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.     

How should we preclot knitted Dacron grafts?

We studied the change in water porosity over time of 10 Sauvage Bionit-II and 10 DeBakey Vasculour-II knitted velour Dacron grafts throughout the four stages of the Sauvage preclotting technique. Graft porosity decreased significantly (p less than 0.001) at the ends of stages 1 and 2 for both types of grafts, but stages 3 and 4 did not further reduce graft porosity. These results demonstrate that a two-stage preclotting technique is adequate for the preclotting of knitted velour Dacron grafts. A final rinse with heparinized blood is recommended as this may reduce graft thrombogenicity.     

Dacron arterial grafts: the influence of porosity, velour, and maturity on thrombogenicity

It has been claimed that the neointimal healing of Dacron arterial prostheses can be enhanced by increasing porosity and including both an internal and an external velour layer. To test this, 24 patients received at random either woven (USCI, DeBakey, C. R. Bard, Inc.) or more porous, double-velour, knitted (Microvel, Meadox Medicals, Inc.) Dacron aortobifemoral prostheses. Graft thrombogenicity was measured using autogenous 111In-labeled platelets shortly following surgery and 6 to 9 months later. The thrombogenicity index was defined as the mean daily rise in the ratio of emissions over the graft to emissions over a reference area (aortic arch) and is a measure of platelet deposition. At early study the mean (+/- SE) thrombogenicity index was similar in woven and knitted graft patients at 0.19 +/- 0.4 and 0.14 +/- 0.2, respectively. In both groups it was lower (P less than 0.05) 6 to 9 months later at 0.06 +/- 0.2 (woven( and 0.08 +/- 0.1 (knitted), with again no difference between materials. Although platelet survival was restored to near normal values in both groups by 6 to 9 months, only one woven graft failed to demonstrate continued platelet accumulation by gamma-imaging. Thrombogenicity in Dacron grafts diminishes in the early months of maturation but is not affected by porosity and velour. Moreover, this thrombogenicity persists beyond the period of altered platelet survival.     

Experimental comparison of albumin-sealed and gelatin-sealed knitted Dacron conduits. Porosity control, handling, sealant resorption, and healing.

Two high-porosity knitted Dacron vascular grafts sealed with aldehyde cross-linked gelatin or albumin were compared with respect to the following characteristics. Porosity control by the absorbable sealant was assessed with a water porosity meter at 120 mm Hg pressure. Ease of suturing was determined by an objective needle penetration test. Sealant resorption was assessed histologically in a subcutaneous immature rat model as well as in circulatory implants. Gross and microscopic healing characteristics were compared in circulatory implants in the thoracic aorta of sheep with use of a composite conduit in every animal, which allowed direct comparison of the two graft materials and minimized differences in healing between individual animals. Both grafts demonstrated excellent porosity control and better handling characteristics than woven Dacron. Sealant resorption was generally rapid, although residual albumin sealant was often seen adjacent to anastomoses. Residual sealant appeared to result in focally poor healing with focal loss of adhesion of surrounding tissue to graft. We conclude that details of sealant preparation and application can importantly influence the performance of presealed knitted Dacron grafts and should be carefully evaluated in the laboratory before clinical implantation is begun.     

Biological sealants and knitted Dacron: porosity and histological comparisons of vascular graft materials with and without collagen and fibrin glue pretreatments

Woven Dacron used in extracardiac conduits tends to form a poorly adherent, obstructing layer of pseudointima. Knitted high-porosity conduits allow fibrous and vascular ingrowth and more secure anchoring of the pseudointima. However, at the time of insertion, the porosity rate must be sufficiently low to prevent excessive bleeding in the heparinized patient. Pretreatments with biological sealants are available to temporarily reduce the porosity of knitted Dacron at the time of implantation with subsequent resorption of the sealant. We compared in vitro water porosity rates of knitted Dacron pretreated with conventional techniques, fibrin glue, and collagen impregnation. Only the collagen-impregnated and fibrin glue-treated grafts decreased the porosity of knitted Dacron to an acceptable level. To assess the biocompatibility and resorption of biomaterials used in sealing conduits, pretreated Dacron was implanted subcutaneously in weaning rats. Foreign-body response of untreated Dacron was unchanged by conventional techniques. Fibrin glue also resulted in good capillary ingrowth as well as occasional punctate multifocal deposits of calcium phosphate. The collagen-impregnated grafts differed in the intensity of the inflammatory response and tissue adhesion, possibly related to the degree of collagen cross-linking. This may have important implications regarding structure of the pseudointima in vascular grafts sealed with these materials.     

