1. A Multidisciplinary Approach to CLI is Essential: Wound Care, Risk Factor Modification, and Endovascular Therapy
James P. Zidar, M.D., F.A.C.C., F.S.C.A.I
Clinical Professor of Medicine
UNC Health Systems
Corporate Chief of Cardiology, Rex Healthcare
President, Rex Heart and Vascular Specialists
Raleigh, North Carolina

2. James P. Zidar, MD Grant Support: Cordis Corporation Honoraria:
Medtronic CoreValve
Abbott Vascular

3. PAD ….What are the goals? Asymptomatic – treat risk factors
Claudication – medical therapy or revascularization to improve symptoms
Critical Limb Ischemia – prevent amputation and limb loss

4. Risk Factors for PAD Diabetes Hypertension Smoking Dyslipidemia
Disproportionate prevalence in African Americans
Slightly higher prevalence in males
Increasing age
Hypertension
Dyslipidemia
Inflammatory markers
Hyperviscosity and hypercoagulable states
Hyperhomocysteinemia
Chronic renal insufficiency
TASC II. Journal of Vascular Surgery, January 2007
REFERENCE Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)
The risk factors for PAD are similar to those for coronary heart disease, although DM and cigarette smoking are particularly strong risk factors for PAD.
Prevalence is diproportionate for blacks and with age
Prevelance remarkably high among patients with renal insufficiency 4

5. Limb Loss
Non-diabetics have a “relatively low” risk of either abrupt deterioration (20%) or amputation (<10%)
Diabetes increases risk of amputation 6X
Smoking increases risk 11X

6. Disease Patterns
Non-Diabetics
Diabetics

7. Diagnosis Non-invasive Invasive Bedside Ankle-Brachial Index
Lower extremity Segmental Pressures and PVRs
Arterial Duplex imaging
MRA
CTA
Invasive
Angiography

8. Assessment - baseline Non-Invasive Studies Include:
Ankle Brachial Index (ABI)
Toe Brachial Index (TBI)
Segmental Pressures
Pulse Volume Recordings (PVR)
Waveforms
Arterial Ultrasound
TcPO2
Skin Perfusion Pressures (SPP)
National guidelines-indicate necessity to rule out arterial disease with ABI/TBI for any patient with a lower extremity ulcer.
American Diabetes Association suggests all diabetics >50 years of age be evaluated for PAD
There are numerous non-invasive studies that can be used to further evaluate arterial disease.
National guidelines-indicate a necessity to rule out arterial disease with ABI/TBI for any patient with a lower extremity ulcer.
American Diabetes Association suggest all patients 50 years old or greater with DM be evaluated for PAD 8

9. Arterial Ultrasound
Continuous-Wave Doppler Ultrasound
Assess lower extremity PAD anatomy, severity, and progression
Provide localizing information in patients with poorly compressible arteries
Quantitative data after successful lower extremity revascularization
Duplex Ultrasound
Establish the diagnosis of lower extremity PAD and its anatomic location
Define severity of focal extremity arterial stenoses
Select candidates for endovascular or surgical revascularization
Image downloaded from: December 2008
These yield valuable information regarding flow, obstructions/occlusions, and/or any other abnormalities and can demonstrates possible re-vascularization options (Donnely, R 2000)
Continuous-Wave Doppler Ultrasound— This type of ultrasound is useful to assess lower extremity PAD anatomy, severity, and progression and can provide localizing information in patients with poorly compressible arteries. It also can provide quantitative data after successful lower extremity revascularization.
Duplex Ultrasound—This technique can establish the diagnosis of lower extremity PAD and its anatomic location, as well as define severity of focal extremity arterial stenoses. It can be useful to select candidates for endovascular or surgical revascularization.
Source: Hirsch et al; Begelman et al 9

10. Transcutaneous Oximetry (TcPO2)
Determines the degree of microvascular/tissue perfusion of an area
Predictor of Wound Healing
Normal on room air mmHg
Abnormal mmHg
Clinically significant impaired wound healing <40 mmHg
TcPO2s are useful in determining healing potential, amputation level mapping, evaluating the effectiveness of a re-vascularization procedure, and assessing the severity of peripheral arterial disease.
This is a non-invasive study that is simple to perform. The patient lies recumbent while electrodes are placed on the limb at locations around the wound. Readings are taken at scheduled times. The study is performed on room air and while breathing oxygen to determine if increased oxygen may be of benefit. 10

11. Transcutaneous Oximetry (TcPO2) Values
Condition
Room Air
(mmHg)
100% O2 at 1 ATA
100% O2 at 2 ATA Pressure (mmHg)
Normal
> 300
> 700
Abnormal but not clinically significant
Clinically significant
Impaired healing
< 40
< 100 *
< 200**
These are the values often used to evaluate the quality of response directing further evaluation.
NHC Clinical Policy and Procedure 11

12. Basic Treatment of CLI
Medical Rx- ASA, Ace inhibitor, statin, ?clopidogrel, ?Pletal,
Pin control
Management of ulcer and gangrene
Infection control
Local Rx & pressure relief
Revascularization
Amputation

13. Revascularization of Critical Limb Ischemia - Intervention
Endovascular Procedures:
Percutaneous Transluminal Angioplasty (PTA)
Stents
Atherectomy
Excisional
Laser
“Specialized” Angioplasty Devices
Cutting and Scoring Balloons
Cryoplasty
Possibly Drug eluting balloon

14. Lifestyle changes
Avoid: leg crossing, trauma, cold, friction, constrictive clothing, moisture between toes, bare feet
Routine professional foot care
Foot wear to off-load high risk pressure areas
Supervised walking program
Avoid sedentary lifestyle
Nutritious diet regimen
Simple lifestyle changes can reduce pain and may slow progression of the disease process until an intervention can be performed or other options are deemed appropriate (Patterson, G, 2001) 14

15. Reinstate arterial flow - key to wound healing
Arterial Ulcer Care
Reinstate arterial flow - key to wound healing
Then…
- Adequate debridement
- Dressing choice based on wound needs
Treatments that stimulate angiogenesis
Negative Pressure Wound Therapy
Biologic products
Bioengineered tissues
Growth factors
Hyperbaric Oxygen Therapy
Reinstating or optimizing the arterial flow is imperative for ulcer healing to occur. Once that is achieved, traditional ulcer management can begin to include debridement and appropriate topical treatments based on the ulcers needs. Treatments that stimulate angiogenesis are often used to enhance the wound healing process, decreasing the overall time to heal.
NHC Marketing Library 15

16. Who Staffs Our 3 Wound Healing Centers
10 physicians-each staff ½ day per week
5 general surgeons
1 plastic surgeon
1 orthopedic surgeon
2 vascular surgeons
1 podiatrist
Eliminate financial silos- incent group behavior

17. Hyperbaric Oxygen Therapy
Benefits
Decreases edema through vasoconstriction
Improves collagen production
Increases tissue oxygenation
Increased oxygen tension facilitates phagocytosis
Promotes neo-angiogenesis
Enhances granulation tissue formation
Hyperbaric oxygen therapy is one effective adjunctive modality used to stimulate angiogenesis and wound healing through various mechanisms. 17

18. Requirements of a Successful CLI Program
Excellent primary care screening with widespread baseline non-invasive testing
Wound clinic that can see patient weekly for aggressive debridement
Weekly photos of the wound
Hyperbaric chamber
Aggressive endovascular group with an angiosome approach to revascularization.
Vascular surgery support for the pt who requires open fem-tibial bypass or needs toe or forefoot amp.
Eliminate financial silos- incent group behavior

19. Possibilities….