Heart Valve Replacement with the St. Jude Medical® Valve Prosthesis: Long-Term Experience in 743 Patients Receiving Valve Implants in Switzerland
From November 1978 to June 1986, 743 patients received 828 ST. JUDE MEDICAL® valves (SJM) at the University Clinics of Basel, Berne, and Lausanne, Switzerland. There were 445 men and 298 women, with a mean age of 57 years (range 1–83 years), who were followed for a mean of 2.6 years (22,768 patient-months). Aortic valve replacement (AVR) was performed in 456 patients, mitral valve replacement (MVR) in 200 patients, tricuspid valve replacement (TVR) in 6 patients, double valve replacement in 77 patients, and triple valve replacement in 4 patients. In 187 patients, additional surgical interventions were performed. Operative mortality for the entire population was 1.6% and the 4-week perioperative mortality was 4.0%. During the mean follow-up period of 2.6 years, an additional 58 patients died, accounting for an annual mortality rate of 3.1%. Eighteen of these patients died of noncardiac causes, leaving an annual cardiac mortality rate of 2.1%. The thromboembolic rate was 1.25% per patient-year after AVR, 3.0% per patient-year after MVR, and 1.1% per patient-year after MuVR. In 8 of 32 patients (25%) with thromboembolic complications, symptoms were irreversible and in 14 of 32 patients (44%), the prothrombin time was not within therapeutic range. The incidence of major bleeding complications was 1.3% per patient-year.