Atherectomy Below the Knee
Barry S. Weinstock, MD
Mid-Florida Cardiology Specialists
Orlando, FL
Director, Mid-Florida Cardiology
Vascular Intervention Center

“BTK” Intervention
Primarily performed for limb salvage, i.e.
treatment of patients with rest pain or non-healing
ulcer / threatened limb loss
Sometimes performed to optimize distal run-off to
enhance patency of SFA intervention
Many interventional options!

“BTK” Intervention
Atherectomy desirable in tibial vessels due to
limitations of balloon angioplasty and desire to
avoid extensive stenting of tibial arteries
Angioplasty  Dissection, Elastic Recoil
Stenting  Coronary DES, Abbott Xpert Stent
Atherectomy Options:
FoxHollow, DiamondBack, Laser
NO randomized data comparing these devices!

FoxHollow Plaque Excision
FoxHollow
SilverHawk
Plaque
Excision

Infrapoliteal Plaque Excision
For Limb Salvage
Single Center Study
Amir Motarjame
Good Samaritan Hospital, Downer’s Grove, IL
Patients (29)
Non-healing Ulceration 100%
Scheduled for major amputation 100%
Lesions (40)
Infra-popliteal 100%
Treatment
SilverHawk Standalone 65%
SH + (PTA ± Stent ± Graft) 35%

Infrapoliteal Plaque Excision
For Limb Salvage
Complications
• 2 A-V fistulae were created at the treatment site
Results
• Of 29 patients scheduled for major amputation
• 27 (93%) avoided major amputation
• 13 (45%) had NO amputation
• 12 (41%) had a toe amputation
• 2 (7%) had a transmetatarsal (forefoot) amputation
• 2 (7%) had BKA
Conclusions
• 27 of 29 Limbs salvaged
• SilverHawk effective in treating Critical Limb Ischemia

Plaque excision for CLI
• Multi-center Trial: 7 centers, 8/03 – 8/04
• Rutherford Category > 5
• N=69 (37 women), 76 limbs
• Age 70 + 12 (49-93)
• 1o Endpoint: MACE (Death, MI, unplanned
amputation, or TVR at 30 days)
Kandzari DE, Kiesz RS, Allie D, et al. Procedural and clinical outcomes with
catheter-based plaque excision in critical limb ischemia. J Endovasc Ther. 2006
Feb;13(1):12-22

Plaque excision for CLI: Results
• Procedural Success: 99%
• 30 Day TVR: 4%
• MACE:
• 30 day: 1%
• 6 month: 23%
• Unplanned amputations: 0%
• Less extensive amputation or avoidance of
amputation:
• 30 days: 92%
• 6 months: 82%
Kandzari DE, Kiesz RS, Allie D, et al. Procedural and clinical outcomes with catheter-
based plaque excision in critical limb ischemia. J Endovasc Ther. 2006 Feb;13(1):12-22

Severe Trifurcation Vessel Disease
88 yr old active man
referred from Merritt
Island
Multiple vascular risk
factors
Multiple foot ulcers
bilaterally (right > left)
requiring many months
to heal each ulcer with
extensive would care

Interventional Approach
Multiple passes
with FoxHollow
SilverHawk ES and
SX catheters
No adjunctive
therapy, i.e. no PTA
or stent
ES SX

SilverHawk BTK Result

Tibio-Peroneal Trunk FoxHollow
60 yr old male
DM >20 yr.
Dyslipidemia.
Remote smoking.
Poor circulation
bilaterally. Non-
healing foot
ulcer.
Failed bypass to
distal vessel right
leg (?PT)
Referred by
Podiatry for
angiography,
revascularization

Right BTK FoxHollow
91 year old male
Very active
Rest and
exertional pain
No iliac disease
Mild
femoropopliteal
disease
RH, FL Hosp, Weinstock 8/9/05

Right BTK FoxHollow
TPT and prox
peroneal tx’d
with SilverHawk
SX
Right ant. tibial
tx’d with
SilverHawk ES
and SX
RH, Florida Hosp, Weinstock 8/9/05

Infra-popliteal CTO FoxHollow
74 M 3V CAD, MR,
Carotid Stenosis,
HTN, CRI, severe
bilateral
claudication
Glide wire / cath,
Fox Hollow ES
and SX devices
(stand-alone)
(Lateral view due
to total knee
replacement)
Single vessel run-
off to foot via
Posterior Tibial
Florida Hospital, Weinstock, 8/19/04

