A synthetic fiber-reinforced stentless heart valve.

There is strong evidence that failure of bioprosthetic and synthetic valves occurs as a consequence of high tensile and bending stresses, acting on the leaflets during opening and closing. In stented prostheses, whether synthetic or biological, the absence of contraction of the aortic base causes the leaflets to be subjected to an unphysiological degree of flexure, which is also related to calcification. However, a stentless synthetic valve, which has a flexible aorta base, can be a good alternative for stented synthetic valves. Moreover, fiber-reinforcement is assumed to lead to a decrease of tears and perforation as a result of reduced stresses in the weaker parts of the leaflets in their closed configuration. The manufacturing method for a stentless, fiber-reinforced, synthetic valve is presented. Prototypes are tested in a pulse duplicator system. The results show that the mean systolic pressure difference is very low, while the high regurgitation (up to 26%) is probably caused by a too small coaptation area of the leaflets.