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Development of a Transcatheter Tricuspid Valve Prosthesis Through Steps of Iterative Optimization and Finite Element Analysis
Author(s) -
Pott Desiree,
Kütting Maximilian,
Zhong Zhaoyang,
Amerini Andrea,
Spillner Jan,
Autschbach Rüdiger,
Steinseifer Ulrich
Publication year - 2015
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/aor.12605
Subject(s) - finite element method , stent , regurgitation (circulation) , prosthesis , heart valve , biomedical engineering , tricuspid valve , materials science , pericardium , structural engineering , medicine , surgery , engineering
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.