Evaluation of Capiox RX25 and Quadrox‐i Adult Hollow Fiber Membrane Oxygenators in a Simulated Cardiopulmonary Bypass Circuit

The Capiox RX25 and Quadrox‐i Adult oxygenators are commonly used in clinical adult cardiopulmonary bypass circuits. This study was designed to test the effectiveness of two adult oxygenators in order to evaluate gaseous microemboli (GME) trapping capability and hemodynamic performance. A simulated adult CPB circuit was used and primed with Ringer's lactate and packed red blood cells (hematocrit 25%). All trials were conducted at flow rates of 2–5 L/min (1 L/min increments) with a closed and open arterial filter purge line at 35°C. The postcannula pressure was maintained at 100 mm Hg. After a 5 cc of bolus air was introduced into the venous line, an Emboli Detection and Classification system was used to detect and classify GME at the preoxygenator, postoxygenator, and precannula sites. At the same time, real‐time pressure and flow data were recorded, and hemodynamic energy was calculated using a custom‐made data acquisition system and Labview software. Our results showed that the oxygenator pressure drops of Quadrox‐i Adult oxygenator were lower than Capiox RX25 at all flow rates. The Quadrox‐i Adult oxygenator retained more hemodynamic energy across the oxygenator. Both oxygenators could trap the majority of GME, but Capiox RX25 did better than the Quadrox‐i Adult oxygenator. No GME was delivered to the pseudo patient at all flow rates in the Capiox group. The Capiox RX25 venous reservoir could capture more GME at lower flow rates, while the Quadrox‐i Adult venous reservoir performed better at higher flow rates. An open arterial filter purge line reduced GME slightly in the Capiox group, but GME increased in the Quadrox group. The Quadrox‐i Adult oxygenator is a low‐resistance, high‐compliance oxygenator. The GME handling ability of Capiox RX25 performed well under our clinical setting. Further optimized design for the venous/cardiotomy reservoir is needed.     

Development of a new silicone membrane oxygenator for ECMO.

Two types small and efficient ECMO oxygenators were developed utilizing the most up to date hollow fiber technology. Newly silicone hollow fibers possess sufficient mechanical strength while maintaining ultra thin walls of 50 micro meter. Two types of oxygenators were made with this fiber. The fiber length for the type 1 module is 150mm with a priming volume 194 cc (surface area 1.3 m(2)) and type 2 has a fiber length of 100 mm with a 144 cc priming volume (the surface area 0.8 m(2)). The studies were performed at 0.5, 1.0 and 2.0 L/min of blood flow and these oxygenators demonstrated. O(2) gas transfer rate of 69+/-4 ml/min/L for type 1 and 68+/-6 ml/min/L for type 2. The CO(2) gas transfer rate was 25+/-2 ml/min/L for type 1 and 32+/-2 ml/min/L for type 2. These results demonstrate type 2 oxygenator has similar gas exchange capabilities to those of Kolobows' oxygenator which has about 2.0 times larger surface area. Additionally, comparative hemolysis tests were preformed with this new oxygenator and the Kolbow. The NIH value was 0.006 (g/100 L) for the type 1 oxygenator and 0.01 (g/100 L) for the Kolbow oxygenator. These results suggested that this ECMO oxygenator had sufficient gas exchange performance in spite of being smaller and induced minimal blood damage.     

Development of an Intravenous Membrane Oxygenator: Enhanced Intravenous Gas Exchange Through Convective Mixing of Blood around Hollow Fiber Membranes

Abstract: In vitro testing of a new prototype intravenous membrane oxygenator (IMO) is reported. The new IMO design consists of matted hollow fiber membranes arranged around a centrally positioned tripartite balloon. Short gas flow paths and consistent, reproducible fiber geometry after insertion of the device result in an augmented oxygen flux of up to 800% with balloon activation compared with the static mode (balloon off). Operation of the new IMO device with the balloon on versus the balloon off results in a 400% increase in carbon dioxide flux. Gas flow rates of up to 9. 5 L/min through the 14–cm–long hollow fibers have been achieved with vacuum pressures of 250 mm Hg. Gas exchange efficiency for intravenous membrane oxygenators can be increased by emphasizing the following design features: short gas flow paths, consistent and reproducible fiber geometry, and most importantly, an active means of enhancing convective mixing of blood around the hollow fiber membranes     

