Abstract
PurposeThe Flow Re-direction Endoluminal Device (FRED) has recently become available for flow diversion in Japan. We have encountered cases that failed to deploy the FRED. In this study, we report our initial experience with the FRED for cerebral aneurysms and clarify the causes of failed FRED deployment.MethodsA retrospective data analysis was performed to identify patients treated with the FRED between June 2020 and March 2021. Follow-up digital subtraction angiography was performed at 3 and 6 months and assessed using the O’Kelly-Marotta (OKM) grading scale.ResultsThirty-nine aneurysms in 36 patients (average age: 54.4 years) were treated with the FRED. The average sizes of the dome and neck were 9.9 mm and 5.2 mm, respectively. In nine patients, additional coiling was performed. In one patient (2.6%), proximal vessel injury caused direct carotid-cavernous fistula during deployment. Ischaemic complications were encountered in one patient (2.6%) with transient symptoms. Angiographic follow-up at 6 months revealed OKM grade C or D in 86.6% of patients. FRED deployment was successful in 35 (92.1%) procedures. In the failure group, the differences between the FRED and the minimum vessel diameter (P = 0.04) and the rate of the parent vessel having an S-shaped curve (P = 0.04) were greater than those in the success group.ConclusionsFlow diversion using the FRED is effective and safe for treating cerebral aneurysms. The use of the FRED for patients with an S-shaped curve in the parent vessel and oversizing of more than 2 mm should be considered carefully.
Highlights
The Flow Re-direction Endoluminal Device (FRED; MicroVention-Terumo, Tustin, CA, USA) is a flow diverter (FD) device characterised by a dual-layer self-expanding structure
The FRED is indicated for use for the petrous segment of the internal carotid artery (ICA) to the A1 region of the anterior cerebral artery or M1 region of the middle cerebral artery (MCA) and the intracranial vertebral and basilar arteries for endovascular treatment with wide-necked
39 aneurysms in 36 patients were treated with the FRED at our institute
Summary
The Flow Re-direction Endoluminal Device (FRED; MicroVention-Terumo, Tustin, CA, USA) is a flow diverter (FD) device characterised by a dual-layer self-expanding structure. The FRED has been used for flow diversion in Europe and several other countries and has recently become available in Japan. The FRED is indicated for use for the petrous segment of the internal carotid artery (ICA) to the A1 region of the anterior cerebral artery or M1 region of the middle cerebral artery (MCA) and the intracranial vertebral and basilar arteries for endovascular treatment with wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial unruptured aneurysms. High safety and efficacy have been reported in multi-institutional studies [1,2,3,4], but stent deployment has failed in some cases. We report our initial experience of the FRED with short-term results in the real world and clarify the causes of failed deployment
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