The document discusses peripheral arterial disease and endovascular treatment options. It provides an overview of various devices for treating peripheral artery disease including nitinol stents, stent-grafts, atherectomy devices, specialized balloons, and crossing devices. It then reviews the evidence from studies on these different technologies and discusses considerations for which devices may be best suited for different types of lesions.

1. Justin McWilliams, MD
Department of Interventional Radiology
University of California – Los Angeles

3.  Part I – Background
 Peripheral arterial occlusive disease
 Tried and true: surgery and angioplasty
 Part II – Device-based review
 Nitinol stents
 Stent-grafts
 Atherectomy devices
 Specialized balloons
 Crossing devices
 Part III – What to use, when?
 A somewhat evidence-based approach
 Part IV – A look forward

4. Background

5.  The arteries of the leg are difficult to treat
 Frequent chronic total occlusion
 Extensive calcification
 Dynamic forces with movement
 High degree of elastic recoil
 Few well-studied treatments
 Bypass surgery (too invasive!)
 Angioplasty (poor durability!)
 Multiple new minimally-invasive technologies
have been introduced, but evidence is scarce
 Few RCTs to show superiority to established
techniques
 No comparative trials between new techniques

7. Primary patency in claudicants
1
0.9
0.8
Cumulative patency
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
0 1 2 3 4 5
Years
Autologous vein Synthetic graft
Angioplasty (stenosis) Angioplasty (occlusion)
1

8. Primary patency in CLI
1
0.9
0.8
Cumulative patency
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0 0
0 1 2 3 4 5
Years
Autologous vein Synthetic graft
Angioplasty (stenosis) Angioplasty (occlusion)
1

9.  Stainless steel stents
 Simpson AtheroCath
 Auth Rotablator
 Neodymium:YAG laser

10.  Stainless steel stents
 Improved immediate technical success
 No benefit in long-term patency
 Simpson AtheroCath
 34% 1-year patency (inferior to PTA)
 Ineffective in long or occluded lesions
 Auth Rotablator
 31-61% 1-year patency, 12-19% 2-year
patency
 Frequent thrombosis, spasm, embolization
A wood-burning 1985 Yugo… proving that different is
not always better.
 Neodymium:YAG lasers
 Thermal energy led to vessel wall damage
 High incidence of thrombosis and spasm
2-7

11.  Stent-grafts
 Cryoplasty
 Cutting balloons
 Drug-eluting balloons

12.  Stainless steel stents
Nitinol stents!
 Simpson AtheroCath
Silverhawk!
 Auth Rotablator
Diamondback!
 Neodymium-YAG laser
Cool-tip excimer laser!

14. Nitinol stents

15. Examples of stainless steel stents. Clockwise:
Gianturco Z stent; Palmaz; Wallstent.
Examples of latest-generation Nitinol stents. Clockwise from
Examples of first-generation Nitinol stents. Top upper left: Conformexx; SMART Control; Lifestent; Protégé
to bottom: Intracoil; Symphony; Memotherm. Everflex; Zilver.

16.  More flexible
 Improved radial strength
 Ability to recover from crushing
 Reduced foreshortening

17. First author Year Structure # and type of Lesion Outcome Comments
patients characteristics
Duda 2005 RCT 57 claudicants or TASC B-C Favorable. Primary patency 89/80/67/59% at 1/2/3/4
(SIROCCO II) (vs. DES) rest pain 8 cm No years. SMART stent.
66% occlusions difference
from DES.
Krankenberg 2007 RCT 244 claudicants TASC A No Primary patency 68% (stent) vs. 61%
(FAST) (vs. PTA) 4.5 cm difference. (PTA) at 1 year. Stent fracture rate 12%.
No difference in PTA versus stent for
30% occlusions short stenoses; likely advantage of stent
over PTA for short occlusions.
Bard Luminexx 3 stent.
Schillinger 2007 RCT 104 patients TASC A-B Favorable. Primary patency 63/51% (stent) vs.
(Vienna (vs. PTA) 90% claudicants ~10 cm Better 37/26% (PTA) at 1/2 years. Better
ABSOLUTE) 35% occlusions than PTA. clinical outcomes for stent group at 6
months, tendency for better outcomes at
2 years. Dynalink or Absolute stent.
Katzen 2010 RCT 230 claudicants TASC A-B Favorable. Primary patency 81% (stent) vs. 37%
(RESILIENT) (vs. PTA) 7 cm Better (PTA) at 1 year. (80% vs 60%). 1-year
15% occlusions than PTA. clinical success 72 vs. 32%. 3.8% stent
fracture rate. 2 year freedom from TLR
78% vs. 42%. Lifestent.
Dake (Zilver IP RCT (vs. 479 patients, TASC A-B Favorable. 0.9% fracture rate at 1 year.
PTX) PTA and mostly 5.5 cm Better
DES) claudicants 30% occlusions than PTA
but inferior
to DES.
8-13

