Safety and effectiveness of the LVIS and LVIS Jr devices for the treatment of intracranial aneurysms: Final results of the LEPI multicenter cohort study.
Aneurysm
Device
Intervention
Stent
Journal
Journal of neuroradiology = Journal de neuroradiologie
ISSN: 0150-9861
Titre abrégé: J Neuroradiol
Pays: France
ID NLM: 7705086
Informations de publication
Date de publication:
17 Oct 2023
17 Oct 2023
Historique:
received:
12
07
2023
revised:
16
10
2023
accepted:
16
10
2023
pubmed:
20
10
2023
medline:
20
10
2023
entrez:
20
10
2023
Statut:
aheadofprint
Résumé
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. 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). 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. 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. ClinicalTrial.gov under NCT03553771.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrial.gov under NCT03553771.
Identifiants
pubmed: 37858720
pii: S0150-9861(23)00253-5
doi: 10.1016/j.neurad.2023.10.007
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03553771']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Masson SAS.. All rights reserved.
Déclaration de conflit d'intérêts
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.