Artificial Intelligence-Enhanced Cardiac Point-of-Care Ultrasound: A Prospective Single-Arm Study.
Authors
Affiliations (6)
Affiliations (6)
- Leviev Cardiovascular Institute, Sheba Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
- AISAP.ai, Ramat-Gan, Israel.
- Faculty of Medicine, Sheba Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
- Inova Heart and Vascular Institute, Falls Church, VA.
- Stony Brook Heart Institute, Stony Brook, NY.
- Thomas Jefferson University Hospital, Philadelphia, PA.
Abstract
To evaluate the clinical utility of combining artificial intelligence (AI) with handheld focused cardiac ultrasound (FoCUS) performed by noncardiologist physicians in clinical care settings. In this prospective, single-arm study conducted from July 1, 2022, through December 31, 2023 (ClinicalTrials.gov NCT05455541), 660 adult patients presenting to the emergency department or internal medicine wards were assessed with handheld ultrasound devices enhanced by AI algorithms. These algorithms provided automated analysis of ventricular function, valvular disease, pericardial effusion, and inferior vena cava size. Participating physicians received focused training and performed examinations either in response to clinical suspicion or as part of routine evaluation. The primary outcome was whether AI-guided FoCUS contributed to new diagnoses, treatment modifications, or additional procedures. Artificial intelligence-enhanced FoCUS identified clinically relevant cardiac findings in 193 patients (29%), including newly recognized valvular abnormalities and reduced left ventricular function. In 49 patients (7%), medical therapy was adjusted based on findings, and 9 patients (1.4%) underwent interventional procedures. Diagnostic performance analyses showed high sensitivity for detecting reduced left ventricular function and valvular disease, with lower sensitivity for right-sided abnormalities. This study demonstrates that integrating AI-enhanced FoCUS into routine workflows can provide clinically relevant information that may influence diagnostic assessment and management by noncardiology practitioners in acute care settings.