New Modalities and Advanced Techniques: The Role of Crossing Devices and Atherectomy
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1 New Modalities and Advanced Techniques: The Role of Crossing Devices and Atherectomy Satish Gadi, MD FACC FSCAI Interventional Cardiologist, Cardiovascular Institute of the South (CIS) Baton Rouge Clinical Assistant Professor, Tulane University School of Medicine
2 None Disclosures
3
4 TASC II Classification of Femoro-Popliteal Occlusions Type A Lesions - single occlusions < 5 cm Type B Lesions single occlusions < 15 cm not involving infra-geniculate Popliteal a. Type C Lesions multiple stenoses or occlusions > 15 cm +/- calcification Type D Lesions CTO of SFA > 20 cm involving the Popliteal artery - CTO of Popliteal artery and proximal trifurcation
5 CDC PAD Fact Sheet. July 2013.
6
7 Goodney, JVS 2009; 50:54-60
8 Challenges of CTOs Flush ostial SFA occlusion Severe calcification Long (> 15 cm) occlusions Instent restenosis Popliteal artery occlusions with collaterals
9 What s in a CTO?
10 Proximal cap Body Distal cap
11
12 The simple wire and support catheter
13 TrailBlazer Support Catheter
14
15
16
17 Crossing Devices Wild Cat Avinger Crosser Bard Powerwire Bayliss Truepath BSC Frontrunner Cordis Viance Cordis Ocelot - Avinger
18 High-frequency mechanical vibrations Microbubble cavitation microbubbles erode into the CTO
19
20 Crosser PATRIOT TRIAL Laird, Joye. JIC. Oct, pts with guidewire failure were enrolled Avg. CTO length was 11.7 cm 63.5 % SFA, 20% Popliteal, 16% crural 75% moderate calcification Avg. Crosser activation time = 2 min. 83% procedural success with intraluminal recanalization No perforations 94% limb salvage
21 Crosser - Case 85 y/o/m Severe claudication left limb Ulcer on toe Options: Bypass surgery Vs Endovascular tx.
22
23
24 Ocelot Avinger Inc. Real-time intravascular cross-sectional imaging Optical Coherence Tomography
25
26 100 pts Ocelot CONNECT II TRIAL (VIVA 2012) Mean lesion length 16.6 cm SFA and Popliteal CTOs 97% Crossing Success 98% Freedom from MAEs
27 OCELOT - Case 59 year-old female with lifestyle-limiting claudication Fontiane class 2b Flush Right SFA occlusion, h/o prior SFA stent
28
29
30 Re-Entry Devices BSC Offroad Cordis Outback Covidien Enteer Medtronic - Pioneer
31 PIONEER - Medtronic 6F Premounted needle IVUS-guided (Volcano)
32 Atherectomy Atherectomy is a minimally invasive surgical method of removing, mainly, atherosclerosis from a large blood vessel.
33 Why Atherectomy? Not a final therapy leaves future options open Suitable for complex/calcified lesions Collaterals and side branches are preserved Can be combined with other therapies (ex. Drug-elution, intravascular imaging, etc.)
34 Types of Atherectomy Rotational Orbital Laser Directional
35 CSI Orbital Atherectomy System The burr is located on a coil consisting of 3 helically-wound wires Orbital path of the device around the periphery of the lumen Orbital motion allows for more blood flow and cooling minimizes thermal trauma and ischemia.
36
37 Diamondback - OASIS *Safian RD, Niazi K, Runyon JP, et al. Orbital Atherectomy for Infrapopliteal Disease: Device Concept and Outcome Data for the Oasis Trial. CCI. 2009; 73:
38 Diamondback - Case 59 year-old female Lifestyle-limiting claudication Fontaine class IIb
39
40
41 Photoablation use of light to vaporize, breakdown, and remove matter. Laser Atherectomy
42 Science of Laser Photoablation Atherectomy is performed by direct contact with and absorption of the laser energy by the plaque. Photochemical effects billions of molecular bonds are fractured per UV light pulse Photothermal effects vibration of bonds produces thermal energy with expanding vapor bubble Photomechanical effects expansion and collapse of the vapor bubble breaks down tissue
43
44 Laser - Evidence Laser Angioplasty for Critical Limb Ischemia (LACI) trial - Laird JR, Zeller T, Gray BH, et al. Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI multicenter trial. J Endovasc Ther. 2006;13(1): pts treated with Excimer Laser; total of 423 lesions were treated SFA, Popliteal, and Infrapopliteal. Mean lesion length > 16 cm. Poor surgical candidates. Limb salvage rate of 93% at 6 months.
45 Laser Case 65 year-old male Lifestyle-limiting claudication Rt. Popliteal CTO Prior distal SFA Infrapopliteal bypass
46
47 Directional Atherectomy Silverhawk / Turbohawk Covidien/ev3 Plaque excision Ability to treat a broad spectrum of lesions incl. calcified plaque TurboHawk Micro Efficient Compression (MEC) And Super Cutter 4-angled cutter blades
48
49 Right Pre-Intervention Right Post-Intervention Left Pre-Intervention Left Post-Intervention
50 DEFINITIVE LE Study J Am Coll Cardiol Intv. 2014;7(8): Prospective, nonrandomized, global study 800 subjects at 47 centers (CLI = 201) Lesion length up to 20 cm Periprocedural Outcomes:
51 Key Study Endpoints
52 Periprocedural Complications
53 Avinger, Inc.
54 Avinger, Inc.
55 Avinger, Inc.
56 Pantheris (Lumivascular Directional Atherectomy) Avinger, Inc.
57
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