Medtronic ALERT Study Seeks to Address Disparities in Structural Heart Disease Treatment

November 20, 2024—Medtronic announced the beginning of the randomized study ALERT study, which will use an integrated electronic health record (EHR) platform to address the undertreatment of severe aortic stenosis (AS) or moderate-to-severe or severe mitral regurgitation (MR) and evaluate the racial, ethnic, gender, and geographic disparities associated with guideline-recommended treatments such as transcatheter aortic valve replacement (TAVR).

ALERT is funded by Medtronic and sponsored by Tempus, a technology company addressing the adoption of artificial intelligence (AI) to advance precision medicine and patient care.

According to Medtronic, the study will utilize the Tempus Next EHR platform to identify severe AS or moderate-to-severe MR patients who meet guideline-indicated therapy criteria but have no treatment plan in place. The study will evaluate the impact of EHR notifications generated by Tempus Next on treatment with valve therapies such as TAVR and clinical visits with heart valve centers.

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, noted the press release.

Medtronic stated that data suggest White patients represent the majority (91%) of all TAVR procedures and that patients who are Black, Hispanic, Asian, or part of other racial groups are not being treated with TAVR at the same rates as White patients.

Wayne Batchelor, MD, and Brian R. Lindman, MD, commented on the study in Medtronic’s press release. Dr. Batchelor is Chair of the ALERT Steering Committee and Director of the Interventional Heart Program at Inova Health System in Fairfax, Virginia. Dr. Lindman is Medical Director of the Structural Heart and Valve Center and Associate Professor of Medicine at Vanderbilt University Medical Center in Nashville, Tennessee.

“Undertreatment of symptomatic severe AS can be devastating for patients’ recovery and potentially fatal within 2 years if intervention does not happen,” stated Dr. Batchelor. “The goal of this study is to move toward better solutions for more equitable and timely care and eliminate barriers to treatment.”

Dr. Lindman added, “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.”

Nina Goodheart, Senior Vice President and President of the Structural Heart & Aortic Business, part of the Cardiovascular Portfolio at Medtronic, added in the press release, “Through our collaboration with Tempus, we are able to use AI to equip heart teams with a more efficient way to identify patients with symptomatic severe AS. 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.”

Medtronic further noted that its commitment to addressing disparities in treating patients with valve disease was demonstrated by the company-funded SMART trial, which focused specifically on informing device selection for patients with small aortic annuli, a patient group that is primarily women and has been underrepresented in previous clinical trials for TAVR. In April 2024, the SMART findings were presented at the ACC.24 Annual Scientific Session and published by Howard C. Herrmann, MD, et al in The New England Journal of Medicine (2024;390:1959-1971).

Also at ACC.24, Medtronic announced findings of its comprehensive survey on women’s perceptions and knowledge of risk factors, treatment patterns, and preventive care practices related to heart valve disease. The survey sampled 1,000 women in the United States, targeting a diverse sample of women aged ≥ 50 years, with 53% between ages 50 and 65 years and 47% aged ≥ 66 years. Notably, 23.5% of respondents were Black or Hispanic, ensuring a nationally representative demographic of women in this age group in the United States.