title: Factor VIII inhibitor bypass activity and recombinant activated factor VII in cardiac surgery.
abstract: OBJECTIVE
  Postcardiopulmonary bypass hemorrhage remains a serious complication of cardiac surgery. Given concerns regarding adverse effects of blood product transfusion and limited efficacy of current antifibrinolytics, procoagulant medications, including recombinant factor VIIa (rFVIIa) and factor eight inhibitor bypass activity (FEIBA), increasingly have been used in managing refractory bleeding. While effective, these medications are associated with thromboembolic complications. This study compared the efficacy and risk of adverse events of rFVIIa and FEIBA in cardiac surgical patients with refractory bleeding.
  
  
  METHODS
  This retrospective study evaluated 168 patients who underwent cardiac surgery and received either FEIBA or rFVIIa to manage postbypass hemorrhage. Demographic, clinical, and outcomes data were collected and statistical analysis performed to compare thromboembolic event rates, relative efficacy, and 30-day mortality following administration of these medications.
  
  
  METHODS
  Single university hospital.
  
  
  METHODS
  Patients undergoing cardiac surgery.
  
  
  METHODS
  None.
  
  
  RESULTS
  Sixty-one patients received rFVIIa, and 107 received FEIBA. Demographics, surgical procedures, and preoperative anticoagulation were similar between the cohorts; however, the rFVIIa cohort had longer durations of cardiopulmonary bypass (305.1 v 243.8 min, p<0.01). There were no significant differences in the number of thromboembolic events, 30-day mortality, or rates of revision surgery. Neither group demonstrated a clear relationship between dosage and occurrence of thromboembolic events. The rFVIIa cohort received more platelets than the FEIBA cohort (3.13 v 1.67 units, p = 0.01), but transfusion rates of other blood products were similar.
  
  
  CONCLUSIONS
  This study suggests that rFVIIa and FEIBA have similar efficacy and adverse event profiles in managing intractable postbypass hemorrhage in cardiac surgical patients. Further prospective studies are required.
authors.affiliation: Department of Anesthesiology, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA. Electronic address: vknayak@stanford.edu.
authors.forename: Vidya K
authors.initials: VK
authors.lastname: Rao
authors.affiliation: Department of Anesthesiology, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Lobato
authors.affiliation: Departments of Pharmacy, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: Blake
authors.initials: B
authors.lastname: Bartlett
authors.affiliation: Departments of Pharmacy, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: Mark
authors.initials: M
authors.lastname: Klanjac
authors.affiliation: Department of Anesthesiology, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: Christina T
authors.initials: CT
authors.lastname: Mora-Mangano
authors.affiliation: Department of Anesthesiology, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: P David
authors.initials: PD
authors.lastname: Soran
authors.affiliation: Department of Anesthesiology, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: Daryl A
authors.initials: DA
authors.lastname: Oakes
authors.affiliation: Department of Anesthesiology, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: Charles C
authors.initials: CC
authors.lastname: Hill
authors.affiliation: Department of Anesthesiology, Stanford Hospital and Clinics, 300 Pasteur Drive, Stanford, CA.
authors.forename: Pieter J
authors.initials: PJ
authors.lastname: van der Starre
mesh_terms: D000328:Adult; D000368:Aged; D001779:Blood Coagulation Factors / Q000494:pharmacology / Q000627:therapeutic use*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000401:mortality; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005169:Factor VIII / Q000037:antagonists & inhibitors*; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies
chemical_list: D001779:Blood Coagulation Factors; D011994:Recombinant Proteins; D005169:Factor VIII; C103587:recombinant FVIIa; C065655:anti-inhibitor coagulant complex; D015942:Factor VIIa
keywords: cardiac anesthesia; cardiac surgery; cardiopulmonary bypass; coagulation; hemorrhage; hemostasis; thromboembolic complications; transfusion