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Bivalirudin Monitoring in Pediatric Ventricular Assist Device and Extracorporeal Membrane Oxygenation: Analysis of

Elissa R Engel1,2, Tanya Perry1,3, Mary Block4

  • 1Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.

Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
|May 7, 2024
PubMed

Insights

The activated partial thromboplastin time (aPTT) is unreliable for monitoring bivalirudin in pediatric VAD and ECMO patients. A bivalirudin-calibrated dilute thrombin time (Bival dTT) assay offers superior reliability for anticoagulation management.

Area of Science:

  • Pediatric critical care medicine
  • Pharmacology and therapeutics
  • Clinical laboratory science

Background:

  • The activated partial thromboplastin time (aPTT) is the standard assay for monitoring bivalirudin anticoagulation in pediatric patients on mechanical circulatory support (MCS).
  • However, the aPTT exhibits intrinsic variability, potentially leading to suboptimal anticoagulation and increased risks of bleeding or thrombotic complications.
  • Reliable monitoring is crucial for patients on ventricular assist devices (VADs) and extracorporeal membrane oxygenation (ECMO).

Purpose of the Study:

  • To evaluate the utility and reliability of a bivalirudin-calibrated dilute thrombin time (Bival dTT) assay for monitoring bivalirudin therapy in pediatric VAD and ECMO patients.
  • To compare the performance of the Bival dTT assay with the standard aPTT assay in this population.
  • To assess the correlation between different laboratory parameters and bivalirudin's anticoagulant effect.

Main Methods:

  • Retrospective analysis of clinical data and residual plasma samples from pediatric patients on VAD and ECMO support.
  • Assessment of two drug-calibrated experimental assays, including the Bival dTT assay, validated for clinical use.
  • Statistical analysis using Pearson correlation and simple linear regression to determine R2 correlation coefficients between laboratory parameters.

Main Results:

  • Analysis of 115 plasma samples from 11 VAD patients showed excellent correlation between drug-calibrated assays (R2 = 0.94) and dTT (R2 = 0.87), but poor correlation with aPTT (R2 = 0.1).
  • In 105 clinically ordered results from 11 ECMO patients, the Bival dTT assay demonstrated excellent correlation with standard dTT (R2 = 0.86) but very poor correlation with aPTT (R2 = 0.004).
  • The Bival dTT assay was selected for validation in VAD patients based on initial findings.

Conclusions:

  • The activated partial thromboplastin time (aPTT) is an unreliable assay for monitoring bivalirudin in pediatric VAD and ECMO patients due to poor correlation with anticoagulant effect.
  • A drug-calibrated Bival dTT assay offers superior reliability and standardization potential across institutions for bivalirudin monitoring.
  • Further studies are required to establish appropriate therapeutic ranges and correlate Bival dTT results with clinical outcomes.
Abstract

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