Centrifugal or Roller Blood Pumps for Neonatal Venovenous Extracorporeal Membrane Oxygenation: Extracorporeal Life Support Organization Database Comparison of Mortality and Morbidity.

OBJECTIVES: To investigate outcomes associated with conventional roller or centrifugal pumps during neonatal venovenous extracorporeal membrane oxygenation (ECMO). Our primary hypothesis is that in comparison with conventional roller-pump support, centrifugal pump use is associated with greater odds of survival. Our secondary hypothesis is that centrifugal pump use is associated with lesser odds of complications. DESIGN: Retrospective cohort identified using the Extracorporeal Life Support Organization (ELSO) registry 2016 to 2020 dataset. SETTING: All ECMO centers reporting to the ELSO registry. PATIENTS: All neonates (≤ 28 d) supported with venovenous ECMO and cannulated via right internal jugular vein using dual-lumen venovenous cannulas and polymethyl pentene membrane oxygenators. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 612 neonates (centrifugal, n = 340; conventional roller, n = 272) were included in the analysis. Using a multivariable logistic regression model, centrifugal pump use-as opposed to roller pump use-was associated with lesser odds of survival (odds ratio [OR], 0.53; 95% CI, 0.33-0.84; p < 0.008). Thrombosis and clots in the circuit components were also associated with lesser odds of survival (OR, 0.28; 95% CI, 0.16-0.60; p < 0.001). We failed to show that hemolysis was an independent variable for survival (OR, 0.60; 95% CI, 0.31-1.19; p = 0.14). The primary diagnosis of neonatal aspiration/meconium aspiration is associated with more than seven-fold greater odds of survival (OR, 7.57; 95% CI, 4.02-15.74; p < 0.001). CONCLUSIONS: Contrary to our hypotheses, conventional roller pump use was associated with greater odds of survival. While thrombosis and clots in circuit components were independent variables for lesser odds of survival, further research is needed better to understand the use of centrifugal pumps in neonatal practice.

Safety and utility of modified ultrafiltration in pediatric cardiac surgery.

INTRODUCTION: Modified ultrafiltration (MUF) is employed at the termination of cardiopulmonary bypass (CPB) in pediatric and neonatal patients undergoing congenital heart surgery to reduce the accumulation of total body water thus increasing the concentration of red blood cells and the other formed elements in the circulation. Modified ultrafiltration has been reported to remove circulating pro-inflammatory mediators that result in systemic inflammatory response syndrome (SIRS) postoperatively. METHODS: Four hundred patients undergoing cardiac surgery requiring cardiopulmonary bypass and weighing less than or equal to 12 kg were retrospectively evaluated for the effectiveness of MUF. After the termination of CPB, blood was withdrawn through the aortic cannula and passed through a hemoconcentrator attached to the blood cardioplegia set and returned to the patient through the venous cannula. The entire CPB circuit volume in addition to the patient's circulating blood volume were concentrated until the hematocrit value displayed on the CDI cuvette within the MUF circuit reached 45% or there was no more volume to safely remove. At the same time a full unit of FFP can be infused as water is being removed, thus maintaining euvolemia. RESULTS: MUF was performed in all 400 patients with no MUF-related complications. Following the conclusion of MUF, anecdotal observations included improved surgical hemostasis, improved hemodynamic parameters, decreased transfusion requirements, and decreased ventilator times. CONCLUSIONS: Complete MUF enables the clinician to safely raise the post-CPB hematocrit to at least 40% while potentially removing mediators that could result in SIRS. In addition a full unit of FFP can be administered while maintaining euvolemia.

Are outcomes in congenital cardiac surgery better than ever?

BACKGROUND AND AIM OF THE STUDY: Congenital heart disease is the most common congenital defect among infants born in the United States. Within the first year of life, 1 in 4 of these infants will need surgery. Only one generation removed from an overall mortality of 14%, many changes have been introduced into the field. Have these changes measurably improved outcomes? METHODS: The literature search was conducted through PubMed MEDLINE and Google Scholar from inception to October 31, 2021. Ultimately, 78 publications were chosen for inclusion. RESULTS: The outcome of overall mortality has experienced continuous improvements in the modern era of the specialty despite the performance of more technically demanding surgeries on patients with complex comorbidities. This modality does not account for case-mix, however. In turn, clinical outcomes have not been consistent from center to center. Furthermore, variation in practice between institutions has also been documented. A recurring theme in the literature is a movement toward standardization and universalization. Examples include mortality risk-stratification that has allowed direct comparison of outcomes between programs and improved definitions of morbidities which provide an enhanced framework for diagnosis and management. CONCLUSIONS: Overall mortality is now below 3%, which suggests that more patients are surviving their interventions than in any previous era in congenital cardiac surgery. Focus has transitioned from survival to improving the quality of life in the survivors by decreasing the incidence of morbidity and associated long-term effects. With the transformation toward standardization and interinstitutional collaboration, future advancements are expected.

