ECMO LEft Ventricle UNloading Strategy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venoarterial extracorporeal life support (VA ECLS) implant.
- Who it may be relevant to
- Registry conditions: Shock, Cardiogenic, Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication. Basic parameters: 1 Day — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support
Overview
The present study is an International multicentric prospective observational cohort study. This will be an international research campaign to prospectively collect and analyze clinical data of all VA ECLS patients admitted to participating ICUs with a focus on LV venting modalities. The aims of the study are: * To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support; * To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort. * To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;
Detailed description
Cardiogenic shock and cardiac arrest are among the most lethal manifestations of acute cardiovascular disease, both burdened by extremely high in-hospital mortality rates. Extracorporeal life support is increasingly used either in adults or children with acutely impaired cardiac function refractory to conventional medical management, mainly in profound cardiogenic shock and refractory cardiac arrest. Veno-arterial extracorporeal life support works as a partial cardiopulmonary bypass draining the venous circulation directly into the systemic circulation. Veno-arterial extracorporeal life support provides biventricular support and provides respiratory gas exchange. One of the most important issues occurring during veno-arterial extracorporeal life support is the effect of the retrograde aortic flow which causes a marked increase in the left ventricular afterload with detrimental effects on myocardial performance. Left ventricular overload increases wall stress and myocardial oxygen consumption, jeopardizing ventricular recovery. Nowadays, different techniques are available for unloading the left chambers. However, despite the increasing worldwide experience with extracorporeal life support and the increased knowledge on the benefits of left ventricular unloading, the best veno-arterial extracorporeal life support configuration to achieve hemodynamic support, myocardial recovery, and left ventricular unloading, is still a matter of debate.
This is a prospective clinical study which is observational. The aims of the study are:
* To extensively describe the left ventricular unloading strategy during veno-arterial extracorporeal life support in a large prospective international cohort, providing detailed information on indications, timing, type and modality among a wide spectrum of clinical conditions * To compare different strategies to unload the left ventricular in terms of efficacy and outcomes * To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.
Demographics, clinical, instrumental and laboratory data prior and post implantation of veno-arterial extracorporeal life support will be collected. No interventions on top on the ones necessary as a standard of care will be taken.
Interventions
- Procedure Venoarterial extracorporeal life support (VA ECLS) implant
Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.
Primary outcome measures
- In-hospital mortality [Time frame: Day 30]
- Overload detection, Echocardiographic parameters [Time frame: Within 12 hours before the applied unloading technique]
- Unloading effectiveness, Echocardiographic parameters [Time frame: 12 hours after the unloading technique implementation]
Secondary outcome measures (6)
- Unloading Effectiveness, Qualitative echocardiographic parameters [Time frame: 12 hours after the unloading technique implementation]
- Major adverse events [Time frame: Day 30]
- Left Ventricular functional status [Time frame: Day 30]
- LVAD Implementation [Time frame: Day 30]
- Heart transplant [Time frame: Day 30]
- Neurological status at discharge [Time frame: Day 30]
Eligibility criteria
Inclusion criteria
- All patients undergoing VA ECLS will be enrolled.
Exclusion criteria
- Patients without VA ECMO will not be considered
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Maastricht UMC — Maastricht
Publications
- Camboni D, Schmid C. To vent or not on veno-arterial extracorporeal membrane oxygenation, does it improve myocardial recovery and outcome? J Thorac Dis. 2017 Dec;9(12):4915-4918. doi: 10.21037/jtd.2017.11.98. No abstract available. PMID 29312691
- Schrage B, Becher PM, Bernhardt A, Bezerra H, Blankenberg S, Brunner S, Colson P, Cudemus Deseda G, Dabboura S, Eckner D, Eden M, Eitel I, Frank D, Frey N, Funamoto M, Gossling A, Graf T, Hagl C, Kirchhof P, Kupka D, Landmesser U, Lipinski J, Lopes M, Majunke N, Maniuc O, McGrath D, Mobius-Winkler S, Morrow DA, Mourad M, Noel C, Nordbeck P, Orban M, Pappalardo F, Patel SM, Pauschinger M, Pazzanese PMID 33032450
- Haneya A, Philipp A, Diez C, Schopka S, Bein T, Zimmermann M, Lubnow M, Luchner A, Agha A, Hilker M, Hirt S, Schmid C, Muller T. A 5-year experience with cardiopulmonary resuscitation using extracorporeal life support in non-postcardiotomy patients with cardiac arrest. Resuscitation. 2012 Nov;83(11):1331-7. doi: 10.1016/j.resuscitation.2012.07.009. Epub 2012 Jul 20. PMID 22819880
- Arlt M, Philipp A, Voelkel S, Schopka S, Husser O, Hengstenberg C, Schmid C, Hilker M. Early experiences with miniaturized extracorporeal life-support in the catheterization laboratory. Eur J Cardiothorac Surg. 2012 Nov;42(5):858-63. doi: 10.1093/ejcts/ezs176. Epub 2012 May 3. PMID 22555310
- Donker DW, Brodie D, Henriques JPS, Broome M. Left ventricular unloading during veno-arterial ECMO: a review of percutaneous and surgical unloading interventions. Perfusion. 2019 Mar;34(2):98-105. doi: 10.1177/0267659118794112. Epub 2018 Aug 16. PMID 30112975
- Meani P, Lorusso R, Pappalardo F. ECPella: Concept, Physiology and Clinical Applications. J Cardiothorac Vasc Anesth. 2022 Feb;36(2):557-566. doi: 10.1053/j.jvca.2021.01.056. Epub 2021 Feb 6. PMID 33642170
- Meani P, Gelsomino S, Natour E, Johnson DM, Rocca HB, Pappalardo F, Bidar E, Makhoul M, Raffa G, Heuts S, Lozekoot P, Kats S, Sluijpers N, Schreurs R, Delnoij T, Montalti A, Sels JW, van de Poll M, Roekaerts P, Poels T, Korver E, Babar Z, Maessen J, Lorusso R. Modalities and Effects of Left Ventricle Unloading on Extracorporeal Life support: a Review of the Current Literature. Eur J Heart Fail. 20 PMID 28470925
- Meani P, Delnoij T, Raffa GM, Morici N, Viola G, Sacco A, Oliva F, Heuts S, Sels JW, Driessen R, Roekaerts P, Gilbers M, Bidar E, Schreurs R, Natour E, Veenstra L, Kats S, Maessen J, Lorusso R. Protracted aortic valve closure during peripheral veno-arterial extracorporeal life support: is intra-aortic balloon pump an effective solution? Perfusion. 2019 Jan;34(1):35-41. doi: 10.1177/026765911878742 PMID 30024298
Identifiers
NCT: NCT06766006 · 2023-0112