Benefit of Self-Managed Anticoagulation in Patients with Left Ventricular Assist Device
Background The exact monitoring of the therapeutic-range international normalized ratio (INR) after left ventricular assist device (LVAD) implantation is an important aim to reduce the risk of thrombosis or bleeding complications. Service providers offer a telemedical anticoagulation service (CS).
Methods We compared LVAD patients using the CS (n = 15) to those who received regular medical care (RMC; n = 15) to investigate if telemedicine supervision increased the INR-specific time in the therapeutic range (TTR) during anticoagulation. All patients received self-management training for phenprocoumon medication according to their INR value. INR values were documented for 12 months. A survey (scale: 1 = not satisfied and 10 = very satisfied) was used to determine patient's satisfaction and psychological well-being.
Results A total of 1,798 INR measurements were analyzed. The TTRRosendaal was higher in patients undergoing RMC (78.1 ± 14.3%) compared with that in patients using the CS (58.3 ± 28.0%, p = 0.03). The patient's satisfaction with the coagulation setting at the beginning of the study (RMC: 6.7 ± 3.1, CS: 7.2 ± 3.0, p = 0.74) and psychological wellbeing (RMC: 6.5 ± 1.9, CS: 6.5 ± 2.7, p = 0.97) were comparable between both groups.
Conclusion We found that INR self-management is superior regarding the efficiency of post-LVAD anticoagulation therapy when compared with telemedical (CS)-based INR management in a small study cohort. Intensive training by experienced staff was able to replace CS.
We presented our work as a poster at the AHA Congress (Chicago, Illinois, United States) in 2018 and as an oral presentation at the DGTHG Congress (Wiesbaden) in 2020.
E.V. is a highly motivated medical student who put much effort in data collection, analysis, data interpretation, as well as manuscript writing and editing. M.T.D. is an experienced researcher who attended, completed, and corrected data analysis, data interpretation, and the manuscript writing and editing. Therefore, and in agreement with the coauthors, a shared first authorship is justified.
∗ Both authors contributed equally to this work.
Received: 01 September 2020
Accepted: 23 September 2020
01 December 2020 (online)
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- 1 Bishop MA, Streiff MB, Ensor CR, Tedford RJ, Russell SD, Ross PA. Pharmacist-managed international normalized ratio patient self-testing is associated with increased time in therapeutic range in patients with left ventricular assist devices at an academic medical center. ASAIO J 2014; 60 (02) 193-198
- 2 Menon AK, Götzenich A, Sassmannshausen H, Haushofer M, Autschbach R, Spillner JW. Low stroke rate and few thrombo-embolic events after HeartMate II implantation under mild anticoagulation. Eur J Cardiothorac Surg 2012; 42 (02) 319-323 , discussion 323
- 3 Penning-van Beest FJ, van Meegen E, Rosendaal FR, Stricker BH. Characteristics of anticoagulant therapy and comorbidity related to overanticoagulation. Thromb Haemost 2001; 86 (02) 569-574
- 4 Boyle AJ, Russell SD, Teuteberg JJ. et al. Low thromboembolism and pump thrombosis with the HeartMate II left ventricular assist device: analysis of outpatient anti-coagulation. J Heart Lung Transplant 2009; 28 (09) 881-887
- 5 Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993; 69 (03) 236-239
- 6 Jennings D, McDonnell J, Schillig J. Assessment of long-term anticoagulation in patients with a continuous-flow left-ventricular assist device: a pilot study. J Thorac Cardiovasc Surg 2011; 142 (01) e1-e2
- 7 Barcellona D, Fenu L, Cornacchini S, Marongiu F. Telemedicine can improve the quality of oral anticoagulation using portable devices and self-testing at home. J Telemed Telecare 2013; 19 (06) 298-301
