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Four years' experience with the Edwards-Tekna bileaflet valve prosthesis
Tanzer Calkavur1, Tahir Yagdi, Anil Apaydin
1Ege University Hospital, Department of Cardiovascular Surgery, Bornova, Izmir, Turkey.
The Journal of Heart Valve Disease
|May 10, 2002
Summary
The Edwards-Tekna mechanical valve shows excellent short-term outcomes, with no structural failures reported. Further long-term studies are needed to confirm the durability of this revised heart valve prosthesis.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Prosthetic Devices
Background:
- The Edwards-Duromedics valve was voluntarily suspended due to leaflet escape issues.
- A modified version, the Edwards-Tekna mechanical valve prosthesis, was introduced in 1990.
Purpose of the Study:
- To evaluate the short-term clinical performance of the revised Edwards-Tekna mechanical valve prosthesis.
- Assess complications and patient outcomes following implantation.
Main Methods:
- 137 patients underwent heart valve replacement with the Edwards-Tekna prosthesis between 1994 and 1998.
- Procedures included isolated mitral, isolated aortic, and double-valve replacements.
- Follow-up data was collected for up to 48 months.
Main Results:
- Early hospital mortality was low at 0.72%.
- Two-year actuarial freedom from major complications (thromboembolism, bleeding, endocarditis, valve-related mortality) was high.
- No structural valve failures, including leaflet escape, were observed.
- Significant improvement in NYHA functional class was noted post-surgery.
Conclusions:
- The Edwards-Tekna mechanical valve prosthesis demonstrates excellent short-term clinical performance.
- The absence of structural valve failure is a positive indicator.
- Long-term data is essential to fully ascertain the durability of the Edwards-Tekna valve.