In vitro evaluation of Capiox FX05 and RX05 oxygenators in neonatal cardiopulmonary bypass circuits with varying venous reservoir and vacuum-assisted venous drainage levels.

The purpose of this study was to evaluate the hemodynamic properties and microemboli capture associated with different vacuum-assisted venous drainage (VAVD) vacuum levels and venous reservoir levels in a neonatal cardiopulmonary bypass circuit. Trials were conducted in 2 parallel circuits to compare the performance of Capiox Baby RX05 oxygenator with separate AF02 arterial filter to Capiox FX05 oxygenator with integrated arterial filter. Arterial cannula flow rate to the patient was held at 500 mL/min and temperature maintained at 32°C, while VAVD vacuum levels (0 mm Hg, -15 mm Hg, -30 mm Hg, -45 mm Hg, -60 mm Hg) and venous reservoir levels (50 mL, 200 mL) were evaluated in both oxygenators. Hemodynamic parameters measuring flow, pressure, and total hemodynamic energy were made in real time using a custom-made data acquisition system and Labview software. Nearly 10 cc bolus of air was injected into the venous line and gaseous microemboli detected using an Emboli Detection and Classification Quantifier. Diverted blood flow via the arterial filter's purge line and mean pressures increased with increasing VAVD levels (P < 0.01). Mean pressures were lower with lower venous reservoir levels and were greater in RX05 groups compared to FX05 (P < 0.01). Microemboli detected at the preoxygenator site increased with higher VAVD vacuum levels and lower venous reservoir levels (P < 0.01). The amount of microemboli captured by the FX05 oxygenator with integrated arterial filter was greater than by the RX05 oxygenator alone, although both oxygenators were able to clear microemboli before reaching the pseudo-patient.

Evaluation of centrifugal blood pumps in term of hemodynamic performance using simulated neonatal and pediatric ECMO circuits.

The objective of this translational study was to evaluate the FDA-approved PediMag, CentriMag, and RotaFlow centrifugal blood pumps in terms of hemodynamic performance using simulated neonatal and pediatric extracorporeal membrane oxygenation (ECMO) circuits with different sizes of arterial and venous cannulae. Cost of disposable pump heads was another important variable for this particular study. The experimental circuit was composed of one of the centrifugal pump heads, a polymethylpentene membrane oxygenator, neonatal and pediatric arterial/venous cannulae, and 1/4-inch ID tubing. Circuits were primed with lactated Ringer's solution and packed human red blood cells (hematocrit 35%). Trials were conducted at 36°C using the three pump heads and different cannulae (arterial/venous cannulae: 8 Fr/18 Fr, 10 Fr/20 Fr, and 12 Fr/22 Fr) at various flow rates (200-2400 mL/min, 200 mL/min increments) and rotational speeds. Pseudo patient pressure was 60 mm Hg. Real-time pressure and flow data were recorded for analysis. The RotaFlow pump had a higher pressure head and flow range compared with the PediMag and CentriMag pumps at the same rotational speed and identical experimental settings (P < 0.001). The PediMag pump had lower flow output than others (P < 0.001). Small-caliber arterial cannulae and higher flow rates predictably created higher circuit pressures and pressure drops. There was no significant difference in hemodynamic energy delivered to the pseudo patient with each of the three pumps. The arterial cannula had the highest pressure drop and hemodynamic energy loss in the circuit when compared to the oxygenator and arterial tubing. The RotaFlow centrifugal pump had a significantly better hemodynamic performance when compared to the PediMag and CentriMag blood pumps at identical experimental conditions in simulated neonatal and pediatric ECMO settings. In addition, the cost of the RotaFlow pump head ($400) is 20 to 30-fold less than the other centrifugal pumps [CentriMag ($12 000) or PediMag ($8000)] that were evaluated in this translational study.

Impact of cannula size and line length on venous line pressure in pediatric VA-/VV-ECLS circuits.

