The measurement of bovine pericardium density and its implications on leaflet stress distribution in bioprosthetic heart valves

Purpose: Bioprosthetic Heart Valves (BHVs) are currently in widespread use with promising outcomes. Computational modeling provides a framework for quantitatively describing BHVs in the preclinical phase. To obtain reliable solutions in computational modeling, it is essential to consider accurate leaflet properties such as mechanical properties and density. Bovine pericardium (BP) is widely used as BHV leaflets. Previous computational studies assume BP density to be close to the density of water or blood. However, BP leaflets undergo multiple treatments such as fixation and anti-calcification. The present study aims to measure the density of the BP used in BHVs and determine its effect on leaflet stress distribution. Methods: We determined the density of eight square BP samples laser cut from Edwards BP patches. The weight of specimens was measured using an A&D Analytical Balance, and volume was measured by high-resolution imaging. Finite element models of a BHV similar to PERIMOUNT Magna were developed in ABAQUS. Results: The average density value of the BP samples was 1410 kg/m3. In the acceleration phase of a cardiac cycle, the maximum stress value reached 1.89 MPa for a density value of 1410 kg/m3 , and 2.47 MPa for a density of 1000 kg/m3(30.7% difference). In the deceleration, the maximum stress value reached 713 and 669 kPa, respectively. Conclusion: Stress distribution and deformation of BHV leaflets are dependent upon the magnitude of density. Ascertaining an accurate value for the density of BHV leaflets is essential for computational models.

[1]  U. Benedetto,et al.  Fifty years of the pericardial valve: Long‐term results in the aortic position , 2021, Journal of cardiac surgery.

[2]  A. Kutikhin,et al.  Degeneration of Bioprosthetic Heart Valves: Update 2020 , 2020, Journal of the American Heart Association.

[3]  Austin J. Herrema,et al.  Thinner biological tissues induce leaflet flutter in aortic heart valve replacements , 2020, Proceedings of the National Academy of Sciences.

[4]  B. Griffith,et al.  Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. , 2020, The Journal of thoracic and cardiovascular surgery.

[5]  A. Azadani,et al.  A Non-Invasive Material Characterization Framework for Bioprosthetic Heart Valves , 2018, Annals of Biomedical Engineering.

[6]  P. Herijgers,et al.  A novel tissue treatment to reduce mineralization of bovine pericardial heart valves , 2018, The Journal of thoracic and cardiovascular surgery.

[7]  B. Griffith,et al.  The COMMENCE trial: 2‐year outcomes with an aortic bioprosthesis with RESILIA tissue† , 2017, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[8]  M. Sacks,et al.  Fixation of Bovine Pericardium-Based Tissue Biomaterial with Irreversible Chemistry Improves Biochemical and Biomechanical Properties , 2017, Journal of Cardiovascular Translational Research.

[9]  A. Azadani,et al.  Characterization of three-dimensional anisotropic heart valve tissue mechanical properties using inverse finite element analysis. , 2016, Journal of the mechanical behavior of biomedical materials.

[10]  A. Azadani,et al.  Leaflet stress and strain distributions following incomplete transcatheter aortic valve expansion. , 2015, Journal of biomechanics.

[11]  E. Verbeken,et al.  A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. , 2015, The Journal of thoracic and cardiovascular surgery.

[12]  Jagdish Butany,et al.  Bioprosthetic Heart Valves: Impact of Implantation on Biomaterials , 2013 .

[13]  W. Haschek,et al.  Haschek and Rousseaux's handbook of toxicologic pathology , 2013 .

[14]  D. Goad,et al.  Biomedical Materials and Devices , 2013 .

[15]  G. Goissis,et al.  Preparation and characterization of an acellular bovine pericardium intended for manufacture of valve bioprostheses. , 2011, Artificial organs.

[16]  Hadi Mohammadi,et al.  Prosthetic aortic heart valves: modeling and design. , 2011, Medical engineering & physics.

[17]  J. Gorman,et al.  Effect of Geometry on the Leaflet Stresses in Simulated Models of Congenital Bicuspid Aortic Valves , 2011, Cardiovascular engineering and technology.

[18]  David E. Schmidt,et al.  On the biomechanics of heart valve function. , 2009, Journal of biomechanics.

[19]  Frederick J. Schoen,et al.  Evolving Concepts of Cardiac Valve Dynamics: The Continuum of Development, Functional Structure, Pathobiology, and Tissue Engineering , 2008, Circulation.

[20]  Paul Schmidt,et al.  Bioprosthetic heart valve heterograft biomaterials: structure, mechanical behavior and computational simulation , 2006, Expert review of medical devices.

[21]  Jia Lu,et al.  Dynamic simulation pericardial bioprosthetic heart valve function. , 2006, Journal of biomechanical engineering.

[22]  M. Thubrikar,et al.  Carpentier-Edwards ThermaFix Process : A Method for Extracting Calcium Binding Sites from Pericardial Tissue , 2006 .

[23]  M. Sacks,et al.  Simulated bioprosthetic heart valve deformation under quasi-static loading. , 2005, Journal of biomechanical engineering.

[24]  M. Sacks,et al.  Biaxial mechanical response of bioprosthetic heart valve biomaterials to high in-plane shear. , 2003, Journal of biomechanical engineering.

[25]  M. Sacks,et al.  Collagen fiber disruption occurs independent of calcification in clinically explanted bioprosthetic heart valves. , 2002, Journal of biomedical materials research.

[26]  M. Fishbein,et al.  Tissue characterization and calcification potential of commercial bioprosthetic heart valves. , 2001, The Annals of thoracic surgery.

[27]  F J Schoen,et al.  Mechanisms of bioprosthetic heart valve failure: fatigue causes collagen denaturation and glycosaminoglycan loss. , 1999, Journal of biomedical materials research.

[28]  M. Sacks,et al.  Optimal bovine pericardial tissue selection sites. II. Cartographic analysis. , 1998, Journal of biomedical materials research.

[29]  M. Sacks,et al.  Optimal bovine pericardial tissue selection sites. I. Fiber architecture and tissue thickness measurements. , 1998, Journal of biomedical materials research.