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Atherectomy: Laser and Mechanical Devices and Incorporating These Modalities in
Practice
Patrick Muck MD FACS
Chief – Division of Vascular Surgery
Trihealth – Good Samaritan Hospital
Cincinnati, Ohio
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DISCLOSUREPatrick Muck, MD
• Consulting Fee: Penumbra, Boston Scientific• Speakers Bureau: Penumbra• Stocks: Penumbra
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The Hospital of the Good Samaritan
▪ April 15, 1866
▪ Relocation & Renaming of Hospital
▪ Ninety-Five Beds
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Present
▪ Medical Complex
▪ Over 1 million square feet
▪ Nearly 600 beds
▪ 22 major / 4 minor OR’s
▪ 5 da Vinci surgical robotic systems
▪ Dedicated da Vinci training lab
▪ Dedicated research space
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Surgical Training
▪ 1928 - Formal residency program in general surgery established
▪ 1928 - 3 yr training program
▪ 1956 - 4 yr training program
▪ 1973 - 5 year training program▪ Vascular Surgery Fellowship Established
▪ 2009 – 0 & 5 Vascular Residency established
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Good Samaritan Legacy
Drs. Comerota & Fogarty
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Atherectomy Device Types
All trademarks are registered by their respective owners. Internal Use Only. Do Not Copy or Distribute.EN-2360.A
Jetstream® SC and XCBoston Scientific/Pathway
Rotablator®
Boston Scientific
SilverHawk™, Turbohawk™ and HawkOne™
MDT/Covidien
Phoenix® Atherectomy SystemAtheromed/Volcano/Phillips
DIRECTIONAL ROTATIONAL ORBITALABLATION/PULSATILE~
Excimer Laser System Spectranetics
Stealth 360® & Diamondback 360® Peripheral Orbital Atherectomy Systems Cardiovascular Systems, Inc
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Pulsatile Forces2
Before OAS After OAS Micro-particulate
1. Based on cadaver atherosclerotic lesions, porcine coronary lesions, and graphite blocks2. test models: Zheng et al., 2016. Med Eng Phys. 2016 Jul;38(7):639-47
• 360° crown contact designed to create a smooth, concentric lumen
• Allows constant blood flow and particulate flushing during orbit
Differential Sanding
• Average particulate size1 = 2 µm
• Bi-directional sanding of superficial calcium
• Healthy elastic tissue flexes away from the crown, minimizing damage to the vessel
• Low frequency (18-40 Hz) represents crown orbit inside
vessel
• High frequency (1000-1900 Hz) represents rotation of
eccentric crown over the wire, producing pulsatile
mechanical forces
• These pulsatile forces may affect deeper plaque and
contribute to compliance change
30 µm diamond coating eccentric-mounted mass
CSI’s Unique MOA: Changing Compliance using Centrifugal Force
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Force Radial
(FC) Force Radial (FC)
Force Axial
Unique Mechanism of Actiont = time in contact
Consider the Force Vectors!
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Centrifugal Force Sends Mechanical Pulses Into Vessel Wall
While orbiting, the eccentric crown delivers a localized mechanical pulsatile force into the vessel wall (Figure 1).
These pulsatile forces may contribute to the compliance changes seen with orbital atherectomy.
Surrogate Vessel Model1
Fig. 1: Surrogate model replicates natural healthy vessel properties developed by University of Michigan.
Fig. 2: Finite element model estimates force into the vessel developed by the University of Minnesota.
Plaque
Calcium
OAS
Crown
Finite Element Modeling
High Low
1. Zheng Y., et al NAMRC 2015
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Unique Mechanism of Action
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LASER MECHANISM OF ACTION IN FEM-POP ISR
• Photoablation is the use of ultraviolet laser light to break down and remove matter
• Turbo-Power™ uses ultraviolet light to vaporize and treat complex lesion morphologies, including neointimal hyperplasia and thrombus
• 60-80% of ISR lesions are aqueous in nature→ laser is used to ablate this tissue
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FEM-POP ISR TREATMENT WITH PTA PROVEN SUB-OPTIMAL
1 Tosaka (2012) Interventional Cardiology; 59: 16-23
0% 50% 100%
2-Year Restenosis Rate1
Class I: Short,
focal lesions
(≤ 50mm)
Class II:
Diffuse lesions
(> 50mm)
Class III: Total
Occlusions
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EXCITE ISR Trial
Designed to Provide Level 1
Clinical Evidence
Design & Oversight• Prospective, randomized control, multi-center trial
▪ Turbo Tandem with Turbo Elite + PTA (ELA) vs. PTA alone (PTA)
• Independent DSMB adjudicating all study events• Angiographic and Ultrasound Core Laboratory • 2:1 randomization scheme (ELA:PTA)• Statistical endpoints designed to demonstrate superiority
Primary Safety Endpoint - Major Adverse Events (MAE) during hospitalization through 37-day follow-up to include all death, unplanned major amputation, or target lesion revascularization
Primary Efficacy Endpoint - Freedom from clinically driven TLR through 6 month follow-up (212 days)
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“REAL WORLD” PATIENTS
• Key Inclusion Criteria
– ISR lesion ≥ 4 cm
– Rutherford classification 1-4
– RVD ≥ 5.0 mm and ≤ 7.0 mm
– ≥ 1 patent tibial artery
• Key Exclusion Criteria
– Target lesion extends >3 cm
beyond stent margin
– Untreated inflow lesion
– Grade 4 or 5 stent fracture
• Follow-up
– Discharge, 30 days, 6 months
and 1 year post-procedure
• No lesion length limit• Multiple stents allowed• Common stent fractures
(Grades 1-3)• Popliteal stents included
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IMPROVED EXCIMER LASER CATHETER
• ISR Indication*
• Treats from the tip
• Larger luminal gain than Turbo-Elite™
*EXCITE ISR studied the safety and efficacy of Turbo-Tandem™ plus PTA and PTA alone. Turbo-Power™ is substantially equivalent to Turbo-Tandem™.
THE NEXT GENERATION IN ISR CARE.
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Jetstream Atherectomy
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Jetstream Atherectomy
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IMAGE-GUIDED DIRECTIONAL ATHERECTOMY – NEXT
GEN 3.0
Pantheris110 cm working length
.014” guidewire compatible
Cutter rotation = 1,000 RPM
OCT – frequency domain
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POST TREATMENT / TISSUE ANALYSIS
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DEVICE SPECIFICATIONS – NEXT GEN (V3.0)
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EPD!!!!! - IN OUR LAB - SPIDER OR NAV-6 EPD
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Where Do I Use?
2
8
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In Stent Restenosis- First Line Therapy –
Laser, OCT Guided?
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COMMON & PROFUNDA FEMORAL THERAPY –
REDO/POOR VENOUS CONDUITS
(RUTHERFORD 4 PRESENTATION)
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DELIVERING THERAPY
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FINAL RESULT - STAND ALONE OCT
GUIDED THERAPY
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TIBIALS - FOCAL
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THANK YOU