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Endovascular techniques for lower extremity revascularization

Endovascular techniques for lower extremity revascularization
Literature review current through: Jan 2024.
This topic last updated: Aug 15, 2023.

INTRODUCTION — Endovascular intervention for the treatment of lower extremity arterial disease has been widely adopted due to its minimally invasive nature. With advances in technology including specialized catheters, crossing wires, reentry devices, and increased experience, almost all anatomic lesions can potentially be treated by endovascular means. The success of the intervention is determined by the complexity of the patient's disease overall.

Endovascular interventions for the treatment of lower extremity peripheral arterial occlusive disease, predominantly peripheral artery disease (PAD), is reviewed. The medical management and surgical options for patients with PAD presenting with claudication or chronic limb-threatening ischemia (CLTI; formally termed critical limb ischemia) are presented separately.

(See "Management of claudication due to peripheral artery disease" and "Approach to revascularization for claudication due to peripheral artery disease".)

(See "Management of chronic limb-threatening ischemia".)

(See "Lower extremity surgical bypass techniques".)

BACKGROUND — Endovascular interventions have been widely adopted due to their minimally invasive nature. With advances in technology and increased experience, almost all anatomic lesions can potentially be treated by endovascular means.

A variety of endovascular devices have been developed to treat peripheral arterial occlusive diseases [1-7]. Peripheral devices and the timeline of their development is briefly summarized:

1964 – Teflon dilator

1974 – Balloon angioplasty

1985 – Balloon-expandable stent

1987 – Rotational atherectomy

1989 – Excimer laser atherectomy

1999 – Drug-eluting stents

2004 – Drug-coated balloons

The minimally invasive nature of endovascular techniques and overall favorable outcomes led to increasing adoption of these techniques. In early studies, most interventions were performed in the iliac arteries and were used to treat patients with peripheral artery disease (PAD) at high surgical risk, but over time, the indications have broadened.

A review of revascularizations performed between 1980 to 2000 showed that while the number of endovascular interventions increased dramatically between 1995 and 2000 (980 percent), the major amputation rate was not affected [8]. In a similar review involving United States Medicare beneficiaries treated between 1996 and 2006, the number of endovascular interventions increased threefold during this period, with the greatest increase occurring after 2003 [9]. The increase in endovascular uptake was accompanied by a 42 percent decrease in the number of lower extremity bypass procedures and an overall doubling in the total number of revascularizations. An interesting observation of this later study was the first-time trend in decrease in major amputations, which started around 2001. This coincided with an increased use of femoropopliteal interventions and infrapopliteal endovascular interventions, as well as the more widespread adoption of endovascular interventions by vascular surgeons. A similar trend was reported in a large cohort of revascularizations performed between 1998 and 2007, which found that as the number of endovascular interventions doubled for claudication and quadrupled for chronic limb-threatening ischemia, there was a 38 percent decrease in overall amputations during the same time period [10].

PREINTERVENTION ASSESSMENT — Patients with symptomatic lower extremity peripheral artery disease (PAD) represent a wide spectrum, ranging from minimal discomfort with walking to limb-threatening ischemia (acute or chronic). (See "Clinical features and diagnosis of lower extremity peripheral artery disease".)

For patients presenting with claudication, assessment includes a thorough vascular examination, including a complete pulse examination and measurement of ankle-brachial index (ABI), which may need to be repeated after exercise. A normal ABI at rest may not reflect the hemodynamic impact of exercise in a patient with occlusive disease. During physical examination, particular attention should be given to the quality (present, weak, absent) of the femoral pulses, which provides a good indication of the level of occlusive disease (ie, aortoiliac disease [unilateral/bilateral] versus infrainguinal, or both) and also helps decide on the imaging modality, if revascularization is indicated. (See "Clinical features and diagnosis of lower extremity peripheral artery disease", section on 'Diagnosis of lower extremity PAD' and 'Preprocedural imaging' below.)

The patient's disability (pain-free walking distance, maximum walking distance, as well as how much this impacts their quality of life) also needs to be assessed. It is important to remember that ambulatory leg pain may be due to neurogenic (nerve compression, spinal stenosis, or peripheral neuropathy) or other musculoskeletal (arthritis, muscle pain) causes. It is common to have multiple causes of ambulatory leg pain, each contributing to a different component of pain. (See "Clinical features and diagnosis of lower extremity peripheral artery disease", section on 'Differential diagnosis of PAD'.)

Since most patients with claudication are initially managed medically, the consultation should evaluate adherence to risk factor reduction strategies (smoking cessation, antiplatelets, statin medications, diabetes, hypertension, and other medical issues), as well as tolerance to exercise therapy (supervised if available) and response to other therapies (eg, phosphodiesterase III inhibitors), if given. (See "Management of claudication due to peripheral artery disease", section on 'Approach to management'.)

Chronic limb-threatening ischemia (CLTI) includes patients with more advanced symptoms/signs of PAD such as ischemic rest pain, nonhealing ulcers, or gangrene. The stage of wounds, degree of ischemia, and presence and degree of infection need to be assessed. The Society for Vascular Surgery (SVS) has proposed a Lower Extremity Threatened Limb Classification System (figure 1), which stratifies risk of limb loss and need for revascularization by grading Wound, Ischemia, and foot Infection (WIfI) [11]. (See "Classification of acute and chronic lower extremity ischemia", section on 'WIfI (Wound, Ischemia, foot Infection)'.)

CLTI typically involves multilevel arterial segments, commonly involving infrapopliteal arteries. Patients with PAD may have varying degrees of ischemia, and the improvement in blood flow required to achieve symptom relief and/or wound healing varies from patient to patient. This is particularly notable in patients with diabetes in whom neuropathic ulcerations are common. The majority have either purely ischemic or neuroischemic ulcerations, necessitating assessment of arterial circulation, even in patients with mildly abnormal or normal ABI or toe pressures. (See "Clinical features and diagnosis of lower extremity peripheral artery disease", section on 'Threatened limb' and "Overview of peripheral artery disease in patients with diabetes mellitus" and "Management of diabetic foot ulcers".)

Medical risk assessment — Assessment of the patient's risk for perioperative morbidity and mortality is crucial in determining the type and complexity of the intervention. The patient's general condition and comorbidities should all be evaluated. These may include one or more of, but are not limited to:

Coronary heart disease – Symptomatic or asymptomatic

Chronic obstructive pulmonary disease – Oxygen dependence

Renal function – Chronic kidney disease, dialysis

Diabetes – Insulin dependence, HbA1c level

Functional capacity – Four or more metabolic equivalents versus fewer

Functional status – Unimpaired, impaired but can perform activities of daily living [ADLs] without assistance, needs assistance with ADLs or ambulation, needs full assistance for ADLs, dependent

Ambulatory status – Nonambulatory, transfers only, ambulatory

Frailty

Living situation – At home, nursing home, or in transition

Nutritional status

Previous interventions

Two key assessments include the estimated perioperative (30 day, in-hospital) morbidity and mortality, and the likelihood of two-year or more survival, particularly in patients with CLTI. While a number of risk prediction models for perioperative and long-term risk have been proposed from major trials (eg, LEGS, FINNVASC, PREVENT III, Bypass versus Angioplasty in Severe Ischemia of the Leg [BASIL]) [12-15], some of which have been validated, these have not gained wide acceptance and are only considered to be complementary to clinical judgment of risk.

Decision making for endovascular revascularization — A decision for endovascular versus open surgical revascularization should be individualized and oriented to patient-centered goals. The availability of autologous vein as a bypass conduit (preferably >3 mm single-segment great saphenous vein or two pieces of autologous veins), perioperative morbidity and mortality risk, as well as expected long-term (>2 years) survival, functional status, and the specific goals for the revascularization, all have a significant impact on choosing between an endovascular, open, or hybrid (combined endovascular/open) revascularization procedure. Imaging should not be performed before the clinical decision is made to intervene; anatomic complexity does not determine the need to intervene. (See 'Preprocedural imaging' below.)

Anatomically less complex lesions are typically treated using an endovascular approach in patients being treated for claudication or CLTI; however, for patients with more complex anatomy, whether to pursue endovascular intervention, rather than lower extremity bypass surgery, becomes more difficult. (See "Approach to revascularization for claudication due to peripheral artery disease" and "Lower extremity surgical bypass techniques".)

Claudication — For patients with claudication, revascularization should generally be offered only if medical management fails to sufficiently improve symptoms. (See "Management of claudication due to peripheral artery disease", section on 'Ongoing evaluation and follow-up'.)

The goal of intervention in a patient with claudication is improvement of quality of life, which needs to be emphasized before proceeding. Thus, the durability of the revascularization plays an important role, and the planned intervention should be chosen based on the anatomic complexity of the lesion(s) and the medical condition of the patients. The SVS Committee on lower extremity treatment guidelines for claudication recommends that an intervention should be offered if there is more than a 50 percent likelihood of sustained functional improvement, symptom relief, and anatomic patency for at least two years [16]. Although this recommendation is based on expert opinion, it provides a benchmark for planning intervention in these patients. While initial medical therapy is likewise recommended in patients with aortoiliac occlusive disease, those with severe claudication symptoms can be individually considered for intervention given the likelihood for immediate relief of claudication symptoms and the overall excellent long-term patency of aortoiliac interventions. (See "Approach to revascularization for claudication due to peripheral artery disease", section on 'Clinical criteria for revascularization'.)

Limb-threatening ischemia — For patients with CLTI, most should be considered for intervention to improve perfusion. After general assessment (medical condition, severity of limb threat [ie, WIfI] [11], functional status, risk for intervention, estimated long-term survival), imaging assesses the complexity of the disease. (See 'Medical risk assessment' above and 'Arteriography' below and "Management of chronic limb-threatening ischemia".)

For patients with CLTI and no ulcers or gangrene, improvement of inflow in those with aortoiliac disease or common femoral artery disease may be all that is needed to adequately relieve rest pain. By contrast, for patients with tissue loss, establishing direct in-line flow to the foot is typically necessary for optimal healing, preferably to the specific angiosome that is associated with tissue loss.

