Aim: Expanded polytetrafluoroethylene (ePTFE) grafts are commonly used for femoropopliteal (FP) and femorocrural (FC) bypass grafting. Especially in below-knee (BK) reconstructions, patency is often inferior to the outcome in patients eligible for venous bypass grafting. This study assesses whether the Carmeda BioActive Surface (CBAS), which employs covalent end-point linkage to retain heparin on the device surface, as it is used on the Propaten vascular graft successfully, can prolong patency.
Methods: From June 2002 to December 2005, 138 patients (97 men and 41 women; mean age: 73 years) received the CBAS-ePTFE graft for 153 infrainguinal bypass procedures. Seventy-five above-knee (AK) and 78 BK (including 37 FC) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses.
Results: The overall primary and secondary 2-year patency rates were 73.6% and 86%, respectively. Two-year primary patency rates according to bypass type were 76.2%, 72.6%, and 68.9% for AK FP, BK FP, and FC bypasses, respectively; the corresponding secondary patency rates were 87.5%, 87.8%, and 79.4%. The 2-year limb salvage rate in patients with critical limb ischemia (n=68) was 89.9%.
Conclusion: Our findings show that CBAS-ePTFE bypass grafts appear to give prolonged patency rates and indicate that the use of this graft may represent a viable alternative for BK bypasses, which have traditionally yielded less than desirable outcomes. A prospective randomized trial is required to provide more definitive information about the graft's patency and limb salvage performance.