Tissue integration and biomechanical behaviour of contaminated experimental polypropylene and expanded polytetrafluoroethylene implants.

BACKGROUND: Infection is one of the most devastating complications following implantation of a prosthetic material. The aim of this study was to compare the behaviour of two biomaterials contaminated with Staphylococcus aureus or Staphylococcus epidermidis, used to repair abdominal wall defects. METHODS: Defects (7 x 5 cm) were created in the anterior abdominal wall of 60 white New Zealand rabbits and repaired using polypropylene or expanded polytetrafluoroethylene (ePTFE) prostheses. The site of repair had been previously inoculated with 10(6) colony-forming units/ml S. aureus or S. epidermidis. Seven and 30 days after implantation, prosthetic specimens were examined by light and scanning electron microscopy, and immunohistochemical and biomechanical analysis. RESULTS: No significant differences with respect to controls were observed in the S. epidermidis groups. Two animals inoculated with S. aureus died. S. aureus induced the appearance of denuded areas exposing the filaments in the polypropylene prostheses, whereas the ePTFE prostheses showed zones of erosion, disorganized tissue, haemorrhage and necrosis. The biomechanical strength of the contaminated implants was unaltered. CONCLUSION: Integration within host tissue was affected in the setting of S. aureus infection but the tensile strength of contaminated prostheses was not significantly reduced.

Diseño y ensayo biológico de una nueva prótesis composite (PL-PU99) destinada a la reparación de defectos de la pared abdominal / Design and biological trial of a new composite prosthesis (PL-PU99) for the repair of abdominal wall defects

Introducción. Las prótesis macroporosas, tipo polipropileno (PL), empleadas para la reparación de defectos en la pared abdominal, tienen en algunas ocasiones que ser implantadas en contacto con el peritoneo visceral. La interfase prótesis/peritoneo visceral puede generar problemas en cuanto a formación adherencial con posibilidad de formación de fístulas. El objetivo del presente trabajo ha sido realizar un estudio sobre el comportamiento en esta interfase de una nueva prótesis diseñada en forma de composite (PL-PU99) por nuestro grupo de investigación. Material y métodos. Se han empleado 30 animales (conejo blanco Nueva Zelanda) de un peso aproximado entre 2.000 y 2.500 g. Se crearon defectos de 7 × 5 cm en la pared anterior del abdomen que comprendían todos los planos (aponeurótico, muscular y peritoneo parietal), siendo reparados los mismos con prótesis de PL y PL-PU99. La piel que quedó cubriendo la prótesis fue cerrada con una sutura de polipropileno 3/0. La prótesis PL-PU99 es un composite formado por tres componentes: una prótesis de PL de un poro de 1 mm y una lámina de poliuretano (colocada en contacto con el peritoneo visceral), unidas ambas por un pegamento acrílico. Se establecieron dos grupos de estudio: grupo I (n = 15) o control, implantes de PL, y grupo II (n = 15), implantes de PL-PU99. Los animales fueron sacrificados a los 14, 30 y 90 días de la intervención quirúrgica. Se efectuaron estudios a microscopia óptica, electrónica de barrido (SEM) y transmisión (MET), inmunohistoquímica y morfometría del neoperitoneo. Asimismo, se cuantificaron las adherencias en la interfase prótesis/peritoneo visceral. El estudio biomecánico se realizó con un tensiómetro Instron (TT-DM-1118). El análisis estadístico se efectuó empleando los test de la t de Student-Newman-Keuls y la U de Mann-Whitney. Resultados. No hubo mortalidad en los animales intervenidos ni presencia de infección o rechazo de los implantes. Las adherencias fueron firmes en los implantes de PL y prácticamente inexistentes en los de PL-PU99. La superficie cubierta por adherencias fue de 7,18 ñ 1,11 y 0,11 ñ 0,02 cm2, respectivamente, para los grupos I y II, existiendo diferencias significativas entre ambos grupos (p < 0,01). El neoperitoneo formado en el grupo I presentó una disposición anárquica y desordenada, de textura rugosa. En algunas ocasiones pudieron apreciarse zonas de hemorragia y necrosis que se correspondían con las zonas en las que se habían producido adherencias. Por el contrario, en el grupo II fue homogéneo, conformado por un tejido conectivo ordenado y vascularizado, todo ello tapizado por un mesotelio. El análisis morfométrico del neoperitoneo fue significativamente mayor (p < 0,05) en el PL-PU99 (474,86 ñ 49,73) que en el PL (256 ñ 21,68).Los resultados del estudio inmunohistoquímico demostraron características similares en los dos tipos de implantes. La evaluación de la resistencia biomecánica no evidenció diferencias significativas entre las dos prótesis en los distintos tiempos de estudio. Conclusiones. a) la prótesis PL-PU99 tiene un comportamiento óptimo en cuanto a formación adherencial, en la interfase prótesis/peritoneo visceral; b) el neoperitoneo formado con esta prótesis sustituye casi física y funcionalmente al peritoneo normal, y c) la resistencia biomecánica obtenida no presenta diferencias entre el grupo control y el grupo objeto de estudio (AU)

