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) (HYPO-ECMO study)

IntroductionVenoarterial 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.Methods and analysisThe 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 and disseminationEthics 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.Trial registration numberNCT 02754193.

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Biventricular Unloading with Impella and Venoarterial Extracorporeal Membrane Oxygenation in Severe Refractory Cardiogenic Shock: Implications from the Combined Use of the Devices and Prognostic Risk Factors of Survival

Journal of Clinical Medicine ◽

10.3390/jcm10040747 ◽

2021 ◽

Vol 10 (4) ◽

pp. 747

Author(s):

Georgios Chatzis ◽

Styliani Syntila ◽

Birgit Markus ◽

Holger Ahrens ◽

Nikolaos Patsalis ◽

...

Keyword(s):

Risk Factors ◽

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Risk Scores ◽

Circulatory Support ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation ◽

Refractory Cardiogenic Shock ◽

Lactate Levels ◽

Va Ecmo

Since mechanical circulatory support (MCS) devices have become integral component in the therapy of refractory cardiogenic shock (RCS), we identified 67 patients in biventricular support with Impella and venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO) for RCS between February 2013 and December 2019 and evaluated the risk factors of mortality in this setting. Mean age was 61.07 ± 10.7 and 54 (80.6%) patients were male. Main cause of RCS was acute myocardial infarction (AMI) (74.6%), while 44 (65.7%) were resuscitated prior to admission. The mean Simplified Acute Physiology Score II (SAPS II) and Sequential Organ Failure Assessment Score (SOFA) score on admission was 73.54 ± 16.03 and 12.25 ± 2.71, respectively, corresponding to an expected mortality of higher than 80%. Vasopressor doses and lactate levels were significantly decreased within 72 h on biventricular support (p < 0.05 for both). Overall, 17 (25.4%) patients were discharged to cardiac rehabilitation and 5 patients (7.5%) were bridged successfully to ventricular assist device implantation, leading to a total of 32.8% survival on hospital discharge. The 6-month survival was 31.3%. Lactate > 6 mmol/L, vasoactive score > 100 and pH < 7.26 on initiation of biventricular support, as well as Charlson comorbity index > 3 and prior resuscitation were independent predictors of survival. In conclusion, biventricular support with Impella and VA-ECMO in patients with RCS is feasible and efficient leading to a better survival than predicted through traditional risk scores, mainly via significant hemodynamic improvement and reduction in lactate levels.

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Use of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO) in an Adult Patient with Septic and Cardiogenic Shock

Cardiovascular Surgery ◽

10.1007/978-3-319-57084-6_28 ◽

2018 ◽

pp. 325-339

Author(s):

Henrique Louzan Machado ◽

Leonardo Jadyr Silva Rodrigues Alves ◽

Helmgton José Brito de Souza

Keyword(s):

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Adult Patient ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation ◽

Va Ecmo

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Efficacy of left ventricular unloading strategies during venoarterial extracorporeal membrane oxygenation in patients with cardiogenic shock: a protocol for a systematic review and Bayesian network meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-047046 ◽

2021 ◽

Vol 11 (10) ◽

pp. e047046

Author(s):

Pengbin Zhang ◽

Shilin Wei ◽

Kerong Zhai ◽

Jian Huang ◽

Xingdong Cheng ◽

...

Keyword(s):

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Bayesian Network ◽

Meta Analysis ◽

Left Ventricular ◽

Cochrane Library ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation ◽

Patient Consent ◽

Va Ecmo

IntroductionVenoarterial extracorporeal membrane oxygenation (VA-ECMO) has been widely used for patients with refractory cardiogenic shock. A common side effect of this technic is the resultant increase in left ventricular (LV) afterload which could potentially aggravate myocardial ischaemia, delay ventricular recovery and increase the risk of pulmonary congestion. Several LV unloading strategies have been proposed and implemented to mitigate these complications. However, it is still indistinct that which one is the best choice for clinical application. This Bayesian network meta-analysis (NMA) aims to compare the efficacy of different LV unloading strategies during VA-ECMO.Methods and analysisPubMed, Embase, the Cochrane Library and the International Clinical Trials Registry Platform will be explored from their inception to 31 December 2020. Random controlled trials and cohort studies that compared different LV unloading strategies during VA-ECMO will be included in this study. The primary outcome will be in-hospital mortality. The secondary outcomes will include neurological complications, haemolysis, bleeding, limb ischaemia, renal failure, gastrointestinal complications, sepsis, duration of mechanical ventilation, length of intensive care unit and hospital stays. Pairwise and NMA will respectively be conducted using Stata (V.16, StataCorp) and Aggregate Data Drug Information System (V.1.16.5), and the cumulative probability will be used to rank the included LV unloading strategies. The risk of bias will be conducted using the Cochrane Collaboration’s tool or Newcastle-Ottawa Quality Assessment Scale according to their study design. Subgroup analysis, sensitivity analysis and publication bias assessment will be performed. The Grading of Recommendations Assessment, Development and Evaluation will be conducted to explore the quality of evidence.Ethics and disseminationEither ethics approval or patient consent is not necessary, because this study will be based on literature. The results will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration numberCRD42020165093.

