Rationale and Design of JenaMACS—Acute Hemodynamic Impact of Ventricular Unloading Using the Impella CP Assist Device in Patients with Cardiogenic Shock

Media type: E-Article

Title: Rationale and Design of JenaMACS—Acute Hemodynamic Impact of Ventricular Unloading Using the Impella CP Assist Device in Patients with Cardiogenic Shock

Contributor: Haertel, Franz [Author]; Lenk, Karsten [Author]; Fritzenwanger, Michael [Author]; Pfeifer, Ruediger [Author]; Franz, Marcus [Author]; Memisevic, Nedim [Author]; Otto, Sylvia [Author]; Lauer, Bernward [Author]; Weingärtner, Oliver [Author]; Kretzschmar, Daniel [Author]; Dannberg, Gudrun [Author]; Westphal, Julian [Author]; Baez, Laura [Author]; Bogoviku, Jurgen [Author]; Schulze, P. Christian [Author]; Moebius-Winkler, Sven [Author]

Published: Basel: MDPI, [2023]

Language: English

DOI: 10.3390/jcm11154623

Keywords: acute heart failure ; shock ; extracorporeal circulatory support ; Impella ; intensive care

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Description: Introduction: Cardiogenic shock due to myocardial infarction or heart failure entails areduction in end organ perfusion. Patients who cannot be stabilized with inotropes and who experience increasing circulatory failure are in need of an extracorporeal mechanical support system.Today, small, percutaneously implantable cardiac assist devices are available and might be a solutionto reduce mortality and complications. A temporary, ventricular, continuous flow propeller pumpusing magnetic levitation (Impella®) has been approved for that purpose. Methods and Study Design: JenaMACS (Jena Mechanical Assist Circulatory Support) is a monocenter, proof-of-conceptstudy to determine whether treatment with an Impella CP® leads to improvement of hemodynamicparameters in patients with cardiogenic shock requiring extracorporeal, hemodynamic support. Theprimary outcomes of JenaMACS are changes in hemodynamic parameters measured by pulmonaryartery catheterization and changes in echocardiographic parameters of left and right heart functionbefore and after Impella® implantation at different support levels after 24 h of support. Secondaryoutcome measures are hemodynamic and echocardiographic changes over time as well as clinicalendpoints such as mortality or time to hemodynamic stabilization. Further, laboratory and clinical safety endpoints including severe bleeding, stroke, neurological outcome, peripheral ischemiccomplications and occurrence of sepsis will be assessed. JenaMACS addresses essential questions ofextracorporeal, mechanical, cardiac support with an Impella CP® device in patients with cardiogenicshock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may helpto optimize therapy and improve the outcome in those patients. Conclusion: The JenaMACS studywill address essential questions of extracorporeal, mechanical, cardiac support with an Impella CP®assist device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamicand echocardiographic effects may help to optimize therapy and may improve outcome in thosepatients. Ethics and Dissemination: The protocol was approved by the institutional review board andethics committee of the University Hospital of Jena. Written informed consent will be obtained fromall participants of the study. The results of this study will be published in a renowned internationalmedical journal, irrespective of the outcomes of the study. Strengths and Limitations: JenaMACS isan innovative approach to characterize the effect of additional left ventricular mechanical unloadingduring cardiogenic shock via a minimally invasive cardiac assist system (Impella CP®) 24 h afteronset and will provide valuable data for acute interventional strategies or future prospective trials.However, JenaMACS, due to its proof-of-concept design, is limited by its single center protocol, witha small sample size and without a comparison group.

Access State: Open Access

Rights information: Attribution (CC BY)

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