D-Stat

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Arterial Closure Devices 81

D-Stat

• D-Stat uses an adhesive dressing containing thrombin and is available for use in

the UK. However, clinical information is limited.

• Application is the same as with the Syvek patch, although the company recom-

mends an initial check after 5 min.

• Once hemostasis is achieved, the patch is left in place with a non-occlusive

dressing for 12–24 h.

• The patch can be used for puncture sites up to 8F, and in patients on anticoagula-

tion and/or antiplatelet therapy.

ChitoSeal

• As with the other devices, the ChitoSeal is a topical hemostasis pad. In this case,

the active ingredient is Chitosan gel.

• Application is the same as with the other two devices, although the company

recommends an initial check after 2–3 min.

• Once hemostasis is established, a dressing is applied and removed within 24 h.

Outcomes

• Published outcome data of closure devices in patients with peripheral vascular

disease are relatively limited.

• Published outcomes for passive VCDs are negligible and the limited evidence

involves active VCDs.

• Unfortunately, the use of arterial vascular closure devices has not eliminated the

occurrence of puncture-site complications.

• In a review of the world literature of VCDs, the minor complication rates are

5.3 and 5.9%, and major complication rates are 1.3 and 4% for Angioseal and

Perclose, respectively.

• In a prospective study of 1605 cardiology patients, the major complication

rates were 3.2, 2.3, and 1% for Angioseal, Perclose, and manual compression,

respectively.

• One of the main problems of such studies is the lack of consistency in the

deﬁnition of complications, particularly hematoma formation.

• Most of the published data on closure devices relates to cardiology patients.

However, complication rates are broadly similar in the few published series of

patients with peripheral vascular disease.

• VCD are used in only 20–25% of all catheter-based procedures and the decision

to use them is generally based on the potential advantages and disadvantages in

each case.

82 S.P. D’Souza and D.M. Seriki

Beneﬁts of VCDS

• Patients with an increased risk of hemorrhage:

Large sheath size

Long complex procedures

Anticoagulation

The need for continued anticoagulation immediately post-procedure, e.g.,

post-carotid stenting.

• Improved catheter laboratory throughput:

With the current Perclose, Angioseal, and Starclose devices, hemostasis is

usually achieved in minutes.

Use of VCDs enables more procedures to be performed on a day-case basis.

• Patient comfort:

These devices allow early mobilization and discharge.

Drawbacks of VCDS

• Potentially long learning curve and device/deployment failure:

Deployment success rates vary from 86 to 100%, with evidence of increased

failure early in the learning curve.

Perclose Prostar deployment failure rates vary from 3.6 to 12% of procedures.

• Small vessels (5 mm or less) are unsuitable for active VCDs .

• Non-common femoral artery (CFA) punctures or antegrade CFA punctures may

not be suitable for a VCD.

• Peripheral vascular disease (PVD) is a frequent contraindication to use endolu-

minal components (e.g., Angioseal) as they may promote vessel thrombosis if the

native vessel lumen is narrow.

• Device costs.

• Patients may still require bed rest post-closure.

• Impaired or delayed CFA re-puncture with some VCDs.

• Catastrophic complications (1–2%, but may be underreported):

Detachment and distal embolization of the footplate of the Angioseal device.

The retrograde movement of the needles of the Prostar Perclose devices can

result in device entrapment in the heavily scarred groins of patients with

prosthetic grafts, requiring surgical removal.

• As all of the collagen plug and suture-mediated closure devices involve leaving

a foreign body at the puncture site, there is an increased risk of local infection,

especially in the presence of a hematoma.

Arterial Closure Devices 83

Conclusions

• As with any situation where there are a number of solutions to a problem, no

single method of achieving hemostasis is perfect.

• Without doubt, the most important step in reducing puncture-site complications is

good technique and operator experience, both with respect to the initial puncture

and the use of the favored closure device.

• The available data make it difﬁcult to recommend the use of closure devices

for all patients, but there are certain circumstances and patient types for which

their use may be particularly advantageous, such as day-case procedures, patients

who are unable to lie ﬂat post-procedure, patients who require immediate

post-procedural anticoagulation, and patients who are unable to stop their anti-

coagulant medication before a procedure (e.g., patients with prosthetic heart

valves).

• Interventional radiologists should become familiar with a few of the available

devices and select each device on the basis of each individual patient.

Key Points

• Arterial closure devices have been shown to reduce the time to hemostasis

and ambulation. This is associated with reduced length of hospital stay and

increased patient satisfaction.

