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 After the termination of CPB, blood was withdrawn through the aortic cannula and passed through a hemoconcentrator attached to the blood cardioplegia set and returned to the patient through the venous cannula.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.

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.

Unique static discharge events on two CentriMag® (2nd Gen) ECMO patients causing console failure.

The use of ECMO for cardiovascular support continues to increase in the United States and around the world. It is not a benign endeavor as serious complications may occur. We present our experience of two second generation CentriMag® (Abbott formerly Thoratec Inc.) console failures that occurred while transporting the patients to other areas of the hospital. In each incident, the patients were immediately placed on back-up units and the transport continued. No patient complications could be attributed to the failures. An investigation by Abbott engineers traced the failure to a static build-up and discharge caused by a non-manufacturer-approved metal rod that was utilized to mount the external monitor. The static discharge caused a disruption of electrical continuity between the control system and the motor, stopping the motor as well as the monitoring system. Removal of the mounting rod prevented replication of the situation in the lab. We have removed the rod from our clinical units and have not experienced any other pump failures.

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 Five 6 Fr and 8 Fr Arterial Cannulae in Simulated Neonatal Cardiopulmonary Bypass Circuits.

The objective of this study was to evaluate five small-bore arterial cannulae (6Fr and 8Fr) in terms of pressure drop and hemodynamic performance in simulated neonatal cardiopulmonary bypass (CPB) circuits. The experimental circuits consisted of a Jostra HL-20 roller pump, a Terumo Capiox Baby FX05 oxygenator with integrated arterial filter, an arterial and a venous tubing (1/4, 3/16, or 1/8 in × 150 cm), and an arterial cannula (Medtronic Bio-Medicus 6Fr and 8Fr, Maquet 6Fr and 8Fr, or RMI Edwards 8Fr). The circuit was primed using lactated Ringer's solution and heparinized packed human red blood cells (hematocrit 30%). Trials were conducted at different flow rates (6Fr: 200-400 mL/min; 8Fr: 200-600 mL/min) and temperatures (35 and 28°C). Flow and pressure data were collected using a custom-based data acquisition system. Higher circuit pressure, circuit pressure drop, and hemodynamic energy loss across the circuit were recorded when using small-bore arterial cannula and small inner diameter arterial tubing in a neonatal CPB circuit. The maximum preoxygenator pressures reached 449.7 ± 1.0 mm Hg (Maquet 6Fr at 400 mL/min), and 395.7 ± 0.4 mm Hg (DLP 8Fr at 600 mL/min) when using 1/8 in ID arterial tubing at 28°C. Hypothermia further increased circuit pressure drop and hemodynamic energy loss. Compared with the others, the RMI 8Fr arterial cannula had significantly lower pressure drop and energy loss. Maquet 6Fr arterial cannula had a greater pressure drop than the DLP 6Fr. A small-bore arterial cannula and arterial tubing created high circuit pressure drop and hemodynamic energy loss. Appropriate arterial cannula and arterial tubing should be considered to match the expected flow rate. Larger cannula and tubing are recommended for neonatal CPB. Low-resistance neonatal arterial cannulae need to be developed.

Potential Danger of Pre-Pump Clamping on Negative Pressure-Associated Gaseous Microemboli Generation During Extracorporeal Life Support--An In Vitro Study.

The objectives of this study were to investigate the relationship between revolution speed of a conventional centrifugal pump and negative pressure at the inlet of the pump by clamping the tubing upstream of the pump, and to verify whether negative pressure leads to gaseous microemboli (GME) production in a simulated adult extracorporeal life support (ECLS) system. The experimental circuit, including a Maquet Rotaflow centrifugal pump and a Medos Hilite 7000 LT polymethyl-pentene membrane oxygenator, was primed with packed red blood cells (hematocrit 35%). Negative pressure was created in the circuit by clamping the tubing upstream of the pump for 10 s, and then releasing the clamp. An emboli detection and classification quantifier was used to record GME volume and count at pre-oxygenator and post-oxygenator sites, and pressure and flow rate data were collected using a custom-based data acquisition system. All trials were conducted at 36°C at revolution speeds of 2000-4000 rpm (500 rpm increment). The flow rates were 1092.5-4708.4 mL/min at the revolution speeds of 2000-4000 rpm. Higher revolution speed generated higher negative pressure at the pre-pump site when clamping the tubing upstream of the pump (-108.3 ± 0.1 to -462.0 ± 0.5 mm Hg at 2000-4000 rpm). Moreover, higher negative pressure was associated with a larger number and volume of GME at pre-oxygenator site after de-clamp (GME count 10,573 ± 271 at pre-oxygenator site at 4000 rpm). The results showed that there was a potential danger of delivering GME to the patient when clamping pre-pump tubing during ECLS using a centrifugal pump. Our results warrant further clinical studies to investigate this phenomenon.

