Use of Omniflow for Peripheral Arterial Bypass: A Meta-Analysis and Systematic Review

Abstract

Aim: Omniflow II is a biosynthetic material specifically marketed for arterial bypass procedures at high risk of graft infection. This meta-analysis aimed to combine evidence for the use of Omniflow II in peripheral arterial bypass and compare post-operative outcomes. Method(s): Seven databases were searched using the term Omniflow. Studies were included if they were randomised control trials, cohort studies, or case series where patients underwent peripheral arterial bypass with Omniflow grafts. Primary outcomes were early and late post-operative infection; primary patency; and secondary patency. Data on patients, mode of bypass, and outcomes were extracted. Pooled meta-analysis was performed using STATA. Result(s): From 30 studies identified, 12 were included, incorporating 1,100 bypass procedures with follow-up ranging from 3 months to 5 years. 30-day infection data for 688 procedures showed an average effect size of 0.25 (0.00, 2.12), and late infection data for 977 procedures showed an average effect of 1.68 (0.05, 4.67). Weighted pooled primary patency rates were 71.3 (95%CI 62.83-79.18) at 1 year, 64.9 (95%CI 55.31-73.92) at 2 years, and 54.0 (95%CI 32.57-74.70) at 4-5 years. Secondary patency rates were 83.5 (95%CI 75.10-90.64) at 1 year, 76.8 (95%CI 57.84-91.59) at 2 years, and 73.1 (95%CI 60.16-84.35) at 4-5 years. Thirty-day mortality, reported for 1,060 procedures, ranged from 0% to 7.7%, with an average of 2.2%. Conclusion(s): Omniflow II demonstrates low rates of early and late post-operative infection, as well as favourable patency outcomes comparable to other graft materials. Further comparative work is needed to directly compare Omniflow II to alternative graft materials.