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Objectives: The main aim was a systematic evaluation of the current evidence on outcomes for patients undergoing right ventricular assist device (RVAD) implantation following left ventricular assist device (LVAD) implantation. Methods: This systematic review was registered on PROSPERO (CRD42019130131). Reports evaluating in-hospital as well as follow-up outcome in LVAD and LVAD/RVAD implantation were identified through Ovid Medline, Web of Science and EMBASE. The primary endpoint was mortality at the hospital stay and at follow-up. Pooled incidence of defined endpoints was calculated by using random effects models. Results: A total of 35 retrospective studies that included 3260 patients were analyzed. 30 days mortality was in favour of isolated LVAD implantation 6.74% (1.98–11.5%) versus 31.9% (19.78–44.02%) p = 0.001 in LVAD with temporary need for RVAD. During the hospital stay the incidence of major bleeding was 18.7% (18.2–19.4%) versus 40.0% (36.3–48.8%) and stroke rate was 5.6% (5.4–5.8%) versus 20.9% (16.8–28.3%) and was in favour of isolated LVAD implantation. Mortality reported at short-term as well at long-term was 19.66% (CI 15.73–23.59%) and 33.90% (CI 8.84–59.96%) in LVAD respectively versus 45.35% (CI 35.31–55.4%) p ⩽ 0.001 and 48.23% (CI 16.01–80.45%) p = 0.686 in LVAD/RVAD group respectively. Conclusion: Implantation of a temporary RVAD is allied with a worse outcome during the primary hospitalization and at follow-up. Compared to isolated LVAD support, biventricular mechanical circulatory support leads to an elevated mortality and higher incidence of adverse events such as bleeding and stroke. [ABSTRACT FROM AUTHOR]

Objective: The aim was to evaluate the performance of a newly developed magnetically suspended centrifugal pump head intended for use as a ventricular assistance device with a newly developed extracorporeal membrane oxygenator setup. Methods: In an experimental setup, an extracorporeal membrane oxygenator circuit was established in three calves with a mean weight of 68.2 ± 2.0 kg. A magnetically levitated centrifugal pump was tested, along with a newly designed extracorporeal membrane oxygenator console, at three different flow ranges: (a) 0.0 to 5.2 L/min, (b) 0.0 to 7.1 L/min, and (c) 0.0 to 6.0 L/min. For each setup, the animals were supported by a circuit for 6 h. Blood samples were collected just before caridiopulmonary bypass (CPB) after 10 min on bypass and after 1, 2, 5, and 6 h of perfusion for hemolysis determination and biochemical tests. Values were recorded for blood pressure, mean flow, and pump rotational speed. Analysis of variance was used for repeated measurements. Results: Mean pump flows achieved during the three 6 h pump runs for the three pump heads studied were as follows: (a) flow range 0.0 to 5.2 L/min, 3.6 ± 1.5 L/min, (b) flow range 0.0 to 7.1 L/min, 4.9 ± 1.3 L/min, and (c) flow range 0.0 to 6.0 L/min, 3.8 ± 1.5 L/min. Blood trauma, evaluated by plasma hemoglobin and lactate dehydrogenase levels, did not help in detecting any significant hemolysis. Thrombocytes and white blood cell count profiles showed no significant differences between the groups at the end of the 6 h perfusion. At the end of testing, no clot deposition was found in the oxygenator, and there was no evidence of peripheral emboli. Conclusion: The results suggest that the newly developed magnetically suspended centrifugal pump head provides satisfactory hydrodynamic performance in an acute perfusion scenario without increasing hemolysis. [ABSTRACT FROM AUTHOR]