An in vitro comparison of gas transfer and pressure drop of the Bentley Duraflo Coated Spiral Gold and the Medtronic Carmeda Coated Maxima hollow fiber membrane oxygenators

Two models of heparin coated, hollow fiber membrane oxygenators were tested in vitro to compare gas transfer and transoxygenator pressure drop using an established protocol. Oxygen and carbon dioxide transfer rates were measured at blood flows of 2.5 and 5.0 liters per minute with gas flow: blood flow ratios of 1:1 and 2:1 at both blood flows. All testing was performed under normothermic conditions. The data shows that oxygen transfer increases as blood flow is increased in both oxygenators. Similarly, carbon dioxide transfer is increased by both increased blood and gas flows. Finally, the pressure drop was dependent on blood flow rate alone. This study demonstrated these two oxygenators to be comparable in both oxygen and carbon dioxide transfer and also in transoxygenator pressure drop.     

Impact of oxygenator selection on hemodynamic energy indicators under pulsatile and nonpulsatile flow in a neonatal extracorporeal life support model

This study compared the quality of perfusion delivered by two oxygenators--the hollow-fiber membrane Capiox Baby RX05 and silicone membrane Medtronic 0800--using hemodynamic energy indicators. The oxygenators were tested across varying flow rates and perfusion modes in a neonatal extracorporeal life support (ECLS) model. The experimental ECLS circuit included a Jostra HL-20 heart/lung machine with Jostra Roller pump, oxygenators with associated tubing and components, and a neonatal pseudo-patient. We used a 40/60 glycerin/water solution in the circuit as a blood analog. Testing occurred at flow rates of 250, 500, and 750 mL/min at 37°C under both pulsatile and nonpulsatile flow conditions. Hemodynamic data points consisted of recording 20-s intervals of data, and a total of 96 experimental repetitions were conducted. The pressure drop across the Capiox Baby RX05 oxygenator was significantly lower than the pressure drop across the Medtronic 0800 at all flow rates and perfusion modes. Furthermore, the Medtronic 0800 oxygenator showed significantly lower post-oxygenator energy equivalent pressures, total hemodynamic energy values, and surplus hemodynamic energy retention values compared to those of the Capiox Baby RX05. These results indicate the Medtronic 0800 oxygenator significantly dampens the hemodynamic energy compared to the Capiox Baby RX05. Consequently, clinical use of the Medtronic 0800 in a pulsatile ECLS setting is likely to mitigate the benefits provided by pulsatile flow. In contrast, the Capiox Baby RX05 better transmits hemodynamic energy to the patient with much lower pressure drop.     

In vitro anesthetic washin and washout via bubble oxygenators: influence of anesthetic solubility and rates of carrier gas inflow and pump blood flow

The uptake and elimination of volatile anesthetic agents administered to patients under conditions of hemodilution and hypothermia during cardiopulmonary bypass have not been determined. To define the limitations imposed by oxygenators, we defined washin and washout curves for volatile anesthetic agents administered to bubble oxygenators primed with diluted blood (without connection to a patient). There was rapid equilibration of anesthetic partial pressure between delivered gas and blood (85-90% within 16 minutes). Increasing the gas inflow to the oxygenator from 3 to 12 L/min hastened washin and washout slightly, while increasing the pump blood flow from 3 to 5 L/min had no effect. Rates of washin and washout of anesthetics differed as a function of their blood/gas solubilities: enflurane greater than isoflurane greater than halothane during washin; isoflurane greater than enflurane greater than halothane during washout. However, these differences were small. Oxygenator exhaust partial pressures of anesthetic correlated with simultaneously obtained blood partial pressures, suggesting that monitoring exhaust gas may be useful clinically.     

Contemporary Oxygenator Design: Shear Stress‐Related Oxygen and Carbon Dioxide Transfer

