Congenital heart disease refers to a group of heart conditions that develop before birth. It occurs when the heart or blood vessels around the heart don't form properly during fetal development. The severity of congenital heart disease can range from mild, where it may not even require treatment, to severe, where it can lead to life-threatening complications.
The causes of congenital heart disease are often unknown, but genetics, infections, and environmental factors can all play a role. Advances in medical technology and surgical techniques have improved the survival rate and quality of life for individuals with congenital heart disease. However, it remains a significant health concern, affecting approximately 1% of all live births globally.
While advances in technology have led to improvements in surgical techniques, it is still important to investigate the effects of perfusion modalities on cerebral hemodynamics, vital organ injury, and clinical outcomes. This randomized clinical trial aimed to investigate these effects in risk-stratified congenital cardiac surgery patients.
The trial included 159 consecutive congenital cardiac surgery patients, half of whom received pulsatile perfusion and half of whom received non-pulsatile perfusion. Cerebral hemodynamics were assessed using transcranial Doppler ultrasound, and multiple organ injury was quantified using the Pediatric Logistic Organ Dysfunction-2 (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.
The results of the trial showed that 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. While there were no differences in clinical outcomes between the two 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.
It is important to note that while the Pulsatility Index for the pulsatile group demonstrated a more physiologic pattern compared with the non-pulsatile group, pulsatile perfusion did not increase plasma-free hemoglobin levels or microemboli delivery. Therefore, the trial results suggest that while pulsatile perfusion is a safe method, it is not a “magic bullet” for congenital cardiac operations.
This clinical trial provides valuable information on the effects of perfusion methods on cerebral hemodynamics, vital organ injury, and clinical outcomes in congenital cardiac surgery patients. While there were no significant differences in clinical outcomes between pulsatile and non-pulsatile perfusion, the trial results suggest that pulsatile perfusion may have some advantages in maintaining the Pulsatility Index at the middle cerebral artery and in the arterial line during aortic cross-clamping. It is important to continue investigating the effects of perfusion modalities on congenital cardiac surgery patients to improve surgical techniques and patient outcomes.