Endovascular Treatment in Aorto-Iliac Arterial Disease_cvir

7/27/2019 Endovascular Treatment in Aorto-Iliac Arterial Disease_cvir

1/25

Proofsfo

rReview

Standards for Technical Success and Safety in Aortoiliac

Interventions

Journal: CardioVascular & Interventional Radiology

Manuscript ID: CVR-2012-0794.R2

Manuscript Type: Invited Submission: CIRSE Standards of Practice Guidelines

Key Words/Specialty:

Arterial intervention < SPECIALTY, Clinical Practice < SPECIALTY,Angioplasty/Angiogram < SUB-SPECIALTY/TECHNIQUE, Peripheral Vascular< ORGAN, Revascularization/Revascularisation < SUB-

SPECIALTY/TECHNIQUE, Stenosis/ Restenosis < DISEASE

[email protected]

CardioVascular and Interventional Radiology


2/25


3/25

Proofsfo

rReview

Introduction

In patients with Peripheral Artery Obstructive Disease (PAOD) one third of the lesions affect the

aortoiliac segment [1].

Localized stenosis or occlusion of the infrarenal aorta occurs relatively infrequently, being usually

associated with occlusive disease of the iliac arteries. The most important risk factors for localized

occlusive disease of the infrarenal aorta are heavy smoking, abnormal blood lipid concentrations, and

so-called hypoplastic aorta syndrome [2]. On the other hand, patients with more diffused or multilevel

aortoiliac steno-obstructive disease are much more likely to have other risk factors, such as

hypertension, diabetes, or associated atherosclerotic disease of the coronary or cerebral arteries [2].

Although the percutaneous intervention was born and developed at the beginning as an alternative

treatment to the open surgical by-pass, with the advent of angioplasty and stenting, this technique have

evolved very fast the last two decades [3,4] The design and quality of devices, as well as the ease and

accuracy of performing these procedures, have improved, leading to the preferential treatment of aorto-

iliac steno-obstructive disease via endovascular means with high technical success rate and low

morbidity [5]. This is mirrored by the decreasing number of patients undergoing surgical grafts over the

last years [6-8]. Furthermore, due to the increasing experience and ability of interventionalists,

endovascular procedures are often used as first-line therapy also for extensive, complex aortoiliac

occlusive disease with reduced morbidity and mortality and reported patency, limb salvage, and survival

rates equivalent, to open reconstruction, without precluding any operative option, in case of

unsuccessful outcome [9,10].

These guidelines are intended for use in assessing the standard for technical success and safety in aorto-

iliac interventions and are considered an update of the previously published in 2008 [11].

Any recommendation contained in the text comes from the highest level and extension of literature

review available to date [12]. Recommendations (RC) and Level of Evidence (LOE) are divided in

classes as shown in Appendix I and II.

DefinitionsAnatomy

All this document refers and adopt the TASC II Classification of Aortoiliac lesions [13] (Appendix III).

Clinical Symptoms

The Rutherford clinical classification of disease severity is similar to the Fontaine classification, but is

more commonly cited in newer publications due to the greater clinical accuracy [14].

Page 2

[email protected]



4/25

Proofsfo

rReview

Rutherford

Stage

Fontaine Stage Definition

0 I Asymptomatic

1 IIa Mild Claudication

2 IIb Moderate Claudication

3 Severe claudication

4 III Rest pain

5 IV Ischemic ulceration not exceeding ulcer of the digits of the foot

6 Severe ischemic ulcers or frank gangrene

Claudication is defined as muscle cramps in the leg(s) that occur following exercise and are relieved by

resting. Isolated buttock claudication is usually related to bilateral internal iliac artery stenosis or

obstruction. Symptoms of buttock claudication can occur in association with erectile dysfunction in

patients with absent femoral pulses.

Constellation of symptoms, termed as Leriche syndrome, occurs in case of either pre-occlusive stenosis

or complete occlusion of the infrarenal aorta. Buttock pain extending to both legs and remitting with

rest, should be distiguished from walking and standing induced leg weackness and low back pain wich

could mimic ischemic syndrome but is more likely to be related to spinal canal stenosis.

Rest Pain is defined as pain in feet and toes at rest with or without exacerbation in lying down position

Clinical definition ofCritical Limb Ischemia (CLI) should be used for all patients with chronic ischemic

rest pain, ulcers, or gangrene attributable to objectively proven arterial occlusive disease.

Clinical Signs

Patients often have weakened or absent femoral pulses and a reduced ankle/brachial index (ABI). A

normal resting ABI index is 0.9 to 1.3, whereas an index of 0.49-0.20 is for rest pain and indicative of a

severe PAD; ABI >0.50 is for claudication.

Post-Treatment Evaluation

Outcome timing

Immediate 1-30days after the interventional procedure

Short Term 30days-12months after the procedure

Long Term > 12 months after the procedure

Success

Anatomic


5/25

Proofsfo

rReview

Hemodynamic ABI should be improved by 0.1 or greater above the baseline

value and not deteriorated by more than 0.15 from the

maximum early postprocedural level

Clinical Immediate improvement by at least 1 clinical category*

Technical In the immediate postprocedure time both anatomic and

hemodynamic success should be obtained

* QoL Tests and Walking Tests may also help to accertain the clinical improvement.

The definition ofimprovementused by Rutherford [14] includes clinical and hemodynamic measures:

+3: markedly improved; symptoms are gone or markedly improved; ABI increased to >0.90;

+2: moderately improved; still symptomatic but with improvement in lesion category; ABI

increased by >0.10 but not normalized;

+1: minimally improved; categorical improvement in symptoms without significant ABI

increase (0.10 or less) or vice versa;

0: no change;

-1: mildly worse; either worsening of symptoms or decrease in ABI of >0.10;

-2: moderate worsening; deterioration of the patients condition by one category or unexpected

minor amputation;

-3: marked worsening; deterioration of the patients condition by more than one category or

major amputation.

Complications are graded as minor (not requiring therapy) or major (requiring therapy or unplanned

increase in level of care, prolonged hospitalization, permanent adverse sequelae, death). All

complications and deaths within 30 days or within the same hospitalization should be considered

procedure related.

Pre-treatment Imaging

In order to correctly indicate and plan the endovascular procedure, it is mandatory to:

localize the target lesion

evaluate its extension (involvement of common femoral artery; involvement of aortic or iliac

bifurcation in order to select the stent to implant)

evaluate the involvement of in-flow (arterial system located above the target lesion)

evaluate the involvement of distal run-off (arterial system located below the target lesion, such

as femoro-popliteal-infrapopliteal arteries).

Page 4

[email protected]



6/25

Proofsfo

rReview

The primary imaging modality to be used in the screening of PAOD is Duplex Ultrasonography (DUS),

due to its non-invasive nature, lower risks and costs, while being it strictly dependent on operator skill

and experience. DUS is also useful as post-treatment imaging modality. The degree of stenosis is

estimated by Doppler wave-form analysis and peak systolic velocities and ratios. In detail, modifications

of triphasic waveform can be considered as indirect sign of steno-obstructive disease: a direct sign of

stenosis is represented by an intrastenotic increased peak systolic velocity, as compared with the

adjacent segment. A ratio greater that 2 is commonly used to diagnose a stenosis greater than 50%.

In the evaluation of pelvic arteries DUS is penalized by obesity or gas interposition. The proximal part

of the common iliac artery and the distal part of the external iliac artery can be visualized in about 80%

and >90% respectively. The middle part of the pelvic axis can sufficiently be examined by DUS only in

about 25%. Alternative methods should be considered when the imaging is suboptimal.

Digital Subtraction Angiography (DSA) is the gold standard for imaging of PAOD though it is invasive,

expensive and has a definite, although low, morbidity with a 3-7% complication rate and a mortality rate

of 0.7% [15-17].

Contrast-enhanced MR-angiography (CEMRA) and Multidetector CT-angiography (MDCTA) are both

accurate and reliable non-invasive alternative to conventional DSA. They provide a non-invasive

assessment of vascular anatomy, as well as localization and extension of a vascular lesion, facilitating

planning of interventional or surgical approach in patients with PAOD. CEMRA and MDCTA, however

are not comparable to the high resolution potential of conventional angiography, as they resemble a

static image information on vascular anatomy and pathology without the temporal resolution of DSA.

The advantages of Cross-sectional imaging as opposed to DSA are the non-invasive study of the wall as

well as the possibility to demonstrate pathological findings around the vessels. Both imaging

modalities are today capable to depict vascular lesions with a high degree of sensitivity and specificity.

The data from anatomical imaging should always be analyzed in conjunction with hemodynamic and

clinical tests prior to therapeutic decisions.

The following table summarize the features of the aforementioned imaging modalities and the reference

sources.

Sensitivitystenosis>50%

Specificitystenosis>50%

Advantages Disadvantages/

Limitations

Refer. (LOE)

ge 5 of 24

[email protected]



7/25

Proofsfo

rReview

DUS 85/90 % >90% Low cost

non-invasive

Operator dependent

Obesity/gas interpostion

Lack of full arterial road

map

[15]

[16]

A

MDCTA 96 % 98% Arterial wall

Intra and perivascular evaluation

Contrast Medium

X Rays exposition

Blooming artifacts

[17] A

CEMRA 93-100% 93-100% Arterial wall

Low invasive

Welltolerated

contrast medium

Pace makers

Metal implant, Stent

Claustrophobia

[16]

[17]

A

DSA Gold standard

Dynamic flow

evaluation

Invasiveness

2D flatimaging

Contrast medium

Radiation

The following flowchart summarize the ideal diagnostic pathway of a patient with aortoiliac disease.

RC I (LOE a & b) [15-17]

IndicationsIn symptomatic PAOD there is a general consensus on efficacy of supervised exercise in obtaining

symptoms and time/distance walking capacity improvement (RC I LOE a) [18]. Supervised exercise and

Page 6

[email protected]



8/25

Proofsfo

rReview

best medical treatment can have a long-term benefit comparable to endovascular treatment, especially in

patients with mild to moderate claudication [19]

Although in femoro-popliteal PAOD inadequate response to conservative therapy should always be

demonstrated before starting any invasive procedures, in aorto-iliac obstructive pathology,

revascularization can be considered without attempting to obtaine results with conservative treatment even

in claudication. In CLI, although rare, revascularization is mandatory and is indicated when clinical

features suggest a reasonable likelihood of symptomatic improvement.

When revascularization is indicated, endovascular approach can be considered the first-strategy in all

TASC A-C aorto-iliac lesions, due to the low morbidity and mortality rates and the high technical success

obtained (>90%) (RC I LOE c). Furthermore, it should be considered an endovascualar treatment also for

TASC D aorto-iliac lesions (RC IIb LOE c).

These recommendations suffer from a low evidence level because of a lack of data from published

randomized trials [20-22].

Contraindications

GeneralAbsolute

Medically unstable patients.

Coagulopathy (unless corrected)

Recent myocardial infarction, severe arhythmia or serum electrolyte imbalance

Relative

Impaired renal function (eGFR< 30 ml/min/1.73 m2). Severe allergic reaction to iodinated contrast media.

Buerger disease. Takayasu disease

Anatomical

Some type of lesions D:Obstruction or severe stenosis of the CFA

Abdominal Aortic Aneurism (relative)

PREPARATION

Patient preparation with peripheral venous access, fasting and good hydration follows the standards for

any kind of angiography and vascular intervention. All percutaneous procedures are generally

performed under local anesthetic (Lidocain or Ropivacaine, 7,5mg/ml) with full cardiorespiratory

monitoring.