18. First author Year Structure # and type Lesion Outcome Comments
of patients characteristics
Lugmayr 2002 Prospective 44 TASC A-B Favorable Primary patency 87/85/76% at 1/2/3
single center claudicants 3.5 cm years. Secondary patency 91/91/87%.
registry 41% occlusions Symphony stent.
Mewissen 2004 Retrospective 122 patients TASC B-C Favorable Primary patency 76/60% at 1/2 years.
~12 cm SMART stent.
14% occlusions
Ferreira 2007 Retrospective 59 patients, TASC C-D Favorable Primary patency 90/78/74/69% at 1/2/3/4
85% 19 cm years.
claudicants Zilver stent.
Zeller (FACT) 2008 Multicenter 110 patients TASC A-B Favorable Primary patency 77% at 1 year.
registry <10 cm Conformexx stent.
Dosluoglu 2008 Retrospective 127 patients, TASC C-D Favorable - Primary patency 83/80/74% at 1/2/3
(stent vs. CLI and No years for TASC C. 54/28% at 1/2 years
synthetic AK claudicants difference for TASC D. AK bypass 81/75/65% at
bypass) from surgical 1/2/3 years.
bypass SMART stent.
Bosiers 2009 Prospective 151 patients TASC B-C Favorable Primary patency 72% at 1 year. 8%
(DURABILITY) multicenter ~10 cm fracture rate.
registry 40% occlusions Protégé Everflex stent.
14-19

20. Primary patency of latest generation Nitinol stents
100
90
80
Primary patency (%)
70
Mewissen
60 Dosluoglu
50 Duda
Ferreira
40 Dake
30 Zeller
Katzen
20
Bosiers
10
0
1 2 3 4
Years

21.  The role of primary stenting in the SFA is uncertain
 Not all stents are created equal
 Nitinol better suited to SFA than stainless steel
 Different Nitinol stent designs have yielded different results
 Stent re-stenosis is a significant problem
 The latest generation of Nitinol stents have shown
promising early and mid-term results, even in extensive
disease
 Applications
 Bail-out for dissection or suboptimal angioplasty
 Possible primary role in moderate-length stenoses and
occlusions

22. Stent-grafts

23.  0.035” wire compatible
 7F or 8F sheath
 5-8 mm diameters
 ePTFE lining over Nitinol
skeleton
 Prevents tissue ingrowth
 Extremely flexible
 Lengthens and foreshortens
easily

24. Initial angiogram in a 64-year- A Crosser device was used to A 6 mm x 15 cm Viabahn was
old male claudicant pass through the CTO deployed. Final angiography
demonstrates a 12-cm chronic intraluminally. The lesion was demonstrates excellent flow
total occlusion of the left SFA. then pre-dilated. with no residual stenosis.

25. First author Year Structure # and type Lesion Outcome Comments
of patients characteristics
McQuade 2010 Prospective 100 limbs, TASC A-D Favorable. Primary patency 72 and 59% at 1 and 4
randomized 72% 25 cm No difference years. Secondary patency 83 and 74%.
No difference in ABI or limb salvage.
(vs. AK claudicants from surgical
synthetic bypass
bypass)
Saxon 2003 Prospective 28 TASC B-C Favorable. 93% clinical success for Viabahn; 46%
randomized claudicants 7 cm Better than for angioplasty. 87% primary patency at
(vs. PTA) 10% occlusions PTA 2 years for Viabahn; 23% for PTA.
Ansel IP Prospective 148 18 cm No difference Primary patency 53% for Viabahn, 58%
(VIBRANT) randomized from stent for Zilver at 1 year. Secondary patency
(vs. Zilver 93 vs. 98%.
stent)
20-22

