M. Marois

Carbodiimide cross-linked gelatin: a new coating for porous polyester arterial prostheses

The performance of a polyester arterial prosthesis impregnated with gelatin and cross-linked with carbodiimide (Uni-graft) was compared with its porous parent graft (Protegraft) using a canine thoraco-abdominal bypass model. The grafts were investigated in terms of their handling characteristics, imperviousness at implantation, surface thrombogenicity and healing behaviour. Prostheses 30 cm in length were implanted for the following periods: 4, 24 and 48 h, 1, 2 and 4 weeks, 2, 3, 4, 5 and 6 months. Both types of graft had good handling characteristics. The ready-to-use impregnated graft provided satisfactory haemostasis at implantation with no blood permeating through the wall after flow was restored. Both grafts exhibited low surface thrombogenicity, as determined by the uptake of labelled fibrin and platelets, and the healing sequence of the impregnated graft after resorption of the gelatin was equivalent to that of the preclotted control. Biodegradation of the gelatin was complete within 1 month of implantation with the subsequent development of a collagenous internal capsule at both anastomoses. Endothelial cells were observed between 4 and 6 months, but were confined to small islets distributed along the luminal surface. The prostacyclin/thromboxane A2 (PGI2/TXA2) ratio, which gives an indication of the level of endothelial cell activity, was greater than 1.0 after 1 week of implantation for the control graft. For the impregnated graft it reached 1.0 only after 3 months of implantation, but remained above 1.0 for periods of up to 6 months.(ABSTRACT TRUNCATED AT 250 WORDS)

Expanded polytetrafluoroethylene arterial prostheses in humans: histopathological study of 298 surgically excised grafts

The expanded polytetrafluoroethylene vascular prosthesis is considered to be the best synthetic alternative for peripheral arterial reconstruction. Most studies on the healing characteristics of expanded polytetrafluoroethylene prostheses have been carried out on animals, and very few data are available on prosthesis implanted in humans long term. We implanted 298 expanded polytetrafluoroethylene grafts as arterial substitutes in humans. The mean duration of implantation was 523 d and the grafts were implanted mainly for infrainguinal or axillofemoral bypass. The cellular and collagen infiltration of the microporous expanded polytetrafluoroethylene structure was generally poor. Infiltration occurred mainly in the external region of the prosthetic wall and increased with the duration of implantation. The external reinforcement was not a major factor in limiting tissue infiltration. The luminal surfaces were covered with a thin, irregular layer of organized fibrin, interspersed with exposed expanded polytetrafluoroethylene areas. Mineral deposits were observed in five cases. Despite poor healing, the clinical performance of expanded polytetrafluoroethylene vascular prostheses is relatively good. Since the chief advantage of this material is good mechanical stability in vivo, any modifications of the graft to improve healing characteristics or thrombogenic properties should not be made at the expense of stability in vivo.

An albumin-coated polyester arterial graft: in vivo assessment of biocompatibility and healing characteristics

The albumin-coated vascular graft (ACG) and its uncoated polyester substrate, the Vascular II (V-II), were evaluated in terms of biocompatibility and biofunctionality using two in vivo animal studies. Biocompatibility and immunoreactivity were assessed by implanting intraperitoneally in the rat small segments of the ACG and the V-II graft and harvesting them with their surrounding tissue 3d, 1, 2 and 4 weeks later. Cytofluorometric determination of total T cells (CD3), the ratio of CD4/CD8 subsets and the percentage of IL-2 receptor-positive T cells in the peripheral blood has revealed that no significant difference in any of the T cell populations was found between the ACG and the V-II graft. The cellular reactivity of the ACG in terms of acid phosphatase activity at the implant side was significantly greater at 3 d but not at longer periods. Biofunctionality was evaluated by implanting both grafts as a thoracoabdominal vascular bypass in dogs for 11 different periods ranging from 4 h to 6 months. The rate of albumin resorption was such that traces were still present at 1 month, but no longer observable at 2 months. Tissue incorporation into the graft wall was earlier for the V-II (2 weeks) than for the ACG (4 weeks), which showed complete encapsulation, tissue incorporation and endothelialization after 2 months in vivo. Only small differences were observed between both grafts in terms of platelet and fibrin uptake on the luminal surface. The prostacyclin/thromboxane A2 ratio increased to a level higher that 1.0 aorta within 1 month for the V-II and 4 months for the ACG. In conclusion, the Bard ACG has demonstrated excellent biocompatibility in terms of blood T cell behaviour and acid phosphatase activity at the implant site. Finally, its healing response is equivalent to that of the uncoated Dacron prosthesis once the albumin coating has been resorbed.

