As we reach the end of 2023 and yet another remarkable year at Cleerly, it’s a great opportunity to reflect on all we’ve accomplished and begin...
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Cleerly Personalized Care Pathway is Transforming Heart Health
James K. Min, MD, FACC, FESC, MSCCT, Founder & CEO of Cleerly : August 1, 2022
The current approach to cardiovascular care is flawed for two reasons. One is the lack of a disease-based care paradigm with a focus on actual heart disease–atherosclerosis– in lieu of an emphasis on symptom-driven care that identifies only late-stage disease presentations and relies upon surrogates of heart disease rather than heart disease itself. The second is the lack of a personalized care pathway for coronary artery disease diagnosis and treatment. The end result is an approach that leaves far too many high-risk patients undiagnosed because they don’t present with stereotypical symptoms, whilst subjecting many symptomatic patients to expensive and invasive procedures that are in fact unnecessary because they have little buildup of arterial plaque.
Cleerly’s personalized care pathway for heart disease treatment, backed by nearly two decades of clinical research as well as industry-leading AI technology, addresses both of these issues. Cleerly steadfastly focuses on measuring, characterizing, and tracking atherosclerosis instead of searching for less useful indirect markers of heart disease. The Cleerly care pathway provides a methodology for staging and treating heart disease that’s modeled after the way healthcare has addressed cancer and common chronic conditions for decades. Through this care pathway, Cleerly is positioned to make high-value, personalized, and precision cardiovascular care available to far more patients – and effectively treat the disease that kills more people globally than any other.
Introducing Cleerly's new personalized care pathway for treatment of heart disease
This new care pathway for cardiovascular care gives healthcare a closed-loop, step-by-step approach for early diagnosis, informed decision-making, and personalized treatment and tracking of coronary heart disease. Clinicians are no longer forced to rely on indirect disease markers and inaccurate diagnostic tools as they speculate on patients’ heart disease risk and make “best-guess” care plan recommendations.
Cleerly and its founders have spent more than a decade researching the effectiveness of coronary computed tomography angiography (CCTA) and advanced analytics compared to other methods of measuring atherosclerosis. This body of extensive clinical evidence will enable Cleerly to develop a personalized care pathway for every patient along the care continuum. The intention of the care pathway is to help heart care providers identify more at-risk patients sooner and support a closed-loop healthcare journey for those patients – all with the goal of preventing heart attacks from happening in the first place.
Identify: Leverage comprehensive, whole-heart phenotyping for quantification and characterization.
The first step in addressing heart disease is identifying the existence of atherosclerosis using comprehensive and accurate coronary artery disease detection. Unlike existing approaches that evaluate indirect markers or symptoms like cholesterol or shortness of breath, Cleerly’s analysis delivers comprehensive coronary phenotyping of all coronary arteries and their branches - allowing for quantification of the strongest predictor of future heart attack risk.1
Based on two decades of clinical research, Cleerly's AI-enabled CCTA analysis yields high diagnostic accuracy. Our published clinical data from multi-centered clinical trials prove that Cleerly has high diagnostic performance as compared to multiple invasive gold standards, including, expert (Level III) clinical readers, quantitative coronary angiography (QCA), fractional flow reserve (FFR), intravascular ultrasound (IVUS) and invasive near-field infrared spectroscopy (NIRS) for coronary artery disease evaluation.
Similar to breast cancer, the ability to non-invasively enable direct visualization of actual heart disease early is the most critical step in reducing mortality risk.
Define: Translate advanced imaging science and data into actionable clinical insights for all stakeholders.
Once patients at risk are identified, the next step is to characterize the extent, severity, and type of atherosclerosis present and translate advanced imaging science into actionable clinical insights.
Cleerly analysis provides vessel-by-vessel detail with more precise phenotyping for each coronary artery and its branch. Comprehensive plaque assessment offers an at-a-glance view of characterized plaque volume by coronary region and delivers a clear and concise summary of identified stenosis by severity. Existing approaches like invasive procedures and outdated technologies that prioritize indirect markers or symptoms fail to meet the needs of patients and providers who need to understand individual plaque burden, and determine optimal treatment.
