Caranovic Milenko, Kempf Julius, Li Yi, Regensburger Adrian P, Günther Josefine S, Träger Anna P, Lang Werner, Meyer Alexander, Wagner Alexandra L, Woelfle Joachim, Raming Roman, Paulus Lars-Philip, Buehler Adrian, Uter Wolfgang, Uder Michael, Behrendt Christian-Alexander, Neurath Markus F, Waldner Maximilian J, Knieling Ferdinand, Rother Ulrich
Department of Vascular Surgery, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Institute of Radiology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Commun Med (Lond). 2025 Mar 25;5(1):88. doi: 10.1038/s43856-025-00801-1.
Peripheral arterial disease (PAD) affects more than 200 million people worldwide, with symptoms ranging from none to severe. Despite these different diagnostic options, patients with unclear leg pain remain challenging to diagnose. The primary objective of this study was to evaluate whether multispectral optoacoustic tomography (MSOT) can discriminate between healthy volunteers (HV) and patients with intermittent claudication (IC) by assessing hemoglobin-related biomarkers in calf muscle tissue.
In this monocentric, cross-sectional, observational diagnostic trial (NCT05373927) n = 102 patients were included in two independent derivation (DC, n = 51) and validation cohorts (VC, n = 51). MSOT was performed before and after standardized heel raise provocation and was compared to standardized PAD diagnostics including pulse palpation, ankle brachial index (ABI), duplex sonography, 6-minute walk test (6MWT), assessment of health-related quality of life (VASCUQOL-6), and angiography (aggregated TransAtlantic Inter-Society Consensus classification, aTASC).
Here we show that MSOT is capable of differentiating IC and HV with an area under the receiver operator characteristics curve (AUROC) in DC by 0.99 (sensitivity: 100%, specificity: 95.8%) and in the VC by 0.95 (sensitivity: 96.2%, specificity: 96.0%). MSOT-derived oxygenation positively correlates with the ABI post-exercise (R = 0.83, P = 2.31 × 10), the absolute walking distance in the 6MWT (R = 0.77, P = 3.40 × 10), the VASCUQOL-6 (R = 0.79, P = 4.82 × 10) and negatively with aTASC classification (R = -0.80, P = 2.92 × 10).
Post-exercise MSOT-derived saturation in the calf muscle is validated as a non-invasive imaging biomarker to distinguish HV and IC patients yielding high sensitivity and specificity.
外周动脉疾病（PAD）在全球影响着超过2亿人，症状从无到严重不等。尽管有多种诊断方法，但腿部疼痛原因不明的患者诊断仍具有挑战性。本研究的主要目的是评估多光谱光声断层扫描（MSOT）能否通过评估小腿肌肉组织中与血红蛋白相关的生物标志物，区分健康志愿者（HV）和间歇性跛行（IC）患者。
在这项单中心、横断面、观察性诊断试验（NCT05373927）中，102例患者被纳入两个独立的推导队列（DC，n = 51）和验证队列（VC，n = 51）。在标准化足跟抬高激发前后进行MSOT检查，并与标准化的PAD诊断方法进行比较，包括脉搏触诊、踝臂指数（ABI）、双功超声、6分钟步行试验（6MWT）、健康相关生活质量评估（VASCUQOL-6）和血管造影（汇总的跨大西洋跨学会共识分类，aTASC）。
我们在此表明，MSOT能够区分IC和HV，在推导队列中，受试者工作特征曲线下面积（AUROC）为0.99（敏感性：100%，特异性：95.8%），在验证队列中为0.95（敏感性：96.2%，特异性：96.0%）。MSOT得出的氧合与运动后ABI呈正相关（R = 0.83，P = 2.31×10），与6MWT中的绝对步行距离呈正相关（R = 0.77，P = 3.40×10），与VASCUQOL-6呈正相关（R = 0.79，P = 4.82×10），与aTASC分类呈负相关（R = -0.80，P = 2.92×10）。
运动后MSOT得出的小腿肌肉饱和度经验证可作为一种非侵入性成像生物标志物，用于区分HV和IC患者，具有高敏感性和特异性。