The objective of this study was to do an in vitro evaluation of venous line pressure using different venous line lengths and venous cannula sizes in pediatric venoarterial extracorporeal life support (VA-ECLS) and venovenous ECLS (VV-ECLS) circuits. The pediatric VA-ECLS circuit consisted of a Xenios i-cor diagonal pump, a Maquet Quadrox-i pediatric oxygenator, a Medtronic Biomedicus arterial cannula, a Biomedicus venous cannula, and 1/4″ ID arterial and venous tubing. The pediatric VV-ECLS circuit was similar, except it included a Maquet Avalon ELITE bi-caval dual lumen cannula. Circuits were primed with lactated Ringer's solution and packed red blood cells (hematocrit 40%). Trials were conducted at various flow rates (VA-ECLS: 250-1250 mL/min, VV-ECLS: 250-2000 mL/min) using different venous tubing lengths (2, 4, and 6 feet) and cannula sizes (VA-ECLS: A8Fr/V10Fr, A10Fr/V12Fr and A12Fr/V14Fr, VV-ECLS: 13Fr, 16Fr, 19Fr, 20Fr and 23Fr) at 36°C. Real-time pressure and flow data were recorded for analysis. The use of a small-caliber venous cannula significantly increased the venous line pressure in the 2 pediatric circuits (P < 0.01). Shorter venous tubing lengths significantly reduced the venous line pressure at high flow rates (P < 0.01). The VV-ECLS circuit had larger negative pre-pump pressure drops (7.2 to -102.2 mm Hg) when compared to the VA-ECLS circuit (0.7 to -60.7 mm Hg). Selecting an appropriate venous cannula and a shorter venous tubing when feasible may significantly reduce the pressure drop of the venous line in pediatric VA-ECLS and VV-ECLS circuits and improve venous drainage.

Evaluation of Two Femoral Arterial Cannulae With Conventional Non-Pulsatile and Alternative Pulsatile Flow in a Simulated Adult ECLS Circuit.

The objective of this study is to evaluate the hemodynamic characteristics of two femoral arterial cannulae in terms of circuit pressure, pressure drop, and hemodynamic energy transmission under non-pulsatile and pulsatile modes in a simulated adult extracorporeal life support (ECLS) system. The ECLS circuit consisted of i-cor diagonal pump and console (Xenios AG, Heilbronn, Germany), an iLA membrane ventilator (Xenios AG), an 18 Fr or 16 Fr femoral arterial cannula (Xenios AG), and a 23/25 Fr Estech remote access perfusion (RAP) femoral venous cannula (San Ramon, CA, USA). The circuit was primed with lactated Ringer's solution and packed red blood cells to achieve a hematocrit of 35%. All trials were conducted at room temperature with flow rates of 1-4 L/min (1 L/min increments). The pulsatile flow settings were set at pulsatile frequency of 75 bpm and pulsatile amplitudes of 1000-4000 rpm (1000 rpm increments). Flow and pressure data were collected using a custom data acquisition system. Total hemodynamic energy (THE) is calculated by multiplying the ratio between the area under the hemodynamic power curve (∫flow × pressure dt) and the area under the pump flow curve (∫flow dt) by 1332. The pressure drop across the arterial cannula increased with increasing flow rate and decreasing cannula size. The pressure drops of 18 Fr and 16 Fr cannulae were 19.4-24.5 and 38.4-45.3 mm Hg at 1 L/min, 55.2-56.8 and 110.9-118.3 mm Hg at 2 L/min, 94.1-105.1 and 209.7-215.1 mm Hg at 3 L/min, and 169.2-172.6 and 376.4 mm Hg at 4 L/min, respectively. Pulsatile flow created more hemodynamic energy than non-pulsatile flow, especially at lower flow rates. The percentages of THE loss across 18 Fr and 16 Fr cannula were 16.0-18.7 and 27.5-30.8% at 1 L/min, 35.1-35.7 and 52.3-53.8% at 2 L/min, 48.3-50.3 and 67.3-68.4% at 3 L/min and 62.9-63.1 and 79.0% at 4 L/min. The hemodynamic performance of the arterial cannula should be evaluated before use in clinical practice. The pressure drops and percentages of THE loss across two cannulae tested using human blood were higher compared to the manufacturer's data tested using water. The cannula size should be chosen to match the expected flow rate. In addition, this novel i-cor ECLS system can provide non-pulsatile and ECG-synchronized pulsatile flow without significantly increasing the cannula pressure drop and hemodynamic energy loss.

Hemodynamic Evaluation of Avalon Elite Bi-Caval Dual Lumen Cannulas and Femoral Arterial Cannulas.

