Medtronic, in collaboration with Tempus, has commenced the ALERT (Addressing undertreatment and heaLth Equity in aortic stenosis and mitral regurgitation using an integrated ehR plaTform) study, a randomized trial designed to address the undertreatment of severe aortic stenosis and moderate to severe mitral regurgitation, while also evaluating disparities in treatment based on race, ethnicity, gender, and geography. The study focuses on guideline-recommended treatments like transcatheter aortic valve replacement (TAVR).
Addressing Undertreatment with AI
The ALERT study leverages Tempus' Next platform to identify patients with severe aortic stenosis or moderate to severe mitral regurgitation who meet guideline-indicated therapy criteria but do not currently have a treatment plan. The impact of electronic health record notifications generated by Tempus Next on treatment with valve therapies like TAVR and clinical visits with heart valve centers will be evaluated.
Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business at Medtronic, stated, "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. 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."
Disparities in Treatment
Data indicates that white patients constitute the majority (91%) of TAVR procedures. Conversely, Black, Hispanic, Asian, and other racial groups are undertreated with TAVR compared to white patients. This is particularly concerning, as TAVR offers a minimally invasive option that could result in shorter hospital stays and quicker recovery times compared to open-heart surgery.
Clinical Significance
Symptomatic severe aortic stenosis affects approximately 250,000 people annually in the United States and remains undertreated, according to AHA/ACC guidelines. Untreated patients may experience chest pain, shortness of breath, fatigue, and dizziness, potentially leading to heart failure. Mitral regurgitation presents similar challenges regarding underdiagnosis and undertreatment.
Wayne Batchelor, M.D., director of Interventional Heart Program, Inova Health System, and Steering Committee Chair of the ALERT study, emphasized the urgency of the issue: "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."
Study Design and Implementation
The multicenter study is actively enrolling patients across the country. Brian R. Lindman, MD, MSCI, medical director, Structural Heart and Valve Center at Vanderbilt University Medical Center, expressed enthusiasm for the study's potential impact: "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."
The study is funded by Medtronic, underscoring the company's commitment to addressing health disparities in structural heart disease care.
