Abstract 13244: Real World Evaluation of an Artificial Intelligence Enabled Digital Stethoscope for Detecting Undiagnosed Valvular Heart Disease in Primary Care

Abstract

Background: Clinically significant valvular heart disease (VHD) affects 1 in 10 adults over 65. Cardiac auscultation, the current point of care clinical standard, has shown a 44% sensitivity for detecting VHD, leaving most patients undiagnosed. A deep learning based artificial intelligence (AI) platform that detects cardiac murmurs associated with clinically significant VHD (moderate severity or higher, confirmed by echocardiogram) was used to assess its real-time impact on the point of care. Hypothesis: Use of AI during point of care auscultation may lead to higher discovery rates and earlier diagnosis of VHD compared to conventional practice. Aim: Evaluate real world performance of AI vs. primary care physician (PCP) auscultation in identifying previously undiagnosed VHD. Methods: This blinded, prospective study enrolled 369 patients aged 50 and older without a prior VHD diagnosis or history of murmur from three different primary care clinics. Four-point cardiac auscultation was performed on each patient by (1) PCP with a standard stethoscope, and (2) coordinator with an Eko digital stethoscope to collect phonocardiogram (PCG) data for analysis by the AI. Each patient received an echocardiogram to confirm whether clinically significant VHD was present, and their PCG recordings were reviewed by an outside expert panel to confirm whether audible murmurs were present. PCP and expert panel were blinded to AI and echocardiogram results. Performance metrics were calculated for both PCP auscultation and the AI in detecting audible VHD. Results: The AI showed over twofold improvement in sensitivity vs. PCP auscultation for detecting audible VHD (94.1% vs. 41.2%) with limited impact on specificity (84.5% vs. 95.5%). The AI identified 22 patients with moderate-or-greater VHD who were previously undiagnosed, while PCPs identified eight previously undiagnosed patients with VHD. Conclusion: When applied in a primary care setting, a digital stethoscope with structural murmur detection AI showed meaningful impact on new discovery of VHD as compared to conventional practice. These results suggest that AI-powered auscultation at the point of care may significantly increase earlier VHD discovery, facilitate appropriate patient care, and improve outcomes.