Indications For Atherectomy. Is Debulking Necessary?: No Conflict of Interest

4/25/2015
Y AL E S CHO OL OF MED ICINE
Indications for atherectomy.

Is debulking necessary?
Sasanka Jayasuriya MBBS, FACC

Clinical Instructor, Yale-New Haven Hospital
and
Carlos Mena-Hurtado MD, FACC, FSCAI
Assistant Professor of Cardiology, Medical Director Vascular Medicine
Yale-New Haven Hospital
New Haven, CT Author : John K. Forrest, M.D
Updated : June 2009
No conflict of interest
Background
Large caliber vessels which are prone to

torsion, extension and compression
from high extrinsic pressures systems
1
4/25/2015
Background
• Long segment occlusions and heavily calcified

lesions are common
• Lesions across joint spaces

– the hip and knee joint need treatment and
• lesions with side branches
– CFA
Atherectomy in lower extremity PAD (LE PAD)
• Basic principal of atherectomy is to shave, drill, and

abrade calcific plaque.
• Data has shown a luminal gain of up to 66% with

atherectomy. 1
1. Aboufakher R, Torey J, Szpunar S, Davis T. Peripheral plaque volume

changes pre- and post-rotational atherectomy followed by directional
plaque excision: assessment by intravascular ultrasound and virtual
histology. J Invasive Cardiol. 2009:21(10):501-505.
Current atherectomy devices
• Laser atherectomy:
Excimer laser
Photoablation of plaque
and thrombus
2
4/25/2015

The Jetstream Navitus System (Bayer
• Directional atherectomy:
SilverHawk and TurboHawk devices
Rotating blade in a circular housing with only
part of the blade exposed through a
side window
Battery driven motor unit within the handle
No console

• Orbital atherectomy:
Diamond back 360
Rotational atherectomy technique
Orbiting eccentric diamond-coated
crown
Atherectomy, handle and console
Proprietary wire and fluid

• Jet stream atherectomy:

Rotational atherectomy device
Differential and circumferential cutting blades
Debulks both hard (calcified, fibrotic)
and soft (thrombus, plaque) tissues
Aspiration port
3
4/25/2015

Rotablator atherectomy
• 5-µm diamond-tipped burr
• Ablates calcific plaque
• For infra-inguinal and infra popliteal disease

Crosser device
• Initially designed as a CTO crossing device
• AC power to high frequency mechanical vibrations
• Approved as an atherectomy due to formation of a
channel
The
What is the best time and

place for each device?
The truth lies in the facts :

Evaluation of data
4
4/25/2015
LASER Atherectomy
EXCITE –ISR trial
• Femoro-popliteal in-stent restenosis

• 334 patients
• Randomized prospective multi center trial
• Freedom from major adverse effects at 30 days
• Freedom from TLR for 6 months
• Average lesion length 19cms
• 30% total occlusion
• Excimer laser : significant procedural success and
significant reduction in post treatment stenosis
Dippel EJ et al. EXCITE ISR: A Prospective, Randomized Controlled Trial of
Excimer Laser Atherectomy vs Balloon Angioplasty for the Treatment of
Femoropopliteal In-Stent Restenosis. J. Am Coll Cardiol Intv. 2015;8
PATHWAY PV SYSTEM : JET STREAM

• 172 patients. Multi center trial

• Rutherford Class I-V
• Up to 10cm in SFA and up to 3cm infra popliteal
• 31% total occlusions
• Moderate to severe calcification
• Device success was 99%
• 30 day major adverse effects was 1%
• 1 year restenosis rate was 38.2%
Zeller T, Krankenberg H, Steinkamp H, et al. One-year outcome of percutaneous
rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive
disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009;16(6):653-662
DEFINITE LE : SILVERHAWK AND TURBOHAWK DEVICES

• 47 centers
• Lesions up to 20cms
• 800 subjects enrolled
• End points :
Claudicants – patency at 12 months :78%
CLI – freedom from amputation : 95%
Similar results in DM and non DM patients
• Safe and effective treatment modality
McKinsey JF, Zeller T, Rocha-Singh KJ. Lower extremity revascularization using
directional atherectomy: 12-month prospective results of the DEFINITIVE LE
study. JACC Cardiovasc Interv. 2014 Aug;7(8):923-33
5
4/25/2015
Orbital atherectomy : CONFIRM Registry

