THE CARPENTIER-EDWARDS PERICARDIAL AORTIC-VALVE - INTERMEDIATE RESULTS

The Edwards pericardial aortic valve has unique design features that minimize cusp stress and reduce abrasion wear. Wear tests and in vivo fluid dynamic tests have shown superior performance compared with other bioprostheses. Between August 1981 and July 1985, 719 isolated aortic valves were implanted in 10 US centers. Patients were aged 18 to 90 years (mean, 64 years). Men were 63.3% of the patients. Aortic stenosis was present preoperatively in 63.4% of patients. New York Heart Association functional classes Ill and IV were assigned to 62% of the patients. Valve sizes were 21 mm or less in 49% of patients. Concomitant procedures (most often coronary artery bypass grafting) were performed in 48% of patients. Hospital mortality was 4.7%. There was one valve-related death due to anticoagulant hemorrhage. Late mortality yielded 23 valve-related deaths: endocarditis (13), anticoagulant hemorrhage (4), thromboembolism (3), structural (2), and pannus overgrowth (1). Freedom from valve-related death at 7 years was 95.5%. Regarding valve survival, cusp tears were not seen. There were 11 calcified valves and eight explants (57 to 107 months). Seven-year freedom from all valve reoperation was 95.5% with 11% of the patients receiving warfarin sodium, freedom of the total series from hemorrhage at 7 years was 93.3% and from major thromboembolism, 95.8%. Echocardiographic follow-up of hemodynamics at 7 years yielded the following calculated effective orifice areas: 19 mm, 1 cm2 ; 21 mm, 1.3 cm2; and 23 mm, 1.4 cm2 . Average mean gradient for 19-mm valves was 15 mm Hg. New York Heart Association class improved in 78% of the patients. The Carpentier-Edwards pericardial valve, carefully studied by the Food and Drug Administration guidelines, is easy to use and has excellent hemodynamics. At 7-year follow-up there were no cusp tears and very little calcification. Intermediate-term performance is as good as or better than that of currently available devices, thus making this valve an outstanding bioprosthesis for the small aortic root.