title: Administration of recombinant activated factor VII in the intensive care unit after complex cardiovascular surgery: clinical and economic outcomes.
abstract: OBJECTIVE
  Refractory bleeding after complex cardiovascular surgery often leads to increased length of stay, cost, morbidity, and mortality. Recombinant activated factor VII administered in the intensive care unit can reduce bleeding, transfusion, and surgical re-exploration. We retrospectively compared factor VII administration in the intensive care unit with reoperation for refractory bleeding after complex cardiovascular surgery.
  
  
  METHODS
  From 1501 patients who underwent cardiovascular procedures between December 2003 and September 2007, 415 high-risk patients were identified. From this cohort, 24 patients were divided into 2 groups based on whether they either received factor VII in the intensive care unit (n = 12) or underwent reoperation (n = 12) for refractory bleeding. Preoperative and postoperative data were collected to compare efficacy, safety, and economic outcomes.
  
  
  RESULTS
  In-hospital survival for both groups was 100%. Factor VII was comparable with reoperation in achieving hemostasis, with both groups demonstrating decreases in chest tube output and need for blood products. Freedom from reoperation was achieved in 75% of patients receiving factor VII, whereas reoperation was effective in achieving hemostasis alone in 83.3% of patients. Prothrombin time, international normalized ratio, and median operating room time were significantly less (P < .05) in patients who received factor VII. Both groups had no statistically significant differences in other efficacy, safety, or economic outcomes.
  
  
  CONCLUSIONS
  Factor VII administration in the intensive care unit appears comparable with reoperation for refractory bleeding after complex cardiovascular surgical procedures and might represent an alternative to reoperation in selected patients. Future prospective, randomized controlled trials might further define its role.
authors: Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA.
authors: Walter E
authors: WE
authors: Uber
authors: John M
authors: JM
authors: Toole
authors: Martha R
authors: MR
authors: Stroud
authors: Jason S
authors: JS
authors: Haney
authors: John
authors: J
authors: Lazarchick
authors: Fred A
authors: FA
authors: Crawford
authors: John S
authors: JS
authors: Ikonomidis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000191:economics; D003362:Cost-Benefit Analysis; D003422:Critical Care / Q000191:economics*; D016527:Drug Costs; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D005260:Female; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000191:economics*; D006490:Hemostatics / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D017721:Hospital Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D018579:Patient Selection; D011182:Postoperative Care / Q000191:economics; D019106:Postoperative Hemorrhage / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D012086:Reoperation; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013022:South Carolina; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa