CardioVascular and Interventional Radiology

Standards for Technical Success and Safety in Aortoiliac Interventions

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CardioVascular & Interventional Radiology CVR-2012-0794.R2 Invited Submission: CIRSE Standards of Practice Guidelines Arterial intervention < SPECIALTY, Clinical Practice < SPECIALTY, Angioplasty/Angiogram < SUB-SPECIALTY/TECHNIQUE, Peripheral Vascular < ORGAN, Revascularization/Revascularisation < SUBSPECIALTY/TECHNIQUE, Stenosis/ Restenosis < DISEASE

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Standards for Endovascular Treatment in Aorto-iliac Arterial Disease

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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 aortoiliac 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 aortoiliac 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.

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Definitions Anatomy 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].

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Rutherford Fontaine Stage Stage 0 1 2 3 4 5 6 III IV I IIa IIb

Definition

Asymptomatic Mild Claudication Moderate Claudication Severe claudication Rest pain Ischemic ulceration not exceeding ulcer of the digits of the foot

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 of Critical Limb Ischemia (CLI) should be used for all patients with chronic ischemic rest pain, ulcers, or gangrene attributable to objectively proven arterial occlusive disease.

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Severe ischemic ulcers or frank gangrene

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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 Short Term Long Term Success Anatomic <30% final residual luminal stenosis without flow-limiting dissection (Grade D)
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1-30days after the interventional procedure 30days-12months after the procedure > 12 months after the procedure

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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 Technical

Immediate improvement by at least 1 clinical category* 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 of improvement used 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

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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).

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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.

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Specificity

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Sensitivity
stenosis>50%

Advantages

stenosis>50%

Disadvantages/ Limitations

Refer.

(LOE)

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DUS

85/90 %

>90%

Low cost non-invasive

Operator dependent [15] Obesity/gas interpostion [16] Lack of full arterial road map [17]

MDCTA

96 %

98%

Arterial wall Contrast Medium Intra and peri X Rays exposition vascular evaluation Blooming artifacts Arterial wall Low invasive Welltolerated contrast medium Pace makers Metal implant, Stent Claustrophobia

CEMRA

93-100%

93-100%

[16] [17]

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

DSA

Gold standard Invasiveness Dynamic flow 2D flatimaging evaluation Contrast medium Radiation

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

Indications In 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

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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

General Absolute 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).
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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 [selfexpanding stent (SES) or balloon-expandable stent (BES)], their composition (stainless steel, cobaltbased 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 selfexpandable 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
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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 subintimal recanalization (SR) in order to obtain quickly satisfactory angiographic result and in-line blood flow reconstitution [31].

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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 aortoiliac 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

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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 guidewire 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

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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)

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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.

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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.

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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

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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)

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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].

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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

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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

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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 <60 UI/Kg of heparin with a target ACT<250 seconds, compared with major dosage during peripheral arterial endovascular procedures, have been proved. [48] Patient monitoring:

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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

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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 costeffective 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.

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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)

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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

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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

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3 Years 4 Years 5 Years TASC A/B * Primary (average) 84% 80% 77% Secondary (average) 90% 90% 96% TASC C/D ** Primary (average) 80% 88% Secondary (average) 98% 95,4% * [49; 50; 51; 25; 43; 40; 39; 31; 28; 23; 52] (years of pubblications : 1996-2011) ** [28; 23] (year of pubbilcations : 2011)

10 Years 68% 80% 71% 98%

Unexpectedly the patency of TASC C/D lesions, in recent papers (2011), appears to be longer than TASC 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.

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Table 2
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Complication
Arterial Rupture

Mean rate (min-max) 1,73%

(0.2-3.4%) 1,95% (0.2-3.6%) 1,32% (0.4-3%) 1,70% (0.4-3.9%)

References
[29, 32, 40, 23, 33, 41, 25, 54, 52] [29, 40, 54, 52] [23, 41, 25, 54] [29, 40, 23, 33, 41, 25, 54, 52] [29, 32, 40, 54] [32, 40, 41, 54] [32] [29, 32, 54] [29] [29, 32, 40, 23, 33, 41, 25, 54, 52, 50, 53]

Arterial dissection

Treated vesselThrombosis Distal embolization Pseudoaneurism6 Groin Hematoma

1,40%
(0.4-2%) 3,20% (1.3-4.3%) 1,00% 0,43% (0.1-1%) 0,20%

Retroperitoneal Hematoma Device Malfunction Acute aortic occlusion Cumulative complication Rate

Table 3 summarize the management of the main complications

Table 3
Arterial Rupture Pseudoaneurism Arterial dissection Treated vessel thrombosis or distal embolization Groin Hematoma Retroperitoneal Hematoma

Pr oo

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. Prolonged ballooning for flap stabilization or stenting Catheter based thrombi aspiration or fibrinolysis [54]

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

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7,51% (4.1-16%)

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CONCLUSIONS

Class
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

LOE B

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TASC II A-C lesions have an endovascular first option Some TASC II D lesions can have an endovascular first option in experienced centers 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 Pre procedure ASA antiplatelet therapy is advisable in any case. Clopidogrel loading dose only in selected cases Stent placement and PTA have similar complication rates

I II a I I I I

B C b&c B A 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

Sub intimal recanalization is feasible upon a sufficient safety level and reentry devices increase the immediate recanalization success rate without affecting the patency. ASA is recommended as standard theraphy for mantainance according to the concurrent clinical conditions of the patient

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

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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
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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: 12month 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 stent placement in complex iliac artery occlusive disease classified according to Trans-Atlantic InterSociety 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 stentsupported 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 femoralpopliteal vessels and the use of true lumen reentry devices. Perspect Vasc Surg Endovasc Ther.

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paradigm shift. Catheter Cardiovasc Interv. 2011 May 3.

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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 clinical experience 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

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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

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Appendix I (R1) Classes of recommendations Class I Class II Definition Evidence and/or general agreement than a given treatment or procedure is beneficial, useful, effective Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the given treatment or procedure Weight of evidence/opinion is in favor of usefulness/efficacy Usefulness/efficacy is less well established by evidence/opinion Evidence or general agreement that the given treatment or procedure is not useful/effective, and in some cases may be harmful Suggested wording to use Is recommended/Is indicated

Class IIa Class IIb Class III

Should be considered May be considered Is not recommended

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Data derived from multiple randomized clinical trials or meta-analyses Data derived from a single randomized clinical trial or large nonrandomized studies Consensus of opinion of the experts and/or small studies, retrospective studies, registries

Appendix II

Levels of Evidence (LOE) a B C

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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 CFA D - 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
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