High-Risk Percutaneous Coronary Interventions in Modern Day Clinical Practice: Current Concepts and Challenges
The advances of the percutaneous coronary intervention (PCI) procedure has evolved significantly since the early 1980’s, according to a recent editorial in Circulation: Cardiovascular Interventions. The author, Theodore Bass, MD, from University of Florida College of Medicine, highlights advances in current technologies and techniques that make more complex and high-risk PCI possible today.
Bass distinguished the difference between complex and high-risk PCI using the following case as an example of complex PCI: “A middle-aged male with normal left ventricular function and increasing angina presenting for PCI with a heavily calcified bifurcation lesion involving the left anterior descending-first diagonal bifurcation.” This case would be considered high-risk PCI if it were “an elderly male with a chronically occluded right coronary artery and a severely decreased left ventricular ejection fraction.” The distinction between complex and high-risk PCI is important because the “skills and support systems” needed to conduct PCI on both of these patients may vary greatly.
Bass notes the definition of high-risk PCI is changing, due to advances in percutaneous ventricular assist devices, such as the Impella® heart pump. The recent FDA approval of the Impella heart pump enables interventional cardiologists to perform high-risk PCI and attempt complete revascularization in high-risk patients with complex coronary artery disease. Such patients 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.
Complete revascularization is important because it is associated with improved patient outcomes including decreased major adverse cardiovascular and cerebrovascular events (MACCE), myocardial infarctions, and repeat revascularizations. Bass acknowledges one challenge to improving patient outcomes is a clear definition of high-risk PCI, which needs to be monitored “to track, risk adjust, standardize patient selection protocols and investigate optimal treatment strategies.” The below image captures the 3 components that identify a high-risk PCI, as noted by the FDA in its March 2015 approval of the Impella.
Other challenges include maintaining a highly trained heart team, with specific equipment and “quality assurance required to assure best clinical practice.” Cost-benefit data (Maini et al. 2014) indicate fewer days in the hospital for Impella patients compared to intra aortic balloon pump (IABP) patients and a reduction in hospital readmissions for repeat PCI for Impella® patients compared to IABP 90 days post-PCI procedure (Gregory et al. 2013).
Bass realizes high-risk patients may benefit the most from PCI. However, he concludes “the challenge will be how to provide these services in the most effective and efficient ways possible.”
- Read the original editorial by Bass 2015
- Listen to a webinar about the heart team model
- Learn more about the support systems needed for a Protected PCI program
- Read the press release from the FDA’s approval of Impella 2.5
- Learn more about the use of Impella 2.5 for PCI
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.