CarboMedics Mitroflow pericardial aortic bioprosthesis - performance in patients aged 60 years and older after 15 years.

BACKGROUND: The purpose of this study was to carry out a current assessment of the Mitroflow pericardial bioprosthesis (model 11) according to the durability of the prosthesis after 15 years in patients aged 60 years or older. METHODS: This bioprosthesis was implanted in 161 patients (mean age 69.5 +/- 6.3 years; range 60 - 94 years) undergoing aortic valve replacement (AVR) between 1982 and 1992. There were 84 patients aged 60 - 69 years (mean 64.5 +/- 3.1years) and 77 patients aged 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: Early mortality was 4.8 % (4 patients) in the 60 - 69 year age group and 10.4 % (8) in patients aged 70 years or older ( P = 0.290). Late mortality was 4.5 %/patient-year (35) for those aged 60 - 69 years and 8.1 %/patient-year (49) for those aged 70 years or older ( P = 0.007). Patient survival at 15 years of patients aged 60 - 69 years was 47.6 +/- 6.3 % and of patients aged 70 years or older was 20.9 +/- 5.4 % ( P = 0.003) ( ). Freedom from valve-related mortality for patients in the 60 - 69 year age group was 92.1 +/- 3.5 % at 15 years (0.6 %/patient-year [5]), and in the patient group aged 70 years or older it was 84.4 +/- 5.3 % (1.3 %/patient-year [8]; P = 0.194). Freedom from reoperation for patients in the 60 - 69 year age group was 73.9 +/- 5.0 % (2.6 %/patient-year [20]), and for patients aged 70 years or older it was 91.4 +/- 3.4 % (1.0 %/patient-year [6]; P = 0.029). The structural valve deterioration (SVD) rate for patients in the 60 - 69 year age group was 2.4 %/patient-year (19), and for patients aged 70 years or older it was 1.0 %/patient-year (6) ( P = 0.041). Actuarial freedom from structural valve deterioration at 15 years for patients aged 60 - 69 years was 62.0 +/- 7.3 %, and 80.8 +/- 7.9 % for patients aged 70 years and older ( P = 0.049) (actual freedom 73.9 +/- 5.2 % and 91.4 +/- 3.4 %, respectively). CONCLUSIONS: The Mitroflow pericardial bioprosthesis can still be recommended for aortic valve replacement in patients 70 years and older.