A new transcatheter heart valve concept (the TRISKELE): feasibility in an acute preclinical model.

AIMS

The aim of this study was to introduce and demonstrate the feasibility in an acute preclinical model of a new transcatheter heart valve concept with a self-expanding wire frame, polymeric leaflets and a sealing component.

METHODS AND RESULTS

The TRISKELE valve was developed based on a previously validated polymeric leaflet design, an adaptive sealing cuff and a novel nitinol wire frame which reduces stress on the leaflets and radial pressure on the surrounding tissue. A valve prototype of 26 mm nominal diameter was manufactured by automated dip coating of a biostable polymer. The prototype was implanted via brachiocephalic approach in orthotopic position in an acute ovine model through a highly controllable multistage deployment process. The atraumatic retrievability of the valve after full expansion was verified in situ before final release in the optimal position. Observation indicated secure valve anchoring, adequate leaflet motion, and no interference of coronary flow or mitral valve function.

CONCLUSIONS

The TRISKELE valve system has the potential to mitigate complications related to imprecise valve positioning, and may offer a safer and more economical TAVI solution to a broad range of patients. The valve is currently under preclinical investigation for its long-term function and durability.