Highlights
- •In 281 first-time revascularizations for chronic limb-threatening ischemia, whether treatment was concordant or non-concordant with the Global Vascular Guidelines (GVG) recommended revascularization strategy (endovascular vs open) had no significant effect on freedom from 5-year major adverse limb events (45.3% vs 50.7%) or overall survival (47.9% vs 50.6%).
- •Treatment outcomes for chronic limb-threatening ischemia did not differ significantly based on whether treatment was received in concordance with GVG recommended strategy.
- •Further evaluation of GVG and optimal revascularization approach is required
Abstract
Objectives
The Global Vascular Guidelines (GVG) recommend selecting an endovascular vs open-surgical
approach to revascularization for chronic limb-threatening ischemia (CLTI), based
on the Global Limb Anatomic Staging System (GLASS) and Wound, Ischemia, and Foot Infection
(WIfI) classification systems. We assessed the utility of GVG-recommended strategies
in predicting clinical outcomes.
Methods
We conducted a single-center, retrospective review of first-time lower-extremity revascularizations
within a comprehensive limb-preservation program from 2010-2018. Procedures were stratified
by 1) treatment concordance with GVG-recommended strategy (concordant vs non-concordant
groups), 2) GLASS stages I-III, and 3) endovascular vs open strategies. The primary
outcome was 5-year freedom from major adverse limb events (FF-MALE), defined as freedom
from reintervention or major amputation, and secondary outcomes included 5-year overall
survival, freedom from major amputation, freedom from reintervention, and immediate
technical failure during initial revascularization. Kaplan-Meier (KM) survival analysis
and multivariate analysis with Cox proportional hazard models were performed on the
primary and secondary outcomes,
Results
Of 281 first-time revascularizations for CLTI, 251 (89.3%) were endovascular and 186
(66.2%) were in the concordant group, with a mean clinical follow-up of 3.02±2.40
years. Within the concordant group alone, 167 (89.8%) of revascularizations were endovascular.
The concordant group had a higher rate of chronic kidney disease (60.8% vs 45.3%,
P=.02), WIfI foot infection grade (0.81±1.1 vs 0.56±0.80, P=.03), and WIfI stage (3.1±0.79
vs 2.8±1.2, P<.01) compared to the non-concordant group. After both KM and multivariate
analyses, there were no significant differences in 5-year FF-MALE or overall survival
between concordant and non-concordant groups. There was higher freedom from major
amputation in the non-concordant group on KM analysis (83.9% vs 74.2%, P=.025), though
this difference was non-significant on multivariate analysis (HR 0.49, 95% CI 0.21-1.15,
P=.10). The open group had lower MALE compared to the endovascular group (HR 0.39,
95% CI 0.17-0.91, P=.029) attributed to a lower reintervention rate in the open group
(HR 0.31, 95% CI 0.11-0.87, P=.026). GLASS stage was not associated with significant
differences in outcomes, but the severity of GLASS stage was associated with immediate
technical failure (2.1% in stage 1, 6.4% in stage 2, and 11.7% in stage 3, P=.01).
Conclusions
In this study, CLTI treatment outcomes did not differ significantly based on whether
treatment was received in concordance with GVG-recommended strategy. There was no
difference in overall survival between the endovascular and open groups, though there
was a higher reintervention rate in the endovascular group. The GVG guidelines are
an important resource to help guide the management of CLTI patients. However, in this
study, both concordance with GVG guidelines and GLASS staging were found to be indeterminate
in differentiating outcomes between complex CLTI patients treated primarily with an
endovascular-first approach. The revascularization approach for a CLTI patient is
a nuanced decision that must take into account patient anatomy and clinical status,
as well as physician skill and experience and institutional resources.
