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Objective: The purpose of this experiment was to compare the Sorin KIDS D131 and the Terumo Capiox AF02 pediatric arterial filters in a simulated CPB procedure to determine which filter is the better for clinical use. Methods: The experimental circuit was primed with an 800 ml combination of lactated Ringer’s solution and human blood (hematocrit (Hct) 30%). The two filters were tested under flow rates of 500, 1000, and 1500 ml/min at room temperature and their purge lines opened and closed as 5cc of air was injected into the circuit. Results: As the flow rates increased, the number of gaseous microemboli (GME) being returned to the pseudo patient increased for both of the pediatric arterial filters. Having an open purge line increased the number of GME removed from the CPB circuit, caused less of a pressure drop than when closed and increased the total hemodynamic energy loss than when closed. Both of the filters performed and reacted similarly in decreasing GME, hemodynamic energy loss and pressure drop. The only minor difference was that the Capiox AF02 had slightly less stolen blood flow (109.5 ± 1.7 ml/min at 500 ml/min, 114.7 ± 1.1 ml/min at 1000 ml/min and 105.8 ± 4.2 ml/min at 1500ml/min) from the open purge line than the KIDS D131 (119.5 ± 2.5 ml/min at 500 ml/min, 128.3 ± 1.0 ml/min at 1000 ml/min and 126.3 ± 3.1 ml/min at 1500 ml/min). Conclusion: Our study confirmed that both the Sorin KIDS D131 and the Terumo Capiox AF02 were equivalent in their ability to remove significant numbers of GME, the amount of pressure drop and the total hemodynamic energy loss across the arterial filters at the various flow rates. An arterial filter is not an option, but a necessity for removing microemboli delivered to the patient.

The cardiopulmonary bypass (CPB) procedure has been shown to be a possible cause of postoperative neurological morbidity for various reasons, including: large amounts of gaseous microemboli (GME) reaching the patient and hypoperfusion of the patient due to “stolen” blood flow. This study used a simulated CPB circuit identical to that in a clinical setting to examine three different hollow-fiber membrane oxygenators without intergrated arterial filters - the Capiox RX05, the Quadrox-i neonatal, and the KIDS D100 - to determine their ability to reduce the number of GME delivered to the neonatal patient and their hemodynamic properties in response to varying flow rates, normothermic vs hypothermic conditions, and open vs closed purge line. The circuit was primed with Ringer’s Lactate and then human blood with a hematocrit of 30%. Injections of 5cc bolusses of air were injected into the venous line proximal to the venous reservoir over a thirty-second interval. Six injections were done for each oxygenator at each of the eight different experimental conditions for a total of 64 experiments per oxygenator (192 total injections). A flow probe, pressure transducer, and Emboli Detection and Classification (EDAC) quantifier transducer were positioned both upstream and downstream of the oxygenator to measure differences in each parameter. Results demonstrated that the Capiox RX05 is the most effective oxygenator at reducing the number of microemboli that potentially can be delivered to the neonatal patient. In regards to the hemodynamic properties, the Quadrox-i has the most favorable results, with the lowest mean pressure drop and the best energy retention across the oxygenator.

Objective: To construct an ideal extracorporeal life support (ECLS) circuit in terms of hemodynamic performance, each component of the circuit should be evaluated. Most cannulae manufacturers evaluate their products using water as the priming solution. We conducted this study to evaluate the different sizes of arterial and venous cannulae in a simulated neonatal ECLS circuit primed with human blood. Methods: The simulated neonatal ECLS circuit was composed of a Capiox Baby RX05 oxygenator, a Rotaflow centrifugal pump and a heater & cooler unit. Three Medtronic Bio-Medicus arterial cannulae (8Fr, 10Fr, 12Fr) and three venous cannulae (10Fr, 12Fr, 14Fr) were tested in seven combinations (8A-10V, 8A-12V, 10A-10V, 10A-12V, 10A-14V, 12A-12V, 12A-14V). All the experiments were conducted using human blood at a hematocrit of 40% and at a constant temperature of 37°C. The “tip to tip” priming volume of the entire circuit was 135ml. The blood volume of the pseudo patient was 500ml. Results: Flow rates increased linearly with increasing size in both venous and arterial cannulae at the same pump speeds. The increase in flow rate was greater when changing the arterial cannulae (next size larger) compared to changing the venous cannulae (next size larger). The pressure drops of the arterial cannula were correlated with the flow rates, regardless of the pseudo patient pressure and the venous cannula used simultaneously. Conclusions: The results show the difference in flow ranges and pressure drops of seven combinations of arterial and venous cannulae. It also suggests that the arterial cannula, not the venous cannula, has greater impact on the flow rate when a centrifugal pump is used in a neonatal ECLS circuit. The results of this study have been translated to further advancing the clinical practice in our institution.

