Benzinga | Oct 16, 2020 07:08AM EDT

Abiomed Highlights Presentation Of Data At TCT Connect Showing Higher Survival With Impella Pre-PCI

Two studies of AMI cardiogenic shock (AMICS) patients found higher survival when Impella was placed pre-PCI, compared to when Impella was placed after PCI. The findings were presented at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation.

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Figure 1 (Graphic: Business Wire)

In the first study, presented by Hemindermeet Singh, MD, of Ascension St. John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017--2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008--2014) when the practice of placing Impella pre-PCI was not yet widely adopted. Researchers found an 18% relative improvement in overall survival in the recent cohort, indicating an associated benefit to placing Impella pre-PCI. The recent cohort also had lower incidences of peri-PCI acute kidney injury (AKI) and major bleeding or vascular complications. This is despite a higher prevalence of hypertension, smoking, stroke, and New York Heart Association (NYHA) class III/IV heart failure in the recent cohort. (see figure 1)

"This data shows increased adoption of the cardiogenic shock best practices over the last three years has led to an improvement in overall survival rates," said Amir Kaki, MD, the study's senior author, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital. "In order to improve outcomes for our patients, it is important for practitioners to apply these best practices, which include early identification of shock, use of a right heart cath, reduction of toxic inotropes and use of Impella prior to the PCI."

"Our study demonstrates growing physician and institutional experience. The implementation of standardized cardiogenic shock protocols and the increasing use of strategies to reduce vascular and bleeding complications are associated with better survival. In-depth understanding of these factors has significant potential of improving outcomes in cardiogenic shock patients in the community at large," said Dr. Singh.

The second study, presented by Tayyab Shah, MD, of the Yale School of Medicine, analyzed data collected from the RECOVER III trial between 2017-2019. It found that placing Impella pre-PCI in AMICS patients is associated with higher survival than placing Impella post-PCI, especially in women. Study investigators determined women had a 74% relative survival benefit with Impella use pre-PCI as compared to post-PCI. The study authors conclude early implantation of Impella provides a significant survival benefit, particularly to women. (see figure 2)

"This study suggests that the early use of the Impella device to support patients in cardiogenic shock, before PCI and inotrope/vasopressor usage, may provide a survival benefit particularly to females," said Dr. Shah. "This is an interesting result from an observational study with meaningful clinical implications, which need to be further explored in the upcoming RECOVER IV randomized controlled trial."

Since FDA PMA approval, Abiomed (NASDAQ:ABMD) has collected data on nearly 100% of U.S. Impella patients in the observational Impella Quality (IQ) Database. This clinical data, combined with the FDA post-approval studies, such as RECOVER III, that are embedded in Abiomed's prospective, IRB approved, catheter-based Ventricular Assist Devices (cVAD) Study, helped identify and validate best practices for Impella use associated with improved survival and native heart recovery. These best practices, including use of Impella pre-PCI, early identification of shock, reduction of inotropes, and hemodynamic monitoring with pulmonary artery catheters, have now been validated in multiple publications. (see figure 3)

Additionally, independent physician-led studies with best practice protocols that include placing Impella pre-PCI, such as the National Cardiogenic Shock Initiative Study (NCSI), the Inova Study (Tehrani et al), and the Japanese P-VAD Study (J-PVAD), have demonstrated significant increases in survival compared to historic cardiogenic shock survival rates. (see figure 4) These best practices will inform the study protocol for the upcoming RECOVER IV Randomized Controlled Trial of Impella in AMICS.

To share best practices in AMI cardiogenic shock treatment, Abiomed is hosting a symposium at TCT Connect on Sunday, October 18, 2020 at 10:00 a.m. EDT, titled Achieving >70% AMI-CS Survival: Best Practices from Around the World. The symposium is chaired by William O'Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital.