The Carpentier-Edwards supra-annular bioprosthesis for aortic valve replacement. Clinical experience in 234 patients

Between January 1980 through December 1983, aortic valve replacement (AVR) was performed in 234 patients with a Carpentier-Edwards supra-annular bioprosthesis. There were 177 isolated AVRs and 18 AVRs combined with coronary artery bypass grafting (CABG): one bypass was done in 9 patients, 2 in 7 and 3 in 2 patients. Additional valve surgery was: mitral valve reconstruction in 14, mitral valve replacement in 12 and additional tricuspid reconstruction in 2. AVR combined with various other procedures was performed in 11 other patients. Early mortality for isolated AVR was 5%. Follow-up information was obtained until June, 1984. During this observation period (19.8 +/- 7 months), late mortality was 4%. Follow-up information was obtained on 212 of the 234 patients (91%). Preoperatively, 77% of the patients were in NYHA class III, 16% were in class IV. Postoperatively, 82.5% had improved to functional class I and II (I: 42.5%, II: 40%), only 17% were in class III. A diastolic murmur indicating aortic regurgitation was noted in 25 patients (11%). The murmur occurred early in 3, and late within 2 years in 21 instances: 7 patients required reoperation. Intraoperative findings were: leaflet perforation (3), leaflet rupture (1), suture dehiscence (2), and endocarditis (1). Histology and electron microscopy of the 4 malfunctioning valves showed changes in collagen structure and minimal calcification. The possible causes of valve failure are discussed.