*Unit of Vascular Neurosurgery, Hospital Universitario Río Hortega, Valladolid, Spain; ‡Department of Preventive Medicine, Universidad de Jaén, Jaén, Spain.
Neurosurgery. 2013 Aug;73(2):193-9; discussion 199-200. doi: 10.1227/01.neu.0000430297.17961.f1.
Although the introduction of flow-diverter devices (FDDs) has aroused great enthusiasm, the level of evidence supporting their use has not been systematically evaluated.
To report a systematic review of medical literature up to May 2012 on FDDs to assess the morbidity, case fatality rate, and efficacy of FDDs for intracranial aneurysms.
The literature was searched by using MEDLINE, Embase, and all Evidence-Based Medicine in the OVID database. Eligibility criteria were studies including at least 10 patients, reporting duration of follow-up and number of patients lost to follow-up, and documenting the rate of aneurysm occlusion and death and neurological complications. The endpoints were angiographic success, early and late mortality, and neurological morbidity.
Fifteen studies were analyzed consisting of 897 patients with 1018 aneurysms. The mean value of methodological quality score was 14.4 using the STROBE score. The early mortality rate was 2.8% (95% confidence interval [CI]: 1.7-3.8; I(2) = 93.4%) and the late mortality rate was 1.3% (95% CI: 0.2-2.3; I(2) = 36.9%). The early neurological morbidity rate was 7.3% (95% CI: 5.7-9; I(2) = 91.8%) and the late morbidity rate was 2.6% (95% CI: 1.1-4; I(2) = 81.3%). The Egger test for early and late morbidity and aneurysm occlusion was <0.001.
With the available data from the studies, both heterogeneity and publication biases imply that the current clinical use of FDDs is not supported by high-quality evidence. In the absence of reliable evidence, the use of FDDs in patients eligible for more conventional treatments should be restricted to controlled clinical trials.
尽管血流导向装置（FDD）的引入引起了极大的兴趣，但支持其使用的证据水平尚未得到系统评估。
报告截至 2012 年 5 月的 FDD 治疗颅内动脉瘤的医学文献系统评价，以评估其发病率、病死率和疗效。
通过 MEDLINE、Embase 和 OVID 数据库中的所有循证医学进行文献检索。纳入标准为至少纳入 10 例患者、报告随访时间和失访患者数量、记录动脉瘤闭塞率和死亡率以及神经并发症的研究。终点为血管造影成功率、早期和晚期死亡率以及神经并发症。
分析了 15 项研究，共纳入 897 例患者的 1018 个动脉瘤。采用 STROBE 评分，方法学质量评分的平均值为 14.4。早期死亡率为 2.8%（95%可信区间：1.7-3.8；I²=93.4%），晚期死亡率为 1.3%（95%可信区间：0.2-2.3；I²=36.9%）。早期神经并发症发生率为 7.3%（95%可信区间：5.7-9；I²=91.8%），晚期并发症发生率为 2.6%（95%可信区间：1.1-4；I²=81.3%）。Egger 检验显示早期和晚期发病率和动脉瘤闭塞存在异质性和发表偏倚（P<0.001）。
根据现有研究数据，由于异质性和发表偏倚，目前 FDD 的临床应用缺乏高质量证据支持。在缺乏可靠证据的情况下，对于适合更传统治疗的患者，应将 FDD 的使用限制在对照临床试验中。
