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
...agnosi...
...ure 1. Flow diagram for the investigation of p...
...ested algorithm for anatomic imaging in p...
...ramework of clinical decision-maki...
Diagnosis – Limb Staging
...s – Limb Staging...
...le 1. Wound grading in Wound, Isch...
...able 2. Ischemia grading in Wound, Ischemia, and f...
...ble 3. Foot infection grading in Wound, Ische...
...fI Clinical Limb Stage (Based on estimate...
...benefit of performing revascularization in CL...
Diagnosis – Global Anatomic Staging System (GLASS)
...agnosis – Global Anatomic Staging Syste...
...moropopliteal (FP) disease grading in GLASS...
...apopliteal (IP) disease grading in GLASSCTO,...
...ble 4. Assignment of GLASS stageHaving tro...
...e 8. Flow chart illustrating application of GLASS...
...re 9. Inframalleolar (IM)/pedal disease des...
...riptive summary of GLASS stages of infrainguinal a...
...Preferred initial revascularization strategy for i...
Recommendations
...commendations
...nitions and nomenclature...
...xtremity threatened limb classifica...
...e hemodynamic tests to determine the presence a...
...idemiology and risk factors for CLTI...
...recommendations (, )...
...iagnosis and limb staging in...
...rform a detailed history to determine symptoms, p...
...m a complete cardiovascular physic...
...form a complete examination of the foot, includ...
...nd ABI as the first-line noninvasive test in al...
...BI in all patients with suspected CLTI and tis...
...alternative methods for noninvasive assessment of...
...imaging as the first arterial imaging mod...
...sive vascular imaging modalities (DUS, CTA, MRA)...
...in high-quality angiographic imaging of the l...
...dical managemen...
...iovascular risk factors in all pat...
...modifiable risk factors to recommen...
...patients with CLTI with an antiplatelet...
...clopidogrel as the single antiplat...
Consider low-dose aspirin and rivaroxaban, 2.5 mg...
...ystemic vitamin K antagonists for t...
...or high-intensity statin therapy to...
...hypertension to target level...
...rol of type 2 DM in CLTI patients to achieve a h...
...etformin as the primary hypoglycemic agent...
...r withholding metformin immediately...
...ing cessation interventions (pharmacotherapy, coun...
...patients who are smokers or former smokers ab...
...sics of appropriate strength for CLTI...
...ients with chronic severe pain, use...
...e GLASS for C...
...ed, limb-based anatomic staging system (such as...
...ategies for EBR...
...all patients with suspected CLTI to...
...amputation or palliation to patients with limite...
...stimate periprocedural risk and life expecta...
...patient as average surgical risk when anticipated...
Define a CLTI patient as high surgical risk when...
Use an integrated threatened limb cl...
...rm urgent surgical drainage and dé...
...limb staging after surgical drainage, débridem...
...T perform revascularization in the abs...
...revascularization in very-low–risk limbs (eg...
...revascularization to all average-risk patients wi...
Consider revascularization for average-risk pat...
...revascularization in average-risk patients wi...
...onsider revascularization in average-risk patie...
Obtain high-quality angiographic imaging with dedi...
...ed limb-based staging system (eg, GLASS) to de...
...nd vein mapping when available in all...
...eral GSV and small saphenous vein for plann...
...ify a CLTI patient as being unsuitable for rev...
...nflow disease first when both inflow an...
...ecision for staged vs. combined infl...
...ect inflow disease alone in CLTI patie...
...limb and repeat the hemodynamic assessmen...
...ider simultaneous inflow and outflow revascular...
...vascular-first approach for treatment of CLT...
...der surgical reconstruction for the...
...rform open CFA endarterectomy with patch angiop...
...onsider a hybrid procedure combinin...
...scular treatment of significant CFA...
...the CFA and do NOT place stents across the...
...odynamically significant (≥50% ste...
In average-risk CLTI patients with...
...ular revascularization when technica...
...dovascular revascularization for high-r...
...onsider endovascular revascularization for...
...vascular revascularization for high-ris...
...open surgery in selected high-risk patie...
...ome-guided revascularization in patien...
...FP disease in CLTI patients by endo...
...autologous vein as the preferred conduit for infr...
...nautologous conduit for infrainguinal by...
...perative imaging (angiography, DUS, or both) o...
Nonrevascularization treatments of the li...
...nsider SCS to reduce the risk of amputation...
...o NOT use LS for limb salvage in CLTI p...
...der IPC therapy in carefully selected...
...er prostanoids for limb salvage in CLT...
...vasoactive drugs or defibrinating agents (anc...
...o NOT offer HBOT to improve limb salvage in CL...
...nue to provide optimal wound care until t...
...gic and regenerative medicine approaches i...
...rict use of therapeutic angiogenes...
...of minor and major amputa...
...ransmetatarsal amputation of the forefoot i...
...primary amputation to CLTI patients...
...nsider secondary amputation for patients with CL...
...larization to improve the possibility of...
...onsider a TKA or AKA in patients who are nonambu...
...ultidisciplinary rehabilitation team from the time...
...inue to observe CLTI patients who h...
...tprocedural care and surveillance after infrain...
...ontinue best medical therapy for PAD, in...
...e smoking cessation in all CLTI patients wh...
...der DAPT (aspirin plus clopidogrel) in p...
...ider DAPT (aspirin plus clopidogrel) in patients...
...PT for 1–6 months in patients underg...
...ve patients who have undergone lower extremity v...
...serve patients who have undergone...
...serve patients who have undergone infrainguin...
...der performing additional imaging in patients wit...
...ntervention for DUS-detected vein graft lesi...
...ain long-term surveillance after surgical or...
...ial imaging after endovascular interve...
...der reintervention for patients with...
...mechanical offloading as a primary com...
...counseling on continued protection of...
...udy designs and trial end points...
...search framework such as the IDEAL f...
...ders, journal reviewers, and editors to prioritiz...
...s are not feasible, use the OPG benchmarks fr...
...facilitate sufficient enrollment, l...
...ospective cohort studies, and registrie...
...an integrated, limb-based threatened limb classi...
...be outcomes in CLTI trials using a combina...
...regulatory trials aimed at obtaining pr...
...atients in trials for a time suffic...
...lude a time-integrated measure of clinical diseas...
...lish all CLTI trial protocols together with the...
...arketing surveillance data collect...
...hare clinical trial data to allow s...
...ess the quality of evidence in CLTI research...