Abstract

INTRODUCTION: Multiple FDs are available for clinical use. Over the years, the FDs technology has improved considerably. However, overall complications and safety issues using FRED have not been evaluated in detail. Studies comprehensively investigating the clinical and technical events in FRED usage to treat IAs are not available. The purpose of this study is to investigate the outcome, overall complication rates, occlusion rate, retreatment, thromboembolic, and hemorrhagic complications for different patient cohorts treated with FRED flow diverter. METHODS: The following descriptors were used for the search: Flow-Redirection Intraluminal Device (FRED) system for the treatment of Intracranial aneurysms, Intracranial aneurysms, and Complication with no constraints applied was searched. Two authors independently revived and identified the studies, and two independent review authors extracted the data. A random-effect model was used to pool data, and the results were reported (odds ratios and 95% CI); heterogeneity was reported as I2. RESULTS: Nine studies were included in the final analysis, which involved retrospectively and prospectively collected data on 1167 patients. The use of FRED was associated with a rate of occlusion of 85% (95% confidence interval [CI] 79.5%–90.9%). Low retreatment rate of 2.5% (95% CI 1.0%–4.6%), low thromboembolic complication rate of 4.9% (95% CI 3.0%–7.31%), low hemorrhagic complication rate of 1.35% (95% CI 0.7%–2.0%). The mortality rate was 4% (95% CI 0.8%–2.1%). An overall good outcome was 95.1% (95% CI 92.1%–97.4%), and poor outcome was 4.8% (95% CI 2.5%–7.8%). CONCLUSIONS: The available evidence suggests that FRED offers favorable results for the management of intracranial aneurysms, results in high occlusion rate and low complication rates

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