Building Your Impella Program: Lessons from Greenville Health System

ProtectedPCI
December 8, 2015

impellaprogramOn Friday, December 4, 2015, a course entitled “Building your Impella Program: Lessons from Greenville Health System” was presented to cardiac catheterization laboratory physicians, nurses and technicians in Greenville, South Carolina. Two physicians, Drs. Josh Doll and Jesse Jorgensen from the Greenville Health System, Greenville, SC, led the primary discussion around Protected PCI.

Dr. Doll’s presentation, entitled “Updated Guidelines, Patient Identification and Clinical Data,” reviewed the rationale for hemodynamic support and the growing population of patients with a combination of complex coronary anatomy, reduced left ventricular function and comorbidities. These patients are often turned down for surgery and remain undertreated in community settings. As a result, these patients are often in emergency rooms repeatedly, and readmitted to the hospital, using health care resources at a high cost.

Dr. Doll recommended the use of a heart team, which is a multidisciplinary team that includes cardiologists and cardiothoracic surgeons and others who work together to develop the best treatment plan for each patient. Many times advanced care practitioners (NPs and PAs) can help identify patients who may benefit from different treatment options, such as Protected PCI.

Dr. Doll presented clinical data from the Protect I (Dixon et al. 2009), Protect II (O’Neill et al. 2012; Dangas et al. 2014) and the USPella registry (Maini et al. 2012) studies. He noted the that Protected PCI with Impella® can result in less hypotension and the ability to maintain systemic perfusion. The PROTECT II study compared PCI with the Impella® 2.5 to PCI with the intra aortic balloon pump (IABP) (O’Neill et al. 2012). In the Impella® arm, patients were sicker and received more rotational atherectomy and saphenous vein grafts. Yet the Impella® patients were treated for a shorter time and had, lower rates of major adverse cardiac and cerebral events (MACCE) compared to IABP when measured at 90-days post-procedure. (Dangas et al. 2014). The Impella® is cost effective, as demonstrated by fewer days in the hospital for Impella® patients compared to IABP patients and a reduction in hospital readmissions for repeat PCI for Impella® patients when compared to IABP 90 days post-PCI procedure (Gregory et al. 2013).

Dr. Doll concluded that a Protected PCI program involves identifying appropriate patients, developing physician skills and using the Impella® to obtain complete revascularization. Complete revascularization is important because it can help to improve patient outcomes.

The next discussion, led by Dr. Jorgensen, focused on “The Science of Hemodynamic Support” and reviewed pressure volume loops, the concept of cardiac power output, and the effects of inotropes and fluids on pressure volume relationships. Dr. Jorgensen explained that the Impella® can reduce the work of the heart and can decrease myocardial oxygen demand, wall tension, and microvascular resistance, which results in increased myocardial oxygen supply, improved microvascular resistance and systemic perfusion (Remmelink et al. 2007).

Dr. Jorgensen used pressure-flow (HQ curves) to illustrate characteristics of Impella® flow as it relates to pressure across the Impella® device. At very low pressures the flow is highest and at very high pressures the Impella flow is lowest. Dr. Jorgensen emphasized the importance of understanding flow and allowing mean arterial pressures of 90 mmHg in these patients.

Dr. Jorgensen noted that choosing the level of hemodynamic support appropriate for each patient depends on the hemodynamic burden and the patient’s requirement for hemodynamic support. Impella® is used most often when superior hemodynamic support is needed. IABP provides less hemodynamic support but can be preferred in patients with apical mural thrombus, prosthetic mechanical aortic valves and severe aorto-iliac disease.

Next Steps:

  1. Read the original PROTECT I study by Dixon et al. 2009.
  2. Read the original PROTECT II article by O’Neill et al. 2012.
  3. Read the Dangas et al. 2014
  4. Read the USpella Registry study by Maini et al. 2012.
  5. Read the study by Gregory et al. 2013.
  6. Read the article by Remmelink et al. 2007.
  7. Learn more about the clinical data associated with Protected PCI.

About Impella

The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi.