Arterial Line Filter Research Articles

Comparison of New Technology Integrated and Nonintegrated Arterial Filters Used in Cardiopulmonary Bypass Surgery: A Randomized, Prospective, and Single Blind Study

Background. Innovative cardiopulmonary bypass (CPB) settings have been developed in order to integrate the concepts of “surface-coating,” “blood-filtration,” and “miniaturization.” Objectives. To compare integrated and nonintegrated arterial line filters in terms of peri- and postoperative clinical variables, inflammatory response, and transfusion needs. Material and Methods. Thirty-six patients who underwent coronary bypass surgery were randomized into integrated (Group In) and nonintegrated arterial line filter (Group NIn) groups. Arterial blood samples for the assessments of complete hemogram, biochemical screening, interleukin-6, interleukin-2R, and C-reactive protein were analyzed before and after surgery. Need for postoperative dialysis, inotropic therapy and transfusion, in addition to extubation time, total amount of drainage (mL), length of intensive care unit, and hospital stay, and mortality rates was also recorded for each patient. Results. Prime volume was significantly higher and mean intraoperative hematocrit value was lower in Group NIn, but need for erythrocyte transfusion was significantly higher in Group NIn. C-reactive protein values did not differ significantly except for postoperative second day's results, which were found significantly lower in Group In than in Group NIn. Conclusion. Intraoperative hematocrit levels were higher and need for postoperative erythrocyte transfusion was decreased in Group In.

Balanced Ultrafiltration: Inflammatory Mediator Removal Capacity

Ultrafiltration with a hemoconcentrator may remove excess fluid load and alleviate tissue edema and has been universally adopted in extracorporeal circulation protocols during pediatric cardiac surgery. Balanced ultrafiltration is advocated to remove inflammatory mediators generated during surgery. However, whether balanced ultrafiltration can remove all or a portion of the inflammatory mediator load remains unclear. The inflammatory mediator removal capacity of zero-balanced ultrafiltration was measured during pediatric extracorporeal circulation in vitro. Extracorporeal circulation was composed of cardiotomy reservoir, D902 Lilliput 2 membrane oxygenator, and Capiox AF02 pediatric arterial line filter. The Hemoconcentrator BC 20 plus was placed between arterial purge line and oxygenator venous reservoir. Fresh donor human whole blood was added into the circuit and mixed with Ringer's solution to obtain a final hematocrit of 24-28%. After 2 h of extracorporeal circulation, zero-balanced ultrafiltration was initiated and arterial line pressure was maintained at approximately 100 mmHg with Hoffman clamp. The rate of ultrafiltration (12 mL/min) was controlled by ultrafiltrate outlet pressure. Identical volume of plasmaslyte A was dripped into the circuit to maintain stable hematocrit during the 45 min of the experiment. Plasma and ultrafiltrate samples were drawn every 5 min, and concentrations of inflammatory mediators including interleukin-1β (IL-1β), IL-6, IL-10, neutrophil elastase (NE), and tumor necrosis factor-α (TNF-α) were measured. All assayed inflammatory mediators were detected in the ultrafiltrate, demonstrating that the ultrafiltrator may remove inflammatory mediators. However, dynamic observations suggested that the concentration of NE was highest among the five inflammatory mediators in both plasma and ultrafiltrate (P < 0.001). IL-1β had the lowest concentration in plasma, whereas the concentration of TNF-α was the lowest in ultrafiltrate (P < 0.001). Concentrations of all inflammatory mediators in the ultrafiltrate did not increase linearly compared with those in plasma. The respective ultrafiltrate to plasma concentration and amount ratios indicated that the total removal effect of hemoconcentrator on the inflammatory mediators was 4.17 ± 2.68% for IL-1β, 0.64 ± 0.69% for IL-6, 0.24 ± 0.18% for IL-10, 2.84 ± 1.65% for NE, and 0.51 ± 0.81% for TNF-α, respectively. Balanced ultrafiltration may selectively remove inflammatory mediators from serum. Respective ratios of inflammatory mediators in ultrafiltrate compared with plasma, as well as total amount of inflammatory mediators in the ultrafiltrate suggest that balanced ultrafiltration removes a limited portion of the total inflammatory mediator load.

