PinnacleHealth Heart Recovery Program Aims to Stabilize Unstable Shock Patients

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 - Brijeshwar Maini, MD
Brijeshwar Maini, MD, chair of the structural heart program at PinnacleHealth.

The Impella hemodynamic support system is finding another niche: in patients who have suffered massive heart attacks complicated by cardiogenic shock.

Culture of continuous improvement

For the last two years, PinnacleHealth based in Harrisburg, Pa., has been placed among the top 100 hospitals by Thomson Reuters for superior performance in cardiovascular service and has twice received the Gold Performance Achievement Award from the American Heart Association for its Get With The Guidelines–Heart Failure program.

The healthcare institution has a certified Primary Stroke Center and recently opened an accredited Chest Pain Observation Unit. In 2002, physicians and staff from cardiology, emergency medicine and the surrounding community sought to improve their door-to-balloon times, which averaged 111 minutes. Today, about 97 percent of all STEMI code patients are seen within 62 minutes and the mortality rate is down to 2.8 percent, says Philip W. Guarneschelli, acting president and CEO of PinnacleHealth.

"We are a quality-driven and evidenced-based organization," Guarneschelli says. "We aggressively assess ourselves and try to improve upon our benchmarks annually."

One of PinnacleHealth's latest efforts to advance patient care is the Heart Recovery Program, which includes advanced training in hemodynamic support and complex patient management to better facilitate heart muscle recovery. The program, started in August 2010, targets high-risk patients. An especially difficult patient population to treat involves those patients with massive heart attacks complicated by hemodynamic instability. Statistically, more than half of these patients will die—an average that hasn't changed in two decades despite improvements in PCI techniques and protocols.

The program benefits from use of a new tool, the Impella 2.5, which is percutaneously inserted via the femoral artery into the left ventricle and pumps 2.5 liters of blood per minute (l/min).

"This is a new arena for interventional cardiologists," says Brijeshwar Maini, MD, chair of the structural heart program at PinnacleHealth. "Ventricular assist devices have always been part of the surgical field. It's a new concept, however, for cardiologists to make a decision to put in an active assist device. It gives the interventional cardiologist a new tool to intervene in the cycle of shock earlier, thereby improving outcomes for these patients."

Preliminary data from the USpella registry, reported by Maini at TCT10, found after prophylactic Impella-supported revascularization in complex PCI cases:

  • Significant improvement (17 percent) of left ventricular ejection fraction (LVEF);
  • Significant improvement (49 percent of patients) in NYHA class with a 61 percent reduction in NYHA Class IV;
  • Significant reduction (25 percent) in implantable cardioverter-defibrillator (ICD) target population;
  • More than half of the patients (54 percent) were turned down for CABG and 59 percent of the patients had experienced a prior MI; and
  • Low mortality (3.9 percent) and MACE rate (8.2 percent) in patients compared with literature on patients with high-risk PCI (Cardiovasc Revasc Med 2010;11(2):91-97).
  • Findings after emergent Impella support in high-risk patients with STEMI and/or cardiogenic shock included:
  • Hemodynamic support (cardiac index, cardiac power output, wedge pressure, mean arterial pressure) significantly improved;
  • Cardiac power output, a strong correlate of in-hospital mortality, increased from 0.5 to 1.0 while on the device;
  • Significant improvement (19 percent) of LVEF at discharge; and
  • Ninety percent of the survivors recovered native cardiac function and were discharged with their own hearts.

The registry, which receives data from 24 U.S. and Canadian centers, consisted of 352 patients supported with the Impella at the time of the TCT10 presentation.

"More ischemia leads to more ischemia; it's a downward spiral," says Maini. "If we can provide a cardiac output of 2.5 liters of blood per minute, we won't deprive end organs of the necessary blood volumes. With that concept in mind, we have felt that the Impella device is a good tool to use in patients who are in extremis."

These data are quite promising and will be further elucidated through the registry. Also, early insights to PROTECT II, the randomized controlled trial comparing Impella 2.5 with the intra-aortic balloon pump (IABP), are promising. These results will be presented at ACC 2011 this month.

Coordinated multidisciplinary effort

PinnacleHealth observed an overall reduction in 30-day readmission rates for AMI patients treated with the Impella device compared with those treated with an intra-aortic balloon pump. Shown here is William Bachinsky, MD, medical director of the cath lab.

