[ARTICLE] Building a Protected PCI Program: The Community Hospital Approach

Despite its name, Bakersfield Heart Hospital offers more service lines than just those under its cardiovascular umbrella. It’s an accredited stroke center as well as a go-to site for total joint replacement, neurosurgery, wound management and multispecialty emergency care. At its core, it’s a heart center offering comprehensive community care close to home. This 47-bed, 14-clinic institution excels regionally and leads nationally, having leapt to the forefront in 2008 as an early adopter of Abiomed’s Impella 2.5 miniature temporary heart pump, which is now FDA-approved for use in elective and urgent high-risk PCI procedures.

The PMA approval, received this past March 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 comes in the wake of the PROTECT II study that 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.)

For Bakersfield Heart Hospital, the expanded indications have given the 11 board-certified, subspecialized cardiologists of Bakersfield-based Central Cardiology Medical Clinic a chance to bear out a belief they have held for years: Given the right toolset, cardiologists working in a community setting can meet or exceed the pace of progress expected at academic medical centers.

With a cachement area extending to communities well beyond this California metro area nestled in the large agricultural county of Kern midway between Los Angeles and Fresno, Bakersfield Heart is showing that proficiency in high-risk PCI is the product of real-world experience with notably substantial volumes. And the proof is in the outcomes.  

“If a facility doesn’t do sufficient volume, the quality will never be there,” says Brijesh Bhambi, MD, the interventional cardiologist who serves as the chief medical officer of the heart hospital. “We have performed close to 100 PCIs using Impella, and I actually have a number of patients on the north side of 90 who received the interventions two to five years ago and are still around. That’s amazing.”

It’s also consistent with the findings of the PROTECT II study that showed PCI patients supported by Impella 2.5 had certain improved outcomes at 90 days when compared to those treated with the older intra-aortic balloon pump technology. (Circulation: 2012 Oct 2;126(14):1717-27) “We lean heavily on evidence-based medicine and for PROTECT II there’s considerable evidence that in high-risk interventions, there is a very substantial role for LV assist devices and Impella,” he notes.

Bakersfield Heart’s CEO Michelle Oxford, MBA, likes that the Protected PCI program offers high-tech care within soft-touch surroundings to people in Bakersfield and up to two hours away. “Community care means to our patients that they don’t have to travel to larger facilities out of the area when we have physicians in our community that can meet the standard of care for them,” she says.

Big benefits across the board 

For Bhambi, maintaining the highest standards of clinical care means not only aiming for perfection via practice but also relying on evidence-based medicine to guide clinical decision-making. He points to PROTECT II as a source of high confidence when proceeding with high-risk PCI procedures, that accord with a very substantial role for proven LV assist devices.

“Impella is a useful tool,” he says before likening it to a padded trampoline for an acrobat walking the high wire. “It allows us to perform complex procedures without the stress of a stumble that could lead to a disastrous consequence. Impella has emboldened us in taking on severe heart disease patients who have a damaged heart and who otherwise couldn’t stand the additional insult of ischemia.”

Stated simply: “Impella provides a safety net for the heart,” Bhambi adds, “You have the advantage of continuing the perfusion from a cardiac perspective and you can perform complex interventions that you otherwise would be very bashful about.”

Interventional Cardiologist Sarabjeet Singh, MD, notes that, before the expanded FDA approval, he and his Central Cardiology colleagues were performing Protected PCI primarily for severe LV systolic dysfunction with left main involvement.

“In my experience, I have been able to do complete revascularization,” says Singh. “You can use IVUS. You can use rotablation. You can analyze a lesion and make sure the stents are well apposed.”

Summing up all those benefits and more, Singh spells out the overarching advantage: “You can take your time.”

Choosing (patients) wisely

When it comes to Protected PCI, the Bakersfield interventional cardiologists agree: Ensuring the success of individual procedures—and thus of the program as a whole—begins with selecting the right patients at the right times.

“Right off the bat, we’re talking about high-risk patients and multivessel vascularization or sole-surviving vessel,” says Rasham Sandhu, MD. “The sole-surviving vessel, I believe, is the easier part of it because these patients don’t have much of an option. You have to provide them this.”

In cases involving nuanced judgment calls, Sandhu says, it’s best to consult with a cardiac surgeon and then explain potential risks and benefits, grounded in data, to patient and family alike.

Look at the patient as a whole, not just as a coronary case, Sandhu advises before posing likely questions: What are the other comorbidities? What does the rest of the vascular system look like? What do the end organs look like? What’s the renal function? Is it a frail, older patient with little arteries where we’re going to have problems?