Clinical Evaluation of New Generation Oxygenators With Integrated Arterial Line Filters for Cardiopulmonary Bypass

New generation oxygenators with integrated arterial line filters have been marketed to improve the efficacy of cardiopulmonary bypass (CPB). Differences in designs, materials, coating surfaces, pore size of arterial filter, and static prime exist between the oxygenators. Despite abundant preclinical data, literature lacks clinical studies. From September 2010 to March 2011, 80 consecutive patients were randomized to CPB using Terumo Capiox FX25 (40 patients, Group-T) or Sorin Synthesis (40 patients, Group-S) oxygenators. Pressure drop and gas exchange efficacy were registered during CPB. High-sensitivity C-reactive protein (hs-CRP), white blood cells (WBCs), fluid balance, activated clotting time, international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, platelets (PLTs), serum albumin, and total proteins were measured perioperatively at different timepoints. Clinical outcome was recorded. Repeated measure analysis of variance and nonparametric statistics assessed between-groups and during time differences. The two groups showed similar baseline and intraoperative variables. No differences were recorded in pressure drop and gas exchange (group-P and group*time-P = N.S. for all) during CPB. Despite similar fluid balance (P = N.S. for static/dynamic priming and ΔVolume administered intraoperatively), Group-T showed higher hs-CRP (group-P = 0.034), aPTT (group-P = 0.0001), and INR (group-P= 0.05), with lower serum albumin (group-P = 0.014), total proteins (group-P = 0.0001), fibrinogen (group-P = 0.041), and PLTs (group-P = 0.021). Group-T also showed higher postoperative bleeding (group-P = 0.009) and need for transfusions (P = 0.008 for packed red cells and P = 0.0001 for fresh frozen plasma and total transfused volumes). However, clinical outcome was comparable (P = N.S. for all clinical endpoints). Both oxygenators proved effective and resulted in comparable clinical outcomes. However, Sorin Synthesis seems to reduce inflammation and better preserve the coagulative cascade and serum proteins, resulting in lower transfusions and post-CPB inflammatory response.

Commentary on: Air bubble detector placement in the CPB circuit: a 2011 cross-sectional analysis of the practice of Certified Clinical Perfusionists

The ideal location of air bubble detector (ABD) placement on the cardiopulmonary bypass (CPB) circuit is debatable. There is, however, very little data characterizing the prevalence of specific ABD placement preferences by perfusionists. Therefore, the purpose of this study was to survey the perfusion community to collect data describing the primary locations of air bubble detector placement on the CPB circuit. In June 2011, an 18-question on-line survey was conducted. Completed surveys were received from 627 participants. Of these, analysis of the responses from the 559 certified clinical perfusionists (CCP) was performed. The routine use of ABD during CPB was reported by 96.8% of CCPs. Of this group, specific placement of the bubble detector is as follows: distal to the venous reservoir outlet (35.6%), between the arterial pump and oxygenator (3.8%), between the oxygenator and arterial line filter (35.1%), distal to the arterial line filter (ALF) (23.6%), and other (1.8%). Those placing the ABD distal to the venous reservoir predominately argued that an emptied venous reservoir was the most likely place to introduce air into the circuit. Those who placed the ABD between the oxygenator and the arterial line filter commonly reasoned that this placement protects against air exiting the membrane. Those placing the ABD distal to the ALF (23.6%) cited that this location protects from all possible entry points of air. A recent false alarm event from an ABD during a case was reported by 36.1% of CCPs. This study demonstrates that the majority of CCPs use an ABD during the conduct of CPB. The placement of the ABD on the circuit, however, is highly variable across the perfusion community. A strong rationale for the various ABD placements suggests that the adoption of multiple ABD may offer the greatest comprehensive protection against air emboli.

