Flow-diverter devices for intracranial aneurysms: systematic review and meta-analysis.

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.