Translational research is a useful tool to provide scientific evidence for cannula selection during extracorporeal life support (ECLS). The objective of this study was to evaluate four Avalon Elite bi-caval dual lumen cannulas and nine femoral arterial cannulas in terms of flow range, circuit pressure, pressure drop, and hemodynamic energy transmission in a simulated adult ECLS model. A veno-venous ECLS circuit was used to evaluate four Avalon Elite bi-caval dual lumen cannulas (20, 23, 27, and 31 Fr), and a veno-arterial ECLS circuit was used to evaluate nine femoral arterial cannulas (15, 17, 19, 21, and 23 Fr). The two circuits included a Rotaflow centrifugal pump, a Quadrox-D adult oxygenator, and 3/8 in ID tubing for arterial and venous lines. The circuits were primed with lactated Ringer's solution and packed human red blood cells (hematocrit 40%). Trials were conducted at rotational speeds from 1000 to 5000 RPM (250 rpm increments) for each Avalon cannula, and at different flow rates (0.5-7 L/min) for each femoral arterial cannula. Real-time pressure and flow data were recorded for analysis. Small caliber cannulas created higher circuit pressures, higher pressure drops and higher M-numbers compared with large ones. The inflow side of Avalon dual lumen cannula had a significantly higher pressure drop than the outflow side (inflow vs. outflow: 20 Fr-100.2 vs. 49.2 mm Hg at 1.1 L/min, 23 Fr-93.7 vs. 41.4 mm Hg at 1.6 L/min, 27 Fr-102.3 vs. 42.8 mm Hg at 2.6 L/min, 31 Fr-98.1 vs. 44.7 mm Hg at 3.8 L/min). There was more hemodynamic energy lost in the veno-arterial ECLS circuit using small cannulas compared to larger ones (17 Fr vs. 19 Fr vs. 21 Fr at 4 L/min-Medtronic: 71.0 vs. 64.8 vs. 60.9%; Maquet: 71.4 vs. 65.6 vs. 62.0%). Medtronic femoral arterial cannulas had lower pressure drops (Medtronic vs. Maquet at 4 L/min: 17 Fr-121.7 vs. 125.0 mm Hg, 19 Fr-71.2 vs. 73.7 mm Hg, 21 Fr-42.9 vs. 47.4 mm Hg) and hemodynamic energy losses (Medtronic vs. Maquet at 4 L/min: 17 Fr-43.6 vs. 44.4%, 19 Fr-31.0 vs. 31.4%, 21 Fr-20.8 vs. 22.4%) at high flow rates when compared with the Maquet cannulae. The results for this study provided valuable hemodynamic characteristics of all evaluated adult cannulas with human blood in order to guide ECLS cannula selection in clinical practice. Use of larger cannulas are suggested for VV- and VA-ECLS.

Impact of Heart Rate on Pulsatile Hemodynamic Performance in a Neonatal ECG-Synchronized ECLS System.

The experimental circuit consisted of an i-cor diagonal pump, a Medos Hilite 800 LT oxygenator, an 8Fr Biomedicus arterial cannula, a 10Fr Biomedicus venous cannula, and six feet of 1/4 in ID tubing for arterial and venous lines. The circuit was primed with lactated Ringer's solution and packed red blood cells (hematocrit 40%). Trials were conducted at various heart rates (90, 120, and 150 bpm) and flow rates (200, 400, and 600mL/min) under nonpulsatile and pulsatile mode with pulsatile amplitudes of 1000-4000rpm (1000 rpm increments). Real-time pressure and flow data were recorded for analysis. The i-cor pump was capable of creating nonpulsatile and electrocardiography (ECG)-synchronized pulsatile flow, and automatically reducing pulsatile frequency by increasing the assist ratio at higher heart rates. Reduced pulsatile frequency led to lower hemodynamic energy generation but did not affect circuit pressure drop. Pulsatile flow delivered more hemodynamic energy to the pseudopatient when compared with nonpulsatile flow. The pump generated more hemodynamic energy with higher pulsatile amplitudes. The i-cor pump can automatically adjust the pulsatile assist ratio to create pulsatile flow at higher heart rates, although this caused some hemodynamic energy loss. Compared with nonpulsatile flow, pulsatile flow generated and transferred more hemodynamic energy to the neonate during ECLS (200-600mL/min), especially at high pulsatile amplitudes and low flow rates.

Effects of Pulsatile Control Algorithms for Diagonal Pump on Hemodynamic Performance and Hemolysis.

