Mr. Gonzalez recently learned he had three clogged arteries and a low ejection fraction. His cardiologist recommended a percutaneous coronary intervention (PCI) procedure using either the Impella 2.5™ heart pump or the Intra Aortic Balloon Pump (IABP). He is interested in learning about both devices and recent research on their use—here is some helpful information about both.
The Impella 2.5 heart pump and IABP are two medical devices used to help your heart pump blood during the PCI procedure. Both devices push blood from the left ventricle to the aorta with each heartbeat. The major difference between the two devices is that the IABP works by using the force of each heartbeat to increase blood flow while the Impella 2.5 device functions independently of how forceful your heart beats, pumping up to 2.5 liters of blood per minute. Both devices increase blood flow to your coronary arteries and the rest of your body during the PCI procedure.
IABP has been used by cardiologists since the 1960s. The Impella 2.5 heart pump has been available since 2008 and received FDA approval for use during elective and urgent high–risk PCI procedures on March 23, 2015.
Are both devices equivalent?
A recent paper, (Dangas et al. 2014), commented and analyzed the results of a clinical trial called PROTECT II, which compared the use of the IABP with the use of the Impella 2.5 in certain high-risk patients, with similar cardiovascular problems, who underwent PCI. One group of 216 patients underwent PCI with the Impella 2.5, while the other group of 211 patients experienced PCI with the IABP. One purpose of the trial was to compare patient outcomes 30 and 90 days after the procedure was performed. To do this, the numbers of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE) reported by each group were recorded 30 and 90 days after the PCI procedure. MACCE includes death, stroke, heart attack, or the need for a repeat PCI procedure.
Ninety days after the PCI procedure, the results indicated the Impella 2.5 reduced MACCE by 29% over the IABP.
The authors concluded PCI with the Impella heart pump had fewer adverse events (MAE, MACCE) compared to PCI with the IABP 90 days after the PCI procedure. The FDA reviewed these and other data for the Impella 2.5 System and noted in their March 23, 2015 press release that “the overall data provided evidence that, for patients with severe CAD [coronary artery disease] and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during a HRPCI [high-risk PCI] procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability (e.g., poor circulation, low blood pressure) due to temporary abnormalities in heart function. Moreover, fewer later adverse events (e.g., need for repeat HRPCI procedures) may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump (IABP). The Impella 2.5 System can be used as an alternative to the IABP without significantly increasing the safety risks of the HRPCI procedure.”
- Read the original paper by Dangas et al. 2014.
- Read the original PROTECT II study by O’Neill et al. 2012.
- Learn more about PCI and Protected PCI and what to expect during the Protected PCI procedure.
- Watch how the Impella 2.5 works and learn more about Protected PCI.
- Read the FDA approval for the Impella 2.5 heart pump
- Watch the intra aortic balloon pump in action and learn more about the intra aortic balloon pump and its history.
- Find out how you can talk with your cardiologist and discover if Protected PCI is right for you.
- Review the clinical data on the Impella 2.5 heart pump.
The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/indications-use-safety-information/.