Medtronic has announced the launch of a randomised study—ALERT—aiming to address the undertreatment of severe aortic stenosis or moderate-to-severe or severe mitral regurgitation, whilst evaluating racial, ethnic, gender, and geographic disparities associated with guideline recommended treatments such as transcatheter aortic valve implantation (TAVI).
The study is sponsored by Tempus, a technology company leading the adoption of artificial intelligence (AI) to advance precision medicine and patient 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,” said Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic. “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 TAVI treatment.”
The study will utilise the Tempus Next platform to identify severe aortic stenosis or moderate to severe mitral regurgitation patients who meet guideline indicated therapy criteria, but do not have a treatment plan in place.
The study will evaluate the impact of electronic health record notifications generated by Tempus Next on treatment with valve therapies such as TAVI and clinical visits with heart valve centres. Tempus Next provides a suite of software including a cloud-based, automated patient identification and care pathway management for cardiovascular disease based on practice guidelines, as well as a patient communication and data collection/analysis platform.
Data suggest white patients represent the majority (91%) of all TAVI procedures. Conversely, patients who are Black, Hispanic, Asian, or part of other racial groups are not being treated with TAVI at the same rates as white patients. Existing evidence suggests that this minimally invasive option could result in less time in the hospital and a quicker recovery compared to open heart surgery.
“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 Wayne Batchelor (Inova Health System, Fairfax, USA), steering committee chair of the ALERT study.
“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 Brian R Lindman (Vanderbilt University Medical Center, Nashville, USA).
