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Hemodynamic profile effects of PM101 amiodarone formulation in patients with post-operative tachyarrhythmias

Published online by Cambridge University Press:  20 September 2022

Meredith DeCoy*
Affiliation:
Akron Children’s Hospital, Department of Medical Education, Akron, OH, USA
Christopher Page-Goertz
Affiliation:
Akron Children’s Hospital, Division of Critical Care, Akron, OH, USA
Ryan Nofziger
Affiliation:
Akron Children’s Hospital, Division of Critical Care, Akron, OH, USA
James Besunder
Affiliation:
Akron Children’s Hospital, Division of Critical Care, Akron, OH, USA
Patricia Raimer
Affiliation:
Akron Children’s Hospital, Division of Critical Care, Akron, OH, USA
David Gothard
Affiliation:
Biostats, Inc: Data Analysis for Clinical Research Studies, East Canton, OH, USA
Miraides Brown
Affiliation:
Rebecca D. Considine Research Institute, Akron, OH, USA
Robert Stewart
Affiliation:
Akron Children’s Hospital, Heart Center, Akron, OH, USA
Cassandra Ruggles
Affiliation:
Akron Children’s Hospital, Division of Critical Care, Akron, OH, USA
Kristen Breedlove
Affiliation:
Akron Children’s Hospital, Heart Center, Akron, OH, USA
John Clark
Affiliation:
Akron Children’s Hospital, Heart Center, Akron, OH, USA
*
Author for correspondence: Meredith DeCoy, D.O., Akron Children’s Hospital, Department of Medical Education, One Perkins Square, Akron, OH 44308-1062, USA. Tel: +1 330 543 8178. E-mail: meredith.decoy@gmail.com

Abstract

Amiodarone may be considered for patients with junctional ectopic tachycardia refractory to treatment with sedation, analgesia, cooling, and electrolyte replacements. There are currently no published pediatric data regarding the hemodynamic effects of the newer amiodarone formulation, PM101, devoid of hypotensive agents used in the original amiodarone formulation. We performed a single-center, retrospective, descriptive study from January 2012 to December 2020 in a pediatric ICU. Thirty-three patients were included (22 male and 11 female) between the ages of 1.1 and 1,460 days who developed post-operative junctional ectopic tachycardia or other tachyarrhythmias requiring PM101. Data analysis was performed on hemodynamic parameters (mean arterial pressures and heart rate) and total PM101 (mg/kg) from hour 0 of amiodarone administration to hour 72. Adverse outcomes were defined as Vasoactive-Inotropic Score >20, patients requiring ECMO or CPR, or patient death. There was no statistically significant decrease in mean arterial pressures within the 6 hours of PM101 administration (p > 0.05), but there was a statistically significant therapeutic decrease in heart rate for resolution of tachyarrhythmia (p < 0.05). Patients received up to 25 mg/kg in an 8-hour time for rate control. Average rate control was achieved within 11.91 hours and average rhythm control within 62 hours. There were four adverse events around the time of PM101 administration, with three determined to not be associated with the medication. PM101 is safe and effective in the pediatric cardiac surgical population. Our study demonstrated that PM101 can be used in a more aggressive dosing regimen than previously reported in pediatric literature with the prior formulation.

Type
Original Article
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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