The objectives of this study were: (i) to evaluate the effects of perfusion modes (pulsatile vs. nonpulsatile) on vital organs recovery and (ii) to investigate the influences of two different perfusion modes on the homeostasis of thyroid hormones in pediatric patients undergoing cardiopulmonary bypass (CPB) procedures. Two hundred and eighty-nine consecutive pediatric patients undergoing open heart surgery for repair of congenital heart disease were prospectively entered into the study and were randomly assigned to two groups: the pulsatile perfusion group (Group P, n = 208) and the nonpulsatile perfusion group (Group NP, n = 81). All patients received identical surgical, perfusional, and postoperative care. Study parameters included total drainage, mean urine output in the intensive care unit (ICU), intubation time, duration of ICU and hospital stay, the need for inotropic support, pre- and postoperative enzyme levels (ALT [alanine aminotransaminase] and AST [aspartate aminotransaminase]), c-reactive protein, lactate, albumin, blood count (leukocytes, hematocrit, platelets), creatinine levels, and thyroid hormones (thyroid stimulating hormone [TSH], FT(3) [free triiodothyronine], FT(4) [free thyroxine]). All patients survived the perioperative and postoperative periods. There were no statistically significant differences in either preoperative or operative parameters between the two groups. Group P, compared to Group NP, required significantly less inotropic support, had a shorter intubation period, higher urine output in ICU, and shorter duration of ICU and hospital stay. Lower lactate levels and higher albumin levels were observed in Group P and there were no significant differences in creatinine, enzyme levels, blood counts, or drainage amounts between two groups. TSH, Total T(3) , Total T(4) , and FT(3) , FT(4) levels were markedly reduced versus their preoperative values in both groups. FT(3) and FT(4) levels were reduced significantly further in the nonpulsatile group both during CPB and at 72 h postoperation. The results of this study confirm our opinion that pulsatile perfusion leads to better vital organ recovery and clinical outcomes in the early postoperative period as compared to nonpulsatile perfusion in pediatric patients undergoing CPB cardiac surgery. The plasma concentrations of thyroid hormones are dramatically reduced during and after CPB, but pulsatile perfusion seems to have a protective effect of thyroid hormone homeostasis compared to nonpulsatile perfusion.

The aim of this clinical trial was to evaluate the pulsatile perfusion mode in pediatric patients who had complex cardiac pathologies according to Jenkins stratifications (category 4) undergoing cardiopulmonary bypass procedures (CPB). Patients with transposition of great arteries (TGA) and ventricular septal defect (VSD) were included in this clinical study. Eighty-nine consecutive pediatric patients undergoing open heart surgery for repair of TGA-VSD were prospectively entered into the study and were randomly assigned to either the pulsatile perfusion group (Group P, n = 58) or the nonpulsatile perfusion group (Group NP, n = 31). There were no differences between groups in terms of demographical and intraoperative parameters. The pulsatile group needed significantly less inotropic support (P < 0.05) and had lower lactate levels (P < 0.001), higher urine output (P < 0.01), and higher albumin levels (P < 0.05). In addition, the pulsatile group had less ICU (P < 0.01) and hospital stays (P < 0.001). We conclude that the use of pulsatile flow is a better option and should be considered for repair of the complex congenital heart defects.

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Over the past 6 years at Penn State Hershey, we have established the pediatric cardiovascular research center with a multidisciplinary research team with the goal to improve the outcomes for children undergoing cardiac surgery with cardiopulmonary bypass (CPB) and extracorporeal life support (ECLS). Due to the variety of commercially available pediatric CPB and ECLS devices, both in vitro and in vivo translational research have been conducted to achieve the optimal choice for our patients. By now, every component being used in our clinical settings in Penn State Hershey has been selected based on the results of our translational research. The objective of this review is to summarize our translational research in Penn State Hershey Pediatric Cardiovascular Research Center and to share the latest results with all the interested centers.

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This review on the benefits of pulsatile flow includes not only experimental and clinical data, but also attempts to further illuminate the major factors as to why this debate has continued during the past 55 years. Every single component of the cardiopulmonary bypass (CPB) circuitry is equally important for generating adequate quality of pulsatility, not only the pump. Therefore, translational research is a necessity to select the best components for the circuit. Generation of pulsatile flow depends on an energy gradient; precise quantification in terms of hemodynamic energy levels is, therefore, a necessity, not an option. Comparisons between perfusion modes should be done after these basic steps have been taken. We have also included experimental and clinical data for direct comparisons between the perfusion modes. In addition, we included several suggestions for future clinical trials for other interested investigators.

The objective of this clinical study is to determine whether correlation exists among cerebral and renal near-infrared spectroscopy (NIRS) measurements, renal Doppler ultrasonography parameters (resistive index, peak systolic velocity), and early postoperative clinical outcomes following cardiac surgery in neonates and infants. Thirty-seven patients undergoing surgery for congenital heart defects with an age of less than 3 months, all of whom were in the high-risk group according to Aristotle Basic Complexity risk stratification score, were enrolled in our study. Cerebral, renal NIRS values and renal Doppler ultrasonography measurements were recorded for each patient at the 4th postoperative hour. The renal resistive indices were calculated for each case, and the patients were divided into two groups according to renal resistive index (RI) values. Group I included the patients with a RI of greater than 0.8 (n = 25) and Group II included the patients with a RI of less than 0.8 (n = 12). The postoperative outcome parameters were compared in between two groups. Group I (RI >0.8) had lower postoperative mean urine output than Group II (RI <0.8) (P = 0.041). The lactate levels were significantly higher in Group I (P = 0.049), as well. The postoperative intensive care unit and hospital stay of Group I was significantly higher than Group II (P = 0.048). Both cerebral and renal NIRS values and the assessment of renal RI as well as peak systolic values can be used in order to predict the early clinical outcome in cardiac surgery patients in early infantile and neonatal period.

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