TY - JOUR
T1 - Achieved anticoagulation vs prosthesis selection for mitral mechanical valve replacement
T2 - A population-based outcome study
AU - Le Tourneau, Thierry
AU - Lim, Vanessa
AU - Inamo, Jocelyn
AU - Miller, Fletcher A.
AU - Mahoney, Douglas W.
AU - Schaff, Hartzell V.
AU - Enriquez-Sarano, Maurice
N1 - Funding Information:
Financial/nonfinancial disclosures: Dr. Enriquez-Sarano is a consultant and receives research funding from Edwards LLC. The authors have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
Funding Information:
Funding/Support: This work was supported by the National Institutes of Health, Rochester Epidemiology Project Grant AR30582 , Dr. Walter A. Rocca, Principal Investigator. This work was also supported by a grant from the French Foundation of Cardiology (Dr. Le Tourneau).
PY - 2009/12/1
Y1 - 2009/12/1
N2 - Background: Thromboembolic events (TEs) are frequent after mechanical mitral valve replacement (MVR), but their association to anticoagulation quality is unclear and has never been studied in a population-based setting with patients who have a complete anticoagulation record. Methods: We compiled a complete record of all residents of Olmsted County, MN, who underwent mechanical MVR between 1981 and 2004, for all TE, bleeding episodes, and international normalized ratios (INRs) measured from prosthesis implantation. Results: In the 112 residents (mean [± SD] age, 57 ± 16 years; 60% female residents) who underwent mechanical MVR, 19,647 INR samples were obtained. While INR averaged 3.02 ± 0.57, almost 40% of INRs were < 2 or > 4.5. Thirty-four TEs and 28 bleeding episodes occurred during a mean duration of 8.2 ± 6.1 years of follow-up. There was no trend of association of INR (average, SD, growth variance rate, or intensity-specific incidence of events) with TE. Previous cardiac surgery (p = 0.014) and ball prosthesis (hazard ratio [HR], 2.92; 95% CI, 1.43 to 5.94; p = 0.003) independently determined TE. With MVR using a ball prosthesis, despite higher anticoagulation intensity (p = 0.002), the 8-year rate of freedom from TE was considerably lower (50 ± 9% vs 81 ± 5%, respectively; p < 0.0001). Compared with expected stroke rates in the population, stroke risk was elevated with non-ball prosthesis MVR (HR 2.6; 95% CI, 1.3 to 5.2; p = 0.007) but was considerable with ball prosthesis MVR (HR 11.7; 95% CI, 7.5 to 18.4; p < 0.0001). INR variability (SD) was higher with a higher mean INR value (p < 0.0001). INR variability (HR 2.485; 95% CI, 1.11 to 5.55; p = 0.027) and cancer history (p < 0.0001) independently determined bleeding rates. Conclusion: This population-based comprehensive study of anticoagulation and TE post-MVR shows that, in these closely anticoagulated patients, anticoagulation intensity was highly variable and not associated with TE incidence post-MVR. Higher anticoagulation intensity is linked to higher variability and, thus, to bleeding. The MVR-ball prosthesis design is associated with higher TE rates notwithstanding higher anticoagulation intensity, and its use should be retired worldwide.
AB - Background: Thromboembolic events (TEs) are frequent after mechanical mitral valve replacement (MVR), but their association to anticoagulation quality is unclear and has never been studied in a population-based setting with patients who have a complete anticoagulation record. Methods: We compiled a complete record of all residents of Olmsted County, MN, who underwent mechanical MVR between 1981 and 2004, for all TE, bleeding episodes, and international normalized ratios (INRs) measured from prosthesis implantation. Results: In the 112 residents (mean [± SD] age, 57 ± 16 years; 60% female residents) who underwent mechanical MVR, 19,647 INR samples were obtained. While INR averaged 3.02 ± 0.57, almost 40% of INRs were < 2 or > 4.5. Thirty-four TEs and 28 bleeding episodes occurred during a mean duration of 8.2 ± 6.1 years of follow-up. There was no trend of association of INR (average, SD, growth variance rate, or intensity-specific incidence of events) with TE. Previous cardiac surgery (p = 0.014) and ball prosthesis (hazard ratio [HR], 2.92; 95% CI, 1.43 to 5.94; p = 0.003) independently determined TE. With MVR using a ball prosthesis, despite higher anticoagulation intensity (p = 0.002), the 8-year rate of freedom from TE was considerably lower (50 ± 9% vs 81 ± 5%, respectively; p < 0.0001). Compared with expected stroke rates in the population, stroke risk was elevated with non-ball prosthesis MVR (HR 2.6; 95% CI, 1.3 to 5.2; p = 0.007) but was considerable with ball prosthesis MVR (HR 11.7; 95% CI, 7.5 to 18.4; p < 0.0001). INR variability (SD) was higher with a higher mean INR value (p < 0.0001). INR variability (HR 2.485; 95% CI, 1.11 to 5.55; p = 0.027) and cancer history (p < 0.0001) independently determined bleeding rates. Conclusion: This population-based comprehensive study of anticoagulation and TE post-MVR shows that, in these closely anticoagulated patients, anticoagulation intensity was highly variable and not associated with TE incidence post-MVR. Higher anticoagulation intensity is linked to higher variability and, thus, to bleeding. The MVR-ball prosthesis design is associated with higher TE rates notwithstanding higher anticoagulation intensity, and its use should be retired worldwide.
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U2 - 10.1378/chest.08-1233
DO - 10.1378/chest.08-1233
M3 - Article
C2 - 19482955
AN - SCOPUS:73149105505
SN - 0012-3692
VL - 136
SP - 1503
EP - 1513
JO - Diseases of the chest
JF - Diseases of the chest
IS - 6
ER -