title: Intraoperative use of low-dose recombinant activated factor VII during thoracic aortic operations.
abstract: BACKGROUND
  Numerous studies have supported the effectiveness of recombinant activated factor VII (rFVIIa) for the control of bleeding after cardiac procedures; however safety concerns persist. Here we report the novel use of intraoperative low-dose rFVIIa in thoracic aortic operations, a strategy intended to improve safety by minimizing rFVIIa exposure.
  
  
  METHODS
  Between July 2005 and December 2010, 425 consecutive patients at a single referral center underwent thoracic aortic operations with cardiopulmonary bypass (CPB); 77 of these patients received intraoperative low-dose rFVIIa (≤60 μg/kg) for severe coagulopathy after CPB. Propensity matching produced a cohort of 88 patients (44 received intraoperative low-dose rFVIIa and 44 controls) for comparison.
  
  
  RESULTS
  Matched patients receiving intraoperative low-dose rFVIIa got an initial median dose of 32 μg/kg (interquartile range [IQR], 16-43 μg/kg) rFVIIa given 51 minutes (42-67 minutes) after separation from CPB. Patients receiving intraoperative low-dose rFVIIa demonstrated improved postoperative coagulation measurements (partial thromboplastin time 28.6 versus 31.5 seconds; p=0.05; international normalized ratio, 0.8 versus 1.2; p<0.0001) and received 50% fewer postoperative blood product transfusions (2.5 versus 5.0 units; p=0.05) compared with control patients. No patient receiving intraoperative low-dose rFVIIa required postoperative rFVIIa administration or reexploration for bleeding. Rates of stroke, thromboembolism, myocardial infarction, and other adverse events were equivalent between groups.
  
  
  CONCLUSIONS
  Intraoperative low-dose rFVIIa led to improved postoperative hemostasis with no apparent increase in adverse events. Intraoperative rFVIIa administration in appropriately selected patients may correct coagulopathy early in the course of refractory blood loss and lead to improved safety through the use of smaller rFVIIa doses. Appropriately powered randomized studies are necessary to confirm the safety and efficacy of this approach.
authors.affiliation: Department of Surgery, Division of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA.
authors.forename: Nicholas D
authors.initials: ND
authors.lastname: Andersen
authors.forename: Syamal D
authors.initials: SD
authors.lastname: Bhattacharya
authors.forename: Judson B
authors.initials: JB
authors.lastname: Williams
authors.forename: Emil L
authors.initials: EL
authors.lastname: Fosbol
authors.forename: Evelyn L
authors.initials: EL
authors.lastname: Lockhart
authors.forename: Mayur B
authors.initials: MB
authors.lastname: Patel
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Gaca
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Welsby
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
mesh_terms: D000368:Aged; D001013:Aorta, Thoracic / Q000601:surgery*; D001780:Blood Coagulation Tests; D001803:Blood Transfusion; D019917:Blood Vessel Prosthesis Implantation / Q000191:economics; D002315:Cardiopulmonary Bypass / Q000191:economics; D015331:Cohort Studies; D019091:Critical Pathways; D004305:Dose-Response Relationship, Drug; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D005260:Female; D006324:Heart Arrest, Induced / Q000191:economics; D006488:Hemostasis, Surgical / Q000191:economics / Q000379:methods*; D017721:Hospital Costs / Q000706:statistics & numerical data; D006801:Humans; D007432:Intraoperative Period; D008297:Male; D016555:Matched-Pair Analysis; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000191:economics / Q000517:prevention & control*; D057216:Propensity Score; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D011994:Recombinant Proteins; D015942:Factor VIIa