A survey on air bubble detector placement in the CPB circuit: a 2011 cross-sectional analysis of the practice of Certified Clinical Perfusionists

The ideal location of air bubble detector (ABD) placement on the cardiopulmonary bypass (CPB) circuit is debatable. There is, however, very little data characterizing the prevalence of specific ABD placement preferences by perfusionists. Therefore, the purpose of this study was to survey the perfusion community to collect data describing the primary locations of air bubble detector placement on the CPB circuit. In June 2011, an 18-question on-line survey was conducted. Completed surveys were received from 627 participants. Of these, analysis of the responses from the 559 certified clinical perfusionists (CCP) was performed. The routine use of ABD during CPB was reported by 96.8% of CCPs. Of this group, specific placement of the bubble detector is as follows: distal to the venous reservoir outlet (35.6%), between the arterial pump and oxygenator (3.8%), between the oxygenator and arterial line filter (35.1%), distal to the arterial line filter (ALF) (23.6%), and other (1.8%). Those placing the ABD distal to the venous reservoir predominately argued that an emptied venous reservoir was the most likely place to introduce air into the circuit. Those who placed the ABD between the oxygenator and the arterial line filter commonly reasoned that this placement protects against air exiting the membrane. Those placing the ABD distal to the ALF (23.6%) cited that this location protects from all possible entry points of air. A recent false alarm event from an ABD during a case was reported by 36.1% of CCPs. This study demonstrates that the majority of CCPs use an ABD during the conduct of CPB. The placement of the ABD on the circuit, however, is highly variable across the perfusion community. A strong rationale for the various ABD placements suggests that the adoption of multiple ABD may offer the greatest comprehensive protection against air emboli.

Evaluation of the Maquet Neonatal and Pediatric Quadrox I with an integrated arterial line filter during cardiopulmonary bypass

Perfusion equipment has evolved since its introduction into clinical practice more than fifty years ago to include smaller cardiopulmonary bypass (CPB) circuits and components. Perfusionists are now exploring the function of new oxygenators with an integrated arterial line filter (IALF). The purpose of this trial was to examine the Maquet Quadrox-I Neonatal and Pediatric oxygenators with IALF in a clinical setting, with respect to gas transfer, heat exchange co-efficiency (HEC), trans-membrane pressure (TMP) gradient and clinical experience. The Maquet Quadrox-I Neonatal oxygenator was used on 30 patients ranging from 2.2-13.1 kg. The Maquet Quadrox-I Pediatric oxygenator was used on 15 patients ranging from 12.7-24.5 kg. Arterial and venous blood gases were taken once the patient was stable on CPB and, subsequently, every 30 minutes afterwards, as per institution protocol. The values for gas transfer rates, HEC and TMP gradient were stratified into three main categories with each oxygenator: normothermia, cooling and re-warming. During all conditions, the gas transfer rate with both oxygenators was efficient. The HEC values showed efficient heat exchanger performance during all conditions with both oxygenators. While maintaining CPB flow within the manufacturer's recommended flow rate for each oxygenator, the TMP gradient range for the Neonatal Quadrox-I was 10-40 mmHg and the Pediatric Quadrox-I was 10-60 mmHg. During the clinical trial, foam was shown to break through the cardiotomy on several occasions when high sucker return was required. This new line of oxygenators performed well with regards to gas transfer, HEC and TMP gradient, but there were clinical experiences that did not meet expectations. There were repeated incidences with the venous reservoir which ultimately cast a negative light on the design of this new product from Maquet. In the future, the authors would like to evaluate updated versions of this product from Maquet and any other pediatric perfusion devices that could help the patient in the clinical arena.

In Vitro Evaluation of Gaseous Microemboli Handling of Cardiopulmonary Bypass Circuits with and without Integrated Arterial Line Filters

The delivery of gaseous microemboli (GME) by the cardiopulmonary bypass circuit should be minimized whenever possible. Innovations in components, such as the integration of arterial line filter (ALF) and ALFs with reduced priming volumes, have provided clinicians with circuit design options. However, before adopting these components clinically, their GME handling ability should be assessed. This study aims to compare the GME handling ability of different oxygenator/ALF combinations with our currently utilized combination. Five commercially available oxygenator/ALF combinations were evaluated in vitro: Terumo Capiox SX25RX and Dideco D734 (SX/ D734),Terumo Capiox RX25R and AF125 (RX/AF125),Terumo FX25R (FX), Sorin Synthesis with 102 μm reservoir filter (SYN102), and Sorin Synthesis with 40 μm reservoir filter (SYN40). GME handling was studied by introducing air into the venous return at 100 mL/min for 60 seconds under two flow/ pressure combinations : 3.5 L/min, 150 mmHg and 5 L/min, 200 mmHg. Emboli were measured at three positions in the circuit using the Emboli Detection and Classification (EDAC®) Quantifier and analyzed with the General Linear Model. All circuits significantly reduced GME. The SX/D734 and SYN40 circuits were most efficient in GME removal whilst the SYN102 handled embolic load (count and volume) least efficiently (p&lt; .001). A greater number of emboli &lt;70 μm were observed for the SYN102, FX and RX/AF125 circuits (p&lt; .001). An increase in embolic load occurred with higher flow/pressure in all circuits (p&lt; .001). The venous reservoir significantly influences embolic load delivered to the oxygenator (p&lt; .001). The majority of introduced venous air was removed; however, significant variation existed in the ability of the different circuits to handle GME. Venous reservoir design influenced the overall GME handling ability. GME removal was less efficient at higher flow and pressure, and for smaller sized emboli. The clinical significance of reducing GME requires further investigation.

