Clinical event rates with the On-X bileaflet mechanical heart valve: a multicenter experience with follow-up to 12 years

J Thorac Cardiovasc Surg. 2013 Feb;145(2):420-4. doi: 10.1016/j.jtcvs.2011.12.059. Epub 2012 Feb 17.


Objective: The aim of the study was to establish clinical event rates for the On-X bileaflet mechanical heart valve (On-X Life Technologies Inc, Austin, Tex) using an audit of data from the 3 centers within Europe with the longest history of implanting.

Methods: All patients receiving the On-X valve between March 1, 1998, and June 30, 2009, at 3 European centers were studied. Data were collected using questionnaire and telephone surveys augmented by outpatient visits and examination of clinical records.

Results: There were 691 patients, with a mean age of 60.3 years, who received 761 valves in total: 407 mitral valve replacements, 214 aortic valve replacements, and 70 aortic + mitral valve replacements (dual valve replacement). Total follow-up was 3595 patient-years, with a mean of 5.2 years (range, 0-12.6 years). Early (≤ 30 days) mortality was 5.4% (mitral valve replacement), 0.9% (aortic valve replacement), and 4.3% (dual valve replacement). Linearized late (>30 days) mortality expressed per patient-year was 3.6% (mitral valve replacement), 2.2% (aortic valve replacement), and 4.1% (dual valve replacement), of which valve-related mortality was 0.5% (mitral valve replacement), 0.2% (aortic valve replacement), and 1.8% (dual valve replacement). Late linearized thromboembolism rates were 1.0% (mitral valve replacement), 0.6% (aortic valve replacement), 1.8% (dual valve replacement). Bleeding rates were 1.0% (mitral valve replacement), 0.4% (aortic valve replacement), and 0.9% (dual valve replacement). Thrombosis rates were 0.1% (mitral valve replacement), 0% (aortic valve replacement), and 0.3% (dual valve replacement). Reoperation rates were 0.6% (mitral valve replacement), 0.2% (aortic valve replacement), and 1.2% (dual valve replacement).

Conclusions: The On-X valve has low adverse clinical event rates in longer-term follow-up (mean 5.2 years and maximum 12.6 years).

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Europe
  • Female
  • Heart Valve Diseases / mortality
  • Heart Valve Diseases / surgery*
  • Heart Valve Prosthesis Implantation / adverse effects*
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Humans
  • Linear Models
  • Male
  • Middle Aged
  • Postoperative Complications / etiology*
  • Postoperative Complications / mortality
  • Postoperative Complications / surgery
  • Prosthesis Design
  • Reoperation
  • Retrospective Studies
  • Surveys and Questionnaires
  • Survival Analysis
  • Time Factors
  • Treatment Outcome