Role of angioplasty in chronic lower limb ischemia

1. Role of angioplasty in chronic
lower limb ischemia
DR AWADHESH KUMAR SHARMA
PGIMER & DR RML HOSPITAL
NEW DELHI

2. Chronic lower limb
ischemia
Definition:
 Form of PAD or PAOD.
 Occlusive disease of the arteries of
the lower extremity.
 Most common cause:
o Atherothrombosis
Pathophysiology:
•
Arterial narrowing  Decreased blood flow =
Pain
•
Pain results from an imbalance between supply
and demand of blood flow that fails to satisfy
ongoing metabolic requirements.

4. The Facts:
 The prevalence: >55 years is 10%–25%
 Pt’s with PVD alone have the same relative risk of death
from cardiovascular causes.
 Patients with PAD require medical management to prevent
future coronary and cerebral vascular events.
 Prognosis at 1 yr in patient’s with Critical Limb Ischemia (rest
pain):
• Alive with two limbs — 50%
• Amputation — 25%
• Cardiovascular mortality 25%
J Vasc Surg. 2007;45:S5–S67

5. History:
1. INTERMITTENT CLAUDICATION
• Derived from the Latin word ‘to limp’
• “Reproducible pain on exercise which is relieved by rest”
2. Other Symptom/Signs:
• A burning or aching pain in the feet (especially at night)
• Cold skin/feet
• Increased occurrence of infection
• Non-healing Ulcers
3. Critical Stenosis = >60%, impending acute ischemic limb:
- rest pain
- ischemic ulceration
- gangrene

6. Clinical classification

7. Vascular Anatomy of Lower
Limb

8.  Abdominal aorta bifurcates at the level
of the fourth lumbar vertebra
 External iliac artery gives off other
branches, namely the deep circumflex,
cremasteric, and several muscular and
cutaneous branches, before it
continues as the CFA
 CFA after giving branches to
surrounding tissues, such as the
pudendal arteries and the superficial
circumflex artery becomes the
superficial femoral artery (SFA) after
giving rise to the profunda femoris
artery (PFA), roughly 3.5 cm distal to
the inguinal ligament.

9.  The PFA arises laterally and
posteriorly from the CFA, whereas
the SFA continues its pathway, to
end as the popliteal artery. It
terminates into the anterior tibial
artery and the tibioperoneal trunk.
 PFA gives off perforating branches
(usually three, with the end of the
PFA as the fourth perforating
branch), the circumflex (lateral and
medial) arteries, and muscular
branches.

10.  Anterior tibial artery descends
down to the ankle and then
continues to the dorsum of the
foot, where it becomes the dorsalis
pedis artery
 After giving rise to the peroneal
artery, the tibioperoneal trunk
continues as the posterior tibial
artery behind the leg. It passes
behind the medial malleolus to end
by giving rise to the arteries of the
foot— namely the calcaneal artery,
which anastomoses with the
calcaneal and malleolar branches of
the peroneal, and the medial and
lateral planter arteries.

12. Diagnosis of CLI

14. Ankle-Brachial Index

15. Contrast Angiography
 Despite recent advances in the noninvasive evaluation of
lower extremity PAD, contrast angiography remains the
gold standard.
 Abdominal aortogram in the anteroposterior projection
is done using a straight pigtail catheter (5 or 6 Fr) placed
at the level of the L1-L2 vertebrae.
 Angulated views (30 degrees left anterior oblique) can
then be used to visualize the iliac and femoral
bifurcations without overlap.
Vasc Endovascular Surg. 2002;36:439–445

16. LAO 30

18. Commonly used angiographic
views
 Most favorable angulation for iliac angiography is the
contralateral oblique angle, generally 30 to 40 °
 The optimal view for the common femoral bifurcation is 30
to 45° of ipsilateral oblique angulation
 SFA can be imaged in an anteroposterior view with the
addition of an oblique angle if a stenosis is suspected.
 The popliteal artery, tibeoperoneal trunk, and trifurcation
are best imaged in an ipsilateral oblique angle (30°).
 Infrapopliteal runoff can be performed in either an
anteroposterior or an ipsilateral oblique projection
N Engl J Med. 2006;354:379 –386
Vasc Endovascular Surg. 2002;36:439–445

