title: Investigation of outcomes following recombinant activated FVII use for refractory bleeding during abdominal aortic aneurysm repair.
abstract: OBJECTIVE
  To evaluate the outcomes following recombinant activated factor VII (rFVIIa) use during abdominal aortic aneurysms (AAA) repair.
  
  
  METHODS
  AAA patients were selected from the Australian and New Zealand Haemostasis Registry (ANZHR) who received off-licence rFVIIa to control critical bleeding.
  
  
  METHODS
  Patient characteristics and outcomes were compared between responders (bleeding stopped/attenuated) and non-responders (bleeding continued) to rFVIIa, stratified by aneurysm status (ruptured (r-AAA) vs. non-ruptured (nr-AAA)). Patients were also scored using POSSUM (Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity) and Hardman Index mortality predictive models.
  
  
  RESULTS
  In total, 77 AAA patients were included in the analysis. Approximately 73% (n = 56) of them had ruptured aneurysms and about 50% (n = 35/70 with known data) responded positively to rFVIIa. Eleven incidents of thromboembolic adverse events were reported in 9 patients (6 r-AAA and 3 nr-AAA). Responders in both ruptured and non-ruptured groups had significantly lower 28-day mortality than non-responders (r-AAA: 40% (10/25) vs. 92% (24/26); P < 0.001; nr-AAA: 30% (3/10) vs. 67% (6/9); P < 0.01). Mortality predictive models did not show any difference between overall observed and expected mortality in ANZHR patients.
  
  
  CONCLUSIONS
  Patients who responded to rFVIIa had a lower mortality than those who did not respond to the treatment.
authors: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, VIC, Australia. rangi.kandane-rathnayake@monash.edu
authors: R K
authors: RK
authors: Kandane-Rathnayake
authors: C D
authors: CD
authors: Willis
authors: C B
authors: CB
authors: Beiles
authors: B M
authors: BM
authors: Bourke
authors: P A
authors: PA
authors: Cameron
authors: P
authors: P
authors: McCall
authors: L E
authors: LE
authors: Phillips
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001019:Aortic Rupture / Q000401:mortality / Q000601:surgery*; D001315:Australia; D016063:Blood Loss, Surgical / Q000401:mortality / Q000517:prevention & control*; D016009:Chi-Square Distribution; D058734:Exsanguination / Q000517:prevention & control; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000401:mortality
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa