[ARTICLE] Building a Protected PCI Program: The Heart Team Approach

Team-based approach combined with high-tech breakthrough to spur expansion of Einstein Healthcare’s already successful PCI business

Einstein Healthcare Network already had a dynamic heart team and a robust Protected PCI program when the FDA cleared Abiomed’s Impella 2.5 system, a miniature temporary ventricular assist device, for use in elective and urgent high-risk PCI procedures. That was in the spring of 2015. The program’s success since then may lead to a clear conclusion for other hospitals serving high-risk populations: If Protected PCI and the heart team approach aren’t part of your arsenal, it’s time to take a closer look.

The center of the development is Einstein Medical Center Philadelphia, a 772-bed, inner-city, tertiary care, Level I trauma center that supports the highest emergency department volume in the city. Their patient population is plagued by low per capita income, obesity, poor nutrition, a deficit in primary care and many serious health risks, conditions and co-morbidities. The hospital established a dedicated Protected PCI program fortified by a talented and progressive heart team.

“We always strive to give the patient the best outcome,” he adds, “with the least risk,” says D. Lynn Morris, MD, chair of cardiology and director of the Einstein Institute for Heart and Vascular Health.

The heart and vascular team is among the area’s most experienced, treating thousands of patients each day. Einstein is currently building its fourth cardiac cath lab—the better to perform nearly 4,000 procedures per year.

When it comes to Protected PCI, revascularizing patients is priority one of the Einstein Heart Recovery Center at Einstein Medical Center Philadelphia and within the Einstein Health Network. The Einstein Heart Recovery Center is powered by a multidisciplinary heart team approach that unites interventional cardiologists, cardiac surgeons, heart failure specialists, echocardiographers, anesthesia, ICU physicians and nurses, respiratory therapy, social services, physical therapy and dietary. Appropriate team members meet on every patient to determine the best therapy and once a week gather to look back at their successes and retool their challenges.High-risk patients bring big rewards

High-risk patients bring big rewards

Einstein’s Protected PCI program has operated from a position of strength, but expansion this spring broadened the patient mix to include elective and urgent high-risk PCI patients. At the center of the program is the Impella 2.5. The device received FDA approval for elective and urgent high-risk PCI procedures in March 2015, following its 510(k) clearance in 2008, making it the first percutaneous hemodynamic support device to get the regulatory nod as both safe and effective for patients with complex coronary disease, depressed ejection fraction, other co-morbidities, and who have been refused for surgical treatment. 

The expanded indication came after several studies returned findings on the benefits of the Impella 2.5, including PROTECT II in 2012, in which researchers conducted a prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus the intra-aortic balloon pump (IABP) in patients undergoing high-risk PCI. They found that while the 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support, “trends for improved outcomes were observed for Impella 2.5-supported patients at 90 days.” (Circulation: 2012 Oct 2;126(14):1717-27)

“We have data and evidence and a body, the FDA, that says we can do these procedures at a much safer level,” says Morris. “For a high-risk case that is elective or urgent, we have gained a lot of comfort in using [Impella 2.5].”

The surgical team agrees. “Amazing,” is the way Chief of Cardiothoracic Surgery Mark Anderson, MD, describes the patient outcomes the device enables. Historically, high-risk patients who undergo PCI without ventricular support are not completely revascularized. “It’s very clear that those patients don’t do well in the long term,” he says. “Our goal in the long term is to completely revascularize these patients, and it is truly remarkable how well you can do for them when they are supported.”

Better and safer procedures is the way Cardiothoracic Surgeon Alexandra Tuluca, MD, sees it.  “With the advent of Impella, we are much better able to manage these patients and we often will electively and pre-operatively insert an Impella if we anticipate that we will need some sort of mechanical support to separate from cardiopulmonary bypass. I think it has perhaps expanded our ability to operate on higher risk patients.”

Morris adds the exclamation mark, calling Impella 2.5 a game changer. “It has changed our willingness to take on high-risk interventions and provide complete revascularization in a much more controlled, safe environment,” he says.

Revascularization and recovery

The multidisciplinary heart team model goes well beyond what’s mandated by regulations, Anderson explains, meaning that interventional cardiology, cardiac surgery and heart failure work together from start to finish. “We review the cases with whatever other specialties are needed, and then we have a very direct interaction in deciding on the best approach for the patient,” he says. Stated another way, turf mindsets and clinical siloes are things of the past.

The team at Einstein agrees that the heart team allows them to select the best treatment options for each patient. “We elected to go with the heart team approach for one reason,” says Morris. “It gives the patient the best opportunity for an excellent outcome.”

Good outcomes and teamwork bring good synergy, too, says Salil G. Shah, MD, a cardiothoracic surgeon at Einstein. The cardiologists are “more keen on getting us involved in decision-making from the get-go,” he says. “This has really helped develop the heart team. It has helped us to have a good working relationship as a group.”

