The effect of excessive gas to blood ratios in an ECMO oxygenator.

INTRODUCTION: Oxygenators for paediatric Extracorporeal Membrane Oxygenation (ECMO) are required to operate over a wide range of flow rates, in a patient group ranging from neonates through to fully grown adolescents. ECMO oxygenators typically have a manufacturer's stated maximum gas: blood flow rate (GBFR) ratio of 2:1, however, many patients require greater ratios than this for adequate CO2 removal. Mismatches in GBFR in theory could result in high gas phase pressures. These increased pressures in theory could cause the formation of gross gaseous microemboli (GME) placing the child at higher risk of neurological injury. METHODS: We evaluated 6 paediatric and 6 adult A.L.ONE™ ECMO oxygenators and assessed their gas phase pressures and GME release, in an ex vivo setting, in GBFR ratios up to greater than 2, across a range of gas flow (1L - 10 L/min) rates with a fraction of inspired oxygen (FiO2) content of 50% and 100%. RESULTS: There were no increases above 10 mmHg observed in gas phase pressures in GBFR >= 2:1 in either adult or paediatric oxygenators. Laboratory examination of GME activity demonstrated a small increase in post-membrane GME release over the study period. GME release was unaffected by FiO2 setting or gas flow rate, with a maximum volume of < 6 µL in both paediatric and adult oxygenators. CONCLUSIONS: In an ex vivo setting, increasing GBFR above 2:1 in a paediatric oxygenator, and to a GBFR of 2:1 in an adult oxygenator did not significantly increase gas phase pressures, and no oxygenator membrane rupture was observed. There were no associations between gas flow rates and GME production.

The effect of air-free administration of intravenous drugs on microemboli during cardiopulmonary bypass.

OBJECTIVE: During cardiopulmonary bypass (CPB), gaseous microemboli (GME) that originate from the extracorporeal circuit are released into the arterial blood stream of the patient. Gaseous microemboli may contribute to adverse outcome after cardiac surgery with CPB. Possibly, air may be collected in the right atrium during induction of anesthesia and released during CPB start. The aim of this study was to assess if the GME load entering the venous line of the CPB circuit could be reduced by training of anesthesia personal in avoiding air introduction during administration of intravenous medication. METHODS: In 94 patients undergoing coronary artery bypass grafting with CPB, GME number and volume were measured intraoperatively with a bubble counter (BCC300). The quantity and the relationship between GME number and volume in the venous and arterial line were determined in 2 periods before and after education of the anesthesiologists and nurses. RESULTS: In the venous line no significant differences were observed between numbers and volumes of GME between groups. Comparing patients with low versus high GME load, showed significantly more patients from the intervention group in the low GME-load group, namely 29 versus 18. Administration of medication by anesthesia was confirmed as a clear cause of GME/air-introduction into the venous circulation. Scavenging properties of the CPB circuit including the oxygenator showed a 99.9% reduction of GME. CONCLUSIONS: A wide spread of GME generation during perfusion was present with no difference in generation of GME between groups. Lower GME load observed in patients (intervention group) and examples of air introduction during drug administration suggest that air introduced by anesthesia contributes to the GME load during CPB. Scavenging properties of the CPB circuit contribute very much to patient safety regarding reduction of venous air. Awareness and education create the possibilities for further reduction of GME during cardiopulmonary bypass.

Hypobaric type oxygenators - physics and physiology.

Brain injury is still a serious complication after cardiac surgery. Gaseous microemboli (GME) are known to contribute to both short and longer-term brain injury after cardiac surgery. Hypobaric and novel dual-chamber oxygenators use the physical behaviors and properties of gases to reduce GME. The aim of this review was to present the basic physics of the gases, the mechanism in which the hypobaric and dual-chamber oxygenators reduce GME, their technical performance, the preclinical studies, and future directions. The gas laws are reviewed as an aid to understanding the mechanisms of action of oxygenators. Hypobaric-type oxygenators employ a high oxygen, no nitrogen environment creating a steep concentration gradient of nitrogen out of the blood and into the oxygenator, reducing the risk of GMEs forming. Adequately powered clinical studies have never been carried out with a hypobaric or dual-chamber oxygenator. These are required before such technology can be recommended for widespread clinical use.

