SALSAL 2009
Peripheral Excimer Laser
Atherectomy:
Pros & Cons
October 9, 2009
Nelson Lim Bernardo, MD
Washington Hospital Center

Creager M, ed. Management of Peripheral Arterial Disease. 2000.
Creager M, ed. Management of Peripheral Arterial Disease. 2000.
PAD Prevalence: Increases with Age
Rotterdam Study (ABI <0.9) 1 San Diego Study (PAD by noninvasive tests) 2
60
50
Patients with PAD (%)
40
30
20
10
0
55-59 60-64 65-69 70-74 75-79 80-84 85-89
Age Group (years)
1 Criqui et al. Circulation. 1985;71:510-515.
2 Meijer et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192.

Creager M, ed. Management of Peripheral Arterial Disease. 2000.
Creager M, ed. Management of Peripheral Arterial Disease. 2000.
PAD Prevalence: Increases with Age (Both Sexes)
60
50
Patients with PAD (%)
40
30
20
10
0
55-59 60-64 65-69 70-74 75-79 80-84 85-89
Age Group (years)
1 Criqui et al. Circulation. 1985;71:510-515.
2 Meijer et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192.

PAD: Percutaneous Treatment Modalities
•
• Balloon angioplasty – POBA
Balloon angioplasty – POBA

 Mechanical dilatation
Mechanical dilatation

 Atherotomy -- “cutting ”, “scoring” balloon
Atherotomy - “cutting “scoring” balloon
“cutting”, ” balloon
•
• Stenting
Stenting

 Mechanical -- scaffolding
Mechanical scaffolding
scaffolding

 Drug-eluting stents
Drug-eluting stents
Drug-eluting
• Debulking
 Angiojet rheolytic thrombectomy
 Excimer laser atherectomy
 Orbital atherectomy
 Pathway atherectomy/thrombectomy
 Silverhawk plaque excision system
•
• Adjunctive therapy – Anti -restenosis’
Adjunctive therapy – ‘‘Anti-restenosis’

 Cryoplasty
Cryoplasty

 Pharmacologic -- Drug- coated balloons
Pharmacologic Drug-coated balloons

 Brachytherapy
Brachytherapy
•
• Niche Devices – crossing CTOs
Niche Devices – crossing CTOs

 Excimer laser -- ‘step- by -step’ technique
Excimer laser step-by- step’ technique
‘step-by-step’ technique

 Frontrunner XP CTO catheter -- ‘blunt’ dissection
Frontrunner XP CTO catheter ‘blunt’ dissection
dissection

 Crosser High-frequency ultrasound - hammer -through’
Crosser High- frequency ultrasound -- ‘‘hammer-through’
-

 Safe-cross (with OCR) guide- through’
Safe-cross (with OCR) -- ‘‘‘guide-through’
Safe-cross guide-through’

 Tornus catheter -- ‘screw-through’
Tornus catheter - ‘screw- through’
screw-through’

 CiTop guidewire system inch- through’
guidewire system inch- through’
CiTop guidewire system -- ‘‘inch-through’

PAD: Percutaneous Treatment Modalities
•
• Balloon angioplasty – POBA
Balloon angioplasty – POBA

 Mechanical dilatation
Mechanical dilatation

 Atherotomy -- “cutting ”, “scoring” balloon
Atherotomy - “cutting “scoring” balloon
“cutting”, ” balloon
•
• Stenting
Stenting

 Mechanical -- scaffolding
Mechanical scaffolding
scaffolding

 Drug-eluting stents
Drug-eluting stents
Drug-eluting
• Debulking
 Angiojet rheolytic thrombectomy
 Excimer laser atherectomy
 Orbital atherectomy
 Pathway atherectomy/thrombectomy
 Silverhawk plaque excision system
•
• Adjunctive therapy – Anti -restenosis’
Adjunctive therapy – ‘‘Anti-restenosis’

 Cryoplasty
Cryoplasty

 Pharmacologic -- Drug- coated balloons
Pharmacologic Drug-coated balloons

 Brachytherapy
Brachytherapy
•
• Niche Devices – crossing CTOs
Niche Devices – crossing CTOs

 Excimer laser -- ‘step- by -step’ technique
Excimer laser step-by- step’ technique
‘step-by-step’ technique

 Frontrunner XP CTO catheter -- ‘blunt’ dissection
Frontrunner XP CTO catheter ‘blunt’ dissection
dissection

