Optimization of anticoagulant therapy in patients undergoing mechanical heart valve replacement
https://doi.org/10.23946/2500-0764-2023-8-3-131-142
Abstract
Acquired heart defects have a high prevalence among patients of different age groups and represent a significant social problem. To date, surgery remains the only effective option to treat acquired heart disease, and replacement of the dysfunctional heart valves frequently relies on mechanical prosthetic heart valves which implantation requires lifelong anticoagulant therapy with vitamin K antagonists and constant monitoring of international normalised ratio. However, the optimal target range for international normalised ratio values remains poorly defined. Optimisation of the approaches to anticoagulant therapy for this category of patients is becoming increasingly important. This paper highlights the main problems and possible solutions for patients who have undergone implantation of mechanical heart valves and need constant intake of vitamin K antagonists.
About the Authors
S. A. TkachenkoRussian Federation
Sofya A. Tkachenko - MD, PhD Student, Cardiologist, Meshalkin National Medical Research Center.
15, Rechkunovskaya Street, 630055
D. A. Astapov
Russian Federation
Dmitry A. Astapov - MD, DSc, Deputy Chief Executive Officer, Meshalkin National Medical Research Center.
15, Rechkunovskaya Street, 630055, Novosibirsk
A. V. Bogachev-Prokofiev
Russian Federation
Alexander V. Bogachev-Prokofiev - MD, DSc, Chief Executive Officer, Institute for Circulatory System Diseases, Meshalkin National Medical Research Center.
15, Rechkunovskaya Street, 630055, Novosibirsk
A. S. Zalesov
Russian Federation
Anton S. Zalesov - MD, Junior Researcher, Department of Novel Surgical Technologies, Institute for Circulatory System Diseases, Meshalkin National Medical Research Center.
15, Rechkunovskaya Street, 630055, Novosibirsk
A. N. Pivkin
Russian Federation
Alexey N. Pivkin - MD, PhD, Cardiovascular Surgeon, Meshalkin National Medical Research Center.
15, Rechkunovskaya Street, 630055, Novosibirsk
A. G. Makaev
Russian Federation
Alexander G. Makaev - MD, Clinical Resident, Major Cardiovascular Surgery, Meshalkin National Medical Research Center.
15, Rechkunovskaya Street, 630055, Novosibirsk
Kh. A. Agaeva
Russian Federation
Khava A. Agaeva - MD, PhD Student, Junior Researcher, Department of Arterial Surgery, Institute for Circulatory System Diseases, Meshalkin National Medical Research Centre.
15, Rechkunovskaya Street, Novosibirsk, 630055
R. M. Sharifulin
Russian Federation
Ravil M. Sharifulin - MD, DSc, Senior Researcher, Department of Novel Surgical Technologies, Institute for Circulatory System Diseases, Meshalkin National Medical Research Center.
15, Rechkunovskaya Street, 630055, Novosibirsk,
References
1. Iung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol. 2014;30:962-70. https://doi.org/10.1016/j.cjca.2014.03.022
2. Yesiltas MA, Haberal І, Kuserli Y, Yildiz A, Koyuncu AO, Ozsoy SD. Comparison of Short and Mid-Term Mortality and Morbidity in Patients With Severe Aortic Stenosis (Intermediate/High Risk) Who Underwent Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement. Heart Surg Forum. 2020;23(2):E212-E220. https://doi.org/10.1532/hsf.2913
3. Williams MA, van Riet S. The On-X heart valve: mid-term results in a poorly anticoagulated population. J Heart Valve Dis. 2006;15:80-6. https://doi.org/10.1111/j.0886-0440.2004.04084.x
4. Taniguchi S, Hashizume K, Ariyoshi T, Hisata Y, Tanigawa K, Miura T, Odate T, Matsukuma S, Nakaji S, Eishi K. Twelve years of experience with the ATS mechanical heart valve prostheses. Gen Thorac Cardiovasc Surg. 2012;60(9):561-568. https://doi.org/10.1007/s11748-012-0124-1
5. Torella M, Torella D, Chiodini P, Franciulli M, Romano G, De Santo L, De Feo M, Amarelli C, Sasso FC, Salvatore T, Ellison GM, Indolfi C, Cotrufo M, Nappi G. LOWERing the INtensity of oral anticoaGulant Therapy in patients with bileaflet mechanical aortic valve replacement: results from the "LOWERING-IT" Trial. Am Heart J. 2010;160(1):171- 178. https://doi.org/10.1016/j.ahj.2010.05.005
