For the surgical treatment of critical limb ischemia one of the decisive influencing factors for short-term and long-term limb salvage is the use of autologous veins as bypass material. There is currently a lack of studies on the long-term assessment of alternative bypass materials, which can be used for critical limb ischemia due to a lack of autologous vein material. A prospective database was established that included all patients with critical limb ischemia who received a bypass with the Omniflow-II™ prosthesis. From 2006 until 2014 bypass surgery with the Omniflow-II™ prosthesis was carried out in 123 patients. The mortality was 5 % while the morbidity was 14 % and the 5‑year survival rate was 37 %. In patients with a popliteal bypass (n = 62), the primary and secondary patency rates were 34 % and 69 %, respectively after 5 years. The corresponding results for the crural position (n = 61) over the same time period were 32 % and 34 %, respectively. After 5 years, the group receiving popliteal bypass surgery showed a limb salvage rate of 98 % whereas the crural group had a rate of 70 %. In this study we could demonstrate very promising results using the Omniflow-II™ prosthesis for the surgical treatment of critical limb ischemia.
Background Reports about the use of the Omniflow II prosthesis (Bio Nova International, Victoria, Australia) in a crural position in patients with critical lower limb ischemia are rare. Methods All crural bypass operations were registered in a database. Primary end points of the study were amputation-free survival, limb salvage, and long-term patency. Results From January 2007 to December 2012, we implanted 27 Omniflow II prostheses in the crural position for critical lower limb ischemia. Of these, 12 crural bypasses were conducted with adjuvant distal arteriovenous fistula as a means to increase bypass flow in the presence of severely impaired intraoperative runoff or revision for early failure. Fifteen Omniflow II prosthesis bypasses were performed in the crural position without fistula. Overall, two patients died postoperatively. The limb salvage rate was 92% in the fistula group compared with 60% in the nonfistula group after a median observation time of 19 months in patients getting Omniflow prosthesis bypasses. Conclusion Omniflow II prosthesis in patients with critical lower limb ischemia and absence of sufficient autologous vein is durable. Moreover, the use of adjuvant distal arteriovenous fistula may increase the chance of limb salvage in this group of patients.
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