Effect of core laboratory and multiple-reader interpretation of angiographic images on follow-up outcomes of coiled cerebral aneurysms: a systematic review and meta-analysis.

BACKGROUND AND PURPOSE Reported rates of recanalization following coil embolization vary widely across studies. Some confounders are known to affect outcomes but others remain questionable. In the current study, we assess differences in reported angiographic outcomes for cerebral aneurysms treated with coil embolization as a function of single vs multiple readers and site investigator vs core laboratory settings. MATERIALS AND METHODS Our systematic review covered 1999-2011 by using Ovid MEDLINE and EMBASE. Search terms were subarachnoid hemorrhage, intracranial aneurysms, endovascular treatment, and coiling. Inclusion criteria were >50 aneurysms and available imaging follow-up. Study characteristics of interest were readers at the treating site(s) or at an independent core imaging facility, single vs multiple readers, number of aneurysms treated, mean aneurysm size, mean follow-up time, coil type, initial rupture status, and angiographic follow-up. We defined "unfavorable angiographic outcome" as either "recanalization," <90% occlusion, or "incomplete occlusion." RESULTS There were 104 (2.6%) of 4022 studies that fulfilled our inclusion criteria, comprising a total of 22,134 treated aneurysms, of which 15,969 (72.1%) had reported angiographic follow-up. The overall unfavorable outcome rate was 17.8% (2955/15,969 aneurysms). Eight (7.7%) of 104 studies reported core laboratory readings in which the pooled rate of unfavorable outcomes was 0.23 (95% CI, 0.19-0.28) compared with 0.16 (95% CI, 0.14-0.18) in readings from the treating sites (P < .001). The multivariate meta-regression suggested that core laboratory interpretation was significant for unfavorable outcomes (OR, 5.60; 95% CI, 2.01-15.60; P = .001), after adjustment for initial rupture status, aneurysm size, follow-up duration, and coil type. No significant association was found with use of multiple readers. CONCLUSIONS Core laboratory studies tend to report higher rates of unfavorable outcomes compared with self-reported studies.