Active or passive bio-coating: does it matters in extracorporeal circulation?

Two types of surface coating for cardiopulmonary bypass (CPB) are used: bioactive (heparin, nitric oxide) and biopassive (albumin, polyethyleneoxide (PEO), phosphorylcholine). When haemocompatible coatings are combined with the separation of pleuro-pericardial aspiration, attenuation of both the coagulation and complement cascades, as well as better platelet preservation, has been demonstrated. This study wants to investigate if the combination of a bioactive with a biopassive coating (unfractionated heparin embedded in a phosphorylcholine matrix) combines the beneficial effects of both approaches. Thirty patients undergoing elective CABG were prospectively randomized into two groups of 15 patients. The sole exclusion criterion was an ejection fraction of less than 40%. In the control group (PC), the whole CPB circuit was coated with phosphorylcholine (PC). In the study group (XPC), unfractionated heparin was embedded in the PC matrix of the oxygenator and arterial line filter. No differences were found for haemolytic index, thrombin-anti-thrombin complex (TAT), IL-6, IL-10 and blood loss. PF4 plasma concentration increased from 27.6±22.0 IU/mL to 165.7±43.9 IU/mL (p<0.001) at 15 minutes of CPB in the PC and from 16.0±9.7 IU/mL to 150.9 ± 61.3 IU/mL (p<0.001) in the XPC group. Terminal complement complex (TCC) increased over time in both groups until the end of CPB (Figure 2A). Within each group, TCC generation was statistically significantly higher after the release of the aortic cross-clamp (p<0.001) and at the end of CPB (p<0.001). Total TCC generation was statistically significantly higher in the XPC group compared to the PC group (p=0.026). The difference was statistically significant after the release of the aortic cross-clamp (p=0.005) and at the end of CPB (p=0.001). Based on our results, there is no additional benefit in combining phosphorylcholine with unfractionated heparin in elective patients undergoing coronary artery bypass grafting (CABG). Massive haemodilution leads to enhanced complement activation.

Invited Commentary

Invited Commentary

Monitoring Microemboli During Cardiopulmonary Bypass with the EDAC® Quantifier

Gaseous emboli may be introduced into the bypass circuit both from the surgical field and during perfusionist interventions. While circuits provide good protection against massive air embolism, they do not remove gaseous microemboli (GME) from the bypass circuit. The purpose of this preliminary study is to assess the incidence of GME during bypass surgery and determine if increased GME counts were associated with specific events during bypass surgery. In 30 cases divided between 15 coronary artery bypass grafts and 15 valve repairs, GME were counted and sized at the three locations on the bypass circuit using the EDAC® Quantifier (Luna Innovations, Roanoke, VA). A mean of 45,276 GME were detected after the arterial line filter during these 30 cases, with significantly more detected (p= .04) post filter during valve cases (mean = 72,137 ± 22,113) than coronary artery bypass graft cases (mean = 18,416 ± 7831). GME detected post filter were significantly correlated in time with counts detected in the venous line (p&lt; .001). Specific events associated with high counts included the initiation of cardiopulmonary bypass, heart manipulations, insertion and removal of clamps, and the administration of drugs. Global factors associated with increased counts post filter included higher venous line counts and higher post reservoir/bubble trap counts. The mean number of microemboli detected during bypass surgery was much higher than reported in other studies of emboli incidence, most likely due to the increased sensitivity of the EDAC® Quantifier compared to other detection modalities. The results furthermore suggest the need for further study of the clinical significance of these microemboli and what practices may be used to reduce GME incidence. Increased in vitro testing of the air handling capability of different circuit designs, along with more clinical studies assessing best clinical practices for reducing GME activity, is recommended.