Antiplatelet Therapy

Pre-procedural ASA antiplatelet therapy is advisable in any case [23-26] (RC I - LOE c).

ge 7 of 24

[email protected]



9/25

Proofsfo

rReview

Based on accepted guidelines, patients should be commenced on low-dose aspirin (150 mg/day) 24 h

prior to the procedure.

Athough other reported options include a 5-7 days pre-procedural anti-aggregation (ASA 100-325

mg/die) , or a loading dose (Clopidogrel 300mg ) just the day of the procedure [23-25] , there is no

evidence of a significant advantage in the routine observation of these protocols in the iliac district .

EQUIPMENT SPECIFICATIONS

Angio-suite: it is the most widespread treatment environment for iliac intervention. The room must be

equipped with a dedicated state-of-the-art C-arm and with standard anaesthesiologic and resuscitation

facilities and drugs. US and DUS equipment should be available on site.

Operatory room: unnecessary; possible only if supplied with high-level DSA equipment

DSA equipment: large FOV, road-map options, rapid and free arc movements, must be considered

essential.

Catheters and Guidewires

Wide range of selective catheters, guidewires, semi or non compliant balloons (6-10mm X 40-150 mm) and

stents (6-12mm X 3-150 mm) should be available. In aorto-iliac procedures large stents up to 34 mm may be

needed. In this vascular segment is still preponderant the use of 0.0035-inch guide-wire rather than smaller

ones. Hydrophilic and stiff guidewires are usually used.

Stent type

Stents for peripheral applications are classified according to their mechanism of expansion [self-

expanding stent (SES) or balloon-expandable stent (BES)], their composition (stainless steel, cobalt-

based alloy, tantalum, nitinol, inert coating, active coating, or biodegradable), and their design (mesh

structure, coil, slotted tube, ring, multi-design, or custom design).

- Nitinol self expandable stents are the most diffusely and frequently used ones. Open cell design

give them high flexibility, therefore the main advantage is their conformability to curved tracts and

to different calibres along the vessel to be treated. Their use is largely commendable throughout the

iliac area.

Single, self expandable, long stents, now commercially available, should be preferred to multiple

overlapped stent placement, making faster and easier the procedure, avoiding stiffening in the

overlapped tracts.

Wallstent, an Elgiloy alloy metallic stent, has been widely employed in the past as the first self-

expandable stent. It has a closed cells meshes design. Advantage is the sheathing allowed before

complete deployment and a good radial force. Its worst feature is the unpredictable shortening and

the relative stiffness. Nowdays it has almost fallen into disuse in aortoiliac district. Radial strenght

of some Nitinol stents is equal if not superior to the Wallstent while preserving a high flexibility

Page 8

[email protected]



10/25

Proofsfo

rReview

- Stainless steel balloon-expandable stents have the advantage of significant radial strength. The main

disadvantage is the stiffness and a need for larger access introducer sheath. They are preferred in

cases of heavy calcified, eccentric, short stenosis/obstruction, particularly in the proximal segment

of the common iliac artery [29,30].

Special devices

Re-entry devices.

These devices allow reentry into the true lumen from the sub-intimal plane during intentional sub-

intimal recanalization (SR) in order to obtain quickly satisfactory angiographic result and in-line blood

flow reconstitution [31].

Covered Stents

Covered stents with Dacron or PTFE membrane should always be available on site together with

adequate sized sheaths allowing their percutaneous use (8-9 F), in order to treat eventual procedural

complications such as arterial ruptures/tears. Stent size to implant should have to be 1-2mm larger than

the reference vessel diameter.

PROCEDURAL FEATURES and VARIATION OF TECHNIQUE

Access

Stenoses

Ipsilateral retrograde approach can be considered the standard technique for interventions in the aorto-

iliac arteries, being safe and simple; in detail, more than 80% of pelvic steno-obstructions can be treated

using this approach. However, some lesions including very distal stenoses of the external iliac artery are

not accessible from the ipsilateral common femoral artery; in these cases the cross-over technique

(contralateral approach) may be helpful to perform the procedure.

Particularly for reconstruction of the aortic bifurcation and procedures in the aortic segment, a bilateral

retrograde femoral access or a combined femoral and brachial access is necessary as these treatments are

typically performed in double ballon/stenting technique (kissing-balloon or kissing-stenting). Whenever

possible the left brachial approach should be performed in order to avoid crossing of the aortic arch with

the attendant risk of cerebral embolization. Direct puncture of the axillary artery, which has been

performed in the early days of angiography is largely abandoned. Future developments may lead to a

broader use of the transradial approach, which currently has an evolving role as minimally invasive

approach for coronary procedures.

Occlusions

ge 9 of 24

[email protected]



11/25

Proofsfo

rReview

Whereas the percutaneous treatment of the iliac artery stenoses is mostly a relatively simple procedure,

the recanalization of a totally occluded iliac artery may be technically challenging. As treatment of

stenoses, possible approaches to the occlusion include the retrograde, the cross-over and the brachial

access.

Although frequently used, the ipsilateral retrograde approach has the disadvantage of more difficult

arterial puncture distally to the occluded segment. Furthermore, it may be difficult to navigate the guide-

wire intraluminally through the occlusion. This may result in extensive dissection of the vessel wall,

which particularly in the region of the aortic bifurcation may cause significant problems/complications.

The antegrade catheter and guides advancement, once broken the fibrous cap, will more likely remain

intraluminally, or in case of sub intimal passage, the true lumen re-entry can occur in the iliac segment.

Long obstructions, expecially when involving the origin of the CIA, often need a combined approach:

antegrade and retrograde

Puncture

In presence of palpable femoral pulse: standard technique

In case of absent or poorly palpable femoral pulse:

US guidance (advisable when possible).