6. Model R, Simon P, Wolner E. On-X Prosthetic Heart Valve Trial. The On-X prosthetic heart valve at five years. Ann Thorac Surg. 2002;74:S1312-7. https://doi.org/10.1016/S0003-4975(02)03968-1
7. Eckman MH, Beshansky JR, Durand-Zaleski I, et al. Anticoagulation for noncardiac procedures in patients with prosthetic heart valves. Does low risk mean high cost? JAMA. 1990;263:1513-1521. https://doi.org/10.1001/jama.1990.03440110079032
8. Salem DN, Stein PD, Al-Ahmad A, Bussey HI, Horstkotte D, Miller N, Pauker SG. Antithrombotic therapy in valvular heart disease-native and prosthetic. Chest. 2004;126(Suppl.):457S-482S. https://doi.org/10.1378/chest.126.3_suppl.457S
9. Karas'kov AM, Nazarov VM, Zheleznev SI. Disfunktsii iskusstvennykh klapanov serdtsa. Novosibirsk : Geo, 2008. 247 s. (In Russ.). ISBN 978-5-9747-0125-2
10. Orlovskiy PI, Shevchenko YuL, Gritsenko VV. Iskusstvennye klapana serdtsa. Saint Petersburg: OLMA Media Grupp, 2007. 447 s. ISBN 978-5-373-00314-8
11. Wright IS, Beck DF, Marple CD. Myocardial infarction and its treatment with anticoagulants; summary of findings in 1031 cases. Lancet. 1954;266(6802):92-95. https://doi.org/10.1016/s0140-6736(54)90838-7
12. Hirsh J, Deykin D, Poller L. "Therapeutic range" for oral anticoagulant therapy. Chest. 1986 Feb;89(2 Suppl):11S-15S. https://doi.org/10.1378/chest.89.2_supplement.11s
13. Gadboys HL, Litwak RS, Niemetz J, Wisch N. Role of anticoagulants in preventing embolization from prosthetic heart valves. JAMA. 1967;202:282-286. https://doi.org/10.1001/jama.1967.03130170082012
14. Friedli B, Aerichide N, Grondin P, Campeau L. Thromboembolic complications of heart valve prostheses. Am Heart J. 1971;81:702-708. https://doi.org/10.1016/0002-8703(71)90015-9
15. Chesebro JH, Adams PC, Fuster V. Antithrombotic therapy in patients with valvular heart disease and prosthetic heart valves. J Am Coll Cardiol. 1986;8(6 Suppl B):41B-56B. https://doi.org/10.1016/s0735-1097(86)80006-7
16. Turpie AG, Gunstensen J, Hirsh J, Nelson H, Gent M. Randomised comparison of two intensities of oral anticoagulant therapy after tissue heart valve replacement. Lancet. 1988;1(8597):1242-1245. https://doi.org/10.1016/s0140-6736(88)92070-3
17. Altman R, Rouvier J, Gurfinkel E, D'Ortencio O, Manzanel R, de La Fuente L, Favaloro RG. Comparison of two levels of anticoagulant therapy in patients with substitute heart valves. J Thorac Cardiovasc Surg. 1991;101(3):427-431. https://doi.org/10.1016/S0022-5223(19)36724-8
18. Stein PD, Alpert JS, Copeland J, Dalen JE, Goldman S, Turpie AG. An-tithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest. 1992;102(4 Suppl):445S-455S. https://doi.org/10.1378/chest.102.4_supplement.445s
19. Turpie AG, Gent M, Laupacis A, Latour Y, Gunstensen J, Basile F, Klimek M, Hirsh J. A comparison of aspirin with placebo in patients treated with warfarin after heart-valve replacement. N Engl J Med. 1993;329:524-529. https://doi.org/10.1056/NEJM199308193290802
20. MacIsaac S, Jaffer IH, Belley-Cote EP, McClure GR, Eikelboom JW, Whitlock RP. How Did We Get Here?: A Historical Review and Critical Analysis of Anticoagulation Therapy Following Mechanical Valve Replacement. Circulation. 2019;140(23):1933-1942. https://doi.org/10.1161/CIRCULATIONAHA.119.041105
21. Cannegieter SC, Rosendaal FR, Wintzen AR, van der Meer FJ, Vanden- broucke JP, Briёt E. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med. 1995;333(1):11-17. https://doi.org/10.1056/NEJM199507063330103
22. Acar J, Iung B, Boissel JP, Samama MM, Michel PL, Teppe JP, Pony JC, Breton HL, Thomas D, Isnard R, de Gevigney G, Viguier E, Sfihi A, Hanania G, Ghannem M, Mirode A, Nemoz C. AREVA: multicenter randomized comparison of low-dose versus standard-dose anticoagulation in patients with mechanical prosthetic heart valves. Circulation. 1996;94(9):2107-2112. https://doi.org/10.1161/01.cir.94.9.2107
23. Loeliger EA. Therapeutic target values in oral anticoagulation--justifica- tion of Dutch policy and a warning against the so-called moderate-intensity regimens. Ann Hematol. 1992;64(2):60-65. https://doi.org/10.1007/BF01715346
