Durability and Low Thrombogenicity of the St. Jude Medical® Heart Valve: Long-Term Follow-Up

Abstract

From November 1978 through December 1986, 1953 patients underwent valve replacement at the Texas Heart Institute with the ST. JUDE MEDICAL® cardiac valve prosthesis. Aortic valve replacement (AVR) was done in 1203 patients, mitral valve replacement (MVR) in 572 patients, and double valve replacement (AVR + MVR) in 178 patients. Of the total patients, 65.1% were men and 34.9% were women. The mean age of patients was 52.8 years (range 1–88 years): 52.2 y ears for patients having AVR, 54.0 years for patients having MVR, and 53.4 years for patients having AVR + MVR. There were 619 associated procedures performed. Eighty-three percent of patients were in New York Heart Association (NYHA) Functional Classes HI or IV preoperatively. Total follow-up was 3106 patient-years with a maximum of 99 months (mean 19 months). The early mortality rate (within 30 days) for the entire series of patients was 7.5%. The early mortality rate was lowest inpatients undergoing isolated procedure. The total early mortality rate for AVR was 5.7%; for MVR, 8.9%; and for AVR + MVR, 14.6%, reflecting the severity of disease inpatients requiring double valve replacement. The 7-year actuarial survival rate was 84.9% for AVR, 81.0% for MVR, and 78.7% for patients who underwent AVR + MVR. Few valve-related complications occurred. There were no instances of structural valve failure. Postoperatively, 98.3% of patients were in NYHA Functional Classes I or II, compared with only 17.1% in these two classes preoperatively. In all respects, the ST. JUDE MEDICAL valve proved superior to other mechanical valves. The valve has good hemodynamic characteristics, has a low incidence of thromboembolism, and is durable. It has a low profile and is easily inserted, even in the small aortic root. We currently favor this valve in all patients unless there is a specific contraindication to long-term anticoagulation.