Building a Protected PCI Program: Defining Algorithms, Selecting Patients

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 insights on how to define this group of patients, is probably one of the most serious developments that has allowed physicians to recognize in advance when having hemodynamic support would be valuable for their patient.”

VA North Texas Health’s trajectory moving towards Impella was guided by several factors. First, it is one of the largest databases and evidence base. Second is the device itself has evolved in terms of its capabilities and profile, which has allowed them to reduce potential complications or vascular complications associated with it. And finally, the FDA indication, Banerjee says.

Impella “allows you to think about the case you are undertaking and plan for it and recognize the potential risk associated with it,” he says. “What the hemodynamic support device data has told us is that it is not just the lesion, just the patient, just the comorbid condition, but it is a coalition of all of these factors and many of the factors that go in towards confirming the risk of this particular procedure. If you read the indication carefully, it recognizes the factors that contribute to the risk and emphasizes the need for a thorough interdisciplinary heart team approach towards recognizing and deliberating on those risks.”

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The team approach

The heart team at VA North Texas Healthcare guides a thorough, thoughtful, interdisciplinary decision-making process for patient selection for Protected PCI. A Monday morning interdisciplinary conference brings together cardiothoracic surgery, interventional cardiology, clinical cardiologists, primary care providers, anesthesiologists and other disciplines to discuss cases and craft a plan when an intervention could benefit from a hemodynamic support device. “It's a heart team approach, each and every patient is discussed and then a decision is made,” Brilakis says.

Most patients are challenged with a combination of risk factors. Multivessel disease or diseases in important vessels put the patient at risk for compromise during a procedure. “If they have a combination with low EF or congestive heart failure and need complex PCI, in most cases we would use some support device depending on arterial access,” Brilakis says. “Many patients either have complex coronary artery disease or congestive heart failure, and support is used in some of those patients, especially if left ventricular diastolic pressure measured at the beginning of the procedure is high.”

Patient selection

Getting down to the nitty gritty of which elective and urgent high-risk patients will benefit from hemodynamic support, the VA North Texas Healthcare team starts with the umbrella of the appropriate use criteria and main components of PROTECT II and narrows the parameters based on experience via their clinical decision tree.

They continually refine the guidelines based on every unique patient profile, complexity of the coronary disease and risk factors.

“We try to stick to the evidence very closely,” Banerjee notes. “When we step out of the team conference, we have to go and then discuss with the patient. It is very important to have one's own clinical judgment, and that certainly is the reason why we come and deliberate, but the fundamental basis for our clinical decision making does come from the clinical indication and guideline documents.”

Step one starts with choosing medical management or revascularization. When it is decided a patient could benefit from revascularization via PCI, they next examine underlying LV function or hemodynamics. If a patient has a low ejection fraction or has known congestive heart failure, they try to optimize the patient as much as possible. “We find in many patients, in spite of being in the hospitals for several days, they still have a relatively high LV end-diastolic pressure,” Brilakis says.

The team also looks into comorbidities such as renal failure, diabetes or peripheral vascular disease. An important factor in support device success is having large enough arterial access to be able to use the support device. For patients with good size and relatively disease-free peripheral arteries, they’re more likely to use hemodynamic support.

But what benefit will the procedure bring the patient? That is the team’s ultimate focus. “We are seeking

completeness of the intervention,” Banerjee says. “The relief of angina—and improvement in LV function—in this group is very palpable. We have the potential advantage of doing many lesions because of the stability provided during the case—rather than having the need for subsequent procedures. Being a referral center, the patients are not community patients who live across the street from us. They have to travel a far distance in many cases. That is a significant, tangible patient-centered benefit that the patient can take home.”

While Impella has helped keep patient care up, costs have gone down, namely in length of hospital stay after an uneventful case with support from the Impella 2.5. “It is clear from the registry when compared to other support devices, the patients who left the lab with an Impella are fewer and their length of hospital stay has been shorter,” Banerjee notes. “That cannot be minimized along with the fact that more complete revascularization and fewer readmissions could occur because of that.”

This is a process with many components, Brilakis sums. “The eight points of success applies well. You have to have passion for doing complex procedures in high-risk patients. It takes work to set up a program and time to learn the techniques. It requires focus on building and growing the program. We always look for ideas on how to further improve, by examining current practices, attending meetings, reading journals and attending courses. This is a long-term commitment from people and the institution to persist in providing the best care for the high-risk patient.”

The VA North Texas team sees success in revascularization coming down to making judgments and decisions based on the best evidence and experience they have, one patient at a time.

Editor’s Note: The comments in this story reflect the personal opinions of Dr. Banerjee and Dr. Brilakis and do not reflect the opinion of the Veterans Administration or the U.S. government.