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Published on: February 28, 2012
The St. Jude valve prosthesis: analysis of the clinical results in 815 implants and the need for systemic
M L Myers1, G M Lawrie, E S Crawford
1Cora and Webb Mading Department of Surgery, Baylor College of Medicine, Houston, Texas 77030.
Insights
St. Jude Medical valve prostheses showed excellent results. Long-term warfarin anticoagulation is essential to prevent thromboembolic complications, as antiplatelet agents alone were insufficient.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
Background:
- Mechanical heart valves are crucial for treating valvular heart disease.
- The St. Jude Medical valve prosthesis is a widely used option.
Purpose of the Study:
- To evaluate the long-term clinical outcomes of St. Jude Medical valve prostheses.
- To assess valve-related complications and the efficacy of anticoagulation strategies.
Main Methods:
- Retrospective analysis of 785 patients who received 815 St. Jude Medical valve prostheses between 1979 and 1984.
- Follow-up data collected to assess mortality, thromboembolism, hemorrhage, and reoperation rates.
- Comparison of thromboembolic event rates across different anticoagulation therapies (warfarin, antiplatelet, none).
Main Results:
- Excellent 3-year freedom from valve-related death or reoperation: 96.4% (aortic) and 98.3% (mitral).
- Valve-related mortality included thromboembolism (7), hemorrhage (3), and perivalvular leak (2).
- Thromboembolism rates: 2.6%/patient-year (warfarin), 9.2%/patient-year (antiplatelet), 15.6%/patient-year (none).
Conclusions:
- St. Jude Medical valve replacement offers excellent clinical results.
- Long-term warfarin anticoagulation is necessary to minimize thromboembolic risks.
- Antiplatelet therapy alone is inadequate for preventing thromboembolic complications with this prosthesis.
Abstract:
Between July 1979 and December 1984, 785 patients received 815 St. Jude Medical valve prostheses. Valve-related mortality in the follow-up period was due to thromboembolism in seven cases, anticoagulant-related hemorrhage in three and perivalvular leak in two. Freedom from valve-related death or reoperation at 3 years was 96.4% for aortic valve replacement and 98.3% for mitral valve replacement. The overall rate of thromboembolism was 2.6%/patient-year with warfarin, 9.2%/patient-year with antiplatelet medication and 15.6%/patient-year in patients with no anticoagulant therapy. One episode of thrombotic obstruction of a mitral valve, in a patient receiving no anticoagulant therapy, resulted in an occurrence rate of such obstruction of 0.22%/patient-year. Valve replacement with the St. Jude valve produced excellent clinical results, but long-term anticoagulation with warfarin was required to minimize thromboembolic complications. The use of antiplatelet agents alone provided inadequate protection.
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