19. Non Medical Treatment
Endovascular
Surgical

20. Options in Limb Revascularization
 Endovascular reconstruction options
Percutaneous transluminal angioplasty (PTA)
Stents
 Surgical reconstruction options
Aortoiliac/aortofemoral reconstruction
Femoropopliteal bypass (above knee and below knee)
Femorotibial bypass

21. Selecting revascularization:
endovascular vs. surgical
 Historically, aortobifemoral bypass surgery gold
standard -excellent long-term patency rates (85%90% at 5 years, 75%-80% at 10 years, and 60% at 20
years); however, may be associated with an
intraoperative mortality rate of approximately 1% to
3% and a major complication rate of 5% to 10%.
de Vries S, Hunink M. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a
meta-analysis. J Vasc Surg 1997;26(4):558-69
 Excellent intermediate- to long-term patency rates
after percutaneous intervention-emergence as an
attractive alternative

22. SWEDISH RANDOMIZED CONTROLLED TRIAL
 In the iliac disease subgroup(37%), the patency rate at 1
year was 90% in the PTA arm and 94% in the surgical arm.
 Adverse events included a 1-year death rate of approximately 10% and a reocclusion
rate of 5% (in both treatment groups)
A major amputation rate of 5.7% for PTA versus 16% for
surgery
 The infection and embolization rates were 8.2% each
Whyman MR, et al. J Vasc Surg 1997;26:551-557.

24. BASIL trial
PTA vs. bypass surgery
Overall survival
Th
e
sa
m
e
Amputation-free survival
Bradbury et al. (2010) . Journal of Vascular Surgery, 51, 5S-17S.
FMRP 2011 –
5

25. Endovascular treatment
 Percutaneous transluminal angioplasty is a minimally invasive
therapy for the treatment of patients with peripheral artery
disease who suffer from chronic lower limb ischemia.
 A low complication rate ranging between 0.5% and 4%, a
high technical success rate approaching 90% even in long
occlusions, and an acceptable clinical outcome.
Dormandy JA, Rutherford RB. Management of
peripheral arterial disease
(PAD): TASC Working Group: TransAtlantic InterSociety Consensus
(TASC). J Vasc Surg. 2000;31:S1–S296.

26.  PTA still is the first and most frequently used methodology.
 However, high rates of failure resulting from an unacceptable
incidence of restenosis, particularly in long and complex
disease, are the main limitations of PTA.
 A mean pressure gradient of 10 mm Hg at rest or 15 mm Hg
after vasodilators across the lesion is considered significant.
Johnston KW. Femoral and popliteal arteries:
reanalysis of results of balloon angioplasty.
Radiology. 1992;183:767–771.

27.  3 major parameters determine the success of any
endovascular procedure:
1. Passage of the recanalization wire through the obstruction,
2. Removal of the obstruction by an endovascular tool, and
3. Keeping the artery open in the short and long term.

29. Indications
 Symptom relief in patients with IC for whom medical
therapy has failed,
 Management of CLI (rest pain, ulceration, or gangrene).
 As part of the preparation for a planned distal lower
extremity bypass surgery to restore or preserve the inflow
to the lower extremity.
 Treatment of flow-limiting dissection after invasive
catheterization-based procedures

30. Aor toiliac Occlusive Disease:
Angioplasty With or Without Stenting
 High procedural success rates
(90%)
 Excellent long-term patency (>70%
at 5 years)
 Factors associated with a poor
outcome:
 Long segment occlusion
 Multifocal stenoses
 Eccentric calcification
 Poor runoff

46. ESC guidelines.European Heart Journal (2011) 32, 2851–2906

47. REVASCULARIZATION
TECHNIQUES

48. Vascular access
 Ipsilateral retrograde femoral artery for high iliac lesions
if the FA is relatively free of disease and there is an
adequate “landing zone” for the sheath
 Contralateral retrograde femoral artery access with a
crossover sheath very effective for most common iliac,
internal iliac, and external iliac lesions, especially useful
if the patient’s ipsilateral disease hinders access.
Vascular medicine and endovascular interventions.
Rooke TW et al [Editors]; Malden: Blackwell Futura
2007.

