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

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

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

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

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

Disease Patterns Non-Diabetics Diabetics

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

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

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: http://www.pacificvascular.com/images/technicalLEAlarge.jpg 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

Transcutaneous Oximetry (TcPO2) Determines the degree of microvascular/tissue perfusion of an area Predictor of Wound Healing Normal on room air - 50-90 mmHg Abnormal - 40-50 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

Transcutaneous Oximetry (TcPO2) Values Condition Room Air (mmHg) 100% O2 at 1 ATA 100% O2 at 2 ATA Pressure (mmHg) Normal 50 - 90 > 300 > 700 Abnormal but not clinically significant 40 - 50 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

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

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

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

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

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

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

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

Possibilities….