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.
“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.
