Dataset Information

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial.

ABSTRACT:

Aims

Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularisation but has plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downward spiral towards death, which becomes difficult to reverse. We aimed to test in a robust, prospective, randomised controlled trial whether early support with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides clinical benefit by improving mortality and morbidity.

Methods and results

The EURO SHOCK trial will test the benefit or otherwise of mechanical cardiac support using VA-ECMO, initiated early after acute percutaneous coronary intervention (PCI) for CGS. The trial sets out to randomise 428 patients with CGS complicating ACS, following primary PCI (P-PCI), to either very early ECMO plus standard pharmacotherapy, or standard pharmacotherapy alone. It will be conducted in 39 European centres. The primary endpoint is 30-day all-cause mortality with key secondary endpoints: 1) 12-month all-cause mortality or admission for heart failure, 2) 12-month all-cause mortality, 3) 12-month admission for heart failure. Cost-effectiveness analysis (including quality of life measures) will be embedded. Mechanistic and hypothesis-generating substudies will be undertaken.

Conclusions

The EURO SHOCK trial will determine whether early initiation of VA-ECMO in patients presenting with ACS-CGS persisting after PCI improves mortality and morbidity.

SUBMITTER: Banning AS

PROVIDER: S-EPMC9725005 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial.

Banning Amerjeet Singh AS Adriaenssens Tom T Berry Colin C Bogaerts Kris K Erglis Andrejs A Distelmaier Klaus K Guagliumi Giulio G Haine Steven S Kastrati Adnan A Massberg Steffen S Orban Martin M Myrmel Truls T Vuylsteke Alain A Alfonso Fernando F Van de Werf Frans F Verheugt Freek F Flather Marcus M Sabaté Manel M Vrints Christiaan C Gershlick Anthony H AH

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20210205 15

<h4>Aims</h4>Cardiogenic shock (CGS) occurs in 6-10% of patients with acute coronary syndromes (ACS). Mortality has fallen over time from 80% to approximately 50% consequent on acute revascularisation but has plateaued since the 1990s. Once established, patients with CGS develop adverse compensatory mechanisms that contribute to the downward spiral towards death, which becomes difficult to reverse. We aimed to test in a robust, prospective, randomised controlled trial whether early support with ...[more]

PMID: 33106225

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Project description:BackgoundHyperoxemia is common and associated with poor outcome during veno-arterial extracorporeal membrane oxygenation (VA ECMO) support for cardiogenic shock. However, little is known about practical daily management of oxygenation. Then, we aim to describe sweep gas oxygen fraction (FSO2), postoxygenator oxygen partial pressure (PPOSTO2), inspired oxygen fraction (FIO2), and right radial arterial oxygen partial pressure (PaO2) between day 1 and day 7 of peripheral VA ECMO support. We also aim to evaluate the association between oxygenation parameters and outcome. In this retrospective multicentric study, each participating center had to report data on the last 10 eligible patients for whom the ICU stay was terminated. Patients with extracorporeal cardiopulmonary resuscitation were excluded. Primary endpoint was individual mean FSO2 during the seven first days of ECMO support (FSO2 mean (day 1-7)).ResultsBetween August 2019 and March 2022, 139 patients were enrolled in 14 ECMO centers in France, and one in Switzerland. Among them, the median value for FSO2 mean (day 1-7) was 70 [57; 79] % but varied according to center case volume. Compared to high volume centers, centers with less than 30 VA-ECMO runs per year were more likely to maintain FSO2 ≥ 70% (OR 5.04, CI 95% [1.39; 20.4], p = 0.017). Median value for right radial PaO2 mean (day 1-7) was 114 [92; 145] mmHg, and decreased from 125 [86; 207] mmHg at day 1, to 97 [81; 133] mmHg at day 3 (p < 0.01). Severe hyperoxemia (i.e. right radial PaO2 ≥ 300 mmHg) occurred in 16 patients (12%). PPOSTO2, a surrogate of the lower body oxygenation, was measured in only 39 patients (28%) among four centers. The median value of PPOSTO2 mean (day 1-7) value was 198 [169; 231] mmHg. By multivariate analysis, age (OR 1.07, CI95% [1.03-1.11], p < 0.001), FSO2 mean (day 1-3)(OR 1.03 [1.00-1.06], p = 0.039), and right radial PaO2 mean (day 1-3) (OR 1.03, CI95% [1.00-1.02], p = 0.023) were associated with in-ICU mortality.ConclusionIn a multicentric cohort of cardiogenic shock supported by VA ECMO, the median value for FSO2 mean (day 1-7) was 70 [57; 79] %. PPOSTO2 monitoring was infrequent and revealed significant hyperoxemia. Higher FSO2 mean (day 1-3) and right radial PaO2 mean (day 1-3) were independently associated with in-ICU mortality.

