Prevention and treatment of pulmonary congestion in patients undergoing venoarterial extracorporeal membrane oxygenation for cardiogenic shock.
Cardiogenic shock is still a major driver of mortality on intensive care units and complicates ∼10% of acute coronary syndromes with contemporary mortality rates up to 50%. In the meantime, percutaneous circulatory support devices, in particular venoarterial extracorporeal membrane oxygenation (VA-ECMO), have emerged as an established salvage intervention for patients in cardiogenic shock. Venoarterial extracorporeal membrane oxygenation provides temporary circulatory support until other treatments are effective and enables recovery or serves as a bridge to ventricular assist devices, heart transplantation, or decision-making. In this critical care perspective, we provide a concise overview of VA-ECMO utilization in cardiogenic shock, considering rationale, critical care management, as well as weaning aspects. We supplement previous literature by focusing on therapeutic issues related to the vicious circle of retrograde aortic VA-ECMO flow, increased left ventricular (LV) afterload, insufficient LV unloading, and severe pulmonary congestion limiting prognosis in a relevant proportion of patients receiving VA-ECMO treatment. We will outline different modifications in percutaneous mechanical circulatory support to meet this challenge. Besides a strategy of running ECMO at lowest possible flow rates, novel therapeutic options including the combination of VA-ECMO with percutaneous microaxial pumps or implementation of a venoarteriovenous-ECMO configuration based on an additional venous cannula supplying towards pulmonary circulation are most promising among LV unloading and venting strategies. The latter may even combine the advantages of venovenous and venoarterial ECMO therapy, providing potent respiratory and circulatory support at the same time. However, whether VA-ECMO can reduce mortality has to be evaluated in the urgently needed, ongoing prospective randomized studies EURO-SHOCK (NCT03813134), ANCHOR (NCT04184635), and ECLS-SHOCK (NCT03637205). These studies will provide the opportunity to investigate indication, mode, and effect of LV unloading in dedicated sub-analyses. In future, the Heart Teams should aim at conducting a dedicated randomized trial comparing VA-ECMO support with vs. without LV unloading strategies in patients with cardiogenic shock.
Lüsebrink E
，Orban M
，Kupka D
，Scherer C
，Hagl C
，Zimmer S
，Luedike P
，Thiele H
，Westermann D
，Massberg S
，Schäfer A
，Orban M
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Extracorporeal Membrane Oxygenation for Cardiac Indications in Adults: A Health Technology Assessment.
Extracorporeal membrane oxygenation (ECMO) is a rescue therapy used to stabilize patients with hemodynamic compromise such as refractory cardiogenic shock or cardiac arrest. When used for cardiac arrest, ECMO is also known as extracorporeal cardiopulmonary resuscitation (ECPR). We conducted a health technology assessment of venoarterial ECMO for adults (aged ≥ 18 years) with cardiac arrest refractory to conventional cardiopulmonary resuscitation (CPR) or with cardiogenic shock refractory to conventional medical management (i.e., drugs, mechanical support such as intra-aortic balloon pump and temporary ventricular assist devices). Our assessment included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding ECMO for these indications, and patient preferences and values.
We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Systematic Reviews (ROBIS) tool for systematic reviews and the Risk of Bias Among Nonrandomized Trials (ROBINS-I) tool for observational studies, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis with a lifetime horizon from a public payer perspective. We also analyzed the budget impact of publicly funding ECMO in Ontario for patients with refractory cardiogenic shock or cardiac arrest. To contextualize the potential value of ECMO for cardiac indications, we spoke with patients and caregivers with direct experience with the procedure.
