Resource costing for multinational neurologic clinical trials: methods and results

Failure of synthetic heart valves is usually caused by tearing and calcification of the leaflets. It is postulated that leaflet fibre-reinforcement leads to a decrease of tears and perforations as a result of reduced stresses in the weaker parts of the leaflets. A three-dimensional finite element model of a reinforced three-leaflet valve prosthesis was developed to analyse the stress reduction. Different fibre reinforcements were investigated and the model responses were analysed for stresses that are expected to contribute to failure of fibre-reinforced valve prostheses. Results of these simulations show that, in peak stress areas of reinforced models, up to 60% of the maximum principal stresses is taken over by fibres and that, in some cases of reinforcement, a more homogeneous stress distribution is obtained.