Project description:AimsKnowing the upper time limit for successful weaning from temporary mechanical circulatory support in cardiogenic shock will help with decision-making regarding advanced heart failure (HF) therapy or considering withdrawal of care. The aim of this study was to investigate the association between the support duration and successful weaning from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with cardiogenic shock.Methods and resultsA retrospective single-centre cohort study was conducted between January 2013 and June 2023. It included 100 consecutive patients with cardiogenic shock who were treated with VA-ECMO. Patients with out-of-hospital cardiac arrest were excluded. The primary outcome was successful weaning from VA-ECMO (i.e., VA-ECMO decannulation and survival to discharge). The association between the length of support duration and the weaning success rate was analysed. Patients were divided into three groups according to ECMO support duration: Group A (≤7 days), Group B (8-14 days), and Group C (≥15 days). Multivariable logistic regression analysis was used to evaluate the impact of the length of support duration on successful weaning of VA-ECMO. The median age was 67 years, and 73% of study participants were male. The underlying aetiologies of cardiogenic shock were as follows: acute myocardial infarction, 50; fulminant myocarditis, 19; cardiomyopathy, 15; valvular heart disease, 8; and other, 8. Seventy-five patients (75%) were attempted to wean VA-ECMO, and 67 moved on to decannulation. In total, 43 (43%) patients were successfully weaned from VA-ECMO. The median length of ECMO support duration was 8 [3-15] days. Compared with those who underwent successful ECMO decannulation, those who did not had a significantly longer support duration of VA-ECMO (5 [3-9] days vs. 12 [3-22] days, P = 0.004). The weaning success rate was significantly higher in patients with short support duration; 58% (29/50), 40% (10/25), 16% (4/25) in Groups A, B, and C, respectively (P = 0.002). Overall, none of the patients supported for over 24 days (0/11) were successfully weaned from VA-ECMO. On multivariable logistic regression analysis, the length of support duration was independently associated with successful weaning after adjusting for age, sex, underlying aetiology, and left ventricular ejection fraction (odds ratio, 0.813 [per 3 days]; 95% confidence interval, 0.679-0.914; P = 0.025).ConclusionsLong support duration of VA-ECMO was significantly associated with a low rate of successful weaning in patients with cardiogenic shock. Patients who require VA-ECMO for over 1 week should start considering advanced HF therapy or withdrawal of care.

Project description:BackgroundVasopressors and inotropes are crucial in managing cardiogenic shock (CS) as they enhance microcirculation in patients. Numerous studies have demonstrated the adverse outcomes associated with excessive use of vasoactive drugs and the vasoactive drug scoring system has emerged as a valuable prognostic tool, particularly in pediatric patients. This study aimed to examine the prognostic significance of the Vasoactive Inotropic Score (VIS) in adult patients with CS receiving veno-arterial extracorporeal membrane oxygenation (VA-ECMO) treatment.MethodsThis retrospective multi-center study involved 2,453 adult patients who underwent VA-ECMO in China between 2015 and 2021. Among them, 1,742 adult patients with CS following VA-ECMO were finally included. The maximum VIS (VISmax) was determined by considering the highest doses of vasoactive and inotropic drugs administered within the first 6 hours before ECMO initiation. Based on the VISmax, patients were classified into two groups: 0-20 and >20. The primary outcome of this study was in-hospital mortality.ResultsA total of 1,146 patients were included in the high VISmax group, while 596 patients were assigned to the low VISmax group. Overall, 882 (50.6%) patients experienced in-hospital mortality, with significantly higher rates observed among those with higher VISmax scores (41.4% for VIS ≤20 versus 68.3% for VIS >20; P<0.001). Similar trends were observed for 30-day mortality (40.7% for VIS ≤20 versus 64.9% for VIS >20; P<0.001). Multivariable regression analysis demonstrated that a VIS score exceeding 20 independently predicted in-hospital mortality [odds ratio (OR) 2.64; 95% confidence interval (CI): 2.10-3.33; P<0.001]. The receiver operating characteristic (ROC) analysis revealed that VIS had an area under the curve (AUC) of 0.65 (95% CI: 0.63-0.68; P<0.001) as a predictor of in-hospital mortality, with an optimal cutoff value of 20.1. Moreover, the VIS exhibited good predictive ability for in-hospital mortality in patients with acute myocarditis (AUC 0.70; 95% CI: 0.63-0.78; P<0.001).ConclusionsFirstly, higher maximum level of VIS within the first 6 hours before ECMO initiation independently predicted poorer clinical outcomes in patients supported with ECMO for CS. Secondly, VIS exceeding 20 was significantly associated with increased risks of in-hospital mortality and 30-day mortality. Thirdly, when categorized by the cause of CS, a high VIS exhibited good predictive ability in patients with acute myocardial infarction, heart failure, and acute myocarditis.

Dataset Information

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial.

Aims

Methods and results

Conclusions

Publications

Veno-arterial extracorporeal membrane oxygenation (ECMO) in patients with cardiogenic shock: rationale and design of the randomised, multicentre, open-label EURO SHOCK trial.

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