2. MidAtlantic Vascular, LLC Critical Limb Ischemia. P.A.D. Detection, Treatment, and Referral Paul Sasser MD FACS

3. P.A.D. and Podiatry Podiatrists are positioned to: Recognize the early and advanced signs of P.A.D. Improve lower limb wound healing rates Reduce lower limb amputation rates P.A.D. is routinely seen in the daily practice of podiatrists The feet can reveal the first signs and symptoms of P.A.D. “Podiatric physicians are commonly the first to thoroughly evaluate a patient’s legs and feet regardless of the patient’s reason for a visit.”

4. Clinical Signs of Limb Ischemia Nonhealing wounds Shiny skin Loss of hair growth Cool skin temperature for one limb but not the other Pale or bluish skin Reduced capillary fill times Pallor on elevation and rubor on dependency

5. Patient presents with Critical Limb Ischemia- What do we do next? We know our complex patients can have multiple comorbidities with similar and often overlapping signs & symptoms Are we looking for all contributing factors?

6. Foot Care and P.A.D. Preventative foot care: Daily foot inspection Skin cleansing and moisturizing Appropriate footwear Promptly address skin lesions and ulcers Podiatric care To reduce the risk of ulcers, infection, necrosis, and amputation, high-risk patients should: Perform proper foot care Receive annual foot exams

7. Classical Diabetic Triad of Pathology PVD Infection Neuropathy

8. Diabetic Foot and P.A.D. Diabetic foot ulcers: 15%-25% of persons with diabetes develop a foot ulcer 14%-24% of persons with a foot ulcer require amputation Foot ulcers precede 85% of non-traumatic amputations About 50% of all foot ulcers are due to P.A.D. Peripheral neuropathy can accompany P.A.D. in patients with diabetes and lead to: Decreased pain perception Sudden ulcer formation

9. Multidisciplinary Care of the Diabetic Foot A joint statement from the Society for Vascular Surgery (SVS) and the American Podiatric Medical Association (APMA) specifies that diabetic foot care requires: Vascular assessment and revascularization, if necessary Wound assessment and staging/grading of ischemia and infection Risk monitoring and reduction for reulceration and infection

10. Limb Ischemia and the Diabetic Foot Critical limb ischemia (CLI) in the diabetic population requires multidisciplinary care Ischemia is one of many factors underlying diabetic foot disease, and leads to: Decreased tissue resilience Impeded wound healing Rapid tissue necrosis Left untreated, CLI results in non- healing wounds and potential amputation

11. Classical Diabetic Foot Treatment Plan Stop Smoking Exercise Achieve Ideal Body Weight Control Blood Pressure Control Diabetes Antiplatelet Therapy Off-Loading Debridement Infection Management Ischemia Management Control Cholesterol and Triglycerides

12. Wound Care and P.A.D. P.A.D. is associated with ulcers that heal slowly or not at all Ulcer management: Local wound care/debridement Infection control Offloading Revascularization Limb salvage procedures Healing requires increasing perfusion beyond the level required for healthy skin P.A.D. and infection lead to a 90 times higher risk of amputation

13. Guidelines on Wound Care A consensus panel on treating neuropathic diabetic foot ulcers recommends: Vascular evaluation Palpate pulses and take ABI and/or TBI If P.A.D. is suspected, refer for segmental pressure volume, skin perfusion pressure (SPP), and transcutaneous oxygen (TCPO 2 ) measurements If revascularization is considered, refer for vascular consult and angiography

14. Guidelines on Wound Care Consensus recommendations include P.A.D. management for the treatment of diabetic foot ulcers As part of P.A.D. management, endovascular revascularization is being used increasingly in: Ulcer healing Below-the-knee P.A.D. Small vessels Revascularization is central to wound care and contributes to healing in 90% of patients that receive it expeditiously

15. Vascular Medical Specialists have long believed in the importance of treating the Whole patient and not just the Hole in the patient

16. Early Detection of P.A.D. and Disease Outcomes The major goals of early detection are to slow or stop P.A.D. progression to the more advanced stages AND to reduce cardiovascular morbidity and mortality

17. CLI is a Marker for Death Within three months of presentation CLI:  Death in 9%  MI in 1%  Stroke in 1%  Amputation in 12% 1-year Mortality: 21.0% 2-year mortality: 31.6%

