Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial.


Journal

JAMA cardiology
ISSN: 2380-6591
Titre abrégé: JAMA Cardiol
Pays: United States
ID NLM: 101676033

Informations de publication

Date de publication:
27 Oct 2024
Historique:
medline: 27 10 2024
pubmed: 27 10 2024
entrez: 27 10 2024
Statut: aheadofprint

Résumé

Mechanical circulatory support with a microaxial flow pump (MAFP) has been shown to improve survival in ST-elevation myocardial infarction-induced cardiogenic shock (STEMI-CS). Understanding the impact on hemodynamic stability over time is crucial for optimizing patient treatment. To determine if an MAFP reduces the need for pharmacological circulatory support without compromising hemodynamics compared with standard care in STEMI-CS. This was a substudy of the Danish-German (DanGer) Shock trial, an international, multicenter, open-label randomized clinical trial. Patients from 14 heart centers across Denmark, Germany, and the UK were enrolled. Inclusion criteria for the trial were STEMI and systolic blood pressure less than 100 mm Hg or ongoing vasopressor treatment, left ventricular ejection fraction less than 45%, and arterial lactate level greater than 2.5 mmol/L. Of the enrolled patients, after exclusions from death in the catheterization laboratory or immediately on intensive care unit (ICU) admission, the remaining patients had serial recordings of hemodynamics, arterial lactate, and use of vasoactive drugs. Patients who were in comas after cardiac arrest and patients with mechanical complications or right ventricular failure were excluded. Data were analyzed from May to September 2024. MAFP and standard of care or standard of care alone. Hemodynamic status in terms of heart rate and blood pressure, metabolic status in terms of arterial lactate concentration, and vasoactive-inotropic score (VIS). The clinical events during the first 72 hours were as follows: death from all causes, escalation of mechanical circulatory support, and discharge alive from the ICU. From 355 enrolled patients, 324 (mean [IQR] age, 68 [58-75] years; 259 male [80%]) underwent ICU treatment (169 [52%] in the MAFP group, 155 [48%] in the standard-care group). Baseline characteristics were balanced. There was no difference in heart rate between groups, and mean arterial pressure was above the treatment target of 65 mm Hg in both groups but was achieved with a lower VIS in the MAFP group. No difference in arterial lactate level was found between groups at randomization, but on arrival to the ICU, the MAFP group had significantly lower arterial lactate levels compared with the standard-care group (mean difference, 1.3 mmol/L; 95% CI, 0.7-1.9 mmol/L), a difference that persisted throughout the first 24 hours of observation. The MAFP group achieved lactate normalization (<2 mmol/L) 12 hours (95% CI, 5-18 hours) before the standard-care group. Use of a MAFP reduces the use of vasopressors and inotropic medication while maintaining hemodynamic stability and achieving faster normalization of lactate level in patients with STEMI-CS. ClinicalTrials.gov Identifier: NCT01633502.

Identifiants

pubmed: 39462240
pii: 2825380
doi: 10.1001/jamacardio.2024.4197
doi:

Banques de données

ClinicalTrials.gov
['NCT01633502']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Investigateurs

Matias G Lindholm (MG)
Jacob T Lønborg (JT)
Søren Boesgaard (S)
Rikke Sørensen (R)
Kristian Wachtell (K)
Hanne B Ravn (HB)
Jens F Lassen (JF)
Karsten T Veien (KT)
Evald H Christiansen (EH)
Felix J Woitek (FJ)
Jennifer Hommel (J)
Sven Moebius-Winkler (S)
Inge De Haas (I)
Ralf Westenfeld (R)

Auteurs

Nanna Louise Junker Udesen (NLJ)

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Rasmus Paulin Beske (RP)

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Christian Hassager (C)

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

Lisette Okkels Jensen (LO)

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Research, University of Southern, Odense, Denmark.

Hans Eiskjær (H)

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Norman Mangner (N)

Department of Internal Medicine and Cardiology, Heart Center Dresden, University Hospital, Technische Universität Dresden, Dresden, Germany.

Amin Polzin (A)

Department of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Cardiovascular Research Institute Düsseldorf (CARID), Düsseldorf, Germany.

P Christian Schulze (PC)

Department of Internal Medicine I, Cardiology, Angiology and Intensive Medical Care, University Hospital Jena, Jena, Germany.

Carsten Skurk (C)

Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany.
Deutsches Zentrum für Herz-Kreislauf-Forschung eV, Berlin, Germany.

Peter Nordbeck (P)

Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany.

Peter Clemmensen (P)

Department of Cardiology, University Heart and Vascular Center (UHZ), University Clinic Hamburg - Eppendorf (UKE), Center for Population Health Research (POINT), Hamburg, Germany.
Department of Cardiology, Zealand University Hospital, Roskilde and Nykøbing Falster, Denmark.

Vasileios Panoulas (V)

Department of Cardiology, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, Harefield Hospital, Harefield, United Kingdom.

Sebastian Zimmer (S)

Department of Cardiology, University Hospital Bonn, Bonn, Germany.

Andreas Schäfer (A)

Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.

Nikos Werner (N)

Department of Internal Medicine III, Heart Center Trier, Krankenhaus der Barmherzigen Brüder, Trier, Germany.

Martin Frydland (M)

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Lene Holmvang (L)

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Jesper Kjærgaard (J)

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

Thomas Engstøm (T)

Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Henrik Schmidt (H)

Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.

Anders Junker (A)

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Christian Juhl Terkelsen (CJ)

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Steffen Christensen (S)

Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.

Axel Linke (A)

Department of Internal Medicine and Cardiology, Heart Center Dresden, University Hospital, Technische Universität Dresden, Dresden, Germany.

Jacob Eifer Møller (JE)

Department of Cardiology, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Research, University of Southern, Odense, Denmark.

Classifications MeSH