Objectives: This experiment sought to compare two polymethyl pentene (PMP) hollow-fiber membrane oxygenators: the Medos HILITE 2400 LT and the Maquet Quadrox-iD Pediatric in terms of transmembrane pressure gradients and hemodynamic energy preservation under both pulsatile and non-pulsatile conditions. Methods: A simulated pediatric extracorporeal life support (ECLS) circuit was used to test these two oxygenators. The circuit consisted of a roller pump, ¼ inch tubing for both arterial and venous lines, an oxygenator, and a venous reservoir served as a pseudo-patient. Three pressure transducers were placed upstream and downstream of the oxygenator and the distal arterial line. The experimental system was primed with lactated Ringer’s solution and packed human red blood cells to maintain a hematocrit of 40%.The total volume was 600 ml, including the 350 ml volume of the pseudo-patient.The tests were performed at six flow rates (250, 500, 750, 1000, 1250, 1500 ml/min) and three distal arterial line pressures (MAP) (60, 80, 100 mmHg), under both pulsatile and non-pulsatile perfusion modes.The temperature was kept constant at 37°C for all tests. Results: Both oxygenators had adequate performances in pressure drop and hemodynamic energy preservation. There were no significant differences between pre- and post-oxygenators for mean pressure (MP), energy equivalent pressure (EEP) and total hemodynamic energy (THE). During the pulsatile perfusion mode, the HILITE 2400 LT retained a greater percentage of surplus hemodynamic energy (SHE) across the oxygenator. Conclusions: Both the Quadrox-iD Pediatric and HILITE 2400LT PMP membrane oxygenators are suitable for pediatric ECLS therapy under both non-pulsatile and pulsatile perfusion. An optimized combination of flow rate and MAP should be achieved in order to deliver the maximal pulsatile energy in the extracorporeal circuit.

Introduction: Centrifugal blood pumps have been widely adopted in conventional adult cardiopulmonary bypass and circulatory assist procedures. Different brands of centrifugal blood pumps incorporate distinct designs which affect pump performance. In this adult extracorporeal life support (ECLS) model, the performances of two brands of centrifugal blood pump (RotaFlow blood pump and CentriMag blood pump) were compared. Methods: The simulated adult ECLS circuit used in this study included a centrifugal blood pump, Quadrox D membrane oxygenator and Sorin adult ECLS tubing package. A Sorin Cardiovascular® VVR® 4000i venous reservoir (Sorin S.p.A., Milan, Italy) with a Hoffman clamp served as a pseudo-patient. The circuit was primed with 900ml heparinized human packed red blood cells and 300ml lactated Ringer’s solution (total volume 1200 ml, corrected hematocrit 40%). Trials were conducted at normothermia (36°C). Performance, including circuit pressure and flow rate, was measured for every setting analyzed. Results: The shut-off pressure of the RotaFlow was higher than the CentriMag at all measurement points given the same rotation speed (p < 0.0001). The shut-off pressure differential between the two centrifugal blood pumps was significant and increased given higher rotation speeds (p < 0.0001). The RotaFlow blood pump has higher maximal flow rate (9.08 ± 0.01L/min) compared with the CentriMag blood pump (8.37 ± 0.02L/min) (p < 0.0001). The blood flow rate differential between the two pumps when measured at the same revolutions per minute (RPM) ranged from 1.64L/min to 1.73L/min. Conclusions: The results obtained in this experiment demonstrate that the RotaFlow has a higher shut-off pressure (less retrograde flow) and maximal blood flow rate than the CentriMag blood pump. Findings support the conclusion that the RotaFlow disposable pump head has a better mechanical performance than the CentriMag. In addition, the RotaFlow disposable pump is 20-30 times less expensive than the CentriMag.

