Summary of AKI Data with Impella Unloading

August 9, 2019

Study shows lower than predicted incidence of post-procedural AKI in Protected PCI patients

Dr. Seth Bilazarian, chief medical officer at Abiomed, discusses AKI data from the paper published by Flaherty, et. al, in Catheterization and Cardiac Intervention. This data is in addition to existing data and abstracts published by Flaherty, et al, and Westenfeld, et. al, on reduction of AKI and furthers clinical understanding of reducing risk of AKI with Impella® supported Protected PCI.

Data from the CathPCI registry show that patients who suffer an acute kidney injury during PCI also have an absolute in-hospital mortality of 10%, suffer AMI at a rate of 4%, and have a 6% chance of a major bleeding event, along with prolonged length of stay and added cost to treat.

In 2017, Dr. Michael Flaherty, University of Louisville, performed a single-center study, comparing patients supported with Impella during high-risk PCI procedures to those not supported with Impella. In this patient population, there was a reduction in incidences of AKI from 28% to 5% between the patient cohort not supported with Impella to the patient cohort that received Impella support respectively.

Recently, new data was explored by Dr. Flaherty and Dr. Roxanna Mehran on this topic using a data collection of patients from the cVAD Study and published in Catheterization and Cardiac Intervention. The objective was to assess whether hemodynamic support with Impella during high-risk PCI would decrease acute kidney injury relative to the calculated predicted risk of AKI in high-risk PCI cohort. When Impella support is used during high-risk PCI, the overall incidence of post-procedural acute kidney injury (AKI) is significantly reduced relative to the predicted risk, 4.9% vs., 21.9% (a 78% risk decrease); despite severely reduced EF, anemia, DM, prolonged procedure time, and contrast volume. Observed AKI in this cohort was lower than the predicted AKI rates despite worsening CKD. However, when controlling for clinical and procedural variables, worsening renal function was a predictor for AKI.

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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/