title: Increased recombinant activated factor VII use and need for surgical reexploration following a switch from aprotinin to epsilon-aminocaproic acid in infant cardiac surgery.
abstract: OBJECTIVE
  To evaluate whether conversion from aprotinin to epsilon-aminocaproic acid (EACA) during infant cardiac surgery was associated with increased perioperative bleeding.
  
  
  METHODS
  Structured retrospective chart review.
  
  
  METHODS
  University-affiliated large congenital cardiac surgery program.
  
  
  METHODS
  Records from 145 infants (age < 1 yr) receiving aprotinin as antifibrinolytic therapy for cardiac surgery between 6/1/2006 and 12/31/2006 were compared with a cohort of infants receiving EACA for cardiac surgery between 6/1/2008 and 12/31/2008. Sixty-eight infants received aprotinin and 77 infants received EACA. Measured indicators of perioperative bleeding included transfusion volumes, recombinant activated clotting factor VIIa (rFVIIa) administration, need for reexploration, and perioperative chest tube output.
  
  
  RESULTS
  EACA treated patients received significantly more rFVIIa for uncontrolled bleeding (19/77 [25%] vs 3/68 [4%]; P < 0.001) and required surgical reexploration more frequently (21/77 [27%] vs 7/68 [10%]; P = 0.01]. Median (25th-75th percentiles) intraoperative platelet transfusion requirements were also increased after the switch to EACA (28 mL [0-58 mL] vs 0 mL [0 mL - 34.5 mL]), but this difference did not reach statistical significance (P = 0.06).
  
  
  CONCLUSIONS
  Bleeding in infant cardiac surgery increased following the change in antifibrinolytic therapy from aprotinin to EACA. Given the potential for major harm, especially thrombotic complications, from rFVIIa use, prospective studies examining the safety of postcardiopulmonary bypass rFVIIa administration in infants are necessary before the routine off-label use may be recommended.
authors.affiliation: Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA. Electronic address: scottjake@mcw.edu.
authors.forename: John P
authors.initials: JP
authors.lastname: Scott
authors.affiliation: Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Costigan
authors.affiliation: Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA.
authors.forename: George M
authors.initials: GM
authors.lastname: Hoffman
authors.affiliation: Department of Biostatistics, Division of Quantitative Health Sciences, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA.
authors.forename: Pippa M
authors.initials: PM
authors.lastname: Simpson
authors.affiliation: Department of Biostatistics, Division of Quantitative Health Sciences, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA.
authors.forename: Mahua
authors.initials: M
authors.lastname: Dasgupta
authors.affiliation: Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA.
authors.forename: Rowena
authors.initials: R
authors.lastname: Punzalan
authors.affiliation: Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Berens
authors.affiliation: Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA; Department of Cardiothoracic Surgery, Section of Pediatric Cardiothoracic Surgery, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA.
authors.forename: James S
authors.initials: JS
authors.lastname: Tweddell
authors.affiliation: Department of Anesthesiology, Medical College of Wisconsin, Milwaukee WI 53201-3022, USA; Children's Hospital of Wisconsin, Milwaukee WI 53201-1997, USA.
authors.forename: Eckehard A E
authors.initials: EA
authors.lastname: Stuth
mesh_terms: D015119:Aminocaproic Acid / Q000627:therapeutic use*; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D007611:Aprotinin / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000517:prevention & control; D001803:Blood Transfusion / Q000706:statistics & numerical data; D006348:Cardiac Surgical Procedures / Q000379:methods*; D015942:Factor VIIa / Q000008:administration & dosage; D006490:Hemostatics / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D017713:Platelet Transfusion / Q000706:statistics & numerical data; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies
chemical_list: D000933:Antifibrinolytic Agents; D006490:Hemostatics; D011994:Recombinant Proteins; D007611:Aprotinin; C103587:recombinant FVIIa; D015942:Factor VIIa; D015119:Aminocaproic Acid
keywords: Antifibrinolytic therapy; Aprotinin; Cardiac surgery, pediatric; Epsilon-aminocaproic acid; Infant cardiac surgery; Perioperative bleeding; Tranexamic acid