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Randomized Controlled Trial
. 2025 Feb 18;85(6):595-603.
doi: 10.1016/j.jacc.2024.11.003. Epub 2024 Nov 15.

Treating Older Patients in Cardiogenic Shock With a Microaxial Flow Pump: Is it DANGERous?

Anika Klein  1 , Rasmus P Beske  1 , Christian Hassager  2 , Lisette O Jensen  3 , Hans Eiskjær  4 , Norman Mangner  5 , Axel Linke  5 , Amin Polzin  6 , P Christian Schulze  7 , Carsten Skurk  8 , Peter Nordbeck  9 , Peter Clemmensen  10 , Vasileios Panoulas  11 , Sebastian Zimmer  12 , Andreas Schäfer  13 , Nikos Werner  14 , Thomas Engstøm  1 , Lene Holmvang  1 , Anders Junker  15 , Henrik Schmidt  16 , Christian J Terkelsen  4 , Jacob E Møller  17 ; DanGer Shock Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Treating Older Patients in Cardiogenic Shock With a Microaxial Flow Pump: Is it DANGERous?

Anika Klein et al. J Am Coll Cardiol. .

Abstract

Background: Whether age impacts the recently demonstrated survival benefit of microaxial flow pump (mAFP) treatment in patients with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock (CS) is unknown.

Objectives: The purpose of this study was to assess the impact of age on mortality and complication rates in patients with STEMI-related CS randomized to standard care or mAFP on top of standard care.

Methods: This is a secondary analysis of the Danish-German Cardiogenic Shock (DanGer Shock) trial, an international, multicenter, open-label trial, in which 355 adult patients with STEMI-related CS were randomized to receive an mAFP (Impella CP) plus standard care or standard care alone. The primary outcome of 180-day all-cause mortality is analyzed according to age and intervention.

Results: From lowest to highest age quartile, the median ages (range) were 54 years (Q1-Q3: 31-59 years), 65 years (Q1-Q3: 60-69 years), 73 years (Q1-Q3: 70-76 years), and 81 years (Q1-Q3: 77-92 years). There were no differences in blood pressure, lactate level, left ventricular ejection fraction, or shock severity at randomization across age groups. Mortality increased from lowest to highest quartile (31%, 47%, 61%, and 73%, respectively; log-rank P < 0.001), with an adjusted OR for death at 180 days of 7.85 (95% CI: 3.37-19.2; P < 0.001) in the highest quartile compared to the lowest. The predicted risk of mortality was higher in the standard-care group until approximately 77 years, after which the predicted risk became higher in the mAFP group (P = 0.20). In patients <77 years, a reduced 180-day mortality was observed in patients randomized to the mAFP (OR: 0.45; 95% CI: 0.28-0.73; P = 0.001), opposed to patients aged ≥77 years (OR: 1.52; 95% CI: 0.57-4.08; P = 0.40), P for interaction = 0.028. Complications were more frequent in the mAFP group, but there were no apparent differences in incidence of complications across all ages.

Conclusions: This exploratory secondary analysis of the DanGer Shock trial demonstrates that older patients with STEMI-related CS experience high mortality and may not attain the same benefit from routine treatment with an mAFP as younger patients. Incorporating age as a factor in patient selection may enhance the overall benefit of this therapy. (Danish Cardiogenic Shock Trial [DanShock]; NCT01633502).

Keywords: ST-segment elevation myocardial infarction; age; cardiogenic shock; microaxial flow pump.

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Conflict of interest statement

Funding Support and Author Disclosures Supported by the Danish Heart Foundation and Abiomed. Dr Hassager has received institutional research grants from the Danish Heart Foundation, Lundbeck Foundation, and the Novo Nordisk Foundation. Dr Eiskjær has received institutional research grants from the Nordisk Foundation and the Independent Research Fund Denmark; and has received speaker fees from Novartis. Dr Mangner has received a research and educational grant from Abiomed; has received an educational grant from Boston Scientific; and has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Daiichi-Sankyo, Abbott, Abiomed, B. Braun, and Boston Scientific. Dr Linke has received consultant and speaker honoraria from Abbott Laboratories, Abiomed, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific Corporation, Corvia, Daiichi-Sankyo Europe GmbH, Edwards Lifesciences, Medtronic USA, Novartis, and Pfizer; and has received stock options from Picardia and Transverse Medical Inc. Dr Polzin has received institutional research grants and personal speaker honoraria from Abiomed. Dr Schulze has received grants from Boehringer Ingelheim, Abiomed Inc, Edwards Inc, Cytosorb Inc, and Boston Scientific; has received consulting fees and/or honoraria from Bayer, AstraZeneca, Daiichi- Sankyo, Novartis, Actelion, Roche, Sanofi, Pharmacosmos, Medtronic, Thoratec, Boehringer Ingelheim, Heartware, Coronus, Abbott, Boston Scientific, St Jude Medical, Abiomed, and DGK; and has performed trial committee work for Abbott and Abiomed. Dr Skurk has received speakers fee from Abiomed. Dr Nordbeck has received speaker honoraria from Abiomed, Bayer Healthcare, Boehringer Ingelheim, Daiichi-Sankyo Europe GmbH, and Pfizer. Dr Clemmensen has previous or current involvement in research contracts, consulting, and speakers bureau or received research and educational grants from Abbott, Abiomed, AliveCor Inc. AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CeleCor, Daiichi-Sankyo, Eli Lilly, Evolva, Fibrex, Idorsia, IQVIA, Janssen, Merck, Myogen, Medtronic, Mitsubishi Pharma, The Medicines Company, Nycomed, Organon, Pfizer, Pharmacia, Philips, Regado, Sanofi, Searle, Servier, and ViFor Pharma. Dr Panoulas has received consultant fees, honoraria, and an educational grant from Abiomed J&JVP. Dr Zimmer is an advisory board consultant for Abiomed. Dr Schäfer has received honoraria from Abiomed, ZOLL circulation, AstraZeneca, Amgen, Bristol Myers Squibb, Pfizer, Daiichi-Sankyo, Eli Lilly, and Boehringer Ingelheim; and has received institutional grants from Abiomed and Daiichi-Sankyo. Dr Werner has received consulting fees fromAbiomed, Boehringer Ingelheim, ShockWave Medical, and Protembis. Dr Engstøm has received educational grants from the Novo Nordisk Foundation and the Danish Heart Foundation; has received speaker fees from Boston Scientific, Abbott, and Novo Nordisk; and has received advisory board fees from Novo Nordisk and Abbott. Dr Terkelsen has received research grants from the Novo Nordisk Foundation and the Danish Heart Foundation; and has received unrestricted research grants and lecture and proctor fees from Meril and Terumo. Dr Møller has received institutional research grants from Abiomed and the Novo Nordisk Foundation; and has received advisory board consultant fees from Boston Scientific. The other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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