Tubular heart valves: A new tissue prosthesis design — Preclinical evaluation of the 3F aortic bioprosthesis

Background: It was hypothesized that native heart valves function as if they were simple tubes with sides that collapse when external pressure is applied. Because “form follows function,” this hypothesis could theoretically be confirmed by implanting a simple tube into the anatomic position of any native heart valve and documenting that under the same anatomic constraints and physiologic conditions as the native valve, the tube would assume the form of that native valve. If the hypothesis were thus proved, it would follow that a tissue valve based on a tubular design would have superior flow dynamics and stress distribution and would therefore be expected to outlast currently available tissue valves. Such a tubular tissue valve, the 3F Aortic Bioprosthesis (3F Therapeutics, Inc, Lake Forest, Calif) was designed and tested in vitro against a commercially available stentless aortic bioprosthesis. Methods: With the use of state-of-the-art testing equipment, some of which had to be developed especially to test this truly stentless bioprosthesis in vitro, transvalvular gradients, effective orifice areas, degree of transvalvular laminar flow, finite element analysis of the distribution of leaflet stress, and accelerated wear testing for long-term durability were evaluated for the new 3F Aortic Bioprosthesis in comparison with the St Jude Medical Toronto SPV aortic bioprosthesis (St Jude Medical, Inc, St Paul, Minn). Results: The valve gradients were lower and the effective orifice areas were greater for the 3F Aortic Bioprosthesis at all valve sizes and under all test conditions, including cardiac outputs ranging from 2.0 to 7.0 L/min, mean perfusion pressures from 40 to 200 mm Hg, and aortic compliances of 4% and 16%. The transvalvular flow across the 3F Aortic Bioprosthesis in vitro was qualitatively smooth, with a minimum of surrounding vortices. Maximum stress occurred in the belly of the leaflets of the 3F Aortic Bioprosthesis, with minimum stress at the commissural posts. The 3F Aortic Bioprosthesis was superior to the Toronto SPV valve in accelerated wear tests. Conclusions: These in vitro studies show that a tissue aortic valve designed on the basis of the proved engineering principle that form follows function has better hemodynamics, flow dynamics, stress distribution, and durability when compared under identical in vitro conditions with an excellent commercially available tissue aortic valve