Role of Atherectomy Devices in Peripheral Vascular Procedures

Role of Atherectomy Devices in Peripheral Vascular Procedures D. Chris Metzger MD, FACC, FSCAI Wellmont CVA Heart Institute Kingsport, TN, USA

D. Christopher Metzger, MD Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company • Consulting: • Hands- On PV and CAS Courses: • National Co-PI: • CEC Committee • Abbott, Cordis, IDEV, Medtronic • Abbott, Pathway, Medtronic • SAPPHIRE WW CAS (Cordis) • Covidien(DEFINITIVE)

Potential Arguments Against Atherectomy Device Use • • • Increased Cost Increased Procedural Time (? ) Increased contrast Larger Sheaths Distal Embolization No clear cut evidence of benefit compared to more conventional therapy (RCT’s)

Existing “p Values” & Basic Principals ♥ The primary patency for lesions treated with POBA @ 1 yr is ~ 33%; P = Pretty bad! ♥ Primary patency for long SFA lesions with contemporary stenting @ 1 year is 55%-58% (VIBRANT interim data) ♥ Stent fracture rates for long lesions is potentially high (up to 40%!); P= Pretty scary ♥ FDA-approved SFA stents: Intracoil, Viabahn, Lifestream ♥ Bare metal stents and POBA have high restenosis rates for infrapopliteal interventions; DES are “off label”

Atherectomy: Some “p Values”/ Facts – All 4 major atherectomy devices DO have multi-center , adjudicated trial data – All 4 atherectomy devices ARE FDAapproved and “on label” for PV intervention – Atherectomy data @ 6 -12 months compares well w/ POBA & stenting published results – Many PV devices are widely accepted without randomized data (e. g. embolic protection devices in CAS)

Potential Advantages of Atherectomy – – – – Avoid long stent lengths (and fractures) Potentially less dissection, esp. in “no stent zones” Preserves options for future interventions Plaque modification: → stent delivery/apposition “Deals with” calcium, thrombus, etc. Assists in challenging infrapopliteal anatomy Allows treatment of challenging cases which otherwise may be undoable – Can be coupled with embolic protection (& DCBs? )

So When and Where Do I Use Atherectomy Devices? Selectively, when: The advantages of the device offer improvements in outcome compared with stenting ♥ Nondilatable lesions ♥ “No stent zones” ♥ Heavy calcium ♥ Thrombotic lesions ♥ Long bulky disease ♥ Otherwise “undoable” lesions ♥ Infrapopliteal long lesions

The Increasingly Complex Disease We Treat….

… Sometimes Calls for More Tools

Proper Technique is Essential! • Devices will perform poorly if used incorrectly OR in the wrong patients or lesions • In general, SLOW advancement of devices • Devices work better in the true lumen (CTO’s) • Sizing of device and “speeds” (rotational, “blades up”, rates, fluence, etc. ) • Need experience from others during learning curve • CASE SELECTION !!

Embolic Protection Use • I have ~low threshold for EPD use: use if lesion has embolic risk OR if BTK disease • Spider recent FDA approval, rest “off label” • I prefer independent wire EPD (NAV 6) with XC length wire- ↓basket movement • CSI- can use 0. 017 tip Viper wire w NAV 6

CSI Orbital Atherectomy • Most useful for heavy, relatively focal calcified femoro-popliteal or BTK Ca++ dz • Does have risk of distal embolization, especially when used w long disease • If use EPD (“off label”), use Viper wire (0. 017 tip) in combination with NAV 6

Calcified L SFA disease

Calcified “Non-dilatable” Bifurcation

1. 75, 2. 25 crowns SFA

1. 75, 2. 25 crowns PFA

Pathway Jetstream Atherectomy • Probably most versatile, works well with thrombus AND up to heavy calcium • Incorporates active aspiration w/ atherectomy • Newer devices available for BTK vessels, although caution needed

Pathway-Acute L leg after 2 yr claudication

Pathway -severe CFA & SFA ISR

Laser Advantages/ Disadvantages • Works very well for thrombus (new and old) and up to moderate calcium-versatile • Can do long runs, multiple sizes available, devices small enough to go into foot • ~Good for ISR with Turbo tandem (“off label”); relatively low embolization rates • Excellent for crossing recalcitrant CTO’s • Disadvantages: Not good for heavy Ca++, requires console

Laser Turbo Tandem ISR/CTO

Laser Step by Step for CTO’s

Silver. Hawk Advantages/ Disadvantages • Effective plaque excision, may offer most effective debulking • Potential “stand-alone” results CFA & pop • Well- studied, studies ongoing • No console • Works for ISR carefully (off-label!) • Disadvantages: Not effective for thrombus, previously not for heavy Ca++, frequent device removals, embolization; highly recommend EPD

More Silver Hawk

CONCLUSIONS • Selective use of atherectomy devices may offer advantages when the benefit of the device use justifies the cost of the device • Experience with proper use of adjunctive PVI devices may increase the number of patients we can treat effectively with endovascular therapy • Device selection is individualized • Future trials in combination with DCB’s may lead to an expanded role

Thank You for Your Attention!