Journal of Cardiothoracic and Vascular Anesthesia
Volume 23, Issue 1 , Pages 34-40 , February 2009

Recombinant Activated Factor VII in Cardiac Surgery: A Meta-analysis

  • Alberto Zangrillo, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
  • ,
  • Anna Mizzi, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
  • ,
  • Giuseppe Biondi-Zoccai, MD

      Affiliations

    • Interventional Cardiology, Division of Cardiology, University of Turin, Turin, Italy
  • ,
  • Elena Bignami, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
  • ,
  • Maria Grazia Calabrò, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
  • ,
  • Federico Pappalardo, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
  • ,
  • Elisa Dedola, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
  • ,
  • Luigi Tritapepe, MD

      Affiliations

    • Department of Anesthesiology and Intensive Care, University of Rome “La Sapienza,” Rome, Italy
  • ,
  • Giovanni Marino, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
  • ,
  • Giovanni Landoni, MD

      Affiliations

    • Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milan, Italy
    • Corresponding Author InformationAddress reprint requests to Giovanni Landoni, MD, Department of Cardiothoracic Anesthesia and Intensive Care, Istituto Scientifico San Raffaele, Via Olgettina 60, 20132 Milan, Italy

References 

  1. Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007;356:2301–2311
  2. Carson JL, Diff A, Berlin JA, et al. Perioperative blood transfusion and postoperative mortality. JAMA. 1998;279:199–205
  3. Unsworth-White MJ, Herriot A, Valencia O, et al. Resternotomy for bleeding after cardiac operation: A marker for increased morbidity and mortality. Ann Thorac Surg. 1995;59:664–667
  4. Moulton MJ, Creswell LL, Mackey ME, et al. Reexploration for bleeding is a risk factor for adverse outcomes after cardiac operations. J Thorac Cardiovasc Surg. 1996;111:1037–1046
  5. Crabtree TD, Codd JE, Fraser VJ, et al. Multivariate analysis of risk factors for deep and superficial sternal infection after coronary artery bypass grafting at a tertiary care medical center. Semin Thorac Cardiovasc Surg. 2004;16:53–61
  6. Karkouti K, Wijeysundera DN, Yau TM, et al. The independent association of massive blood loss with mortality in cardiac surgery. Transfusion. 2004;44:1453–1462
  7. Monroe DM, Hoffman M, Oliver JA, et al. Platelet activity of high dose factor VIIa is independent of tissue factor. Br J Haematol. 1997;99:542–547
  8. Hedner U, Erhardtsen E. Potential role for rFVIIa in transfusion medicine. Transfusion. 2002;42:114–124
  9. Karkouti K, Beattie WS, Wijeysundera DN, et al. Recombinant factor VIIa for intractable blood loss after cardiac surgery: A propensity score-matched case-control analysis. Transfusion. 2005;45:26–34
  10. Diprose P, Herbertson MJ, O'Shaughnessy D, et al. 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
  11. Von Heymann C, Redlich U, Jain U, et al. Recombinant activated factor VII for refractory bleeding after cardiac surgery—A retrospective analysis of safety and efficacy. Crit Care Med. 2005;33:2241–2246
  12. Gelsomino S, Lorusso R, Romagnoli S, 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
  13. Tritapepe L, De Santis V, Vitale D, et al. Recombinant activated factor VII for refractory bleeding after acute aortic dissection surgery: A propensity score analysis. Crit Care Med. 2007;35:1685–1690
  14. Von Heymann C, Hotz H, Konertz W, et al. Successful treatment of refractory bleeding with recombinant factor VIIa after redo coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2002;16:615–616
  15. Van de Garde EMW, Bras LJ, Heijmen RH, et al. Low-dose recombinant factor VIIa in the management of uncontrolled postoperative hemorrhage in cardiac surgery patients. J Cardiothorac Vasc Anesth. 2006;20:573–575
  16. Faber P, Reid C, El-Shafei H, et al. Recombinant factor VIIa in the management of postoperative bleeding after repair for inadvertently thrombolysed acute type A aortic dissection. J Cardiothorac Vasc Anesth. 2006;20:736–741
  17. Bui JD, Despotis GD, Trulock EP, et al. Fatal thrombosis after administration of activated prothrombin complex concentrates in a patient supported by extracorporeal membrane oxygenation who had received activated recombinant factor VII. J Thorac Cardiovasc Surg. 2002;124:852–854
  18. Pang G, Donaldson A. Probable right atrial thrombus immediately after recombinant activated factor VII administration. Br J Anaesth. 2007;99:221–225
  19. White MC, Pryn SJ, Monk CR. Thrombogenic side-effects of recombinant factor VIIa after use in coronary artery bypass surgery. Anaesth Intensive Care. 2006;34:664–667