Can a low prime volume arterial filter be used as an alternative for a venous bubble trap in minimal extracorporeal circulation? An in vitro investigation.

BACKGROUND: During cardiac surgery the use of a minimal extracorporeal circulation (MiECC) system may reduce the adverse effects for the patient. This is probably caused by reduced inflammation and hemodilution. For the use of a MiECC circuit, a venous bubble trap (VBT) is warranted for safety reasons. The aim of this study was to assess if an arterial filter with a small prime volume has the same (or better) air removal capacities as a VBT in a MiECC circuit and subsequentially may be used as an alternative. METHODS: In an in vitro study, air removal properties were compared between the arterial filter and three VBT's on the market, VBT160 (Getinge), VBT 8 (LivaNova and VARD (Medtronic). In a MiECC circuit, the filter devices were placed in a venous position and challenged with massive and micro air. Gaseous microemboli (GME) were measured with a bubble counter proximal and distal of the VBT device. RESULTS: More than 99.9 % of the air was removed after a bolus air challenge by all VBT's. Both the VARD and the AF100 showed better GME removal properties (not significant for the AF100) compared to the other devices. All filters showed GME generation after a challenge with massive air. Compared to the other filters, only the VARD showed no passing of larger bubbles when a volume of 50 mL of air was present in the filter. CONCLUSIONS: The AF100 seems to be a safe and low prime alternative for use in a MiECC system as a venous air trap. A word of caution, placement of the AF100 arterial filter in the venous line is off label use.

Vibrational characterization of cavitation in left ventricular assist device.

BACKGROUND: The left ventricular assist device (LVAD) is a mechanical circulatory support device for patients with severe heart failure. Microbubbles caused by cavitation in the LVAD can potentially lead to physiological and pump-related complications. The aim of this study is to characterize the vibrational patterns in the LVAD during cavitation. METHODS: The LVAD was integrated into an in vitro circuit and mounted with a high-frequency accelerometer. Accelerometry signals were acquired with different relative pump inlet pressures ranging from baseline (+20 mmHg) to -600 mmHg in order to induce cavitation. Microbubbles were monitored with dedicated sensors at the pump inlet and outlet to quantify the degree of cavitation. Acceleration signals were analyzed in the frequency domain to identify changes in the frequency patterns when cavitation occurred. RESULTS: Significant cavitation occurred at the low inlet pressure (-600 mmHg) and was detected in the frequency range between 1800 and 9000 Hz. Minor degrees of cavitation at higher inlet pressures (-300 to -500 mmHg) were detected in the frequency range between 500-700, 1600-1700 Hz, and around 12 000 Hz. The signal power of the dominating frequency ranges was statistically significantly different from baseline signals. CONCLUSION: Vibrational measurements in the LVAD can be used to detect cavitation. A significant degree of cavitation could be detected in a wide frequency range, while minor cavitation activity could only be detected in more narrow frequency ranges. Continuous vibrational LVAD monitoring can potentially be used to detect cavitation and minimize the damaging effect associated with cavitation.

Effect of aortic cannulation depth on air emboli transport during cardiopulmonary bypass: A computational study.

