Short-term fatigue testing can predict medium-term pericardium behaviour.

The medium-term fatigue behaviour of calf pericardium (similar to the one used to manufacture cardiac bioprostheses valve leaflets) has been studied. 96 samples were tested under fatigue subjecting them to biaxial stress at 1 Hz frequency for 5000 cycles, in 4 series of 24 samples, at several supra-physiological mean pressures and pressure amplitudes. Short-term damage parameters such as the accumulated energy consumption in 10 cycles (E10) and medium-term ones after 5000 cycles like total energy consumption (Et) and maximum displacement of the membrane (Dt) have been evaluated. E10 showed exponential growing tendency with pressure and linear tendency with pressure amplitude when only one parameter curve was plotted. Similar results were found when analysing Et and Dt. Linear correlation models were established between E10 and Et and E10 and Dt. Similar results were achieved in the four series, with excellent determination coefficients. The results confirm that the fatigue behaviour from the very first cycles of the test can predict the medium-term behaviour of the tissue by means of measurement of suitable damage markers. The tendencies observed between the parameters seem to show that the results could have been the same ones if the test had been performed at physiological pressures and amplitudes. This work opens the door to a non-destructive test of the tissue prior to employ it to manufacture valve leaflets.

Innovative self management system for guided cardiac rehabilitation.

This paper describes the design and development of a system for cardio rehabilitation of patients that suffered a myocardial infarction. The proposed solution focuses on exercise prescriptions and the encouragement of healthy behaviors. The innovative strategy of the design takes into account health promotion models to provide safe, assistive exercise training sessions, personalized feedbacks, and educational contents.

Monitoreo de DDI en la provincia de La Rioja (2006) / Monitoring of DDI in the province of La Rioja (2006)

Un total de 712 alumnos de escolaridad primaria, de ambos sexos, fue estudiado en este monitoreo de bocio endémico en dos localidades de la provincia de La Rioja: Ciudad de La Rioja (442 niños) y Chilecito (270 niños). La edad de los escolares osciló entre 5 y 16 años. La palpación tiroidea fue hecha por el conjunto de los médicos participantes. Sin embargo, con la finalidad de aunar criterios con lo realizado previamente (1-24), se tomó como única referencia la palpación de H.N., que se llevó a cabo en la totalidad de los niños estudiados. La definición del grado de bocio fue similar a la utilizada en los otros relevamientos (1). Se determinó la yoduria en muestras casuales de orina emitidas por los niños una vez que fueron palpados (125 de La Rioja y 128 de Chilecito). Se recolectaron 251 muestras de sal de consumo hogareño de La Rioja y 141 de Chilecito, para medir su contenido en yodo. El examen palpatorio de los niños reveló la existencia de bocio grado 1 solamente. La prevalencia de bocio encontrada fue de 1,8% en La Rioja y de 2,6% en Chilecito. Los niveles de yoduria alcanzaron, en La Rioja, una media de 226 ± 181 (DS) μg/L y una mediana de 186μg/L, al tiempo que en Chilecito la media fue de 217 ± 161μg/L y la mediana de 185μg/L. El contenido de yodo de las sales, que aportaron los alumnos desde sus hogares, fue adecuado para casi todas las marcas. De esta manera, observamos que en la ciudad de La Rioja el promedio de yodo en la sal, tomada en conjunto, fue de 33,1 ± 12,5 mg/Kg, mientras que para Chilecito fue de 28,1 ± 8,2 mg/Kg. Al analizar las concentraciones de yodo <15mg/Kg, observamos que fue del 10,7% en La Rioja y del 9,5% en Chilecito. Teniendo en cuenta la línea de corte del 10% que fija el ICCIDD (25) como valor óptimo, podemos observar que la situación fue prácticamente satisfactoria en ambas poblaciones. Concluímos que en estas dos poblaciones de la provincia de La Rioja no existe, actualmente, bocio endémico por deficiencia de yodo. Estos resultados indican que la profilaxis con sal yodada fue óptima en esta provincia, dado que en el pasado solía ser una típica zona yodo-deficiente con un muy alto porcentaje de bocio endémico.

