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DR. SAHER SABRI
1. Mechanical Devices: Where, When
and Which?
Saher Sabri, MD
Associate Professor of Radiology and Surgery
Vice Chair of Education
Radiology Residency Program Director
Division of Interventional Radiology
University of Virginia Health System
2. 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.
3. Atherectomy devices
Types of atherectomy device
Directional
Orbital (or 360)
Rotational
Excimer laser
4. Atherectomy devices
Types of atherectomy device
Directional
SilverHawk and TurboHawk (Covidien).
Orbital (or 360)
Rotational
Excimer laser
6. 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
9. 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
10. Atherectomy devices
Types of atherectomy device
Directional
Orbital (or 360)
CSI Diamondback Orbital atherectomy
system (Cardiovascular Systems)
Rotational
Excimer laser
11. 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
19. 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)
20. Atherectomy devices
Types of atherectomy device
Directional
Orbital (or 360)
Rotational
Jetstream; Pathway Medical Technologies
Excimer laser
21. 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
26. 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
27. 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
32. 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
36. 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
37. Atherectomy devices
Directional. Silverhawk
SFA origin, pop a, instent stenosis. New device for
calcified lesions
Orbital (or 360°). Diamondback
For calcified lesions SFA, pop and infrapopliteal
Rotational. Jetstream
For instent stenosis/thrombosis. Calcified lesions
Excimer laser
Instent stenosis, noncalcified infrapopliteal