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Annals of Vascular SurgeryAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
1.6 References
- Impact of Pedal Arch Patency on Tissue Loss and Time to Healing in Diabetic Patients with Foot Wounds Undergoing Infrainguinal Endovascular Revascularization.Korean J Radiol. 2018; 19: 47-53https://doi.org/10.3348/kjr.2018.19.1.47
Cheun TJ, Jayakumar L, Sideman MJ, Pounds LC, Davies MG. Outcomes of isolated inframalleolar interventions for chronic limb-threatening ischemia in diabetic patients. J Vasc Surg. Published online February 17, 2020. doi:10.1016/j.jvs.2019.07.094
- Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system after first-time lower extremity revascularizations.J Vasc Surg. 2017; 65: 695-704https://doi.org/10.1016/j.jvs.2016.09.055
- The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI).J Vasc Surg. 2014; 59 (e1-2): 220-234https://doi.org/10.1016/j.jvs.2013.08.003
- Global vascular guidelines on the management of chronic limb-threatening ischemia.J Vasc Surg. 2019; 69 (3S-125S.e40)https://doi.org/10.1016/j.jvs.2019.02.016
- Editor’s Choice – Relationship Between Global Limb Anatomic Staging System (GLASS) and Clinical Outcomes Following Revascularisation for Chronic Limb Threatening Ischaemia in the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 Trial.Eur J Vasc Endovasc Surg. 2020; 60: 687-695https://doi.org/10.1016/j.ejvs.2020.06.042
- Validation of the Global Limb Anatomical Staging System in First-time Lower Extremity Revascularization.J Vasc Surg. 2020; (Published online October 20)https://doi.org/10.1016/j.jvs.2020.08.151
- The Global Limb Anatomic Staging System is associated with outcomes of infrainguinal revascularization in chronic limb threatening ischemia.J Vasc Surg. 2021; 73: 2009-2020.e4https://doi.org/10.1016/j.jvs.2020.12.094
- Validation of Global Limb Anatomical Staging System (GLASS) in patients with hemodialysis and Chronic Limb-Threatening Ischemia after endovascular treatment.Heart Vessels. 2021; 36: 809-817https://doi.org/10.1007/s00380-020-01747-1
- Prediction of the Technical Success of Endovascular Therapy in Patients with Critical Limb Threatening Ischaemia Using the Global Limb Anatomical Staging System.Eur J Vasc Endovasc Surg. 2020; 60: 696-702https://doi.org/10.1016/j.ejvs.2020.05.003
Haga M, Shindo S, Motohashi S, et al. Early evaluation of the infrainguinal revascularization strategy selection tool of the Global Vascular Guidelines for chronic limb-threatening ischemia patients. J Vasc Surg. Published online May 1, 2021. doi:10.1016/j.jvs.2021.04.034
- Benefit of multidisciplinary wound care center on the volume and outcomes of a vascular surgery practice.J Vasc Surg. 2019; 70: 1612-1619https://doi.org/10.1016/j.jvs.2019.01.087
- Endovascular Therapy Provides Similar Results of Bypass Graft Surgery in the Treatment of Infrainguinal Multilevel Arterial Disease in Patients with Chronic Limb-Threatening Ischemia in All GLASS Stages.Ann Vasc Surg. 2020; 68: 400-408https://doi.org/10.1016/j.avsg.2020.04.028
- Comparison of Long Term Outcomes After Endovascular Treatment Versus Bypass Surgery in Chronic Limb Threatening Ischaemia Patients with Long Femoropopliteal Lesions.Eur J Vasc Endovasc Surg. 2021; 61: 258-269https://doi.org/10.1016/j.ejvs.2020.11.009
- Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial.The Lancet. 2005; 366: 1925-1934https://doi.org/10.1016/S0140-6736(05)67704-5
- Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.N Engl J Med. 2022; 387: 2305-2316https://doi.org/10.1056/NEJMoa2207899
Bontinis V, Bontinis A, Koutsoumpelis A, Giannopoulos A, Ktenidis K. A systematic review and meta-analysis of GLASS staging system in the endovascular treatment of chronic limb-threatening ischemia. J Vasc Surg. Published online August 8, 2022. doi:10.1016/j.jvs.2022.07.183
Hicks CW, Zhang GQ, Canner JK, et al. The Global Anatomic Staging System Does Not Predict Limb Based Patency of Tibial Endovascular Interventions. Ann Vasc Surg. Published online April 24, 2021. doi:10.1016/j.avsg.2021.04.007
- The Global Limb Anatomic Staging System (GLASS) for CLTI: Improving Inter-Observer Agreement.J Clin Med. 2021; 10: 3454https://doi.org/10.3390/jcm10163454
Article info
Publication history
Accepted:
February 10,
2023
Received in revised form:
February 8,
2023
Received:
November 11,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Inc. All rights reserved.