Energy consumption as a predictor test of the durability of a biological tissue employed in cardiac bioprosthesis.

The mechanical behavior of the young bull pericardium in a fatigue test has been studied. This material is a similar tissue to those used in valve leaflet construction for a cardiac bioprosthesis. The consumed energy on each test was evaluated and afterwards used as a predictor of the biomaterial strength. Two-hundred and nine samples were tested to cyclical fatigue. The cut-off point to determine the sample quality was whether or not they resisted at least 4500 cycles. Only 22 samples withstood over that point (10.52%). The samples were classified according to their fatigue behavior in excellent, undefined and unsuitable. By using as a reference the consumed energy in the first 25 cycles, we could distinguish correctly (between 93.2 and 96.1%) the unsuitable material and most of the excellent (between 78.1 and 95.2%). From the rejected material 77% was really detachable and from the accepted, only 50% was excellent, with an equal methodology. The receiver operating characteristics curve was employed to establish decision levels when selecting samples, being 0.85 the best area (theoretical maximum value of 1). It is concluded that the energy wasted is a good predictor of the strength of the tissue. More than 90% of the unsuitable material and 50% of the excellent material (5% of all the material) is detected with this method.

Influence of the suture in the propagation of tears in calf pericardium employed in the construction of cardiac bioprostheses.

The tearing of the fibers of biomaterials employed in implants or bioprostheses leads to early the failure of these devices. The purpose of this study was to determine the force necessary to propagate a tear in a biological tissue, calf pericardium, when sutured. We analyzed the outcome of 230 trials. There was a loss of resistance to tearing in samples sutured edge-to-edge as compared to unsutured control samples. This loss was not observed when the suture was preceded by an intact or protective zone. The values corresponding to the tearing force for an overlapping suture, especially when sewn with Gore-Tex(R), were higher than those obtained in controls. This study confirms the deleterious effect of the edge-to-edge suture, which can be minimized by protecting the suture, and the excellent behavior of the overlapping suture.

Hysteresis of a biomaterial: influence of sutures and biological adhesives.

We studied the changes in energy consumption of samples of calf pericardium, when joined or not joined by sutures and adhesives, by means of hysteretic cycles. Sixty-four samples were subsequently subjected to tensile stress until rupture. An overlapping suture sewn in the form of a rectangle presented an acceptable mean resistance to rupture of over 10 MPa, although lower than the mean values in an unsutured control series where the mean resistance surpassed 15 MPa. The contribution of an acrylic adhesive to the resistance to rupture was negligible. The sutured samples that were reinforced with adhesives and had not been subjected to hysteretic cycles prior to rupture showed an anisotropic behavior. This behavior appeared to be lost in all the samples that underwent hysteretic cycles. We found an inflection point in the stress/strain curve following the stepwise increase in the load, with a value greater than and proximate to the final load applied. This inflection should be analyzed by means of microscopy. Finally, the mathematical relationship between the energy consumed and the stress applied, the strain or deformation produced and the number of cycles of hysteresis to which the samples were subjected was established as the ultimate objective of this study. The bonding systems provoked a greater consumption of energy, with the greatest consumption corresponding to the first cycle in all the series assayed. An equation relating the energy consumption in a sample to the number of hysteretic cycles to which it was subjected was obtained. Its asymptote on the x-axis indicates the energy consumption for a theoretical number of cycles, making it possible to estimate the durability of the sample.

Biochemical and mechanical behavior of ostrich pericardium as a new biomaterial.

We have performed a comparative analysis of glutaraldehyde-preserved ostrich pericardium, as a novel biomaterial, with bovine pericardium. The biochemical characteristics (histology, water content, amino acid composition, and collagen and elastin contents), mechanical properties, and in vivo calcification in a subcutaneous rat model were examined. Ostrich pericardium is slightly thinner and shows a higher water content (70+/-2% vs. 62+/-2%) than bovine pericardium. Additionally, ostrich pericardium presents 1.6-fold lower elastin content and a lower percentage of collagen in reference to the total protein content (68+/-2% vs. 76+/-2%). However, ostrich pericardium shows better mechanical properties, with higher tensile stress at rupture (32.4+/-7.5 vs. 11.5+/-4.6) than calf pericardium. In vivo calcification studies in a rat subcutaneous model show that ostrich pericardium is significantly less calcified than bovine pericardium (23.95+/-13.30 vs. 100.10+/-37.36 mg/g tissue) after 60 days of implantation. In conclusion, glutaraldehyde-stabilized ostrich pericardium tissue shows better mechanical properties than calf tissue. However, calcium accumulation in implanted ostrich tissue is still too high to consider it a much better alternative to bovine pericardium, and anticalcification treatments should be considered.

