Building a Protected PCI Program: The Heart Team Approach

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 - Abiomed - Einstein PCI
D. Lynn Morris, MD, the chair of cardiology and director of the Einstein Institute for Heart and Vascular Health works on a cardiac patient with members of his heart team as others assist in and facilitate the procedure.

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.

Hear more from the team at Einstein Medical Center Philadelphia, watch Episode 1: The Heart Team Approach, from the series, Building a Protected PCI Program.

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