Abstract
Purpose
Flow diverter stents are gaining wider use in the treatment of complex intracranial aneurysms; however, there are limited data on occlusion and complication rates of flow diverters in very large and giant aneurysms. This study assessed the safety and efficacy of flow redirection endoluminal device (FRED) and FRED Jr. stents in aneurysms ≥ 20 mm.
Methods
We retrospectively analyzed all aneurysms ≥ 20 mm treated with FRED/FRED Jr. between January 2010 and June 2020 from three centers. Endpoints for clinical safety were absence of major stroke, aneurysmal rupture, or death and complete or near-complete occlusion for efficacy.
Results
A total of 45 patients with very large (28 cases) and giant aneurysms (17 cases) were treated with FRED (41 cases), and FRED Jr. (4 cases) stents. The majority of the aneurysms (40/45, 88.9%) were in the anterior circulation. Adjunctive aneurysm coiling was performed in 21 aneurysms (46.7%).
Technical complications were encountered in 4 procedures (8.9%). Ischemic and hemorrhagic complication rates were 6.7% and 8.9%, respectively. There was no case with major stroke. The mortality rate was 8.9%, and all cases were due to hemorrhagic complications from aneurysmal rupture.
Median angiographic follow-up was 21.5 months (range 3–60 months). Complete occlusion was achieved in 32 aneurysms (71.1%), and near-complete occlusion in 5 cases (11.1%).
Conclusion
The use of FRED/FRED Jr. for the treatment of aneurysms ≥ 20 mm achieved a long-term aneurysm occlusion rate and a safety profile comparable to the large series reported with other flow diverter stents.
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S.G. Kandemirli, F. Baltacioglu, J. Jesser and O. Kizilkilic declare that they have no competing interests. N. Kocer: consulting and proctoring agreement with Microvention. C. Islak: proctoring and training agreement with Microvention, NDI cofounder and shareholder, Neuravention INC shareholder. M. Möhlenbruch has received grants from Balt, Medtronic, MicroVention and Stryker outside the submitted work.
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This retrospective chart review study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The Institutional Review Board (IRB) of each participating center approved this study.
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The authors Markus Möhlenbruch and Naci Kocer contributed equally to the manuscript.
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Kandemirli, S.G., Baltacioglu, F., Jesser, J. et al. Flow Redirection Endoluminal Device (FRED) with or without Adjunctive Coiling in Treatment of Very Large and Giant Cerebral Aneurysms. Clin Neuroradiol 32, 471–480 (2022). https://doi.org/10.1007/s00062-021-01061-x
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DOI: https://doi.org/10.1007/s00062-021-01061-x