26. First author Year Structure # and type Lesion Outcome Comments
of patients characteristics
Jahnke 2003 Single center 52 TASC B-C Favorable Primary patency 78% at 1 year, 74% at 2
registry claudicants 8.5 cm years.
83% occlusions
Fischer 2006 Retrospective 57 10.7 cm Favorable in Primary patency 67/57/45, secondary
claudicants 87% occlusions optimal patency 81/80/69% at 1/3/5 years. With
conditions optimal conditions (no heavy
calcification, no popliteal obstruction, no
complete SFA occlusion, minimum 1
vessel distal runoff, adequate antiplatelet
therapy), primary patency was
80/71/62% at 1/3/5 years.
Saxon 2007 Single center 87 limbs TASC C and D Favorable Primary patency 76% at 1 year, 55% at 4
registry claudicants 14 cm years. Secondary patency 93/79%.
and CLI 42% occlusions Patency independent of lesion length, or
stenosis vs occlusion. 5 mm devices
had worse patency. Clinical success in
88% at mean 28 months.
Farraj 2009 Prospective 32 TASC D Favorable Primary patency 80% at 1 year. 3%
single center claudicants 15 cm subacute thrombosis; 7% restenosis;
registry 10% silent occlusion.
23-26

27. Primary patency of Viabahn endoprosthesis
100
90
80
Primary patency (%)
70
Kedora
60
Saxon 2003
50 Jahnke
40 Fischer
Saxon 2007
30
Farraj
20 Ansel
10
0
1 2 3 4 5
Years

31.  Patency rates appear independent of lesion length and lesion
type in some studies (but VIBRANT suggests otherwise)
 Comparable to above-knee synthetic bypass, superior to PTA
 Flexibility and ability to shorten and lengthen make it well-suited
to SFA
 No fractures have been reported
 Covering collaterals may increase risk of limb threat if re-
thrombosis occurs (uncertain)
 Applications
 Bail-out for perforation or vessel rupture
 Chronic total occlusions
 TASC C and D who can’t have surgery
 In-stent restenosis

32. Directional atherectomy

33.  0.014” compatible monorail
catheter
 Multiple sizes for vessels 2-7 mm
 6F or 7F sheath
 Concave shaped carbide
cutting blade spins at 8000
rpm
 Shaves off plaque as catheter is
advanced
 Long nose cone for plaque
collection

34. After wire placement, advance Slowly advance catheter under Deactivate catheter, which
Silverhawk to near edge of lesion fluoroscopy (1-2 mm/sec) until end straightens it and re-sheaths the
and activate catheter. The cutting of lesion is reached. Ribbons of cutting blade. Withdraw the
blade will be exposed and pressed plaque will be shaved off and stored catheter to the near edge of the
against the plaque. in the nose cone. lesion, rotate it 90 degrees, and
repeat. Empty nose cone as
needed.

35. First Year Structure # and type of Lesion Outcome Comments
author patients characteristics

RamaiahNo prospective randomized trials
2006 Observational 601 patients, 70% ~5 cm Favorable Stand-alone treatment in 73%. Freedom
from TLR 80% at 1 year (primary
(TALON) multicenter claudicants, above patency not reported). Worse outcomes
 Contradictory data
Zeller 2004
registry
Prospective
and below knee
84 patients, above De novo: 4.3 cm Favorable
with longer lesions.
Stand-alone treatment in 35%, 59% low
single center knee. 1/3 each de Restenotic: 10.5 cm pressure PTA, 6% stent. 1-year primary
registry novo, restenotic, In-stent: 13.1 cm patency was 84/54/54% for de
in-stent restenosis 8% occlusions novo/restenotic/in-stent restenosis.
Secondary patency was 100/93/91%.
McKinsey 2008 Prospective 275 patients, 63% TASC A-D Favorable Stand-alone in 65%, 24% adjunctive
single center CLI, above and ~8 cm PTA, 8% stent. Primary patency 62/46%
registry below knee. 39% occlusions at 1/2 years. Secondary patency
80/72%. 88% limb salvage for CLI at 18
months. 1-year primary patency by
TASC class: A-71 B-70 C-56 D-54%.
Biskup 2008 Retrospective 35 patients, 74% TASC A-D Equivocal 1-year primary patency 68%, secondary
CLI, above and 9.4 cm patency 73%. Limb salvage 74% at 6
below knee months.
Chung 2008 Retrospective 19 patients, above TASC A-C Unfavorab Primary patency 10% at one year. 74%
knee le limb salvage.
Keeling 2007 Prospective 60 patients, 67% TASC A-D. Equivocal Stand-alone treatment in 76%. 1-year
single center CLI, above knee. 9 cm primary patency 62%, secondary
registry patency 76%. Limb salvage 86% at 1
year for CLI. 7% embolization rate.
27-32

