Atherectomy as Primary Therapy for Lower Extremity Artery Disease: What will Be its Role in the Drug-Eluting Era John R. Laird Professor of Medicine Medical Director of the Vascular Center UC Davis Medical Center
Disclosure Statement of Financial Interest 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 Fees/Honoraria Research Support Boston Scientific, Medtronic, Bard Peripheral Vascular, AngioScore, Abbott, ev3, Lutonix Atrium Medical Advisory Board/equity interest (Modest) AngioScore, Endoluminal Sciences Angioslide, NexGen, NovoStent, Major Stock Shareholder/Equity (Significant) AccessClosure Board Member VIVA Physicians
3 Device Evolution Predator 360º 1.25 mm crown Diamondback 360º 1.25 mm crown
Laser Angioplasty The Early Laser Years 4
Excimer Laser Technology evolution: Catheter Designs Extreme, Vitesse Optimally Spaced Point 9 Turbo Turbo Elite Turbo Booster Turbo Tandem 2.3 mm and 2.5 mm peripheral catheters FDA approved 2004
Turbo Tandem Turbo Booster
Why Excimer Laser? Easy to use Less distal embolization May facilitate crossing of difficult occlusions Simplifies complex anatomy Thrombus containing lesions Long occlusions Diffuse disease
Following 2.5 mm Laser Catheter
Turbo Booster/Turbo Tandem Pretreatment Angio 100% Lt SFA 11
IVUS Post 2 mm Pilot channel Angio Post 2 mm Pilot channel 60 Fl/40 Hz 12
IVUS Post TURBO-Booster Angio Post 8 Fr TURBO-Booster with 2 mm catheter at 60 Fl/40 Hz 4 passes/11,114 pulses 13
IVUS Post PTA Angio Post PTA using 5 mm x 8 cm and 6 mm x 2 cm balloons @ 2 atm 14
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Potential Roles for Laser Diffuse disease and long occlusions Instent restenosis (EXCITE Trial) Thrombus containing lesions Critical limb ischemia occluded or diffusely diseased tibial arteries 16
TurboHawk
TurboHawk BTK Device Iterations Supporting Design Feature High Efficiency Super Cutter Incorporates four contoured blades to engage a wide range of plaque morphologies Improved Drive Shaft Transfers more energy from motor to cutter for more efficient cutting Dual Catheter Jog Ensures consistent cutter contact enabling effective tissue engagement across 2.0-4.0 mm vessels 18
Procedural Efficiency and Ease of Use Supporting Design Feature Low Profile, Tapered Tip Provides ease of deliverability and minimized need for adjunctive therapy 145cm Catheter Effective Length (SS-CL) To treat distal tibial lesions in 99% of patients* Full Housing Throughout Nose Cone Length Provides increased tip pushability Micro Efficient Compression (MEC ) Technology Provides increased tissue storage which can lead to fewer insertions, potentially reducing overall procedure time 19
No Stent Zones
Tips and Tricks Above the knee: LS-C, LS-M, LX-C, LX-M catheters Below the knee: SX-L or EX-L Passes no longer than the distance of the nosecone Each click on Torquer represents 10 To eliminate wire wrap limit torquing of device to 180 degrees in either direction
Tips and Tricks Shallower cuts for instent restenosis or calcified plaque L series =.012 M & Calcium:.009 E & S Series:.008 Always use distal embolic device with TurboHawk catheter, calcified lesions, complex lesions
Right SFA Instent Restenosis
Silverhawk Excisional Atherectomy
Tissue Removal
Angioslide Protection Balloon
After Silverhawk excisional atherectomy and Angioslide angioplasty
Potential Roles for Plaque Excision Non-stent zones (CFA, popliteal) Heavily calcified lesions Instent restenosis Ostial lesions, eccentric lesions Prior to drug eluting balloon???
Predator 360 Atherectomy System New crown material (Tungsten) New crown shape Shorter 2.25 mm Solid Crown 1.25 mm Crown for CTO s Predator 360º 1.25 mm crown Diamondback 360º 1.25 mm crown
STEALTH 360º PAD SYSTEM CLASSIC CROWN SOLID CROWN Electric Handle Small Crossing Profile Optimum Torque Portable
Dealing with Calcification
ealing with Calcification 2.25 mm Crown
Predator 360 2.25 mm Crown Caption 35
Jetstream G3: Pathway Medical (Acquired by Medrad/POSSIS) Active Aspiration Only atherectomy systems with this safety feature Minimizes risk of distal embolization Continuous removal of debris Designed to reduce procedure time Aspiration Port
JetStream G3 SF JETSTREAM Catheter Control Pod Console 1.6 mm 1.85 mm 1.6 mm OTW 145cm Front Cutting, High Speed Rotational Catheter.014GW / 7F sheath compatible Fixed Cutter for Tortuousity Differential cutting tip removes all plaque types Aspiration port collects plaque & thrombus 1.85 mm Integrated system control within the sterile field Rotational Speed 73K rpm (target therapy speed) Easy set up and data display outside sterile field
JetStream G3 SF Potential Advantages: Active Aspiration Reduced risk of distal embolization? Avoid use of embolic protection device? Effective for multiple plaque morphologies Multiple vessel sizes JETSTREAM G3 SF Distal Cutters JETSTREAM Navitus Distal Cutter 1.6 mm 1.85 mm 1.6mm 1.85mm 5 Flute Design 2.1 mm
Atherectomy in the DEB era Optimizing the angiographic result Less flow limiting dissection Avoid crossover to stenting (10 40% of cases with balloon angioplasty alone) Treating the non-dilatable lesion Prepping the vessel for drug delivery Removal of calcium, thrombus and bulky plaque Improved drug penetration and retention
Atherectomy in the DEB Era Definitive AR Study Assess the effect of plaque excision in combination with Paclitaxel coated balloon angioplasty (Paccocath) as compared to treatment with Paclitaxel PTA alone 100 patient, prospective, multicenter, randomized pilot study 1-year follow up: target lesion percent stenosis Principal investigators: Gunnar Tepe, MD and Thomas Zeller, MD
Summary Continued evolution of devices and improvements in technique Allows for treatment of complex lesion morphology and avoidance of stents Device specific capabilities with regards to lesion types: Calcified lesions: TurboHawk-C, Diamondback Predator Thrombus containing lesions: Excimer laser, Pathway Complementary with DEB?