Peritoneal regeneration after implant of a composite prosthesis in the abdominal wall.

Prosthetic materials currently used to repair abdominal wall defects occasionally must be placed in direct contact with the visceral peritoneum. The prosthesis-peritoneum interface is the site of several possible problems, including the formation of adhesions and erosion of the intestinal loops, which may lead to the formation of fistulas. This investigation was designed to compare the behavior of two prosthetic biomaterials in composite form at the level of the peritoneum. Defects (7 x 5 cm) were created in the abdominal wall of 18 white New Zealand rabbits weighing approximately 2500 g. The defects (involving aponeurotic and muscular planes and the parietal peritoneum) were repaired with polypropylene (PL) + ePTFE (Preclude dura substitute) or Parietex composite (PC) prostheses. The prostheses were secured to the edges of the defect by continuous PL sutures interrupted at the corners of the implant. Three study groups were established according to the type of implant: group I (n = 6) (controls)--PL; group II (n = 6)--PL + ePTFE; and group III (n = 6)--PC. The animals were sacrificed 14 days after implant, and the prostheses were examined by light microscopy and scanning electron microscopy (SEM). The formation of adhesions at the prosthesis-visceral peritoneum interface were quantified according to a protocol previously described by us. The biomechanical resistance of the implant was evaluated using strips comprising prosthetic material and anchorage tissue. The Mann-Whitney U-test was used to compare data corresponding to each group. There was no postimplant mortality. No infection or rejection of the prosthesis was observed in any of the animals. Firm adhesions were detected in the PL implants, whereas in the PL + ePTFE and PC implants the adhesions were loose. The mean prosthetic surface areas covered by adhesions were 7.67, 0.10 and 0.19 cm2 for groups I, II, and III, respectively, showing a significant difference between values corresponding to groups I and II and to groups I and III (p < 0.05). Comparison of values recorded for groups II and III yielded no significant difference (p > 0.05). In groups II and III, the neoperitoneum was homogeneous and composed of organized and vascularized connective tissue covered by a mesoendothelium that was interrupted by accumulations of fibroblasts and white blood cells. In contrast, a disorganized neoperitoneum of rough texture was observed in the group I specimens. At times, areas of hemorrhage and necrosis corresponding to the sites of adhesion formation could be observed. Resistance to traction of composite implants (mean +/- SD: 15.72 +/- 1.32 and 15.89 +/- 2.73) was similar to that of the PL implants (15.03 +/- 2.92) (Mann-Whitney U-test, p < 0.05). It may be concluded that (1) composite prostheses show optimum behavior in terms of adhesion formation at the prosthesis-visceral peritoneum interface; (2) the neoperitoneum formed after the implant of a composite prosthesis almost physically and functionally replaces the normal peritoneum; (3) a significantly greater degree of peritoneal regeneration is achieved after implant of a PC prosthesis; and (4) there was no significant difference regarding biomechanical resistance between PL prostheses and PL + ePTFE and Parietex composites.

Rapid thawing increases the fragility of the cryopreserved arterial wall.

