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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
81.
82. 1. Hunink MG, Wong JB, Donaldson MC, et al. Patency results of percutaneous and surgical revascularization for femoropopliteal
arterial disease. Med Decis Making 1994;14:71.
2. Muradin GS, Bosch JL, Stijnen T, Hunink MG. Balloon dilation and stent implantation for treatment of femoropopliteal arterial
disease: meta-analysis. Radiology 2001;221:137-45.
3. Mwipitayi BP, Hockings A, Hofmann M, et al. Balloon angioplasty compared with stenting for treatment of femoropopliteal occlusive
disease: a meta-analysis. J Vasc Surg 2008;47:461-469.
4. Kasapis C, Henke PK, Chetcuti SJ, et al. Routine stent implantation vs. percutaneous transluminal angioplasty in ffemoropopliteal
artery disease: a meta-analysis of randomized controlled trials. Eur Heart J 2009;30:44-55.
5. Ahn SS, Concepcion B. Current status of atherectomy for peripheral arterial occlusive disease. World J Surg 1996;20:635-643.
6. Vroegindeweij D, Tielbeek AV, Buth J, et al. Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery
disease: two-year follow-up with color-flow duplex scanning. J Vasc Surg 1995;21:255-268.
7. Cumberland DC, Sanborn TA, Tayler DI, et al. Percutaneous laser thermal angioplasty: initial clinical results with a laser probe in
total peripheral artery occlusions. Lancet 1986;1:1457-1459.
8. Zdanowski Z, Albrechtsson U, Lundin A, et al. Percutaneous transluminal angioplasty with or without stenting for femoropopliteal
occlusions? A randomized controlled study. Int Angiol 1999;18:251-255.
9. Duda SH, Bosiers M, Lammer J, et al. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease:
the SIROCCO II trial. J Vasc Interv Radiol 2005;16:331-338.
10. Krankenberg H, Schluter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in
superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation 2007;116:285-292.
11. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N
Engl J Med 2006;354:1879-88.
12. Schillinger M, Sabeti S, Dick P, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon
angioplasty with optional stenting. Circulation 2007;115:2745-49.
13. Katzen BT. The RESILIENT trial: two-year update of outcomes. Paper presented at: International Symposium on Endovascular
Therapy; January 21, 2009; Hollywood, FL.
14. Lugmayr HF, Holzer H, Kastner M, et al. Treatment of complex arteriosclerotic lesions with nitinol stents in the superficial femoral
and popliteal arteries: a midterm follow-up. Radiology 2002;222:37-43.
15. Mewissen MW. Self-expanding nitinol stents in the femoropopliteal segment: technique and mid-term results. Tech Vasc Interv
Radiol 2004;7:2-5.
16. Ferreira M, Lanziotti L, Monteiro M, et al. Superficial femoral artery recanalization with self-expanding nitinol stents: long-term
follow-up results. Eur J Vasc Endovasc Surg 2007;34:702-708.
17. Zeller T, Tiefenbacher C, Steinkamp HJ, et al. Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the
femoral artery conformexx trial (FACT). J Endovasc Ther 2008;15:390-398.
18. Dosluoglu HH, Cherr GS, Lall P, et al. Stenting vs above knee polytetrafluoroethylene bypass for transatlantic inter-society
consensus-II C and D superficial femoral artery disease. J Vasc Surg 2008;48:1166-74.
19. Bosiers M, Torsello G, Gissler HM, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the
DURABILITY I study. J Endovasc Ther 2009;16:261-269.
83. 20. Kedora J, Hohmann S, Garrett W, et al. Randomized comparison of percutaneous viabahn stent grafts vs prosthetic femoral-
popliteal bypass in the treatment of superficial femoral arterial occlusive disease. J Vasc Surg 2007;45:10-16.
21. McQuade K, Gable D, Hohman S, et al. Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-
popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg 2009;49:109-116.
22. Saxon RR, Coffman JM, Gooding JM, et al. Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery:
single center experience from a prospective, randomized trial. J Vasc Interv Radiol 2003;14:303-311.
23. Jahnke T, Andresen R, Muller-Hulsbeck S, et al. Hemobahn stent-grafts for treatment of femoropopliteal arterial obstructions:
midterm results of a prospective trial. J Vasc Interv radiol 2003;14:41-51.
24. Saxon RR, Coffman JM, Gooding JM and Ponec DJ. Long-term patency and clinical outcome of the viabahn stent-graft for
femoropopliteal artery obstructions. J Vasc Interv Radiol 2007;18:1341-50.
25. Fischer M, Schwabe C, and Schulte KL. Value of the hemobahn/viabahn endoprosthesis in the treatment of long chronic lesions of
the superficial femoral artery: 6 years of experience. J Endovasc Ther 2006;13:281-290.fa
26. Farraj N, Srivastava A, and Pershad A. One-year outcomes for recanalization of long superficial femoral artery chronic total
occlusions with the viabahn stent graft. J Invasive Cardiol 2009;21:278-281.
