Fatal outcome of recombinant factor VIIa in heart transplantation with extracorporeal membrane oxygenation.

Recombinant activated factor VII (rFVIIa) has been approved for treatment of bleeding episodes in patients with hemophilia and in nonhemophilia patients with acquired antibodies against factor VIII or IX. The application of rFVIIa in nonapproved settings, as in cardiac surgery, has not been established. It raises concerns regarding its safety. We used rFVIIa in a patient with excessive nonsurgical bleeding on extracorporeal membrane oxygenation, which was established for early graft failure after heart transplantation and after 3 months of biventricular assist device support. After rFVIIa administration, cardiac thrombosis developed and caused the patient's death.