ECMO LEft Ventricle UNloading Strategy

NCT06766006 | Recruiting DMC

• 1 other identifier: 2023-0112
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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;

Conditions

Shock, Cardiogenic; Cardiac Arrest; Extracorporeal Membrane Oxygenation Complication

Keywords

Extracorporeal Membrane Oxygenation; Left ventricle unloading; Cardiogenic shock; Cardiac Arrest; Mechanical Circulatory Supports

Outcome Measures

Primary Outcomes (3)

• In-hospital mortality

  Death during hospital stay

  Day 30

• Overload detection, Echocardiographic parameters

  Presence of left ventricle (LV) overload (defined as: aortic valve opening impairment and/or smoke like effect and/or LA distension and/or LV distension). The aforementioned criteria are defined as follows: * Aortic valve opening impairment: Aortic valve does not open every beat. * Smoke like effect: spontaneous echo contrast inside left ventricle chamber. * Left Atrium (LA) distension: male/female LA volume/body surface area (BSA)\>=34 or increase\>15% * LV distension: LV end-diastolic volume (ml) \>150 ml, male; female LV end-diastolic volume (ml) \>106 ml or increase\>15%

  Within 12 hours before the applied unloading technique

• Unloading effectiveness, Echocardiographic parameters

  Echocardiographic qualitative parameters: * aortic valve opening (yes/no) * smoke like effect (yes/no) * LA distension (yes/no) * LV distension (yes/no) * inferior vena cava collapse/dilation (yes/no) * grade of mitral regurgitation (mild/moderatre/severe) Echocardiographic quantitative parameters: * LV end-diastolic diameter (mm) * LV end-diastolicvolume (ml) * LV end-systolic diameter (mm) * LV end-systolic volume(ml) * LA volume (ml) * E/E' septal and lateral (ratio, no unit of measurement ) * systolic pulmonary artery pressure (mmHg)

  12 hours after the unloading technique implementation

Secondary Outcomes (6)

• Unloading Effectiveness, Qualitative echocardiographic parameters

  12 hours after the unloading technique implementation

• Major adverse events

  Day 30

• Left Ventricular functional status

  Day 30

• LVAD Implementation

  Day 30

• Heart transplant

  Day 30

Other Outcomes (7)

• Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic diameter (mm)

  12 hours after the unloading technique implementation

• Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic volume (ml)

  12 hours after the unloading technique implementation

• Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic diameter (mm)

  12 hours after the unloading technique implementation

Study Arms (1)

VA ECLS patients

All patients undergoing VA ECLS will be enrolled. Patients without VA ECLS will not be considered. Centers will follow their standard protocols for the management of patients on VA ECLS.

Procedure: Venoarterial extracorporeal life support (VA ECLS) implant

Interventions

Venoarterial extracorporeal life support (VA ECLS) implant PROCEDURE

Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.

VA ECLS patients

Eligibility Criteria

• Age: 1 Day - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by cardiogenic shock or cardiac arrest independent of etiology supported with VA ECLS.

You may qualify if:

• All patients undergoing VA ECLS will be enrolled.

You may not qualify if:

• Patients without VA ECMO will not be considered

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• IRCCS Policlinico S. Donato: collaborator

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 V, Reichenspurner H, Sandri M, Schulze PC, H G Schwinger R, Sinning JM, Aksoy A, Skurk C, Szczanowicz L, Thiele H, Tietz F, Varshney A, Wechsler L, Westermann D. Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study. Circulation. 2020 Dec;142(22):2095-2106. doi: 10.1161/CIRCULATIONAHA.120.048792. Epub 2020 Oct 9.

  PMID: 33032450 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. 2017 May;19 Suppl 2:84-91. doi: 10.1002/ejhf.850.

  PMID: 28470925 BACKGROUND

• 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: 10.1177/0267659118787426. Epub 2018 Jul 19.

  PMID: 30024298 BACKGROUND

• Patel SM, Lipinski J, Al-Kindi SG, Patel T, Saric P, Li J, Nadeem F, Ladas T, Alaiti A, Phillips A, Medalion B, Deo S, Elgudin Y, Costa MA, Osman MN, Attizzani GF, Oliveira GH, Sareyyupoglu B, Bezerra HG. Simultaneous Venoarterial Extracorporeal Membrane Oxygenation and Percutaneous Left Ventricular Decompression Therapy with Impella Is Associated with Improved Outcomes in Refractory Cardiogenic Shock. ASAIO J. 2019 Jan;65(1):21-28. doi: 10.1097/MAT.0000000000000767.

  PMID: 29489461 BACKGROUND

• Grandin EW, Nunez JI, Willar B, Kennedy K, Rycus P, Tonna JE, Kapur NK, Shaefi S, Garan AR. Mechanical Left Ventricular Unloading in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation. J Am Coll Cardiol. 2022 Apr 5;79(13):1239-1250. doi: 10.1016/j.jacc.2022.01.032.

  PMID: 35361346 BACKGROUND

• Raffa GM, Kowalewski M, Meani P, Follis F, Martucci G, Arcadipane A, Pilato M, Maessen J, Lorusso R; ECMO in TAVI Investigators Group (ETIG). In-hospital outcomes after emergency or prophylactic veno-arterial extracorporeal membrane oxygenation during transcatheter aortic valve implantation: a comprehensive review of the literature. Perfusion. 2019 Jul;34(5):354-363. doi: 10.1177/0267659118816555. Epub 2019 Jan 11.

  PMID: 30632894 BACKGROUND

• Pappalardo F, Schulte C, Pieri M, Schrage B, Contri R, Soeffker G, Greco T, Lembo R, Mullerleile K, Colombo A, Sydow K, De Bonis M, Wagner F, Reichenspurner H, Blankenberg S, Zangrillo A, Westermann D. Concomitant implantation of Impella(R) on top of veno-arterial extracorporeal membrane oxygenation may improve survival of patients with cardiogenic shock. Eur J Heart Fail. 2017 Mar;19(3):404-412. doi: 10.1002/ejhf.668. Epub 2016 Oct 6.

  PMID: 27709750 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Arrest

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Paolo Meani, MD, PhD

CONTACT

43 38811067; paolo.meani@mumc.nl

Roberto Lorusso, MD,PhD

CONTACT

43 38811067; roberto.lorussobs@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 9, 2025
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

NL (1)