• 3135 prospective patient registry

• Mean lesion length 72mm
• Moderate to severe calcium in 88%
• Above knee 46% and below knee 36%
• Pre procedural stenosis reduced from 88 to 35%.
• Plaque removal was most effective for severely
calcified lesions and least effective for soft plaque.
Das T, Mustapha J, Indes J, et al. Technique optimization of orbital atherectomy
in calcified peripheral lesions of the lower extremities: the CONFIRM series, a
prospective multicenter registry. Catheter Cardiovasc Interv. 2014 Jan 1;83(1):115-
22
Observed patterns of atherectomy device use world wide
Device Above Below In stent Thro Soft Calcified

knee kneee restenosis mbus plaque lesions
Laser ✔ ✔ ✔ ✔ ✔ ✔
SilverHawk ✔ ✔ ✔
JetStream ✔ ✔ ✔ ✔
Diamond ✔ ✔ ✔
back 360
Rotablator ✔ ✔
Summary
• Many atherectomy devices are available for use.
• Calcification, thrombus, location and ISR define the choice

of a device.
• Great value in the appropriate lesion – but not in every

lesion!
6
Atherectomy for lower limb revascularization
Lawrence A. Garcia, MD
Chief, Section Interventional Cardiology
and Vascular Interventions
Director, Vascular Medicine
St. Elizabeth’s Medical Center
Tufts University School of Medicine
Boston, MA
Case JC 2015
• 67 year old male with history HTN, HLP,

CAD s/p PCI in the past and PVD with
claudication
• Non-invasive work-up included ABI/duplex
with ABI on the RLE 0.62 and duplex with
serial lesions in the CFA/SFA and popliteal.
Outflow appears preserved
• Angiography planned and images taken
1
2
Stenting?
• To date the current default technology is stenting
• To date the meaningful studies have evaluated 5-6 cm
lesions and only 2 studies have tested long lesions
closer to 20 cms that we consider “real world” cases
• The gorilla in the room is restenosis
– In-stent restenosis vs de-novo restenosis
– Focal vs diffuse
– Recurrent vs recurrent
• Alternative therapies have been shown to be just as
durable and safe as DES/BMS and combination
therapy appears very appealing
A Calcium
C D
3
Current endovascular data
Patients (n) Device Lesion 1 year primary patency
length (%) (PSVR)
(cm)
MIMIC 81 PTA NA NA
ABSOLUTE 104 Stent 10.2 63 (2.5)
RESILIENT 137 Stent 6.3 81 (2.4)
VIBRANT 76 Stent graft 19.6 53 (2.5)
VIPER 119 Stent graft 19.0 73(2.5)
ZilverPTX 240 DES-SES 5.4 83 (2.0)
THUNDER 54 DCB 7.4 74 (2.4)
LEVANT 50 DCB 8.1 78 (2.5)
IN-PACT 301/220 DCB 8.9 90 (2.4)
IN-PACT
• 2:1 randomized single blinded study DCB vs

PTA alone
• 1 year results presented of 5 year study
• Lesions under 18 cm
– Occlusions under 10 cm
– RB 2-4 enrolled
• 331 randomized (all subjects) ITT 301 patients
• Provisional stenting listed in all subjects
Baseline characteristics
IN-PACT PTA P
n=220 subjects n=111 subjects
(221 lesions) (113 lesions)
Lesion Type De-novo 95.0% (209/220) 94.6% (105/11) 0.875
Restenotic 5.0% (11/220) 5.4% (6/111)
Run off vessels 0 3.3% (7/212) 4.5% (5/112) 0.76
1 13.7% (29/212) 26.8% (30/112) <0.05
2 41.5% (88/212) 33.0% )37/112) 0.15
3 41.5% (88/212) 35.7% (40/112) 0.34
Prox popliteal involvement 6.8% (15/221) 7.1% (8/113) 1.00
(%)
Lesion length (cm) 8.94±4.89 8.81±5.12 0.81
Total occlusions (%) 25.8% (57/221) 19.5% (22/113) 0.22
Severe calcification (%) 8.1% (18/221) 6.2% (7/113) 0.66
RVD (mm) 4.65±0.84 4.68±0.83 0.73
MLD pre (mm) 0.90±0.78 0.93±0.77 0.71
Diameter stenosis pre (%) 81.1±15.5 81.3±13.7 0.95
4
All ITT, 12 month patency
Directional atherectomy
SilverHawk
Key Study Design Elements

• Study Design and Oversight:
– Prospective, non-randomized, global study
– 800 subjects enrolled at 47 centers
– CEC and Steering Committee oversight and CEC adjudicaiton
– Angiographic and Duplex core laboratory analyses
• Inclusion Criteria
– RCC 1-6
– ≥ 50% stenosis
– Lesion lengths up to 20cm
– Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm
• Exclusion Criteria
– Severe calcification
– In-stent restenosis
– Aneurysmal target vessel
5
Primary Patency in Subgroups
Subgroup Claudicants (n=743)
Patency Lesion Length
(PSVR < 2.4) (cm)
All (n=1022) 78% 7.5
By Lesion Length
< 4 cm (n=318) 81% 2.2
4-9.9 cm (n=418) 83% 6.5
≥ 10 cm (n=283) 67% 14.4
SFA Only By Lesion Length
< 4 cm (n=184) 78% 2.3
4-9.9 cm (n=253) 83% 6.5
≥ 10 cm (n=232) 65% 14.6
Effective treatment for all lesion lengths

12 Month Primary Patency Rates from DEFINITIVE LE
100%
90%
81% 83%
80%
70% 67%
60%
50%
PSVR < 2.4
40%
30%
20%
10%
0%
< 4 cm 4-9.9 cm ≥ 10 cm
Mean length : 2.2 cm 6.5 cm 14.4 cm