An endovascular-first approach was adopted by many for patients with CLTI based primarily on the results of the BASIL-1 trial, which randomly assigned 452 patients between 1999 and 2004 to an endovascular-first or bypass-first approach [17]. The one- and three-year amputation-free survival rates were similar; however, among patients who survived more than two years, amputation-free survival was better in the surgical arm. Those in the endovascular-first group who failed treatment and had a bypass fared worse compared with those who had bypass initially, suggesting a possible deleterious impact of endovascular interventions in some patients. In the BASIL-1 trial, approximately 25 percent of patients had infrapopliteal interventions and the technical failure rate was 27 percent in this group; some had bypasses using synthetic grafts.

A subsequent phase two parallel-trial, the Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial, identified differences in revascularization outcomes for two cohorts, one cohort with and the other cohort without a suitable great saphenous vein. All patients were deemed appropriate for either surgical or endovascular revascularization. This trial suggested that an endovascular-first approach may be appropriate for those without an adequate single segment of great saphenous vein, provided the goals of revascularization can be achieved. Surgical bypass may be more appropriate for those with a suitable great saphenous vein.

The BASIL-2 trial differed from the BASIL-1 trial. In the BASIL-1 trial, only approximately 25 percent of patients had infrapopliteal interventions, some of who had bypasses using synthetic grafts. There were similarities between the BEST-CLI and later BASIL-2 trial [18], including technical success rate (85 and 87 percent), included patients with diabetes (70 percent), antiplatelet and statin use, and high mortality rates (approximately 10 percent per year). However, there were differences in the enrolled populations, with BEST-CLI including and a greater difference in patients with prior history of myocardial infarction. All patients in BASIL-2 had infrapopliteal level interventions, whereas in BEST-CLI, just over half of the patients had infrapopliteal interventions. It is also important to note that amputation rates were higher in both arms of the BASIL-2 trial (20 percent in the vein bypass group and 18 percent in best endovascular therapy groups compared with 10.4 and 14.9 percent in cohort I of BEST-CLI). Perioperative mortality was higher in the surgery arm in BASIL-2 (6 versus 1.7 percent in cohort I), and the main difference in amputation free survival in BASIL-2 was due to the difference in late mortality in surgical arm. At this time, it is unclear if the differences between the two study outcomes are due to differences in enrolled patient cohorts, anatomic differences, or the care delivered. The BASIL II and the BEST-CLI trial investigators have collaborated closely and entered into a data-sharing agreement before either trial was analyzed. Further in-depth analysis using individual patient-level data may help clarify the differences between the studies and allow better understanding on the approach to patients with CLTI who need infrapopliteal level revascularization.

Preprocedural imaging — The decision to intervene is based primarily on the clinical assessment of symptoms and response to medical management, and the potential for improvement in quality of life rather than being purely lesion based. (See 'Decision making for endovascular revascularization' above and "Advanced vascular imaging for lower extremity peripheral artery disease".)

However, the anatomic complexity of the occlusive disease does have a bearing on the durability of the intervention. The goal of imaging is to assess the extent of arterial disease, assess the inflow and runoff arteries, and plan the appropriate intervention modality and technical conduct of the intervention. The location(s) of disease, length of stenoses and occlusions, calcium content, presence of thrombus, and quality of the runoff vessels as well as other anatomic factors all play a role in choosing between endovascular or open surgical revascularization. It is important to emphasize that vascular imaging should never be performed before a decision is made for revascularization, since the indication for intervention is never the anatomic complexity of disease.

Duplex ultrasound is typically the first imaging study to evaluate the level and extent of disease prior to revascularization because it is widely available, noninvasive, inexpensive, does not require ionizing radiation or iodinated contrast material, and can be used for arterial mapping before revascularization [19]. Vein mapping can also be performed at the time of duplex imaging, particularly in patients with CLTI. However, duplex imaging may not provide adequate information for the aortoiliac segment due to body habitus, bowel gas, or patient movement, and for the infrapopliteal arteries, due to calcification and overlying tissue loss.

Computed tomographic (CT) angiography provides complete imaging of the arterial tree from the aorta to the pedal vessels and can assess the nature (calcification), severity, and extent of atherosclerotic involvement, particularly of the proximal vasculature (aorta, iliac and common femoral arteries). CT angiography is appropriate as the initial imaging modality in patients with weak or nonpalpable femoral pulse(s) in patients with normal or mildly decreased renal function. Imaging of the tibial vessels with CT angiography can be suboptimal, particularly if the vessels are calcified.

Magnetic resonance (MR) angiography has the advantage of imaging the arterial tree without ionizing radiation or iodinated contrast material and is an excellent imaging modality for patients with CLTI with infrapopliteal disease. However, MR angiography fails to image vessel wall calcification, may overestimate the degree of stenosis, and may also be limited by motion artifact. MR angiography is also more expensive, and availability of the study (equipment, radiologic expertise) may be limited. MR angiography can be helpful in patients with decreased renal function (estimated glomerular filtration rate [eGFR] <60, >30 mL/min); however, a plain CT may still be needed to assess the calcium content of the wall, particularly if open aortoiliac revascularization is planned. However, MR angiography cannot be used in dialysis-dependent patients due to risk of nephrogenic systemic fibrosis.

Digital subtraction angiography (DSA) remains the gold standard for assessing arterial anatomy, particularly in patients with CLTI due to the limitations of CT and MR angiography for the infrainguinal vessels. DSA can be performed immediately after the initial duplex ultrasound evaluation in such patients with the option for endovascular intervention in the same setting. Using selective catheterization, the volume of iodinated contrast can be minimized with excellent demonstration of the distal vasculature.

Patient evaluation prior to these imaging modalities and measures to prevent complications are reviewed in more detail separately. (See "Patient evaluation prior to oral or iodinated intravenous contrast for computed tomography" and "Patient evaluation before gadolinium contrast administration for magnetic resonance imaging" and "Prevention of contrast-induced acute kidney injury associated with computed tomography" and "Nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy in advanced kidney disease", section on 'Prevention'.)

PROCEDURAL OVERVIEW — Percutaneous peripheral arterial interventions may be performed in a variety of settings (inpatient, outpatient) using fixed or portable fluoroscopy in an interventional suite in an operating room for hybrid procedures that combines both endovascular and open surgical techniques.

Percutaneous procedures are typically performed under conscious sedation; however, for patients who will be undergoing prolonged procedures or those undergoing hybrid procedures, deep sedation or general anesthesia may be needed, which occurs in 10 to 20 percent of patients. A single dose of intravenous antibiotics is often provided at the beginning of the procedure (table 1). For patients who are systemically anticoagulated for acute limb ischemia or other reasons, anticoagulation is not discontinued.

The basic conduct of the endovascular intervention is the following:

Obtain arterial access (percutaneous or surgical) and place the necessary sheath(s). (See 'Arterial access' below.)

Perform initial arteriography and determine whether to proceed with the intervention. (See 'Arteriography' below.)

Anticoagulate the patient and monitor to maintain an adequate level. (See 'Anticoagulation' below.)

Identify target lesions, place a sheath through which wires, catheters, and other devices are delivered. Cross stenoses and occlusions and treat the diseased segment to achieve a patent lumen followed by completion arteriography. For multilevel disease, the goal of treatment is to establish in-line flow to the foot in a patient with tissue loss, and typically the lesions are treated from proximal to distal in sequence. (See 'Lesion crossing and treatment' below.)

Remove devices and manage the access site. (See 'Management of access site' below.)

ARTERIAL ACCESS — Most endovascular procedures are performed percutaneously. However, if needed, the endovascular intervention can be performed via an open arterial access (with or without concomitant open surgical bypass or other procedures). Antegrade (in the direction of blood flow) or retrograde (opposite the direction of flow) access can be used as determined by the patient's anatomy. (See "Percutaneous arterial access techniques for diagnostic or interventional procedures".)

Percutaneous access — The most common percutaneous access site for aortoiliac and infrainguinal endovascular intervention is the common femoral artery; however, brachial access may be used, particularly for aortoiliac occlusions when a contralateral femoral access site is not feasible, as determined by preoperative cross-sectional imaging, or fails. Radial artery access is not widely used for lower extremity peripheral interventions, due to the limited availability of stents and balloons with sufficiently long shafts, but is gaining popularity, particularly in office-based interventions. From the Vascular Quality Initiative registry, among the 160,000 patients who underwent lower extremity endovascular interventions between 2016 to 2020, 0.66 percent were performed using radial access [20]. Retrograde access using pedal access has also been increasingly used. A systematic review that included 31 studies involving 1910 patients reported a 96 percent technical success rate with pedal access; perforation, flow-limiting dissection, distal embolization, and local hematoma at the retrograde access site were infrequent (2.1, 0.6, 0.1, and 1.3 percent, respectively) [21].

Percutaneous access to the common femoral artery access is often performed using ultrasound guidance, but it can be performed using palpation based on landmarks, or using fluoroscopic guidance (eg, imaging the calcified arteries, aiming for the medial third of the femoral head). Pedal and radial artery access are typically performed using ultrasound guidance.

Open access (hybrid) — For patients undergoing hybrid procedures, which commonly involve common femoral artery endarterectomy, the endovascular component starts after exposure of the artery but before any necessary endarterectomy.

Hybrid procedures were initially described in patients undergoing lower extremity bypass procedures with the endovascular intervention used to improve inflow by treating a focal iliac artery lesion prior to femoral bypass (eg, femoral-femoral, femoral-popliteal, femoral-distal), or to treat the superficial femoral artery (SFA) in patients undergoing popliteal-distal bypass. The inflow lesion can be treated either prior to the planned bypass or simultaneously at the time of the bypass procedure.

More complex hybrid procedures have been adopted, in which the endovascular treated segment can involve complex lesions (long occlusions), with the center of the reconstruction being femoral endarterectomy (image 1).

Sheath placement — The type of sheath used depends on the planned procedure. The size and length of the sheath are selected based on the outer diameter of the device(s) that are selected.

