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Published on: October 17, 2013
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Structural valve deterioration in the Mitroflow biological heart valve prosthesis
Issa Farah Issa1, Steen Hvitfeldt Poulsen2, Farhad Waziri2
1Department of Cardiology and OPEN-Odense Patient Data Explorative Network, Odense University Hospital, Odense, Denmark.
Summary
The Mitroflow bioprosthesis shows a high risk of structural valve degeneration (SVD), particularly in smaller and older valves. Undetected SVD incidence equals operated SVD incidence, highlighting durability concerns.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Cardiology
Background:
- Concerns exist regarding the long-term durability of the Mitroflow biological heart valve prosthesis.
- Structural valve degeneration (SVD) is a primary cause of bioprosthetic valve failure.
Purpose of the Study:
- To assess the incidence of SVD for the Mitroflow bioprosthesis in a nationwide Danish study.
- To evaluate the long-term performance and durability of the Mitroflow aortic bioprosthesis.
Main Methods:
- Nationwide cross-sectional study of patients with Mitroflow aortic bioprosthesis implanted since 2000 in Denmark.
- Predefined definition of SVD used for evaluation.
- Competing risk regression analysis with death as the competing event.
Main Results:
- 173 patients diagnosed with SVD (64 severe, 109 moderate).
- Severe SVD associated with prosthesis age and smaller sizes (e.g., Size 19 HR 6.26).
- Cumulative incidence of reoperation or severe SVD at 9 years was 12.5% for Size 19.
Conclusions:
- The incidence of undetected severe SVD is comparable to operated SVD.
- High overall risk for SVD with Mitroflow bioprosthesis, especially for small and older prostheses (>5 years).
- Prosthesis size and age are critical factors influencing SVD risk.
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