Blood Temperature Management and Gaseous Microemboli Creation: An In-Vitro Analysis

Gaseous microemboli have been associated with post operative neurological deficits in patients undergoing cardiopulmonary bypass. Creating an optimal perfusion system that minimizes microemboli production and has enhanced abilities to sequester entrained air during the bypass procedure has been an important focus. This study examines the air-handling capabilities of a cardiopulmonary bypass circuit and correlates blood temperatures with microemboli loads proximal and distal to the arterial line filter within the circuit. Utilizing a Capiox RX25R oxygenator, Capiox 37 micron arterial filter, vacuum assisted venous return, and emboli detectors, 30 mL of air were injected into the venous line of a bypass circuit at eight different temperatures. Emboli were counted distal to the arterial line filter by the EDAQ® Quantifier (Emboli Detection and Classification). The average number of emboli detected distal to the arterial filter progressively increased as the perfusate temperature was dropped. At 37.0°C an average of 1.4 emboli was observed distal to the arterial filter within 90 seconds of the air injection. At 23.0°C an average of 49.8 emboli was detected. Air introduced into the venous side of the bypass circuit resulted in showers of microemboli being sent past the arterial line filter. In addition, as the bovine blood was cooled, the air handling capability of the circuit was diminished.

Pre-clinical laboratory evaluation of the new ‘AF’ arterial line filter range

The presence of emboli was recognised relatively early in the history of open heart surgery. The emboli produced during cardiopulmonary bypass have the predisposition to distribute into, and ultimately obstruct, microvessels of all tissues. The Sorin Group has recently developed a new range of arterial line filters. Before the Sorin AF range of filters was released for pre-launch clinical trials, our group performed in vitro laboratory testing of the AF range against a selection of commercially available filters on the global market. The Sorin AF620 and AF640 demonstrate both the smallest prime volume and smallest surface contact area (92ml and 290 cm(2), respectively).The results of the GME Handling Efficiency experiments ranged by 39.6%, from 95.9% to 56.3%. In terms of an air bolus handling, the results of the Limit Bolus experiment ranged by 97 ml, from 147.5 ml down to 50 ml. The pressure drop across all the filters was measured under steady state experimental conditions. All of the above investigations were considered against surface area and prime volume. It is clear from the results that some commercially available arterial line filters perform better than others, not only in overall performance, but also with regard to individual characteristics. Evaluating arterial line filters for hospital-specific use has to balance pressure drop, surface area, micro air handling, prime volume and gross air handling; all points need to be considered. In the AF620 and AF640, Sorin boast that they are the two smallest prime and smallest surface area filters commercially available on the global market. The Sorin AF filter range performs well in all of the areas we investigated and will be a competitive option for centres, irrespective of which characteristics they use to evaluate and select their arterial line filter.

An in vitro comparison of the ability of three commonly used pediatric cardiopulmonary bypass circuits to filter gaseous microemboli

The purpose of this study was to compare the ability of three commonly used pediatric cardiopulmonary bypass (CPB) circuits to filter gaseous microemboli (GME) in an in vitro model. Devices were tested at different levels of two specific independent variables: volume of air injected (1, 3, 5ml) and percentage of each oxygenator's rated flow (50%, 75%, 100%, 125%). The air-handling ability of each CPB circuit was determined by the Emboli Detection and Classification Quantifier (Luna Innovations Inc., Roanoke,VA). At all tested conditions, the FX-05 allowed a higher percentage of GME when compared to either one or both of the other two CPB circuits. When comparing oxygenators at similar absolute flow rates, the KIDS D100/D130 CPB circuit performed worse compared to the other two CPB circuits. The combination of the Baby RX-05 oxygenator and Capiox AF02 arterial line filter provides the highest level of protection from air emboli in an in vitro investigation.

