Abstract
Background: Four factor prothrombin complex (PCC4), a concentrate of
factors II, VII, IX, X and protein C and S, has been used selectively
for reversal of oral anticoagulation prior to surgery. There is data to
support PCC4 as opposed to supplemental fresh frozen plasma (FFP) to
manage postoperative bleeding following cardiac surgery. The
preemptive, intraoperative use of PCC4 in cardiothoracic surgery has not
been studied though it may prevent postoperative bleeding, the need for
blood transfusion and the risk of transfusion related acute lung injury,
volume overload, and right ventricular (RV) heart failure. The purpose
of this study is to evaluate the intraoperative administration of PCC4
to decrease bleeding and lower the rate of blood transfusion.
Methods: A single institution retrospective chart review conducted from
May 2020 to November 2021 of patients who received PCC4 intraoperatively
during cardiothoracic surgery of high risk variety. Patients were
evaluated for type of surgery, demographics, baseline anticoagulation,
PCC4 dose, type and quantity of blood transfusion within 72 hours
postoperatively, chest tube output, incidence of right ventricular
failure, hypersensitivity reactions, acute kidney injury, thrombosis,
acute lung injury, and mortality within 45 days of the operative dose of
PCC4.
Results: Thirty five patients received PCC4 at a mean dose of 2920
units. Sixty five percent of cases were LVAD or heart transplant. The
protocol is to use PCC4 30 units/kilogram immediately after completion
of protamine administration. Inclusion criteria are: cardiothoracic
surgery with increased risk of postoperative right heart failure
commonly secondary to blood product transfusion, or cardiothoracic
surgery associated with increased risk of bleeding, including: heart
transplant, LVAD implant, aortic dissection, and redo sternotomy (e.g.
coronary artery bypass). Total chest tube output was recorded as a mean
of 757 mL for 24 hours after surgery (32 ml/hr). Overall median event
rates of fresh frozen plasma (FFP) and red blood cell (RBC) transfusion
were 0 (interquartile range 0 - 3 units) and 4 (interquartile range 2-5
units). Overall, forty-three percent and eighty-nine percent of cases
received FFP and RBC, respectively. There was one occurrence of right
ventricular failure, one occurrence of acute kidney injury requiring
renal replacement therapy, one occurrence of venoarterial extracorporeal
membrane oxygenation, one occurrence of venous thromboembolism related
to a central venous access line, and one death unrelated to surgery or
PCC4 that was attributed to advanced heart failure not amenable to
advanced therapies.
Conclusion: Overall patients received a low rate of blood transfusion,
had minimal chest tube output, and there was a small incidence of right
heart failure. Patients did not have an increased risk of adverse
effects such as acute kidney injury or venous thromboembolism. A
randomized controlled clinical trial comparing the observed dose and
timing of PCC4 versus routine postoperative bleeding management with
blood product transfusion is recommended.