Claudication and Critical Limb Ischemia

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1 Claudication and Critical Limb Ischemia Endovascular Treatment of Peripheral Arterial Disease Jason Wollmuth, MD, FACC Heart Center Cardiology Peripheral Arterial Disease Affects ~20% of adults older than 55 Estimated 27 million in the US and Europe ~50% are asymptomatic Prevalence increases with age, smoking, diabetes Incidence of symptomatic PAD between 1 and 3.6 per 1000 population Incidence 2-fold 2 higher in men In patients with asymptomatic disease, 5-10% 5 will develop symptoms in 5 years Peripheral Arterial Disease Critical leg ischemia most frequent in DM One fifth of people with PAD have typical symptoms One-third with atypical leg symptoms Despite relatively slow and low rate of local complications, patients with PAD have 5 year mortality rates of 25-30% (mainly from coronary or cerebral vascular disease) Symptoms Intermittent claudication Calf pain most common Buttock/hip pain with proximal disease Ankle/foot pain with distal disease Critical limb ischemia Rest pain, ulceration, gangrene Indicates severe, often multilevel arterial disease Acute arterial occlusion Trauma, thrombosis, embolism Differential Diagnosis PAD Neurogenic pseudoclaudication Venous claudication Skeletal muscle metabolic abnormalities Arterial entrapment syndromes Thromboangiitis obliterans Fibromuscular dysplasia Extravascular compression Physical Findings Subcutaneous atrophy Hair loss Pallor Coolness Dependent rubor Brittle toenails Decreased/absent pulses bruits 1

2 Diagnostic Modalities Ankle-Brachial Index (ABI) = Highest ankle pressure/highest brachial pressure Normal 0.9 to mild obstruction moderate obstruction <0.4 severe obstruction Should also be measured after exercise If no drop in ABI after exercise likely not PAD 20 mm Hg drop considered significant BP below 90 mm Hg intermittent claudication, below 60 mm Hg c/w rest pain ABI may underestimate disease in calcified, noncompressible arteries (often ABI>1.5) Diagnostic Modalities Segmental Pressure Measurements Pulse volume recordings Pulse waveform analysis Duplex ultrasonography MR Angiography CT Angiography Invasive Angiography CT Angiography MR Angiography Lesion Classification TASC Classification A Single stenosis <3 cm B Single stenosis cm, heavily calcified lesion <3 cm, multiple lesions <3 cm C Single stenosis or occlusion >5 cm, multiple stenosis or occlusion each 3 to 5 cm D Complete FA, SFA occlusions Medical Therapy Smoking Cessation Doesn t t significantly improve walking capacity May decrease severity of claudication and risk of developing rest pain¹ Exercise Significantly improves walking time in addition to surgery versus exercise or surgery alone² More effective than antiplatelet therapy² Patients should walk to near-maximal pain daily for over 6 months Mechanism? 1. Arch Intern Med. 1999;159: JAMA. 1995;274:

3 Medical Therapy Statins 4S trial significantly less new claudication in patients treated with statins (3.6 vs 2.3%)¹ Improved walking time² Pentoxifylline no significant benefit found in meta-analysis analysis Cilostazol phosphodiesterase 3 inhibitor Significantly improved walking times³ Inhibits platelet aggregation and vasodilates 1. Am J Cardiol. 1998;88: Circulation. 2003;108: Am J Cardiol. 2002;90: Surgical Treatment Considered gold standard against which percutaneous treatments measured Primary recommendation for Type D lesions, failed endovascular therapy Long-term patency rates dependent on graft type¹ PTFE grafts patency rate ~60% at 4 years Decreased OR time, hospital stays, infections. Preserve SVG SVGs patency rate ~80% at 4 years Risks wound infection, MI, death. Peri-op mortality historically higher than for percutaneous treatment J Cardiovasc Surg. 2004;3: Surgery versus Percutaneous Therapy Historically, PTA used in patients with lifestyle limiting claudication and surgery for patients with rest pain and critical limb ischemia PTA increasingly used in CLI Technological advances leading to more aggressive percutaneous approaches with improved outcomes Percutaneous Therapy Favorable predictors of benefit from endovascular procedures include intermittent claudication,, proximal location, short lesions, stenosis rather than occlusion, good distal run-off, lack of residual stenosis after treatments Balloon Angioplasty Equivalent risk of long-term failure compared to PTFE bypass grafts and roughly twice the risk of venous bypass grafts¹ Meta-analysis analysis revealed patency rates of 59% at 1 year and 45% at 5 years² 1. Med Decision Making. 1994;14: J Vasc Interv Radiol. 1995;6: Stents Initially used to treat suboptimal PTA or related complications 1 st stents were balloon expandable with poor clinical outcomes (4 year patency rates 37-52%) Significant intimal hyperplasia and external compression No improvement over balloon angioplasty alone Improved outcomes with self-expanding expanding and nitinol stents. Nickel-titanium alloy with superelasticity and thermal shape memory ideal for SFA/popliteal SMART stent primary patency 75-84% at 1 year, 60-84% at 2 years. Fracture rate >15% Improved fracture rate with next generation stents (Lifestent, Zilver PTX, Leipzig) RESILIENT trial - multicenter trial Lifestent vs. PTA pt 1 patency 79.5 with stenting versus 37.6% with PTA. Primary patency 78% at 2 years Fracture rate 3.8% at 18 months FDA approval 2/09 for SFA Drug-eluting Stents DES (SMART stent, Cordis, sirolimus-eluting) have shown mixed results SIRROCCO 1 Trial (36 patients)¹ 6-month data restenosis 0% versus 17% 18-month data, restenosis 0% with slow-eluting stents, 33% with fast-eluting stents, and 29% with BMS 24-months, DES >40% with BMS 47% SIRROCCO 2 Trial (57 patients)² 6 month data similar to SIRROCCO 1 18 month pooled data showed (mean stent diameter) early advantage was lost 1. Circulation. 2002;106: TCT,

