Abstract
Continuous flow left ventricular assist devices (CF-LVAD) require therapeutic anticoagulation which is often interrupted for procedures or bleeding. Prior to the availability of four factor prothrombin complex concentrate (4F-PCC) in the United States, warfarin was held and its effects reversed by vitamin K or fresh frozen plasma. We evaluated the use of 4F-PCC for temporary warfarin reversal in patients with CF-LVADs and assessed outcomes. This analysis is a retrospective study of CF-LVAD patients who received 4F-PCC for warfarin reversal in the setting of bleeding or need for urgent or elective procedures. Primary outcome assessments included feasibility of administration in elective versus emergent situations, safety measured as incidence of thrombotic events, and change in INR after administration. In total, 37 CF-LVAD patients received 49 4F-PCC administrations. The average 4F-PCC dose was 1842 units (range 518–4292 units), or 22 units/kg (range 5.8–58 units/kg). 4F-PCC significantly decreased the mean INR from 2.9 to 1.7 (p < 0.0001) in 47 of 49 administrations; two patients did not have post infusion INR testing. No cases of new confirmed or suspected pump thrombosis, stroke, venous thromboembolism, arterial thrombosis, or myocardial infarction were observed within 30 days of administration of 4F-PCC. 4F-PCC administration for temporary warfarin reversal was demonstrated to be feasible, effective, and, safe in CF-LVAD patients and judged to be 96% effective in patients for whom data were available. We observed no thrombotic events attributed to use of 4F-PCC.
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Abbreviations
- CF-LVAD:
-
Continuous flow left ventricular assist devices
- IV:
-
Intravenous
- FFP:
-
Fresh frozen plasma
- FDA:
-
Food and Drug Administration
- 4F-PCC, KCentra®:
-
Four-factor prothrombin complex concentrate
- INR:
-
International normalized ratio
- LDH:
-
Lactate dehydrogenase
- IQR:
-
Interquartile range
- PICC:
-
Peripherally inserted central catheter
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Acknowledgements
Rebecca Nashett PharmD, Hisham Badreldin PharmD.
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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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Jessica Rimsans, Amy Levesque, Erin Lyons, Michael Givertz, and Garrick Stewart declares that they have no conflict of interest. Mandeep Mehra is a consult for Abbott, Medtronic Johnson & Johnson, NuPulseCV, Mesoblast, Stealth BioTherapeutics, and Portola. Jean M. Connors has received honoraria from Bristol-Meyer Squibb, Boehringer Ingleheim, and research funding to the institution from CSL Behring.
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Rimsans, J., Levesque, A., Lyons, E. et al. Four factor prothrombin complex concentrate for warfarin reversal in patients with left ventricular assist devices. J Thromb Thrombolysis 46, 180–185 (2018). https://doi.org/10.1007/s11239-018-1680-8
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DOI: https://doi.org/10.1007/s11239-018-1680-8