Hasan Dinc1, Isil Saatci2, Sukru Oguz1, Feyyaz Baltacioglu3, Altan Yildiz4, Halil Donmez5, Umit Belet6, Baran Onal7, Cagatay Andic8, Osman Koc9, Omer Kocak10, Mert Koroglu11, Mustafa Cetin12, H Saruhan Cekirge13. 1. Radiology Department, School of Medicine, Karadeniz Technical University, Trabzon, Turkey. 2. Interventional Neuroradiology Section, Koru Hospitals, Kizilirmak mah, 1450 sokak 9/19 Cukurambar, 06510, Ankara, Turkey. isaatci@gmail.com. 3. Radiology Department, School of Medicine, Marmara University, Istanbul, Turkey. 4. Radiology Department, School of Medicine, Mersin University, Mersin, Turkey. 5. Radiology Department, School of Medicine, Erciyes University, Kayseri, Turkey. 6. Radiology Department, University of Health Sciences, Tepecik Training and Research Hospital, Izmir, Turkey. 7. Radiology Department, School of Medicine, Gazi University, Ankara, Turkey. 8. Radiology Department, Faculty of Medicine, Baskent University, Adana, Turkey. 9. Radiology Department, Meram Faculty of Medicine, Necmettin Erbakan University, Konya, Turkey. 10. Radiology Department, Koru Hospitals, Ankara, Turkey. 11. Interventional Radiology Clinic, Medical Park VM Hospital, Samsun, Turkey. 12. Radiology Department, University of Health Sciences Antalya Training and Research Hospital, Antalya, Turkey. 13. Interventional Neuroradiology Section, Koru Hospitals, Kizilirmak mah, 1450 sokak 9/19 Cukurambar, 06510, Ankara, Turkey.
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.
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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