4 Zilver PTX Paclitaxel eluding self-expanding expanding stent Zilver PTX trial pts randomized to Zilver PTX vs. angioplasty with second randomization (Zilver( PTX vs Zilver BMS) in pts with suboptimal PTA Event-free survival (death, TLR, amputation, worsening claudication) % vs. 77.6% Vessel Patency at 2 years PTA % Zilver PTX 74.8% Provisional stenting Zilver BMS 62.7% Zilver PTX 81.2% Fracture rate 0.9% FDA approved 10/11 Duration of antiplatelet therapy? Stent-grafts Initial home-made from balloon expandable stents and vascular grafts High complication rates, 20% early occlusion, high restenosis rates (<20% at 3 years) Current endovascular grafts more promising, now made with PTFE and nitinol Only Gore VIABAHN endoprosthesis with data in peer- reviewed literature 3 year patency rates ~80% (1200 limbs, cm), higher than synthetic graft bypass¹ Kedora,, et al. 100 patents randomized to Viabahn stent vs. fem- pop bypass with synthetic graft. 1 1 patency rate (74%) and 2 patency (84%) same in both groups Ideal lesions - >1 cm of healthy vessel proximal and distal to lesion, no popliteal lesions, at least 1 open lower leg vessel, no significant calcification?thrombosis risk, collaterals 1. J Cardiovasc Surg. 2004;3: J Vasc Surg. 2007;45: Directional Atherectomy Silverhawk Plaque Excision Device (Fox Hollow Technologies) FDA approved in June 2003 for peripheral vasculature Single center reports Univ. Arizona patency %, 2 73% at 10 months Columbia patency %, 2 83% at 18 months Cleveland Clinic patency 1 43%, 2 57% at 1 year South Florida patency 1 62%, 2 76% at 1 year Iowa - patency 1 10% at 1 year TALON Registry 19 centers, 601 patients, 1258 lesions Target lesion revascularization free 90% at 6 months, 80% at 1 year Limb salvage rates universally > 70% No randomized-controlled trials currently Silverhawk atherectomy Crosser CTO catheter High frequency mechanical cycles/sec for crossing CTO s PATRIOT trial 84% success crossing wire resistant CTO s,, no perforations Novel Therapies Re-entry catheters Distal protection devices 4

5 Antiplatelet Therapy after PTA ASA, dipyridamole,, and ticlopidine have all been shown superior to placebo No comparative studies Patients with PAD in CAPRIE had a 24 % relative risk reduction in CVA, MI or vascular death Most interventionalist treating with ASA indefinitely and plavix for one month Case #1 62 yo male with RLE exertional claudication and stable angina Risk factors FH CAD, HTN, tobacco abuse ABI at rest 0.54 on RLE, left leg normal Referred for LE angiogram, coronary angiogram Abdominal aorta Left common iliac artery Left external iliac artery Left common femoral artery 5

6 Case #2 69 yo with nonhealing wound on left big toe Exertional calf claudication CAD, ischemic cardiomyopathy, NYHA class 3 CHF, DM with peripheral neuropathy, Class 4 CKD Popliteal artery Genicular collateral Occluded anterior tibial Tibioperoneal tunck Distal peroneal reconstitution 6

7 Distal peroneal artery Distal posterior tibial reconstitution Case #3 79 year old female with limiting left lower extremity claudication and nighttime rest symptoms Previous right iliac artery stenting CAD, ongoing tobacco abuse Long right SFA occlusion known from previous cath Common femoral artery Superficial femoral artery Profunda femoral artery Distal SFA reconstitution 7

8 Case #4 80 year old with bilateral non-healing foot ulcers DM with severe neuropathy Evaluated by orthopedist who recommended amputation Palpable femoral and popliteal pulses bilaterally without pulses in feet Peroneal artery Dorsalis pedis artery Anterior tibial artery Plantar artery 8

9 Peroneal artery Anterior tibial artery Plantar artery Dorsalis pedis artery Case 5 72 yo with DM, HTN, hyperlipidemia,, CRI, ongoing tobacco abuse Underwent aortobifemoral bypass for AAA and bilateral iliac stenosis in 1/2009 Developed severe limiting claudication several months later LE ultrasound revealed markedly elevated peak velocities at anastamotic sites (>6 m/s on right, >3 m/s on left, rest ABI 0.61 on right, 0.89 on left) 9

10 Intervention - Left Intervention - Right Case # 6 82 year old Madras cowboy with left calf claudication CAD with multiple PCI s,, chronic stable angina, HTN, hyperlipidemia,, ongoing tobacco use Absent left pedal pulses, 2+ onright ABI 0.67 on left MRA showed focal distal left SFA stenosis SFA 10

11 PRE POST-ATHERECTOMY Case #6 86 year old with left calf claudication Risk factors DM, previous smoking history, hyperlipidemia,, known CAD Abnormal ABI s MRA showing diffuse distal SFA and popliteal disease 11