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...

Figure 1. Flow diagram for the investigation of pa...


...Suggested algorithm for anatomic imagi...


.... PLAN framework of clinical decision-maki...


Diagnosis – Limb Staging

...Diagnosis – Limb Staging...

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


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


...le 3. Foot infection grading in Wound, Ischemia...


...S WIfI Clinical Limb Stage (Based on est...


...The benefit of performing revascularizat...


Diagnosis – Global Anatomic Staging System (GLASS)

...Diagnosis ...

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


...nfrapopliteal (IP) disease grading in G...


...Assignment of GLASS stage Infrai...


...ure 8. Flow chart illustrating application of G...


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


...tive summary of GLASS stages of infrainguinal...


...erred initial revascularization strategy f...


Recommendations

...Recommendations...

...Definit...

...a lower extremity threatened limb classi...

...e objective hemodynamic tests to determine the pr...


...Global epidemiology and...

...mmendations (, )681...


...Diagnosis...

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

...orm a complete cardiovascular physical examina...

Perform a complete examination of t...

...nd ABI as the first-line noninvasive test in all...

...TP and TBI in all patients with suspected CLT...

...alternative methods for noninvasive assessment o...

...r DUS imaging as the first arterial imag...

Consider noninvasive vascular imaging modalitie...

...n high-quality angiographic imaging of the low...


...iovascular risk factors in all patients with s...

...fiable risk factors to recommended levels...

...at all patients with CLTI with an antiplatelet...

...opidogrel as the single antiplatelet age...

...sider low-dose aspirin and rivaroxaban, 2.5 mg tw...

...NOT use systemic vitamin K antagonists for...

...erate- or high-intensity statin therapy to redu...

...tension to target levels of...

...er control of type 2 DM in CLTI patie...

...as the primary hypoglycemic agent in patients...

...olding metformin immediately before and f...

...fer smoking cessation interventions (pharmacother...

...LTI patients who are smokers or former smoker...

...nalgesics of appropriate strength for CLTI...

...TI patients with chronic severe pain, use paraceta...


...The GLASS for CLTI...

...egrated, limb-based anatomic staging system (...


...Strategies for EBR...

Refer all patients with suspected CL...

...primary amputation or palliation to patien...

...cedural risk and life expectancy i...

...patient as average surgical risk when anticipa...

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

...grated threatened limb classification syste...

...urgical drainage and débridement (including mi...

...at limb staging after surgical drain...

...T perform revascularization in the absence...

...OT perform revascularization in very-low...

...arization to all average-risk patients...

...revascularization for average-risk patients...

...sider revascularization in average-risk p...

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

...high-quality angiographic imaging with...

...e an integrated limb-based staging system (eg, G...

...ultrasound vein mapping when availab...

...e ipsilateral GSV and small saphenous vein for pl...

...sify a CLTI patient as being unsuitable for revasc...

...ct inflow disease first when both...

...se the decision for staged vs. combined i...

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

...ge the limb and repeat the hemodynamic a...

...er simultaneous inflow and outflow revascular...

...vascular-first approach for treatment of CLTI pa...

...ical reconstruction for the treatme...

...CFA endarterectomy with patch angioplasty, with...

...hybrid procedure combining open CFA en...

...ider endovascular treatment of significant CFA...

...n the CFA and do NOT place stents across the orig...

...ynamically significant (≥50% stenosis) d...

...average-risk CLTI patients with infraingu...

...r endovascular revascularization when technically...

...dovascular revascularization for high-risk...

...endovascular revascularization for high-...

...ndovascular revascularization for high-risk p...

...onsider open surgery in selected high...

...ome-guided revascularization in patient...

...disease in CLTI patients by endovascular me...

...ogous vein as the preferred conduit fo...

...nonautologous conduit for infrainguinal bypass u...

...intraoperative imaging (angiography...


...ider SCS to reduce the risk of amputation an...

...r limb salvage in CLTI patients in wh...

...herapy in carefully selected patients (e...

...o NOT offer prostanoids for limb salvage...

...offer vasoactive drugs or defibrinating...

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

...nue to provide optimal wound care unt...


...Biologic and rege...

...se of therapeutic angiogenesis to CLTI patien...


...The role of...

Consider transmetatarsal amputation of the fo...

...mputation to CLTI patients who have a pre-e...

...r secondary amputation for patients with CLTI w...

...vascularization to improve the possibili...

...A or AKA in patients who are nonambulatory for...

...multidisciplinary rehabilitation tea...

...bserve CLTI patients who have undergone amputatio...


...Postprocedural ca...

...st medical therapy for PAD, includin...

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

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

...er DAPT (aspirin plus clopidogrel) in...

...nsider DAPT for 1–6 months in pa...

...rve patients who have undergone lo...

...patients who have undergone lower extremi...

...serve patients who have undergone infrainguinal en...

...der performing additional imaging in pat...

...tervention for DUS-detected vein graft...

...g-term surveillance after surgical...

...er arterial imaging after endovascular int...

...vention for patients with DUS-detected restenosis...

...anical offloading as a primary compon...

...e counseling on continued protection of the...


...Study designs and tri...

...a research framework such as the IDE...

...rage funders, journal reviewers, and editors...

...are not feasible, use the OPG benchmarks...

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

...gn RCTs, prospective cohort studies, and regis...

...an integrated, limb-based threatene...

...escribe outcomes in CLTI trials using a comb...

...atory trials aimed at obtaining premarke...

...ents in trials for a time sufficient (this wil...

...ntegrated measure of clinical disease severity (su...

...ublish all CLTI trial protocols toget...

...postmarketing surveillance data coll...

...trial data to allow subsequent ind...

...s the quality of evidence in CLTI research usi...