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Extracorporeal life support systems (ECLS) have become common in cardiothoracic surgery, but are still “Terra Incognita” in other medical fields due to the fact that perfusion units are normally bound to cardiothoracic centres. The Lifebridge B2T® is an ECLS that is meant to be used as an easy and fast-track extracorporeal cardiac support to provide short-term perfusion for the transport of a patient to a specialized centre. With the Lifebridge B2T®, it is now possible to provide extracorporeal bypass for patients in hospitals without a perfusion unit. The Lifebridge B2T® was tested on three calves to analyze the handling, performance and security of this system. The Lifebridge B2T® safely can be used clinically and can provide full extracorporeal support for patients in cardiac or pulmonary failure. Flows up to 3.9 ± 0.2l/min were reached, with an inflow pressure of −103 ± 13mmHg, using a 21Fr. BioMedicus® (Medtronic, Minneapolis, MN, USA) venous cannula. The “Plug and Play” philosophy, with semi-automatic priming, integrated check-list, a long battery time of over two hours and instinctively designed user interface, makes this device very interesting for units with high-risk interventions, such as catheterisation labs. If a system is necessary in an emergency unit, the Lifebridge can provide a high security level, even in centres not acquainted with cardiopulmonary bypass.

Background. To date, there is no quality assurance program that correlates patient outcome to perfusion service provided during cardiopulmonary bypass (CPB). A score was devised, incorporating objective parameters that would reflect the likelihood to influence patient outcome. The purpose was to create a new method for evaluating the quality of care the perfusionist provides during CPB procedures and to deduce whether it predicts patient morbidity and mortality. Methods. We analysed 295 consecutive elective patients. We chose 10 parameters: fluid balance, blood transfused, Hct, ACT, PaO2, PaCO2, pH, BE, potassium and CPB time. Distribution analysis was performed using the Shapiro-Wilcoxon test. This made up the PerfSCORE and we tried to find a correlation to mortality rate, patient stay in the ICU and length of mechanical ventilation. Univariate analysis (UA) using linear regression was established for each parameter. Statistical significance was established when p < 0.05. Multivariate analysis (MA) was performed with the same parameters. Results. The mean age was 63.8 ± 12.6 years with 70% males. There were 180 CABG, 88 valves, and 27 combined CABG/valve procedures. The PerfSCORE of 6.6 ± 2.4 (0—20), mortality of 2.7% (8/295), CPB time 100 ± 41 min (19—313), ICU stay 52 ± 62hrs (7—564) and mechanical ventilation of 10.5 ± 14,8hrs (0—564) was calculated. CPB time, fluid balance, PaO2, PerfSCORE and blood transfused were significantly correlated to mortality (UA, p < 0.05). Also, CPB time, blood transfused and PaO2 were parameters predicting mortality (MA, p < 0.01). Only pH was significantly correlated for predicting ICU stay (UA). Ultrafiltration (UF) and CPB time were significantly correlated (UA, p < 0.01) while UF ( p < 0.05) was the only parameter predicting mechanical ventilation duration (MA). Conclusions. CPB time, blood transfused and PaO 2 are independent risk factors of mortality. Fluid balance, blood transfusion, PaO2, PerfSCORE and CPB time are independent parameters for predicting morbidity. PerfSCORE is a quality of perfusion measure that objectively quantifies perfusion performance. Perfusion (2007) 22, 311—316.

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

Since the inception of cardiopulmonary bypass (CPB), little progress has been made concerning the design of cardiotomy suction (CS). Because this is a major source of hemolysis, we decided to test a novel device (Smartsuction [SS]) specifically aimed at minimizing hemolysis during CPB in a clinical setting. Block randomization was carried out on a treated group (SS, n = 28) and a control group (CTRL, n = 26). Biochemical parameters were taken pre-, peri-, and post CPB and were compared between the two groups using the Student's t-test with statistical significance when P

Cardiopulmonary bypass (CPB) remains the key technology for more complex cardiac operations. The perfusion equipment used nowadays has seen tremendous progress since its introduction into clinical practice 50 years ago. However, overall, CPB is still far from perfect. Major haemodilution is not only a problem for red cell-dependent gas transport, but also for the platelet and humeral factor-dependent coagulation, the protein-dependent intravascular oncotic pressure and so forth. Reduction of the priming volume through further miniaturization of CPB equipment is, therefore, the most obvious next step. A systematic approach needs to optimize all CPB components, including pumps, oxygenator/heat exchanger structures, filters, reservoirs, cardiotomy suction, tubings and cannulas. This report provides an update of already commercially available low prime perfusion devices (e.g., the CORx integrated pump-oxygenator) as well as promising prototypes like the smart suction system and the smartcanula.™

