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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.

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The fate of 1001 pericardial xenograft valves was analysed during a maximum follow-up period of 13 years. Two basic types of pericardial valves have been implanted. Between 1971 and 1975, 213 patients received 'hospital made' valves (single replacement). Between 1976 and 1983, 601 patients received 788 pericardial valves manufactured by Shiley Inc. (474 Standard and 314 Low profile valves) for both single and multiple replacement. There were 27 instances of valve dysfunction between 13 and 92 months after operation, 20 with 'hospital made' and 7 with Shiley valves. The actuarial freedom from valve failure at 8 years is 94.0 +/- 4.6% for aortic and 98.8 +/- 1.2% for mitral replacement in patients with Shiley valves. In patients with 'hospital made' valves the actuarial freedom from valve failure at 12 years of follow-up is 86.7 +/- 7.6% for aortic and 84.7 +/- 14.1% for mitral replacement. The linearised rate of valve dysfunction was 0.31% per annum for Shiley valves and 1.27% per annum for 'hospital made' valves. This analysis demonstrates that the pericardial xenograft has a low risk of valve failure and a predictable behaviour over a period of 13 years. The Shiley made valves have shown improved durability when compared with the 'hospital made' valves.

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