Randomized trial of the Terumo Capiox FX05 oxygenator with integral arterial filter versus Terumo Capiox Baby RX05 and Terumo Capiox AF02 arterial filter in infants undergoing cardiopulmonary bypass

The purpose of this clinical trial was to evaluate the effect of the Terumo Capiox FX05 oxygenator with integrated arterial filter during cardiopulmonary bypass (CPB) compared with the Terumo Capiox RX05 Baby RX and arterial filter on inflammatory mediators and blood product utilization. Forty patients weighing less than 10 kg who underwent congenital heart surgery utilizing cardiopulmonary bypass were randomized into either oxygenator group. The endpoints included measuring inflammatory markers at six different time points (preoperative baseline, CPB circuit being primed, 15 minutes after CPB initiation, status post protamine administration, prior to transport to intensive care unit, and within 12 to 24 hours post surgery), blood product utilization, extubation time, and days until discharge. The inflammatory mediators showed no significant differences between oxygenators at any time points. However, looking at the inflammatory mediators of both the FX and RX groups combined, a statistically significant difference was seen in interleukin (IL)-6 at 12/24 hour post surgery (p < .001) versus baseline and all other time points. IL-8 at status post protamine (p < .001) and 12/24 hours post surgery (p < .001) demonstrated significant differences versus all other time points, and IL-10 at status post protamine (p < .001) and prior to leaving the operating room (p < .001) were statistically different compared to all other time points. Cardiopulmonary bypass stimulates the systemic inflammatory response through various components of the extracorporeal system. This investigation did not find significant differences in cytokines interferon-gamma, IL-1beta, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 p70, tumor necrosis factor (TNF)-alpha, and TNF-beta when comparing these two oxygenators. It is well known that various mechanisms contribute to the levels of cytokines circulating in a patient's blood volume and many manipulations throughout cardiac surgery have the ability to demonstrate anti-inflammatory interventions. Further investigation is needed as to how modification of the extracorporeal circuit may minimize increases in inflammatory mediators. Keywords: infant, bypass, cytokines, blood, infant perfusion strategy.     

Clinical evaluation of the microporous hollow fiber oxygenator

This report concerns a clinical evaluation for a newly devised hollow fiber oxygenator, Capiox II. It functions on a one-pump system, and is simple to set up and operate. This equipment was used for 118 patients undergoing cardiac surgery at Tokyo University Hospital from February 1982 through February 1983. The gas transfer capacity proved to be satisfactory. The employment of an air-oxygen blender prevented overoxygenation, and reasonable levels of PaO₂ and PaCO₂ were demonstrated with a FiO₂ 0.7, ratio 0.7 at normothermia. The destruction of platelets was much less with the use of this oxygenator, as compared to findings with the BOS-10. Hemolysis by Capiox II appeared to be lower than that by BOS-10, but the difference was not statistically significant. Differences were distinct in the amount of microbubbles; strikingly, no bubble was evidenced in Capiox II by the ultrasound bubble detector, during general procedures. We conclude that Capiox II is of excellent clinical value, and should be used especially for infants as well as adult patients with possible long perfusions. The merits and demerits of this equipment are given attention.     

Experimental evaluation of the Medtronic Maxima Forté hollow fiber membrane oxygenator.

A new hollow fiber membrane oxygenator, the Medtronic Maxima Forté, was tested for gas transfer, blood path resistance and blood handling characteristics in a standardized setting with surviving animals. Three calves (mean body weight: 71 +/- 9.6 kg) were placed on cardiopulmonary bypass at a mean flow rate of 50 ml/kg/min for six hours. The circuit included the Maxima Forté oxygenator. The animals were weaned from cardiopulmonary bypass and then from the ventilator. After seven days, the animals were sacrificed electively. Physiologic blood gas values could be maintained throughout perfusion in all animals. Mean pressure drop through the oxygenator varied between 49 mmHg and 66 mmHg. The respective baseline values for red blood cell count, white blood cell count and platelets were 8.90 +/- 1.26 10(6)/mm3, 7.46 +/- 3.17 10(3)/mm3. and 680 +/- 216 10(3)/mm3. Red blood cell and platelet counts dropped slightly to 7.26 +/- 1.61 10(6)/mm3 and 400 +/- 126 10(3)/mm3 at the end of the bypass, whereas the white blood cell count increased up to 9.13 +/- 5.25 10(3)/mm3. All three cell lines returned to near their baseline values after seven days. Blood trauma evaluated as a function of plasma hemoglobin (plasma Hb) and lactate dehydrogenase (LDH) showed stable values during all the perfusion time. Both peaked at 24 hours before returning to their baseline values at seven days. LDH showed a statistically significant variation: 3255 +/- 693 IU at 24 hours versus 2029 +/- 287 IU at baseline (p = 0.04). The variation of plasma Hb was not statistically significant (93.5 +/- 7.7 mumol/l at 24 hours versus 77.3 +/- 52.3 mumol/l at baseline) indicating a weak effect of the perfusion on blood trauma. The Medtronic Maxima Forté hollow fiber membrane oxygenator offered good gas exchange capabilities, a low pressure drop, and low blood trauma over a prolonged perfusion time of six hours in this evaluation.     

