Mark W. Walker

An experimental study of eight current arterial prostheses

Eight currently used arterial prostheses with differing constructions and materials were implanted in the descending thoracic aorta of mongrel dogs. The prostheses were Gore-Tex (polytetrafluoroethylene), DeBakey Woven, Cooley Woven, Meadox Woven Double Velour, Cooley Knitted Double Velour, Microvel, Vasculour II, and Bionit II. Five series of these eight prostheses were serially implanted in heparinized subjects. During the 40 implantations, attention was focused on three major characteristics: preclotting efficiency, surgical handling characteristics, and healing. Gore-Tex is impervious to blood. The DeBakey and Cooley woven grafts are nearly so. The remaining prostheses required preclotting. The Meadox Woven Double Velour became impervious after two preclotting steps, the Cooley Knitted Double Velour and the Bionit II required three, and the Vasculour II and the Microvel required four. The surgical handling characteristics of the knitted prostheses clearly surpassed those of the DeBakey and Cooley woven and Gore-Tex prostheses. Although the Meadox Woven Double Velour prosthesis had better conformability than the nonveloured woven, the tendency of its cut edge to fray was more pronounced. Healing was much more advanced in the knitted and woven prostheses than in the Gore-Tex.

The direct effect of graft compliance mismatch per se on development of host arterial intimal hyperplasia at the anastomotic interface

To study thedirect andsole effect of compliance mismatch on anastomotic intimal hyperplasia of the host arterial wall and to minimize possible confounding factors, dogs with a low thrombotic potential were selected as experimental subjects. Externally supported 6 cm × 5 mm Dacron grafts with a compliance value of approximately 1/300 of the host artery were implanted into the carotid arteries with end-to-end anastomoses on one side and end-to-side anastomoses on the other. The control graft was an autogenous carotid artery segment 4 cm in length transplanted into the femoral artery. Eight cases (24 grafts) were studied for 1 year and three (nine grafts) for 6 months. All were patent throughout the study period except for two noncompliant grafts with end-to-end anastomoses; thrombosis was the documented cause of occlusion. For the patent grafts, follow-up arteriograms showed no progressive narrowing of noncompliant anastomoses. Whether compliant or noncompliant, light microscopy studies showed slight intimal thickening within 1 to 2 mm of the anastomotic line, possibly the result of the normal healing response to stitch and surgical trauma. Quantitatively, 22 measurements representing longitudinal and circumferential thickness of the neointima were taken at each of the 40 patent noncompliant and 22 patent compliant control anastomoses. There was no statistically significant difference in anastomotic neointimal thickness in compliant and noncompliant grafts or for the different implantation periods. These data suggest that graft/host artery compliance mismatch does not cause arterial intimal hyperplasia at the anastomotic interface.

Experimental comparison of the thrombogenicity of fibrin and PTFE flow surfaces.

Two types of 4 mm ID prostheses were studied in the carotid arteries of the dog. These were noncrimped polypropylene-supported filamentous velour knitted Dacron® (PPSFV) and expanded polytetralfluoroethylene (e-PTFE, Gore-Tex®). Thrombus-“Free” Surface (TFS) areas and patency rates were determined at the end of the implant periods. One series of implants was subjected to controlled low flow rates for six hours; another was exposed to physiologic flow rates and observed at seven days, 14 days, and 12 weeks. At six hours the filamentous Dacron, preclotted according to a specific regimen utilizing heparin, performed as well as, and possibly better than, e-PTFE. The Gore-Tex developed surface coagulum in an irregular fashion which was related to graft wetting and blood soakage. Seven-day TFS scores and patency rates of the two graft types were comparable at physiologic flow rates. At two weeks, TFS scores and patency rates dropped. This was sufficiently marked in the case of e-PTFE that longer-term implants were not done. However, PPSFV grafts were implanted for 12 weeks, and all grafts examined at that time had closed. It appears that patency of 4 nim ID grafts of this construction will not be reliably attained in the dog carotid artery without the use of platelet-inhibitory drugs until complete healing has occurred.

Differences in reendothelialization after balloon catheter removal of endothelial cells, superficial endarterectomy, and deep endarterectomy

