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4/16/2016 GOALS Staging the Limb at Risk Review Major Risk Factors leading to The WiFi System amputations Review Existing Classifications WiFi Alexander Reyzelman DPM Co-Director, Center for Limb Preservation University of


  1. 4/16/2016 GOALS Staging the Limb at Risk • Review Major Risk Factors leading to The WiFi System amputations • Review Existing Classifications • WiFi Alexander Reyzelman DPM Co-Director, Center for Limb Preservation University of California, San Francisco Center for Limb Preservation No Disclosures Center for Limb Preservation Center for Limb Preservation 1

  2. 4/16/2016 Center for Limb Preservation Center for Limb Preservation Purpose of a Classification System Wagner Classification � To facilitate communication � Stage 0- pre-ulcerative lesion � To promote a logical treatment-based � Stage I- superficial with exposed sub Q thought process � Stage II- down to tendon, ligament or bone, � To predict risk and outcomes not infected � Stage III- infected � Stage IV- localized gangrene of forefoot � Stage V - extensive gangrene Center for Limb Preservation 2

  3. 4/16/2016 UT Diabetic Wound Classification System Grade Clinical manifestations IDSA/PEDI S 0 1 2 3 0 No symptoms or signs of infection Uninfected A Pre or Superficial, not Penetrates to Penetrates to 1 Meets two criteria Mild postulcerative involving tendon, tendon or Bone ●local swelling or induration ●erythema <2cm lesion capsule or bone capsule ●local tenderness ●local warmth ●purulent discharge (epithelialized) B INFECTION INFECTION INFECTION INFECTION 2 Local infection with >2cm erythema Moderate OR: Involves structures deeper than skin and sub-q No SIRS C ISCHEMIA ISCHEMIA ISCHEMIA ISCHEMIA 3 Local infection with the signs of SIRS Severe ●Temp >38 of <36 ●Resp Rate >20 ●Heart Rate >90bpm ●WBC >12,000 D INFECTION and INFECTION and INFECTION and INFECTION and ISCHEMIA ISCHEMIA ISCHEMIA ISCHEMIA Infection Grades Center for Limb Preservation Limb Staging: Rutherford Classification All Rutherford 5!! Diabetics were meant to be excluded! Center for Limb Preservation Center for Limb Preservation 3

  4. 4/16/2016 Wound Description 0 No wound present. No gangrene 1 Minor tissue loss. Will need simple digital amputation or skin coverage. No gangrene. 2 More advanced, at most needs TMA. Gangrenous changes limited to digits. 3 Extensive tissue loss that will require amputation proximal to TMA or will require a free flap. Includes large full thickness heel ulcers. Extensive gangrene. Ischemia ABI Ankle systolic pressure TP, TcPO2 0 > 0.80 <100 mm Hg >60 mm Hg 1 0.6-0.79 70-100 mm Hg 40-59 mm Hg 2 0.4-0.59 50-70mm Hg 30-39 mm Hg • Wound : extent and depth 3 <0.40 <50 mm Hg <30 mm Hg • Ischemia: perfusion/flow Infection Clinical manifestations IDSA/PEDIS • Foot Infection : presence and extent 0 No symptoms or signs of infection Uninfected 1 Meets two criteria: ●local swelling or induration ●erythema <2cm Mild ●local tenderness ●local warmth ●purulent discharge Excluded: acute limb ischemia, emboli/”trash foot”, trauma, vasculitides, pure 2 Local infection with >2cm erythema OR Involves structures deeper than skin Moderate venous ulcers, neoplastic disease, radiation and sub-q. Does not meet SIRS criteria. J Vasc Surg 2013; 3 Local infection and meets 2+ SIRS criteria: ●Temp >38 of <36 Severe Center for Limb Preservation ●Resp Rate >20 ●Heart Rate >90bpm ●WBC >12,000 Risk of Amputation • Stage 1 • Minimal ischemia; no/minor TL • Not in strict “CLI” definition • Stage 2 • Stage 1 with more infection • Rest pain without infection • Minor tissue loss/ mod infection Benefit of Revascularization? • Stage 3 • Range of tissue loss/ischemia • Mild to mod infection • Stage 4 • Advanced in one or more categories • Stage 5 is an unsalvageable foot J Vasc Surg 2014; 59(1):220-34 Center for Limb Preservation Center for Limb Preservation 4

  5. 4/16/2016 Limitations Not intended for: • Pure venous ulcers • Acute limb ischemia • Ischemia 2/2 emboli • Acute trauma • Non atherosclerotic conditions: ‒ Vasculitis, collagen vascular disease, Buerger’s disease, neoplasm, dermatoses, radiation J Vasc Surg 2014; ePub Center for Limb Preservation Center for Limb Preservation Thank You Center for Limb Preservation Center for Limb Preservation 5

