Long-term results of heart valve replacement with the Edwards Duromedics bileaflet prosthesis: a prospective ten-year clinical follow-up.

Objective: The Edwards Duromedics valve (Baxter Healthcare Corp., Edwards Division, Santa Ana, Calif.) was designed with a self-irrigating hinge mechanism to reduce thromboembolic complications. After good initial clinical results, distribution was suspended in 1988 after reports of valve fracture after 20,000 valves had been implanted. The manufacturer conducted extensive studies to improve the Edwards Duromedics and reintroduced a modified version, which is available as Edwards Tekna. The purpose of the study was the evaluation of long-term results of the original Edwards Duromedics that might be important for the current version, the Edwards Tekna valve.

Methods: A prospective clinical 10-year follow-up was performed of 508 patients who underwent valve replacement with the Edwards Duromedics valve in the aortic (n = 268), mitral (n = 183), and aortic and mitral (n = 56) position.

Results: The perioperative mortality rate was 6.9%; follow-up was 98% complete, comprising 3648 patient-years for a mean follow-up of 86 months (range: 33 to 144 months). The actuarial freedom from complications at the 10-year follow-up and the incidence rate (percent per patient-year) were as follows: late mortality rate, 69.2% +/- 2.4% (3.5% per patient-year); thromboembolism, 90.7% +/- 1.6% (0.96% per patient-year); anticoagulation-related hemorrhage, 87.7% +/- 1.7% (1.34% per patient-year); prosthetic valve endocarditis, 96.7% +/- 0.09% (0.38% per patient-year); valve-related mortality rate, 89.3% +/- 1.6% (1.21% per patient-year); valve failure, 86.2% +/- 1.85% (1.54% per patient-year); and valve-related morbidity and mortality rate, 71.1% +/- 2.3% (3.2% per patient-year). Three leaflet escapes were observed (one lethal, two successful reoperations; 99.1% +/- 0.05% freedom, 0.08% per patient-year). All patients functionally improved (86% in New York Heart Association classes I and II), and incidence of anemia was insignificant.

Conclusions: These results confirm that the Edwards Duromedics valve shows excellent performance concerning thromboembolism, hemolysis, and functional improvement and will serve as a reference for the last version, the Edwards Tekna valve, where comparable long-term data are currently not available.