24. Hering D, Piper C, Bergemann R, Hillenbach C, Dahm M, Huth C, Horstkotte D. Thromboembolic and bleeding complications following St. Jude Medical valve replacement: results of the German Experience With Low-Intensity Anticoagulation Study. Chest. 2005;127(1):53-59. https://doi.org/10.1378/chest.127.1.53
25. Koertke H, Zittermann A, Wagner O, Secer S; Christ of Huth, Sciangu- la A, Saggau W, Sack FU, Ennker J, Cremer J, Musumeci F, Gummert JF. Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants. Eur Heart J. 2015;36(21):1297-1305. https://doi.org/10.1093/eurheartj/ehu330
26. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigo- lin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guide-line for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiolo- gy/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2021 Feb 2;143(5):e228] [published correction appears in Circulation. 2021 Mar 9;143(10):e784]. Circulation. 2021;143(5):e35-e71. https://doi.org/10.1161/CIR.0000000000000932
27. Puskas JD, Gerdisch M, Nichols D, Fermin L, Rhenman B, Kapoor D, Copeland J, Quinn R, Hughes GC, Azar H, McGrath M, Wait M, Kong B, Martin T, Douville EC, Meyer S, Ye J, Jamieson WRE, Land- vater L, Hagberg R, Trotter T, Armitage J, Askew J, Accola K, Levy P, Duncan D, Yanagawa B, Ely J, Graeve A. Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement. J Am Coll Cardiol. 2018;71(24):2717-2726. https://doi.org/10.1016/j.jacc.2018.03.535.
28. Gupta S, Belley-Cote EP, Sarkaria A, Pandey A, Spence J, McClure G, Panchal P, Jaffer IH, An K, Eikelboom J, Whitlock RP. International Normalized Ratio Targets for Left-Sided Mechanical Valve Replacement. Thromb Haemost. 2018;118(5):906-913. https://doi.org/10.1055/s-0038-1637755
29. Brenner B. Haemostatic changes in pregnancy. Thromb Res. 2004;114(5- 6):409-414. https://doi.org/10.1016/j.thromres.2004.08.004.
30. Burke N, Flood K, Murray A, Cotter B, Dempsey M, Fay L, Dicker P, Geary MP, Kenny D, Malone FD. Platelet reactivity changes significantly throughout all trimesters of pregnancy compared with the nonpregnant state: a prospective study. BJOG. 2013;120:1599-1604. https://doi.org/10.1111/1471-0528.12394
31. Holmes VA, Wallace JM. Haemostasis in normal pregnancy: a balancing act? Biochem Soc Trans. 2005;33:428-432. https://doi.org/10.1042/BST0330428
32. Ansari J, Carvalho B, Shafer SL, Flood P. Pharmacokinetics and phar-macodynamics of drugs commonly used in pregnancy and parturition. Anesth Analg. 2016;122:786-804. https://doi.org/10.1097/01.aoa.0000504701.05570.8d
33. Krauer B, Krauer F. Drug kinetics in pregnancy. Clin Pharmacokinet. 1977;2:167-181. https://doi.org/10.2165/00003088-197702030-00002
34. Toyoda K. Antithrombotic therapy for pregnant women. Neurol Med Chir (Tokyo). 2013;53(8):526-530. https://doi.org/10.2176/nmc.53.526
35. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM, Thomas JD. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published correction appears in Circulation. 2014 Jun 10;129(23):e650]. Circulation. 2014;129(23):2440-2492. https://doi.org/10.1161/CIR.0000000000000029
36. Goland S, Elkayam U. Anticoagulation in pregnancy. Cardiol Clin. 2012;30(3):395-405. https://doi.org/10.1016/j.ccl.2012.05.003
37. McLintock C. Anticoagulant therapy in pregnant women with mechanical prosthetic heart valves: no easy option. Thromb Res. 2011;127 Suppl 3:S56-S60. https://doi.org/10.1016/S0049-3848(11)70016-0
38. Cannegieter SC, Rosendaal FR, Briet E. Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. Circulation. 1994;89(2):635-641. https://doi.org/10.1161/01.CIR.89.2.635
39. Makhija N, Tayade S, Tilva H, Chadha A, Thatere U. Pregnancy After Cardiac Surgery. Cureus. 2022;14(11):e31133. https://doi.org/10.7759/cureus.31133
40. Nadeem S, Khilji SA, Ali F, Jalal A. Continued use of Warfarin in lower dose has safe maternal and neonatal outcomes in pregnant women with Prosthetic Heart Valves. Pak J Med Sci. 2021;37(4):933-938. https://doi.org/10.12669/pjms.37.4.3924.
