Limited long-term durability of the Cryolife O'Brien stentless porcine xenograft valve

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Durability

Background:

• Early and midterm outcomes of the Cryolife O'Brien (CLOB) stentless valve are favorable.
• Long-term durability and clinical outcomes of the CLOB valve are not well-established.

Purpose of the Study:

• To analyze the 10-year outcomes of aortic valve replacement using the CLOB valve.
• To assess the long-term durability and clinical performance of the CLOB valve.

Main Methods:

• Retrospective analysis of 185 patients undergoing aortic valve replacement with the CLOB valve (1994-2004).
• 100% complete follow-up to assess actuarial survival, freedom from structural valve deterioration, and freedom from reoperation.
• Patient demographics included a high prevalence of elderly females with small aortic roots.

Main Results:

• Actuarial survival at 10 years was 40%.
• Freedom from structural valve deterioration dropped significantly to 44% at 10 years.
• Freedom from reoperation declined to 57% at 10 years, with a notable increase in hazard after 8 years.

Conclusions:

• The CLOB valve demonstrated satisfactory clinical results up to 8 years in a high-risk population.
• A significant increase in structural valve deterioration and reoperation occurred in the late follow-up period (after 8 years).
• Long-term durability of the CLOB valve is limited, particularly in elderly patients with small aortic roots.