An integrated pericardial valved stent special for percutaneous tricuspid implantation: an animal feasibility study

Various percutaneous valve replacement approaches have been reported in animals to replace the aortic and pulmonary valve. To broaden the indications of percutaneous approach to atrioventricular valves replacement, we developed a novel valved stent and evaluated the feasibility and safety of percutaneous implantation of the device in the tricuspid position.

A unidirectional semilunar valve of porcine pericardium was sutured to a valvular ring. Then the ring with pericardial valve was mounted on a double-edge nitinol stent to construct the tricuspid valved stent. Transcatheter tricuspid valved stent implantation was performed on 10 healthy sheep. These sheep were followed up shortly after procedure with echocardiography evaluation and 64-slice CT imaging examination during the periodical follow-up at 1 mo and at 6 mo post-implantation. Additionally, two sheep were sacrificed after the procedure for anatomic and histological evaluation one at 1 h and the other at 1 mo, respectively.

Percutaneous valve implantation was successful in eight of 10 sheep. Two sheep died during the procedure due to migration of stent and fatal arrhythmia. The pressure of right heart did not significantly change after the procedure. Further echocardiography and imaging confirmed the stents were in desired position during the follow-up. The remaining six sheep with normal valvular and cardiac functionality survived for 6 mo after implantation.

The tricuspid stent with a valvular ring and pericardial valve can be implanted in tricuspid annulus percutaneous. The double-edge stent could substitute the native tricuspid valve chronically.