  20. Lichtman AD, Carullo V, Minhaj M, et al. Case 6-2007: Massive intraoperative thrombosis and death after recombinant activated factor VII administration. J Cardiothorac Vasc Anesth. 2007;21:897–902
  21. Reade MC, Toyoda YN, Murray HN. Failure of an Abiomed ventricular assist device in association with factor VIIa administration. Minerva Anestesiol. 2008;74:145–148
  22. Mayer SA, Brun NC, Broderick J, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005;352:777–785
  23. Ranucci M, Isgrò G, Soro G, et al. Efficacy and safety of recombinant activated factor VII in major surgical procedures: Systematic review and meta-analysis of randomised clinical trials. Arch Surg. 2008;143:296–304
  24. Biondi-Zoccai GGL, Agostoni P, Abbate A, et al. A simple hint to improve Robinson and Dickersin's highly sensitive PubMed search strategy for controlled clinical trials. Int J Epidemiol. 2005;34:224–225
  25. Fleiss JL. The statistical basis of meta-analysis. Stat Methods Med Res. 1993;2:121–145
  26. Higgins JPT, Green S. The Cochrane Handbook for Systematic Reviews of Interventions 4.2.5. http://www.cochrane.org/resources/handbook/hbook.htmAccessed October 10, 2005
  27. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–560
  28. Karkouti K, Yau MT, Riazi S, et al. Determinants of complications with recombinant factor VIIa for refractory blood loss in cardiac surgery. Can J Anaesth. 2006;53:802–809
  29. McCall P, Story DA, Karapillai D. Audit of factor VVIa for bleeding resistant to conventional therapy following complex cardiac surgery. Can J Anaesth. 2006;53:926–933
  30. Diprose P, Gill R. The potential role for recombinant factor VIIa in cardiac surgery. Br J Cardiol (Acute Interv Cardiol). 2004;11:77–79
  31. Warren O, Mandal K, Hadjianastassiou V, et al. Recombinant activated factor VII in cardiac surgery: A systematic review. Ann Thoracic Surg. 2007;83:707–714
  32. Karkouti K, Bettie WS, Crowther MA, et al. The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference. Can J Anaesth. 2007;54:573–582
  33. Karkouti K, Beattie WS, Arellano R, et al. Comprehensive Canadian review of the off-label use of recombinant activated factor VII in cardiac surgery. Circulation. 2008;118:331–338
  34. Bowman LJ, Uber WE, Stroud MR, et al. Use of recombinant activated factor VII concentrate to control postoperative hemorrhage in complex cardiovascular surgery. Ann Thorac Surg. 2008;85:1669–1677
  35. Dunkley S, Phillips L, McCall P, et al. Recombinant activated factor VII in cardiac surgery: Experience from the Australian and New Zealand Haemostasis Registry. Ann Thorac Surg. 2008;85:836–844
  36. Isbister J, Phillips L, Dunkley S, et al. Recombinant activated factor VII in critical bleeding: Experience from the Australian and New Zealand Haemostasis Register. Intern Med J. 2008;38:156–165
  37. Ekert H, Brizard C, Eyers R, et al. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: Controlled study of rFVIIa and standard haemostatic replacement therapy. Blood Coag Fibrinolysis. 2006;17:389–395
  38. Essam MA, Essam M. Prophylactic administration of recombinant activated factor VII in coronary revascularizaion surery. The Internet Journal of Anesthesiology. 2007;17:389–395vol 13, no 1 http://www.ispub.com/ostia/index.php?xmlFilePath=journals/ija/vol13n1/factor.xmlAccessed November 1, 2008
  39. Romagnoli S, Bevilacqua S, Gelsomino S, et al. Small-dose recombinant activated factor VII (NovoSeven) in cardiac surgery. Anesth Analg. 2006;102:1320–1326
  40. Murphy GJ, Reeves BC, Rogers CA, et al. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007;116:2544–2552
  41. Koch CG, Li L, Sessler DI, et al. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008;358:1229–1239
  42. Karkouti K, Beattie WS. Pro: The role of recombinant factor VIIa in cardiac surgery. J Cardiothorac Vasc Anesth. 2008;22:779–782
  43. Al-Ruzzeh S, Ibrahim K, Navia JL. Con: The role of recombinant factor VIIa in the control of bleeding after cardiac surgery. J Cardiothorac Vasc Anesth. 2008;22:783–785
  44. Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: A meta-analysis of randomized control trials. Ann Surg. 2008;248:61–68
  45. Use of activated recombinant factor VII in cardiac surgery. http://clinicaltrials.gov/ct2/show/NCT00154427?term=rFVIIa&rank=8Accessed November 1, 2008
  46. Biondi-Zoccai GG, Agostoni P, Abbate A. Parallel hierarchy of scientific studies in cardiovascular medicine. Ital Heart J. 2003;4:819–820

 This study is part of a senior training project of the Meta-analysis, and Evidence-based medicine Training in Cardiology (METCARDIO) Center, based in Milan, Italy (http://www.metcardio.org).

PII: S1053-0770(08)00298-X

doi: 10.1053/j.jvca.2008.09.017

Journal of Cardiothoracic and Vascular Anesthesia
Volume 23, Issue 1 , Pages 34-40 , February 2009