Oral Anticoagulation Therapy in Children: Successfully Controlled by Self-Management
Background: Children with congenital heart disease and who are on oral anticoagulation therapy present special challenges due to, for example, rapid fluctuations in international normalized ratio (INR) values, interruption in daily life due to frequent hospital/doctor visits, and difficulties and pain to the child in the performance of venipuncture. We hypothesize that oral anticoagulation therapy can be successfully controlled by self-management for this subset of patients. The aim of this study was to assess the treatment quality of self-managed oral anticoagulation therapy as the proportion of time within the therapeutic INR target range in children with congenital heart disease.
Methods: Children (N = 22) with a mean age of 10.6 years (range, 1.8-18.6 years) and their parents were trained in home blood analysis of INR and in coumarin dosage adjustment. After training, the children were monitored by weekly INR measurements. The therapeutic range in target INR values was ± 0.5. The indications for initiating oral anticoagulation therapy were the presence of a mechanical heart valve (n = 16) and total cavopulmonary connection (n = 6). The children had no physical restrictions.
Results: The mean observation time was 3.6 years (range, 0.9-5.8 years), and the total number of patient-years was 75.4. The patients were within the therapeutic INR target range for a median of 73.1% (range, 30.3%-91.0%) of the observation time. Two children died for reasons not related to the oral anticoagulation therapy. None of the patients experienced thromboembolic or bleeding complications requiring doctor intervention.
Conclusion: Self-management of oral anticoagulation therapy is safe and provides a good quality of treatment for selected children with congenital heart disease.
Hasenkam JM, Kimose HH, Knudsen L, et al. 1997. Self management of oral anticoagulant therapy after heart valve replacement. Eur J Cardiothorac Surg 11:935-42.nHorstkotte D, Piper C, Schulte HD, Schultheiss HP. 1996. Improvement of prognosis by home prothrombin estimation in patients with lifelong anticoagulant therapy [abstract]. Eur Heart J 17(suppl):230.nChristensen TD, Attermann J, Hjortdal VE, Maegaard M, Hasenkam JM. 2001. Self-management of oral anticoagulation in children with congenital heart disease. Cardiol Young 11:269-76.nCromheecke ME, Levi M, Colly LP, et al. 2000. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison. Lancet 356:97-102.nGünther T, Mazzitelli D, Schreiber C, et al. 2000. Mitral-valve replacement in children under 6 years of age. Eur J Cardiothorac Surg 17:426-30.nAndrew M, Marzinotto V, Brooker LA, et al. 1994. Oral anticoagulation therapy in pediatric patients: a prospective study. Thromb Haemost 71:265-9.nAnsell JE, Hughes R. 1996. Evolving models of warfarin management: anticoagulation clinics, patient self-monitoring, and patient self-management. Am Heart J 132:1095-100.nMarzinotto V, Monagle P, Chan A, et al. 2000. Capillary whole blood monitoring of oral anticoagulants in children in outpatient clinics and the home setting. Pediatr Cardiol 21:347-52.nMassicotte P, Marzinotto V, Vegh P, Adams M, Andrew M. 1995. Home monitoring of warfarin therapy in children with a whole blood prothrombin time monitor. J Pediatr 127:389-94.nMichelson AD, Bovill E, Andrew M. 1995. Antithrombotic therapy in children. Chest 108:506S-22S.nSamsa GP, Matchar DB. 2000. Relationship between test frequency and outcomes of anticoagulation: a literature review and commentary with implications for the design of randomized trials of patient self-management. J Thromb Thrombolysis 9:283-92.nCabalka AK, Emery RW, Petersen RJ, et al. 1995. Long-term follow-up of the St. Jude Medical prosthesis in pediatric patients. Ann Thorac Surg 60:S618-23.nAttermann J, Kynde K, Hasenkam JM. 1998. Precision of patients' measurements of the international normalized ratio (INR) using a patient operated whole blood home coagulometer. Thromb Res 92:287-91.nBuck ML. 1996. Anticoagulation with warfarin in infants and children. Ann Pharmacother 30:1316-22.nKörtke H, Körfer R. 2001. International normalized ratio self-management after mechanical heart valve replacement: is an early start advantageous? Ann Thorac Surg 72:44-8.nSpevak PJ, Freed MD, Castaneda AR, Norwood WI, Pollack P. 1986. Valve replacement in children less than 5 years of age. J Am Coll Cardiol 8:901-8.nSteffensen FH, Kristensen K, Ejlersen E, Dahlerup JF, Sørensen HT. 1997. Major haemorrhagic complications during oral anticoagulant therapy in a Danish population-based cohort. J Intern Med 242:497-503.nStewart S, Cianciotta D, Alexson C, Manning J. 1987. The long-term risk of warfarin sodium therapy and the incidence of thromboembolism in children after prosthetic cardiac valve replacement. J Thorac Cardiovasc Surg 93:551-4.nStreif W, Andrew M, Marzinotto V, et al. 1999. Analysis of warfarin therapy in pediatric patients: a prospective cohort study of 319 patients. Blood 94:3007-14.nVan den Besselaar AM. 2001. Accuracy, precision, and quality control for point-of-care testing of oral anticoagulation. J Thromb Thrombolysis 12:35-40.nVan den Besselar AM. 2000. A comparison of INRs determined with a whole blood prothrombin time device and two international reference preparations for thromboplastin. Thromb Haemost 84:410-2.n
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