Abiomed Looks at Healthcare Disparities with Trial

Circulatory support and oxygenation device company, Abiomed, is looking at healthcare disparities through data with its newest trial of its Impella heart pump.

Findings suggest that access to care such as the pump can lead to better outcomes for non-white patients, making access to the care option important for minority patients, according to the company.

The data comes from the company’s PROTECT II randomized controlled trial of Abiomed’s Impella pump vs. an intra-aortic balloon pump. A subgroup analysis within the study included 93 non-Caucasian patients who are at high risk for PCI, and showed better outcomes with the Impella pump.

The study was recently published in Circulation.

Reduction of risk for high-risk patients

“This data about the benefit of Impella-supported procedures for non-Caucasian patients is highly compelling and should be used to inform physicians’ clinical decision-making when treating non-Caucasian patients who have heart disease,” said William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Health and the principal investigator of the PROTECT II RCT.

According to the data, Impella reduced the risk of major adverse events by 48% at 90 days after procedure, as noted in the figure. This parameter was the primary endpoint of the study, and in the overall study population led to the company’s FDA approval as a safe and effective treatment for high-risk PCI.

Further, major adverse cardiac and cerebral events were reduced by 60% 90 days from a procedure and stroke, death, myocardial infarction, or “irreversible events” were reduced by 70% in the timeframe from discharge to 90 days after procedure.

Expanding access to heart pumps

Based on the current data and Impella’s potential to reduce risk for patients with high-risk PCI, right heart failure, and cardiogenic shock, Abiomed has launched a patient assistance program aimed at lessening healthcare and treatment disparities. Named the W. Gerald Austen Disparities in Healthcare Initiative, the program will aid domestic facilities using Impella on its best practice and treatment for patients who are on Medicaid or who do not have adequate health insurance.

“Systematic and social factors create disparities in the treatment options available to heart disease patients who are candidates for a PCI procedure. This program is a step toward righting these disparities and improving healthcare in underserved communities by helping all patients receive appropriate care when they are in cardiogenic shock, right heart failure, or in need of a Protected PCI,” said Myron Rolle, MD, global neurosurgery fellow at Massachusetts General Hospital, chair of the Caribbean Neurosurgery Foundation and a member of the Abiomed Board of Directors. “I am particularly excited this initiative will help in the Bahamas, an island nation of more than 90% African descent with ischemic heart disease as the number one cause of death.”

Abiomed is also in the process of being acquired by Johnson & Johnson for $16.6 billion. The announcement of the deal came earlier this week.