Prosthetic peripheral vascular graft infections are poorly evaluated, despite a grim prognosis with high mortality and major amputation rates. The vascular substitute of choice remains controversial when autologous veins are unavailable. The main objective of this study was to evaluate the mid-term results of a new alternative biosynthetic collagen graft (Omniflow II®) in an infected field in patients with unavailable or unsuitable autologous saphenous vein.
This retrospective, observational, multicentric study included all consecutive patients in whom an Omniflow II® graft was used for infra-inguinal revascularization in the context of sepsis from January 2015 to January 2020. The primary endpoint was freedom from major amputation; secondary endpoints were 30-day mortality, perioperative morbidity, and estimated survival, patency, and freedom from reinfection estimated using the Kaplan-Meier method.
Twenty-nine patients (27 men, median age 69 years (IQR:60;76) were included. Fever was present in 58.6% of cases, a septic rupture in 17.9%, and a pseudo-aneurysm in 25.0%. The 30-day mortality rate was 3.4% (septic shock). The median follow-up reached 49 months. At 1 and 3 years, the estimated freedom from major amputation was 88.4% and 83.9%, survival was 96%, primary patency was 74.6% and 65.8%, secondary patency was 82.1% and 77.7% and reinfection free-survival was 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 the first 6 months which led to 1 death and 3 major amputations), and a total of 4 major amputations. The risk of major amputation increased with bypass reinfection (p=.004), occlusion (p=.005), and polymicrobial infection (p=.05).
In a septic context, the Omniflow II® bioprosthetic graft represents an acceptable vascular substitute in the absence of an autologous vein. It provides acceptable freedom from major amputation and reinfection considering the seriousness of this pathology. This usage remains outside the instructions for use, it is, therefore, essential to pursue longer-term studies in larger cohorts.

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