title: A general method for estimating deformation and forces imposed in vivo on bioprosthetic heart valves with flexible annuli: in vitro and animal validation studies.
abstract: OBJECTIVE
  The use of flexible structures within cardiovascular prostheses such as valves, stents and vascular grafts has been proposed as a means of more closely modeling native mechanics, and thereby reducing the biomechanical problems associated with rigid materials. However, the design of such materials has been hampered by the paucity of quantitative information on the in-vivo behavior of such structures. The aim of this study was to explore the use of 3D ultrasound imaging coupled with finite element analysis (FEA) as a tool to estimate deformation and forces imposed in vivo on a novel bioprosthetic valve design.
  
  
  METHODS
  The method was first tested using in-vitro static loading conditions, where good agreement between displacements seen on video and those obtained from application of the identical force within the finite element program was seen. The method was then tested in a porcine model with valves implanted in the mitral position. Images of the deforming annular ring were obtained over the cardiac cycle using 3D intravascular ultrasound; these images were fed into the FEA program for calculation of reaction forces.
  
  
  RESULTS
  Results in vitro showed that a force of 2.7-8.0 Newtons (N) was required to produce a deformation of between 1.0 and 3.0 mm in the radial direction. A time history of deformation and force around the ring of the valve stent could be obtained for the in-vivo conditions. These results revealed a maximum deformation of 0.5-1.7 mm along the short axis (anteroposterior) of the mitral valve. Coupled to this, a peak reaction force of 4.4-13.9 N was found at the points corresponding to maximal deflection. Both deformation and reaction force reached maximum during atrial contraction.
  
  
  CONCLUSIONS
  This method provides an accurate means of estimating deformation and corresponding forces imposed in vivo on intracardiac prostheses. The results provide information on the dynamic behavior of the mitral valve annulus. Such information should be useful in the design of flexible cardiovascular prostheses.
authors.affiliation: Department of Cardiology, The Children's Hospital, Denver, Colorado 80218, USA.
authors.forename: R
authors.initials: R
authors.lastname: Shandas
authors.forename: M
authors.initials: M
authors.lastname: Mitchell
authors.forename: C
authors.initials: C
authors.lastname: Conrad
authors.forename: O
authors.initials: O
authors.lastname: Knudson
authors.forename: J
authors.initials: J
authors.lastname: Sorrell
authors.forename: S
authors.initials: S
authors.lastname: Mahalingam
authors.forename: M
authors.initials: M
authors.lastname: Fragoso
authors.forename: L
authors.initials: L
authors.lastname: Valdes-Cruz
mesh_terms: D000818:Animals; D001696:Biomechanical Phenomena; D001705:Bioprosthesis; D019560:Echocardiography, Three-Dimensional; D020342:Finite Element Analysis; D006350:Heart Valve Prosthesis; D006801:Humans; D066298:In Vitro Techniques; D008943:Mitral Valve / Q000000981:diagnostic imaging* / Q000637:transplantation; D012107:Research Design; D013552:Swine; D018084:Ultrasonography, Interventional