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

Abstract

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.

Long-term experience in autologous in vitro endothelialization of infrainguinal ePTFE grafts

“…The often eccentrically narrowing formations of a pannus-like tissue, whose potential precursors may be the mild luminal irregularities visible on 5% of year one angiographies in the present cohort and described by others, 11 presented a mixed picture between the cell-poor fibrous cap of an arteriosclerotic lesion and its large accumulations of foam cells in the depth. Most peculiar, however, were those stretches were a thin layer of endothelium was directly attached to a densely packed layer of inflammatory cells wedged between the endothelium and the ePTFE surface.…”

“…In the second half of the 1980s, sufficient experimental data had been accumulated by a few groups to justify the commencement of three independent clinical pilot studies. [9][10][11] In contrast to the "single staged" seeding trials of previous years, in vitro endothelialization significantly improved clinical patency rates. 9,[11][12][13] Adding weight to these rather small clinical studies was the fact that retrieved samples demonstrated the presence of a confluent endothelium in the midgraft region weeks to years after implantation.…”

Engineering of vascular ingrowth matrices: Are protein domains an alternative to peptides?

“…After in vitro shear stress-testing and preclinical primate studies, we eventually commenced clinical trials with in vitro endothelialized femoro-popliteal bypass grafts in 1989 (Zilla et al, 1994;Meinhart et al, 1997;Deutsch et al, 1997;Magometschnigg et al, 1992). To date, four different groups have reported their experience with clinical in vitro endothelialization with a follow-up period of up to 11 years.…”

Point-of-Care Rapid-Seeding Ventricular Assist Device with Blood-Derived Endothelial Cells to Create a Living Antithrombotic Coating

“…The benefit of artificial surface endothelialization has been previously demonstrated, but its clinical application has been hindered by the need for an invasive procedure to surgically harvest ECs from native vessels. 16,17 Further, the need for prolonged ex vivo culture of ECs on circulatory assist devices for surface endothelialization has made this method clinically impractical. Hence, the preferred approach to endothelialize artificial surfaces would be to rapidly seed devices with ECs obtained by a minimally invasive method, such as a peripheral blood draw.…”