The objective of this study is to compare hemodynamic performances under different pulsatile control algorithms between Medos DeltaStream DP3 and i-cor diagonal pumps in simulated pediatric and adult ECLS systems. An additional pilot study was designed to test hemolysis using two pumps during 12h-ECLS. The experimental circuit consisted of parallel combined pediatric and adult ECLS circuits using an i-cor pump head and either an i-cor console or Medos DeltaStream MDC console, a Medos Hilite 2400 LT oxygenator for the pediatric ECLS circuit, and a Medos Hilite 7000 LT oxygenator for the adult ECLS circuit. The circuit was primed with lactated Ringer's solution and human packed red blood cells (hematocrit 40%). Trials were conducted at various flow rates (pediatric circuit: 0.5 and 1L/min; adult circuit: 2 and 4L/min) under nonpulsatile and pulsatile modes (pulsatile amplitude: 1000-5000rpm [1000 rpm increments] for i-cor pump, 500-2500rpm [500 rpm increments] for Medos pump) at 36°C. In an additional protocol, fresh whole blood was used to test hemolysis under nonpulsatile and pulsatile modes using the two pump systems in adult ECLS circuits. Under pulsatile mode, energy equivalent pressures (EEP) were always greater than mean pressures for the two systems. Total hemodynamic energy (THE) and surplus hemodynamic energy (SHE) levels delivered to the patient increased with increasing pulsatile amplitude and decreased with increasing flow rate. The i-cor pump outperformed at low flow rates, but the Medos pump performed superiorly at high flow rates. There was no significant difference between two pumps in percentage of THE loss. The plasma free hemoglobin level was always higher in the Medos DP3 pulsatile group at 4 L/min compared to others. Pulsatile control algorithms of Medos and i-cor consoles had great effects on pulsatility. Although high pulsatile amplitudes delivered higher levels of hemodynamic energy to the patient, the high rotational speeds increased the risk of hemolysis. Use of proper pulsatile amplitude settings and intermittent pulsatile mode are suggested to achieve better pulsatility and decrease the risk of hemolysis. Further optimized pulsatile control algorithms are needed.

Clinical outcomes of neonatal and pediatric extracorporeal life support: A seventeen-year, single institution experience.

The objective of this study was to describe a single-center experience with neonatal and pediatric extracorporeal life support (ECLS) and compare patient-related outcomes with those of the Extracorporeal Life Support Organization (ELSO) Registry. A retrospective review of subject characteristics, outcomes, and complications of patients who received the ECLS at Penn State Health Children's Hospital (PSHCH) from 2000 to 2016 was performed. Fisher's exact test was used to compare the PSHCH outcomes and complications to the ELSO Registry report. Data from 118 patients were included. Survival to discontinuation of the ECLS was 70.3% and 65.2% to discharge/transfer. Following circuitry equipment changes, the survival to discharge/transfer improved for both neonatal (<29 days) and pediatric (29 days to <18 years) patients. The most common complications associated with ECLS were clinical seizures, intracranial hemorrhage, and culture-proven infection. ECLS for pulmonary support appeared to be associated with a higher risk of circuit thrombus and cannula problems. When compared to the ELSO Registry, low volume ECLS centers, like our institution, can have outcomes that are no different or statistically better as noted with neonatal and pediatric cardiac patients. Pediatric patients requiring pulmonary support appeared to experience more mechanical complications during ECLS suggesting the need for ongoing technological improvement.

In Vitro Evaluation of ECG-Synchronized Pulsatile Flow Using the i-cor Diagonal Pump in Neonatal and Pediatric ECLS Systems.

