Development of a Transcatheter Tricuspid Valve Prosthesis Through Steps of Iterative Optimization and Finite Element Analysis

The development of a transcatheter tricuspid valve prosthesis for the treatment of tricuspid regurgitation ( TR ) is presented. The design process involves an iterative development method based on computed tomography data and different steps of finite element analysis ( FEA ). The enhanced design consists of two self‐expandable stents, one is placed inside the superior vena cava ( SVC ) for primary device anchoring, the second lies inside the tricuspid valve annulus ( TVA ). Both stents are connected by flexible connecting struts ( CS ) to anchor the TVA‐stent in the orthotopic position. The iterative development method includes the expansion and crimping of the stents and CS with FEA . Leaflet performance and leaflet–stent interaction were studied by applying the physiologic pressure cycle of the right heart onto the leaflet surfaces. A previously implemented nitinol material model and a new porcine pericardium material model derived from uniaxial tensile tests were used. Maximum strains/stresses were approx. 6.8% for the nitinol parts and 2.9  MPa for the leaflets. Stent displacement because of leaflet movement was ≤1.8 mm at the commissures and the coaptation height was 1.6–3 mm. This led to an overall good performance of the prosthesis. An anatomic study showed a good anatomic fit of the device inside the human right heart.