Use of Recombinant Factor VIIa(Novoseven??) in Combination with Other Coagulation Products Led to a Thrombotic Occlusion of the Truncus Brachiocephalicus in a Neonate Supported by Extracorporal Membrane Oxygenation

To the Editor: A 15-day-old girl weighing 3000 g with a thoracal arteriovenous extracorporal membrane oxygenation (ECMO) device in situ presented for replacement of a partially occluded pulmonalis graft on day 7 post-Ross procedure. Indication for the Ross procedure (1) was initially given by a congenital aortic stenosis accompanied by left ventricular fibroelastosis. Because weaning from cardiopulmonary bypass failed, thoracal arteriovenous ECMO had to be restarted. In addition to protamine sulfate (7300 IU), fresh-frozen plasma (5 U), platelets (3 U) and red packed blood cells (5 U), we also administered coagulation factor preparations (1200 IU activated prothrombin complex concentrate (Prothromplex total®, Baxter AG, Vienna, Austria); 1000 IU antithrombin III (Atenativ®, Biovitrum, Stockholm, Sweden); 2 g fibrinogen (Hemocompletan®, Aventis-Behring, Vienna, Austria). Although laboratory findings and modified thrombelastography indicated improved coagulation, bleeding from pulmonary left upper lobe fistulas increased despite extensive surgical hemostasis. Only administration of recombinant Factor VIIa (90 μg/kg IV) brought sufficient hemostasis. Postoperatively, life-threatening bleeding from the pulmonary fistulas suddenly recurred. Because the child had already been undergoing ECMO therapy for 1 wk, further surgical therapy was avoided. Autopsy revealed fresh thrombotic occlusion of both subclavian arteries and the truncus brachiocephalicus (Fig. 1). We recommend that caution be exercised in administering recombinant Factor VIIa in neonates supported by a circulatory assist device, especially when other coagulation products are also administered.Figure 1.: Thrombus is shown in the truncus brachiocephalicus (arrow).