Related Experiment Video
Updated: May 8, 2026
Engineering Biological-Based Vascular Grafts Using a Pulsatile Bioreactor
Published on: June 14, 2011
Omniflow II Biosynthetic Graft for Infrainguinal Arterial Reconstruction in Infected Fields: A Systematic Review
Maxence Aubertin1, Paolo Perini2, Salomé Kuntz3
1Department of Vascular Surgery, Kidney Transplantation and Innovation, University Hospital of Strasbourg, Strasbourg, France; GEPROMED, Strasbourg, France.
Objective:
This review aimed to evaluate the use of Omniflow II biosynthetic grafts for infrainguinal 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 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).
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. 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.
Conclusion:
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.
Insights
The Omniflow II biosynthetic graft shows promise for infrainguinal vascular reconstruction in infected fields, offering a viable alternative when autologous veins are unavailable. Further research is needed to confirm its long-term effectiveness.
Area of Science:
- Vascular Surgery
- Biomaterials Science
- Infectious Disease Management
Background:
- Infrainguinal vascular reconstruction in infected fields presents significant challenges.
- Autologous vein grafts are often the preferred choice but may not always be available.
- Biosynthetic grafts offer a potential alternative for complex vascular repairs.
Purpose of the Study:
- To systematically evaluate the efficacy of the Omniflow II biosynthetic graft in infrainguinal vascular reconstruction within infected surgical sites.
- To assess key outcomes including graft re-infection, mortality, patency, and amputation rates.
Main Methods:
- A systematic literature search adhering to PRISMA guidelines was conducted across major databases.
- Included studies focused on Omniflow II grafts for infrainguinal reconstruction in infected fields, excluding case series with fewer than five patients.
- Primary outcome was freedom from re-infection at one and three years; secondary outcomes included mortality, patency, and amputation rates.
Main Results:
- Six studies involving 116 patients were synthesized. Freedom from re-infection was 90% at one year and 76% at three years.
- One-year survival was 93%, primary patency was 76%, and freedom from amputation was 89%.
- Evidence certainty for key outcomes was assessed as low or very low using GRADE criteria.
Conclusions:
- The Omniflow II graft serves as a valuable off-the-shelf option for infrainguinal reconstructions in infected fields when autologous options are absent.
- Larger prospective studies are essential to definitively establish the long-term performance and safety of this biosynthetic graft.
