Long term clinical and haemodynamic evaluation of the Ionescu-Shiley pericardial xenograft heart valve

Abstract

The experience with the Ionescu-Shiley pericardial xenograft used for heart valve replacement over a period of 7 years has demonstrated, in both the aortic and atrioventricular position, excellent long term clinical and haemodynamic results. There were very few valve related complications and none occurred with valves manufactured since May 1976 by Shiley Laboratories. The long term durability of the glutaraldehyde stabilised pericardial xenografts was demonstrated by a rigorous and complete clinical follow-up as well as by histological and haemodynamic investigations. Valve thrombosis or calcification have not been encountered in this series. The embolic rate has been very low in both the aortic and mitral positions in the absence of long term anticoagulant treatment. The superior haemodynamic performance of this valve, even in very small sizes, represents an additional advantage and makes it particularly suitable for use in patients with narrow aortic root and in children. The very good results obtained with the pericardial xenograft fully justify its continued clinical use in the aortic, mitral and tricuspid positions.