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Ten-year results of aortic valve replacement with first-generation Mitroflow bioprosthesis : is early degeneration a structural or a technical issue?

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Abstract
OBJECTIVES: Concerns have been raised about the durability of the first-generation Mitroflow aortic bioprosthesis (model 12 A-LX) due to the lack of anticalcification treatment. This study reflects a 10-year experience with this prosthesis for aortic valve replacement. METHODS: From June 2003 to May 2012, the Mitroflow prosthesis was used for aortic valve replacement in 510 patients, of whom only 467 with complete clinical follow-up were included for analysis. Study end-points were survival and incidence of structural valve degeneration (SVD). Analysis of SVD was based on cumulative incidence function and competing-risk Cox regression. RESULTS: The mean patient age was 76.4 +/- 6.1 years. Valve sizes from 23 to 25 were used in 70.4%, whereas sizes from 19 to 21 were used in only 19.2%, thereby avoiding patient-prosthesis mismatch in 89.1%. Within a median follow-up time of 6.6 years (interquartile range 4.4), a cumulative 2375 patient-years, the survival rate was 86.2%, 67.3% and 33.3% at 1, 5 and 10 years, respectively. The cumulative incidence of SVD, with death as a competing risk, was 0%, 0.7% and 6.2% at 1, 5 and 10 years, respectively. Only age <75 years tended to affect the late hazard of SVD (hazard ratio 0.50, 95% confidence interval 0.23-1.08, P = 0.08), regardless of valve-specific issues. CONCLUSIONS: The data do not support the concerns about early accelerated structural degeneration of the first-generation Mitroflow bioprosthesis used for aortic valve replacement in patients older than 75 years. We postulate that limiting the number of small prostheses using a proper implantation technique has enhanced the reduction in risk of significant patient-prosthesis mismatch as the main determinant of early SVD.
Keywords
Aortic valve replacement, Bioprosthesis, Valve-related outcome, PATIENT-PROSTHESIS MISMATCH, AMERICAN-HEART-ASSOCIATION, PERICARDIAL BIOPROSTHESIS, TASK-FORCE, INFECTIVE ENDOCARDITIS, LARGE COHORT, GUIDELINES, EXPERIENCE, DETERIORATION, PERFORMANCE

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Chicago
Lootens, Liesbeth, Jonas Verbeke, Thomas Martens, Tine Philipsen, Frank Caes, Yves Van Belleghem, Guido Van Nooten, Katrien François, Dirk De Bacquer, and Thierry Bové. 2017. “Ten-year Results of Aortic Valve Replacement with First-generation Mitroflow Bioprosthesis : Is Early Degeneration a Structural or a Technical Issue?” European Journal of Cardio-thoracic Surgery 52 (2): 272–278.
APA
Lootens, Liesbeth, Verbeke, J., Martens, T., Philipsen, T., Caes, F., Van Belleghem, Y., Van Nooten, G., et al. (2017). Ten-year results of aortic valve replacement with first-generation Mitroflow bioprosthesis : is early degeneration a structural or a technical issue? EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 52(2), 272–278.
Vancouver
1.
Lootens L, Verbeke J, Martens T, Philipsen T, Caes F, Van Belleghem Y, et al. Ten-year results of aortic valve replacement with first-generation Mitroflow bioprosthesis : is early degeneration a structural or a technical issue? EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. 2017;52(2):272–8.
MLA
Lootens, Liesbeth, Jonas Verbeke, Thomas Martens, et al. “Ten-year Results of Aortic Valve Replacement with First-generation Mitroflow Bioprosthesis : Is Early Degeneration a Structural or a Technical Issue?” EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 52.2 (2017): 272–278. Print.
@article{8533872,
  abstract     = {OBJECTIVES: Concerns have been raised about the durability of the first-generation Mitroflow aortic bioprosthesis (model 12 A-LX) due to the lack of anticalcification treatment. This study reflects a 10-year experience with this prosthesis for aortic valve replacement. 
METHODS: From June 2003 to May 2012, the Mitroflow prosthesis was used for aortic valve replacement in 510 patients, of whom only 467 with complete clinical follow-up were included for analysis. Study end-points were survival and incidence of structural valve degeneration (SVD). Analysis of SVD was based on cumulative incidence function and competing-risk Cox regression. 
RESULTS: The mean patient age was 76.4 +/- 6.1 years. Valve sizes from 23 to 25 were used in 70.4\%, whereas sizes from 19 to 21 were used in only 19.2\%, thereby avoiding patient-prosthesis mismatch in 89.1\%. Within a median follow-up time of 6.6 years (interquartile range 4.4), a cumulative 2375 patient-years, the survival rate was 86.2\%, 67.3\% and 33.3\% at 1, 5 and 10 years, respectively. The cumulative incidence of SVD, with death as a competing risk, was 0\%, 0.7\% and 6.2\% at 1, 5 and 10 years, respectively. Only age {\textlangle}75 years tended to affect the late hazard of SVD (hazard ratio 0.50, 95\% confidence interval 0.23-1.08, P = 0.08), regardless of valve-specific issues. 
CONCLUSIONS: The data do not support the concerns about early accelerated structural degeneration of the first-generation Mitroflow bioprosthesis used for aortic valve replacement in patients older than 75 years. We postulate that limiting the number of small prostheses using a proper implantation technique has enhanced the reduction in risk of significant patient-prosthesis mismatch as the main determinant of early SVD.},
  author       = {Lootens, Liesbeth and Verbeke, Jonas and Martens, Thomas and Philipsen, Tine and Caes, Frank and Van Belleghem, Yves and Van Nooten, Guido and Fran\c{c}ois, Katrien and De Bacquer, Dirk and Bov{\'e}, Thierry},
  issn         = {1010-7940},
  journal      = {EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY},
  keyword      = {Aortic valve replacement,Bioprosthesis,Valve-related outcome,PATIENT-PROSTHESIS MISMATCH,AMERICAN-HEART-ASSOCIATION,PERICARDIAL BIOPROSTHESIS,TASK-FORCE,INFECTIVE ENDOCARDITIS,LARGE COHORT,GUIDELINES,EXPERIENCE,DETERIORATION,PERFORMANCE},
  language     = {eng},
  number       = {2},
  pages        = {272--278},
  title        = {Ten-year results of aortic valve replacement with first-generation Mitroflow bioprosthesis : is early degeneration a structural or a technical issue?},
  url          = {http://dx.doi.org/10.1093/ejcts/ezx117},
  volume       = {52},
  year         = {2017},
}

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