Long-term Follow-up After Aneurysm Treatment with the Flow Redirection Endoluminal Device (FRED) Flow Diverter.

Abstract

Introduction: This study focuses on long-term outcomes after aneurysm treatment with either the Flow Re-Direction Endoluminal Device (FRED) or the FRED Jr. to investigate the durability of treatment effect and long-term complications.

Methods: This study is based on a retrospective analysis of a prospectively maintained patient data base. Patients treated with either FRED or FRED Jr. between 2013 and 2017 at our institution, and thus a possibility for ≥ 5 years of follow-up, were included. Aneurysm occlusion rates, recurrence rates, modified Rankin scale score shifts to baseline, and delayed complications were assessed.

Results: In this study 68 patients with 84 aneurysms had long-term follow-up with a mean duration of 57.3 months and 44 patients harboring 52 aneurysms had a follow-up ≥ 5 years with a mean follow-up period of 69.2 months. Complete occlusion was reached in 77.4% at 2 years and increased to 84.9% when the latest available imaging result was considered. Younger age and the absence of branch involvement were predictors for aneurysm occlusion in linear regression analysis. After the 2‑year threshold, there were 3 reported symptomatic non-serious adverse events. Of these, one patient had a minor stroke, one a transitory ischemic attack and one had persistent mass effect symptoms due to a giant aneurysm, none of these resulted in subsequent neurological disability.

Conclusion: This long-term follow-up study demonstrates that the FRED and FRED Jr. are safe and effective for the treatment of cerebral aneurysms in the long term, with high rates of complete occlusion and low rates of delayed adverse events.