Chronic Limb-Threatening Ischemia

Publication Date: June 3, 2019

Key Points

Key Points

Chronic limb-threatening ischemia (CLTI) represents the end stage of peripheral artery disease (PAD), a problem of growing prevalence and increased health care costs around the globe. CLTI is a highly morbid disease, incurring significant mortality, limb loss, pain, and diminished health-related quality of life.

Vascular specialists evaluate patients with CLTI across a broad range of disease severity. This guideline promotes the use of the SVS Threatened Limb Classification System (WIfI) for clinical staging and proposes the Global Anatomic Staging System (GLASS) for defining the extent and complexity of PAD along the Target Artery Pathway (TAP).

Objective measurement of perfusion (eg, ankle, toe pressures) is essential for accurate staging of CLTI. The presence and degree of ischemia is an important determinant of risk of limb loss and treatment approach.

Optimum medical therapy reduces overall mortality as well as major adverse cardiovascular and limb-related events. All vascular specialists treating CLTI should assess and provide evidence-based recommendations on lifestyle and medical therapies.

The goals of limb treatment in CLTI are to prevent amputation, maintain function, reduce pain, and heal wounds. Selection of appropriate candidates for revascularization depends on careful assessment of patient risk, functional status, clinical severity and salvageability of the affected foot.

Structured decision-making in CLTI follows the PLAN concept, assessing (in order) Patient risk, Limb stage, and ANatomic complexity of disease to define appropriate candidates for, and the best approach to revascularization in individual patients.

The effectiveness of non-revascularization treatments for CLTI including pharmacotherapies, hyperbaric oxygen, pneumatic compression, spinal cord stimulation, cell and gene therapies appears limited and further research is needed to establish their role, if any.

Patients with CLTI require long-term surveillance for disease recurrence/progression and should be maintained on appropriate risk factor modification and cardiovascular protective medications.

Future clinical trials in CLTI should exclude patients with intermittent claudication, incorporate stratification by disease stage, employ meaningful clinical and patient-oriented outcomes, and have appropriate follow up duration to better define clinical and cost effectiveness.

Diagnosis

...Diagnosis

...igure 1. Flow diagram for the inve...


...ted algorithm for anatomic imaging in patient...


...ramework of clinical decision-making in CLTI...


Diagnosis – Limb Staging

...Diagnosis – L...

...Wound grading in Wound, Ischemia,...


...le 2. Ischemia grading in Wound, Isc...


...fection grading in Wound, Ischemia, and foo...


...SVS WIfI Clinical Limb Stage (Based on estimate...


...5. The benefit of performing revascular...


Diagnosis – Global Anatomic Staging System (GLASS)

...Diagnosis – Glo...

...gure 6. Femoropopliteal (FP) disease grading in...


...opliteal (IP) disease grading in GL...


...nment of GLASS stageHaving trouble viewing tabl...


Figure 8. Flow chart illustrating applicatio...


...malleolar (IM)/pedal disease descripto...


...e 5. Descriptive summary of GLASS stages of infr...


Figure 10. Preferred initial revascula...


Recommendations

...Rec...

...Definitions and no...

...remity threatened limb classification...

...emodynamic tests to determine the presenc...


...Glob...

...recommendations (, )...


...Diagnosis an...

...ailed history to determine symptoms, past...

...lete cardiovascular physical examin...

...te examination of the foot, including an assessme...

...re AP and ABI as the first-line non...

...TBI in all patients with suspected CLTI...

...g alternative methods for noninvasive assessm...

...imaging as the first arterial imagi...

...er noninvasive vascular imaging modalities (DUS,...

...high-quality angiographic imaging...


Me...

...rdiovascular risk factors in all pati...

...fiable risk factors to recommended lev...

...tients with CLTI with an antiplatelet agent. (...

...grel as the single antiplatelet agent of...

...er low-dose aspirin and rivaroxaban, 2.5...

...temic vitamin K antagonists for the treatment of...

...r high-intensity statin therapy to reduc...

...tension to target levels of...

...ider control of type 2 DM in CLTI patients to ach...

...metformin as the primary hypoglycemic a...

...sider withholding metformin immediatel...

