|Year : 2022 | Volume
| Issue : 1 | Page : 85-88
Retrospective validation of global limb anatomic staging system with respect to technical failures in endovascular infrainguinal revascularization for critical limb threatening ischemia
Shabnam Fathima1, Sairam Subramanian2
1 Department of Vascular Surgery, Stanley Medical College, Chennai, Tamil Nadu, India
2 Department of Vascular Surgery, Sundaram Medical Foundation Hospital, Chennai, Tamil Nadu, India
|Date of Submission||22-Oct-2021|
|Date of Decision||15-Nov-2021|
|Date of Acceptance||11-Dec-2021|
|Date of Web Publication||23-Mar-2022|
Department of Vascular Surgery, Stanley Medical College, Chennai, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Introduction: The Global Vascular Guidelines proposed the Global limb anatomic staging system (GLASS) to overcome the shortcomings of previous multiple classification system. It grades the infrainguinal disease into three stages with a specific algorithm to score the femoropopliteal and tibial segments. We aim to retrospectively validate the GLASS staging in primary endovascular therapy with respect to immediate technical failures (ITFs). Materials and Methods: Retrospective data from November 2017 to September 2021 were collected from the existing clinical database. All patients who underwent primary infrainguinal endovascular intervention for critical limb-threatening ischemia were included in the study. The patient who had isolated infrapopliteal disease without a named tibial outflow and only inframalleolar disease were excluded. The GLASS scoring was applied to the angiographic details in the database. The ITFs from the database were compared to the predicted technical failure according to GLASS staging. Statistical analysis was done. Results: Hundred thirty-two patients were studied from clinical database. We had 13 (9.8%) ITFs. None of those in GLASS Stage I had failure. Among 26 patients in Stage II, 1 (4%) had failure, against the predicted failure rate of lesser than 20%. Among 89 patients in GLASS Stage III, only 12 (13.5%) had failures against the predicted failure rate of more than 20%. The majority of failures had occurred in higher GLASS staging. Conclusion: Higher failures in higher GLASS staging have been validated by our study. However, it is limited considering the small cohort and retrospective analysis.
Keywords: Endovascular, global limb anatomic staging system, infrainguinal, technical failure
|How to cite this article:|
Fathima S, Subramanian S. Retrospective validation of global limb anatomic staging system with respect to technical failures in endovascular infrainguinal revascularization for critical limb threatening ischemia. Indian J Vasc Endovasc Surg 2022;9:85-8
|How to cite this URL:|
Fathima S, Subramanian S. Retrospective validation of global limb anatomic staging system with respect to technical failures in endovascular infrainguinal revascularization for critical limb threatening ischemia. Indian J Vasc Endovasc Surg [serial online] 2022 [cited 2022 May 28];9:85-8. Available from: https://www.indjvascsurg.org/text.asp?2022/9/1/85/340494
| Introduction|| |
The Global Vascular guidelines proposed the Global limb anatomic staging system (GLASS) to grade the infrainguinal critical limb ischemia patients according to the anatomical complexity of vessel pathology such as stenosis, occlusion, and calcification into Stage I, II, and III. The femoropopliteal and infrapopliteal segments are scored individually from 0 to 4. Then, the overall disease burden is evaluated to arrive at the stage. It defines the target artery path as least diseased vessel which needs to be cleared of significant disease to restore and maintain in line to the foot. Thus, the endovascular revascularization procedures aim to establish patency in target artery path. The GLASS predicts the immediate technical failure (ITF) and limb-based patency of such endovascular procedures with respect to staging. We aim to do retrospective validation of GLASS with respect to ITFs in endovascular revascularization.
| Materials and Methods|| |
In the month of September 2021, a retrospective study was done to validate the GLASS staging with respect to ITFs in infrainguinal endovascular revascularization and to identify anatomic predictors of ITF. Therefore, retrospective data from November 2017 to September 2021 were collected from the existing clinical database. All except in those whom GLASS staging could not be applied were excluded. Patients who underwent infrainguinal endovascular intervention as primary procedure for critical limb-threatening ischemia were included in the study. The patient who had isolated infrapopliteal disease without a named tibial outflow and only inframalleolar disease were excluded as target artery path could not be defined in such patients. The GLASS scoring was applied to the digital subtraction angiography. Angiographic details were collected in the database and GLASS staging was arrived at. The angiography was not reviewed to arrive at the GLASS score and stage. The ITFs were defined as residual disease in the vessel more than 30%. The ITFs from the database were compared to the predicted technical failure according to GLASS staging.
The raw data were extracted in excel, cleaned, and checked for inconsistencies. Missing values were not imputed. The outcomes were defined as either successful or failure. There were 132 patients for the analysis [Figure 1]. All of them had critical limb ischemia. 30 (22.7%) had only femoropopliteal segment disease, 62 (47%) had tibial segment disease, and 40 (30.3%) had both femoropopliteal and tibial disease segment. Majority of our patients among those who underwent infrainguinal endovascular revascularization had tibial segment disease. Among the 132 patients, 13 (9.8%) had ITF.