The size of the sheath is sized based on the inner luminal diameter, whereas the size of catheters and devices is sized based on their outer diameter. When using guiding catheters, instead of sheaths, it is important to remember that the size of these devices is also based on their outer diameter.

The lengths of the sheaths or guiding catheters and their tip shapes are chosen based on the planned intervention. Deflectable sheaths are also available, which allow maneuvering the tip of the sheath after delivery to the desired location.

ARTERIOGRAPHY — After placement of the sheath, arteriography is performed to identify target vessels and the status of the runoff vessels as well as to provide documentation of the baseline status of distal circulation prior to the intervention.

Lesion classification and approach — The classification of the anatomic complexity of occlusive disease has been described in the TASC documents [22], ranging from A to D, and in the Global Anatomic Staging System (GLASS) from the Global Vascular Guideline (table 2) [23]. (See "Classification of acute and chronic lower extremity ischemia", section on 'GLASS classification' and "Classification of acute and chronic lower extremity ischemia", section on 'TASC classification'.)

The original TASC classification was designed to help decide between endovascular and open revascularizations (eg, preference to treat TASC A lesions via endovascular means, preference to treat TASC D lesions via open reconstruction). However, in the iliac arteries, this classification is used only for lesion classification given that the majority of TASC C and D lesions in the iliac vessels are now treated via endovascular means. Patency rates of TASC C and D lesions in the iliac segment are similar to those reported in TASC A and B lesions, which is in contrast to outcomes in the femoropopliteal segment [24-26]. (See 'Techniques and outcomes by anatomic site' below.)

The TASC II classification for the femoropopliteal segment is widely used to determine lesion complexity; characteristics such as the length of the lesion(s) as well as involvement of the popliteal artery and the trifurcation vessels determine the complexity of the TASC II disease. In the GLASS classification (table 2), the most severe grade is defined as >20 cm occlusion, which can include >5 cm popliteal disease, with or without extension to the trifurcation, or any popliteal occlusion [27]. The length of femoropopliteal lesions for which endovascular interventions are recommended has increased over the years. The Society for Vascular Surgery (SVS) supports endovascular treatment for lesions up to 15 cm (TASC II C) [16], whereas the European Society of Cardiology and European Society for Vascular Surgery have a greater maximal length of 20 cm. Surgical revascularization is recommended for occlusions longer than 15 to 20 cm in length (ie, TASC II D lesions) [28]. An update to the European guidelines allows lesions up to 25 cm to be treated with endovascular means, based on available data for intervention with drug-coated balloons [29].

The anatomic grading of infrapopliteal vessels was originally proposed in the TASC 2000 document [30]; however, this was not updated in the TASC II document [22]. An update of TASC II was published in 2015 with a proposed infrapopliteal classification (not endorsed by the Society for Vascular Surgery, European Society for Vascular Surgery, and World Federation of Vascular Societies) [31]. Other classifications have been suggested; however, none have been adopted. The proposed GLASS classifies infrapopliteal lesions to four grades (table 2) [27]. This system is meant to help define the target artery path (TAP) that is necessary to achieve in-line flow to the foot and optimal limb-based patency. The TAP may be achieved by treating the least diseased infrapopliteal artery; however, if the goal is to achieve angiosome-specific flow, this may require treating multiple infrapopliteal vessels in selected patients.

In addition to the length of the lesions, the degree of calcification may also have an impact on the likelihood of immediate technical success and long-term patency rates of endovascular interventions. Severe calcification is commonly observed in patients with diabetes and/or chronic kidney disease. In addition to increasing the difficulty of crossing these lesions, excessive calcification impedes adequate angioplasty.

ANTICOAGULATION — After the access is obtained and the decision is made to proceed with the intervention, the patient is typically anticoagulated with heparin given as intravenous bolus (80 to 100 U/kg). Activated clotted time (ACT) is typically maintained between 200 to 300 seconds during the procedure.

LESION CROSSING AND TREATMENT

Lesion crossing — Following arteriography and placement of a sheath with tip placed close to the target, appropriate wires and catheters are chosen to cross the target vessel. For stenotic lesions, intraluminal crossing can usually be accomplished; however, for occlusions, crossing these lesions can be using an intraluminal or subintimal approach, or a combination of the two. A variety of specialty wires (eg, glidewire, crossing wires) are used for this purpose. Once the wire reenters the lumen, a catheter is advanced over the wire into the distal lumen, and a small amount of dye is injected to verify the distal intraluminal location of the catheter. If distal vessels were not adequately seen before crossing, the distal vessels including the pedal circulation can be imaged at this time. A working wire is then placed, and the vessel is treated over this wire. It is important to maintained controlled wire access across the lesion(s) until after all interventions are completed.

When reentry back into the distal lumen after crossing a lesion subintimally is not successful, one of the reentry devices (eg, Pioneer, Outback) can be used (image 2 and image 3). Alternatively, percutaneous access to the distal vessel (eg, popliteal, tibial) can be used to cross the occlusion(s) in a retrograde fashion, sometimes requiring an above and below approach (rendezvous technique). The wire is then retrieved from the sheath above, and the intervention is completed (image 4).

Treatment options — Treatment options for managing occlusive vascular lesions include balloon angioplasty (plain balloon, specialty balloon), stenting, and atherectomy.

Balloon angioplasty — Balloon dilatation of the diseased artery causes fracture and separation of the media from the intima and stretching of the media and adventitia. Typically, the duration of balloon dilation is one to three minutes for stenosis, but up to five minutes for occlusions. Severely fibrotic lesions or heavily calcified lesions are more resistant to balloon dilation, and intimal dissection or elastic recoil may be observed. These lesions are typically treated with stents if the lesion is flow-limiting or there is a residual stenosis >30 percent.

Standard balloons — Standard balloons are available in various sizes and lengths with various radial pressures and are characterized as compliant or noncompliant. The nominal pressure, rated burst pressure (beyond which <1 percent will rupture), and mean burst pressure (at which 50 percent will rupture) are provided on the device label. A compliant balloon will track better and is used in curved portions of the vessels. Noncompliant balloons are high-pressure balloons that are used for severely calcified or fibrotic lesions.

Balloon catheters may be over-the-wire, or of the rapid exchange type, for which the wire exits the catheter 20 to 25 cm distal to the tip. The pushability of the balloon is better with over-the-wire systems.

Specialty balloons — To decrease the incidence of dissection, residual stenosis, and restenosis, a variety of specialty balloons have been used.

Cutting balloons – Cutting balloons have three to four microsurgical blades that are intended to cut the intima in a controlled fashion, rather than fracturing it. A main goal is to decrease the need for stent usage, which may be particularly useful in no-stent zones (eg, common femoral artery, popliteal artery) or for ostial lesions. Cutting balloons are also helpful for fracturing fibrotic lesions or for managing in-stent restenosis.

Drug-coated balloons – Drug-coated (eg, paclitaxel) balloons have been used to decrease intimal hyperplasia. The target lesion is typically treated with a plain balloon first and subsequently treated with the drug-coated balloon provided there is no residual stenosis or dissection after the plain balloon angioplasty. Drug-coated balloons are effective in reducing restenosis rates in femoropopliteal lesions. Their effectiveness in the tibial vessels is under evaluation. While drug-coated devices may improve lesion outcomes, the question of whether the associated drug administration has any effect on long-term mortality is an ongoing controversy. (See 'Concern over paclitaxel' below.)

Focal pressure balloons – Focal pressure balloons with either spiraling wires (Angiosculpt) or parallel wires (Vascutrak) have been used with the goal of decreasing stent usage, but there are limited data and they have not gained wide acceptance due to added cost.

Cryoplasty balloons – Cryoplasty balloons were designed to treat the vessel wall with a combination of dilation and freezing temperatures (-10 degrees Celsius). The intention is to reduce the incidence of dissections and intimal hyperplasia; however, these have not proven effective and are not used.

Lithotripsy balloons – Intravascular lithotripsy balloons use acoustic shockwaves to induce fracture in severely calcific plaques, facilitating luminal gain and vessel expansion to prepare the vessel for subsequent intervention. In one randomized trial, lithotripsy improved technical success rates from 50 to 66 percent in moderate and severely calcified femoropopliteal arteries [32].

Stents — Stents (a mesh of metal) are used to maintain lumen patency by preventing recoil and by tacking down any intimal flaps. Stents can be balloon expandable or self-expanding and may be bare or covered. Bare metal stents are composed of any of a number of metals or metal alloys including nitinol (an alloy of nickel and titanium), stainless steel, cobalt-chromium, and others. Covered stents have expanded polytetrafluoroethylene (ePTFE), polyurethane, or silicone coverings. Covered stents placed into larger vessels (eg, aorta) are often referred to as stent-grafts. Stents have varying degrees of flexibility, radial strength, and kink resistance and are predominantly chosen based upon the location of treated vessels.

Balloon-expandable devices (bare stents, covered stents, stent-grafts) are used mostly in the aortoiliac location. These stents are very precise in deployment, with high radial force and minimal, if any, recoil. They are ideal for severely calcified or resistant lesions, and ostial lesions. Covered stents and stent-grafts completely line the artery and can be used in vessels at risk for rupture or embolization. Covered stents and stent-grafts may also prevent intimal hyperplasia, although this can still occur at the edges of the stent. Stent-grafts typically require larger sheaths and are more expensive. To deliver the balloon-expandable stents to a target, a sheath must first be placed across the lesion to prevent the mounted stent from becoming dislodged or from simply not being properly delivered to the site due to the large device profile.

Self-expanding devices (bare stents, covered stents) are flexible and accommodate the curves and bends in arteries and are widely used in the femoropopliteal arteries and external iliac arteries. Although self-expanding stainless steel stents foreshorten significantly, nitinol-based stents do not, and nitinol-based delivery systems are quite precise. Self-expanding covered stents are also available for these locations and can be considered as a primary intervention for long occlusions or for covering areas that are causing embolization, but they can also be used secondarily in cases of vessel rupture.