Comparison of hemolysis between CentriMag and RotaFlow rotary blood pumps during extracorporeal membrane oxygenation.

The purpose of this investigation was to compare the hemolysis levels for patients on extracorporeal membrane oxygenation (ECMO) incorporating two different rotary blood pumps (CentriMag [CMAG] and RotaFlow [RF]) in identical circuits otherwise. The difference between the two pumps is the cost. One is 20-30 times less expensive than the other. A retrospective analysis of all patients placed on ECMO from June 2008 through May 2012 was done to evaluate hemolysis. Daily plasma hemoglobin (pHb), lactate dehydrogenase (LDH), and lactate levels were collected on all patients. Values were compared between those patients who received a CMAG and those who received an RF. Patients had to be on ECMO for more than 2 days to be included in the study. Linear mixed effects models were fit to the data to assess differences over time for each continuous outcome. Forty patients were placed on ECMO incorporating CMAG, whereas 40 patients received an RF. There were no significant statistical differences between CMAG and RF groups when comparing days on support (8.7 ± 5.0; 8.4 ± 5.7), age (44.8 ± 18.3; 46.1 ± 16.0), body surface area (2.03 ± 0.36; 1.96 ± 0.31), gender (male: 58%, female: 42%; male: 55%, female: 45%), etiology, type of support (veno-arterial [VA)]: 78%, veno-venous [VV)]: 22%; VA: 82%, VV: 18%) and pre-ECMO LDH levels (4004.0 ± 3583.2; 3603.7 ± 3354.1). There were also no significant differences between the CMAG and RF groups when comparing the mean values for daily pHb levels (5.7 ± 3.6; 5.7 ± 4.2), lactate levels (2.8 ± 1.9; 3.0 ± 2.1), and LDH levels (2656.3 ± 1606.8; 2688.6 ± 1726.1) or daily lactate, LDH, and pHb levels for the first 10 days of support. From our investigation, there is no difference between the CMAG and the RF blood pumps in regard to the creation of hemolysis during ECMO. The difference in cost of the devices does not correlate with the performance and outcomes.

Hemodynamic evaluation of the Avalon Elite bi-caval dual lumen cannulae.

In previous studies, we have evaluated the hemodynamic properties of selected oxygenators, pumps (centrifugal and roller), and single lumen cannulae. Because the dual lumen cannulae are widely used in veno-venous extracorporeal life support (ECLS) and are receiving popularity due to their advantages over the single lumen cannulae, we evaluated the flow ranges and pressure drops of three different sizes of Avalon Elite dual lumen cannulae (13Fr, 16Fr, and 19Fr) in a simulated neonatal ECLS circuit primed with human blood. The experimental ECLS circuit was composed of a RotaFlow centrifugal pump, a Capiox BabyRX05 oxygenator, 3 ft of 1/4-in venous and arterial line tubing, an Avalon Elite dual lumen cannula, and a soft reservoir as a pseudo-right atrium. All experiments were conducted at 37°C using an HCU 30 heater-cooling unit and with human blood at a hematocrit of 36%. The blood pressure in the pseudo-right atrium was continuously monitored and maintained at 4-5 mm Hg. For each cannula, pump flow rates and pressures at both the arterial and venous sides were recorded at revolutions per minute (RPMs) from 1750 to 3750 in 250 intervals. For each RPM, six data sets were recorded for a total of 162 data sets. The total volume of the system was 300 mL. The flow range for the 13Fr, 16Fr, and 19Fr cannulae were from 228 to 762 mL/min, 478 to 1254 mL/min, and 635 to 1754 mL/min, respectively. The pressure drops at the arterial side were higher than the venous side at all tested conditions except at 1750 rpm for the 19Fr cannula. The results of this study showed the flow ranges and the pressure drops of three different sized dual lumen cannulae using human blood, which is more applicable in clinical settings compared with evaluations using water.

Translational research in pediatric extracorporeal life support systems and cardiopulmonary bypass procedures: 2011 update.

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.