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A Randomized Clinical Trial of Perfusion Modalities in Pediatric Congenital Heart Surgery Patients
Akif Ündar1, Krishna Patel2, Ryan M Holcomb2
1Departments 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.
Insights
Pulsatile perfusion in pediatric cardiac surgery maintained better cerebral blood flow but did not improve organ injury scores or clinical outcomes. This suggests pulsatile perfusion is safe but not a definitive solution for these complex operations.
Area of Science:
- Cardiology
- Pediatric Surgery
- Intensive Care Medicine
Background:
- Congenital cardiac surgery often requires cardiopulmonary bypass.
- Perfusion strategies significantly impact patient outcomes.
- Optimizing cerebral hemodynamics is crucial in pediatric cardiac procedures.
Purpose of the Study:
- To compare pulsatile versus nonpulsatile perfusion during congenital cardiac surgery.
- To evaluate the effects on cerebral hemodynamics, organ injury (PELOD-2 score), and clinical outcomes.
- To assess the safety and efficacy of pulsatile perfusion in this patient population.
Main Methods:
- Randomized clinical trial involving 159 pediatric cardiac surgery patients.
- Comparison of pulsatile (n=83) and nonpulsatile (n=76) perfusion.
- Assessment of cerebral hemodynamics via transcranial Doppler ultrasound and Pulsatility Index.
- Quantification of organ injury using the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score.
- Evaluation of clinical outcomes including intubation time, ICU/hospital LOS, and mortality.
Main Results:
- Pulsatile perfusion group showed a better Pulsatility Index in the middle cerebral artery and arterial line.
- No significant differences were observed in clinical outcomes (intubation time, LOS, mortality) between groups.
- Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores improved over time in both groups but without statistically significant differences.
- Demographics and cardiopulmonary bypass characteristics were similar between the pulsatile and nonpulsatile groups.
Conclusions:
- Pulsatile perfusion demonstrates a more physiologic cerebral hemodynamic pattern compared to nonpulsatile perfusion.
- Pulsatile perfusion did not lead to increased plasma-free hemoglobin or microemboli.
- Despite improved hemodynamics, pulsatile perfusion did not significantly improve clinical outcomes or organ injury scores in congenital cardiac surgery.
- Pulsatile perfusion is a safe technique but not a universally superior method for pediatric cardiac operations.
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.