INTRODUCTION: Varying the insertion depth of the aortic cannula during cardiopulmonary bypass (CPB) has been investigated as a strategy to mitigate cerebral emboli, yet its effectiveness associated with CPB flow is not fully understood. We compared different arterial cannula insertion depths and pump flow influencing air microemboli entering the aortic arch branch arteries (AABA). METHODS: A computational approach used a patient-specific aorta model to evaluate four cannula locations at (1) proximal arch, (2) mid arch, (3) distal arch, and (4) descending aorta. We injected 0.1 mm microemboli (N=720) at 2 and 5 L/min and assessed the embolic load and the particle averaged transit times ( entering the AABA. RESULTS: Location 4 had the lowest embolic load (2 L/min: N= 63) and (5 L/min: N= 54) compared to locations 1 to 3 in the range of (N= 118 to 116 at 2 L/min:) and (N= 92 to 146 at 5 L/min). There was no significant difference between 2 L/min and 5 L/min (p = 0.31), despite 5 L/min attaining a lower mean (±standard deviation) than 2 L/min (38.0±23.4 vs 44.5±21.1), respectively. Progressing from location 1 to 4, increased 3.11s -7.40 s at 2 L/min and 1.81s -4.18s at 5 L/min. CONCLUSION: It was demonstrated that the elongated cannula insertion length resulted in lower embolic loads, particularly at a higher flow rate. The numerical results suggest that CPB management could combine active flow variation with improving cannula performance and provide a foundation for a future experimental and clinical investigation to reduce surgical cerebral air microemboli.

Dynamics of appearance and decay of gaseous microemboli during in vitro extracorporeal circulation.

INTRODUCTION: Extracorporeal life support (ECLS) patients are at risk for complications caused by gaseous microemboli (GME). GMEs can cause hypoxia, inflammation, coagulation, and end-organ damage. The objective of this in vitro study was to assess dynamics of GME formation during circulation of whole blood or a glycerol blood surrogate. We hypothesized that there is no difference in GME counts and sizes between whole blood and the glycerol blood surrogate and that the membrane lung reduces GME counts over time. METHODS: A circulation platform was developed using the Cardiohelp ECLS system to run either donor blood or glycerol solution. We conducted 10 repetitions consisting of three phases of ultrasound GME detection using the EDAC™ Quantifier (Luna Innovations, Charlottesville, VA, USA) for each group. Phases were 3-minute recordings at the initiation of 2 L/min flow (Phase 1), post-injection of a GME suspension (Phase 2), and 10 minutes after injection (Phase 3). The number and size of GME pre- and post-ML were recorded separately and binned based on diameter ranges. RESULTS: In Phase 1, GME count in blood was higher than in glycerol. In Phase 2, there was a large increase in GME counts; however, most GME were reduced post-membrane in both groups. In Phase 3, there was a significant decrease in GME counts compared to Phase 2. GME > 100 µm in glycerol decreased post membrane. CONCLUSIONS: We demonstrated GME formation and decay dynamics during in vitro circulation in an ECLS system with blood and glycerol. GME counts were higher in blood, likely due to varying rheological properties. There were decreases in GME levels post membrane in both groups after GME injection, with the membrane lung effectively trapping the GME, and additional reduction 10 minutes after GME injection.

In vivo analysis of the origin and characteristics of gaseous microemboli during catheter-mediated irreversible electroporation.

AIMS: Irreversible electroporation (IRE) ablation is a non-thermal ablation method based on the application of direct current between a multi-electrode catheter and skin electrode. The delivery of current through blood leads to electrolysis. Some studies suggest that gaseous (micro)emboli might be associated with myocardial damage and/or (a)symptomatic cerebral ischaemic events. The aim of this study was to compare the amount of gas generated during IRE ablation and during radiofrequency (RF) ablation. METHODS AND RESULTS: In six 60-75 kg pigs, an extracorporeal femoral shunt was outfitted with a bubble-counter to detect the size and total volume of gas bubbles. Anodal and cathodal 200 J IRE applications were delivered in the left atrium (LA) using a 14-electrode circular catheter. The 30 and 60 s 40 W RF point-by-point ablations were performed. Using transoesophageal echocardiography (TOE), gas formation was visualized. Average gas volumes were 0.6 ± 0.6 and 56.9 ± 19.1 µL (P < 0.01) for each anodal and cathodal IRE application, respectively. Also, qualitative TOE imaging showed significantly less LA bubble contrast with anodal than with cathodal applications. Radiofrequency ablations produced 1.7 ± 2.9 and 6.7 ± 7.4 µL of gas, for 30 and 60 s ablation time, respectively. CONCLUSION: Anodal IRE applications result in significantly less gas formation than both cathodal IRE applications and RF applications. This finding is supported by TOE observations.

