An assessment of the mechanical properties of leaflets from four second-generation porcine bioprostheses with biaxial testing techniques.

The aim of this study was to determine whether second-generation porcine bioprostheses, glutaraldehyde fixed at pressures said to be less than 4 mm Hg, exhibit more natural leaflet material properties than earlier valves fixed at 80 to 100 mm Hg. Biaxial mechanical testing techniques were used to compare Carpentier-Edwards SAV, St. Jude Medical BioImplant, Hancock II, and Medtronic Intact bioprostheses (12 leaflets from four valves in each case) with fresh porcine aortic valves and high pressure-fixed Carpentier-Edwards 6625 bioprostheses (14 leaflets from five valves in each case). The circumferential extensibility of leaflets from Medtronic Intact bioprostheses and from fresh porcine aortic valves were not significantly different (p greater than 0.05), whereas leaflets from the other second-generation valves tested and from Carpentier-Edwards 6625 valves were highly inextensible in the circumferential direction. The radial material properties of leaflets from all bioprostheses differed from those of fresh porcine aortic valves, which were very extensible with a high pretransitional compliance. The radial extensibility and compliance of Hancock II, St. Jude Medical BioImplant, and Carpentier-Edwards 6625 leaflets were not significantly different (p greater than 0.05). In the radial direction, Carpentier-Edwards SAV and Medtronic Intact valve leaflets were substantially more extensible than Carpentier-Edwards 6625 leaflets (p less than 0.01), whereas Medtronic Intact leaflets were more compliant than all other bioprostheses. These data demonstrate (1) that second-generation porcine bioprosthetic valves do not necessarily exhibit more natural leaflet material properties than earlier high pressure-fixed xenografts and (2) that Medtronic Intact valve leaflets have material properties most closely approximating the fresh porcine aortic valve.