CarboMedics Mitroflow Pericardial Aortic Bioprosthesis - Performance in Patients Aged 60 Years and Older after 15 Years

Abstract

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) ([Fig. 1]). 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.

Key words

heart valve surgery - aortic disease - cardiovascular surgery - heart disease

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