[ARTICLE] Building a Protected PCI Program: The Programmatic Approach

The University of Washington Medical Center in Seattle, already a major national referral center, has recently undergone a significant culture shift. The change began when Robb MacLellan, MD, joined as chief of cardiology of UW Medicine Regional Heart Center in 2011. He quickly identified interventional cardiology as an opportunity for growth. UW invested in resources. It recruited leading physicians and acquired leading 

And that’s just the beginning of the story behind the new day-to-day routine at this institution. The UW Medicine heart team—which has procedure volumes placing it at or near the top in the U.S. in echo, transplantation, atherectomy, LVAD and PCI for chronic total occlusion—has become a national training site for high-risk PCI with hemodynamic support. The cachement area of this academic medical center stretches across 23 percent of the geographic land mass of the U.S., and from sea to shining sea as a national referral base. Tough is their middle name when it comes to performing high-risk procedures others won’t—and passion is their game in teaching others to master and improve their skills, too.

UW also has left behind its erstwhile ivory-tower image to become a highly engaged member of the community. This has meant opening access so that any physician with a Washington State license can get temporary privileges for admitting and operating. That strong dedication to learning stretches across the state and around the globe. Practical, hands-on, in-depth, in-person, collaborative learning sits at the core of the program.  

Physicians “get to learn new devices, new techniques and new skill sets,” explains William Lombardi, MD, director of complex coronary artery disease therapies. The learning is done in a finely tuned environment of medical-staff, medico-legal and educational processes, he says, “so physicians can build practical skill sets, go back and be able to use them at their own center.”

A key technological leap facilitating the transformation came in the spring of this year when the FDA approved Abiomed’s Impella 2.5, a miniature temporary ventricular assist device, for use in elective and urgent high-risk PCI procedures. The approval, which expanded the device’s indications from its 2008 510(k) clearance 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. This showed that patients supported—or, more precisely, protected—during PCI by Impella 2.5 had improved outcomes at 90 days. (Circulation: 2012 Oct 2;126(14):1717-27)

“What you have now is a hemodynamic-support tool allowing you to get that high-risk patient safely through the procedure he or she needs, which is complete revascularization,” says Lombardi. 

The device also allows the multidisciplinary heart team to closely collaborate around high-risk patients.

“There is a subset of patients who will benefit from high-tech intervention” involving not only interventional cardiologists but also cardiac surgeons, heart-failure experts, transplant specialists and numerous others, says Claudius Mahr, DO, the institution’s medical director of the mechanical circulatory support program and director of clinical integration at UW Regional Heart Center.

A culture of constant conversation

Cardiothoracic surgeon Jason Smith, MD, characterizes the culture change of collaboration he’s seen as part of a natural progression. “Over the last two years, we have really evolved a coronary team that is very similar to what we do for heart failure and transcatheter valve,” he says. “It is a constant conversation and collaborative evaluation between the high-risk PCI interventionalists and the cardiac surgery team. We are constantly sharing our expertise to come up with the best plan for the patient.”

The clinical trials showed that patients randomized to an Impella 2.5 received more out of their PCI, and the clinical improvements proved perdurable. Lombardi believes that’s because Protected PCI helps the heart team relax and focus. Members can spend more time working on atherectomy, vessel preparation and other interventional activities that lead to better long-term outcomes.

“It's very clear…The more work you do, the better patients do,” Lombardi says. “I am a CTO [chronic total occlusion] guy. Impella gives me the time and the comfort level that I don’t have to sweat it. I can just focus on doing what I need to do rather than spending the whole time worried about other stuff.”

For Interventional Cardiologist Creighton Don, MD, implementing the technology has meant ensuring the stability of high-risk patients to a reassuringly high degree.

“We can now do a prolonged PCI procedure, one that could cause a great deal of ischemia and cause more LV dysfunction, more heart failure,” he says. “We can get away with that while being more complete in our revascularization. Plus we can offer the patient the procedure all at one time to do it more safely.”

Prior to having the Impella 2.5 available, interventionalists would stage procedures based on patient fragility, Don says. “We would do a couple of things to get the patient through it so he or she is not exposed to all that risk at one time. Since having the [Impella] 2.5, it maintains the stability of a patient so we can do a prolonged procedure.”

Not having to stage PCI is far safer for patients, too, according to just-released 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%).

Don adds the not needing to stage also brings peace of mind. “When I consent patients,” Don notes, “I can tell them this is a high-risk procedure and I'm confident telling them that things are going to go well.”

Local training, global classroom 

Don also likes that, once the staff became familiar with the device, they went from sighing over “another new thing to learn” to getting excited about doing their best for patients without undergoing a long learning curve. They already knew what to do in a PCI procedure, he adds. Expanding skill sets to include Protected PCI for high-risk patients didn’t entail reading exhaustive instructions.

All members of the heart team, from clinicians to support staff, got a morale boost knowing that, in the long run, Protected PCI adds an element yet ends up saving time. 

Much of the training revolves less around the Impella 2.5 than around the extremely sick patients it supports. These patients require closer monitoring than average-risk PCI patients.

That educational mindset extends well beyond the walls of UW Medical Center. Every four to six weeks, 10 to 15 physicians come in from around the world to observe live case demonstrations. Between cases, a lecture series covers topics such as what skill sets are required for a successful Protected PCI program, how to use the device and what other tools may come into play.

