Diagnosis and Endovascular Treatment of Critical Limb Ischemia: What You Need to Know S. Jay Mathews, MD, MS, FACC Interventional Cardiologist/Endovascular Specialist Bradenton Cardiology Center Bradenton, FL, USA
Disclosures Speaker s Bureau: Astra Zeneca Abbott Vascular Volcano Corporation Spectranetics Maquet Reflow Medical Consultant: Penumbra Spectranetics Grant/Research Support: Spectranetics Bard Medtronic Veryan Medical Terumo Cordis Reflow Medical Medical/Scientific Boards: Boston Scientific Abbott Vascular
PAD Outcomes Hirsch AT, et al. Circulation. 2006;113:e463-654.
Survival (%) PAD Outcomes 100 75 50 25 Normal subjects Asymptomatic PAD Symptomatic PAD Severe symptomatic PAD 0 2 4 6 8 10 12 Year Resnick, H. E. et al. Circulation. 2004;109:733-739.
Incidence of Death per 1000 Patient Years PAD Outcomes 80 70 60 50 n=4393 Nondiabetic IFG Diabetic 40 30 20 10 0 <0.90 0.91 to 1.40 >1.4 Ankle-Brachial Index Mortality DM and CLI OR 2.38, P < 0.001 Resnick, H. E. et al. Circulation. 2004;109:733-739 Vrsalovic M, et al. Clin Cardiol. Impact of diabetes on mortality in peripheral artery disease: a meta-analysis. 2017. 40(5):287-291.
Diagnosis: Various Modalities Resting Ankle Brachial Index/Toe Brachial Index Perfusion Testing TCPO 2 (< 30 mm Hg)- Useful for HBO Fluorescence i.e. SpyElite Handheld Doppler Exercise Ankle Brachial Index Segmental Pressures Pulse Volume Recordings Arterial Duplex CT Angiogram with Runoff MR Angiogram with Runoff Invasive Angiography (Contrast/CO2 Angiography)
Diagnosis: Toe Brachial Index The toe-brachial index (TBI) is calculated by dividing the toe pressure by the higher of the two brachial pressures. TBI values remain accurate when ABI values are not possible due to noncompressible pedal pulses. TBI values 0.7 are usually considered diagnostic for lower extremity PAD. Toe Pressure < 55 mm Hg Consistent with Ischemic Ulcers Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192. Figure 6.
Treatment SMOKING CESSATION CLI is often a smoker s disease Progression is guaranteed with ongoing abuse Hypertension Control Goal <140/90; <130/80 in CKD and Diabetics Use ACE-I if possible Beta blockers are not contraindicated Tight Lipid Control LDL < 100 mg/dl in all patients LDL < 70 mg/dl in patients with high risk of ischemic events
Treatment Glycemic Control in Diabetics Affects treatment success and patency rates A1C > 6.9% associated with increased risk of amputation Exercise Program If the patients do not move, they will lose the limb Difficult as many patients are not ambulatory with their wounds Antiplatelet Therapy ASA 75-325 mg Plavix 75 mg Cilostazol 100 mg BID Combination cilostazol/plavix increases endothelial progenitor cells (p < 0.003) and improves ulcer healing (p < 0.01) Endovascular or Open Revascularization Takahara M. The influence of glycemic control on the prognosis of Japanese patients undergoing percutaneous transluminal angioplasty for critical limb ischemia. Diabetes Care. 2010 Dec;33(12):2538-42. Sheu JJ. Levels and values of lipoprotein-associated phospholipase A2, galectin-3, RhoA/ROCK, and endothelial progenitor cells in critical limb ischemia: pharmaco-therapeutic role of cilostazol and clopidogrel combination therapy. J Transl Med. 2014;12:101.
