Impact of an oral anticoagulation self-monitoring and self-management program in patients with mechanical heart valve prosthesis
Publication: Journal of Comparative Effectiveness Research
Abstract
Objective: To analyze impact of implementation of an oral anticoagulation self-monitoring and self-management program among patients with mechanical valve prosthesis. Materials & methods: Observational and retrospective study performed in Hospital Moises Broggi, Barcelona, Spain. The program started on June 2019. The study compared 6-month period before and after the implementation of the program. Results: The study included 44 patients. There was a numerical increase of time in therapeutic range from 53.6 ± 21.3% to 57.1 ± 15.7% (p = 0.30). Proportion of patients with international normalized ratio (INR) >5 significantly decreased from 3.9 to 2.0% (p = 0.04). No significant differences were observed in thromboembolic or bleeding complications. Visits to emergency department decreased from (29.5 to 22.7%; p = 0.41). Conclusion: Oral anticoagulation self-monitoring and self-management program seems an appropriate approach that could provide additional benefits in selected patients with mechanical valve prosthesis.
Formats available
You can view the full content in the following formats:
References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Barnes GD, Lucas E, Alexander GC, Goldberger ZD. National trends in ambulatory oral anticoagulant use. Am. J. Med. 128(12), 1300–1305 (2015).
2.
Eikelboom JW, Connolly SJ, Brueckmann M et al. RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N. Engl. J. Med. 369(13), 1206–1214 (2013).
3.
Pengo V, Denas G, Zoppellaro G et al. Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood 132(13), 1365–1371 (2018).
4.
Fanaroff AC, Ohman EM. Non-vitamin K antagonist oral anticoagulants in the treatment of atrial fibrillation. Ann. Rev. Med. 70, 61–75 (2019).
5.
Mueller S, Pfannkuche M, Breithardt G et al. The quality of oral anticoagulation in general practice in patients with atrial fibrillation. Eur. J. Intern. Med. 25(3), 247–254 (2014).
6.
Heneghan CJ, Garcia-Alamino JM, Spencer EA et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst. Rev. 7, CD003839 (2016).
•• Self-monitoring and self-management program implies that the patient takes responsibility about the control of its anticoagulation treatment leading to a better anticoagulation control.
7.
Sølvik UØ, Løkkebø E, Kristoffersen AH, Brodin E, Averina M, Sandberg S. Quality of warfarin therapy and quality of life are improved by self-management for two years. Thromb. Haemost. 19(10), 1632–1641 (2019).
8.
Tamayo Aguirre E, Galo-Anza A, Dorronsoro-Barandiaran O et al. Oral anticoagulation with vitamin K inhibitors and determinants of successful self-management in primary care. BMC Cardiovasc. Disord. 16(1), 180 (2016).
9.
Christensen TD, Skjøth F, Nielsen PB, Maegaard M, Grove EL, Larsen TB. Self-management of anticoagulant therapy in mechanical heart valve patients: a matched cohort study. Ann. Thorac. Surg. 101(4), 1494–1499 (2016).
10.
Christensen TD, Johnsen SP, Hjortdal VE, Hasenkam JM. Self-management of oral anticoagulant therapy: a systematic review and meta-analysis. Int. J. Cardiol. 118(01), 54–61 (2007).
11.
Jowett S, Bryan S, Murray E et al. Patient self-management of anticoagulation therapy: a trial-based cost–effectiveness analysis. Br. J. Haematol. 134(06), 632–639 (2006).
12.
Bussey HI. Transforming oral anticoagulation by combining international normalized ratio (INR) self-testing and online automated management. J. Thromb. Thrombolysis 31(3), 265–274 (2011).
13.
Sawicki PT. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working group for the study of patient self-management of oral anticoagulation. JAMA 281, 145–150 (1999).
14.
Crystal Sing Yee Tan, Alan Yean Yip Fong, Yuan Hsun Jong, Tiong Kiam Ong. INR control of patients with mechanical heart valve on long-term warfarin therapy. Glob. Heart 13(4), 241–244 (2018).
15.
Butchart EG, Payne N, Li HH, Buchan K, Mandana K, Grunkemeier GL. Better anticoagulation control improves survival after valve replacement. J. Thorac. Cardiovasc. Surg. 123(4), 715–723 (2002).
16.
Havers-Borgersen E, Butt JH, Vinding NE et al. Time in therapeutic range and risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis. J. Thorac. Cardiovasc. Surg. 159(1), 74–83.E4 (2020).
•• Risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis.
17.
Thompson JL, Burkhart HM, Daly RC et al. Anticoagulation early after mechanical valve replacement: improved management with patient self-testing. J. Thorac. Cardiovasc. Surg. 146(3), 599–604 (2013).
•• Management of anticoagulation with vitamin K antagonists after mechanical valve replacement may be improved with self-monitoring.
18.
Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb. Haemost. 69(3), 236–239 (1993).
19.
Schapkaitz E, Jacobson BF, Becker P, Conway G. Thrombo-embolic and bleeding complications in patients with mechanical valve replacements – a prospective observational study. S. Afr. Med. J. 96(8), 710–713 (2006).
20.
Raparelli V, Proietti M, Cangemi R, Lip GY, Lane DA, Basili S. Adherence to oral anticoagulant therapy in patients with atrial fibrillation. Focus on non-vitamin K antagonist oral anticoagulants. Thromb. Haemost. 117(02), 209–218 (2017).
21.
Corrochano M, Jiménez B, Millón J et al. Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up. BMC Cardiovasc. Disord. 20, 166 (2020).
22.
Fitzmaurice DA, Murray ET, McCahon D et al. Self-management of oral anticoagulation: randomised trial. BMJ 331(7524), 1057 (2005).
