In a first-of-its-kind randomized clinical trial led by researchers at the Smidt Heart Institute and the Division of Artificial Intelligence in Medicine at Cedars-Sinai, artificial intelligence (AI) proved more successful in assessing and diagnosing cardiac function when compared to echocardiogram assessments made by sonographers.

The results, announced during a late-breaking presentation at the European Society of Cardiology Congress 2022, have immediate translational implications for patients undergoing cardiac function imaging and broader implications for the field of cardiac imaging. “This is the first randomized clinical trial of artificial intelligence in cardiology,” said David Ouyang, MD, a cardiologist in the Department of Cardiology in the Smidt Heart Institute and principal investigator of the study, known as EchoNet-RCT. “With this new knowledge, we hope to improve the quality and effectiveness of echo-cardiogram imaging for patients everywhere.”

Building on past research, the most recent study assessed the impact of artificial intelligence in clinical deployment as part of a prospective, blinded and randomized controlled clinical trial. “There has been much excitement about the use of AI in medicine, but the technologies are rarely assessed in prospective clinical trials,” said Ouyang. “This trial was powered to show non-inferiority of the AI compared to sonographer tracings, and so we were pleasantly surprised when the results actually showed superiority for AI with respect to the pre-specified outcomes.”

One of the major findings was that cardiologists more frequently agreed with the AI initial assessment, such that they corrected only 16.8% of the initial assessments made by AI and simultaneously corrected 27.2% of the initial assessments made by the sonographers. This difference demonstrated not only non-inferiority but actually superiority of AI.
The research team also discovered that cardiologists were unable to distinguish between initial assessments made by the AI and sonographers.

Additionally, the Smidt Heart Institute research team learned that this type of clinical trial can be seamlessly integrated into the standard clinical workflow. “We are excited by the implications of this clinical trial and what it means for the future of artificial intelligence and cardiology,” said Susan Cheng, MD, MPH, director of the Institute for Research on Healthy Aging in the Department of Cardiology at the Smidt Heart Institute and EchoNet-RCT investigator. “When developed in the right way, artificial intelligence offers the opportunity to improve the quality of echocardiogram readings as well as increase efficiencies in the time and effort spent by busy cardiologists and sonographers alike.”

Source: Ouyang D. EchoNet-RCT: Safety and Efficacy Study of AI LVEF. Presented at: ESC 2022. August 27, 2022. Barcelona, Spain.

David Ouyang, MD, cardiologist in the Department of Cardiology in the Smidt Heart Institute