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Promising early sheep results support human feasibility trials; leaves open long-term durability and clinical outcomes.
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.
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S. et al. (2003) studied this question.
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