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Calf pericardium, similar to that used in the manufacturing of prosthetic valve cusps, was fatigue tested. After six batches of 100 cycles of 1 MPa of loading pressure, half of the samples broke. The mean energy dissipated in the first cycle by the surviving samples was 0.16 J, which is lower than the 0.28 J dissipated by the specimens that broke (p = 0.005). The hysteresis of the first cycle was characteristic and different from the following ones and correlated superbly with fatigue resistance. Setting a threshold value for the energy of the first cycle of 0.20 J, the performance index (the percentage of true predictions) was almost 80%, and the area under the ROC curve was 0.823 (maximum value is 1). When including the mean thickness in the selection parameters, as an indirect measure of the specimen mass, the performance index grew over 95%, meaning that the error of the predictions was less than 5%. Combining both parameters in one, a high performance index is maintained at 87.5% and the area under the ROC curve increases to 0.917. This non‐destructive method should help optical methods in the process of selecting the most appropriate and homogenous biological material. © 2010 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2010. [ABSTRACT FROM AUTHOR]

The use of biological materials in the construction of bioprostheses requires the application of different chemical procedures to improve the durability of the material without producing any undesirable effects. A number of crosslinking methods have been tested in biological tissues composed mainly of collagen. The aim of this study was to evaluate the in vitro biocompatibility, the mechanical properties, and in vivo calcification of chemically modified bovine pericardium using glutaraldehyde acetals (GAAs) in comparison with glutaraldehyde (GA) treatment. Homsy's tests showed that the most cytotoxic treatment is GA whereas GAA treatments showed lower cytotoxicity. Regarding the mechanical properties of the modified materials, no significant differences in stress at rupture were detected among the different treatments. Zeta-Potential showed higher negative values for GA treatment (−4.9 ± 0.6 mV) compared with GAA-0.625% (−2.2 ± 0.5 mV) and GAA-1% (−2.2 ± 0.4 mV), which presented values similar to native tissue. Similar results were obtained for calcium permeability coefficients which showed the highest values for GA treatment (0.12 ± 0.02 mm2/min), being significantly lower for GAA treatments or non-crosslinked pericardium. These results confirmed the higher propensity of the GA-treated tissues for attraction of calcium cations and were in good agreement with the calcification degree obtained after 60 days implantation into young rats, which was significantly higher for the GA group (22.70 ± 20.80 mg/g dry tissue) compared with GAA-0.625% and GAA-1% groups (0.49 ± 0.28 mg/g dry tissue and 3.51 ± 3.27 mg/g dry tissue, respectively; P < 0.001). In conclusion, GAA treatments can be considered a promising alternative to GA treatment. [ABSTRACT FROM AUTHOR]

The tearing of the collagen fibers of biological materials utilized in implants or bioprostheses is an important, and sometimes early cause of the failure of these devices. We studied the force necessary to propagate a tear in a biomaterial, pericardium from young bulls, and the influence of the suture. An Elmendorf pendulum capable of measuring the force necessary to tear a given length of tissue was employed. We analyzed 112 trials (70%) that proved valid after achieving the homogeneity of the samples according to their thickness, thus making the results comparable. Mean forces ranging between 19.87 and 150 N were required to propagate tears measuring from 0.25 to 2.0 cm. In the samples with a 1-cm-long suture, sewn using an edge-to-edge technique, the propagation of the tear required a mean force of 15.75 N when the suture was made of nylon and 28.73 N when Prolene was utilized. When these results were compared with the mean recorded in an unsutured control series (56.76 N), the loss of resistance was significant in both sutured series ( P = 0.000 and P = 0.011, respectively). Finally, the equation that relates the force ( y) with the length of the tear made in unsutured tissue ( x) was also obtained: y = 58.14 + 9.62 x2 ( R2 = 0.924). The force necessary to produce a microtear, thus estimated, can be utilized as a parameter for comparison. [ABSTRACT FROM AUTHOR]

The durability of existing calf pericardium bioprostheses is limited by phenomena such as mechanical stress and calcification, the factors most frequently implicated in valve failure. Varying the preferred direction of the collagen fibers influences the mechanical behavior of the pericardial membrane. Given this possible variation, a strict control of the selection of the biomaterial employed in the construction of valve leaflets is essential, but a reliable method of selection has yet to be established. This study describes the development of a new system of in vitro selection involving a hydraulic simulator that reproduces the mechanical behavior of pericardial membranes subjected to the stress of continuous flow. By combining morphological criteria such as thickness and homogeneity with those of mechanical behavior, and by selecting paired samples from different parts of the pericardium, we obtained excellent mathematical fits. Linear regression analysis provided the mode of predicting the tensile strength in a given sample when this value had been determined in its twin. The upper zones of calf pericardium, corresponding to either right or left ventricle but at a distance from ligamentous structures, showed the best mean results at rupture (60 MPa) and permitted the most reliable prediction. The expected stress for an elongation of 30% was 1.12 MPa, as was previously observed, with a 95% confidence interval of between 1.11 and 1.14 MPa. These trials, together with the careful selection of the pairs, should help to establish definitive selection criteria. © 2001 Kluwer Academic Publishers [ABSTRACT FROM AUTHOR]