Door to Unloading Trial Indicates Unloading Plus 30 Minute Delay Reduces Reperfusion Injury, and Results in Smaller Infarct Size.

Hackensack University Medical Center One of Twelve Hospitals Participating in Groundbreaking Pivotal Trial.

In patients with STEMI the standard of care has been door to balloon time. Hackensack University Medical Center has been a lead participant in two clinical studies to examine the benefits of unloading the left ventricle prior to reperfusion.

In a pilot study, unloading the left ventricle with the Impella CP mechanical circulatory support device and delaying PCI by 30 minutes appeared to be feasible and safe in patients with STEMI who did not have cardiogenic shock. Hackensack University Medical Center, 1 of 12 sites chosen for the trial, had the 2nd highest enrollment with 50 patients. The study compared results and confirmed using Impella for 30 minutes – resting the heart – prior to catheterization improved outcomes. The associated increase in door-to-balloon time from 73 to 97 minutes—did not increase adverse events or infarct size at 30 days.

There has been a lot of preclinical work done on mechanically unloading the left ventricle to reduce infarct size and reduce the development of heart failure after MI, with evidence suggesting that unloading alone is not sufficient. Unloading plus a delay of 30 minutes before PCI conditions the myocardium so that there’s less reperfusion injury, and as a result the infarct size is even smaller.

Hackensack University Medical Center is one of twelve U.S. centers now participating in the pivotal trial, which will compare LV unloading before reperfusion to the current standard of care

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