Ten year experience with the negatively charged glutaraldehyde-tanned vascular graft in peripheral vascular surgery. Initial multicenter trial.
The negatively charged glutaraldehyde-tanned vascular graft was developed to determine the utility of grafts of biologic origin to provide satisfactory revascularization for ischemic limbs with advanced arteriosclerotic peripheral vascular disease. The bovine carotid artery was modified under a number of conditions using a large number of variables and evaluated in the carotid artery and aorta of dogs. Eventually ficin-digested carboxylated glutaraldehyde-tanned grafts were selected as being most antithrombotic and most resistant to aneurysm formation. Under an Investigational Device Exemption with the Food and Drug Administration, 146 grafts were evaluated in 108 patients with patency approaching 67 percent for all grafts at 5 years and 59 percent at 9 years plus. Total aneurysm formation has been 4 percent (six grafts) occurring only in hypertensive patients. The graft is now undergoing clinical use and evaluation worldwide.