Mitroflow Pericardial Bioprosthesis: Experience to Seven Years

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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.