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Ann Thorac Surg 1995;60:1053-1058
© 1995 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

The CarboMedics Valve: Midterm Follow-up With Analysis of Risk Factors

Department of Cardiothoracic Surgery, Rikshospitalet, University of Oslo, Oslo, Norway

Accepted for publication May 22, 1995.

Background. This study examined the midterm results with the CarboMedics prosthetic valve.

Methods. From 1987 through 1991 a total of 569 patients received the CarboMedics prosthesis.

Results. Early mortality was 4.9% and related to emergency operation, presence of diabetes mellitus, coronary artery disease, preoperative New York Heart Association class, duration of cardiopulmonary bypass, and aortic cross-clamp time. Midterm follow-up with respect to mortality was 100% complete. All patients were followed up in the hospital after 1 year. In addition 86% of the patients responded to a questionnaire. Mean follow-up was 3 years (range, 0 to 5.6 years). Cumulative survival at 1 and 4 years was 91.2% ± 1.2% and 83.7% ± 1.8%, respectively. Five patients experienced obstructive valve thrombosis (0.3%/patient-year), 16 patients had major thromboembolic events (0.9%/patient-year), and 10 patients had major warfarin-related bleeding (0.6%/patient-year) requiring hospitalization or blood transfusions. Eight patients were reoperated on for paraprosthetic leak (0.4%/patient-year). Prosthetic valve endocarditis developed in 4 patients (0.2%/patient-year). No structural valve failure was observed.

Conclusions. Midterm follow-up demonstrates that the CarboMedics mechanical prosthesis is reliable and has an acceptable rate of valve-related complications.

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