27. Ramaiah V, Gammon R, Kiesz S, et al. Midterm outcomes from the TALON registry: treating peripherals with silverhawk:
outcomes collection. J Endovasc Ther 2006;13:592-602.
28. Zeller T, Rastan A, Sixt S, et al. Long-term results after directional atherectomy of femoro-popliteal lesions. J Am Coll Cardiol
2006;48:1573-78.
29. McKinsey JF, Goldstein L, Khan HU, et al. Novel treatment of patients with lower extremity ischemia: use of percutaneous
atherectomy in 579 lesions. Ann Surg 2008;248:519-528.
30. Biskup NI, Ihnat DM, Leon LR, et al. Infrainguinal atherectomy: a retrospective review of a single-center experience. Ann Vasc
Surg 2008;22:776-782.
31. Chung SW, Sharafuddin MJ, Chiqurupati R, and Hoballah JJ. Midterm patency following atherectomy for infrainguinal occlusive
disease: a word of caution. Ann Vasc Surg 2008;22:358-365.
32. Keeling WB, Shames ML, Stone PA, et al. Plaque excision with the silverhawk catheter: early results in patients with claudication
or critical limb ischemia. J Vasc Surg 2007;45:25-31.
33. Zuckerman G. Doctors take stock, supply data. Wall Street Journal, August 15, 2005.
34. Visona A, Perissinotto C, Lusiani L, et al. Percutaneous excimer laser angioplasty of lower limb vessels: results of a prospective
24-month follow-up. Angiology 1998;49:91-98.
35. Steinkamp HJ, Wissgott C, Rademaker J, et al. Short (1-10 cm) superficial femoral artery occlusions: results of treatment with
excimer laser angioplasty. Cardiovasc Intervent Radiol 2002;25:388-396.
36. Bosiers M, Peeters P, Elst FV, et al. Excimer laser assisted angioplasty for critical limb ischemia: results of the LACI Belgium
study. Eur J Vasc Endovasc Surg 2005;29:613-619.
37. Laird JR, Zeller T, Gray BH, et al. Limb salvage following laser-assisted angioplasty for critical limb ischemia: results of the LACI
multicenter trial. J Endovasc Ther 2006;13:1-11.
38. Stoner MC, deFreitas DJ, Phade SV, et al. Mid-term results with laser atherectomy in the treatment of infrainguinal occlusive
disease. J Vasc Surg 2007;46:289-295.
39. Dave RM. CELLO study: 12 month results. Presented at Leipzig Interventional Course, Leipzig, Germany, January 14, 2009.
40. Safian RD, Niazi K, Runyon JP, et al. Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the
OASIS trial. Catheter Cardiovasc Interv 2009;73:406-412.
84. 41. Wissgott C, Kamusella P, Richter A, et al. Treatment of the femoropopliteal arteries with a novel rotational atherectomy system:
early single-center experience with the pathway PV atherectomy system. Fortschr Rontgenstr 2008;180:809-815. [German]
42. Zeller T, Krankenberg H, Rastan A, et al. Percutaneous rotational and aspiration atherectomy in infrainguinal peripheral arterial
occluisve disease: a multicenter pilot study. J Endovasc Ther 2007;14:357-364.
43. Barath P. Microsurgical dilatation concept: animal data. J Invasive Cardiol 1996;8:2A-5A.
44. Inoue T, Sakai Y, Hoshi K, et al. Lower expression of neutrophil adhesion molecule indicates less vessel wall injury and might
explain lower restenosis rate after cutting balloon angioplasty. Circulation 1998;97:2511-18.
45. Hara H, Nakamura M, Asahara T, et al. Intravascular ultrasonic comparisons of mechanisms of vasodilatation of cutting balloon
angioplasty versus conventional balloon angioplasty. Am J Cardiol 2002;89:1253-56.
46. Canaud L, Alric P, Berthet JP, et al. Infrainguinal cutting balloon angioplasty in de novo arterial lesions. J Vasc Surg 2008;48:1182-
88.
47. Amighi J, Schillinger M, Dick P, et al. De novo superficial femoropopliteal lesions: peripheral cutting balloon angioplasty and
restenosis rates – randomized controlled trial. Radiology 2008;247:267-272.
48. Dick P, Sabeti S, Mlekusch W, et al. Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of
femoropopliteal artery in-stent restenosis: initial experience. Radiology 2008;248:297-302.
49. Tatsutani K, Joye JD, Virmani R, et al. In vitro evaluation of vascular endothelial and smooth muscle cell survival and apoptosis in
response to hypothermia and freezing. Cryo Lett 2005;26:55-64.