Number of lesions: 220 307 214
DEFINITIVE AR Study Design

Purpose: assess and estimate the effect of treating a vessel
with directional atherectomy + DCB (DAART) compared to
treatment with DCB alone
Registry arm for severely calcified lesions created to limit
bail-out stenting (and therefore variables) in randomized
arm.
DAART*
No Guidewire passage, (N = 48)
enrollment &
Randomization
DCB
General and
Lesion severely (N = 54)
Angiographic Criteria
calcified?
Assessment Yes
Guidewire Passage DAART*
& Enrollment
(N=19)
* Directional Atherectomy + Anti-Restenotic Therapy
6
Baseline Lesion Characteristics
Per Core Lab
Baseline DAART DCB p-Value* DAART
Characteristics (N= 48) (N = 54) Severe Ca++ Arm
(N=19)
Lesion Length (cm) 11.2 9.7 0.05 11.9
Diameter Stenosis 82% 85% 0.35 88%
Reference vessel
4.9 4.9 0.48 5.1
diameter (mm)
Minimum lumen
1.0 0.8 0.34 0.7
diameter (mm)
Calcification 70.8% 74.1% 0.82 94.7%
Severe calcification 25.0% 18.5% 0.48 89.5%
* p-value for DAART and DCB groups
Key Study Outcome at 12 Months

Angiographic Patency shows similar pattern
DAART , Lesions >

DAART , All 10 cm, 90.9
Patients, 82.4
DCB , All Patients, DCB , Lesions > 10
71.8 cm, 68.8 DAART , All Severe
Ca++, 58.3 DAART
DCB , All Severe
Ca++, 42.9 DCB
N = 34 N = 39 N = 22 N = 16 N = 24 N=7
Results for all patients who returned for

angiographic follow-up
12-Month Patency: DAART RCT Patients

Is it Important to Achieve ≤30% Residual Stenosis with Directional Atherectomy
Post-Procedure?
4.5 MLD = 4.27 DCB ≤30%>30% ≤30%>30%

≤30%
4
MLD = 3.78 DA Residual
Residual Residual
Residual Residual
0.92 Pre-Dilatation Stenosis
Stenosis Stenosis
Stenosis Stenosis
3.5 Baseline
p = 0.045 Post-DA,
Post-DA, Post-DA,
Post-DA, Post-DA
3 1.61 DUS DUS Angiogra
Angiogra
Patency,
Patency, phic phic >30%
2.5
2.16 90.0 77.8 Patenc…
Patenc… Residual
2 Stenosis
Post-DA
1.5 1.39
1 0.23
0.5 0.96 0.78

0
DAART Arm DCB Arm
~15.1 ~11.8 mm2

lumen area N = 20 N = 18 N = 17 N = 16
mm2
lumen
DAART
area
resulted in a significantly larger
minimum lumen diameter (MLD) following the
protocol-defined treatment in DEFINITIVE AR
7
Comparing non-stent technologies at 12 months
Durability II IMPACT
Fem-Pac Resilient
Durability
100%
Levant 1
90%
Supera Durability II
80% Viper
Primary Patency
70%
60% Absolute Durability II
ZilverPTX
50% Vibrant
Thunder
40%
30% 78% 83% 68%
20%
10% DEFINITIVE LE
0%
3 8 13 18 23
Lesion Length (cm)
Long lesion atherectomy

• Drug coated balloon technology is safe and effective
• IN-Pact has shown benefit at 1 year higher than any other trial to date in a
level 1 randomized protocol at near 9 cm LL.
• DEFINITIVE LE proved atherectomy safe & effective at 12 months
– Effective for short, medium and long lesions in claudicants & CLI patients
• DEFINTIVE AR pilot study demonstrated a signal of benefit for combined
therapy
• Initial signal suggests an potential role for DCB with atherectomy that may
obviate the need for stenting as an upfront need for our patients with complex
peripheral vascular disease
• Opportunity for re-therapy remains open to the operator and patient if no
endoprosthesis is left behind at the index procedure.
• Overall cost benefit needs assessment but remember repeat revascularization
for ISRS may not benign and only once
8
Rotational and Aspiration Atherectomy for
Treating calcified Femoropopliteal
Atherosclerotic Obstructive Disease
Nicolas W Shammas, MD, MS, FACC, FSCAI

