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