Progress of anticoagulant therapy of the patients with mechanical prosthetic valve replacement_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

HE Fan ^1,2 ,  XIAO Xijun ¹

1. Department of Cardiovascular Surgery, West China Hospital of Sichuan University, Chengdu, 610041, P.R.China;
2. Heart Center of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, 310020, P.R.China;

Corresponding author：

XIAO Xijun, Email: dr_xijunxiao@163.com

Keywords：

Mechanical heart valve replacement; early anticoagulation; warfarin

DOI：

10.7507/1007-4848.201511034

Video：

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The patients with mechanical prosthetic valve replacement need anticoagulant therapy for all their life. The incidence of thromboembolism and anticoagulation-related bleeding events still account for major postoperative complications after mechanical heart valve replacement. Most of the complications happen in the first half year after operation. Therefore, early anticoagulation therapy is very important. Of course, so far most guidelines focus stating their opinions on long-term anticoagulant therapy. However, there is no consensus about anticoagulant therapy in the early period of postoperation. In this review, we summarize early anticoagulant therapy of the patients with mechanical heart valve replacement through consulting domestic and abroad relevant research in recent years and give an overview of the present situations of early anticoagulant therapy.

Citation： HE Fan, XIAO Xijun. Progress of anticoagulant therapy of the patients with mechanical prosthetic valve replacement. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2017, 24(11): 896-901. doi: 10.7507/1007-4848.201511034 Copy