Durability of a cardiac valve leaflet made of calf pericardium: fatigue and energy consumption.

We studied the mechanical behavior of membranes of calf pericardium, similar to those employed in prosthetic valve leaflets, when subjected to tensile fatigue. The objective was to assess its durability, as a fundamental property of cardiac bioprosthesis, and analyze the energy consumption. For this purpose, the authors built a hydraulic simulator to subject a spherical valve leaflet made of calf pericardium to cyclic stress mimicking cardiac function. A total of 522 assays were performed in 40 samples, subjected to cyclic pressures greater than 6 atm, and 482 subjected to pressures ranging between 2 and 6 atm. The mathematical expression that establishes the relationship between the pressure exerted and the frequency was obtained. If we assume that the function is continuous, this equation provides the range of fatigue tolerated for a given number of cycles. Using the optimal values (the five highest values per series), the expression was found to be y = 9.95x(-0 1214) (R(2) = 0.955), where x represents the frequency in cycles per second and y the pressure in atmospheres. In addition, we established the mathematical relationship between the energy consumed and the frequency, which was a function of the pressure exerted, regardless of the region or zone from which the samples had been obtained. The methods of manual and morphology-based selection employed produced widely dispersed results. When a mechanical criterion was included, the similarity in the energy consumed during fatigue testing markedly improved the correlation, with a coefficient of determination between paired samples of R(2) = 0.7477. A mechanical criterion, such as energy consumption, can help to improve sample selection and produce more consistent results. Finally, we obtained the mathematical expression that relates the energy consumed to the pressure exerted and the number of cycles per second to which the valve leaflet was subjected. This procedure enables us to establish the limit to the energy that a biomaterial can consume over a period of time during which it is subjected to a working pressure and, thus, calculate more precisely its durability.

Tissue heart valve mineralization: Review of calcification mechanisms and strategies for prevention.

Attempts to replace diseased human valves with prostheses began more than 30 yrs ago. Heart valve prostheses can be broadly classified into mechanical prostheses (made out of non-biological materials) and bioprostheses made out of biological tissue. Biological valves are made from animal tissue bovine pericardium and porcine valves. The use of these tissues became commercially available after the introduction of the glutaraldehyde (GA) fixation technique. GA reacts with tissue proteins to form inter- and intramolecular crosslinks, resulting in improved durability. The advantage of bioprostheses compared with mechanical valves is the freedom from thromboembolism; and therefore, the avoidance of long-term anticoagulation therapy. These prostheses are preferable in elderly people and in patients who do not tolerate anticoagulants. However, tissular calcification and primary tissue failure (caused by the mechanical stress) are the main unresolved problems. The causes of calcification are numerous and, to date, a satisfactory solution to this question has not been found, although chemical treatments with metal cations, diphosphonates and treatments eliminating phospholipids have proved to mitigate calcification. In addition, alterna-tive approaches to GA chemical treatment fixation are being proposed to provide the tissue with greater resistance to this process. Studies are under way using polyepoxy compounds, derivates of amino oleic acid (AOA), agents such as diphenylphosphorylazide, carbodiimide, amino acids etc. Further improvements in fixation techniques, as well as in bioprosthesis design (stentless valves) are being made to improve the durability and functional characteristics of bioprosthetic heart valves. The development of a biomaterial capable of withstanding calcification and mechanical stress, while being as durable as mechanical prostheses, would convert the bioprostheses into the replacement of choice by eliminating the need for anticoagulation therapy.

Resistance and stability of a new method for bonding biological materials using sutures and biological adhesives.

