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In the developed world, extreme prematurity is the leading cause of neonatal mortality and morbidity due to a combination of organ immaturity and iatrogenic injury. Until now, efforts to extend gestation using extracorporeal systems have achieved limited success. Here we report the development of a system that incorporates a pumpless oxygenator circuit connected to the fetus of a lamb via an umbilical cord interface that is maintained within a closed ‘amniotic fluid’ circuit that closely reproduces the environment of the womb. We show that fetal lambs that are developmentally equivalent to the extreme premature human infant can be physiologically supported in this extra-uterine device for up to 4 weeks. Lambs on support maintain stable haemodynamics, have normal blood gas and oxygenation parameters and maintain patency of the fetal circulation. With appropriate nutritional support, lambs on the system demonstrate normal somatic growth, lung maturation and brain growth and myelination. The ability to support the development of a premature fetus in the form of an extracorporeal system has had limited success. Here, the authors show that an extra-uterine device that mimics the intra-uterine environment can provide physiologic support for the extreme premature lamb fetus for four weeks.

BackgroundRecent trends on outcomes in cardiogenic shock (CS) complicating acute myocardial infarction (AMI) suggest improvements in early survival. However, with the ever-changing landscape in management of CS, we sought to identify age-based trends in these outcomes and mechanical circulatory support (MCS) use among patients with both AMI and non-AMI associated shock.MethodsWe queried the 2005–2014 Nationwide Inpatient Sample databases to identify patients with a diagnosis of cardiogenic shock. Trends in the incidence of hospital-mortality, and use of MCS such as intra-aortic balloon pump (IABP), Impella/TandemHeart (IMP), and extra corporeal membrane oxygenation (ECMO) were analyzed within the overall population and among different age-categories (50 and under, 51–65, 66–80 and 81–99 years). We also made comparisons between patient groups admitted with CS complicating AMI and those with non-AMI associated CS.ResultsWe studied 144,254 cases of CS, of which 55.4% cases were associated with an AMI. Between 2005 and 2014, an overall decline in IABP use (29.8–17.7%; ptrend < 0.01), and an uptrend in IMP use (0.1–2.6%; ptrend < 0.01), ECMO use (0.3–1.8%; ptrend < 0.01) and in-hospital mortality (44.1–52.5% AMI related, 49.6–53.5% non-AMI related; ptrend < 0.01) was seen. Patients aged 81–99 years had the lowest rate of MCS use (14.8%), whereas those aged 51–65 years had highest rate of MCS use (32.3%). Multivariable analysis revealed that patients aged 51-65 years (aOR 1.46, 95% CI 1.40–1.52; p<0.001), 66–80 years (aOR 2.51, 95% CI 2.39–2.63; p<0.01) and 81–99 years (aOR 5.04, 95% CI 4.78–5.32; p<0.01) had significantly higher hospital mortality compared to patients aged ≤ 50 years. Patients admitted with CS complicating AMI were older and had more comorbidities, but lower hospital mortality (45.0 vs. 48.2%; p < 0.001) when compared to non-AMI related CS. We also noted that the proportion of patients admitted with CS complicating AMI significantly decreased from 2005 to 2014 (65.3–45.6%; ptrend < 0.01) whereas those admitted without an associated AMI increased.ConclusionsIABP use has declined whereas IMP and ECMO use has increased over time among CS admissions. Older age was associated with an incrementally higher independent risk for hospital mortality. Recent trends indicate an increase in both proportion of patients admitted with CS without associated AMI and in-hospital mortality across all CS admissions irrespective of AMI status.

Venovenous (VV) and venoarterial (VA) extracorporeal membrane oxygenation (ECMO) are effective support modalities to treat critically ill patients. ECMO-associated hemolysis remains a serious complication. The aim was to disclose similarities and differences in VA- and VV ECMO-associated hemolysis. This is a retrospective single-center analysis (January 2012 to September 2018) including 1,063 adult consecutive patients (VA, n = 606; VV, n = 457). Severe hemolysis (free plasma hemoglobin, fHb > 500 mg/l) during therapy occurred in 4% (VA) and 2% (VV) (p≤0.001). VV ECMO showed significantly more hemolysis by pump head thrombosis (PHT) compared to VA ECMO (9% vs. 2%; p≤0.001). Pretreatments (ECPR, cardiac surgery) of patients who required VA ECMO caused high fHb pre levels which aggravates the proof of ECMO-induced hemolysis (median (interquartile range), VA: fHb pre: 225.0 (89.3-458.0); VV: fHb pre: 72.0 (42.0-138.0); p≤0.001). The survival rate to discharge from hospital differed depending on ECMO type (40% (VA) vs. 63% (VV); p≤0.001). Hemolysis was dominant in VA ECMO patients, mainly caused by different indications and not by the ECMO support itself. PHT was the most severe form of ECMO-induced hemolysis that occurs in both therapies with low frequency, but more commonly in VV ECMO due to prolonged support time.

