Background: The aim of this study was to retrospectively analyze early and late outcomes of infrainguinal revascularization performed with the Omniflow-II® (LeMaitre Vascular, Inc., Burlington, MA, USA) biosynthetic vascular graft (BVG) for complex femoro-popliteal obstructive disease.
Methods: Over a 10-year period, this BVG was used in 110 patients who underwent infrainguinal femoro-popliteal or femoro-distal bypass. Early (intraoperative and <30 days) results were analyzed in terms of death, thrombosis, amputations and reinterventions. Follow-up results were analyzed in terms of primary and secondary graft patency, and amputation-free survival.
Results: We performed 87 (79.1%) above-the-knee bypass, 20 (18.2%) below-the-knee bypass, and 3 (2.7%) tibial artery bypass. In-hospital mortality was not observed. Mean follow-up was 66±37 months (range, 3-150). Estimated primary patency rate at 1, 2 and 5-years of follow-up was 77%±4 (95%CI: 68-84), 73%±5 (95%CI: 63.5-83), and 59%±6 (95%CI: 47-70.5) respectively. Predictors of primary patency loss were the presence of critical limb ischemia (P=0.048; HR: 2.1; 95%CI: 1.01-4.28), and the necessity of below-the-knee bypass (P=0.012; HR: 2.4; 95%CI: 1.22-4.75). Aneurysmal degeneration of the BVG was detected in 4 (3.6%) patients, an infected BVG occurred in 3 (2.7%) patients. The amputation-free survival was 96%±2 (95%CI: 91-99), 93%±3 (95%CI: 86-96), and 76%±5 (95%CI: 66-84) at 1, 2 and 5-years respectively.
Conclusions: In our experience, Omniflow-II® is a valid first-line alternative for infrainguinal revascularization when the ipsilateral autologous saphenous vein is not available. Aneurysmal degeneration was lower than previously reported with alternative BVGs, and the incidence of BVG infection was acceptably low.