The valve leaflets of cardiac bioprostheses are secured and shaped by sutures which, given their high degree of resistance and poor elasticity, have been implicated in the generation of stresses within the leaflets, contributing to the failure of the bioprostheses. Bioadhesives are bonding materials that have begun to be utilized in surgery, although there is a lack of experience in their use with inert tissues or bioprostheses. Tensile testing is performed until rupture in samples of calf pericardium, a biomaterial employed in the manufacture of bioprosthetic heart valve leaflets. One hundred and thirty-two trials are carried out in three types of samples: intact or control tissue (n = 12); samples transected and glued in an overlapping manner with a cyanoacrylate (n = 60); and samples transected, sewn with a commercially available suture material and reinforced at the suture holes with the same cyanoacrylate (n = 60). Seven days after their preparation, 12 samples from each group, including the controls, are subjected to tensile testing until rupture and the findings are compared. In the stability study, groups of 12 each of the remaining 48 glued and 48 sutured and glued samples underwent tensile testing until rupture on days 30, 60, 90, and 120, after their preparation. The results show that bonding with the adhesive provided a resistance ranging between 1.04 and 1.87 kg, probably insufficient for use in valve leaflets, but also afforded a high degree of elasticity. After 120 days, both the glued and the sutured and glued series show excellent elastic behavior, with no rigidity or hardening of the pericardium. These samples present reversible elongation, or strain, when they surpass their elastic limit at rupture. This finding may be due to a load concentration that is damaging to the pericardium, to the behavior of the tissue as an amorphous material, or perhaps to both circumstances. These results need to be confirmed in future studies as they may be of value in the design and manufacture of cardiac bioprostheses.

Comparative study of the mechanical behaviour of a cyanoacrylate and a bioadhesive.

We compared the mechanical resistance of 18 samples of calf pericardium bonded with a 100 mm2 overlap, by two types of glues: a cyanoacrylate (Loctite 4011) and a bioadhesive (BioGlue). Comparative tensile testing was also carried out in 40 paired samples, 20 bonded with the cyanoacrylate and 20 unbonded controls. The findings at rupture showed a greater resistance of the calf pericardium glued with cyanoacrylate, with a mean tensile strength of 0.15 MPa vs. 0.04 MPa for the biological glue (p= 0.000). They also demonstrated a loss of resistance of the samples bonded with cyanoacrylate when compared with that of the unbonded other halves of the pairs: 0.20 MPa and 0.27 MPa vs. 19.47 MPa and 24.44 MPa (p < 0.001). The method of selection by means of paired samples made it possible to establish the equations that relate the stress and strain, or deformation, with excellent coefficients of determination (R2). These equations demonstrate the marked elastic behaviour of the bonded samples. Moreover, these findings show the cyanoacrylate to be superior to the biological glue, leading to the examination of the compatibility, inalterability over time and mechanical behaviour of the cyanoacrylate in sutured samples, as well as the study of the anisotropy of the biomaterial when bonded with a bioadhesive.

Resistance to tensile stress of a bioadhesive utilized for medical purposes: Loctite 4011.

Sutures are the materials presently employed to secure and give shape to the valve leaflets of cardiac bioprostheses. Their high resistance and low degree of elasticity in comparison with the calf pericardium of which the leaflets are made generates internal stresses that contribute to the failure of the bioprostheses. Biological adhesives are bonding materials that have begun to be utilized in surgery, although there is a lack of experience in their use with inert tissues or bioprostheses. We report our study of Loctite 4011, a biological glue composed of a cyanoacrylate that has been employed for medical purposes, in which samples of pericardium bonded with this adhesive were subjected to uniaxial tensile stress. The samples were glued in such a way as to leave an overlap of 1 cm2 between the surfaces of the tissue. The series included 83 samples: 12 tested 24 h after bonding, 17 after 45 days, 17 after 90 days, 19 after 106 days and 18 after 152 days. The samples subjected to deferred trials were preserved using three types of chemical substances: glutaraldehyde, glycerol or saline plus antibiotics. The mean resistance to rupture of the series tested 24 h after gluing was 0.15 MPa (1.47 machine kg). This resistance remained nearly unchanged, regardless of the preservation solution employed, for at least 152 days, the time at which the study ended. The stress-strain curves demonstrated a high degree of elasticity throughout the 152 days, a finding that was not influenced by the preservation solution. This adhesive showed a considerable resistance to tensile stress, although probably insufficient to replace sutures. However, it maintained a surprisingly high degree of elasticity in the samples. Perhaps the time has come to combine these two elements, sutures and adhesives, to improve the elasticity of the structure without a loss of resistance, and increase the durability of bioprostheses.

