[The Mitroflow bioprosthesis. Results after 6 years]

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Engineering

Context:

• The study evaluates the clinical performance of the Mitroflow pericardial heart valve.
• 139 valves were implanted in 129 patients between March 1982 and December 1986.
• Patient demographics included a mean age of 55.2 years, with 69 males and 60 females.

Purpose:

• To assess the medium-term clinical performance and durability of the Mitroflow pericardial heart valve.
• To report on outcomes including mortality, thromboembolism, tissue failure, and reoperation rates.
• To identify any specific complications associated with the valve's use.

Summary:

• Overall hospital mortality was 1.6%, with 3 late deaths (2.4%).
• The linearized incidence of late mortality was 0.49% per patient/year, with 96% +/- 1.8 actuarial survival.
• Thromboembolism incidence was 1.22% per patient/year (93% +/- 2.7 freedom rate).
• Three patients experienced primary tissue failure in the mitral position (0.73% linearized incidence, 95% +/- 3.2 freedom rate).
• Four patients required reoperation (0.49% per patient/year).

Impact:

• The Mitroflow pericardial heart valve demonstrates satisfactory medium-term clinical performance.
• A significant rate of early primary tissue failure was observed specifically in the mitral position.
• Findings highlight the need for continued monitoring and potential design improvements for mitral valve applications.