 Crosser High-frequency ultrasound - hammer -through’
Crosser High- frequency ultrasound -- ‘‘hammer-through’
-

 Safe-cross (with OCR) guide- through’
Safe-cross (with OCR) -- ‘‘‘guide-through’
Safe-cross guide-through’

 Tornus catheter -- ‘screw-through’
Tornus catheter - ‘screw- through’
screw-through’

 CiTop guidewire system inch- through’
guidewire system inch- through’
CiTop guidewire system -- ‘‘inch-through’

LASER
Light
Amplification
Stimulated
Emission
Radiation
• Excimer Laser
 Is a form of ultraviolet laser.
 A cold laser which does not burn or cut. Vaporize
tissue by breaking bonds between molecules.

Excimer Laser: Light Spectrum
Laser light emitted from
the Turbo Elite is “cool”
(308nm)
=> Similar to laser light
employed for LASIK
(193.3nm)
• Photoablation
 use of ultraviolet laser light to dissolve and remove
matter

Excimer Laser: Athermic Photoablation
• Pulsed XeCl-Laser (Spectranetics CVX-300)
 Wavelength 308 nm
 Pulse duration 125-200 nS
 Fluence 30-50* mJ/mm2
 RepetitionRate 25-80* Hz
 Catheter-diameter 0.9 - 2.5 mm
• Ultraviolet energy photoablates arterial blockages
into particles most of which are smaller than a red
blood cell and are absorbed into the blood stream

Excimer Laser: Athermic Photoablation
• Pulsed XeCl-Laser (Spectranetics CVX-300)
 Wavelength 308 nm
 Pulse duration 125-200 nS
 Fluence 30-50* mJ/mm2
 RepetitionRate 25-80* Hz
 Catheter-diameter 0.9 - 2.5 mm
• Ultraviolet energy photoablates arterial blockages
into particles most of which are smaller than a red
blood cell and are absorbed into the blood stream

PELA (Peripheral Excimer Laser Atherectomy)
• PRO
 Debulking = NO distal embolization vs other
devices
• CON

PELA: Debulking
• Vaporizes plaque and thrombus by delivering very
high energy in extremely short pulses.
pulses.
• Mechanisms of action.
  
Photochemical Photothermal Photomechanical
Dissolving molecular Produces photo- Creating
bonds thermal energy kinetic energy

Excimer Laser: Photochemical
Dissolves
molecular
bonds
• Light pulse targets tissue for 125 billionths of a second
 Pulsing aids in keeping the target cool – energy dissipates

between pulses
• 50 microns penetration depth
 Contact laser allows for focused ablation

• Micron sized particles generated
 Sub-cellular sized material is easily absorbed by the bloodstream,

minimizing risk of distal embolization.

Excimer Laser: Photothermal
Produces
photothermal
energy
• Absorption creates molecular vibration in molecules through
heating of intracellular water - water vaporizes, rupturing
cells
 Plaque is dissolved

• Gaseous by-products produce a vapor bubble
• Occurs in 100 millionths of a second
 Speed of vapor bubble formation and dissipation minimizes vessel

trauma

Excimer Laser: Photomechanical
Creates
kinetic
energy
• Expansion and collapse of vapor bubble breaks down tissue
and clears by-products away from tip
 Tip is continually in contact with lesion material

• By-products of ablation are water, gas, and small particles
(90%<10 microns, ~ size of red blood cell)
 Easily absorbed by the blood stream


Excimer Laser: Photoablation mechanism
nd on
d Timeline of a Pulse
co c
on
d
se se c
a a se
of of a
th
s
ths of
s
on li on th
lli il on
bi m il li
5 0
12 10 0
m
40
25 thousandths of a second at 25 Hz
25
Resting Period (Cooling time)
Bonds Thermal
Thermal Kinetic
dissolve
dissolve energy
energy energy
energy
Pulse rate = repetition rate per second = Hz

Excimer Laser: Why ‘debulk‘
• Excimer laser ‘‘debulking’ prior to balloon
debulking’
angioplasty transforms diffuse, multi-level
multi-level
arterial disease into more easily ballooned
stenoses.
= Lesion modification
Provisional stenting
Better stenting result
• Improved ‘‘acute’ outcome ≠ ‘‘chronic’ long
acute’ chronic’
term patency.

