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Ten-year results with the St. Jude Medical prosthesis
C K Nair1, S M Mohiuddin, D E Hilleman
1Division of Cardiology, Creighton University School of Medicine, Omaha, Nebraska 68131.
Insights
The St. Jude valve prosthesis demonstrates safety and reliability with modest anticoagulation. Patients receiving St. Jude valves without anticoagulants face high thromboembolic event rates, even with antiplatelet therapy.
Area of Science:
- Cardiology
- Cardiovascular Surgery
- Biomaterials Science
Background:
- The St. Jude valve prosthesis is widely used, but optimal anticoagulation strategies remain debated.
- Previous reports focused on hemodynamic characteristics and durability, not definitive anticoagulation needs.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of the St. Jude valve prosthesis.
- To assess the impact of anticoagulation regimens on clinical outcomes.
Main Methods:
- A 10-year retrospective study of 165 patients undergoing valve replacement with St. Jude prostheses.
- Analysis of anticoagulation (warfarin) intensity, antiplatelet therapy use, and clinical events (thromboembolism, hemorrhage, valve failure, survival).
Main Results:
- 10-year event-free incidence for thromboembolism was 84% and for hemorrhage was 95% with modest anticoagulation.
- Patients on antiplatelet therapy alone or no anticoagulation had significantly higher thromboembolic event rates.
- 10-year actuarial event-free incidence from valve failure was 95%, with 55% patient survival.
Conclusions:
- The St. Jude valve prosthesis is safe and reliable with a modest anticoagulation regimen.
- Anticoagulation is crucial for St. Jude valve recipients to minimize thromboembolic complications.
- Absence of anticoagulation, even with antiplatelet agents, leads to a high incidence of thromboembolic events.
Abstract:
Although the hemodynamic characteristics and durability of the St. Jude valve prosthesis have been reported, the need for and the degree of anticoagulation in patients who receive these valves remain uncertain. Our 10-year experience with 165 patients (100 men and 65 women, mean age of 58 +/- 13 years), who underwent valve replacement with St. Jude prostheses, is reported. Of the 165 patients, 147 were treated with warfarin. A prothrombin time 1.3 to 1.8 times control (range 15 to 20 seconds) was maintained in 134 patients with single valve and 1.8 to 2 times control (range 20 to 25 seconds) in 13 patients with double valve prostheses. The 10-year actuarial event-free incidence from thromboembolic and hemorrhagic complications was 84 and 95%, respectively. Of the 8 patients receiving antiplatelet therapy alone, 4 had thromboembolic events. Of the 10 patients on neither warfarin nor antiplatelet therapy, 3 had thromboembolic events. The 10-year actuarial event-free incidence from valve failure was 95%. The 10-year actuarial patient survival was 55%. Thus, the St. Jude valve is a safe and reliable prosthesis with acceptable overall long-term performance in patients given a modest anticoagulation regimen. Patients who receive St. Jude prosthetic valves without anticoagulants have a high incidence of thromboembolic events despite therapy with antiplatelet agents.