GLOBAL VASCULAR GUIDELINES: A NEW PATHWAY FOR LIMB SALVAGE

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1 GLOBAL VASCULAR GUIDELINES: A NEW PATHWAY FOR LIMB SALVAGE Michael S. Conte MD Professor and Chief, Vascular and Endovascular Surgery Co-Director, Center for Limb Preservation Co-Director, Heart and Vascular Center University of California, San Francisco DF Con 2018

2 Disclosures Symic, Inc (SAB) Abbott Vascular (advisory board) VasaRx (co-founder) BEST-CLI Trial (EC Co-Chair; NHLBI) Co-Editor, Global Vascular Guidelines on the management of chronic limb-threatening ischemia

3 The Global Vascular Guidelines (GVG) initiative is sponsored by an international consortium of vascular societies, led by the European Society for Vascular Surgery (ESVS), the Society for Vascular Surgery (SVS), and the World Federation of Vascular Societies ()

4 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)

5 Rationale for a Global Vascular Guideline in CLTI Growing global prevalence of disease and risk factors High patient and public health costs Diverse specialties/providers and care settings Highly variable utilization of vascular interventions Wide disparity in outcomes, unclear standard of care Continuously evolving technology, shifting practice patterns Lack of consensus definitions and disease staging a major limitation to evidence-based medicine and clinical/outcomes research Define Key Research Questions Foster Improved Care and Quality Outcomes for Patients

6 A New Framework for Evidence Based Care in Chronic Limb Threatening Ischemia (CLTI) Definitions Staging of disease Anatomic patterns Evidence based revascularization UNDER FINAL REVIEW (release Q1 2019)

7 Definitions: CLTI The term critical limb ischemia (CLI) is outdated and fails to encompass the full spectrum of patients who are evaluated and treated for limb-threatening ischemia in modern practice Instead, the term chronic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 ischemia that can often delay wound healing and increase amputation risk.

8 CLTI: criteria for diagnosis Objectively documented atherosclerotic PAD Ischemic rest pain typically described as pain in the mid- and forefoot at rest, often worse with recumbency and relieved by dependency, present for more than 2 weeks ABPI <0.4 (using higher of the DP / PT) Absolute highest ankle pressure <50 mmhg Absolute toe pressure <30 mmhg TcP02 <20 Torr Flat pulse volume recording waveforms Tissue Loss diabetic foot ulcer, nonhealing lower limb or foot ulceration of at least 2 weeks duration, any gangrene WIfI ischemia score 1

9 Need for Structured Decision Making in CLTI PLAN: Patient Risk Limb threat severity: WIfI Staging ANatomic pattern of disease: GLASS system

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12 Risk stratification tools High Risk defined as expected perioperative mortality >5% OR expected 2 year survival <50%

13 VQI Survival Model for CLTI N= 38,470; PVI= 24,214; LEB= 14,256 Risk group POD 2-YR survival LOW <3% >70% MEDIUM 3-5% 50-70% HIGH >5% <50% Simons J, et al. J Vasc Surg (in press)

14 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

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16 Wound Grade Clinical Category Grade Clinical Description 0 Ischemic rest pain; Pre gangrenous skin change, without frank ulcer or gangrene (Pedis or UT Class 0) 1 Minor tissue loss: small shallow ulceration) < 5 cm 2 on foot or distal leg (Pedis or UT Class 1); no exposed bone unless limited to distal phalanx 2 Major tissue loss: deeper ulceration(s) with exposed bone, joint or tendon, ulcer 5 10 cm 2 not involving calcaneus (Pedis or UT Classes 2 and 3); gangrenous changes limited to digits. Salvageable with multiple digital amps or standard TMA + skin coverage 3 Extensive ulcer/gangrene > 10 cm 2 involving forefoot or midfoot; full thickness heel ulcer > 5 cm 2 + calcaneal involvement. Salvageable only with complex foot reconstruction, nontraditional TMA (Chopart/Lisfranc); flap coverage or complex wound management needed