The data were then analyzed using IBM Statistical Package for the Social sciences v23. The outcomes were compared with GLASS staging using cross-tabulation and Chi-square analysis. The statistical significance was fixed at P < 0.5.
| Results|| |
The mean age of the participants is 69.04 years (standard deviation = 8.3 years), ranging between 40 and 91 years. Majority of them were males (n = 103, 78.1%). [Table 1] shows the incidence of risk factors. Minor tissue loss was present in 95 patients (72%), major tissue loss was found in 37 patients (28%). WIFI was not used. WAS WIFI USED? Rutherford Category V was present in 95 patients (72%) and Category VI was found in 37 patients (28%). [Table 2] shows the findings from the diagnostic angiography.
Antiplatelet therapy with clopidogrel was given in 107 patients (81.1%), aspirin in two patients (1.5%), both in 8.3% of cases (n = 11). Statins were given in 89 cases (67.4%). Clinical diagnosis was atherosclerosis in majority of the patients (n = 124, 93.9%). Intervention was equally on both right and left. Primary access was antegrade common femoral artery (CFA) in 109 patients (82.6%), and retrograde contralateral CFA in 20 patients (15.2%). Ultrasound guidance was used in 95.5% (n = 126) of the cases. At first follow-up, inline flow to pedal arch was found in 75.8% (n = 100) patients.
None of the 17 patients who had GLASS Stage I disease had failures against the predicted failure of lesser than 10%. Among 26 patients in Stage II, 1 (4%) had failure, against the predicted failure rate of lesser than 20%. Failure was observed in Stage II in a patient who had tibial intervention, who went to develop a thrombotic occlusion of the vessel during the procedure. Among 89 patients in GLASS Stage III, only 12 (13.5%) had failures against the predicted failure rate of more than 20%. The majority of failures had occurred in higher GLASS staging. Among 30 patients who had only femoropopliteal occlusions only 1 (3%) had failure. Among the 62 who had only tibial interventions, 9 (14.5%) had failures. In 40 patients both femoropopliteal and tibial segments were intervened, only 3 (7.5%) had failed among them. The commonest cause of failure was heavy calcification of the vessel which was upstaged by 1 (38.5%). Recoil, thrombotic occlusion, difficulty to negotiate balloon and severe pedal disease led to ITF in the rest. We noticed that the chronic total popliteal occlusions which were scored as 4 and staged as III with a predicted technical failure of more than 20% had only 13.3% failure rate. Popliteal chronic total occlusions consisted 15 (11.4%) of all 132 cases. [Table 3] shows the final outcomes.
| Discussion|| |
Multiple clinical trials and grading system such as Total Administrative Services Corporation (TASC), Bollinger score were previously developed to correlate between severity of infrainguinal arterial disease and its influence on immediate technical outcomes following revascularization. The Bollinger scoring was found to be better predictor of survival and outcomes than TASC II in infrainguinal disease. The TASC II system is limited being lesion and segment-based tool to stratify diseased vessels. The Global Vascular Guidelines introduced in September 2019 recommends the GLASS system to overcome the shortcomings of previous scoring systems. The GLASS is expected to be an better and independent predictor of clinical and technical outcomes in infrainguinal endovascular therapy. GLASS is used to predict restenosis and reinterventions. Bypass has shown better outcome than endovascular therapy with respect to long-term outcomes. We have retrospectively analyzed our endovascular clinical database. Although we were skewed for bypass in long femoropopliteal lesions toward bypass, both endovascular and open bypass can have comparable results based on patient and anatomical variables. Multiple studies have demonstrated higher failure rates in higher GLASS staging, which is more validated by our study also. Further, we have demonstrated that our primary technical failures have been better than those predicted by GLASS but it needs further validation considering we studied a small cohort of patients. Majority of our interventions involved the tibial segment. In a single-institution retrospective study, Tokuda et al. demonstrated inferior technical success and inferior levels of total target arterial path revascularization for higher GLASS stages, which is further supported by similar outcome in our study.
Statistically, the findings are not significant (P > 0.05). This is because there were no failures in GLASS staging I which makes it difficult to compare. The smaller sample size affects the statistical significance. Our results were compared to the results of the article “Validation of GLASS in the Bypass versus Angioplasty in Severe Ischemia of the Leg 1 Best endovascular therapy cohort” published in December 2018 and we found that there were 43, 54, and 116 patients in GLASS Stage I, II, and III respectively. ITF occurred in 22% of patients with majority being diabetic.
It is a retrospective study in a small cohort of patients involving only patients who underwent endovascular intervention. GLASS scoring and staging were done based on target artery path selection based on data in the database and not angiographic review. The femoropopliteal segment long lesions were skewed towards open bypass procedure due to operator bias. The limb-based patency was not analyzed. The entire PLAN concept can be applied for a larger study and complete outcome analysis in future studies.
| Conclusion|| |
We would like to conclude that the real world ITF rates in primary infrainguinal endovascular interventions are lesser than those predicted by GLASS staging system. Higher technical failures as predicted by GLASS staging in higher stages were validated.
This original article is being submitted as a requirement for award paper presentation session in VSICON 2021 conference.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]