This study compared four pediatric cardiopulmonary bypass (CPB) circuits with four different hollow-fiber membrane oxygenators and their specific reservoirs, Capiox RX15, Quadrox-i pediatric, Quadrox-i pediatric with integrated arterial filter (IAF) and KIDS D101, in a simulated CPB circuit identical to that used in the clinical setting at our institution to test their ability to maintain hemodynamic properties, remove gaseous microemboli (GME), and to test the amount of blood “stolen” by the arterial filter purge line. The circuit was first primed with Ringer’s Lactate solution, then red blood cells were added and the hematocrit was maintained at 30%. A 5-cc bolus of air was injected just proximal to the venous reservoir over a thirty-second interval and GME were monitored using an Emboli Detection and Classification quantifier. Transducers were placed at pre-oxygenator, post-oxygenator and distal arterial line (post-filter) positions. Flow probes were also placed both pre and post filter. The injections were made at three flow rates, hypothermic and normothermic temperatures, and with the purge line in both the opened and closed positions. Six injections were done at each of the 12 experimental conditions. Results demonstrated that GME in the arterial line increased with increasing temperature and flow rate. The Capiox RX15 had the least GME in the arterial line at all experimental conditions. The KIDS D101 had the largest pressure drop and the lowest retention of hemodynamic energy, while the Capiox had the lowest pressure drop. All of the oxygenators had a similar amount of “stolen” blood flow and it was consistently under 10% of the total flow reaching the patient.

Perfusion quality during cardiopulmonary bypass (CPB) procedures can contribute to postoperative neurological complications and influence patient recovery and outcome. Gaseous microemboli generated in the circuit and hemodynamic properties of blood reaching the patient can be monitored during CPB to optimize perfusion. Oxygenators that oxygenate the blood during CPB can significantly influence the quality of blood reaching the patient by their manufacturing designs. New hollow-fiber membrane oxygenators are developed with integrated arterial filters to reduce priming volume and eliminate a separate arterial filter in the circuit. To evaluate the performance of these new oxygenators, we used a simulated model to compare the Quadrox-i Neonatal and the Capiox Baby FX05 neonatal oxygenators and to provide a review of these oxygenators with their respective counterparts which have separate arterial filters. We found that microemboli counts for the new Quadrox-i and Capiox FX05 oxygenators are similar in the arterial line, but different across the oxygenator for all experimental conditions. The arterial purge line diverting blood from the patient reduces microemboli count for the Capiox FX05, but is inconsistent for the Quadrox-i Neonatal. While hemodynamic energy delivered to the patient is similar for both oxygenators, shunted blood flow for the Quadrox-i Neonatal oxygenator is three times higher than the Capiox FX05 (103.6 mL/min vs 33.0 mL/min at 400 mL/min and 35°C) (p

Emerging technologies and practices for pediatric and neonatal extracorporeal life support (ECLS) are promising. This experiment sought to compare the Medtronic 0800 silicon rubber membrane oxygenator to the Quadrox-iD Pediatric oxygenator in the conventional roller pump circuit, as well as comparing the conventional circuit to an alternative circuit. Three circuits were set up in the experiment. Two conventional roller pump circuits were used to compare the two oxygenators and an alternative circuit consisting of the Quadrox-iD Pediatric oxygenator and Maquet Rotaflow centrifugal pump system was used to identify differences between circuits. All three circuits were primed with Lactated Ringers’ solution and human blood, with an hematocrit of 40%. Testing occurred at flow rates of 250, 500, and 750 ml/ min at 37°C for mean arterial line pressures of 60, 80, and 100 mmHg. The results of the experiment showed lower pressure drops and greater retention of total hemodynamic energy (THE) across the Quadrox-iD Pediatric oxygenator compared to the Medtronic 0800 oxygenator. Furthermore, the centrifugal pump used in the alternative circuit showed no back flow at flow rates as low as 250 ml/min while, on the other hand, rpm levels were kept below 2200 for flow rates as high as 750 ml/min. Findings support the usage of the Quadrox-iD Pediatric oxygenator in a circuit utilizing the Maquet Rotaflow centrifugal pump system due to lower pressure drops and greater percentage of THE retained across the circuit. Additional advantages of the alternative circuit include rapid set-up time, easy transport, lower priming volumes, and no gravity-dependent venous drainage system so that it can be situated in close proximity to and at the level of the patient.

