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The intraoperative use of recombinant activated factor VII in arterial switch operations

Published online by Cambridge University Press:  19 November 2020

Jessica Zink ,
Zachary A. Spigel Open the ORCID record for Zachary A. Spigel [Opens in a new window] ,
Christopher Ibarra Open the ORCID record for Christopher Ibarra [Opens in a new window] ,
Erin A. Gottlieb ,
Iki Adachi ,
Carlos M. Mery ,
Michiaki Imamura ,
Jeffrey S. Heinle ,
Emmett Dean McKenzie  and
Charles D. Fraser
...Show all authors
Jessica Zink
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
Zachary A. Spigel
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
Christopher Ibarra
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
Erin A. Gottlieb
Affiliation:
Dell Children’s Medical Center of Central Texas, Austin, TX, USA
Iki Adachi
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
Carlos M. Mery
Affiliation:
Dell Children’s Medical Center of Central Texas, Austin, TX, USA
Michiaki Imamura
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
Jeffrey S. Heinle
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
Emmett Dean McKenzie
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
Charles D. Fraser
Affiliation:
Dell Children’s Medical Center of Central Texas, Austin, TX, USA
Ziyad M. Binsalamah*
Affiliation:
Texas Children’s Hospital, Houston, TX, USA
*
Author for correspondence: Ziyad M. Binsalamah, MD, MSc, FRCSC, Division of Congenital Heart Surgery, Texas Children’s Hospital; Michael E. DeBakey Department of Surgery, Baylor College of Medicine 6651 Main street, LT19345H, Houston, TX 77030, USA. Tel: +1 832 826 1929; Fax: +1 832 825 1905. E-mail: ziyadmss@gmail.com
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Abstract

Background:

The rate of bleeding complications following arterial switch operation is too low to independently justify a prospective randomised study for benefit from recombinant factor VIIa. We aimed to evaluate factor VIIa in a pilot study.

Methods:

We performed a retrospective cohort study of patients undergoing arterial switch operation from 2012 to 2017. Nearest-neighbour propensity score matching on age, gender, weight, and associated cardiac defects was used to match 27 controls not receiving recombinant factor VIIa to 30 patients receiving recombinant factor VIIa. Fisher’s exact test was performed to compare categorical variables. Wilcoxon’s rank-sum test was used to compare continuous variables between cohorts.

Results:

Post-operative thrombotic complications were not associated with factor VIIa administration (Odds Ratio (OR) 0.28, 95% CI 0.005–3.77, p = 0.336), nor was factor VIIa administration associated with any re-explorations for bleeding. No intraoperative transfusion volumes were different between the recombinant factor VIIa cohort and controls. Post-operative prothrombin time (10.8 [10.3–12.3] versus 15.9 [15.1–17.2], p < 0.001) and international normalised ratio (0.8 [0.73–0.90] versus 1.3 [1.2–1.4], p < 0.001]) were lower in recombinant factor VIIa cohort relative to controls.

Conclusions:

In spite of a higher post-bypass packed red blood cell transfusion requirement, patients receiving recombinant factor VIIa had a similar incidence of bleeding post-operatively. With no difference in thrombotic complications, and with improved post-operative laboratory haemostasis, a prospective randomised study is warranted to evaluate recombinant factor VIIa.

Keywords

Arterial switch operationrecombinant factor VIIahaemostasis
Type
Original Article
Information
Cardiology in the Young , Volume 31 , Issue 3 , March 2021 , pp. 386 - 390
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Copyright
© The Author(s), 2020. Published by Cambridge University Press

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Footnotes

Southern Thoracic Surgical Association 66th Annual Meeting, Marco Island, FL, USA.

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