The composite Corethane/Dacron vascular prosthesis. Canine in vivo evaluation of 4 mm diameter grafts with 1 year...

Polyurethane vascular prostheses offer the potential of superior thromboresistance and reduced anastomotic hyperplasia compared to existing Dacron and ePTFE alternatives, but have suffered from susceptibility to biodegradation, with resulting mechanical failure. To address this problem, the authors have developed and evaluated a composite prosthesis comprised of: 1) an inner blood interfacing elastomeric porous membrane made from Corethane, a proprietary Shore 80A polyurethane like material substantially devoid of ether/ester linkages, with superior biostability over conventional polyether urethanes, spun into a nonwoven structure with fiber diameters 10-15 microns and pore sizes 30-60 microns filled with gelatin +/- heparin; and 2) an outer soft, tissue interfacing, warp knitted Dacron mesh bonded to the inner layer to assure long-term dimensional stability. Twenty 4 mm ID x 5 cm L composite prostheses, half with heparinized gelatin (the remainder nonheparinized) were implanted as femoral interposition grafts in 10 dogs. Four of the 10 nonheparinized grafts occluded. All 10 with heparin remained widely patent, with two explanted at 6 months showing vascularized connective tissue growth through the graft, in contrast to the giant cell inflammatory response to the Dacron mesh, with a substantially endothelialized neointima and no Corethane biodegradation. Of the 10 patent grafts at 1 year follow-up, none showed aneurysm formation. This vascular prosthesis provides compliance superior to ePTFE and Dacron alternatives, with excellent suture retention and good kink resistance, while combining the superior thromboresistance and tissue ingrowth properties of polyurethanes with the proven biostability of Dacron.