Aortic valve replacement in sheep with a novel trileaflet mechanical heart valve prosthesis without anticoagulation

BACKGROUND: Even after decades of intensive research, an ideal heart valve prosthesis remains elusive. Shortcomings of conventional devices include reduced durability of bioprostheses and the thrombogenicity of mechanical substitutes, necessitating anticoagulation and resulting in imperfect hemodynamics. Here we present in vivo results of a novel mechanical heart valve prosthesis aiming for freedom from anticoagulation. METHODS: Four female sheep had their aortic valves replaced using the novel mechanical heart valve (size 21 mm), with no postoperative anticoagulation treatment. This trileaflet heart valve was designed with the pivots in the systolic central flow. Hemodynamics, biochemistry, hematology, and macroscopy and microscopy were studied at 90 days in 2 sheep and at 1 year in the other 2 sheep. RESULTS: Mean (<6 mm Hg) and peak (<10 mm Hg) aortic transvalvular gradients remained low during the study period. Aortic regurgitation was trivial, and central traces were only rarely observed. The rate of thrombotic events was very low, with none macroscopically and microscopically visible thrombotic material on the device. Biochemistry and hemotology were unchanged without hemolysis. In 3 sheep, the fibrous pannus and mitral leaflet were partially folded over the edge of the annular body. Apart from organic/inorganic deposits on the leaflets after 1 year, the ultrastructurally evaluated leaflets were similar to those of nonimplanted controls. CONCLUSIONS: The preliminary in vivo results of this novel anticoagulation-free aortic mechanical heart valve are promising with excellent hemodynamics and a very low risk of thrombotic events.