During cardiopulmonary bypass (CPB), venous drainage may be impeded due to small vessel and cannula size or chattering, thus, blood return to the heart-lung machine is reduced. We designed a self-expandable prototype cannula, which is able to maintain the vein open and overcome this problem and analysed its performance capability. This prototype and several other cannulae were tested using an access vessel diameter of 7 mm. An in vitro circuit was set up with a 10 mm penrose latex tube simulating the patient’s vein placed between the patient preload reservoir and the cannula, encasing the cannula’s inlet(s). Maximum flow rate was determined for passive venous drainage (PVD) at preloads (P) of 2 and 4 mmHg. We compared these results to three classic single-stage venous cannulae: basket tip, thoracic drain and percutaneous tip. By comparing the other cannulae to the prototype, under PVD conditions and a central venous pressure (CVP) of 2 mmHg, the prototype cannula’s flow rate (1.329 /0.04 L/min) outperformed the basket type (the best performing comparator) (1.029 /0.08 L/min) by 23% (p B /0.005). When the preload was increased to 4 mmHg under PVD conditions, the same trend was noted with the prototype cannula (1.659 /0.05 L/min), outperforming the basket cannula’s value (1.269 /0.05 L/min) by 24% (p B /0.001). This new cannula design provides superior flow characteristics, under all test conditions, compared to the classic single-stage venous cannulae used for paediatric CPB surgery.

PMEA is a hydrophilic polymer coating with a unique design that minimizes the adsorption and denaturation of proteins and blood cells. This study compares thrombus resistance, blood path resistance, thrombocyte profile, and blood trauma of the PMEA coated Capiox membrane oxygenator (Terumo, Japan) vs. an uncoated version. Methods Six calves (mean bodyweight: 75.3±4.5kg) were placed on cardiopulmonary bypass for 6 hours and randomly assigned to the coated or uncoated oxygenator, with a low heparinisation protocol (ACT>180s). Results Macroscopically, red staining was observed in all uncoated oxygenators, and in none of the coated ones. Inlet pressure was significantly higher in the uncoated group (at 1h: 279±25 vs. 175±11mmHg, pConclusions When compared with uncoated oxygenator, PMEA coated oxygenator exhibited increased thrombus resistance with lower inlet pressure and lower thrombocyte consumption. In both groups, trauma to red cells was minimal, emphasizing the efficient design of this type of oxygenator.

Peripheral cannulation for cardiopulmonary bypass (CPB) is of prime interest in minimally invasive open heart surgery. As CPB is initiated with percutaneous cannulae, venous drainage is impeded due to smaller vessel and cannula size. A new cannula was developed which can change shape in situ and therefore may improve venous drainage. An in vitro circuit was set-up with a penrose latex tubing placed between the preload reservoir and the cannula, encasing the cannula's inlet and simulating the vena cava. The preload (P) was stabilised at 2 and at 5mmHg respectively. The maximum flow rate was determined for 4 conditions: passive venous drainage (PVD) and assisted venous drainage (AVD) using a centrifugal pump at the 2 preload settings. We compared the results of the prototype cannula to classical femoral venous cannulae: basket 28Fr, a thoracic 28Fr and a percutaneous 27Fr. Under PVD conditions and a CVP of 2mmHg, the prototype cannula's flow rate outperformed the next best cannula by 14% (p=0.0002) and 13% under AVD conditions (p=0.0001). Under PVD conditions and a CVP of 5mmHg, the prototype cannula outperformed the percutaneous cannula by 19% (p=0.0001) and 14% under AVD conditions (p=0.0002). The new cannula outperforms the classical percutaneous venous cannulae during all of the four conditions tested in vitro.

