4/8/19 CLTI: What’s in a name and why we need a new framework Michael S. Conte MD Professor and Chief UCSF Division of Vascular and Endovascular Surgery UCSF Vascular Symposium April 4-5, 2019 Global Vascular Guideline for the Management of Chronic Limb-Threatening Ischemia Michael S. Conte MD, Andrew W. Bradbury MBA, MD, FRCS Philippe Kolh MD, PhD (Co-Editors) WFVS 1
4/8/19 Definitions: CLTI The term critical limb ischemia (CLI) is outdated and fails to encompass the full spectrum of patients who are evaluated and treated for limb-threatening ischemia in modern practice Instead, the term chronic limb-threatening ischemia (CLTI) is proposed, in order to include a broader and more heterogeneous group of patients with varying degrees of ischaemia that can often delay wound healing and increase amputation risk. WFVS All Rutherford 5!! 2
4/8/19 A broad range of perfusion deficits may be limb- threatening in specific circumstances, depending on severity of tissue loss and concomitant factors The utility of a single threshold value for “critical limb ischemia” in the presence of tissue loss is questioned Andersen CA J Vasc Surg 2010; 52:Suppl S CLTI : wide spectrum of disease that includes patients with objectively documented PAD and any of the following: • ischemic rest pain with confirmatory haemodynamic studies, • diabetic foot ulcer • non-healing lower limb / foot ulceration for at least 2 weeks • gangrene involving any portion of the lower limb or foot Patients with purely venous ulcers, acute limb ischemia, acute trash foot, ischemia due to emboli, acute trauma, mangled extremity, and those with wounds related to nonatherosclerotic conditions, such as vasculitis, collagen vascular disease, Buerger’s disease, neoplastic disease, dermatoses, and radiation may have many underlying causes of their lower extremity disease and these are beyond the scope of these guidelines . WFVS 3
4/8/19 CLTI: exclusions § Absence of any significant PAD, e.g., WIfI ischemia grade=0 • May be unique circumstances where impaired local perfusion (angiosome) is not reflected by the WIfI ischemia grade for the limb as a whole § Lower extremity wounds that are a direct result of acute trauma § Ulcers of primarily venous origin § Acute limb ischemia (onset symptoms ≤ 14 days) § Impaired tissue perfusion related to non-atherosclerotic conditions WFVS CLTI: criteria for diagnosis Objectively documented atherosclerotic PAD Ischemic rest pain typically described as Tissue Loss diabetic foot ulcer, non- pain in the mid- and forefoot at rest, often healing lower limb or foot ulceration of worse with recumbency and relieved by at least 2 weeks duration, any dependency, present for more than 2 weeks gangrene ABPI <0.4 (using higher of the DP / PT) WIfI ischemia score ≥1 Absolute highest ankle pressure <50 mmHg Absolute toe pressure <30 mmHg TcP02 <20 Torr Flat pulse volume recording waveforms WFVS 4
4/8/19 Diagnosis & Evaluation Importance of Limb Staging in CLTI § Broad spectrum of complexity and risk for limb loss § Complicates analysis of outcomes and treatment decisions § Previous classification systems inadequately capture the full range of neuro-ischemic compromise § Fallacy of a specific hemodynamic threshold for “critical” ischemia § SVS Wound, Ischemia, Foot Infection (WIfI) system § Characterizes each of the three major components § Grouped into 4 stages based on estimated risk for limb loss § Multiple validation reports WFVS 5