• However, there is no evidence that overall complication rates are reduced

compared with manual compression.

• Closure devices are expensive.

• There is a reasonable case for using closure devices for day-case pro-

cedures, patients who are unable to lie ﬂat post-procedure, patients who

require immediate post-procedural anticoagulation, and patients who are

unable to stop their anticoagulant medication before a procedure (e.g.,

patients with prosthetic heart valves).

Aortoiliac Angioplasty and Stenting

Robert A. Hieb

Diagnostic Evaluation

Clinical

• Aortoiliac occlusive disease often presents as hip, buttock, or thigh claudication.

Diminished or absent femoral pulses as well as impotence in men may also be

noted. This constellation of ﬁndings is known as the “Leriche Syndrome.”

• Hypoplastic aortoiliac syndrome is a similar situation often seen in middle-aged

women with a signiﬁcant smoking history and consists of a severe stenosis at

the terminal abdominal aorta extending into both common iliac arteries. The syn-

drome is thought to represent congenital hypoplasia of the distal aorta aggravated

by tobacco-induced occlusive disease.

• Aortoiliac disease may also be seen as part of more global atherosclerotic

vascular disease in patients with multilevel disease and critical limb ischemia.

• Stigmata of distal embolization in the so-called blue toe syndrome may also be

seen even in the absence of signiﬁcant stenosis. These patients may not describe

pre-existing claudication.

• As with peripheral vascular disease in general, the prevalence of aortoiliac

occlusive disease increases with age and is more common in men than in women.

• Patients usually describe hip, buttock, and thigh claudication, which may be

unilateral or bilateral and occasionally will proceed to calf claudication if

challenged.

• Clinical symptoms of peripheral vascular disease can be classiﬁed using

Fontaine’s stages or Rutherford’s categories (Table 1).

• Note of the severity and duration of the symptoms, as well as aggravating

and alleviating factors should be made. An understanding of the impact of the

symptoms on the patient’s life is essential.

• A focused history with respect to the patient’s risk factors for peripheral arterial

disease should also be obtained. Well-known risk factors for peripheral vascu-

lar disease include increased age (males over age 60 and females over 70), male

gender, family history of peripheral vascular disease, stroke or myocardial infarc-

tion, diabetes mellitus, chronic hypertension, tobacco use hypercholesterolemia,

and coronary artery disease.

R.A. Morgan, E. Walser (eds.), Handbook of Angioplasty and Stenting Procedures,

Techniques in Interventional Radiology, DOI 10.1007/978-1-84800-399-6_8,



Springer-Verlag London Limited 2010

86 R.A. Hieb

Ta bl e 1 Fontaine’s stages and Rutherford’s categories of chronic lower limb ischemia

Fontaine Rutherford

Stage Clinical Grade Category Clinical

I Asymptomatic O 0 Asymptomatic

IIa Mild claudication I 1 Mild claudication

IIb Moderate to severe claudication I 2 Moderate claudication

I 3 Severe claudication

III Ischemic rest pain II 4 Ischemic rest pain

IV Ulceration or gangrene III 5 Minor tissue loss

III 6 Major tissue loss

Reprinted from Norgren L. et al. [3].

• Physical examination should include a complete pulse examination as well as

auscultation for carotid, abdominal, and femoral bruits. Decreased or absent

femoral pulses are commonly found; however, the femoral pulses may be normal

or near normal occasionally.

• At a minimum, bedside ankle/brachial indices (ABIs) should be obtained. Ideally,

a complete vascular laboratory evaluation with ABIs and segmental limb pres-

sures should be performed. An ABI <

0.90 is diagnostic of peripheral vascular

disease. Treadmill testing is useful in the setting of claudication and relatively

normal physical examination and resting ABIs. Post-exercise ABIs demonstrate

an abrupt decrease in lower extremity pressures with a prolonged recovery to

normal. Exercise ABIs can help separate claudication from other causes of lower

extremity symptoms.

Laboratory

• Routine laboratory evaluation as would be obtained prior to any endovascular

procedure is all that is required for aortoiliac intervention. Attention should be

given to the patient’s renal function, coagulation status, and known allergies.

Imaging

• CTA (computed tomographic angiography) and MRA (magnetic resonance

angiography) are t he preferred modalities for imaging peripheral vascular

disease. Both are well suited for aortoiliac disease and are often combined with

“runoff” examinations to evaluate the infrainguinal anatomy. Physician prefer-

ence, institutional expertise or capabilities, as well as patient factors may dictate

the modality of choice. In general, MRA is best for calciﬁc disease and for

patients with allergy to iodinated contrast material, while CTA is best for arterial

aneurysms/dissections and in patients with pacemakers or claustrophobia.

