Carpentier-Edwards pericardial bioprosthesis in aortic position: long-term follow-up 1980 to 1994.

Aortic valve replacement with Carpentier-Edwards pericardial bioprosthesis was associated with excellent midterm clinical results. Long-term evaluation, however, remained to be determined. We reviewed the first 124 patients who underwent aortic valve replacement with a Carpentier-Edwards bioprosthesis at the Hôpital Broussais between 1980 and 1985. There were 67 males (54%) and 57 females (46%). The mean age at operation was 65 years (range, 18-83 years). The operative mortality (30 days) was 4%. All but 2 patients were followed up for an average of 7.7 years and a total of 973 patient years. There were 45 late deaths (4.7%/patient-year) of which 16 were valve-related (1.7%/patient-year). The actuarial survival rate was 49.9% at 12 years. The actuarial rate for freedom from valve-related mortality was 78.3% at 12 years. There were 7 thromboembolic events in 5 patients and 3 anticoagulation-related hemorrhages. Freedom from structural valve deterioration was 100% at 12 years and 83.3% at 13 years. We conclude that implantation of Carpentier-Edwards pericardial bioprosthesis in aortic position is associated with an excellent long-term clinical outcome. It is believed that the improved results of this valve result from the following original features: fully flexible stent, distensible struts, infrastent tissue mounting, optimal tissue orientation, and improved preservation.