Latest advancements in heart disease treatment with Impella highlighted at ACC.25 - Johnson & Johnson MedTech

Last month, the ACC and the American Heart Association (AHA) updated their guideline for the treatment of acute coronary syndrome (ACS), upgrading Impella from Class 2b to Class 2a due to Impella’s proven ability to increase survival in patients with cardiogenic shock secondary to ST-segment elevation myocardial infarction (STEMI). The guideline update states it is reasonable to specifically use Impella in this patient population and that its survival benefit outweighs the risk. 

ACC/AHA Updated Guideline
The guideline upgrade for Impella (Impella CP) is based on evidence from the DanGer Shock RCT, which was published in the New England Journal of Medicine (see citation below) and presented at ACC.24. DanGer Shock is the first acute myocardial infarction cardiogenic shock (AMICS) trial to achieve its primary survival endpoint and showed a 26% overall relative risk reduction with a number needed to treat of 8 (p-0.04) in patients treated with Impella compared to the control arm. Since the data was released last year, multiple DanGer Shock sub analyses have been published, providing important details about the data:

i) A Journal of the American College of Cardiology study demonstrates that patients under 77 years of age experience an even greater effect with an NNT of 5 (p=0.001).

ii) A JAMA Cardiology study shows that Impella reversed shock-related lactic acidosis significantly faster than controls and reduces the dependency on vasoactive drugs. 

“The DanGer Shock RCT results provide the highest level of scientific evidence demonstrating that Impella CP increases survival in patients with cardiogenic shock secondary to STEMI, which led the ACC/AHA to update their acute coronary syndrome treatment guideline within a year of the data being released,” says Chuck Simonton, MD, Executive Vice President and Chief Medical Officer, Heart Recovery, Johnson & Johnson MedTech. “We will continue working with healthcare professionals to ensure that they are equipped with the training and clinical support necessary to implement guideline-informed care in their institutions, which will allow more patients to achieve heart recovery.”

Additional subanalyses show that adverse events in the DanGer Shock RCT are transient, including that bleeding was not associated with an impact on survival and no patients requiring temporary dialysis remained on dialysis at six months. Previous studies have demonstrated that STEMI-related cardiogenic shock patient outcomes can be further optimized with the use of Impella best practices, including a 2023 Japanese Percutaneous Ventricular Assist Device (J-PVAD) publication.

Impella, the world’s smallest heart pump, is inserted into the heart to temporarily take over the heart’s pumping function, allowing the heart to rest and recover while maintaining the flow of oxygenated blood throughout the body. This therapy allows patients to return to their life and families with their native heart and experience an equal – or improved – quality of life.

Citations: Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. Authors: Jacob E. Møller, D.M.Sc., Thomas Engstrøm, D.M.Sc., Lisette O. Jensen, D.M.Sc. et al. Published April 7, 2024 N Engl J Med 2024;390:1382-1393 DOI: 10.1056/NEJMoa2312572 VOL. 390 NO. 15

Treating Older Patients in Cardiogenic Shock With a Microaxial Flow Pump: Is it DANGERous? Authors: Anika Klein, Rasmus P. Beske, Christian Hassager, Lisette O. Jensen et al. JACC. 2025 Feb, 85 (6) 595–603

Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic ShockA Substudy of the DanGer Shock Randomized Clinical Trial. Authors: Nanna Louise Junker Udesen, MD, PhD; Rasmus Paulin Beske, MD; Christian Hassager, MD, DMSc; et al. JAMA Cardiol. 2025;10(1):9-16. doi:10.1001/jamacardio.2024.4197