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Yale University Study Demonstrates Significant Survival Benefit in High-Risk PCI with Impella Support

An analysis of over 2,000 patients from a large real-world database in the United States reveals that patients who underwent high-risk elective PCI with the Impella heart pump (n=1447) had significantly improved survival, reduction in myocardial infarction, reduction in cardiogenic shock after PCI, and shorter length of stay than matched patients treated with an intra-aortic balloon pump (IABP) ( n = 709). The study’s findings are consistent with and reinforce findings from other peer-reviewed studies over the past 10 years.

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Figure 1 (Graphic: Business Wire)

The study published on October 7 in The American Journal of Cardiology. It was conducted by a group of expert physician-researchers, led by Alexandra Lansky, MD, professor of medicine at the Yale School of Medicine and practicing cardiologist at Yale-New Haven Hospital. Dr. Lansky is also director of the Yale Cardiac and Vascular Clinical Research Program and the Yale Cardiovascular Research Center, specializing in the evaluation of interventional devices.

“This study from a large, contemporary, real-life database is further evidence of the benefits of using Impella during high-risk PCI to stabilize hemodynamics, prevent hemodynamic collapse, enable revascularization and improve clinical outcomes,” said Dr. Lansky.

The study looked at patients from the Premier Healthcare database treated between 2016 and 2019 with Impella or IABP for elective high-risk PCI. Patients were matched using propensity score methods to control for differences in baseline, procedural, and post-PCI medical treatment between groups. The study found:

  • In-hospital survival was significantly higher with Impella compared to IABP (unadjusted 95.3% vs. 91.0%, p=0.0002; adjusted odds ratio (OR) 1.55, range 95% confidence (CI) 1.02, 2.36, p=0.042).

  • Myocardial infarction was significantly reduced with Impella compared to IABP (unadjusted 2.5% vs 11.9%, p

  • Cardiogenic shock after PCI was significantly reduced with Impella compared to IABP (8.3% vs 18.9% p

  • Shorter length of stay for Impella patients compared to IABP patients (unadjusted 3.1 days vs 5.5 days, p

Additionally, the safety profile for bleeding and stroke was the same between the Impella and IABP groups. This is consistent with data demonstrating improvements in bleeding over time for large bore devices, with the adoption of contemporary practices such as ultrasound-guided vascular access and optimal use of closure devices. (see figure 2)

The authors of Lansky et al. analyzed contemporary payer data from the years following FDA approval of Impella for high-risk PCIs, a time when best practices for using Impella had been established. Additionally, they used a simpler propensity-matching methodology than previous studies from similar datasets.

The results of Lansky et al. validate and extend the results of other Impella studies in high-risk PCI, including the PROTECT II Randomized Controlled Trial (RCT)the PROTECT III study and the RESTORE EF Study. The PROTECT II RCT found that Impella use resulted in a 29% reduction in the relative risk of MACCE at 90 days compared to IABP. The PROTECT III study demonstrated additional improvement in 90-day clinical outcomes, completeness of revascularization and safety compared to the PROTECT II RCT. (see figure 3) Restore EF has demonstrated that the use of contemporary best practices with Impella in high-risk PCI significantly improves left ventricular ejection fraction (LVEF), heart failure symptoms, and angina symptoms at follow-up of 90 days in patients treated in various hospital settings including rural, urban, community and academic medical centers. (see figures 4 & 5)

ABOUT IMPELLA HEART PUMPS

Impella 2.5® and Impella CP® are approved by the US FDA to treat certain patients with advanced heart failure undergoing elective and urgent percutaneous coronary interventions (PCI), such as stent placement or balloon angioplasty, to reopen blocked coronary arteries.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed (Nasdaq: ABMD) is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to allow the heart to rest and recover by improving blood flow and/or providing sufficient oxygenation to people with respiratory failure. For more information, please visit abiomed.com.

FORWARD-LOOKING STATEMENTS

Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed’s periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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