1.	Chesebro JH, Adams PC, Fuster V. Antithrombotic therapy in patients with valvular heart disease and prosthetic heart valves. J Am Coll Cardiol, 1986, 8(6s2): 41B-56B.
2.	Koertke H, Minami K, Boethig D, et al. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation, 2003, 108(10 suppl 1): II75-II78.
3.	Kulik A, Rubens FD, Wells PS, et al. Early postoperative anticoagulation after mechanical valve replacement: a systematic review. Ann ThoracSurg, 2006, 81(2): 770-781.
4.	朱晓东, 张宝仁, 主编. 心脏外科学. 北京: 人民卫生出版社. 2007. 808-821.
5.	Stein B, Fuster V, Halperin JL, et al. Antithrombotic therapy in cardiac disease. An emerging approach based on pathogenesis and risk. Circulation, 1989, 80(6): 1501-1513.
6.	Nemerson Y, Turitto VT. The effect of flow on hemostasis and thrombosis. Thromb Haemost, 1991, 66(3): 272-276.
7.	Torn M, Cannegieter SC, Bollen WL, et al. Optimal level of oral anticoagulant therapy for the prevention of arterial thrombosis in patients with mechanical heart valve prostheses, atrial fibrillation, or myocardial infarction: a prospective study of 4202 patients. Arch Intern Meds, 2009, 169(13): 1203-1209.
8.	Brais M, Braunwald NS. Acceleration of tissue ingrowth on materials implanted in the heart. Ann Thorac Surg, 1976, 21(3): 221-229.
9.	Bull B, Braunwald NS. Human histopathologic response to a completely fabric-covered prosthetic heart valve. Ann Surg, 1971, 174(5): 755.
10.	Butchart EG,Lewis PA, Kulatilake EN, et al. Anticoagulation variability between centres: implications for comparative prosthetic valve assessment. Eur J Cardiothorac Surg, 1987, 2(2): 72-81.
11.	Butchart EG, Lewis PA, Bethel JA, et al. Adjusting anticoagulation to prosthesis thrombogenicity and patient risk factors. Recommendations for the Medtronic Hall valve.Circulation, 1991, 84(5 Suppl): Ⅲ61-Ⅲ69.
12.	Haibo Z, Jinzhong L, Yan L, et al. Low-intensity international normalized ratio (INR) oral anticoagulant therapy in Chinese patients with mechanical heart valve prostheses. Cell Biochem Biophys, 2012, 62(1): 147-151.
13.	Meijer K, Kim YK, Schulman S. Decreasing warfarin sensitivity during the first three months after heart valve surgery: Implications for dosing. Thromb Res, 2010, 125(3): 224-229.
14.	Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med, 2009, 361(12): 1139-1151.
15.	Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.N Engl J Med, 2011, 365(10): 883-891.
16.	Larsen TB, Rasmussen LH, Skjøth F, et al. Efficacy and safety of dabigatran etexilate and warfarin in " real-world” patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol, 2013, 61(22): 2264-2273.
17.	刁明强, 董力. 心脏机械瓣膜置换术后早期抗凝及监测.中国胸心血管外科临床杂志, 2005, 12(2):110-113.
18.	聂艳霞, 张志彪, 李娟, 等. 影响华法林抗凝作用的因素. 血栓与止血学, 2007, 13(4): 170-172.
19.	Kulik A, Rubens FD, Wells PS, et al. Early postoperative anticoagulation after mechanical valve replacement: a systematic review. Ann Thorac Surg, 2006, 81(2): 770-781.
20.	Bonow RO, Carabello BA, Chatterjee K, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation, 2008, 118(15): e523-e661.
21.	Ageno W, Turpie AG, Steidl L, et al. Comparison of a daily fixed 2.5-mg warfarin dose with a 5-mg, international normalized ratio adjusted, warfarin dose initially following heart valve replacement. Am J Cardiol, 2001, 88(1): 40-44.
22.	Passaglia LG, Barros GM, Sousa MR. Early postoperative bridging anticoagulation after mechanical heart valve replacement: a systematic review and meta-analysis. J Thromb Haemost, 2015, 13(9): 1557-1567.
23.	Mathew JG, Spyropoulos AC, Yusuf A, et al. Efficacy and safety of early parenteral anticoagulation as a bridge to warfarin after mechanical valve replacement. Thromb Haemost, 2014, 112(6): 1120-1128.
24.	Thulin LI, Olin CL. Initiation and long-term anticoagulation after heart valve replacements. Arq Bras Cardiol, 1987, 49(5): 265-268.
25.	Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest, 2004, 126(3 suppl): 338S-400S.
26.	Hirsh J, Raschke R. Raschke, Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest, 2004, 126(3 suppl): 188S-203S.