4/8/19 § Wound : extent and depth § Ischemia: perfusion/flow § Foot Infection : presence and extent Excluded: acute limb ischemia, emboli/”trash foot”, trauma, vasculitides, pure venous ulcers, neoplastic disease, radiation J Vasc Surg 2014; 59:220-34 6
4/8/19 Estimated 1-Year Amputation Risk by Stage J Vasc Surg 2014; 59(1):220-34 There Is a Free App for That: https://itunes.apple.com/app/id1014644425 7
4/8/19 Benefit of revascularization varies with severity of limb threat and ischemia Appropriateness of revascularization • Severe ischemia (WIfI ischemia grade 3) mandates revascularization • With increased stages of limb threat (WIfI stages 3, 4) moderate degrees of ischemia (grades 1, 2) may be appropriate to address • Low risk limbs (WIfI Stage 1) should be treated with wound care; revascularization should be reserved for failure to heal (50% improvement within 4-6 weeks) or clinical deterioration • Revascularisation not indicated for WIfI ischaemia grade 0 WFVS 8
4/8/19 UCSF Center: Summary of Procedures/WIfI Overall Stage 1 Stage 2 Stage 3 Stage 4 P- (N=168) (N=21, (N=48, (N=42, (N=49, Value 13%) 29%) 25%) 29%) Revascularization (Any) 71% 29% 75% 64% 90% 0.001 Infrainguinal Revasc. 64% 14% 60% 62% 90% 0.001 Endovascular 50 (46%) 1(33%) 8(28%) 13(50%) 25(57%) 0.17 Surgical 58(54%) 2(67%) 21(72%) 13(50%) 19(43%) 0.17 Podiatric Procedures No. procedures/limb 1.4 1.5 0.7 1.2 2.3 0.001 Minor Amputation 71(42%) 8(38%) 6(13%) 20(48%) 34(69%) 0.001 Digital 52(31%) 8(38%) 4(8%) 16(38%) 21(43%) 0.003 Transmetatarsal 33(20%) 1(5%) 2(4%) 6(14%) 22(45%) 0.001 Hindfoot procedure 8(5%) 0(0%) 0(0%) 0(0%) 8(16%) 0.001 Causey MW et al J Vasc Surg 2016; 63:1563-73. 9
4/8/19 Center for Limb Preservation and Diabetic Foot WIfI and evidence-based revascularization (EBR) Bypass versus endovascular therapy for WIfI Repetitive endovascular therapy versus WIfI Stage 4;Ramanan et al. J Vasc Surg 2017 stage, Kobayashi et al. Catheter Cardiovasc Interv. 2017;1–10. 10
4/8/19 Amputation risk with revascularization: WIfI Study (year): # Limbs at Risk Stage 1 Stage 2 Stage 3 Stage 4 Cull (2014):151 37 (3%) 63 (10%) 43 (23%) 8 (40%) Zhan (2015): 201 39 (0%) 50 (0%) 53 (8%) 59 (64%)* Darling (2015): 551 5 (0%) 111 (10%) 222 (11%) 213 (24%) Causey (2016): 160 21 (0%) 48 (8%) 42 (5%) 49 (20%) Beropoulis (2016): 126 29 (0%) 42 (2%) 29 (3%) 26 (12%) Ward (2016): 98 5 (0%) 21 (14%) 14 (21%) 58 (34%) Darling (2017): 992 12 (0%) 293 (4%) 249 (4%) 438 (21%) Robinson (2017): 262 48 (4%) 67 (16%) 64 (10%) 83 (22%) Mathioudakis (2017): 279 95 (6.5%) 33 (6%) 87 (8%)** 64 (6%)*** N = 2820 (weighted mean) 291 ( 3.2% ) 728 ( 6.8% ) 803 ( 8.5% ) 998 ( 24% ) Median (% 1 year amputation) 0% 8% 8% 22% Ind J Vasc Endovasc Surg 2018; 5(2) 11
4/8/19 J Vasc Surg 2018; 68(4): 1104-13 Need for Structured Decision Making in CLTI § PLAN: § P atient Risk § L imb threat severity: WIfI Staging § AN atomic pattern of disease: GLASS WFVS 12
4/8/19 Revascularization Decision Matrix in CLTI Limb Salvage is a TEAM SPORT • Easy referral access • Diagnostics, podiatric and vascular consultations in a single venue/appointment • Timely, coordinated interventions for advanced limb threatening conditions • Emphasis on communication and care transitions 13
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