OBJECTIVE: To extend present knowledge of the biomechanical and structural changes which occur in the cryopreserved, rapidly thawed arterial wall. MATERIALS AND METHODS: Minipig iliac arterial segments were cryopreserved at -196 degrees C in either minimum essential medium or Wisconsin solution. Fresh segments served as the control group. After 1 month, the specimens were rapidly thawed (37 degrees C) and processed for biomechanical, ultrastructural, morphological and immunohistochemical (MMP-1, MMP-2, MMP-3 and MMP-9) analysis. Visualisation of apoptotic cells was performed by TUNEL method. For the mechanical distension analysis, an in vitro circuit was designed. RESULTS: The cryopreserved segments showed a 42% incidence of spontaneous fracture and the appearance of microfractures which affected the endoluminal third of the vessel. An accumulation of liquid in the subelastica was observed. An increased expression of wall-degradative enzymes (mainly MMP-2) was also observed following cryopreservation. No significant differences were detected in the proportional elasticity module or tensile strength of the specimen groups. No differences in mechanical distension were observed between groups after the vessel segments were subjected to the pulsatile circuit flow for 72 h. Cell damage was most intense in the specimens cryopreserved in Wisconsin solution. CONCLUSIONS: Cryopreservation in both the solutions employed, followed by rapid thawing, induce changes in the permeability which increase the fragility of the cryopreserved arterial wall. Both increased expression of wall-degradative enzymes and accumulation of liquid may contribute to graft failure after implantation.

Reparación de defectos de pared abdominal con prótesis composite. Estudio del comportamiento peritoneal / Abdominal wall defect repair using a graft-prosthesis composite

Introducción. Los materiales protésicos actuales empleados para la reparación de defectos en la pared abdominal en algunas ocasiones tienen que ser implantados en contacto con el peritoneo visceral. Esta interfase prótesis/peritoneo visceral plantea en ocasiones problemas debido a la formación de adherencias y a la presencia en algunos casos de erosión en las asas intestinales, con posibilidad de formación de fístulas. El objetivo del presente trabajo ha sido realizar un estudio comparativo sobre el comportamiento peritoneal de dos materiales protésicos diseñados en forma de composite. Material y métodos. Se han empleado 14 animales (conejo blanco Nueva Zelanda) de un peso aproximado entre 2.000 y 2.500 g. Se crearon defectos de 7 * 5 cm en la pared anterior del abdomen que comprendían todos los planos (aponeurótico, muscular y peritoneo parietal), siendo reparados con prótesis de Parietex composite® (Pc) y Vypro® (Vy), que fueron ancladas en los márgenes del defecto con una sutura continua de polipropileno, interrumpida en los ángulos del implante. Se establecieron dos grupos de estudio. Grupo I (n = 7): implantes de Pc; Grupo II (n = 7): implantes de Vy. Los animales fueron sacrificados a los 14 día de la intervención quirúrgica. Se efectuaron estudios mediante microscopia óptica, electrónica de barrido (SEM) y morfometría a través de análisis de imagen computarizado. El estudio biomecánico se realizó con un tensiómetro Instron empleando tiras de 2 cm de ancho que comprendían el biomaterial y los tejidos de anclaje a la pared. El análisis estadístico de los resultados se efectuó empleando el test de la U de Mann-Whitney. Resultados. No hubo mortalidad, infección o rechazo en ninguno de los animales intervenidos. Las adherencias fueron firmes en los implantes de Vy y laxas en los de Pc. El área ocupada por las mismas fue para el Pc de 0,19 ñ 0,02 y para el Vy de 22,3 ñ 2,78, existiendo diferencias significativas entre los dos grupos (p < 0,01). El neoperitoneo formado en los implantes de Pc fue homogéneo y ordenado, muy vascularizado y tapizado por mesotelio típico. En los implantes de Vy el peritoneo neoformado presentaba una estructura desordenada, con una textura rugosa debido al relieve de los filamentos y nudos de la prótesis. El análisis morfométrico del peritoneo neoformado fue estadísticamente significativo, superior para el Pc (154,02 ñ 5,05) comparado con el Vy (50,83 ñ 9,18) (p < 0,05). Sin embargo, la resistencia tensiométrica puso de manifiesto diferencias significativas a favor del Vy (30,39 ñ 2,99) en relación con el Pc (15,03 ñ 2,92) (p < 0,05). Conclusiones. a) Los dos biomateriales tienen un buen comportamiento de integración tisular, siendo superior la resistencia biomecánica para el Vypro, y b) el comportamiento óp timo en la interfase peritoneal se consigue con el Parietex composite (AU)

The influence of chemical treatment and suture on the elastic behavior of calf pericardium utilized in the construction of cardiac bioprostheses.

