Abstract: Expanding Access to Vascular Care Using BlueDop Vascular Expert: A Prospective Cohort Study.
Authors
Affiliations (1)
Affiliations (1)
- University of South Dakota Sanford School of Medicine.
Abstract
Peripheral artery disease (PAD) affects millions of individuals annually and can lead to severe morbidity and mortality. Risk factors for development of PAD include hypertension, obesity, diabetes mellitus, and smoking. Conventional methods to detect PAD include the Ankle-Brachial Index (ABI) with duplex ultrasound being the gold standard for diagnosis. Factors such as vessel compressibility, cuff placement, patient positioning, and sequence of measurements serve as limitations or sources of inaccuracy for ABI. BlueDop Vascular Expert (BVE) is an artificial intelligence (AI) powered device that offers a standardized, accurate, and reliable method to detect early PAD development regardless of comorbidities. The device is portable, user-friendly, easy to interpret and has the potential to expand early PAD detection. Individuals at risk for PAD underwent both ABI and BVE testing. Full leg arterial duplex interpreted by an independent vascular surgeon served as the reference standard. Subgroup analysis compared BVE and ABI capabilities among those with underlying comorbidities such as diabetes mellitus, hypertension, tobacco use, and obesity. Data from two cohorts were used: this study and Tessendorf et al. For all-comers overall accuracy was 91.2% and 80.6% for BVE and ABI respectively. Overall sensitivity for BVE was 82.5% and specificity was 93.9%. In contrast, ABI sensitivity was 58.3%, specificity was 87.4%. Increased accuracy, sensitivity, specificity, and κ constant was present in all analyzed subgroups when comparing BVE to ABI. Across diverse patient populations, BVE provides more accurate and reliable PAD screening than ABI, including those with comorbidities that reduce ABI accuracy. BVE's portability, usability, and minimal reliance on specialized interpretation support it as a first-line screening tool, particularly in rural and underserved settings. Broader implementation of BVE could help reduce diagnostic disparities and improve outcomes for patients at risk of PAD.