1. Rationale and Design of JenaMACS—Acute Hemodynamic Impact of Ventricular Unloading Using the Impella CP Assist Device in Patients with Cardiogenic Shock
- Author
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Haertel, Franz, Lenk, Karsten, Fritzenwanger, Michael, Pfeifer, Ruediger, Franz, Marcus, Memisevic, Nedim, Otto, Sylvia, Lauer, Bernward, Weingärtner, Oliver, Kretzschmar, Daniel, Dannberg, Gudrun, Westphal, Julian, Baez, Laura, Bogoviku, Jurgen, Schulze, P. Christian, Moebius-Winkler, Sven, Haertel, Franz, Lenk, Karsten, Fritzenwanger, Michael, Pfeifer, Ruediger, Franz, Marcus, Memisevic, Nedim, Otto, Sylvia, Lauer, Bernward, Weingärtner, Oliver, Kretzschmar, Daniel, Dannberg, Gudrun, Westphal, Julian, Baez, Laura, Bogoviku, Jurgen, Schulze, P. Christian, and Moebius-Winkler, Sven
- Abstract
Introduction: Cardiogenic shock due to myocardial infarction or heart failure entails a reduction 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 solution to reduce mortality and complications. A temporary, ventricular, continuous flow propeller pump using magnetic levitation (Impella®) has been approved for that purpose. Methods and Study Design: JenaMACS (Jena Mechanical Assist Circulatory Support) is a monocenter, proof-of-concept study to determine whether treatment with an Impella CP® leads to improvement of hemodynamic parameters in patients with cardiogenic shock requiring extracorporeal, hemodynamic support. The primary outcomes of JenaMACS are changes in hemodynamic parameters measured by pulmonary artery catheterization and changes in echocardiographic parameters of left and right heart function before and after Impella® implantation at different support levels after 24 h of support. Secondary outcome measures are hemodynamic and echocardiographic changes over time as well as clinical endpoints such as mortality or time to hemodynamic stabilization. Further, laboratory and clinical safety endpoints including severe bleeding, stroke, neurological outcome, peripheral ischemic complications and occurrence of sepsis will be assessed. JenaMACS addresses essential questions of extracorporeal, mechanical, cardiac support with an Impella CP® device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may help to optimize therapy and improve the outcome in those patients. Conclusion: The JenaMACS study will address essential questions of extracorporeal, mechanical, cardiac support with an Impella CP® assist device in patients with cardiogenic shock. Knowledge of the acute and subac
- Published
- 2022