This was the case for Terry Schemmel, a 58-year-old with no symptoms of heart disease and no family history of heart health problems. However, Schemmel’s Cleerly analysis showed a 95% blockage in his left anterior descending artery. Instead of suffering a “widowmaker” heart attack because his high risk could not be detected through indirect markers, Schemmel had a stent implanted and was prescribed an anticoagulant. He also sees a cardiologist every six months to monitor his heart health and adheres to his treatment plan, which includes lifestyle modifications and low-cost medical therapy.
Fast, accurate, and comprehensive disease phenotyping is critical to early identification and characterization of a patient’s heart attack risk. Clinical evidence indicates that CCTA technology, coupled with artificial intelligence that has been cleared by the U.S. Food and Drug Administration, is superior to other methods for identifying and defining arterial plaque.
The multi-center, international CLARIFY 1 and CLARIFY 2 studies have demonstrated that Cleerly’s technology is very close in performance to invasive coronary angiography (ICA) technology superior to individual expert CCTA readers. Additional research has shown that CCTA is very similar to invasive intravascular ultrasound (IVUS) for estimating luminal area, percentage of area stenosis, plaque volume, and plaque area. Again, it’s worth noting that CCTA is non-invasive compared to both ICA and IVUS.
Empower: Improve patient health literacy through innovative tools that meet patients where they are.
Education and empowerment are critical components of any care pathway, and cardiovascular care is no exception. Health literacy has been linked to a 67% increased risk of mortality and a 20% increased risk of hospitalization for patients who have been diagnosed with heart failure.
Efforts to improve heart health education are numerous and varied, emphasizing medication adherence, symptom monitoring, self-management, and nutrition and lifestyle modification. Success rates for these programs are mixed, with one-off, in-person programs shown to have low adherence and limited effectiveness. In fact, traditional methods of patient education don’t contribute to decreases in deaths, heart attacks, invasive procedures, or hospitalizations for heart disease. Put another way: Those who participate in education programs fare no better than those who don’t.
Cleerly’s personalized care pathway for coronary artery disease treatment addresses education on two fronts. Providers receive an easy-to-read data visualization that color-codes and scores stenosis based on its severity, allowing them to clearly communicate with patients about their risk of a heart attack and guide appropriate treatment. Patients receive personalized reports that pair the results of their CCTA scan with personalized resources to help them understand their risk factors.
This approach benefits patients such as Steven Rowell, 63, who had a Cleerly analysis following a procedure to repair an abdominal aortic aneurysm. This analysis found a severe atherosclerotic plaque burden of 987mm3, the presence of non-calcified plaque, and stenosis ranging from 5% to 100%. The Cleerly report gave Rowell a complete breakdown of his heart health – and it helped his cardiologist decide on a treatment plan that avoided an invasive procedure in place of aggressive medical therapy and a modified diet.
Treat: Enable personalized cardiovascular care through a first-of-a-kind-staging system
Until recently, heart disease didn’t have a staging system – a critical missed opportunity for providing a prognosis or treatment plan. The lack of a staging system stemmed from the lack of a reliable way to measure and treat heart disease risk given the current standard of cardiovascular care.
That’s why Cleerly has developed a four-stage system for measuring the disease burden of coronary artery disease based on atherosclerotic plaque, which describes patients based on either the total plaque volume or percent atheroma volume, which is the proportion of arterial volume occupied by plaque. Stages are defined as normal (no plaque), mild, moderate, and severe. This staging system provides a first-of-its-kind methodology to describe the severity of heart disease risk. This is possible because CCTA can quantify the total atherosclerotic plaque burden, which technology such as ICA and IUVS cannot do and which even expert CCTA readers cannot reliably do without Cleerly’s advanced AI technology.
