Mechanical Devices: Where, When and Which?Saher Sabri, MDAssociate Professor of Radiology and SurgeryVice Chair of EducationRadiology Residency Program DirectorDivision of Interventional RadiologyUniversity of Virginia Health System

Why use atherectomy devices? Plaque modification and decrease plaque burden To facilitate low-pressure balloon inflation as a

stand-alone therapy ( changing vessel compliance) To prepare the vessel prior to stent placement. The theoretical advantage of protecting side

branches by minimizing plaque shift. Have to be intraluminal

A disadvantage of atherectomy is the risk of debris embolization to the distal vasculature, and thus the use of embolic protection device is recommended.

Atherectomy devices Types of atherectomy device

Directional Orbital (or 360) Rotational Excimer laser

Atherectomy devices Types of atherectomy device

DirectionalSilverHawk and TurboHawk

(Covidien). Orbital (or 360) Rotational Excimer laser

Directional Atherectomy

Directional Atherectomy SilverHawk has one inner blade. Small

and large vessel application TurboHawk has four inner blades. More

plaque removal per pass . Appropriate for larger vessels ( 4-7 mm)

TurboHawk with calcium cutter and long packing tip to treat calcified lesions.

Recommended use at the origin of SFA and pop a. In stent stenosis

Debris Removed

The DEFINITIVE-LE .799 claudicants and critical limb ischemia patients treated with a SilverHawk atherectomy device.

Primary patency rate of 78% in the claudicant cohort and 71% in the critical limb ischemia group at 1 year of follow-up

3.8% distal embolization rate and a 5.3% rate of vessel perforation.

3% of the patients received provisional stenting

Atherectomy devices Types of atherectomy device

Directional Orbital (or 360)CSI Diamondback Orbital atherectomy

system (Cardiovascular Systems) Rotational Excimer laser

Orbital atherectomy This system employs a 360° rotational

device with a diamond-coated crown that orbits eccentrically within the vessel contour.

Circumferential plaque removal Change the vessel compliance Low-pressure balloon angioplasty Lowering rates of stent use due to

fewer dissections

CSI Diamondback Orbital atherectomy system

Initial Post atherectomy Post PTA

Initial Post atherectomy Post PTA

Post PTA

Initial post 2 months post

CSI Diamondback The CALCIUM 360° (Orbital Atherectomy Plus PTA vs

PTA) 50 patients with Rutherford class 4-6 and heavily

calcified popliteal or infrapopliteal arteries. The primary patency rate in the orbital atherectomy

with PTA arm was 93% compared to 82% in the PTA-only group.

stenting was needed in 7% in the combined arm and in 14% in the PTA-only group.

lower balloon inflation pressures (3.9 atm for the combination therapy vs 9.1 atm in the PTA-only group) ( Compliance 360 trial)

Atherectomy devices Types of atherectomy device

Directional Orbital (or 360) Rotational Jetstream; Pathway Medical

Technologies Excimer laser

Rotational Atherectomy Rotational atherectomy devices typically employ a high-

speed rotating cutting blade (or “burr”) coated with abrasive material such as microscopic diamond particles.

Continuous aspiration Mostly used for soft plaque and instent stenosis or

thrombosis and calcified lesions

Courtesy of : Warren Swee, MD

Atherectomy devices Types of atherectomy device

Directional Orbital (or 360) Rotational Excimer laser ( Spectranetics)

Excimer laser atherectomy Removal of plaque by photoablation without

damaging the surrounding tissue. Converts plaque and clot to water vapor and

CO2 Best used in soft-plaque, instent restenosis

limitations are a relatively low gain in the luminal area that

is achieved using only the catheter limited efficacy in the treatment of heavily

calcified vessels

Excimer laser atherectomy SIZE: Laser catheter

diameter should not exceed 2/3 of the reference vessel diameter

SALINE: Essential to remove contrast from the photoablation location

SLOW: Advance SLOWLY at a rate of 1mm/sec for cleaner and larger lumens

The Turbo-Booster/Turbo-Elite laser catheter is a modified device to increase luminal gain

Initial Post laser Post PTA

Excimer laser atherectomy

The PATENT study . 90 patients with in-stent restenosis who were treated using laser atherectomy with PTA or using PTA alone. The primary patency rate was 64% in the

laser atherectomy with PTA group versus 34% in the PTA-only group at 1 year of follow-up.

LACI study. 145 patients with CLI limb salvage rate of 92% at 6 months. 96% of patients required PTA in 96% and 45%

required stent

Turbo Booster

Future studies Randomized phase-II trial that involve treatment

with directional atherectomy before use of DCB. The DEFINITIVE-AR (Directional Atherectomy

Followed by a PaclItaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: A Pilot Study of Anti-Restenosis Treatment)

Liberty 360°. A prospective multicenter study to compare all FDA-approved devices to treat PAD. 1200 patients with Rutherford categories 2-6. follow-up period will be 5 years

Atherectomy devices Directional. Silverhawk

SFA origin, pop a, instent stenosis. New device for calcified lesions

Orbital (or 360°). DiamondbackFor calcified lesions SFA, pop and infrapopliteal

Rotational. Jetstream For instent stenosis/thrombosis. Calcified lesions Excimer laser

Instent stenosis, noncalcified infrapopliteal