18. A Big Problem: Lesion Assessment Less than half of the patients that eventually received a PRIMARY amputation (49%) had any diagnostic evaluation prior to their amputation! Not even a simple ABI Must go beyond PAD Assessments: Vascular history Physical Examination Non-invasive vascular laboratory Access pulses Arteriography

19. Appropriate Route for Limb Salvage DPM Gatekeeper Endovascular Interventionalists ABI Arterial Duplex Scanning Venous Duplex Scanning with appropriate technologist Contrast Angiography Endovascular intervention RF Closure Surgical Bypass Amputation only if needed

20. Podiatry and P.A.D. Case Study: Patient presented with a foot ulcer Podiatrist prescribed antibiotics and requested a 2-week follow-up At follow-up, patient was referred for a vascular consult 17 days later Prior to consult, patient developed a necrotic foot Below-the-knee amputation was performed one month after consult Jury awarded patient $1.23 million for not receiving a prompt vascular referral “Medical-legally, we also find ourselves in the position where recognition of P.A.D. and pro-active intervention will not only be expected, but also necessary for better risk management.”

21. Prognosis & Economic Impact of CLI Critical Limb Ischemia (CLI) is defined as extremity pain at rest or as impending tissue loss that is caused by a severe compromise of blood flow. DX of CLI should be confirmed by ankle- brachial index (ABI) : Ischemic rest pain most commonly occurs below an ankle pressure of 50mm HG or a toe pressure less than 30 mm Revascularization is central to wound care and contributes to healing in 90% of patients that receive it expeditiously

22. P.A.D. Evaluation P.A.D Patients: 80% are current or former smokers Diabetes is associated with a 21% risk of amputation as compared with 3% in nondiabetic patients Traditional cardiovascular risk factors also play a lesser role: males, age, black race, & hypertension. “Remarkably a recent study showed that only 35% of patients undergoing limb amputation in the U.S. had an ABI documented and only 16% of amputees underwent peripheral angiography”

23. Clinical Presentation P.A.D. Physical Examination:  Dry skin, thickened nails, loss of hair.  Coolness to palpation  Decreased or absent pulses  Pallor or dependent rubor  Nonhealing wound or ulcer, especially over bony prominences, and on the plantar surface of the

24. Clinical Presentation P.A.D. Noninvasive Vascular Laboratory:  Ankle-Brachial index 1.3  Ankle systolic pressure < 50 mm Hg  Toe systolic pressure < 30 mm Hg  Transcutaneous oxygen tension < 10 mm HG

25. CLI “Rule of ¼” For patients with Critical Limb Ischemia, after one year :  ¼ Resolution  ¼ Ongoing  ¼ Require amputation  ¼ Dead “One-year CLI outcomes could approximate the following one- fourth rule..”

26. Be a Proactive Part of the Solution A program to promote:  Early identification and diagnosis of CLI by podiatrists  Followed by prompt referral to endovascular specialists in your patients’ communities  Completed by aggressive wound care and surveillance programs by the health care partners

27. LE Amputation Impact:  Devastating psychological and quality of life issues  Survival Perioperative mortality – BKA 5-10% – AKA 15-20%  Second amputation required in 30% of cases.  Full mobility achieved in 50% of BKA & 25% of AKA

28. LE Amputation Impact:  It is estimated that between 220,000 and 240,000 major and minor lower extremity amputations are performed for CLI in the US and Europe annually Charleston West Virginia, Population 240K

29. LE Amputation LE Amputation Rate:  Despite advances in medical and interventional therapies, the amputation rate has increased from 19 to 30 per 100,000 person/year over the past 2 decades  Mainly driven by an increase in diabetes and aging patient populations

30. LE Amputation Success of Rehabilitation:  Below Knee Amputation (BKA) less than two thirds  Above Knee Amputation (AKA) less than one half  Fewer than 50% of amputees ever achieve full mobility

31. CLI Economic Impact Expenses, difficult to assess in cost- effectiveness analysis:  Home Health Aids  Construction & adaptation of home  Influence on family  Productivity economics  Long-term health care costs

32. CLI Economic Impact- First Line Treatment Recent cost-effectiveness analysis of US Medicare patients – First line treatment:  67% Primary Amputation  23% Surgical Revascularization  10% Percutaneous Revascularization  Amputation seems to be over utilized despite being associated with worse patient outcome.