President and Research Director,
Midwest Cardiovascular Research Foundation
Adjunct Clinical Associate Professor,
University of Iowa Hospitals and Clinics
Interventional Cardiologist,
Cardiovascular Medicine, PC
Davenport, Iowa
Conflict of Interest
Research grants (to the Midwest Cardiovascular Research Foundation)
Significant Grants for investigator initiated studies have been received from Boston Scientific, Possis,
Edwards, the Medicines Co, ev3, Schering-Plough, Fox-Hollow, Spectranetics, Atrium, Gilead,
Medtronic, Genesis Foundation, CSI, Bayer
Educational grants (to the Midwest Cardiovascular Research Foundation)
Abbott Vascular, AGA Medical, Astellas Pharmaceuticals, AstraZeneca, Boehringer-Ingelheim, Boston
Scientific, Cordis Vascular, Daiichi Sankyo, ev3, Gilead Sciences, IDEV Technologies, Lilly USA, Pfizer,
BMS, The Medicines Company, Medtronic Cardiovascular, Spectranetics, St. Jude Medical, Takeda
Pharmaceuticals, Terumo Medical, and Zoll Lifevest.
Consultant
CSI, Medicines Company, Covidien/ev3, NAMSA, Boston Scientific
Trainer
Covidien. RF ablation procedure
Boston Scientific. JetStream Atherectomy
CSI. Orbital atherectomy
Stocks, Options, Investments
Dr Shammas has no commercial, proprietary or financial interest in any pharmaceutical or device
companies or their products and has no intention in doing so in the near future.
Board member or employment with industry
None
Calcium in peripheral arteries

 Calcium is a heterogenous component of
advanced atherosclerotic plaque
 It can be superficial or deep within the layers of
the artery (Mönckeberg's medial sclerosis)
 There is no standardized way to quantify calcium
in peripheral arteries at this time
 Angiography underestimates the severity of
calcium deposits by more than 50%
1
Predictors of calcium in the peripheral arteries
Old age 
Diabetes
 Hyperlipidemia
 Hypertension
 End-stage renal disease
 Advanced Fontaine class
High calcium scores are associated with disease severity and
outcomes, including amputation and all-cause mortality, in patients
with symptomatic peripheral artery disease
Huang CL. PLoS One. 2014 Feb 26;9(2):e90201 ; Rocha-Singh KJ et al. CCI 214;83(6):E212-220
Presence of Severe Calcium in peripheral arteries
Below The Knee Calcium Above The Knee Calcium
30% Heavily
Calcified
70% Heavily
Calcified
Why Calcium is a Concern in Treating

Femoropopliteal Arterial Disease?
 Higher residual stenosis (inability to dilate lesion)
 Higher rate of dissection and need for stenting
 Higher perforation rates
 High rate of stent fracture and subsequently lower
patency rates
 Inability to expand stents adequately
 A higher rate of distal embolization
 A barrier to antiproliferative drug transport
2
Archive : Shammas
JETSTREAM® System
Mechanisms of Action
 Rotational cutting of tissue (organized
thrombus, fibrotic, fatty or calcified tissue)
 Thrombectomy or aspiration of debris or
thrombus
Device Selection
Cutter size: JETSTREAM®XC

- 2.1mm/3.0mm 120 cm
Vessel size 3.5-5 mm
BD 3.5-4.0 mm
BD/BU 4.0-5.0 mm
- 2.4mm/3.4mm 135 cm
Vessel size > 5.0 mm
Cutter size: JETSTREAM®SC
- 1.6 mm 145 cm Vessel size 2.0-2.5 mm
- 1.85 mm 145 cm Vessel size 2.6-3.5 mm
- Avoid 1.85 mm on origin of AT
BD=blades down, BU=blades up
3
Wire Positioning
 Intraluminal position
 The wire needs to be positioned distally in a
small tibial or peroneal vessel or in an angulated
tibial such as the AT
 Provides more stability to the wire and the catheter’s
cutter.
 Do not wedge the wire at the end of a small
branch or place it very far in the tibial vessel.
 Allow room for the wire to move with the device as
this can still happen to avoid perforations
Treating the Lesion

 1 Liter saline flush bag has 1 mg of nitroglycerin and 5 mg
of verapamil.
 Start with Blades-down before changing to blades up
 Some resistance is expected. Rest the Blades on the
calcified plaque and apply a gentle push with slow
advancement
 Speed is generally 1 mm per second
 Do not stall the cutter in the lesion. Use tactile and
auditory senses to guide treatment
 Embolic filters are used particularly in long calcified
lesions.
Use of Embolic Filter Protection*

with JETSTREAM ATHERECTOMY
 FDA approved with Turbohawk in calcified
Spider Filter (Covidien):
femoropopliteal vessels. In general, avoid with JetStream
Atherectomy.
 Problems: Filter wire have stuck on the Jetstream device and could not be rexed.
Basket moves with wire.
 Nav 6 (Abbott): is preferred. It allows wire movement independent
of the filter. Filter has enhanced capture efficiency. Capture 100
micrometers debris.
 Advantage: the wire can be placed far from the filter into the tibials or peroneal
while the filter is positioned in the popliteal or distal SFA.
 Disadvantage: can create slow flow because of capturing small debris. If slow
flow occurs with Nav-6 filter in, complete the case as usual. When filter is
retrieved, flow generally returns back to normal
*Filters have not been approved with JetStream
4
Technique (Heavily Calcified CTO)
Case 2
Case JetStream Atherectomy: Shammas NW
Case 2 IVUS
Pre treatment IVUS Post treatment IVUS
5
Case 3
Case JetStream Atherectomy: Shammas NW
Scoring Calcium in Peripheral Arteries

