Ripped From the Headlines of ACC: DanGer Shock RCT Results

Chuck Simonton, M.D., and a panel of physicians—Navin Kapur, M.D., Katherine Kunkel, M.D., Amir Kaki, M.D., and Aditya Bharadwaj, M.D.—provide perspectives and insights regarding the DanGer Shock randomized controlled trial data presented as a late breaker at the 2024 American College of Cardiology Scientific Session and simultaneously published in the New England Journal of Medicine.

“It has been 25 long years since we've had a positive trial in this space,” Dr. Bharadwaj emphasizes in the opening of his presentation of the clinical data leading up to the DanGer Shock trial. He mentions trials, such as IABP Shock II and ECLS Shock, in which IABP and ECMO were not shown to improve mortality in acute myocardial infarction cardiogenic shock (AMICS) and he highlights some of the best practices emerging from observational studies, such as early identification, early unloading with Impella® and use of right heart catheters to determine weaning and escalation strategies. 

In an interview recorded at ACC, Jacob Møller, M.D., the principal investigator of the DanGer Shock trial, discusses trial results. “For the primary endpoint we saw an absolute reduction in all-cause mortality of 13%,” Dr. Møller reports. While mortality was high in both groups, he calls the 13% reduction “quite remarkable” and notes that the curves kept separating. He highlights the ability of Impella to lower both wall stress and filling pressure as a key to heart recovery, and also discusses the importance of patient selection and the risk/benefit balance in these patients. 

“I think we now have a mandate on, an emphasis on early recognition of shock,” Dr. Kunkel states in her discussion of how the results from the DanGer Shock trial will move practice forward. She emphasizes the need for drawing lactate as a default in STEMI patients, improving device and complications management, becoming more facile at escalating and de-escalating patients and the importance of disseminating best practices out to community hospitals.

“I'm excited for the life in the post-DanGer era. I think it opens up huge possibilities,” Dr. Kapur emphasizes. “We are now in a data enriched zone. The DanGer Shock trial provides unequivocal evidence for the use of Impella to reduce mortality and LV dominant STEMI shock.” He also states, “one of the most important things is that DanGer illustrates that early LV support improves late term survival in STEMI and shock. And this is counter to our current real-world practice here in the United States.”

“One of the things that I think is also critical here in the field for research,” Dr. Kapur adds, “is that we're learning that the power of ventricular unloading extends beyond just the first 24 hours or 30 days. And I think that's critically important because the results of DanGer out to six months really start us to think about what is the effect of what we're doing in that immediate setting and what is the biologic effect, not only for the heart, but also for multiple organs downstream.”

Dr. Kaki concludes the panel discussion talking about complications. He provides insights for reducing stroke, bleeding, limb ischemia, need for temporary renal replacement therapy and sepsis. He highlights many of the best practices from his institution that are already improving complication rates, including replacing heparin in the purge with bicarbonate, using both ultrasound and fluoroscopy for femoral access, bringing patients back to the cath lab for Impella removal and following protocols and utilizing multidisciplinary shock teams. “Rest assured, we have a lot more work to do. But we're going to together do it and get the complication rates down. And I think we could actually even get the survival even better.” 

In the Q&A that follows the panel discusses topics including survival bias, ICU management, protocols and evolving systems of care.

Impella is associated with a number of risks including risk of bleeding and risk of hemolysis. Results vary by patient. Outcomes seen in one patient are not indicative of all patients. To learn more about the important risk and safety information, please visit www.abiomed.com/isi.