Postoperative alteration in the size of dacron vascular prostheses implanted in the infrarenal abdominal aorta

The degree and significance of postoperative alteration in the size of Dacron grafts in the infrarenal abdominal aorta was assessed by computed tomography. We studied a total of 41 knitted Dacron fabric grafts, comprising 28 Gelseal triaxial grafts and 13 Hemashield Microvel grafts, and 29 woven Dacron fabric (Veri-Soft Woven) grafts which were used to replace the infrarenal abdominal aneurysms. These three types of Dacron fabric dilated immediately after replacement to 1.4–1.5 times the manufactured size, but did not dilate further after the surgery.     

The effect of autoclave resterilisation on polyester vascular grafts.

OBJECTIVES: polyester grafts are expensive, single-use items. Some manufacturers of uncoated, woven grafts include instructions for autoclave resterilisation to be performed at the surgeon's own request. Others warn against such manipulation. Theoretically, the glass transition point of polyester at 70-80 degrees C and the possible acceleration of hydrolysis suggest that autoclave resterilisation at 135 degrees C might be a problem. MATERIALS AND METHODS: a DeBakey Soft Woven Dacron Vascular Prosthesis (Bard) and a Woven Double Velour Dacron Graft (Meadox) were autoclave-resterilised 0 to 20 times, having been weighed before and after sterilisation. Tactile testing was performed. Mechanical properties were examined by probe puncture and single-filament testing, the surface was examined by scanning electron microscopy and the degree of hydrolysis by infra-red spectroscopy. RESULTS: tactile testing revealed a change of feeling with increasing cycles of resterilisation. Investigation of weight, textile strength, single-filament strength, electron microscopy of the surface and infra-red spectroscopy showed no change of the material. CONCLUSIONS: changes felt are presumably a surface phenomenon, not measurably affecting strength or chemistry of material after autoclave resterilisation. We therefore feel that it is safe to use once-autoclave-resterilised surplus uncoated polyester grafts, provided that sterility is guaranteed.     

An experimental study of the strength in arterial prosthetic anastomoses: relationship between anastomotic tensile strength and its organization]

Five types of 6-mm diameter arterial prostheses, i.e.m woven Teflon, woven Dacron, velour woven Dacron, velour knitted Dacron and expanded polytetrafluoroethylene (E-PTFE), were studied in the dog to assess anastomotic tensile strength and its organization. Five types of composite grafts, about 3.0cm in length, were implanted in the abdominal aorta of fifty-two adult mongrel dogs using absorbable polyglycolic acid suture. At 16 weeks after the implantation, if the composite graft was patent, tensile strength of the bilateral anastomoses were measured and its organizations were examined microscopically. The mean forces required to disrupt the anastomoses of velour woven Dacron, velour knitted Dacron and E-PTFE were greater than those of woven Teflon and woven Dacron. At the disrupted sites of woven Teflon and woven Dacron, which were non-velour grafts, fibrous outer sheath were remarkably separated from the grafts. This results indicate that organization and fixation of fibrous outer sheath are the most important factors in the strength of arterial prosthetic anastomoses and velour grafts have superiority over non-velour grafts. The organization of E-PTFE was poor, but its tensile strength was equal to velour grafts. It is considered E-PTFE has an advantage due to non-crimped structure and requires further evaluation over longer period.     

An in vitro study of the properties influencing Staphylococcus epidermidis adhesion to prosthetic vascular graft materials.

This study examines the influence of the properties of various vascular graft materials on the bacterial adherence process of two different strains of Staphylococcus epidermidis (mucous and normucous producing). Dacron grafts (both knitted and woven), Teflon grafts, and Dacron grafts coated with one and two layers of silicone were studied because these materials differ significantly in porosity, hydrophobicity, and surface charge (zeta potential). Graft segments were immersed in 3H-labeled bacteria solution for periods ranging from 5 to 180 minutes and liquid scintillation techniques were used to quantify bacterial adherence. The porous knitted Dacron material had a significantly higher rate of bacterial adherence than either the woven Dacron or Teflon (p less than 0.05). Silicone coating (either one or two layers) reduced adherence by a factor of four for the knitted Dacron (p less than 0.05) and by a factor of two for woven Dacron (p less than 0.05). The mucous producing strain of S. epidermidis displayed significantly better adherence to woven and knitted Dacron than the normucous producing strain, but only when 0.25% dextrose was added to the bacteria solution. These findings indicate that the highly porous knitted Dacron grafts have the highest propensity for bacterial adhesion. Graft materials with the most negative zeta potentials are more resistant to bacterial adherence. Silicone coating of Dacron material significantly changed adherence characteristics, suggesting that this may be a viable strategy for protecting implantable medical devices containing materials to which bacteria readily adhere.     