 No universal definition
 Uses AP or orthogonal fluoroscopic views
 Include one or more of the following:
 Absolute calcium length in a lesion
 Calcium length relative to lesion length (% ca)
 One sided (unilateral) vs double-sided (bilateral)
location of calcium
 Intimal vs medial
Definition: Definitive Ca
 Severe calcification:
 Bilateral
radioopacity
 Andextending > 1 cm of length prior to
contrast injection or DSA.
 Moderate calcification
 radiopacities
on one side of the arterial wall
 OR < 1 cm of length prior to contrast injection
or DSA
6
Definition: Calcium 360
 Severe: the lesion has concentric calcification

of more than 75% of the treated segment
 Moderate to Severe: 50-75% of the treated

segment has visible calcium on fluoroscopy
 Mild to none: <50% of the treated segment

has calcium on fluoroscopy
Definition PACSS:
Peripheral Arterial Calcium Scoring System
Proposed Fluoroscopy/DSA based Peripheral Arterial Calcification Scoring Systems
(PACSS): Intimal and medial vessel wall calcification at the target lesion site as
assessed by high intensity fluoroscopy and digital subtraction angiography (DSA)
assessed in the AP projection.
Grade 0: No visible calcium at the target lesion site

Grade 1: unilateral calcification < 5cm; a) intimal calcification; b) medical calcification;
c) mixed type
Grade 2: unilateral calcification ≥ 5cm; a) intimal calcification; b) medical calcification;
c) mixed type
Grade 3: bilateral calcification < 5cm; a) intimal calcification; b) medical calcification;
c) mixed type
Grade 4: bilateral calcification ≥ 5cm; a) intimal calcification; b) medical calcification;
c) mixed type
Rocha-Singh KJ et al. CCI 214;83(6):E212-220
Definition. JETSTREAM CA study
IVUS based
Superficial Calcium
Arc of calcium: > 90 degrees
Length > 5 mm
Arc of reverberation
7
Arc of reverberation in calcified lesion
Change in arc of reverberation

indicates Device modification
of calcium
(typically arc is increased

with calcium removal)
JETSTREAM CALCIUM
prospective, single-arm, multicenter study in severely calcified femoral-
popliteal artery (superficial calcium >90° and >5mm by IVUS)
Lesion location
Superficial femoral artery 76%
Popliteal artery 33%
Common femoral artery 5%
Superficial and popliteal artery 10%
Common and superficial femoral
5%
artery
De novo lesion 90.5%
Operator visual assessment Calcium grading
Moderate 33.3%
Severe 66.7%
Lesion length (mm) 55 [20, 120]
Lesion diameter (mm) 5.0 [4.3, 6.0]
Diameter stenosis
Pre-treatment (%) 82 [80, 90]
Post-atherectomy (%) 40 [30, 40]
http://www.bostonscientific.com/en-US/products/atherectomy-systems/jetstream-atherectomy-system.html
Final data in Print in Eurointervention 2015
JETSTREAM CALCIUM
Clinical Results
“Minimum lumen area increased from 4.3 [3.0, 5.5] mm2

to 7.4 [6.6, 10.3] mm2 (p<0.0001)
Lumen symmetry (minimum/maximum lumen diameter)

increased from 0.70 [0.60, 0.78] to 0.79 [0.73, 0.87]
(p=0.02) after treatment
Calcium reduction resulted in a 78% [70, 86] increase in

lumen area
Although the arc of superficial calcium did not change,

the arc of reverberation increased significantly”
http://www.bostonscientific.com/en-US/products/atherectomy-systems/jetstream-atherectomy-system.html
Final data in Print in Eurointervention 2015
8
Heavily Calcified CTO. Eccentric lesion
Heavily calcified distal SFA CTO Post JETSTREAM and DCB (lutonix) Post Supera stent
Conclusion
 Rotational and aspiration atherectomy is effective in
treating severely calcified lesions in the FP artery
 Technique is of paramount importance for excellent
results
 Slow advancement of the cutter
 Avoid stalling of the device and allow room for aspiration
 Distal embolization protection
 Unanswered question: Role of Rotational and Aspiration
atherectomy prior to DCB treatment
 Eccentric lesions remain a challenge with this technology
THANK YOU
9
4/29/2015
Tips & Tricks To Maximize Results with Rotational &

Aspirational Atherectomy in CLI Cases
First Coast Cardiovascular

Institute
Yazan Khatib, MD, FACC, FSCAI, FABVM
President
www.firstcoastcardio.com
CLI Anatomy
 CKD Common
 Diabetes Mellitus Common
 Multilevel PAD
 CTO Common
 Long Segment Disease, Common
 Heavy calcium Load Common
 Thrombus Component, not infrequent
Critical Limb Ischemia CLI
 CLI has typically been associated with Long

hospitalizations
 Surgical Revascularization has fallen out of
favor for most CLI patients even among the
vascular surgeons
1
4/29/2015
Spring 2014
Advantages of Rotational & Aspirational