Comparison of the mechanical behaviors of biological tissues subjected to uniaxial tensile testing: pig, calf and ostrich pericardium sutured with Gore-Tex.

The purpose of this study was to compare the mechanical behavior of calf pericardium, pig pericardium and ostrich pericardium when subjected to tensile testing. Tensile stress was applied to 108 tissue samples, 36 of each type of tissue, until rupture. Groups of three adjacent strips measuring 12 x 2 cm(2) were cut longitudinally. Each group consisted of an unsutured center sample, or control, and the two contiguous samples, that on the right sutured with Gore-Tex at a 90 degrees angle with respect to the longitudinal axis and that on the left sewn with the same suture material at 45 degrees angle. The sutured samples showed a statistically significant loss of resistance (p<0.001) when compared with the corresponding unsutured tissue. The mean stresses at rupture for sutured ostrich pericardium were 21.81 and 20.81 MPa in the samples sewn at 45 degrees and 90 degrees, respectively, higher than those corresponding to unsutured calf and pig pericardium, 14.0 and 11.49 MPa, respectively, at rupture. The analysis of the stress/strain curve shows a smaller difference between sutured and unsutured ostrich pericardium than those observed in the other two biomaterials. These results demonstrate that, in addition to its greater resistance, ostrich pericardium also presents a less pronounced interaction with the suture material. Its capacity to absorb the shearing stress produced by the suture is greater. This report also confirms that the method of selection using paired samples ensures their homogeneity and makes it possible to predict the behavior of a sample by determining that of the other half of the pair.

Sutured calf pericardium: influence of the type and angle of the suture on mechanical behavior.

Careful selection of the biological tissue to be used in cardiac bioprostheses and a thorough knowledge of its mechanical behavior, facilitating both the prediction of this behavior and the interactions between the tissue and the other materials employed, is the best approach to designing a durable implant. For this purpose, a study involving uniaxial tensile testing of calf pericardium was carried out. Two sets of three contiguous strips of tissue were obtained from each pericardial membrane, to perform a total of 144 trials. Two samples were sewn with one of four commercially available suture materials: Gore-Tex, nylon, Prolene and silk. In each set of three samples, the center strip remained intact and unsutured to serve as a control, while the left-hand strip was sutured at a 45 degrees angle with respect to the longitudinal axis and the right-hand strip was sewn at a 90 degrees angle. All the samples were tested until rupture. The results demonstrated a significant loss of mean load (p<0.01) in the sutured samples at rupture. The angle of the suture had no influence on these results, although the stress/strain curves showed that, as the tensile stress increased, the mechanical behaviors were less uniform. The rupture of the collagen fibers could explain this phenomenon. The pericardium sutured with Gore-Tex presented a greater strain, or deformation (elongation), at lower levels of stress, regardless of the angle of the suture. The tissue selection criteria, based on the use of paired samples, enabled a correct prediction of the mechanical behavior of the tissue, with excellent correlation coefficients (>0.98) and a high degree of homogeneity in the results.

Mechanical behavior of chemically treated ostrich pericardium subjected to uniaxial tensile testing: influence of the suture.