Drug-coated self-expanding stents have been used in the femoropopliteal segment and have been shown to improve primary patency rates compared with bare metal stents. Drug-coated balloon-expandable coronary stents have also been used selectively at the infrapopliteal level when balloon angioplasty has failed. (See 'Concern over paclitaxel' below.)

Atherectomy — A variety of debulking atherectomy devices have been introduced and are considered to have value for decreasing the late complications of stents, such as in-stent restenosis and stent fracture, particularly in areas where stent use is suboptimal, such as in the common femoral artery, popliteal artery, ostial lesions, and for heavily calcified lesions. Available devices are classified as directional (excisional), rotational, or as laser atherectomy devices.

Directional atherectomy devices consist of a carbide cutting blade and a nose cone into which the atheroma is packed as its cutting blade rotates and shaves the plaque. Some are designed to cut through severe calcification. Due to high embolization potential, a distal embolic protection filter is often used concurrently.

Rotational and orbital atherectomy devices use a burr to decimate plaque into very small fragments, most of which are less than 5 microns, to create a smooth lumen. Nevertheless, embolization can still occur. Orbital atherectomy is particularly effective in calcified lesions.

Laser atherectomy uses an excimer laser to ablate soft plaque and thrombus, with minimal injury to the surrounding structures. It is not effective for calcified lesions.

Management of access site — Once the procedure has been completed, manual compression is safe and effective after removal of devices, wires, and sheaths. However, compression is labor intensive and uncomfortable for patients; thus, a variety of closure devices are commonly used.

Closure devices are associated with decreased time to hemostasis and time to ambulation as well as aiding closure of the access site in patients who are anticoagulated or on multiple antiplatelet medications. However, closure devices have never been shown to be superior to manual compression with respect to access site complications, and they do increase costs.

Closure devices can be suture mediated or plug based, and most practitioners prefer using a particular device with which they have familiarized themselves. Failure of closure device can usually be managed with manual compression. Closure device failure can be associated with ischemic symptoms, particularly if embolization has occurred. Although atherectomy devices have occasionally been shown to be useful for retrieving embolized plug material, these may cause even further embolization, and surgery is often the safer approach.

Brachial artery access is also typically managed by manual compression; however, when the sheath size is 7 F or more, a small cutdown and direct arterial closure is preferred by many surgeons to minimize complications (eg, nerve palsy).

TECHNIQUES AND OUTCOMES BY ANATOMIC SITE

Aortoiliac — Endovascular treatment of aortoiliac occlusive disease has been widely adopted. Aortoiliac intervention is commonly performed for patients with claudication and is also commonly needed in patients who need multilevel revascularization. Associated infrainguinal revascularization may be accomplished using either endovascular or open techniques, with or without concomitant femoral endarterectomy for bulky disease of the common femoral artery. While aortoiliac interventions are mostly performed percutaneously, including common femoral endarterectomy as a combined (hybrid) procedure is appropriate.

Femoral endarterectomy is needed in 15 to 20 percent of patients undergoing aortoiliac revascularization and is also the major determinant of the choice of location in which to undertake revascularization (ie, interventional suite or hybrid operating room). Most of these patients have external iliac artery stenosis/occlusion with or without concomitant common iliac artery occlusion. When femoral endarterectomy is planned, the femoral artery is exposed first before any attempt is made to cross the occlusions. After femoral exposure, the occlusions are crossed before the arteriotomy is made for endarterectomy (pre-arteriotomy guidewire access [PAGA]) [33], thus ensuring inflow early in the procedure. The wire is placed in the aorta and maintained during the endarterectomy and patching, and the iliac artery is treated after the patch has been completed (picture 1). Femoral endarterectomy should include a profundaplasty if significant disease is present at the profunda femoris orifice.

Endovascular interventions can be performed in any patient with aortoiliac occlusive disease, even in those with more complex anatomy. However, juxtarenal occlusions, hypoplastic aortic syndrome, or those with concomitant aortic aneurysmal dilatation (small or large) with thrombus burden present particular endovascular challenges. While the increased use of bifurcated stent-grafts in such cases offers a less invasive alternative, severe iliac occlusive disease or the risk of renal or mesenteric embolization remains a concern. In these cases, open surgical reconstruction may be the better alternative in good-risk surgical patients.

Iliac stenosis — Stenosis of the iliac artery is typically crossed from the ipsilateral femoral access in a retrograde fashion.

Lesions in the external iliac artery are treated with self-expanding stents or stent-grafts, although balloon-expandable stents or stent-grafts can also be used as long as the device will not cross the inguinal ligament. For patients with external iliac artery occlusions, stent-grafting has better patency rates compared with bare stents.

Common iliac artery lesions are typically treated with balloon-expandable stents or stent-grafts (image 5). Balloon angioplasty of the iliac arteries without stenting is rarely used, except for the most focal lesions; however, stenting would still be required for a focal lesion if there is flow-limiting dissection or residual stenosis of >30 percent. If the lesions in the common iliac artery extend to the iliac bifurcation and into the aorta, kissing stent-grafts or stents can be used; these elevate the bifurcation and ensure unimpeded flow to both lower extremities (image 6).

Aortoiliac occlusion — For patients with aortoiliac occlusions, brachial (or radial) artery access is used to cross the aortic occlusion, and the wire is snared from the femoral accesses. Provided the iliac arteries can accommodate 17 to 18 F sheath delivery in at least one iliac artery, the occlusion is treated with either a double-barrel stent, stent-grafts extended proximally, or bifurcated stent-grafts (image 7).

For those with small iliac arteries, the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique can be used [34]. In this technique, a large balloon-expandable stent-graft is placed in the aorta extending to above the bifurcation, and two covered stents are placed to both common iliac arteries in a kissing fashion recreating the flow divider (image 8). The presence of an aortic aneurysm with concomitant iliac occlusions was once considered a strong indication for open repair or endovascular revascularization using an aortouniiliac stent graft with femorofemoral bypass; however, bifurcated stent-grafts are increasingly used in these cases, decreasing overall morbidity (image 9).

For patients with common iliac artery (CIA) occlusions, an antegrade or retrograde approach can be used. The advantage of the antegrade approach is that the crossing wire enters the CIA at the takeoff, whereas with retrograde crossing, unless a reentry device (Pioneer or Outback) is used, the reentry may occur more proximally than the lesion with the dissection plane extending to the aorta. In patients with external iliac artery (EIA) occlusions and patent internal iliac arteries, antegrade crossing from the contralateral femoral access preserves the internal iliac artery (IIA) and is particularly safer in those who will need a femoral endarterectomy distal to the EIA occlusion. The guidewire can be retrieved during endarterectomy in the common femoral artery (CFA) (picture 2). Retrograde crossing of EIA occlusions is also feasible; however, if the IIA is patent, reentry above the iliac bifurcation may result in loss of IIA patency after recanalization of the EIA.

Aortoiliac outcomes — Balloon angioplasty with selective stenting for aortoiliac lesions was initially suggested as having similar outcomes compared with primary stenting [35,36]. However, early studies typically included patients with less severe disease (ie, TASC A or B). Based on the available data, in the author's practice, we routinely stent all iliac occlusions or long iliac stenoses, limiting plain balloon angioplasty to only to those patients with short stenoses or who have no evidence of residual stenosis or dissection following intervention. In a systematic review that included over 1300 patients, primary iliac artery stenting was associated with significantly reduced long-term failure (by 39 percent) [37].

For patients with TASC A and B lesions, early and late outcomes are excellent. In a retrospective review of 394 interventions in 276 patients (77 percent with claudication), technical success was 98 percent [38]. Stents were placed in 51 percent. Cumulative assisted patency was 71 percent at 10 years. Two-vessel femoral and two or more vessel tibial runoff or both was associated with improved patency. Procedure-related complications occurred in 7 percent.

There is increasing interest in using covered stents for complex aortoiliac occlusions, in particular for covering long occlusions, such as those with heavy calcification, which have a high risk of rupture during dilation. Significantly better patency has also been reported in patients receiving covered stents compared with bare stents in the EIA in combination with common femoral endarterectomy [39]. In a small randomized trial (COBEST trial) comparing bare metal stents to stent-grafts in patients with aortoiliac occlusive disease, the five-year primary patency was significantly better in patients with TASC C and D lesions in the covered stent cohort compared with those treated with bare stents, but there was no difference observed in those with TASC B lesions [40]. We use balloon-expandable stent-grafts routinely in CIA occlusions and self-expanding stent-grafts (eg, Fluency, Viabahn) in EIA occlusions when performing concomitant CFA endarterectomy; however, more data are needed to support routine use of these more costly stent grafts.

In a systematic review, technical success and patency rates were significantly improved at 12 months for primary compared with selective stenting in patients with TASC C or D aortoiliac occlusive disease (94.2 versus 88 percent, and 92.1 versus 82.9 percent, respectively) [41]. In a meta-analysis of 19 nonrandomized cohort studies in 1711 patients with TASC C or D aortoiliac disease who had endovascular revascularization between 2000 and 2009, technical success varied between 86 and 100 percent, with clinical improvement in 83 to 100 percent of patients. The long-term (four- or five-year) primary patency rates ranged from 60 to 86 percent, and secondary patency rates ranged from 80 to 98 percent [42]. Although the primary patency rates were lower than those reported for direct surgical revascularization, similar secondary rates could be achieved with reinterventions, most of which were percutaneous. In a study with five-year follow-up, primary patency rates were 84, 79, 82, and 80 percent for stented TASC II A, B, C, and D iliac lesions in 436 patients, respectively [24]. In a study of 413 patients who had routine iliac stenting between 1997 and 2009, the technical success rate was 99 percent [25]. Primary patency rates at 5 and 10 years were 83 and 71 percent, respectively, in the TASC II C/D group and 88 and 83 percent in the TASC II A/B group. There are no modern series with large numbers of open aortic reconstructions to directly compare these outcomes [43]. A systematic review and metaanalysis compared outcomes from 9319 patients (66 studies) with TASC C/D aortoiliac occlusive disease treated with open surgical bypass (n = 5875), standard endovascular interventions (n = 3204), or CERAB (n = 240) [44]. Pooled outcomes for open, standard endovascular and CERAB, respectively, were:

Perioperative (30-day) mortality – 3, 0.8, and 0 percent

Three-year primary patency rates – 93, 78, and 82 percent

Three-year secondary patency rates – 97, 93, and 97 percent

Five-year primary patency – 89, 71, not reported

Fiver-year secondary patency – 95, 88, not reported

In summary, although 30-day morbidity and mortality favored endovascular techniques, primary patency remained better with open bypass early and midterm, with comparable secondary patency in all groups of patients with complex aortoiliac occlusive disease.

