AI tech detects high-risk coronary inflammation in many asymptomatic patients

The first U.S. study of Caristo Diagnostics’ U.S. Food and Drug Administration (FDA)-cleared CaRi-Heart technology for coronary inflammation detection found a large number of asymptomatic adult patients were actually at an elevated risk of cardiac events.

The study, conducted by the Biograph concierge medicine clinic, found coronary inflammation was common in asymptomatic, low-risk adults, and frequently occurs without any plaque buildup or blockage. Patients who underwent cardiac CT scans for preventive screenings using Caristo's fat attenuation index (FAI) artificial intelligence (AI) algorithm found inflammation in 42.9% of study participants. Of these, 17.9% had very high inflammation levels in at least one major artery.

Approximately 47% of participants who had no detectable coronary plaque were found to have elevated coronary perivascular inflammation, which raises their risk of a cardiac event. The researchers said this suggests there are potential limitations to the standard cardiac assessments currently used by clinicians. Evaluating coronary inflammation in addition to traditional imaging assessments may offer a better picture of a patient's individualized cardiovascular risk.

Subscribe to Cardiovascular Business News

“Coronary heart disease, whether plaque accumulation or arterial stenosis, is likely a late consequence of an active inflammatory process in the vessel wall," Michael Doney, MD, executive medical director at Biograph, said in a statement. "What is striking about our findings is that more than 42% of asymptomatic, conventionally low-risk adults had elevated coronary inflammation, and many individuals with the highest inflammatory levels had completely normal coronary anatomy on CT. Crucially, no routine blood biomarker, lipid metric, or clinical risk score could identify these individuals with inflamed coronary arteries."

He said the FAI technology could be a better way of predicting disease and offer a new approach to initiate preventive drug treatments. He added that more research is needed to validate this and establish the prognostic value of FAI, but the technology seems to be very promising.

The FDA granted de novo market clearance for the CaRi-Heart technology in late July. It has been heralded by numerous cardiac CT experts as a potential paradigm shift in cardiology. It is the first technology that can visualize and clearly quantify coronary inflammation using FAI scores.

Dave Fornell is a digital editor with Cardiovascular Business and Radiology Business magazines. He has been covering healthcare for more than 16 years.

Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]

Subscribe to Cardiovascular Business News

Subscribe to Cardiovascular Business News