Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study - Université de Lorraine Access content directly
Journal Articles Journal de Neuroradiologie / Journal of Neuroradiology Year : 2021

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

Abstract

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.
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Dates and versions

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

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Attribution - NonCommercial

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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⟩
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