1. Y A L E S C H O O L O F M E D I C I N E Author : John K. Forrest, M.D Updated : June 2009 Endovascular Treatment of Critical Limb Ischemia Krishnan Ramaraj, MD Section of Cardio VASCULAR Medicine

2. Y A L E S C H O O L O F M E D I C I N E Author : John K. Forrest, M.D Updated : June 2009 Southern Regional AHEC adheres to ACCME Essential Areas and Policies regarding industry support of continuing medical education. All those in a position to control content have disclosed and there are no unresolved conflicts prior to this program. The following presenters and panelists (and their family members) have no relevant financial disclosures to make: Krishnan Ramaraj, MD (910) 615-4000| 1638 Owen Drive | Fayetteville, NC 28304 There will not be discussion of any off-label, experimental, or investigational use of drugs or devices in this presentation This program is not being supported by any commercial funding.

3. Y A L E S C H O O L O F M E D I C I N E - ~314,000 cases annually in the United States - 5-year mortality estimated at >50% - 2.7 billion dollars spent in-hospital on CLI in 2007 - Endovascular-first and bypass-first strategies appear to provide equivalent long-term limb salvage rates Scope of CLI Moridzadeh R, et al. Subsequent open surgical revascularization following an initial endovascular approach for critical limb ischemia. Presented at: Annual Meeting of Eastern Vascular Society; September 12-15, 2012; Pittsburgh, PA

4. Y A L E S C H O O L O F M E D I C I N E - ~30% of Medicare patients undergo primary amputation as the only therapy provided - 60% of amputations occur without any revascularization attempt - 46-73% of amputations occur without a diagnostic angiogram - Estimated 2010 Medicare cost of major amputation exceeds $10 billion US dollars Scope of CLI Yost ML. The economic cost of dysvascular amputation. Atlanta (GA): The Sage Group; 2013. In press. Baser O, et al. Prevalence, incidence, and outcomes of critical limb ischemia in the US Medicare population. Vasc Dis Mgmt. 2013:10; E26-36.

5. Y A L E S C H O O L O F M E D I C I N E 63 yr-old female Insulin-Dependent Diabetes Hypertension Heavy Smoker COPD Prior Transmetatarsal amputation on the R Case Presentation

6. Y A L E S C H O O L O F M E D I C I N E Early September 2012 Non-healing ulcer at tip of L great toe Late September 2012 L great toe osteomyelitis Partial L hallux amputation Runoff without inflow disease and only the peroneal in-line to foot Peroneal angioplasty performed Case Presentation

7. Y A L E S C H O O L O F M E D I C I N E Jan 2013 Admitted with fever and non-healing amputation site Regadenoson stress with moderate anterior ischemia and TID, anterior hypo in stress images, preserved LVEF Case Presentation

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20. 63 year-old diabetic smoker with COPD and prior transmetatarsal amputation on the R Non-healing L partial hallux amputation site, despite recent peroneal angioplasty High-risk stress test with 3-vessel CAD, including mid-LAD CTO NOW WHAT??!! Case Presentation

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26. Above knee Popliteal Below knee Anterior Tibial Tibio-Peroneal Trunk Peroneal Posterior Tibial

27. Y A L E S C H O O L O F M E D I C I N E -When revascularization is not attempted in diabetics with CLI, major amputation occurs >50% at 5-year follow-up -With DIRECT revascularization, major amputation is reduced to ~15% at 5-year follow- up Angiosome Concept Faglia E, et al. Long-term prognosis of diabetic patients with critical limb ischemia: a population- basedcohort study. Diabetes Care. 2009;32:822-827.

28. Y A L E S C H O O L O F M E D I C I N E 1 MEDIAL CALCANEAL 2 MEDIAL PLANTAR 3 LATERAL PLANTAR 5 LATERAL CALCANEAL 4 DORSALIS PEDIS PosteriorTibial Peroneal Anterior Tibial

29. Y A L E S C H O O L O F M E D I C I N E 2. 3. 1. 4. 5. MEDIAL CALCANEAL MEDIAL CALCANEAL MEDIAL PLANTAR LATERAL PLANTAR LATERAL PLANTAR DORSALIS PEDIS DORSALIS PEDIS LATERAL CALCANEAL LATERAL CALCANEAL PTa. ATa. Peroneal PTa. PTa.

30. Y A L E S C H O O L O F M E D I C I N E Posterior Tibial Angiosome Medial Calcaneal (Artery) Angiosome Medial Plantar (Artery) Angiosome Lateral Plantar (Artery) Angiosome

31. Y A L E S C H O O L O F M E D I C I N E Revascularization of a Specific Angiosome for Limb Salvage: Does the Target Artery Matter? Neville RF, Attinger CE, Bulan EJ, Thomassen M, Sidawy AN Annals of Vascular Surgery Volume 23, Issue 3, May–June 2009, 367–373 - Investigated whether bypass to artery directly feeding the ischemic angiosome had an impact on wound healing and limb salvage - Retrospective review of all wounds (n=52) requiring tibial bypass over 2 year period - Patients divided based on pre-op angiograms: - DIRECT REVASCULARIZATION  BYPASS TO THE ARTERY DIRECTLY FEEDING ISCHEMIC ANGIOSOME (n=27) - INDIRECT REVASCULARIZATION  BYPASS UNRELATED TO ISCHEMIC ANGIOSOME (n=25) - Endpoints: complete healing, amputation, death unrelated to the wound, and time to healing for healed wounds