Design of contemporary oxygenators requires better understanding of the influence of hydrodynamic patterns on gas exchange. A decrease in blood path width or an increase in intraoxygenator turbulence for instance, might increase gas transfer efficiency but it will increase shear stress as well. The aim of this clinical study was to examine the association between shear stress and oxygen and carbon dioxide transfer in different contemporary oxygenators during cardiopulmonary bypass (CPB). The effect of additional parameters related to gas transfer efficiency, that is, blood flow, gas flow, sweep gas oxygen fraction (FiO₂), hemoglobin concentration, the amount of hemoglobin pumped through the oxygenator per minute—Qhb, and shunt fraction were contemplated as well. Data from 50 adult patients who underwent elective CPB for coronary artery bypass grafting or aortic valve replacement were retrospectively analyzed. Data included five different oxygenator types with an integrated arterial filter. Relationships were determined using Pearson bivariate correlation analysis and scatterplots with LOESS curves. In the Capiox FX25, Fusion, Inspire 8F, Paragon, and Quadrox‐i groups, mean blood flows were 4.8 ± 0.9, 5.3 ± 0.7, 4.9 ± 0.7, 5.0 ± 0.6, and 5.7 ± 0.6 L/min, respectively. The mean O₂ transfer/m² membrane surface area was 44 ± 14, 51 ± 9, 60 ± 10, 63 ± 14, and 77 ± 18, respectively, whereas the mean CO₂ transfer/m² was 26 ± 14, 60 ± 22, 73 ± 29, 74 ± 19, and 96 ± 20, respectively. Associations between oxygen transfer/m² and shear stress differed per oxygenator, depending on oxygenator design and the level of shear stress (r = 0.249, r = 0.562, r = 0.402, r = 0.465, and r = 0.275 for Capiox FX25, Fusion, Inspire 8F, Paragon, and Quadrox‐i, respectively, P < 0.001 for all). Similar associations were noted between CO₂ transfer/m² and shear stress (r = 0.303, r = 0.439, r = 0.540, r = 0.392, and r = 0.538 for Capiox FX25, Fusion, Inspire 8F, Paragon, and Quadrox‐i, respectively, P < 0.001 for all). In addition, O₂ transfer/m² was strongly correlated with FiO₂ (r = 0.633, P < 0.001), blood flow (r = 0.529, P < 0.001), and Qhb (r = 0.589, P < 0.001). CO₂ transfer/m² in contrast was predominately correlated to sweep gas flow (r = 0.567, P < 0.001). The design‐dependent relationship between shear stress and gas transfer revealed that every oxygenator has an optimal range of blood flow and thus shear stress at which gas transfer is most efficient. Gas transfer is further affected by factors influencing the O₂ or CO₂ concentration gradient between the blood and the gas compartment.     

A Clinical Study for the Durability of Oxygenators on Cardiopulmonary Support

Abstract: Cardiopulmonary support (CPS) requires durability of the oxygenator. The life span of the oxygenator is affected by various clinical factors, including patient condition, perfusion condition, and equipment usage. Predictors for the durability of oxygenators were evaluated clinically in this study. Thirty-two patients, who had undergone CPS during the last 3 years in our institute were assigned to this study. Fifty oxygenators had been used (Capiox SX in 19, CB Maxima in 23, and AL-6000 in 8). Significant predictors for the durability of oxygenators were evaluated by nonparametric survival analysis and proportional hazards regression analysis. Univariate regression analysis revealed 6 significant predictors for the life span of oxygenators. These were the oxygenator type, type of centrifugal pump, acidosis with blood pH less than 7.35, base excess less than -5, blood glutamic-oxaloacetic transaminase (GOT) levels greater than 1,000 IU, and blood lactate dehydrogenase (LDH) levels greater than 3,000 IU. After multivariate analysis, there remained only 2 significant predictors. An oxygenator used with a noncoated CPS system (Capiox SX with Capiox EBS) proved to have a significantly shorter life span than one used with a heparin-coated system (CB Maxima or AL-6000 with CB BP-80) (hazards ratio, 3.588, p = 0.0065). Patient conditions, which revealed acidosis with less than -5 of base excess, significantly shortened the life of the oxygenator (hazards ratio, 3.595, p = 0.0188).     

Evaluation of neonatal membrane oxygenators with respect to gaseous microemboli capture and transmembrane pressure gradients