36.  Plaque debulking without barotrauma
 More effective debulking compared to laser or
rotational atherectomy
 May reduce recurrent intimal hyperplasia (not
proven)
 Technical success >95% in most
series
 Learning curve first 15-25 cases
 Adjunctive PTA needed in 25-50%
 Stent needed in <10%
 Low reported complication rate with
proper use
 Similar to other endovascular techniques
 But… Use of filterwire with SilverHawk
demonstrated plaque embolization in all
cases (0.5-10 mm shavings)
33,60

37. Pros Cons
• Expensive
• Decreases reliance on stents • Limited calcium efficacy
• Time-consuming with long
• Reduces barotrauma; may occlusions (15-90 minutes)
decrease dissection rate and • Not effective in thrombus
intimal hyperplasia
• Possible embolization risk
• Multiple devices if upsizing
• Safer treatment of problem required
areas (CFA, popliteal, branch
points, etc.) • No proof of superiority over
established methods

38.  Role in SFA treatment is uncertain
 Ability to remove plaque is attractive
 Avoids implantable devices
 Apparent good results in complex
lesions and limb salvage
 No RCTs to demonstrate relative
effectiveness
 Possible applications
 Branch points (CFA and
trifurcation)
 In-stent restenosis
 Infrapopliteal lesions in CLI
 Eccentric SFA/popliteal lesions

39. Laser atherectomy

40.  Turbo-Elite excimer laser
 0.9 – 2.5 mm diameters; 4F-8F sheath
 “Cold-tipped”
 Bursts of 308-nm UV energy ablate
plaque and thrombus photochemically
 Shallow tissue penetration = less tissue
damage
 Chronic total occlusions can be
crossed with step-by-step technique
 Converts occlusion to stenosis, possibly
making PTA more effective and durable
 Once the lesion is
recanalized, angioplasty is used to
enlarge the channel (if needed)
 May reduce need for stenting

41.  Laser is “forward-firing”: the
lumen created is only slightly
larger than the catheter itself
 Relatively small volume of
plaque ablated
 Insufficient to fully recanalize
larger vessels (SFA)
 TURBO-Booster deflects the
catheter tip, thereby enlarging the
lumen created
 Functions as a directional
atherectomy catheter
 May reduce need for
adjunctive angioplasty

42. Diffuse, severe in-stent Following 4 passes of Following adjunctive Doppler ultrasound 6 months later demonstrates
restenosis 1 year after TURBO-Booster excimer cryoplasty, an excellent continued patency. The patient is asymptomatic.
placement of a Nitinol laser, the lumen is much angiographic result is
SFA stent. The patient improved. Mild stenosis/ achieved.
presented with irregularity remains.
recurrent claudication.