The mechanical behavior of sutured ostrich pericardium was studied by uniaxial tensile testing. One hundred forty-four tissue specimens were assessed: 96 sutured samples (48 in which a centrally located suture was placed at an angle of 90 degrees with respect to the longitudinal axis, whereas in the remaining 48, a centrally located suture was placed at a 45 degrees angle to the longitudinal axis, in sets of 12 samples each, sewn with sutures made of Gore-Tex, nylon, Prolene, or silk), and 48 unsutured controls. Each group of 24 samples sewn at one angle or the other with the different suture materials was assayed together with a corresponding control group of 12 unsutured samples. The mean tensile strengths in the unsutured controls ranged between 30.16 MPa and 43.42 MPa, whereas those of the sutured sets ranged from 14.68 MPa to 21.91 MPa. The latter presented a statistically significant loss of resistance (p < 0.01) when compared with the unsutured tissue samples. The angle of the suture with respect to the longitudinal axis influenced the degree of shear stress produced by the suture, as well as the behavior of the different suture materials used. The set of samples sewn with Prolene appeared to be that most sensitive to changes in the angle of the suture, whereas tissue sewn at a 45 degrees angle with Gore-Tex presented lower shear stress values in comparison with samples in which the other three materials were used. A method of tissue selection based on morphological and mechanical criteria was used to ensure the homogeneity of the results in such a way that the coefficients of determination (R2) for the stress/strain curve fitting equation ranged between 0.888 and 0.995. This excellent fit made it possible, applying regression analysis, to predict the mechanical behavior of a specimen by determining that of a contiguous tissue sample. Thus, it should be possible, at least theoretically, to characterize the behavior of a specific region or zone of the biomaterial. In conclusion, ostrich pericardium exhibits strong resistance to rupture, even when sutured. The selection method used ensures the homogeneity of the samples and, thus, of the results. The angle of the suture with respect to the longitudinal axis, where the load is centered, determines the shear stress produced by the suture and the mechanical behavior of each suture material.

The telescoping suture--Part 1: Does this technique improve the mechanical behavior of a biomaterial?: Calf pericardium.

The authors study the mechanical behavior of calf pericardium employed in the construction of cardiac valve leaflets when subjected to telescoping suture, followed by tensile stress until rupture. One hundred twenty pericardial tissue samples were employed, 60 cut from root-to-apex and another 60 cut in transverse direction. Each of these two groups consisted of 12 control samples that were left unsutured and four sets of 12 samples each that were rejoined by telescoping suture using silk, Prolene, nylon or Gore-Tex., and subjected to tensile stress. At the rupture of the sutured tissues, the tensile stress of the suture materials ranged between 57.54 MPa for the series sewn lengthwise with Gore-tex and 114.08 MPa for the series sewn crosswise with silk. At these levels of stress, the deformation of the suture thread was much less marked than that of the calf pericardium, and internal stresses were produced that were difficult for the biomaterial to absorb. There was a loss of real load in all the sutured series when the observed resistance to rupture, expressed in kilograms, was compared with the estimated value. This loss of resistance did not invalidate the telescoping suture technique since the resistance to rupture was still much greater than that associated with suturing the two edges of the cut pericardium together. This report confirms the deleterious role of the shear force generated in the pericardium by the suture.

The telescoping suture--Part II: A novel method to improve the mechanical behavior of a new biomaterial: ostrich pericardium.

Ostrich pericardium, sutured using a telescoping or overlapping technique, was studied to determine its mechanical behavior. From each of 12 pericardial sacs, four contiguous strips were cut longitudinally, from root to apex, and another four contiguous strips were cut in transverse direction. One of the strips in each set of four was used as an unsutured control and the remaining three were sutured by overlapping 0.5 cm of the tissue and sewing with Gore-tex, Prolene or Pronova. These 96 samples were then subjected to tensile testing along their major axes until rupture. The tensile stresses recorded in the suture materials at the moment tears appeared in the pericardium ranged between 55.99 MPa and 70.23 MPa for Gore-tex in samples cut in the two directions. Shear stress became ostensible at 56 MPa, with clearly evident tears. However, microfracture of the collagen fibers must be produced at much lower stress levels. The comparison of the resistance in kilograms (machine-imposed), without taking into account the sections in which the load was applied, demonstrated only a slight loss of load when the telescoping suture was employed in ostrich pericardium samples. Ostrich pericardium may continue to be an alternative biological material for the construction of heart valve leaflets.

Mechanical effects of increases in the load applied in uniaxial and biaxial tensile testing. Part II. Porcine pericardium.

