Six-year follow-up after heart valve replacement with the Edwards Duromedics bileaflet prosthesis

The Duromedics Edwards valve (DE) was designed with a self-irrigating hinge mechanism to reduce the rate of thromboembolic complications. This report presents a prospective follow-up of patients after valve replacement with this prosthesis in a university hospital. Five hundred seven patients had DE prostheses implanted in the aortic (n = 268), mitral (n = 183) or aortic and mitral positions (n = 56). The perioperative mortality was 6.9%. Follow-up was 98% complete, comprising 2009 patient years for a mean follow-up of 48 months: (range 27-84). The actuarial freedom from complications is calculated as follows (linearized rates in parentheses): late mortality 81.0 +/- 2.3% (3.4%/patient year), thromboembolism 93.5 +/- 1.5% (1.1%/patient year), anticoagulation-related hemorrhage 89.5 +/- 2.0% (1.9%/patient year), prosthetic valve endocarditis 96.0 +/- 1.2% (0.7%/patient year), valve-related mortality 93 +/- 1.8% (1.5%/patient year), valve failure 89 +/- 2.0% (2%/patient year), treatment failure 88.0 +/- 2.0% (2.2%/patient year) and all valve-related morbidity and mortality 74.0 +/- 2.8% (5.3%/patient year). Two events of leaflet escape were observed in the study group (0.09%/patient year). Both patients were reoperated successfully. Mechanical hemolysis was subclinical in all cases. The DE shows a complication rate comparable to other modern mechanical valve prostheses. After solving the problem of durability, reconsideration of this valve is worthwhile due to its low risk of thromboembolic complications.