Jf. Nistal et al., CLINICAL-EXPERIENCE WITH THE CARBOMEDICS VALVE - EARLY RESULTS WITH ANEW BILEAFLET MECHANICAL PROSTHESIS, Journal of thoracic and cardiovascular surgery, 112(1), 1996, pp. 59-68
Between January 1989 and August 1992, 612 CarboMedics mechanical prost
heses (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, a
nd 106 had multiple valve replacement. The total follow-up was 1182 pa
tient-years. The hospital mortality rate was 7.4% for mitral valve rep
lacement, 5.3% for aortic valve replacement, and 13.2% for multiple va
lve replacement. Linearized rates for the different complications for
mitral valve replacement, aortic valve replacement, and multiple valve
replacement (in events per 100 patient-gears) were, respectively, as
follows: late mortality, 2.6 +/- 0.8, 1.5 +/- 0.5, and 3.9 +/- 1.3; th
romboembolim, 3.7 +/- 0.9, 3.1 +/- 0.8, and 3.9 +/- 1.3; valve thrombo
sis, 0.5 +/- 0.3 for mitral valve replacement and 0.4 +/- 0.4 for mult
iple 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 va
lve replacement and aortic valve replacement and 4.5 years for multipl
e valve replacement) were, respectively, as follows: overall death, 83
% +/- 4%, 89% +/- 2%, and 76% +/- 4%; thromboembolism or valve thrombo
sis, 88% +/- 3%, 91% +/- 2%, and 86% +/- 5%; anticoagulant-related hem
orrhage, 89% +/- 3%, 95% +/- 2%, and 90% +/- 5%; nonstructural dysfunc
tion, 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 s
atisfactory at 5 years of follow-up but thromboembolic and hemorrhagic
phenomena are still serious complications of mechanical prostheses.