A Randomized Clinical Trial of Perfusion Modalities in Pediatric Congenital Heart Surgery Patients

Akif Ündar; Krishna Patel; Ryan M Holcomb; Joseph B Clark; Gary D Ceneviva; Christine A Young; Debra Spear; Allen R Kunselman; Neal J Thomas; John L Myers

doi:10.1016/j.athoracsur.2022.02.053

A Randomized Clinical Trial of Perfusion Modalities in Pediatric Congenital Heart Surgery Patients

Ann Thorac Surg. 2022 Oct;114(4):1404-1411. doi: 10.1016/j.athoracsur.2022.02.053. Epub 2022 Mar 12.

Authors

Affiliations

¹ Departments of Pediatrics, Penn State Hershey Pediatric Cardiovascular Research Center, Hershey, Pennsylvania; Department of Surgery, Penn State Hershey Pediatric Cardiovascular Research Center, Hershey, Pennsylvania; Department of Biomedical Engineering, Penn State Hershey Pediatric Cardiovascular Research Center, Hershey, Pennsylvania. Electronic address: aundar@pennstatehealth.psu.edu.
² Departments of Pediatrics, Penn State Hershey Pediatric Cardiovascular Research Center, Hershey, Pennsylvania; Department of Surgery, Penn State Hershey Pediatric Cardiovascular Research Center, Hershey, Pennsylvania.
³ Departments of Pediatrics, Penn State Hershey Pediatric Cardiovascular Research Center, Hershey, Pennsylvania; Division of Pediatric Critical Care Medicine, Penn State Health Children's Hospital, Penn State College of Medicine, Hershey, Pennsylvania.
⁴ Departments of Pediatrics, Penn State Hershey Pediatric Cardiovascular Research Center, Hershey, Pennsylvania; Department of Public Health Sciences, Penn State Health Children's Hospital, Penn State College of Medicine, Hershey, Pennsylvania.

PMID: 35292258
DOI: 10.1016/j.athoracsur.2022.02.053

Abstract

Background: The objective of this randomized clinical trial was to investigate the effects of perfusion modalities on cerebral hemodynamics, vital organ injury, quantified by the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) Score, and clinical outcomes in risk-stratified congenital cardiac surgery patients.

Methods: This randomized clinical trial included 159 consecutive congenital cardiac surgery patients in whom pulsatile (n = 83) or nonpulsatile (n = 76) perfusion was used. Cerebral hemodynamics were assessed using transcranial Doppler ultrasound. Multiple organ injury was quantified using the PELOD-2 score at 24, 48, and 72 hours. Clinical outcomes, including intubation time, intensive care unit length of stay (LOS), hospital LOS, and mortality, were also evaluated.

Results: The Pulsatility Index at the middle cerebral artery and in the arterial line during aortic cross-clamping was consistently better maintained in the pulsatile group. Demographics and cardiopulmonary bypass characteristics were similar between the 2 groups. While risk stratification with The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) Mortality Categories was similar between the groups, Mortality Categories 1 to 3 demonstrated more patients than Mortality Categories 4 and 5. There were no differences in clinical outcomes between the groups. The PELOD-2 scores showed a progressive improvement from 24 hours to 72 hours, but the results were not statistically different between the groups.

Conclusions: The Pulsatillity Index for the pulsatile group demonstrated a more physiologic pattern compared with the nonpulsatile group. While pulsatile perfusion did not increase plasma-free hemoglobin levels or microemboli delivery, it also did not demonstrate any improvements in clinical outcomes or PELOD-2 scores, suggesting that while pulsatile perfusion is a safe method, it not a "magic bullet" for congenital cardiac operations.

Publication types

Randomized Controlled Trial

MeSH terms

Cardiopulmonary Bypass* / methods
Child
Heart Defects, Congenital* / surgery
Hemoglobins
Humans
Perfusion / methods
Pulsatile Flow

Substances

Hemoglobins