Objective: This review aimed to evaluate the use of Omniflow II biosynthetic grafts for infra-inguinal vascular reconstruction in infected fields. Data sources: A systematic literature search (Pubmed, Embase, Cochrane Library) following PRISMA guidelines was performed (Prospero registration number CRD420251000785). Review methods: All English full text studies from 1989 - 2024 reporting on infra-inguinal 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 mortality, survival, primary and secondary patency, freedom from amputation, and aneurysmal degeneration. Statistical analysis was conducted using Prometa 3.0 and OpenMeta software. Evidence certainty for key outcomes was assessed using GRADE. Results: 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. All cause 30 day mortality 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. Conclusion: The Omniflow II graft offers an off the shelf solution for infra-inguinal reconstructions in infected fields when there is no option for autologous vein. Larger prospective cohorts are needed to further validate its effectiveness.
Omniflow II Biosynthetic Graft for Infra-inguinal Arterial Reconstruction in Infected Fields: A Systematic Review / Aubertin, Maxence; Perini, Paolo; Kuntz, Salomé; Chakfe, Nabil; Lejay, Anne. - In: EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY. - ISSN 1078-5884. - (2025). [10.1016/j.ejvs.2025.05.040]
Omniflow II Biosynthetic Graft for Infra-inguinal Arterial Reconstruction in Infected Fields: A Systematic Review
Perini, Paolo;Chakfe, Nabil;
2025-01-01
Abstract
Objective: This review aimed to evaluate the use of Omniflow II biosynthetic grafts for infra-inguinal vascular reconstruction in infected fields. Data sources: A systematic literature search (Pubmed, Embase, Cochrane Library) following PRISMA guidelines was performed (Prospero registration number CRD420251000785). Review methods: All English full text studies from 1989 - 2024 reporting on infra-inguinal 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 mortality, survival, primary and secondary patency, freedom from amputation, and aneurysmal degeneration. Statistical analysis was conducted using Prometa 3.0 and OpenMeta software. Evidence certainty for key outcomes was assessed using GRADE. Results: 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. All cause 30 day mortality 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. Conclusion: The Omniflow II graft offers an off the shelf solution for infra-inguinal reconstructions in infected fields when there is no option for autologous vein. Larger prospective cohorts are needed to further validate its effectiveness.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