49.  Both ipsilateral and contralateral femoral access,
particularly with aortoiliac bifurcation disease, chronic
occlusions, and during interventions when a dissection
may have occurred and it is critical to preserve the vessel
via the true lumen
 Uncommon scenarios- popliteal, brachial or radial artery
access
Vascular medicine and endovascular
interventions. Rooke TW et al [Editors];
Malden: Blackwell Futura 2007.

50. Antegrade access
 Considered more challenging technically
 Limits angiography to the ipsilateral leg, but it offers a more stable
platform for intervention.
 The patient's orientation is reversed
 As in retrograde access, the desired site of entry is in the middle of
the CFA below the inguinal ligament, but given the different
angulation, the skin puncture is made at or above the top of the
femoral head
 A 9-cm needle is frequently required, as compared with the standard
7-cm needle used for retrograde access.
 A less acute needle angle, generally <45°, facilitates catheter and
sheath insertion by avoiding the kinking associated with a steeperangled entry.

51. Antegrade femoral artery puncture. The skin nick at the top of the femoral head (needle), with
ideal entry at the middle of the common femoral artery with angle <45°.

52.  To confirm the site of antegrade access, angiography with 30
to 50° of ipsilateral oblique angulation will define the
arteriotomy site in relation to the common femoral
bifurcation.
 Anticoagulation should be administered once the correct
position of the access point has been confirmed.
 Extra care should be taken to remove the antegrade sheath
promptly following the procedure to minimize
complications,consider reversing anticoagulation to facilitate
immediate sheath removal in the catheterization laboratory.
Peripheral Endovascular Interventions.
White RA, et al.; New York: Springer; 1999

53.  Intravenous heparin (3000–6000 units);activated clotting
time (ACT) of at least 200 seconds
 Usually, 0.035-mm guidewires are used, but 0.018 or 0.014
guidewires may be used. For nonocclusive lesions, a regular
nonhydrophilic guidewire may be used, but, if crossing such
lesions is difficult, then the use of hydrophilic wires is
indicated
Acta chir belg, 2004, 104, 532-539

54. Balloon angioplasty
 Because of their large lumen and high flow rates, the iliac
arteries have less risk of restenosis and occlusion than
most other arteries of the periphery and are thus
excellent targets for percutaneous reperfusion.
 Percutaneous transluminal balloon angioplasty (PTA) of
the iliac arteries is an established, safe, and effective
technique with immediate technical success reported in
various series in the 85–97% range

57. Stents
 PTA alone of the iliac artery is highly successful but limited
by elastic recoil of the vessel which decreases acute gain,
acute closure, and restenosis of the occluded segment; and
by intimal dissections which can sometimes be flow limiting.
In addition, PTA has been less successful with certain lesion
characteristics: irregular, ulcerated stenoses, occlusions,
eccentric, or long lesions
 The deployment of stent primarily or immediately after
PTA has significantly reduced the impact of each of these
limitations.

62. Endovascular Treatment for Claudication:
Iliac Arteries
I IIa IIb III
Provisional stent placement is indicated
for use in iliac arteries as salvage therapy
for suboptimal or failed result from balloon
dilation (e.g. persistent gradient, residual
diameter stenosis >50%, or flow-limiting
dissection).
I IIa IIb III
Stenting is effective as primary therapy for
common iliac artery stenosis and
occlusions.
I IIa IIb III
Stenting is effective as primary therapy in
external iliac artery stenosis and occlusions.
ACC Guidelines 2011

