Quality of Life after Valve Replacement with the St. Jude Medical Bioimplant™ Heart Valve: A Four-Year Study

Abstract

We restricted the use of the St. Jude Medical, Inc. BIOIMPLANT™ heart valve to patients in an underdeveloped population group where anticoagulation was not possible and infernales anticipating childbearing. Between 1983 and 1986, 158 patients received 180 valves. All patients received at least 1 BIOIMPLANT valve; 17 patients also received ST. JUDE MEDICAL® mechanical valves. Seven MEDTRONIC HALL™ valves were implanted in the aortic position. Forty-four patients were male and 114 were female. Mean age was 31 years. The majority of patients were in New York Heart Association (NYHA) Class III or IV. All patients received dipyridamole and aspirin, but not warfarin. The overall perioperative mortality was 5% (8 of 158 patients). Fifteen of the 158 patients could not be contacted, giving a follow-up of 90%. The longest follow-up was 4 years; the minimum was 4 months. One hundred thirty-five patients were followed for a total of 3050 months, with a mean follow-up period of 21 months. Good hemodynamic function and improved quality of life were demonstrated by the low operative mortality (5%), a generally uncomplicated postoperative course, and dramatic improvement in Functional Class. Most patients achieved an improvement of 2 or 3 NYHA Classes. In addition, since these patients did not receive anticoagulants, they were not subject to hemorrhagic complications. There were no late deaths, but 1 mitral valve prosthesis had to be replaced 23 months after insertion, due to diffuse calcification of the valve. The thromboembolic rate was 1.3% per patient-year (3 patients). In summary, although a favorable and encouraging initial experience has been documented, longer term follow-up studies will be required, especially to determine whether the low early failure rate will accelerate.