The Duromedics Edwards (DE) bileaflet valve prosthesis was withdrawn from the market after 12 leaflet escapes had been reported in 20,000 implants. Effort is necessary to identify the failure mode to improve valve design or production, but the rate of other valve related complications will tell if it is worthwhile reintroducing this prosthesis. Five-hundred and sixty-four DE valves have been implanted in 508 patients between September 1983 and May 1988. Two-hundred and sixty-eight had aortic valve replacement (AVR), 183 mitral valve replacement (MVR) and 56 double valve replacement (DVR); the perioperative mortality was 6.9%. Follow-up has been 98.7% complete for a total of 1064 patient years and a mean follow-up of 26 months (range 3 to 54 months). Late mortality was 3.7%/yr and actuarial survival was 85 +/- 3% without and 78 +/- 3% including operative mortality after 54 months. Event free actuarial rates (linearized rates in parenthesis) were 93 +/- 2% (1.5%/yr) for thromboembolism, 91.7 +/- 1.9% (2.3%/yr) for anticoagulant related hemorrhage, 89 +/- 4.8% (2.3%/yr) for valve failure, 93 +/- 2% (1.8%/yr) for valve related mortality, 72 +/- 4.8% (6.3%/yr) for all valve related morbidity and mortality and 83 +/- 4.4% (3%/yr) for treatment failure. Two leaflet escapes occurred in the study group (0.18%/yr), both patients survived reoperation. The concept of reducing thrombus formation by a specially designed irrigating hinge mechanism was proven by a low rate of thromboembolism in our clinical follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)