Circulation, 2018: Analysis reinforces best practices of reduced use of inotropes and placement of Impella pre-PCI leads to improved survival rates. Survival benefit of Impella pre-PCI revealed trend vs “matched” IABP-Shock: 57.3% vs. 46.7% (p=0.18). Significant survival to discharge benefit with Impella in patients who did not receive inotropes (56.6% vs. 29.4% p<0.01). A subset of patients from this paper was presented at American College of Cardiology (ACC) 2019 Scientific Sessions when Andreas Schäfer, MD, presented an abstract that showed improved survival to discharge when Impella is placed pre-PCI of 71% vs. 49% post-PCI (p= 0.0021).
Journal of the American College of Cardiology, 2018: Rab, et al., summarizes data from IQ Database, cVAD Study and NCSI and concluded that best practices are associated with improved survival in AMI cardiogenic shock.
New Data Published This Week

The most recent results that further validate best practices published online this week in the Journal of the American College of Cardiology. After Inova Heart and Vascular Institute instituted a best practice protocol that includes early use of percutaneous mechanical circulatory support, AMI cardiogenic shock survival at 30 days rose from 44% to 82% (p=0.0001).
“The totality of the data on Impella use for cardiogenic shock demonstrates that coordinated care with a multidisciplinary team-based approach, a standardized protocol, and the best available tools, can lead to a remarkable increase in survival,” said William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit. “This gives us hope for making real improvements to patient outcomes in this patient population that has historically been difficult to treat.”

Cardiogenic shock patients who have benefited from treatment at leading centers from physicians who implanted Impella include Jay Sanchez, Stephon Betts and Ricky Payne. Survival with native heart recovery is the best option for the patient and one of the most cost-effective medical therapies.

“Abiomed has built the field of heart recovery by partnering with our hospitals and physicians to use real-world data, combined with FDA post-approval studies, to identify and validate best practices to improve patient outcomes,” said Abiomed Chairman, President and CEO, Michael R. Minogue. “It is inspiring that, over the last three years, cardiogenic shock patients have returned home to their families with their native heart.”

Impella’s FDA PMA for AMI cardiogenic shock was granted based on the following: Analysis of 494 cardiogenic shock patients from the U.S. Impella Registry (now called cVAD Study) and the RECOVER I FDA Study, safety and effectiveness analysis from FDA studies for high-risk PCI (PROTECT I & PROTECT II RCT), 709 high-risk PCI patients from U.S. Impella Registry, Impella literature review including 692 cardiogenic shock patients and 756 high-risk PCI patients treated with Impella, hemodynamic science demonstrating the benefits of unloading the left ventricle to reduce work and oxygen demand for the left ventricle and perfuse the end organs, the Journal of American College of Cardiology article, Hemodynamics of Mechanical Circulatory Support, D. Burkhoff et al., (2015), and a safety analysis of more than 25,000 Impella-treated patients using the FDA medical device reporting database, which draws from eight years (2008-2016) of U.S. experience with Impella 510(k) clearance. Furthermore, the RECOVER II RCT demonstrated the difficulty in consenting and enrolling these U.S. patients due to ethical and logistical concerns. The intra-aortic balloon pump is now a class III recommendation in Europe and Japan based on the IABP-Shock II study.

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