The safety and efficacy of antifibrinolytic therapy in neonatal cardiac surgery.

Chih-Yuan Lin,Hua Liu,Hugo Loyola,Pedro Del Nido,Frank A Pigula,James A Dinardo,Jeffery H Shuhaiber,Peter Rosenberger

doi:10.1371/journal.pone.0126514

Chih-Yuan Lin, Hua Liu + Show 6 more

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https://doi.org/10.1371/journal.pone.0126514

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Journal: PloS one	Publication Date: May 8, 2015
Citations: 54	License type: CC BY 4.0

Affiliation: Boston Children's Hospital, Harvard University

Abstract

BackgroundNeonates undergoing open-heart surgery are particularly at risk of postoperative bleeding requiring blood transfusion. Aprotinin has attained high efficacy in reducing the requirement for a blood transfusion following a cardiopulmonary bypass, but is seldom studied in the neonatal age group. The aim of this study was to compare the efficacy and adverse effects of aprotinin and tranexamic acid in neonates undergoing open-heart surgery at a single centre.MethodsBetween October 2003 and March 2008, perioperative data of 552 consecutive neonatal patients undergoing open-heart surgery in Children’s Hospital Boston were reviewed. Among them, 177 did not receive antifibrinolytic therapy (Group A); 100 were treated with tranexamic acid only (Group B); and 275 patients received aprotinin with or without tranexamic acid (Group C). Except for antifibrinolytic therapy, the anaesthesiological and surgical protocols remained identical. Postoperative complications and in-hospital mortality were the primary study endpoints.ResultsBody weight and Risk Adjustment for Congenital Heart Surgery (RACHS-1) scores were statistically comparable among the three groups. No statistically significant differences were observed between the duration of hospitalization, chest tube drainage, reexploration for bleeding, and kidney function impairment. In Group C, less blood was transfused within 24 hours than in GroupB. Operative mortality was similar among the three groups.ConclusionNo further risk and kidney injury were observed in the use of aprotinin in neonatal cardiac surgery, aprotinin demonstrated a reduced requirement for blood transfusion compared with tranexamic acid. Our data provide reasonable evidence that aprotinin and tranexamic acid are safe and efficacious as antifibrinolytic modalities in neonatal patients undergoing cardiac surgery.

Highlights

Cardiopulmonary bypass (CPB) and cardiovascular surgery activate coagulation, inflammation, and fibrinolysis, which often exert potentially deleterious effects on patient outcome, if CPB is prolonged [1, 2]
Body weight and Risk Adjustment for Congenital Heart Surgery (RACHS-1) scores were statistically comparable among the three groups
Haemodilution can produce impaired haemostasis related to both qualitative and quantitative abnormalities in coagulation factors, leading to fibrinolysis [2,3,4,5,6], antifibrinolytics can be helpful in reducing loss and transfusion requirements [7, 8]

Summary

Introduction

Cardiopulmonary bypass (CPB) and cardiovascular surgery activate coagulation, inflammation, and fibrinolysis, which often exert potentially deleterious effects on patient outcome, if CPB is prolonged [1, 2]. In a randomized controlled trial published in 1987, aprotinin was found to reduce blood loss and the need of transfusion in re-do open heart surgery [10]. Several randomized, prospective, placebo-controlled, carefully performed trials on aprotinin use have indicated a reduced blood transfusion requirement in adult cardiac surgery [11]. Neonates undergoing open-heart surgery are at risk of postoperative bleeding requiring blood transfusion. Aprotinin has attained high efficacy in reducing the requirement for a blood transfusion following a cardiopulmonary bypass, but is seldom studied in the neonatal age group. The aim of this study was to compare the efficacy and adverse effects of aprotinin and tranexamic acid in neonates undergoing open-heart surgery at a single centre

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