HEALTHCARE & MEDICARE

Regulatory metastasis paves the AI-driven approach to heart disease diagnosis

In his new book Super Elderly: Evidence-based approach to longevityrenowned cardiologist Eric Topol highlights the revolutionary development of heart disease prevention: the use of AI to predict the risk of a fatal heart attack before symptoms occur. As Dr. Topol notes, AI-enhanced imaging of fat around the coronary artery now enables doctors to see inflammation, a potential driver of previously invisible heart attacks and strokes.

Topol predicts that American cardiologists will soon use these AI tools to identify high-risk individuals early before traditional methods detect diseases, potentially saving thousands of lives.

How radical is this development? Just consider it. For decades, our approach to coronary artery disease (CAD) has revolved around identifying and treating coronary artery obstructions – visible blood flow barriers, such as plaques. However, recent advances in medical research and technology are driving a fundamental re-evaluation of this approach. We now know that the initial driver of heart disease and stroke is not plaque, but plaques are used in combination with inflammation of the coronary artery. New anti-inflammatory drugs provide reliable treatments for the disease.

Despite this understanding, “The cardiovascular community does not continue to change practices, acknowledging our ability to detect inflammation and do something for it.”

This is mainly because we lack the technology to diagnose and quantify coronary inflammation.

Finally started to change. As Topol points out, the United States is in the process of diagnosing coronary inflammation as a diagnosis in routine clinical practice due to breakthroughs in AI that can visualize inflammation in standard CT scans.

If this approach is finally widely adopted, then as Topol predicts, the outcome will be ocean changes in cardiovascular medicine that not only enhances the patient's outcomes but also how CAD can be diagnosed and managed.

Inflammation: The invisible driving force of heart disease

Cardiologists have long learned that coronary inflammation is a key driver of plaque formation and instability, leading to obstruction and heart attacks. However, our diagnostic tools focus only on identifying obstacles rather than potential inflammation. And there are good reasons. Traditional stress tests and nuclear imaging are excellent when it comes to evaluating arterial occlusion, but cannot measure the inflammatory response behind physical symptoms.

An important example of this limitation emerged in a major study The Lancet. Researchers examined CT scans of 40,000 patients and found that only one-third of heart events have occurred in people with obstructive CAD over the next seven years.

In other words, two-thirds of patients are sent home, thinking they have a low risk of heart disease and are only suffering one person in the next few years.

The study highlights the huge need for diagnostic tools to detect silent coronary inflammation, which was before the development of obstructive CAD.

Technological breakthroughs: AI and cardiac inflammation

this The Lancet The study leveraged groundbreaking research by Oxford’s team of cardiologists. In 2017, Oxford Professor of Cardiovascular Medicine Charalambos Antoniades introduced the Fat Attenuation Index (FAI), a method to detect coronary inflammation in a heart CT scan by analyzing the perivascular fat in peripheral arteries. Subsequent studies, including the Lancet study described above, provide clear evidence that FAI scores can accurately predict patients’ risk for up to ten years.

The practical application of this knowledge has just begun. Several AI solutions visualize plaques on CT scans – but no FDA-approved spots can visualize inflammation, which will burden arterial plaques with a more complete field of view than previously possible. The Oxford team's research has led to the development of the world's first AI that can visualize coronary inflammation. The technology is currently in use in the UK, the EU and Australia and is currently awaiting FDA approval in the United States.

Regulatory changes clear the clinical approach

With advances in technology, the development of new regulatory and reimbursement frameworks supports widespread clinical adoption. Two recent policy changes in the United States have laid the foundation for integrating AI-driven inflammatory analysis into routine practice:

The American Medical Association has released a new Class 3 CPT code for billing and reimbursement: Starting in 2026, the code will allow providers to charge using AI to analyze cardiac CT scans in the presence of coronary inflammation to ensure that hospitals and clinics have financially serious triggers for the technology adoption.

Also starting in 2026, the cardiac CT scan of Medicare & Medicaid Services (CMS) will almost double. This will allow healthcare providers to prioritize CT-based diagnosis over traditional stress testing, which already has significant limitations in predicting cardiovascular risk.

In conclusion, these regulatory changes are already accelerating the transition to inflammation-centric diagnosis, ensuring that more patients benefit from new CT imaging analyses.

New standards for cardiovascular care

These changes have profound implications. The main reason why heart disease remains the world’s leading killer is that we cannot identify people at high risk before suffering major heart events. Now, with AI-enhanced CT scans to measure coronary inflammation and more accurately identify a person’s risk of heart disease, we can intervene earlier and more effectively. This represents a huge shift in our detection and prevention of heart attacks.

Patients can now receive earlier interventions and improve prevention, reducing the risk of sudden cardiac events. Physicians finally have a tool that goes beyond the full range of detecting blockages to assess risk for heart disease. Moreover, our healthcare system can greatly reduce the financial burden of cardiovascular disease by actively preventing major acute cardiovascular events.

What once seemed like a theoretical concept—the ability to see and measure coronary inflammation—has become the key to advancing preventive care. With clinically proven AI-driven diagnosis and expanded reimbursement policies, cardiovascular medicine is entering a new era.

The next challenge is to ensure that these innovations are adopted quickly and are delivered to millions of patients who can benefit from it.

Author's resume:

Frank Cheng is the CEO of Caristo Diagnostics. Over the past 20 years, he has led several digital health companies. Frank previously led two venture-invested companies as CEOs and held executive roles with GE, Roche, Hillrom and Stereotaxis. Prior to Caristo, he was the president and chief commercial officer of an autonomous AI technology diagnostics company that was liquidated by FDA, reimbursed by health insurance, and supported by new Class 1 CPT codes and adopted worldwide.

Image: Magician, Getty Images

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