Pericardial xenograft heart valves have been used in 469 patients for single or multiple valve replacement. Early in the series, valves were made in-house, but since May 1976, valves have been made by Shiley Laboratories, Inc. During the eight-year observation period, there were 7% early and 7.9% late deaths. Although no anti-coagulants were used on a long-term basis, there were only eight mild embolic episodes. Preoperatively, 56--98% of all patients were in class III or IV of the NYHA classification; postoperatively, all surviving patients have been found to have improved by at least one classification.
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.
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