A Unified Software Platform for Integrated Structural and Functional Carotid Ultrasound Assessment

Objective: A comprehensive evaluation of vascular health relies on the analysis of both structural and functional biomarkers. In current practice, these parameters are typically derived from separate technologies, such as imaging and applanation tonometry, resulting in fragmented approaches. This work addresses the need for an integrated solution by presenting the development and preliminary assessment of a unified ultrasound-based software platform for carotid artery analysis. Design and method: The proposed platform was built upon two previously validated medical devices (the ARCSolver and the Carotid Studio) enhanced through new modules and an integration strategy, enabling full interoperability between structural and functional analyses. Structural metrics, including carotid diameter and intima-media thickness, were extracted from longitudinal ultrasound acquisitions using the Carotid Studio. In parallel, a newly developed generalized transfer function (newGTF) was developed to derive aortic pressure waveforms from ultrasound-based diameter signals, allowing ARCSolver algorithms to estimate central hemodynamic indices via pulse wave analysis. System performance, with a focus on the newGTF, were evaluated in a pilot study involving repeated measurements in 14 healthy volunteers, using paired carotid ultrasound recordings and reference tonometric measurements. Comparison with the reference method was assessed for waveform reconstruction, while precision was examined through repeatability assessment. Usability was additionally evaluated by a group of clinical operators. Results: The integrated software provides a user-friendly graphical interface enabling, from a single ultrasound acquisition, local geometric analysis and model- and machine-learning–based waveform transformation to estimate central aortic pressure. Intraclass Correlation Coefficient, ICC, of the functional parameters demonstrated good repeatability (ICC for heart rate = 0.907, 95% CI: 0.736–0.969; ICC for central systolic blood pressure = 0.984, 95% CI: 0.952–0.995, ICC for augmentation index = 0.741, 95% CI: 0.384–0.908) and waveform comparison with tonometric reference measurements showed root mean square error RMSE of 3.17 ± 1.58 mmHg and correlation coefficient of 0.96 ± 0.04. Usability testing indicated a high level of acceptance among operators. Conclusions: This integrated ultrasound-based platform enables combined structural and functional vascular assessment within a single software environment and represents a promising tool for both research and clinical applications.