The data presented is from an adjunct study of PROTECT III, the ongoing, prospective U.S. Food and Drug Administration (FDA) post-approval study for Impella in high-risk PCI. The research is authored by William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital and Jeffrey W. Moses, M.D., 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 percent vs. 27.2 percent, p=0.0002), the median baseline left ventricular ejection fraction was significantly higher (40 percent vs. 30 percent, p<0.0001), heart failure was less prevalent (42.1 percent vs. 56.9 percent, p=0.039), and left main disease was less prevalent (40.0 percent vs. 56.1 percent, 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 percent vs. 4.3 percent, 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, M.D., 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 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.”
The Impella 2.5 and Impella CP devices are FDA PMA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with Smart Assist are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP is FDA-approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Impella is the most studied mechanical circulatory support device in the history of the FDA with more than 10 years of FDA studies, real world clinical data on more than 140,000 patients and more than 650 peer-reviewed publications.
In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to five days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with Smart Assist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia.