Use of recombinant activated factor VII concentrate to control postoperative hemorrhage in complex cardiovascular surgery.
BACKGROUND
Complex cardiovascular surgery often results in postoperative hemorrhage. Excessive blood product use may cause systemic thrombosis, end-organ dysfunction, and edema preventing chest closure. Recombinant activated factor VII (rFVIIa) concentrate may decrease hemorrhage where other treatment measures failed. We reviewed our experience with rFVIIa after complex cardiovascular surgery.


METHODS
A retrospective review evaluating 846 complex cardiovascular surgery patients of whom 36 received rFVIIa between January 1, 2001, and December 31, 2006, was performed. Efficacy and safety data were collected for the entire cohort in addition to delayed sternal closure requirements, reoperation, and operative mortality in the patient cohort temporally separated into two groups (pre-rFVIIa era, 2001 to 2003, 1 patient received rFVIIa; rFVIIa era, 2004 to 2006, 35 patients received rFVIIa).


RESULTS
A total of 36 patients received 41 rFVIIa doses with an in-hospital survival of 91.7%. Hemorrhage was controlled in 83.3% of patients, with 1 dose sufficient in 75.0%. There was a significant decrease (p < 0.005) in all blood product requirements post-rFVIIa compared with pre-rFVIIa administration. In the intensive care unit (n = 6), rFVIIa significantly reduced chest tube output (p = 0.028) and prevented reexploration for bleeding in 5 patients. The requirement for delayed sternal closure was significantly higher in the pre-rFVIIa era versus the rFVIIa era (p = 0.011). The incidence of thrombosis in all patients receiving rFVIIa was 11.1%. In the rFVIIa era, a higher incidence of postoperative renal failure (p = 0.005) and pneumonia (p < 0.002) was detected in patients receiving rFVIIa.


CONCLUSIONS
Recombinant activated factor VII appears to be effective in patients with refractory coagulopathy undergoing high-risk cardiovascular surgery.
Bowman
Lyndsey J
LJ
Department of Pharmacy Services, Medical University of South Carolina, Charleston, South Carolina 29425, USA.
Uber
Walter E
WE
Stroud
Martha R
MR
Christiansen
Lydia R
LR
Lazarchick
John
J
Crumbley
Arthur J
AJ
Kratz
John M
JM
Toole
John M
JM
Crawford
Fred A
FA
Ikonomidis
John S
JS
D058186:Acute Kidney Injury / Q000139:chemically induced / Q000401:mortality; D000328:Adult; D000368:Aged; D001018:Aortic Diseases / Q000097:blood / Q000601:surgery*; D001780:Blood Coagulation Tests; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006331:Heart Diseases / Q000097:blood / Q000601:surgery*; D016027:Heart Transplantation; D017052:Hospital Mortality; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000139:chemically induced / Q000401:mortality; D019106:Postoperative Hemorrhage / Q000097:blood / Q000401:mortality / Q000517:prevention & control*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012086:Reoperation; D012189:Retrospective Studies; D012307:Risk Factors; D013927:Thrombosis / Q000139:chemically induced / Q000401:mortality
D011994:Recombinant Proteins; D015942:Factor VIIa