Poor mechanical properties of biological tissue are known to cause wear, leading to the failure of cardiac bioprostheses made of calf pericardium. Different chemical agents such as sodium dodecyl sulfate (SDS) are presently being tested as possible inhibitors of the calcification process. The objective of this report was to determine the mechanical behavior of calf pericardium treated with SDS for 24 h and the influence of the suture on the mechanical properties of the tissue. Forty-eight samples were tested: 24 subjected to a standard treatment with glutaraldehyde (12 sewn with 4/0 silk suture thread) and 24 incubated with SDS for 24 h (12 sewn with the same suture thread). Each sutured and non-sutured sample was cut into two strips to yield paired samples. All were subjected to tensile stress to breaking point. The mean stress at breaking point in the non-sutured series treated with glutaraldehyde alone was 16.42 and 13.85 MPa depending on the region of the pericardium, while in the sutured samples subjected to glutaraldehyde the mean stress was 7.50 and 7.63 MPa, respectively, differences which were statistically significant (p = 0.03 and p = 0.003, respectively) when the means for non-sutured samples from equivalent regions treated with glutaraldehyde were compared. The stress at breaking point was lower in the SDS-treated series, ranging between 2.60 and 3.56 MPa. The mathematical functions that govern the stress/strain or deformation were obtained. In the series of pericardium treated with SDS, deformations of 10% were produced with stresses of under 0.4 MPa, an outcome that is intolerable from the constructive point of view. We established a regression model that enabled us to determine the mechanical behavior of a sutured sample by testing a contiguous piece of tissue, with a high correlation coefficient (r \gt 0.99). We consider this finding to be of interest in the selection of pericardium for use in the construction of leaflets for cardiac bioprostheses.

The influence of chemical treatment and suture on the elastic behavior of calf pericardium utilized in the construction of cardiac bioprostheses.

Poor mechanical properties of biological tissue are known to cause wear, leading to the failure of cardiac bioprostheses made of calf pericardium. Different chemical agents such as sodium dodecyl sulfate (SDS) are presently being tested as possible inhibitors of the calcification process. The objective of this report was to determine the mechanical behavior of calf pericardium treated with SDS for 24 h and the influence of the suture on the mechanical properties of the tissue. Forty-eight samples were tested: 24 subjected to a standard treatment with glutaraldehyde (12 sewn with 4/0 silk suture thread) and 24 incubated with SDS for 24 h (12 sewn with the same suture thread). Each sutured and nonsutured sample was cut into two strips to yield paired samples. All were subjected to tensile stress to breaking point. The mean stress at breaking point in the nonsutured series treated with glutaraldehyde alone was 16.42 and 13.85 MPa, depending on the region of the pericardium, while in the sutured samples subjected to glutaraldehyde the mean stress was 7.50 and 7.63 MPa, respectively, differences which were statistically significant (p=0.03 and p=0.003, respectively) when the means for nonsutured samples from equivalent regions treated with glutaraldehyde were compared. The stress at breaking point was lower in the SDS-treated series, ranging between 2.60 and 3.56 MPa. The mathematical functions that govern the stress/strain or deformation were obtained. In the series of pericardium treated with SDS, deformations of 10% were produced with stresses of under 0.4 MPa, an outcome that is intolerable from the constructive point of view. We established a regression model that enabled us to determine the mechanical behavior of a sutured sample by testing a contiguous piece of tissue, with a high correlation coefficient (r\gt 0.99). We consider this finding to be of interest in the selection of pericardium for use in the construction of leaflets for cardiac bioprostheses.

Effect of relaparotomy through previously integrated polypropylene and polytetrafluoroethylene experimental implants in the abdominal wall.