We included one systematic review (with 13 observational studies) and two additional observational studies in the clinical review. Compared with traditional CPR for patients with refractory cardiac arrest, ECPR was associated with significantly improved 30-day survival (pooled risk ratio [RR] 1.54; 95% CI 1.03 to 2.30) (GRADE: Very Low) and significantly improved long-term survival (pooled RR 2.17; 95% CI 1.37 to 3.44) (GRADE: Low). Overall, ECPR was associated with significantly improved 30-day favourable neurological outcome in patients with refractory cardiac arrest compared with traditional CPR; pooled RR 2.02 (95% CI 1.29 to 3.16) (GRADE: Very Low). For patients with cardiogenic shock, ECMO was associated with a significant improvement in 30-day survival compared with intra-aortic balloon pump (pooled RR 2.11; 95% CI 1.23 to 3.61) (GRADE: Very Low). Compared with temporary percutaneous ventricular assist devices, ECMO was not associated with improved survival (pooled risk ratio 0.94; 95% CI 0.67 to 1.30) (GRADE: Very Low).We estimated the incremental cost-effectiveness ratio of ECPR compared with conventional CPR is $18,722 and $28,792 per life-year gained (LYG) for in-hospital and out-of-hospital cardiac arrest, respectively. We estimated the probability of ECPR being cost-effective versus conventional CPR is 93% and 60% at a willingness-to-pay of $50,000 per LYG for in-hospital and out-of-hospital cardiac arrest, respectively. We estimate that publicly funding ECMO in Ontario over the next 5 years would result in additional total costs of $1,673,811 for cardiogenic shock (treating 314 people), $2,195,517 for in-hospital cardiac arrest (treating 126 people), and $3,762,117 for out-of-hospital cardiac arrest (treating 247 people).The eight patients and family members with whom we spoke had limited ability to assess the impact of ECMO or report their impressions because of their critical medical situations when they encountered the procedure. All had been in hospital with acute hemodynamic instability. In the decision to receive the procedure, participants generally relied on the expertise and judgment of physicians.
For adults treated for refractory cardiac arrest, ECPR may improve survival and likely improves long-term neurological outcomes compared with conventional cardiopulmonary resuscitation. For patients treated for cardiogenic shock, ECMO may improve 30-day survival compared with intra-aortic balloon pump, but there is considerable uncertainty.For adults with refractory cardiac arrest, ECPR may be cost-effective compared with conventional CPR. We estimate that publicly funding ECMO for people with cardiac arrest and cardiogenic shock in Ontario over the next 5 years would cost about $845,000 to $2.2 million per year.People with experience of ECMO for cardiac indications viewed it as a life-saving device and expressed gratitude that it was available and able to help stabilize their acute medical condition.
Ontario Health (Quality)
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Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYP
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is widely used to support the most severe forms of cardiogenic shock (CS). Nevertheless, despite extracorporeal membrane oxygenation (ECMO) use, mortality still remains high (50%). Moderate hypothermia (MH) (33°C-34°C) may improve cardiac performance and decrease ischaemia-reperfusion injuries. The use of MH during VA-ECMO is strongly supported by experimental and preliminary clinical data.
The Hypothermia-Extracorporeal Membrane Oxygenation (HYPO-ECMO) study is a multicentre, prospective, controlled randomised trial between an MH group (33°C≤T°C≤34°C) and normothermia group (36°C≤T°C≤37°C). The primary endpoint is all-cause mortality at day 30 following randomisation. The study will also assess as secondary endpoints the effects of targeted temperature management strategies on (1) mortality rate at different time points, (2) organ failure and supportive treatment use and (3) safety. All intubated adults with refractory CS supported with VA-ECMO will be screened. Exclusion criteria are patients having undergone cardiac surgery for heart transplantation or left or biventricular assist device implantation, acute poisoning with cardiotoxic drugs, pregnancy, uncontrolled bleeding and refractory cardiac arrest.Three-hundred and thirty-four patients will be randomised and followed up to 6 months to detect a 15% difference in mortality. Data analysis will be intention to treat. The differences between the two study groups in the risk of all-cause mortality at day 30 following randomisation will be studied using logistic regression analysis adjusted for postcardiotomy setting, prior cardiac arrest, prior myocardial infarction, age, vasopressor dose, Sepsis-related Organ Failure Assessment (SOFA) score and lactate at randomisation.
Ethics approval has been granted by the Comité de Protection des Personnes Est III Ethics Committee. The trial has been approved by the French Health Authorities (Agence Nationale de la Sécurité du Médicament et des Produits de Santé). Dissemination of results will be performed via journal articles and presentations at national and international conferences. Since this study is also the first step in the constitution of an 'ECMO Trials Group', its results will also be disseminated by the aforementioned group.
NCT02754193.
Jacquot A
，Lepage X
，Merckle L
，Girerd N
，Levy B
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《BMJ Open》
ResearchGate
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