64.  When the lesion to be stented is located in a tortuous
arterial segment, Self-expandable stents are more flexible
and better able to conform to the tortuous vessel segment.
 They are better in areas in which there is a quick transition
of vessel diameter, such as from the common iliac artery to
the external iliac artery
 Stents in general are not recommended for placement across
the joints, however if no other options for revascularization
are present, then a self-expandable stent should be selected
because it is more crush-resistant and less likely to have
stent fracture

65.  Balloon-expandable stents are generally sized 1:1 to the
reference vessel diameter
 Operator should seek to achieve full expansion of the
balloon and stent with no evidence of a “waist” within
the stent length.
 Post-dilatation may be required for persistent narrowing

66.  Self-expanding stents are generally sized approximately 1
mm larger than the reference vessel diameter such that they
will continue to exert radial pressure along the length of the
lesion.
 They are also sized approximately 1 cm longer than the
lesion due to the difficulty in precise deployment of the
stent and because the stent will shorten beyond its nominal
length as it is post-dilated

67. COVERED STENTS
 Covered stents playing an increasing role
 Covered stents are usually self-expandable but balloon-
expandable covered stents are also available.
 The major disadvantage to covered stents is the higher
profile of the delivery systems.
J Vasc Surg. 2005;42:185–193.

69. J Endovasc Ther. 2006;13:281–290.

70.  Technical success is commonly defined as less than 30%
residual stenosis (anatomic success), a postintervention
mean translesional gradient of <5 mm Hg, and an
increase in the ABI of at least 0.1 and/or a decrease in
symptoms by one category (hemodynamic success).

72. Complications
 Access site complications - groin hematoma, retroperitoneal
bleed, pseudoaneurysm, arteriovenous fistula formation
 Thrombosis at the site of PTA, arterial rupture, and distal
embolization.Rate of less than 5% to 6% in most series.
 Death, contrast-induced nephropathy, myocardial
infarction, and cerebrovascular accident occur at a rate of
less than 0.5%.
 The need for urgent vascular repair is reported to be about
2%.
J Endovasc Ther. 2006;13:281–290.

78. ESC guidelines.European Heart Journal (2011) 32, 2851–2906

81. Profunda Femoris Artery
 Revascularization of the PFA may be needed in the setting of
total occlusion of the SFA or of a femoropopliteal bypass
graft.
 May be tried in the setting of severe limb-threatening
ischemia if surgery is contraindicated or if the disease
involves the distal portion of the descending branch of the
PFA, which is less accessible to the surgeons.
 No available data regarding the placement of stents .
J Endovasc Ther. 2001;8:75– 82

83.  A meta analysis of 19 interventional studies performed
between 1999 and 2003 showed that in patients with limbthreatening ischemia, 3-year patency rates were 30–43%
following angioplasty and 60–65% following stent
placement.
Conrad, MF, Cambria, RP, Stone, DH, et
al. Intermediate results of percutaneous
endovascular therapy of femoropopliteal
occlusive disease: a contemporary series.
J Vasc Surg 2006; 44: 762–769.

85.  Advantage of placing a stent in the SFA is that it limits
elastic recoil, scaffolds flow-limiting dissection, and
provides a higher acute technical support.
 However, these advantages are counterbalanced by the
stent-induced enhanced endothelial hyperplasic
response, which may result in in-stent restenosis and
negate the noted advantages of stenting on long term
follow-up.

88. Trend for greater efficacy in the sirolimus-eluting stent group, no
statistically significant differences in any of the variables

89. Zilver® PTX™
 Paclitaxel only
 No polymer or binder
 3 µg/mm2 dose density
 Zilver®, self-expanding nitinol stent
 Flexible, durable platform
Uncoated
PTX™ Coated

90. Clinical Outcomes
Clinical
Measure
Preprocedure
12 Months
24 Months
ABI
0.65 ± 0.26
(n = 686)
0.90 ± 0.24 *
(n = 582)
0.88 ± 0.21 *
(n = 161)
3
(n = 433/763)
0*
(n = 290/563)
0*
(n = 77/171)
Walking
Distance
Score
31 ± 26
(n = 659)
71 ± 32 *
(n = 565)
68 ± 33 *
(n = 158)
Walking
Speed
Score
35 ± 28
(n = 643)
66 ± 31 *
(n = 553)
67 ± 31 *
(n = 156)
Most
Common
Rutherford
Score
* p < 0.01 compared to pre-procedure

99. Keeling et alJVS 2007 45;25-31

101. Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D,
Zetterlund P,Moen E, Joye JD. Cryoplasty for the treatment
of femoropopliteal arterialdisease: results of a prospective,
multicenter registry. J Vasc Interv
Radiol. 2005;16:1067–1073.