A series of studies performed at our center demonstrates that gaseous microemboli (GME) remain a challenge in cardiac surgical procedures. Evaluation of novel oxygenators must address hemodynamic parameters and microemboli capture capability. The objective of this study is to compare two neonatal membrane oxygenators, the Quadrox‐i (MAQUET Cardiopulmonary AG, Hirrlingen, Germany) and the Capiox RX05 (Terumo Corporation, Tokyo, Japan), with respect to GME capture and hemodynamic energy delivery. The experimental circuit included a Maquet HL‐20 heart‐lung machine, a Heater‐Cooler Unit HCU 30 (MAQUET Cardiopulmonary AG), a membrane oxygenator (Quadrox‐i Neonatal or Capiox RX05), and ¼‐inch tubing from the COBE Heart/Lung Perfusion Pack (COBE Cardiovascular, Inc., Arvada, CO, USA). A Capiox cardiotomy reservoir CX*CR10NX (Terumo Corporation) acted as a pseudopatient. The circuit was primed with human packed red blood cells and lactated Ringer's solution and de‐aired according to clinical priming procedure. Heparin (5000 IU) was added into the circuit. The total volume was 400 mL and hematocrit was 30%. Pump flow rate was maintained at 500 or 1000 mL/min under both pulsatile and nonpulsatile modes. All trials were conducted under 100 mm Hg of circuit pressure at normothermia (35°C). In each trial, bolus air (0.5 mL) was injected into the circuit at the prepump site over 5 s. Total emboli counts and total emboli volume were significantly reduced by the Quadrox‐i Neonatal membrane oxygenator compared to the Capiox RX05 membrane oxygenator. Classification and quantification of GME detected at the postoxygenator site at two different flow rates indicated that the Quadrox‐i Neonatal captures the majority of microemboli larger than 40 µm in diameter. The Quadrox‐i Neonatal membrane oxygenator had a higher transmembrane pressure drop at 500 mL/min, whereas it had a lower pressure drop at 1000 mL/min compared to the Capiox Baby RX05 oxygenator. Additionally, the Quadrox‐i Neonatal oxygenator preserved more pulsatile energy than the Baby RX05 oxygenator at both flow rates. Compared to the Capiox RX05 membrane oxygenator, the Quadrox‐i Neonatal membrane oxygenator has significantly improved GME handling capacity and had better hemodynamic energy preservation. Further research encompassing in vivo and clinical studies is needed to investigate the magnitude and mechanisms of these benefits.     

Mathematical and Experimental Methods for Design and Evaluation of Membrane Oxygenators

Three categories of membrane oxygenators are considered: passive flow, secondary flow induced by the mainstream, secondary flow induced by an external application of energy. The current status of mathematical methods for analysis of fluid mechanics, O2 and CO2 exchange for these categories are briefly reviewed. Emphasis is given to approximate methods for calculation of gas exchange. Practical methods for experimental design optimization studies are outlined; these methods are extended to evaluation of O2 and CO2 exchange in clinical operation. A new method for estimation of internal ventilation and perfusion maldistribution and diffusion resistance is described. A brief assessment of blood damage in clinical application of the oxygenator is presented from the point of view of deterioration of gas exchange performance.     

The effects of preprimed oxygenators on gas transfer efficiency

Cancellation of on-pump coronary artery bypass grafting after the circuit is primed may result in the discarding of unused circuits. In some off-pump cases, a surgeon may request that the circuit be primed, but complete the surgical procedure without utilizing the circuit. The major concerns about the unused circuit are its sterility and the performance of the oxygenator after it has been primed for a long period of time. The goal of this study is to determine whether prepriming of the circuit with and without albumin has an effect on the gas transfer efficiency of oxygenators during simulated cardiopulmonary bypass. Monolyth integrated membrane lungs (Sorin Biomedical, Arvada, CO) were used to deoxygenate and oxygenate the bovine blood. Oxygenators were preprimed for 72 (N = 6) and 24 (N = 6) hours before testing. In control group (N = 6), oxygenators were tested immediately (0 h) after they were primed. Three different priming solutions were used: physiological saline solution (Group A); 1.25% of human albumin (Group B); and 5% human albumin (Group C). The blood was modified to the American Association of Medical Instrumentation Standards before testing. The blood flow through the oxygenators was set at 2 Lpm and 4 Lpm, with gas (FiO2 at 1.0) to blood flow ratio at 1:1. Cultures were also obtained from preprimed oxygenators to test circuit sterility. Oxygen transfer in oxygenators primed for 0 h at blood flow of 4 Lpm were 203 mL/min +/- 9.7 (Group A), 263.1 mL/min +/- 52.9 (Group B), and 270.5 mL/min +/- 13.1(Group C, p < .01 vs. Group A). In oxygenators preprimed for 72 h, the CO2 transfers were 135.0 mL/min +/- 21.8 (Group A), 104.9 mL/min +/- 2.4 (Group B), and 148.9 +/- 26.6 (Group C, p < .006 vs. Group B). In addition, the pressure drops were 56.5 mmHg +/- 5.5 (Group A), 82.6 mmHg +/- 13.4 (Group B), and 67.6 mmHg +/- 15.3 (Group C, p < .05 vs. Group B). In group A, O2 transfer were 203.5 mL/min +/- 9.7 (0 h), 272.4 mL/min +/- 66.6 (24 h), and 260.8 mL/min +/- 31.1 (72 h, p < .01 vs. 0 h). In group B, O2 transfer were 263.1 mL/min +/- 52.0 (0 h), 302.7 mL/min +/- 77.4 (24 h), and 235.2 mL/min +/- 16.5 (72 hr, p < .02 vs. 24 hr). Cultures obtained from 12 preprimed oxygenators presented no organism growth for up to 5 days. In conclusion, oxygen transfer increases in oxygenators preprimed with albumin immediately after they were primed. However, gas transfer decreased after they were primed with albumin for 72 h. Oxygenators preprimed for 24 h and 72 h with 0.9% saline had better O2 transfer than those primed for 0 h.     

