Thirty-year experience with a bileaflet mechanical valve prosthesis

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Evaluation

Background:

• The St. Jude Medical mechanical valve prosthesis has been implanted since 1979.
• Evaluating long-term patient outcomes is crucial for understanding device performance.

Purpose of the Study:

• To assess the long-term clinical outcomes of St. Jude Medical mechanical valve prosthesis implantation.
• To determine the durability and complication rates associated with this prosthetic valve over an extended period.

Main Methods:

• A cohort of 1023 patients receiving St. Jude mechanical valves between 1979 and 2014 were followed annually.
• Data collected included operative mortality, late survival, and freedom from reoperation, thromboembolism, valve thrombosis, bleeding, and endocarditis.

Main Results:

• Thirty-year actuarial survival rates were 14% ± 3% for both aortic and mitral valve replacements.
• Thirty-year freedom from reoperation was 92% ± 2% (aortic) and 85% ± 5% (mitral).
• Incidence of bleeding and thromboembolism were reported per patient-year for both valve positions.

Conclusions:

• Annual follow-up facilitated the identification of valve-related issues and events.
• The St. Jude Medical mechanical valve prosthesis demonstrates reliability over three decades of clinical observation.