Despite the progress made in the development of cardiopulmonary bypass (CPB) equipment, systemic anticoagulation with unfractioned heparin and post-bypass neutralization with protamine are still used in most perfusion procedures. However, there are a number of situations where unfractioned heparin, protamine or both cannot be used for various reasons. Intolerance of protamine can be addressed with extracorporeal heparin removal devices, perfusion with (no) low systemic heparinization and, to some degree, by perfusion with alternative anticoagulants. Various alternative anticoagulation regimens have been used in cases of intolerance to unfractioned heparin, including extreme hemodilution, low molecular weight heparins, danaparoid, ancrod, r-hirudin, abciximab, tirofiban, argatoban and others. In the presence of heparin-induced thrombocytopenia (HIT) and thrombosis, the use of r-hirudin appears to be an acceptable solution which has been well studied. The main issue with r-hirudin is the difficulty in monitoring its activity during CPB, despite the fact that ecarin coagulation time assessment is now available. A more recent approach is based on selective blockage of platelet aggregation by means of monoclonal antibodies directed to GPIIb/IIIa receptors (abciximab) or the use of a GPIIb/IIIa inhibitor (tirofiban). An 80% blockage of the GPIIb/IIIa receptors and suppression of platelet aggregation to less than 20% allows the giving of unfractioned heparin and running CPB in a standard fashion despite HIT and thrombosis. Likewise, at the end of the procedure, unfractioned heparin is neutralized with protamine as usual and donor platelets are transfused if necessary. GPIIb/IIIa inhibitors are frequently used in interventional cardiology and, therefore, are available in most hospitals.

Coating of cardiopulmonary bypass circuits may be a solution to prevent adverse effects induced by contact of blood elements with foreign surfaces. Using an animal model, we investigated the Trillium™ coating of cardiopulmonary bypass circuits (a new process involving polyethylene oxide, sulphonate groups and heparin) at low systemic heparinization, focusing on haemolysis and clot formation. Cardiopulmonary bypass was initiated through jugulo-carotid acess with ACT maintained around 180 sec. Treated circuits (Trillium group) were evaluated in 3 calves (mean weight of 66.0±8.7 kg), vs. untreated circuits in 3 control calves (mean weight of 60.7±7.5 kg). Blood samples were drawn at regular intervals for biochemical, hematological and blood gas analyses. After 6 consecutive hours, the animals were weaned from CPB and were awakened. The circuits were analyzed for clot deposits. After 7 days the animals were sacrificed and an autopsy was carried out. Red cell and white cell counts did not change over the 6 hours. Platelet counts dropped to 75.9±7.3% of the baseline value in the Trillium group after 6 hours whereas counts dropped to 57.2±26.0 in the control group (p

Reduction of priming volumes of the cardiopulmonary bypass (CPB) circuit in neonatal cardiac surgery to decrease haemodilution and blood transfusion requirements can be achieved with the use of neonatal low prime oxygenators and smaller diameter tubing. We have further reduced our prime volume with the use of a custom-designed arm allowing for remote positioning of a double-headed roller pump. This arm enables the double pump to be placed alongside the main heart-lung machine close to the operating table, and to position the pump inlet and outlet tubing immediately at the reservoir outlet and oxygenator inlet, respectively, therefore reducing tubing lengths. Priming volumes of four cases using this configuration were compared to four cases using our standard neonatal bypass setup. Results showed a 29% decrease in priming volume and a 58% reduction in blood utilization during CPB. This reduction in priming volume is clinically significant as it lowers the ratio of priming volume to patient blood volume and reduces homologous blood requirements.

Cardiotomy suction is known for its deleterious effects on formed and unformed blood elements. The authors investigated an "intelligent" remote controlled automatic suction system. A suction cannula with an optic sensor at its tip was connected to a special closed cardiotomy reservoir. Contact with blood immediately generated a reservoir vacuum from 0 to -100 mmHg, permitting aspiration until the blood was no longer detected (automatic shut off). Blood trauma was evaluated in a bovine model, comparing the automatic suction system vs standard continuous aspiration (control) adjusted to -100 mmHg. After full systemic heparinization, five calves (weight, 62.5 +/- 4.4 kg) for the automatic suction system group, and four (weight, 62.8 +/- 5.1 kg) for the control group, were equipped with a jugular cannula connected via a roller pump to the cardiotomy reservoir. Through a small thoracotomy, a standardized hole was created in the right atrium, allowing for a blood loss of approximately 400 ml/min. The suction cannula was placed into the chest cavity in a fixed position. Blood samples were drawn at regular intervals for cell count and chemistry. Lactate dehydrogenase values, for the automatic suction system and the control groups, respectively, expressed as percent of baseline value, were 88 +/- 14 vs 116 +/- 22 after 1 hr; 94 +/- 16 vs 123 +/- 23 after 2 hr; and 97 +/- 19 vs 140 +/- 48 after 3 hr (p < 0.05). Values for free hemoglobin in plasma (percent of baseline value), for the automatic suction system and the control groups, respectively, were 102 +/- 18 vs 200 +/- 69 after 1 hr; 98 +/- 29 vs 163 +/- 37 after 2 hr; and 94 +/- 37 vs 179 +/- 42 after 3 hr (p < 0.05). Compared with a standard continuous aspiration system, in situ regulation of suction significantly reduces blood trauma.

