Building a Protected PCI Program: Defining Algorithms, Selecting Patients

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Good outcomes in revascularizing high-risk, complex PCI patients start with careful patient selection. The well-seasoned team at VA North Texas Healthcare System in Dallas likens the process to a popular TED Talk on the eight points of success that start with passion and move through work, focus, push, ideas, improve, serve and persist. The secret to success in complete revascularization with Protected PCI involves some art, some science and begins with following proven protocols.

Hear more from the team at VA North Texas Healthcare System, watch Episode 4: Defining Algorithms, Selecting Patients from the series, Building a Protected PCI Program.  

“You have to have a passion for doing [Protected PCI],” says Emmanouil S. Brilakis, MD, PhD, director of the cardiac catheterization laboratories at VA North Texas Healthcare System and professor of medicine at the University of Texas Southwestern Medical School. “You have to have a passion about treating coronary artery disease and believe in the benefits of complete state-of-the-art revascularization to take care of those patients.”

Passion for progressive medicine and excellence is what launched the interventional program at VA North Texas a dozen years ago. Brilakis signed on to run the cath labs while Subhash Banerjee, MD, piloted the renaissance as chief of cardiology. He also is a professor of medicine at University of Texas Southwestern Medical Center.

Since then, the program has grown significantly. This tertiary care referral center takes care of veterans living across a large region in the southwestern United States that includes parts of Texas, New Mexico, Oklahoma and Arkansas. It is the VA’s second largest healthcare system and one of six referral sites across the country within the system offering leading edge interventional, structural heart, peripheral vascular and electrophysiology programs.

VA North Texas Health System was the first TAVR center within the VA healthcare system, with their arsenal today including every kind of coronary, structural and peripheral intervention currently available. The system was part of the earliest Impella trials, starting with the U.S. Impella registry and PROTECT II trial, and became an early adopter of Abiomed’s Impella 2.5 miniature temporary heart pump, which is now FDA-approved for temporary use in elective and urgent high-risk PCI procedures.

The PMA approval, received in March 2015, expanded the device’s indications from its 2008 510(k) clearance, and now permits treatment of elective and urgent high-risk PCI patients who are hemodynamically stable, but have severe coronary artery disease and depressed left ventricular ejection fraction. The approval came in the wake of the PROTECT II trial, which showed that patients supported during PCI by the Impella 2.5 had certain improved outcomes at 90 days (Circulation 2012 Oct 2;126(14):1717-27; Dangas GD, Kini AS, Sharma SK, et al. Am J Cardiol 2014;113(2):222-228).

“The new indication allows not only us but clinical providers who do not perform interventions to recognize that this is a category of patients that should not be left on the table,” Banerjee notes. “It opens up options and opportunities to a group of patients where they previously did not exist. This changes lives. Our outcomes have been excellent and our administration has been highly supportive.”

Defining the patient population

When it comes to patients, incredibly complex and high risk is how Banerjee and Brilakis describe their patient base, which is largely referral based. The composition used to be about 99 percent male, but now includes an increasing proportion of women. The mean age of patients is approximately 65-70 years, with about 90 percent having hypertension, half suffering from diabetes and a quarter each having vascular disease and chronic kidney disease. Many patients have had previous coronary bypass and chronic total occlusions. Most of them are or have been smokers and have high rates of obesity.

“We have many patients who have multivessel disease and because of comorbidities are found to not be good candidates for coronary bypass or surgical vascularization,” Brilakis says. “That is where Protected PCI and support with Impella 2.5 comes in. About half the patients we do, or slightly over half, have acute coronary syndrome (ACS) and the other half are elective.”

The risk/benefit ratio is the discussion that is front and center, Banerjee adds, “and this new indication, along with novel