Atherectomy in CLI Cases
 Ability to treat with one device two different levels

and different size vessels
 Ability to Treat with one Device the whole spectrum
of plaque from heavily calcified to thrombus
 The ability to image through the sheath without the
need to remove the device
 The central cutting feature by design reduces the
concern for perforations and gives uniform round
lumens
 Less need for Fluoro use during procedure due to the
predictable path
 The lack of concern for “stent grabbing”
Dis-Advantages of Rotational & Aspirational

Atherectomy in CLI Cases
 The Need to use 7 Fr. Sheath

 The Potential for Embolization
 The potential for perforation
2
4/29/2015
Our Anecdotal Experience & Tips & Tricks To

Maximize Results & reduce Complications
1. Always Use a lubricant in the infusion bag to enhance the

aspiration function of the device
2. Low Threshold for adding 2-4 mg of TPA to the infusion bag
when suspicious of thrombotic component
3. Treat long lesions in Segments of 5-7 cms activating blades
down then coming back to blades up mode in each
segment before moving to the next, thus having the more
distal disease act at a “filter” while treating the more proximal
disease
4. Replace the device if there is slow or no aspiration
5. Consider IVUS for sizing the distal popliteal and tibials before
choosing what device to use to optimize outcome and
reduce risk of perforation
6. Respect “pain” and avoid blades up mode in segments
associated with pain
Example
 60 YO BM with rest pain >3 months in the left leg

 Aorto Iliac vessels are normal
 Total Left SFA long occlusion
 ABI 0.6 on the Left side normal on the right
9 9
3
4/29/2015
10 10
11 11
12 12
4
4/29/2015
EXAMPLES
CASE 2
a. 59 year old gentleman with sudden onset right

leg pain and coolness due to acute occlusion of
the right femoropopliteal bypass graft (a).
b. He underwent successful thrombectomy with a
Jetstream device, restoring flow in the graft (b).
c. There was still a 100% occlusion of the distal
right popliteal artery beyond the anastomosis of
the bypass graft (c), which likely was the culprit
lesion for causing thrombosis of the bypass graft.
d. This was successfully treated as well to restore
brisk flow down the right leg (d).
13
a
b
Occlusion of the entire Fem pop Bypass graft
c d
Widely patent Fem pop Bypass post

thrombectomy
CASE 2 14
Thank You
Call with questions

Or Better yet come join our
Endovascular Fellowship
15 15
5
4/29/2015
How to Save Legs & Save Lives
First Coast Cardiovascular

Institute
Yazan Khatib, MD, FACC, FSCAI, FABVM

www.firstcoastcardio.com
(904) 493-3333
16
6
4/22/2015
Treating Complex CLI with

Orbital Atherectomy
George L. Adams MD, MHS, FACC, FSCAI

North Carolina Heart and Vascular
Director of Cardiovascular and Peripheral Vascular Research,
Rex / UNC Healthcare
Clinical Associate Professor of Medicine,
University of North Carolina Health Systems
Disclosures
• Consultant • Research
– Abbott Vascular • Boston Scientific
– Asahi • CloSys
– Bard • CSI
– Cook Medical • Daiichi Sankyo
– Cordis • Medtronic
– CSI • Volcano
– Daiichi Sankyo
– Lake Region Medical
• Speaker
– Medtronic • Abbott Vascular
– Penumbra • Cook Medical
– Terumo
• CSI
– Volcano
• Spectranetics
Which Patients are More Likely to Have Calcium?
PAD Patients with Calcified Plaque
Advanced Kidney
Diabetes
Age Disease
Up to 26M in U.S.(2) Up to 31M in U.S. (4)
40.3M 65+yrs old in U.S.(1)
Diabetes is fastest Diabetes is leading
85+ age group is fastest
growing health problem cause of kidney
growing in U.S.(1)
in U.S.(3) disease(2)
1. The Older Population: 2010 (2010 U.S. Census Briefs; C2010BR-09)

2. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S.
Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.
3. Diabetes Fact Sheet from American Diabetes Association
4. American Kidney Fund News Release: American Kidney Fund’s Fourth Annual Gala, “The Hope Affair” Brings the Renal Community Together on October 17, 2012 (September 26, 2012)
1
4/22/2015
CSI Unique Mechanism of Action:

Differential Sanding & Centrifugal Force
Differential Sanding: Centrifugal Force:

• 30 micron diamond coating • 360° crown contact designed to create a smooth,
• Bi- directional sanding, eccentric concentric lumen
mounted crown • Allows constant blood flow and particulate flushing
• Healthy elastic tissue flexes away during orbit
minimizing damage to the vessel • Ability to treat multiple vessel diameters with one
• Micro-particulate crown
1.25 Coronary Classic crown orbiting in a 3mm glass tube
CSI’s Orbital Atherectomy System
Diamondback Specs:
• 160 cm working length
• 4 Fr sheath compatible
• Easy set-up
ViperWire:
• 335 cm length
• .014” wire with .014” or .017” tip
Crown Sizes:
• Classic Crown: 1.50 and 2.0 mm
• Solid Crown: 1.25, 1.50, and 2.0 mm
• Micro Crown: 1.25 mm
DIAMONDBACK CROWN STRATEGY

