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Background: The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a "Randomized Embedded Multifactorial Adaptive Platform (REMAP)" in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP)., Methods: REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is "successful weaning from ECMO" being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until 1 year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered., Conclusion: This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone., Trial Registration: ClinicalTrials.gov, NCT05913622., Competing Interests: Conflict of interest Christiaan L. Meuwese: • Received research grants from the Dutch Heart Foundation and Erasmus Medical Center. Dirk W. Donker: • Research cooperation: Getinge-Maquet Critical Care AB, Solna, Sweden Research cooperation: Sonion BV, Hoofddorp, The Netherlands • Research consultancy: HBOX Therapies GmbH, Aachen, Germany • No personal fees received, all financial benefits paid to the University of Twente, Enschede, The Netherlands Rudolf A. de Boer: • Received research grants and/or fees from AstraZeneca, Abbott, Boehringer Ingelheim, Cardior Pharmaceuticals GmbH, Novo Nordisk, and Roche; • Speaker engagements with and/or received fees from and/or served on an advisory board for Abbott, AstraZeneca, Bristol Myers Squibb, Cardior Pharmaceuticals GmbH, NovoNordisk, and Roche; • Received travel support from Abbott, Cardior Pharmaceuticals GmbH, and NovoNordisk. Adriaan O. Kraaijeveld: • Received an institutional research grant van Xenios AG Diederik A.M.P.J. Gommers: •Received speakers fee and travel expenses from: Draeger, GE Healthcare, Maquet and Novalung. •Member of medical advisory board: GE Healthcare (2009-2012), Novalung (2015-2018) Roberto Lorusso • Received research grants from Medtronic and LivaNova • Principle Investigator of the PERSIST AVR Trial (sponsored by LivaNova) • Consultant for Medtronic, LivaNova and Getinge • Member of the Medical Advisory Board for Eurosets and Xenios • Honoraria for moderations or presentations from ABIOMED • Payments to the Institution/University Nicolas M.D.A. Van Mieghem • Received research grant support from: Abbott, Astra Zeneca*, Biotronik, Boston Scientific, CSI, Daiichi Sankyo, Edwards Lifesciences*, Medtronic, Pie Medical, PulseCath BV, Teleflex • Received advisory fees from: 415 Capital Management GmbH, Abbott, Abiomed, Acist Medical, Amgen, Anteris, Approxima Srl, Biotronik, Bolt Medical, Boston Scientific, CSI, Daiichi Sankyo, Jenavalve, LUMA Vision, Materialise, Medtronic, Opsens, Pie Medical, PulseCath BV, Shockwave, Siemens, Springer Healthcare, Teleflex All other authors have no conflicts of interest to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: In refractory cardiogenic shock, temporary mechanical support (tMCS) may be crucial for maintaining tissue perfusion and oxygen delivery. tMCS can serve as a bridge-to-decision to assess eligibility for left ventricular assist device (LVAD) implantation or heart transplantation, or as a bridge-to-recovery. ECPELLA is a novel tMCS configuration combining venoarterial extracorporeal membrane oxygenation with Impella. The present study presents the clinical parameters, outcomes, and complications of patients supported with ECPELLA., Methods: All patients supported with ECPELLA at University Medical Centre Utrecht between December 2020 and August 2023 were included. The primary outcome was 30-day mortality, and secondary outcomes were LVAD implantation/heart transplantation and safety outcomes., Results: Twenty patients with an average age of 51 years, and of whom 70% were males, were included. Causes of cardiogenic shock were acute heart failure (due to acute coronary syndrome, myocarditis, or after cardiac surgery) or chronic heart failure, respectively 70 and 30% of cases. The median duration of ECPELLA support was 164 h (interquartile range 98-210). In 50% of cases, a permanent LVAD was implanted. Cardiac recovery within 30 days was seen in 30% of cases and 30-day mortality rate was 20%. ECPELLA support was associated with major bleeding (40%), haemolysis (25%), vascular complications (30%), kidney failure requiring replacement therapy (50%), and Impella failure requiring extraction (15%)., Conclusion: ECPELLA can be successfully used as a bridge to LVAD implantation or as a bridge-to-recovery in patients with refractory cardiogenic shock. Despite a significant number of complications, 30-day mortality was lower than observed in previous cohorts., (© 2024. The Author(s).)