The objective was to assess the i-cor electrocardiogram-synchronized diagonal pump in terms of hemodynamic energy properties for off-label use in neonatal and pediatric extracorporeal life support (ECLS) circuits. The neonatal circuit consisted of an i-cor pump and console, a Medos Hilite 800 LT oxygenator, an 8Fr arterial cannula, a 10Fr venous cannula, 91 cm of 0.6-cm ID arterial tubing, and 91 cm of 0.6-cm ID venous tubing. The pediatric circuit was identical except it included a 12Fr arterial cannula, a 14Fr venous cannula, and a Medos Hilite 2400 LT oxygenator. Neonatal trials were conducted at 36°C with hematocrit 40% using varying flow rates (200-600 mL/min, 200 mL increments) and postarterial cannula pressures (40-100 mm Hg, 20 mm Hg increments) under nonpulsatile mode and pulsatile mode with various pulsatile amplitudes (1000-4000 rpm, 1000 rpm increments). Pediatric trials were conducted at different flow rates (800-1600 mL/min, 400 mL/min increments). Mean pressure and energy equivalent pressure increased with increasing postarterial cannula pressure, flow rate, and pulsatile amplitude. Physiologic-like pulsatility was achieved between pulsatile amplitudes of 2000-3000 rpm. Pressure drops were greatest across the arterial cannula. Pulsatile flow generated significantly higher total hemodynamic energy (THE) levels than nonpulsatile flow. THE levels at postarterial cannula site increased with increasing postarterial cannula pressure, pulsatile amplitude, and flow rate. No surplus hemodynamic energy (SHE) was generated under nonpulsatile mode. Under pulsatile mode, preoxygenator SHE increased with increasing postarterial cannula pressure and pulsatile amplitude, but decreased with increasing flow rate. The i-cor system can provide nonpulsatile and pulsatile flow for neonatal and pediatric ECLS. Pulsatile amplitudes of 2000-3000 rpm are recommended for use in neonatal and pediatric patients.

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

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.

In Vitro Hemodynamic Evaluation of ECG-Synchronized Pulsatile Flow Using i-Cor Pump as Short-Term Cardiac Assist Device for Neonatal and Pediatric Population.

The objective of this study was to assess the hemodynamic properties of the i-cor ECG-synchronized cardiac assist system for off-label use as a short-term cardiac assist device for neonatal and pediatric patients and compare nonpulsatile to pulsatile flow with different amplitudes. The circuit consisted of the i-cor diagonal pump with 3 feet of » inch arterial and venous tubing and a soft-shell reservoir, primed with lactated Ringer's solution and human packed red blood cells (hematocrit 42%). Trials were conducted with three different sets of cannulas (8-Fr arterial 10-Fr venous, 10-Fr arterial 12 Fr-venous, and 12-Fr arterial 14-Fr venous) with increasing flow rates at varying pseudo-patient pressures (40, 60, 80, and 100 mm Hg) and under nonpulsatile mode and pulsatile mode with pulsatile amplitudes 2000, 2500, and 3000 rpm at 36°C. Pressure and flow waveforms were recorded using a custom-made data acquisition device for each trial. Energy equivalent pressure (EEP) was higher than mean pressure under pulsatile mode, and increased with increasing pseudo-patient's pressure and flow rate while EEP was the same as the mean pressure under nonpulsatile mode. Total hemodynamic energy (THE) levels increased with pressure and pulsatile amplitude and slightly decreased with increasing flow rate. The percent THE lost throughout the circuit increased with flow rate and pulsatile amplitude and decreased with pseudo-patient's pressure. SHE levels also increased with pseudo-patient pressure and pulsatile amplitude and decreased with increasing flow rate. The i-cor diagonal pump can be used as a short term cardiac assist device for neonatal and pediatric patients and is able to provide nonpulsatile as well as pulsatile flow. Compared with nonpulsatile flow, pulsatile flow can generate and deliver more hemodynamic energy to the patients.

Evaluation and Comparison of Hemodynamic Performance of Three ECLS Systems in a Simulated Adult Cardiogenic Shock Model.

The objective of this study was to evaluate three commercially available ECLS systems with rotary pumps in terms of circuit pressure, pressure drop, perfusion modes, and hemodynamic energy transmission in a simulated adult cardiogenic shock model. One circuit consisted of a Cardiohelp system, which included a Cardiohelp console and HLS Module Advanced 7.0 tubing set with integrated centrifugal pump and oxygenator. The alternative circuit was composed of a Quadrox-D Adult oxygenator connected in series with either an i-cor diagonal pump and console or a Rotaflow centrifugal pump and console. The circuit was primed with lactated Ringer's solution and packed red blood cells (hematocrit 40%). The trials were conducted at flow rates of 1-5 L/min with pseudo patient pressures of 60 mm Hg and 80 mm Hg. Pulsatile flow was tested when using the i-cor system. Mean pre-oxygenator pressure and pressure drop across ECLS circuit (including oxygenator and arterial tubing) were lower when using the Cardiohelp system as compared to the Rotaflow and i-cor systems (P < 0.01). The i-cor system was able to deliver more hemodynamic energy to the pseudo patient because of its ability to produce pulsatile flow (P < 0.01). The Cardiohelp HLS Module Advanced 7.0 integrated oxygenator had a lower resistance than the Quadrox-D oxygenator. Although the compact Cardiohelp system had a better hemodynamic performance when compared to Rotaflow and i-cor systems, the pulsatile flow of the i-cor system delivered more hemodynamic energy to the pseudo patient. This may render more physiological benefits in high-risk patients on ECLS.

