Mitral valve replacement with the Hancock stabilized glutaraldehyde valve. Clinical and laboratory evaluation

From March 1971 through April 1975, one hundred twenty patients underwent mitral valve replacement with a Hancock "stabilized glutaraldehyde process" porcine aortic xenograft. A simultaneous canine experimental series was also carried out. In the clinical series, the early mortality was 8.3%. Actuarial analyses of all patients predicts survival at two years of 81.0% and at four years of 70.0%. The predicted survival for patients without coronary disease or prior prosthetic valve replacement is 87.5% at two years and 77.5% at four years. There were four thromboembolic episodes, a rate of 2.4% per patient-year. None were fatal. No valve failure were noted. Histologic examination and shrink temperature analysis of recovered valves show excellent tissue preservation at 40 months. The data indicate that the Hancock valve is durable, enjoys a low incidence of thromboembolism, and may be the valve of choice for mitral valve replacement.