A low-cost, wireless near-infrared spectroscopy device detects the presence of lower extremity atherosclerosis as measured by computed tomographic angiography and characterizes walking impairment in peripheral artery disease

Background: Patients with peripheral artery disease (PAD) who experience intermittent claudication report a range of symptoms. Patients with symptoms other than classically described intermittent claudication may be at the highest risk for functional decline and mobility loss. Therefore, technologies allowing for characterization of PAD severity are desirable. Near-infrared spectroscopy (NIRS) allows for measurements of muscle heme oxygen saturation (StO₂) during exercise. We hypothesized lower extremities affected by PAD would exhibit distinct NIRS profiles as measured by a low-cost, wireless NIRS device and that NIRS during exercise predicts walking limitation. Methods: We recruited 40 patients with PAD and 10 control participants. All patients with PAD completed a computed tomographic angiography, 6-minute walk test, and a standardized treadmill test. Controls completed a 540-second treadmill test for comparison. StO₂ measurements were continuously taken from the gastrocnemius during exercise. Variables were analyzed by Fischer's exact, χ², Wilcoxon rank-sum, and Kruskal-Wallis tests as appropriate. Correlations were assessed by partial Spearman correlation coefficients adjusted for occlusive disease pattern. Results: Patients with PAD experienced claudication onset at a median of 108 seconds with a median peak walking time of 288 seconds. The baseline StO₂ was similar between PAD and control. The StO₂ of PAD and control participants dropped below baseline at a median of 1 and 104 seconds of exercise, respectively (P <.0001). Patients with PAD reached minimum StO₂ earlier than control participants (119 seconds vs 522 seconds, respectively; P <.001) and experienced a greater change in StO₂ at 1 minute of exercise (−73.2% vs 8.3%; P <.0001) and a greater decrease at minimum exercise StO₂ (−83.4% vs −16.1%; P <.0001). For patients with PAD, peak walking time, and 6-minute walking distance correlated with percent change in StO₂ at 1 minute of exercise (r = −0.76 and -0.67, respectively; P <.001) and time to minimum StO₂ (r = 0.79 and 0.70, respectively; P <.0001). Conclusions: In this initial evaluation of a novel, low-cost NIRS device, lower extremities affected by PAD exhibited characteristic changes in calf muscle StO₂, which differentiated them from healthy controls and were strongly correlated with walking impairment. These findings confirm and expand on previous work demonstrating the potential clinical value of NIRS devices and the need for further research investigating the ability of low-cost NIRS technology to evaluate, diagnose, and monitor treatment response in PAD.