Measuring plaque using CCTA is just the first step, though. The next step is developing an appropriate treatment plan that varies based on the stage of disease progression – not on cholesterol or other indirect markers. This is similar to the use of other disease staging systems to determine the type and intensity of medical management; the more severe the disease the more aggressive the medical intervention. To address this need, disease treatment algorithms that integrate coronary atherosclerosis stages as defined by CCTA combined with the presence of additional risk factors (lipid disorders, diabetes, hypertension, obesity, and tobacco use) are under development and peer-review to provide effective personalized treatment recommendations for everyone.
In addition, Cleerly’s upcoming TRANSFORM trial will determine whether preemptive screening for asymptomatic patients at high risk due to atherosclerosis combined with a treatment strategy emphasizing prevention will improve health outcomes and reduce heart attacks and cardiac death compared to the historical standard of care that treats risk factors alone. With the positive results of this trial, Cleerly hopes to eventually attain guidance recommendations for universal CCTA screening from organizations such as the American Heart Association and the American College of Cardiology. (CCTA has already received Class 1, Level A recommendations from AHA and ACC, among others, for diagnosing symptomatic patients.)
Track: Provide direct, longitudinal disease tracking to optimize therapeutic success
Improving outcomes for any chronic condition is more than a matter of putting patients on a care plan. Clinical teams need to be able to track patients to demonstrate the success of a given therapy over time. If the disease continues to progress, providers will know that the treatment plan is ineffective, and that different or additional therapies are warranted. If the atherosclerosis stabilizes or regresses (gets lower in volume), then they can be assured that the patient is receiving the correct regimen. Since the goal of the new standard of cardiovascular care is to treat the disease and not its symptoms or surrogates, Cleerly’s personalized care pathway for heart disease treatment focuses on tracking atherosclerosis, not cholesterol or blood pressure.
The PARADIGM, EVAPORATE, and DISCO trials demonstrated that quantitative analysis of CCTA can accurately indicate whether lifestyle interventions and/or medications have either stopped atherosclerosis progression or transformed high-risk plaque into low-risk plaque. Cleerly has special software that will compare two CCTA exams performed in the same patient at two different timepoints, such as before and following the initiation of therapy. This will then directly compare the volume and type of plaque as well as the presence and degree of any stenoses (blockages) and thereby help the physician determine the effectiveness of therapy and make modifications if needed.
Cleerly’s staging system and disease treatment algorithm addresses tracking as well as treatment, providing recommendations for frequency of future scans based on a patient’s current stage of disease stabilization or progression and the results of baseline treatment options.
Our goal is personalization
The ultimate goal of the Cleerly digital care pathway for cardiovascular care is to empower physicians with the insights needed to personalize heart disease treatment for hundreds of thousands of patients in the United States and around the world.
To date, there has only been one large-scale, randomized control trial that has shown how non-invasive CCTA can save lives. The SCOT HEART trial showed a 41% reduction in deaths and non-fatal heart attacks at a five-year endpoint. Patients in the experimental arm underwent CCTA in addition to a standard of care testing; because the CCTA was able to depict atherosclerosis in many patients where the stress test was read as “normal”, those patients were prescribed and adhered to primary prevention (medication) at a significantly higher rate. There was no difference between the control group and the CCTA group in the number of angiograms, stents, or bypass surgeries. Detection and treatment of non-obstructive atherosclerosis saves lives.
Cleerly is picking up where SCOT-HEART left off. Through multiple studies, Cleerly has shown extraordinary ability to detect and classify atherosclerosis. Cleerly uncovers high-risk arterial plaque in 58% more patients as compared to expert human readers, reduces referrals for invasive coronary angiography by up to 87%, and affirm the value of Cleerly’s AI-enabled CCTA approach over invasive methods for heart disease evaluation.
Through the adoption of the Cleerly personalized care pathway, healthcare will no longer be overlooking the more than 50% of patients who will suffer heart attack or death without any prior symptoms or the 90% of patients who undergo an unnecessary stress test. That’s the power of the new standard of care.
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