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VOLUME 20 , ISSUE 9 ( 2016 ) > List of Articles

RESEARCH ARTICLE

Comparison of low- and high-dose recombinant activated factor VII for postcardiac surgical bleeding

Aly Makram Habib

Keywords : Bleeding, cardiac surgery, low dose, recombinant activated factor VIIa

Citation Information : Habib AM. Comparison of low- and high-dose recombinant activated factor VII for postcardiac surgical bleeding. Indian J Crit Care Med 2016; 20 (9):497-503.

DOI: 10.4103/0972-5229.190365

License: CC BY-ND 3.0

Published Online: 01-09-2016

Copyright Statement:  Copyright © 2016; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Aim of the Study: A retrospective observational study to compare safety and efficacy of high and low doses of recombinant activated factor VIIa (rFVIIa) in severe postcardiac surgical bleeding. Patients and Methods: From 2004 to 2014, all patients who received rFVIIa for bleeding after cardiac surgery were included and arranged in two groups; Group 1: Low dose (40–50 mcg/kg) (n = 98) and Group 2: High dose (90–120 mcg/kg) (n = 156). Results: There was no significant difference in demographic and surgical characteristics of both groups on admission to Cardiac Surgical Intensive Care Unit (CSICU). There was no significant difference between the two groups regarding the reduction in chest tube bleeding in the first 6 h or the transfusion requirement in the 24 h after admission to CSICU. A total of 15 patients (5.9%) had thromboembolic adverse events. (Seven (7.1%) patients in Group 1 compared to 8 (5.1%) patients in Group 2, P = 0.58). There were no significant differences in all-cause mortality at 30 days (2% in Group 1 vs. 3.2% in Group 2, P = 0.6) and at hospital discharge between the two study groups (6.1% in Group 1 vs. 8.3% in Group 2, P = 0.5), respectively. There was no significant difference between the two groups regarding the need for re-exploration, days on mechanical ventilation, CSICU, or hospital stay. Conclusion: In this report, Low-dose rFVIIa showed equivalent efficacy and safety to high-dose rFVIIa. Further prospective randomized studies are needed to confirm these findings.