Extended support with the Terumo Baby-RX oxygenator

The Terumo Baby-RX, a new-generation low prime oxygenator, recently has entered the perfusion market in North America. This oxygenator is designed exclusively for neonates and infants and has the smallest priming volume of any clinically available oxygenator. The BABY-RX also is treated with X Coating, Terumo's biocompatible, hydrophilic polymer surface coating that reduces platelet adhesion and protein denaturation. The oxygenator has a blood flow range of 0.1 to 1500 mL/min and operates with a minimum reservoir volume of 15 mL. A 3.2-kg patient, status post-Stage 1 Norwood, Palliation was placed on cardiopulmonary support after thrombus formation within the modified Blalock-Taussig shunt during a general surgery procedure. The extended support circuit incorporated the Baby-RX oxygenator for 17.5 hours. The oxygenator performed well over this time period at flows of 600-800 mL/min, sweep rates of 100-300 mL/min, FiO2 of 30-40%, and ACTs of 140-200 seconds. There were no indices of oxygenator failure noted within the time frame of support. After placement of a new systemic to pulmonary shunt, the patient was removed from support and the oxygenator drained of residual blood. No evidence of fiber damage or clot formation was noted. The patient had a successful support run without complications related to cardiopulmonary support.     

Initial clinical experience with a more efficient hollow fiber oxygenator of unique design

The first 90 cardiac surgery cases perfused with a new hollow fiber membrane oxygenator in which the gas flows through the fibers and blood flows around the fibers are reported. The fibers are microporous polypropylene with a pore size of 0.03 microns. Membrane surface area is 2.0 M2 and priming volume is 480 ml, including heat exchanger PaO2 is controlled by FIO2 and PaCO2 by gas flow rate. Patients as large as 2.36 M2 were perfused up to 348 min using hemodilution and hypothermia. The mean PaO2 was 200 mmHg and the mean PaCO2 39.5 mmHg. Oxygen transfer was as high as 230 ml/min. This low prime device transfers large volumes of gas, an efficiency which results from a crossed arrangement of the fibers to break up laminar flow of the blood around them. The low priming volume makes it appropriate for use in all but the smallest patients.     