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Cost-utility of venoarterial extracorporeal membrane oxygenation in cardiogenic shock and cardiac arrest

European Heart Journal Acute Cardiovascular Care ◽

10.1177/2048872619900090 ◽

2020 ◽

Vol 9 (4) ◽

pp. 333-341

Author(s):

Salla Jäämaa-Holmberg ◽

Birgitta Salmela ◽

Raili Suojaranta ◽

Karl B Lemström ◽

Jyri Lommi

Keyword(s):

Cardiac Arrest ◽

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Cost Utility ◽

Quality Adjusted Life Years ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation ◽

Life Years ◽

The Cost ◽

Quality Adjusted Life

Background: The use of venoarterial extracorporeal membrane oxygenation in cardiogenic shock keeps increasing, but its cost-utility is unknown. Methods: We studied retrospectively the cost-utility of venoarterial extracorporeal membrane oxygenation in a five-year cohort of consequent patients treated due to refractory cardiogenic shock or cardiac arrest in a transplant centre in 2013–2017. In our centre, venoarterial extracorporeal membrane oxygenation is considered for all cardiogenic shock patients potentially eligible for heart transplantation, and for selected postcardiotomy patients. We assessed the costs of the index hospitalization and of the one-year hospital costs, and the patients’ health-related quality of life (response rate 71.7%). Based on the data and the population-based life expectancies, we calculated the amount and the costs of quality-adjusted life years gained both without discount and with an annual discount of 3.5%. Results: The cohort included 102 patients (78 cardiogenic shock; 24 cardiac arrest) of whom 67 (65.7%) survived to discharge and 66 (64.7%) to one year. The effective costs per one hospital survivor were 242,303€. Median in-hospital costs of the index hospitalization per patient were 129,967€ (interquartile range 150,340€). Mean predicted number of quality-adjusted life years gained by the treatment was 20.9 (standard deviation 9.7) without discount, and the median cost per quality-adjusted life year was 7474€ (interquartile range 10,973€). With the annual discount of 3.5%, 13.0 (standard deviation 4.8) quality-adjusted life years were gained with the cost of 12,642€ per quality-adjusted life year (interquartile range 15,059€). Conclusions: We found the use of venoarterial extracorporeal membrane oxygenation in refractory cardiogenic shock and cardiac arrest justified from the cost-utility point of view in a transplant centre setting.

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Ten thousand kilometre transfer of cardiogenic shock patients on venoarterial extracorporeal membrane oxygenation for emergency heart transplantation: Cooperation between Reunion Island and Metropolitan France

European Heart Journal Acute Cardiovascular Care ◽

10.1177/2048872617719652 ◽

2017 ◽

Vol 7 (4) ◽

pp. 371-378 ◽

Cited By ~ 6

Author(s):

Clément Charon ◽

Jérôme Allyn ◽

Bruno Bouchet ◽

Fréderic Nativel ◽

Eric Braunberger ◽

...