Objective: The present study was designed to assess in vivo a new, optimized, virtually wall-less, dual-lumen, bi-caval cannula for veno-venous ECMO in comparison to a commercially available cannula. Methods: Veno-venous extracorporeal membrane oxygenation (ECMO) was carried out in a bovine study (n=5, bodyweight 75±5kg). Following systemic heparinization, ECMO was established in a trans-jugular fashion through a calibrated 23F orifice, using a new, optimized, virtually wall-less, dual-lumen, bi-caval 24F cannula (Smartcanula LLC, Lausanne, Switzerland) versus a commercially available 23F bi-caval, dual-lumen control cannula (Avalon Elite®, Maquet, Rastatt, Germany) in a veno-venous ECMO setup. Veno-venous ECMO was initiated at 500 revolutions per minute (RPM) and increased by incremental steps of 500 RPM up to 2500 RPM. Catheter outlet pressure, catheter inlet pressure, oxygen saturation and pump flow were recorded at each stage. Results: Mean flow accounted for 0.37±0.04 L/min for wall-less versus 0.29± 0.07 L/min for control at 500 RPM, 0.97±0.12 versus 0.67±0.06 at 1000 RPM, 1.60±0.14 versus 1.16±0.08 at 1500 RPM, 2.31±0.13 versus 1.52±0.13 for 2000 RPM and 3.02±0.5 versus 2.11±0.18 (p<0.004). The mean venous suction required was 19±8 mmHg for wall-less versus 20±3 mmHg for control at 500 RPM, 7±3 versus 9±4 for 1000 RPM, -11±10 versus -12±8 at 1500 RPM, -39±15 versus -49±10 for 2000 RPM and -60±28 versus -94±7 for 2500 RPM. The mean venous injection pressure accounted for 29±7 mmHg for wall-less versus 27±5 mmHg for control at 500 RPM, 50±6 versus 61±7 at 1000 RPM, 89±10 versus 99±17 for 1500 RPM, 142±14 versus 161±9 at 2000 RPM and 211±41 versus 252 ±3 for 2500 RPM. Conclusion: Compared to the commercially available control cannula, the new, optimized, virtually wall-less, dual-lumen, bi-caval 24F cannula allows for significantly higher blood flows, requires less suction and results in lower injection pressures in vivo. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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, PaO[sub2], PaCO[sub2], 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[sub2] are independent risk factors of mortality. Fluid balance, blood transfusion, PaO[sub2], PerfSCORE and CPB time are independent parameters for predicting morbidity. PerfSCORE is a quality of perfusion measure that objectively quantifies perfusion performance. [ABSTRACT FROM AUTHOR]

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[sup TM]. [ABSTRACT FROM AUTHOR]

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 (1.32 ± 0.04 L/min) outperformed the basket type (the best performing comparator) (1.02 ± 0.08 L/min) by 23% (p < 0.005). When the preload was increased to 4 mmHg under PVD conditions, the same trend was noted with the prototype cannula (1.65 ± 0.05 L/min), outperforming the basket cannula's value (1.26 ± 0.05 L/min) by 24% (p < 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. [ABSTRACT FROM AUTHOR]

During off-pump coronary artery bypass grafting (OPCAB) which allows complete revascularization through a median sternotomy, revascularization of the lateral and posterior walls requires the verticalization of the heart, which may cause haemodynamic disturbance. This concern has stimulated the development of circulatory support with mini-pumps. Initially, these pumps were designed for the right side of the heart, which was found to be the main contributor to haemodynamic instability under experimental conditions. The three types of mini-pumps that have been developed so far - two for the right side of the heart and one for both sides - are reviewed as well as a new concept of integrated cardiopulmonary bypass (CPB) circuit with reduced surface and priming volume. However, with increasing experience and improved methods of exposition, OPCAB has become a procedure that can be performed without support in the majority of the cases. Nevertheless, the concept of miniaturization and the possibility to insert these devices through a peripheral access has opened the way to new indications, mainly short-term circulatory support for acute heart failure. This development is welcome in a field where available devices are invasive and plagued with a heavy morbidity. [ABSTRACT FROM AUTHOR]

Off-pump coronary artery bypass (OPCAB) requires heart manipulation during exposure of the lateral and posterior walls of the heart, which may cause hemodynamic instability, mainly through right ventricular dysfunction. A coaxial atrial cannula connected to a minicentrifugal pump was developed to bypass the right heart. This study was designed to test the hemocompatibility of this pump ongoing for 6 h. In five calves (bodyweight, 70.3 ± 4.2 kg), the pump was inserted and set to its maximal motor speed of 7000 rpm. Blood samples were taken for blood gas analyses, hematology and chemistry on an hourly basis. ANOVA was used for statistical analysis. During the 6-h run, hematocrit and red blood cell count were stable (p = 0.77 and 0.87, respectively). Platelet count was not significantly altered (p = 0.55). LDH was stable (p = 0.61) and plasma free hemoglobin remained below 100 mg/l throughout the experiment. Adequate tissue perfusion was maintained as reflected by the stable mixed venous oxygen saturation (baseline, 72.5 ± 2%, and 6 h, 65.6 ± 3.4%) and no defect of any pump system was detected during this 6-h testing. This right heart minipump appears to have a minimal impact on red cells and platelets when set at its maximal speed for 6 h, underlining the hematological safety of the system. [ABSTRACT FROM AUTHOR]

Heparin surface coating is a convenient means of improving the thrombo resistance of blood-exposed surfaces. At this time, heparin can be bonded to oxygenator/heat-exchanger structures, soft venous reservoirs, cardiotomy reservoirs, centrifugal pump heads, tubings, and cannulae. Following experimental evaluation, these devices have become available for clinical application. Cardiopulmonary bypass with low or no systemic heparinization can be realized in selected cases. Improved haemostasis in combination with modification of standard surgical techniques results in limited blood loss and reduced transfusion requirements and appears to be the main benefit of cardiopulmonary bypass with heparin-bonded surfaces. Experience using heparin- bonded equipment in various clinical situations is reviewed. [ABSTRACT FROM PUBLISHER]

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. [ABSTRACT FROM AUTHOR]