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Related Experiment Videos

Early results with composite strut caged ball prostheses

Q Macmanus, G Grunkemeier, L Housman

    The American Journal of Cardiology
    |October 1, 1980
    PubMed
    Summary

    The Starr-Edwards composite strut valve prosthesis offers a durable alternative for mitral and aortic valve replacement. This design shows favorable thromboembolic performance and low complication rates in patients on anticoagulant therapy.

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    CARDIOVASCULAR SURGERY.

    A listing of research in the cardiovascular field·2014

    Area of Science:

    • Cardiovascular Surgery
    • Biomaterials Science
    • Medical Devices

    Background:

    • Mechanical heart valves are prone to cloth wear and thromboembolism.
    • Previous cloth-covered valves aimed for favorable thromboembolic outcomes but risked wear.
    • The Starr-Edwards composite strut design integrates metallic tracks to mitigate cloth wear while maintaining performance.

    Purpose of the Study:

    • To evaluate the long-term safety and efficacy of the Starr-Edwards model 6400/10 mitral and 2400/10 aortic valve prostheses.
    • To assess thromboembolic events, bleeding complications, survival, and prosthesis durability.
    • To compare the performance of this composite strut design with existing valve prostheses.

    Main Methods:

    • Prospective follow-up study of 200 mitral and 240 aortic valve replacement survivors.

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  • Patients received continuous anticoagulant therapy.
  • Data collected on survival, prosthesis explantation, thromboembolic events, and bleeding complications.

    • Main Results:

    • Mitral valve: 5-year survival 91%, removal-free rate 94%. Embolism rate 4.6%/patient-year, bleeding 1.0%/patient-year.
    • Aortic valve: 5-year survival 84%, removal-free rate 98%. Embolism rate 3.3%/patient-year, bleeding 2.1%/patient-year.
    • Cloth wear and hemolysis were not significant issues; thromboembolic rates are comparable to bioprostheses.

    Conclusions:

    • The Starr-Edwards composite strut valve prosthesis is a durable alternative to tissue valves.
    • It demonstrates acceptable thromboembolic and bleeding complication rates in patients managed with anticoagulant therapy.
    • This design offers a viable option for patients requiring mechanical valve replacement who can tolerate anticoagulation.