Article Text
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.
- intracranial aneurysm
- flow diverters
- endovascular therapy
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Footnotes
Twitter @AdamArthurMD
Contributors All authors participated in the conception and design of the study. Mr Gache and Ms Frame contributed the data collection, analysis, and developed the initial draft. All authors revised and contributed to the final version and approved the final version for publication.
Funding This study was funded by Cerenovus, part of Johnson & Johnson Medical Devices Companies.
Competing interests Dr Fiorella is a consultant for Balt, Marblehead, Medtronic, Stryker, Microvention, Stryker, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work. Mr Gache is an employee of CTI Clinical Trial & Consulting Services, which is a consultant to Cerenovus, part of Johnson & Johnson Medical Devices Companies. Ms Frame is a consultant for CTI Clinical Trial & Consulting Services, which is a consultant to Cerenovus, part of Johnson & Johnson Medical Devices Companies. Dr Arthur is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside of the submitted work.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.