In vivo evaluation of the new „Biophysio“ next generation bioprosthesis

Objectives: The new Biophysio (Edwards Lifesciences LLC, Irvine, CA) bioprosthesis was designed to further improve hemodynamic performance currently achieved by stented valves. Therefore, two unique design features were added.

1. A flexible nitinol stent that preserves aortic root dynamics.

2. A suture line that follows the natural undulation of the native aortic annulus. Hemodynamic performance and preservation of dynamic aortic root motion were evaluated in an ovine model.

Material and Methods: Ten juvenile sheep (61.2±8kg) received size 19mm or 21mm Biophysio aortic bioprostheses. The animals were fully equipped for hemodynamic monitoring and transvalvular gradient measurements. Before and after implantation, cineangiography was performed, to assess aortic root dynamics, and document the absence of aortic regurgitation. Hemodynamic performance was evaluated by transesophageal echocardiography.

Results: At a mean cardiac output of 5.9±0.4 l/min, the mean transaortic pressure gradients were 5.9±1.9mmHg (19mm valves) and 3.6±0.7mmHg (21mm valves), the mean effective orifice areas were 2.08±0.43 cm² (19mm valves) and 2.65±0.24 cm² (21mm valves). The preserved mean dilatation of the aortic root, measured as the maximum expansion of the radiopaque frame in systoly, was 9.01±4.9%.

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