FRED-EPI study: Safety and efficacy of FRED/FRED Jr aneurysm treatment in current clinical practice

Flow diversion is increasingly used as an endovascular treatment for intracranial aneurysms. FRED-EPI is a prospective, multicenter, French study, conducted to analyze the safety and efficacy of aneurysm treatment with FRED/FRED Jr (Microvention, AlisoViejo, CA, USA) in current clinical practice.

Patients with intracranial aneurysms treated with FRED and FRED Jr who agreed to participate were prospectively and consecutively included in all French centers using these devices.

From June 2020 to January 2022, 135 patients (110 females, 81.5%, and 25 males, 18.5%) with 154 aneurysms were included in 13 French interventional neuroradiology centers. The mean age was 53.9 ± 12.2 years (range: 20 - 77 years). Aneurysm was unruptured in 123 cases (79.9%), ruptured in 4 cases (2.6%), and recanalized in 27 cases (17.5%). Most aneurysms were small (135/154, 87.7%). Aneurysm locations were supraclinoid ICA in 83 (53.9%), cavernous and petrous ICA in 25 (16.2%), anterior cerebral artery or anterior communicating artery in 19 (12.3%), MCA in 7 (4.5%), and posterior circulation in 20 (13.0%). Three patients (2.2%) had hemorrhagic complications (1 delayed aneurysm rupture and 2 delayed remote hematoma) and 3 (2.2%) ischemic complications (2 intrastent thrombosis and 1 stroke related to atherosclerosis) leading to 1-year morbimortality of 4.4%. Complete aneurysm occlusion was reported in 105/139 aneurysms (75.5%).

FRED-EPI confirms good safety of aneurysm treatment with FRED/FRED Jr in current clinical practice with 4.4% 1-year morbimortality.