32. Y A L E S C H O O L O F M E D I C I N E Revascularization of a Specific Angiosome for Limb Salvage: Does the Target Artery Matter? Neville RF, Attinger CE, Bulan EJ, Thomassen M, Sidawy AN Annals of Vascular Surgery Volume 23, Issue 3, May–June 2009, 367–373 19% mortality rate during follow-up 65% SVG 35% PTFE 1 bypass failed periop

33. Y A L E S C H O O L O F M E D I C I N E Revascularization of a Specific Angiosome for Limb Salvage: Does the Target Artery Matter? Neville RF, Attinger CE, Bulan EJ, Thomassen M, Sidawy AN Annals of Vascular Surgery Volume 23, Issue 3, May–June 2009, 367–373 Statistically significant difference in complete healing rate with p = 0.03 (Fisher's exact test). 9% amputation rate in Direct Revasc 38% amputation rate in Indirect Revasc

34. Y A L E S C H O O L O F M E D I C I N E Durability of the Tibial Artery Bypass in Diabetic Patients Shah DM, Chang BB, Fitgerald KM, Kaufman JL, Leather RP American Journal of Sugery Volume 156, Issue 2, August 1988, 133-135 - Single-center, large, prospective comparison of patency for femoral-to-tibial SVG bypass in diabetics (n=387) and non- diabetics (n=294) - 681 bypasses over 7-yr period, all performed for limb salvage - More patients in diabetic arm had gangrene or frank tissue loss - Cumulative patency rates followed to 5 yrs

35. Y A L E S C H O O L O F M E D I C I N E Durability of the Tibial Artery Bypass in Diabetic Patients Shah DM, Chang BB, Fitgerald KM, Kaufman JL, Leather RP American Journal of Sugery Volume 156, Issue 2, August 1988, 133-135 - 30% 5-yr mortality for diabetics - 4% operative mortality across both arms

36. Y A L E S C H O O L O F M E D I C I N E Popliteal-to-Distal Bypass for Limb Salvage Grego F, Antonello M, Stramana R, Deriu GP, Lepidi S Annals of Vascular Surgery Volume 18, Issue 3, May 2004, 321-328 Life-table analysis of primary and secondary patency (A) and limb salvage and survival rates (B) at 5 years. Limb Salvage Survival Secondary Patency Primary Patency

37. Y A L E S C H O O L O F M E D I C I N E Popliteal-to-Distal Bypass for Limb Salvage Grego F, Antonello M, Stramana R, Deriu GP, Lepidi S Annals of Vascular Surgery Volume 18, Issue 3, May 2004, 321-328 Life-table analysis of primary patency rates of SVG and PTFE bypass. Saphenus Vein PolyTetraFluoro Ethylene

38. Y A L E S C H O O L O F M E D I C I N E The Vascular Study Group of New England Cardiac Risk Index (VSG-CRI) predicts cardiac complications more accurately than the Revised Cardiac Risk Index in vascular surgery patients Bertges DJ, Goodney PP, Likolsky DS, Cronenewett JL Journal of Vascular Surgery Volume 52, Issue 3, September 2010, 674-683

39. Y A L E S C H O O L O F M E D I C I N E The Vascular Study Group of New England Cardiac Risk Index (VSG-CRI) predicts cardiac complications more accurately than the Revised Cardiac Risk Index in vascular surgery patients Bertges DJ, Goodney PP, Likolsky DS, Cronenewett JL Journal of Vascular Surgery Volume 52, Issue 3, September 2010, 674-683

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56. 1 MEDIAL CALCANEAL 2 MEDIAL PLANTAR 3 LATERAL PLANTAR 5 LATERAL CALCANEAL 4 DORSALIS PEDIS PosteriorTibial Peroneal Anterior Tibial

57. Y A L E S C H O O L O F M E D I C I N E 2. 3. 1. 4. 5. MEDIAL CALCANEAL MEDIAL CALCANEAL MEDIAL PLANTAR LATERAL PLANTAR LATERAL PLANTAR DORSALIS PEDIS DORSALIS PEDIS LATERAL CALCANEAL LATERAL CALCANEAL PTa. ATa. Peroneal PTa. PTa.

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68. Patients with CLI requiring BTK revascularization have high degree of cardiac morbidity and mortality at baseline. Lower extremity bypass surgery caries high-degree of perioperative morbidity and mortality for patients with coexistent CAD Angiosome principle must be employed to maximize wound-healing. Summary

69. Y A L E S C H O O L O F M E D I C I N E Percutaneous endovascular therapies for CLI are emerging. Investigation into long-term patency and adequacy of wound-healing after percutaneous revascularization is needed. Summary

70. Y A L E S C H O O L O F M E D I C I N E Thank You. Case Presentation