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