This Article Résumé de cet Article Full Text Full Text (PDF) Submit a scholarly reply Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Karkouti, K. Articles by Beattie, W. S. Search for Related Content PubMed PubMed Citation Articles by Karkouti, K. Articles by Beattie, W. S.

Determinants of complications with recombinant factor VIIa for refractory blood loss in cardiac surgery

[Les déterminants de complications avec le facteur VIIa recombinant utilisé pour les pertes sanguines réfractaires en chirurgie cardiaque]

Keyvan Karkouti, MD^*,, Terrence M. Yau, MD, Sheila Riazi, MD^*, Kathleen M. Dattilo^*, Marcin Wasowicz, MD^*, Massimiliano Meineri, MD^*, Stuart A. McCluskey, MD^*, Duminda N. Wijeysundera, MD^*,, Adriaan van Rensburg, MD^* and W. Scott Beattie, MD^*

^* From the Departments of Anesthesia, Health Policy, Management, and
Evaluation; and the
Division of Cardiac Surgery, University of Toronto, University Health Network, Toronto, Ontario, Canada.

Address correspondence to: Dr. Keyvan Karkouti, Toronto General Hospital, University Health Network, Department of Anesthesia, 3 Eaton North, 200 Elizabeth Street, Toronto, Ontario M5G 2C4, Canada. Phone: 416-340-5164; Fax: 416-340-3698; E-mail: keyvan.karkouti{at}uhn.on.ca

Purpose: Recombinant factor VIIa (rFVIIa) is being used for refractory, excessive blood loss (EBL) after cardiac surgery, but its safety for this indication is not known.

Methods: The unadjusted and risk-adjusted adverse event (AE) rates were compared between 114 consecutive cardiac surgical patients who received rFVIIa for refractory EBL and 541 concurrent patients who developed EBL but did not receive rFVIIa. Similarly, timing of rFVIIa therapy was assessed by dichotomizing rFVIIa patients based on median number of red blood cell (RBC) units received before therapy. The measured AE was a composite of death, stroke, renal failure, myocardial infarction, and major vein thrombosis. For risk adjustment, logistic regression models for this outcome were constructed using known predictors of AEs.

Results: The median RBC units transfused before rFVIIa therapy was eight. The AE rates in the untreated, early ( 8 U), and late (> 8 U) treated patients were 24% (129/541), 30% (20/66), and 60% (29/48). The risk-adjustment model included total RBC units, pump time, weaning difficulty, gender, weight, and age. The unadjusted and adjusted AE odds ratios (OR) in the treated vs untreated groups were 2.41 [confidence interval (CI) 1.58 – 3.67; P < 0.0001] and 1.04 (CI 0.60 – 1.81; P = 0.9). In the rFVIIa group, the adjusted AE OR was lower in the early treated group (OR 0.41; CI 0.18 – 0.92; P = 0.03).

Conclusion: In cardiac surgical patients with refractory hemorrhage, rFVIIa therapy is not associated with increased risk of AEs, and early treatment may be associated with better outcomes.

This article has been cited by other articles:

				K. Karkouti, W. S. Beattie, R. Arellano, T. Aye, J. S. Bussieres, J. L. Callum, D. Cheng, L. Heinrich, B. Kent, T. W.R. Lee, et al. Comprehensive Canadian Review of the Off-Label Use of Recombinant Activated Factor VII in Cardiac Surgery Circulation, July 22, 2008; 118(4): 331 - 338. [Abstract] [Full Text] [PDF]

				L. J. Bowman, W. E. Uber, M. R. Stroud, L. R. Christiansen, J. Lazarchick, A. J. Crumbley III, J. M. Kratz, J. M. Toole, F. A. Crawford Jr, and J. S. Ikonomidis Use of Recombinant Activated Factor VII Concentrate to Control Postoperative Hemorrhage in Complex Cardiovascular Surgery. Ann. Thorac. Surg., May 1, 2008; 85(5): 1669 - 1677. [Abstract] [Full Text] [PDF]

				S. Dunkley, L. Phillips, P. McCall, J. Brereton, R. Lindeman, G. Jankelowitz, and P. Cameron Recombinant Activated Factor VII in Cardiac Surgery: Experience From the Australian and New Zealand Haemostasis Registry Ann. Thorac. Surg., March 1, 2008; 85(3): 836 - 844. [Abstract] [Full Text] [PDF]

				K. Karkouti REPLY Can J Anesth, December 1, 2007; 54(12): 1027 - 1028. [Full Text] [PDF]

				K. Karkouti and S. A. McCluskey Perioperative blood conservation - The experts, the elephants, the clinicians, and the gauntlet/La conservation peri-operatoire du sang : les experts, les elephants, les cliniciens et le gant Can J Anesth, November 1, 2007; 54(11): 861 - 867. [Full Text] [PDF]

				K. Karkouti, W. S. Beattie, M. A. Crowther, J. L. Callum, R. Chun, S. E. Fremes, J. Lemieux, V. C. McAlister, B. D. Muirhead, J. M. Murkin, et al. The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference: [Le role du facteur VIIa recombinant dans la chirurgie cardiaque avec circulation extra-corporelle : Rapport de la Conference canadienne de consensus] Can J Anesth, July 1, 2007; 54(7): 573 - 582. [Abstract] [Full Text] [PDF]

				K. Karkouti and K. M. Dattilo Perioperative hemostasis and thrombosis Can J Anesth, December 1, 2006; 53(12): 1260 - 1262. [Full Text] [PDF]