Long-term experience with the St. Jude Medical valve prosthesis.

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Prosthetic Devices

Background:

• Prospective follow-up of patients receiving St. Jude Medical valve replacements since 1979.
• Study conducted at the Medical University of South Carolina.

Purpose of the Study:

• To evaluate the long-term performance of the St. Jude Medical valve prosthesis.
• To assess valve-related complications and survival rates in adult patients undergoing aortic and mitral valve replacements.

Main Methods:

• Analysis of data from 710 adult patients (418 aortic valve replacements - AVR, 292 mitral valve replacements - MVR) between January 1979 and December 1996.
• Prospective follow-up with a median duration of 5.7 years for AVR and 6.4 years for MVR.
• Evaluation of survival, thromboembolic events, bleeding complications, and functional class improvement (New York Heart Association - NYHA).

Main Results:

• Thirty-day operative mortality was 5.3% for AVR and 5.1% for MVR.
• Actuarial survival at 15 years was 36.8% for AVR and 49.3% for MVR.
• Rates of thromboembolic events and anticoagulant-related bleeding were reported per patient-year for both AVR and MVR groups.
• Significant improvement in NYHA functional class observed post-operatively for both AVR and MVR patients.
• No mechanical failures of the prosthesis were reported in either group.

Conclusions:

• The St. Jude Medical valve is a reliable mechanical prosthesis.
• Low and stable rates of valve-related complications are demonstrated.
• Long-term follow-up up to 17 years supports the prosthesis's durability and effectiveness.