Clinical Evaluation of Pulsatile Flow Mode of Terumo Capiox Centrifugal Pump

Abstract: The Terumo Capiox centrifugal pump system possesses an automatic priming function in which the motor repeatedly stops and runs intermittently to eliminate air bubbles in the circuit through the micropores of the hollow-fiber membrane oxygenator. By modifying this mechanism, we have developed a pulsatile flow mode. In this mode, maximum and minimum pump rotational speeds can be independently set every 20 rpm in the range of 0 to 3,000 rpm. The duration of the pump run at maximum and minimum speeds can also be independently set every 0.1 s in the range of 0.2 to 15 s. In a clinical trial, after obtaining the desired flow rate, 2.4 L/min/m²in nonpulsatile flow mode, a pulsatile flow mode of 60 cycles/min (with 1 cycle being maximum speed for 0.4 s and minimum speed for 0.6 s) was obtained by adding and subtracting 500 rpm to and from the rotational speed in nonpulsatile flow mode. Pulse pressures in the femoral artery and in the circuit just proximal to the perfusion cannula (6.5 mm Sarns high flow cannula with metal tip) were measured in 5 patients who underwent pulsatile cardiopulmonary bypass (CPB) for a coronary artery bypass graft (CABG), and compared to pulse pressures obtained by intraaortic balloon pumping (IABP) in 3 patients and by the pulsatile mode of the 3M Delphin pump in 3 patients. The platelet count, free hemoglobin, and β-thromboglobulin (β-TG) were measured and compared with measurements from another 5 patients who underwent nonpulsatile CPB. Although the pulse pressure measured in the circuit was 180 mm Hg on average, the pressure in the femoral artery was only 15 to 40 mm Hg with a mean of 20 mm Hg. In the same patients, 60 to 80 mm Hg pulse pressure was obtained with IABP. The pulse pressure obtained with the Delphin pump was not more than that obtained with the Terumo pump. There were no significant differences in percents of preoperative levels of platelet counts (pulsatile, 87.6 ± 15.8% and nonpulsatile, 72.4 ± 40.6%), free hemoglobin (pulsatile, 18 ± 8 mg/dl and nonpulsatile, 25 ± 7 mg/dl), and β-TG (pulsatile 298 ± 28 ng/ml and nonpulsatile, 312 ± 143 nglml). In conclusion, although the pulsatile mode of the Terumo centrifugal pump did not exhibit any adverse effects hematologically, the pulse pressure obtained was unsatisfactorily small, mainly because of dumping caused by the perfusion cannula.     

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.     

Development of silicone rubber hollow fiber membrane oxygenator for ECMO

Silicone rubber hollow fiber membrane produces an ideal gas exchange for long-term ECMO due to nonporous characteristics. The extracapillary type silicone rubber ECMO oxygenator having an ultrathin hollow fiber membrane was developed for pediatric application. The test modules were compared to conventional silicone coil-type ECMO modules. In vitro experiments demonstrated a higher O2 and CO2 transfer rate, lower blood flow resistance, and less hemolysis than the conventional silicone coil-type modules. This oxygenator was combined with the Gyro C1E3 centrifugal pump, and three ex vivo experiments were conducted to simulate pediatric V-A ECMO condition. Four day and 6 day experiments were conducted in cases 1 and 2, respectively. Case 3 was a long-term experiment up to 2 weeks. No plasma leakage and stable gas performances were achieved. The plasma free hemoglobin was maintained within a normal range. This compact pump-oxygenator system in conjunction with the Gyro C1E3 centrifugal pump has potential for a hybrid total ECMO system.     

Preclinical evaluation of a new hollow fiber silicone membrane oxygenator for pediatric cardiopulmonary bypass: ex-vivo study.

Based on the results of many experimental models, a hollow fiber silicone membrane oxygenator applicable for long-term extracorporeal membrane oxygenation (ECMO) was developed. For further high performance and antithrombogenicity, this preclinical model was modified, and a new improved oxygenator was successfully developed. In addition to ECMO application, the superior biocompatibility of silicone must be advantageous for pediatric cardiopulmonary bypass (CPB). An ex vivo short-term durability test for pediatric CPB was performed using a healthy miniature calf for six hours. Venous blood was drained from the left jugular vein of a calf, passed through the oxygenator and infused into the left carotid artery using a Gyro C1E3 centrifugal pump. For six hours, the O2 and CO2 gas transfer rates were maintained around 90 and 80 ml/min at a blood flow rate of 2 L/min and V/Q=3, respectively. The plasma free hemoglobin was maintained around 5 mg/dl. These data suggest that this newly improved oxygenator has superior efficiency, less blood trauma, and may be suitable for not only long-term ECMO but also pediatric CPB usage.     

Biocompatibility of a silicone-coated polypropylene hollow fiber oxygenator in an in vitro model.

BACKGROUND: A silicone-coated microporous hollow-fiber membrane oxygenator has been developed to prevent plasma leakage during long-term use. The objective of this study was to evaluate the biocompatibility of the oxygenator. METHODS: A silicone-coated oxygenator was compared with an uncoated oxygenator in an in vitro model of cardiopulmonary bypass. Simulated circulation was maintained for 6 h at 37 degrees C. RESULTS: Platelet counts decreased significantly (p < 0.05) and leukocyte counts tended to decline; however, the differences between groups were not significant. Concentrations of C3a increased significantly in both groups (p < 0.05), but levels were significantly less in the silicone-coated oxygenator (p = 0.008). In contrast, concentrations of C4a, beta-thromboglobulin, and granulocyte elastase increased significantly (p < 0.05), but the differences between groups were not significant. CONCLUSIONS: Silicone coating over a microporous hollow-fiber membrane may improve biocompatibility by reducing C3a activation.     

