Late re-operation for aortic and mitral Starr-Edwards ball valve prostheses

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Medical Device Engineering

Background:

• Starr-Edwards ball valves have been used for decades in cardiac valve replacement surgery.
• Long-term explantation studies are crucial for understanding device durability and failure modes.
• Cloth coverings were introduced to improve tissue ingrowth and reduce paravalvular leaks.

Purpose of the Study:

• To investigate the long-term explanted Starr-Edwards ball valves (≥15 years post-implantation).
• To evaluate the macroscopic condition and identify failure mechanisms, particularly cloth wear.
• To correlate explantation findings with clinical indicators of valve dysfunction.

Main Methods:

• Retrospective macroscopic investigation of explanted Starr-Edwards ball valves (≥15 years).
• Analysis of valve models (cloth-covered vs. non-cloth-covered), position (aortic/mitral), and explantation time.
• Correlation of explant findings with patient re-operation data and clinical signs of hemolysis.

Main Results:

• Cloth wear was observed in all explanted cloth-covered valves, irrespective of position, leading to significant hemolysis.
• Non-cloth-covered valves exhibited only mild ball variance.
• Autologous tissue ingrowth was noted on components, but thrombus formation was absent.

Conclusions:

• Cloth wear is the primary long-term complication of Starr-Edwards cloth-covered ball valves.
• Clinical signs like hemolysis and regurgitation indicate cloth wear and necessitate valve replacement.
• Consideration of cloth wear is essential for patients with these valves >15 years post-implantation.