Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study - 03/06/21
, Gaultier Marnat a , Xavier Barreau a , Patrice Menegon a , Romain Bourcier b , Laurent Pierot c , Lauren Spelle d , Alain Bonafé e , Francis Turjman f , Benjamin Gory g, h , Jérôme Berge a DIVERSION investigators
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Highlights |
• | Flow diverters are essential tools in the stent-based treatment of complex intracranial aneurysms. |
• | DIVERSION was a national prospective cohort study including all flow diverters placement between 2012 and 2014 in France. |
• | We performed a subgroup analysis of patients included in the DIVERSION and treated with the Silk flow diverter. |
• | Flow diversion with the Silk device is safe and effective in the endovascular treatment of intracranial aneurysms. |
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.
El texto completo de este artículo está disponible en PDF.Keywords : Intracranial aneurysms, Endovascular treatment, Flow diversion, Flow diverter, Silk
Abbreviations : DSMB, FD, mRS
Esquema
Vol 48 - N° 4
P. 293-298 - juin 2021 Regresar al número
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