Recombinant Factor VIIa (rFVIIa) is often used intra-operatively for refractory bleeding in heart and lung transplant recipients (HTxR, LTxR). While this off-label use may help achieve hemostasis, the risk of post-operative thromboembolic (TE) events in such patients has not been well characterized. We sought to determine if TE event frequency was increased in HTxR and LTxR who received intra-operative rFVIIa versus controls.

The primary outcome of this retrospective, case-controlled study was the proportion of HTxR and LTxR who developed upper or lower extremity (UE, LE) deep vein thrombosis (DVT), pulmonary embolism, embolic stroke, ventricular clot, or myocardial infarction in patients receiving intra-operative rFVIIa versus controls. rFVIIa patients were matched 1:1 with controls based on transplant date and indication. TE events occurring up to 7 days post-Tx were included. Fisher’s exact and the t-test were used for categorical and continuous variables, respectively.

Thirty-six rFVIIa patients were included; 29 HTxR and 7 LTxR. The proportion of patients with a TE event was significantly higher in the rFVIIa group (Table1 and Table2). More rFVIIa patients had vascular ultrasounds (US) performed in the first 7 days versus controls [16 (44.4%) vs. 5 (13.9%), p = 0.009]; however, the proportion of those patients with a positive US was similar [9/16 (56%) vs. 2/5 (40%), p = 0.6].

A higher proportion of HTxR and LTxR who received intra-operative rFVIIa had a TE event within 7 days of transplantation versus controls. The majority of TE events were UE DVTs. However, 1 stroke and 1 LE DVT occurred in the rFVIIa group; neither of these events occurred in controls. More data, perhaps from multiple centers, is needed to better define the risks and benefits of intra-operative rFVIIa in HTxR and LTxR.

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