Recombinant Activated Factor VII Significantly Reduces Transfusion Requirements in Cardiothoracic Surgery

Abstract

BackgroundThe off-label use of recombinant activated factor VII (rFVIIa) for intractable bleeding is associated with a risk of thrombotic events. The objective of this study was to evaluate the incidence and predictors of rFVIIa-related thrombotic events and its efficacy in the reduction of transfusion requirements during various surgeries.MethodsNinety-two cases received rFVIIa for uncontrollable bleeding despite medical and surgical hemostasis. The incidence and risk factors of thrombotic events were analyzed. Blood products transfused in the 24 h before and after rFVIIa injection were calculated. Subgroup analysis was performed to see which types of surgeries benefited most from rFVIIa.ResultsThe main indication for rFVIIa administration was uncontrollable bleeding during cardiothoracic surgery followed by coagulopathy due to liver failure followed by neurosurgical procedures. Requirements of blood products after rFVIIa decreased significantly by 45 % (p = 0.012), 52 % (p = 0.0001), and 75 % (p = 0.0001) for red blood cells, plasma, and cryoprecipitate, respectively. Subgroup analysis showed that cardiothoracic surgery was the sole group that benefited from rFVIIa with a reduction in transfusion of red blood cells (p = 0.013), plasma (p = 0.0001), and cryoprecipitate (p = 0.0001). Thrombotic events occurred in 9.8 % of the cases mostly on the arterial side (89 %) and have not contributed to mortality.ConclusionrFVIIa can significantly reduce transfusion requirements when given for intractable bleeding during cardiothoracic surgery at the expense of thrombotic events in approximately one tenth of the cases. Further prospective studies are necessary to study if this effect of rFVIIa is translated to a favorable outcome.Electronic supplementary materialThe online version of this article (doi:10.1007/s40268-015-0093-9) contains supplementary material, which is available to authorized users.

Antithrombotic and hemostatic stewardship: evaluation of clinical outcomes and adverse events of recombinant factor VIIa (Novoseven®) utilization at a large academic medical center

“…A number of previously published reports have suggested that rFVIIa is appropriate for rescue therapy of massive bleeding in cardiovascular surgery patients. 9,[20][21][22][23][24][25][26][27][28][29] The NYULH off-label guideline recommends a dose of 20 µg/kg for this indication, followed by repeat dosing of 20 µg/kg to a maximum cumulative dose of 80 µg/kg if needed. This recommendation was implemented in order to mitigate potential harm associated with the use of rFVIIa, without compromising efficacy.…”

“…Although previous studies have used higher doses in this patient population, the antithrombotic therapy oversight group along with cardiac surgery at NYULH recommended a lower initial dose, with the ability to repeat dosing if refractory bleeding persisted. 6,9,20,29 In our evaluation, 77% of doses were according to the NYULH guideline, 4% All values expressed as n (%). One patient had both an ischemic and hemorrhagic stroke.…”

Comparison of low- and high-dose recombinant activated factor VII for postcardiac surgical bleeding

“…Omar et al . [ 30 ] conducted a subgroup analysis for a group of patients received rFVIIa for uncontrolled bleeding. He showed that cardiothoracic surgery subgroup had 4.3% thrombotic events.…”

The Judicious Use of Recombinant Factor VIIa

“…A second study in 70 patients undergoing cardiothoracic surgery found that rFVIIa significantly reduced blood component transfusions postadministration, with 9.8% of patients suffering thromboembolic events. 31 A third single-center experience in 144 complex cardiac surgery patients matched with 359 control patients reported a significant increase in mortality associated with perioperative use of rFVIIa (40 vs. 18%, respectively). 32 In pediatric patients, a single randomized trial was conducted to assess the benefit of prophylactic rFVIIa during and after surgical correction of congenital heart defects while on CBP.…”