age 55.9 ± 11.4) on an intention-to-treat basis. Four patients (3.1 %) had 2 target aneurysms; 134 total aneurysms were treated. The aneurysms were mainly located on the middle cerebral artery (41/134; 30.6 %) and the anterior communicating artery (31/134; 23.1 %). The CMMR at 1 year linked to the procedure and/or device was 4.6 % (6/130). The overall mortality was 1.5 % (2/130), none of these deaths adjudged as being linked to the procedure and/or device. All aneurysms (134/134, 100 %) were successfully treated with LVIS stent and/or other devices. At a mean FU of 16.8 months post-procedure, complete/nearly complete occlusion was achieved in 112 aneurysms (92.6 %), and only 3 patients (2.5 %) required aneurysm retreatment., Conclusion: This study provides evidence that the LVIS/LVIS Jr devices are safe and effective in the treatment of complex intracranial aneurysms, with very high rates of adequate occlusion at FU. These angiographic results are stable over time with an acceptable complication rate., Trial Registration: ClinicalTrial.gov under NCT03553771., Competing Interests: Declaration of Competing Interest MP reports support for attending meetings and/or travel from Balt, and stock or stock options (Basecamp Vascular, Synchron, Radical Catheter, Vastrax, Intradys). LP reports consulting fees from Balt, Microvention, Phenox. FC reports consulting fees from Balt, Medtronic, Microvention, Stryker, stock or stock options (Collavidance, Intradys), and leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid (Artedrone). PM reports consulting fees from Medtronic, Stryker, Artiria, payment to his institution (Codman), and served as chairman of the adverse events monitoring committee for this study, sponsored by Microvention. GM reports consulting fees from Microvention, Balt, Stryker, honoraria for lectures (Medtronic, Johnson & Jonhson). AR reports consulting fees from Balt. The other authors report no conflicts., (Copyright © 2023 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)
- Published
- 2024
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