Abstract

BACKGROUND

The four-factor Prothrombin Complex Concentrate (4f PCC) is FDA approved for urgent reversal of vitamin K antagonist (VKA) anticoagulation. It offers an alternative to plasma with immediate, low volume reversal. However, there is a risk of thromboembolic events associated with the use of 4f PCC. Patients with ventricular assist devices (VAD) while awaiting heart transplantation are routinely anticoagulated with warfarin and aspirin. At the time of transplant, these must be reversed. We believed that warfarin reversal with 4f PCC could offer advantages over plasma to these patients, but could also increase the risk of thromboembolic events.

PATIENTS AND METHODS

We retrospectively investigated the effects of 4f PCC on bleeding and thromboembolism in VAD patients who underwent orthotopic heart transplantation (VAD-OHT) at our institution. One arm included VAD-OHT patients receiving 4f PCC for urgent warfarin reversal prior to OHT. The other non-4f PCC (control) arm is consecutive VAD-OHT patients receiving plasma for VKA reversal before 4f PCC availability. Endpoints included intra-operative and 24 hour post-operative blood component use; cardiopulmonary bypass (CPB) time, OR time; chest tube output within 24 hour postoperative period; incidence of reoperation for bleeding; time to extubation; 30-day in-house incidence of thrombosis/embolism and 30-day in-house mortality. 4f PCC's impact on the cost of blood components for VAD-OHT patients was investigated by comparing the combined costs of blood products and 4f PCC. Unpaired T-test and chi-square test were used for the statistical analysis.

RESULTS

There were 17 patients in the 4f PCC arm, and 20 patients in non-4f PCC arm.

4f PCC significantly reduced the number of units of transfused red blood cells, single donor platelets, and cryoprecipitate during OHT. The average cost saving from reduced blood product use per patient in the 4f PCC arm was $2388. The average cost of 4f PCC over plasma for warfarin reversal was $2569 per patient, resulting in a net overall additional cost of 4f PCC use per patient of $181. 4f PCC was also associated with a reduced CPB time during the operation. 4f PCC did not significantly affect the other endpoints, suggesting it may have a similar safety profile to plasma for warfarin reversal in VAD-OHT patients.

DISCUSSION

This study shows that 4f PCC, similar to plasma, can be safely used for urgent warfarin reversal in VAD-OHT patients. 4f PCC may be superior to plasma for intraoperative hemostasis in VAD-OHT patients, resulting in a significant reduction in blood component use. The cost saving of intra-and post-operative blood product use mitigated the expense of 4f PCC. To our knowledge, this is the first report on the impact of 4f PCC on VAD-OHT patients. A prospective randomized trial with a larger number of VAD-OHT patients with adequate statistical power is warranted to provide more insight.

Disclosures

No relevant conflicts of interest to declare.

Author notes

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Asterisk with author names denotes non-ASH members.