27.	Hirsh J, Warkentin TE, Shaughnessy SG, et al. Heparin and low-molecular-weight heparin mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest, 2001, 119(1 suppl): 64S-94S.
28.	Spyropoulos AC, Turpie AG, Dunn AS, et al. Perioperative bridging therapy with unfractionated heparin or low-molecular-weight heparin in patients with mechanical prosthetic heart valves on long-term oral anticoagulants (from the REGIMEN Registry). Am J Cardiol, 2008, 102(7): 883-889.
29.	Kindo M, Gerelli S, Minh TH, et al. Exclusive low-molecular-weight heparin as bridging anticoagulant after mechanical valve replacement. Ann thorac Surg, 2014, 97(3): 789-795.
30.	Fanikos J, Tsilimingras K, Kucher N, et al. Comparison of efficacy, safety, and cost of low-molecular-weight heparin with continuous-infusion unfractionated heparin for initiation of anticoagulation after mechanical prosthetic valve implantation. Am J Cardiol, 2004, 93(2): 247-250.
31.	Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012) The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg, 2012, 33(19): 2451-2496.
32.	Turpie AG, Gent M, Laupacis A, et al. A comparison of aspirin with placebo in patients treated with warfarin after heart-valve replacement. N Engl J Med, 1993, 329(8): 524-529.
33.	Koertke H, Zittermann A, Tenderich G, et al. Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II. Eur Heart J, 2007, 28(20): 2479-2484.
34.	Little SH, Massel DR. Antiplatelet and anticoagulation for patients with prosthetic heart valves. Cochrane Database Syst Rev, 2003, (4): CD003464.
35.	Wen MS, Lee MT. Warfarin pharmacogenetics: new life for an old drug. Acta Cardiologica Sinica, 2013, 29(3): 235-242.
36.	Torella M, Torella D, Chiodini P, et al. 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.
37.	Puskas J, Gerdisch M, Nichols D, et al. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg, 2014, 147(4): 1202-1210.
38.	Pruefer D, Dahm M, Dohmen G, et al. Intensity of oral anticoagulation after implantation of St.Jude Medical mitral or multiple valve replacement: lessons learned from GELIA (GELIA 5). Eur Heart J Suppl, 2001, 3(suppl Q): Q39-Q43.
39.	Kodani E, Atarashi H, Inoue H, et al. Target intensity of anticoagulation with warfarin in Japanese patients with valvular atrial fibrillation-subanalysis of the J-RHYTHM Registry.Circ J, 2015, 79(2): 325-330.
40.	Zhou XM, Zhuang W, Hu JG, et al. Low-dose anticoagulation in Chinese patients with mechanical heart valves. Asian Cardiovasc Thorac Ann, 2005, 13(4): 341-344.
41.	Kimmel SE. Warfarin therapy: in need of improvement after all these years. Expert Opin Pharmacother, 2008, 9(5): 677-686.
42.	郑策, 梅丹. 影响华法林抗凝血作用的有关因素. 药物不良反应杂志, 2007, 9(4): 256-261.
43.	Haber LT, Maier A, Gentry PR, et al. Genetic polymorphisms in assessing interindividual variability in delivered dose. Regul Toxicol Pharmacol, 2002, 35(2Pt 1): 177-197.
44.	Kealey C, Chen Z, Christie J, et al. Warfarin and cytochrome P450 2C9 genotype: possible ethnic variation in warfarin sensitivity. Pharmacogenomics, 2007, 8(3): 217-225.
45.	Yuan HY, Chen JJ, Lee MT, et al. A novel functional VKORC1 promoter polymorphism is associated with inter-individual and inter-ethnic differences in warfarin sensitivity. Hum Mol Genet, 2005, 14(13):1745-1751.
46.	Miao L, Yang J, Huang C, et al. Contribution of age, body weight, and CYP2C9 and VKORC1 genotype to the anticoagulant response to warfarin: proposal for a new dosing regimen in Chinese patients. Eur J Clin Pharmacol, 2007, 63(12): 1135-1141.
47.	Yang L, Ge W, Yu F, et al. Impact of VKORC1 gene polymorphism on interindividual and interethnic warfarin dosage requirement—a systematic review and meta analysis. Thromb Res, 2010, 125(4): e159-e166.
48.	Caldwell MD, Awad T, Johnson JA, et al. CYP4F2 genetic variant alters required warfarin dose. Blood, 2008, 111(8): 4106-4112.
49.	Borgiani P, Ciccacci C, Forte V, et al. CYP4F2 genetic variant (rs2108622) significantly contributes to warfarin dosing variability in the Italian population. Pharmacogenomics, 2009, 10(2): 261-266.

