Outcomes of Omniflow® II prosthesis used for revascularization in the femoral tract both in infected and non-infected setting.

Background: Evidence regarding the outcomes of Omniflow^® II prosthesis in peripheral arterial revascularization at different anatomical sites and for different indications is scarce. Therefore, the aim of this study was to evaluate the outcomes of the Omniflow^® II used at various positions within the femoral tract both in infected and non-infected setting.

Methods: Patients who underwent reconstructive lower leg vascular surgery with implantation of an Omniflow^® II from 2014 until 2021 at five medical centers were retrospectively included (N.=142). Patients were subdivided into the following categories: femoro-femoral crossover (N.=19), femoral interposition (N.=18), femoro-popliteal (above-the-knee [N.=25; AK] or below-the-knee [N.=47; BK]), and femoro-crural bypass grafts (N.=33). Primary outcome was primary patency and secondary outcomes included primary assisted patency, secondary patency, major amputation, vascular graft infection, and mortality. Outcomes were compared according to different subgroups and the surgical setting (infected versus non-infected).

Results: The median follow-up was 35.0 (17.5-54.3) months. Three years primary patency of 58% was observed for femoro-femoral crossover bypass, 75% for femoral interposition graft, 44% for femoro-popliteal above-the-knee bypass, 42% for femoro-popliteal below-the-knee bypass, and 27% in the femoro-crural position (P=0.006). Freedom from major amputation at three years were 84% for femoro-femoral crossover bypass, 88% for femoral interposition bypass, 90% for femoro-popliteal AK bypass, 83% for femoro-popliteal BK bypass, and 50% for femoro-crural bypass (P<0.001).

Conclusions: This study demonstrates the safety and feasibility of the use of Omniflow^® II for femoro-femoral crossover-, femoral interposition-, and femoro-popliteal (AK and BK) bypass. Omniflow^® II seems to be less suitable for femoro-crural bypass with a significantly lower patency compared to other positions.