Fluoroscopic guidance (calcifications as landmarks)

Road-map guidance (needs contralateral or brachial access)

Sheath introduction

The majority of balloons, self-expandable stents and re-entry devices can be delivered through sheaths

as small as 6Fr. Devices working on 0.0018inch guidewires can be also delivered thorugh smaller

sheaths. On the other hand, balloon-expandable stents or covered stents need larger sheaths (7-9Fr).

The routine use of larger sheaths (6-7Fr) could be useful to perform a flush control with the stent in

place, just before its deployment.

Aorto-iliac Recanalization

Infra-renal long aorto-iliac steno-obstructions are the most challenging lesions to be recanalized.

It should be performed a retrograde intraluminal recanalization through bilateral transfemoral approach,

with eventual combined arm access to manage and put in tension long guidewires; in selective cases, it

could also be useful to put a guide-wire into the renal and superior mesenteric arteries, as a caution

manouvers bailout for vessel salvage.

Page 10

[email protected]



12/25

Proofsfo

rReview

Large balloon expandable stent can be deployed into the aorta followed by self expandable stents into

the iliac axis (bilateral or unilateral eventually followed by fem-fem by-pass) [38,39]. If the lesion

involves aortic bifurcation, a kissing-stent technique should be performed, by deploying the stents

simultaneously and recreating the aortic bifurcation [38]. For optimal reconstruction of the aorto-iliac

segment, the stents should extend slightly (about 2mm) into the lumen of the aorta to prevent plaque

protrusion at the bifurcation.

Retrograde subintimal recanalization with re-entry into the aorta above the obstruction has been

described as safe but only in small series (RC II b LOE c)

Iliac Recanalization

Intraluminal recanalization should have to be the first option being characterized by a less chance to

induce arterial wall rupture, with sub-intimal approach as secondary option; in this a primary stenting

implantation is mandatory to stabilize the intimal flap.

In the recent literature the subintimal technique appears as a recurrent topic [32-35]. Iliac sub intimal

recanalization seems to be safe as the femoral one [32-34]. However the number of patients is still low

and there is a lack of data comparing sub-intimal vs intraluminal in terms of complications rate and long

term patency.

A stiff J shaped, hydrophilic looped guide wire, advanced subintimally together with an angled support

catheter is the technique of choice. Spontaneous true lumen re-entry in a relatively healthy segment is

possible.

Antegrade dissection distally to the origin of the superficial epigastric artery must be avoided.

The lesions requiring sub intimal recanalization and reentry devices are the most complex ones and have

an increased risk of rupture with angioplasty.

However intentional reentry into the true lumen is possible with the commercially available devices to

date. There is an adequate evidence of safety and efficacy with a success rate ranging from 71 to 100%.

[36,37] RC IIa (LOE c)

Angioplasty and Stenting

PTA is characterized by the possibility of acute technical failure, such as elastic recoil and dissections,

and late restenosis. These limitations have advocated the use of stent placement. The question, wheter or

not all iliac steno-obstructive lesions should undergo stent treatment has been addressed in different

published papers. It was demonstrated that the application of stents improves the immediate

hemodynamic and long-term clinical results of iliac PTA [43,44].

ge 11 of 24

[email protected]



13/25

Proofsfo

rReview

As regarding the primary vs secondary stenting issue, the superiority of primary or direct stenting over

selective stenting has not been proven yet [46,47].

To date, stand alone angioplasty is reasonable in relatively short, nonocclusive lesions; whereas, in more

complex iliac lesions and occlusions, primary stent implantation rather than provisional stenting should

be considered. (RC I - LOE b).

In these cases, predilatation before stenting could be performed [29, 39-41]. Predilation should be

performed in any case of difficult advancement of the catheter or the stent shaft in heavily calcified

lesions, in order to avoid the uncorrect/partial expansion of the stent with possible difficulty in

balloon advancement for post-dilatation. On the other hand, primary stenting without predilatation

may prevent distal embolization by fixation of the atherosclerotic or thrombotic material to the

vessel wall [24,42] (RC IIa LOEc).

Stent and balloon size

Length of the stent should be determined by measurement of the diseased tract.

Self expandable stent diameter should be 1mm oversizing the RVD (reference vessel diameter).

For post dilatation balloons and balloon-expandable stents the diameter should be the same of the inner

vessel diameter.

Diameters mismatch along a vessel requires the use of self expandable stents in order to have moore

possibility of optimal wall apposition. Two or more overlapped stents seem to represent a factor

increasing late restenosis/obstruction risk.[24]

MEDICATION AND PERIPROCEDURAL CARE

Anticoagulation Therapy

An intraprocedural anticoagulation, provided that contraindications for comorbidities are absent, is

always practiced.

Dosage: intra-arterial 5000 IU of unfractioned heparin (UFH) boluses at a distance of one hour is the

most common routine way and dosage administration.

The dose may be adjusted according to patient body weight from 30 up to 80 UI/Kg [26] .

A lower incidence of complications and a substantial corresponding efficacy in the administration of


14/25

Proofsfo

rReview

The patients should receive continuous monitoring of vital signs including blood pressure, cardiac

frequency, oxygen saturation, electrocardiographic tracing, especially when sedation is contemplated.

Pain should be closely monitored . It is moderate and localized in the pelvic site during dilatation and

usually does not require treatment.

Pain persistence also after balloon deflation represents suspect of arterial wall fissuring.

Slowly growing retroperitoneal hematoma, undetected during the procedure, can unfold with bladder

wall extrinsic impaction. US should be available on site to exclude or confirm this contingency.

Vaso-vagal syndrome with hypotension, bradycardia and sweating may occur : heart rate and blood

pressure should be checked out to determine the need for atropine administration at a dosage ranging

from 0.5 to 1 mg.

