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Original Research: ANTITHROMBOTIC THERAPY |

Achieved Anticoagulation vs Prosthesis Selection for Mitral Mechanical Valve Replacement: A Population-Based Outcome Study

Thierry Le Tourneau, MD; Vanessa Lim, MD; Jocelyn Inamo, MD; Fletcher A. Miller, MD; Douglas W. Mahoney, MS; Hartzell V. Schaff, MD; Maurice Enriquez-Sarano, MD
Author and Funding Information

Affiliations: From the Division of Cardiovascular Diseases (Drs. Le Tourneau, Lim, Inamo, Miller, and Enriquez-Sarano), the Section of Biostatistics (Mr. Mahoney), and Division of Cardiovascular Surgery (Dr. Schaff), Mayo Clinic, Rochester, MN.

Correspondence to: Maurice Enriquez-Sarano, MD, Division of Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, MN 55905; e-mail: sarano.maurice@mayo.edu


For editorial comment see page 1451

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).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).


© 2009 American College of Chest Physicians


Chest. 2009;136(6):1503-1513. doi:10.1378/chest.08-1233
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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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