43. First author Year Structure # and type of Lesion Outcome Comments
patients characteristics
Visona 1998 Single center 78 claudicants, 7.2 cm Equivocal 83% adjunctive PTA. 8% early
registry above knee 100% occlusions thrombosis. Primary patency 47/40% at
1/2 years. Poor results in longer (>10
cm) lesions and poor run-off.
Steinkamp 2002 Single center 312 claudicants, 1-10 cm Favorable 100% adjunctive PTA and/or stent. 4%
registry above knee occlusions perforation. Primary patency 75/62/49%
at 1/2/3 years.
Bosiers 2005 Multicenter 48 CLI, above Unknown; severe Favorable 86% adjunctive PTA and/or stent. 90%
(LACI registry and below knee diffuse disease limb salvage at 6 months.
Belgium)
Laird (LACI) 2005 Multicenter 145 CLI, above TASC C-D Favorable 96% adjunctive PTA, 45% stent. 92%
registry and below knee 16 cm limb salvage at 6 months. 69%
92% occlusions improved Rutherford category. Primary
patency 93% at 6 months.
Stoner 2007 Retrospective 40 patients, 65% TASC B-C Equivocal 75% adjunctive PTA, 14% stent. Primary
CLI. Above and 45% occlusions patency 44% at 1 year. 55% limb
below knee. salvage in CLI. 33% complication rate in
1st month.
Dave 2009 Prospective, 65 claudicants. 5.5 cm Equivocal 77% adjunctive PTA, 23% stent. Primary
(CELLO, not multicenter 16% occlusions patency 54% at 1 year. 78% freedom
yet published) trial from TLR. TURBO-Booster.
34-39

44. Pros Cons
• Can cross and debulk • Relatively small lumen
lesion with one device created
• Facilitates angioplasty at • Expensive
lower pressures, perhaps
lowering dissection rate • Rarely stand-alone
• Good limb salvage rate • Unimpressive patency
in CLI rate in claudicants

45.  No randomized controlled trials
 Expensive, particularly given that adjunctive
PTA and/or stent is almost always needed
 Occasional perforation and distal embolization
 Possible applications
 Limb salvage in CLI
 Long, complex occlusions that are refractory to other
treatments
 In-stent restenosis

46. Orbital atherectomy

47.  0.014” compatible catheter  0.014” compatible catheter
 6F or 7F sheath  8F sheath
 Eccentrically-mounted crown  Cutting tip 2.1 mm with blades
 Crown sizes 1.25-2.25 mm down, 3.0 mm with blades up
 Lumen diameter can be increased
by increasing orbital speed
 2.25 mm crown at max RPM – 4  Control pod allows for
mm lumen created simultaneous saline infusion
and plaque/debris aspiration
 Rotation of crown “sands” down
the plaque
 99% of particles are <5 microns

48. 40-42

49. 40-42

50. First author Year Structure # and type of Lesion Outcome Comments
patients characterist
ics
Safian (OASIS) 2009 Multicenter 124 patients, 3 cm Favorable? Stand-alone in 58%. Adjunctive PTA in
registry 68% claudicants, 12% 39%, stent in 3%. 78% clinical
below knee only occlusions improvement at 6 months. Low
complication rate. Patency unknown.
Diamondback 360.
Wissgott 2008 Single 23 claudicants, 2.6 cm Favorable? Stand-alone in 30%. Adjunctive PTA in
center at or above knee 26% 61%, stent in 9%. 92% primary patency
registry occlusions at 6 months. Pathway.
Zeller 2009 Multicenter 172 patients, 3.5 cm, 31% Favorable Stand-alone in 33%. Adjunctive PTA in
(PATHWAY prospective claudicants and occlusions 57%, stent in 7%. 1-year primary
PVD) trial CLI, above or patency 62% (duplex). Rutherford class
below knee 3.0 (baseline), 1.5 (1 year). 1% MAE.
40-42

51.  Diamondback 360
 Similar mode of action to Rotablator (which
did not improve results of PTA)
 Effective in calcified lesions
 Multiple devices needed for upsizing
 Distal slow-flow/spasm possible; hemolysis
 Limited data set; reasonable safety and
efficacy
 Pathway Jetstream G2
 Similar mode of action to TEC atherectomy
device (which did not improve results of PTA)
 Active aspiration and front-end cutting
 2 sizes in 1 device
 Minimal distal embolization
 Prospective trial showed angiographic and
clinical success and safety
 Uncertain role in PAD treatment at
present
 Further study is awaited

52.  Possible roles
 Stent avoidance
 No stent zones
 Long diffuse non-occlusive
disease
 Stent promotion/expansion
 Densely calcified areas
 Preparation for biologic
restenosis solutions

53. Cutting balloons

54.  0.014” or 0.018” wire
compatible balloon catheter
 6F or 7F sheath
 Monorail or OTW
 4 microsurgical blades mounted
longitudinally on the balloon
 In vitro advantages over PTA
 Decreases inflammatory
response
 Decreases endothelial damage
 Decreases proliferative response
 Achieves larger lumen areas
43-45

55. First author Year Structure # and type Lesion Outcome Comments
of patients characteristics
Canaud 2008 Single 128, 86% CLI <10 cm Favorable Primary patency 75% at 1 and 2 years
center 10% occlusions for fem-pop lesions. 4% dissection rate.
registry
Amighi 2008 RCT vs. 43, 80% 2.5 cm Unfavorable Primary patency 68% at 6 months for
PTA claudicants 25% occlusions PTA; 38% for CBA. 73% clinical patency
for PTA, 38% for CBA.
Dick 2008 RCT vs. 40, 76% In-stent restenosis No Primary patency 27% for CBA, 35% for
PTA claudicants 8 cm difference PTA at 6 months. No difference in ABI
10% occlusions or walking distance. No difference in
laboratory parameters of inflammation.
46-48

56.  In vitro advantages have not been
demonstrated in vivo
 Appears equivalent or even inferior to PTA
 No definite role in PAD treatment at
present
 Possible application in fibrotic/calcified
lesions resistant to conventional PTA

57. Cryoplasty

58.  0.014” or 0.035” wire compatible
balloon catheters
 0.035”: 6F-8F sheath, SFA/popliteal
use
 0.014”: 4F-6F sheath, below knee use
 Nitrous oxide used for balloon
inflation
 Dilates and cools vessel wall to -10° C
simultaneously
 Induces apoptosis in the smooth
muscle cells that contribute to
restenosis
 Alters plaque response
 May result in less dissection, less
elastic recoil, and less re-stenosis
compared to conventional PTA
49-51

59. First Year Structure # and type of Lesion Outcome Comments
author patients characteristics
Fava 2004 Single center 15 claudicants 6.5 cm Favorable? Only 9/15 had 1-year angiographic
registry 33% occlusions follow-up (8 were patent); 2 late
occlusions were not studied
Laird 2005, Single center 102 claudicants 4.5 cm Favorable? Primary patency 70% at 9 months.
2006 registry 15% occlusions Clinical patency 82% at 9 months, 75%
at 3 years. 7% dissection rate.
Samson 2006, Single center 64, 80% 4 cm Favorable, Early results: 82% 1-year patency.
2008 registry claudicants 0% occlusions then Later results: Primary patency 57/49%
at 1/2 years. Less effective in calcified
unfavorable lesions. 8% dissection rate.
Korteweg 2008 Single center 32 claudicants Half TASC A, half Equivocal 67% 1-year primary patency in TASC A.
registry TASC B-C 32% 1-year primary patency in TASC B-
C. No ABI improvement over baseline at
1 year.
Banerjee 2009 Retrospective 27 patients, 39 14 cm Favorable 72% stand-alone; 29% stent. 67%
lesions, 80% 33% occlusions primary patency at 1 year.
claudicants 18% in-stent
Das (BTK 2009 Prospective 108 patients, Infrapopliteal Favorable Adjunctive stent placement in 3%. Limb
CHILL) trial CLI. Below salvage rate 85% at 1 year. Freedom
knee only from TLR 79% at 1 year.
Jahnke 2009 Prospective 77 patients, Popliteal only; No advantage 29% treatment success for cryo, 52% for
(COLD, in randomized 77% claudicants stenosis or (early results) PTA. 9-month patency 76% for cryo,
progress) trial (vs. PTA) occlusion 63% for PTA. 37% dissection rate with
cryo, 26% for PTA.
52-60

60.  Fava 2004: 83% patency at 18 months
 Laird 2006: 75% patency at 3 years
 Samson 2006: 82% patency at 1 year
 Analysis of studies shows:
 Incomplete follow-up
 Subjective outcome measures (“clinical
patency”)
 Non-standard definition of restenosis
52,53,55,69

