Landmark Study on EchoGo® Amyloidosis
A recent extensive international multi-center study published in the
European Heart Journal has yielded promising results that could reshape the landscape of cardiac diagnosis. Ultromics, an innovative health technology company based in Oxford, has developed EchoGo® Amyloidosis, a groundbreaking AI-powered tool for detecting cardiac amyloidosis using standard echocardiograms. This tool is the first of its kind to receive FDA clearance specifically for this condition and has also been awarded Breakthrough Device designation by the FDA.
Importance of Early Detection
Cardiac amyloidosis, while a life-threatening condition often leading to heart failure, is frequently overlooked in clinical practice. It arises from abnormal deposits of amyloid proteins within the heart, which can impair its function and stiffness, leading to significant health challenges. The urgency for timely diagnosis has grown, particularly in light of newly available disease-modifying therapies that can alter patient outcomes if administered early.
Study Findings
The findings from the study highlight the capabilities of EchoGo® Amyloidosis in diagnosing various subtypes of cardiac amyloidosis, including AL, ATTRwt, and ATTRv. The tool demonstrated impressive diagnostic metrics, achieving an astonishing 85% sensitivity and 93% specificity. Importantly, EchoGo® successfully differentiated cardiac amyloidosis from other similar conditions, such as hypertensive heart disease and hypertrophic cardiomyopathy, which is crucial in cases where clinical identification is often poor.
Ross Upton, CEO and Founder of Ultromics, emphasizes that “EchoGo® Amyloidosis is a breakthrough tool that can help us identify at-risk patients so they can receive the treatment they need.” This technology employs deep learning to analyze a single echocardiographic video clip, providing actionable insights that assist clinicians in determining when to pursue further diagnostics.
The Challenge Ahead
Despite new advancements, many cases of cardiac amyloidosis continue to be missed. Studies estimate that up to two-thirds of such cases evade detection during routine checks. Complicating matters further is the subset of heart failure with preserved ejection fraction (HFpEF), where cardiac amyloidosis often mimics other heart conditions. Research suggests that nearly 15% of patients diagnosed with HFpEF may actually have undiagnosed cardiac amyloidosis, underscoring the need for advanced screening tools like EchoGo®.
Methodology of the Study
The clinical study assessing this AI technology took a rigorous two-phase approach:
1.
Development and Optimization Phase: This initial stage involved 9,786 patients at the Mayo Clinic, including 1,349 confirmed cardiac amyloidosis cases and a matched control group. Here, the deep learning model was trained and fine-tuned.
2.
External Validation Phase: Subsequently, the model was validated in a diverse cohort of 2,719 patients from 18 centers globally, comparing its efficacy against the gold-standard diagnostic methods.
Results and Future Directions
EchoGo® exhibited high diagnostic performance across different types of cardiac amyloidosis. Specifically, it achieved sensitivities of approximately 84% for AL, 85% for ATTRwt, and 86% for ATTRv. In high-risk HFpEF cases, the AI maintained reliable diagnostic accuracy, showcasing its potential in one of the most complex areas of cardiac care.
EchoGo® also proved superior to existing clinical scoring systems, outperforming the Transthyretin Cardiac Amyloidosis Score (TCAS) and the Increased Wall Thickness Score (IWT) with an impressive area under the curve (AUC) of 0.921.
Dr. Patricia A. Pellikka, a senior figure in the study and Vice Chair of Cardiovascular Medicine at Mayo Clinic, remarked that the technology significantly improves early detection and could lead to better patient outcomes by reducing diagnostic uncertainty.
Conclusion
With its ability to integrate seamlessly into workflow processes, EchoGo® Amyloidosis is on course to significantly enhance clinician capabilities in diagnosing cardiac amyloidosis. As Ultromics continues to innovate within the realm of cardiovascular imaging powered by AI, timely and accurate detection will likely revolutionize patient access to effective treatment options. Both EchoGo® Amyloidosis and its related products form an integral part of Ultromics’ commitment to pioneering health technology in the evolving landscape of cardiac care.
For further details and the full study findings, you can visit
Ultromics' official website.