Extracorporeal gas exchange with the DeltaStream rotary blood pump in experimental lung injury

In most severe cases of the acute respiratory distress syndrome, veno-venous extracorporeal membrane oxygenation (ECMO) can be used to facilitate gas exchange. However, the clinical use is limited due to the size and the concomitant risk of severe adverse events of conventionally-used centrifugal blood pumps with high extracorporeal blood volumes. The DeltaStream blood pump is a small-sized rotary blood pump that may reduce extracorporeal blood volume, foreign surfaces, contact activation of the coagulation system, and blood trauma. The aim of the present study was to test the safety and efficacy of the DeltaStream pump for ECMO in animals with normal lung function and experimental acute lung injury (ALI). Therefore, veno-venous ECMO was performed for 6 hours in mechanically ventilated pigs with normal lung function (n=6) and with ALI induced by repeated lung lavage (n=6) with a blood flow of 30% of the cardiac output. Gas flow with a FiO2 of 1.0 was set to equal blood flow. With a mean activated clotting time of 121 +/- 22 s, no circulatory impairment or thrombus formation was revealed during ECMO. Furthermore, free plasma Hb did not increase. In controls, hemodynamics and gas exchange remained unchanged. In animals with ALI, hemodynamics remained stable and gas transfer across the extracorporeal oxygenators was optimal, but only in 2 animals was a marked increase in PaO2 observed. CO2 removal was efficacious in all animals. We concluded that the DeltaStream blood pump may be used for veno-venous ECMO without major blood damage or hemodynamic impairment.     

An in vitro protocol for evaluation and comparison of membrane oxygenators

With the trend in open heart surgery toward normothermic bypass and warm blood cardioplegia, greater demand is being placed on the perfusionist to select an oxygenator that will perform safely and efficiently under a variety of conditions. While manufacturers report performance parameters for their products, the data is often not comparable due to widely differing conditions. Recent in vitro evaluation techniques employed to characterize membrane oxygenators do not simulate the actual oxygenator conditions observed during cardiopulmonary bypass. Biocompatibility and drug delivery are reported but comparisons of different oxygenator performance parameters are not completely addressed. We have designed a test circuit and an evaluation protocol to simultaneously characterize the performance of multiple oxygenators under identical conditions. The test circuit is designed to simulate clinical conditions and to evaluate gas exchange, blood path pressures, gas path pressures, and hemolysis. Previously reported studies have relied on a comparison of a single membrane oxygenator and a single bubble oxygenator. Our protocol will compare multiple membrane oxygenators, in vitro, under similar clinically relevant conditions. Such testing would be done prior to animal or clinical trials. Furthermore in vitro tests should be more reproducible and more discriminating than are ex vivo tests.     

