Two years' experience with the duromedics bileaflet heart valve prosthesis

The new Duromedics Bileaflet Cardiac Valve prosthesis has a special moving hinge mechanism for its two leaflets to wash the critical articulation area and thus reduce thrombus formation. Between October 1983 and June 1985, we implanted 278 of these prostheses in 254 patients. We did 114 aortic valve replacements, 109 mitral valve replacements, 34 double valve replacements, and two tricuspid valve replacements. Nearly 20% of the patients had had previous cardiac procedures. The hospital mortality was 5.9%. Follow-up was started with 214 surviving Austrian patients, and up to the present time, we have a follow-up period of 1704 patient months. Five patients died late after the operation (3.5 per 100 patient years). We observed 10 valve-related complications in nine patients (7 per 100 patient years). There were three cases of prosthetic endocarditis (2.1 per 100 patient years), two paravalvular leaks, and four bleeding episodes (2.8 per 100 patient years). The mechanical hemolysis was minimal, and the postoperative hemoglobin value averaged 15 g%. The LDH increased from 230 IU to 307 in the aortic valve replacements, 406 in the mitral valve replacements, and 435 in the double valve replacements. Intraoperative pressure gradients and postoperative Doppler echocardiography showed good hemodynamic performance. We conclude that good clinical results and a low complication rate can be achieved with the Duromedics Valve.