April 8, 2024 — A study published in the American College of Cardiology’s Annual Scientific Papers shows that implanting the Impella CP micro-axial flow pump within hours of a heart attack improves 60% of people suffering from cardiogenic shock. sessions that significantly improved survival rates after months.

Cardiogenic shock occurs in approximately 5% to 10% of heart attacks and is one of the leading causes of heart attack-related mortality. This occurs when the heart suddenly cannot pump enough blood to meet the body’s needs, depriving the heart and other vital organs of oxygen and often resulting in death if not treated immediately. It happens. The study met its primary endpoint and suggests the device may help improve survival rates in these severe cases by helping restore the flow of oxygen-rich blood into the body. ing.

Jacob E. Moller, MD

“This is the first time in a very long time that we have had positive studies on the management of cardiogenic shock,” said Dr. Kremlin, a professor in the Department of Cardiology at Odense University Hospital in Denmark and a consultant in the Center for Cardiac Intensive Care. said Jacob E. Moller, MD. Care Unit of Copenhagen University Hospital Rigshospitalet and lead author of the study. “I think this will become a routine device used for patients with these hopeless diseases.”

The Impella CP is a small transcutaneous pump that is placed in the left ventricle of the heart and pumps oxygenated blood from the left ventricle to the body at a flow rate of up to 3.5 liters per minute. Previous trials evaluating the potential benefits of this and other heart pumps for cardiogenic shock have yielded mixed results. The new trial, called DanGer Shock, investigated whether the use of microaxial flow pumps could improve survival in ST-elevation myocardial infarction (STEMI, the most severe type of heart attack) complicated by cardiogenic shock. This is the first test aimed at finding out whether .

The trial enrolled 360 patients treated for STEMI with cardiogenic shock at 14 centers in Denmark, Germany, and the United Kingdom. Patients who were in a coma and had an out-of-hospital cardiac arrest, putting them at increased risk of brain injury, were excluded from the study. Researchers randomly assigned patients to receive standard treatment or standard treatment plus treatment with the Impella CP pump. Participants were randomly assigned, depending on when they were diagnosed with cardiogenic shock, before, during, or within 12 hours after treatment in the cardiac catheterization laboratory.

Of the 355 patients included in the analysis, 58.5% of those receiving standard care alone and 45.8% of those receiving the Impella pump died 6 months after randomization. The heart pump reduced mortality by 13 percentage points in absolute terms, the study’s primary endpoint. Additionally, the results showed that patients who received heart pumps had a reduction in the composite endpoint of additional ventricular support, heart transplantation, or death, although there was no difference in hospital discharge days between the two groups. did.

“What was surprising to us was that the effects seemed to last beyond 30 days,” Moller said. “It looks like we’re not just saving lives, we’re saving heart muscle.” [heart muscle] Therefore, patients continue to survive and the survival curves continue to separate beyond the first 30 days. ”

However, the results also showed significantly higher rates of complications such as bleeding, limb ischemia, renal replacement therapy, and sepsis among patients who received heart pumps.

“It’s not cost-free, and we’ve seen more severe complications in patients treated with Impella,” Moller said. “Overall, we’re seeing more complications, but we’re also saving lives.”

Professor Moller said the trial was an improvement over previous studies in terms of identifying the patients most likely to benefit from the use of heart pumps, e.g. He said the study could not be generalized to all cases of cardiogenic shock, as it was more selective than the trial. Risk of brain damage. However, within this patient population, the results are likely to be transferable beyond Northern Europe to large centers with the necessary expertise to use the device, he said.

Subgroup analyzes suggested that patients with very low blood pressure or with multiple coronary artery lesions may benefit more from Impella pumps. Moller will evaluate the benefit in a more diverse patient population, investigate how the duration of mechanical support affects the incidence of serious complications, and aim to minimize complications. further research is needed to identify opportunities to further optimize practice.

The study was funded by the Danish Heart Foundation and Abiomed/Johnson & Johnson, the manufacturer of Impella CP.

The study was published online in the New England Journal of Medicine upon publication.

For more information, please visit www.acc.org.

Click here for detailed coverage of the ACC24 conference.