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%).