Chronic Limb-Threatening Ischemia
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
...e 1. Flow diagram for the investigati...
...ested algorithm for anatomic imaging in patient...
...igure 3. PLAN framework of clinical decision-mak...
Diagnosis – Limb Staging
...osis – Limb Staging...
...Wound grading in Wound, Ischemia, and foot Infe...
...ia grading in Wound, Ischemia, and foot Infecti...
...Foot infection grading in Wound, Ischemia,...
...e 4. SVS WIfI Clinical Limb Stage (Based on estima...
...5. The benefit of performing revascularization in...
Diagnosis – Global Anatomic Staging System (GLASS)
...s – Global Anatomic Staging System (GLASS)...
...emoropopliteal (FP) disease grading in GLASS...
...igure 7. Infrapopliteal (IP) disease gra...
...4. Assignment of GLASS stageHaving trouble vie...
Figure 8. Flow chart illustrating application of G...
...igure 9. Inframalleolar (IM)/pedal...
...escriptive summary of GLASS stages of infraing...
...igure 10. Preferred initial revascularizati...
Recommendations
...mmendations...
...nitions and nomenclature...
...ective hemodynamic tests to determine the presenc...
Use a lower extremity threatened limb classificat...
...logy and risk factors for CLTI
...o recommendations (,...
...nd limb staging in CLTI...
...a detailed history to determine sympto...
...complete cardiovascular physical examination of a...
...lete examination of the foot, including...
...and ABI as the first-line noninvasive test in all...
...easure TP and TBI in all patients with suspect...
...sider using alternative methods for noninvas...
...sider DUS imaging as the first art...
...r noninvasive vascular imaging modali...
...btain high-quality angiographic imaging of the...
...dical managemen...
...vascular risk factors in all patients with suspe...
...fiable risk factors to recommended levels...
...reat all patients with CLTI with an antip...
...opidogrel as the single antiplatelet agent of c...
...e aspirin and rivaroxaban, 2.5 mg t...
...T use systemic vitamin K antagonists for the tre...
...high-intensity statin therapy to redu...
...hypertension to target levels of...
Consider control of type 2 DM in CLTI patients to...
...as the primary hypoglycemic agent in patient...
Consider withholding metformin immediately...
...fer smoking cessation interventions...
...I patients who are smokers or former...
...rescribe analgesics of appropriate strength f...
...ents with chronic severe pain, use pa...
The GLASS fo...
...ed, limb-based anatomic staging system (such as th...
...trategies for EB...
...fer all patients with suspected CLTI to a va...
...primary amputation or palliation to...
...iprocedural risk and life expectancy in...
...patient as average surgical risk when anticipa...
...patient as high surgical risk when anticipa...
Use an integrated threatened limb class...
...ent surgical drainage and débridement (including...
...taging after surgical drainage, dé...
...o NOT perform revascularization in the absence o...
...NOT perform revascularization in ver...
...ffer revascularization to all average...
...larization for average-risk patients...
Consider revascularization in avera...
...ularization in average-risk patients...
...n high-quality angiographic imaging with de...
...an integrated limb-based staging system (e...
...nd vein mapping when available in all CLT...
...e ipsilateral GSV and small saphen...
...lassify a CLTI patient as being unsuitable for r...
...rect inflow disease first when both inflow and...
...n for staged vs. combined inflow and outfl...
...inflow disease alone in CLTI patients with multi...
...age the limb and repeat the hemodyna...
...simultaneous inflow and outflow r...
...scular-first approach for treatment of CLTI patien...
...urgical reconstruction for the treatment o...
...rm open CFA endarterectomy with patch angioplast...
...brid procedure combining open CFA endarterectom...
...ider endovascular treatment of significant...
...id stents in the CFA and do NOT place sten...
...ct hemodynamically significant (≥5...
...sk CLTI patients with infrainguinal disease, base...
...fer endovascular revascularization when t...
...ider endovascular revascularization for high-risk...
...onsider endovascular revascularization for h...
...cular revascularization for high-risk patien...
...open surgery in selected high-risk pa...
Consider angiosome-guided revascularization in pa...
...eating FP disease in CLTI patients...
...gous vein as the preferred conduit for infr...
...oid using a nonautologous conduit for...
...raoperative imaging (angiography, DUS, or bo...
...vascularization treatments of the limb
...sider SCS to reduce the risk of amputat...
...for limb salvage in CLTI patients i...
...C therapy in carefully selected patients (eg...
...ostanoids for limb salvage in CLTI patients. Cons...
...T offer vasoactive drugs or defibrinating agents (...
...fer HBOT to improve limb salvage in CLTI patient...
...provide optimal wound care until the lo...
...iologic and regenerative medicine...
...therapeutic angiogenesis to CLTI patien...
...minor and major amputations...
...der transmetatarsal amputation of the f...
...r primary amputation to CLTI patients wh...
...ry amputation for patients with CLTI wh...
...evascularization to improve the po...
Consider a TKA or AKA in patients who a...
...multidisciplinary rehabilitation te...
...ue to observe CLTI patients who have un...
...tprocedural care and surveillance after infraingu...
...edical therapy for PAD, including the long-t...
...mote smoking cessation in all CLTI patients wh...
...r DAPT (aspirin plus clopidogrel) in patient...
...(aspirin plus clopidogrel) in patient...
...DAPT for 1–6 months in patients undergo...
...patients who have undergone lower...
...ve patients who have undergone low...
...e patients who have undergone infra...
...der performing additional imaging in patie...
...ntion for DUS-detected vein graft l...
...aintain long-term surveillance after...
...terial imaging after endovascular i...
...tervention for patients with DUS-detected restenos...
...e mechanical offloading as a primary componen...
...nseling on continued protection of the heale...
...y designs and trial end points in...
...se a research framework such as the IDEAL...
...rage funders, journal reviewers, and editors...
...ot feasible, use the OPG benchmarks...
...ate sufficient enrollment, limit RCT exclusion cri...
...sign RCTs, prospective cohort stud...
Use an integrated, limb-based threatened limb cl...
...s in CLTI trials using a combination...
...uire regulatory trials aimed at obtai...
...tients in trials for a time sufficien...
...a time-integrated measure of clinical disease sev...
...ll CLTI trial protocols together with the fu...
...tmarketing surveillance data collection using w...
...linical trial data to allow subsequent indiv...
...ssess the quality of evidence in CLTI research...