“All those factors come into play and, as we go forward with the program, we find that there are some things that you learn,” says Sandhu. “The key is to strike the right balance between being aggressive enough to do high-risk stuff and not be on the other end of aggression, where you fall into the trap of doing it on someone who may not benefit from it.”

To this Bhambi adds that the Bakersfield area, for example, has a high incidence of diabetes, obesity and coronary artery disease. Many Protected PCI candidates are not good surgical candidates, as they often have poor heart function on top of such problems as multivessel disease, heavy calcification or arteries requiring rotational atherectomy and multivessel intervention.

“If I have a 10 to 15 percent ejection fraction in a multivessel coronary heart disease,” Bhambi says, “it’s really playing with fire if I don’t have protection from a left ventricular assist device.”

The economics of social responsibility—and cost effectiveness

Looking at Bakersfield Heart’s investment from the sweeping vantage point of U.S. healthcare’s march toward value-based reimbursement, Interventional Cardiologist William Nyitray, MD, observes that, too often, various expenses have been eyed without serious concern for the “global cost.”

“Our society has been very fragmented” over the high cost of healthcare, says Nyitray. “We’ve been reimbursed for procedures. We have not been reimbursed for our patients doing well. When you take [the concerns of] a whole patient together—quality of life, symptoms, longevity, how they feel, repeat hospitalizations—it really should all come together.”

How might taking a more holistic approach help control costs? Simple, says Nyitray. Patients who are good candidates for Protected PCI but do not get the procedure “end up in the hospital more frequently. They have more complications. There is a higher risk of dying. Even though the costs of these procedures is relatively higher than regular procedures, when you encompass the whole of patient care and the cost of taking care of this patient, it may work out to actually cost a lot less.” That’s cost-effectiveness in a nut shell.

Interventional Cardiologist Sanjiv Sharma, MD, adds that the team is constantly cost-conscious—and never more so than when performing Protected PCI for a patient presenting multivessel coronary artery disease.

“Our usual goal is to do complete revascularization in one go,” says Sharma. He says translating that goal into the prevention of rehospitalization “can possibly, to some extent, offset the initial cost of use of the device.”

Fewer interventions and specifically not having to stage PCI is far safer for patients, too, according to five-year outcomes data from the SYNTAX study (EuroIntervention. 2015 Apr;10(12):1402-8). Patients undergoing staged vs. single-session PCI for 3-vessel and/or left main disease have a higher incidence of major adverse cardiac and cerebrovascular events (MACCE) over the first five years of follow-up. While these patients had more comorbidities and more diffuse disease, MACCE was significantly increased in staged patients (48.1% vs. 35.5%) as was the composite of death, stroke or MI (32.2% vs. 19%). Cardiac death and stroke occurred more often in the staged PCI group. Repeat revascularization was significantly higher in staged patients (32.8% vs. 24.8%,), as was stent thrombosis (10.9% vs. 4.7%).

Impella also performs well from the standpoint of fiscal responsibility, according to Oxford who calls its performance “outstanding.”

“I receive a spreadsheet as new patients are brought into the cath lab and have the procedure,” she says. “I know within days of what the reimbursement should have been, what the cost should be, as well as reimbursement when that data comes through.” She adds that a report is run every month to track payments and delays thereof. “We are very cognizant of the bottom line for the Impella program. At our hospital, it has been very successful.”

Engaging, defining and leading

Sandhu nicely sums up what Bakersfield Heart Hospital has gained since adopting Impella in 2008 and expanding its uses in 2015.

“If we can provide high-risk patients complete revascularization from the get-go, knowing they’re protected while we take our time—whether to [take care of] high-risk lesions and whether we involve rotablation or difficult stenting to do a complete job—I think it translates into patient benefit. And that’s what PROTECT II showed.”

He offers advice to peers around the country considering starting a Protected PCI program: Organize a team, consider your patient population’s health status and then, if the need is there, “Conquer your fear about dealing with the sickest of the sick.”

“I think that every community with sufficient volume should try to develop [a Protected PCI] program as best as possible,” says Nyitray. “Being in the community for over 25 years, I have seen the various aspects of a physician’s care, and this is relatively simple. Keep your patients in mind and have excellent education. Practice, make sure you do a great job, look at your outcomes and then progress.”

As Bhambi says: Our vision is endless. "We are trying to engage multiple players, including health plans and tertiary centers. We want to make sure we remain relevant in the cardiovascular space. We will define the cardiovascular space—and we will lead in it.”

Series: Building a Protected PCI Program