Cardiopulmonary bypass (CPB) can be a potential cause of morbidity in patients for several reasons, including significantly higher gaseous microemboli (GME) formation than extracorporeal life support (ECLS) and physiological circulation, diverted blood flow from the patient via an open purge line of the arterial filter, and pressure drop across the oxygenator that is used in the circuit. Using a combined oxygenator and arterial filter may minimize these harmful factors and can effectively reduce the chances for postoperative morbidity. This study investigated the new QUADROX-i Neonatal Oxygenator (D-72145, Maquet, Hirrlingen, Germany) with an integrated arterial filter in terms of the hemodynamic properties and ability to clear GME in response to hypothermic versus normothermic conditions, open versus closed arterial filter purge line, and varying flow rates in a simulated CPB circuit identical to that of the clinical setting. A flow probe, pressure transducer, and Emboli Detection and Classification (EDAC) quantifier transducer were placed upstream and downstream to the oxygenator to measure changes in each parameter. The circuit was primed with fresh human blood with an hematocrit (Hct) of 26% diluted with Ringer’s lactate solution. Five milliliters of air were injected proximal to the venous cardiotomy reservoir, under non-pulsatile perfusion, with flow rates of 500 ml/min, 750 ml/min, and 1000 ml/min. A total of 8 air bolus injections were made at each individual set of conditions for a total of 96 injections. Results showed that the QUADROX-i Neonatal Oxygenator with an integrated filter has excellent hemodynamic properties with extremely low pressure drops and blood flow diverted from the patient, as well as high rates of GME capturing. The arterial filter purge line has a significant effect on the degree of blood flow diverted from the patient (p < 0.001), but does not affect pressure drop across the oxygenator.

Purpose: The objectives of this investigation were (1) to compare two hollow-fiber membrane oxygenators (Capiox Baby RX versus Lilliput 1-D901) in terms of pressure drops and surplus hemodynamic energy (SHE) during normothermic and hypothermic cardiopulmonary bypass (CPB) in a simulated neonatal model; and (2) to evaluate pulsatile and non-pulsatile perfusion modes for each oxygenator in terms of SHE levels. Methods: In a simulated patient, CPB was initiated at a constant pump flow rate of 500 mL/min. The circuit was primed with fresh bovine blood. After 5 min of normothermic CPB, the pseudo-patient was cooled down to 25°C for 10 min followed by 30 min of hypothermic CPB. The pseudo-patient then underwent 10 min of rewarming and 5 min of normothermic CPB. At each experimental site (pre- and post-oxygenator and pre-aortic cannula), SHE was calculated using the following formula {SHE (ergs/cm3) = 1332 [((ffpdt)/(ffdt))-mean arterial pressure]} (f = pump flow and p = pressure). A linear mixed-effects model that accounts for the correlation among repeated measurements was fit to the data to assess differences in SHE between oxygenators, pumps, and sites. Tukey’s multiple comparison procedure was used to adjust p-values for post-hoc pairwise comparisons. Results: The pressure drops in the Capiox group compared to the Lilliput group were significantly lower during hypothermic non-pulsatile (21.3∓0.5 versus 50.7∓0.9 mmHg, p B < 0.001) and pulsatile (22∓0.0 versus 53.3∓0.5 mmHg, p < 0.001) perfusion, respectively. Surplus hemodynamic energy levels were significantly higher in the pulsatile group compared to the non-pulsatile group, with Capiox (1655∓92 versus 10 008∓1370 ergs/cm3, p < 0.001) or Lilliput (1506∓112 versus 7531∓483 ergs/cm3, p < 0.001) oxygenators. During normothermic CPB, both oxygenators had patterns similar to those observed under hypothermic conditions. Conclusions: The Capiox oxygenator had a significantly lower pressure drop in both pulsatile and non-pulsatile perfusion modes. For each oxygenator, the SHE levels were significantly higher in the pulsatile mode.