Keyword(s):

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Heart Transplantation ◽

Adult Patients ◽

Long Term Results ◽

Reunion Island ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation ◽

Réunion Island ◽

Va Ecmo

Background: There is no heart transplantation centre on the French overseas territory of Reunion Island (distance of 10,000 km). The aim of this study was to describe the characteristics of cardiogenic shock adult patients on venoarterial extracorporeal membrane oxygenation (VA-ECMO) who were transferred from Reunion Island to mainland France for emergency heart transplantation. Methods: This retrospective observational study was conducted between 2005 and 2015. The characteristics and outcome of cardiogenic shock patients on VA-ECMO were compared with those of cardiogenic shock patients not on VA-ECMO. Results: Thirty-three cardiogenic shock adult patients were transferred from Reunion Island to Paris for emergency heart transplantation. Among them, 19 (57.6%) needed mechanical circulatory support in the form of VA-ECMO. Median age was 51 (33–57) years and 46% of the patients had ischaemic heart disease. Patients on VA-ECMO presented higher Sequential Organ Failure Assessment score ( p = 0.03). No death occurred during the medical transfer by long flight, while severe complications occurred in 10 patients (30.3%). Incidence of thromboembolic events, severe infectious complications and major haemorrhages was higher in the group of patients on VA-ECMO than in the group of patients not on VA-ECMO ( p <0.01). Seven patients from the VA-ECMO group (36.8%) and six patients from the non-VA-ECMO group (42.9%, p=0.7) underwent heart transplantation after a median delay of 10 (4–29) days on the emergency waiting list. After heart transplantation, one-year survival rates were 85.7% for patients on VA-ECMO and 83.3% for patients not on VA-ECMO ( p=0.91). Conclusions: This study suggests the feasibility of very long-distance medical evacuation of cardiogenic shock patients on VA-ECMO for emergency heart transplantation, with acceptable long-term results.

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Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock and Cardiac Arrest

Circulation Heart Failure ◽

10.1161/circheartfailure.118.004905 ◽

2018 ◽

Vol 11 (9) ◽

Cited By ~ 52

Author(s):

Prashant Rao ◽

Zain Khalpey ◽

Richard Smith ◽

Daniel Burkhoff ◽

Robb D. Kociol

Keyword(s):

Cardiac Arrest ◽

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation

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Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation

Circulation ◽

10.1161/circulationaha.120.048792 ◽

2020 ◽

Vol 142 (22) ◽

pp. 2095-2106 ◽

Cited By ~ 1

Author(s):

Benedikt Schrage ◽

Peter Moritz Becher ◽

Alexander Bernhardt ◽

Hiram Bezerra ◽

Stefan Blankenberg ◽

...

Keyword(s):

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Left Ventricular ◽

Lower Mortality ◽

Severe Bleeding ◽

Complication Rates ◽

Matched Cohort ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation ◽

Va Ecmo

Background: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality. Methods: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score–matched cohort. Results: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63–0.98]; P =0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site–related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%). Conclusions: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

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Erratum to: Venoarterial extracorporeal membrane oxygenation for cardiac arrest/cardiogenic shock

Intensive Care Medicine ◽

10.1007/s00134-016-4637-4 ◽

2016 ◽

Vol 43 (2) ◽

pp. 297-297

Author(s):

Anders Aneman ◽

Peter Macdonald

Keyword(s):

Cardiac Arrest ◽

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Membrane Oxygenation ◽

Venoarterial Extracorporeal Membrane Oxygenation

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Venoarterial Extracorporeal Membrane Oxygenation in Cardiogenic Shock: Lifeline of Modern Day CICU

Journal of Intensive Care Medicine ◽

10.1177/0885066619894541 ◽

2019 ◽

pp. 088506661989454

Author(s):

Aniket S. Rali ◽

Jonathan Chandler ◽

Andrew Sauer ◽

Michael A. Solomon ◽

Zubair Shah

Keyword(s):

Extracorporeal Membrane Oxygenation ◽

Cardiogenic Shock ◽

Mechanical Circulatory Support ◽

Treatment Modalities ◽

Circulatory Support ◽

Steady Increase ◽

Membrane Oxygenation ◽

Cardiopulmonary Support ◽

Venoarterial Extracorporeal Membrane Oxygenation ◽

Va Ecmo

Cardiogenic shock (CS) portends an extremely high mortality of nearly 50% during index hospitalization. Prompt diagnoses of CS, its underlying etiology, and efficient implementation of treatment modalities, including mechanical circulatory support (MCS), are critical especially in light of such high predicted mortality. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) provides the most comprehensive cardiopulmonary support in critically ill patients and hence has seen a steady increase in its utilization over the past decade. Hence, a good understanding of VA-ECMO, its role in treatment of CS, especially when compared with other temporary MCS devices, and its complications are vital for any critical care cardiologist. Our review of VA-ECMO aims to provide the same.

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