Severe Left PT Disease / Non-Healing Ulcer
Chronically non-healing
ulceration on plantar
surface of left foot
Anterior tibial prox
occlusion
Peroneal distal
occlusion
Severe diffuse disease
mid- and distal left PT
with distal total
occlusion

Left PT Post-Fox Hollow
Prox/Mid Mid/Distal Ankle/Foot

Left PT Post-FoxHollow

CSI DiamondBack Orbital Atherectomy
CLASSIC CROWN SOLID CROWN
Speed: 80, 140, 200K RPMs Speed: 60, 90 120K
1.5 x orbit 1.75 x orbit
Firm, Flexible wires Firm wire
Crown sizes: 1.25, 1.5, 1.75, 2.0, 2.25 Crown sizes: 1.5, 1.75, 2.0, 2.25

Diamondback 360˚
Orbital Atherectomy System
Diamondback Device Controller
•Drive shaft with eccentrically Automatic
mounted abrasive crown speed control
•Proximal and distal sanding action
Fluid infusion
pump
Foot pedal for
procedure
control
Procedure
Guide Wire timers
•Exclusive ViperWire™

Differential Sanding Advantage
• Diamondback minimizes
damage to vessel wall
• Sands non-compliant, calcified
tissue
• Healthy, more elastic tissue
flexes away from crown
• No barotrauma, as with
balloon angioplasty1
1. Ever D Grech. BMJ. 2003;326;1080-1082.

Small Device Creates Large Lumens
2.5 mm crown = 5.75 mm lumen
Before After
70% occluded SFA < 10% residual
Creates Lumen with minimal Barotrauma

OASIS and OASIS LT
Clinical Results
Orbital Atherectomy System for the
Treatment of Peripheral Vascular Stenosis
Safian R. Catheterization and Cardiovascular Interventions. 2009. 73:406–412

OASIS Patient Characteristics
Patients Diabetic CLI Mean Age Male
70.4 + 9.8
124 55% 32% 67%
years
AT
18% TPT
17% PT
Peroneal
37% Popliteal
13%
6% 9% SFA

OASIS Lesion Characteristics
201 treated 48% diffuse 50% focal
lesions (>3 cm) (<3 cm)

OASIS Results
Endpoint OASIS Result
Procedural Success: 30% residual
90%
stenosis with adjunctive therapy
Device Success: ≤ 30% residual stenosis 75%
with orbital atherectomy alone
Mortality (to 30 days) 2 (1.6%)
Major amputations (to 180 days) 0
Patients with planned minor amputation
3 (2.4%)
(to 180 days)

Slide 26
MSOffice1 , 7/16/2007

OASIS Acute Device-Related
Complications
Endpoint Result
Dissections (major) 0
Dissections (minor) 5 (2.5%)
Slow or no flow 2 (1.6%)
Thrombus formation 1 (0.8%)
Embolization 1 (0.8%)
Perforations 2 (1.6%)

Stand-Alone Procedures
in More Than Half

180-Day Target Vessel
and Lesion Revascularization
5.6
6
5
4
% Patients 3 2.4
2
1
0
TVR TLR

OASIS ABI Improvements
Significant at 180 Days
0.9 0.83
0.8
0.69
0.7
0.6
0.5 Baseline
0.4
180 Days
0.3
0.2
0.1
0
p < 0.0001 (t)

Rutherford Class Improves
45
40
35
30
25
# Patients Baseline
20
180 Days
15
10
5
0
0 1 2 3 4 5 6

OASIS LT* Overview
• Retrospective data collection after close of OASIS
study
• 12/17 sites provided long-term data
• 4 sites under IRB
• 8 sites via one-page data sheet
• Purpose:
• Fulfill physician requests for longer-term data
• Confirm durability of OASIS 6-month TLR/TVR results
• Review amputation rates, ABI beyond 6 months
*Presented TCT 2009

OASIS LT Overview
OASIS OASIS LT
Number of patients 124 64
Number of lesions 201 103
Number of sites 17 12
Patient demographics
Gender (M%) 66.9% 71.9%
Age (M/F) 71.7 73.2
Medical history
Diabetes 55.3% 51.6%
Hypertension 91.9% 81.3%
Hyperlipidemia 85.4% 71.4%
Smoker 63.1% 56.5%
Rutherford Class 3 3
ABI 0.68 0.61
Lesions
Below the knee 85.5% 80%
Above the knee 14.5% 20%

