A new equine pericardial stentless valve

Objective: Small aortic valve replacement remains a challenging hemodynamic problem. A new bioprosthesis (3F Therapeutics, Lake Forest, Calif) was designed to further improve the hemodynamic performance currently achieved with stentless bioprostheses. This valve consists of a tubular structure assembled from 3 equal sections of equine pericardial material, with virtually no foreign material except for a thin polyester ring. Its hemodynamic performance was compared with that of a commercially available stentless prosthesis in a bovine model. Patients and Methods: Twelve calves (55 +/- 2.8 kg) received a 19-mm 3F valve (317 group, n = 6) or a 19-mm stentless control valve (control group, n = 6). The animals were fully equipped for hemodynamic monitoring and transvalvular gradient measurements. After implantation, dopamine was infused in increasing doses, and the hemodynamic values were recorded at each step of 100-mug/min increase. Linear regression analysis was applied for group comparison of each variable. Results: The mean transvalvular gradient at 4.5 L/min was 3.48 +/- 0.14 rum Hg (95% confidence interval) in the 3F group and 5.72 +/- 0.28 rum Hg in the control group (P < .0001) and at 6.5 L/min, 7.4 +/- 1.55 mm Hg, and 11.13 +/- 0.18 rum Hg, respectively (P < .0001). The effective orifice area at 4.5 L/min was 2.4 +/- 0.03 cm(2) in the 3F group and 1.86 +/- 0.02 cm(2) in the control group (P < .0001) and at 6.5 L/min, 2.41 +/- 0.04 cm(2), and 1.96 +/- 0.02 cm(2), respectively (P < .0001). Conclusions: This new bioprosthesis without a stent and without a supporting wall that has its commissures fixed directly to the aorta outperforms in vivo standard stentless prostheses in the immediate postimplant period.