@article {Fiorella869, author = {David Fiorella and Larry Gache and Diana Frame and Adam S Arthur}, title = {How safe and effective are flow diverters for the treatment of unruptured small/medium intracranial aneurysms of the internal carotid artery? Meta-analysis for evidence-based performance goals}, volume = {12}, number = {9}, pages = {869--873}, year = {2020}, doi = {10.1136/neurintsurg-2019-015535}, publisher = {British Medical Journal Publishing Group}, abstract = {Background The objective of this meta-analysis was to establish safety and effectiveness benchmarks for endovascular therapy of unruptured small-to-medium internal carotid artery (ICA) aneurysms using flow diverters.Methods A systematic literature review and subsequent meta-analysis were performed using best research methods. Studies of any design with at least 10 patients treated with flow diverters for predominantly (>=90\%) unruptured small/medium ICA aneurysms and >=6 month follow-up were included. The primary effectiveness endpoint was complete aneurysm occlusion rate at 12 months. The primary safety endpoint was a composite measure of cumulative events that could indicate a stroke or neurologic death: any death, stroke, intracranial hemorrhage, or worsening on the modified Rankin Scale.Results 41 studies (2614 patients) met eligibility criteria for the meta-analysis. The core lab adjusted complete occlusion rate was 74.9\% (95\% CI 69.6\% to 79.8\%) at 12 months for studies using any flow diverter. With an aim of generating performance goals for a US Investigational Device Exemption (IDE) study, a pre-specified analysis was conducted using only studies with flow diverters commercially available in the USA. In this cohort, 12 month complete occlusion was 74.6\% (95\% CI 66.8\% to 81.7\%). The primary safety event rate for flow diverters commercially available in the USA was 7.8\% (95\% CI 4.8\% to 11.4\%).Conclusions The treatment of small and medium-sized aneurysms with flow diverters is effective in achieving curative reconstruction in most cases and is associated with low rates of morbidity and mortality. This meta-analysis informs robust performance goals for evaluating new flow diverters in small/medium unruptured carotid aneurysms.}, issn = {1759-8478}, URL = {https://jnis.bmj.com/content/12/9/869}, eprint = {https://jnis.bmj.com/content/12/9/869.full.pdf}, journal = {Journal of NeuroInterventional Surgery} }