How to Reduce Unnecessary, Invasive Procedures

Cleerly is excited to have released our vision statement calling for a new approach to cardiovascular care. It's an important topic - not just for Cleerly, but for the healthcare industry and all the patients impacted by heart disease - and we're going to be talking about it a lot over the next few months.

Offering CCTA scanning as a first line of defense provides more accurate diagnoses and enables a personalized approach to heart health - all while greatly reducing the need for invasive procedures.

Address the number one killer

Heart disease is the No. 1 cause of death in the United States. We lose about 700,000 Americans to heart disease every year. That's roughly the population of Washington, D.C. – or, put another way, it's the equivalent of nine fully loaded 737 airplanes crashing every day and killing everyone on board.

If nine passenger planes were crashing every day, there would be national outrage. We'd have public and private inquiries into what was going wrong and countless initiatives underway to fix the problem and make our airplanes safe.

Consider a new approach to cardiovascular care

Why aren't we doing the same for heart diseases? That's why Cleerly is calling for a new approach to cardiovascular care. In a previous post, we talked about one of our motivations for this work: Treating the symptoms of heart disease and not its underlying cause for preventing heart attacks.

Here, we're going to address another important reason why the current standard of care isn't working. Most referrals to the catheterization laboratory and the cardiologist are actually unnecessary, leaving patients and payers with hefty bills but no better insight into whether they are truly at high risk of a heart attack.

Here's what we mean:

• 50% of the stents placed in patients with stable chest pain are possible or definitely inappropriate. Half of patients with stents don't benefit from them.
• 66% of cath lab referrals are unnecessary. Two in three patients who receive a procedure such as invasive coronary angiography (ICA) don't need them.
• 90% of cardiac stress tests come back with normal results. Nine in ten patients are referred to a cardiologist for a test that isn't necessary.

Continued use of expensive but ineffective procedures contributes to significant spending – and it's only going to get worse. The United States spent $315 billion on cardiovascular care in 2010, and that figure is expected to nearly triple to $918 billion by 2030. By then, more than 1 in 4 Americans are expected to be at risk of cardiovascular disease, stroke, or heart attack. Simply put, the status quo is no longer a viable option.

Shift from invasive angiography to CT scanning

Our previous post outlined Cleerly's vision for a new standard of cardiovascular care. This approach leverages coronary computed tomography angiography (CCTA) screening, coupled with actionable insights and an embrace of precision medicine to develop care plans based on a patient's individual level of heart attack risk.

A central component of this approach is empowering primary care and family health physicians. With comprehensive coronary analysis, reporting, decision support, and educational resources more readily available at the point of care, they can play a greater role in managing their patients' cardiovascular health.

Instead of referring nearly all heart health matters to cardiology, and subjecting patients to procedures they don't need, primary care and family health physicians can refer patients to imaging centers for a simple scan. Then, based on the results of the scan, they can work with patients to develop longitudinal and proactive treatment plans. In many cases, that plan can focus on lifestyle interventions or statin prescriptions and consider invasive procedures only as a last resort. And all the while, patients feel more comfortable having heart health conversations with a physician they already know and trust.

As we've said, this represents a seismic shift in cardiovascular care. However, clinical evidence suggests that a new standard of care would lead to better patient outcomes and reduced costs.

• In one study comparing CCTA to ICA, both diagnostic approaches had a similar rate of effectiveness, but CCTA was linked to a lower rate of coronary revascularization. That typically requires angioplasty or bypass surgery to correct, and those procedures can cost more than $10,000.
• An additional analysis of CCTA versus ICA found that 77% of patients who were initially referred for an ICA but received a CCTA screening instead no longer needed an ICA. This also resulted in a 57% decrease in diagnostic evaluation costs.
• A cost analysis concluded that CCTA can be completed for just 13% the cost of an ICA. Put another way, an ICA costs roughly 7.6 times as much as a CCTA – and its ability to measure cross-sectional stenosis is less effective for early identification of patients with coronary heart disease than CCTA.

As one paper put it, the growing body of evidence shows that CCTA is a useful "gatekeeper" for the cath lab, ensuring that the only patients who receive an invasive procedure are those who truly require one.

Demonstrate value through clinical evidence

Cleerly recognizes that challenging the status quo in healthcare is never easy. Not only does it take time to change people's minds, but it also requires evidence. That's why our push for a new standard of cardiovascular care is based on nearly two decades of large-scale multi-center clinical trials. Through our work at Cleerly Labs, we've been able to reduce referrals for ICA procedures by 77% compared to expert clinical readers.

Heart disease is our largest public health epidemic. For too long, our approach to diagnosis and treatment has relied on expensive, ineffective, and unnecessary invasive procedures. The evidence increasingly shows that it's time for a new standard of cardiovascular care – and Cleerly is ready to lead the way.

References:

• Heart Disease Facts. Centers of Disease Control and Prevention. Last reviewed February 7, 2022.
• Trends in U.S. Cardiovascular Care: 2016 Report from 4 ACC National Cardiovascular Data Registries. Journal of the American College of Cardiology. March 2017.
• Low Diagnostic Yield of Elective Coronary Angiography. New England Journal of Medicine. March 11, 2010.
• Temporal Trends in the Frequency of Inducible Myocardial Ischemia During Cardiac Stress Testing. Journal of the American College of Cardiology. March 12, 2013.
• Healthcare Reform and Cardiovascular Imaging: Clinical Issues and Technology. Applied Radiology. July 4, 2014.
• Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. Journal of the American College of Cardiology. September 18, 2018.
• Healthcare Reform and Cardiovascular Imaging: Clinical Issues and Technology. Applied Radiology. July 4, 2014.
• Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. Journal of the American College of Cardiology. September 18, 2018.
• Cost-Effectiveness of Computed Tomography Coronary Angiography Versus Conventional Invasive Coronary Angiography. The European Journal of Health Economics. July 16, 2015.
• CONSERVE Your Energy and Resources. Journal of the American College of Cardiology. July 12, 2019.

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