1. 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
- Author
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Mustafa Cetin, Mert Koroglu, Sukru Oguz, Altan Yıldız, Umit Belet, H Saruhan Cekirge, Omer Kocak, Feyyaz Baltacioglu, Hasan Dinç, Osman Koç, Baran Onal, Halil Donmez, Isil Saatci, and Cagatay Andic
- Subjects
medicine.medical_specialty ,Medical surveillance ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Aneurysm ,Occlusion ,Medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Adverse effect ,Neuroradiology ,Retrospective Studies ,business.industry ,Endovascular Procedures ,Intracranial Aneurysm ,medicine.disease ,Embolization, Therapeutic ,Surgery ,Cerebral Angiography ,Stenosis ,Treatment Outcome ,Cohort ,Stents ,Neurology (clinical) ,Neurosurgery ,Cardiology and Cardiovascular Medicine ,business ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
© 2021, The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.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.
- Published
- 2020