LONG-TERM RESULTS OF HEART-VALVE REPLACEMENT WITH THE EDWARDS DUROMEDICS BILEAFLET PROSTHESIS - A PROSPECTIVE 10-YEAR CLINICAL FOLLOW-UP

Objective: The Edwards Duromedics valve (Baxter Healthcare Corp., Edwa rds Division, Santa Ana, Calif.) was designed with a self-irrigating h inge mechanism to reduce thromboembolic complications. After good init ial clinical results, distribution was suspended in 1988 after reports of valve fracture after 20,000 valves had been implanted. The manufac turer conducted extensive studies to improve the Edwards Duromedics an d 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 curren t version, the Edwards Tekna valve. Methods: A prospective clinical 10 -year follow-up was performed of 508 patients who underwent valve repl acement with the Edwards Duromedics valve in the aortic (n = 268), mit ral (n = 183), and aortic and mitral (n = 56) position. Results: The p erioperative mortality rate was 6.9%; follow-up was 98% complete, comp rising 3648 patient-years for a mean follow-up of 86 months (range: 33 to 144 months). The actuarial freedom from complications at the 10-ye ar 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); anticoagula tion-related hemorrhage, 87.7% +/- 1.7% (1.34% per patient-year); pros thetic valve endocarditis, 96.7% +/- 0.09% (0.38% per patient-year); v alve-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-rel ated morbidity and mortality rate, 71.1% +/- 2.3% (3.2% per patient-ye ar). Three leaflet escapes were observed (one lethal, two successful r eoperations; 99.1% +/- 0.05% freedom, 0.08% per patient-year). All pat ients functionally improved (86% in New York Heart Association classes I and II), and incidence of anemia was insignificant, Conclusions: Th ese results confirm that the Edwards Duromedics valve shows excellent performance concerning thromboembolism, hemolysis, and functional impr ovement and will serve as a reference for the last version, the Edward s Tekna valve, where comparable long-term data are currently not avail able.