Evaluation of prosthetic grafts of different porosity for arterial reconstruction.

Autogenous jugular veins and Dacron grafts of different porosities were implanted as short bypass grafts around ligated femoral arteries in the dog. Patency rates for periods up to eight months were: vein, 79 per cent; DeBakey Dacron (lowest porosity), 39 per cent; Wesolowski Weavenit (imtermediate porosity), 56 per cent; high porosity Dacron, 8 per cent. The failure of sixteen of the twenty-four high porosity grafts was related to perigraft hematomas that occurred two to seven days after operation and later thrombosis. The higher the porosity of the graft, the better the healing pattern as evidenced by fibrous bonding of the inner and outer linings of the grafts through the interstices. In the spectrum of grafts with increasing porosity there is apparently an optimal porosity beyond which late bleeding counterbalances the better healing properties of the higher porosity graft.     

Indium 111-labeled platelet deposition in woven and knitted Dacron bifurcated aortic grafts with the same patient as a clinical model

A study was designed to compare platelet deposition between knitted and woven Dacron grafts in the same patient. Twenty patients received aortoiliac or aortofemoral bifurcated Dacron grafts, each composed of one woven and one double-velour knitted limb. External nuclear graft imaging was carried out after injection of autologous platelets labeled with indium 111. The patients were studied postoperatively in time periods ranging from 6 days to 42 months. Platelet accumulation was almost identical in knitted and woven limbs in all patients. This study appears to indicate that there is no difference in thrombogenicity between knitted and woven bifurcated Dacron grafts in the aortoiliac or aortofemoral positions measured by platelet accumulation.     

A prospective study of 100 gelatin-sealed aortic grafts

A gelatin-sealed knitted Dacron graft has been developed which has zero porosity at Implantation and does not require preclotting. Its patency rate up to 57 months and effectiveness at saving blood loss have been studied. Gelatin-sealed aortic grafts were implanted into 100 consecutive patients-77 men, 23 women. Surgery was performed for aneurysm in 36 patients (including four with rupture), intermittent claudication in 44, rest pain in 17, and gangrene in three, over an 18 month period. The patients were followed up prospectively for 57 months. Perioperative mortality was 1%. Cumulative primary graft patency was 99%. There was no measurable blood loss at implantation. Forty-seven patients required blood transfusion: mean volume transfused was 430 ml. There were no problems related to the sealant.     

Experimental and clinical experience with a gelatin impregnated Dacron prosthesis

Laboratory and clinical evaluation of a knitted Dacron graft impregnated with gelatin to confer zero porosity is described. Graft performance was tested by standard methods for biodegradation of the sealant and in vitro thrombogenicity. The gelatin sealant was removed after seven to nine days and there was no platelet adhesion to Gelseal compared with unsealed Dacron. Animal experiments revealed normal macroscopic appearances in the graft and histological disappearance of the gelatin impregnate between five and ten days, allowing a cellular response similar to unsealed Dacron. The first 100 patients to have Gelseal aortic bifurcation graft implanted at Glasgow Royal Infirmary are described. The graft did not require preclotting. Blood transfusion was not necessary in 74% of patients. There is 100% patency at 21 months. A knitted Dacron graft sealed with gelatin is a safe, nonporous prosthesis at implantation.     

Histopathological evaluation of woven and knitted Dacron grafts for right ventricular conduits: a comparative experimental study

Composite extracardiac conduits consisting of a low-porosity woven graft and a high-porosity knitted double-velour Dacron graft presealed with fibrin glue were implanted between the right ventricle and the pulmonary artery in 6 dogs under partial heparinization. Two grafts were explanted after 6 weeks, 2 after 12 weeks, and 2 after 6 months. The healing properties of both types of prosthesis were studied macroscopically, under light microscopy, and with scatter electron microscopy. Spontaneous peeling of both the inner and outer capsules of the graft occurred in 3 of 6 woven prostheses during transection. In the remaining 3, peeling could be easily induced by blunt dissection; this was impossible in the knitted grafts. Microscopically, in a comparison of the different weaves after identical time intervals, the inner capsule was noticeably thicker in woven than in knitted grafts. Transtitial ingrowth of fibroblastic tissue could be observed in knitted grafts after 6 weeks; only poor transmural tissue bridging was detectable in woven prostheses after 6 months. Neovascularization of the inner capsule was detectable earlier and was more advanced toward the luminal surface of highly porous grafts. In conclusion, knitted grafts in the position of extracardiac right ventricular conduits showed firmer attachment of both inner and outer capsules to the prosthetic material. Also, the inner capsule remained thinner and revealed a higher degree of neovascularization than in the woven Dacron grafts.     

