Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)

Summary

Structural heart disease (SHD), including valvular heart disease and left ventricular systolic dysfunction, is common in older adults and often goes undetected until symptoms or complications such as heart failure develop. Current detection relies on opportunistic clinical evaluation, including cardiac auscultation, which has limited sensitivity and is inconsistently performed, and echocardiography, which is accurate but resource-intensive. The IMPROVE trial (IMportance of Point-of-caRe ultrasOund for Early Detection of Valvular and Cardiac DiseasEs) evaluates whether an artificial intelligence-guided point-of-care ultrasound (POCUS) screening strategy, embedded in routine primary care and geriatrics ambulatory visits, increases detection of clinically significant SHD compared with usual care. Provider clusters at three health systems will be randomized 1:1 to the AI-POCUS screening strategy or usual care, and approximately 1,440 patients aged 65 years and older will be enrolled over 24 months. In the screening arm, trained clinic staff will acquire cardiac images using an AI-guided handheld ultrasound device; images will be analyzed by FDA-cleared AI software under core laboratory supervision, and patients with a positive screen will be referred to their primary care provider for consideration of a confirmatory transthoracic echocardiogram. The primary outcome is a new diagnosis of SHD (moderate or greater valvular disease, or left ventricular ejection fraction of 50% or less) confirmed by echocardiography within 90 days of the index visit. Secondary outcomes include recall rate, downstream testing and costs, cardiology or cardiac surgery referrals, and major adverse cardiac events over two years. The trial uses a type 1 hybrid effectiveness-implementation design and will concurrently assess the acceptability, feasibility, and determinants of AI-POCUS adoption in ambulatory practice.