Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump

NCT06645990 | Recruiting

• 1 other identifier: 2024-06-079
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past decade, VA-ECMO has become the main mechanical support for cardiogenic shock (CS) unresponsive to medical therapy. However, recent studies failed to show any significant survival benefit at 30 days compared to medical treatment for myocardial infarction-related CS. This could be due to the complications of VA-ECMO, such as LV overload and increased LV distension, which can hinder heart recovery. To address this, early LV unloading using devices like IABP or Impella (ECMELLA) may help by reducing LV wall stress and oxygen consumption. However, these techniques carry risks, and their benefit is still unclear. A randomized trial is needed to compare these approaches, but observational studies are also contributing to understanding the best strategies

Conditions

Cardiogenic Shock

Keywords

ECMO; ECLS; Impella; IABP; pVAD; mortality

Outcome Measures

Primary Outcomes (1)

• Myocardial recovery

  Hospital Survival without chronic mechanical circulatory support (LVAD) and heart transplantation.

  from start of hospitalization until hospital discharge assessed up to 3 month

Secondary Outcomes (6)

• Early mortality

  from start of hospitalization until hospital discharge assessed up to 3 month

• Adverse events related to LV unloading technics

  from start of hospitalization until hospital discharge assessed up to 3 month

• Duration of mechanical ventilation

  from start of hospitalization until hospital discharge assessed up to 3 month

• Duration of temporary MCS support

  from start of hospitalization until hospital discharge assessed up to 3 month

• Lengh of stay

  from start of hospitalization until hospital discharge assessed up to 3 month

Study Arms (2)

ECMELLA group

VA-ECMO + Impella implemented before or within 24 h of ECMO initiation

Device: Impella

ECMO+IABP group

VA-ECMO + IABP implemented before or within 24h of ECMO initiation

Device: IABP

Interventions

Impella DEVICE

LV unloading with Impella (ECMELLA) before or within 24 h of ECMO initiation

ECMELLA group

IABP DEVICE

LV unloading with IABP before or within 24 h of ECMO initiation

ECMO+IABP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Adult patients (more than or =18 years) admitted for Cardiogenic Shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023

You may qualify if:

• Adult patients (more than or =18 years) admitted for cardiogenic shock supported by ECMO+ IABP or ECMELLA between January 1, 2010, and December 31, 2023

You may not qualify if:

• Ongoing extra-corporeal CardioPulmonary Resuscitation (eCPR) at time of ECMO implantation
• Cardiogenic shock with previous prolonged continuous cardiopulmonary resuscitation (CPR) more than 30 minutes
• Acute irreversible neurological injury
• Previous known severe chronic cardiomyopathy (LVEF less than 25%) or awaiting heart transplantation or LVAD implantation
• Contraindication to the implantation of an Impella or IABP
• Mechanical complications of myocardial infarction
• Moribund patient (SAPS more than 90)
• Previous known severe chronic renal or hepatic failure
• Age less than18 years

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Arnaud de Villeneuve

Montpellier, 34295, France

RECRUITING

Related Publications (15)

• Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.

  PMID: 35083827 BACKGROUND

• Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.

  PMID: 21900289 BACKGROUND

• Hernan MA, Sauer BC, Hernandez-Diaz S, Platt R, Shrier I. Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses. J Clin Epidemiol. 2016 Nov;79:70-75. doi: 10.1016/j.jclinepi.2016.04.014. Epub 2016 May 27.

  PMID: 27237061 BACKGROUND

• Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18.

  PMID: 26994063 BACKGROUND

• Ezad SM, Ryan M, Donker DW, Pappalardo F, Barrett N, Camporota L, Price S, Kapur NK, Perera D. Unloading the Left Ventricle in Venoarterial ECMO: In Whom, When, and How? Circulation. 2023 Apr 18;147(16):1237-1250. doi: 10.1161/CIRCULATIONAHA.122.062371. Epub 2023 Apr 17.

  PMID: 37068133 BACKGROUND

• Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM; Chairs:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:; Chair:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant. 2023 Apr;42(4):e1-e64. doi: 10.1016/j.healun.2022.10.028. Epub 2023 Feb 6. No abstract available.

  PMID: 36805198 BACKGROUND

• Ostadal P, Rokyta R, Karasek J, Kruger A, Vondrakova D, Janotka M, Naar J, Smalcova J, Hubatova M, Hromadka M, Volovar S, Seyfrydova M, Jarkovsky J, Svoboda M, Linhart A, Belohlavek J; ECMO-CS Investigators. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. Circulation. 2023 Feb 7;147(6):454-464. doi: 10.1161/CIRCULATIONAHA.122.062949. Epub 2022 Nov 6.