Membrane oxygenators have now gained wide acceptance. A new hollow-fibre membrane oxygenator, the Dideco D903 Avant 1.7, with an optimized membrane surface (1.7 m2) and a wavy blood flow pattern, was tested for gas transfer and blood path resistance in a standardized setting with surviving animals. Three calves (mean body weight 63.29 ± 2.9 kg) were connected to cardiopulmonary bypass by jugular venous and carotid arterial cannulation, classic roller pump and the Dideco D903 oxygenator with a mean flow rate of 53 ± 0.1 ml/kg/min for 6 h. After this time, the animals were weaned from the CPB and thereafter from the ventilator. After 7 days, the animals were killed electively. Blood gas analysis was performed before bypass, after mixing (10 min) and then hourly for the 6 h of perfusion. Further samples were taken 30 min (spontaneous breathing) and 60 min after bypass (extubated). Physiological blood gas values could be maintained throughout perfusion in all animals. Mean arterial oxygen saturation varied between 99.3% and 99.7% for the arterial side of the oxygenator compared to 64.6% and 71% for the venous side. The highest mean pressure drop through the oxygenator was 54 mmHg. Postbypass blood gas analysis showed physiological values and no evidence of major lung trauma or pulmonary oedema in relation to the 6 h perfusion. The hollow-fibre membrane oxygenator, Dideco D903, offers excellent gas exchange capabilities and a low pressure drop under experimental conditions, despite reduced membrane surface area. The post mortem examination did not show any deleterious lesion.

Despite an overall improvement in cardiopulmonary bypass (CPB) technology and materials, air emboli still occur. The latest generation membrane oxygenator from Bentley Laboratories, the SpiralGold™, was tested ex vivo for its air handling ability. The study was conducted on four calves. Bolus amounts of air of 10, 15 and 20 cm3 were each injected three times, upstream of the oxygenator and a bubble detector located directly downstream. The amount of bubbles was measured semiquantitatively on a 10 unit scale (U = one semiquantitative unit). The animals were killed 10 days after the CPB. When 10 cm3 of air was injected, no bubbles were detected. With 15 and 20 cm3, respectively, 1 ± 1.5 and 5 ± 3.3 U of bubbles were detected. Despite a total of 135 cm3 of air injected as large bolus amounts, all the animals survived without any obvious neurological deficit secondary to air bubble manipulation. In conclusion, the Spiral Gold™ oxygenator per se can reliably trap an air bolus of up to 10 cm3. This feature should be taken into account when choosing an oxygenator, as it offers an additional barrier to air bubbles in the CPB circuit.

Background: There are no guidelines for the management of patients with cryoglobulins during cardiopulmonary bypass (CPB) necessitating core hypothermia. Objective : To evaluate a simple, pragmatic protocol of in vitro temperature-dependent cryoprecipitation of serum in patients with cryoglobulinemia before elective cardiac surgery with CPB. Methods : A 44-year-old female patient was known for chronic hepatitis C and type III cryoglobulinemia. Elective surgery was planned for an aortic arch aneurysm. A differential serum cryoprecipitation profile was established in vitro prior to surgery. Results: Whereas, at temperatures 5 /158C, cryoglobulin levels were ] /0.112 g/L (normal value B /0.05 g/L), at 208C and above, the precipitate was 5 /0.016 g/L. Accordingly, surgery was performed without any cryoglobulin-related complications at an extracorporeal circulation temperature of 22248C, to minimise the risk of cryoprecipitation. Conclusion : In elective cases of surgery with CPB and hypothermia, temperature-dependent differential serum cryoprecipitation profile may be an easy and efficient way to assess a safe peroperative level of temperature to avoid complications due to cryoglobulins, without enhancing the patient’s tissue ischemia risks. Perfusion (2006) 21, 263 265.

