PROTECT III Study: Data from more than 1,000 patients presented during the virtual 2020 Society for Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions demonstrates Impella reduced in-hospital mortality when placed before a non-emergent percutaneous coronary intervention (PCI) is performed. As detailed in the online presentation, the research found, in the setting of high-risk PCI, when Impella is placed pre-PCI, it is associated with a ten times reduction of in-hospital mortality, compared to when Impella is placed during bailout PCI (see figure 1).

Bailout PCI is defined as when a physician starts an elective or urgent PCI without planning to use Impella support, then initiates Impella support during the procedure when the patient becomes hemodynamically unstable.

The data presented is from an adjunct study of PROTECT III, the ongoing, prospective FDA post-approval study for Impella in high-risk PCI. The research is authored by William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital and Jeffrey W. Moses, MD, director of interventional cardiovascular therapeutics and professor of medicine at Columbia University Medical Center.

The study’s authors write, “Support with Impella in hemodynamically stable patients undergoing non-emergent PCI, also termed Protected PCI, is now a well-established indication in a selective patient population at high risk for hemodynamic collapse during PCI. However, some physicians may eschew preventive hemodynamic support and prefer a bailout strategy should hemodynamic collapse occur.” The study aimed to quantify the risk of such a bailout strategy.

The study analyzed 1,028 patients supported with Impella 2.5 or Impella CP (971 in Protected PCI group and 57 in bailout group). In the bailout group, females were more prevalent (50.9% vs. 27.2%, p=0.0002), the median baseline left ventricular ejection fraction was significantly higher (40% vs 30%, p<0.0001), heart failure was less prevalent (42.1% vs 56.9%, p=0.039), and left main disease was less prevalent (40.0% vs 56.1%, p=0.03). In summary, the bailout group had a higher percentage of women, the patients were younger, and had a higher ejection fraction with less heart failure. Despite these differences the study found:

• In-hospital mortality was significantly higher in the bailout group compared to the Protected PCI group, respectively (49.1% vs. 4.3%, p<0.0001). The difference in mortality was significant across patients experiencing hemodynamic collapse secondary to refractory hypotension or coronary perforation/dissection.

“Failure to prospectively identify patients who may experience hemodynamic collapse during non-emergent PCI leads to excessive in-hospital mortality. This data shows that Impella support prior to initiation of the PCI can reduce this risk,” said Dr. O’Neill.

“Many of these patients requiring bailout Impella are younger women with healthier ejection fractions, so they are often overlooked for mechanical support,” said Cindy Grines, MD, chief scientific officer of Northside Hospital Cardiovascular Institute in Atlanta. “However, these women may not tolerate prolonged ischemia during PCI. These data show that we need to recognize women as a vulnerable population and consider support in advance.”

The use of Impella can also allow for a high-risk patient to receive a more complete revascularization, as detailed in the 2020 SCAI Position Statement on Optimal Percutaneous Coronary Interventional Therapy for Complex Coronary Artery Disease. The SCAI guidelines, which published on Thursday, note, “Observational studies demonstrate improved procedural cardiovascular hemodynamics and more complete revascularization in the presence of MCS (mechanical circulatory support) devices despite higher-risk patient profiles.”