A new system that uses artificial intelligence (AI) to assess cardiovascular risk based on retinal images demonstrated a strong correlation with standard cardiovascular risk assessment, according to research presented during an Investigative Horizons session at ACC.26 in New Orleans. Researchers said using AI to screen for heart disease risk during routine eye exams could help more people become aware of their risk and facilitate referrals for preventive care.

Michael V. McConnell, MD, FACC, et al., enrolled 874 participants between 40-75 years of age who were not taking lipid-lowering medications and did not have known atherosclerosis. Participants were recruited at 10 eye care and primary care sites across the U.S. Half were women, 19% were Black or African American and 26% were Hispanic.

For the study, standard retinal cameras captured high-resolution images of each participant; 94% of which were usable by the CLAiR system, an AI system that received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The results of this first prospective evaluation of the CLAiR system in the U.S. will be used to support FDA submission.

During the same clinic visit, data were collected on participants’ age, sex, smoking status, blood pressure and cholesterol to calculate their 10-year risk of atherosclerotic cardiovascular disease (ASCVD) using a standard risk estimator.

Results showed that in total, 26% of participants were found to have a 10-year ASCVD risk score ≥7.5% using the standard risk estimator. The CLAiR system showed agreement with these results, with a 91.1% sensitivity and 86.2% specificity.

Based on the results, researchers said the AI system shows promise as a noninvasive screening method that should be feasible to implement in most eye care settings, although more work is needed to facilitate referral of at-risk patients for cardiovascular evaluation and treatment in primary care following retinal image screening.

“This approach would not replace the standard cardiovascular risk evaluation, but it’s a potential way to bring greater awareness, especially for people who should be on preventive care, but who have not yet had a thorough evaluation,” McConnell explained. “For patients to benefit, we need to implement clear pathways to connect your elevated risk from your eye exam to help you see your clinician and ultimately get guideline-based preventive therapy.”

Although retinal imaging is available in most U.S. eye clinics, it is not covered by all vision insurance plans as part of a standard visit, and patients may be charged an additional fee for the imaging. The CLAiR system is not designed for use in people who are pregnant or have advanced eye disease.

Editor’s Note: McConnell serves as chief health officer at Toku, the company that created the AI system used in the study.

Keywords: ACC Annual Scientific Session, ACC26, New Orleans, Artificial Intelligence, Risk