Comparison of survival after aortic valve replacement with Mitroflow or Perimount prostheses
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Comparison of survival after aortic valve replacement with Mitroflow or Perimount prostheses. / Aasbjerg, Kristian; Mortensen, Poul Erik; Nørgaard, Martin Agge; Rytgaard, Helene Charlotte; Gerds, Thomas Alexander; Søgaard, Peter; Torp-Pedersen, Christian; Mortensen, Rikke Nørmark; Bagge, Berit Jamie; Køber, Lars; Nielsen, Per Hostrup.
In: Seminars in Thoracic and Cardiovascular Surgery, Vol. 31, No. 3, 2019, p. 350-358.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Comparison of survival after aortic valve replacement with Mitroflow or Perimount prostheses
AU - Aasbjerg, Kristian
AU - Mortensen, Poul Erik
AU - Nørgaard, Martin Agge
AU - Rytgaard, Helene Charlotte
AU - Gerds, Thomas Alexander
AU - Søgaard, Peter
AU - Torp-Pedersen, Christian
AU - Mortensen, Rikke Nørmark
AU - Bagge, Berit Jamie
AU - Køber, Lars
AU - Nielsen, Per Hostrup
N1 - Copyright © 2018. Published by Elsevier Inc.
PY - 2019
Y1 - 2019
N2 - OBJECTIVES: Bioprosthetic aortic valves degenerate over time, and differences between brands could be expected. We compared two brands implanted in three different centers serving 3.3 million people.METHODS: Between 2000-2014 we identified 1,241 bioprosthetic aortic valve replacements using Mitroflow (Sorin, Milan, Italy) and 3,212 using Perimount (Edwards Lifesciences, Irvine, CA, USA) covering 88% of all aortic valve replacements in the region. Average differences in t-year mortality were derived from Cox regression.RESULTS: The complete case analyses included 881 Mitroflow replacements and 2,488 Perimount replacements. The median follow-up time and 25/75 percentiles was 5.0 years (3.3-7.2) and 8.4 (5.1-10.6) years for Perimount and Mitroflow respectively. Multiple Cox regression analyses demonstrated significantly higher mortality with Mitroflow valves compared with Perimount (hazard ratio 1.27; 95% CI: 1.1-1.5; p<0.001). Average risk of death within five years was 25.0% with Mitroflow and 20.4% with Perimount. Average difference in 5-year mortality based on Cox regression was 4.60% in favor of Perimount (95% CI: 1.02-8.02%; p=0.01) and the number needed to harm was 21.9 (95% CI: 12.7-80.5) within five years. Propensity matching confirmed two year survival differences 4.6% in favor of Perimount (95% CI: 1.2-7.9%; p=0.004), and further confirmed in a series of subgroups and a double robust analysis that takes into account both propensity for treatment and covariate relation to outcome.CONCLUSIONS: Mitroflow valves were associated with a significantly increased risk of death when compared to Perimount valves.
AB - OBJECTIVES: Bioprosthetic aortic valves degenerate over time, and differences between brands could be expected. We compared two brands implanted in three different centers serving 3.3 million people.METHODS: Between 2000-2014 we identified 1,241 bioprosthetic aortic valve replacements using Mitroflow (Sorin, Milan, Italy) and 3,212 using Perimount (Edwards Lifesciences, Irvine, CA, USA) covering 88% of all aortic valve replacements in the region. Average differences in t-year mortality were derived from Cox regression.RESULTS: The complete case analyses included 881 Mitroflow replacements and 2,488 Perimount replacements. The median follow-up time and 25/75 percentiles was 5.0 years (3.3-7.2) and 8.4 (5.1-10.6) years for Perimount and Mitroflow respectively. Multiple Cox regression analyses demonstrated significantly higher mortality with Mitroflow valves compared with Perimount (hazard ratio 1.27; 95% CI: 1.1-1.5; p<0.001). Average risk of death within five years was 25.0% with Mitroflow and 20.4% with Perimount. Average difference in 5-year mortality based on Cox regression was 4.60% in favor of Perimount (95% CI: 1.02-8.02%; p=0.01) and the number needed to harm was 21.9 (95% CI: 12.7-80.5) within five years. Propensity matching confirmed two year survival differences 4.6% in favor of Perimount (95% CI: 1.2-7.9%; p=0.004), and further confirmed in a series of subgroups and a double robust analysis that takes into account both propensity for treatment and covariate relation to outcome.CONCLUSIONS: Mitroflow valves were associated with a significantly increased risk of death when compared to Perimount valves.
U2 - 10.1053/j.semtcvs.2018.11.016
DO - 10.1053/j.semtcvs.2018.11.016
M3 - Journal article
C2 - 30529158
VL - 31
SP - 350
EP - 358
JO - Seminars in Thoracic and Cardiovascular Surgery
JF - Seminars in Thoracic and Cardiovascular Surgery
SN - 1043-0679
IS - 3
ER -
ID: 210004337