In many ways, the Heart Recovery Program at PinnacleHealth was a natural evolution of previous programs, beginning with the revamped STEMI code program, which significantly lowered door-to-balloon times, to the initial use of the Impella device in patients with complex PCI.

"Our physicians saw how the Impella was working in these complex PCI patients and wanted to move it to the urgent care setting," says Jean Wiest, vice president of cardiovascular and pulmonary services at PinnacleHealth. "They saw the benefits from resting the heart, which is what Impella does differently than the intra-aortic balloon pump, in their STEMI patients, and wanted to develop a program for using the device in the urgent setting for hemodynamically unstable patients."

To develop the Heart Recovery Program, Wiest and others, including Maini, Kate Acquaviva, RCIS, director of invasive services, Raj Davé, MD, chairman of endovascular medicine, and William Bachinsky, MD, medical director of the cath lab, led a multidisciplinary effort to get everyone onboard.

First, the group decided to appoint a dedicated on-call person who understood the technology and could arrive early at the cath lab to prepare it for the Impella device. Of course, this would initially demand extra resources; however, the average set-up and insertion time for the Impella pump has since improved, taking clinicians only two to five minutes.

"If a product like the Impella just delivered a return on investment [ROI] and didn't drive quality, we probably wouldn't consider it," says Guarneschelli. "Obviously, we need to make money in our business, but we believe that if you drive quality, the ROIs will come."

The Heart Recovery Program has been a work in progress of adjusting guidelines and matrices, and educating not just the cath lab personnel and the immediate interventionalists, but also all the periphery caregivers that might interact with the continuum of care of these patients when they come to the emergency department (ED). The ED physicians needed to be educated about informing the interventional cardiologist that not only do they have a STEMI patient, but they potentially have a STEMI patient who is hemodynamically unstable. The cardiologist would then notify the on-call nurse to come in and set up the cath lab for the potential use of the Impella assist device.

The EMS team already was a part of the chest pain committee, which meets weekly. For them, it was a matter of becoming aware of the Heart Recovery Program, so that if they know or suspect a STEMI patient is in cardiogenic shock or hemodynamically unstable, they need to relay that information as quickly as possible to the hospital.

Part of the outreach effort included educating referring physicians and hospitals to recognize signs of emergent patients with congestive heart failure. "We need them to be aware that we have a program with the potential to improve outcomes in these patients," says Acquaviva.

Improving outcomes

When Wiest and Acquaviva first approached Guarneschelli with the concept of the Heart Recovery Program, they had many of the details worked out. Davé and Maini were the behind-the-scene drivers advocating for the program.

"The Impella provides unloading of the left ventricle that can be useful," says Davé. "In our clinical experience, we feel it is a useful device and fairly easy to implant, which is critically important in terms of timing for these vulnerable patients."

In addition, these patients often leave the cath lab with the device still implanted, which highlights the importance of training critical care nurses to be familiar with the device, its functions and the console on which it runs.  

"The Heart Recovery Program essentially means that our center is facile enough to implant the Impella emergently in patients with acute coronary syndromes," he says. "The protocols are streamlined; it all happens automatically. It makes a big difference to have the algorithms in place that allow us to implant the device in a moment's notice."

Generally, cardiac failure with cardiogenic shock continues to be a frustrating clinical problem and these patients will likely have many issues. "But if you can stabilize the patient and prevent further myocardial damage, there is the possibility that the patient will survive with a fairly normal ejection fraction, less damage to other organs and an overall better quality of life," Davé says. Such positive outcomes also could reduce the need for an ICD or a permanent left ventricular assist device.

"The idea is that for appropriate patients, rather than provide half a liter of cardiac output with a balloon pump, we want to offer better support—2.5 liters of blood per minute—to salvage as much myocardium as possible," says Maini. "In addition, as the team gets savvier with the Impella, it actually becomes simpler to use than a balloon pump."

While mortality is the most important marker in patients with cardiogenic shock, infarct size is important for STEMI patients without shock. "There currently is no clear evidence in human studies that hemodynamic support devices reduce the infarct size, which would improve left ventricular systolic function and ultimately mortality, although animal studies are promising," Davé says.

To gather the necessary data, Impella's manufacturer Abiomed is conducting the MINI-AMI trial, a prospective, randomized, controlled investigational device exemption study designed to assess the potential role of the Impella 2.5 in reducing infarct size in patients with STEMI. The study is based on the hypothesis that Impella's ability to unload the left ventricle will reduce overall infarct area relative to the total area at risk. Fifty patients at five hospital sites will be randomized to Impella 2.5 support for 24 hours following primary PCI or the institution's standard of care with no circulatory support post-PCI.

