Prospective clinical study with in vitro endothelial cell lining of expanded polytetrafluoroethylene grafts in crural...

A nonrandomized prospective clinical study was undertaken to evaluate the technique and efficacy of in vitro endothelial cell lining of synthetic grafts. Twenty-six patients (10 men and 16 women with a mean age of 68.4 years; range, 49 to 80 years) with end stage chronic peripheral vascular disease requiring reoperation were entered into the study. In 13 patients venous endothelial cells were harvested 4 to 7 weeks before operation, grown to confluency in culture flasks, and seeded onto the inner surface of expanded polytetrafluoroethylene grafts. Thirteen patients received untreated expanded polytetrafluoroethylene grafts and served as a control. A scoring system with use of intraarterial angiography was used to assess disease severity. No statistically significant differences in angiographic score were seen between the two groups, indicating comparable severity of disease. Early secondary graft patency (0 to 30 days) was 92% for the in vitro endothelial cell lining group and 53% for control patients. The amputation rate after 18 months for the in vitro endothelial cell lining group was 15%, with a 31% rate in the control group. The functional performance of the in vitro endothelial cell lining bypasses was superior to that of untreated bypass grafts during the observed follow-up period. These early results suggest that in vitro endothelial cell lining is a method that can reduce the early occlusion rate now seen after repeat reconstruction of crural vessels.