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

...gnosis

...Flow diagram for the investigation of patients...


...Suggested algorithm for anatomic imag...


...PLAN framework of clinical decision-making in...


Diagnosis – Limb Staging

...nosis – Limb Staging...

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


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


...ot infection grading in Wound, Ischemia, and foot...


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


...5. The benefit of performing revas...


Diagnosis – Global Anatomic Staging System (GLASS)

... Global Anatomic Staging System (GLASS)...

...ure 6. Femoropopliteal (FP) disease g...


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


...4. Assignment of GLASS stageHaving trouble...


...ow chart illustrating application of GLASS to...


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


.... Descriptive summary of GLASS stages of infrai...


.... Preferred initial revascularization strateg...


Recommendations

...ecommendatio...

...nitions and nomenclature...

...emity threatened limb classification staging...

...ive hemodynamic tests to determine the presence an...


...emiology and risk factors for CLTI...

...recommendations (, )681


...s and limb staging in CLTI...

...ed history to determine symptoms,...

...erform a complete cardiovascular phy...

Perform a complete examination of the...

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

...nd TBI in all patients with suspected...

...er using alternative methods for noninva...

...DUS imaging as the first arterial imaging...

...sider noninvasive vascular imaging mo...

...ality angiographic imaging of the lower limb (w...


...dical managem...

...iovascular risk factors in all patients...

...difiable risk factors to recommended lev...

...ients with CLTI with an antiplatelet agent....

...nsider clopidogrel as the single an...

...low-dose aspirin and rivaroxaban, 2.5 mg t...

...o NOT use systemic vitamin K antagoni...

...erate- or high-intensity statin therap...

...hypertension to target levels of...

...trol of type 2 DM in CLTI patients to achie...

...the primary hypoglycemic agent in patie...

...ider withholding metformin immediately befor...

...cessation interventions (pharmacothe...

...CLTI patients who are smokers or former smokers ab...

...algesics of appropriate strength for CLT...

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


...he GLASS for...

...an integrated, limb-based anatomic sta...


...rategies for EBR...

...ts with suspected CLTI to a vascular spec...

...er primary amputation or palliation t...

...periprocedural risk and life expectanc...

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

Define a CLTI patient as high surgical...

...ntegrated threatened limb classification system...

...rm urgent surgical drainage and débr...

...b staging after surgical drainage,...

...OT perform revascularization in the absence of...

...revascularization in very-low–risk lim...

...fer revascularization to all averag...

...nsider revascularization for average-risk...

...er revascularization in average-risk...

...r revascularization in average-risk pat...

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

...an integrated limb-based staging system (eg, GL...

...und vein mapping when available in all C...

...ateral GSV and small saphenous vein for planning o...

...a CLTI patient as being unsuitable f...

Correct inflow disease first when both inf...

...ision for staged vs. combined infl...

...disease alone in CLTI patients wit...

...age the limb and repeat the hemodynamic assessm...

...simultaneous inflow and outflow revascularization...

...ular-first approach for treatment of CLTI patie...

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

...A endarterectomy with patch angioplas...

...rid procedure combining open CFA endarterect...

...ider endovascular treatment of signi...

...oid stents in the CFA and do NOT pla...

...hemodynamically significant (≥50% sten...

...erage-risk CLTI patients with infr...

Offer endovascular revascularization wh...

...er endovascular revascularization for hi...

...onsider endovascular revascularization f...

...ovascular revascularization for hig...

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

...giosome-guided revascularization in pa...

...ating FP disease in CLTI patients b...

Use autologous vein as the preferred conduit...

...nautologous conduit for infrainguinal bypass unle...

...aoperative imaging (angiography, DUS,...


...ascularization treatments of the limb...

...r SCS to reduce the risk of amputation and to decr...

...LS for limb salvage in CLTI patients in whom re...

...der IPC therapy in carefully selected pa...

...r prostanoids for limb salvage in CLTI p...

...T offer vasoactive drugs or defibrinating age...

Do NOT offer HBOT to improve limb sa...

...ue to provide optimal wound care until the lowe...


...enerative medicine approaches in CLTI...

...rict use of therapeutic angiogenesis to...


...of minor and major amputations...

...tatarsal amputation of the forefoot...

Offer primary amputation to CLTI patients who ha...

...ondary amputation for patients with CLTI who have...

...ider revascularization to improve the possi...

...sider a TKA or AKA in patients who are nonamb...

...a multidisciplinary rehabilitation team...

...ntinue to observe CLTI patients who have u...


...tprocedural care and surveillance a...

...st medical therapy for PAD, including t...

...ng cessation in all CLTI patients wh...

...(aspirin plus clopidogrel) in patien...

...PT (aspirin plus clopidogrel) in patients who ha...

...DAPT for 1–6 months in patients undergoing...

...patients who have undergone lower extremity vein b...

...nts who have undergone lower extremity...

...bserve patients who have undergone i...

...rforming additional imaging in patients w...

...ion for DUS-detected vein graft le...

...ain long-term surveillance after surgical...

...er arterial imaging after endovascular intervent...

...ntervention for patients with DUS-detected r...

...e mechanical offloading as a primary c...

...counseling on continued protection of...


...esigns and trial end points in CLT...

...arch framework such as the IDEAL fo...

...rs, journal reviewers, and editors to prioritize...

...t feasible, use the OPG benchmarks fro...

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

...s, prospective cohort studies, and regist...

...n integrated, limb-based threatened limb cla...

...be outcomes in CLTI trials using a combina...

...e regulatory trials aimed at obtai...

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

...time-integrated measure of clinica...

...sh all CLTI trial protocols together with the ful...

...eting surveillance data collection using...

...inical trial data to allow subsequent individ...

...ss the quality of evidence in CLTI research...