Division of Endovascular Interventions Mount Sinai Hospital New York 07/31/2019

Patient history 71 year old female patient, presents with LLE claudication (buttock, thigh and calf). Rutherford class 3 PMH: active smoker, HTN and HLD. Medication: aspirin, atorvastatin, lisinopril.

Non-invasive Imaging CT-angiogram LE Arterial Duplex: Right: atherosclerotic plaque, no significant stenosis Left: atherosclerotic plaque with blunted wave forms suggestive of severe external  iliac disease. CT-angiogram

Iliac artery revascularization

Indication for revascularization ACC/AHA Guidelines Gerhard-Herman et al. JACC 2017;e71-126.

Appropriate use criteria Aorto-Iliac PVI Klein AJ et al. Catheter Cardiovasc Interv. 2017;90(4):E90-E110.

Appropriate use criteria Aorto-Iliac PVI Klein AJ et al. Catheter Cardiovasc Interv. 2017;90(4):E90-E110.

Technical considerations Access: Bilateral femoral artery Radial/brachial artery Angiographic views: contralateral oblique to better visualize the bifurcation (external and internal iliac artery) Sheath: minimum of 7Fr. Length 25cm Anticoagulation: preferred heparin, but bivalirudin is associated with similar outcomes*. ACT 250-275 * Sheikh, JACC int. 2009 vol 2; 871-876

Lesion crossing Non-occlusive lesion: Occlusive lesion: Hydrophilic-coated glide wire Angled support catheter Occlusive lesion: Hydrophilic coated and specialty wires (0.014 or 0.018) Microcatheter Exchange for more supportive 0.35 wire after crossing the lesion

Adjunctive crossing/re-entry devices for iliac CTO Crossing devices: Frontrunner, Viance, Ocelot Re-entry devices Outback, Offroad, Pioneer

Intravascular imaging IVUS: Calcium distribution MLA Vessel size JACC Intv 2015;8:1893–901

PTA: Important rules to follow Use initially nominally undersized balloon To avoid perforations, dissections To assess the degree of calcification Slow and sequential upsizing of balloons is recommended Avoid additional balloon expansion with onset of abdominal pain

Plaque modification: Cutting or scoring balloons are mainly used for cases of ISR Intravascular lithotripsy

Stent selection Self expanding stent (SE) Balloon expanding stents (BE) Covered stents SE BE

Pros and cons Device Advantages Disadvantages BE High radial strength (optimal for CIA, calcified lesion) Precise deployment Higher propensity of edge dissection/perforation Higher likelihood of plaque shift to the contralateral SE High flexibility Low risk of perforation Low radial strength Not suitable for precise deployment Cannot be post-dilated beyond their designated diameter Covered Excludes aneurysms Prevents neointimal growth in the stent lumen Excludes side branches Higher likelihood of edge restenosis

BE vs. SE ICE trial Inclusion criteria RF 1-4 single significant (>=70% diameter stenosis or occlusion by DUS) CIA or EIA lesion of 10-200 mm in length, not extending into the aorta or the common femoral artery. Comparison: BE (Visi-Pro, ev3 Endovascular, Inc., Plymouth, Minnesota) SE (Protege, ev3 Endovascular, Inc.) Primary endpoint: binary restenosis at 12 months (PSVR>=3.4 by DUS). Primary patency Freedom from TLR Independent predictors of restenosis JACC Intv 2017;10:1694–1704

Jaff MR. SCAI 2012. Las Vegas, NV MOBILITY: Modern Endovascular Management of Patients with Iliac Artery Disease PAD with high prevalence of calcification and multilevel disease SE: Absolute Pro vs. BE: Omnilink Elite stenting systems (Abbott Vascular, Santa Clara, CA). 9-Month Follow-up Absolute Pro (n = 151 pts, 181 lesions) Omnilink Elite (n = 153 pts, 203 lesions) Major Adverse Events 6.1% 5.4% Restenosis 8.4% 9.0% Freedom from TLR 97.1% 94.9% Functional improvements were noted in walking distance and speed as well as in stair climbing (P < 0.0001 for all endpoints vs. baseline). Jaff MR. SCAI 2012. Las Vegas, NV

Covered vs. non-covered stent COBEST trial Patients with aortoiliac occlusive disease - Inclusion criteria Men and women aged >18 years Informed consent obtained Evidence of TASC B, C, or D lesions Hemodynamically significant dissections and recurrent stenosis after angioplasty - Comparison: CS Advanta V12 balloon-expandable covered stent (Atrium Medical Corp, Hudson, NH) BE commercially available BMS - Primary endpoint: Freedom from binary restenosis (defined as >50% reduction in lumen diameter) or stent occlusion by DUS, CTA or DSA @ 18 months J Vasc Surg 2011;54:1561-70.

COBEST @ 18 months FUP J Vasc Surg 2011;54:1561-70.

COBEST @ 5-years FUP Primary patency Secondary patency Predictors of primary patency J Vasc Surg 2016;64:83-94.

Summary Endovascular iliac artery interventions are increasing including more complex lesions (TASC C and D) Careful case selection, work-up and planning is mandatory to achieve maximum success Despite the reported safety of bivalirudin, heparin is preferred AC Various stents are available for different lesion subsets with favorable long-term outcomes

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