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Cited by 2,015Peripheral Artery Disease ManagementVascular Procedures and ComplicationsAbdominal vascular conditions and treatments

Global Vascular Guidelines on the management of chronic limb-threatening ischemia.

Open access
Conte, Michael S., Bradbury, Andrew W., Kolh, Philippe, White, John V., Dick, Florian, Fitridge, Robert, Mills, Joseph L., Ricco, Jean-Baptiste +51 more·2019·Journal of Vascular Surgery
DOI 10.1016/j.jvs.2019.02.016PMC PMC8365864
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Abstract

Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

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Crossref · 10.1016/j.jvs.2019.02.016

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  • A systematic review and meta-analysis of 25 studies that included 3789 patients reported that transcutaneous oxygen pressure demonstrated high accuracy in predicting ulcer healing and limb amputation.

    “A systematic review and meta-analysis of 25 studies that included 3789 patients reported that transcutaneous oxygen pressure demonstrated high accuracy in predicting ulcer healing and limb amputation.44”

    From Diabetic Foot Ulcers (2023) · cites this paper as [44]

    The HBOT section reports that preintervention TcPO2 correlated with ulcer healing, and the Level of amputation section says wound complications increase when TcPO2 falls below 40 mm Hg. Our copy does not report a meta-analysis of 25 studies or 3,789 patients, or establish high accuracy for predicting both outcomes; the latter section cautions that no single perfusion measure accurately predicts healing or failure at an amputation site. Page numbers were not available in the indexed passages. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • The sensitivity and specificity of transcutaneous oxygen pressure for ulcer healing were 0.72 (95% CI, 0.61-0.81) and 0.86 (95% CI, 0.68-0.95), respectively, with a diagnostic OR of 15.81 (95% CI, 3.36-74.45).

    “The sensitivity and specificity of transcutaneous oxygen pressure for ulcer healing were 0.72 (95% CI, 0.61-0.81)and 0.86 (95% CI, 0.68-0.95),respectively, with a diagnostic OR of 15.81 (95% CI, 3.36-74.45).”

    From Diabetic Foot Ulcers (2023) · cites this paper as [44]

    The Hyperbaric oxygen therapy section (page unavailable) reports that preintervention TcPO2 correlated with ulcer healing. It does not report the claimed sensitivity, specificity, diagnostic odds ratio, or their confidence intervals, so the numerical claim is unsupported by the available copy. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

  • Ankle-brachial index is less useful in patients with diabetes, kidney disease, and diabetic foot ulcers due to falsely elevated ankle pressure from medial calcinosis; low prognostic accuracy for ulcer healing.

    “Less useful in patients with diabetes, kidney disease, and diabetic foot ulcers due to falsely elevated ankle pressure from medial calcinosis; low prognostic accuracy for ulcer healing.”

    From Diabetic Foot Ulcers (2023) · cites this paper as [44]

    In ‘Definitions and nomenclature > CLTI’ and ‘Diagnosis and limb staging in CLTI > Noninvasive hemodynamic tests’ (page unavailable), the guidelines say medial calcinosis can falsely elevate ankle pressure and ABI, particularly in people with diabetes or kidney disease. They recommend toe measurements when ABI may be misleading. The passages do not establish low prognostic accuracy of ABI for diabetic foot-ulcer healing; the outcome comparison given concerns one-year amputation risk. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

  • Transcutaneous oxygen pressure ≥25 mm Hg is associated with higher rates of ulcer healing and high accuracy in predicting ulcer healing and limb amputation.

    “Transcutaneous oxygen pressure ≥25 mm Hg is associated with higher rates of ulcer healing and high accuracy in predicting ulcer healing and limb amputation.”

    From Diabetic Foot Ulcers (2023) · cites this paper as [44]

    The Hyperbaric oxygen therapy section (page unavailable) reports that preintervention TcPO2 correlated with ulcer healing and that patients below 25 mm Hg did not heal. It does not establish a higher healing rate specifically at ≥25 mm Hg or high predictive accuracy for either healing or limb amputation. The Level of amputation section (page unavailable) says no single tissue-perfusion method accurately predicts healing or failure at an amputation site. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • The ankle-brachial index (with cutoffs of <0.9 and ≥1.3) has a relatively low prognostic accuracy for ulcer healing, with a sensitivity of 0.48 (95% CI, 0.36-0.61), a specificity of 0.52 (95% CI, 0.42-0.63), and a diagnostic OR of 1.02 (95% CI, 0.40-2.64).

    “This is compared with a relatively low prognostic accuracy for ulcer healing using the ankle-brachial index (with cutoffs of <0.9 and ≥1.3), with a sensitivity of 0.48 (95% CI, 0.36-0.61),a specificity of 0.52 (95% CI, 0.42-0.63),and a diagnostic OR of 1.02 (95% CI, 0.40-2.64).44”

    From Diabetic Foot Ulcers (2023) · cites this paper as [44]

    Split into 2 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 2 unverifiable. Expand the claim to see per-atom verdicts.

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Cites

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15 of the 716 references couldn’t be matched to a known paper.

