The Role of the Omniflow II Biosynthetic Graft in Postoperative Wound Problems After Lower Limb Revascularization: A Single Center Prospective Registry.

Objective: To investigate the role of the Omniflow II prosthesis in the prevention of vascular graft infection (VGI) in patients with peripheral arterial disease and to report on short-and mid-term graft-related morbidity.

Material And Methods: Patients were included in prospective registry between October 2019 and March 2023. The primary endpoint was to report infection-related problems, operation-related wound problems, and short- and mid-term graft-related morbidity. Secondary endpoint was to report the bypass patency rates and limb salvage rates.

Results: A total of 146 Omniflow II grafts were implanted in 125 patients. Sixty-seven patients (45.9%) received a femoral interposition graft, and 77 patients (52.7%) underwent ipsilateral bypass surgery (femoropopliteal or femorocrural). Forty-one patients (28.1%) underwent crural bypass surgery. Seventy-six patients (52.1%) had previous vascular operation in the groin. The mean follow-up time was 352 days (range 0-1108 days). 3.4% of the patients suffered a wound infection limited to the dermis, and in 8.2%, the subcutaneous tissue was involved. Five early VGI (3.4%) and one late VGI (0.7%) occurred. One year primary patency rate of above-the-knee bypass was significantly better compared to the bypass below the knee (74.5% ± 0.131 versus 54% ± 0.126 (P = 0.049)). This difference was not significantly different when below-the-knee bypass surgery was compared with crural bypass surgery (54% ± 0.126 versus 23.8% ± 0.080 (P = 0.098)).

Conclusions: The performance of the Omniflow II prosthesis in the preventive setting is highly influenced by the anatomic location of the distal anastomosis. No influence on the incidence of postoperative wound problems could be observed. The rate of Omniflow II VGI in a high-risk population is similar to reported outcomes in other prosthetic grafts.