Lack of Association Between Gaseous Microembolisms Assessed by a Single Detection Device and Cerebral Complications in Cardiac Surgery Patients.

OBJECTIVE: To assess the association between total volume and number of gaseous microemboli (GME) in the cardiopulmonary bypass (CPB) circuit and the occurrence of new postoperative cerebral infarctions and postoperative cognitive dysfunction (POCD) in patients undergoing cardiac surgery. DESIGN: Predefined subanalyses of the randomized controlled Perfusion Pressure Cerebral Infarcts (PPCI) trial. SETTING: Primary heart center in a university hospital. PARTICIPANTS: A total of 143 adult patients undergoing cardiac surgery with CPB. INTERVENTIONS: Patients were allocated 1:1 to a low-target mean arterial pressure (MAP) of 40 to 50 mmHg or a high-target MAP of 70 to 80 mmHg during CPB with a fixed pump flow of 2.4 liters per minute per square meter body surface area plus 10% to 20%. MEASUREMENTS AND MAIN RESULTS: The total volume and number of GME in the CPB circuit were assessed by the Bubble Counter Clinical 200® (GAMPT GmbH). New cerebral infarcts were identified by diffusion-weighted magnetic resonance imaging (DWI) 3 to 6 days after surgery. The median number of GME per patient was 8069 (range 1,523-204,095) with a median total volume of 1.2 µL (range 0.07-48 µL). A total of 66 (46%) patients had DWI detected cerebral infarcts postoperatively, and 36 (28%) patients had POCD after 7 days. The authors found no significant association between volume or number of GME with MAP target allocation, presence of cerebral infarction, or POCD. CONCLUSIONS: The authors found no significant associations between volume or number of GME with the occurrence of cerebral infarction or cognitive dysfunction in cardiac surgery patients.

To Purge or Not to Purge.

To remove gaseous microemboli (GME) using an oxygenator with an integrated arterial filter, it is recommended by some manufacturers to purge the oxygenator as an additional safety feature while on bypass. In this in vitro study, we evaluated whether purging of oxygenators with an integrated arterial filter is efficient in reducing GME. Five different types of commercially available contemporary oxygenators with an integrated arterial filter based on progressive filter filtration (1), cascade filtration (1), screen filtration (2), or self-venting (1) were tested for their efficiency in removing GME while keeping the purge line open or closed. A bubble counter was used for pre- and post-oxygenator GME signaling, from which the filter efficiency was computed. Freshly drawn heparinized porcine blood was used at blood flow rates of 3 and 5 L/min. Three units of each oxygenator were tested with its specific reservoir at a fixed volume level of 1,500 mL. GME load was introduced into the venous line at 1,000 mL air/min. Measurements started as soon as GME were detected by the pre-oxygenator probe and then continued for 1 minute. There was no statistically significant difference in filter efficiency between the purged and non-purged groups for specific oxygenators. At a blood flow of 3 L/min, the average filter efficiency stayed approximately invariable when comparing the non-purged and purged groups, where 89.1-88.2% indicated the largest difference between the groups. At a blood flow rate of 5 L/min, the filter efficiency changed in one screen filter group from an average of 55.7% in the non-purged group to 42.4% in the purged group. Other filter efficiencies at the blood flow rate of 5 L/min for non-purged compared with purged groups were, respectively, 98.0 vs. 98.0% (screen filtration), 88.6 vs. 85.8% (self-venting filtration), 82.8 vs. 75.5% (progressive filter filtration), and 65.4 vs. 65.1% (cascade filtration). Based on these results, purging while confronted with continuous GME challenge did not result in an increased filter efficiency.

The influence of gaseous microemboli on various biomarkers after minimized cardiopulmonary bypass.