The mechanical behavior of porcine pericardium was analyzed to compare it with that of calf pericardium employed in valve leaflets for cardiac bioprostheses. Forty samples of pericardium were subjected to uniaxial tensile testing, 20 as controls and 20 exposed to loads increasing stepwise from 0.5 to 1.5 kg and to 3 kg, and thereafter to rupture, with a return to zero load between each new increment. Another 20 samples were used in biaxial tensile tests involving the application of loads increasing stepwise (to 0.5, 1.5, 3 and 5 kg) until rupture with a zero-load interval before each increment. The ultimate stresses were very similar, showing no statistically significant differences when compared in terms of type of assay, controls and study samples or region of pericardial tissue being tested. In the stepwise biaxial assays, the mean stresses at rupture were also very homogeneous. Using morphological and mechanical criteria for sample selection, it was possible to obtain mathematical fits for the stress/strain relationship, with excellent coefficients of determination. The relationship between the area under the stress/strain curve and the load applied or the strain observed was also studied in the biaxial assay as an equivalent to the cycles of hysteresis produced in the test. The increment in the area under the curve (the energy consumed) may be a good parameter for assessing the changes in the collagen fiber architecture of the pericardial tissue, changes that may help to detect early failure.

Mechanical effects of increases in the load applied in uniaxial and biaxial tensile testing: Part I. Calf pericardium.

The authors analyzed the mechanical behavior of the calf pericardium employed in the construction of valve leaflets for cardiac bioprostheses. Forty samples of pericardium were subjected to uniaxial tensile testing, 20 as controls and 20 exposed to loads increasing stepwise until rupture, with a return to zero load between each new increment. Another 20 samples were used similarly in biaxial tensile tests involving loads increasing stepwise until rupture, again returning to zero load between steps. The ultimate stresses in the uniaxial study were very similar and were not influenced by the region of pericardial tissue being tested or the increments in load to which the tissue was exposed. The mean stresses at rupture in the stepwise biaxial assays were significantly greater (p<0.01). Using morphological and mechanical criteria for sample selection, it was possible to obtain mathematical fits for the stress/strain relationship in both types of assays, with excellent coefficients of determination (R (2)>0.90). In uniaxial tests in which the selection criteria were not applied, the correlation improved as the load increased, a phenomenon that did not occur in the biaxial studies. The values varied throughout the different cycles, adopting exponential forms when the strain was greatest. These variations, which demonstrate that the increase in the energy consumed is a function of the stress applied and of the strain produced, should be good parameters for assessing the changes in the collagen fiber architecture of pericardial tissue subjected to cyclic stress, and may help to detect early failure.

Ostrich pericardium, a biomaterial for the construction of valve leaflets for cardiac bioprostheses: mechanical behaviour, selection and interaction with suture materials.

The mechanical behavior of ostrich pericardium was studied for the purpose of assessing its utility in the construction of bioprosthetic cardiac valve leaflets. The tissue was tested biaxially using a hydraulic simulator that subjected it to increasing stress until rupture. One hundred eighty trials were performed, 36 with unsutured pericardium and four series of 36 trials each with pericardium sutured with silk, Prolene, nylon or Gore-Tex. The samples were tested in pairs from three different pericardial regions. One sample from each pair (the predictive specimen) was assessed according to morphological and mechanical criteria, while the other (the predicted or selectable specimen) was subjected only to morphological analysis. The findings show that ostrich pericardium treated with glutaraldehyde according to standard methods has an excellent resistance to rupture in biaxial testing, withstanding stresses of up to 100 MPa, and never lower than 30 MPa. Its resistance to rupture is lowered by suturing, a loss that is less pronounced when silk sutures are used. The results with Gore-Tex are very homogeneous and the elastic behavior of the pericardium/suture unit appears to be similar to that of unsutured tissue, suggesting that the interaction between the two biomaterials is minor. Similar results were observed in the series sutured with Prolene and nylon. The use of paired samples makes it possible to closely estimate the mechanical behavior of the tissue in a given zone by determining that of its mate. The statistical study shows that this estimation is not conditioned by the suture employed, thus validating this approach and providing more precise criteria for tissue selection.