41. Xu Z, Fan J, Luo X, Zhang WB, Ma J, Lin YB, Ma SH, Chen X, Wang ZP, Ou JS, Zhang X. Anticoagulation Regimens During Pregnancy in Patients With Mechanical Heart Valves: A Systematic Review and Meta-analysis. Can J Cardiol. 2016;32(10):1248.e1-1248.e9. https://doi.org/10.1016/j.cjca.2015.11.005
42. van Driel D, Wesseling J, Sauer PJ, Touwen BC, van der Veer E, Heymans HS. Teratogen update: fetal effects after in utero exposure to coumarins overview of cases, follow-up findings, and pathogenesis. Teratology. 2002;66(3):127-140. https://doi.org/10.1002/tera.10054
43. Chan WS, Anand S, Ginsberg JS. Anticoagulation of pregnant women with mechanical heart valves: a systematic review of the literature. Arch Intern Med. 2000;160(2):191-196. https://doi.org/10.1001/archinte.160.2.191
44. Wang J, Li K, Li H, Zhu W, Sun H, Lu C. Comparison of anticoagulation regimens for pregnant women with prosthetic heart valves: A meta-analysis of prospective studies. Cardiovasc Ther. 2017;35(6):10.1111/1755-5922.12292. https://doi.org/10.1111/1755-5922.12292
45. Ayad SW, Hassanein MM, Mohamed EA, Gohar AM. Maternal and Fetal Outcomes in Pregnant Women with a Prosthetic Mechanical Heart Valve. Clin Med Insights Cardiol. 2016;10:11-17. https://doi.org/10.4137/CMC.S36740
46. Leonardi F, Maria N, Villa E. Anticoagulation in cirrhosis: a new paradigm?. Clin Mol Hepatol. 2017;23(1):13-21. https://doi.org/10.3350/cmh.2016.0110
47. Self TH, Owens RE, Sakaan SA, Wallace JL, Sands CW, Howard- Thompson A. Effect of diseases on response to vitamin K antagonists. Curr Med Res Opin. 2016;32(4):613-620. https://doi.org/10.1185/03007995.2015.1134464
48. Leonardi F, Maria N, Villa E. Anticoagulation in cirrhosis: a new paradigm?. Clin Mol Hepatol. 2017;23(1):13-21. https://doi.org/10.3350/cmh.2016.0110
49. McMurry HS, Jou J, Shatzel J. The hemostatic and thrombotic complications of liver disease. Eur J Haematol. 2021;107(4):383-392. https://doi.org/10.1111/ejh.13688
50. Rijken DC, Kock EL, Guimaraes AH, Talens S, Darwish Murad S, Janssen HL, Leebeek FW. Evidence for an enhanced fibrinolytic capacity in cirrhosis as measured with two different global fibrinolysis tests. J Thromb Haemost. 2012;10(10):1538-7836. https://doi.org/10.1111/j.1538-7836.2012.04901.x
51. Tripodi A, Mannucci PM. The coagulopathy of chronic liver disease. N Engl J Med. 2011;365:147-156. https://doi.org/10.1056/NEJMra1011170
52. McMurry HS, Jou J, Shatzel J. The hemostatic and thrombotic complications of liver disease. Eur J Haematol. 2021;107(4):383-392. . https://doi.org/10.1111/ejh.13688
53. Brigden ML, Kay C, Le A, Graydon C, McLeod B. Audit of the frequency and clinical response to excessive oral anticoagulation in an outpatient population. Am J Hematol. 1998;59:22-27. https://doi.org/10.1002/(SICI)1096-8652(199809)59:1<22::AID-AJH5>3.0.CO;2-1
54. Gallus AS, Lucas CR, Hirsh J. Coagulation studies in patients with acute infectious hepatitis. Br J Haematol. 1972;22(6):761-771. https://doi.org/10.1111/j.1365-2141.1972.tb05720.x
