National Cardiogenic Shock Initiative Update

November 25, 2019

Dr. Bill O’Neill Discusses Ongoing Progress in NCSI

Bill O’Neill, MD presents some of the overall outcomes for the first 250 patients prospectively enrolled in the National Cardiogenic Shock Initiative (NCSI). Dr. O’Neill is the medical director of the Center for Structural Heart Disease at Henry Ford Hospital.

Dr. O’Neill recounts that in the Fall of 2016, the Detroit Cardiogenic Shock Initiative was launched in 5 hospital systems in Detroit to look for a systematic approach to managing patients with AMI cardiogenic shock with Impella. The initiative then went national and “the overall outcomes have been consistently positive,” he tells interviewer Dr. Cathy Jeon. Dr. O’Neill reports overall survival rate of 72% and 90% of patients have TIMI 3 flow post-PCI. He also noted that data is now available on right ventricular dysfunction and useful culprit data for clinicians.

In the next phase of investigation, Dr. O’Neill explains that the aim is to get survival rates to exceed 80% and he notes that the focus is on patients who are not doing well early on, notably patients with cardiac power output (CPO) less than 0.8, who have a higher mortality. He hopes to have data within a year on whether early escalation of support may improve survival.

Dr. O’Neill also reports that, as announced at TCT 2019, NCSI is becoming the International Cardiogenic Shock Initiative, with collaborators in Hong Kong, Singapore, Japan, Germany, and Milan. While this initiative will continue to accrue information, Dr. O’Neill notes that the initiative has already identified a pathway to success. “If you have a patient with acute MI shock, and you treat them with early Impella, before you do the PCI, and you use hemodynamics to guide management, you should be able to get more than a 70% survival.” he tells Dr. Jeon. “We have set the standard now for management of acute MI shock. And anyone that is treating these patients really has to strive to reach those goals.”

Dr. O’Neill also tells Dr. Jeon, “We have a very good appreciation of the outcome for these patients within the first 24 hours of care, which I think is a great advance.” He explains that it is becoming possible within the first 12 hours of managing the AMI cardiogenic shock patient, to begin to figure out the patient’s trajectory. Within the first 12 to 24 hours, if the CPO normalizes and if the lactate washes out, those patients do very well and can have Impella removed within the next day or so. “Conversely, at 12 to 24 hours if the CPO remains sort of lowish, less than 0.8, and the lactates remain persistently elevated, then they’re not doing well, and you have to figure out how to change the trajectory.”

As Dr. Jeon notes, Dr. O’Neill is continuing to change the landscape of AMI cardiogenic shock management and we’re excited to follow his pioneering efforts on this journey.

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To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/

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