Purpose Flow diversion is 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 in a real life setting.
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 and anatomical results were independently evaluated.
Results From July 2014 to July 2016, 103 patients with 103 aneurysms were included. 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 2.0% (2/103 patients. Up to 12 months, mortality was 2.0% (2/99 patients) and morbidity 3.0% (3/99 patients). Anatomical results at 6 months were complete occlusion in 58/95 aneurysms (61.1%), neck remnant in 8/95 aneurysms (8.4%), and aneurysm remnant in 29/95 aneurysms (30.5%). Anatomical results at 12 months were complete occlusion in 66/90 aneurysms (73.3%), neck remnant in 7/90 aneurysms (7.8%), and aneurysm remnant in 17/90 aneurysms (18.9%).
Conclusion SAFE study shows very good safety and good mid-term efficacy of FRED and FRED Jr in aneurysm treatment.
Disclosures L. Pierot: 2; C; Microvention. J. Gauvrit: None. J. Lejeune: None. A. Derelle: None. E. Chabert: None.
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