Objectives: Femoral artery cannulation is routinely used in circulatory support scenarios for cardiorespiratory support in patients with acute cardiac and/or pulmonary decompensation. During prolonged perfusion, this may cause acute ischemia of the leg and, in the worst case, even amputation. The aim of this experimental study was to test a newly designed arterial cannula allowing proximal and distal blood flow. Methods: Veno-arterial cardiopulmonary bypass was established in three calves (67.6 ± 5.1 kg). The venous line was secured by cannulation of the external jugular vein. The arterial line of each animal was secured by cannulation of iliac arteries on both legs. On one side, we used a modified SmartCannula (SmartCannula 18Fr 130 mm) and, on the other side, a standard rectilinear BioMedicus cannula system was used, 19 Fr for retrograde and an 8 Fr BioMedicus shunt for anterograde flow toward the leg. An ultrasonic flow probe was used to quantify the perfusion of the distal leg. Results: At 0.5, 1.0, 1.5, and 2.0 l/min, the anterograde leg blood flow increased steadily for each cannula, but remained higher in the self-expanding cannula. That is, the 8 F rectilinear cannula achieved a blood flow of 0.02 ± 0.01, 0.1 ± 0.04, 0.22 ± 0.09, and 0.21 ± 0.02 l/min, respectively, and the 18 F self-expanding cannula achieved 0.06 ± 0.02, 0.15 ± 0.03, 0.24 ± 0.07 and 0.36 ± 0.04 l/min. Conclusion: The modified self-expanding cannula exhibited superior distal arterial flow compared to the routinely used rectilinear shunt system. This has a potential to reduce ischemic events of the inferior extremity in prolonged perfusion.

Background: In an experimental setting, the performance of the LifeBox, a new portable extracorporeal membrane oxygenator (ECMO) system suitable for patient transport, is presented. Standard rectilinear percutaneous cannulae are normally employed for this purpose, but have limited flow and pressure delivery due to their rigid structure. Therefore, we aimed to determine the potential for flow increase by using self-expanding venous cannulae. Methods: Veno-arterial bypass was established in three pigs (40.6±5.1 kg). The venous line of the cardiopulmonary bypass was established by cannulation of the external jugular vein. The arterial side of the circulation was secured by cannulation of the common carotid artery. Two different venous cannulae (SmartCanula 18/36F 430mm and Biomedicus 19F) were examined for their functional integrity when used in conjunction with the centrifugal pump (500-3000 RPM) of the LifeBox system. Results: At 1500, 2000, 2500, and 3000 RPM, the blood flow increased steadily for each cannula, but remained higher in the self-expanding cannula. That is, the 19F rectilinear cannula achieved a blood flow of 0.93±0.14, 1.47±0.37, 1.9±0.68, and 1.5±0.9 l/min, respectively, and the 18/36F self-expanding cannula achieved 1.1±0.1, 1.9±0.33, 2.8±0.39 and 3.66±0.52 l/min. However, when tested for venous line pressure, the standard venous cannula achieved -29±10.7mmHg while the self-expanding cannula achieved -13.6 ±4.3mmHg at 1500 RMP. As the RPM increased from 2500 to 3000, the venous line pressure accounted for −141.9±20 and −98±7.3mmHg for the 19F rectilinear cannula and -30.6±6.4 and -45±11.6mmHg for the self-expanding cannula. Conclusion: The self-expanding cannula exhibited superior venous drainage ability when compared to the performance of the standard rectilinear cannula with the use of the LifeBox. The flow rate achieved was approximately 40% greater than the standard drainage device, with a maximal pump flow recorded at 4.3l/min.

The Admiral, a new microporous membrane oxygenator with a low surface area, decreased priming volume and two separate reservoirs, was tested in 30 adult patients. This study was undertaken to evaluate blood path resistance, gas exchange capabilities and blood trauma in clinical use, with and without shed blood separation. Patients were divided into 3 groups. Group 1 had valve surgery without separation of suction, Group 2 had coronary artery bypass grafting (CABG) with direct blood aspiration and Group 3 had coronary artery bypass grafting with shed blood separation. The suctioned, separated, cardiotomy blood in Group 3 was treated with an autotransfusion device at the end of bypass before being returned to the patient. Theoretical blood flow could be achieved in all cases without problem. The pressure drop through the oxygenator averaged 88 ± 13 mmHg at 4 l/min and 109 ± 12 mmHg at 5 l/min. O2 transfer was 163 ± 27 ml/min. Free plasma haemoglobin rose in all groups, but significantly less in group 3. Lactate dehydrogenase (LDH) rose significantly in Groups 1 and 2. Platelets decreased in all groups without significant differences. Clinical experience with this new oxygenator was safe, the reduced membrane surface did not impair gas exchange and blood trauma could be minimized easily by separating shed blood, using the second cardiotomy reservoir.

