Textile heart valve prosthesis: from fabric design criteria to early in-vivo performances.

BACKGROUND AND AIM OF THE STUDY: Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients at high risk for open-chest surgery. Biological valve tissue is, however, a fragile material when folded for small-diameter catheter insertion purposes. Textile polyester is a less fragile material, and could be an alternative replacement for the valve leaflets. The dynamic performances obtained in vitro with a valve prosthesis made from textile have proven in previous studies to be satisfactory. However, as textile is a porous material the interaction processes between the fabric leaflet surfaces and living tissues remain unknown. The study aim was to discuss the fabric design criteria which are best suited to clinical application.

METHODS

An appropriate design provided strength, limited porosity and low bulk to the fabric, which was particularly suited for small-diameter catheter insertion purposes. The in-vivo behavior of a non-coated polyester textile valve prototype was then studied in the mitral position in a sheep model.

RESULTS

The results showed that limited tissue ingrowth occurred, and Ca deposits tended to stiffen the fabric leaflets after a two-month implantation period, which was not compatible with the survival of the animal.

CONCLUSION

The initial results obtained with this non-coated polyester textile valve confirmed that this revolutionary fabric is worthy of further investigation.