BACKGROUND: The appearance of new pathologies affecting abdominal organs after implant of a prosthesis to repair an abdominal wall defect may necessitate reintervention. The aim of this study was to compare the behavior of two types of biomaterial widely used in clinical practice, polypropylene (PL) and polytetrafluoroethylene (ePTFE), after a second laparotomy involving the implant. The behavior, in terms of tensile resistance and integration with tissues, of intact prostheses was compared to that of prostheses subjected to opening and repair. METHODS: A defect (7x5 cm) involving all tissue layers was created in the anterior abdominal wall of 24 male New Zealand rabbits. These defects were repaired with a reticular, macroporous PL mesh (Marlex, Bard Card., Madrid, Spain) or a laminar, micro/macroporous ePTFE prosthesis (Mycro Mesh, W.L. Gore, Flagstaff, AZ) of similar size to the defect. Four study groups were established: Intact PL/Intact ePTFE (n = 6 each): animals implanted with a PL or ePTFE prosthesis and sacrificed 90 days after implant; Repaired PL/Repaired ePTFE (n = 6 each): animals implanted with a PL or ePTFE prosthesis subjected to midlongitudinal relaparotomy through the center of the prosthesis 90 days postimplant, followed by repair with continuous polypropylene 4/0 suture. Animals in repaired groups were sacrificed 90 days after the second intervention. Specimens comprised of prosthesis and neoformed tissue were subjected to light and scanning electron microscopy. In addition, 2 cm-wide strips, consisting of the prosthesis and anchorage tissue, were subjected to biomechanical analysis using an Instron tensiometer (Instron, Canton, MA). The results obtained were statistically compared using the Mann-Whitney U-test. RESULTS: The intact PL implants were fully infiltrated by dense, disorganized, well-vascularized scar tissue with fibers concentric to the mesh monofilaments. The appearance of the repaired PL prostheses was similar, with establishment of neoformed tissue in repaired areas of the prosthesis such that both cut edges of the prosthesis were joined together. In contrast, intact ePTFE prostheses were encapsulated by organized tissue with fibers running parallel to the surface of the biomaterial. Repaired ePTFE prostheses including sutured areas were similarly encapsulated. But the edges of the sutured middle area did not fuse. Tensile resistance values of intact and repaired PL prostheses were similar (intact, mean, 34.78 Newtons; repaired, mean, 34.74N, p>0.001). Tensile resistance values of intact ePTFE implants were significantly different to those of the repaired ePTFE prostheses (intact, mean, 22.64N; repaired, mean, 17.21N, p<0.001). Breakage of both types of PL specimen strips was restricted to recipient tissue while breakage of intact ePTFE specimens occurred in the areas of anchorage to the abdominal wall. Rupture of repaired ePTFE specimens took place in the sutured central areas of the prostheses. CONCLUSIONS: We conclude that relaparotomy through an existing PL prosthesis previously integrated with the abdominal wall does not affect the tissue integration process or the tensile resistance of the implant. When the relaparotomy involves an ePTFE prosthesis, however, although the repair process itself is unaffected, significant loss in tensile strength is incurred. In addition, relaparotomy through both types of biomaterial is likely to result in the neoformation of adhesions in the areas of the prosthesis subjected to opening and repair but, in general, the number of adhesions formed in the presence of intact or repaired polypropylene implants was larger than that observed with the use of ePTFE.

Tissue response to polypropylene meshes used in the repair of abdominal wall defects.

The degree of integration of biomaterials used in the repair of abdominal wall defects seems to depend upon the structure of the prosthesis. Several polypropylene (PP) prostheses are currently available which differ in the number of PP filaments, the type of weave and the porosity. The aim of this study was to evaluate the integration, adhesion formation and resistance to traction of three types of PP prostheses (Marlex, Trelex and Prolene) used in the partial or total repair of abdominal wall defects. Abdominal wall defects (7 x 5 cm) were created in 54 New Zealand rabbits involving all the tissue layers (total substitutions (TS); n = 27) or all layers excluding the parietal peritoneum (partial substitutions (PS); n = 27). The defects were repaired with PP monofilament prostheses of different weave (1 mm porosity) (Marlex, n = 18; Trelex, n = 18) or bifilament (2 mm porosity) (Prolene; n = 18). They were placed in contact on one side with subcutaneous tissue and on the other with abdominal viscera or parietal peritoneum. Animals were killed at 30, 60 and 90 days and samples of prosthesis and scar tissue processed for light and scanning microscopy. The adhesion formation with viscera was evaluated. Resistance to traction was measured with a tensiometer using strips including the prosthesis and anchorage tissue. Adhesions were detected in all the TS and in four PS. Microscopic analysis revealed total integration of the TS samples by fibrous and disorganized tissue. Prostheses used for PS were integrated by white adipose tissue with the exception of the areas around the mesh nodes and anchorage zones. The foreign body reaction could be seen as a moderate accumulation of white blood cells. Tensiometric analysis showed an increase in resistance to traction with time (P < 0.001) in each type of prosthesis, but no differences were detected (P > 0.001) between them. We concluded that: (a) the formation of adhesions was almost inhibited when the parietal peritoneum was left intact; (b) in both TS and PS, polypropylene prostheses integrated completely although the composition of the scar tissue was seem to differ; and (c) resistance to traction was similar in both TS and PS.

