Experience with the Mitroflow aortic bioprosthesis

From October 1985 to May 1990, the Mitroflow bovine pericardial valve was placed in the aortic position in 168 patients (97 men, 71 women) with a mean age of 69.7 years. Eighty-nine patients had isolated aortic valve replacement, and 79 had aortic valve replacement and additional procedures. Follow-up over 7 1/2 years includes 781 patient years (426 for isolated aortic valve replacement). Mean follow-up time is 56 months. Peak-to-peak gradients (in millimeters of mercury) measured in the intraoperative period averaged 11.0 +/- 8.7, 11.8 +/- 10.8, and 8.6 +/- 8.2 for 19 mm, 21 mm, and 23 mm valves, respectively. Hospital mortality was 7.3% (14 patients); all deaths were non-valve related. Late mortality of 20.1% in 31 patients resulted from cardiac failure (n = 8), sepsis (n = 4), valve reoperation (n = 1), non-cardiac causes (n = 15) and sudden, unknown causes (n = 3). Fifteen thromboembolic episodes occurred, but only three late thromboembolic episodes occurred in isolated aortic valve replacement without other risk factors. Four early and four late episodes of endocarditis occurred. Seven patients had clinical valve dysfunction, and five others required reoperation for structural deterioration, with one death. At 94 months, overall survival was 64% +/- 5%. Freedom from thromboembolic episode was 87% +/- 3% and 90% +/- 4% for isolated aortic valve replacement. Freedom from combined reoperation or clinical dysfunction was 75% +/- 8%: 64% +/- 15% for those under 70 years of age, and 87% +/- 7% for those 70 years of age and older. The valve has favorable hemodynamics. Durability begins to decline during the sixth year after implantation, possibly at a slower rate in patients older than 70 years of age.