3 VARIABLES TO CONSIDER
Solid Crown
1. Vessel Diameter
– ≥ 4mm use 1.50 to 2.00 crown
– < 4mm use 1.25 to 1.50 crown
Classic Crown
2. Vessel Tortuosity
– If yes, use Classic or Micro Crown
– If no, use any crown
Micro Crown
3. Lesion Length
– If > 60mm use Classic or Micro Crown
– If < 60mm use any crown
2
4/22/2015
TAKE HOME TIPS & TECHNIQUES

OF ORBITAL ATHERECTOMY
When to Use
– Calcified Plaque
How to Use
– Treat distal to proximal
– Run times to 20-30 seconds with rest periods of 20-30
seconds between runs
– Administer vasodilators liberally before and during the
procedure
– Use ViperSlide to wipe ViperWire when exchanging devices,
balloons and catheters
– Try to keep the distal tip of the ViperWire in the field of view
Results: Reliable and Predictable
Thank you
3
4/29/2015
Laser Atherectomy for the

Treatment of In-Stent Restenosis
6 Mth Results of the EXCITE ISR Study
Eric J Dippel, MD FACC
Davenport, Iowa, USA
April 29, 2015
Conflict of Interest
 Consultant
– Abbott Vascular
– Bard
– Boston Scientific
– Covidien
– Medtronic
– Spectranetics
– WL Gore
 Shareholder
– Spectranetics
Study Overview
 Design
– Prospective, multi-center, randomized control trial
for the treatment of femoropopliteal artery in-stent
restenosis (ISR)
– Excimer Laser Atherectomy (ELA) plus PTA
versus PTA alone
• 2:1 randomization (ELA+PTA:PTA)
• Up to 353 patients
• Interim analysis with Bayesian hierarchical modeling
and stopping rules at 200, 250 and 300 patients
– FDA approved IDE
– Steering Committee, DSMB, and CEC
– Angiographic and Ultrasound Core Labs
1
4/29/2015
Study Design
Femoropopliteal artery in-stent restenosis (ISR)
ELA + PTA
Enrolled &
Yes Randomized
Lesion PTA
General &
Crossable
Angiographic
by
Screening
Guidewire Total ELA
Occlusion Step-by-
No Registry* Step
*Total Occlusion Registry utilized step-by-step laser facilitated crossing of lesion
Study Enrollment
252 Randomized
Laser + PTA PTA alone

N=170 N=82
Primary
Primary Endpoints Endpoints
30 day N= 167
30 day N= 76
6 month N= 156 6 month N= 72
6-Month Follow- 6-Month Follow-

up Complete up Complete
Death n=1 Death n=2
Lost to Follow Up n=3 Lost to Follow Up n=5
Withdrew Consent n=10 Withdrew Consent n=3
Devices
2
4/29/2015
In-Stent Restenosis
•2.0 Turbo Elite Pilot Channel

•8 Fr Turbo Booster
•6.0x300 VascuTrak balloon
Primary Endpoints
 Primary Safety Endpoint
– Major Adverse Events through 30 days:
• Death
• Unplanned Major Amputation
• Target Vessel Revascularization (TLR)
 Primary Efficacy Endpoint
– Freedom from clinically driven TLR at 6
months
• Return of clinical symptoms
• DUS binary restenosis
• Deteriorated ABI or Rutherford Classification
Secondary Endpoints
 Acute procedural success
 6 and 12 month:
– Target vessel revascularization (TVR)
– Primary patency rate
– Assisted primary patency rate
– Assisted secondary patency rate
– Ankle-brachial index
– Rutherford class
– WIQ functional status
– Stent integrity
– Duplex ultrasound
3
4/29/2015
“Real World” Patients

 Key Inclusion Criteria
• No lesion length limit – ISR lesion ≥ 4 cm
• Multiple stents allowed – Rutherford classification 1-4
• Common stent fractures – RVD ≥ 5.0 mm and ≤ 7.0 mm
(Grades 1-3) – ≥ 1 patent tibial artery
• Popliteal stents included  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
Patient Demographics
ELA + PTA PTA Alone
(N=169) (N=81) P-value
Age (mean) 68.5 67.8 0.60
Male 62.7 % 61.7 % 0.89
Hypertension 95.8 % 93.8 % 0.53

Hyperlipidemia 96.4 % 95.0 % 0.73
Diabetes Mellitus 47.0 % 47.5 % 1.00
CAD 64.3 % 68.8 % 0.57
Previous ISR 32.5 % 29.6 % 0.77
Smoking 75% 91.3% 0.05
Rutherford Class 0.54
1 3.0% 3.7%
2 18.9% 14.8%
3 62.1% 69.1%
4 15.4% 11.1%
5 0.6% 0.0%
6 0.0% 0.6%
Baseline Lesion Characteristics

