Six-year experience with the St. Jude Medical prosthesis: early and late results of 540 valves in 462 patients.

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From July 1978 to June 1984, 540 St. Jude Medical valve prostheses were implanted in 462 adult patients. Overall operative mortality was 4.8% (22/462): 5.7% after aortic valve replacement (AVR) (8/140); 3.3% after mitral valve replacement (MVR) (8/244); and 7.7% after aortic and mitral valve replacement (DVR) (6/78). There were 16 late deaths among 440 operative survivors; six (38%) were valve related. The actuarial survival rate at six years was 94.5% in AVR and 93.5% in MVR. At five years it was 91.6% in DVR. The freedom from valve-related death at six years after AVR, MVR and at five years after DVR was 97.8%, 98.6% and 95.8%, respectively. The incidence of valve-related complications (expressed as %/patient-year (number of events] was as follows: thrombo-embolism (AVR 0.7 (2), MVR 2.0 (13), DVR 2.8 (5], valve thrombosis (AVR 0.3 (1), MVR 0.2 (1), DVR 0 (0], prosthetic valve endocarditis (AVR 0.3 (1), MVR or DVR 0 (0]. There were no cases of primary structural failure, serious anticoagulant-related hemorrhage or clinical event of hemolysis. The incidence of all valve-related complications in AVR, MVR and DVR was 1.3, 2.2 and 2.8%/pt-yr, respectively. The freedom from thrombo-embolism at six years after AVR and MVR and at five years after DVR were 91.4%, 92.4% and 88.7%, respectively. Re-operation was performed in only one patient with MVR because of valve thrombosis (0.2%/pt-yr after MVR, overall 0.1%/pt-yr). These results indicate that St. Jude Medical prosthesis has provided a satisfactory performance with acceptable risks of late complications in patients who were properly anticoagulated during six-year follow-up period.