Objective: A new tri-leaflet mechanical heart valve made of titanium was inserted in the mitral position to evaluate early results.
Methods and results: Five sheep were followed between 3 and 6 months (mean 4.7 months) and performed very well clinically during the follow-up period. In three of five animals a minor para-valvular leakage without hemodynamic importance was observed. The invasive pressure measurements at the end of follow-up revealed only minor transvalvular pressure differences between 1 and 4 mmHg (mean 2.4 mmHg). Similar results were obtained by echo-Doppler technique. Histological examination of the tissue around the valve showed no signs of foreign body reaction or chronic inflammatory reaction.
Conclusion: This new tri-leaflet heart valve has shown an excellent hemodynamic performance and good tissue compatibility, and therefore may be an alternative to other currently used valve prostheses.