Low TVR/TLR
at 2 Years in OASIS LT
15.5%
16% 13.6%
14%
12%
10%
TLR
8% 5.6% TVR
6%
4% 2.4%
2%
0%
OASIS OASIS LT
• OASIS LT patients followed 24+ months (median 29)

OASIS LT Conclusions
• OASIS LT patients followed 24+ months (median 29)
• “LT” patient population smaller, but similar demographics
and lesion characteristics to original OASIS population
• Durable TLR/TVR
• 100% limb salvage rate maintained!
• No additional amputations
• Significantly improved ABI
• 0.61 (at baseline) to 0.90 at last follow-up
• +0.29 ↑from baseline (p<0.0001)

Case History*
• 80 year old male
• Diabetic, hypertensive, CAD, CHF
• Failed 2 previous distal bypasses
• Failed percutaneous attempt
• Consulted for amputation
Presbyterian Hospital, Dallas

Distal Run-Off Prior to
Diamondback

Pre & Post-DB of TPT, AT, PT and
Peroneal

Distal Run-Off Post-Procedure

CSI’s Commitment to Clinical Rigor
Studies Underway Primary Endpoint
COMPLIANCE 360°
Restenosis at 6 and 12 months
• Prospective, randomized (measured by arterial Duplex
• Evaluating the clinical benefit of alteration in vessel compliance by ultrasound) or TLR (including the
comparing the Diamondback 360° to high-pressure balloon angioplasty need for bailout stenting)
• Calcified femoral-popliteal vessels
• 50 patients (25 each arm) First enrollment: June 2009
• 5 sites
CALCIUM 360° Comparison of acute device
• Prospective, randomized success defined as < 30% residual
• Comparing effectiveness of Diamondback 360° to POBA stenosis (via QVA) with no
dissection of grade C or above
• Calcified popliteal, tibial & peroneal lesions
• 50 patients (25 each arm) First enrollment: September 2009
• 5 sites

Conclusions
• Below-the-knee atherectomy is both safe and
effective for treating critical limb ischemia
• Highly encouraging data available from “single arm”
studies of FoxHollow plaque excision and CSI
Diamondback orbital atherectomy
• Laser for CLI supported by several trials also but
with nearly complete use of adjunctive therapy
(angioplasty and/or stent)
• Difficult to determine “best” device for CLI in
absence of randomized trials comparing different
devices

Thank you for your
attention!
Barry S. Weinstock, MD, FACC
Orlando Health
Orlando Regional Medical Center
Orlando, Florida

Back up slides
Excimer Laser for Treatment of CLI

Excimer Laser for CLI
• 145 pts., 15 sites (US & Germany)
• 155 limbs with CLI, 423 lesions
• 41% SFA, 15% popliteal, 41% infra-popliteal
• 70% of patients had multi-level disease
• Laser tx delivered in 99% of cases
• Adjunctive PTA in 96% of cases, Stenting in 45%
• Staightline flow to foot: 89%
• ABI improved from 0.54+0.21  0.84+0.20
*Scheinert, D et al. Excimer laser assisted recanalization of long chronic superfical femoral occlusions. J
Endovasc Ther 2001:8:156-166

Excimer Laser for CLI: LACI 2
• Six month Mortality: 10% (mostly cardiac)
• Six Month Limb Salvage Rate: 92.5%
• 2% required surgical Intv.
• 16% required additional catheter intv.
• Major amputation: 11/145 (8%)
• Rutherford Category
• 69% improved
• 27% stable
• 4% worse

CIS Experience: “LACI Equivalent”
• 62 CLI limbs in 62 patients, Rutherford
Category 5-6 with severe infra-popliteal
disease
• Procedural success: 95.2%
• 14.5% required re-intv’n (mean 7 months)
• Six month mortality: 8.1%, 12 month: 16.6%
• Limb Salvage Rate
• Six month: 91.8%, 12 month: 83.3%
Allie, DE, et al. Excimer Laser Assisted Angioplasty in Severe Infrapopliteal Disease and CLI: The CIS “LACI
Equivalent” Experience, Infrapopliteal Disease and CLI, October 2004

Laser CLI Case (left PT)

Laser CLI Case Study: Mid-PT
Pre-Laser Post-Laser

Laser CLI Case Study: Distal-PT
Pre-Laser Post-Laser

Laser CLI Case Study: Left Foot
Pre-Laser Post-Laser