Translating the cost savings

“In our clinical experience, we feel the Impella is a useful device and fairly easy to implant, which is critically important in terms of timing for these vulnerable patients,” says Raj Davé, MD, chairman of endovascular medicine at PinnacleHealth.

Before go-live of the Heart Recovery Program, the team projected the number of Impella devices it would use, created a profit and loss report, scrutinized the capital costs and looked at the resources—both labor and supplies. "We then projected volume, and if at the end of the day, the program was in the black and improved quality, we were hard pressed not to approve it," Guarneschelli says.

Since the Heart Recovery Program began last August, Acquaviva and her team have conducted quarterly reviews of higher-level financial data, such as the DRG and the charges per patient. Within the last month or so, they have been "diving deeper" to get a finer look at details such as costs related to adverse events, length of stay, surgery, reoperations, readmission, blood products, staffing and ancillary costs in pharmaceuticals.

A reduction in 30-day readmission rates was observed in the overall AMI patient populations (17 percent vs. 10 percent for patients treated with Impella, a 41 percent relative reduction) and compared to patients treated with IABP (13 percent vs. 8 percent for patients treated with Impella, a 38 percent relative reduction). Similar benefits have been observed in reducing length of stay, a key operational metric. Overall length of stay for AMI patients was reduced by 0.6 days (8.4 days with IABP vs. 7.8 days with Impella, a 7 percent relative reduction).

"It is exciting to translate the clinical benefits of Pinnacle's Heart Recovery Program to cost savings and other operational efficiencies," said Acquaviva. "This is important data that will prepare Pinnacle for the new era of health reform and accountable care."

Pinnacle progress

PinnacleHealth operates five primary care facilities, as well as a network of family practice and urgent care centers, managed care entities, home healthcare, hospice and an array of other healthcare services. There are three specialist procedures emanating from invasive cardiology: coronary, peripheral and electrophysiology procedures. Annually, the healthcare system performs about 6,500 coronary and peripheral diagnostic catheter procedures, 4,300 coronary and peripheral interventional procedures, 450 pacemaker implantations and 450 ICD and biventricular device implantations.

The health system is currently involved in its "Journey to Excellence," which seeks to strengthen its goal-driven accountability, according to Guarneschelli. Each level of the organization knows the corporate goals and is trained and developed accordingly. "This is another way our culture of continuous improvement prevails," he says. "Next year, there will be a new benchmark and a new standard will be set."

The Heart Recovery Program is in its infancy, but Bachinsky says it is headed in the right direction. "As a whole, medical organizations have excelled with the message that time is muscle. Now, we need to direct our efforts at these high-risk patients and identify them sooner rather than later," he says.

Too often, an intervention is perceived as a success when the artery is opened and there is good perfusion to the heart, but the organ is still showing signs of heart failure, Bachinsky says. This can lead to a cascade of end organ dysfunction, which ultimately will lead to the demise of the patient. "Patients with true cardiogenic shock have a mortality rate that is greater than 50 percent, whereas the mortality rate of patients with similar blockages but no shock is below 5 percent," he says.

While these patients can be identified in the prehospital setting, it is the ED physicians that will propel the program forward by being able to better identify someone who has true signs of cardiogenic shock and activate the muscle recovery program team.

As the team has become more accustomed to the program, more nurses and technologists have become familiar with the Impella device, giving PinnacleHealth a larger pool of on-call individuals who can respond to the need for a potential implantation in an unstable patient.

Reproducing the success

For other facilities that want to initiate a similar program, it is best if they already have a robust door-to-balloon STEMI code program, says Wiest. "It's not designed for everyone," she says, "but if you already believe in this technology and have an underlying foundation for swift treatment of STEMI patients, then you have a place to start."

"The door-to-balloon initiative has been a very visible part of many hospitals' goals for improvement," says Acquaviva. "Now, they just need to take it a step further and concentrate on a more vulnerable patient population that may need time for the heart muscle to rest and recover."

Bachinsky cautions that there is a learning curve with the device and that it's best to begin with patients undergoing potentially high-risk interventions that are not necessarily in the throes of a large MI. He also suggests that physicians and staff visit other institutions that have protocols in place to get a better understanding of how the program is run.

"We are leading the way," Guarneschelli says, "and these types of products must be in your portfolio if you want to compete at a high level of patient care."