1. Chesebro JH, Adams PC, Fuster V. Antithrombotic therapy in patients with valvular heart disease and prosthetic heart valves. J Am Coll Cardiol, 1986, 8(6s2): 41B-56B.
2. Koertke H, Minami K, Boethig D, et al. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation, 2003, 108(10 suppl 1): II75-II78.
3. Kulik A, Rubens FD, Wells PS, et al. Early postoperative anticoagulation after mechanical valve replacement: a systematic review. Ann ThoracSurg, 2006, 81(2): 770-781.
4. 朱晓东, 张宝仁, 主编. 心脏外科学. 北京: 人民卫生出版社. 2007. 808-821.
5. Stein B, Fuster V, Halperin JL, et al. Antithrombotic therapy in cardiac disease. An emerging approach based on pathogenesis and risk. Circulation, 1989, 80(6): 1501-1513.
6. Nemerson Y, Turitto VT. The effect of flow on hemostasis and thrombosis. Thromb Haemost, 1991, 66(3): 272-276.
7. Torn M, Cannegieter SC, Bollen WL, et al. Optimal level of oral anticoagulant therapy for the prevention of arterial thrombosis in patients with mechanical heart valve prostheses, atrial fibrillation, or myocardial infarction: a prospective study of 4202 patients. Arch Intern Meds, 2009, 169(13): 1203-1209.
8. Brais M, Braunwald NS. Acceleration of tissue ingrowth on materials implanted in the heart. Ann Thorac Surg, 1976, 21(3): 221-229.
9. Bull B, Braunwald NS. Human histopathologic response to a completely fabric-covered prosthetic heart valve. Ann Surg, 1971, 174(5): 755.
10. Butchart EG,Lewis PA, Kulatilake EN, et al. Anticoagulation variability between centres: implications for comparative prosthetic valve assessment. Eur J Cardiothorac Surg, 1987, 2(2): 72-81.
11. Butchart EG, Lewis PA, Bethel JA, et al. Adjusting anticoagulation to prosthesis thrombogenicity and patient risk factors. Recommendations for the Medtronic Hall valve.Circulation, 1991, 84(5 Suppl): Ⅲ61-Ⅲ69.
12. Haibo Z, Jinzhong L, Yan L, et al. Low-intensity international normalized ratio (INR) oral anticoagulant therapy in Chinese patients with mechanical heart valve prostheses. Cell Biochem Biophys, 2012, 62(1): 147-151.
13. Meijer K, Kim YK, Schulman S. Decreasing warfarin sensitivity during the first three months after heart valve surgery: Implications for dosing. Thromb Res, 2010, 125(3): 224-229.
14. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med, 2009, 361(12): 1139-1151.
15. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.N Engl J Med, 2011, 365(10): 883-891.
16. Larsen TB, Rasmussen LH, Skjøth F, et al. Efficacy and safety of dabigatran etexilate and warfarin in " real-world” patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol, 2013, 61(22): 2264-2273.
17. 刁明强, 董力. 心脏机械瓣膜置换术后早期抗凝及监测.中国胸心血管外科临床杂志, 2005, 12(2):110-113.
18. 聂艳霞, 张志彪, 李娟, 等. 影响华法林抗凝作用的因素. 血栓与止血学, 2007, 13(4): 170-172.
19. Kulik A, Rubens FD, Wells PS, et al. Early postoperative anticoagulation after mechanical valve replacement: a systematic review. Ann Thorac Surg, 2006, 81(2): 770-781.
20. Bonow RO, Carabello BA, Chatterjee K, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation, 2008, 118(15): e523-e661.
21. Ageno W, Turpie AG, Steidl L, et al. Comparison of a daily fixed 2.5-mg warfarin dose with a 5-mg, international normalized ratio adjusted, warfarin dose initially following heart valve replacement. Am J Cardiol, 2001, 88(1): 40-44.
22. Passaglia LG, Barros GM, Sousa MR. Early postoperative bridging anticoagulation after mechanical heart valve replacement: a systematic review and meta-analysis. J Thromb Haemost, 2015, 13(9): 1557-1567.
23. Mathew JG, Spyropoulos AC, Yusuf A, et al. Efficacy and safety of early parenteral anticoagulation as a bridge to warfarin after mechanical valve replacement. Thromb Haemost, 2014, 112(6): 1120-1128.
24. Thulin LI, Olin CL. Initiation and long-term anticoagulation after heart valve replacements. Arq Bras Cardiol, 1987, 49(5): 265-268.
25. Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest, 2004, 126(3 suppl): 338S-400S.
26. Hirsh J, Raschke R. Raschke, Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest, 2004, 126(3 suppl): 188S-203S.