23.
De Felipe MR, Cáceres Cortés C, Jiménez Merino MR, Alonso Arizcun B, Luna ÁR. Estudio comparativo del autocontrol domiciliario frente al control convencional de pacientes anticoagulados seguidos en un centro de atención primaria. Med. Gen. Y Fam. 2(6), 176–183 (2013).
24.
Garcia-Alamino JM, Ward AM, Alonso-Coello P et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst. Rev. 4, CD003839 (2010).
25.
Menéndez-Jándula B, Souto JC, Oliver A et al. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann. Intern. Med. 142(1), 1–10 (2005).
26.
Xu Z, Wang Z, Ou J, Xu Y, Yang S, Zhang X. Two monitoring methods of oral anticoagulant therapy in patients with mechanical heart valve prothesis: a meta-analysis. J. Thromb. Thrombolysis 33(1), 38–47 (2012).
27.
Haas S, Ten Cate H, Accetta G et al. GARFIELD-AF Investigators. Quality of vitamin k antagonist control and 1-year outcomes in patients with atrial fibrillation: a global perspective from the GARFIELD-AF Registry. PLoS ONE 11(10), e0164076 (2016).
28.
Grove EL, Skjøth F, Nielsen PB, Christensen TD, Larsen TB. Effectiveness and safety of self-managed oral anticoagulant therapy compared with direct oral anticoagulants in patients with atrial fibrillation. Sci. Rep. 8(1), 15805 (2018).
29.
Labaf A, Själander A, Stagmo M, Svensson PJ. INR variability and outcomes in patients with mechanical heart valve prosthesis. Thromb. Res. 136(6), 1211–1215 (2015).
30.
Grzymala-Lubanski B, Labaf A, Englund E, Svensson PJ, Själander A. Mechanical heart valve prosthesis and warfarin – treatment quality and prognosis. Thromb. Res. 133(5), 795–798 (2014).
31.
Grzymala-Lubanski B, Svensson PJ, Renlund H, Jeppsson A, Själander A. Warfarin treatment quality and prognosis in patients with mechanical heart valve prosthesis. Heart 103(3), 198–203 (2017).
32.
Hylek EM. Treatment persistence in atrial fibrillation: the next major hurdle. Thromb. Haemost. 118(12), 2018–2019 (2018).
33.
Thomson Mangnall LJ, Sibbritt DW, Al-Sheyab N, Gallagher RD. Predictors of warfarin non-adherence in younger adults after valve replacement surgery in the South Pacific. Heart Asia 8(2), 18–23 (2016).
34.
Christensen TD, Grove EL, Nielsen PB, Larsen TB. Self-managed oral anticoagulant therapy: a call for implementation. Expert Rev. Cardiovasc. Ther. 14(3), 255–257 (2016).
35.
Christensen TD, Andersen NT, Attermann J, Hjortdal VE, Maegaard M, Hasenkam JM. Mechanical heart valve patients can manage oral anticoagulant therapy themselves. Eur. J. Cardiothorac. Surg. 23(3), 292–298 (2003).
36.
Bardakci H, Altıntaş G, Çiçek OF et al. Comparison of the CoaguChek XS handheld coagulation analyzer and conventional laboratory methods measuring international normalised ratio (INR) values during the time to therapeutic range after mechanical valve surgery. J. Card. Surg. 28(3), 254–257 (2013).
37.
Jennings I, Kitchen D, Keeling D, Fitzmaurice D, Heneghan C. BCSH Committee. Patient self-testing and self-management of oral anticoagulation with vitamin K antagonists: guidance from the British Committee for Standards in Haematology. Br. J. Haematol. 167(05), 600–607 (2014).
38.
Connock M, Stevens C, Fry-Smith A et al. Clinical effectiveness and cost–effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling. Health Technol. Assess. 11(38), iii–iv (2007).
• Cost–effectiveness of different models of managing long-term oral anticoagulation therapy.
39.
Norwegian Institute of Public Health. Norwegian Prescription Database (NorPD) (2019). www.fhi.no/en/hn/health-registries/norpd/
40.
Sharma P, Scotland G, Cruickshank M et al. Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation. BMJ Open 5, e007758 (2015).
41.
Alvarez-Sabín J, Quintana M, Masjuan J et al. CONOCES Investigators Group. Economic impact of patients admitted to stroke units in Spain. Eur. J. Health Econ. 18(4), 449–458 (2017).
• Cost of patients admitted in stroke units € per patient/year, being social costs.
Information & Authors
Information
Published In
Pages: 307 - 314
PubMed: 33594899
Copyright
© 2021 Future Medicine Ltd.
History
Received: 1 October 2020
Accepted: 10 December 2020
Published online: 17 February 2021
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
Impact of an oral anticoagulation self-monitoring and self-management program in patients with mechanical heart valve prosthesis. (2021) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2020-0215
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Hossameldin Hussein, Amr Yosry Emam, Karimeldeen Hafez, Sara Abdelmordy Abdelmagid Ragab, Maha Abdallah, Eman Mahmoud Ramadan, Asmaa Abdelnaby, Mahmoud Abdelhay, Ahmed Hassan, Mohammed Hosny, Quality of anticoagulation in self versus standard management: Assessing the influence of education level on self-managed patient outcomes, Indian Heart Journal, 10.1016/j.ihj.2026.07.003, (2026).
- Sonia Gulia, Kusum Kumari, Vasantha C. Kalyani, Sudhir Kumar Shahi, Comprehensive Management of Anticoagulants Induced Decompensated Severe Anemia in Postmitral Valve Replacement, Journal of Applied Sciences and Clinical Practice, 10.4103/jascp.jascp_43_23, 5, 1, (61-64), (2024).
