Ochsner Excels with Percutaneous LV Assist Program for High-Risk Patients

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Source: Impella.jpg - Impella 2.5
The Impella 2.5 cardiac assist device is used for elective high-risk PCI procedures, as well as emergent PCI.

Heart failure and complex coronary artery disease are persistent problems in the U.S. and a significant beneficiary of healthcare dollars. A model of care emerging for these patients is a strategy that focuses on the continuum of care. At Ochsner Medical Center’s Heart and Vascular Institute in New Orleans, physicians have taken a multidisciplinary approach to treating these high-risk patient populations. Percutaneous left ventricular assist devices (LVADs) are an integral part of Ochsner’s strategy to improve care for these very sick patients.

Building on success

For more than six decades, Ochsner has been associated with excellence in care. One of the nation’s largest private academic medical centers, Ochsner has received numerous accolades, which in 2010, include: Being one of Thomson Reuters Top 100 Hospitals and Top 15 Major Teaching Hospitals in the U.S.; ranking in the top 5 percent in the U.S. for exceptional patient outcomes with the Distinguished Hospitals for Clinical Excellence award from HealthGrades; and being cited by U.S. News and World Report as one of America’s best hospitals for its exceptional delivery of medical care across seven categories—including in Heart & Heart Surgery.

Due to an unmet need for some of their critically ill cardiac patients, Ochsner recently developed a Percutaneous LVAD Program (pLAVD). A key to treating these complex patients is access to various hemodynamic support devices such as microaxial flow pumps and left atrial to femoral bypass systems. The microaxial flow pumps are available in two sizes. The Impella 2.5 pumps 2.5 liters of blood per minute (l/min), whereas the larger Impella 5.0 pumps 5 l/min. The 2.5 can be implanted percutaneously through the femoral artery, while the 5.0 requires a femoral surgical cut down and is generally reserved for the very sickest heart failure patients, says Mark A. Grise, MD, interventional director for Percutaneous VAD Support

As an organization, Ochsner has for many years aggressively treated PCI, including high-risk coronary interventions. The institution also is known for its strong heart transplant program. In recent years, these two patient populations have begun to overlap: Patients with weak hearts and low ejection fractions who also need complex coronary intervention. “That is one of the reasons why we started a Percutaneous LVAD Program,” says John P. Reilly, MD, associate director of the Cardiac Catheterization Laboratory.

In the beginning of the Percutaneous LVAD Program, the multidisciplinary team, comprised of interventional cardiologists, heart failure cardiologists and surgeons, would only use the smaller Impella 2.5 device in heart failure patients, but that quickly changed. “As our program evolved, we added the 5.0 devices for advanced heart failure patients,” Grise says.

The Impella 2.5 is mainly used for elective and emergent high-risk PCI procedures. Patients with complex coronary artery disease and weakened hearts will prophylactically receive the device. If the patient is stable at the end of the procedure, the device is taken out. Reilly has been the point man for quality care metrics for patients with acute MI (AMI), particularly regarding response time and mortality rates. Those patients suffering acute MI and or cardiogenic shock can easily be implanted with the device “without delaying door-to-balloon time,” says Reilly. “The Impella is set up and implanted in parallel with the PCI procedure.” These patients can be sent to the critical care unit (CCU) with the device still implanted post-procedure to give their hearts much needed hemodynamic support. “It may take three to five days for the heart to regain its strength and then the device is pulled out, often at bedside,” Reilly adds. 

Setting up the pLVAD Program

Before the stamp of approval was affixed to the Percutaneous LVAD Program, a team was charged with assessing the clinical significance of the device. Members sought to decide if it was a good match for Ochsner’s patient population. The team concluded the Impella had great potential for their high-risk heart failure patients. Next, the team crunched numbers to make sure the program would be financially viable. “We determined it would be,” says Vico Marizale, manager of the Cardiac Catheterization and Electrophysiology Laboratories.

“Our institution looked at reimbursement very carefully from several standpoints,” Grise says. “We performed an extensive analysis to ensure that we could offer this technology to a wide range of patients while maintaining fiduciary responsibility. Our experience has borne out our research. The program is a successful one for us.”

The team then presented their findings to a review committee, which agreed that the Impella cardiac assist device would benefit patient care. Marizale, along with Grise and others, spearheaded a “kick-off” meeting where they brought everybody together. “As with the introduction of any game-changing technology, a key ingredient for success is involving all the stakeholders in every step of the way,” Marizale says. For the Impella, those people include interventional cardiologists, heart failure cardiologists, transplant surgeons, CCU and cath lab nurses, technologists and perfusionists, as well as people in coding, billing and documentation.