INTRODUCTION: Gaseous microemboli that originate from the cardiopulmonary bypass circuit may contribute to adverse outcome after cardiac surgery. We prospectively evaluated the influence of gaseous microemboli on the release of various biomarkers after use of a minimally invasive extracorporeal technology system. METHODS: In 70 patients undergoing coronary artery bypass grafting with minimized cardiopulmonary bypass, gaseous microemboli were measured intraoperatively with a bubble counter. Intra- and postoperative biomarker levels for inflammatory response (interleukin-6, C5b-9), endothelial damage (von Willebrand factor, soluble vascular cell adhesion molecule-1), oxidative stress (malondialdehyde, 8-isoprostane, neuroketal), and neurological injury (neuron-specific enolase, brain-type fatty acid-binding protein) were analyzed using immune assay techniques. The relationship between gaseous microemboli number or volume and the incremental area under the curve (iAUC24h) or peak change for the biomarkers was calculated. RESULTS: All biomarkers except for malondialdehyde increased at least temporarily after coronary artery bypass grafting with a minimally invasive extracorporeal technology system. The median total gaseous microemboli number was 6,174 (interquartile range: 3,507-10,531) and the median total gaseous microemboli volume was 4.31 µL (interquartile range: 2.71-8.50). There were no significant correlations between total gaseous microemboli number or volume and iAUC24h or peak change for any of the biomarkers. After controlling for the variance of possible other predictor variables, multiple linear regression analysis showed no association between gaseous microemboli parameters and release of biomarkers. CONCLUSION: This study showed no evidence that gaseous microemboli contribute to increased biomarker levels after coronary artery bypass grafting with cardiopulmonary bypass. A reason for the absence of damage by gaseous microemboli may be the relative and considerably small amount of gaseous microemboli entering the patients in this study.

Air removal capacity of two different minimal invasive ECC systems: an in vitro comparison.

Minimally invasive extracorporeal circulation systems are developed to decrease the deleterious effects of cardiopulmonary bypass. For instance, prime volume and foreign surface area are decreased in these systems. However, because of the lack of a venous reservoir in minimized systems, air handling properties of these minimally invasive extracorporeal circulation systems may be decreased as compared to conventional cardiopulmonary bypass systems. The aim of this in vitro study is to compare the air handling properties of two complete minimized cardiopulmonary bypass systems of two manufacturers, of which one system is provided with the air purge control. In an in vitro study, two minimally invasive extracorporeal circulation systems, Inspire Min.I manufactured by Sorin Group Italia, Mirandola, Italy (LivaNova, London, United Kingdom) and minimized extracorporeal circulation manufactured by Maquet, Rastatt, Germany (Getinge, Germany), were challenged with two types of air challenges; a bolus air challenge and a gaseous microemboli challenge. The air removal characteristics of the venous bubble traps and of the complete minimally invasive extracorporeal circulation systems were assessed by measuring the gaseous microemboli volume and number downstream of the venous bubble traps in the arterial line with a bubble counter. No significant differences were observed in air reduction between the venous bubble traps of Getinge (venous bubble traps) and LivaNova (Inspire venous bubble traps 8 in conjunction with the air purge control). Similarly, no significant differences were observed in volume and number of gaseous microemboli in the arterial line of both complete minimally invasive extracorporeal circulation systems. However, the gaseous microemboli load of the Inspire Min.I system was marginally lower after both the bolus air and the gaseous microemboli challenges. Both minimally invasive extracorporeal circulation systems assessed in this study, the LivaNova Inspire Min.I and the Getinge minimized extracorporeal circulation, showed comparable air removal properties, after both bolus and gaseous microemboli air challenges. Besides, air purge control automatic air removal system provided with the LivaNova Inspire Min.I. system may enhance patient's safety with the use of a minimally invasive extracorporeal circulation system. We consider both systems equally safe for clinical use.

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.

Measurement of gaseous microemboli in the prime before the initiation of cardiopulmonary bypass.