33. CLI Economic Impact Surgical Revascularization Surgical revascularization for limb salvage:  34% increase in 5-year survival  Primary amputation three times more costly than surgical revascularization in both diabetic and non diabetic patients  Percutaneous revascularization offers 30-50% improved cost per procedure cost and cost per leg year saved

34. Contrast Angiography Identifies the level of arterial disease such that endovascular and/or surgical interventions can be planned appropriately Endovascular therapy, such as atherectomy, angioplasty, and/or stenting, can be performed during contrast angiography, if warranted.

35. Endovascular Therapy- PTA Percutaneous Transluminal Angioplasty (PTA)  Is the initial therapy of choice for CLI in patients who are candidates for either surgery or endovascular therapy  Avoids the additional morbidity associated with vascular surgery  Does not preclude the possibility of subsequent surgery

36. Bypass Versus Angioplasty in Severe Ischemia of the Leg BASIL (2005) study of 452 patients – Shows that endovascular therapy and surgery were comparable as first-line therapies for CLI but that PTA was less expensive and did not preclude subsequent treatment with surgery

37. Infrapopliteal PTA Two recent trials have shown the efficacy and attractiveness of an initial percutaneous approach for patients with CLI and infrapopliteal vascular disease :  90% limb salvage after 2-5 years  Suggests angioplasty of the tib-peroneal trunk should not be reserved just for limb-salvage

38. Endovascular Therapy Atherectomy  A minimally invasive technique for removing atherosclerosis from a blood vessel  The advantage of atherectomy over angioplasty is that it removes plaque. It reduces the amount of barotrauma on the vessel wall.

39. Vascular Surgery, Podiatric Medicine & Primary Care practices are loaded with Chronic Venous Insufficiency among the Patients we serve Vascular diseases of the periphery can be the marker for overall cardiovascular events involving the coronary, renal and cerebral arteries, as well as the superficial venous system

40. Another Solution: Better Dietary Habits Diabesity – Work in Progress Supersizing End Result

41. This critical gatekeeper position presents an opportunity for the Podiatric Medicine Specialist & Primary Care Physician to identify potential or actual life-threatening diseases, before otherwise clinically evident to patients or other health care providers

42. As a Vascular Surgeon, I can treat the entire cascade of arterial or venous problems Many of your patients with skin changes, swelling and leg pain may be candidates for procedures such as closure, atherectomy, stenting, angioplasty and/or bypass Please join me to institute relationships with your colleagues who are the Vascular Interventionalists

43. MidAtlantic Vascular Associates in Surgery Sasser Ellis Epstein Rimkus Borowicz Moore

44. Call to Action for Podiatrists & Primary Providers 1.Use medical history and recognize P.A.D. risk factors 2.Take ABI measurements for high-risk patients 3.Provide proper wound care 4.Aggressively and promptly treat risk factors or refer patients for risk reduction treatment 5.Make appropriate referrals to restore blood flow

45. Our Patients deserve our best collaborative & comprehensive expertise Total team care is imperative to have a concerted effort to promote a positive effect and avoid a potential catastrophe

46. Each stage of the management, from presentation of the problem until resolution, necessitates continuous communication and cooperation among: Podiatric Medicine Specialist Primary Care Physician Vascular Interventionalist

47. Know When To Punt! Our Patients deserve our collaborative efforts

48. CLI – Conclusions

49. Bibliography 1) Bell (2009); APMA (2008); Sanders (2005) 2) Hirsch et al. (2006) ACC/AHA Practice Guidelines for PAD; Norgren et al. (2007) TASC II Guidelines for PAD 3) Hirsch et al. (2006) ACC/AHA Practice Guidelines for PAD; Norgren et al. (2007) TASC II Guidelines for PAD; Bell (2009) 4) Norgren et al. (2007) TASC II Guidelines for PAD; Bevilacqua et al. (2010); Sumpio et al. (2010) 5) Sumpio et al. (2010) 6) Janov (2007); Bell (2009) 7) Allie (2005), Ouriel (2001), Ruffolo (2010) 8) Soder (2000) Dorros (2001)