Johnson & Johnson (J&J) has presented clinical data at the European Society of Cardiology Congress and published in the New England Journal of Medicine. The data shows that the routine use of Impella CP in heart attack patients with cardiogenic shock results in a 16.3% absolute reduction in mortality at 10 years, compared to standard care. Patients with Impella CP gained an average of 600 additional days of life. The trial recruited 360 participants at 14 sites in Denmark, Germany, and the UK between 2013 and 2023.
Johnson & Johnson (J&J) has presented compelling clinical data at the European Society of Cardiology Congress, which was also published in the New England Journal of Medicine. The study, titled "Long Term Outcomes of the DanGer Shock Trial," demonstrates that the routine use of Impella CP in patients who have experienced a heart attack with cardiogenic shock results in a significant 16.3% absolute reduction in mortality at 10 years, compared to standard care. This finding is a substantial advancement in the field of mechanical circulatory support (MCS).
The trial, known as the DanGer Shock randomized controlled trial (RCT), enrolled 360 participants across 14 sites in Denmark, Germany, and the United Kingdom between 2013 and 2023. The study found that patients using Impella CP gained an average of 600 additional days of life compared to those receiving standard care. This improvement is a testament to the device's ability to enhance patient outcomes and quality of life.
The data presented at the ESC Congress and published in the NEJM further validates the original findings of the DanGer Shock RCT, which was initially presented at the American College of Cardiology (ACC) in May 2024. The American College of Cardiology and American Heart Association have upgraded Impella to a class 2a guideline based on these findings.
Approximately 750,000 people in the United States experience an ST-elevation myocardial infarction (STEMI), an acute heart attack, each year. The overall incidence rate of cardiogenic shock in patients with STEMI is up to 10%. Cardiogenic shock is the leading cause of in-hospital mortality in patients with STEMI, highlighting the critical need for innovative treatments like Impella CP.
Impella CP, 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 enables patients to return to their life and families with their native heart and experience an equal – or improved – quality of life.
References:
[1] https://www.prnewswire.com/news-releases/new-data-from-the-danger-shock-randomized-control-trial-published-in-the-new-england-journal-of-medicine-confirms-the-long-term-survival-benefit-of-the-impella-cp-heart-pump-302542682.html
[2] https://www.biospace.com/press-releases/new-data-from-the-danger-shock-randomized-control-trial-published-in-the-new-england-journal-of-medicine-confirms-the-long-term-survival-benefit-of-the-impella-cp-heart-pump
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