  PMID: 36335478 RESULT

• Banning AS, Sabate M, Orban M, Gracey J, Lopez-Sobrino T, Massberg S, Kastrati A, Bogaerts K, Adriaenssens T, Berry C, Erglis A, Haine S, Myrmel T, Patel S, Buera I, Sionis A, Vilalta V, Yusuff H, Vrints C, Adlam D, Flather M, Gershlick AH. Venoarterial extracorporeal membrane oxygenation or standard care in patients with cardiogenic shock complicating acute myocardial infarction: the multicentre, randomised EURO SHOCK trial. EuroIntervention. 2023 Aug 21;19(6):482-492. doi: 10.4244/EIJ-D-23-00204.

  PMID: 37334659 RESULT

• Thiele H, Zeymer U, Akin I, Behnes M, Rassaf T, Mahabadi AA, Lehmann R, Eitel I, Graf T, Seidler T, Schuster A, Skurk C, Duerschmied D, Clemmensen P, Hennersdorf M, Fichtlscherer S, Voigt I, Seyfarth M, John S, Ewen S, Linke A, Tigges E, Nordbeck P, Bruch L, Jung C, Franz J, Lauten P, Goslar T, Feistritzer HJ, Poss J, Kirchhof E, Ouarrak T, Schneider S, Desch S, Freund A; ECLS-SHOCK Investigators. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock. N Engl J Med. 2023 Oct 5;389(14):1286-1297. doi: 10.1056/NEJMoa2307227. Epub 2023 Aug 26.

  PMID: 37634145 RESULT

• Schmidt M, Burrell A, Roberts L, Bailey M, Sheldrake J, Rycus PT, Hodgson C, Scheinkestel C, Cooper DJ, Thiagarajan RR, Brodie D, Pellegrino V, Pilcher D. Predicting survival after ECMO for refractory cardiogenic shock: the survival after veno-arterial-ECMO (SAVE)-score. Eur Heart J. 2015 Sep 1;36(33):2246-56. doi: 10.1093/eurheartj/ehv194. Epub 2015 Jun 1.

  PMID: 26033984 RESULT

• Muller G, Flecher E, Lebreton G, Luyt CE, Trouillet JL, Brechot N, Schmidt M, Mastroianni C, Chastre J, Leprince P, Anselmi A, Combes A. The ENCOURAGE mortality risk score and analysis of long-term outcomes after VA-ECMO for acute myocardial infarction with cardiogenic shock. Intensive Care Med. 2016 Mar;42(3):370-378. doi: 10.1007/s00134-016-4223-9. Epub 2016 Jan 29.

  PMID: 26825953 RESULT

• Dickerman BA, Garcia-Albeniz X, Logan RW, Denaxas S, Hernan MA. Avoidable flaws in observational analyses: an application to statins and cancer. Nat Med. 2019 Oct;25(10):1601-1606. doi: 10.1038/s41591-019-0597-x. Epub 2019 Oct 7.

  PMID: 31591592 RESULT

• Meuwese CL, Koudstaal S, Braithwaite S, Hermens JAJ, Donker DW. Left Ventricular Unloading During Extracorporeal Membrane Oxygenation: Insights From Meta-Analyzed Observational Data Corrected for Confounders. J Am Coll Cardiol. 2019 Jun 18;73(23):3034-3035. doi: 10.1016/j.jacc.2019.03.505. No abstract available.

  PMID: 31196464 RESULT

• Beurton A, Michot M, Herion FX, Rienzo M, Oddos C, Couffinhal T, Imbault J, Ouattara A. Systemic Hemodynamics, Cardiac Mechanics, and Signaling Pathways Induced by Extracorporeal Membrane Oxygenation in a Cardiogenic Shock Model. ASAIO J. 2024 Mar 1;70(3):177-184. doi: 10.1097/MAT.0000000000002139. Epub 2024 Jan 23.

  PMID: 38261663 RESULT

• Ughetto A, Eliet J, Nagot N, David H, Bazalgette F, Marin G, Kollen S, Mourad M, Zeroual N, Muller L, Gaudard P, Colson P. Early temporary mechanical circulatory support for cardiogenic shock: Real-life data from a regional cardiac assistance network. J Heart Lung Transplant. 2024 Jun;43(6):911-919. doi: 10.1016/j.healun.2024.02.009. Epub 2024 Feb 15.

  PMID: 38367739 RESULT

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Aurore UGHETTO, MD

  Montpellier University Hospital, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore UGHETTO, MD

CONTACT

0033622054893; a-ughetto@chu-montpellier.fr

Clément DELMAS, MD, PhD

CONTACT

0033673147951; delmas.clement@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 17, 2024
• Study Start: January 1, 2010
• Primary Completion: January 1, 2023
• Study Completion: January 30, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

FR (1)