Thorac Cardiovasc Surg 2017; 65(S 01): S1-S110
DOI: 10.1055/s-0037-1598933
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Very Low-Dose Recombinant Activated Factor VIIa: A Paradigm Shift in Major Bleeding Therapy?

A. Assmann
1   Department of Cardiovascular Surgery and Research Group for Experimental Surgery, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany
,
A. Albert
1   Department of Cardiovascular Surgery and Research Group for Experimental Surgery, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany
,
A. Dierksen
1   Department of Cardiovascular Surgery and Research Group for Experimental Surgery, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany
,
E. Roussel
2   Heinrich Heine University, Medical Faculty, Institute of Haemostaseology, Haemotherapy and Transfusion Medicine, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany
,
S. Sixt
3   Heinrich Heine University, Medical Faculty, Department of Anaesthesiology, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany
,
A. Lichtenberg
1   Department of Cardiovascular Surgery and Research Group for Experimental Surgery, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany
,
T. Hoffmann
2   Heinrich Heine University, Medical Faculty, Institute of Haemostaseology, Haemotherapy and Transfusion Medicine, Medical Faculty, Heinrich Heine University, Duesseldorf, Germany
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Publikationsdatum:
03. Februar 2017 (online)

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Objectives: Recombinant activated factor VIIa (rFVIIa) has become an important component in major bleeding therapy, although its usage in patients without hemophilia is off-label. However, recent reports on enhanced morbidity and mortality in patients after heart surgery, particularly due to thromboembolic complications, have raised a controversy on indications and contraindications of rFVIIa.

The present study evaluated the safety and efficacy of single shot very low-dose rFVIIa (vld-rFVIIa) in cardiosurgical patients.

Methods: Hemostaseological real-time monitoring was conducted in two-hundred-eighty-one patients undergoing heart surgery. Coagulation deficits were compensated by individualized point-of-care hemotherapy. In case of ongoing bleeding (n = 167), a single shot of vld-rFVIIa (≤20 µg/kg) was applied. Morbidity and mortality as well as the hemostatic efficacy were examined in comparison to patients without rFVIIa administration (n = 114).

Results: Neither the risk of thromboembolic complications (6.6 vs. 9.7%; p = 0.372) nor the 30-day (4.4 vs. 7.3%; p = 0.418) or 1-year mortality (14.4 vs. 19.3%; p = 0.325) of vld-rFVIIa patients were increased as compared with patients without rFVIIa. Hence, the hemostatic efficacy proved to be high, since hemostasis was achieved directly after vld-rFVIIa application in 61.3% to 88.6 of the patients (p < 0.0001 in comparison to patients without rFVIIa). Moreover, a “priming effect” was observed, resulting in 97.8% hemostasis after subsequent hemotherapeutic substitution following vld-rFVIIa (vs. 47.3% in patients without previous rFVIIa; p < 0.0001). Besides obvious clinical effects, vld-rFVIIa significantly improved hemostaseological laboratory values such as the CTEXTEM-shortening in thromboelastometry (−19 ± 1.5 seconds vs. −12 ± 2.6 seconds; p < 0.0001) and the prothrombin time (11 ± 0.2 seconds vs. 15 ± 0.4 seconds; p < 0.0001).

Conclusion: Early single shot therapy with very low-dose-rFVIIa optimizes the hemostasis in cardiosurgical patients at high risk of hemorrhage. This dosage of rFVIIa increases neither mortality nor morbidity, particularly respecting thromboembolic complications.