DanGer Shock Discussion with Jacob Møller at TCT 2024

Jacob Møller, MD, and Chuck Simonton, MD, discuss the DangerShock randomized controlled trial (RCT), which Dr. Simonton deems, “probably the most impactful trial in interventional cardiology in the last 20 years.” Dr. Møller is the principal investigator of the DanGer Shock trial, which showed a significant reduction in mortality in patients supported with Impella® heart pump with a number-needed-to-treat (NNT) of 8 to save a life and absolute mortality reduction of 12.7%.

Dr. Møller and Dr. Simonton discuss the unique phenotype of the patients enrolled in the trial, emphasizing how sick the patient population was and the prevalence of left ventricular (LV) failure. They address the paradox of lower mortality among patients having cardiac arrest and highlight the role of left ventricular unloading in patients supported with the Impella.

Dr. Møller discusses new DanGer Shock data he presented at TCT 2024. He begins with data showing faster lactate clearance, as well as reduced need for vasopressors and inotropes in patients supported with the Impella in DanGer Shock. Then he discusses the complex issue of acute kidney injury (AKI) and new data from the study indicating that it is often related to suction events with Impella. “So, if the Impella is not running perfectly,” he emphasizes, “you should really take it seriously. Go back and see what is the placement of the device, because that was very strongly associated with AKI.”

Next, Dr. Møller highlights new bleeding data, explaining that only about 25% of bleeding is access site bleeding, and less than 3% of bleeding occurs in the cath lab. He reports that only 45-47% of bleeding events occur while the Impella is in place and the rest occur after the device is removed. Dr. Møller also discusses why BARC may be a poor measure of bleeding in the DanGer Shock patients.

Finally, Dr. Møller discusses the “really important and really intriguing” reported finding that women did not benefit in the DanGer Shock trial. “It’s not about small hearts and small access vessels,” he tells Dr. Simonton. “It’s something completely different.” He explains that women are 10 years older when they present in shock and that they come in later. “Symptom to balloon time is more than twice as long in women than in men. And the time from onset of symptoms to support time is even longer.” Dr. Møller reports that even the time from arrival at the hospital to balloon is longer in women. However, he emphasizes that these factors, just like suction events, are modifiable.