BACKGROUND: Recently, a compact cardiopulmonary support (CPS) system designed for quick set-up for example, during emergency cannulation, has been introduced. Traditional rectilinear percutaneous cannulas are standard for remote vascular access with the original design. The present study was designed to assess the potential of performance increase by the introduction of next-generation, self-expanding venous cannulas, which can take advantage of the luminal width of the venous vasculature despite a relatively small access orifice. METHODS: Veno-arterial bypass was established in three bovine experiments (69+/-10 kg). The Lifebridge (Lifebridge GmbH, Munich, Germany) system was connected to the right atrium in a trans-jugular fashion with various venous cannulas; and the oxygenated blood was returned through the carotid artery with a 17 F percutaneous cannula. Two different venous cannulas were studied, and the correlation between the centrifugal pump speed (1500-3900 RPM), flow and the required negative pressure on the venous side was established: (A) Biomedicus 19 F (Medtronic, Tolochenaz, Switzerland); (B) Smart canula 18 F/36 F (Smartcanula LLC, Lausanne, Switzerland). RESULTS: At 1500 RPM, the blood flow was 0.44+/-0.26 l min(-1) for the 19 F rectilinear cannula versus 0.73+/-0.34 l min(-1) for the 18/36 F self-expanding cannula. At 2500 RPM the blood flow was 1.63+/-0.62 l min(-1) for the 19F rectilinear cannula versus 2.13+/-0.34 l min(-1) for the 18/36 F self-expanding cannula. At 3500 RPM, the blood flow was 2.78+/-0.47 l min(-1) for the 19 F rectilinear cannula versus 3.64+/-0.39 l min(-1) for the 18/36 F self-expanding cannula (p

When lung function is compromised, alternative devices need to be deployed in order to maintain blood oxygenation. A new device, NovaLung®, has been designed for acute lung failure. We went about evaluating its gas exchange capability. Three calves (79.5±7.8 kg) were connected to the NovaLung® System with a priming volume of 240 mL, gas exchange surface area of 1.3 m2 and exhibiting a biologically coated surface. A standard battery of blood samples were taken before implantation and over a six hour period. Hematocrit remained stable ranging from 27±4% (baseline) to 29±5% (6 hrs). Platelets were preserved ranging from 882±27.4 U/L (baseline) to 734±147 (6 hrs). LDH remained stable at 719±85 U/L (baseline) vs 686±190 U/L (6 hrs) and the pressure drop was maintained below 20 mmHg. Minimal hemolysis was observed. Oxygen transfer peaked at two hours acute extracorporeal lung support (ECLS) with a mean value of 130±50 ml/min. In conclusion, the device is easy to use, provides adequate O2 and CO2 transfer for partial lung support in an acute setting. Shows minimal signs of hemolysis and platelets levels are maintained throughout the six hour ECLS period.

OBJECTIVE: Transthoracic echocardiography (TTE) has been used clinically to disobstruct venous drainage cannula and to optimise placement of venous cannulae in the vena cava but it has never been used to evaluate performance capabilities. Also, little progress has been made in venous cannula design in order to optimise venous return to the heart lung machine. We designed a self-expandable Smartcanula (SC) and analysed its performance capability using echocardiography. METHODS: An epicardial echocardiography probe was placed over the SC or control cannula (CTRL) and a Doppler image was obtained. Mean (V(m)) and maximum (V(max)) velocities, flow and diameter were obtained. Also, pressure drop (DeltaP(CPB)) was obtained between the central venous pressure and inlet to venous reservoir. LDH and Free Hb were also compared in 30 patients. Comparison was made between the two groups using the student's t-test with statistical significance established when p

Since the initiation of cardiac surgery using cardiopulmonary bypass, little progress has been made concerning the design of catheters for vascular access. However, in the last few years, research in this specialized field has established that catheter performance not only depends on size but also on the catheter's design. The catheter's drainage hole surface area correlates with its performance, i.e., flow; the ratio of the catheter's diameter to the patient's vein diameter also correlates with flow. These findings should influence the design of future models. An example is presented with the development of the Smartcanula which maximizes hole surface area and minimizes the wall thickness in order to optimize flow rate and vascular access to the patient.

Because of the risk of vein collapse, the benefits of using a centrifugal pump to assist venous drainage for cardiopulmonary bypass are limited when the tips of peripheral cannulas are maintained within the vena cava. Using a mock circuit including 20 mm diameter latex tubing to mimic a vena cava, we compared the performance of 6 commercially available peripheral venous cannulas and attempted to determine potential factors influencing maximal flow drainage before vein collapse. A close correlation was observed with the total hole area of the cannula. Best performance (5.10 ′ 0.08 L/min) was obtained with an 8 mm internal diameter (ID) cannula and 343 mm 2 total hole area. A larger cannula (ID 9.2 mm) with only 209 mm 2 total hole area drained 5.03 ′ 0.05 L/min whereas a smaller cannula (ID 6.7 mm) with a total hole area of 586 mm 2 also allowed a similar flow of 5.03 ′ 0.12 L/min. Therefore, the total hole area appears to be a critical factor in designing peripheral cannulas used in restricted chambers such as vena cavae.