Research works printed but not linked: 8

  1. [153]Macfarlane RM, Jeffcoate WJ. Classification of diabetic foot ulcers: the S(AD) SAD system. Diabetic Foot 1999; 2: 123– 6.
  2. [169]Salaun P, Desormais I, Lapébie FX, Rivière AB, Aboyans V, Lacroix P, Comparison of ankle pressure, systolic toe pressure, and transcutaneous oxygen pressure to predict major amputation after 1 year in the COPART cohort. Angiology 2018. 3319718793566. 30114947
  3. [216]National Institute for Health and Care Excellence. Peripheral arterial disease: diagnosis and management. Clinical guideline CG147. Available at: https://www.nice.org.uk/guidance/cg147/chapter/Recommendations. Accessed October 30, 2018. 31846252
  4. [374]Peeters P, Verbist J, Deloose K, Bosiers M. Will heparin-bonded PTFE replace autologous venous conduits in infrapopliteal bypass? Ital J Vasc Endovasc Surg 2008; 15: 143– 8.
  5. [391]Baumann F, Bloesch S, Engelberger RP, Makaloski V, Fink HP, Do DD, Clinically driven need for secondary interventions after endovascular revascularization of tibial arteries in patients with critical limb ischemia. Vasa 2013; 42(Suppl 84): 57. 24093325
  6. [401]Yiu WK, Conte MS. The roles of drug-eluting technology and atherectomy in infrapopliteal occlusive disease. Ital J Vasc Endovasc Surg 2015; 22: 1– 2.
  7. [421]Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: an intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg 2010; 51: 5S– 17S. 20435258
  8. [616]Pappalardo J, Plemmons B, Armstrong D. Wound healing simplification: a vertical and horizontal philosophy illustrated. J Wound Technol 2013; 19: 38– 9.

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Authors
Conte, M. S., Bradbury, A. W., Kolh, P., White, J. V., Dick, F., Fitridge, R., Mills, J. L., Ricco, J.-B., Suresh, K. R., Murad, M. H., Aboyans, V., Aksoy, M., Alexandrescu, V.-A., Armstrong, D., Azuma, N., Belch, J., Bergoeing, M., Bjorck, M., Chakfé, N., Cheng, S., Dawson, J., Debus, E. S., Dueck, A., Duval, S., Eckstein, H. H., Ferraresi, R., Gambhir, R., Gargiulo, M., Geraghty, P., Goode, S., Gray, B., Guo, W., Gupta, P. C., Hinchliffe, R., Jetty, P., Komori, K., Lavery, L., Liang, W., Lookstein, R., Menard, M., Misra, S., Miyata, T., Moneta, G., Prado, J. A. M., Munoz, A., Paolini, J. E., Patel, M., Pomposelli, F., Powell, R., Robless, P., Rogers, L., Schanzer, A., Schneider, P., Taylor, S., Vega De Ceniga, M., Veller, M., Vermassen, F., Wang, J., & Wang, S.
Affiliations
  • University of California, San Francisco (US)
  • University of Birmingham (GB)
  • University of Liège (BE)
  • Advocate Lutheran General Hospital (US)
  • Kantonsspital St. Gallen (CH)
  • The University of Adelaide (AU)
  • Baylor College of Medicine (US)
  • Université de Poitiers (FR)
  • Mayo Clinic (US)
  • University of Dundee (GB)
Corresponding author
Conte, Michael S.
ORCID
Venue
Journal of Vascular Surgery
Publisher
Elsevier BV
Published
2019-06
Volume
69
Issue
6
Pages
3S-125S.e40
ISSN
0741-5214 (ISSN-L)
DOI
10.1016/j.jvs.2019.02.016
PMC
PMC8365864
OpenAlex
W2947332499
Cited by
2,015
References
716
Citations by year
2026: 247 · 2025: 267 · 2024: 320 · 2023: 342 · 2022: 294 · 2021: 279 · 2020: 216 · 2019: 47 · 2018: 1 · 2015: 1
FWCI
199.72
Type
journal article
Language
en
Update notices
erratum (2019-08-01)
Open access
Licence
Locations
  • Journal of Vascular Surgery (publishedVersion)
  • PubMed (publishedVersion)
  • Pure Amsterdam UMC (publishedVersion)
  • Bristol Research (University of Bristol) (publishedVersion, cc-by-nc-nd)
  • PubMed Central (acceptedVersion)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
  • Discovery Research Portal (University of Dundee) (submittedVersion, cc-by-nc-nd)
  • mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
  • Open Repository and Bibliography (University of Liège) (submittedVersion, other-oa)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
  • National Institutes of Health (UL1TR001855)
  • National Heart, Lung, and Blood Institute (R01HL098967)
  • National Institute of Diabetes and Digestive and Kidney Diseases (R44DK102244, R01DK124789)
  • National Center for Advancing Translational Sciences
Topics
  • Health Sciences › Medicine › Surgery › Peripheral Artery Disease Management
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vascular Procedures and Complications
  • Health Sciences › Medicine › Surgery › Abdominal vascular conditions and treatments
Keywords
critical limb ischemia, peripheral arterial disease, revascularization, WIfI classification, toe pressure, vein bypass, endovascular intervention, optimal medical therapy, regenerative medicine, amputation prevention
MeSH terms
Cardiology, Chronic Disease, Heart Function Tests, Humans, Ischemia, Terminology as Topic, Predictive Value of Tests, Risk Factors, Treatment Outcome, Evidence-Based Medicine, Consensus, Cardiac Imaging Techniques, Peripheral Arterial Disease

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