Selection and interaction of biomaterials used in the construction of cardiac bioprostheses.

The mechanical behavior of calf pericardium employed in the manufacture of cardiac bioprostheses was assessed according to the region from which it was selected. For this purpose, selected samples of the tissue were sewn with different types of commercially available sutures and subjected to tensile testing, the results of which were compared with the findings in selected, but not sutured, tissue used as a control. The results confirm a loss of resistance--that is, a reduction of the capacity of sutured samples of the biomaterial to withstand breakage stress compared with control samples. Taking into account the marked resistance to breakage of the suture thread, this phenomenon can only be explained as a consequence of the deleterious mechanical interaction between the suture and chemically treated pericardium. This interaction is illustrated by the shearing force which is responsible for the loss of resistance in the tested samples. These trials demonstrate that the results can be improved and the deleterious interaction diminished, although not eliminated, when the pericardium is selected from a given region.

Analysis of shearing stress in the limited durability of bovine pericardium used as a biomaterial.

The objective of the study was to determine the shearing stress exerted by the suture thread under conditions of normal working stress. Thirty-six samples of calf pericardium, similar to that employed in the manufacture of bioprosthetic cardiac valve leaflets, were subjected to tensile testing. Prior to the trial, a continuous suture was sewn in the central zone of each sample, at a 45 degrees angle to the longest axis of the sample, using commercially-available threads (silk, Gore-Tex, Surgilene and nylon). Application of the Mohr circle for combined wear revealed that the shearing stress ranged between 2.68-fold greater (for samples sewn with silk) and 5.48-fold greater (for samples sewn with nylon) than the working tensile stress in the region of the suture. It is concluded that the shearing stress is responsible for the limited durability of sutured samples of calf pericardium prepared to simulate bioprosthetic cardiac valve leaflets.

The use of biomaterials in the repair of abdominal wall defects: a comparative study between polypropylene meshes (Marlex) and a new polytetrafluoroethylene prosthesis (Dual Mesh).

In this study we compared the behaviour of the non-porous on one side ePTFE Dual Mesh prosthesis and the macroporous polypropylene mesh Marlex in the repair of abdominal wall defects in rabbits. We evaluated the degree of integration with recipient tissue, biological tolerance, adhesion formation with viscera and the biomechanical resistance of the repair zone. Our results showed good biological tolerance of both prostheses and a high degree of adhesion formation in Marlex implants. In animals with Dual Mesh implants, only loose adhesions were seen. Marlex implants induced the presence of disorganized scar tissue, while the Dual Mesh prostheses were encapsulated by organized tissue. The macrophage response was similar in both decreasing with time. The resistance to traction was higher when the reparation was done with polypropylene. We concluded that the structure of the prosthesis determines its degree of integration and the resistance to traction of the repaired zone.

The behavior of different types of polytetrafluoroethylene (PTFE) prostheses in the reparative scarring process of abdominal wall defects.

