Acute Hemodynamic Impact of Ventricular Unloading Using the IMPELLA CP Assist Device in Patients with Cardiogenic Shock – Results from the JENAMACS Trial

https://doi.org/10.1007/s00392-025-02625-4

Franz Härtel (Jena)1, J. Bogoviku (Jena)1, J. G. Westphal (Jena)1, L. Baez (Jena)1, S. Otto (Gera)2, B. Lauer (Jena)1, G. Dannberg (Jena)1, R. Pfeifer (Jena)1, M. Fritzenwanger (Jena)1, O. Weingärtner (Jena)1, N. Memisevic (Jena)1, M. Franz (Rotenburg an der Fulda)3, C. Schulze (Jena)1, S. Möbius-Winkler (Jena)1

1Universitätsklinikum Jena Klinik für Innere Medizin I - Kardiologie Jena, Deutschland; 2Herz- und Gefäßpraxis Gera, Internistisch-kardiologische Gemeinschaftspraxis Gera, Deutschland; 3Herz-Kreislauf-Zentrum, Klinikum Hersfeld-Rotenburg GmbH Klinik für Kardiologie, Angiologie und Intensivmedizin Rotenburg an der Fulda, Deutschland

 

BACKGROUND and OBJECTIVE 

Despite aggressive therapeutic strategies including mechanical circulatory support (MCS) devices, mortality of patients with cardiogenic shock (CS) due to myocardial infarction or decompensated heart failure remains alarmingly high, ranging up to 50%. While the Impleaa system offers a limited option for left ventricular (LV) unloading, the use of MCS via veno - arterial extracorporeal membrane oxygenation (VA - ECMO) in contrast presents challenges for hemodynamic stabilization due to its potential to increase LV afterload and the associated increase in invasiveness. The objective of this study is to evaluate the hemodynamic short - term effects of LV unloading in patients with CS following Impella implantation.

 

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. Between 2018 and 2022, our study enrolled 21 patients experiencing cardiogenic shock (CS) attributed to acute or acute – on - chronic heart failure, who were subsequently treated with an Impella CP as an LV - assist device. Each patient underwent comprehensive hemodynamic and echocardiographic assessments at three specific time points: immediately prior to Impella implantation, after 10 minutes of Impella support, and again after 24 hours of Impella support. Hemodynamic evaluation involved Swan - Ganz catheter measurements, while echocardiography followed a standardized algorithm for assessment.

RESULTS

Our study included 16 male and 5 female patients, with a mean age of 68.9 ± 11.9. Among the patients, 12 had acute heart failure due to acute coronary syndrome (ACS), while 9 had acute-on-chronic heart failure due to dilated cardiomyopathy (DCM). Changes in hemodynamics were recorded as follows: a significant reduction in pulmonary capillary wedge pressure (PCWP) from 28.9 ± 9.6mmHg to 19.6 ± 7.4 mmHg (p < 0.05), a mean pulmonary artery pressure (PAP) from 36.7 ± 8.1mmHg to 28.9 ± 8.7mmHg (p < 0.05) and a cardiac index increase from 1.9 ± 0.6 L/min to 2.9 ± 0.8 L/min (p < 0.05). Other changes indicated trends and involved: a pulmonary artery oxygen saturation improvement from 53.2 ± 14.7% to 59.2 ± 7.4% (p=0.13), a decrease in central venous pressure from 14.3 ± 5.5 mmHg to 11.8 ± 5.2mmHg (p=0.16). Echocardiographic data revealed trends and demonstrated: an improvement in left ventricular ejection fraction (LVEF) from 24.7 ± 9.8% to 26.8 ± 8.1% (p=0.47),  right ventricular enddiastolic diameter (RVEDD) from 44.8 ± 10.5mm to 39.7 ± 7.5mm (p = 0.094) and tricuspid annular plane systolic excursion (TAPSE) from 17.2 ± 4.1mm to 18.7 ± 2.7mm (p= 0.19).

CONCLUSION

LV unloading within a period of 24 hours following Impella implantation in CS is associated with improved hemodynamics measured by Swan - Ganz catheter. Possible improvements leading to reduced echocardiographic RV diameter and improved RV / LV ejection fraction might require a period longer than 24 hours of Impella support.

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