[Omniflow-IITM for critical limb ischemia : Long-term results]
F Dünschede1, M Youssef2, J Stabrauskaite2
1Klinik für Herz-, Thorax- und Gefäßchirugie, Universitätsmedizin Mainz, Langenbeckstr. 1, 55131, Mainz, Deutschland. friedrich.duenschede@unimedizin-mainz.de.
Insights
The Omniflow-II™ prosthesis shows promising results for critical limb ischemia surgery when autologous veins are unavailable. This study found high limb salvage rates, particularly for popliteal bypasses, suggesting its potential as an alternative bypass material.
Area of Science:
- Vascular Surgery
- Regenerative Medicine
- Biomaterials
Background:
- Autologous veins are the gold standard for bypass surgery in critical limb ischemia (CLI).
- A shortage of autologous vein material necessitates evaluating alternative bypass conduits for CLI treatment.
- Long-term outcomes of alternative bypass materials for CLI remain understudied.
Purpose of the Study:
- To assess the long-term efficacy and safety of the Omniflow-II™ prosthesis as an alternative bypass material in patients with critical limb ischemia.
- To evaluate patency rates and limb salvage in patients undergoing bypass surgery with Omniflow-II™ prosthesis.
- To compare outcomes between popliteal and crural bypasses using the Omniflow-II™ prosthesis.
Main Methods:
- A prospective database was established for patients with CLI undergoing bypass surgery with the Omniflow-II™ prosthesis.
- Data collected from 2006 to 2014 included 123 patients.
- Outcomes analyzed included mortality, morbidity, survival rates, bypass patency, and limb salvage at 5 years.
Main Results:
- The overall 5-year survival rate was 37%, with 5% mortality and 14% morbidity.
- For popliteal bypasses (n=62), 5-year primary and secondary patency rates were 34% and 69%, respectively.
- For crural bypasses (n=61), 5-year primary and secondary patency rates were 32% and 34%, respectively.
- Five-year limb salvage rates were 98% for popliteal bypasses and 70% for crural bypasses.
Conclusions:
- The Omniflow-II™ prosthesis demonstrates promising outcomes for surgical treatment of critical limb ischemia.
- High limb salvage rates, especially in the popliteal position, support its use when autologous veins are unavailable.
- Further research may validate Omniflow-II™ as a viable alternative conduit in vascular reconstruction for CLI.
Abstract:
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.
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