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Ann Thorac Surg 2007;84:168-169
© 2007 The Society of Thoracic Surgeons

Original Articles: Cardiovascular

Invited commentary

Ian J. Welsby, MBBSa, Thomas L. Ortel, MD, PhDb

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@mc.duke.edu; ortel001@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 . . . [Full Text of this Article]


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