POST PROCEDURAL FOLLOW-UP CARE

First steps:

Local access site compression and elastic compressive medication

In case of day-surgery or one-day surgery procedures the use of closure devices are preferable

Pain, renal function, and blood pressure monitoring

Peripheral pulses and access site control

In selective cases, in long and complex recanalizations, it should be advisable to perform CT scan in

order to exclude poorly symptomatic tears /hematoma before patient discharge.

Follow-up

F.U. should be composed of clinical examination, palpation of pulses. Clinical evaluation remain a cost-

effective F.U. method.

DUS is highly useful for the follow-up after angioplasty or to monitor bypass grafts. [49] comment

It should be performed 30days after treatment and repeated in case of clinical worsening.

MD-CTA or CE-MRA, should be considered when imaging is suboptimal or when sided dull pain is

persisting.

Medications

Post procedural anticoagulation therapy, although administered by some Authors in the early reports

(1992-2000) can now limited to selected cases, as antiplatelet therapy has replaced it.

ge 13 of 24

[email protected]



15/25

Proofsfo

rReview

Dual antiplatelet therapy composed of ASA combined with clopidogrel or ticlopidine, is indicated in

the majority of the studies and usually maintained for at least one month in carotid, femoral and tibial

districts.

To date there is no evidence of dual antiplatelet therapy benefit in the aorto-iliac interventions. ASA is

recommended as periprocedural theraphy as well for mantainance according to the concurrent clinical

conditions of the patient (26).

Dicumarol anticoagulation and antibiotic therapy coverage are not indicated in standard cases.

(RC I- LOE b)

OUTCOME

Endovascular technical success rate is very high in almost all series and greater than 90%.

As regarding the primary vs secondary stenting issue, the superiority of primary or direct stenting over

selective stenting has not been proven yet [46,47]. In the Dutch Iliac Stent Trial, 279 patients were

randomly assigned to direct stent placement or primary angioplasty with subsequent stent placement in

case of a residual mean pressure gradient greater than 10mmHg across the treated site, with a stent

frequency in this group of 43%. As there were no significant differences in technical results and clinical

outcomes of the two treatment strategies both at short-term and long-term follow-up, provisional

stenting in case of an insufficient angioplasty result can be considered the state-of-art in treatment of

iliac artery stenoses. The immediate postprocedural results of a randomized trial of percutaneous

transluminal angioplasty (PTA) that compared provisional stent placement (stent placement for

unsatisfactory balloon angioplasty results) versus primary stent placement in iliac arteries,

demonstrated that pressure gradients across the lesions after primary stent placement (5.84.7 mm Hg)

were significantly lower than after PTA alone (8.96.8 mm Hg) but not after provisional stent

placement (5.93.6 mm Hg) [45. 46]. The primary clinical success rate, defined as an improvement of at

least 1 clinical grade category, was not different for the primary stent group (81%) than for the PTA plus

provisional stent group (80%). By using provisional stenting, the authors avoided stent placement in

63% of the lesions and still achieved an equivalent acute hemodynamic result compared with primary

stent placement. At a mean follow-up of 5.6 years, there was no difference in repeat interventions

between the 2 groups, with a target-vessel revascularization rate of 18% in the primary stent group and

20% in the provisional stent group [47].

Generally the immediate success is higher in A&B TASC II lesions as compared to C&D. However a

meta-analysis published in 2011, enrolling sixteen articles published between 2000 and 2010, consisting

of 958 patients, demonstrated that early and midterm outcomes of endovascular treatment for TASC D

Page 14

[email protected]



16/25

Proofsfo

rReview

aorto-iliac lesions were acceptable, with a technical success rate and a 12-month primary patency rate of

90.1% and 87.3%, respectively [20]. Furthermore, in the last years, a prospective, non-randomized,

multicenter, multinational trial (BRAVISSIMO study) was conducted enrolling a total of 325 patients,

to validate the product and technique in TASC A&B lesions (190 patients) and to answer the question if

we can extend endovascular treatment as primary approach for TASC C&D lesions (135 patients). Their

published study confirmed that endovascular therapy is the preferred treatment for patients with TASC

A&B aortoiliac lesions [28].

When considering TASC C&D subgroup, even if these results have not been published yet, they

obtained no significant differences in 12-month primary patency between TASC C (55 patients) and

TASC D (80 patients) groups, with a rate of 91.3% and 90.2%, respectively. These and other

preliminary data seem to support an endovascular-first approach also for TASC D aortoiliac lesions.

[21, 22]

The patency rates with stenting of iliac arteries compare favorably with those of surgical

revascularization. However direct data comparison is difficult due to the lack of patients stratification.

A paper comparing open repair vs percutaneous recanalization angioplasty or stenting for extensive

aorto-iliac occlusive disease (AIOD) reports a limb-based primary patency rate at 3 years higher for

aorto bifemoral by-pass (93% vs 74%, P =.002). Secondary patency rates (97% vs 95%), limb salvage

(98% vs. 98%), and long-term survival (80% vs 80%) were similar [10].

The 5- and 10-year, patient based, mean patency rate, has been reported as 85% and 79% for

claudication, 80% and 72 % for CLI (critical limb ischemia). The aggregated sistemic morbidity ranged

from 13.1 % to 8.3 % in moore recent studies [7].

To date there is no proof of the superiority of SES vs BES and vice versa in terms of patency [28]

There has been debate about whether stent architecture or composition has any effect on restenosis rates.

The Cordis Randomized Iliac Stent Project (CRISP) trial failed to show any difference in outcomes

between iliac artery stents made of nitinol (SMART, Cordis, a Johnson & Johnson Company, Miami

Lakes, Fla) and Elgiloy alloy of stainless steel (Wallstent, Boston Scientific, Natick, Mass) at 1 year

[27].

