BACKGROUND: The Mitroflow pericardial bioprosthesis (model 11), a second-generation pericardial prosthesis, has clinical performance assessment to 10 years. The authors previously recommended the prosthesis for aortic valve replacement in patients 70 years or older. The purpose of the current assessment is to report on performance in patients 60 years or older undergoing aortic valve replacement. METHODS: This bioprosthesis was implanted in 161 patients (mean age, 69.5+/-6.3 years; range, 60 to 94 years) with aortic valve replacement from 1982 to 1992. There were 84 patients 60 to 69 years (mean, 64.5+/-3.1 years) and 77 patients 70 years or older (mean, 74.8+/-4.3 years). Of the total population, concomitant procedures were performed in 63 patients (39.1%); of these, coronary artery bypass grafting was performed in 39 (24.2%). RESULTS: The early mortality was 4.8% (4 patients) for the 60 to 69-year age group and 10.4% (8) for those 70 years or older (not significant). The late mortality was 4.4%/patient-year (27) for those 60 to 69 years and 6.9%/ patient-year (35) for those 70 years or older (not significant). The patient survival for those 60 to 69 years was 58.0%+/-6.3% and for those 70 years or older, 45.3%+/-5.9% at 10 years (p < 0.05). The valve-related mortality for those 60 to 69 years was 0.82%/patient-year (5) and for those 70 years or older, 1.58%/patient-year (8) (not significant). The reoperation rate for those 60 to 69 years was 3.29%/patient-year (20) and for those 70 years or older, 1.0%/patient-year (5) (p < 0.05). The structural valve deterioration rate for those 60 to 69 years was 3.13%/ patient-year (19) and for those 70 years or older, 1.2%/ patient-year (6) (p < 0.05). CONCLUSIONS: The Mitroflow pericardial bioprosthesis remains recommended for aortic valve replacement in patients 70 years and older.
BACKGROUND: The Mitroflow pericardial bioprosthesis (model 11), a second-generation pericardial prosthesis, has clinical performance assessment to 10 years. The authors previously recommended the prosthesis for aortic valve replacement in patients 70 years or older. The purpose of the current assessment is to report on performance in patients 60 years or older undergoing aortic valve replacement. METHODS: This bioprosthesis was implanted in 161 patients (mean age, 69.5+/-6.3 years; range, 60 to 94 years) with aortic valve replacement from 1982 to 1992. There were 84 patients 60 to 69 years (mean, 64.5+/-3.1 years) and 77 patients 70 years or older (mean, 74.8+/-4.3 years). Of the total population, concomitant procedures were performed in 63 patients (39.1%); of these, coronary artery bypass grafting was performed in 39 (24.2%). RESULTS: The early mortality was 4.8% (4 patients) for the 60 to 69-year age group and 10.4% (8) for those 70 years or older (not significant). The late mortality was 4.4%/patient-year (27) for those 60 to 69 years and 6.9%/ patient-year (35) for those 70 years or older (not significant). The patient survival for those 60 to 69 years was 58.0%+/-6.3% and for those 70 years or older, 45.3%+/-5.9% at 10 years (p < 0.05). The valve-related mortality for those 60 to 69 years was 0.82%/patient-year (5) and for those 70 years or older, 1.58%/patient-year (8) (not significant). The reoperation rate for those 60 to 69 years was 3.29%/patient-year (20) and for those 70 years or older, 1.0%/patient-year (5) (p < 0.05). The structural valve deterioration rate for those 60 to 69 years was 3.13%/ patient-year (19) and for those 70 years or older, 1.2%/ patient-year (6) (p < 0.05). CONCLUSIONS: The Mitroflow pericardial bioprosthesis remains recommended for aortic valve replacement in patients 70 years and older.