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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
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
 Directional
SilverHawk 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°). Diamondback
For calcified lesions SFA, pop and infrapopliteal
 Rotational. Jetstream
For instent stenosis/thrombosis. Calcified lesions
 Excimer laser
Instent stenosis, noncalcified infrapopliteal

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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
  • 7.
  • 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
  • 12. CSI Diamondback Orbital atherectomy system
  • 13.
  • 14.
  • 16. Initial Post atherectomy Post PTA Post PTA
  • 17.
  • 18. Initial post 2 months post
  • 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
  • 22.
  • 23.
  • 25. Atherectomy devices  Types of atherectomy device  Directional  Orbital (or 360)  Rotational  Excimer laser ( Spectranetics)
  • 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
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  • 31. Initial Post laser Post PTA
  • 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
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  • 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