Preliminary feasibility and hemodynamic performance of a newly-developed self-expanding bioprosthesis and 16-F delivery system in transcatheter aortic valve implantation in sheep

We sought to evaluate the feasibility and hemodynamic performance of a new self-expanding bioprosthesis and 16-F delivery system in sheep. A 23-mm new self-expanding aortic bioprosthesis was implanted in sheep (n = 10) with a 16-F catheter via the right common carotid artery. Each sheep underwent angiography and coronary angiography before intervention, immediately and 1 h after stent implantation. Electrocardiographic monitoring was carried out during and 2 h after the procedure. Transthoracic echocardiography was employed to detect hemodynamic performance before intervention, immediately and 1 and 2 h after stent implantation. All sheep were euthanized 2 h after successful implantation for macroscopic inspection. In all cases, the new self-expanding aortic bioprosthesis was successfully delivered to the aortic root and released with a 16-F catheter. Successful implantation was achieved in 8 of 10 sheep. Hemodynamic performance and device position of successful implantation were stable 2 h after device deployment. Atrioventricular block was not observed. We conclude that it is feasible to implant the new self-expanding aortic valve with a 16-F delivery system into sheep hearts via the retrograde route.