Incidence and Timing of Thromboembolic Events after the Norwood Procedure in the Single Ventricle Reconstruction Clinical Trial of the Pediatric Heart Network Restricted; Files Only
White, Michael (Spring 2019)
Published
Abstract
Background: Thromboembolic events lead to increased morbidity and mortality in infants with single ventricle congenital heart disease undergoing staged surgical reconstruction. The reported incidence and timing of thrombosis varies widely, making it difficult to understand the burden of thrombosis and target prevention.
Objectives: Determine the cumulative incidence and timing of thrombosis following the Stage I Norwood, and determine the association between thrombosis and baseline, surgical, and clinical characteristics, and hospital length of stay.
Methods: The Pediatric Heart Network Single Ventricle Reconstruction trial dataset was used to perform a retrospective cohort study, which includes infants with hypoplastic left heart physiology from 2005 to 2009 who underwent randomization to the Stage I Norwood with modified Blalock-Taussig shunt or right ventricle to pulmonary artery shunt. Cumulative incidence of thrombosis was determined and thrombosis-free survival was evaluated using the Kaplan-Meier method and cumulative incidence function. Patient characteristics and hospital length of stay were compared between thrombosis and non-thrombosis groups.
Results: There were 549 infants included in the trial and the cumulative incidence of thrombosis was 6.4% during Stage I. Through Stage II discharge, thrombosis-free survival was lower in males (85 vs 93%; 95% CI, 80-89% vs 88-96%; p < 0.001 by log-rank test) and infants with non-HLHS anatomy (80 vs 89%; 95% CI, 86-92% vs 68-89%; p = 0.01 by log-rank test) but did not different by shunt type. Using multivariable logistic regression, male sex (OR 3.01, 95% CI, 1.4-6.6, p = 0.01), longer cardiopulmonary bypass time (per 10 min increase, OR 1.01, 95% CI, 1.0-1.01, p = 0.05), non-HLHS anatomy (OR 2.5, CI: 1.1-5.7, P=0.02), and lower oxygen saturation (per 1% increase, OR 0.9, 95% CI, 0.9-0.98, p = 0.02) were associated with thrombosis. Thrombosis was associated with prolonged Norwood hospital length of stay; median 36 vs. 23 days (IQR: 26-58 vs. 15-38 days, p < 0.001).
Conclusion: The cumulative incidence of thrombosis was highest during Stage I (6.4%), with most events occurring within 15 days of surgery. Thrombosis was associated with longer cardiopulmonary bypass time and lower oxygen saturation, and thrombosis-free survival was lower for males and those with non-HLHS anatomy.
Table of Contents
TABLE OF CONTENTS
A. INTRODUCTION.………………………………………………………………………………….1
B. BACKGROUND……………………………………………………………………………………..3
C. METHODS………………………………………………………………………………..…………7
D. RESULTS……………………………………………………………………………...…..……….13
E. DISCUSSION……………………………………………………………………………...………17
F. REFERENCES………………………………………………………………………………….….21
G. TABLES/FIGURES………………………………………………………………….…….……...24
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