Femoropopliteal — Endovascular interventions have been widely adopted as the first line of revascularization for the femoropopliteal segment. Femoropopliteal lesions are approached mostly from a contralateral femoral access, although when the proximal superficial femoral artery is not involved, antegrade ipsilateral access can be used. After a sheath is placed in the distal external iliac artery, the lesions are crossed with a wire. In patients with stenoses, this is performed intraluminally using a glidewire or soft-tipped 0.018 or 0.014" wires; however, in those with chronic total occlusions, a combination of glidewire and catheter is used to cross the occluded segment. Initially an intraluminal crossing is attempted, but not uncommonly the wires travel in the subintimal plane and reenter distal to the occlusion (preferably as close to the occlusion as possible). If the wire travels intraluminally without any resistance through an occlusion, the possibility of an organized clot and therefore a higher risk of embolization should be noted, and distal embolic protection (eg, filter device) should be considered.

After crossing the occlusion, the intraluminal position of the catheter is verified by injecting contrast into the artery and placing a wire (typically a 0.018" wire) over which the intervention will be performed. If crossing fails, mainly due to failure to reenter the distal lumen, a reentry device (Pioneer or Outback) can be used to reenter the lumen (image 2). The reentry device not only helps increase the technical success rate of the intervention but also allows for a more controlled distal entry, especially when preservation of a large collateral geniculate branch is desired. However, these devices are expensive and are not uniformly available in all centers.

Alternatively, distal access to the popliteal artery or distal vessels can also be used to cross the lesions in a retrograde fashion. The wire is then retrieved via the indwelling proximal sheath either using a snare or simply entering the catheter with the wire, and the desired intervention is completed.

The approach to femoropopliteal angioplasty depends on the length of the lesion:

For patients with short lesions (<5 cm), plain balloon angioplasty (PBA) with provisional stent placement for flow-limiting dissections or >30 percent residual stenoses is recommended (image 10).

For patients with lesion 5 to 10 cm in length, the need for stent placement is increased, especially in those with occlusions. In a meta-analysis of 19 studies (923 patients), primary patency (61 percent at three years) was best in claudicants with <10 cm stenotic lesions and progressively worsened in patients with CLTI and occlusions (30 percent at three years) [45].

For lesions >10 cm in length (TASC II B/C, Global Anatomic Staging System [GLASS] 2), primary stent placement can be considered. The patency for balloon angioplasty along in the femoropopliteal segment is poor. In one review, the patency rate at 12 months for balloon angioplasty alone for 4 to 15 cm femoropopliteal lesions was 28 percent [46]. The adjunctive use of self-expanding nitinol stents has improved patency in long-segment femoropopliteal disease and provides more durable results compared with balloon-expandable stainless steel stents. In a randomized trial involving 104 patients comparing primary stenting with PBA and selective stenting, restenosis was significantly higher in the PBA group compared with the primary stent group [47]. Similarly, the DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II) trial reported a three-year primary patency rate of 60 percent in patients with a mean femoropopliteal lesion length of 8.9 cm (range 7 to 20 cm) who were treated with self-expanding nitinol stents [48]. However, due to late failures of stents from stent fractures or restenosis, a "leaving no metal behind" strategy has been adopted by many, but the bailout stent ratio remains very high, particularly in patients with complex lesions (severe calcification, chronic, long total occlusions). Although drug-coated balloons (DCBs) have been associated with less stent use and improved patency, there remain concerns over potential long-term effects. (See 'Concern over paclitaxel' below.)

For patients with long-segment lesions (>15 cm), especially those with long-segment occlusions (>20 cm), angioplasty with nitinol stent placement is the most commonly used treatment modality. A study that investigated placement of 200 mm long nitinol stents in lesions with a mean length of 24 cm (range 16 to 45 cm) reported a 12 month patency of 64 percent [49]. In the STELLA registry [50], 30 month primary patency was 62 percent in a cohort of patients, which included 60 percent CLTI patients with a mean lesion length of 26 cm. Another option for treating long-segment femoropopliteal occlusions is heparin-bonded polytetrafluoroethylene (PTFE)-covered stents. While earlier results with the non-heparin-bonded covered stent (Viabahn) did not show superiority over bare metal stents [51], later trials comparing heparin-bonded Viabahn with bare metal stents have shown improved midterm patency with covered stents in long femoropopliteal lesions [52]. However, these results need to be validated, and the concern remains regarding the failure mode of covered stents being more associated with limb-threatening acute limb ischemia, possibly due to loss of collaterals. Covered stents are preferred in patients with large thrombus loads who present with distal embolization, and in patients who develop in-stent restenosis.

Plaque debulking with various atherectomy devices (directional, orbital, rotational, and laser atherectomy) has also been used to treat femoropopliteal lesions, both as an alternative or adjunct; however, current evidence only shows noninferiority of atherectomy as compared with PBA and stenting [53-55]. Atherectomy can be used in short- to medium-length calcified lesions, ideally with distal protection; however, not all atherectomy devices are compatible with distal protection. Concerns remain for long-term durability of these interventions along with the risk for complications (eg, dissection, perforation, distal embolization) [56]. Their role in the treatment of in-stent restenosis with DCB angioplasty is under investigation, with promising early results.

DCBs and drug-eluting stents (DES) have been increasingly used to treat femoropopliteal disease. DCBs can be used as adjuncts or as an alternative to PBA for the treatment of medium- to long-length lesions. In the IN.PACT SFA trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter versus Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]), paclitaxel DCB angioplasty was associated with improved primary patency compared to plain balloon angioplasty [57,58]. Primary patency rates at three years were 69.5 versus 45.1 percent, respectively. Freedom from clinically driven target lesion revascularization was significantly improved for the DCB group at three years (84.5 versus 69 percent) and five years (74.5 versus 64.3 percent).

One of the advantages of DCBs is the avoidance of stents, particularly in locations associated with high risk of in-stent restenosis, such as the popliteal arteries. However, there is concern regarding limited efficacy of DCB in heavily calcified lesions [59]. Using atherectomy to debulk the plaque before treating with DCB has been suggested to improve outcomes [60]. There may be a role of DCB in treatment of in-stent restenosis. In a meta-analysis of four studies including 467 patients, target lesion revascularization (TLR) and recurrent in-stent restenosis were lower for DCB compared with PBA [61].

The Zilver PTX randomized trial showed sustained superiority of DES over PBA with provisional bare metal stenting (BMS). Subgroup analysis of DES versus BMS showed improved results with DES over the study period [62]. A decision to use DES versus DCBs is made after the predilatation with PBA; a DCB is used in those without dissection or residual stenosis, whereas a DES is used when these occur, and in those with calcified lesions or those with embolization potential.

A relatively small number of trials have been conducted comparing different pairs of treatments, making direct comparisons between the many options difficult. In a network meta-analysis of randomized trials, TLR and primary patency rates were compared for balloon angioplasty, BMS, covered stent, DCBs, and DESs for femoropopliteal peripheral arterial disease [63]. Twenty-two trials including 4381 participants provided data on TLR, and 16 trials including 3691 participants provided data on primary patency. Compared with balloon angioplasty, point estimates for freedom from TLR at 12 months were highest for DCB (odds ratio [OR] 4.23, 95% credible interval [CrI] 2.43-7.66) followed by covered stent (OR 3.65, 95% CrI 1.11-12.55), DES (OR 2.64, 95% CrI 0.72-9.77), and BMS (OR 2.3, 95% CrI 1.11-4.76). However, for primary patency, point estimates at 12 months compared to balloon angioplasty were highest with DES (OR 8.93, 95% CrI 3.04, 27.14) followed by covered stent (OR 3.91, 95% CrI 1.18, 13.84), DCB (OR 3.32, 95% CrI 1.8, 6.25), and BMS (OR 3.5, 95% CrI 1.58, 7.99). In brief, DCB has the lowest need for TLR, whereas DES has the highest primary patency rate, and DCB, covered stent, and BMS were associated with significant reductions in TLR compared with balloon angioplasty, whereas DCB, DES, covered stent, and BMS were associated with significantly improved primary patency compared with balloon angioplasty.

Cutting and scoring balloon angioplasties, and cryoplasty, have been used in small series, but currently there is not enough evidence to support their use in the femoropopliteal segment.

Concern over paclitaxel — A number of medical therapies aimed at preventing restenosis related to percutaneous angioplasty have been tried, but only local delivery of the drug paclitaxel has been shown to improve the longevity of interventions. Because of the concerns discussed below, we make the decision to use paclitaxel-coated balloons on a case-by-case basis after a thorough discussion of the potential benefits and risks.

Limb outcomes — Whether paclitaxel improves long-term limb outcomes is unclear. The outcomes of reported trials studying paclitaxel-coated devices have overwhelmingly used lesion-oriented outcome measures, such as target lesion revascularization (TLR) or primary restenosis, rather than functional or patient-oriented measures, such as improved walking distance or increased limb salvage rates.

A systematic review and meta-analysis of eight trials evaluated amputation-free survival (composite endpoint of death and major amputation) among patients treated with and without paclitaxel-coated balloons in the infrapopliteal arteries [64]. TLR was a secondary efficacy endpoint. Amputation-free survival was significantly worse for those who received paclitaxel (13.7 versus 9.4 percent, hazard ratio [HR] 1.52, 95% CI 1.12-2.07). The need for TLR was significantly reduced for paclitaxel (11.8 versus 25.6 percent, risk ratio 0.53; 95% CI 0.35-0.81). The harm signal was more evident for high dose (3.0-3.5 μg/mm2) compared with low dose (2.0 μg/mm2) for which the affect was attenuated below significance.

