Abstract
Objective: The 2020 Global Vascular Guidelines aim at improving decision making in Chronic Limb-Threatening Ischemia (CLTI) by providing a framework for evidence-based revascularization. Herein, the Global Limb Anatomic Staging System (GLASS) serves to estimate the chance of success and patency of arterial pathway revascularization based on the extent and distribution of the atherosclerotic lesions. We report the preliminary feasibility results and observer variability of the GLASS. GLASS is a part of the new global guideline and posed as a promising additional tool for EBR strategies to predict the success of lower extremity arterial revascularization. This study reports on the consistency of GLASS scoring to maximize inter-observer agreement and facilitate its application. Methods: GLASS separately scores the femoropopliteal (FP) and infrapopliteal (IP) segment based on stenosis severity, lesion length and the extent of calcification within the target artery pathway (TAP). In our stepwise approach, we used two angiographic datasets. Each following step was based on the lessons learned from the previous step. The primary outcome was inter-observer agreement measured as Cohen’s Kappa, scored by two (step 1 + 2) and four (step 3) blinded and experienced observers, respectively. Steps 1 (n = 139) and 2 (n = 50) were executed within a dataset of a Dutch interventional RCT in CLTI. Step 3 (n = 100) was performed in randomly selected all-comer CLTI patients from two vascular centers in the United States. Results: In step 1, kappa values were 0.346 (FP) and 0.180 (IP). In step 2, applied in the same dataset, the use of other experienced observers and a provided TAP, resulted in similar low kappa values 0.406 (FP) and 0.089 (IP). Subsequently, in step 3, the formation of an altered stepwise approach using component scoring, such as separate scoring of calcification and adding a ruler to the images resulted in kappa values increasing to 0.796 (FP) and 0.730 (IP). Conclusion: This retrospective GLASS validation study revealed low inter-observer agreement for unconditioned scoring. A stepwise component scoring provides acceptable agreement and a solid base for further prospective validation studies to investigate how GLASS relates to treatment outcomes.
Highlights
While Chronic Limb-Threatening Ischemia (CLTI) represents less than 10% of all PAD patients, it comes with a considerable burden in terms of morbidity, mortality and socio-economic costs
The 2020 Global Vascular Guidelines aim at improving structured decision making in CLTI by providing a framework for evidence-based revascularization (EBR) [8]
The target artery pathway (TAP) is defined by the proceduralist and identified either prospectively during a case, from operative notes, or based on imaging evidence of the IP artery that was primarily targeted for intervention
Summary
While Chronic Limb-Threatening Ischemia (CLTI) represents less than 10% of all PAD patients, it comes with a considerable burden in terms of morbidity, mortality and socio-economic costs. Existing anatomic classifications in PAD are based on the location and severity of individual arterial lesions (e.g., TASC) [6] or quantify the overall burden of atherosclerotic disease [7] These individual lesion-based classification systems correlate poorly with clinically effective revascularization in patients with CLTI and leave vascular specialists trying to integrate data for arterial segments into a management strategy for the whole limb. The 2020 Global Vascular Guidelines aim at improving structured decision making in CLTI by providing a framework for evidence-based revascularization (EBR) [8]. This framework is composed of three dimensions: (1) Patient risk, (2) Limb status and (3) ANatomical pattern (PLAN). Components of each of those three dimensions are respectively: The Vascular Quality Initiative prediction model (VQI) for determining overall patient risk [9], WIfI for limb staging, and the Global Limb Anatomic Staging System (GLASS) for identifying different anatomical patterns of disease and related chance of success of revascularization
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