  6. 4/16/2016 Summary of Procedures 30- Day and midterm outcomes stratified by SVS Threatened Limb Classification System (WIfI) Overall Stage 1 Stage 2 Stage 3 Stage 4 P- (N=168) (N=21, (N=48, (N=42, (N=49, 29%) Value 30 Day Outcomes Overall Stage 1 Stage 2 Stage 3 Stage 4 P- 13%) 29%) 25%) (N=168) (N=21, (N=48, (N=42, (N=49, 29%) Value Revascularization (Any) 71% 29% 75% 64% 90% 0.001 13%) 29%) 25%) Mortality 3% 0% 4% 7% 0% 0.27 Infrainguinal Revasc. 64% 14% 60% 62% 90% 0.001 MACE 8% 0% 13% 10% 4% 0.33 Endovascular 50 (46%) 1(33%) 8(28%) 13(50%) 25(57%) 0.17 MALE 4% 0% 0% 5% 6% 0.24 Surgical 58(54%) 2(67%) 21(72%) 13(50%) 19(43%) 0.17 Readmission 21% 14% 21% 17% 29% 0.54 Podiatric Procedures Hospital Length of Stay 12 8 11 8 18 0.02 (days) No. procedures/limb 1.4 1.5 0.7 1.2 2.3 0.001 Midterm Outcomes Minor Amputation 71(42%) 8(38%) 6(13%) 20(48%) 34(69%) 0.001 Survival 85% 100% 80% 83% 88% 0.10 Digital 52(31%) 8(38%) 4(8%) 16(38%) 21(43%) 0.003 Major Amputation 10% 0% 8% 5% 20% 0.037 Transmetatarsal 33(20%) 1(5%) 2(4%) 6(14%) 22(45%) 0.001 MALE 19% 0% 19% 14% 31% 0.018 Amputation Free Survival 77% 100% 75% 79% 69% 0.048 Hindfoot procedure 8(5%) 0(0%) 0(0%) 0(0%) 8(16%) 0.001 MALE Free Survival 70% 100% 67% 71% 59% 0.022 Causey MW et al J Vasc Surg (in press) Causey MW et al J Vasc Surg (in press) Summary of Current Classifications Classification Rest Ulcer Gangrene Ischemia Infection Pain Rutherford √ √ √ √ All Rutherford 5!! Magnitude of perfusion increase and durability required Fontaine √ √ √ √ may vary for different settings of “CLI” PEDIS √ √ √ The modern definition of “Critical” limb ischemia is called UT √ √ √ into question Wagner √ √ SAD system √ √ Saint Elian √ √ √ IDSA √ Speaker Name SVS √ √ √ √ √ 6

  7. 4/16/2016 Grade Description How Do We Estimate the Severity 0 No wound present. No gangrene of Limb Threat Across the Spectrum of Neuroischemia? 1 Minor tissue loss salvageable with simple digital amputation or skin coverage. No gangrene. 2 More advanced, but potentially salvageable with multiple digital amputations or at most, a standard TMA. Gangrenous changes limited Three Critical Factors: to digits. • Severity of Ischemia 3 Extensive tissue loss that will require amputation proximal to the level • Degree of Tissue Loss of the standard TMA (Chopart/Lisfranc) or will require a free flap. • Presence and severity of Infection Includes large full thickness heel ulcers. Extensive gangrene. Wound Grades Center for Limb Preservation Center for Limb Preservation Ischemia – Noninvasive Assessment Grade ABI Ankle SP TP, TcpO2 0 > 0.80 > 100 mm Hg > 60 mm Hg 1 0.60-0.79 70-99 mmHg 40-59 mm Hg 2 0.40-0.59 50-69 mm Hg 30-39 mm Hg 3 < 0.40 < 50 mm Hg < 30 mm Hg ABI=ankle brachial index; SP= systolic pressure; TP=toe pressure TcPO2=transcutaneous oximetry Center for Limb Preservation Center for Limb Preservation 7

  8. 4/16/2016 Interventional Challenges in CLI � Multi-level disease is COMMON � Long-segment disease and CTOs are COMMON � Extensive calcification is frequent Anatomic Patterns of Disease and • Diabetes and renal disease Revascularization Strategies � Advanced tissue loss requirements • Support healing of foot reconstructions e.g. TMA • Large defects may take weeks or months to heal • Comorbid conditions often slow wound healing • Weight bearing stresses • Concomitant infection Center for Limb Preservation Center for Limb Preservation � Does not address all diabetic ulcerations/infections � Only 1 of 6 grades involves infection � Describes vascular disease as gangrene 8

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