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Published on: September 22, 2017
Three Decades of Evidence on Pulsatile Cardiopulmonary Bypass in Pediatrics: No Significant Clinical Benefit
Akif Ündar1,2,3,4, Marc J Lussier1, Srihari Rajesh1
1Penn State Hershey Pediatric Cardiovascular Research Center, Penn State College of Medicine, Hershey, PA, USA.
Insights
Pulsatile cardiopulmonary bypass (CPB) shows no significant clinical benefits for pediatric patients with congenital heart defects. While not harmful, this technique does not improve short-term or long-term outcomes compared to nonpulsatile flow.
Area of Science:
- Cardiovascular Surgery
- Pediatric Cardiology
- Biomedical Engineering
Background:
- Extensive expertise in in-vitro, in-vivo, and clinical trials informs this research on pulsatile cardiopulmonary bypass (CPB).
- Over 30 years of experience guide the analysis of pulsatile CPB's role in pediatric cardiac surgery.
Purpose of the Study:
- To evaluate the efficacy and clinical outcomes of pulsatile cardiopulmonary bypass (CPB) in pediatric and neonatal patients.
- To synthesize evidence from peer-reviewed studies on optimizing CPB circuitry for pulsatile flow in young patients.
Main Methods:
- Conducted a comprehensive literature search of PubMed using keywords: "Pulsatile flow," "Cardiopulmonary Bypass," "Vital Organ Injury," "Clinical outcomes," "Pediatrics," "Neonates and infants."
- Analyzed 88 peer-reviewed studies published between 1996 and 2025, including randomized clinical trials and retrospective analyses.
- Included data from a randomized clinical trial of 159 patients and a retrospective study of 284 patients at Penn State Health Children's Hospital.
Main Results:
- Neonatal piglet models showed improved cerebral hemodynamics with pulsatile flow and deep hypothermic circulatory arrest.
- Randomized clinical trials and retrospective studies questioned the efficacy of pulsatile flow in clinical settings.
- A rigorous randomized trial (159 patients) and retrospective study (284 patients) found no significant clinical advantage of pulsatile over nonpulsatile flow.
- Pulsatile flow did not demonstrate measurable benefits but also did not result in adverse outcomes in clinical trials.
Conclusions:
- Current evidence indicates that pulsatile cardiopulmonary bypass (CPB) does not offer significant short-term or long-term advantages for pediatric patients undergoing congenital heart surgery.
- While pulsatile CPB is not associated with adverse outcomes, its clinical utility in this population remains unproven.
- Further research may be needed to identify specific subgroups or conditions where pulsatile flow might confer benefits.
Abstract:
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.
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