55. Lisman T, Kamphuisen PW, Northup PG, Porte RJ. Established and new- generation antithrombotic drugs in patients with cirrhosis - possibilities and caveats. J Hepatol. 2013;59(2):358-366. https://doi.org/10.1016/j.jhep.2013.03.027
56. Hoffman M, Monroe DM. Coagulation 2006: a modern view of hemostasis. Hematol Oncol Clin North Am. 2007;21(1):1-11. https://doi.org/10.1016/j.hoc.2006.11.004
57. Lisman T., Porte R.J. Rebalanced hemostasis in patients with liver disease: evidence and clinical consequences. Blood. 2010;116(6):878- 885. https://doi.org/10.1182/blood-2010-02-261891
58. Steuber TD, Howard ML, Nisly SA. Direct Oral Anticoagulants in Chronic Liver Disease. Annals of Pharmacotherapy. 2019;53(10):1042- 1049. https://doi.org/10.1177/1060028019841582
59. Gallagher J, Biesboer AN, Killian AJ. Pharmacologic Issues in Liver Disease. Crit Care Clin. 2016;32(3):397-410. https://doi.org/ 10.1016/j. ccc.2016.02.003
60. Kumar S, Lim E, Covic A, Verhamme P, Gale CP, Camm AJ, Goldsmith D. Anticoagulation in Concomitant Chronic Kidney Disease and Atrial Fibrillation: JACC Review Topic of the Week. J Am Coll Cardiol. 2019;74(17):2204-2215. https://doi.org/10.1016/j.jacc.2019.08.1031.
61. Potpara TS, Ferro CJ, Lip GYH. Use of oral anticoagulants in patients with atrial fibrillation and renal dysfunction. Nat Rev Nephrol. 2018;14(5):337-351. https://doi.org/10.1038/nrneph.2018.19
62. Lau YC, Proietti M, Guiducci E, Blann AD, Lip GYH. Atrial Fibrillation and Thromboembolism in Patients With Chronic Kidney Disease [published correction appears in J Am Coll Cardiol. 2016 Dec 27;68(25):2921]. J Am Coll Cardiol. 2016;68(13):1452-1464. https://doi.org/10.1016/j.jacc.2016.06.057
63. Aursulesei V, Costache II. Anticoagulation in chronic kidney disease: from guidelines to clinical practice. Clin Cardiol. 2019;42(8):774-782. https://doi.org/10.1002/clc.23196
64. Limdi NA, Nolin TD, Booth SL, Centi A, Marques MB, Crowley MR, Allon M, Beasley TM. Influence of kidney function on risk of supratherapeutic international normalized ratio-related hemorrhage in warfarin users: a prospective cohort study. Am J Kidney Dis. 2015;65(5):701-709. https://doi.org/10.1053/j.ajkd.2014.11.004
65. Sakaan SA, Hudson JQ, Oliphant CS, Tolley EA, Cummings C, Alabdan NA, Self TH. Evaluation of warfarin dose requirements in patients with chronic kidney disease and end-stage renal disease. Pharmacotherapy. 2014;34(7):695-702. https://doi.org/10.1002/phar.1445
66. Limdi NA, Beasley TM, Baird MF, Goldstein JA, McGwin G, Arnett DK, Acton RT, Allon M. Kidney function influences warfarin responsiveness and hemorrhagic complications. J Am Soc Nephrol. 2009;20(4):912-921. https://doi.org/10.1681/asn.2008070802
Review
For citations:
Tkachenko S.A., Astapov D.A., Bogachev-Prokofiev A.V., Zalesov A.S., Pivkin A.N., Makaev A.G., Agaeva Kh.A., Sharifulin R.M. Optimization of anticoagulant therapy in patients undergoing mechanical heart valve replacement. Fundamental and Clinical Medicine. 2023;8(3):131-142. (In Russ.) https://doi.org/10.23946/2500-0764-2023-8-3-131-142