In Vitro Comparison of Two Neonatal ECMO Circuits Using a Roller or Centrifugal Pump With Three Different In-Line Hemoconcentrators for Maintaining Hemodynamic Energy Delivery to the Patient.

The objective of this study was to compare three different hemoconcentrators (Hemocor HPH 400, Mini, and Junior) with two different neonatal ECMO circuits using a roller or a centrifugal pump at different pseudo-patient pressures and flow rates in terms of hemodynamic properties. This evidence-based research is necessary to optimize the ECMO circuitry for neonates. The circuits used a 300-mL soft-shell reservoir as a pseudo-patient approximating the blood volume of a 3 kg neonate, two blood pumps, and a Quadrox-iD Pediatric oxygenator with three different in-line hemoconcentrators (Hemocor HPH 400, Mini, and Junior). One circuit used a Maquet H20 roller pump and another circuit used a Maquet RotaFlow centrifugal pump. The circuit was primed with lactated Ringer's solution followed by heparinized packed red blood cells with a hematocrit of 40%. The pseudo-patient's pressure was manually maintained at 40, 60, or 80 mm Hg and the flow rate was maintained at 200, 400, or 600 mL/min with a circuit temperature of 36°C. Pressure and flow data was recorded using a custom-made data acquisition device. Mean pressures, diverted blood flow, pressure drops, and total hemodynamic energy (THE) were calculated for each experimental condition. The roller pump and centrifugal pump performed similarly for all hemodynamic properties with all experimental conditions. The Hemocor HPH Junior hemoconcentrator added the highest resistance to the circuit. The Hemocor HPH Junior provided the highest circuit pressures, lowest diverted blood flow, highest pressure drop across the circuit, and highest THE generated by the pump. The Hemocor HPH 400 added the least resistance to the circuit, providing the lowest circuit pressures, more diverted flow, lowest pressure drop, and the lowest THE generated by the pump. However, the THE delivered to the patient was the same for the three hemoconcentrators. While the three hemoconcentrators performed differently in terms of hemodynamic properties throughout the circuit, the THE transmitted to the patient was similar for all three hemoconcentrators due to the consistent pseudo-patient's pressure that was manually maintained for each trial. While the THE delivered to the patient indicates similar perfusion for these patients with any of the three hemoconcentrators, the differences in added resistance to the circuit may impact the decision of which hemoconcentrator is used. There was no clinically significant difference between the two circuits with the roller versus centrifugal pump in terms of hemodynamic properties in this study. Further in vivo research is warranted to confirm our findings.

In Vitro Hemodynamic Evaluation of an Adult Pulsatile Extracorporeal Membrane Oxygenation System.

The objective of this study was to evaluate a pulsatile extracorporeal membrane oxygenation (ECMO) system in terms of hemodynamic energy generation and transmission under various pulsatile amplitudes, flow rates, and pseudopatient pressures in a simulated adult ECMO circuit. Surplus hemodynamic energy (SHE), a measure of the quality of pulsatility, was used to quantify pulsatile flow. The circuit consisted of an i-cor diagonal pump, an adult XLung oxygenator, a 21 Fr Medtronic Biomedicus femoral arterial cannula, a 23/25 Fr Sorin RAP femoral venous cannula, and 3/8 in ID tubing for both arterial and venous lines. The circuit was primed with lactated Ringer's solution and then packed red blood cells (hematocrit 37%). Trials were conducted at 36°C with flow rates of 2-5 L/min (1 L/min increments) under nonpulsatile and pulsatile mode with pulsatile amplitudes of 1000-5000 rpm (1000 rpm increments). The pseudopatient pressure was maintained at 40-100 mm Hg (20 mm Hg increments). Real-time pressure and flow data were recorded for analysis using a custom-made data acquisition system. There was no SHE generated by the pump under nonpulsatile mode. Under pulsatile mode, SHE levels increased with increasing pulsatile amplitude and pseudopatient pressure (P < 0.01) but decreased with increasing flow rate. SHE levels were significantly higher at flow rates of 2-4 L/min. In addition, the XLung oxygenator had acceptable pressure drops (36.1-104.9 mm Hg) and percentages of total hemodynamic energy loss (19.6-43.9%) during all trials. The novel pulsatile ECMO system can create nonpulsatile and pulsatile flow in an adult ECMO model. However, pulsatility gradually weakened with increasing flow rates. Pulsatile amplitude settings were found to have a great impact on pulsatility.