The process of reendothelialization was studied in a deendothelialized 3 cm segment of the canine descending thoracic aorta from which peripheral endothelial cell ingrowth had been prevented by impervious prosthetic graft sleeves. Three preparations were studied: (1) removal of only the endothelial cells, accomplished by flow surface drying and balloon catheter denudation, (2) removal of the superficial portion of the nonvasal media, accomplished by endarterectomy to a depth of 200 to 300 micron, and (3) removal of the entire inner (nonvasal) media, accomplished by endarterectomy to a depth of 500 to 600 micron to reach the outer (vasal) media. A total of 44 specimens were studied after implantation periods of 7, 14, 28, and 56 days. In all cases endothelial cell ingrowth from the host aorta into the test specimen was prevented by the impervious graft sleeves. In the deep endarterectomy group there were scattered areas of reendothelialization at 1 week, extensive reendothelialization at 2 weeks, almost complete reendothelialization at 4 weeks, and confluence by 8 weeks. However, in the superficial endarterectomy group scanning electron microscopy showed scattered areas of factor VIII/von Willebrand factor (FVIII/vWF)-negative, endothelial-like cells at 4 weeks, whereas at 8 weeks most of the surface was covered by endothelial cells identified by FVIII/vWF. In those specimens subjected to balloon catheter removal of endothelial cells only, reendothelialization was not seen, even at 8 weeks.

Implant site: a determinant of completeness of arterial prosthesis healing in the dog and possibly in humans.

This paper compares the healing of supported knitted Dacron prostheses implanted in the descending thoracic aorta and in the subcutaneous carotid-femoral positions in each of 10 dogs. The descending thoracic aorta prostheses were 6 cm long and the carotid-femoral prostheses averaged 76 cm in length. The healing of four porous clinical axillofemoral grafts is compared to that of the experimental carotid-femoral grafts. There was little similarity between the healing observed in the descending thoracic aortic and subcutaneous positions; the descending thoracic aorta grafts healed rapidly and completely by eight weeks, with thrombus-free flow surfaces covered with confluent endothelial cells. However, the inner wall of the carotidfemoral grafts remained largely unhealed at one year, with endothelialization largely confined to a limited pannus ingrowth across the anastomoses. This indicates that the implant site in the dog is a primary determinant of the rapidity and completeness of healing. The clinical axillofemoral grafts explanted after 20 months to six and one-half years exhibited healing characteristics that were similar to those seen in the carotid-femoral position in the dog. These findings suggest that valid comparisons of interspecies healing require data obtained from similar implant locations. They present a challenge to the previously held concepts of major interspecies differences in speed and extent of tissue ingrowth based on data obtained from noncomparable implant sites.

Glutaraldehyde preparation of coronary artery bypass bioprostheses

A method for glutaraldehyde (GA) fixation of canine carotid arteries has been developed for the preparation of small caliber biologic prostheses for coronary artery bypass. The biologic grafts were preserved by a static inflation technique that proved to be more advantageous than the standard stenting method. The most suitable static inflation pressure was found to be 120 mm Hg. By means of colorimetric measurements the minimal tanning time and the amount of GA required for complete fixation for canine vascular tissue were established. Stabilization of the vessel collagen and confirmation of GA-collagen cross-linking were verified by evaluation of the elastic properties and shrinkage temperature of the grafts. Stress-strain measurements were evaluated to determine the number of cross-links introduced in the vascular tissue by GA. This number was shown to be proportional to the inflation pressure. Ethyl alcohol was chosen as the storage solution because it maintained the best physical, chemical, and histologic characteristics of the grafts. Biological evaluations were performed with carotid implants that were examined following acute low flow studies and implantations up to 112 days. All implantations have yielded 100% patencies.

The Evolution of a Clinically Relevant Experimental Model for the Realistic Evaluation of Long-Length (80-cm) Arterial Prostheses

A new carotid-femoral experimental model has been developed which has significant clinical relevance to human limb salvage bypass grafting in the areas of graft length, hemodynamics and tissue environment. More significantly, the graft healing pattern observed with this model is similar to what is seen in humans. Therefore, this experimental model provides a challenging and critical site for dynamic healing studies and comparisons of different types of vascular prostheses.

Comparative Evaluation of the Elasticity and Flexibility of Bioimpregnated Knitted Grafts

Longitudinal elasticities of whole human blood clot, whole canine blood clot, Factor XIII cross-linked fibrin, glutaraldehyde-fixed human albumin, and formaldehyde-fixed collagen, gelatin and collagen/gelatin were determined and normalized to human whole blood clot. Matrices of a knitted Dacron graft were then impregnated with albumin, collagen, and collagen/gelatin and their longitudinal elasticities were determined and normalized to a preclotted graft. Comparisons were also made for the longitudinal elasticities of a virgin graft, a manipulated control for a preclotted graft, and a manipulated control for the matrix-impregnated grafts. Flexibilities were then calculated based on the weights and elasticities of these grafts and normalized to the flexibility of the preclotted graft. Fibrin had twice and 39 times more longitudinal elasticity than human blood clot and collagen, respectively. The preclotted graft has longitudinal elastic properties similar to a virgin graft, and is 2.8, 2, and 1.4 times more elastic than the albumin, collagen and collagen/gelatin grafts, respectively. The preclotted graft was 2.5, 2, and 1.4 times more flexible than the albumin, collagen and collagen/gelatin grafts, respectively.