Journal of neurointerventional surgery
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Multicenter Study Observational Study
SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results.
Flow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year. ⋯ Unique identifier: NCT02921698; Results.
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Hypoglossal canal dural arteriovenous fistulae (HC-dAVF) are a rare subtype of skull base fistulae involving the anterior condylar confluence or anterior condular vein within the hypoglossal canal. Transvenous coil embolization is a preferred treatment strategy, however delineation of fistula angio-architecture during workup and localization of microcatheter tip during embolization remain challenging on planar DSA. For this reason, our group have utilized intra-operative cone beam CT (CBCT) and selective cone beam CT angiography (sCBCTA) as adjuncts to planar DSA during workup and treatment. The purpose of this article is to present our experience in the treatment of HC-dAVF using transvenous coil embolization (TVCE) with cone beam CT assistance, describing our technique as well as presenting our angiographic and clinical outcomes. ⋯ This study demonstrates that TVCE with CBCT assistance is a highly effective treatment option for HC-dAVF, achieving complication-free fistula occlusion in our entire patient cohort. We have found low-dose sCBCTA and CBCT to be an extremely useful adjunct to planar DSA imaging during both workup and treatment of these rare fistulae.