Development of the Terumo Capiox Centrifugal Pump and Its Clinical Application to Open Heart Surgery: A Comparative Study with the Roller Pump

Abstract: We have developed the Terumo Capiox centrifugal pump (CXP), which consists of a rotor having a unique straight-path design to reduce pump rotational speed without decreasing hydraulic efficiency. The CXP was tested in vitro for blood trauma with a specially designed test circuit using fresh bovine blood. The Biopump (BP) (Medtronic, Minneapolis, MN, U.S.A.) and the roller pump (RP) were used as controls. The CXP demonstrated the smallest elevation of free plasma hemoglobin compared with the BP and the RP. The CXP was then applied to cardiopulmonary bypass (CPB) in 10 patients (CXP group) who underwent elective coronary artery by-pass grafting (CABG), and the results were compared with those for a comparable roller pump group (RP group). Free plasma hemoglobin level, platelet count, and serum β -thromboglobulin ( β -TG) level were measured during CPB. There were no CXP-related complications nor hemodynamic abnormalities during CPB. The CXP group demonstrated less hemolysis and less platelet depletion than the RP group. Furthermore, the serum β -TG level was significantly lower in the CXP group than in the RP group. The CXP showed excellent hemodynamic performance with less blood trauma both in vitro and in clinical application to open heart surgery. Thus, the CXP has significant potential to be safely applied to CPB for open heart surgery and circulatory support.     

Development of a new hollow fiber silicone membrane oxygenator for ECMO: the recent progress.

Throughout the last 50 years, many improvements have been made for a more effective oxygenator. A large plate type membrane oxygenator, used by Clowes, and a coil type, used by Kolff, has evolved into the small hollow fiber oxygenator. The complex bubble oxygenator, or rotating disk oxygenator, has become a small disposable bubble oxygenator. The currently available oxygenators are extremely small, efficient, and can be used for extended periods of time. However, there are some problems with extracorporeal membrane oxygenation (ECMO). Currently in the United States, there are no clinically applicable hollow fiber ECMO oxygenators available, in spite of the extended ECMO application. Therefore, the development of a small, yet efficient, silicone hollow fiber membrane oxygenator for long-term ECMO usage was attempted. Based on the results of many experimental models, preclinical oxygenator models for long-term ECMO were developed in our laboratory using an ultra-thin silicone rubber hollow fiber membrane.     

A new bubble oxygenator (OCVC oxygenator): Development and clinical application

A new bubble oxygenator, designed for simple operation and clinical efficacy in intracardiac surgery, has been developed and clinically evaluated. This device is characterized by an oxygenating chamber with controllable blood-volume, integral heat exchanger and two-stage microfilter of gravity drainage system, an apparatus for creating and uniformly distributing oxygen bubbles, and construction materials of the device known to be minimally traumatic to the blood. Clinical experience in 132 infantile and pediatric open heart procedures has demonstrated its effectiveness as measured by embolic complications and simplicity in maintaining physiologic blood gas levels.     

Comparison of gaseous microemboli counts in arterial, simultaneous and venous heat exchange with a hollow fiber membrane oxygenator

Potential sources of gaseous microemboli during cardiopulmonary bypass are varied. However, it is known that membrane oxygenators generate fewer gaseous microemboli than bubble oxygenators and that bubblers cannot utilize arterial heat exchange without generating significant gaseous microemboli during rewarming. A membrane oxygenator utilizing simultaneous gas and heat exchange raises the concern that concurrent gas and heat exchange would result in a higher production of gaseous microemboli compared to conventional venous heat exchange devices. This in vitro study compared venous, simultaneous, arterial and control (venous) heat exchanger gaseous microemboli counts during rewarming. No significant difference was found between the four heat exchangers when comparing inlet and outlet gaseous microemboli counts. This in vitro study suggests that there is no difference in gaseous microemboli generation when varying the position of the heat exchanger in the extracorporeal circuit incorporating a microporous membrane oxygenator.