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
DISCLOSUREPatrick Muck, MD
• Consulting Fee: Penumbra, Boston Scientific• Speakers Bureau: Penumbra• Stocks: Penumbra
The Hospital of the Good Samaritan
▪ April 15, 1866
▪ Relocation & Renaming of Hospital
▪ Ninety-Five Beds
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
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
Good Samaritan Legacy
Drs. Comerota & Fogarty
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
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
Force Radial
(FC) Force Radial (FC)
Force Axial
Unique Mechanism of Actiont = time in contact
Consider the Force Vectors!
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
Unique Mechanism of Action
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
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
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)
“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
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.
Jetstream Atherectomy
Jetstream Atherectomy
IMAGE-GUIDED DIRECTIONAL ATHERECTOMY – NEXT
GEN 3.0
Pantheris110 cm working length
.014” guidewire compatible
Cutter rotation = 1,000 RPM
OCT – frequency domain
POST TREATMENT / TISSUE ANALYSIS
DEVICE SPECIFICATIONS – NEXT GEN (V3.0)
EPD!!!!! - IN OUR LAB - SPIDER OR NAV-6 EPD
Where Do I Use?
2
8
In Stent Restenosis- First Line Therapy –
Laser, OCT Guided?
COMMON & PROFUNDA FEMORAL THERAPY –
REDO/POOR VENOUS CONDUITS
(RUTHERFORD 4 PRESENTATION)
DELIVERING THERAPY
FINAL RESULT - STAND ALONE OCT
GUIDED THERAPY
TIBIALS - FOCAL
THANK YOU