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Ann Thorac Surg 2007;84:168-169
© 2007 The Society of Thoracic Surgeons
a Department of Anesthesiology, Duke University Medical Center, Room 3409A, DUMC Box 3094, Erwin Rd, Durham, NC 27710
b Hemostasis & Thrombosis Center, Duke University Health System, Box 3422, Room 0563 Stead Building, Durham, NC 27710
(Email: welsb001{at}mc.duke.edu; ortel001{at}mc.duke.edu).
So far, the off-label use of recombinant activated factor VII (rFVIIa) in cardiac surgery has been driven by enthusiastic case reports that carry a well-recognized, positive submission and positive publication bias. There is no replacement for prospective, randomized, placebo-controlled data to guide routine clinical practice; case reports are better suited to postmarketing surveillance aimed at identifying adverse events and safety concerns. However, larger retrospective case series or case control studies are helpful both to identify potential safety concerns and pitfalls for prospective studies and to start deciphering the conflicting information surrounding the role of rFVIIa in cardiac surgery.
The current case control study by Agarwal and colleagues [1] is a positive contribution to this literature and the strength of this study lies in the focus on adverse, thrombotic events, which are a major clinical concern when using rFVIIa. The possible extension of a preexisting clot in the extracorporeal membrane oxygenation circuitry (not an uncommon finding), and the thrombotic occlusion of a small caliber, injured vessel after rFVIIa are also sobering thoughts for rFVIIa use in the presence of intraaortic balloon pumps, ventricular assist devices, and small caliber vascular anastamoses.
When the prospective studies are designed, the focus should be on outcome. Chest tube drainage is not an outcome, neither is the sparing of a few blood products in an otherwise massively transfused patient, if the consequence is an increase in morbid thrombosis. A benefit in terms of improved morbidity or mortality and a careful evaluation of safety needs to be demonstrated.
What dose should we use? In cell-based models of thrombin generation, the response to a given dose of rFVIIa is dependent on the concentration of other coagulation proteins and platelets. Such considerations are important when planning a prospective study of rFVIIa, as lower doses may be effective after aggressive transfusion with higher or repeated doses needed when trying to avoid transfusion. Currently there is no consensus on the appropriate dose for off-label use, with reports ranging from 20 to 200 mcg/kg.
As noted by O’Connell and colleagues [2], patients with active bleeding are more at risk of thrombotic complications after rFVIIa. This paradox opens the whole debate about the timing of rFVIIa. Is rescue therapy too late and too risky? Should we identify patients at risk of massive transfusion and deploy selective prophylaxis to preempt massive transfusion? If there is a thrombotic risk, is early treatment justified? These questions will no doubt continue to be debated after the publication of a prospective study, which will not likely answer them all, but at least we will have some evidence to guide our practice.
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  S. Kylasam, K. Mos, S. Fijtin, B. Webster, R. Chard, and J. Egan Recombinant Activated Factor VII Following Pediatric Cardiac Surgery J Intensive Care Med, March 1, 2009; 24(2): 116 - 121. [Abstract] [PDF]
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