Early Graft, Limb and Mortality Outcomes from the Omniflow II Bio-Synthetic Graft

BACKGROUND: Omniflow II biosynthetic grafts are a commonly used alternative to autologous grafts in vascular bypass procedures. They are chosen for their purported resilience to infection, often in instances of existing graft failure or infection. We examined the short term, 1-3 year outcomes of Omniflow grafts in terms of patency, limb survival and mortality in a sample of 24 individuals. METHODS: This is a single centred retrospective study of Omniflow II grafts implanted between September 23, 2015 and April 05, 2018 in our department. It includes grafts in all anatomical locations. Primary outcome measures were overall patient survival and time to this, primary graft patency (patency with no intervention) and then limb survival at 1 and 3 years. Kaplan-Meier survival analysis was plotted for the 3 primary outcome measures. RESULTS: A total of 24 grafts from 24 individuals were included with mean age 71.4 ± 11.7. We included 5 female and 19 male patients. The commonest indication was rest pain/claudication (N = 8) followed by graft occlusion (N = 6). Femoro-popliteal bypass (N = 13) and Femoro-distal bypass (N = 5) were the commonest procedures. Kaplan-Meier survival analysis demonstrated that 1 and 3-year primary patency rates were 54.2% and 37.5% respectively with Limb survival probability of 75% at 1 year and 70.8% at 3 years. These rates were all considerably lower than those found in previous comparative studies. Mortality however, compared favourably with 1 and 3-year survival probability 91.7% and 87.5% on average 296 days (range 95-451 days) after graft implantation. CONCLUSIONS: We found that rates of primary patency and limb salvage for this graft type were markedly lower than in comparable studies. Further work in the form of a RCT is indicated.