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.

[Noise origin and noise-induced complaints after heart valve replacement with mechanical prostheses]. / Lärmentwicklung und lärmabhängige Beschwerden nach Herzklappenersatz mit mechanischen Prothesen.

143 patients were investigated in order to determine whether there is a difference in the intensity of the closing click between different mechanical heart valve prostheses. 35 had St. Jude Medical (SJM), 38 Duromedics Edwards (DE), 36 Björk Shiley Monostrut (BSM) and 34 had Carbomedics prostheses implanted. Sound pressure level determined at 1 meter distance was significantly higher for the DE 33.5 +/- 6 dB(A) and BSM 31 +/- 4 dB(A) than for the SJM 24 +/- 4 dB(A) and CM 25 +/- 6 dB(A) prostheses (p = 0.0001). Valves developing higher sound pressures were more frequently audible for the patients (p = 0.0012), caused more sleep disturbances (p = 0.024) and more complaints during daytime (p = 0.07). Significantly more patients carrying such valves wished to have a less noisy valve implanted (0.0047). Symptomatic patients wear louder valves, were younger, had better hearing and were more frequently in sinus rhythm. Valve diameter correlated with the developed sound pressure level. 349 patients answered a questionnaire after valve replacement with DE (256) or BSM (93) prostheses. 5% registered their noise-related complaints as being severe, but more than one third wished to have a less noisy valve implanted. The noise created by the closing click of mechanical prostheses causes significant complaints and this factor should be considered when a mechanical valve is selected.