Clinical excellence + economics

Einstein’s Protected PCI program has clearly achieved the first two goals of healthcare’s triple aim: Improving the patient experience of care and the health of populations. But what about reducing the per capita cost of healthcare? We can check that off the list too.

The fiscal metrics of Protected PCI work. The real economic benefits come downstream in terms of minimizing or avoiding rehospitalization, minimizing reinterventions, reducing the length of stay for patients in the pricey ICU, more complete revascularization in fewer trips to the cath lab.

“There is a growing database of literature suggestive that it is beneficial in the long term with respect to cost reductions,” Anderson says.

The heart team: The wave of the future

Combining the right tools and techniques with the right team members, Morris and Anderson agree, means that the patient is optimally positioned to improve and, in more than a few cases, to get a second shot at life. “It comes down to patients,” says Anderson with the nod of the team.

“We are treating sicker patients, many of whom probably would not have gotten through a procedure” in years past, Shah notes, adding that more than a few patients would have been written off as too sick to survive any intervention at all. “Now we’re getting them through PCI, providing comprehensive care and improving their quality of life. We are all working together very well to get these patients to the final goal” of a good prognosis and a better life.

“It is so gratifying to see the improvement in patients. It can be dramatically fast and dramatically complete,” says Morris.

And the team that is giving that second chance, the heart team, is here to stay. “The heart team is the wave of the future for much of what we are going to do, whether it is structural heart disease or these high-risk interventions,” says Anderson. “The government sees that it is a good idea and from the physician point of view, we see it is a good idea that we can provide the best care to the patients and get the best outcomes. When we work together, we achieve this. I have no doubt that this is here to stay and will become much more common in everything we do, both in cardiovascular medicine and medicine in general.”

“The only way to give patient centric care at the highest level is to have a team work,” Morris says, “where there are no turf battles and what only matters is what is good for the patient.”

Setting Up a Protected PCI Program: The Top How-to’s

For hospitals looking to launch or further fortify a similarly dynamic Protected PCI program, Drs. Morris, Anderson, Tuluca and Shah suggest building several steps into the process at its outset. Among the most important are:

• Secure buy-in from the C-suite. “It really takes physician champions and an administrative champion all working together as an [enterprise team] to develop this kind of program and support it,” says Morris. “It does take capital, so without administration you will not get very far down the road.” Set expectations, share goals and communicate successes, failures and solutions.
• Make sure the team is committed. There will be issues and complications, says Shah. “Make sure the entire team is invested” before embarking on a new program.
• Make an honest assessment of your current program. Question one needs to be: “What components do I need?” Morris says. He recommends the program already be good at left ventricular support and opening chronic total occlusions, have a strong heart failure team, good surgeons and interventional cardiologists willing to do high risk, complex procedures.
• Be considerate of the team. Mutual respect and an open line of communication are musts, says Shah.
• Build awareness within the health system and out in the community. “Marketing is helpful, but what we have found to be more powerful is physician-to-physician interaction,” says Anderson, “especially with primary care docs and non-interventional cardiologists.”
• Time and Space. You need both. “This goes beyond the routine PCI,” Anderson says. “You need to be in the environment where you are not trying to get through eight cases in one room in a day. It just doesn’t work.”
• Take a road trip. “Go visit a place doing high-risk procedures to get a feel what they are doing,” Morris recommends. “Physician champions need to tell administrative leaders this is really good for our patient population and good for the hospital.”
• Extend training to members of the care team who touch the patient. That means “cath lab nurses, ICU nurses, PAs or residents, whoever is going to be involved in taking care of these patients, and making decisions, whoever is going to be at the bed side those are the people who have to be trained, who have to understand what the device is, why is it used and how to troubleshoot it,” Tuluca says. Shah agrees, adding: “there is a definite change in the training that the nurses and the staff have to undergo to care these patients because these patients are sicker, they have a new device inside of them and they require quite a bit more in terms of attentiveness. Also in terms of monitoring them for very subtle signs that there could be an issue or problem.”
• Consider the economics, but don’t expect an instant return on investment. “Reimbursement is good as long as you accurately code and document appropriately,” says Anderson. But I think the real benefit is going to come downstream, in minimized re-hospitalizations and re-interventions and avoidance of advanced therapies.”
• Make metrics matter. “These are very sick patients, so you won’t use the same metrics for survival, bleeding, infection, readmission and so on as you would for routine bypass surgery,” says Morris. Have firm numbers, keep meticulous records, utilize benchmarks and participate in the major registries. Also keep an eye on procedure time, success rates in revascularization, issues with procedures Anderson says.
• Meet regularly and commit to continual improvement. Once you identify the key players, establish a routine and a plan for meetings to evaluation and discuss patients, Anderson says. “The more communication and planning that can take place on the front end will make it work much, much better on the back end.”

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