Evaluation of Combined Extracorporeal Life Support and Continuous Renal Replacement Therapy on Hemodynamic Performance and Gaseous Microemboli Handling Ability in a Simulated Neonatal ECLS System.

The objective of this study was to evaluate the hemodynamic performance and gaseous microemboli (GME) handling ability of a simulated neonatal extracorporeal life support (ECLS) circuit with an in-line continuous renal replacement therapy (CRRT) device. The circuit consisted of a Maquet RotaFlow centrifugal pump or HL20 roller pump, Quadrox-iD Pediatric diffusion membrane oxygenator, 8-Fr arterial cannula, 10-Fr venous cannula, and Better-Bladder (BB) with "Y" connector. A second Quadrox-I Adult oxygenator was added postarterial cannula for GME experiments. The circuit and pseudo-patient were primed with lactated Ringer's solution and packed human red blood cells (hematocrit 40%). All hemodynamic trials were conducted at ECLS flow rates ranging from 200 to 600 mL/min and CRRT flow rate of 75 mL/min at 36°C. Real-time pressure and flow data were recorded with a data acquisition system and GME were detected and characterized using the Emboli Detection and Classification Quantifier System. CRRT was added at distinct locations such that blood entered CRRT between the pump and oxygenator (A), recirculated through the pump (B), or bypassed the pump (C). With the centrifugal pump, all CRRT positions had similar flow rates, mean arterial pressure (MAP), and total hemodynamic energy (THE) loss. With the roller pump, C demonstrated increased flow rates (293.2-686.4 mL/min) and increased MAP (59.4-75.5 mm Hg) (P < 0.01); B had decreased flow rates (129.7-529.7 mL/min), and MAP (34.2-45.0 mm Hg) (P < 0.01); A maintained the same when compared to without CRRT. At 600 mL/min C lost more THE (81.4%) (P < 0.01) with a larger pressure drop across the oxygenator (95.6 mm Hg) (P < 0.01) than without CRRT (78.3%; 49.1 mm Hg) (P < 0.01). C also demonstrated a poorer GME handling ability using the roller pump, with 87.1% volume and 17.8% count reduction across the circuit, compared to A and B with 99.9% volume and 65.8-72.3% count reduction. These findings suggest that, in contrast to A and B, adding CRRT at position C is unsafe and not advised for clinical use.

Evaluation of Hemodynamic Performance of a Combined ECLS and CRRT Circuit in Seven Positions With a Simulated Neonatal Patient.

As it is common for patients treated with extracorporeal life support (ECLS) to subsequently require continuous renal replacement therapy (CRRT), and neonatal patients encounter limitations due to lack of access points, inclusion of CRRT in the ECLS circuit could provide advanced treatment for this population. The objective of this study was to evaluate an alternative neonatal ECLS circuit containing either a Maquet RotaFlow centrifugal pump or Maquet HL20 roller pump with one of seven configurations of CRRT using the Prismaflex 2000 System. All ECLS circuit setups included a Quadrox-iD Pediatric diffusion membrane oxygenator, a Better Bladder, an 8-Fr arterial cannula, a 10-Fr venous cannula, and 6 feet of »-inch diameter arterial and venous tubing. The circuit was primed with lactated Ringer's solution and packed human red blood cells resulting in a total priming volume of 700 mL for both the circuit and the 3-kg pseudopatient. Hemodynamic data were recorded for ECLS flow rates of 200, 400, and 600 mL/min and a CRRT flow rate of 50 mL/min. When a centrifugal pump is used, the hemodynamic performance of any combined ECLS and CRRT circuit was not significantly different than that of the circuit without CRRT, thus any configuration could potentially be used. However, introduction of CRRT to a circuit containing a roller pump does affect performance properties for some CRRT positions. The circuits with CRRT positions B and G demonstrated decreased total hemodynamic energy (THE) levels at the post-arterial cannula site, while positions D and E demonstrated increased post-arterial cannula THE levels compared to the circuit without CRRT. CRRT positions A, C, and F did not have significant changes with respect to pre-arterial cannula flow and THE levels, compared to the circuit without CRRT. Considering hemodynamic performance, for neonatal combined extracorporeal membrane oxygenation (ECMO) and CRRT circuits with both blood pumps, we recommend the use of CRRT position A due to its hemodynamic similarities to the ECMO circuit without CRRT.