At the first few meetings, the responsibilities for each individual who would be involved with the new technology were determined, as was the level of training each would need. The third key element was to understand patient selection. “If you can assign responsibility and determine training needs early on, you will have a strong foundation for the program,” Marizale says.

The next phase involved four to six weeks of training. One crucial decision was whether the patients would be cared for in the surgical unit or the CCU. Since most of the sick cardiac patients go to the CCU, the team decided that’s where these patients would recover. The core team met with CCU nurse managers and charge nurses to determine the number of nurses needed to be trained to ensure there would always be enough staff available who thoroughly understood the technology, Grise shares.
“It was an evolution of learning to be comfortable with these devices,” says Grise. “And the folks from Abiomed talked with everybody from the physicians to the charge nurses, offering support and making sure that everyone was comfortable with the technology, particularly in the early phase.”

It can be challenging to get everyone onboard with new technology, says Marizale, but the Impella device had some excitement associated with it because of its potential to improve patient outcomes and decrease mortality rates in high-risk cardiac patients. If there were any staff members not quite convinced of the Impella’s importance to patient care, they became converts after one of the first implants when an acute MI patient went into cardiogenic shock. The Impella went into action, keeping the patient’s pressure up. “Many people witnessed that event,” says Marizale, “and there was no doubt from that day forward about the benefits this device will provide for patients. Once you see the Impella in action, doing its job, it’s pretty amazing.” 

Patient selection

The cath lab performs about 3,600 to 3,800 procedures per year, which include adult coronary and endovascular diagnostic and interventional work. There are six cath labs utilized by nine interventional cardiologists, one interventional pediatric cardiologist and three transplant cardiologists. One lab is dedicated to pediatrics, one to the transplant cardiologists, and the other four to the adult interventionalists. EP has three dedicated labs.

Interestingly, there is a niche for the pLVAD devices in the EP lab, which Ochsner has employed. Patients with chronic heart failure are more susceptible to arrhythmias and ablation procedures can be very long. The Impella device, inserted by interventional cardiologists, gives EPs the confidence to know they can provide optimal care for these patients, Grise says.

The cardiology team at Ochsner is currently working on protocols to determine when to use the pLVADS and in what patients. For now, they rely on a team approach to arrive at consensus. “We are gaining more and more experience,” Grise says. “We believe in these technologies, but we also want to ensure we use it in the right people.”

Grise and his colleagues are discussing formal guidelines for patient selection. How severe are the symptoms? What is the amount of pressors the patient is on? What are the hemodynamics? What is the desired outcome? What is the ultimate goal or destination? What variables and outcomes do we want to evaluate moving forward? These and other questions must be carefully deliberated.

They are also working to standardize order forms. “Now that we have a body of work and some experience behind us, we all have individual thoughts about how best to proceed,” Grise says. “By the end of the year, we should have more defined protocols.”

Benefits to treating advanced heart failure
As a very large heart transplant referral center, Ochsner admits many patients with advanced heart failure, many of whom for various reasons are not candidates for transplants. “We have this fairly large population of very sick patients and we wanted to offer them a bridge to either a surgical assist device or a transplant,” Grise says. “In the past, these patients would often be treated with intra-aortic balloon pumps, which are helpful, but they often do not provide enough hemodynamic support. The pLVADs, such as the Impella, have been shown to clearly provide superior hemodynamic support in several different clinical scenarios, including acute MI, high risk PCI, and decompensated heart failure.”

“Patients with advanced heart failure benefit from mechanical support,” says Hector O. Ventura, MD, section head of the Heart Failure & Transplant Program. “We have defined pathways to take care of patients and we’re very vigilant about them.” The multidisciplinary team provides patient coordinators for every area of recovery, including transplant coordinators, assist device coordinators, heart failure coordinators and medication coordinators. And the effort has paid off as Ochsner has a nearly 90 percent one-year survival rate for its transplant patients.

Ventura likes how the temporary Impella device augments permanent assist devices and transplants. Used as a bridge to a permanent device implantation or a transplant, the Impella helps many patients regain strength in other organ systems such as the liver and kidneys that have suffered from weak cardiac output. “The longest we have used an Impella in a patient was 19 days. We will leave the device in until we are sure the patient is ready for further surgery, but that is generally seven to 10 days,” he says. 

The IT link

A large part of Ochsner’s standards of excellence is due to its cutting-edge IT. The hospital uses a homegrown IT system supported by a team of six full-time programmers. “As government and private payors require more evidence-based benchmarks to be met to get paid, IT will be the driver,” says Richard V. Milani, MD, vice chairman of the Department of Cardiology and a strong proponent of IT.

