Angioplasty in chronic lower limb ischemia

DR AWADHESH KUMAR SHARMAPGIMER & DR RML HOSPITAL

NEW DELHI

Role of angioplasty in chronic lower limb ischemia

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.

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

History:

3. Critical Stenosis = >60%, impending acute ischemic limb:- rest pain- ischemic ulceration- gangrene

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

1. INTERMITTENT CLAUDICATION• Derived from the Latin word ‘to limp’• “Reproducible pain on exercise which is relieved by rest”

Clinical classification

Vascular Anatomy of Lower Limb

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.

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.

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.

Diagnosis of CLI

Ankle-Brachial Index

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

LAO 30

Commonly used angiographic viewsMost 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 –386Vasc Endovascular Surg. 2002;36:439–445

Non Medical Treatment

Endovascular

Surgical

Options in Limb Revascularization

Endovascular reconstruction optionsPercutaneous transluminal angioplasty (PTA)Stents

Surgical reconstruction optionsAortoiliac/aortofemoral reconstructionFemoropopliteal bypass (above knee and

below knee)Femorotibial bypass

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

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.

FMRP 2011 – 5

BASIL trialPTA vs. bypass surgery

Bradbury et al. (2010) . Journal of Vascular Surgery, 51, 5S-17S.

Amputation-free survival Overall survival

The

sam

e

Endovascular treatmentPercutaneous 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 Inter-Society Consensus(TASC). J Vasc Surg. 2000;31:S1–S296.

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.

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.

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

Aortoiliac 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 occlusionMultifocal stenosesEccentric calcificationPoor runoff

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

REVASCULARIZATION TECHNIQUES

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.

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.

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 steeper-angled entry.

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 <45Â°.

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

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

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

StentsPTA 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.

Endovascular Treatment for Claudication: Iliac Arteries

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII



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).

Stenting is effective as primary therapy for common iliac artery stenosis and occlusions.

Stenting is effective as primary therapy in external iliac artery stenosis and occlusions.

ACC Guidelines 2011

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

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

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

COVERED STENTSCovered 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.

J Endovasc Ther. 2006;13:281–290.

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).

ComplicationsAccess 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.


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

A meta analysis of 19 interventional studies performed between 1999 and 2003 showed that in patients with limb-threatening 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 femoropoplitealocclusive disease: a contemporary series. J Vasc Surg 2006; 44: 762–769.

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.

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

Zilver® PTX™

Paclitaxel onlyNo polymer or binder3 µg/mm2 dose density

Zilver®, self-expanding nitinol stentFlexible, durable platform

Uncoated PTX™ Coated

Clinical OutcomesClinical Measure

Pre-procedure

12 Months 24 Months

ABI0.65 ± 0.26(n = 686)

0.90 ± 0.24 *

(n = 582)0.88 ± 0.21 *

(n = 161)

Most Common Rutherford Score

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)

WalkingSpeed Score

35 ± 28(n = 643)

66 ± 31 *(n = 553)

67 ± 31 *(n = 156)

* p < 0.01 compared to pre-procedure

Keeling et alJVS 2007 45;25-31

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 IntervRadiol. 2005;16:1067–1073.

PELA TrialPeripheral Excimer Laser Angioplasty TrialRandomized 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.

Basics of Femoro-popliteal intervention

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.

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.

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.

The PARADISE trial

Feiring et al, J Am Coll Cardiol 2010

Systematic review of BTK stenting

Biondi-Zoccai et al, J Endovasc Ther 2009

ResultsHead-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 paclitaxel-eluting stents in terms of primary patency (p<0.001) and repeat revascularizations (p=0.014).

Biondi-Zoccai et al, J Endovasc Ther 2009



CONCLUSIONEndovascular 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

THANKS

Education

Angioplasty in chronic lower limb ischemia