In vitro hydrodynamic evaluation of a biovalve with stent (tubular leaflet type) for transcatheter pulmonary valve implantation

Hirohito Sumikura, Yasuhide Nakayama, Kentaro Ohnuma, Satoru Kishimoto, Yoshiaki Takewa, Eisuke Tatsumi

We have been developing an autologous heart valve-shaped tissue with a stent (stent-biovalve) for transcatheter pulmonary valve implantation (TPVI) using "in-body tissue architecture" technology. In this study, the hydrodynamic performance of a stent-biovalve with tubular leaflets was evaluated by changing its leaflet height in an in vitro test in order to determine the appropriate stent-biovalve form for the pulmonary valve. A specially designed, self-expandable, stent-mounted, cylindrical acrylic mold was placed in a dorsal subcutaneous pouch of goat, and the implant was extracted 2 months later. Only the cylindrical acrylic mold was removed from the implant, and a tubular hollow structure of membranous connective tissue impregnated with the stent strut was obtained. Half of tubular tissue was completely folded in half inwards, and 3 commissure parts were connected to form 3 leaflets, resulting in the preparation of a stent-biovalve with tubular leaflets (25-mm ID). The stent-biovalve with adjusting leaflet height (13, 14, 15, 17, 20, and 25 mm) was fixed to a specially designed pulsatile mock circulation circuit under pulmonary valve conditions using 37 °C saline. The mean pressure difference and effective orifice area were better than those of the biological valve. The lowest and highest leaflet heights had a high regurgitation rate due to lack of coaptation or prevention of leaflet movement, respectively. The lowest regurgitation (ca. 11 %) was observed at a height of 15 mm. The leaflet height was found to significantly affect the hydrodynamics of stent-biovalves, and the existence of an appropriate leaflet height became clear.