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Ann Thorac Surg 1998;66:443-448
© 1998 The Society of Thoracic Surgeons

Original articles: cardiovascular

Up to eight years’ follow-up of 997 patients receiving the CarboMedics prosthetic heart valve

Arnt E. Fiane, MDa, Odd R. Geiran, MD, PhDa, Jan L. Svennevig, MD, PhDa

a Department of Surgery A, Rikshospitalet, University of Oslo, Oslo, Norway

Accepted for publication March 15, 1998.

Address reprint requests to Dr Fiane, Department of Surgery A, Rikshospitalet, Pilestredet 32, 0027 Oslo, Norway

Background. The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis.

Methods. Nine hundred ninety-seven consecutive patients underwent mechanical valve implantation (aortic, 771; mitral, 169; double, 52; tricuspid, 5) with this prosthesis from September 1987 through December 1993. The mean age was 62.3 ± 13.7 years (range, 0.4 to 84 years); 56.6% (564 patients) were men. Four hundred seventy patients (47.1%) underwent additional surgical procedures. Mean follow-up was 4.1 ± 2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years.

Results. Early mortality was 5.0% (50/997; aortic, 4.4%; mitral, 6.4%; double, 9.6%). Late mortality was 14.8% (140/947). Survival at 7 years was 75.9% ± 1.8% (aortic, 78.4% ± 2%; mitral, 70.7% ± 4.5%; double, 60.8% ± 7.4%). When matched for sex and age and compared with the normal Norwegian population, our patients had an increased standard mortality ratio in both men (1.9 ± 0.4) and women (2.9 ± 0.6). The linearized rate of major thromboembolism was 0.9% per patient-year, valve thrombosis 0.2% per patient-year, major bleeding event 0.6% per patient-year, paravalvular leak needing reoperation 0.5% per patient-year, prosthetic valve endocarditis 0.1% per patient-year, and of all reoperations 0.6% per patient-year.

Conclusions. The CarboMedics Heart Valve Prosthesis has incidences of morbid events comparable with or better than reported for other mechanical valves.




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