Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume

• Published in: Medical devices (Auckland, N.Z.) N.Z.), 2021-01, Vol.14, p.105-118
• Main Authors: Chausiaux, Oriane, Williams, Gareth, Nieznański, Michał, Bagdu, Adem, Downer, Philip, Keyser, Melanie, Husheer, Shamus
• Format: Article
• Language: English
• Subjects: Ankle; Automation; Clinical medicine; Clinical trials; Comparative analysis; congestion; Edema; heart failure; lymphedema; Measurement; medical device; Medical equipment; Methods; Original Research; Patients; peripheral edema; Physiological apparatus; renal disease
• ISSN: 1179-1470; 1179-1470
• DOI: 10.2147/MDER.S297713

Peripheral edema, change in foot volume, is a marker of congestion which is regularly assessed in routine clinical care. A novel video and Artificial Intelligence (AI)-based solution used to measure anatomical parameters, including volume and foot length, Heartfelt HF-1, is compared to the laboratory gold standard (water displacement) and a medical disposable measuring tape. 58 healthy volunteers were measured with the Heartfelt device; 22 were also measured with the water displacement method and 19 with the medical tape. Bland-Altman analysis was performed for both volumes and foot lengths. Left/right foot differences provided covariance-corrected standard error of measurement (ccSEM) and minimum detectable difference (MDD) for each measurement method. Heartfelt device measured volumes displayed excellent correlation to the gold standard (water displacement), with Bland-Altman bias of +32mL ±81mL (1 std.dev). Clinically important change in foot volume is approximately 13%. Water displacement yielded ccSEM of ± 32.1mL and MDD of 90mL (6.7% of average foot volume), while the Heartfelt device measurements yielded ccSEM of ±12.6mL and MDD of 35.3mL (2.6% of average foot volume). The majority of differences were attributable to manual positioning of the patient foot in the waterbath. This study finds that in clinical and non-clinical settings, the Heartfelt device measures foot volume and length more precisely than either the water displacement technique or manual foot length measurements using a medical disposable tape, while having an excellent agreement with these methods.