Chronic Limb-Threatening Ischemia
Key Points
Key Points
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
Diagnos...
.... Flow diagram for the investigation of pat...
...re 2. Suggested algorithm for anato...
...PLAN framework of clinical decision-making in...
Diagnosis – Limb Staging
Diagnosis – Limb Stagin...
.... Wound grading in Wound, Ischemia, and foot I...
Table 2. Ischemia grading in Wound, Ischemia, and...
...able 3. Foot infection grading in Wound, Ische...
...SVS WIfI Clinical Limb Stage (Based on esti...
...ure 5. The benefit of performing revascularizati...
Diagnosis – Global Anatomic Staging System (GLASS)
...gnosis – Global Anatomic Staging System (G...
...emoropopliteal (FP) disease grading in GLASS...
...nfrapopliteal (IP) disease grading in GL...
...nment of GLASS stageHaving trouble viewi...
...Flow chart illustrating applicatio...
...nframalleolar (IM)/pedal disease descriptor...
...5. Descriptive summary of GLASS stages of infrai...
...ure 10. Preferred initial revascular...
Recommendations
Recommendation...
...nitions and nomenclature...
...wer extremity threatened limb classification sta...
...objective hemodynamic tests to dete...
...emiology and risk factors for C...
No recommendations (,...
Diagnosis and limb staging in...
...form a detailed history to determine...
...lete cardiovascular physical examination of al...
...form a complete examination of the...
...sure AP and ABI as the first-line noninvasive te...
...and TBI in all patients with suspected C...
...nsider using alternative methods for non...
...DUS imaging as the first arterial imaging m...
...er noninvasive vascular imaging modali...
...uality angiographic imaging of the lo...
...edical manag...
...diovascular risk factors in all patients with su...
...nage all modifiable risk factors to recom...
Treat all patients with CLTI with an antip...
...clopidogrel as the single antiplatelet agent o...
...low-dose aspirin and rivaroxaban, 2.5 mg twi...
...NOT use systemic vitamin K antagonists for the t...
...or high-intensity statin therapy to reduc...
...rol hypertension to target levels of
...ol of type 2 DM in CLTI patients to achieve a hem...
...e metformin as the primary hypoglycemic...
...nsider withholding metformin immediately before an...
...ffer smoking cessation interventions (pharmacothe...
...tients who are smokers or former smokers about...
...nalgesics of appropriate strength for...
...ents with chronic severe pain, use pa...
...LASS for CLTI...
...ntegrated, limb-based anatomic staging system (suc...
...trategies for E...
...all patients with suspected CLTI to...
...y amputation or palliation to patients with limite...
...te periprocedural risk and life expectancy in pa...
...ine a CLTI patient as average surgical...
...CLTI patient as high surgical risk...
...ted threatened limb classification...
...urgent surgical drainage and débrideme...
...imb staging after surgical drainage, débride...
...rm revascularization in the absence of signifi...
...perform revascularization in very-low–ri...
...rization to all average-risk patients with a...
...revascularization for average-risk patients...
Consider revascularization in avera...
...ularization in average-risk patients with interm...
...igh-quality angiographic imaging with ded...
...integrated limb-based staging system (eg,...
...form ultrasound vein mapping when available...
...ipsilateral GSV and small saphenous vein f...
...sify a CLTI patient as being unsuitabl...
...disease first when both inflow and outflow disease...
Base the decision for staged vs. combi...
Correct inflow disease alone in CLTI patien...
...stage the limb and repeat the hemodynamic a...
...aneous inflow and outflow revasculari...
...n endovascular-first approach for treatmen...
Consider surgical reconstruction for the treatme...
...endarterectomy with patch angioplasty, with...
...hybrid procedure combining open CFA en...
...der endovascular treatment of significant CFA d...
...n the CFA and do NOT place stents acro...
...rrect hemodynamically significant (...
...average-risk CLTI patients with infraingui...
...er endovascular revascularization when techni...
...nsider endovascular revascularization...
...der endovascular revascularization for...
...onsider endovascular revascularization for hi...
Consider open surgery in selected high...
...onsider angiosome-guided revasculariz...
...n treating FP disease in CLTI patients by endova...
...us vein as the preferred conduit for infraing...
...using a nonautologous conduit for infra...
...rform intraoperative imaging (angiography, DUS, o...
...larization treatments of the...
Consider SCS to reduce the risk of amputation an...
...r limb salvage in CLTI patients in w...
...erapy in carefully selected patients (eg, rest p...
...NOT offer prostanoids for limb salvag...
...oactive drugs or defibrinating agents (ancrod...
...HBOT to improve limb salvage in CLTI patients...
...to provide optimal wound care until the lower ext...
...egenerative medicine approaches in CLT...
...trict use of therapeutic angiogenesis to CLTI...
...e role of minor and major amput...
...smetatarsal amputation of the forefo...
...ary amputation to CLTI patients who have a pr...
...condary amputation for patients with C...
...ularization to improve the possibil...
...der a TKA or AKA in patients who are nonambulator...
...ve a multidisciplinary rehabilitation t...
...inue to observe CLTI patients who have...
...ocedural care and surveillance after infraing...
...tinue best medical therapy for PAD,...
...ng cessation in all CLTI patients who h...
...aspirin plus clopidogrel) in patients who ha...
...spirin plus clopidogrel) in patient...
...sider DAPT for 1–6 months in patient...
Observe patients who have undergone lowe...
Observe patients who have undergone lower extrem...
...bserve patients who have undergone infrai...
Consider performing additional imaging in p...
...ervention for DUS-detected vein graft lesions wi...
...term surveillance after surgical or cat...
...rial imaging after endovascular interve...
...sider reintervention for patients w...
...al offloading as a primary component for care o...
...counseling on continued protection of t...
...dy designs and trial end points in CLTI...
...ch framework such as the IDEAL for gathering...
...s, journal reviewers, and editors to prioritize...
...not feasible, use the OPG benchmarks from the S...
...tate sufficient enrollment, limit RC...
...ospective cohort studies, and registri...
...an integrated, limb-based threatened limb cl...
...s in CLTI trials using a combination o...
...ire regulatory trials aimed at obtain...
...ollow up patients in trials for a time sufficien...
...time-integrated measure of clinica...
...CLTI trial protocols together with...
...postmarketing surveillance data collectio...
...al trial data to allow subsequent individu...
...ss the quality of evidence in CLTI re...