Superficial Femoral Artery Intervention: The gift that keeps on giving! Wm. Britton Eaves,MD WKHSC Bossier City, LA

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1 : The gift that keeps on giving! Wm. Britton Eaves,MD WKHSC Bossier City, LA

2 Peripheral arterial disease (PAD) of the superficial femoral artery (SFA) is the most common cause of intermittent claudication An isolated occlusion or stenosis of the SFA often results in decreased perfusion of the leg, resulting in demand related, reversible, ischemic pain localized to the calf Despite newer devices and advancements of older endovascular procedures, the principal failure continues to be recurrent restenosis Durability and long-term patency of interventional results remain the major challenges

3 Endovascular treatment of the SFA was first described by Charles Dotter in In Dotters original description, he used Teflon coated dilators to sequentially angioplasty the SFA in an 82-year-old woman to treat critical limb ischemia that was considered nonoperable Andreas Gruntzig popularized the concept of catheter directed balloon angioplasty

4 TASC II Guidelines for Endovascular Intervention Endovascular treatment of infra-inguinal disease should be limited to patients with failed exercise or pharmacotherapy with intermittent claudication or Critical Limb Ischemia Class I recommendation Endovascular procedures are indicated for individuals with a vocational or lifestylelimiting disability due to intermittent claudication and (a) there has been an inadequate response to exercise or pharmacological therapy and/or (b) there is a very favorable risk benefit ratio Class IIa recommendation stents (and other adjunctive techniques such as lasers, cutting balloons, atherectomy devices, and thermal devices) can be useful as salvage therapy for a suboptimal or failed result from balloon dilation

5 TASC Classification

6

7 GUIDELINES!!!! Not very helpful on SFA treatment

8 25% shortening 1 60 twisting 2 3 lbs compression 3 8 bending 4 These issues are under-appreciated with AP angiograms! Image courtesy of Dr. Chris Metzger. Source: Scholten, F., et al., Dept. of Radiology, University Hospital, Utrecht, The Netherlands, Femoropopliteal occlusions and the adductor canal hiatus, Duplex study, European Journal of Vascular Surgery 7:6:1993: Data on file at Abbott Vascular. 1. Range of 23-25% shortening for 90 degree bend. Jonker, Frederik H.W., et al., Dynamic Forces in the SFA and Popliteal Artery During Knee Flexion, Endovascular Today. Buyer s Guide, 2009, pp Average twisting ± 34 Cheng, C.P., et al., In vivo MR angiographic quantification of axial and twisting deformations of the superficial femoral artery resulting from maximum hip and knee flexion. J Vasc Interv Radiol, 2006;17: Maximum compression from muscular contraction; based on arterial pressure of 160 mmhg for a 6 x 100 mm vessel under 1 mm compression. Supinski GS, et al., Effect of diaphragmatic contraction on intramuscular pressure and vascular impedance, Journal of Applied Physiology, 1990, 68(4): Average bending ± 4 Nikanorov, A., et al., Assessment of Self-Expanding Nitinol Stent Deformations Implanted into the Femoropopliteal Artery. Journal of Vascular Surgery, 2009; 49(5, Supplement): S24.

9 Straight Bent Region A Region B Region C Region D Hunter s Canal Bend / Kink Compress / Slight Curve Fixed Bend / Kink Modified from Lansky, A. Angiographic Analysis of Strut Fractures in the SIROCCO Trial. TCT 2004.

10 Angioplasty Angioplasty has been the gold standard Relatively inexpensive and technically easy to perform Provides good short term patency Poor stand alone therapy in TASC C and D lesions Long term patency is a problem with as much as 60% restenosis at one year

11 Stents Initially used as bailout for failed angioplasty Multiple trials have shown improved long term patency versus angioplasty alone Stent fractures can occur and cause significant restenosis and make revascularization difficult Expensive May result in significant and extensive restenosis in some patients which may be challenging to treat

12

13 Stents Stents were originally designed to maintain an open vessel after angioplasty Standard nitinol stents (SNS) are laser cut from a single, rigid nitinol tube Nitinol stents are designed to be oversized by 10-20% Ensures vessel wall apposition Oversizing results in a radial outward force that is designed to apply a constant force on the vessel

14 Covered Stents

15 Woven Nitinol Stent Mimics the natural structure and movement of the anatomy 1 Optimizes luminal gain: maintains a round open lumen in challenging anatomy Provides unparalleled strength and flexibility 2 for a durable solution 3 > 4x compression resistance than standard nitinol stents High fracture resistance Minimal chronic outward force Clinically proven 3

16 The data from the ZILVER PTX trial of paclitaxel-eluting stents for femoropopliteal disease showed 5-year primary patency of 66.4% Drug Coated Stents

17 In-Stent restenosis

18 Drug Coated Balloons

19 Drug Coated Balloons IN.PACT Admiral (Medtronic) LUTONIX (BAIRD) STELLAREX (PHILLIPS) Paclitaxel-coated balloons theoretically greater drug delivery per square mm with DCBs vs DES lack of the ongoing presence of both drug and polymer may lead to more rapid vascular healing

20 Athrectomy Devices

21 Focal Pressure Balloons Cutting Balloon (Boston Scientific) Vascutrac (Baird) Angiosculpt (Phillips) Reduce stretching and overexpansion of the vessel wall by inducing longitudinal cuts Reduced uncontrolled dissection, less elastic recoil, fewer barotraumas and with this a reduced restenosis rate

22 Developing a Strategy Determine extent and length of the plaque Is the Ostium involved?...often an ipsilateral oblique view is required to adequately access Evaluate the runoff Is a filter indicated? Determine the access site.contralateral, Antegrade, Popliteal or Pedal Evaluate the degree of Calcification or whether Thrombus may be present

23 My Strategy Typically Contralateral approach Hydrophilic wire and crossing catheter Exchange for an wire when entering the popliteal and park distally Determine whether a filter is indicated Determine the extent of Calcification and Thrombus

24 My Strategy After crossing is the wire in the true lumen or is it subintimal If the lesion is ISR would debulk with athectomy and use focal pressure balloons and drug coated balloons For De Novo or recurrent unstented lesions, if the wire is in the true lumen would proceed with athrectomy and focal pressure/deb

25 My Strategy If the wire is subintimal unlikely to use athrectomy Focal pressure balloon, POBA and DEB Low threshold for stenting in long lesions, CTO and recurrent disease after previous intervention Prefer Woven Nitinol stent for the adductor canal and popliteal due to zero fracture and vasculomimetic properties

26 My Strategy Newer generation slotted nitinol stents work well in the mid section of SFA For ostial lesions accurate deployment is essential 40 degree RAO or LAO with masking is very helpful SFA (same side) Post procedure DAP important, newer P2Y12 may have additional benefits Risk factor modification: smoking cessation, diabetic control and lipid management

27 The Future I believe athrectomy and focal pressure balloons will continue to have an important role in debulking and plaque modification DEB in conjunction with athrectomy may prove to be the ideal solution DES technology with newer generation stents with high scaffolding ability and low fractures for lesions with increased calcium and significant elastic recoil SFA treatment has advanced significantly and will continue to do so

28 Thank You For Your Attention

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