Angiographic Core Lab Assessment
ELA + PTA PTA Alone

(N=169) (N=81) P-value
Mean Lesion Length (cm) 19.6 19.3 0.85
Diameter Stenosis (%) 81.7% 83.5% 0.42
Popliteal Lesion 21.3% 23.4% 0.93
Total Occlusion 30.5% 36.8% 0.37
Calcium (Mod/Sev) 27.1% 9.1% 0.005
Stent Fracture 0.16
0 85.8% 95.8%
1 5.0% 0.0%
2 6.4% 4.2%
3 2.1% 0.0%
4 0.0% 0.0%
5 0.7% 0.0%
20% of lesions were > 30 cm in length
4
4/29/2015
Procedural Characteristics
ELA+PTA PTA P
n = 169 n = 81 Value
Turbo Elite use 79.9 na
Distal protection 40.2 30.9 0.16
% Diameter Stenosis 23.9±9.3 25.1±10.9 0.24
Residual Stenosis >30% 4.7 13.6 0.02
Acute Procedural Success

ELA+PTA
Investigator Assessment
PTA
100
93.5%
p=0.01
95
Percent
90 82.7%
(%)
85
80
75
Procedural Success
Acute Procedural Success

ELA+PTA
Investigator Assessment
PTA
18.1%
25
20 11.5% p=0.004
Percent
15
(%)
10
0
%DS Post Treatment
5
4/29/2015
Acute Procedural Complications

25 ELA+PTA
CEC Adjudicated
PTA
p=0.008 p=0.03 p=0.02
20
17.2%
16.0%
15 11.1%
Percent
p=0.08 p=0.47 p=0.25 p=0.23

8.3%
10
(%)
7.7% 7.4%
5.3% 4.9%
4.1%
5 2.4% 2.5%
1.2%
0.6% 0.0%
0
Procedural Any > Grade C Stenting Embolization Thrombosis Abrupt
TLR Dissection Closure
Primary 30d Safety Endpoint

ELA+PTA
CEC Adjudicated
PTA
100
P<0.001
95
90
94.6% 80.3%
Percent
85
(%)
80
75
70
Freedom from MAE
Primary 6mth Efficacy Endpoint

ELA+PTA
CEC Adjudicated
PTA
100
P<0.005
90
80 78.2%
Percent
59.7%
70
(%)
60
50
40
Freedom from TLR
6
4/29/2015
Freedom from TLR

Product-Limit Survival Estimates
With number of subjects at risk
p < 0.003
Survival Probability
365
Days from Index Procedure
Freedom from MAE

Product-Limit Survival Estimates
With number of subjects at risk
p < 0.001
Survival Probability
365
Days from Index Procedure
Cox Proportional Hazards

Subgroup Analysis
Lower Upper
Variable Estimate
CL CL
P-value Favors ELA & PTA Favors PTA
Overall 0.48 0.31 0.74 0.001
Age > 70 .047 0.23 0.95 0.04
Diabetes 0.65 0.34 1.26 0.20
Previous ISR 0.54 0.31 0.93 0.03
RVD ≤ 5.5 0.52 0.33 0.82 0.005
TASC D 0.42 0.20 0.91 0.03
Occlusion 0.46 0.24 0.91 0.02
> 10 cm 0.53 0.34 0.84 0.007
Risk Estimate
7
4/29/2015
Lesion Length and TLR
Favors ELA & PTA Favors PTA
Variable
Estimate Lower CL Upper CL
(Lesion Length)
5 cm 0.96 0.43 2.14
15 cm 0.66 0.39 1.12
25 cm 0.46 0.29 0.70
35 cm 0.31 0.17 0.58
Risk Estimate
6 Month Clinical Status

Laser + PTA PTA Alone
P- Value
(N=156) (N=72)
Primary Patency (%) 75.0 59.8 0.02
Freedom from MAE (%) 81.7 64.8 0.007
Survival (%) 99.3 97.1 0.30
Freedom from
100 98.5 NA
Amputation (%)
Rutherford Class (RC) 1.3 ± 1.2 1.4 ± 1.5 0.48
Improved (%) 75 69.4
Same (%) 22.7 16.3 0.01
Worsened (%) 2.3 14.3
Increase in Stent
0 0 NA
Fracture Grade (%)
Analysis at 180 days post-procedure
Conclusions
EXCITE ISR
 Complete 6 month results confirm Laser with

adjunctive PTA is superior to PTA alone for
the treatment of femoropopliteal ISR:
– Difficult to treat lesions averaging 20 cm and 30% total occlusion
– Significantly higher freedom from MAE
– Significantly higher freedom from TLR
 1st FDA approved IDE randomized
control study demonstrating the benefits
of atherectomy in the lower extremities
 ELA with PTA should be considered the
standard care for femoropopliteal ISR
 12 month follow up ongoing
8
4/29/2015

Indications For Atherectomy. Is Debulking Necessary?: No Conflict of Interest

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Indications For Atherectomy. Is Debulking Necessary?: No Conflict of Interest

Uploaded by

Copyright:

Available Formats

4/25/2015

Y AL E S CHO OL OF MED ICINE