Carbon dioxide absorption and gas exchange during pelvic laparoscopy

Twelve ASA physical status I-II patients undergoing pelvic laparoscopy for infertility were enrolled in a study to quantify the effects of CO2 insufflation and the Trendelenburg position on CO2 elimination and pulmonary gas exchange, and to determine the minute ventilation required to maintain normocapnia during CO2 insufflation. Measurements of O2 uptake (VO2), CO2 elimination (VCO2), minute ventilation (VE), FIO2, and respiratory exchange ratio (RQ) were made during three steady states: control (C) taken after 15 min of normoventilation but before CO2 insufflation, after 15 min (L1) and 30 min (L2) of hyperventilation during CO2 insufflation. The FIO2 was controlled at 0.5 and arterial blood gases were used to calculate the oxygen tension-based indices of pulmonary gas exchange. After 15 min and 30 min of CO2 insufflation, the volume of CO2 absorbed from the peritoneal cavity was estimated at 42.1 +/- 5.1 and 38.6 +/- 6.6 (SEM) ml.min-1 respectively, increasing CO2 elimination through the lungs by about 30%. Hyperventilation of the lungs by a 20-30% increase in minute ventilation maintained normocapnia. Despite the CO2 pneumoperitoneum and Trendelenburg position, there was no impairment of pulmonary oxygen exchange as estimated by (A-alpha)DO2. This study demonstrated that a 30% increase in minute ventilation, achieved by increasing tidal volume to more than 10 ml.kg-1, is sufficient to eliminate the increased CO2 load and maintain normal pulmonary O2 exchange during pelvic laparoscopy.     

A comparative clinical assessment of a hollow-fibre membrane oxygenator (Capiox II) and a bubble oxygenator (Harvey 1500)

Personal experience is reported on the use of a membrane oxygenator, the Capiox II, which is clinically compared with a bubble oxygenator for medium-term perfusion. The characteristics considered were the efficiency of the heat exchanger, the oxygenating capacity, traumatic effects on the blood and the direct effect on the renal and cardiopulmonary systems. The Capiox II demonstrated a better oxygenating capacity, less platelet damage, a smaller variation in the free plasma haemoglobin, a significant difference in postoperative bleeding and blood transfusion requirements, but showed no variation in renal and cardiopulmonary function. The authors suggest that the Capiox II is to be preferred for extra-corporeal circulation of medium duration, for which it combines the advantages of both bubble and membrane oxygenators, while being less complex and costly than previously marketed membrane devices.     

Comparison of Pumps and Oxygenators With Pulsatile and Nonpulsatile Modes in an Infant Cardiopulmonary Bypass Model

As the evidence mounts in favor of pulsatile perfusion during CPB, it is necessary to investigate the effect of circuit components on the quality of pulsatility delivered throughout the circuit. We compared two bloodpumps, the Jostra HL‐20 heart‐lung machine and the MEDOS DELTASTREAM DP1 Bloodpump, and two oxygenators, the Capiox Baby RX05 and the MEDOS HILITE 800LT, in terms of mean arterial pressure, energy equivalent pressure, surplus hemodynamic energy, total hemodynamic energy, and pressure drop over the oxygenators using a blood analog. The pumps and oxygenators were combined in unique circuits and tested in nonpulsatile and pulsatile modes, at two flow rates (500 and 800 mL/min), and three rotational speed differentials when using the MEDOS DELTASTREAM DP1 Bloodpump for 144 trials in total. The Jostra Roller pump produced some pulsatility in nonpulsatile mode and better pulsatility in pulsatile mode than the MEDOS DP1 Bloodpump at a rotational speed differential of 2500 rpm, but not at 3500 or 4500 rpm. The MEDOS DP1 Bloodpump produced almost no pulsatility in nonpulsatile mode. Pressure drops over the Capiox Baby RX05 were markedly higher, at 92.5 ± 0.4 mm Hg with the MEDOS DP1 Bloodpump at 800 mL/min and 4500 rpm in pulsatile mode, than those of the MEDOS HILITE 800LT oxygenator, which was 67.0 ± 0.1 mm Hg at the same settings. These results suggest that careful selection of each circuit component, based on the individual clinical case and component specifics, are necessary to achieve the best quality of pulsatility.     

Development of a New Hollow Fiber Silicone Membrane Oxygenator: In Vitro Study

An experimental silicone hollow fiber membrane oxygenator for long-term extracorporeal membrane oxygenation (ECMO) was developed in our laboratory using an ultrathin silicone hollow fiber. However, the marginal gas transfer performances and a high-pressure drop in some cases were demonstrated in the initial models. In order to improve performance the following features were incorporated in the most recent oxygenator model: increasing the fiber length and total surface area, decreasing the packing density, and modifying the flow distributor. The aim of this study was to evaluate the gas transfer performances and biocompatibility of this newly improved model with in vitro experiments. According to the established method in our laboratory, in vitro studies were performed using fresh bovine blood. Gas transfer performance tests were performed at a blood flow rate of 0.5 to 6 L/min and a V/Q ratio (V = gas flow rate, Q = blood flow rate) of 2 and 3. Hemolysis tests were performed at a blood flow rate of 1 and 5 L/min. Blood pressure drop was also measured. At a blood flow rate of 1 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 72.45 +/- 1.24 and 39.87 +/- 2.92 ml/min, respectively. At a blood flow rate of 2 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 128.83 +/- 1.09 and 47.49 +/- 5.11 ml/min. Clearly, these data were superior to those obtained with previous models. As for the pressure drop and hemolytic performance, remarkable improvements were also demonstrated. These data indicate that this newly improved oxygenator is superior to the previous model and may be clinically acceptable for long-term ECMO application.     

