Abstract
Background: The genetically engineered recombinant activated factor VII (rFVIIa) was primarily developed for the treatment of bleeding episodes in haemophilia patients with inhibitors. Different outcomes have been described in a number of studies evaluating the off-label use in patients with liver disease and consequently with complex coagulopathies. We here evaluated the use of rFVIIa in patients undergoing orthotopic liver transplantation (OLT). The aim of this study was to determine the safety within this patient population. Methods: Overall, 1343 OLTs were performed at Hannover Medical School between 2002 and 2014. Out of this group we selected patients having received rFVIIa in the early phase after OLT. We retrospectively analyzed the outcome of patients treated with rFVIIa and compared our findings to those from other transplant centers. Results: In a single center retrospective analysis we identified eight patients after OLT who received treatment with rFVIIa (0.59%). Five out of eight (62.5%) patients suffered graft loss due to hepatic artery thrombosis (HAT). None of these patients had a history of thrombosis or signs of hypercoagulopathy. 60% of the patients who developed HAT had a primary graft non-function. Interestingly, rFVIIa administration was the only risk factor for HAT and consequently for graft loss in our cohort. Other known risk factors such as cold ischaemic time, number of anastomoses, donor age of > 60 years and CMV status could be excluded. Conclusion: This study shows that rFVIIa treatment is a highly likely risk factor for the development of HAT and consequently graft loss in patients after OLT. Thus, usage of rFVIIa in this patient population should be avoided.
Highlights
Orthotopic liver transplantation (OLT) is the standard of care and the only definitive treatment for patients with end-stage liver disease (ESLD)
Most life-threatening complications associated with orthotopic liver transplantation (OLT) occur within the perioperative period and include primary graft dysfunction, severe infections and technical complications such as hepatic artery thrombosis (HAT) or biliary leaks [4,5]
No patients were excluded from this analysis due to loss of followup (Figure 1). rFVIIa was available in our center since approval by the European Medicines Agency (EMA) in 1996
Summary
Orthotopic liver transplantation (OLT) is the standard of care and the only definitive treatment for patients with end-stage liver disease (ESLD). Advancement in surgical and pharmacological treatment has led to high rates of graft and patient survival, one major source of post-operative morbidity in patients receiving OLT continues to be extensive bleeding [6]. Reasons for post-operative bleeding are multifactorial and include technical difficulties and graft dysfunction with ongoing severe coagulopathy. Different outcomes have been described in a number of studies evaluating the off-label use in patients with liver disease and with complex coagulopathies. We here evaluated the use of rFVIIa in patients undergoing orthotopic liver transplantation (OLT). The aim of this study was to determine the safety within this patient population
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