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CarboMedics mechanical prosthesis: performance at eight years.

W R Jamieson1, G J Fradet, R T Miyagishima

  • 1St. Paul's Hospital, Vancouver, BC, Canada.

The Journal of Heart Valve Disease
|October 21, 2000
PubMed
Summary

The CarboMedics mechanical prosthesis demonstrates satisfactory clinical performance in aortic, mitral, and multiple valve replacements. This study evaluated its long-term outcomes, including thromboembolism and hemorrhage rates, confirming its reliability.

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Area of Science:

  • Cardiovascular Surgery
  • Biomaterials Science
  • Clinical Outcomes Research

Background:

  • The bileaflet St. Jude Medical mechanical prosthesis has a long clinical history.
  • The CarboMedics (CM) mechanical prosthesis was introduced in 1986 as an alternative option.

Purpose of the Study:

  • To evaluate the clinical performance and long-term outcomes of the bileaflet CarboMedics mechanical prosthesis.
  • Assess safety and efficacy across different valve positions (aortic, mitral, multiple).

Main Methods:

  • A cohort of 1,258 patients received the CM prosthesis between 1989 and 1997.
  • Follow-up data collected over 4,765 patient-years, with 98.4% completeness.
  • Analysis included early and late mortality, thromboembolism, hemorrhage, and reoperation rates.

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Main Results:

  • Early mortality was 5.6%; late mortality was 3.7%/pt-yr, with valve-related mortality at 1.1%/pt-yr.
  • Thromboembolism (TE) rate was 4.1%/pt-yr (major TE 1.9%/pt-yr); hemorrhage rate was 2.7%/pt-yr.
  • Eight-year actuarial freedom from TE was 77.3%, major TE 88.5%, and hemorrhage 76.4%. Reoperation freedom was 91.1%.

Conclusions:

  • The CarboMedics mechanical prosthesis exhibits satisfactory clinical performance.
  • The prosthesis is suitable for implantation in aortic, mitral, and multiple valve positions.
  • Long-term outcomes support its use in cardiac valve replacement surgery.