Clinical Research & Data, Safety & Efficacy, AMI Cardiogenic Shock, Protected PCI
Discover New Data on Protected PCI versus Bailout PCI
Alexander Truesdell, MD discusses Protected PCI versus bailout PCI using data from the cVAD Study and the PROTECT III study. The question he asks is, “What are the outcomes if you use Impella® as a bailout strategy versus planning to use it as part of a Protected PCI procedure?”
Dr. Truesdell begins by reviewing the definition of “bailout,” noting that it includes patients who were having either elective or urgent PCI and did not have cardiogenic shock on admission to the hospital. These patients were not in shock prior to the start of PCI and Impella® heart pump support was initiated after the start of PCI, without upfront intent to use it, in response to cardiogenic shock or hemodynamic instability not meeting the criteria for cardiogenic shock.
Dr. Truesdell discusses the relatively young patient populations in the cVAD Study (65±13.5 years) and PROTECT III study (70.9±11.0 years). He emphasizes that it is often overlooked in debates over resources for cardiogenic shock and high-risk PCI, that these patients are relatively young to be “written off.”
Dr. Truesdell also emphasizes that the patients in the cVAD Study and PROTECT III study represent a very sick patient population with severely depressed ejection fraction and a high percentage of patients with diabetes. Looking at the procedural characteristics in these patient populations, he notes multiple vessels treated and, in the PROTECT III study, use of atherectomy in 43.3% of patients.
Looking at clinical outcomes in Protected PCI and bailout PCI, Dr. Truesdell shows that the in-hospital mortality is 5% for Protected PCI compared to 37% for bailout PCI. Yet he notes, “Obviously this is not a 1-to-1 correlation because these are sicker patients, so you’re using bailout, so you expect to have a higher mortality.”
“Just as we have to think rigorously about whether we use a device,” Dr. Truesdell explains, “I think there has to be a lot of rigorous thought about why is it that we’re not using a device.” He points out that the data from the PROTECT III study shows that for the people who are appropriate, mortality is very low for upfront use of Impella in this very sick patient population.