Efficacy and Safety of Recombinant Factor VII as Rescue for Severe Perioperative Bleeding in HeartMate II Recipients.
BACKGROUND
We aimed to study the efficacy and safety of recombinant factor VIIa (rFVIIa) for management of perioperative bleeding in HeartMate II recipients.


METHODS
Fifty-seven patients underwent HeartMate II implantation. Sixteen patients received rFVIIa (six intraop, eight early postop, and two both intra- and postop). The effect of rFVIIa on transfusion of blood products as well as the amount of chest tube drainage was used to assess efficacy and 30-day incidence of thromboembolic events was used to assess safety.


RESULTS
Patients who received intraoperative rFVIIa had been transfused significantly more blood products prior to rFVIIa administration compared to total amount of intraoperatively transfused blood products in those who did not receive intra-op rFVIIa; however, there were no significant differences in the amount of transfused blood products and chest tube output in the 24-hour postoperative period between the two groups. Postoperative administration of rFVIIa did not have a significant impact on the amount of red blood cell transfusion but there was a trend towards decreased requirement for fresh frozen plasma (mean 2.7 vs. 1.1, p = 0.08), platelet (1.5 vs. 0.7, p = 0.14), and cryoprecipitate (5.3 vs. 1.2, p = 0.09). The hourly rate of chest tube output also decreased significantly from an average of 235 ± 57 mL/hour prior to rFVIIa administration to an average of 98 ± 36 mL/hour in the first four hours after rFVIIa administration (p value = 0.003). There were no 30-day thromboembolic events in those patients who received rFVIIa.


CONCLUSIONS
This study supports selective use of rFVIIa in HeartMate II recipients for the management of severe perioperative bleeding.
Department of Medicine, Division of Cardiology, University of Florida, Gainesville, Florida.
Ashkan
A
Karimi
Department of Anesthesiology, University of Florida, Gainesville, Florida.
Sarah S
SS
Daigle
Department of Anesthesiology, University of Florida, Gainesville, Florida.
William B
WB
Smith
Department of Anesthesiology, University of Florida, Gainesville, Florida.
Gregory M
GM
Janelle
Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida.
Charles T
CT
Klodell
D000328:Adult; D000368:Aged; D001803:Blood Transfusion / Q000706:statistics & numerical data; D015942:Factor VIIa / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006470:Hemorrhage / Q000209:etiology* / Q000517:prevention & control* / Q000628:therapy; D006801:Humans; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D012306:Risk; D012449:Safety; D012720:Severity of Illness Index; D013923:Thromboembolism / Q000453:epidemiology / Q000209:etiology
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa