Now That You Crossed How Best
to Treat, is it Art or Science?
Jeffrey E. Indes M.D.
Assistant Professor of Surgery and Radiology
Section of Vascular Surgery
Yale University School of Medicine

No Disclosures

In The Tibials it’s also Anarchy

Not Going to Blind you with
Science…

Tibial Artery Disease
Long CTO’s

Tibial Artery Disease
Diffuse Disease in Long Small arteries

Tibial Artery Disease
Poor Run off

Below-the-Knee, Calcium is a Challenge
Below The Knee Calcium Above The Knee Calcium
30% Heavily
Calcified1
70% Heavily
Calcified1
“… calcification increases in distal arteries in PAD patients” 2
1. CSI data on file.
2. Bishop P, et al. (Cleveland Clinic). Annals of Vascular Surgery. 2008. Vol. 22, Issue 6, p. 799-805.

Beauty is in the Eye of the
Beholder
Art
• Training
• Experience
• Personal preference

A Yale Vascular Surgeon’s
Perspective

I am across, now what do I do?
• Angioplasty
• Cutting balloon
angioplasty
• Cryoplasty
• Directional atherectomy
• Orbital atherectomy
• Laser atherectomy
• Selective Stenting

I am across, now what do I do?
• Angioplasty
• Cutting balloon
angioplasty
• Cryoplasty
• Directional atherectomy
• Orbital atherectomy
• Laser atherectomy
• Selective Stenting

Techniques
• Adequate
anticoagulation is very
important because the
tibial vessels have
slower flow of blood
and a higher propensity
for thrombus formation
than more proximal
vessels
• Nitroglycerin 400mcg
• TPA 4mg
• Papaverine 30 mcg

It’s a long road
Wire in plantar arch

CryoPlasty
 CryoPlasty combines the dilatational force of
angioplasty with delivery of cold thermal energy to
vessel wall.
 Limit use of stents in the Fem-Pop area
 CryoPlasty was developed to:
 Improve the immediate technical results of PTA
 Improve the late results associated with PTA ie.
restenosis

CryoPlasty
 The PolarCath Peripheral
Dilatation System is APOPTOSIS
delivered to the lesion and
is inflated with nitrous oxide SMC
gas. The vessel wall is
cooled with a 20-second
treatment at -10°C.
Inhibits Myointimal Hyperplasia

CryoPlasty
 The PolarCath Peripheral
Dilatation System is APOPTOSIS
delivered to the lesion and
is inflated with nitrous oxide SMC
gas. The vessel wall is
cooled with a 20-second
treatment at -10°C.
Inhibits Myointimal Hyperplasia
Balloon Diameters:
0.035" – 4 thru 8mm
0.014" – 2.0mm, 2.5mm, 3mm, 3.5mm,
4mm, 5 mm, 6 mm
Balloon Lengths:
0.035" – 20, 40, 60, 80 & 100mm
0.014" – 20, 40, 60 & 100mm

Target lesion location (n=102)
SFA 84.3%
pop 13.7%
comb 2.0%
Ref. vessel diameter 5.5+ 0.5 mm
Diameter stenosis 87+10%
Total occlusions 14.7%
Lesion length 4.7+2.6 cm
TASC
A 34.3%
B 25.5%
C 40.2%
JVIR 2005; 16:1067

Procedural success 94.1%
Technical success 85.3%
Dissection rate 6.9%
Bail-out stent rate 8.8% JVIR 2005; 16:1067
Residual diameter stenosis 11+ 11% *
Target lesion revasc 17.8%
TASC A 11.4%
B 15.4%
C 19.5%
9 mon clinical patency 82.2%
9 mon primary patency 70.1%
Extended clinical follow-up (11 to 41 months, mean 31).
• Freedom from TLR = 83.2%
After > 3 years (1253 days)
• Freedom from TLR = 75% J Endovasc Ther. 2006 Feb;13 Suppl 2:II52-9

Limited Data BKA
Below-the-Knee Chill Study Results*
6 mo Outcomes Below-the-Knee Chill Study: 97% Acute technical success (N = 111)
2% >50% residual stenosis
1% Clinically significant dissections (due to guide wire Investigator Report)
6% Non-clinically significant dissections (Type A or B)
93% 180-day freedom from major amputation (N = 91)*
85% 365-day freedom from major amputation (N = 78)*
*N = total limbs reported
www.bostonscientific.com

Cryoplasty-YNHH
• FDA approved September 2002
• Used at YNHH as treatment for
PVD beginning December 2003
• December 2003- August 2007
– 88 Patients treated
– (85 analyzed)

Number of Lesions in 85 Patients
Above
Knee/Knee Below
49 BK Knee
15 46
AK/K+ BK
13
BK+Distal
AK/K 5 13
Distal 1/3
31
26
Distal
8
AK/K+BK+Distal

Cryoplasty of lower leg

Indications According To Lesion
Nonhealing Wounds
BK
Below Knee
Claudication
(15) 46
Rest Pain
Above
Knee/Knee AK/K+ BK
(13)
49 BK+Distal
AK/K (13)
(31)
(5)
Distal
Distal 1/3
(8)
26
AK/K+BK+Distal

Outcomes According To Lesion
Salvage
Bypass BK 6, 40%
Below Knee
BKA (15)
Lost 7, 46% 46
1, 7%
1, 7%
AK/K+ BK
(13)
11, BK+Distal
AK/K 79%
(13)
(31)
1, 7%
5, 36%
6, 43%
9, 29% 2, 14% (5) Distal
0, 0%
16,
3, 21% 0, 0% (8) Distal 1/3
52%
5, 62%
0, 0%
5, 16% 26
1, 3%
3, 38%
0, 0%
AK/K+BK+Distal
Above Knee/Knee 0, 0%
2, 40%
49
0, 0% 3, 60%

Kaplan Meier ANALYSIS
(Technical success rate was 97%)
78%
69%

Does Cryoplasty Have a Role in
Limb Salvage?
Definitely!!

I am across, now what do I do?
• Angioplasty
• Cutting balloon
angioplasty
• Cryoplasty
• Directional atherectomy
• Orbital atherectomy
• Laser atherectomy
• Selective Stenting

Diamondback 360 Components

Unique Mechanism of Action - Centrifugal Force
Speed = Lumen
• Increased Speed and/or decreased radius increase the centrifugal force.
• Greater Centrifugal Force creates greater lumenal gain.
2mm crown at 80k RPM’s 2mm crown at 200k RPM’s
CF=mass*rotational speed2
radius of the orbit
70% occluded SFA < 10% residual

Atherectomy + PTA
CSI Diamondback 1.75mm L,M,H + 3ATM PTA

Atherectomy + PTA
CSI Diamondback 1.25mm L,M + 3ATM PTA

Recent Advances for Tibials
• Pretreat orbital
atherectomy with Nitro
(400mcg) + Papaverine
(30mg) to decrease
vasospasm
• Longer balloons
– Cook advance 18 LP,
Boston Sc Sterling 80mm
– Cordis Sleek + Savvy
220mm
• Cutting balloons

Conclusions
• Art, Science and Anarchy in the tibials
• Science in Devices not Outcomes
• Art = Experience, Training and Preference
• The Outcome to Treating CLI BK is Limb
Salvage Not Primary Patency

Special Thanks for Educational
Grant Support

Thank You