As one example of using IT to improve care, Milani and colleagues designed a computer-assisted decision support (CADS) program for patients admitted with acute coronary syndrome (ACS). The CADS program utilizes patient clinical data, including risk scoring, to suggest specific therapeutics and drug dosing based on consensus guidelines. It also lists contraindicated medications based on certain risk assessments such as age and creatinine clearance.

At the 2010 AHA Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke meeting, Milani reported on 452 consecutive patients in 2009 where physicians had the option of using either pre-printed ACS orders (standard orders) or CADS-generated orders. Although only 77 patients were admitted using CADS-generated orders, they were twice as likely to receive “perfect” care versus standard orders patients (84 vs. 44 percent). While the CADS patients trended toward higher TIMI risk cores, their mortality was reduced by half compared to patients admitted with standard orders (2 vs. 4 percent). A similar program is being planned for heart failure. “This is where we’re headed—where you can have an iterative interaction with software that ultimately improves patient outcomes,” Milani says.

The cardiology department also mines data to keep outliers from straying too far in either direction. Weekly meetings review every case, every lesion. “It is as an opportunity for us all to share our thoughts and techniques, learn from one another and raise the level of care across the board,” says Stephen R. Ramee, MD, director of the Cardiac Catheterization Laboratory.

He adds the Percutaneous LVAD program is another example of Ochsner’s commitment to maintaining the highest level of patient care by careful use of sophisticated technology, talent and teamwork. 

Collaborative PARTNERs

Ochsner has five cardiology sections: transplant, noninvasive imaging, clinical cardiology, EP and interventional. There are 35 cardiologists almost equally divided among the different groups. All of these groups are involved with advanced heart failure patients and it is imperative that they work together seamlessly. “You also need a firm commitment from the administration to provide the best and most efficient patient care,” says Ramee, adding that the multidisciplinary approach is one of the most exciting things about the Percutaneous LVAD Program.

Currently, Ochsner has one hybrid OR located in surgery that is primarily used for difficult pacemaker lead extractions and abdominal and thoracic aortic endografts. The hospital expects to have a hybrid cath lab within a few years. Ramee says they will use it for any procedure that requires a cut down, for patients who are prepped for general surgery or for procedures that require anesthesia including percutaneous valve replacement and percutaneous LVAD implantation.

“Hybrid cath labs are the wave of the future because of the structural heart work,” Ramee says. “Besides, many hospitals are out of operating space and this expands the operating room capability without using up valuable space in the OR.”

The hybrid lab will be another example of Ochsner’s commitment to excellence and to collaborative relationships within the various specialties.

The Ochsner team also has experienced interdisciplinary collegiality as a participating hospital in the PARTNER trial, which assessed transcatheter valve replacement in high-risk surgical and non-operable patients with severe aortic stenosis. The trial is completed and under review by the FDA, but anecdotally, Ramee says the patients have done remarkably well, most progressing from class III and IV to class I and II, a benefit that has been sustained in the life of the patient.

One of the more interesting aspects of Ochsner’s involvement in the PARTNER trial is a resurgence in balloon aortic valvuloplasty: from one a month to two to three a week. Previously, aortic valvuloplasty was performed only to palliate nonsurgical candidates’ shortness of breath.

“We now perform it routinely in patients who are not candidates for this generation of percutaneous valve, but may be a candidate for the next smaller generation to be trialed next year,” says Ramee. “We also perform valvuloplasty to see if patients with low gradient valve flow and weak hearts will improve upon valve dilation. If they do, they are reconsidered to be candidates for transcatheter valve replacement.”

Similar to the PARTNER trial, the Percutaneous LVAD Program also enables Ochsner to bring in more patients who otherwise are unable to be treated. “Overall, with the Percutaneous LVAD program, we have seen a rapid turnaround in the hemodynamic status and kidney and liver function of patients with advanced heart disease,” Grise says. “These patients are very sick, generally on multiple pressor agents and our aggressive up-front approach can reverse some of the deleterious effects of decompensated heart failure.” He adds that the same is true in the cath lab. “The aggressive up-front approach to treating patients with acute MI and cardiogenic shock allows them to stop the pressor agents sooner, stabilize sooner and reverse organ deterioration in a much more rapid timeframe than otherwise would have been possible.”

“We strive to achieve excellence in everything we do, and we generally achieve it,” Ramee says. “Everyone works as a team. Everyone knows the patient comes first. Technology plays a big role for us, and the Impella devices have allowed us to offer patients with limited options a chance for a better quality of life. It’s a win-win situation for everybody.”