Variations in the Application of Various Perfusion Technologies in Great Britain and Ireland—A National Survey

In an attempt to reduce the negative sequelae of cardiopulmonary bypass (CPB), a variety of new technologies have been created. This study investigates variations in the application of these technologies throughout Great Britain and Ireland (GB & I). All perfusion departments within GB & I were surveyed about equipment and technologies used in CPB. Eighty-five percent of units use a standard arterial line filter in all cases. Forty percent of units occasionally use leukocyte-depleting filters in various sites within the circuit. Sixteen percent always use some element of heparin-bonded circuit, but 62% never use them. Twenty-five percent use solely rotary pumps, 18% use solely centrifugal pumps, and 56% use both. Finally, 20% are now using minimal extracorporeal circulation in certain clinical scenarios. These decisions are most frequently affected by clinician preference and cost. This survey has highlighted significant variation in the utilization of various technologies used in CPB. While some variation between centers is to be expected, as innovative technologies are adopted at varying rates, surveys such as this are useful for alerting clinicians to gaps between evidence-based knowledge and clinical practice.

An In Vitro Study of the Effectiveness of Carbon Dioxide Flushing of Arterial Line Filters

Gaseous microemboli (GMEs) have been connected to neurologic impairment and other ischemic complications after surgery. The components of the extracorporeal circuit (ECC) have a large influence on GME production. This in vitro study investigates the use of carbon dioxide flushing of the 38-μm Medtronic Affinity CB351 and 38-μm Medtronic Affinity 351 arterial line filters (ALFs) to decrease GMEs and time for air to clear the ALF. An adult circuit was implemented with a silicone oxygenator for vacuum-assisted gas removal and to reduce air before ALF. The 48 filters were separated into four equal groups: flushed coated and non-coated and non-flushed coated and non-coated. Carbon dioxide flushing was performed at 6 L/min for 3 minutes. ALFs were retrograde primed at 200 mL/min. An Emboli Detection and Classification Quantifier (EDAC) was used to gather data. The average total emboli and time to clear (seconds) for flush coated were 20.25 ± 16.78 and 142.17 ± 174.80 seconds, respectively, flushed non-coated were 30.5 ± 34.65 and 124.17 ± 131.40 seconds, non-flushed coated were 162.08 ± 79.90 and 390.42 ± 84.36 seconds, and non-flushed non-coated were 163.67 ± 212.67 and 305.92 ± 179.36 seconds. Flushed filters had an average total emboli count of 25.375 ± 27.14 and an average time to clear of 133.167 ± 151.51 seconds. Non-flushed filters had an average total emboli count of 162.875 ± 157.11 and an average time to clear of 348.167 ± 143.70 seconds. Coated and non-coated filters for total emboli and time to clear had p values of .86 and .24, respectively. Flushed and non-flushed filters had total emboli and time to clear p values of &lt;.001 and &lt;.001, respectively. No significant difference was found between coated and non-coated filters involving total embolic count and time to clear. A significant difference was found in total embolic count and time to clear between flushed and non-flushed filters. This study shows that fewer emboli and faster embolic clearance time correlate with carbon dioxide flushing of the ALF.

Bubble Tracking Through Computational Fluid Dynamics in Arterial Line Filters for Cardiopulmonary Bypass

Gaseous embolism is still a concern in cardiopulmonary bypass, and the use of arterial line filters (ALFs) is widespread because of their recognized role in increasing safety. Currently, the methods used for the optimization/evaluation of ALF designs are based on a trial-and-error approach. In this work, we propose a method to objectively assess the air-handling capabilities of ALFs, using computational fluid dynamics (CFD) simulations to track the trajectory of large numbers of bubbles traversing the device under examination. We applied the CFD method to ALF prototypes, whose design featured the classical purge/screen configuration, to establish the relative roles of the bubble-trap and bubble-barrier deairing effects. Simulations were run at the maximum rated blood flows. Clusters of hundred bubbles in the micro- to macroembolic size range (10-1,000 microm diameter) were tracked. The results quantified the relative amount of bubbles whose fate is either to reach the purge line or to be intercepted by the filter screen. For microbubbles, the analysis detailed how the screen barrier is exploited, mapping the percent distribution of the intercepted bubbles along the screen surface. We conclude that the method proposed increases knowledge and awareness in designing an optimal exploitation of the filtration mechanisms involved in ALFs.