INTRODUCTION: The use of cardiopulmonary bypass is associated with a risk of neurocognitive deficit caused by gaseous microemboli. Flushing the empty bypass circuit with carbon dioxide, which is more soluble than air, may reduce the amount of gaseous microemboli in the priming solution before the initiating of cardiopulmonary bypass. METHOD: We measured the amount of gaseous microemboli in twenty primed bypass circuits. Ten circuits were flushed with carbon dioxide before being primed and ten circuits were non-flushed. All circuits in both groups were primed with crystalloid priming. An ultrasonic clinical bubble counter was used to count gaseous microemboli in the prime for 20 minutes. RESULTS: The median numbers of gaseous microemboli counts were highest during the first minute in both groups, with a significantly lower median value in the group flushed with carbon dioxide (397.5) versus the non-flushed group (1900). In the 20th minute, the median values of gaseous microemboli were significantly lower (p<0.023) in the flushed (0.5) versus non-flushed (10.75) groups. The gaseous microembolic count in the flushed group remained lower than in the non-flushed group when tested minute by minute throughout the whole 20-minute period. CONCLUSION: Flushing the bypass circuits with carbon dioxide before priming significantly decreased the number of gaseous microemboli in the priming solution.

In Vitro Evaluation of Pediatric Hollow-Fiber Membrane Oxygenators on Hemodynamic Performance and Gaseous Microemboli Handling: An International Multicenter/Multidisciplinary Approach.

The objective of this study was to compare the hemodynamic performances and gaseous microemboli (GME) handling ability of two pediatric oxygenators in a simulated pediatric cardiopulmonary bypass (CPB) model and the importance of adding an arterial filter in the circuit. The circuit consisted of a Braile Infant oxygenator or a Maquet Quadrox-I Pediatric oxygenator without integrated arterial filter (parallel arrangement), 1/4 in. ID tubing A-V loop, and a 12-Fr arterial cannula, primed with lactated Ringer's solution and packed red blood cells. Trials were conducted at flow rates ranging from 500 to 2000 mL/min (500 mL/min increment) at 35°C and 28°C. Real-time pressure and flow data were recorded using a custom-based data acquisition system. For GME testing, 5 cc of air was manually injected into the venous line. GME were recorded using the Emboli Detection and Classification Quantifier (EDAC) System. An additional experiment using a separate arterial filter was conducted. There was no difference in the mean circuit pressure, pressure drop, total hemodynamic energy level, and energy loss between the two oxygenators. The venous line pressures were higher in the Braile than in the Quadrox group during all trials (P <0.01). GME count and volume at pre-/post oxygenator and pre-cannula sites in the Quadrox were lower than the Braile group at high flow rates (P < 0.05). In the additional experiment, an arterial filter captured a significant number of microemboli at all flow rates. The Braile Infant oxygenator has a matched hemodynamic characteristic with the Quadrox-i Pediatric oxygenator. The Quadrox-i has a better GME handling ability compared with the Braile Infant oxygenator. Regardless of type of oxygenator an additional arterial filter decreases the number of GME.

In Vitro Evaluation of an Alternative Neonatal Extracorporeal Life Support Circuit on Hemodynamic Performance and Bubble Trap.

