Randomized Trial of Pulsatile and Nonpulsatile Flow in Cyanotic and Acyanotic Congenital Heart Surgery

Krishna Patel; Tracie K Lin; Joseph B Clark; Gary D Ceneviva; Jason R Imundo; Debra Spear; Allen R Kunselman; Neal J Thomas; John L Myers; Akif Ündar

doi:10.1177/21501351241288835

Randomized Trial of Pulsatile and Nonpulsatile Flow in Cyanotic and Acyanotic Congenital Heart Surgery

World J Pediatr Congenit Heart Surg. 2024 Dec 22:21501351241288835. doi: 10.1177/21501351241288835. Online ahead of print.

Authors

Krishna Patel^{1

2

3}, Tracie K Lin^{1

4}, Joseph B Clark^{1

2

3}, Gary D Ceneviva^{1

5}, Jason R Imundo^{1

2}, Debra Spear^{1

5}, Allen R Kunselman^{1

6}, Neal J Thomas^{1

5

6}, John L Myers^{1

2

3}, Akif Ündar^{1

2

3

7}

Affiliations

¹ Penn State Hershey Pediatric Cardiovascular Research Center, Penn State College of Medicine, Hershey, PA, USA.
² Division of Pediatric Cardiology, Department of Pediatrics, Penn State College of Medicine, Hershey, PA, USA.
³ Department of Surgery, Penn State College of Medicine, Hershey, PA, USA.
⁴ Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Virginia Children's Hospital, Charlottesville, VA, USA.
⁵ Division of Pediatric Critical Care Medicine, Department of Pediatrics, Penn State College of Medicine, Hershey, PA, USA.
⁶ Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.
⁷ Department of Biomedical Engineering, College of Engineering, The Pennsylvania State University, University Park, PA, USA.

PMID: 39711070
DOI: 10.1177/21501351241288835

Abstract

Background: The study objective was to determine the impact of cardiopulmonary bypass perfusion modalities on cerebral hemodynamics and clinical outcomes in congenital cardiac surgery patients stratified by acyanotic versus cyanotic heart disease.

Methods: A total of 159 pediatric (age <18 years) cardiac surgery patients were prospectively randomized to pulsatile or nonpulsatile cardiopulmonary bypass and stratified by type of congenital heart disease: acyanotic versus cyanotic. Intraoperative cerebral gaseous microemboli counts and middle cerebral artery pulsatility index were assessed. Organ injury was quantified by Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24, 48, and 72 h postoperatively. Additional outcomes included Pediatric Risk of Mortality-3 score, vasoactive-inotropic score, duration of mechanical ventilation, intensive care and hospital length of stay, and 180-day mortality. Heterogenous variance linear models (ie, ANOVA and mixed models) and χ² tests were used to compare groups for continuous and categorical variables, respectively.

Results: Within congenital heart disease subgroups, patients randomized to nonpulsatile versus pulsatile bypass had similar preoperative and operative characteristics. While the intraoperative pulsatility index was higher in the pulsatile subset of both acyanotic and cyanotic groups (P < .05), regional cerebral oxygen saturation, mean arterial pressure, and gaseous microemboli counts were similar. Postoperative PELOD-2 scores decreased at similar rates in the acyanotic and cyanotic subgroups regardless of the perfusion modality utilized. There were also no significant between-group differences in the additional postoperative outcomes by perfusion modality in either acyanotic or cyanotic groups.

Conclusions: Despite patients undergoing pulsatile cardiopulmonary bypass experiencing a more physiologic pulsatility index in both acyanotic and cyanotic groups, no significant differences in cerebral hemodynamics or clinical outcomes were appreciated.

Keywords: Pediatric Logistic Organ Dysfunction (PELOD-2) Score; Pediatric Risk of Mortality 3 (PRISM-3) score; Pulsatile and Nonpulsatile Flow; cyanotic and acyanotic; randomized clinical trial.