Discussion
Limitations including: single-center, unblinded study design, and
retrospective chart review make it prohibitive to perform robust data
analysis. It is difficult to discern true benefit compared to available
meta-analysis data, which predominantly compares PCC4 to blood product
administration after this surgical population is already
bleeding postoperatively .6
Transfusion rates and amount of individual blood products compare
favorably to available literature, including compared to the
meta-analysis’ data trending toward less products used ((overall FFP
rate of 0 (IQR 0-3 units) compared to available literature 3-14
units)).5,6,7 Further, chest tube output was lower
than generally expected as described in the literature for this surgical
population (overall output of 757 ml compared to 935ml +/-
583).7 Comparable incidence of volume overload driven
right ventricular failure and acute kidney injury were low when
reviewing the current literature, where AKI has been described as
potentially more likely post PCC4 dosing in this surgical
population.6,8,9 Our findings did not support the
notion of this kidney injury risk, albeit a smaller sample size. To
concretize the intervention and its potential benefit, this analysis at
minimum establishes an intermediate weight based PCC4 dose, operative
timing, and consideration for PCC4 where it is believed the data
presented is favorable for the use in select patients undergoing high
risk cardiac surgery, and perhaps more specifically, those patients
undergoing aortic dissection, LVAD placement, or heart transplant.
From a cost to provide intervention perspective, PCC4 costs
approximately $1.81 per unit. Therefore, a dose of approximately 3,000
units costs $5450 per dose. Comparatively, the acquisition cost at our
institution to provide a single unit of fresh frozen plasma is $ 200,
packed red blood cells $ 196, platelets $ 634, and cryoprecipitate $
475 for one pooled bag of five units. The cost of intensive care
management for a transfusion-dependent postoperative patient is
substantial, and for the purposes of this review, is too challenging to
quantitatively describe; although, the cost avoidance of such
complications would seem significant. From this data it is reasonable to
suggest that providing a single dose of PCC4 intraoperatively after
protamine at minimum may positively impact critical blood product
supply, and even more so offset the cost of blood product administration
and its deleterious clinical consequences. Compared to available
individual trial and meta-analysis data, the patients in our sample had
less blood transfusion, decreased postoperative chest tube site
bleeding, no increase in acute kidney injury or occlusive disease, and a
low incidence of right ventricular dysfunction. Specifically, the
cost-benefit to the patient by principally avoiding transfusion related
acute lung injury, volume associated right ventricular dysfunction,
additional intensive care unit time and ultimately, the associated
increase in intensive care complications - may be where the patient most
benefits. The use of intraoperative PCC4 timed to be given immediately
after protamine may decrease bleeding complications, right heart
failure, and the unfavorable collateral damage associated with blood
product transfusion. Further large randomized controlled trials are
recommended.