Clinical Gaseous Microemboli Assessment of an Oxygenator with Integral Arterial Filter in the Pediatric Population

The use of an arterial line filter (ALF) within the pediatric cardiopulmonary bypass (CPB) circuit is not a new concept. It has always presented the perfusionist with a circuit component that while valuable, increased prime volume. The purpose of this study was to evaluate the change in prime volume and emboli between a conventional oxygenator with separate ALF and a new generation oxygenator with integral arterial filter (AF). We performed a clinical, non-randomized retrospective evaluation of the Terumo Capiox® RX15 (Terumo Cardiovascular Systems Corporation, Ann Arbor, MI) (n= 10) in conjunction with the Terumo Capiox® AF125X ALF or the Capiox ® AF02 vs. the Terumo Capiox® FX15 oxygenator with integral AF (n= 10). The above circuit components, in combination with the LUNA EDAC® (emboli detection and classification) Quantifier (LUNA Innovations, Blacksburg, VA) were placed at various locations within each patient’s CPB circuit to establish and quantify the presence and volume of gaseous emboli during all phases of cardiopulmonary bypass. The EDAC® system is available/used for all patients undergoing CPB at this institution. When compared to a more conventional CPB circuit, the Capiox® FX15 primes more easily as it does not require a carbon dioxide flush while still providing a 32 μ AF. There was no statistical difference in air handling between the tested oxygenators and their associated circuits. During this review it was determined that use of the Capiox® FX15 simplifies the arterial limb of the pediatric CPB circuit. Removal of the separate ALF led to the removal of several, now unnecessary, arterial connectors and additional tubing (arterial line filter bypass). Removal of these components led to a reduction in prime volume and decreased the hemodilutional effect. The FX15 provided a safe, simplified pediatric CPB circuit and was as effective in gaseous microemboli removal as was the more traditional RX15 with separate ALF during this review.

Clinical Evaluation of the Terumo Capiox ® FX05 Hollow Fiber Oxygenator with Integrated Arterial Line Filter

Perfusion techniques and equipment in pediatric open heart surgery have continued to focus on decreasing prime volumes and lowering surface areas of the cardiopulmonary bypass circuit. While this has improved drastically over the last 20 years, greater demand is being placed on the perfusionist to reduce the deleterious effects of bypass without compromising safety or efficiency. Specifically, manufacturers of disposable perfusion equipment have focused on providing pediatric perfusionists with oxygenators that provide the smallest prime and surface area possible while attempting to maximize performance. Recently,Terumo Cardiovascular has introduced the Capiox® FX05, a neonatal hollow fiber oxygenator that includes an integrated arterial line filter. The FX05 provides a blood flow range of 0.1–1.5 L/min and a low priming volume of 43 mL. Additionally, it is coated with X Coating”, a biocompatible, hydrophilic polymer surface coating that reduces platelet adhesion and protein denaturation. The purpose of this study was to test the FX05 for gas transfer, blood path resistance, and blood handling characteristics in a standardized clinical setting. Heat exchange coefficients were also calculated during the cooling and warming period. Other data analyzed includes bypass circuit prime volumes and initial patient hematocrit along with the total operative homologous blood donor exposures. In summary, the FX05 offers good gas exchange capabilities and a low pressure drop during normal cardiopulmonary bypass parameters along with the safety of an integrated arterial line filter. Furthermore, the FX05 with integrated filter allows a reduction in overall bypass prime volume and surface area while promoting the reduction of homologous blood transfusions, optimizing hemostasis.

Cardiopulmonary Bypass in 2009: Achieving and Circulating Best Practices

Cardiopulmonary Bypass in 2009: Achieving and Circulating Best Practices

Evaluation of air handling in a new generation neonatal oxygenator with integral arterial filter

Prime volume of the cardiopulmonary bypass circuit may lead to significant hemodilution and the potential need for blood products for all patients, but may be more critical in the pediatric and, specifically, the neonatal patient. We report on the first use of the Terumo CAPIOX FX05 (Baby-FX) oxygenator with integral arterial filter, prime volume 43 ml, evaluating performance and air-handling of six Baby-FX versus thirteen Baby-RX oxygenators. The Terumo Baby-FX primes and performs as easily as the Baby-RX series. A significant prime component in the neonatal CPB circuit can be the arterial line filter (ALF). Removal of the ALF may lead to significant reduction in prime volume, decreased exposure to foreign surfaces with subsequent reduction in inflammation, and potential elimination or reduction in blood product exposures.