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CLINICAL STATEMENTS AND GUIDELINES

Circulation. 2024;149:e1313–e1410. DOI: 10.1161/CIR.0000000000001251 June 11, 2024 e1365

team (see Section 10.1, “Team-Based Care for CLTI”). A 2020 review proposed a classification system for such patients with no options for revascularization based on anatomic categories (Table 18).13 Beyond wound care (see Section 10.3.2, “Wound Care and Management of Infection for CLTI”), few treatments are available for these patients, including the emerging technique of venous arterialization,8–12 as well as intermittent pneumatic compression devices4–7 and prostanoids.1–3 Experimental therapies, such as angiogenic gene therapy and growth factors, are unavailable in clinical practice and are beyond the scope of this document. Lumbar sympathectomy is a palliative procedure that disrupts the efferent autonomic pain pathways and reduces distal sympathetic vasoconstriction.14–16 Lumbar sympathectomy is performed surgically or pharmacologically under CT guidance but is rarely performed in current clinical practice and is largely of historical interest.14–16

Recommendation-Specific Supportive Text

1 Prostanoids have been considered as poten-

tial treatment for “no-option” CLTI for >30 years because they have multiple potential beneficial properties affecting circulation, including vasodilation, inhibition of platelet aggregation and activation, and vascular endothelial cytoprotection.1,2 Examples of this group of mediators include prostaglandin E1, prostacyclin, and iloprost, a synthetic prostacyclin analog (unavailable in the United States). In a meta-analysis of 18 trials, prostanoids were associated with a significantly lower risk of major amputations (OR: 0.77 [95% CI: 0.63-0.93]), although no significant effect on total amputations was observed.1 A Cochrane systematic review analyzed 33 studies and reported low-quality evidence of no clear benefit of prostanoids on cardiovascular mortality reduction (risk ratio [RR]: 0.81 [95% CI: 0.41-1.58]), high-quality evidence of no effect on the total amputation reduction (RR: 0.97 [95% CI: 0.86-1.09]), and moderate-quality evidence that adverse events were more frequent with prostanoids (RR: 2.11 [95% CI: 1.79-2.50]), including gastrointestinal adverse effects, headaches, and hypotension.2 Moderate-quality evidence demonstrated that prostanoids reduced ischemic rest pain (RR: 1.30 [95% CI: 1.06-1.59]) and were associated with improved wound healing (RR: 1.24 [95% CI: 1.04-1.48]) compared with placebo.2 The efficacy of these agents has been called into question because of their marginal results and low quality of evidence within some trials but may be considered when no other viable treatments are available, particularly for short-term relief of pain.3

2 An arterial intermittent pneumatic compression

device (“arterial pump”) is an alternative treatment for patients with no-option CLTI and involves the sequential inflation and deflation of pneumatic cuffs placed on the leg, which increases arterial blood flow, peak systolic blood flow, and pulse volume. Intermittent pneumatic compression is proposed to work through multiple mechanisms: increasing arteriovenous pressure gradient, reversing vasomotor paralysis, and enhancing nitric oxide release.5 A 2015 systematic review by Moran et al4 suggested that intermittent pneumatic compression devices may provide modest clinical benefit (specifically, decreased amputation rates and improved QOL) in patients with CLTI ineligible for revascularization, with potential benefits appearing to outweigh the low risk associated with their use. However, risk of significant bias was noted in available data, along with relatively small populations studied.4 Zaki et al6 performed a retrospective analysis of 187 patients with no-option CLTI who used a specific sequential intermittent pneumatic compression device versus those who did not use intermittent pneumatic compression. They showed reduced minor amputation, prolonged amputation-free survival, and improved rest pain, but no significant reduction in major amputation.6 A subsequent systematic review consisting of 9 studies of intermittent pneumatic compression showed reduction in rest pain with ulcer-healing rates of 26% and limb salvage rate of 58% to 83% at 1 to 3 months and 58% to 94% at 1.5 to 3.5 years.7 Based on these data, intermittent pneumatic

Table 18.  Anatomic Classification of the No-Option Patient With CLTI

Type Conventional Revascularization Options No or Poor Option Description I. Desert foot pedal anatomy No No option No patent pedal vessels

Should be staged with the WIfI17 and GLASS18 staging classifications (including pedal modifier)

II. Inadequate venous conduit No No option Patent pedal target without adequate venous conduit for bypass

No endovascular options

III. Extensive tissue loss Yes Poor option Tissue loss with exposure of vital structures precluding limb salvage of a functional foot Modified from page 189 of Kim et al.13 Copyright 2021 by SAGE Publications, by permission of SAGE Publications. CLTI indicates chronic limb-threatening ischemia; GLASS, Global Limb Anatomic Staging System; and WIfI, wound, ischemia, and foot infection.

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