Durability of the pericardial valve

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Engineering

Background:

• Pericardial xenograft valves are utilized in cardiac valve replacement surgery.
• Assessing the long-term performance and durability of these devices is crucial for patient outcomes.
• Two distinct types of pericardial valves were evaluated: 'hospital made' and Shiley Inc. manufactured valves.

Purpose of the Study:

• To analyze the long-term fate and performance of 1001 pericardial xenograft valves.
• To compare the durability and failure rates between 'hospital made' and Shiley pericardial valves.
• To evaluate the risk of valve dysfunction and freedom from valve failure over a 13-year follow-up period.

Main Methods:

• Retrospective analysis of 1001 pericardial xenograft valve implantations.
• Follow-up period extended up to 13 years post-operation.
• Valve dysfunction and failure rates were documented and actuarial analysis was performed.

Main Results:

• The linearised rate of valve dysfunction was 0.31% per annum for Shiley valves versus 1.27% per annum for 'hospital made' valves.
• Actuarial freedom from valve failure at 8 years was 94.0% (aortic) and 98.8% (mitral) for Shiley valves.
• Actuarial freedom from valve failure at 12 years was 86.7% (aortic) and 84.7% (mitral) for 'hospital made' valves.

Conclusions:

• Pericardial xenograft valves exhibit a low risk of failure and predictable performance over 13 years.
• Shiley manufactured pericardial valves demonstrated significantly improved durability compared to 'hospital made' valves.
• These findings support the use of pericardial xenografts, particularly Shiley valves, in cardiac valve replacement.