Clinical Research & Data, IABP, AMI Cardiogenic Shock, Protected PCI
Bleeding and Vascular Complications: A Look at Impella® Data Over Time
Daniel Raess, MD, presents clinical data on bleeding and vascular complication rates with the Impella® heart pump, providing a perspective on the trajectory the data has taken over time. Dr. Raess is vice president and senior medical director at Abiomed.
Dr. Raess begins his presentation with PROTECT II study data, demonstrating that in 2012, the rate of vascular complications with Impella was similar to IABP, both being less than 2%. Then looking at FDA data and data from large clinical studies in patients with cardiogenic shock, he notes the significant difference in bleeding rates between Impella and competing technologies, such as TandemHeart® and extracorporeal membrane oxygenation (ECMO). The incidence of major or significant bleeding or bleeding requiring transfusion in these patients was between 10% and 15.7% for Impella compared to more than 40% for TandemHeart and ECMO.
Looking at Impella bleeding requiring transfusion reported in FDA studies in the high-risk PCI (HRCI)/STEMI patient population, Dr. Raess describes how the data speak to the learning curve with Impella. Data from the PROTECT II randomized controlled trial (RCT) FDA PMA show that bleeding complications steadily decreased from 14.6% in 2008 to 7.4% in 2010 and continue to decline over time in USpella registry FDA PMA data from 6.1% in 2011 to 4.0% in 2012. He notes that in the most current data from the STEMI DTU™ FDA Pilot study in 2017 and 2018, the rate of bleeding requiring transfusion was 6%.
Looking at the declining bleeding rates since 2008, Dr. Raess notes, “And this is in the face of the fact that during that time the catheter actually got bigger. We went from 12Fr to 14Fr...But there were also procedural and technique improvements that we recognized along the way and the clinical community has adopted. So, we feel that’s an important part of the evolution of the bleeding data over time.”
Dr. Raess also looks at data from centers that do higher volumes of Impella procedures, noting, “we know that as their experience grows, we see a decreased rate of major adverse events and bleeding over time.” This again, demonstrates the learning curve seen in the PROTECT II study and USpella registry data.
In summary, Dr. Raess emphasizes that most of the Impella data is high level clinical data from FDA studies and randomized controlled trials. “In the setting of cardiogenic shock, and that’s basically long-term support,” he explains, “FDA audited studies demonstrate major bleeding rates to be similar between balloon pump and Impella, and considerably lower than extracorporeal centrifugal pumps and ECMO. In the setting of high-risk PCI and STEMI, and these are basically short-term support, FDA audited studies demonstrate major bleeding rates to have reduced over time due to product and technique improvements and increasing user experience leads to similar rates between Impella and balloon pump, despite the very different profile of those two technologies. In the setting of high-risk PCI, FDA-audited and randomized controlled trial data demonstrates similar vascular complication rates between Impella and the balloon pump.”