The objective of this study was to evaluate an alternative neonatal extracorporeal life support (ECLS) circuit with a RotaFlow centrifugal pump and Better-Bladder (BB) for hemodynamic performance and gaseous microemboli (GME) capture in a simulated neonatal ECLS system. The circuit consisted of a Maquet RotaFlow centrifugal pump, a Quadrox-iD Pediatric diffusion membrane oxygenator, 8 Fr arterial cannula, and 10 Fr venous cannula. A "Y" connector was inserted into the venous line to allow for comparison between BB and no BB. The circuit and pseudopatient were primed with lactated Ringer's solution and packed human red blood cells (hematocrit 35%). All hemodynamic trials were conducted at flow rates ranging from 100 to 600 mL/min at 36°C. Real-time pressure and flow data were recorded using a data acquisition system. For GME testing, 0.5 cc of air was injected via syringe into the venous line. GME were detected and characterized with or without the BB using the Emboli Detection and Classification Quantifier (EDAC) System. Trials were conducted at flow rates ranging from 200 to 500 mL/min. The hemodynamic energy data showed that up to 75.2% of the total hemodynamic energy was lost from the circuit. The greatest pressure drops occurred across the arterial cannula and increased with increasing flow rate from 10.1 mm Hg at 100 mL/min to 114.3 mm Hg at 600 mL/min. The EDAC results showed that the BB trapped a significant amount of the GME in the circuit. When the bladder was removed, GME passed through the pump head and the oxygenator to the arterial line. This study showed that a RotaFlow centrifugal pump combined with a BB can help to significantly decrease the number of GME in a neonatal ECLS circuit. Even with this optimized alternative circuit, a large percentage of the total hemodynamic energy was lost. The arterial cannula was the main source of resistance in the circuit.

Building a Better Neonatal Extracorporeal Life Support Circuit: Comparison of Hemodynamic Performance and Gaseous Microemboli Handling in Different Pump and Oxygenator Technologies.

Neurologic complications during neonatal extracorporeal life support (ECLS) are associated with significant morbidity and mortality. Gaseous microemboli (GME) in the ECLS circuit may be a possible cause. Advances in neonatal circuitry may improve hemodynamic performance and GME handling leading to reduction in patient complications. This study compared hemodynamic performance and GME handling using two centrifugal pumps (Maquet RotaFlow and Medos Deltastream DP3) and polymethylpentene oxygenators (Maquet Quadrox-iD and Medos Hilite 800LT) in a neonatal ECLS circuit model. The experimental circuit was primed with Lactated Ringer's solution and packed human red blood cells (hematocrit 40%) and arranged in parallel with the RotaFlow and DP3 pump, Quadrox-iD and Hilite oxygenator, and Better-Bladder. Hemodynamic trials evaluating pressure drops and total hemodynamic energy (THE) were conducted at 300 and 500 mL/min at 36°C. GME handling was measured after 0.5 mL of air was injected into the venous line using the Emboli Detection and Classification Quantifier System with unique pump, oxygenator, and Better-Bladder combinations. The RotaFlow pump and Quadrox oxygenator arrangement had lower pressure drops and THE loss at both flow rates compared to the DP3 pump and Hilite oxygenator (P < 0.01). Total GME volume and counts decreased with Better-Bladder at both flow rates with all combinations (P < 0.01). Hemodynamic performance and energy loss were similar in all of the circuit combinations. The Better-Bladder significantly decreased GME. All four combinations of pumps and oxygenators also performed similarly in terms of GME handling.

Carbon Dioxide Flush of an Integrated Minimized Perfusion Circuit Prior to Priming Prevents Spontaneous Air Release Into the Arterial Line During Clinical Use.

Recently, an oxygenator with an integrated centrifugal blood pump (IP) was designed to minimize priming volume and to reduce blood foreign surface contact even further. The use of this oxygenator with or without integrated arterial filter was compared with a conventional oxygenator and nonintegrated centrifugal pump. To compare the air removal characteristics 60 patients undergoing coronary artery bypass grafting were alternately assigned into one of three groups to be perfused with a minimized extracorporeal circuit either with the conventional oxygenator, the oxygenator with IP, or the oxygenator with IP plus integrated arterial filter (IAF). Air entering and leaving the three devices was measured accurately with a bubble counter during cardiopulmonary bypass. No significant differences between all groups were detected, considering air entering the devices. Our major finding was that in both integrated devices groups incidental spontaneous release of air into the arterial line in approximately 40% of the patients was observed. Here, detectable bolus air (>500 µm) was shown in the arterial line, whereas in the minimal extracorporeal circulation circuit (MECC) group this phenomenon was not present. We decided to conduct an amendment of the initial design with METC-approval. Ten patients were assigned to be perfused with an oxygenator with IP and IAF. Importantly, the integrated perfusion systems used in these patients were flushed with carbon dioxide (CO2 ) prior to priming of the systems. In the group with CO2 flush no spontaneous air release was observed in all cases and this was significantly different from the initial study with the group with the integrated device and IAF. This suggests that air spilling may be caused by residual air in the integrated device. In conclusion, integration of a blood pump may cause spontaneous release of large air bubbles (>500 µm) into the arterial line, despite the presence of an integrated arterial filter. CO2 flushing of an integrated cardiopulmonary bypass system prior to priming may prevent spontaneous air release and is strongly recommended to secure patient safety.