Table 1 and the underlying graphical representation, summarize mean, 3-to10-years, primary and

secondary patency rates after endovascular aortoiliac intervention, from the main series available in the

literature since 1995.

Table 1

ge 15 of 24

[email protected]



17/25

Proofsfo

rReview

3 Years 4 Years 5 Years 10 Years

TASC A/B *

Primary (average) 84% 80% 77% 68%

Secondary (average) 96% 90% 90% 80%

TASC C/D **

Primary (average) 88% 80% 71%

Secondary (average) 98% 95,4% 98%

* [49; 50; 51; 25; 43; 40; 39; 31; 28; 23; 52] (years of pubblications : 1996-2011)

** [28; 23] (year of pubbilcations : 2011)

Unexpectedly the patency of TASC C/D lesions, in recent papers (2011), appears to be longer thanTASC AB lesions, as reported from 1995 to 2011. This could be explained by the fact that data on

TASC C/D lesions come from more recent series, regarding patients treated with stenting, whereas

results on TAS A/B lesions are influenced by older publications data, analyzing cumulative outomes,

including treatments with stand-alone angioplasty or with old generation stent types.

COMPLICATIONS

Cases of retroperitoneal hematoma and hemoglobin drop , although not requiring intervention, are reported

[9] . Iliac arteries rupture during angioplasty /stenting is one of the most dangerous, life-threatening

complication. [32-35,38]

In table 2 are listed the most frequent complications and their mean occurrence rate as from the relative

literature refercences.

Table 2

Page 16

[email protected]



18/25

Proofsfo

rReview

Complication Mean rate (min-max) References

Arterial Rupture 1,73%(0.2-3.4%)

[29, 32, 40, 23, 33, 41, 25,

54, 52]

Arterial dissection 1,95%(0.2-3.6%) [29, 40, 54, 52]Treated vesselThrombosis

1,32%(0.4-3%)

[23, 41, 25, 54]

Distal embolization1,70%

(0.4-3.9%)[29, 40, 23, 33, 41, 25, 54,

52]

Pseudoaneurism6 1,40%(0.4-2%)

[29, 32, 40, 54]

Groin Hematoma3,20%

(1.3-4.3%)[32, 40, 41, 54]

Retroperitoneal Hematoma1,00% [32]

Device Malfunction0,43%

(0.1-1%)[29, 32, 54]

Acute aortic occlusion 0,20% [29]

Cumulative complication Rate7,51%

(4.1-16%)

[29, 32, 40, 23, 33, 41, 25,

54, 52, 50, 53]

Table 3 summarize the management of the main complications

Table 3

CONCLUSIONS

Class LOE

Clinical indications are life style limiting claudication ( Rutheford category 2- 3) in motivated

patients not or poorly responding to conservative therapies or Rutheford category 4-6

I B

Arterial Rupture

Pseudoaneurism

Local high-compliance balloon inflation. In case of failure to stop blood extravasation: covered stent or occlusion

balloon followed by surgical repair or by-pass.

Arterial dissection Prolonged ballooning for flap stabilization or stenting

Treated vessel thrombosis or

distal embolizationCatheter based thrombi aspiration or fibrinolysis [54]

Groin Hematoma

Retroperitoneal HematomaConservative management. Clinical observation and instrumental f.u. Covered stent or surgery

ge 17 of 24

[email protected]



19/25

Proofsfo

rReview

TASC II A-C lesions have an endovascular first option I B

Some TASC II D lesions can have an endovascular first option in experienced centers II a C

DUS is a first level and CE-MRA/MD-CTA a second level imaging examination. They must

be supplemented with clinical and physical examination before therapeutic decisions

I b&c

Pre procedure ASA antiplatelet therapy is advisable in any case. Clopidogrel loading dose only in

selected casesI B

Stent placement and PTA have similar complication rates I A

The application of stents has improved the immediate hemodynamic and probably long-term

clinical results of iliac PTA. However, the superiority of primary or direct stenting over selective

stenting has not been proven

I A

Sub intimal recanalization is feasible upon a sufficient safety level and reentry devices increase the

immediate recanalization success rate without affecting the patency.

IIb C

ASA is recommended as standard theraphy for mantainance according to the concurrent clinical

conditions of the patient I B

Page 18

[email protected]



20/25


21/25

Proofsfo

rReview

color-guided duplex USa meta-analysis. Radiology 2000;216:6777.

16.Collins R, Cranny G, Burch J, Aguiar-Ibanez R, Craig D, Wright K, Berry E, Gough M, Kleijnen

J, Westwood M. A systematic review of duplex ultrasound, magnetic resonance angiography and

computed tomography angiography for the diagnosis and assessment of symptomatic, lower limb

peripheral arterial disease. Health Technol Assess 2007;11:iiiiv, xixiii, 1184.discussion 360

351.

17.Met R, Bipat S, Legemate DA, Reekers JA, Koelemay MJ. Diagnostic performance of computed

tomography angiography in peripheral arterial disease: a systematic review and meta-analysis.

JAMA 2009;301:415424.

18.Watson L, Ellis B, Leng GC. Exercise for intermittent claudication. Cochrane Database Syst Rev

2008;4:CD000990.

19.Spronk S, Bosch JL, den Hoed PT, Veen HF, Pattynama PM, Hunink MG. Intermittent

claudication: clinical effectiveness of endovascular revascularization versus supervised hospital-

based exercise trainingrandomized controlled trial. Radiology 2009;250:586595.

20.Ye W, Liu CW, Ricco JB, Mani K, Zeng R, Jiang J. Early and late outcomes of percutaneous

treatment of TransAtlantic Inter-Society Consensus class C and D aorto-iliac lesions. J Vasc Surg.

