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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Rivista di Chirurgia Vascolare ed Endovascolare
Italian Journal of Vascular and Endovascular Surgery 2006 September;13(3):137-47
Heparin-bonded expanded polytetrafluoroethylene vascular graft for occlusive vascular disease of the lower extremity
Walluscheck K. P.
Department of Vascular Surgery Diako Flensburg, Flensburg, Germany
Autologous saphenous vein (ASV) is generally the preferred bypass material for treatment of patients with severe occlusive arterial disease. However, in many patients requiring infrainguinal bypass for critical limb ischemia, ASV is unavailable or unsuitable for use as an arterial conduit. Therefore, the search for a prosthetic vascular graft with performance characteristics similar to those of ASV continues, with varying results. The patency of prosthetic grafts used in below-knee bypasses has been especially poor. A heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft was developed with the aim of improving the thromboresistance of the graft lumen and thereby mitigating one of the principal causes of early graft failure: deposition of thrombus on the luminal surface. A special process is used to attach the heparin to this graft (Carmeda BioActive Surface [CBAS]) to promote uniform heparinization, retention of heparin on the lumen, and maintenance of heparin bioactivity. Laboratory studies found that the CBAS-ePTFE graft offers stable, bioactive luminal-surface heparinization for weeks, as well as thromboresistance and inhibition of anastomotic intimal hyperplasia. No randomized controlled clinical studies of the graft have yet been reported, but one prospective study and several retrospective investigations have yielded encouraging patency and limb-salvage results up to 2 years after surgery, especially in below-knee bypasses. The studies have also indicated that the CBAS-ePTFE graft is safe to use, with no reports of heparin-induced thrombocytopenia. Longer term and randomized studies of the CBAS-ePTFE are warranted to provide conclusive assessments of its clinical performance.