50. Mandeville AF and McCabe BF. Some observations on the cryobiology of blood vessels. Laryngoscope 1967;77:1328-50.
51. Durand E, Mallat Z, Addad F, et al. Time courses of apoptosis and cell proliferation and their relationship to arterial remodeling and
restenosis after angioplasty in an atherosclerotic rabbit model. J Am Coll Cardiol 2002;39:1680-85.
52. Fava M, Loyola S, Polydorou A, et al. Cryoplasty for femoropopliteal arterial disease: late angiographic results of initial human
experience. J Vasc Interv Radiol 2004;15:1239-43.
53. Laird J, Jaff MR, Biamino G, et al. Cryoplasty for the treatment of femoropopliteal arterial disease: results of a
prospective, multicenter registry. J Vasc Interv Radiol 2005;16:1067-73.
54. Laird JR, Biamino G, McNamara T, et al. Cryoplasty for the treatment of femoropopliteal arterial disease: extended follow-up
results. J Endovasc Ther 2006;13:II52-59.
55. Samson RH, Showalter DP, Lepore MR Jr, and Ames S. Cryoplasty therapy of the superficial femoral and popliteal arteries: a
single center experience. Vasc Endovascular Surg 2006;40:446-450.
56. Samson RH, Showalter DP, Lepore MR Jr, et al. Cryoplasty therapy of the superficial femoral and popliteal arteries: a reappraisal
after 44 months’ experience. J Vasc Surg 2008;48:634-637.
57. Korteweg MA, van Gils M, Hoedt MT, et al. Cryoplasty for occlusive disease of the femoropopliteal arteries: 1-year follow-up.
Cardiovasc Intervent Radiol 2009;32:221-225.
58. Banerjee S, Brilakis ES, Das TS, et al. Treatment of complex superficial femoral artery lesions with polarcath cryoplasty. Am J
Cardiol 2009;104:447-449.
59. Das TS, McNamara T, Gray B, et al. Primary cryoplasty therapy provides durable support for limb salvage in critical limb ischemia
patients with infrapopliteal lesions: 12-month follow-up results from the BTK chill trial. J Endovasc Ther 2009;16:II19-30.
60. Jahnke T, Muller-Hulsbeck S, Charalambous N, et al. Prospective, randomized single-center study to compare cryoplasty versus
POBA in the popliteal artery: first results. Presented at the Society of Interventional Radiology, 2009.
85. 61. Karthik S, Tuite DJ, Nicholson AA, et al. Cryoplasty for arterial restenosis. Eur J Vasc Endovasc Surg 2007;33:40-43.
62. Mossop PJ, Amukotuwa SA, and Whitbourn RJ. Controlled blunt microdissection for percutaneous recanalization of lower limb
arterial chronic total occlusions: a single center experience. Cath Cardiovasc Interv 2006;68:304-310.
63. Gandini R, Volpi T, Pipitone V, and Simonetti G. Intraluminal recanalization of long infrainguinal chronic total occlusions using the
crosser system. J Endovasc Ther 2009;16:23-27.
64. Beschorner U, Sixt S, Schwarzwalder U, et al. Recanalization of chronic occlusions of the superficial femoral artery using the
outback re-entry catheter: a single centre experience. Catheter Cardiovasc Interv 2009 (online in advance of print).
65. Jacobs DL, Motaganahalli RL, Cox DE, et al. True lumen re-entry devices facilitate subintimal angioplasty and stenting of chronic
total occlusions: initial report. J Vasc Surg 2006;43:1291-96.
66. Kaid KA, Gopinathapillai R, Qian F, et al. Analysis of particulate debris after superficial femoral artery atherectomy. J Invasive
Cardiol 2009;21:7-10.
67. Wildgruber M, Weiss W, Berger H, et al. Early endothelial and heaematological response to cryoplasty compared with balloon
angioplasty of the superficial femoral artery – a pilot study. Br J Radiol 2007;80:430-436.
68. Wildgruber M and Berger H. Cryoplasty for the prevention of arterial restenosis. Cardiovasc Interv Radiol 2008;31:1050-58.
69. Kessel DO, Samson RH. What is the evidence for the efficacy of cryoplasty? J Cardiovasc Surg 2008;49:179-185.
70. Speck U, Scheller B, Abramjuk C, et al. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery
and a drug-eluting stent in porcine coronary arteries. Radiology 2006;240:411-418.
71. Scheller B, Hehrlein C, Bocksch W, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N
Engl J Med 2006;355:2113-24.
72. Werk M, Langner S, Beinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated
balloon: femoral paclitaxel randomized pilot trial. Circulation 2008;118:1358-65.
73. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med
2008;358:689-699.
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
Notes de l'éditeur
Dox and epi but pinocytosis not as good in epi as per al mufasti
Dox and epi but pinocytosis not as good in epi as per al mufasti
Dox and epi but pinocytosis not as good in epi as per al mufasti