Cardiovascular disease (CVD) remains the leading cause of death in developed countries, responsible for one in every three deaths.[i] And while numerous drugs and procedural interventions are available, we haven’t seen any of them really bend the curve. Heart attack and stroke rates continue to increase, and giving each patient the same treatment does not lead to optimal outcomes. Elucid is a new, AI-driven form of diagnosis that offers a non-invasive way to identify individual patients’ CVD risks and inform personalized treatment options.
Understanding the Diagnosis Dilemma
Until recently, clinicians could not avoid taking the one-size-fits-all approach to treating CVDs, although the diseases are deeply individualized. In the past, physicians would use an inaccurate treadmill stress test with 60% accuracy, or they would examine a black-and-white CT scan image and try to assess the presence of plaque visually.
The resulting inaccurate plaque diagnoses led to many patients being sent home because they were deemed low risk, when in fact they were at high risk. Statistically, three-quarters of first-time heart attack patients were initially considered low risk. On the other hand, many patients tested this way showed false positives and received unnecessary procedures, presenting multiple challenges for clinicians.
Addressing the Challenges
In 2009, Andrew Buckler, a computer scientist, electrical engineer, and molecular biologist with 30 years of experience, realized there had to be a solution to bridge these gaps. He concluded that if pathologists or gene biologists gained access to patient tissue samples, their findings could enable clinicians to make personalized treatment decisions. However, getting tissue samples is an invasive, expensive procedure that isn’t possible in many instances.
To address this challenge, Buckler developed a method of estimating tissue composition from a CT scan as though a pathologist had the tissue under a microscope. The data could then be analyzed using artificial intelligence-driven software and deliver accurate results showing the quantity and type of plaque present.
This process enables cardiologists, radiologists, and vascular surgeons to assess patients’ levels of risk with 87 percent accuracy, compared with the 60 percent accuracy average of traditional methods. This diagnostic method saves about $4,000 per patient compared to the cost of standard care.
Formulating a Non-Invasive Approach
The result of this development is that the software can now analyze CT scans as a pathologist would under a microscope. This non-invasive approach enables clinicians to measure the true composition of the plaque in the artery to understand the patient’s level of risk, and whether any arterial blockages exist. These findings determine whether the patient needs a stent and guide the clinician’s decision on what medication to administer.
Realizing that this exciting development would take years to finalize and implement, Buckler obtained around $6 million in grants from the NIH. He began work in 2009, founding Elucid Bioimaging Inc. in 2013 with the primary aim of predicting and preventing heart attacks and strokes. The process was developed using tissue taken from patients who also had CT scans, examining it under a microscope, and using the findings to train machine learning algorithms.
Taking a Longer Trajectory
Buckler’s new venture achieved its first real success when it received FDA clearance in 2018. As the first—and still the only—software that can quantify plaque and validate it against histology, the process underwent a lengthy development trajectory that took up to six years to complete.
Instead of training the technology to simply replicate what a physician could do visually, the team at Elucid chose to take the more difficult route. They monitored patients who had a CT scan followed by surgical plaque removal. After surgery, they sent collective tissue to a leading global cardiac pathologist to review and then developed software to emulate the pathologist’s method.
Overall, the solution’s development process was a long, expensive, and time-consuming trajectory, but ultimately, the pathway delivered a better result for patients.
Applying Precision Medicine to CVD
These days, cancer treatments are deeply personalized, and outcomes have improved dramatically as a result. We should be doing the same for cardiovascular patients, but diagnostic limitations previously made it impossible. Elucid’s new, non-invasive approach brings the possibility of true precision medicine to the CVD arena. The CT scans provide physicians with information to incorporate into their care decisions and precisely choose the correct treatment pathway for each patient.
Additional benefits of the technology include improved patient adherence to treatment. By providing access to patient-facing information, clinicians can help individuals visualize their disease. They can see their plaque buildup and why it’s different from how a normal artery looks without disease. Patients can understand and take ownership of their condition, which drives higher motivation to adhere to treatment. Since drugs are only helpful if patients take them, increased adherence results in improved outcomes.
The technology also enables physicians to track patients’ responses to drugs. They can review the plaque deposits on day one and then take another look two years later. Rather than waiting for an outcome that could be a devastating event, physicians can see how patients respond to their treatments over time. This patient-centric focus promotes understanding of CVD in patients and helps to improve outcomes.
Monitoring Market Acceptance
For any new medical product, FDA approval is paramount, as is EU MDR for companies aiming to operate in Europe. Both approvals have been secured for Elucid. This non-invasive technology is now used at clinical sites across the U.S. and South Korea.
In October 2021, the American Heart Association, the American College of Cardiology, and other major medical societies elevated CT angiography (CTA) to the preferred standard of care for patients with chest pain. Reimbursement levels show most payers support this solution, indicating positive progress towards the technology’s usage becoming standard.
Forging Future Developments
The success of Elucid so far shows tremendous promise for the future. Since technology enabled diagnosing the amount and type of plaque in arteries, the company has developed a means to estimate blood flow limitation. If blood flow slows beyond a certain threshold, that’s when the patient likely requires a stent. This is the first (and only) solution that can estimate blood flow limitation simply by examining a CT scan and measuring the plaque to determine the risk of ischemia.
The software’s next generation is launching at the American Heart Association’s Scientific Sessions in November 2022. This achievement follows our Series A and Series B funding and incorporates the feedback received since the product’s inception. Elucid is the singular tool that combines the assessment of plaque and obstructive blockages in a rotatable, fully interactive visual. It enables clinicians to determine the level of risk and helps them plan treatment procedures.
Cultivating a Passion
The success of Elucid to date is attributable to our inspired, driven team, which has done a fantastic job. I’m super proud of their work and our company culture. Overall, we’re a passionate, collaborative group. Our engineers could work anywhere, including places like Google or Facebook. They’re choosing to be at Elucid because they believe in our mission to prevent heart attacks and strokes. Our whole team believes that technological solutions will have an outsized impact on global health, and we want to scale this in a manner that’s great for patients and cost-effective for providers.
Making CVD More Treatable
Cardiovascular disease is much more treatable than currently occurs in practice. With AI-driven diagnostics providing specific and accurate assessments, there’s a real opportunity to better understand a patient’s risk of heart attack and the optimal treatment for each individual.
As Todd C. Villines, MD, FACC, FAHA, MSCCT, and Chief Medical Officer at Elucid, says: “We’re living in the era of plaque. By using plaque and its characterization to assess the vasodilatory capacity of coronaries, we can actually deploy the plaque to predict physiology. This guides patient treatment, eliminates unnecessary procedures, reduces healthcare costs, and ultimately saves patient lives.”
This sentiment lies at the heart of Elucid’s mission and vision and is the impetus behind taking the long approach to development and implementation. We want to deliver an outstanding product for diagnosing and treating this devastating disease, and to achieve the best possible outcomes for humanity.
Editor’s Note: Blake Richards has extensive healthcare technology experience, including leading strategy for several imaging & AI-driven MedTech organizations, as a MedTech management consultant for Deloitte, and as a revenue cycle and patient confidentiality leader for Epic Systems. He holds an MBA from Columbia Business School.