17 Ischemia Grade Noninvasive Assessment Grade ABI Ankle SP TP 0 > 0.80 > 100 mm Hg > 60 mm Hg mmhg mm Hg mm Hg mm Hg 3 < 0.40 < 50 mm Hg < 30 mm Hg ABI=ankle brachial index; SP= systolic pressure; TP=toe pressure

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19 Risk of amputation vs SVS WIfI Stage Study (year): # Limbs at Risk Stage 1 Stage 2 Stage 3 Stage 4 Cull (2014): (3%) 63 (10%) 43 (23%) 8 (40%) Zhan (2015): (0%) 50 (0%) 53 (8%) 59 (64%)* Darling (2015): (0%) 111 (10%) 222 (11%) 213 (24%) Causey (2016): (0%) 48 (8%) 42 (5%) 49 (20%) Beropoulis (2016): (0%) 42 (2%) 29 (3%) 26 (12%) Ward (2016): 98 5 (0%) 21 (14%) 14 (21%) 58 (34%) Darling (2017): (0%) 293 (4%) 249 (4%) 438 (21%) Robinson (2017): (4%) 67 (16%) 64 (10%) 83 (22%) Mathioudakis (2017): (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%

20 Limb staging and appropriateness of revascularization CLTI represents a range of limb severity and ischemia as described in WIfI staging. Severe ischemia (WIfI ischemia grade 3) mandates revascularization for limb salvage 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% within 4 6 weeks) or clinical signs of deterioration Not indicated for Ischemia grade 0

21 Benefit of revascularization varies with severity of limb threat and ischemia Severity of Ischemia (WIfI Ischemia 3 Grade) 2 1 N/A N/A High benefit Low/Nil benefit Limb Severity (WIfI Stage)

22 Rationale for a new anatomic staging system in CLTI Schemes focused on individual lesions (e.g. TASC) or overall burden of disease (e.g. Bollinger) are not useful for defining evidence-based revascularization in CLTI Restoration of in-line flow to the foot is a primary technical goal of revascularization in CLTI, particularly in patients with tissue loss Factors that determine clinical success for endovascular and open bypass surgery are intrinsically different

23 GLASS*: Assumptions and Approach Focus on Infrainguinal Disease (SFA origin to foot) Clinician defines the primary Target Artery Path (TAP) Femoro-popliteal (FP) and Infra-popliteal (IP) segments separately graded (0-4), then combined into Three GLASS Stages for the limb (I-III) Infra-malleolar (pedal) disease graded; used as a modifier only Calcification graded as Severe or not; simplified system *Global Limb Anatomic Staging System

24 GLASS: Target Artery Path and Limb-Based Patency Restoration of in line flow to the ankle and foot is a primary goal Target artery path (TAP): the selected continuous route of in line flow from groin to ankle TAP usually involves the least diseased IP artery; may be angiosome based Limb based patency (LBP): maintained patency of the TAP. Lost when: Occlusion, critical stenosis, or re intervention affecting any portion of the TAP (anatomical failure), and/or: Fall in ABI ( 0.15) or TBI ( 0.10), or 50% stenosis in the TAP, in the presence of recurrent or unresolved clinical symptoms (e.g. rest pain, worsening/persistent tissue loss; signifying hemodynamic failure)

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27 GLASS: Consensus Staging of TAP Complexity for Endovascular Intervention

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29 FP grading: SFA: no significant stenosis Popliteal: no significant stenosis FP grade = 0 IP grading: TAP = peroneal artery Peroneal: CTO 3 10cm IP grade = 3 GLASS Stage = II

30 FP grading: Total length of SFA disease: cm Popliteal disease: <5cm does not involve trifurcation Calcification + 1 FP grade = 4 IP grading: TAP= peroneal artery Peroneal: stenosis TP trunk IP grade = 2 GLASS Stage = III

31 Preferred initial revascularization strategy: average risk CLTI patient with available GSV

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