Samin Sharma: Outcomes of Impella-supported High Risk PCI

Samin Sharma, M.D., FSCAI, FACC, discusses his paper titled “Outcomes of Impella-supported high-risk nonemergent percutaneous coronary intervention in a large single-center registry.” The senior author of the paper also discusses his algorithm for selecting cases for Protected PCI. Dr. Sharma is the director of interventional cardiology, director of clinical cardiology and a professor of medicine at Mount Sinai Medical Center.

Dr. Sharma emphasizes that Impella support during high-risk PCI provides interventional cardiologists with the time they need to do their job “calmly and perfectly.” When asked if he could have done particular cases without Impella support, he responds, “Yeah. But if patient became hypotensive I might have rushed the procedure. And let’s say I needed to put two stents, needed to do kissing balloon dilatation; I would have avoided that.”

Dr. Sharma explains that it is important to have guidelines for determining the appropriate use of Impella^® during PCI. He discusses the algorithm developed at Mount Sinai for selecting Protected PCI cases. Patients are candidates for Protected PCI if they have a combination of low left ventricular ejection fraction (LVEF ≤ 35%) and complex coronary artery disease (CAD). This includes patients with high SYNTAX scores indicative of higher risk of adverse cardiac events and mortality, left main disease, total occlusion of the right coronary artery, or calcific bifurcation LAD with a low ejection fraction.

In his paper, Dr. Sharma and colleagues report the results from their single-center retrospective study at Mount Sinai Medical Center of all patients who underwent high-risk nonemergent PCI supported with Impella 2.5^® or Impella CP^® between January 2009 and June 2018. The primary endpoint was major adverse cardiac events (MACE), which included all-cause death at one-year follow-up.

Dr. Sharma explains that Impella use steadily increased from about 1% of patients to 3-4% of high-risk PCI cases by the end of the study period. While patients in the study were propensity score matched, patients who were supported with Impella had different procedural characteristics, including more three-vessel disease and more left main disease and these patients were treated with different procedural techniques, such as more vessels treated and more left main atherectomy. Yet despite higher procedural complexity, Dr. Sharma emphasizes, “by using the Impella in these patients there was no increase in mortality.”

Dr. Sharma acknowledges that there was an increase in bleeding complications and an increase in creatine kinase-MB (CK-MB) levels in patients treated with Impella; however, despite these short-term complications, patients did well with no difference in mortality. In addition, Dr. Sharma has seen a decrease in the rate of bleeding complications with best practices over time from about 6% to about 2.2%. He also highlights that no patients treated with Impella experienced a stroke.

Dr. Sharma summarizes by reiterating that Impella-supported PCI is appropriate when clearly indicated. “Be meticulous in terms of vascular access,” he emphasizes, and give patients supported with Impella the benefit of opening as many arteries as possible. He also looks forward to further improvements as smaller diameter Impella devices become available.

Dr. Samin Sharma is compensated by and presenting on behalf of Abiomed and must present information in accordance with applicable regulatory requirements. This presentation includes Dr. Sharma's opinions and findings based on their own knowledge and experience.