Roundtable Discusses Protected PCI for High-Risk Patients

ProtectedPCI
December 1, 2015

In the video below, Dr. John Lasala from Washington University, St. Louis, Missouri, hosts a roundtable discussion on Protected PCI with Dr. Bill Lombardi from the University of Washington, Seattle, Washington, Dr. Jeff Moses, Columbia University, New York, NY, and Dr. Bill O’Neill, Henry Ford Hospital, Detroit, Michigan.

Dr. Lasala begins with the FDA’s recognition and new indication that high-risk patients that are hemodynamically stable, but who are experiencing severe coronary artery disease and depressed left ventricular ejection fraction may benefit from the hemodynamic support provided by the Impella® 2.5 heart pump, when undergoing a percutaneous coronary intervention. The Impella® 2.5 heart pump is the first hemodynamic support device proven safe and effective for use during elective and urgent high-risk PCI.

Dr. Moses explains that high-risk patients are those with complex coronary artery disease who are hemodynamically stable, have left ventricular ejection fraction ≤35%, and comorbid conditions such as heart failure, peripheral vascular disease, complex lesions, diabetes, advanced age, and unstable angina.

Through a case study, Dr. Lombardi illustrates how the Impella 2.5 increases and maintains mean arterial pressure during the PCI procedure, allowing the cardiologist the time for a thorough procedure and complete revascularization of blood vessels, even if chronic total occlusions are present.

Complete revascularization is the therapeutic goal of the PCI procedure. The benefits of complete revascularization include, among other outcomes decreased major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarctions, and repeat revascularizations.

Dr. O’Neill reviews clinical outcomes from Protected PCI studies, specifically the PROTECT II study (O’Neill et al. 2012). When hemodynamic support with Impella was provided to allow for complete revascularization, these high-risk patients had reduced MACCE compared to IABP.

Clinically, patient outcomes improve left ventricular ejection fraction, provide symptom relief, and a better quality of life after the Protected PCI procedure. The Protected PCI procedure is cost-effective as indicated by shorter hospital stays and a decreased need for readmission for repeat procedures.

The participants discuss postgraduate education and fellowships for specific training to treat this high-risk group of patents and conduct Protected PCI procedures with hemodynamic support.

Listen to the details of this fascinating discussion on treating this high-risk group of patients with hemodynamic support to reduce their symptoms and improve their lives by watching the video above or by clicking here.


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.