2011 Jun;53(6):1728-37

21.Chang IS, Park KB, Do YS, et al.Heavily Calcified Occlusive Lesions of the Iliac Artery: Long-

Term Patency and CT Findings After Stent Placement J Vasc Interv Radiol 2011; 22:11311137

22.Balzer JO, Gastinger V, Ritter R, Herzog C, Mack MG, Schmitz-Rixen T, Vogl TJ. Percutaneous

interventional reconstruction of the iliac arteries: primary and long-term success rate in selected

TASC C and D lesions. Eur Radiol. 2006 Jan;16(1):124-31.

23.Pulli R, Dorigo W, Fargion A, Innocenti AA, Pratesi G, Marek J, Pratesi C Early and long-term

comparison of endovascular treatment of iliac artery occlusions and stenosis J Vasc Surg

2011;53:92-8

24.Sapoval MR, Chatellier G, Long AL, Rovani C, Pagny JY, Raynaud AC, Beyssen BM, Gaux JC.

Self-expandable stents for the treatment of iliac artery obstructive lesions: long-term success and

prognostic factors. AJR Am J Roentgenol. 1996May;166(5):1173-9.

25.Carnevale FC, De Blas M, Merino S, Egaa JM, Caldas JG. Percutaneous endovascular treatment

of chronic iliac artery occlusion. Cardiovasc Intervent Radiol. 2004 Sep-Oct;27(5):447-52.

26.Altenburg A, Haage P. Antiplatelet and anticoagulant drugs in interventional radiology.

Cardiovasc Intervent Radiol 2012; 35: 30-42.

27.Ponec D, Jaff MR, Swischuk J, Feiring A, Laird J, Mehra M, Popma JJ, Donohoe D, Firth B,

Keim E, Snead D; CRISP Study Investigators. The Nitinol SMART stent vs Wallstent for

Page 20

[email protected]



22/25

Proofsfo

rReview

suboptimal iliac artery angioplasty: CRISP-US trial results. J Vasc Interv Radiol. 2004

Sep;15(9):911-8.

28.Bosiers M, Deloose K, Callaert J, Verbist J, Keirse K, Peeters P. BRAVISSIMO study: 12-

month results from the TASC A/B subgroup. J Cardiovasc Surg (Torino). 2012 Feb;53(1):91-9.

29.Ichihashi S, Higashiura W, Itoh H, et al.Long-term outcomes for systematic primary stentplacement in complex iliac artery occlusive disease classified according to Trans-Atlantic Inter-

Society Consensus (TASC)-II J Vasc Surg 2011;53:992-9.)

30.Grenacher L, Rohde S, Ganger E, Deutsch J, Kauffmann GW, Richter GM. In vitro comparison of

self-expanding versus balloon-expandable stents in a human ex vivo model. Cardiovasc Intervent

Radiol 2006;29:249254

31.Krishnamurthy VN, Eliason J L, Henke P K, Intravascular UltrasoundeGuided True Lumen

Reentry Device for Recanalization of Unilateral Chronic Total Occlusion of Iliac Arteries:

Technique and Follow-Up.Ann Vasc Surg 2010; 24: 487-497

32.Chen BL, Holt HR, Day JDet al.Subintimal angioplasty of chronic total occlusion in iliac arteries:

A safe and durable option J Vasc Surg 2011;53:367-73.)

33.Ko YG, Shin S, Kim KJ, Kim JS, Hong MK, Jang Y, Shim WH, Choi D. Efficacy of stent-

supported subintimal angioplasty in the treatment of long iliac artery occlusions J Vasc Surg

2011;54:116-22.

34.Jacobs DL, Cox DE, Motaganahalli R. Crossing chronic total occlusions of the iliac and femoral-

popliteal vessels and the use of true lumen reentry devices. Perspect Vasc Surg Endovasc Ther.

2006 Mar;18(1):31-7.

35.Minko P, Katoh M, Opitz A, Jger S, Bcker A. Subintimal revascularization of chronic iliac

artery occlusions using a reentry-catheter. Rofo. 2011

36.Rezq A, Aprile A, Sangiorgi G. Pioneer re-entry device for iliac chronic total occlusion: Truly a

paradigm shift. Catheter Cardiovasc Interv. 2011 May 3.

37.Etezadi V, Benenati JF, Patel PJ, Patel RS, Powell A, Katzen BT. The reentry catheter: a second

chance for endoluminal reentry at difficult lower extremity subintimal arterial recanalizations. J

Vasc Interv Radiol. 2010 May;21(5):730-4.

38.Varcoe RL, Nammuni I, Lennox AF, Walsh WR. Endovascular reconstruction of the occluded

aortoiliac segment usingdouble-barrel self-expanding stents and selective use of the Outback

LTD catheter. J Endovasc Ther. 2011 Feb;18(1):25-31.

39.Krankenberg H, Schlter M, Schwencke C, Walter D, Pascotto A, Sandstede J, Tbler T.

Endovascular reconstruction of the aortic bifurcation in patients with Leriche syndrome Clin Res

Cardiol (2009) 98:657664

ge 21 of 24

[email protected]



23/25

Proofsfo

rReview

40.Ozkan U, Oguzkurt L, Tercan F.Technique, Complication, and Long-Term Outcome for

Endovascular Treatment of Iliac Artery Occlusion Cardiovasc Intervent Radiol (2010) 33:1824

41.Gandini R, Fabiano S, Chiocchi M, Chiappa R, Simonetti G. Percutaneous Treatment in Iliac

Artery Occlusion: Long-Term Results. Cardiovasc Intervent Radiol (2008) 31:10691076

42.Vorwerk D, Gnther RW. Stent placement in iliac arterial lesions: three years of clinicalexperience with the Wallstent. Cardiovasc Intervent Radiol. 1992 Sep-Oct;15(5):285-90

43.Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and

stent placement for aortoiliac occlusive disease. Radiology. 1997 Jul;204(1):87-96. Erratum in:

Radiology 1997 Nov;205(2):584.

