Abstract
BACKGROUND AND PURPOSE: Flow diversion emerged as a crucial treatment option for intracranial aneurysms. We report a multicenter retrospective analysis of the safety and efficacy in the treatment of intracranial aneurysms with the Flow-Redirection Endoluminal Device (FRED) flow diverter, a dual-layer flow-modulation device. MATERIALS AND METHODS: All intracranial aneurysms treated with the FRED between March 2013 and February 2016 at 4 neurovascular centers were included. Angiographic and clinical results were retrospectively analyzed, including all follow-up examinations. Aneurysms were unruptured in 44 cases, whereas 8 treatments were due to an acute SAH from the target aneurysm. RESULTS: Successful implantation of the FRED was possible in 96.2% (50/52) of cases. At 3-month follow-up, complete occlusion was determined in 58.1% (25/43) and near-complete in 25.6% (11/43). At 12-month follow-up, aneurysm occlusion was complete in 75.0% (27/36) and near-complete in 22.2% (8/36). The overall acute and late thromboembolic and hemorrhagic complication rate was 17.3% (9/52), with a permanent treatment-related morbidity and mortality of 4.0% (2/50) and 2.0% (1/50), respectively, to date. CONCLUSIONS: The FRED device offers an effective tool in the treatment of intracranial aneurysms. The dual-layer design promotes contemporary and stable long-term occlusion rates. Sufficient device expansion should be documented by angiographic CT. Further studies might help to identify a more optimal antiplatelet regimen to avoid thromboembolic complications during the follow-up period.