Purpose Extracorporeal membrane oxygenation (ECMO) is a rescue therapy for patients with acute respiratory distress syndrome (ARDS). The aim of this study was to evaluate associations between ventilatory settings during ECMO for refractory hypoxemia and outcome in ARDS patients. Methods In this individual patient data meta-analysis of observational studies in adult ARDS patients receiving ECMO for refractory hypoxemia, a time-dependent frailty model was used to determine which ventilator settings in the first 3 days of ECMO had an independent association with in-hospital mortality. Results Nine studies including 545 patients were included. Initiation of ECMO was accompanied by significant decreases in tidal volume size, positive end-expiratory pressure (PEEP), plateau pressure, and driving pressure (plateau pressure − PEEP) levels, and respiratory rate and minute ventilation, and resulted in higher PaO 2 /FiO 2 , higher arterial pH and lower PaCO 2 levels. Higher age, male gender and lower body mass index were independently associated with mortality. Driving pressure was the only ventilatory parameter during ECMO that showed an independent association with in-hospital mortality [adjusted HR, 1.06 (95 % CI, 1.03–1.10)]. Conclusion In this series of ARDS patients receiving ECMO for refractory hypoxemia, driving pressure during ECMO was the only ventilator setting that showed an independent association with in-hospital mortality.

Background Veno-venous extracorporeal membrane oxygenation (VV ECMO) has become standard of care in patients with the most severe forms of acute respiratory distress syndrome. However, hemolysis and bleeding are one of the most frequent side effects, affecting mortality. Despite the widespread use of VV ECMO, current protocols lack detailed, in-vivo data-based recommendations for safe ECMO pump operating conditions. This study aims to comprehensively analyze the impact of VV ECMO pump operating conditions on hemolysis by combining in-silico modeling and clinical data analysis. Methods We combined data from 580 patients treated with VV ECMO in conjunction with numerical predictions of hemolysis using computational fluid dynamics and reduced order modeling of the Rotaflow (Getinge) and DP3 (Xenios) pumps. Blood trauma parameters across 94,779 pump operating points were associated with numerical predictions of shear induced hemolysis. Results Minimal hemolysis was observed at low pump pressures and low circuit resistance across all flow rates, whereas high pump pressures and circuit resistance consistently precipitated substantial hemolysis, irrespective of flow rate. However, the lower the flow rate, the more pronounced the influence of circuit resistance on hemolysis became. Numerical models validated against clinical data demonstrated a strong association (Spearman’s r = 0.8) between simulated and observed hemolysis, irrespective of the pump type. Conclusions Integrating in-silico predictions with clinical data provided a novel approach in understanding and potentially reducing blood trauma in VV ECMO. This study further demonstrated that a key factor in lowering side effects of ECMO support is the maintenance of low circuit resistance, including oxygenators with the lowest possible resistance, the shortest feasible circuit tubing, and cannulae with an optimal diameter.

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) stabilizes patients in refractory cardiogenic shock. However, ECMO-related complications strongly affect the outcome, especially if a long-term LVAD is needed. We describe a new strategy in management of INTERMACS 1 patients consisting in early weaning from VA-ECMO with axillary Impella 5.0 as a bridge to LVAD implantation. Nine patients in two European centres are described. All patients were implanted with VA-ECMO for initial hemodynamic and metabolic stabilization. After a median time of 8 days, Impella 5.0 was implanted. Impella support allowed in all patients weaning from inotropes and from VA-ECMO (after a median time of 22 h). No patients had right ventricular failure after ECMO-weaning and most patients were mobilized and orally fed (88.9%) during Impella support. All patient underwent LVAD implantation after a median Impella time of 17 days. Only one patient had right-ventricular failure after LVAD implantation. All patients were discharged from hospital after a median time of 40 days. Early weaning from VA-ECMO with Impella 5.0 as a bridge to LVAD is a safe and effective strategy in management of INTERMACS 1 patients. This approach minimizes ECMO-related complications and allows patient mobilization and right ventricular function optimization before LVAD implantation. •Early weaning from VA-ECMO with Impella 5.0 is a safe and effective strategy for INTERMACS 1 patients•This approach minimizes ECMO-related complications•This approach allows patient mobilization•This approach allows evaluation of right ventricular function and optimization before LVAD implantation

Thrombus formation in extracorporeal membrane oxygenation (ECMO) remains a major concern as it can lead to fatal outcomes. To the best of our knowledge, there is no standard non-invasive method for quantitatively measuring thrombi. This study’s purpose was to verify thrombus detection in an ECMO circuit using novel, non-invasive ultrasonic sensors in real-time, utilizing the fact that the ultrasonic velocity in a thrombus is known to be higher than that in the blood. Ultrasonic sensors with a customized chamber, an ultrasonic pulse-receiver, and a digital storage oscilloscope (DSO) were used to set up the measuring unit. The customized chamber was connected to an ECMO circuit primed with porcine blood. Thrombi formed from static porcine blood were placed in the circuit and ultrasonic signals were extracted from the oscilloscope at various ECMO flow rates of 1–4 L/min. The ultrasonic signal changes were successfully detected at each flow rate on the DSO. The ultrasonic pulse signal shifted leftward when a thrombus passed between the two ultrasonic sensors and was easily detected on the DSO screen. This novel real-time non-invasive thrombus detection method may enable the early detection of floating thrombi in the ECMO system and early management of ECMO thrombi.

