In-vivo evaluation of the BioPhysio valve prosthesis in the aortic position

The new BioPhysio aortic prosthesis is a pericardial valve with a flexible stent that can be implanted with a single suture line. The study aim was to evaluate the in-vivo implantation characteristics, preservation of dynamic motion of the aortic root, and hemodynamic performance of this bioprosthesis.

The BioPhysio valve was implanted, in the aortic position, in 10 young adult male sheep. Transesophageal and intracardiac echocardiography were carried out postoperatively for hemodynamic evaluation. Cineangiography was performed both preoperatively and postoperatively to assess aortic root dynamics and to document the absence of aortic regurgitation. Cardiac output was monitored via a Swan-Ganz catheter, both preoperatively and postoperatively.

The BioPhysio valve was implanted with interrupted mattress sutures in seven cases, and with continuous sutures in three cases. At a mean cardiac output of 5.9 l/min, the mean transaortic pressure gradients were 5.93 and 3.6 mmHg for the 19- and 21-mm valves, respectively, and the mean effective orifice areas were 2.08 and 2.65 cm2. Mean dilation of the aortic root, measured as the maximum expansion of the radiopaque frame in systole, was 9.01%.

The unique flexible stent design of the new BioPhysio valve preserves the dynamic motion of the aortic root, by combining the hemodynamic benefits of stentless valves with the ease of implantation of stented bioprostheses.