POTENTIAL BENEFITS FOR USING ePTFE AS A MATERIAL FOR PROSTHETIC HEART VALVES

Abstract

Background The current study highlights potential benefits of using ePTFE, a polymeric material, as the main component suitable for fabrication of prosthetic heart valves. Novel polymeric materials seem to be promising for replacing biological elements commonly used in medical products for cardiovascular surgery. High biocompatibility and mechanical properties prolong their lifespan during direct blood contact. Nevertheless, it is necessary to conduct a series of specific tests to determine their properties and benefits of their application. Despite well-known biological properties of ePTFE, there are few studies assessing it as a material for heart valve leaflets. Aim To evaluate the mechanical properties of the commercially available sample of ePTFE and to conduct a numerical experiment assessing its potential for the application. Methods The polymer properties (Gore & Associates Inc., USA) were evaluated under uniaxial tension in two mutually perpendicular directions to determine the degree of anisotropy of the material. A xenopericardial patch (ZAO “NeoCor”, Russia), routinely used for the fabrication of bioprosthetic leaflets, was taken as the control sample. The spatial model of the investigated material was carried out in CAD SolidWorks 2016 (Dassault Systemes, USA). Numerical modeling of the samples was performed with the finite element method using the orthotropic material model in the Abaqus/CAE (Dassault Systemes, USA). Results There are significant difference found in the mechanical properties of the studied materials: the tension at stretching of ePTFE in the longitudinal and transverse directions differed from xenopericardium by 1.9 and 7.5 times, respectively (p<0.05). The elongation before rupture of ePTFE in direction I and direction II was greater than that of xenopericardium (2.39 vs. 1.9 times, respectively). Numerical modeling demonstrated insignificant qualitative differences in the valve opening while applying pressure equal to normal physiological pressure>< 0.05). The elongation before rupture of ePTFE in direction I and direction II was greater than that of xenopericardium (2.39 vs. 1.9 times, respectively). Numerical modeling demonstrated insignificant qualitative differences in the valve opening while applying pressure equal to normal physiological pressure and low pressure. In addition, the zones of high stress in commissural racks, which are critical zones for fatigue resistance, have been identified, albeit require additional in vitro research. Conclusion Mechanical properties of ePTFE suggests it to be a promising polymeric material suitable for fabrication of flexible leaflets of the heart valve prosthesis. It has similar leaflet functioning, compared with the xenopericardium sample, routinely used in manufacturing. ePTFE is more resistant to rupture, which confirms its greater fatigue strength. However, it requires further study by advanced methods.