Background: Although the introduction of flow-diverter devices (FDDs) has aroused great enthusiasm, the level of evidence supporting their use has not been systematically evaluated.
Objective: 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.
Methods: 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.
Results: 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.
Conclusion: 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.