Aortoiliac Angioplasty and Stenting 87

• Catheter angiography is rarely used for diagnostic imaging unless combined

with an intervention or in those rare cases where all contrast must be avoided

necessitating CO

angiography (i.e., severe renal dysfunction).

Endovascular Treatment of Aortoiliac Occlusive Disease

Indications

• The primary indication for aortoiliac intervention is signiﬁcant lifestyle limiting

claudication or limb salvage in the setting of critical limb ischemia and multi-

level disease.

• Mild claudication symptoms may require no therapy, but rather optimal medical

management and reduction of the patient’s general cardiovascular risk factors.

The overall health and activity level of the patient should also be considered.

• Another indication is stent placement over complex/ulcerated aortoiliac athero-

mata responsible for distal embolization in the “blue toe syndrome”

• Endovascular treatment of aortoiliac stenosis as an inﬂow procedure for either

extra anatomic or femoral bypass is also appropriate. Treatment of so-called

inﬂow lesions prior to bypass are often performed as a “hybrid” procedure at

the same setting.

• Aortoiliac intervention may also be performed either preoperatively for renal

transplant surgery or postoperatively in the setting of stenosis proximal to a

transplant renal artery mimicking renal artery stenosis.

Contraindications

• Most contraindications for aortoiliac interventions are relative. However, as with

any endovascular procedure, the risk/beneﬁt ratio must be evaluated with clear

beneﬁt anticipated for the patient.

• Life-threatening contrast allergy, severe renal insufﬁciency in a patient not yet

on dialysis, as well as uncorrectable coagulopathies can be considered medical

contraindications.

• Relative anatomic contraindications include ipsilateral common femoral artery

occlusion, severe aneurysmal disease, or the lack of appropriate, safe arterial

access.

Alternative Therapies

• Monitored exercise program such as daily walking or treadmill programs.

• Risk factor reduction such as smoking cessation (with or without pharmacologic

adjuncts), glycemic and blood lipid control, as well as hypertension management

88 R.A. Hieb

are recommended for all patients with symptomatic peripheral vascular disease.

Antiplatelet therapy in the simple form of one aspirin per day is indicated for

all patients tolerant of this. For patients who are only mildly symptomatic, such

risk factor modiﬁcation may be all that is indicated. Pletal (Cilostazol) has been

shown to improve walking distances in claudicants, especially when coupled with

a supervised exercise program.

• Despite the excellent 3- and 5-year primary patencies for endovascular inter-

ventions, young patients who have severe bilateral iliac occlusive disease and

who are healthy enough to undergo surgery may beneﬁt from consideration for

aortobifemoral bypass. This is especially true if there i s signiﬁcant concomi-

tant common femoral artery disease − also easily corrected during open surgical

bypass.

• Combined open surgical and endovascular procedures (so-called hybrid proce-

dures) such as a common femoral endarterectomy and an iliac intervention are

often performed in the setting of signiﬁcant common femoral disease.

• Extra-anatomic bypasses such as axillofemoral and crossed femoral bypasses

have acceptable 5-year patencies (50−75%) and may be the best option for

patients without endovascular or other surgical options.

Patient Preparation

• Full-informed consent from the patient regarding the nature of the procedure,

the intended outcome, as well as the potential risks and complications should be

obtained. Alternative forms of therapy should be discussed.

• Both groins should be sterilely prepared, as bilateral retrograde femoral artery

access is frequently needed.

• Placement of a urinary bladder catheter should be considered, especially if the

procedure is expected to be lengthy. A large amount of excreted contrast in the

bladder may interfere with imaging and increase pelvic radiation exposure.

Relevant Anatomy

Normal Anatomy

• The aorta enters the abdominal cavity at the level of T12 through the diaphrag-

matic hiatus. It continues along the left anterolateral aspect of the spine until

approximately the L4 vertebral level, where it bifurcates into the common iliac

arteries. The common iliac arteries subsequently divide into the internal iliac

arteries, which supply the pelvis and the external iliac arteries, which continue

to the level of the inguinal ligament, where they become the common femoral

arteries.

Aortoiliac Angioplasty and Stenting 89

• Disease in the abdominal aorta is typically found in the infrarenal segment. The

pattern of occlusive disease may either be focal or diffuse with involvement of

the entire aorta and iliac system. Occasionally, both aneurysmal and occlusive

disease are seen in the same patient.