A subsequent meta-analysis of 21 randomized trials evaluated outcomes of 3760 lower limbs treated with either a paclitaxel-coated or plain balloon for lower extremity angioplasty in femoropopliteal and infrapopliteal arteries (intermittent claudication: 52 percent; CLTI: 48 percent) at a median of two years follow-up [65]. The rate of major amputation was significantly increased among those who received paclitaxel-coated balloons (4 versus 2.7 percent, HR 1.66, 95% CI 1.14-2.42). The observed amputation risk was similar for femoropopliteal and infrapopliteal vessels. The authors reported a nonlinear dose response relationship with accelerated risk per cumulative paclitaxel dose. The actual cause remains largely unknown, but systemic release and downstream embolization of cytotoxic paclitaxel particles in combination with the underlying ischemia and inflammation has been proposed as a plausible mechanism, but this remains to be proven. In addition, the findings relate only to DCBs and may not be applicable to paclitaxel-coated stents, as the mechanism of drug release and dosing are different. The findings of this analysis will likely lead to further scrutiny, like the mortality signal noted for paclitaxel-coated devices. (See 'Long-term survival' below.)

Long-term survival — The overall safety of paclitaxel-coated balloons and stents placed into the legs of patients with PAD has come into question. Based on a review of long-term follow-up data from premarket randomized trials, the US Food and Drug Administration (FDA) has concluded that paclitaxel does not pose a risk to long-term survival [66], but still urges health care providers to discuss the potential benefits of paclitaxel-coated devices (ie, reduced reinterventions) and risks in individual patients along with potential risks (ie, late mortality) before using paclitaxel-coated devices for the treatment of PAD [67].

The long-term data from the pivotal premarket trials was initially presented by the FDA at a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee [68]. In the FDA's meta-analysis of these trials (1090 patients), overall mortality at five years was significantly increased for patients treated with paclitaxel-coated devices compared with those treated with uncoated devices (19.8 versus 12.7 percent, relative risk [RR] 1.57, 95% CI 1.16-2.13). These results confirmed a meta-analysis by Vascular InterVentional Advances (VIVA) clinicians of patient-level data provided by manufacturers (HR of 1.38, 95% CI 1.06-1.80) [69], and an earlier meta-analysis (mortality risk ratio 1.93, 95% CI 1.27-2.93) [70]. A secondary analysis of data from eight trials gathered by VIVA identified missing vital status data and included 2185 subjects with a median four years follow-up [71]. There were 271 deaths included in the primary analysis and 386 in the updated analysis. With the recovery of lost vital status data, mortality risk was slightly lower compared with the prior analysis but still significantly increased for paclitaxel-coated devices compared with balloon angioplasty (HR 1.27, 95% CI 1.03-1.58). The absolute mortality risk difference associated with paclitaxel-coated devices was 4.6 percent. The mechanism of increased death could not be determined; mortality risk was increased for all major causes of death (cancer, cardiovascular, infection, pulmonary, other) with no subgroup differences. A paclitaxel dose-mortality association was not identified. The potential increased mortality should nevertheless be interpreted with caution given the remaining limitations in the available data (eg, pooling of studies of different paclitaxel-coated devices that were not intended to be combined, no identified pathophysiologic mechanism for the late deaths) [72-74]. Recommendations for informed consent, monitoring patients, and adverse event reporting can be found on the FDA website [67].

Later studies from large, high-quality databases with reliable data on mortality and comorbidities as well as an interim analysis of the temporarily halted multicenter trial, The Swedish Drug Elution Trial in Peripheral Arterial Disease (SWEDPAD) refuted the prior increased mortality signal identified in patients with paclitaxel-eluting endovascular devices [75-78].

In an analysis of data from the Vascular Quality Initiative, which included a total of 8376 patients, mortality was overall similar among those receiving paclitaxel-eluting stents compared with bare-metal stents at a median follow-up of 13.1 months (8.8 and 9.8 percent, respectively) [75]. Among those treated for claudication, mortality was significantly lower among those who received paclitaxel devices (balloon, stent) compared with non-paclitaxel devices (1.6 versus 4.4 percent; adjusted HR 0.59, 95% CI 0.39-0.89) at one year. For CLTI, the mortality difference was not significant (15.5 percent).

In a retrospective analysis of insurance claims from 37,914 patients in Germany between 2010 to 2018, the use of paclitaxel-coated balloons and stents in patients with CLTI were associated with improved outcomes at five years compared with those who were treated with uncoated devices (overall survival: HR 0.83, 95% CI 0.77-0.90; amputation-free survival: HR 0.85, 95% CI 0.78-0.91; freedom from major cardiovascular events: HR 0.82, 95% CI 0.77-0.89) [76]. In the claudication cohort, mortality was significantly lower in paclitaxel group (HR 0.88, 95% CI 0.80-0.98).

In the SWEDPAD trial, which randomly assigned 2289 patients to paclitaxel-coated or uncoated devices for treatment of symptomatic PAD, all-cause mortality was similar between the treatment groups at a median follow-up of 2.5 years (25.5 versus 24.6 percent) and was also similar among those with disabling claudication (10.9 versus 9.4 percent) or CLTI (33.4 versus 33.1 percent) [77]. Whether the lack of difference in mortality will be sustained over time remains unknown.

Common femoral artery — Patients with bulky CFA disease with or without proximal or distal extension are treated with femoral endarterectomy with or without profundoplasty. Most patients tolerate this procedure well. However, for patients with very high risk, endovascular interventions for CFA have been reported. In small single-center studies, technical success has been >90 percent with one-year primary patency ranging from 73 to 81 percent [79]. In one randomized trial in patients with CFA stenoses (no occlusions) comparing open with endovascular treatment, 24 month patency and reintervention rates were similar, and the stented group had significantly less morbidity and mortality (12.5 versus 26 percent) [80].

Atherectomy and angioplasty with or without drug delivery has also been reported in small series with acceptable early outcomes.

Infrapopliteal — Infrapopliteal interventions are typically performed in patients with CLTI, particularly those presenting with tissue loss. These patients commonly require multilevel revascularizations with concomitant femoropopliteal and even more proximal interventions and may require hybrid interventions to achieve in-line flow to the foot. Infrapopliteal disease with patent femoropopliteal arteries is not uncommon, particularly in patients with diabetes or chronic kidney disease. Infrapopliteal interventions for claudication are almost never performed, and intervening on infrapopliteal arteries for improving runoff status in patients having femoropopliteal interventions has not been studied, although femoropopliteal patency has been reported to be associated with improved patency rates in patients with two or more runoff vessels.

Access for infrapopliteal interventions is commonly via a contralateral CFA approach, particularly when concomitant femoropopliteal artery intervention is planned; however, ipsilateral antegrade access can be considered, particularly when crossing a calcified infrapopliteal occlusion is planned in patients with patent or minimally diseased femoropopliteal arteries. This provides more pushability of the guidewires and catheters across calcified occlusions. The crossing is typically intraluminal using 0.014" wires; however, with occlusions, subintimal crossing is common. A variety of crossing wires and support catheters are used for crossing. Retrograde pedal access is used when crossing antegrade fails. Pedal access is performed using ultrasound-guided or fluoroscopy-guided access to the tibial artery (image 1), followed by placement of the inner cannula of the micropuncture catheter, then using either a 0.014 or 0.018" crossing wire. When catheter support is needed, the inner cannula can be exchanged to a 0.014 or 0.018" (our preference) support catheter. A need to place a sheath in these small arteries is uncommon. Adjunctive use of vasodilators may be necessary, but this is rarely necessary when a sheath is not used. Once crossing is achieved, the wire is retrieved from the proximal sheath and the intervention is completed as usual.

The most common intervention in the infrapopliteal arteries is balloon angioplasty, and typically long balloons (up to 21 cm in length) with prolonged inflation times (three to five minutes) are used to minimize the recoil or dissections and the need for stents at this location. DCBs have been compared to balloon angioplasty for infrapopliteal arteries in a number of studies [81-83]. In a systematic review that identified 10 trials involving 1593 patients, pooled results showed no significant difference in limb salvage (five studies), amputation-free survival (two studies), restenosis (four studies), or target lesion revascularization at 12 months (four studies) [82]. However, a later randomized trial of 105 patients with CLTI evaluating the safety and efficacy of a DCB (Litos; paclitaxel) for below-the-knee intervention (Rutherford class ≥4) reported significantly less late lumen loss on angiography at six months for those randomly assigned to drug-coated compared with plain balloon angioplasty (0.51 ± 0.60 mm versus 1.31 ± 0.72 mm) [81]. At 12 months, occlusive restenosis rates were also reduced (8.6 versus 48.4 percent, respectively), as was clinically driven target revascularization (10 versus 41 percent, respectively). The treated lesions in this trial were longer (mean length 18 cm) compared with prior studies that treated predominantly focal lesions, and many of the lesions were occlusive. Larger, multicenter randomized trials will be needed to confirm these encouraging results and to assess the impact of the improvement of early luminal patency on later clinical outcomes such as limb salvage and survival.

Bare metal stents have also not been shown to improve patency over balloon angioplasty; however, DESs are associated with lower rates of restenosis and amputation [84,85]. It is important to note that the treated lesions in available trials were mostly focal lesions, whereas most treated lesions in daily practice are more complex with longer stenoses and occlusions.

Various atherectomy devices have been used and are currently used to treat infrapopliteal disease; however, these have not been shown to have any benefit over the PBA. However, the bailout stenting rate has been shown to be less after atherectomy than PBA.

For patients with nonhealing ulcers despite infrapopliteal intervention, inframalleolar interventions can also be considered. Balloon angioplasty using small balloons (1 to 2 mm) with prolonged inflations are required for optimal outcomes (image 11).