27. Hirsh J, Warkentin TE, Shaughnessy SG, et al. Heparin and low-molecular-weight heparin mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest, 2001, 119(1 suppl): 64S-94S.
28. Spyropoulos AC, Turpie AG, Dunn AS, et al. Perioperative bridging therapy with unfractionated heparin or low-molecular-weight heparin in patients with mechanical prosthetic heart valves on long-term oral anticoagulants (from the REGIMEN Registry). Am J Cardiol, 2008, 102(7): 883-889.
29. Kindo M, Gerelli S, Minh TH, et al. Exclusive low-molecular-weight heparin as bridging anticoagulant after mechanical valve replacement. Ann thorac Surg, 2014, 97(3): 789-795.
30. Fanikos J, Tsilimingras K, Kucher N, et al. Comparison of efficacy, safety, and cost of low-molecular-weight heparin with continuous-infusion unfractionated heparin for initiation of anticoagulation after mechanical prosthetic valve implantation. Am J Cardiol, 2004, 93(2): 247-250.
31. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012) The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg, 2012, 33(19): 2451-2496.
32. Turpie AG, Gent M, Laupacis A, et al. A comparison of aspirin with placebo in patients treated with warfarin after heart-valve replacement. N Engl J Med, 1993, 329(8): 524-529.
33. Koertke H, Zittermann A, Tenderich G, et al. Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II. Eur Heart J, 2007, 28(20): 2479-2484.
34. Little SH, Massel DR. Antiplatelet and anticoagulation for patients with prosthetic heart valves. Cochrane Database Syst Rev, 2003, (4): CD003464.
35. Wen MS, Lee MT. Warfarin pharmacogenetics: new life for an old drug. Acta Cardiologica Sinica, 2013, 29(3): 235-242.
36. Torella M, Torella D, Chiodini P, et al. 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.
37. Puskas J, Gerdisch M, Nichols D, et al. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg, 2014, 147(4): 1202-1210.
38. Pruefer D, Dahm M, Dohmen G, et al. Intensity of oral anticoagulation after implantation of St.Jude Medical mitral or multiple valve replacement: lessons learned from GELIA (GELIA 5). Eur Heart J Suppl, 2001, 3(suppl Q): Q39-Q43.
39. Kodani E, Atarashi H, Inoue H, et al. Target intensity of anticoagulation with warfarin in Japanese patients with valvular atrial fibrillation-subanalysis of the J-RHYTHM Registry.Circ J, 2015, 79(2): 325-330.
40. Zhou XM, Zhuang W, Hu JG, et al. Low-dose anticoagulation in Chinese patients with mechanical heart valves. Asian Cardiovasc Thorac Ann, 2005, 13(4): 341-344.
41. Kimmel SE. Warfarin therapy: in need of improvement after all these years. Expert Opin Pharmacother, 2008, 9(5): 677-686.
42. 郑策, 梅丹. 影响华法林抗凝血作用的有关因素. 药物不良反应杂志, 2007, 9(4): 256-261.
43. Haber LT, Maier A, Gentry PR, et al. Genetic polymorphisms in assessing interindividual variability in delivered dose. Regul Toxicol Pharmacol, 2002, 35(2Pt 1): 177-197.
44. Kealey C, Chen Z, Christie J, et al. Warfarin and cytochrome P450 2C9 genotype: possible ethnic variation in warfarin sensitivity. Pharmacogenomics, 2007, 8(3): 217-225.
45. Yuan HY, Chen JJ, Lee MT, et al. A novel functional VKORC1 promoter polymorphism is associated with inter-individual and inter-ethnic differences in warfarin sensitivity. Hum Mol Genet, 2005, 14(13):1745-1751.
46. Miao L, Yang J, Huang C, et al. Contribution of age, body weight, and CYP2C9 and VKORC1 genotype to the anticoagulant response to warfarin: proposal for a new dosing regimen in Chinese patients. Eur J Clin Pharmacol, 2007, 63(12): 1135-1141.
47. Yang L, Ge W, Yu F, et al. Impact of VKORC1 gene polymorphism on interindividual and interethnic warfarin dosage requirement—a systematic review and meta analysis. Thromb Res, 2010, 125(4): e159-e166.
48. Caldwell MD, Awad T, Johnson JA, et al. CYP4F2 genetic variant alters required warfarin dose. Blood, 2008, 111(8): 4106-4112.
49. Borgiani P, Ciccacci C, Forte V, et al. CYP4F2 genetic variant (rs2108622) significantly contributes to warfarin dosing variability in the Italian population. Pharmacogenomics, 2009, 10(2): 261-266.

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