Dr. John Lasala Discusses Benefits of Protected PCI at Scripps 2015

ProtectedPCI
October 29, 2015

Protected percutaneous coronary intervention (PCI) with the Impella® 2.5 heart pump was the focus of the talk by Dr. John Lasala, Director of Interventional Cardiology at the Washington University School of Medicine in St. Louis, Missouri. His talk was titled “Preparing for a Growing Population in the Cath Lab" and was presented at the 26th annual 2015 Scripps Cardiovascular Interventions Conference on Tuesday, October 27, 2015. Dr. Lasala was a featured speaker in the preconference session called “A New Procedure in the Cath Lab: Protected PCI Treating Complex and Higher-Risk Indicated Patients (CHIP).”

Dr. Lasala began by describing the Impella 2.5, which is the only hemodynamic support device proven safe and effective for use in treating elective and urgent high-risk PCI patients, and which may reduce peri and post-procedural adverse events. The Impella heart pump is designed to protect the patient hemodynamically during a high-risk PCI procedure.

ppci_patientsHigh-risk PCI with hemodynamic support can be appropriate for certain high-risk patients with complex coronary artery disease. Such patients are hemodynamically stable, often have an ejection fraction ≤35%, and comorbid conditions such as heart failure, peripheral vascular disease, complex lesions, diabetes, advanced age, unstable angina, non ST-segment elevation myocardial infarction, or prior surgeries.

Dr. Lasala described the hemodynamic support provided by the Impella 2.5. When the Impella 2.5 is turned on, systolic pressure, diastolic pressure, and mean arterial pressure increase in patients undergoing high risk PCI, as described by Maini et al. 2012. Dr. Lasala contrasted the Impella 2.5 with the intra aortic balloon pump (IABP), which, in the normal course, increases only diastolic pressure.

Dr. Lasala cited the study by Kovacic et al. (2015), which demonstrated that the Impella 2.5 maintained patient hemodynamics and allowed physicians the time to perform a more complete revascularization of blood vessels compared to IABP. Complete revascularization with the Impella 2.5 was a factor, which led to a 29% reduction in major adverse cardiac and cerebral events (MACCE) compared to IABP, as demonstrated during the PROTECT II trial (Dangas et al. 2014).

The clinical benefits of the Impella 2.5 for high-risk PCI patients include improved left ventricular ejection fraction at follow up (Burzotta et al. 2008; Dixon et al. 2009; Maini et al. 2012; O’Neill et al. 2012), decreased heart failure symptoms (O’Neill et al. 2012), required fewer days in the hospital (Gregory et al. 2013; Maini et al. 2014) and a reduction in repeat PCI procedures (Gregory et al. 2013).

Conclusion

The Impella 2.5 is safe and effective for treating elective and urgent high risk PCI patients, who are hemodynamically stable, and who present with severe coronary artery disease and a depressed left ventricular ejection fraction. The Impella 2.5 further enables patients with complex coronary artery disease to be treated successfully with high risk PCI to reduce the need for repeat high-risk PCI procedures and obtain more complete revascularization..

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About Impella

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/hcp/information/isi.