Angiosome concept — Angiosomes are defined as the tissue fed by a specific artery (anterior tibial, posterior tibial, or peroneal). The foot is divided into six angiosomes. Choke vessels connect the angiosomes, which may be a problem in patients without these collaterals, as commonly seen in patients with diabetes. Angiosome-specific endovascular revascularization is associated with improved limb salvage and improved ulcer healing rate [86,87]. However, in the presence of adequate collaterals, direct compared with indirect revascularization seems to have less impact on wound healing. In a large study involving 486 patients, limb salvage and ulcer healing rates were similar for direct revascularization compared with indirect revascularization through collaterals, and both were superior to indirect revascularization without collaterals [88].

Multivessel revascularization — Multivessel revascularization has been proposed as an advantage of endovascular revascularization over open surgical bypass. The benefits of multivessel recanalization have been proposed to be the possible additive effect of two arteries in one angiosome, especially in those with incomplete pedal arch, as well as the potential of compensating for loss of patency in one vessel over time. Healing time and rate were better in two-vessel revascularization compared with single-vessel revascularization, with less effect of the angiosome concept in some studies [89]; however, others have found no impact for multivessel revascularization [90]. A small randomized trial found that multivessel revascularization was associated with faster and higher healing rate with a trend for better limb salvage in patients with tissue loss [91]. It seems that selected patients with incomplete pedal arch in whom indirect revascularization would not provide adequate flow to the ulcer may benefit from multivessel revascularization.

In patients undergoing multivessel infrapopliteal interventions, multiple wires can be used to cross lesions, and the kissing balloon technique when necessary can be used (image 12). In patients with multiple vessel interventions, it is useful to work with multiple wires until all interventions are complete.

COMPLICATIONS AND MANAGEMENT — Although endovascular interventions are minimally invasive, complications related to access site, during the intervention on the target vessel, and device-related complications can all occur in spite of appropriate planning. The consequences may result in significant morbidities or even fatality if not addressed in a timely fashion.

Complications include systemic complications, such as acute kidney injury (contrast induced or other causes), and those directly related to the intervention, such as vessel rupture, dissections, loss of branch vessels, early and late occlusions, and distal embolization. The risk of complications parallels the increase of the complexity of the revascularizations.

Most procedure-related complications can be managed using endovascular techniques. Thus, a variety of covered stents, snares, wires and catheters, and reentry devices should be available. Although infrequent, surgical conversion is more likely in patients with complex aortoiliac occlusive disease, especially those with severe calcification, bulky common femoral artery disease, and those with subacute occlusions with organized clot content (prone to embolization). The complication rate for iliac artery lesions was reported to be higher in the TASC C/D group (9 versus 3 percent), with significantly longer procedure times in a large study [24].

Hematoma/pseudoaneurysm — Hematoma after percutaneous interventions can occur and is typically managed conservatively. Ultrasound (US) helps identify those with a pseudoaneurysm. Small pseudoaneurysms can be observed, and US-guided thrombin injection is used in those that persist or are symptomatic (algorithm 1). Due to low success rate and discomfort associated with US-guided manual compression, thrombin injection remains the treatment of choice. (See "Femoral artery pseudoaneurysm following percutaneous intervention".)

High femoral sticks may result in retroperitoneal hematoma and may result in significant blood loss. If there is evidence of ongoing blood loss, the leaking femoral artery site needs to be repaired with a stent-graft placement, although open repair may be necessary.

Thrombosis/embolism — Thrombosis of the access site would typically require exploration, thromboendarterectomy, and patch closure. However, endovascular treatment using thrombectomy and stenting can be considered in high-risk patients.

Embolization can occur with any type of endovascular intervention, and recognition of high-risk lesions is important to prevent this complication. Embolization during iliac intervention can occur in patients with soft iliac plaques or those containing fresh or organizing clots, which is more likely in subacute occlusions. For patients at high risk for embolization, femoral cutdown and clamping of the femoral artery before the intervention can be considered before proceeding with the recanalization (balloon angioplasty and stenting) (image 13).

Microembolization can result in tissue loss (eg, trash foot) and may be very difficult to treat. It is important to assess the patency of the runoff vessels before the procedure not only by reviewing preprocedural vascular imaging but also by injecting contrast via the crossing catheter after crossing the occlusions to determine if any embolization has occurred during crossing. Filter protection can be considered when treating more distal lesions at high risk of embolization or during procedures known to be associated with higher risk of embolization, such as atherectomy procedures.

Once embolization has occurred, initial management includes ensuring adequate systemic anticoagulation. Embolization can managed either using pharmacomechanical thrombolysis or by surgical thrombectomy, which may be more appropriate for patents with large clot embolization to the common femoral artery. Removal can be attempted using a variety of thrombectomy catheters (suction or mechanical such as Angiojet, Penumbra); however, adjunctive thrombolysis will likely be necessary, and these devices may themselves cause additional embolization to more distal vessels, even with the use of protective distal filters during thrombectomy. Surgical embolectomy may be needed if embolic material cannot be adequately retrieved (image 14). (See "Embolism to the lower extremities".)

Embolization to the renal and mesenteric arteries during aortoiliac interventions can cause significant morbidity and mortality, so high-risk patients should be considered for open reconstruction. Embolization to these arteries may not always respond to thrombolysis or thrombectomy, and loss of renal function would have a significant negative impact, especially if the embolization is due to atherosclerotic debris, rather than clots.

Arterial dissection/perforation — Dissection of the treated artery occurs either during wire manipulation inadvertently, or as part of the crossing occlusions in a subintimal fashion, at the site of reentry, or after balloon angioplasty.

Arterial dissections that occur during iliac angioplasty are easily treated with a self-expanding bare metal stent; however, this is rarely an issue in aortoiliac occlusive disease as primary stenting is typically used for these lesions (image 15). The stent may need to be extended to the aorta as well as down to the common femoral artery, and occasionally conversion to open surgery to manage the common femoral artery may be necessary to prevent extension of the dissection into the deep or superficial femoral arteries. When the anatomy is not clear, intravascular ultrasound (IVUS) can be helpful to identify the extent of the dissection.

Stent placement may also be needed to tack down more distal dissections when they are flow limiting. Prolonged balloon inflation, especially in infrapopliteal dissections, should first be attempted, with stenting reserved for those unresponsive to the balloon dilation.

Perforation — Arterial perforation can occur with wire manipulation while crossing occlusions. The more clinically significant vessel perforation occurs due to overdistension of vessels, or can occur if a subadventitial rather than a subintimal passage while crossing an occlusion is not recognized and a balloon angioplasty is performed to post-dilate a noncovered stent. When recognized early with wire access maintained, treatment is usually straightforward. Reversal of anticoagulation may be considered if expeditious control of perforation cannot be achieved; however, this is rarely needed.

Iliac artery rupture is immediately apparent when massive retroperitoneal hemorrhage causing moderate to severe pain and immediate hypotension occurs; however, a localized perforation may present later as a pseudoaneurysm or late rupture. The liberal use of covered stents, particularly in patients with chronic total iliac artery occlusions, may decrease this complication. Overdilating the arteries with oversized balloons should be avoided. Once rupture occurs in the iliac artery, immediate injection of dye via the sheath will identify the site of rupture, and an appropriately sized balloon should be immediately introduced to tamponade the ruptured artery, providing time to prepare and deploy a stent-graft across the perforation (image 16). More proximal control with an aortic or common iliac artery balloon may be needed since the sheath may need to be upsized to accommodate a stent-graft. If the rupture is at the distal aorta, or the aortoiliac junction, kissing covered stents may seal the perforation; however, placement of an aortoiliac unibody stent graft and femorofemoral bypass with or without coil embolization of the common iliac artery may provide the most expedient repair.

Microperforation of the femoropopliteal and infrapopliteal vessels may be observed and sometimes may occasionally result in arteriovenous fistulas. These may simply disappear with prolonged balloon dilatation. For femoropopliteal perforations that persist, stent-graft coverage may be needed. Since there are no stent-grafts that are readily available for use at the infrapopliteal level, perforations that persist in spite of prolonged balloon inflation can be managed with external compression and reversal of anticoagulation, if needed. Persistent bleeding in infrapopliteal vessels due to perforation is rare. Arteriovenous fistulization may also occur, and most are managed conservatively, but covered stenting may be necessary.

Renal dysfunction — One of the most commonly encountered systemic complications of endovascular interventions is contrast nephrotoxicity. (See "Contrast-associated and contrast-induced acute kidney injury: Clinical features, diagnosis, and management".)

The contrast load needed for infrainguinal interventions can be significant, especially in those having complex procedures. Typically, 50 to 100 cc of contrast dye is used during peripheral interventions, with as little as 20 to 30 cc for an infrapopliteal intervention with adequate inflow. Measures are routinely taken to use as low a dose of contrast as possible. This is done by diluting the contrast, using as little dose as possible for each injection, minimizing repeat injections by road-mapping, or external marking, and by selective catheterization of the territory of interest. In patients with chronic kidney disease, CO2 can be used as an adjunct for arterial imaging below the diaphragm.

POSTINTERVENTIONAL MANAGEMENT — Postoperative medical management is crucial in patients who have undergone a peripheral intervention for symptomatic peripheral artery disease (PAD) with the main goal of reducing their risk for future cardiovascular events, including death.

Management should include lifestyle modification and improvement of their functional status. Smoking cessation should be emphasized if the patient is actively smoking and adjunctive therapies provided. Optimal management of hypertension, diabetes, and hyperlipidemia is crucial.

Antiplatelet therapy — There is some evidence to suggest that the rate of restenosis/reocclusion following peripheral endovascular treatment is reduced with the use of antiplatelet drugs compared with placebo [92], but the available trials are small and of variable quality [93-95]. Recommendations and prescribing practices vary widely [93,95,96]. In the absence of high-quality data, we suggest giving patients aspirin (<325 mg/day) plus clopidogrel (75 mg/day) for one to three months, followed by lifelong aspirin (for ongoing secondary prevention of future cardiovascular events). Based on data from the coronary literature, we suggest that patients who receive a drug-eluting stent receive clopidogrel for a longer period (3 to 12 months).

