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

...iagnosis

...w diagram for the investigation of patien...


...ure 2. Suggested algorithm for anatomic imag...


...3. PLAN framework of clinical decision-ma...


Diagnosis – Limb Staging

Diagnosis – Limb Stagin...

...grading in Wound, Ischemia, and foot Infection...


...2. Ischemia grading in Wound, Isch...


...ble 3. Foot infection grading in Wo...


...ure 4. SVS WIfI Clinical Limb Stage (Based on esti...


.... The benefit of performing revascula...


Diagnosis – Global Anatomic Staging System (GLASS)

...€“ Global Anatomic Staging System (G...

...popliteal (FP) disease grading in G...


...7. Infrapopliteal (IP) disease grading in G...


...gnment of GLASS stageHaving trouble viewing tab...


...igure 8. Flow chart illustrating application o...


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


...ptive summary of GLASS stages of infrainguinal ar...


...eferred initial revascularization strat...


Recommendations

...ommendations...

...nitions and nomenclature...

...emity threatened limb classification staging...

...tive hemodynamic tests to determine the pre...


...pidemiology and risk factors for CLTI...

No recommendations...


...nd limb staging in CLTI...

...a detailed history to determine symptoms,...

...a complete cardiovascular physical examinat...

...erform a complete examination of the...

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

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

...ing alternative methods for noninvasive asse...

...S imaging as the first arterial imaging...

...ninvasive vascular imaging modalities (DUS, CTA,...

...btain high-quality angiographic imaging...


...l management...

...ovascular risk factors in all patie...

...ll modifiable risk factors to recommended l...

...ts with CLTI with an antiplatelet agent. ( S , A...

...clopidogrel as the single antiplatelet agent of c...

...ose aspirin and rivaroxaban, 2.5 mg twice daily, t...

...ystemic vitamin K antagonists for the trea...

Use moderate- or high-intensity statin ther...

...pertension to target levels of...

...l of type 2 DM in CLTI patients to achiev...

...se metformin as the primary hypoglyc...

...withholding metformin immediately before and for 2...

...cessation interventions (pharmacotherapy, cou...

...LTI patients who are smokers or forme...

...e analgesics of appropriate strength...

...atients with chronic severe pain, use parace...


The GLASS for C...

...n integrated, limb-based anatomic staging sy...


...rategies for...

...fer all patients with suspected CLTI to a vasc...

...amputation or palliation to patients with l...

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

...I patient as average surgical risk w...

...a CLTI patient as high surgical risk...

Use an integrated threatened limb cla...

...m urgent surgical drainage and débrid...

...staging after surgical drainage, débridement, mi...

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

...perform revascularization in very-low–ris...

...ascularization to all average-risk pati...

...larization for average-risk patients...

...der revascularization in average-risk patients wi...

...er revascularization in average-risk patients with...

...ality angiographic imaging with dedicate...

...an integrated limb-based staging system...

Perform ultrasound vein mapping when available in...

Map the ipsilateral GSV and small sap...

...a CLTI patient as being unsuitable for revascular...

...w disease first when both inflow an...

...the decision for staged vs. combined inflow an...

...orrect inflow disease alone in CLTI patients...

...e the limb and repeat the hemodyna...

...ltaneous inflow and outflow revascularization in C...

Use an endovascular-first approach...

...ider surgical reconstruction for the treatment...

...rform open CFA endarterectomy with patch angi...

...d procedure combining open CFA endarterectomy and...

...ider endovascular treatment of significant...

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

...hemodynamically significant (≥50% stenos...

...CLTI patients with infrainguinal disease, bas...

...er endovascular revascularization when techni...

...ovascular revascularization for high-risk...

Consider endovascular revascularization for h...

...er endovascular revascularization for high-ri...

Consider open surgery in selected...

...ider angiosome-guided revascularization...

...disease in CLTI patients by endovascular m...

...gous vein as the preferred conduit for infraing...

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

...rform intraoperative imaging (angi...


...revascularization treatments...

...sider SCS to reduce the risk of amputat...

...OT use LS for limb salvage in CLTI patients...

Consider IPC therapy in carefully sel...

...er prostanoids for limb salvage in CL...

...vasoactive drugs or defibrinating agent...

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

...provide optimal wound care until the lower ext...


...generative medicine approaches in CLTI...

...f therapeutic angiogenesis to CLTI pa...


...of minor and major amputatio...

...transmetatarsal amputation of the f...

...er primary amputation to CLTI patie...

...sider secondary amputation for patien...

...cularization to improve the possibility of healin...

...KA or AKA in patients who are nonambulat...

...isciplinary rehabilitation team from the...

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


...ural care and surveillance after infraingui...

...st medical therapy for PAD, includi...

...smoking cessation in all CLTI patients...

...nsider DAPT (aspirin plus clopidogrel)...

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

...APT for 1–6 months in patients und...

...atients who have undergone lower extremity vein by...

...e patients who have undergone lower extremity p...

...s who have undergone infrainguinal...

...r performing additional imaging in patients with...

...ntervention for DUS-detected vein graft lesions...

...-term surveillance after surgical o...

...arterial imaging after endovascular intervention...

...intervention for patients with DUS-detected resten...

...rovide mechanical offloading as a primary c...

...ng on continued protection of the healed wound...


Study designs and trial end...

...framework such as the IDEAL for gathering ne...

...ncourage funders, journal reviewers, and editor...

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

...sufficient enrollment, limit RCT exclusion crite...

...sign RCTs, prospective cohort studies, a...

...egrated, limb-based threatened limb classifica...

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

...atory trials aimed at obtaining prem...

...ents in trials for a time sufficien...

...me-integrated measure of clinical disease se...

...lish all CLTI trial protocols toge...

...ct postmarketing surveillance data collectio...

...clinical trial data to allow subsequent individu...

...quality of evidence in CLTI research using framew...