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

Omniflow IIⓇ is a biosynthetic material specifically marketed for arterial bypass procedures at high risk of graft infection. This meta-analysis aimed to combine current evidence for the use of Omniflow IIⓇ in peripheral arterial bypass and compare postoperative outcomes.

Seven databases were searched for the term "Omniflow." Studies were reviewed and included if: they were a randomized control trial, cohort study or case series; some patients in the study received Omniflow graft for peripheral arterial bypass. Primary outcomes were early and late postoperative infection; primary patency; and secondary patency. Number of patients, mode of bypass and postoperative outcomes were extracted from each eligible study. Meta-analysis of pooled results was undertaken using STATA.

Literature search identified 30 studies. Following duplicate removal, abstract and full-text review, 12 studies were included, incorporating 1,100 bypass procedures. Follow-up ranged from 3-months to 5-years. Thirty-day postoperative infection data were available for 688 procedures with an average effect size of 0.25 (0.00, 2.12). Late postoperative infection data was available for 977 bypass procedures with an average effect of 1.68 (0.05, 4.67) after 30 days. Weighted pooled primary patency was 71.33% (95% confidence interval [CI] 62.83-79.18) at 1 year, 64.88% (95% CI 55.31-73.92) at 2 years, and 54.00% (95% CI 32.57-74.70) at 4-5 years. Weighted pooled secondary patency was 83.53% (95% CI 75.10-90.64) at 1 year, 76.75% (95% CI 57.84-91.59) at 2 years, and 73.10% (95% CI 60.16-84.35) at 4-5 years. Mortality data were reported for 1,068 procedures. Thirty-day mortality ranged from 0% to 7.69%, with an average mortality rate of 2.23%.

Omniflow IIⓇ presents a viable option for peripheral bypass graft material with low rates of early and late postoperative infection. Pooled primary and secondary patency rates for Omniflow IIⓇ appear comparable to other graft materials. Further comparative work is needed to directly compare Omniflow IIⓇ to alternative graft materials.