St. Jude medical valve prosthesis: An analysis of long-term outcome and prognostic factors

Abstract

Between 1979 and 1984, 321 patients received 354 St. Jude Medical prostheses (194 aortic, 94 mitral, 1 tricuspid, and 32 multiple valve replacements). Follow-up was 96% complete (2967 patient-years; mean 9.5 years per patient). Actuarial event-free rates at 10 years and linearized rates (in parentheses) of late complications were as follows: embolism, 85.0% +/- 2.3% (2.3% per patient-year); anticoagulant-related hemorrhage, 74.8% +/- 2.7% (3.3% per patient-year); cerebrovascular accident, 81.8% +/- 2.5% (2.6% per patient-year); prosthesis thrombosis, 98.5% +/- 0.7% (0.1% per patient-year); endocarditis, 97.2% +/- 1.1% (0.4% per patient-year); prosthesis dysfunction, 97.1% +/- 1.0% (0.4% per patient-year); hemolytic anemia, 98.5% +/- 0.7% (0.1% per patient-year); reoperation, 97.4% +/- 1.0% (0.4% per patient-year); overall mortality, 63.3% +/- 2.7% (4.2% per patient-year); and valve-related death (including sudden death), 84.7% +/- 2.2% (1.4% per patient-year). Independent preoperative risk factors were as follows: (1) for embolism, cardiac failure as indication for operation and history of prior systemic embolism; (2) for cerebrovascular accidents, the same two factors and age; (3) for endocarditis, diabetes, chronic alcoholism, and aortic valve replacement; (4) for overall mortality, age, ejection fraction (or cardiac index or cardiothoracic index), chronic alcoholism, and history of systemic embolism; and (5) for valve-related death, chronic alcoholism, degenerative cause of valve disease, and prosthetic diameter 23 mm or smaller. Ninety percent of survivors were in New York Heart Association functional class I or II at the end of follow-up. In conclusion, this study confirms the excellent durability of the St. Jude Medical valve and the remarkable functional benefit for the majority of the patients. However, prosthesis-related complications are still common, particularly for small-diameter prostheses. Outcome is strongly related to the patient's preoperative cardiac condition and to the adequacy of anticoagulation control.

Twenty-Year Outcome of Aortic Valve Replacement With St. Jude Medical Mechanical Valves in Japanese Patients

“…22 The incidence of thromboembolic events after AVR with mechanical valves ranges from 0.5% to 3.5% per patient-year according to the previous reports. 23 The present result (1.1% per patient-year) is consistent with or even lower than these other studies. For the last 2 decades, it has been standard practice in Japan to maintain INR slightly lower than that in the Western countries.…”

Low-Intensity International Normalized Ratio (INR) Oral Anticoagulant Therapy in Chinese Patients with Mechanical Heart Valve Prostheses

“…It should be mentioned, however, that the incidence of hemorrhages related to anticoagulant therapy is clearly diminished (0.72%/p-ty) and is 7-fold lower than the average national rate (0.8-9.2%/p-ty) [17]. The incidence of total (i.e., combined thromboembolism and hemorrhage) complications was 2.0%/p-ty, which is lower by approximately onefold than the one reported internationally (3.5%/p-ty) [18].…”

Valve prosthesis-patient mismatch: hemodynamic, echocardiographic and clinical consequences

“…This variable has been suggested to be associated with increased mortality following AVR. The use of a small size St. Jude Medical Regent mechanical valve [13,14] has been proposed in patients with small annulus when aortic enlargement is not attempted. Its modified outer profile, along with a larger inside lumen area of the prosthesis, should improve hemodynamic by increasing the EOA of the valve.…”