61.  Samson re-evaluated cryoplasty in 2008
 Often fails in heavily calcified lesions
 Low patency rates (43% at 1 year, 51% at 2 years)
 Adds ~$1700 to cost of procedure
 Technique is no longer used in his practice
 Recent cryoplasty trial for restenosis was abandoned
 All 12 patients developed restenosis within 1 year
 In vivo, no difference from PTA in release of
adhesion molecules, growth factors, and cytokines
 Recent review of cryoplasty concludes that there is
no evidence of any benefit over conventional PTA
56,61,67,68

62.  In vitro advantages have not been
demonstrated in vivo
 Safe and feasible, with low dissection rate,
but no evidence of benefit over PTA
 Expected advantage in restenotic lesions
has not been seen
 No definite role in PAD treatment at
present

63. Drug eluting balloons

64.  Studies in swine demonstrate
sustained inhibition of smooth
muscle proliferation after short
exposure of tissue to paclitaxel Control
 Coated balloon allows more even
delivery of drug to the lesion than a
drug-eluting stent Cypher (sirolimus-
eluting stent)
 Early effectiveness demonstrated in
coronary circulation
Paccocath (paclitaxel-
coated balloon)
70,71

65. First Year Structure # and type Lesion Outcome Comments
author of patients characteristics
Werk 2008 RCT 87 patients, TASC A-D DEB better Primary patency 81% for DEB vs. 53%
(FEMPAC) claudicants 6 cm for PTA at 6 months.
Freedom from TLR 87% for DEB vs.
and CLI 16% occlusions 50% for PTA at 2 years.
Paclitaxel-coated balloon.
Tepe 2008 RCT 154 patients, 7.4 cm DEB better Primary patency 78/68% at 1/2 years for
(THUNDER) claudicants 27% occlusions DEB, 42/41% for PTA.
and CLI 36% restenotic Freedom from TLR 85% for DEB vs.
lesions 48% for PTA at 2 years.
Paclitaxel-coated balloon.
72,73

66.  Promising technology
 Superiority to PTA demonstrated in small
RCTs
 Effective in de novo and restenotic lesions
 Avoids device implantation (except in cases
of dissection or residual stenosis)
 Await FDA approval (2011?) and larger
RCTs

67. Specialized crossing devices

68.  Wire passage across CTO is a requisite
step to recanalization
 About 20% of SFA CTOs are resistant to
conventional crossing techniques
 Fibrous cap
 Heavy calcification
 Long lesions
 Subintimal wire passage with unsuccessful
re-entry

69.  6 French sheath, 0.039” crossing profile
 Catheter jaws create blunt
microdissection through the occlusion
 Micro guide catheter is advanced over the
device to allow distal wire placement

70.  5 French sheath, 0.014” wire compatible
 Low-amplitude, high-velocity microvibration
pulverizes the CTO, creating a channel
 The elastic arterial wall is resistant to the
vibration, allowing the catheter to remain
selectively intraluminal
Advance Pull
Activate Advance
catheter guidewire
catheter guidewire
over back into
and gently into distal
guidewire catheter
advance lumen
to CTO lumen
www.flowcardia.com

71. Outback Pioneer
 6 French sheath, 0.014” wire  7 French sheath, 0.014” wire
compatible compatible
 Use “L” and “T” markers to  Intravascular ultrasound allows
orient re-entry cannula toward orientation of re-entry cannula
true lumen under fluoroscopy toward true lumen
 22 gauge nitinol cannula  Nitinol needle extends into true
deploys into true lumen, followed by wire
lumen, followed by wire passage
passage

72. Chronic total occlusion of SFA. Outback catheter advanced to Needle deployed and wire
Lesion crossed subintimally, but site of reconstitution. passed, followed by angioplasty
wire would not re-enter. Inset: L marker of Outback is and stent placement.
turned in the direction of desired
puncture.

