Preclinical assessment of a trileaflet mechanical valve in the mitral position in a calf model.

Autor: Gregoric, Igor, Conger, Jeff L., Reul, Helmut, Tamez, Daniel, Clubb Jr, Fred J., Stainback, Raymond F., Hernandez, Antonieta, Cervera, Roberto, Eya, Kazuhiro, Byler, Denise, Kadipasaoglu, Kamuran A., Frazier, O. H.
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Zdroj: Annals of Thoracic Surgery; Jan2004, Vol. 77 Issue 1, p196, 7p
Abstrakt: : BackgroundThe bileaflet valve is currently the mechanical replacement valve of choice. Though durable, it does not closely mimic native valve hemodynamics and remains potentially thrombogenic.: MethodsPrototype 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.: ResultsValve 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.: ConclusionsPrototype 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. [Copyright &y& Elsevier]
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