Purpose Flow diversion is now a well-established endovascular technique for the treatment of intracranial aneurysms. FRED and FRED Jr are dual-layer, self-expanding nickel titanium flow-diverters. SAFE is a prospective, multicenter study conducted in 14 French and Belgian centers to evaluate the safety and efficacy of these devices.
Materials and Methods Only aneurysms located in the anterior circulation were included. The primary efficacy endpoint is the rate of complete aneurysm occlusion at 6 months without associated stenosis of the parent vessel. The primary safety endpoint is the rate of morbidity (mRS >2) and mortality at 6 months. Adverse events as well as anatomical results were independently evaluated.
Results From July 2014 to July 2016, 103 patients (Females: 87; 84.5%) with 103 aneurysms were included. Mean age was 52.4±11.0 years. Aneurysm location was supraclinoid ICA in 71 patients (68.9%), cavernous ICA in 15 patients (14.6%), ACA in 9 patients (8.7%), and MCA in 8 patients (7.8%). Seventy-one aneurysms (68.9%) were small (<10 mm), 29 (28.2%) were large (10–24 mm), and 3 (2.9%) were giant (≥25 mm). Neck was wide (≥4 mm) in 69 aneurysms (67.0%). Twenty-seven aneurysms (26.2%) were previously treated.
FRED or FRED Jr was successfully implanted in 98/103 patients (95.2%). At 6 months mortality was 1.0% (1/103 patients) and morbidity (mRS >2) 2.0% (2/103 patients. Anatomical results at 6 months were complete occlusion in 57/94 aneurysms (60.6%), neck remnant in 8/94 aneurysms (8.5%), and aneurysm remnant in 29/94 aneurysms (30.9%). Stenosis (≥50%) or occlusion of the parent vessel was observed in 7/94 patients (7.4%). Fifty-one out of 94 aneurysms (54.8%) met the primary endpoint (complete occlusion without stenosis ≥50%).
Conclusion SAFE study shows good safety and short-term efficacy of FRED and FRED Jr in aneurysm treatment. One-year clinical and anatomical follow-up will be obtained and analyzed.
Disclosures L. Pierot: 2; C; Microvention. J. Gauvrit: 1; C; Microvention. J. Lejeune: 1; C; Microvention. A. Degrelle: 1; C; Microvention. E. Chabert: 1; C; Microvention.
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