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Eur J Cardiothorac Surg 2003;23:292-298
© 2003 Elsevier Science NL
a Department of Cardiothoracic and Vascular Surgery, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
b Institute of Experimental Clinical Research, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark
c Department of Biostatistics, Aarhus University, DK-8000 Aarhus C, Denmark
Received 13 September 2002; accepted 4 December 2002.
* Corresponding author. Department of Cardiothoracic and Vascular Surgery & Institute of Experimental Clinical Research, Skejby Sygehus, Aarhus University Hospital, DK-8200 Aarhus N, Denmark. Tel.: +45-8949-5486; fax: +45-8949-6016
e-mail: t.d.christensen{at}iekf.au.dk
Objectives: Thromboembolism and anticoagulant related bleeding are still the most common complications in mechanical heart valve patients. Management of the oral anticoagulant therapy is therefore a key determinant for these clinical complications. We hypothesize that patients selected to self-managed oral anticoagulant therapy have a better treatment quality than patients in conventional oral anticoagulant therapy. The aim of this study was to assess the time within the therapeutic International Normalized Ratio (INR) target range and the incidence of clinical complications in our group of patients, and compare these data with published data on conventional management. Methods: Mechanical heart valve patients (N=94) with a mean age of 47.6 years (range 4.276.6 years) were trained in home blood analysis of INR using a CoaguChek® home coagulometer and coumarin dosage adjustment. After training, the patients were followed by weekly INR measurements. The therapeutic range was a target INR ±0.5. The indications for initiating oral anticoagulant therapy were: aortic valve (N=62), mitral valve (N=29), tricuspid valve (N=1) and multiple valves (N=2). Results: The mean observation time was 2.1 years (range 0.046.2 years), and the total number of patient-years was 197. The patients were within the therapeutic INR target range for a median of 76.0% (range 32.1100.0%) of the time. There were two major thromboembolic events and five major bleedings events, comprised of two deep vein thromboses (both in the same patient), four episodes of epistaxis and one case of gastrointestinal bleeding. All the events required short hospitalization, and after treatment all the patients were discharged from the hospital without any sequelae or other complications. Using published work as references the expected number of major thromboembolic and bleeding complications in conventional management was four and 12, respectively. Conclusions: Self-management of oral anticoagulant therapy provides a good treatment quality for mechanical heart valve patients. We therefore consider self-management of oral anticoagulant therapy as an equally as good or potentially better treatment option for selected patients compared to conventional management.
Key Words: Prosthetic heart valve Oral anticoagulant therapy Self-management International Normalized Ratio Complications
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