Comparison of Outcomes of ePTFE Vascular Grafts With Heparin End-Point Covalent Bond and Alternative Autologous Vein for Below-Knee Surgical Bypass Procedures in Critical Limb Ischemia Patients

OBJECTIVES: Critical limb ischemia is an advanced stage of peripheral arterial disease. Great saphenous vein (GSV) is the gold standard conduit recommended for lower limb bypass procedures. Other types of conduits such as alternative autologous saphenous veins (AAV) and synthetic vascular grafts are options when GSV is unavailable.

This study compares outcomes reported from literature reviews, for AAV and a synthetic graft, the GORE^® PROPATEN^® Vascular Graft with heparin end-point covalent bond (PROPATEN^® Device).

METHODS: Four literature reviews, pooling data on PROPATEN^® Device, and AAV were conducted, the methods and results have been published elsewhere. These reviews were used for making an indirect comparison of outcomes on hospital stay, operating room (O.R.) time, clinical patency and wound infection rate.

RESULTS: There were no studies that compared only PROPATEN^® Device and AAV. In comparative studies the comparator was GSV or other synthetic & cryopreserved grafts. Literature reviews pooled data for the respective arms and this indirect comparison method is a limitation of this study.

Hospital stay reported was lower by 3.1 days for PROPATEN^® Device compared to AAV (6.6 days vs. 9.7 days). O.R. time was lower by 124 minutes for PROPATEN^® Device compared to AAV (138 minutes vs. 262 minutes). Primary patency at year 1 & 3 was higher for PROPATEN^® Device (78.9% vs. 39.4%, 62.2% vs 32.3%). Secondary patency at year 1 & 3 was higher for PROPATEN^® Device (84.8% vs. 66.9%, 68.9% vs. 55.1%). Wound infection rate was lower for PROPATEN^® Device at 1.9% compared to 15.9% for AAV.

CONCLUSIONS: The data reported indicate that treatment with PROPATEN^® Device has a lower hospital stay and O.R. time. PROPATEN^® Device may offer better clinical outcomes of improved patency rates and lower rates of infection. The lack of comparative studies is a limitation and more comparative studies are recommended.