Heat-denatured albumin-coated Dacron vascular grafts: physical characteristics and in vivo performance

Dacron fabrics with a wide range of porosities were autoclaved for 3 minutes after being soaked in serum, 5% albumin, or 25% albumin. Porosity of compound Dacron grafts made with 25% albumin was less than 1 ml/min/cm2 regardless of the fabric base, whereas porosity of grafts made with serum or 5% albumin was proportional to the porosity of the base fabric. Porosity of the compound grafts remained stable for more than 48 hours and to pressure greater than 450 mm Hg, if the grafts were kept moist. Tubes of Marlex mesh coated with heat-denatured albumin, implanted as infrarenal aortic replacements in dogs, showed complete albumin absorption by 3 weeks. However, perigraft tissue reaction and graft incorporation were minimal and extensive false aneurysm formation resulted. Knitted filamentous Dacron 6 mm tubes coated with heat-denatured albumin were implanted as iliofemoral bypass grafts in 12 dogs, with blood-preclotted knitted filamentous Dacron grafts implanted as contralateral control grafts. Comparison of the albumin-coated grafts with the blood-preclotted control grafts showed no differences in healing or patency at 4 to 6 months. Heat-denatured 25% albumin forms a strong and hemostatic coating regardless of fabric base. Albumin-Dacron compound grafts are easily and rapidly made in the operating room, handle well, and are suitable for large and medium-sized arterial replacements without changes in healing or patency. Because of slow tissue incorporation, however, albumin-coated knitted Dacron grafts should be avoided in patients who require long-term anticoagulation therapy.     

Clinical experience with a collagen-impregnated knitted Dacron vascular graft

This report describes our first clinical experience with collagen-impregnated Dacron grafts in the aortic position. Fifty-four consecutive patients (43 men and 11 women), average age 67.5 years (44-84), received 11 tube grafts and 23 bifurcated grafts for abdominal aortic aneurysm replacement, 17 bifurcated grafts for aortic occlusive disease, two grafts for aortic pseudoaneurysm, and one graft for thoracoabdominal aneurysm repair. No preclotting maneuvers were used and there was no blood leak from the fabric upon restoration of blood flow, in spite of the use of systemic heparin. The hospital transfusion rate averaged 1.2 units in patients with occlusive disease and 2.7 units in patients undergoing aneurysm resection, which were similar to the transfusion rate in patients receiving standard knitted grafts prior to this study. There were two postoperative deaths from a myocardial infarction and a cerebral hemorrhage and no perioperative thromboembolic events. During a follow-up averaging 41.5 months (26-59), there were two late graft limb thromboses secondary to outflow disease progression. One patient died of aspiration two months postoperatively. Four patients died secondary to cardiac disease in at 13 and 21 months with functioning grafts. The rest of the patients are alive with functioning grafts. We conclude that the collagen-impregnated Dacron graft obviates the need for preclotting maneuvers because of a zero functional porosity.     

A quantitative and qualitative comparison of fibrin glue, albumin, and blood as agents to pretreat porous vascular grafts