Excimer Laser in CTO: Step-by-step technique
Step-by-step
• Left SFA total
occlusion
• Use of excimer
laser to recanalize
– “debulk” and
“debulk”
open a channel
– “pilot” channel
“pilot”
Left SFA CTO
Pre-treatment
Pre-treatment

CTO: Laser recanalization
‘‘Step-by-step’
Step-by-step’
Pre-treatment
Pre-treatment technique

CTO: Laser recanalization
Successful
‘‘Step-by-step’
Step-by-step’ crossing

CTO: Excimer laser assisted recanalization
Adjunct balloon angioplasty

CTO: Excimer laser assisted recanalization
• Successful
recanalization of the
totally occluded left
SFA
Left SFA Post-treatment
Post-treatment

PELA (Peripheral Excimer Laser Atherectomy)
• PRO
 Debulking = NO distal embolization vs other
devices
• CON
 Large vessel - Recanalized channel
≠ ??adequate luminal gain vs other devices

CELLO Trial
CLiRpath Excimer Laser System to Enlarge
Lumen Openings
• Non-randomized, prospective trial at 20 centers in
the US
• 65 patients with de novo or restenotic lesions
• Purpose: Evaluate the safety and efficacy of the
Turbo-Booster, in combination with the available
laser catheters ≤2.0 mm, to create larger lumens
for treatment within the superficial femoral and
popliteal arteries.

CELLO Trial: 1O Endpoints
Efficacy
• Laser success - defined as achieving
 20% average reduction in the
percent (%) diameter stenosis, post-
laser with Turbo-Booster and prior to adjunctive therapy,
based on angiographic core laboratory analysis.
Safety
• Occurrence of major adverse events (clinical perforation,
major dissection requiring surgery, major amputation,
cerebrovascular accidents (CVA), myocardial infarction, and
death at the time of the procedure), prior to release from
the hospital, at 30 days, and at six (6) months post-
procedure.

Turbo-Booster: Proof of Concept
Turbo-Booster:
mm
3.0 mm 5.0 mm
1 pass with CLiRpath 4 passes with CLiRpath
2.5 TURBO Catheter 2.0 Booster Catheter

CELLO Trial: % Stenosis Reduction
Angiographic Core Lab Assessment Visual Assessment
80 100
77.00
60 80 89.00
60
40
42.00
40
20
21 20
15
0 0
%DS %DS
Pre TURBO Booster
Post TURBO Booster
Pre TURBO Booster Final
Final

CELLO Trial: IVUS Findings
100% Increase in MLA 60% Due to Vessel Expansion
Minimum Lumen Area 40% Due to Plaque Ablation
Plaque Area
Vessel Area
% %
23
12.0 31
22.5 22.90 30.5 30.90
10.0
30
10.40 22
29.5
8.0 21.5
29
21 28.5
6.0
20.5 28
4.0 4.90 20.50 27.5 27.90
20
27
2.0 19.5
26.5
19 26
0.0
p-value=0.0003 p-value <0.0001
p-value<0.0001
P ost P ilot Channel(mm2) P ost P ilot Channel(mm2)
P ost P ilot Channel(mm2)
P ost TURBO Booster(mm2) P ost TURBO Booster(mm2)
P ost TURBO Booster(mm2)
©2009 Spectranetics All Rights Reserved. Approved for External Distribution D008110-00 002009 27

CELLO Trial: Patency (n = 65)
100 100
90 96.90 90 100.00
80 80 86.00
70 70 78
60 60
50 59.30 50
% 54.3 %
40 40
30 30
20 20
10 10
0 0
%DS %
30 Day 30 Day
6 Month 6 Month
12 Month 12 Month

CELLO Patient
Washington Hospital Center
Left SFA – Pre-treatment
Pre-treatment

CELLO Patient
Washington Hospital Center
IVUS: CSA = 2.2 mm2
2

CELLO Patient
Washington Hospital Center
Turbo -Booster - 8 passes
Turbo-Booster

CELLO Patient
IVUS – s/p Turbo-Booster
Turbo-Booster Washington Hospital Center
CSA increased from 2.2 to 7.3 Increased lumen but with a
s/p Booster large intimal flap

CELLO Patient
Post Turbo-Booster
Turbo-Booster Washington Hospital Center
• Tack up the flap
 long 3- 5 minute
low 4 atm inflation
• Size the balloon
according to the IVUS
(media to media
dimension)
6.6 x 6.0 mm media to media

