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J Thorac Cardiovasc Surg 1996;112:59-68
© 1996 Mosby, Inc.

SURGERY FOR ACQUIRED HEART DISEASE

CLINICAL EXPERIENCE WITH THE CARBOMEDICS VALVE: EARLY RESULTS WITH A NEW BILEAFLET MECHANICAL PROSTHESIS

From the Department of Cardiovascular Surgery, Hospital Marqués de Valdecilla, University of Cantabria, Santander, Spain.

Received for publication April 10, 1995 Accepted for publication August 30, 1995. Address for reprints: J. F. Nistal, MD, Servicio de Cirugía Cardiovascular, Hospital Universitario Marqués de Valdecilla, Avda. de Valdecilla s/n, 39008 Santander, Spain.

Abstract

Between January 1989 and August 1992, 612 CarboMedics mechanical prostheses (CarboMedics, Inc., Austin, Tex.) (295 mitral, 308 aortic, and 9 tricuspid) were implanted in 504 patients: 189 patients had isolated mitral valve replacement, 209 had isolated aortic valve replacement, and 106 had multiple valve replacement. The total follow-up was 1182 patient-years. The hospital mortality rate was 7.4% for mitral valve replacement, 5.3% for aortic valve replacement, and 13.2% for multiple valve replacement. Linearized rates for the different complications for mitral valve replacement, aortic valve replacement, and multiple valve replacement (in events per 100 patient-years) were, respectively, as follows: late mortality, 2.6 ± 0.8, 1.5 ± 0.5, and 3.9 ± 1.3; thromboembolim, 3.7 ± 0.9, 3.1 ± 0.8, and 3.9 ± 1.3; valve thrombosis, 0.5 ± 0.3 for mitral valve replacement and 0.4 ± 0.4 for multiple valve replacement; anticoagulant-related hemorrhage, 2.8 ± 0.8, 1.9 ± 0.6, and 2.6 ± 1.1; nonstructural dysfunction, 1.6 ± 0.6, 0.8 ± 0.4, and 3.5 ± 1.2; and reoperation, 1.1 ± 0.5, 0.4 ± 0.3, and 3.1 ± 1.1. Actuarial estimates of freedom from the different complications for mitral valve replacement, aortic valve replacement, and multiple valve replacement (at 5 years of follow-up for mitral valve replacement and aortic valve replacement and 4.5 years for multiple valve replacement) were, respectively, as follows: overall death, 83% ± 4%, 89% ± 2%, and 76% ± 4%; thromboembolism or valve thrombosis, 88% ± 3%, 91% ± 2%, and 86% ± 5%; anticoagulant-related hemorrhage, 89% ± 3%, 95% ± 2%, and 90% ± 5%; nonstructural dysfunction, 97% ± 1%, 98% ± 1%, and 91% ± 3%; and reoperation, 96% ± 2%, 99% ± 1%, and 87% ± 5%. There were no instances of prosthetic structural dysfunction. The performance of the CarboMedics valve is satisfactory at 5 years of follow-up but thromboembolic and hemorrhagic phenomena are still serious complications of mechanical prostheses. (J THORACCARDIOVASCSURG1996;112:59-68)

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