103. PELA Trial
Peripheral Excimer Laser Angioplasty Trial
Randomized 251 patients with claudication & total SFA
occlusion to either PTA or laser assisted PTA.
At 1 year follow up no benefit.
Steinkamp HJ, Rademaker J, Wissgott C, Scheinert D, Werk M, Settmacher
U, Felix R. Percutaneous transluminal laser angioplasty versus
balloon dilation for treatment of popliteal artery occlusions. J Endovasc
Ther. 2002;9:882– 888.
Scheinert D, Laird JR Jr, Schroder M, Steinkamp H, Balzer JO, Biamino
G. Excimer laser-assisted recanalization of long, chronic superficial
femoral artery occlusions. J Endovasc Ther. 2001;8:156 –166.

104. Basics of Femoro-popliteal
intervention

109.  Though first reported case of endovascular intervention in
the management of infrapopliteal PAD as early as in 1964 by
Dotter and Judkins- endovascular therapy has had a limited
role in the management of infrapopliteal PAD.
 In patients with IC secondary to infrapopliteal PAD, medical
therapy is the most appropriate initial strategy, limited by
recurrence.
 Endovascular procedures below the popliteal artery are
usually indicated for limb salvage.
Dorros, G, Lewin, RF, Jamnadas, P, Mathiak, LM.
Below the-knee angioplasty: tibioperoneal vessels, the
acute outcome.
Cathet Cardiovasc Diagn 1990; 19: 170–178.

110.  Angioplasty of infrapopliteal vessels is reported to have limb
salvage rates of between 92% and 95% in CLI patients.
 Primary stent placement yields primary patency and limb
salvage rates similar to those of angioplasty alone.
 Current guidelines acknowledge the role for provisional
(bail-out) stent placement.
Siablis, D, Kraniotis, P, Karnabatidis, D, et al. Sirolimuseluting versus
bare stents for bailout after suboptimal infrapopliteal angioplasty for
critical limb ischemia: 6-month angiographic results from a
nonrandomized prospective single-center study.
J Endovasc Ther 2005; 12: 685–695.

111.  Tibial angioplasty usually performed with 2- to 4-mm
balloons on catheter shafts of 4 French and smaller.
 In general, 3- and 4-mm balloons are used in the
proximal to mid tibial vessels, 2- and 3-mm balloons are
used in the mid- to distal tibial vessels, and 2-mm
balloons are used in the foot vessels.

113. The PARADISE trial
Feiring et al, J Am Coll Cardiol 2010

114. Systematic review of BTK stenting
Biondi-Zoccai et al, J Endovasc Ther 2009

115. Results
Head-to-head comparisons showed that sirolimus-eluting
stents were superior to balloon-expandable bare metal
stents in preventing restenosis and increasing primary
patency (both p<0.001).
Sirolimus-eluting stents were also better than paclitaxeleluting stents in terms of primary patency (p<0.001) and
repeat revascularizations (p=0.014).
Biondi-Zoccai et al, J Endovasc Ther 2009

118. ESC guidelines.European Heart Journal (2011) 32, 2851–2906

119. ESC guidelines.European Heart Journal (2011) 32, 2851–2906

120. CONCLUSION
 Endovascular treatment of lower-extremity PAD
continues to evolve, with the expectation of
improvement in acute success rates and safety and the
anticipation of improving long-term durability with
newer technologies ranging from local drug delivery to
bioabsorbable stents.
 In future, increasing use of endovascular techniques
likely to replace surgical revascularization

122. THANKS