Blood compatibility of a newly developed trileaflet mechanical heart valve.

ABSTRACT

An ideal heart valve prosthesis, which has both the flow dynamic properties and blood compatibility of a tissue valve prosthesis and the durability of a mechanical prosthesis, does not exist. The Triflo trileaflet mechanical heart valve (MHV; Triflo Medical Inc., Irvine, CA) is a newly developed MHV prosthesis with the following design goals central flow, minimal flow disturbance and stasis around the hinge region, and durability. The current study was conducted to evaluate the blood compatibility of a 29 mm Triflo MHV in the mitral position of eight calves for 5 months without any postoperative anticoagulation. Whole blood platelet aggregometry and the Xylum Clot Signature Analyzer (Xylum Corporation, Scarsdale, NY) were used to evaluate the postoperative changes in platelet and coagulation functions. Full autopsies, histological examinations of major internal organs, and scanning electron microscopy analyses of the explants were performed. Early termination occurred in two cases; one was because of valve thrombosis on the 25th day, and the other was killed because of a nonvalvular complication on the 105th day. The valve thrombosis was attributed to prolonged ventricular fibrillation at the time of valve replacement surgery. Whole blood platelet aggregometry and clot signature analyzer parameters did not show any sign of activation of platelets or the coagulation system. No hemolysis was observed. There was no macroscopic valve thrombosis or embolism observed in the remaining seven cases. Scanning electron microscopy analyses showed clean leaflet and valve ring surfaces, with only occasional minute platelet aggregations. Excellent blood compatibility of the Triflo MHV was demonstrated in this study.