Description of a flow optimized oxygenator with integrated pulsatile pump

Extracorporeal membrane oxygenation (ECMO) is a well-established therapy for several lung and heart diseases in the field of neonatal and pediatric medicine (e.g., acute respiratory distress syndrome, congenital heart failure, cardiomyopathy). Current ECMO systems are typically composed of an oxygenator and a separate nonpulsatile blood pump. An oxygenator with an integrated pulsatile blood pump for small infant ECMO was developed, and this novel concept was tested regarding functionality and gas exchange rate. Pulsating silicone tubes (STs) were driven by air pressure and placed inside the cylindrical fiber bundle of an oxygenator to be used as a pump module. The findings of this study confirm that pumping blood with STs is a viable option for the future. The maximum gas exchange rate for oxygen is 48mL/min/L(blood) at a medium blood flow rate of about 300mL/min. Future design steps were identified to optimize the flow field through the fiber bundle to achieve a higher gas exchange rate. First, the packing density of the hollow-fiber bundle was lower than commercial oxygenators due to the manual manufacturing. By increasing this packing density, the gas exchange rate would increase accordingly. Second, distribution plates for a more uniform blood flow can be placed at the inlet and outlet of the oxygenator. Third, the hollow-fiber membranes can be individually placed to ensure equal distances between the surrounding hollow fibers.     

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.     

Comparing oxygen transfer performance between three membrane oxygenators: effect of temperature changes during cardiopulmonary bypass

Recently, a new oxygenator (Dideco 903 [D903], Dideco, Mirandola, Italy) has been introduced to the perfusion community, and we set about testing its oxygen transfer performance and then comparing it to two other models. This evaluation was based on the comparison between oxygen transfer slope, gas phase arterial oxygen gradients, degree of blood shunting, maximum oxygen transfer, and diffusing capacity calculated for each membrane. Sixty patients were randomized into three groups of oxygenators (Dideco 703 [D703], Dideco; D903; and Quadrox, Jostra Medizintechnik AG, Hirrlingen, Germany) including 40/20 M/F of 68.6 +/- 11.3 years old, with a body weight of 71.5 +/- 12.1 kg, a body surface area (BSA) of 1.84 +/- 0.3 m(2), and a theoretical blood flow rate (index 2.4 times BSA) of 4.4 +/- 0.7 L/min. The maximum oxygen transfer (VO(2)) values were 313 mL O(2)/min (D703), 579 mL O(2)/min (D903), and 400 mL O(2)/min (Quadrox), with the D903 being the most superior (P < 0.05). Oxygen (O(2)) gradients were 320 mm Hg (D703), 235 mm Hg (D903), and 247 mm Hg (Quadrox), meaning D903 and Quadrox are more efficient versus the D703 (P < 0.05). Shunt fraction (Qs/Qt) and diffusing capacity (DmO(2)) were comparable (P = ns). Diffusing capacity values indexed to BSA (DmO(2)/m(2)) were 0.15 mL O(2)/min/mm Hg/m(2) (D703), 0.2 mL O(2)/min/mm Hg/m(2) (D903), and 0.18 mL O(2)/min/mm Hg/m(2) (Quadrox) with D903 outperforming D703 (P < 0.0005). During hypothermia (32.0 +/- 0.3 degrees C), there was a lower absolute and relative VO(2 )for all three oxygenators (P = ns). The O(2) gradients, DmO(2) and DmO(2)/m(2), were significantly lower for all oxygenators (P < 0.01). Also, Qs/Qt significantly rose for all oxygenators (P < 0.01). The oxygen transfer curve is characteristic to each oxygenator type and represents a tool to quantify oxygenator performance. Using this parameter, we demonstrated significant differences among commercially available oxygenators. However, all three oxygenators are considered to meet the oxygen needs of the patients.