Aging Population Leading to Increase in CHIP Patients Who Could Benefit from Protected PCI

ProtectedPCI
November 16, 2015

On Friday, November 6, 2015, Dr. Jeffrey Moses, Director of Interventional Cardiac Therapeutics at Columbia University Medical Center, NY and Director of Complex Coronary Interventions at St. Francis Hospital, Roslyn, NY gave a talk entitled “Protected PCI for High-Risk Patients: For Whom and With What” at the Advanced Hemodynamic Course hosted by Abiomed in Frankfurt, Germany.

Dr. Moses began his presentation with the changing demographics observed in the cardiac catheterization laboratory namely that of older patients, aged over 80 years. These patients often have more complex disease with history of congestive heart failure, low ejection fraction, prior coronary artery bypass graft surgery (CABG), peripheral vascular disease, and multi-vessel disease. Other comorbidities may include diabetes mellitus, renal insufficiency (PROTECT II study) or complex anatomy such as calcification, bifurcation, or chronic total occlusion.

While these high-risk patients are normally not eligible for CABG, they often qualify for complex, high-risk and indicated PCI or CHIP for short. Many CHIP patients can benefit from coronary revascularization by PCI. Data has demonstrated that when blood vessels are completely revascularized in a single session, patients can benefit in the form of better outcomes. (Burzotta et al. 2008; Dixon et al. 2009; Maini et al. 2012; O’Neill et al. 2012)

Dr. Moses noted that incomplete revascularization is common. However, complete revascularization is the goal of PCI. This is important because complete revascularization is associated with significantly less major adverse cardiovascular events (MACE, P<0.001), myocardial infarction (P=0.0007) and revascularization procedures (P<0.001), according to studies by Rosner et al. 2012 and Garcia et al. 2013.

In addition, a 2015 study by Watkins et al. 2015 reported that revascularization procedures conducted in a single session have significantly fewer major adverse cerebral and cardiovascular events (MACCE, p=0.004) and deaths (p=0.006) compared to staged PCI procedures.

Dr. Moses noted that hemodynamic support can help enable one to complete revascularization in one PCI session. Dr. Moses considers hemodynamic support when PCI is conducted in the following situations: a) on the last remaining vessel; b) when severe left ventricular dysfunction is present; c) difficult wiring; d) difficult stent delivery; e) there is a high risk of no reflow, such as saphenous vein graft and rotoblation, and; f) the presence of retrograde chronic total occlusion through a major blood vessel. Dr. Moses reminded the audience that the goals of hemodynamic support are to maintain the patient’s hemodynamics and facilitate complete revascularization in the safest manner possible. This is supported by a 58% reduction (P<0.001) in NYHA Class III and IV 90 days after PCI, which translated into improved quality of life for these patients (O’Neill et al. 2012).

Conclusion

Patients with complex coronary disease, depressed left ventricular function and clinical comorbidities comprise a new and growing patient population for the cardiac catheterization laboratory. These patients may not qualify for CABG, and extensive and complete coronary revascularization in a single PCI session is an alternative treatment with the use of hemodynamic support, reduced complications and improved quality of life for patients.

Next Steps

  1. Read the original PROTECT II article by O’Neill et al. 2012.
  2. Read the article by Burzotta et al. 2008.
  3. Read the original article by Dixon et al. 2009.
  4. Read the USpella Registry study by Maini et al. 2012.
  5. Read the ACUITY trial study by Rosner et al. 2012.
  6. Read the study by Garcia et al. 2013.
  7. Read the results of the staged PCI study by Watkins et al. 2015.
  8. Learn more about 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.