“We often invite people to bring cases they want to discuss or that have been challenging for them at their institution,” says James McCabe, MD, medical director, UW cardiac cath labs. “We also can see what they are doing and learn from them, discussing how we might approach things and making sure we are continuing to all evolve together.”

There are two aspects of training, Don says, hands on and cognitive. “There is certainly a muscle memory, a skill level that you get with doing a procedure multiple times over and over again. On the other hand, there is a cognitive piece, too. If you read the instructions ahead of time, if you go to training courses, internalize that and take notes, and if before the procedure you look at those notes and review it all, actually the learning curve is flattened. You will learn how to do this procedure much faster if you are really cognitively engaged.”

Drilling into data, realizing ROI

Good training makes for good procedures. The truth is in the numbers. Patients are benefiting and so is the program. “The data tell the story,” says Mahr noting that success needs to extend far beyond the cath lab. “Yes, you can more safely intervene on somebody with high-risk anatomy but the question is are they well 30 days, 90 days, six months, a year after their procedure. That is the objective. It requires collecting that data, benchmarking it against other institutions, having a very robust mortality review, and identifying issues as they arise and addressing them.”

The data show Protected PCI can provide a benefit for certain patients, but the statistics need to be understood up the ladder, McCabe notes. “Taking on high-risk cases means that sometimes you are going to have less pretty data to show. You need to make sure that people up and down your organization understand the benefit of what you are doing, understand the mission, and realize that if you risk-adjust these patients appropriately your numbers aren’t bad.”

At UW, what is good for patients, is also good for cardiovascular medicine. Establishing a Protected PCI program, and sustaining it over time, makes good fiscal sense for hospitals that invest in it. “It brings significant economic benefit to the institution,” Lombardi confirms.

Don says savings are realized in the form of more complete PCI procedures, leading to shorter hospitalization and fewer recurrent MI costs. “I can do it correctly so that the patient is not having complications down the line,” he says. “The cost of the device is balanced out by some of the savings that you realize downstream.”

Mahr takes an even bigger-picture view of ROI. Advanced heart failure programs tend to be economic engines of cardiovascular portfolios and drive a lot of other areas that, in and of themselves, may not be independently profitable, he points out. However, it makes more sense to look at programmatic carryover rather than individual performance. “To have high-end programs like these, we have to make a commitment,” Mahr explains. “Area XYZ may not in and of itself be profitable, but it is supported by the contribution margin of the larger part of the program.”

Top takeaways 

Asked to share lessons learned during the expansion of its Protected PCI program this spring—and over the months since—members of the UW Medical Center heart team offer several points. Each is worth considering by healthcare provider institutions thinking about taking the leap.

Ask questions: At its core, Protected PCI is a program which includes the thoughtful evaluation of high-risk patients and then, in a collaborative fashion, the determination of the best strategy to provide those patients an optimal outcome. “That means talking to your surgeons,” says Lombardi. “Can you do complete revascularization? Does the patient need hemodynamic support? At what level? Do they need atherectomy of their left main? What support do we take as optimal? How do we do that from an access point? Are the staff comfortable getting the pump ready, getting the access point in? Are we comfortable doing pre-close and managing the groins? Do the nurses have the right drips, the dobutamine and the epi? Are they going to make sure they are managing the ACT because we've got other things to do. Is the ICU and recovery staff good at managing big holes in groins and dealing with very sick patients? These things all factor in.”

• Get buy-in: Make sure affected individuals and departments throughout the institution understand the benefit of what you are doing and realize that, if you risk-adjust these patients appropriately, the numbers make sense. “Your observed-to-expected ratios for any given event stay right in line with where they should be,” says McCabe. “Your bleeding rates may marginally go up. Your kidney injury rates may marginally go up. But the expectation of these events also goes up. That’s why the observed-to-expected ratio stays the same.” Meanwhile, the aggregate effect of a program with this kind of profile is that “the public health of your cachment area improves. People do better en masse.”
• Get ready to work, team: Building a program starts with doing your homework and spending time in cath labs, observing and continuing to hone your skills. “Institutionally and professionally, if you are going to build a Protected PCI program, you are going to have to go work in other labs, go to multiple meetings, and [commit to] continually updating your clinical and tactical skill sets.”
• Rally ’round the heart, troops: Do what you must to get your heart team to pull together. “There is a lot of perceived conflict between surgery and cardiology in terms of holding onto patients and, operationally, just in terms of not losing patients. You have to get beyond that,” says Smith. Whether that means restructuring to align cardiology and cardiac surgery to create a financially sound relationship, so be it. “If you are competing with cardiology as a surgeon, you’re going to fail. And if you are competing with surgery as a cardiologist, you’re going to fail.” To this Mahr adds: “In the academic medical center setting, this requires a comprehensive, dedicated team of heart failure and transplant specialists, cardiologists and cardiac surgeons, and everybody has to be on board with this kind of program.”

Lombardi points to the Impella 2.5 as a center of gravity from which all these aims and priorities emanate.

“I love one of my nurse’s quotes. She says, ‘Impella can be a big warm blanket” for certain patients in the cath lab, he concludes. “When the Impella goes in, our staff can be comfortable that the heart is being supported and we can focus on doing our jobs.”

Series: Building a Protected PCI Program