CELLO Patient
IVUS post PTA 6-mm balloon
6-mm Washington Hospital Center
CSA 15.3mm
CSA 15.3mm
Flap is tacked up & with much a
larger lumen

Final Angiogram CELLO Patient
Washington Hospital Center

Excimer Laser Debulking: Future
• Turbo-TandemTM-controlled directional laser
Turbo-Tandem -controlled
ablation
• Improved design for ease of use
• Designed to create larger lumens
• Pending 510K clearance

IA: Critical Limb Ischemia
• 77 yo AAM with PAD, s/p
PEI of left L.E. for CLI, and
resting right leg pain.
• (+) CAD, s/p CABG.
(+) HTN. (+) lipids. (-) DM.
• (+) PAD
5/19/06 - PEI of left SFA &
left popliteal artery.
3/23/07 - PEI of left PT &
left peroneal artery.
• (-) smoker, 1 ppd.
• ABI: Right = 0.3
Left = 0.9
Right BTK - Baseline

IA: Critical Limb Ischemia
Distal run-off - Post Tibial A.
run-off Right BTK - Baseline

IA: Debulking BTK
Distal run-off - Post Tibial A.
run-off Right BTK - Baseline

IA: Debulking BTK
1.4- mm Turbo Elite
45 mJ/mm2 at 25 Hz
PT – 2,074 pulses
Peroneal – 4,769
Adjunct POBA
Post-PELA
Post-PELA Right BTK - Baseline

IA: Debulking BTK
Right BTK - Baseline Right BTK - Post

IA: Debulking BTK
Right Foot - Post Right BTK - Post

Laird, J. et al. Journal of Endovascular Therapy. 2006. 13:1-11.
Laird, J. et al. Journal of Endovascular Therapy. 2006. 13:1-
13:1-11.
LACI (Laser Angioplasty for Critical Limb Ischemia)
(Laser
• Prospective, multi-center study (14: 11 - US, 3 --OUS).
multi-center OUS).
April 2001 to April 2002.
• Patients with CLI
 Rutherford Category 4-6
4-6
 Poor surgical candidates (No outflow/conduit, +cardiac)
(No outflow/conduit, +cardiac)
• Treatment: PELA of SFA, popliteal and/or
infrapopliteal arteries, with adjunctive PTA and
provisional stenting
• Primary Endpoint: Limb salvage at 6 months
 Freedom from amputation at or above the ankle

Laird, J. et al. Journal of Endovascular Therapy. 2006. 13:1-11.
Laird, J. et al. Journal of Endovascular Therapy. 2006. 13:1-
13:1-11.
LACI: Vascular Lesions Treated
45%
40%
% of Identified Lesions
35%
30%
25%
20%
15%
10%
5%
0%
SFA popliteal infrapopliteal other

Laird, J. et al. Journal of Endovascular Therapy. 2006. 13:1-11.
Laird, J. et al. Journal of Endovascular Therapy. 2006. 13:1-
13:1-11.
LACI: 6-Month Results
6-Month
Total enrollment 155 limbs
Death 17
Lost to follow-up
follow-up 11_
Reached 6-month follow-up
6-month follow-up 127
Major amputation among
survivors 9
Survival with limb
salvage 118/127 = 93%

PELA (Peripheral Excimer Laser Atherectomy)
• PRO
 Debulking = NO distal embolization vs other
devices
 BTK ‘ adequate debulking’ = Provisional stenting
‘adequate debulking’
• CON
 Large vessel - Recanalized channel
≠ ??adequate luminal gain vs other devices
 $$Cost = Improved long term outcome

PELA & other ‘debulking’ devices
‘debulking’
• Debulking devices - ‘‘niche’ role; improves acute
niche’
success.
• There is ‘‘paucity’ of good data to favor any
paucity’
particular treatment modality
– “Tailor to lesion”. Outcome data needed.
“Tailor lesion”.
We have more “toys” in the Peripheral lab vs.
“toys”
Coronary lab.
• Improved ‘‘acute’ outcome ≠ ‘‘chronic’ long term
acute’ chronic’
patency.

Peripheral Excimer Laser Atherectomy
• Peripheral Excimer Laser Atherectomy is an
important armamentarium in our percutaneous
management of PAD.
• As with other debulking devices – “Tailor to
“Tailor
lesion”
lesion”
• To optimize outcomes & minimize complications
– Device training and case selection
• USE:
ISR > BTK > SFA

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Summer Palace