Although shown to be more effective than aspirin in a multicenter randomized trial for decreasing cardiovascular mortality [97], particularly in the subgroup of patients with PAD, long-term use of clopidogrel has not gained wide acceptance due to increased cost and bleeding risk. Whether long-term dual antiplatelet therapy (DAPT) provides a benefit following endovascular intervention is not clear. A meta-analysis did not show a significant benefit of DAPT for restenosis in the peripheral arteries (risk ratio 1.02, 95% CI 0.56-1.82) [98]. However, in a Vascular Quality Initiative study cohort of 40,000 patients, dual antiplatelet therapy was associated with improved survival for patients with chronic limb-threatening ischemia (CLTI) [99-101].

There is no known benefit of long-term anticoagulation with vitamin K antagonists on target lesion or limb outcomes following endovascular intervention [94]. It is typically reserved for patients with hypercoagulable states or other indications, such as atrial fibrillation.

There is an emerging interest in combining anticoagulants with antiplatelet therapy with the introduction of direct oral anticoagulants. In the COMPASS trial of 27,395 patients, 27 percent of whom had PAD [102], rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily was superior to aspirin alone with a 24 percent reduction (4.1 versus 5.9 percent) in cardiovascular death, stroke, or myocardial infarction. The trial was stopped early due to superiority of the rivaroxaban plus aspirin arm. Adding rivaroxaban twice daily to aspirin therapy (75 to 100 mg orally each day) is increasingly being prescribed after endovascular and open revascularization procedures, particularly among those patients with a high risk of ischemic events and low risk of bleeding.

Cilostazol, which is often prescribed to improve pain-free walking distance, may also be effective for improving outcomes of vascular intervention [94,103]. In a systematic review, a meta-analysis of two trials [104,105], cilostazol significantly reduced the rate of reocclusion compared with ticlopidine (odds ratio 0.32, 95% CI 0.13-0.76).

Statin therapy — Updated guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) recommend that all patients with atherosclerotic cardiovascular events, including those with PAD, who are older than 75 years should receive moderate-intensity statin therapy, and patients younger than 75 years should be treated with high-intensity statin [106]. While the impact of statins on improving survival and decreasing cardiovascular events is well known, their impact on patency and limb salvage rates is inconclusive. Statin medications were reported to decrease major adverse limb events and improve survival rates in patients who were compliant with the current 2013 AHA/ACC recommendations after revascularization for CLTI [107]. Also, in a subgroup analysis of a meta-analysis of 46 studies involving patients undergoing lower extremity revascularization, statins were associated with improved primary and secondary patency rates and significantly decreased amputation rates [108].

Surveillance after endovascular interventions — Ongoing clinical evaluation is recommended following lower extremity revascularization, but strategies for surveillance of the treated lesions following endovascular intervention are not well defined. Surveillance of endovascular treated arteries, ankle-brachial index (ABI), and duplex imaging is considered appropriate when obtained postprocedurally and for recurrent or new symptoms [109]. Thus, we obtain initial postoperative noninvasive vascular studies within a month to help assess the adequacy of revascularization and establish a baseline reference for future studies. While duplex ultrasonography is considered by many to be the best method for detecting problems following lower extremity revascularization, the clinical value of routine duplex surveillance following endovascular intervention and the interval for testing is debated, and intervening on detected lesions may increase the risk for complications [110-112]. Patients with failing endovascular interventions are typically not treated in the absence of symptoms, but many patients with recurrent symptoms (claudication, rest pain) or failure of ulcer or wound healing will have significant restenosis and may benefit from reintervention.

For ongoing evaluation, we include duplex ultrasonography in our clinical surveillance schedule. In addition to clinical evaluation including wound assessment, we repeat noninvasive vascular studies at three and six months and, if stable, annually thereafter. Arteriography and possible reintervention is indicated for restenosis as evidenced by a peak systolic velocity (PSV) >300 cm/second and velocity ratio (Vr) >2.0, or a decrease in ABI >0.15, if clinically indicated [113].

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Occlusive carotid, aortic, renal, mesenteric, and peripheral atherosclerotic disease".)

SUMMARY AND RECOMMENDATIONS

Endovascular revascularization – Endovascular intervention for lower extremity arterial disease has been widely adopted due to its minimally invasive nature. Almost all types of anatomic lesions can potentially be treated by endovascular means. Whether to pursue endovascular intervention, rather than lower extremity bypass surgery, depends on the severity of symptoms, anatomic complexity of the disease, availability of potential conduit, and patient's overall medical condition. (See 'Decision making for endovascular revascularization' above.)

Preprocedure imaging – Once a decision has been made to intervene, vascular imaging is necessary to assess the extent of arterial disease, assess the inflow and runoff arteries, and plan the technical conduct of the intervention. The selected imaging modality used to accomplish these goals is based upon the level of arterial obstruction on clinical examination. (See 'Preprocedural imaging' above.)

Procedural overview – Endovascular intervention can be performed in an interventional suite or hybrid operating room, typically using moderate sedation. Prophylactic antibiotics are given, and heparin is administered to prevent arterial thrombosis during intravascular manipulation of sheaths, wires, and other devices. Endovascular intervention is performed in a stepwise fashion, as follows (see 'Procedural overview' above):

Obtain arterial access (percutaneous or surgical) and place the necessary sheath(s) to deliver wires, catheters, and other devices by which to cross stenoses or occlusions and gain access to the distal lumen. The most commonly used access site is the common femoral artery, typically using ultrasound guidance. Endarterectomy of the access vessel may be necessary to pass the appropriate devices. (See 'Arterial access' above.)

Perform initial arteriography and determine whether to proceed with the intervention. Arteriography identifies target vessels for revascularization and also documents the baseline status of the lower extremity circulation. (See 'Arteriography' above.)

Anticoagulate the patient and monitor to maintain an adequate level. The patient is typically anticoagulated with heparin given as an initial intravenous bolus (80 to 100 U/kg). (See 'Anticoagulation' above.)

Treat the diseased segment(s) to achieve a patent lumen followed by completion arteriography. The general goal is to establish in-line flow to the foot. Lesions are treated from proximal to distal in sequence. For apparent occlusions, intraluminal crossing is attempted first; however, if this is not successful, subintimal crossing with the aid of a reentry device may be successful. A variety of devices are available by which to accomplish angioplasty (standard balloon, cutting balloon, atherectomy) and/or stenting (bare metal, covered stent, stent-graft). The selected devices depend upon the severity of the lesion and its location. (See 'Lesion crossing and treatment' above.)

Remove devices and manage the access site. While closure devices are associated with a decreased time to hemostasis and time to ambulation, these have not been shown to be superior to manual compression with respect to access site complications, and closure devices increase cost. (See 'Management of access site' above.)

Outcomes – Outcomes of endovascular intervention for PAD vary depending upon the anatomic site treated. (See 'Techniques and outcomes by anatomic site' above.)

Aortoiliac – Occlusive disease of the aortoiliac segment is typically treated with angioplasty and balloon-expandable stents or stent-grafts. For mild-to-moderate aortoiliac artery disease (TASC A, B), overall outcomes are excellent. For more severe disease (TASC C, D), the use of secondary percutaneous interventions can achieve patency rates that are similar to those of open surgical revascularization. (See 'Aortoiliac' above.)

Femoropopliteal – Occlusive disease in the femoropopliteal segment is treated with angioplasty and self-expanding stents, as needed. The approach to stenting depends upon the length of the stenotic segment. For short lesions (less than 5 cm), plain balloon angioplasty often suffices, with stenting reserved for residual stenosis, dissection, or vessel rupture. As the length of the lesion increases, the need for provisional stenting also increases. An alternative for short- to medium-length calcified lesions is atherectomy, ideally with distal protection. For longer lesions (greater than 10 cm), primary stenting (self-expanding nitinol) provides a more durable result. (See 'Femoropopliteal' above.)

Infrapopliteal – Infrapopliteal interventions are typically performed in patients with chronic limb-threatening ischemia (CLTI), particularly those presenting with tissue loss. They are almost never performed for claudication. The most common intervention in the infrapopliteal arteries is balloon angioplasty, typically using long balloons (up to 21 cm in length) with prolonged inflation times (three to five minutes), which helps to minimize elastic recoil or dissections, and thus the need for any stents at this location, which do poorly. (See 'Infrapopliteal' above.)

Complications – Complications of endovascular intervention are most commonly related to arterial access (eg, hematoma, pseudoaneurysm) but may also be related to the administration of intravenous contrast or device deployment (arterial dissection, arterial rupture, distal embolism). Most device-related complications can be managed using endovascular techniques. Surgery may be needed with complications related to the treatment of the more proximal vasculature (eg, aortoiliac, femoral). (See 'Complications and management' above and "Access-related complications of percutaneous access for diagnostic or interventional procedures".)

Postinterventional management

Antiplatelet therapy – Following endovascular intervention in the lower extremity that requires stent placement, we suggest a combination of aspirin and clopidogrel for one to three months, followed by lifelong aspirin. For patients in whom a drug-eluting stent (DES) is placed, clopidogrel is maintained for a longer duration (3 to 12 months). The goal of antiplatelet medications is to improve stent patency rates as well as to reduce the risk of future cardiovascular events. (See 'Antiplatelet therapy' above and "Overview of lower extremity peripheral artery disease", section on 'Adjuncts to improve patency of revascularization'.)

Surveillance – Following endovascular intervention, we perform surveillance of treated arteries (a combination of clinical evaluation and duplex ultrasound) in the immediate postprocedure period, at three months, at six months, and, if stable, annually thereafter. The threshold for reevaluation with arteriography is a peak systolic velocity (PSV) >300 cm/second and velocity ratio (Vr) >2.0 with a decrease in ankle brachial index (ABI) >0.15. (See 'Surveillance after endovascular interventions' above.)

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Topic 15217 Version 20.0

References

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