Although gravity drainage has been the standard technique for cardiopulmonary bypass (CPB), the development of min imally invasive techniques for cardiac surgery has renewed interest in using vacuum assisted venous drainage (VAVD) Dideco (Mirandola, Italy) has modified the D903 Avant oxygenator to apply a vacuum to its venous reservoir. The impact of VAVD on blood damage with this device is analyzed. Six calves (mean body weight, 71.3 +/- 4.1 kg) were con nected to CPB by jugular venous and carotid arterial cannu lation, with a flow rate of 4-4.51 L/min for 6 h. They were assigned to gravity drainage (standard D903 Avant oxygen ator, n = 3) or VAVD (modified D903 Avant oxygenator, n = 3). The animals were allowed to survive for 7 days. A standard battery of blood samples was taken before bypass, throughout bypass, and 24 h, 48 h, and 7 days after bypass. Analysis of variance was used for repeated measurements. Thrombocyte and white blood cell counts, corrected by hematocrit and normalized by prebypass values, were not significantly different between groups throughout all study periods. The same holds true for hemolytic parameters (lactate dehydrogenase [LDH] and plasma hemoglobin). Both peaked at 24 hr in the standard and VAVD groups: LDH, 2,845 +/- 974 IU/L vs. 2,537 +/- 476 IU/L (p = 0.65), respectively; and plasma hemoglobin, 115 +/- 31 mg/L vs. 89 +/- 455 mg/L (p = 0.45), respectively. In this experimental setup with prolonged perfusion time, VAVD does not increase trauma to blood cells in comparison with standard gravity drainage.

Protamine sulphate is routinely used after cardiopulmonary bypass (CPB) to restore the patient’s baseline coagulatory state. However, adverse reactions are encountered, and alternative means to neutralize heparin are, therefore, necessary. The Heparin Removal Device (HRD) constitutes an extracorporeal circuit that allows ex vivo deheparinization by mean of a polycationic ligand that binds heparin molecules. This paper presents the setup of the HRD circuit. It is illustrated by the report of a 68-year-old man with a known severe crustacean allergy. The patient (78 kg, 170 cm) was admitted for elective coronary artery bypass graft surgery. It was decided that the HRD would be used as a precaution in order to avoid the risks of using protamine sulphate. The CPB time and aortic crossclamp time were 70 and 40 min, respectively. At the end of CPB, the device was inserted and processing started. Activated coagulation time values were monitored over a 130 min period and diminished from 480 to 300 s after 45 min, 220 s after 90 min, and settled at 150 s. Haemostasis was acceptable and processing stopped. The operation was terminated and the patient transferred to the intensive care unit. Clinical evolution was excellent, with minimal postoperative bleeding. The HRD presents an alternative to protamine sulphate when this drug is contraindicated for a certain patient population who might have a suspected, known or emergency adverse reaction.

Right atrial procedures require snaring the venous cannulas to prevent air entrapment in the venous line. In particular situations with complex congenital morphology and/or presence of severe pericardial adhesions the right atrial opening without the inferior vena cava cannula in the surgical field and without dissecting and snaring the inferior vena cava itself, might substantially facilitate the surgical technique, provided an adequate venous drainage is assured to avoid flow reduction or circulatory arrest. In several patients with congenital or acquired heart disease with potentially complicated venous drainage, like extracardiac Fontan procedure and tricuspid valve replacement, cardiopulmonary bypass was conducted either on normothermia (congenital lesions) or with mild hypothermia (acquired disease), with 3 l/min per m 2 flow index and venous drainage through femoral vein cannulation. The right atrium was opened without snaring the inferior vena cava, never provoking reduction of the venous drainage nor air locks in the venous line. This approach substantially enhanced the surgical exposure and therefore facilitated the operative technique without any negative consequence to the patients. Right atrial surgery on cardiopulmonary bypass without direct cannulation and snaring of both superior and inferior vena cava is feasible without flow reduction for surgeons taking care of both congenital and acquired cardiac lesions. q 2004 Elsevier B.V. All rights reserved.