...moking cessation interventions (pharmacother...

...k all CLTI patients who are smokers or form...

...lgesics of appropriate strength for CLTI pati...

...CLTI patients with chronic severe pain, use pa...


...The...

...tegrated, limb-based anatomic staging system...


...Strategies for...

...tients with suspected CLTI to a vascular specia...

...er primary amputation or palliation to pa...

...te periprocedural risk and life expectancy in pati...

...CLTI patient as average surgical risk when antici...

...TI patient as high surgical risk w...

...integrated threatened limb classification...

...ent surgical drainage and débridement (i...

...eat limb staging after surgical drainage, déb...

...OT perform revascularization in the absence o...

...evascularization in very-low–ris...

...revascularization to all average-ri...

...revascularization for average-risk patients with i...

...r revascularization in average-ris...

...ularization in average-risk patients w...

...igh-quality angiographic imaging with...

...n integrated limb-based staging system...

...rasound vein mapping when available in al...

...lateral GSV and small saphenous vein for p...

...T classify a CLTI patient as being...

...isease first when both inflow and outflow disease...

...sion for staged vs. combined inflow and outf...

...isease alone in CLTI patients with multilevel...

...estage the limb and repeat the hemodynamic...

...er simultaneous inflow and outflow revasculariza...

...an endovascular-first approach for trea...

...sider surgical reconstruction for t...

...en CFA endarterectomy with patch angio...

...nsider a hybrid procedure combining open CFA e...

...er endovascular treatment of signifi...

...stents in the CFA and do NOT place stents acr...

Correct hemodynamically significant (≥...

...n average-risk CLTI patients with infrai...

...endovascular revascularization when technicall...

Consider endovascular revascularization for h...

...er endovascular revascularization for high-risk...

...ascular revascularization for high-risk patien...

...sider open surgery in selected high-risk pati...

...me-guided revascularization in patients with sign...

In treating FP disease in CLTI patients by e...

...s vein as the preferred conduit for infrai...

...using a nonautologous conduit for infraingu...

...erative imaging (angiography, DUS, or...


...Nonrevasculari...

Consider SCS to reduce the risk of amputation...

...S for limb salvage in CLTI patients in whom r...

...sider IPC therapy in carefully sel...

Do NOT offer prostanoids for limb salvage in CLT...

...oactive drugs or defibrinating agents (ancrod)...

...HBOT to improve limb salvage in CLTI...

...rovide optimal wound care until th...


...Biologic and...

...use of therapeutic angiogenesis to CLTI patients...


...The role of mino...

...transmetatarsal amputation of the forefoot in CLTI...

...mputation to CLTI patients who have...

...ary amputation for patients with CLTI...

...cularization to improve the possibil...

...er a TKA or AKA in patients who are...

...nvolve a multidisciplinary rehabilitation te...

...ue to observe CLTI patients who have under...


...Postprocedural...

...dical therapy for PAD, including the long...

...oking cessation in all CLTI patients who have u...

...der DAPT (aspirin plus clopidogrel) in patie...

...PT (aspirin plus clopidogrel) in patie...

...for 1–6 months in patients undergoin...

...bserve patients who have undergone lower...

...ts who have undergone lower extremity...

...serve patients who have undergone infraingui...

Consider performing additional imaging...

...intervention for DUS-detected vein graft l...

...erm surveillance after surgical or cathe...

...arterial imaging after endovascular interventio...

...vention for patients with DUS-detecte...

...de mechanical offloading as a primary com...

...ng on continued protection of the heale...


...Study designs and tr...

...a research framework such as the ID...

...ders, journal reviewers, and editors to pr...

When RCTs are not feasible, use the OPG benc...

...acilitate sufficient enrollment, limi...

...s, prospective cohort studies, and registries th...

...se an integrated, limb-based threatened...

...outcomes in CLTI trials using a com...

...regulatory trials aimed at obtaining pr...

...atients in trials for a time sufficient (this will...

...a time-integrated measure of clinic...

...sh all CLTI trial protocols togethe...

...postmarketing surveillance data coll...

...cal trial data to allow subsequent indi...

...uality of evidence in CLTI research...