Three Decades of Evidence on Pulsatile Cardiopulmonary Bypass in Pediatrics: No Significant Clinical Benefit

BackgroundDrawing on more than 30 years of valuable expertise in in-vitro, in-vivo, and clinical trials, we report the key findings of our institutional research on pulsatile cardiopulmonary bypass (CPB).MethodsA detailed search was performed in the National Institutes of Health National Library of Medicine, focusing on the PubMed database. This search combined key terms such as "Pulsatile flow," "Cardiopulmonary Bypass," "Undar A," "Vital Organ Injury," "Clinical outcomes," "Pediatrics," and "Neonates and infants" to find relevant peer-reviewed publications.ResultsA comprehensive review article was crafted by analyzing 88 peer-reviewed studies published between 1996 and 2025. This research provided substantial scientific evidence on optimizing neonatal and pediatric cardiopulmonary bypass (CPB) circuitry, focusing not only on pump performance but also on selecting appropriate oxygenators and arterial cannulas for effective pulsatile flow. While significant benefits regarding cerebral hemodynamics were observed in neonatal piglet models using pulsatile flow in conjunction with deep hypothermic circulatory arrest, the results from randomized clinical trials and retrospective studies raised questions regarding its efficacy. Despite some promising indications of improved Apolipoprotein E and plasminogen activator inhibitor-1/tissue plasminogen activator ratios, a rigorous randomized clinical trial involving 159 patients, along with a comprehensive retrospective study of 284 patients at Penn State Health Children's Hospital, demonstrated no significant clinical advantage of pulsatile flow compared with nonpulsatile flow. Importantly, while pulsatile flow did not provide a measurable benefit, it also did not result in any adverse outcomes in our clinical trials.ConclusionsThe existing evidence clearly indicates that pulsatile CPB does not provide significant short-term or long-term benefits for pediatric patients undergoing congenital heart surgery.