Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study - Université de Lorraine Accéder directement au contenu
Article Dans Une Revue Journal de Neuroradiologie / Journal of Neuroradiology Année : 2021

Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study

Résumé

Background and purpose: Flow diverters are considered as an essential tool in the stent-based treatment of complex intracranial aneurysms. We report here a subgroup analysis of the nationwide prospective DIVERSION study to investigate the safety and efficacy of the Silk flow diverter at 12 months follow-up. Methods: We performed a subgroup analysis of patients included in the DIVERSION, a national prospective cohort study including all flow diverters placement between 2012 and 2014 in France, and treated with the Silk. The primary outcome was the morbi-mortality at 12 months, including death, morbidity event and aneurysm retreatment within 12 months post-treatment. All reported serious events were adjudicated by an independent Data Safety and Monitoring Board. Satisfactory occlusion was defined as 3 or 4 on Kamran's scale by an independent imaging core laboratory during follow-up. Results: A total of 102 procedures involving 101 patients (mean age±standard deviation, 54.3±13.5 years) harbouring 118 aneurysms (113/118 located in the anterior circulation; mean size 8.2±7.1mm) were included. During the 12-month follow-up, 34 (33.3%) procedures experienced at least one morbi-mortality event: 3 deaths, 27 morbidity events and 4 retreatments. Overall, 1/3 deaths and 10/27 morbidity events were related to the device and/or the procedure, leading to a specific survival rate and a specific free-morbidity survival rate at 12 months of 98.98% [95% confidence interval, 92.98%-99.86%] and 89.73% [95%CI, 81.71%-94.36%], respectively. The rate of permanent-related neurological deficit was 5.9% within 12 months. One year follow-up imaging showed satisfactory occlusion in 82.2% of cases. Conclusion: Flow diversion with the Silk device has a reasonable safety and effectiveness profile for the endovascular treatment of intracranial aneurysms.
Fichier principal
Vignette du fichier
S0150986120302030.pdf (235.74 Ko) Télécharger le fichier
Origine Fichiers produits par l'(les) auteur(s)

Dates et versions

hal-03269103 , version 1 (13-06-2023)

Licence

Identifiants

Citer

Florent Gariel, Gaultier Marnat, Xavier Barreau, Patrice Menegon, Romain Bourcier, et al.. Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study. Journal de Neuroradiologie / Journal of Neuroradiology, 2021, 48 (4), pp.293-298. ⟨10.1016/j.neurad.2020.06.006⟩. ⟨hal-03269103⟩
70 Consultations
51 Téléchargements

Altmetric

Partager

Gmail Mastodon Facebook X LinkedIn More