73. First author Year Structure # and type of Lesion Outcome Comments
patients characteristics
Mossop 2006 Prospective 44 patients, iliac 9.5 cm Favorable 91% technical success. 22 minutes
(Frontrunner) trial and SFA average crossing time. Lumen re-entry
catheter necessary in 35% of successful
occlusions crossings. No complications related to
device. Prototype version used.
Gandini 2009 Retrospective 12 patients, 26 cm Favorable 75% technical success. 4 minute
(Crosser) SFA, SFA-pop catheter activation time to cross.
or SFA-distal Failures usually due to extensive
occlusions calcification. No complications.
Steinkamp 2002 Prospective 312 patents, 7.5 cm Favorable 92% technical success. 3% had
(Spectranetics trial SFA occlusions eccentric calcified plaque that could not
laser) be debulked; 4% perforation rate.
Beschorner 2009 Retrospective 61 patients, SFA 20 cm Favorable 88% technical success. 55% of
(Outback) occlusions procedures required pre-dilation of
subintimal space in order to deliver the
catheter. One death related to delayed
femoral bleeding from extensive
puncture attempts.
Jacobs 2006 Retrospective 20 patients, iliac 9.5 cm Favorable 100% technical success. <10 minutes to
(Pioneer) and SFA achieve re-entry. Bleeding at
occlusions recanalization site in 18%, but did not
appear to be at the site of needle
deployment.
62-65

74.  Frontrunner
 Difficult to use and takes the longest.
 35% of crossings are extraluminal (really only 55% success rate!)
 Too large for below-the-knee use.
 Crosser
 Easy to use
 Success rate 64-75%
 Excimer laser
 >90% success rate
 Can cross and debulk with one device
 Occasional perforation
 Outback and Pioneer
 Both are very effective for true lumen re-entry
 Outback favored (smaller sheath size, no IVUS needed)

75. What to use, when?

76.  Poor study design in the endovascular
literature makes it difficult to apply the
existing evidence to individual patient
scenarios
 Small sample sizes
 Patient heterogeneity
 Lesion heterogeneity

77.  Of all the novel endovascular devices, only
three have demonstrated superiority to PTA
in randomized controlled trials
 Nitinol stents – not all trials have shown benefit!
 Stent-grafts – only two small RCTs!
 Drug-eluting balloons – not available in USA!

78.  Conventional angioplasty remains the
treatment of choice for short lesions
 Moderate-length stenoses and occlusions
may be best treated with nitinol stents or
stent-grafts
 Long, complex occlusions may be best
treated with stent-grafts or bypass surgery (or
subintimal angioplasty!)
 Drug-eluting balloons and atherectomy
devices may reduce our reliance on
implantable devices, but further research is
needed

79. A look forward

80. Trial name Year Structure # and type of Lesion Outcome Comments
patients characteristics
SUPER UK, 2005-2008 RCT 150, 120, 120 5-14.5 cm ? SMART stent vs. PTA
SIT-UP,
DURAVEST
ZILVER PTX 2005-? RCT 480 <14 cm ? Paclitaxel-eluting Zilver stent vs.
PTA
VIBRANT 2005-2010 RCT 150 >8 cm ? Viabahn vs. bare nitinol stent
SUPER SL 2005-2008 RCT 200 5-22 cm ? Cordis SMART stent vs. Bard
Luminexx stent
MASCOT 2008-2009 Prospective, 50 >5 cm ? AngioSculpt scoring balloon
non-randomized catheter
trial
DEFINITIVE 2009-2010 Prospective, 800, above and TASC A-D, <20 ? Silverhawk atherectomy
LE non-randomized below knee cm
trial
ATHERO 2006-? Prospective 100 claudicants <10 cm ? Cryoplasty vs. Silverhawk
randomized trial

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86. Conservative Surgical Bypass
• Medical management • Considerable morbidity
• Exercise therapy • Need autologous vein (ideally)
• Often insufficient on its own • 5-year patency 39-74%
Treatment of PAD
Amputation Endovascular
• Last resort • Minimally invasive
• Limb salvage is preferable whenever possible • High technical success rate
• 5-year patency (angioplasty)12-68%

87. Pros Cons
• Extremely flexible (no • Expensive (3-4x cost of
fractures) bare stent)
• Good patency even in • Larger sheath
TASC C-D lesions
• Possible collateral loss
• Occasional acute
thrombosis

88.  Endovascular treatment of peripheral
arterial occlusive disease is rapidly
becoming first-line, regardless of
disease severity
 The explosion of new devices over the
last 10 years has raised more questions
than answers
 The next 10 years should bring much-
needed clarity to PAD treatment