Carotid Endarterectomy Plaques: Correlations of Clinical and Anatomic Findings

To establish possible relationships between the structure of carotid plaque and neurologic symptoms, 187 consecutive endarterectomy specimens were studied prospectively. Each specimen was examined for gross and histopathological features. Intraplaque hemorrhage, although found infrequently, was closely correlated with the presence of symptoms. Plaque ulcerations were encountered more often when lesions were symptomatic. Calcifications were more frequently associated with asymptomatic lesions. Consistency of plaque was related to its morphological features (stenosis or ulceration) and symptoms. Soft plaques with predominant atheromatous grumous material and hemorrhage were associated more often with tightiy stenotic, ulcerated, and symptomatic lesions. Consistency of atherosclerotic carotid plaques should be assessed and considered as an important element in the therapeutic decision.

Expanded PTFE Prostheses as Arterial Substitutes in Humans: Late Pathological Findings in 73 Excised Grafts

Through collaboration of surgeons, pathologists and bioengineers at five centers in Canada and France, this study analyzed the late pathology and structural changes in 73 expanded PTFE arterial prostheses harvested from patients at autopsies and reoperations. The degree of tissue encapsulation increased with the duration of implantation but was reduced by the presence of infection. In several cases, the fibrous tissue penetrated the wall of the prosthesis and partitioned off the thin outer layer, thus disrupting the delicate microporous structure of the wall. The presence of aneurysms was observed in models that had no external reinforcing layer and among grafts that apparently suffered from surgical trauma. Wrinkling of grafts was noted at areas of flexion and was often associated with thickening of the external capsule and reduced luminal diameters. Endothelialization was found within only a few millimeters of the anastomoses. The luminal surfaces were generally not well healed. The PTFE structure was usually readily visible under a thin covering of loosely adhering thrombotic deposits. Bacteria were observed in 46% of the cases, even though only 29% were considered clinically infected. The incidence of lipid or cholesterol deposits was high. Avoiding iatrogenic trauma to the external wall of the prosthesis during implantation is important. Those features where design improvements are required to provide longer term structural integrity and dimensional stability in future models of expanded PTFE prostheses should be identified.

Vascugraft polyurethane arterial prosthesis as femoro-popliteal and femoro-peroneal bypasses in humans: pathological, structural and chemical analyses of four excised grafts.

Following positive results obtained in in vitro studies and in vivo implantations in animals, a clinical trial using the Vascugraft polyurethane arterial prosthesis as a below-knee substitute was undertaken in 15 patients. Eight grafts became occluded during the first year, and segments from four of them were explanted and made available for pathological, structural and chemical investigations. The implantation periods ranged from 21 to 358 days. Failures were associated with kinking (one case), possible anastomotic mismatch between the graft and the artery (one case), and poor run-off (two cases). No organized collagenous internal encapsulation was noted; however, endothelial-like cells were observed at the anastomotic site of one graft. No significant structural degradation of the prostheses was observed in those grafts implanted for 21, 38 and 46 days. Some deteriorations in the fibrous structure were observed on the external surface of the prosthesis implanted for 358 days. High-resolution carbon C1s analysis by ESCA demonstrated a 60 to 80% decrease in carbonate content on the surface of all explanted prostheses. Chemical analyses of each polyurethane graft by IR, SEC and DSC revealed no significant chemical changes. The clinical performance of the Vascugraft prosthesis for below-knee implantation proved to be no more impressive than that of expanded polytetrafluorethylene, the currently accepted reference. The decision by B. Braun Melsungen AG to end this program is therefore to be regarded as highly professional.