Acute myocardial infarction-related cardiogenic shock (AMI-CS) is a severe, life-threatening condition characterised by inadequate tissue perfusion due to the heart’s inability to pump blood effectively. The pathophysiology of AMI-CS usually arises from the sudden loss of myocardial contractility, leading to a decrease in cardiac output and systemic hypoperfusion. In approximately 90% of AMI-CS cases, the left ventricle is the primary site of dysfunction.Despite early recognition and the implementation of strategies such as primary percutaneous coronary intervention, the mortality rate associated with AMI-CS remains alarmingly high, reflecting significant unmet clinical needs. A major challenge lies in identifying the optimal patient population for mechanical circulatory support (MCS) devices, as these interventions are costly and can lead to serious complications.This review provides a comprehensive overview of the pathophysiological mechanisms underlying AMI-CS, explores the current range of MCS devices available and offers an in-depth discussion on the balance of benefits and risks associated with these devices. By highlighting key evidence from recent studies, we aim to shed light on the clinical decision-making process and improve outcomes in this high-risk patient population.

Introduction Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary mechanical circulatory support device capable of providing robust cardiopulmonary support for days to weeks, most commonly in the setting of refractory cardiogenic shock or cardiac arrest as a bridge to recovery or heart replacement therapies (HRT, e.g., durable left ventricular assist device or cardiac transplantation) [1]. Considerations prior to weaning VA-ECMO supports circulation while treatment of the underlying pathology is prioritized to facilitate successful weaning or bridge to HRT. Because the potential for ventricular recovery is often difficult to ascertain, we advocate that all patients where HRT is a realistic consideration undergo early evaluation even if the intended goal is recovery [2,3,4,5]. ABG, lactate, and a full set of invasive hemodynamics are obtained at this new flow rate to detect any impact on hemodynamics, tissue perfusion, or respiratory status [7]. Because a subset of patients who tolerate reduced support transiently are unable to tolerate the decreased support over a prolonged duration, lower flow rates are maintained for a minimum of 8 h prior to further weaning attempts.

Key Points Cardiogenic shock is characterized by acute hypoperfusion and end-organ dysfunction owing to reduced cardiac output, and is commonly caused by acute myocardial infarction (AMI) with left ventricular dysfunction Emergent revascularization is the only therapy that has been shown to reduce mortality in patients with cardiogenic shock complicating AMI Refractory cardiogenic shock can be defined as ongoing evidence of tissue hypoperfusion despite administration of adequate doses of two vasoactive medications and treatment of the underlying aetiology Refractory cardiogenic shock carries a poor prognosis, with an inhospital mortality of ∼50% despite pharmacological and mechanical circulatory support The use of mechanical circulatory support devices for cardiogenic shock is increasing, but there is currently no evidence showing that they improve clinical outcomes Novel therapeutics and robust randomized trial data are needed to address the persistently high mortality in patients with refractory cardiogenic shock Refractory cardiogenic shock carries a poor prognosis, with an inhospital mortality of ∼50%. In this Review, Reyentovich and colleagues discuss the current therapeutic and management options available for patients with refractory cardiogenic shock. Cardiogenic shock is a life-threatening condition that occurs in response to reduced cardiac output in the presence of adequate intravascular volume and results in tissue hypoxia. Cardiogenic shock has several underlying aetiologies, with the most common being acute myocardial infarction (AMI). Refractory cardiogenic shock presents as persistent tissue hypoperfusion despite administration of adequate doses of two vasoactive medications and treatment of the underlying aetiology. Investigators of the SHOCK trial reported a long-term mortality benefit of emergency revascularization for shock complicating AMI. Since the publication of the SHOCK trial and subsequent guideline recommendations, the increase in community-based use of percutaneous coronary intervention for this condition has resulted in a significant decline in mortality. Despite these successes in the past 15 years, mortality still remains exceptionally high, particularly in patients with refractory cardiogenic shock. In this Review, we discuss the aetiology and pathophysiology of cardiogenic shock and summarize the data on the available therapeutics and their limitations. Although new mechanical circulatory support devices have been shown to improve haemodynamic variables in patients with shock complicating AMI, they did not improve clinical outcomes and are associated with high costs and complications.