Aberrant Anatomy

• Aberrant anatomy is usually not a factor in treatment of aortoiliac occlusive dis-

ease. Rarely, however, absent or very short common iliac artery segments may be

seen. Other rare anatomic variants exist, such as a persistent sciatic artery (runoff

to the popliteal artery originates as a branch of the internal iliac artery) with an

absent or hypoplastic external iliac artery.

Equipment

• The importance of adequate imaging in treating aortoiliac disease cannot be over-

stated. The relative depth of the anatomy in question, as well as the frequent

presence of overlying bowel gas can be challenging with suboptimal equipment.

A large ﬁeld of view image intensiﬁer or ﬂat panel system is desirable for com-

plete evaluation of the aortoiliac system. Digital subtraction capabilities as well

as the ability to perform carbon dioxide angiography are also useful.

• Multi side-hole catheters (“pigtails”) are useful for complete angiographic eval-

uation as well as for accurate measurement of pressure gradients. Complex,

long-segment stenoses, and occlusions may require hydrophilic torqueable wires,

directable catheters of various shapes, or chronic total occlusion (CTO) devices

for successful recanalization. Occasionally re-entry devices to regain access to

the true lumen may be necessary after inadvertent subintimal passage.

• In addition, longer sheaths (25 cm), as well as ﬂexible sheaths for contralat-

eral interventions are essential. Radiopaque distal markers on sheaths are most

useful.

Pre-procedure Medications

• There is no consensus (or data) regarding pre procedural antiplatelet therapy for

patients undergoing aortoiliac intervention. However, many patients are already

on some form of antiplatelet therapy either as part of medical management of

their vascular disease or because of a prior endovascular intervention. There

is no need to withhold these medications prior to angiographic evaluation or

intervention.

90 R.A. Hieb

• Occasionally, pre procedural anxiolysis with oral benzodiazepines is helpful for

patients who are overly anxious.

• Routine antibiotic prophylaxis is not warranted. Some advocate prophylactic use

of antibiotics for especially long cases with multiple catheter exchanges, for

patients receiving overnight catheter-directed thrombolysis, or when puncturing

a prosthetic graft.

Procedure

Access

• Use of the patient’s history, physical examination ﬁndings, noninvasive testing,

and pre procedural imaging is mandatory in order to best plan the approach for

aortoiliac revascularization.

• Ipsilateral retrograde common femoral artery access is often the easiest and most

convenient, provided that the pre-procedural imaging is adequate. If such imag-

ing is inadequate or unavailable, the standard practice of retrograde access on the

side of absent or reduced symptoms is favored for thorough diagnostic arterio-

graphic evaluation and subsequent intervention. Bilateral common femoral access

is frequently needed when treating long segment occlusions.

• Fluoroscopic marking of the puncture site is helpful to prevent access related

complication. The use of ultrasound guidance may also be beneﬁcial.

• Arterial access from other than the common femoral artery (CFA) approach, such

as the brachial or axillary arteries is occasionally needed but should be done

carefully due to the increased risk of access related complication.

Angiography

• Flush aortic evaluation with a pigtail or other multi side-hole catheter positioned

above the level of the renal arteries is essential for complete evaluation of the

abdominal aorta. Digital subtraction technique and rapid ﬁlming (3–4 frames per

second) is routine.

• Conventional iodinated contrast and/or carbon dioxide angiographic techniques

may be used depending on the clinical scenario.

• In the setting of aortic stenosis, lateral aortography may be useful to better proﬁle

the extent and severity of the lesion.

• Bilateral oblique pelvic angiography allows for complete evaluation of the distal

aorta, the iliac, and femoral arteries, as well as their respective bifurcations. The

importance of the appearance of the common femoral arteries when contemplat-

ing or performing an aortoiliac intervention cannot be overstated. These vessels

not only serve as the runoff for the intervention, but if highly diseased, are also

much better addressed surgically.

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D-Stat

ChitoSeal

Outcomes

Drawbacks of VCDS

Conclusions

Key Points

Suggested Reading

Aortoiliac Angioplasty and Stenting

Diagnostic Evaluation

Clinical

Laboratory

Imaging

Endovascular Treatment of Aortoiliac Occlusive Disease

Indications

Contraindications

Alternative Therapies

Patient Preparation

Relevant Anatomy

Normal Anatomy

Aberrant Anatomy

Equipment

Pre-procedure Medications

Procedure

Access

Angiography