Contemporary Results with the Biosynthetic Glutaraldehyde Denatured Ovine Collagen Graft (Omniflow II) in Lower Extremity Arterial Revascularization in a Septic Context.

ABSTRACT

BACKGROUND: Peripheral vascular graft infections are poorly-evaluated, despite high mortality and amputation rates. The vascular substitute of choice remains controversial when veins are unavailable. This study aims to evaluate the results of a biosynthetic collagen graft (Omniflow II®) in an infected field when autologous veins are unavailable. METHODS: This retrospective, multicentric study included all consecutive patients in whom an Omniflow II graft was used for infra-inguinal revascularization in a septic context from January 2015 to January 2020. The primary end-point was freedom from major amputation; secondary end-points were 30-day mortality, survival, patency, and freedom from reinfection estimated using the Kaplan-Meier method. RESULTS: Twenty-nine patients (27 men, median age of 69 years interquartile range IQR60; 76) were included. Fever was present in 58.6%, a septic rupture in 17.9%, a pseudo-aneurysm in 25.0%. The 30-day mortality rate was 3.4%. Median follow-up reached 49 months. At 1 and 3 years, estimated freedom from major amputation was 88.4% and 83.9%, survival 96%, primary patency 74.6% and 65.8%, and reinfection free-survival 85.6%. There were 7 occlusions (1 iliofemoral, 1 below-knee, and 5 above-knee bypasses), 3 explantations for persistent sepsis, 4 reinfections (all within 6 months which led to 1 death and 3 out of 4 major amputations). The risk of major amputation increased with bypass reinfection (P = 0.004), occlusion (P = 0.005), and polymicrobial infection (P = 0.05). CONCLUSIONS: In a septic context, the Omniflow II graft shows acceptable freedom from major amputation and reinfection. This usage remains outside the instructions of use, it is, therefore, is essential to pursue longer-term studies in larger cohorts.