The Intraoperative Use Of Recombinant Activated Factor VII In Arterial Switch Operations
Ziyad Binsalamah, Jessica Zink, Christopher Ibarra, Zachary Spigel, Iki Adachi, Michiaki Imamura, Jeffrey Heinle.
Baylor College of Medicine, Houston, TX, USA.
The rate of bleeding complications following arterial switch operation (ASO) is too low to justify a prospective randomized study for benefit from recombinant activated factor VII (rFVIIa). We aimed to evaluate these points in a pilot study.
We performed a retrospective cohort study of patients undergoing ASO from 2012-2017. Nearest-neighbor propensity score matching on age, gender, weight, and associated cardiac defects was used to match 27 controls not receiving rFVIIa to 31 patients receiving rFVIIa. Fisher’s exact test was performed to compare categorical variables. Wilcoxon’s Rank Sum test was used to compare continuous variables between cohorts
There was no difference in bleeding complications post-operatively between the rFVIIa cohort and controls (10% vs 19%, p = 0.45), nor was there a difference in thrombotic complications (3% vs 11%, p=0.33). Volume of packed red blood cell transfusion was clinically higher in the rFVIIa cohort (337ml ± 102 vs 386ml ± 108, p=0.086). All other intra-operative transfusion volumes were not different between the rFVIIa cohort and controls. Post-operative coagulation levels were lower in rFVIIa cohort relative to controls (PT [11.5 ± 1.79 vs 16.2 ± 1.47, p<.0001] and INR [0.85 ± 0.17 vs 1.3 ± 0.14, p<.0001])
In spite of a higher post-bypass packed red blood cell transfusion requirement, patients receiving rFVIIa had a similar incidence of bleeding post-operatively. With no difference in thrombotic complications, and with improved post-operative laboratory hemostasis, a prospective randomized study is warranted to evaluate rFVIIa.