Preclinical assessment of a trileaflet mechanical valve in the mitral position in a calf model. Academic Article uri icon


  • BACKGROUND: The bileaflet valve is currently the mechanical replacement valve of choice. Though durable, it does not closely mimic native valve hemodynamics and remains potentially thrombogenic. METHODS: Prototype trileaflet valves (T1 and T2) were implanted in the mitral position in calves. Group I calves received either a T1 valve (n = 12) or a control bileaflet valve (n = 5); Group II, either a T2 valve (n = 7) or a control bileaflet valve (n = 5). Valve function, perivalvular leakage, and transvalvular pressure gradients were evaluated. Also, long-term prototype leaflet wear was evaluated in vivo in one Group I calf (502 days) and two Group II calves (385 and 366 days). Calves were euthanized and necropsied at study termination, and major organs weighed and examined. RESULTS: Valve function was excellent and hematologic parameters remained normal in all calves that survived to study termination. Mean peak transvalvular pressure gradients were 10 +/- 7 mm Hg for T1 valves, 6 +/- 3 mm Hg for T2 valves, and 12 +/- 4 mm Hg for bileaflet control valves. Clinically insignificant valvular regurgitation was observed in both prototypes. Explanted valves showed no thrombus-impaired leaflet motion, except in two T1-fitted calves and one T2-fitted calf. Major organs showed no evidence of clinically significant thromboembolic events. There were no other significant differences between the results of experimental and control groups. CONCLUSIONS: Prototype trileaflet valves performed safely and effectively in the mitral position in calves, even without long-term anticoagulation. This warrants their evaluation as an equivalent alternative to bileaflet valves.

published proceedings

  • Ann Thorac Surg

author list (cited authors)

  • Gregoric, I., Conger, J. L., Reul, H., Tamez, D., Clubb, F. J., Stainback, R. F., ... Frazier, O. H.

citation count

  • 11

complete list of authors

  • Gregoric, Igor||Conger, Jeff L||Reul, Helmut||Tamez, Daniel||Clubb, Fred J||Stainback, Raymond F||Hernandez, Antonieta||Cervera, Roberto||Eya, Kazuhiro||Byler, Denise||Kadipasaoglu, Kamuran A||Frazier, OH

publication date

  • January 2004