Clinical evaluation of the air-handling properties of contemporary oxygenators with integrated arterial filter.

Gaseous microemboli (GME) may originate from the extracorporeal circuit and enter the arterial circulation of the patient. GME are thought to contribute to cerebral deficit and to adverse outcome after cardiac surgery. The arterial filter is a specially designed component for removing both gaseous and solid microemboli. Integration of an arterial filter with an oxygenator is a contemporary concept, reducing both prime volume and foreign surface area. This study aims to determine the air-handling properties of four contemporary oxygenator devices with an integrated arterial filter. Two oxygenator devices, the Capiox FX25 and the Fusion, showed significant increased volume of GME reduction rates (95.03 ± 3.13% and 95.74 ± 2.69%, respectively) compared with both the Quadrox-IF (85.23 ± 5.84%) and the Inspire 6F M (84.41 ± 12.93%). Notably, both the Quadrox-IF and the Inspire 6F M as well as the Capiox FX 25 and the Fusion showed very similar characteristics in volume and number reduction rates and in detailed distribution properties. The Capiox FX25 and the Fusion devices showed significantly increased number and volume reduction rates compared with the Quadrox-IF and the Inspire 6F M devices. Despite the large differences in design of all four devices, our study results suggest that the oxygenator devices can be subdivided into two groups based on their fibre design, which results in screen filter (Quadrox-IF and Inspire 6F M) and depth filter (Capiox FX25 and Fusion) properties. Depth filter properties, as present in the Capiox FX25 and Fusion devices, reduced fractionation of air and may ameliorate GME removal.

Cerebral Microembolization During Aortic Valve Replacement Using Minimally Invasive or Conventional Extracorporeal Circulation: A Randomized Trial.

To compare intraoperative cerebral microembolic load between minimally invasive extracorporeal circulation (MiECC) and conventional extracorporeal circulation (CECC) during isolated surgical aortic valve replacement (SAVR), we conducted a randomized trial in patients undergoing primary elective SAVR at a tertiary referral hospital. The primary outcome was the procedural phase-related rate of high-intensity transient signals (HITS) on transcranial Doppler ultrasound. HITS rate was used as a surrogate of cerebral microembolism in pre-defined procedural phases in SAVR using MiECC or CECC with (+F) or without (-F) an oxygenator with integrated arterial filter. Forty-eight patients were randomized in a 1:1 ratio to MiECC or CECC. Due to intraprocedural Doppler signal loss (n = 3), 45 patients were included in final analysis. MiECC perfusion regimen showed a significantly increased HITS rate compared to CECC (by a factor of 1.75; 95% confidence interval, 1.19-2.56). This was due to different HITS rates in procedural phases from aortic cross-clamping until declamping [phase 4] (P = 0.01), and from aortic declamping until stop of extracorporeal perfusion [phase 5] (P = 0.05). Post hoc analysis revealed that MiECC-F generated a higher HITS rate than CECC+F (P = 0.005), CECC-F (P = 0.05) in phase 4, and CECC-F (P = 0.03) in phase 5, respectively. In open-heart surgery, MiECC is not superior to CECC with regard to gaseous cerebral microembolism. When using MiECC for SAVR, the use of oxygenators with integrated arterial line filter appears highly advisable. Only with this precaution, MiECC confers a cerebral microembolic load comparable to CECC during this type of open heart surgery.