A compound arterial prosthesis: the importance of the sterilization procedure on the healing and stability of albuminated polyester grafts

In response to the demand for a vascular prosthesis which achieves reliable haemostasis without preclotting, a new compound albumin/polyester prosthesis has been developed. In order to optimize the sterilization procedures for this device, two series of implantations in the thoracic aorta of dogs were undertaken to compare the effects of ethylene oxide (EtO) and gamma-radiation. Preclotted polyester prostheses were implanted in two additional control series. Pathological analysis of the explanted grafts indicated that gamma-radiation is to be preferred over EtO because it results in faster rates of healing. While the albumin coating delayed the thrombotic response and fibrinolytic activity, the extent of healing of the radiation sterilized graft was equivalent to that achieved by preclotted polyester prostheses in the medium and long term. Measurements of the strength and dimensional changes of the graft demonstrated that, in addition to reducing the risks of acute thrombosis and postoperative haemorrhage, the albumin coating improves the dimensional stability of the knitted structure.

In vivo evaluation of hydrophobic and fibrillar microporous polyetherurethane urea graft

Mitrathane hydrophobic and fibrillar microporous prosthesis was implanted as infrarenal arterial substitute in dogs; it was evaluated in terms of patency rates, healing characteristics and biostability. Segments of grafts were implanted in duplicate for a period of implantation of 24 h, 1 wk, 1 month and 6 month. Two control grafts from the Ontario Research Foundation were implanted: one for 1 month, the other for six month. All except the two Mitrathane grafts implanted for 6 month were patent at death. The Mitrathane grafts showed kinking at one and 6 month post-implantation. The ORF graft implanted for 1 month was found crinkled in its mid-section and the external capsule was ruptured in the graft implanted for 6 month, without crinkling. Histological studies showed fibrin deposits on the flow surface and infiltration of blood elements into the wall of the Mitrathane grafts implanted for 24 h and 1 wk. A thin internal capsule was present on the graft flow surface of both types of graft tested 1 month post-implantation; scanning electron microscopy revealed the presence of endothelial-like cells on the luminal surface, particularly in the vicinity of the anastomoses. At 6 month, the Mitrathane grafts were occluded by a thick thrombus originating from the anastomoses, while the ORF graft showed infiltration of collagen through the polyurethane fibrillar structure of the wall with an endothelial-like lining covering the flow surface in the vicinity of both anastomoses.

Can collagen impregnated polyester arterial prostheses be recommended as small diameter blood conduits

&NA; A collagen impregnated graft and its parent preclotted prosthesis were implanted as thoraco‐abdominal bypasses in dogs for periods ranging from 4 hr to 6 months and evaluated for their ease of handling, imperviousness, and healing behavior in terms of luminal surface thrombogenicity using labeled platelets and fibrinogen, prostacyclin (PGI2) secretion, histomorphometric determination of internal capsule thickness, and histopathologic and scanning electron microscopic studies. The collagen impregnated graft was impervious to blood and both grafts showed excellent handling characteristics. Fibrin uptake was negligible on both grafts; however, platelet uptake was higher on the collagen impregnated graft than on the control graft at 4 and 24 hr. The headling behavior of the collagen impregnated graft was also found to be different than that of the control graft between 1 and 6 months post implantation. The development of a host collagenous internal capsule at the anastomoses, and a confluent endothelial lining, was observed in both grafts at 1 month; in later implantation periods, the healing of the medial region was found to be more irregular in the collagen impregnated grafts, showing a lower mean PGI2 secretion than the preclotted control grafts. Histomorphometric analysis showed the internal capsule on the collagen impregnated grafts to be thicker than on the control grafts for most periods of implantation. The current study illustrates that the healing process of collagen impregnated grafts is delayed and that bovine collagen has a stimulating effect on tissue encapsulation. Current impregnated polyester arterial prostheses therefore cannot be recommended as small diameter blood conduits. ASAIO Journal 1996;42:947‐983.

New polyester arterial prostheses from great britain: anin vitro andin vivo evaluation

Two models of knitted velour polyester prostheses have been developed in Great Britain, i.e. the VP1200K and the VP50K Triaxial. The evaluation of these new devices in vitro and in vivo in dogs has demonstrated that, while the first model has similar surgical, mechanical and healing characteristics in the short term to other commercial knitted velour prostheses, the second model has lower water permeability and superior strength and dimensional stability. On the basis of these results, clinical investigations can be undertaken.