Mitroflow Pericardial Bioprosthesis: Experience to Seven Years

Abstract

Between 1983 and 1987, the Mitroflow pericardial prosthesis was implanted in 99 patients, ranging in age from 28 to 94 years (mean 62.8 years). Early mortality was 6.1% (6 patients), and late mortality was 4.8% per patient-year (22 patients). Total cumulative follow-up was 458 patient-years (mean 4.6 years). At 7 years, patient survival was 62% for aortic valve replacement and 63% for mitral valve replacement. The overall rate of valve-related complications was 7.4% per patient-year (34 events): thromboembolism, 2.8%; antithromboembolic-relatedhemorrhage, 1.1%; prosthetic valve endocarditis, 0.7%; non-structural dysfunction, 0.7%; and structural valve deterioration, 2.8%. At 7 years, freedom from thromboembolism was 80.3%, and freedom from prosthetic valve endocarditis was 95.5%. At 5 and 7 years, freedom from structural valve deterioration was 93.4% and 69.7%, respectively. At 5 years, freedom from structural valve deterioration was 97.3% for aortic valve replacement (AVR), 86.6% for mitral valve replacement (MVR), and 100% for multiple valve replacement (MR). At 7 years, freedom from structural valve replacement was 84.6% and 61.3% for AVR and MVR, respectively. At 7 years, overall freedom from reoperation was 68.2%; from valve-related mortality, 81.4%; from valve-related residual morbidity, 97.4%; and from treatment failure (valve-related mortality and residual morbidity), 79.0%. At 7 years, the Mitroflow pericardial bioprosthesis has provided satisfactory clinical performance, especially in the aortic position, with an acceptable freedom from structural valve deterioration.