Background Flow diverters are a breakthrough treatment for large and giant intracranial aneurysms but carry a risk of periprocedural death or major stroke. Pipeline Flex is a second-generation device that is thought to have lower complication rates because of improvements in the delivery system as well as increased operator experience. Our objective was to analyze the risk of periprocedural death or major complications using Pipeline Flex for unruptured intracranial aneurysms.
Methods A systematic search of three databases was performed for studies of ≥10 treatments using Pipeline Flex for unruptured intracranial aneurysms (2014–2019) using PRISMA guidelines. Random effects meta-analysis was used to pool the rates of periprocedural (<30 days) death, major ischemic stroke, symptomatic intracranial hemorrhage, and minor stroke/transient ischemic attack.
Results We included eight studies reporting 901 treatments in 879 patients. Periprocedural mortality (<30 days) was 0.8% (5/901; 95% CI 0.4% to 1.5%; I2=0%). Rate of major complications (death, major ischemic stroke, or symptomatic intracranial hemorrhage) was 1.8% (14/901; 95% CI 1.0% to 2.7%; I2=0%). Aneurysm size ≥10 mm was a statistically significant predictor of a major complication (OR 6.4; 95% CI 2.0 to 20.7; p=0.002). Risk of a major complication in aneurysms <10 mm was 0.9% (95% CI 0.3% to 1.7%; I2=0%). The meta-analysis was limited by the predominance of anterior circulation aneurysms.
Conclusion Treatment of unruptured intracranial aneurysms using the Pipeline Flex flow diverter has a low periprocedural risk of death (0.8%) or major complication (1.8%). The risk of a major complication is significantly higher for large/giant aneurysms (4.4%) and is very low for aneurysms <10 mm (0.9%).
- flow diverter
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Contributors KDB was the primary author of the study protocol, was one of the two reviewers, performed data extraction and collation, undertook data analysis, and drafted and revised the manuscript. He is the guarantor. HK was one of the two reviewers, performed data collation and data quality checking, assisted with data analysis, and edited the manuscript. EO advised upon and edited the study protocol, performed data analysis, and edited the manuscript. JMK advised upon and edited the study protocol, performed data analysis, and edited the manuscript. VMP advised upon the methodology, assisted with revising the draft protocol, checked collated data for accuracy, analyzed the data output for suitability of meta-analysis, and edited and helped revise the manuscript. TK supervised the project, acted as the senior reviewer in cases of non-consensus, advised upon and assisted with editing of the protocol, advised upon the methodology, analyzed the data output for suitability of meta-analysis, and edited and helped revise the manuscript. All authors assisted in the design of the study.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests VMP is a consultant and proctor for Medtronic Neurovascular and Stryker and a consultant for Phenox and Balt. One of the studies included in this meta-analysis (Pereira et al, 2015) was published by members of our research group.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.