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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

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4/16/2016 1

Staging the Limb at Risk The WiFi System

Alexander Reyzelman DPM Co-Director, Center for Limb Preservation University of California, San Francisco

Center for Limb Preservation

Review Major Risk Factors leading to

amputations

Review Existing Classifications
WiFi

GOALS

Center for Limb Preservation

No Disclosures

Center for Limb Preservation

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Center for Limb Preservation Center for Limb Preservation Center for Limb Preservation

Purpose of a Classification System

To facilitate communication To promote a logical treatment-based thought process To predict risk and outcomes

Wagner Classification

Stage 0- pre-ulcerative lesion Stage I- superficial with exposed sub Q Stage II- down to tendon, ligament or bone,

not infected

Stage III- infected Stage IV- localized gangrene of forefoot Stage V - extensive gangrene

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UT Diabetic Wound Classification System

1 2

3

A

Pre or postulcerative lesion (epithelialized) Superficial, not involving tendon, capsule or bone Penetrates to tendon or capsule Penetrates to Bone

B

INFECTION INFECTION INFECTION INFECTION

C

ISCHEMIA ISCHEMIA ISCHEMIA ISCHEMIA

D

INFECTION and ISCHEMIA INFECTION and ISCHEMIA INFECTION and ISCHEMIA INFECTION and ISCHEMIA

Center for Limb Preservation

Infection Grades

Grade Clinical manifestations IDSA/PEDI S No symptoms or signs of infection Uninfected 1 Meets two criteria

local swelling or induration ●erythema <2cm
local tenderness ●local warmth ●purulent discharge

Mild 2 Local infection with >2cm erythema OR: Involves structures deeper than skin and sub-q No SIRS Moderate 3 Local infection with the signs of SIRS

Temp >38 of <36 ●Resp Rate >20
Heart Rate >90bpm ●WBC >12,000

Severe

Center for Limb Preservation

Limb Staging: Rutherford Classification

Diabetics were meant to be excluded!

Center for Limb Preservation

All Rutherford 5!!

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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 2013;

Center for Limb Preservation Ischemia ABI Ankle systolic pressure TP, TcPO2 > 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 3 <0.40 <50 mm Hg <30 mm Hg Infection Clinical manifestations IDSA/PEDIS No symptoms or signs of infection Uninfected 1 Meets two criteria: ●local swelling or induration ●erythema <2cm

local tenderness ●local warmth ●purulent discharge

Mild 2 Local infection with >2cm erythema OR Involves structures deeper than skin and sub-q. Does not meet SIRS criteria. Moderate 3 Local infection and meets 2+ SIRS criteria: ●Temp >38 of <36

Resp Rate >20 ●Heart Rate >90bpm ●WBC >12,000

Severe Wound Description 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. Center for Limb Preservation

Risk of Amputation Benefit of Revascularization?

Center for Limb Preservation

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
Stage 3
Range of tissue loss/ischemia
Mild to mod infection
Stage 4
Advanced in one or more

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Center for Limb Preservation

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

Center for Limb Preservation J Vasc Surg 2014; ePub Center for Limb Preservation Center for Limb Preservation

Thank You

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30 Day Outcomes Overall (N=168) Stage 1 (N=21, 13%) Stage 2 (N=48, 29%) Stage 3 (N=42, 25%) Stage 4 (N=49, 29%) P- Value Mortality 3% 0% 4% 7% 0% 0.27 MACE 8% 0% 13% 10% 4% 0.33 MALE 4% 0% 0% 5% 6% 0.24 Readmission 21% 14% 21% 17% 29% 0.54 Hospital Length of Stay (days) 12 8 11 8 18 0.02 Midterm Outcomes Survival 85% 100% 80% 83% 88% 0.10 Major Amputation 10% 0% 8% 5% 20% 0.037 MALE 19% 0% 19% 14% 31% 0.018 Amputation Free Survival 77% 100% 75% 79% 69% 0.048 MALE Free Survival 70% 100% 67% 71% 59% 0.022

30- Day and midterm outcomes stratified by SVS Threatened Limb Classification System (WIfI)

Causey MW et al J Vasc Surg (in press)

Overall (N=168) Stage 1 (N=21, 13%) Stage 2 (N=48, 29%) Stage 3 (N=42, 25%) Stage 4 (N=49, 29%) P- Value 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

Summary of Procedures

Causey MW et al J Vasc Surg (in press)

All Rutherford 5!!

Magnitude of perfusion increase and durability required may vary for different settings of “CLI” The modern definition of “Critical” limb ischemia is called into question

Speaker Name

Summary of Current Classifications

Classification Rest Pain Ulcer Gangrene Ischemia Infection Rutherford √ √ √ √ Fontaine √ √ √ √ PEDIS √ √ √ UT √ √ √ Wagner √ √ SAD system √ √ Saint Elian √ √ √ IDSA √ SVS √ √ √ √ √

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Center for Limb Preservation

How Do We Estimate the Severity

f Limb Threat Across the

Spectrum of Neuroischemia?

Three Critical Factors:

Severity of Ischemia
Degree of Tissue Loss
Presence and severity of Infection

Center for Limb Preservation

Wound Grades

Grade Description No wound present. No gangrene 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 to digits. 3 Extensive tissue loss that will require amputation proximal to the level

f the standard TMA (Chopart/Lisfranc) or will require a free flap.

Includes large full thickness heel ulcers. Extensive gangrene.

Center for Limb Preservation

Ischemia – Noninvasive Assessment

Grade ABI Ankle SP TP, TcpO2 > 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

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Center for Limb Preservation

Anatomic Patterns of Disease and Revascularization Strategies

Center for Limb Preservation

Interventional Challenges in CLI

Multi-level disease is COMMON Long-segment disease and CTOs are COMMON Extensive calcification is frequent

Diabetes and renal disease

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

Does not address all diabetic ulcerations/infections Only 1 of 6 grades involves infection Describes vascular disease as gangrene