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  1. Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, et al. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg 2014;147:1458-63.e1.
  2. Karkouti K, Wijeysundera DN, Yau TM, Beattie WS, Abdelnaem E, McCluskey SA, et al. The independent association of massive blood loss with mortality in cardiac surgery. Transfusion 2004;44:1453-62.
  3. Karkouti K, Wijeysundera DN, Beattie WS, Callum JL, Cheng D, Dupuis JY, et al. Variability and predictability of large-volume red blood cell transfusion in cardiac surgery: A multicenter study. Transfusion 2007;47:2081-8.
  4. Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, et al. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. Ann Thorac Surg 2011;91:944-82.
  5. Ferraris VA, Ferraris SP. Limiting excessive postoperative blood transfusion after cardiac procedures. A review. Tex Heart Inst J 1995;22:216-30.
  6. Moulton MJ, Creswell LL, Mackey ME, Cox JL, Rosenbloom M. Reexploration for bleeding is a risk factor for adverse outcomes after cardiac operations. J Thorac Cardiovasc Surg 1996;111:1037-46.
  7. Dacey LJ, Munoz JJ, Baribeau YR, Johnson ER, Lahey SJ, Leavitt BJ, et al. Re-exploration for hemorrhage following coronary artery bypass grafting: Incidence and risk factors. Northern New England cardiovascular disease study group. Arch Surg 1998;133:442-7.
  8. Warren O, Mandal K, Hadjianastassiou V, Knowlton L, Panesar S, John K, et al. Recombinant activated factor VII in cardiac surgery: A systematic review. Ann Thorac Surg 2007;83:707-14.
  9. Diprose P, Herbertson MJ, O'Shaughnessy D, Gill RS. Activated recombinant factor VII after cardiopulmonary bypass reduces allogeneic transfusion in complex non-coronary cardiac surgery: Randomized double-blind placebo-controlled pilot study. Br J Anaesth 2005;95:596-602.
  10. Welsby IJ, Monroe DM, Lawson JH, Hoffmann M. Recombinant activated factor VII and the anaesthetist. Anaesthesia 2005;60:1203-12.
  11. Yank V, Tuohy CV, Logan AC, Bravata DM, Staudenmayer K, Eisenhut R, et al. Systematic review: Benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications. Ann Intern Med 2011;154:529-40.
  12. Al-Ruzzeh S, Navia JL. Letter by Al-Ruzzeh and Navia regarding article, “Safety and efficacy of recombinant activated factor VII: A randomized placebo-controlled trial in the setting of bleeding after cardiac surgery”. Circulation 2010;121:e234.
  13. Hauser CJ, Boffard K, Dutton R, Bernard GR, Croce MA, Holcomb JB, et al. Results of the CONTROL trial: Efficacy and safety of recombinant activated factor VII in the management of refractory traumatic hemorrhage. J Trauma 2010;69:489-500.
  14. Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, et al. Safety and efficacy of recombinant activated factor VII: A randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation 2009;120:21-7.
  15. Willis C, Bird R, Mullany D, Cameron P, Phillips L. Use of rFVIIa for critical bleeding in cardiac surgery: Dose variation and patient outcomes. Vox Sang 2010;98:531-7.
  16. Andersen ND, Bhattacharya SD, Williams JB, Fosbol EL, Lockhart EL, Patel MB, et al. Intraoperative use of low-dose recombinant activated factor VII during thoracic aortic operations. Ann Thorac Surg 2012;93:1921-8.
  17. White MC, Pryn SJ, Monk CR. Thrombogenic side-effects of recombinant factor VIIa after use in coronary artery bypass surgery. Anaesth Intensive Care 2006;34:664-7.
  18. Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, et al. The EuroSCORE II study group. Eur J Cardiothorac Surg 2012;41:734-45.
  19. Brase J, Finger B, He J, Wirtz K, Stun L, McMillen R, et al. Analysis of outcomes using low-dose and early administration of recombinant activated factor VII in cardiac surgery. Ann Thorac Surg 2016;102:35-40.
  20. Payani N, Foroughi M, Dabbagh A. The effect of intravenous administration of active recombinant factor VII on postoperative bleeding in cardiac valve reoperations; a randomized clinical trial. Anesth Pain Med 2015;5:e22846.
  21. Safani M, Drachenberg MR, Ferro ET, Hill SE, Thomas GS, Bethencourt DM. Low-dose recombinant activated factor VII (rFVIIa) for excess hemorrhage after cardiac operation. Ann Thorac Surg 2015;99:1865-70.
  22. Romagnoli S, Bevilacqua S, Gelsomino S, Pradella S, Ghilli L, Rostagno C, et al. Small-dose recombinant activated factor VII (NovoSeven) in cardiac surgery. Anesth Analg 2006;102:1320-6.
  23. Gelsomino S, Lorusso R, Romagnoli S, Bevilacqua S, De Cicco G, Billè G, et al. Treatment of refractory bleeding after cardiac operations with low-dose recombinant activated factor VII [NovoSeven]: A propensity score analysis. Eur J Cardiothorac Surg 2008;33:64-71.
  24. van de Garde EM, Bras LJ, Heijmen RH, Knibbe CA, van Dongen EP, Wiltink EH, et al. Low-dose recombinant factor VIIa in the management of uncontrolled postoperative hemorrhage in cardiac surgery patients. J Cardiothorac Vasc Anesth 2006;20:573-5.
  25. Feih J, Rinka J, Ghadiali H, Kaiser M. High-versus low-dose recombinant activated factor VII use in cardiac surgery patients. Crit Care Med 2015;43(12 Suppl 1):152.
  26. Alfirevic A, Duncan A, You J, Lober C, Soltesz E. Recombinant factor VII is associated with worse survival in complex cardiac surgical patients. Ann Thorac Surg 2014;98:618-24.
  27. Chapman AJ, Blount AL, Davis AT, Hooker RL. Recombinant factor VIIa (NovoSeven RT) use in high risk cardiac surgery. Eur J Cardiothorac Surg 2011;40:1314-8.
  28. Masud F, Bostan F, Chi E, Pass SE, Samir H, Stuebing K, et al. Recombinant factor VIIa treatment of severe bleeding in cardiac surgery patients: A retrospective analysis of dosing, efficacy, and safety outcomes. J Cardiothorac Vasc Anesth 2009;23:28-33.
  29. Hacquard M, Durand M, Lecompte T, Boini S, Briançon S, Carteaux JP. Off-label use of recombinant activated factor VII in intractable haemorrhage after cardiovascular surgery: An observational study of practices in 23 French cardiac centers [2005-7]. Eur J Cardiothorac Surg 2011;40:1320-7.
  30. Omar HR, Enten G, Karlnoski R, Ching YH, Mangar D, Camporesi EM. Recombinant activated factor VII significantly reduces transfusion requirements in cardiothoracic surgery. Drugs R D 2015;15:187-94.
  31. Kouchoukos NT, Blackstone EH, Hanley FL, Kirklin JK. Kirklin/Barrett-Boyes Cardiac surgery: Expert Consult. 4th ed. Philadelphia: Elsevier Saunders; 2013.
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