Impact of Translational Research on Optimization of Neonatal Cardiopulmonary Bypass Circuits and Techniques—The Penn State Health Approach

Ündar, Akif; Wang, Shigang; Palanzo, David A; Wise, Robert; Woitas, Karl; Baer, Larry D.; Kunselman, Allen R.; Clark, Joseph B.; Myers, John L.

doi:10.1111/aor.12906

Cited by 8 publications

(10 citation statements)

References 28 publications

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“…In addition, temperature management strategies (such as pH‐stat vs. alpha‐stat), employed during deep hypothermia, moderate hypothermia, or the rewarming phase may create more GME. Therefore, further development of new techniques for brain protection and circuit optimization is necessary for this underserved pediatric CPB population .…”

Section: Discussionmentioning

confidence: 99%

In Vitro Comparison of Pediatric Oxygenators With and Without Integrated Arterial Filters in Maintaining Optimal Hemodynamic Stability and Managing Gaseous Microemboli

et al. 2018

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The purpose of this study was to compare the Capiox FX15 oxygenator with integrated arterial filter to the Capiox RX15 oxygenator with separate Capiox AF125 arterial filter in terms of hemodynamic properties and gaseous microemboli (GME) capturing. Trials were conducted at varying flow rates (2.0 L/min, 3.0 L/min, 4.0 L/min), temperatures (30°C, 35°C), and flow modalities (pulsatile, nonpulsatile). Pressure and flow waveforms were recorded using a custom-made data acquisition system. GME data were recorded using an Emboli Detection and Classification Quantifier after injecting a 5 mL air bolus into the venous line. Maximum instantaneous pre-oxygenator flows reached 7.4 L/min under pulsatile conditions when the roller pump was set to a flow rate of 4 L/min. Mean pressure drops were slightly greater in the FX15 group (P < 0.0001), and the diverted flow from the arterial purge line was slighter greater in the FX15 group at 3 L/min and 4 L/min (P < 0.0001). There was a slight generation of surplus hemodynamic energy (SHE) at the pre-oxygenator site for both oxygenators under "nonpulsatile mode." However, higher pre-oxygenator SHE levels were recorded for both groups with "pulsatile mode." The RX15 and FX15 groups were both able to remove all microemboli from the circuit at 2 L/min and 3 L/min in "nonpulsatile mode." Microemboli were delivered to the patient at 4 L/min with pulsatile flows in both groups. The RX15 oxygenator with separate AF125 arterial filter and FX15 oxygenator with integrated arterial filter performed similarly in terms of hemodynamic performance and microemboli capturing. Pulsatile flows at 4 L/min produced instantaneous flow rates that surpassed the documented maximum flow rates of the oxygenators and might have contributed to the delivery of GME to the pseudo-patient.

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Section: Discussionmentioning

confidence: 99%

In Vitro Comparison of Pediatric Oxygenators With and Without Integrated Arterial Filters in Maintaining Optimal Hemodynamic Stability and Managing Gaseous Microemboli

et al. 2018

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“…Truth: Pulsatile flow has been shown to minimize vital organ injury, but it has not been consistently shown that pulsatile flow directly improves clinical outcomes. In our clinical practice at Penn State Health Children's Hospital, pulsatile perfusion did not reduce the duration of ICU or hospital stay in congenital heart surgery patients with various risk stratifications.…”

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Pulsatile flow is not a magic bullet for congenital heart surgery patients during CPB procedures

Ündar

Moroi

2019

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“…As always, our recommendations are based on our multidisciplinary research team's collective efforts and scientific evidence, along with the FDA approval of current devices in the US market (8).…”

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confidence: 99%

“…Based on our translational research projects that tested other neonatal, pediatric, and adult CPB oxygenators, we recommend different hollow-fiber membrane oxygenators for clinical practice in the USA (4-7). As always, our recommendations are based on our multidisciplinary research team's collective efforts and scientific evidence, along with the FDA approval of current devices in the US market (8).…”

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confidence: 99%

Translational Research on Evaluation of Pediatric Cardiopulmonary Bypass Oxygenators

Ündar

2018

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In response to our recent publication on membrane oxygenators (1), we have read the letter entitled "Translational research: comparing oxygenators from different international markets" by Matte and Neirotti with a great interest (2). We very much appreciate their constructive comments and suggestions. We would like to include a brief clarification of the conclusions for that particular international multicenter and multidisciplinary study (1).Our recent study was a continuation of our previous collaboration regarding the evaluation of neonatal oxygenators used at the Heart Institute of the University of Sao Paulo, Brazil. In the first study, we compared the Braile infant 1500 oxygenator and the Dideco Kids D100 oxygenator in a neonatal set-up (3). We used an arterial filter along with Penn State Children's Hospital's neonatal tubing packs (Sorin) for both circuits. In the earlier study, the Braile neonatal oxygenator had a better hemodynamic performance and gaseous microemboli capturing ability when compared to the Dideco Kids D100 oxygenator (3).In the current study, pediatric oxygenators (Braile infant oxygenator and Maquet Quadrox-I oxygenator without an integrated arterial filter) along with custom-made tubing packs from the Heart Institute of the University of Sao Paulo were used because we focused on the cardiopulmonary bypass (CPB) circuitry used by that particular organization. Based on the results of this particular study, the Quadrox-i oxygenator trapped more emboli compared to the Braile. We would like to clarify that these current results and suggestions are intended for clinical practices in Latin American countries that use the same CPB circuitry.Based on our translational research projects that tested other neonatal, pediatric, and adult CPB oxygenators, we recommend different hollow-fiber membrane oxygenators for clinical practice in the USA (4-7). As always, our recommendations are based on our multidisciplinary research team's collective efforts and scientific evidence, along with the FDA approval of current devices in the US market (8).We also believe that, in addition to our current approach for evaluating different oxygenators in terms of hemodynamic performance and microemboli capturing, the testing standards for membrane oxygenators and the instruction for their clinical use should be updated (9).

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Impact of Translational Research on Optimization of Neonatal Cardiopulmonary Bypass Circuits and Techniques—The Penn State Health Approach

Cited by 8 publications

References 28 publications

In Vitro Comparison of Pediatric Oxygenators With and Without Integrated Arterial Filters in Maintaining Optimal Hemodynamic Stability and Managing Gaseous Microemboli

In Vitro Comparison of Pediatric Oxygenators With and Without Integrated Arterial Filters in Maintaining Optimal Hemodynamic Stability and Managing Gaseous Microemboli

Pulsatile flow is not a magic bullet for congenital heart surgery patients during CPB procedures

Translational Research on Evaluation of Pediatric Cardiopulmonary Bypass Oxygenators

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