Complete Revascularization with Hemodynamic Support

ProtectedPCI
February 17, 2016

Complete Revascularization with Hemodynamic SupportAt the recent 2015 the San Diego Cardiovascular Interventions 2015 Course, Dr. Ehtisham Mahmud, MD, University of California, San Diego, presented a case titled Complete Revascularization with Hemodynamic Support. He reviewed his case of a 74-year-old man with unprotected left main and multivessel coronary artery disease. He had left ventricular dysfunction and an ejection fraction of 35%. An angiogram revealed a distal left main lesion and lesions in the left anterior descending and circumflex arteries. Coronary artery bypass graft surgery (CABG) was recommended, but the patient did not want surgery and came to Dr. Mahmud for a second opinion.

Dr. Mahmud determined that a Protected PCI procedure with the Impella 2.5® heart pump, was the best option for the patient. Dr. Mahmud explained that the Impella 2.5™ pumps blood from the left ventricle to the aorta, which increases cardiac output, moves the pressure-volume curve to the left and decreases myocardial oxygen demand. Dr. Mahmud emphasized that the use of the Impella 2.5™ allowed him more opportunity to completely revascularize and place stents in the mid left anterior descending artery, distal left main lesion into the left anterior descending and circumflex arteries of this patient. At the 30-day follow-up visit, this patient was doing well. Data to support this approach was reported by the PROTECT II study (O’Neill et al. 2012).

Dr. Mahmud reviewed data that indicated placement of the Impella 2.5™ before the PCI procedure is linked to higher survival rates at discharge and 30 days post-PCI procedure (O’Neill et al. 2013). Prior placement of the Impella 2.5™ also allows for more complete revascularization and results in improvements in ejection fraction and reductions in congestive heart failure (Burzotta et al. 2008; Dixon et al. 2009; Maini et al. 2012).

Like Dr. Mahmud’s patient, Protected PCI is appropriate for patients who are hemodynamically stable, have ejection fraction ≤35%, and possess comorbid conditions such as heart failure, peripheral vascular disease, complex lesions, diabetes, advanced age, unstable angina, non ST-segment elevation myocardial infarction, or prior surgeries.

Dr. Mahmed emphasized the goal of PCI is complete revascularization. Complete revascularization is important because it is associated with improved patient outcomes. The PROTECT II and Acuity trials indicate that the more revascularization achieved, the lower the 90-day major adverse cardiovascular and cerebrovascular events (MACCE) reported, regardless of device (Impella 2.5™ or intra aortic balloon pump [IABP]) used. Ninety days after the PCI procedure, Dangas et al. 2014 reported a 29% reduction in MACCE with Impella 2.5™ compared to IABP.

Conclusion

The Impella 2.5™ and the Protected PCI procedure allow for more complete revascularization in patients with complex coronary artery disease. More complete revascularization is associated with improved patient outcomes.

Next Steps:

  1. Listen to Mahmud’s presentation
  2. Read the PROTECT II studies by O’Neill et al. 2012; O’Neill et al. 2013
  3. Read the Dangas et al. 2014 article  original Dangas et al. 2014
  4. Read the original ACUITY trial article by Rosner et al. 2012
  5. Read the Maini et al. 2012 article
  6. Read the Burzotta et al. 2008 article
  7. Read the Dixon et al. 2009 article
  8. Learn more about the hemodynamics of Protected PCI with the Impella 2.5 heart pump
  9. Learn more about the clinical data associated with Protected PCI
  10. Learn more about identifying patients for CABG or 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.