- 8 Koschack J, Marx G, Schnakenberg J, Kochen MM, Himmel W. Comparison of two self-rating instruments for medication adherence assessment in hypertension revealed insufficient psychometric properties. J Clin Epidemiol 2010; 63 (03) 299-306
- 9 Vitaphone GmbH- innovative telemedzin. Available at: www.gesundheitsindustrie-bw.de/de/fachbeitrag/aktuell/vitaphone-gmbh-innovative-telemedizin/ . Accessed June 6, 2020
- 10 The Vitagroup AG. Vitaphone: Telemedizin Für Professionelle Anwender. Available at: www.vitagroup.ag/de_DE/Ueber-uns/vitaphone . Accessed June 15, 2020
- 11 Mair H, Sachweh J, Sodian R. et al. Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions. Interact Cardiovasc Thorac Surg 2012; 14 (03) 253-257
- 12 Wells PS, Brown A, Jaffey J, McGahan L, Poon MC, Cimon K. Safety and effectiveness of point-of-care monitoring devices in patients on oral anticoagulant therapy: a meta-analysis. Open Med 2007; 1 (03) e131-e146
- 13 Barcellona D, Fenu L, Marongiu F. Point-of-care testing INR: an overview. Clin Chem Lab Med 2017; 55 (06) 800-805
- 14 Medical Advisory Secretariat. Point-of-care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy: an evidence-based analysis. Ont Health Technol Assess Ser 2009; 9 (12) 1-114
- 15 Brasen CL, Madsen JS, Parkner T, Brandslund I. Home management of warfarin treatment through a real-time supervised telemedicine solution: a randomized controlled trial. Telemed J E Health 2019; 25 (02) 109-115
- 16 Braun S, Watzke H, Hasenkam JM. et al. Performance evaluation of the new CoaguChek XS system compared with the established CoaguChek system by patients experienced in INR-self management. Thromb Haemost 2007; 97 (02) 310-314
- 17 Cosmi B, Palareti G, Moia M. et al. Accuracy of a portable prothrombin time monitor (Coagucheck) in patients on chronic oral anticoagulant therapy: a prospective multicenter study. Thromb Res 2000; 100 (04) 279-286
- 18 da Silva Saraiva S, Orsi FA, Santos MP. et al. Home management of INR in the public health system: feasibility of self-management of oral anticoagulation and long-term performance of individual POC devices in determining INR. J Thromb Thrombolysis 2016; 42 (01) 146-153
- 19 Gardiner C, Williams K, Mackie IJ, Machin SJ, Cohen H. Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. Br J Haematol 2005; 128 (02) 242-247
- 20 Barcellona D, Mastino D, Marongiu F. Portable coagulometer for vitamin K-antagonist monitoring: the patients' point of view. Patient Prefer Adherence 2018; 12: 1521-1526
- 21 Baumann Kreuziger LM. Management of anticoagulation and antiplatelet therapy in patients with left ventricular assist devices. J Thromb Thrombolysis 2015; 39 (03) 337-344
- 22 Lee JH, Lee KS, Kim DS, Lee HS, Choi SI, Cho YG. [Evaluation of CoaguChek XS for measuring prothrombin time in patients receiving long-term oral anticoagulant therapy] (in Korean). Korean J Lab Med 2007; 27 (03) 177-181
- 23 Verhoef TI, Redekop WK, Daly AK, van Schie RM, de Boer A, Maitland-van der Zee AH. Pharmacogenetic-guided dosing of coumarin anticoagulants: algorithms for warfarin, acenocoumarol and phenprocoumon. Br J Clin Pharmacol 2014; 77 (04) 626-641
- 24 Planès S, Villier C, Mallaret M. The nocebo effect of drugs. Pharmacol Res Perspect 2016; 4 (02) e00208
- 25 Christensen H, Lauterlein JJ, Sørensen PD, Petersen ER, Madsen JS, Brandslund I. Home management of oral anticoagulation via telemedicine versus conventional hospital-based treatment. Telemed J E Health 2011; 17 (03) 169-176
- 26 Kuyumjian YM, Miyares MA, Leverock J, Chaparro S, Baker WL, Jennings DL. A multidisciplinary team-based process improves outpatient anticoagulation quality with continuous-flow left-ventricular assist devices. Int J Cardiol 2016; 218: 118-119