Currently one of the most widely used prosthetic materials in the repair of abdominal wall defects, is expanded polytetrafluoroethylene (ePTFE). It has been suggested that its behavior with respect to the reparative process may depend on its structure. The aim of the present study was to evaluate the effect of the structure of 3 ePTFE prostheses on the scarring process in an abdominal-wall-defect experimental model. The prostheses employed were the Soft Tissue Patch (STP) which is laminar in structure, Mycro Mesh (MM) which is multilaminar with perforations, and the Dual Mesh (DM) prosthesis which has one non-porous surface. Abdominal wall defects (7 x 5 cm) were created in 36 New Zealand rabbits and repaired using fragments of STP, MM and DM. Follow-up periods were 14, 30, 60 and 90 days post-implant. At these times prostheses were macroscopically examined for the presence of infection and/or rejection and the formation of adhesions to abdominal viscera. Specimens were also taken for microscopic analysis (optical and scanning electron) and for immunohistochemical analysis using the rabbit macrophage-specific monoclonal antibody RAM-11. Labelled macrophage counts were performed at each follow-up session. No cases of infection or rejection were found. Loose adhesions between prosthesis and underlying viscera were observed in 2 of the STP, 4 of the MM and 2 of the DM implants. STP and DM implants were progressively encapsulated by organized connective tissue on both peritoneal and subcutaneous surfaces. Cellular colonization was observed on both STP surfaces and on the porous surface of the DM although no more than a third of the biomaterial was penetrated by cells in either case. Colonization was very slight at prosthesis anchorage points. MM implants differed only in the formation of connective tissue bridges in perforated areas, and cellular infiltration in interlaminar spaces. Macrophage response was similar in the 3 prostheses with a reduction in RAM-11 labelled cells (p < 0.05) between 14 and 90 days post-implant. We conclude: a) the 3 types of PTFE prosthesis induced low incidence of adhesion formation between biomaterial and viscera; b) integration mechanism of the 3 prostheses were similar and culminated with the encapsulation of the PTFE by the neoformed tissue; c) the macrophage response induced by the 3 prostheses was similar to that of any reparative process in the absence of biomaterial.

Elastic behaviour of sutured calf pericardium: influence of the suture threads.

The purpose of this study was to assess the elastic behaviour of calf pericardium used in the construction of cardiac bioprosthesis valve leaflets, sutured with different types of commercially available sutures: silk, Gore-Tex, Surgilene and nylon. Thirty-two samples (four series of eight samples each) were subjected to tensile strength testing to breakage. The breaking stress (MPa) ranged between 4.89 MPa for samples sutured with Gore-Tex and 5.22 MPa for those sewn with nylon. Three samples from each series were subjected to a stepwise stress test, involving increasing levels of stress followed by return to zero, to define the elastic limit (the cut-off point beyond which strain is no longer reversible). Analysis of the results provided the mathematical functions that govern the elastic behaviour (stress/strain) within the elastic range for each type of sutured sample. The series sutured with Surgilene presented the highest mean value (1.649 MPa). Finally, a statistical study was carried out to determine which series showed the greatest probability of having the least interaction between the thread and the pericardium. Allowing an interval of +/- 10%, Gore-Tex showed the best probability in this respect. However, real fatigue testing is necessary to definitively determine which is the best suture to use.

Comparison of a new type of polytetrafluoroethylene patch (Mycro Mesh) and polypropylene prosthesis (Marlex) for repair of abdominal wall defects.

BACKGROUND: Two types of prosthetic material used for repairing hernial defects of the abdominal wall were compared: Mycro Mesh and Marlex. Mycro Mesh (MM) is a new polytetrafluoroethylene product of layered, microporous structure. Macroscopically, it presents regularly distributed, 2-mm orifices that perforate the biomaterial. Marlex (PL) is a well-known polypropylene mesh product with a macroporous structure. STUDY DESIGN: In 24 white New Zealand rabbits, a full-thickness (except skin) 5 x 7-cm defect was created in the anterior wall of the abdomen. Defects were repaired with either MM (n = 12) or PL (n = 12) implants and studied at 14, 30, 60, and 90 days after implantation. Samples of the interfaces between prosthesis and subcutaneous tissue, visceral peritoneum, and receptor tissue, respectively, were studied. Samples were processed for optical microscopy and scanning electron microscopy (SEM). An immunohistochemical study was made using RAM-11, a monoclonal antibody specific for rabbit macrophages. The tensile strength of the repairs was made using an Instron tensiometer on 2-cm wide transversal strips that included the prosthesis and its anchor zones to the receptor tissue. RESULTS: The formation of adhesions between the prosthesis and intestine was important with the PL implants but not with the MM implants. Optical microscopy and SEM showed formation of an organized connective tissue surrounding the MM implants. At 90 days, compact bridges of connective tissue linked the tissue on the subcutaneous and peritoneal sides of the prosthesis. The PL implants became integrated into a disorganized, highly vascularized connective tissue. The intensity of the macrophage response was similar in both prostheses and decreased between days 14 and 90 (Student-Newman-Keuls test p = 0.01). The tensile strength of the PL implants was greater than that of the MM implants. At 90 days, the tensile strength of the PL implants was mean equals 33.11 N and of the MM implants, mean equals 22.65 N (Mann-Whitney test p < 0.001). CONCLUSIONS: The tissue integration of the PL and MM implants differed; fewer visceral adhesions formed on MM than on PL; the macrophage reaction was not determinant of the success of failure of either biomaterial; and the tensile strength of the prosthesis-receptor tissue interface was much greater in the PL implants than in the MM implants.

