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CC BY-NC-ND 4.0 · Thromb Haemost
DOI: 10.1055/s-0043-1777827
Coagulation and Fibrinolysis

Outcomes of Patients with a Mechanical Heart Valve and Poor Anticoagulation Control on Warfarin

Isabelle Johansson 
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
2   Division of Cardiology, Department of Medicine K2, Karolinska University Hospital Solna, Karolinska Institutet, Stockholm, Sweden
,
Alexander P. Benz 
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
3   Department of Cardiology, University Medical Center Mainz, Johannes Gutenberg-University, Mainz, Germany
,
Tanya Kovalova
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
,
Kumar Balasubramanian
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
,
Bianca Fukakusa
4   Division of Cardiology, Department of Pediatrics, The University of British Columbia, Vancouver, Canada
,
Matthew J. Lynn
5   Department of Medicine, University of British Columbia, Vancouver, Canada
,
Nikhil Nair
6   Division of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Canada
,
Omaike Sikder
7   Division of Medicine, School of Nursing, McMaster University, Hamilton, Canada
,
Kashyap Patel
8   Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
,
Sai Gayathri
9   Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Canada
,
Marlene Robinson
10   Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Canada
,
Colin Hardy
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
,
Jessica Tyrwhitt
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
,
Sam Schulman 
10   Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Canada
,
John W. Eikelboom
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
,
Stuart J. Connolly
1   Population Health Research Institute, Hamilton Health Sciences, McMaster University, Ontario, Canada
› Author Affiliations Funding This study was supported by the Hamilton Health Sciences' New Investigator Fund. Swedish Heart Lung Foundation, Stockholm County Council, AstraZeneca, and Swedish Society of Cardiology also supported this project.
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Abstract

Background Patients with a mechanical heart valve (MHV) require oral anticoagulation. Poor anticoagulation control is thought to be associated with adverse outcomes, but data are limited.

Objective To assess the risks of clinical outcomes in patients with a MHV and poor anticoagulation control on warfarin.

Patients/Methods We conducted a retrospective study of consecutive patients undergoing MHV implantation at a tertiary care center (2010–2019). Primary outcome was a composite of ischemic stroke, systemic embolism, or prosthetic valve thrombosis. Major bleeding and death were key secondary outcomes. We constructed multivariable regression models to assess the association between time in therapeutic range (TTR) on warfarin beyond 90 days after surgery with outcomes.

Results We included 671 patients with a MHV (80.6% in aortic, 14.6% in mitral position; mean age 61 years, 30.3% female). Median follow-up was 4.9 years, mean TTR was 62.5% (14.5% TTR <40%, 24.6% TTR 40–60%, and 61.0% TTR >60%). Overall rates of the primary outcome, major bleeding, and death were 0.73, 1.41, and 1.44 per 100 patient-years. Corresponding rates for patients with TTR <40% were 1.31, 2.77, and 3.22 per 100 patient-years. In adjusted analyses, every 10% decrement in TTR was associated with a 31% increase in hazard for the primary outcome (hazard ratio [HR]: 1.31, 95% confidence interval [CI]: 1.13–1.52), 34% increase in major bleeding (HR: 1.34, 95% CI: 1.17–1.52), and 32% increase in death (HR: 1.32, 95% CI: 1.11–1.57).

Conclusion In contemporary patients with a MHV, poor anticoagulation control on warfarin was associated with increased risks of thrombotic events, bleeding, and death.

Keywords

mechanical heart valve - outcomes - stroke - TTR - VKA

Authors' Contribution

A.P.B. and S.J.C. conceived the study idea. I.J., A.P.B., S.J.C., and J.W.E. designed the study. C.H. developed the study database. I.J., A.P.B., M.R., S.S., J.W.E., B.F., K.P., M.J.L., S.G., O.S., and N.N. conducted the data collection and data extraction. T.K. and K.B. conducted the data analyses and developed tables and figures with inputs from I.J., A.P.B., S.S., J.W.E., and S.J.C. I.J. and A.P.B. wrote the first draft of the manuscript with further inputs from J.W.E., S.S., and S.J.C. All authors read and approved the final version of the manuscript.


Supplementary Material



Publication History

Received: 18 April 2023

Accepted: 22 September 2023

Article published online:
29 December 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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