Safety and efficacy of aprotinin and tranexamic acid in pulmonary endarterectomy surgery with hypothermia: review of 200 patients

Abstract

Background: The effectiveness and safety of aprotinin in cardiac surgery has been questioned. The study aim was to compare both the blood-sparing effect and side effects of aprotinin and tranexamic acid in patients undergoing pulmonary endarterectomy.

Methods: Data were analyzed retrospectively for 200 consecutive patients who underwent pulmonary endarterectomy between October 2006 and September 2009. Pulmonary endarterectomy was performed with deep hypothermia (20°C) in all patients. Antifibrinolytic therapy changed from aprotinin to tranexamic acid in June 2008 after the withdrawal of aprotinin in the United Kingdom.

Results: Mean age was 55.9 years, and 58% of subjects were male. One hundred patients were studied in each group. Postoperatively, a higher incidence of seizures in the first 48 hours was seen with tranexamic acid compared with aprotinin (11% versus 4%, p = 0.06). This difference became statistically significant when excluding patients with structural brain lesions from both groups (7 versus 0, p = 0.02). Tranexamic acid patients had significantly higher median blood loss (700 mL versus 525 mL, p = 0.01). There was no significant difference between the groups in reexploration for bleeding, renal failure requiring hemofiltration, intensive care unit stay, median total stay in hospital, or in-hospital mortality.

Conclusions: In our experience of patients undergoing pulmonary endarterectomy, the tranexamic acid group had a higher median blood loss and more seizures. The trend to increased seizure frequency in the tranexamic acid group may be a direct consequence of this treatment, consistent with other recently published reports.