Implantation of the Duromedics bileaflet cardiac valve prosthesis in 400 patients.

From September, 1983, to April, 1986, 451 Duromedics bileaflet cardiac valve prostheses were implanted in 400 patients at our institution in Vienna. Aortic valve replacement was done in 190 patients, 157 underwent mitral valve replacement (1 patient also underwent tricuspid valve replacement), 52 underwent double valve replacement, and 1 patient underwent isolated reoperation for tricuspid valve replacement. Concomitant procedures were performed in 86 patients (21.5%). Sixty-one patients (15.2%) had undergone previous cardiac surgery; 32 (8%) had undergone earlier valve replacement. The early mortality rate (within 30 days) was 6.25% (25 patients). Follow-up was done on 337 surviving Austrian citizens; this represents 429 patient-years. The late mortality rate was 2.1% per patient-year (9 patients). We observed paravalvular leak in 3 patients (0.7% per patient-year), thromboembolism in 4 (0.9%), prosthetic valve endocarditis in 5 (1.2%), and anticoagulant-related hemorrhage in 10 (2.3%). Valve failure occurred in 8 patients (1.8%). We conclude, therefore, that good clinical results and a low complication rate can be achieved with this new type of valve.