Considerations in the development of artificial heart valve substitutes for use in infants in small children

Experimental studies carried out in our laboratory suggest that it is possible to develop a family of stent-supported tissue valve substitutes suitable for use in tissue and annuli of the hearts of small children in tissue annulus sizes ranging from 12 to 22 mm. Either glutaraldehyde-preserved, stent-supported primate tissue aortic valves or tissue leaflet valves constructed from dura mater preserved in 98 per cent glycerine can be used. In both instances, hemodynamics assessment of the valve substitutes in a mock circulation indicated that function was acceptable at the cardiac outputs normal for infants and children during the first few years of life. Stent-supported dura mater valves 16 nm. in diameter have been used to replace the mitral valve in 2 infants 7 and 8 months of age with complete atrioventricular canal defects and mitral regurgitation, one of whom survives with demonstratable satisfactory hemodynamic function of the valve substitute.