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Randomized Controlled Trial
. 2025 Jan 1;10(1):9-16.
doi: 10.1001/jamacardio.2024.4197.

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

Nanna Louise Junker Udesen  1 , Rasmus Paulin Beske  2 , Christian Hassager  2   3 , Lisette Okkels Jensen  2   4 , Hans Eiskjær  5 , Norman Mangner  6 , Amin Polzin  7   8 , P Christian Schulze  9 , Carsten Skurk  10   11 , Peter Nordbeck  12 , Peter Clemmensen  13   14 , Vasileios Panoulas  15 , Sebastian Zimmer  16 , Andreas Schäfer  17 , Nikos Werner  18 , Martin Frydland  2 , Lene Holmvang  2 , Jesper Kjærgaard  2   3 , Thomas Engstøm  2 , Henrik Schmidt  19 , Anders Junker  1 , Christian Juhl Terkelsen  5 , Steffen Christensen  20 , Axel Linke  6 , Jacob Eifer Møller  1   2   4 ; DanGer Shock Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Nanna Louise Junker Udesen et al. JAMA Cardiol. .

Abstract

Importance: 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.

Objective: To determine if an MAFP reduces the need for pharmacological circulatory support without compromising hemodynamics compared with standard care in STEMI-CS.

Design, setting, and participants: 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.

Interventions: MAFP and standard of care or standard of care alone.

Main outcomes and measures: 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.

Results: 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.

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT01633502.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Udesen reported receiving grants from Abiomed during the conduct of the study. Dr Jensen reported receiving grants from Biotronik, Biosensors, and OrbusNeich outside the submitted work. Dr Mangner reported receiving grants from Abiomed and Boston Scientific outside the submitted work and personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Daiichi Sankyo, Abbott, Abiomed, B. Braun, and Boston Scientific. Dr Polzin reported receiving grants and personal fees from Abiomed during the conduct of the study. Dr Skurk reported receiving educational honoraria from Abiomed. Dr Nordbeck reported receiving lecture and advisory fees from Abiomed outside the submitted work. Dr Clemmensen reported receiving funding from University of Southern Denmark; fees for managing the clinical trial unit from Abbott, Abiomed, AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Evolva, Fibrex, Janssen, Merck, Myogen, Medtronic, Mitsubishi Pharma, Novo Nordisk, The Medicines Company, Nycomed, Organon, Pfizer, Pharmacia, Regado, Sanofi, Searle, and Servier; working with Western Institutional Review Board and Copernicus Group; and receiving data safety monitoring board and clinical committee fees from wcgTM Clinical Solutions, Princeton, New Jersey (AstraZeneca, Boehringer Ingelheim, Janssen). Dr Panoulas reported receiving grants and honoraria from Abiomed J&J during the conduct of the study. Dr Zimmer reported receiving trial fees from Abiomed during the conduct of the study. Dr Schaefer reported receiving grants and personal fees from Abiomed outside the submitted work. Dr Werner reported receiving grants and speaker fees from Abiomed and speaker fees, advisory board fees, travel expenses, and personal fees from Shockwave outside the submitted work. Dr Holmvang reported receiving a travel grant from Boston Scientific outside the submitted work. Dr Kjærgaard reported receiving grants from Novo Nordisk Foundation outside the submitted work. Dr Engstrøm reported receiving speaker/personal fees from Abbott, Boston Scientific, and Novo Nordisk outside the submitted work. Dr Terkelsen reported receiving grants and personal fees from Meril; personal fees from Edwards; grants from Medtronic; and personal fees from Terumo outside the submitted work. Dr Linke reported receiving personal fees from Abiomed, Abbott, Boston Scientific, Novartis, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Pfizer, Meril; personal fees and grants from Edwards Lifesciences; and stock options from Picardia, Transverse Medical, and Filterlex outside the submitted work. Dr Møller reported receiving grants from Abiomed and Hjerteforeningen and personal/advisory/speaker fees from Boston Scientific, Abbott, and Boehringer Ingelheim outside the submitted work. No other disclosures were reported.

Comment in

References

    1. Aissaoui N, Puymirat E, Delmas C, et al. . Trends in cardiogenic shock complicating acute myocardial infarction. Eur J Heart Fail. 2020;22(4):664-672. doi:10.1002/ejhf.1750 - DOI - PubMed
    1. Bogerd M, Ten Berg S, Peters EJ, et al. . Impella and venoarterial extracorporeal membrane oxygenation in cardiogenic shock complicating acute myocardial infarction. Eur J Heart Fail. 2023;25(11):2021-2031. doi:10.1002/ejhf.3025 - DOI - PubMed
    1. Helgestad OKL, Josiassen J, Hassager C, et al. . Temporal trends in incidence and patient characteristics in cardiogenic shock following acute myocardial infarction from 2010 to 2017: a Danish cohort study. Eur J Heart Fail. 2019;21(11):1370-1378. doi:10.1002/ejhf.1566 - DOI - PubMed
    1. Hochman JS, Sleeper LA, Webb JG, et al. . Early revascularization in acute myocardial infarction complicated by cardiogenic shock—SHOCK Investigators: should we emergently revascularize occluded coronaries for cardiogenic shock. N Engl J Med. 1999;341(9):625-634. doi:10.1056/NEJM199908263410901 - DOI - PubMed
    1. Léopold V, Gayat E, Pirracchio R, et al. . Epinephrine and short-term survival in cardiogenic shock: an individual data meta-analysis of 2583 patients. Intensive Care Med. 2018;44(6):847-856. doi:10.1007/s00134-018-5222-9 - DOI - PubMed

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