Clinical evaluation of the novel Capiox NX19 adult oxygenator-a multicenter study.

INTRODUCTION: The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting. METHODS: A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 (n = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro. RESULTS: The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O2 transfer was 69 ± 30 mL/min/m2 and the CO2 transfer 73 ± 34 mL/min/m2. The O2 gradient was 44 ± 19 mmHg/LPM and the O2 diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm2, respectively. CONCLUSION: This multicenter study displayed good clinical safety and performance of the NX19 oxygenator.

Dynamic oxygenator blood volume during prolonged extracorporeal life support.

Current methods for identification of oxygenator clotting during prolonged extracorporeal life support include visual inspection, evaluation of oxygenator resistance and oxygen exchange performance, and assessment of clotting-related laboratory parameters. However, these observations do not provide a quantitative assessment of oxygenator clot formation. By measuring changes in the dynamic oxygenator blood volume this study aimed to evaluate the relation to oxygenator resistance and oxygen transfer performance. Sixty-seven oxygenators were studied during adult extracorporeal life support. Oxygenator blood volume, oxygenator resistance, and oxygen transfer efficiency were monitored. Oxygenator blood volume decreased with increasing runtime (r = -0.462; p <0.001). There was a statistically significant, fair negative correlation between oxygenator blood volume and oxygenator resistance (r = -0.476; p<0.001) in all oxygenators, which became stronger analyzing only exchanged oxygenators (r = -0.680; p<0.001) and oxygenators with an oxygenator blood volume <187 mL (r = 0.831; p<0.001). No relevant correlation between oxygenator blood volume and O2 transfer was found. Oxygenator blood volume declined over time and was clearly associated with an increasing oxygenator resistance during prolonged extracorporeal life support, though O2 transfer was less affected.

Oxygen delivery, oxygen consumption and decreased kidney function after cardiopulmonary bypass.

INTRODUCTION: Low oxygen delivery during cardiopulmonary bypass is related to a range of adverse outcomes. Previous research specified certain critical oxygen delivery levels associated with acute kidney injury. However, a single universal critical oxygen delivery value is not sensible, as oxygen consumption has to be considered when determining critical delivery values. This study examined the associations between oxygen delivery and oxygen consumption and between oxygen delivery and kidney function in patients undergoing cardiopulmonary bypass. METHODS: Oxygen delivery, oxygen consumption and kidney function decrease were retrospectively studied in 65 adult patients. RESULTS: Mean oxygen consumption was 56 ± 8 ml/min/m2, mean oxygen delivery was 281 ± 39 ml/min/m2. Twenty-seven patients (42%) had an oxygen delivery lower than the previously mentioned critical value of 272 ml/min/m2. None of the patients developed acute kidney injury according to RIFLE criteria. However, in 10 patients (15%) a decrease in the estimated glomerular filtration rate of more than 10% was noted, which was not associated with oxygen delivery lower than 272 ml/min/m2. Eighteen patients had a strong correlation (r >0.500) between DO2 and VO2, but this was not related to low oxygen delivery. Central venous oxygen saturation (77 ± 3%), oxygen extraction ratio (21 ± 3%) and blood lactate levels at the end of surgery (1.2 ± 0.3 mmol/l) showed not to be indicative of insufficient oxygen delivery either. CONCLUSIONS: This study could not confirm an evident correlation between O2 delivery and O2 consumption or kidney function decrease, even at values below previously specified critical levels. The variability in O2 consumption however, is an indication that every patient has individual O2 needs, advocating for an individualized O2 delivery goal.

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.