title: Recombinant factor VII is associated with worse survival in complex cardiac surgical patients.
abstract: BACKGROUND
  Recombinant activated factor VII (rFVIIa) decreases requirements for allogeneic blood transfusion and chest reexploration in patients undergoing cardiac surgery. Whether rFVIIa increases the risk of postoperative adverse events is unclear. We tested whether rFVIIa administration was associated with increased mortality and neurologic and renal morbidity in patients undergoing cardiac surgery. Risk of thromboembolic complications and the dose-response of rFVIIa on mortality and morbidity were also evaluated.
  
  
  METHODS
  Of 27,977 patients who had complex cardiac surgery, 164 patients (0.59%) received rFVIIa perioperatively. Using propensity-matching techniques, patients were matched to a maximum of 3 control patients. Patients who received rFVIIa were compared with control patients on risk of mortality, neurologic and renal morbidity, and thromboembolic complications, including a composite of myocardial infarction, pulmonary embolism, and deep venous thrombosis. A corresponding dose-response analysis using multivariable logistic regression was also performed.
  
  
  RESULTS
  Propensity techniques successfully matched 144 patients (88%) with 359 control patients. Of patients who received rFVIIa, 40% experienced in-hospital mortality compared with 18% of control patients (odds ratio, 2.82; 98.3% confidence interval, 1.64 to 4.87; p<0.001). Furthermore, 31% of patients treated with rFVIIa versus 17% of control patients experienced renal morbidity (odds ratio, 2.07; 98.3% confidence interval, 1.19 to 3.62; p=0.002); however, neurologic morbidity and thromboembolic complications were not different among groups. High-dose rFVIIa (>60 μg/kg) did not increase the risk for mortality compared with treatment with low-dose rFVIIa (<60 μg/kg).
  
  
  CONCLUSIONS
  Administration of rFVIIa is associated with increased mortality and renal morbidity in patients undergoing cardiac surgery.
authors: Department of Cardiothoracic Anesthesia, Cleveland Clinic, Cleveland, Ohio. Electronic address: alfirea@ccf.org.
authors: Andrej
authors: A
authors: Alfirevic
authors: Department of Cardiothoracic Anesthesia, Cleveland Clinic, Cleveland, Ohio.
authors: Andra
authors: A
authors: Duncan
authors: Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.
authors: Jing
authors: J
authors: You
authors: Pharmacy Department, Cleveland Clinic, Cleveland, Ohio.
authors: Cheryl
authors: C
authors: Lober
authors: Cardiothoracic Surgery, Cleveland Clinic, Cleveland, Ohio.
authors: Edward
authors: E
authors: Soltesz
mesh_terms: D006348:Cardiac Surgical Procedures / Q000401:mortality*; D015942:Factor VIIa / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000139:chemically induced / Q000453:epidemiology; D011994:Recombinant Proteins / Q000009:adverse effects; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa