[Twelve years' experience with Carbomedics bileaflet valves]

The authors report long-term results of a cohort of patients who underwent valve replacement with a Carbomedics bileaflet mechanical prosthesis. The influence of patient age on the results was examined. Three hundred and ninety patients were operated between 1988 and 2000. Complete follow-up was available in 98.5% of cases. For aortic valve replacement, the total experience was 1,061 person-years. The hospital mortality was 2.3%. Global actuarial 12 year survival was 74 +/- 7%. The actuarial probability of absence of thrombo-embolic complications at 12 years was 95 +/- 3%, and of absence of haemorrhagic complications 89 +/- 4%. For mitral valve replacement, the total experience was 610 person-years. The hospital mortality was 3.4%. The global actuarial 12 year survival was 78 +/- 5%. The actuarial probability of absence of thrombo-embolic complications at 12 years was 79 +/- 9% and of absence of haemorrhagic complications 82 +/- 5%. The results of survival and prosthesis-related complications were comparable to those reported in the literature with second generation mechanical prostheses, with the exception of thromboses of the mitral valve for which a higher linear rate was observed. Multivariate analysis showed an increased (x 2.3) risk of haemorrhage after 60 years of age irrespective of the site of implantation of the prosthesis. In patients over 60 years of age, the risks of long-term anticoagulant therapy should raise questions concerning the modality of follow-up and the indications. The use of biological prostheses is a possible alternative.