44.AbuRahma AF, Hayes JD, Flaherty SK, Peery W.Primary iliac stenting versus transluminal

angioplasty with selective stenting.J Vasc Surg. 2007 Nov;46(5):965-970

45.Tetteroo E, van der Graaf Y, Bosch JL, van Engelen AD, Hunink MG, Eikelboom BC, Mali WP.

Randomised comparison of primary stent placement versus primary angioplasty followed by

selective stent placement in patients with iliac-artery occlusive disease. Dutch Iliac Stent Trial

Study Group. Lancet. 1998 Apr18;351(9110):1153-9.

46.Tetteroo E, Haaring C, van der Graaf Y, van Schaik JP, van Engelen AD, Mali WP. Intraarterial

pressure gradients after randomized angioplasty or stenting of iliac artery lesions. Dutch Iliac

Stent Trial Study Group. Cardiovasc Intervent Radiol. 1996 Nov-Dec;19(6):411-7

47.Klein WM, van der Graaf Y, Seegers J, Spithoven JH, Buskens E, van Baal JG, Buth J, Moll FL,

Overtoom TT, van Sambeek MR, Mali WP. Dutch iliac stent trial: long-term results in patients

randomized for primary or selective placement. Radiology. 2006 Feb;238(2):734-44.

48.Kasapis C, Gurm HS, Chetcuti SJ, Munir K, Luciano A, Smith D, Aronow HD, Kassab EH, Knox

MF, Moscucci M, Share D, Grossman PM. Defining the optimal degree of heparin anticoagulation

for peripheral vascular interventions: insight from a large, regional, multicenter registry. Circ

Cardiovasc Interv. 2010 Dec;3(6):593-601

49.Bandyk DF, Chauvapun JP. Duplex ultrasound surveillance can be worthwhile after arterial

intervention. Perspect Vasc Surg Endovasc Ther 2007;19:354359; discussion 360351.

50.Vorwerk D, Gunther RW, Schurmmann K,et al. Primary stent placement for chroniciliac artery

occlusions: follow-up results in 103 patients. Radiology 1995; 194:745749.

51.Vorwerk D, Gnther RW, Schrmann K, Wendt G. Aortic and iliac stenoses: follow-up results of

stent placement after insufficient balloon angioplasty in 118 cases. Radiology. 1996

Jan;198(1):45-8.

52.Schrmann K, Mahnken A, Meyer J, Haage P, Chalabi K, Peters I, Gnther RW, Vorwerk D.

Long-term results 10 years after iliac arterial stent placement. Radiology 2002 Sep;224(3):731-8.

Page 22

[email protected]



24/25

Proofsfo

rReview

53.Davies MG, Bismuth J, Saad WE, Naoum JJ, Peden EK, Lumsden AB. Outcomes of

reintervention for recurrent disease after Percutaneous iliac angioplasty and stenting. J endovasc

Ther. 2011 Apr;18(2):169-80

54.Uberoi R, Milburn S, Moss J, Gaines P; BIAS Registry Contributors. British Society of

Interventional Radiology Iliac Artery Angioplasty-Stent Registry III. Cardiovasc Intervent Radiol

(2009) 32:887895

55.Taddei G, Tamellini P, Faccioli N, et al.Thrombolysis during the endovascular treatment of iliac

artery Occlusions. Diagn Interv Radiol 2010; 16:8489

ge 23 of 24

[email protected]



25/25

Proofsfo

rReview

Appendix I (R1)

Classes of

recommendations

Definition Suggested wording to use

Class I Evidence and/or general agreement than a given

treatment or procedure is beneficial, useful, effective

Is recommended/Is

indicated

Class II Conflicting evidence and/or a divergence of opinion

about the usefulness/efficacy of the given treatment

or procedure

Class IIa Weight of evidence/opinion is in favor of

usefulness/efficacy

Should be considered

Class IIb Usefulness/efficacy is less well established by

evidence/opinion

May be considered

Class III Evidence or general agreement that the given

treatment or procedure is not useful/effective, and in

some cases may be harmful

Is not recommended

Appendix II

Levels of Evidence (LOE)

a Data derived from multiple randomized clinical trials or meta-analyses

B Data derived from a single randomized clinical trial or large non-

randomized studies

C Consensus of opinion of the experts and/or small studies, retrospective

studies, registries

Appendix III

TASC classification of aorto-iliac lesions

A - Unilateral or bilateral stenoses of CIA- Unilateral or bilateral single short ( 3 cm) stenosis of EIA

B - Short (3cm) stenosis of infrarenal aorta

- Unilateral CIA occlusion

- Single or multiple stenosis totaling 310 cm involving the EIA not extending into the CFA- Unilateral EIA occlusion not involving the origins of internal iliac or CFA

C - Bilateral CIA occlusions

- Bilateral EIA stenoses 310 cm long not extending into the CFA

- Unilateral EIA stenosis extending into the CFA

- Unilateral EIA occlusion that involves the origins of internal iliac and/or CFA

- Heavily calcified unilateral EIA occlusion with or without involvement of origins of internal

iliac and/or CFAD - Infra-renal aortoiliac occlusion

- Diffuse disease involving the aorta and both iliac arteries requiring treatment

- Diffuse multiple stenoses involving the unilateral CIA, EIA and CFA

- Unilateral occlusions of both CIA and EIA

- Bilateral occlusions of EIA

- Iliac stenoses in patients with AAA requiring treatment and not amenable to endograft

placement or other lesions requiring open aortic or iliac surgery

CIA common iliac artery; EIA external iliac artery; CFA common femoral artery; AAA abdominal

aortic aneurysm

Page 24CardioVascular and Interventional Radiology

Documents

Endovascular Treatment in Aorto-Iliac Arterial Disease_cvir