Percentage change from baseline MWD (mean) Treatment: Adjunctive Agents 50 40 Cilostazol 100 mg 2 times/day (n=227) Pentoxifylline 400 mg 3 times/day (n=232) Placebo (n=239) * 30 20 10 0 MWD=maximal walking distance. *P<.001 vs pentoxifylline. 0 4 8 12 16 20 24 Treatment (weeks) Dawson DL et al. Am J Med. 2000;109:523-530
Treatment: Endovascular vs. Surgical Inflow Procedure Operative Mortality (%) Expected Patency Rate at Follow-up (%) Follow-up Aortobifemoral bypass 3.3 87.5 5 years Aortoiliac or Aortofemoral bypass 1-2 85-90 5 years Iliac endarterectomy 0 79-90 5 years Femorofemoral bypass 6 71 5 years Axillofemoral bypass 6 49-80 3 years Axillofemoral-femoral bypass 4.9 63-67.7 5 years Femorotibial bypass (vein) 70-80 6 years Femorotibial bypass (PTFE) 30-50 6 years Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192. Veith FJ et al. Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions. J Vasc Surg. 1986; 3(1):104-14
Treatment: Endovascular vs. Surgical Primary Patency (%, 95% CI) 0 20 40 60 80 100 Iliac PTA Iliac Stent Femoropopliteal PTA Femoropopliteal Stent Infra- Popliteal PTA Mean 1-year data 2-year data 3-year data 4-year data 5-year data Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192. Updated to Include MAJESTIC data for Eluvia DES
Angiosome Concept Direct Flow Associated with Better Outcomes- Especially in the Absence of Adequate Collaterals Improved Wound Healing (RR 0.60) Major Amputation (RR 0.56) Amputation-free Survival Rates (RR 0.83) Jongsma H. Angiosome-directed revascularization in patients with critical limb ischemia. J Vasc Surg. 2017;65(4):1208-1219.
Case Example #1 70 Year old Man Nonhealing Diabetic Ulcer of the Hallux for Over 6 Months Multiple Risk Factors Diabetic Hypertensive Smoker Rutherford 6
Initial Angiogram Antegrade Access into the AT- Unable to Cross the DP CTO Direct PT Access Spasm Addressed with Vasodilators
Initial Angiogram Identify the Occluded Plantar- Pedal Loop (Arch Reconstruction) Cross with MicroES 14 and CommandES + Fielder XT Coronary Crossing Catheters and Wires Are Useful
Initial Angiogram Reversed the Access and Now Wired from AT Can Cross with Wire of Choice (I Crossed with an 0.018 Glidewire Advantage)
Initial Angiogram Reversed the Access and Now Wired from AT Can Cross with Wire of Choice (I Crossed with an 0.018 Glidewire Advantage) Changed out to 0.014 Wire and Used a 3.0 mm Coyote Balloon
Initial Angiogram Pedal Arch Flow Restored
Initial Angiogram Pedal Arch Flow Restored Straight Line Flow to Hallux Wound Healed Within 2 Weeks
Case Example #2 75 Year old Man Nonhealing Ulcer of the Right Lateral Forefoot Prior Fem-Fem Bypass Known Occluded Right Iliac Multiple Risk Factors Diabetic Hypertensive CKD Prior Smoker Rutherford 6
Initial Angiogram Accessed the Fem-Fem Severe SFA Stenosis Seen Single Vessel Runoff Via Peroneal to Anterior Comm Branch to AT/DP
Initial Angiogram Accessed the Fem-Fem Severe SFA Stenosis Seen Single Vessel Runoff Via Peroneal to Anterior Comm Branch to AT/DP
Initial Angiogram Accessed the Fem-Fem Severe SFA Stenosis Seen Single Vessel Runoff Via Peroneal to Anterior Comm Branch to AT/DP
Treat Inflow 2.0 mm TE to the SFA 6 x 200 Angiosculpt and DCB
Retro Crossing Selective Angio of the Peroneal Show Communicating Branch Access with 135 mm Corsair and Externalize 0.014 Command ES Wire Via Retrograde up AT 1.4 mm TE Laser Antegrade
Retro Crossing Selective Angio of the Peroneal Show Communicating Branch Access with 135 mm Corsair and Externalize 0.014 Command ES Wire Via Retrograde up AT 1.4 mm TE Laser Antegrade
Retro Crossing Selective Angio of the Peroneal Show Communicating Branch Access with 135 mm Corsair and Externalize 0.014 Command ES Wire Via Retrograde up AT 1.4 mm TE Laser Antegrade
Retro Crossing Selective Angio of the Peroneal Show Communicating Branch Access with 135 mm Corsair and Externalize 0.014 Command ES Wire Via Retrograde up AT 1.4 mm TE Laser Antegrade
Final Angiogram
Diagnosis and Endovascular Treatment of Critical Limb Ischemia: What You Need to Know S. Jay Mathews, MD, MS, FACC Interventional Cardiologist/Endovascular Specialist Bradenton Cardiology Center Bradenton, FL, USA