Biosynthetic Prosthesis Omniflow II in Chronic-Limb Threatening Ischemia: Results of the Multicenter National Registry Omni-Femoropopliteal.

BACKGROUND

Chronic limb-threatening ischemia (CLTI) represents a severe condition associated with high morbidity and mortality, particularly in patients lacking optimal autologous vein. The prevalence of CLTI accentuates the need to find a different conduit. Biological prostheses have emerged as a viable alternative given the limitations of conventional synthetic grafts for the treatment of CLTI patients. The objective of this study was to evaluate the clinical outcomes, patency, and limb salvage rates of the Omniflow II biosynthetic prosthesis (LeMaitre Vascular, Inc., Burlington, MA) in infrainguinal bypass procedures among CLTI patients.

METHODS

This was a national, prospective, multicenter study conducted between 2019 and 2023, including patients with CLTI who underwent femoropopliteal bypass using Omniflow II. Patency, reintervention, postoperative complications (including graft degeneration or infection), and limb salvage rates were assessed.

RESULTS

A total of 83 patients were included: 28 underwent above-knee femoropopliteal bypass (AK group), and 55 underwent below-knee femoropopliteal bypass (BK group). The mean follow-up was 18 ± 12 months. At 2 years, primary and secondary patency rates were 51% and 71% in the AK group, and 60% and 70% in the BK group, respectively. An amputation-free survival rate of 81,4% at 2 years was observed. Prosthetic infection requiring explantation occurred in 4 patients (4.8%), and aneurysmal degeneration was reported in one case (1.2%) that did not require surgical intervention.

CONCLUSION

The use of Omniflow II in patients with CLTI demonstrated favorable midterm outcomes, particularly regarding patency in bypasses with distal infragenicular anastomosis. These findings support its consideration as an alternative in patients without available autologous vein.