Resistance and elasticity of the suture threads employed in cardiac bioprostheses.

The mechanoelastic features of five types of sutures were studied. The breaking stress for each was determined by means of tensile tests in which a constant strain rate was applied, and a tensile test with graduated stress and relaxation defined the elastic limit, i.e. the point beyond which deformation becomes irreversible. The study of the stress-strain curve during this elastic period enabled us to obtain the mathematical function that governs these reversible deformations, which shows excellence of fit (R2 > 0.98). The prime derivative at each point of the resulting functions is the elastic modulus, the best parameter for comparing the elasticities of the suture threads. Since breaking stress alone does not suitably define the mechanical quality of a suture, we propose the use of other parameters during the elastic period, such as percentage of elongation at a point 10 times lower than the elastic limit (safety coefficient of 10), and tensile stress and elastic modulus at the said point, which are more reliable in the assessment of the resistance and elasticity of these threads.

Description of the mathematical law that defines the relaxation of bovine pericardium subjected to stress.

A material subjected to traction stress increases in length; if we maintain the elongation constant, the stress varies over a period of time. This phenomenon has been referred to as relaxation. The purpose of this study was to define a mathematical law that relates the variation in stress to time when elongation remains constant in bovine pericardium. The mathematical function obtained after assaying 34 samples to the point of relaxation, subjected to initial stresses ranging from 0.17-10.07 MPa, responds to the following equation: y = -0.0252 + 0.953 alpha - (0.0165 + 0.015 alpha)lnt, where y is the stress withstood at an instant in time, t, after initial stress alpha. A normogram, validated by assays of up to 6,340 min duration (4.40 days), is presented for graphic calculation, permitting the computation of the loss of stress due to relaxation of this biomaterial, with initial stresses ranging from 1-10 MPa.

Effect of the suture on the durability of bovine pericardium used in cardiac bioprostheses.

Our study of the different biomaterials used in the construction of biological cardiac prostheses has shown it to be of vital importance that the physical properties of the tissue and of the suture that anchors it to the rigid polymeric support are compatible. By means of dynamic tests, we have determined the fatigue curve in sutured bovine pericardial tissue, expressed by the equation log y = 1.27 +/- 0.18 (0.26 +/- 0.05) log t, where y is the initial fatigue stress (MPa) and t is the time (min) it takes to achieve permanent deformation of the tissue. By applying this correction, we determine a set of values for stress-time which, when compared with those obtained with a non-sutured sample, reveal a significant fall in this ratio and, thus, a decrease in the durability. The use of suture threads of lesser elasticity than the pericardium may play an important role in reducing the durability of the bioprosthesis constructed with these materials.

Behaviour of the bovine pericardium used in cardiac bioprostheses when subjected to a real fatigue assay.

The behaviour of bovine pericardium was studied using a fatigue assay. Twenty-three samples were assayed, maintaining the preset initial stress and measuring the time it took for the onset of load loss due to permanent deformation. The results indicated a mathematical relationship defined by the expression: log y = 1.3 - 0.211 log t, where y is the fatigue stress (MPa) and t the duration of the assay. The correlation coefficient was 0.948 (P < 0.001). The safety coefficient of the material diminished significantly as the period of time during which it was subjected to fatigue increased. The theoretical durability of the tissue was much greater than the real durability of the prostheses, which is determined by unsolved problems such as calcification and those derived from suture-related cutting.

Is cutting stress responsible for the limited durability of heart valve bioprostheses?

The limited durability of the valve bioprostheses made from calf pericardium is partially due to the calcification of this biomaterial and to mechanical fatigue of the tissue. The object of this study is to determine the harmful effect on the pericardial membrane of cutting caused by the suture thread by showing the different elastic behaviors of the biomaterials employed. This cutting stress is established during the process of molding the valve leaflet, creating a vulnerable point from the very moment of construction, which is an important factor in the limited duration of the bioprosthesis.