Recent reports suggest that fibrin glue can be used to seal porous vascular grafts prior to insertion, but this ability has not been quantitatively compared to existing methods. We compared blood loss from and handling characteristics of grafts pretreated with either fibrin glue (FG) (Tisseel), albumin autoclaving (AA), or blood preclotting (BP). Five 6-cm segments of 6-mm internal diameter grafts, both knitted and woven double velour Dacron were treated in each group (30 specimens). Human blood was forced through the BP group until clotted; AA segments were soaked in 25% human albumin and autoclaved for 10 min; FG segments were treated with a topical application of Tisseel (0.5 ml/graft) followed by treatment with topical thrombin + CACl (0.5 ml/graft). Graft ends were sealed and attached to a transducer/syringe pump mechanism which pumped heparinized human blood into the graft at 100 mm Hg intraluminal pressure. All blood that leaked through the grafts over 2 min was collected and the amount was averaged for the five grafts in each group. Graft handling was characterized as either pliable or stiff. Blood pretreatment caused 21 +/- 2 and 13 +/- 4 cc/2 min of leak in knitted and woven grafts, respectively. Albumin autoclaving resulted in 9 +/- 2 and 1 +/- 0.5 cc of leak (P less than 0.01 compared to blood), while fibrin glue produced 2 +/- 2 and 0.4 +/- 0.5 cc leaks (P less than 0.01 compared to blood). Both blood and fibrin glue produced soft pliable grafts, while albumin pretreatment resulted in stiff grafts.(ABSTRACT TRUNCATED AT 250 WORDS)     

Geometric comparison of aortic bifurcation prostheses to the normal and atherosclerotic human aorta, and clinical trial of a vertical seamed bifurcation prosthesis

The 12 bifurcation prostheses generally available in the United States were compared. One was woven Teflon, two woven Dacron, and nine knitted Dacron. Ten were "seamless" in construction, and two were "seamed," but close examination revealed that all prostheses actually were seamed at the bifurication point. The grafts varied considerably in construction, porosity, and geometry. To compare the geometries, each prosthesis was preclotted in plasma, inflated to 120 mm. Hg, and quick frozen in alcohol and dry ice. Transverse and frontal bisections of the frozen specimens were photographed with a millimeter scale for sizing. For comparison, eight human aortofemoral bifurcations were distended and frozen similarly. The prostheses had far wider bifurcation shelves than did the normal aortas. The five normal human aortofemoral bifurcations had an average ratio of limb: body diameter of 0.61; the three atherosclerotic specimens averaged 0.49. The prostheses had an average limb:body diameter ratio of 0.48. or the "seamless" grafts, 0.48 for the circular transverse limb-seamed grafts, and 0.58 for the vertical-seamed grafts. Vertical-seamed aortic bifurcation grafts implanted in 102 patients between 1970 and 1976 (average follow-up, 29.5 months) have developed only a single limb closure, at 53 months.     

Ease of suturing surgical fabrics. A quantitative evaluation

Based on the definition that suturability is the amount of force required to puncture a graft using a surgical needle, a simple testing procedure was devised, using an Instron testing machine to measure the suturability of a number of vascular graft materials. The grafts tested, in order of preference were Cooley double velour, Weavenit, Sauvage filamentous, Cooley knitted, DeBakey woven, and Cooley woven. It has been shown that the suturability of a graft is directly related to its water porosity and the size of the needle used.     

Long-term evaluation of a new selectively biodegradable vascular graft coated with polyethylene oxide-polylactic acid for right ventricular conduit. An experimental study

Low-porosity woven Dacron grafts have been used extensively as an extracardiac conduit in the surgical treatment of congenital and acquired heart diseases involving total heparinization. Caution is still warranted in their use, however, because of long-term complications, including calcification and development of obstructive fibrous peel. In contrast, high-porosity grafts offer much better tissue anchorage and healing but cannot be used under heparinization. We have developed a compound vascular prosthesis in which a knitted Dacron graft is coated with a polymeric biodegradable sealant. Polyethylene oxide-polylactic acid-segmented copolymers comprised the degradable component of the graft. In vitro studies showed that the coated prosthesis exhibited a highly flexible elastomer-like mechanical response. The prostheses were completely watertight, and significant degradation started after 1 week, with absorption completed after 3 weeks. Seven woven and six knitted polyethylene oxide-polylactic acid-coated Dacron grafts used as extracordiac conduits (16 mm), connecting the right ventricle and the pulmonary artery were implanted in dogs. The dogs were killed after 12 to 18 months, and the results are reported. Scanning electron microscopy examination showed peel detachment and nonhomogenous intimal surface with fenestrations in the woven graft group, but complete healing and incorporation of the pseudointima with homogenous, thin lining of the luminal surface in the polyethylene oxide-polylactic acid-coated group. Histologic studies indicated much superior healing and anchorage of the periprosthetic tissue and the pseudointima in the polyethylene oxide-polylactic acid-coated grafts. The biodegradable polymer was fully degraded and exhibited a complete incorporation of the compound vascular prosthesis. This study indicates the superior healing properties of these selectively biodegradable grafts, which might increase long-term patency and decrease complications of right ventricular conduits.