Medtronic has announced the launch of a study to address racial, ethnic, gender and geographic disparities in heart disease treatment.
The study, called ALERT (for “Addressing undertreatment and heaLth Equity in aortic stenosis and mitral regurgitation using an integrated ehR plaTform”) and sponsored by health technology company Tempus, will use AI to identify patients with severe aortic stenosis or mitral regurgitation who could benefit from minimally invasive therapies like transcatheter aortic valve replacement (TAVR).
The trial seeks to improve outcomes for patients with these conditions and provide insight into why many individuals, particularly in underserved communities, are not receiving guideline-recommended care.
“Through our collaboration with Tempus, we are able to use artificial intelligence to equip heart teams with a more efficient way to identify patients with symptomatic severe aortic stenosis,” Nina Goodheart, SVP and president of the Structural Heart & Aortic business in Medtronic’s Cardiovascular portfolio, said in a news release. “Ultimately, our goal is to provide a pathway to patients who are currently underserved, so they are one step closer to heart valve clinic care and access to lifesaving TAVR treatment.”
Addressing disparities in heart valve disease
Structural heart diseases such as severe aortic stenosis and mitral regurgitation are often underdiagnosed and undertreated, particularly among minority populations.
According to existing data, 91% of TAVR procedures in the U.S. are performed on white patients, leaving significant gaps in care for Black, Hispanic, Asian, and other racial groups.
Without timely intervention, symptomatic severe aortic stenosis can lead to heart failure and death. Similarly, mitral regurgitation poses serious health risks when untreated, Medtronic said.
“Undertreatment of symptomatic severe aortic stenosis can be devastating for patients’ recovery and potentially fatal within two years if intervention does not happen. The goal of this study is to move towards better solutions for more equitable and timely care and eliminate barriers to treatment,” said Dr. Wayne Batchelor, director of the Interventional Heart Program, Inova Health System in Fairfax, Virginia, and the ALERT study steering committee chair.
Earlier this year, Medtronic announced survey results that found that only 30% of women aged 50 and older had heard of aortic stenosis. Awareness levels were even lower among Black and Hispanic women, at 10% and 21%, respectively. Despite their increased risk, many women face significant barriers to care, including fear of medical visits and concerns about symptom dismissal by healthcare providers.
Using AI to improve outcomes and move toward equitable care
The ALERT study will use the Tempus Next platform, which combines electronic health record (EHR) notifications, automated patient identification, and care pathway management. The platform aims to increase access to interventions such as TAVR and facilitate clinical visits with heart valve centers by identifying patients who meet treatment criteria but lack a care plan.
“We are excited to be one of the first sites activated in this critically important study. We look forward to working to address health disparities to bring more equitable and timely care to patients with valvular heart disease in our community. I am encouraged by the potential impact of this initiative as additional sites are activated around the country,” said Dr. Brian Lindman, medical director at the Vanderbilt University Medical Center Structural Heart and Valve Center.
