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

Eur J Cardiothorac Surg. 1993;7(2):84-90. doi: 10.1016/1010-7940(93)90186-f.

Abstract

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.

MeSH terms

  • Aortic Valve
  • Austria / epidemiology
  • Female
  • Follow-Up Studies
  • Heart Valve Diseases / mortality
  • Heart Valve Diseases / surgery*
  • Heart Valve Prosthesis / methods*
  • Heart Valve Prosthesis / mortality
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve
  • Prospective Studies
  • Prosthesis Failure
  • Survival Rate