The efficiency of left ventricular assist devices (LVADs) depends on the capacity of the inflow cannula to drain blood into the pump. Left atrial (LA) and left ventricular (LV) sites were compared in an animal model mimicking different hemodynamic conditions. Three calves (56.3+/-5.0 kg) were equipped with a Thoratec LVAD. A regular cardiopulmonary bypass (CPB) circuit was used as a right ventricular assist device (RVAD) (jugular vein/pulmonary artery), and preload conditions were adjusted by storage (or perfusion) of blood into (or from) the venous reservoir. LA and LV drainage, tested separately or simultaneously, was measured by its effect on the LVAD's performance. The LVAD was used alone on a beating heart or together with the RVAD (biVAD) on a beating and on a fibrillating heart. Increasing the central venous pressure (CVP) highlighted the differences between the LA and LV cannulation sites when the LVAD was tested either alone or together with the RVAD (biVAD) on a beating heart. Drainage through the LA or the LV was similar when CVP was set at 8 mm Hg, and increasing CVP to 14 mm Hg allowed for better drainage through the LV cannula. In contrast, after induction of fibrillation to mimic extreme heart failure, the drainage was better through the LA cannula. Using both LA and LV cannulae simultaneously did not improve the LVAD output in any of the conditions tested. LV cannulation provides better blood drainage when used on a normal beating heart and, therefore, allows for increased LVAD performance. However, in severe heart failure, blood drainage through the LV cannula decreases and the LA cannulation site is superior.

The Heparin Removal Device is a deheparinization system that provides a good alternative when adverse reaction to protamine is suspected or when a heparin coated device is employed for cardiopulmonary bypass. In a bovine model, after systemic heparinization with 300 IU/kg body wt, the authors investigated the rate of deheparinization using this plasmapheresis system that allows exposition of heparinized plasma to an immobilized cationic ligand. Blood was shunted through a heparin coated veno-venous circuit to the plasma separator at a flow rate of 500 ml/min (n = 3, body wt 68 +/- 4 kg) or 1,000 ml/min (n = 3, body wt 57 +/- 4 kg). All plasma separators remained patent without any failure of the devices. Blood samples were drawn at regular intervals for coagulation parameters. The evolution of the activated coagulation time (ACT) was measured during the first 60 min of the deheparinization procedure, and results were compared with spontaneous evolution in a control group (n = 3, body wt 73 +/- 5 kg) without reversal of heparinization. After heparin administration, mean ACT was longer than 1,000 sec in the three groups. Fifteen minutes later it was still > 1,000 sec in the control group, whereas it was 427 +/- 8 sec in the slow flow group (500 ml/min) and 340 +/- 26 sec in the high flow group (1,000 ml/min). At 30 min it was 1,000, 367 +/- 26, and 200 +/- 24 sec, respectively, in the three groups. A regression curve was calculated for each group, and areas under the curves were compared. Ex vivo deheparinization was efficient in normalization of ACT, but removal of heparin appeared to be flow rate dependent. Increased blood flow from 500 to 1,000 ml/min across the deheparinization system resulted in significant acceleration of ACT normalization (p < 0.05).

Cannula design is of prime importance for venous drainage during cardiopulmonary bypass (CPB). To evaluate cannulas intended for CPB, an in vitro circuit was set up with silicone tubing between the test cannula encased in a movable preload reservoir and another static reservoir. The pressure-drop (Delta P) value (P-drainage - P-preload) was measured using Millar pressure transducers. Flow rate (Q) was measured using an ultrasound flowmeter. Data display and data recording were controlled using a LabView application, custom made particularly for our experiments. Our results demonstrated that Delta P, Q, and cannula resistance (Delta P/Q) values were significantly decreased when the cannula diameter was increased for Smart and Medtronic cannulas. Smartcanula(R) showed 36% and 43% less resistance compared to Medtronic venous and Medtronic femoral cannulas, respectively. The cannula shape (straight- or curved-tips) did not affect the DLP cannula resistance. Out of five cannulas tested, the Smartcanula(R) outperforms the other commercially available cannulas. The mean (Delta P/Q) values were 3.3 +/- 0.08, 4.07 +/- 0.08, 5.58 +/- 0.10, 5.74 +/- 0.15, and 6.45 +/- 0.15 for Smart, Medtronic, Edwards, Sarns, and Gambro cannulas, respectively (two-way ANOVA, p < 0.0001). In conclusion, the present assay allows discrimination between different forms of cannula with high or low lumen resistance.