Abstract
Purpose
Our aim was to determine the long-term safety and efficacy of the Flow Re-Direction Endoluminal Device (FRED) in this multicenter study with prospective design.
Materials-method
This study included 136 consecutive patients with 155 aneurysms treated between March 2013 and June 2016 in 10 centers. Twenty-two (16.2%) patients presented with rupture of the index aneurysm. Large/giant aneurysms comprised 1/3 of the cohort. Adjuvant coil use during the treatment was 15.5%. The effectiveness measure in the study was the percentage of aneurysms with stable occlusion at follow-up.
Results
Vascular imaging follow-up was performed at least once in 131/136 (96.3%) patients with 148/155 (95.5%) aneurysms up to 75 months (mean: 37.3 months; median: 36 months according to latest follow-up), and 102/155(65.8%) aneurysms in 90/136 (66.2%) patients had ≥ 24-month control. According to the latest controls, the overall stable occlusion rate was 91.9% (95% CI, 87.5 to 96.3%). Three out of 148 aneurysms with follow-up were retreated (2%, 95% CI 0.0 to 4.3%). Adverse events were noted in 19/136 (14%, 95% CI, 9 to 21%) patients with a morbidity of 1.5% (95% CI, 0.0 to 3.5%). Mortality was 1/136 (0.7%, 95% CI, 0.02 to 2.2%) and was unrelated to aneurysm treatment. In-stent stenosis (ISS) was detected in 10/131 of the patients with follow-up (7.6%, 95% CI; 3.1 to 12.2%), only one being symptomatic. No adverse events have occurred in any of the patients with follow-up after 24 months, except the one resulting from ISS.
Conclusion
In the treatment of cerebral aneurysms which were candidates for flow diversion technique, this study showed long-term efficacy of FRED with good safety and occlusion rates.
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Data availability
The datasets analyzed during the current study are not publicly available due to data protection but are available from the corresponding author upon reasonable request.
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Isil Saatci (Cekirge): Consultancy and Proctorship agreements with Medtronic Inc. (Minneapolis, USA) and MicroVention Inc. (Aliso Viejo, CA, USA).
Feyyaz Baltacioglu: Financial support for attending symposia and educational programs MicroVention Inc. (Aliso Viejo, CA, USA), Medtronic Inc. (Minneapolis, USA), and Stryker (Neurovascular, Freemont, CA, USA).
H.Saruhan Cekirge: Consultancy and Proctorship agreements with Medtronic Inc. (Minneapolis, USA) and MicroVention Inc. (Aliso Viejo, CA, USA) and shareholder of NDI Technologies, eLUM Technologies Inc., and Vesalio LLC.
The remaining authors declare they have no competing interest.
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• All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
• The study protocol was approved by the ethics committee of the organizing institution (Karadeniz Technical University Faculty of Medicine Ethical Committee: (24237859-85).
• Informed consent was obtained from all individual participants included in the study.
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Dinc, H., Saatci, I., Oguz, S. et al. Long-term clinical and angiographic follow-up results of the dual-layer flow diverter device (FRED) for the treatment of intracranial aneurysms in a multicenter study. Neuroradiology 63, 943–952 (2021). https://doi.org/10.1007/s00234-020-02627-1
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DOI: https://doi.org/10.1007/s00234-020-02627-1