Many strategies, including intraoperative acute normovolemic
hemodilution (ANH) and pharmacologic agents, exist to minimize the use of allogeneic blood products in pediatric congenital heart surgery. Recombinant activated
factor VIIa (
rFVIIa) is a
hemostatic agent approved for the treatment of
bleeding episodes and prevention of
bleeding in surgical interventions in patients with
hemophilia A or B with inhibitors, acquired
hemophilia, or congenital
factor VII deficiency.
Off-label use in nonhemophilic patients for uncontrolled
hemorrhage is increasing although still under investigation. We present our experience with ANH and
rFVIIa in nine patients. All were <16 months of age and underwent complex cardiac surgery with the end point of achieving hemostasis while decreasing or eliminating the need for allogeneic blood products. Clinically, we have observed rapid hemostasis in patients who underwent ANH and then had autologous blood reinfused after
cardiopulmonary bypass, along with
rFVIIa, without any time delay. The patients required no allogeneic blood products and therefore results suggested the potential utility of this practice. The study group consisted of nine patients <16 months of age who received
rFVIIa in the operating room after open-heart surgery. Amount of autologous blood removed preoperatively, blood product use, time from
protamine to
rFVIIa administration, platelet count, INR, and
fibrinogen level were retrospectively obtained. Of the nine patients, the three who underwent the most aggressive
hemodilution received
rFVIIa most rapidly and required no allogeneic blood products to achieve hemostasis although they had an average lower
fibrinogen level on admission to the cardiothoracic intensive care unit. These preliminary data suggest that
hemodilution before surgical stimulation and the rapid administration of
rFVIIa, along with the reintroduction of autologous blood, may decrease or potentially eliminate the need for allogeneic blood products. Prospective trials are warranted to further explore this technique.