Omniflow II Biosynthetic Graft for Infrainguinal Arterial Reconstruction in Infected Fields: A Systematic Review.

Abstract

This review aimed to evaluate the use of Omniflow II biosynthetic grafts for infrainguinal vascular reconstruction in infected fields. A systematic literature search (PubMed, Embase, Cochrane Library) following PRISMA guidelines was performed (PROSPERO registration number CRD420251000785). All English full text articles from 1989 - 2024 reporting on infrainguinal vascular reconstruction using an Omniflow II in an infected field were included. Cases series and cohorts with fewer than five patients were excluded from the pooled analysis. The primary outcome was freedom from re-infection at one year and three years. Secondary outcomes were 30 day all cause death, and survival, primary and secondary patency, freedom from amputation, and aneurysmal degeneration at one and three years. Statistical analysis was conducted using Prometa 3.0 and OpenMeta software. Evidence certainty for key outcomes was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Six studies (116 patients) were included in the quantitative synthesis. Overall risk of bias was low in four studies and high in two studies. Freedom from re-infection was 90% (95% confidence interval [CI] 82 - 95%) at one year and 76% (95% CI 47 - 92%) at three years. The all cause 30 day mortality rate was 4% (95% CI 0 - 10%). Survival was 93% (95% CI 86 - 97%) at one year and 87% (95% CI 73 - 95%) at three years. Primary patency was 76% (95% CI 66 - 83%) at one year and 68% (95% CI 56 - 77%) at three years. Secondary patency was 83% (95% CI 74 - 89%) at one year and 77% (95% CI 65 - 86%) at three years. Freedom from amputation was 89% (95% CI 82 - 94%) at one year and 88% (95% CI 77 - 94%) at three years. No aneurysmal degeneration was reported. GRADE certainty was low or very low for all outcomes. The Omniflow II graft offers an off the shelf solution for infrainguinal reconstructions in infected fields when there is no autologous vein option. Larger prospective cohorts are needed to further validate its effectiveness.