Trilogy Pericardial Valve: Hemodynamic Performance and Calcification in Adolescent Sheep

Background We assessed the hemodynamic performance and calcification potential of a new design of bovine pericardial valve, the Trilogy valve (Arbor Surgical Technologies Inc, Irvine, CA). We compared this new valve with the Perimount valve (Edwards Lifesciences, Irvine, CA) in a randomized prospective study in adolescent sheep. Methods Nine Trilogy valves (size 21) and six Perimount valves (size 23 or 25) were implanted in the mitral position in adolescent sheep and studied during five months. Hemodynamic measurements were performed at one week, three months, and five months using transthoracic echocardiography. Valve calcification was assessed by X-ray and calcium content was measured by atomic absorption spectrometry after five months implantation in sheep. Tissues were also evaluated histologically (Von Kossa staining). Results The nine Trilogy valves had lower peak velocity, peak gradient, and mean gradient compared with the six Perimount valves. These 21-mm Trilogy valves had similar deceleration time and effective orifice area compared with the 23- and 25-mm Perimount valves. Calcification of the Trilogy valves was significantly lower than Perimount valves (p < 0.01), particularly in the commissural (p < 0.01) and free margin regions (p < 0.03). In all parameters assessed, the Trilogy valves exhibited less variation valve-to-valve compared with Perimount valves. Conclusions These findings demonstrate that a valve designed to reduce stress in the tissue, improve leaflet kinematics, with advanced antimineralization treatment, can exhibit superior calcification resistance in the mitral position of adolescent sheep. The trilobal geometry and independent leaflet suspension design, combined with an advanced tissue treatment, appears to be a promising breakthrough in the effort to develop a more durable and hemodynamically efficient bioprosthetic valve.