Anthem Blue Cross California Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization Form

Subject:

Description

This document addresses the use of peripheral vascular angioplasty, with and without stenting, and with or without atherectomy, for the treatment of occlusive peripheral arterial disease (PAD) of the lower extremities.

Note: The following procedures are NOT addressed in this document:

• Procedures for venous peripheral vascular disease
• Open bypass procedures

Note: Please see the following document for additional information:

• CG-THER-RAD-07 Intravascular Brachytherapy (Coronary and Non-Coronary)
• TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products

Clinical Indications

Medically Necessary:

A.  Treatment of Claudication

For individuals with claudication due to lower extremity occlusive arterial disease, the use of either percutaneous or open exposure angioplasty is considered medically necessary for individuals who meet ALL of the following criteria:

1. Presence of severe disability (inability to perform usual work or life-style activities) due to intermittent claudication; and
2. There has been an inadequate response to at least 6 months of conservative treatment including lifestyle initiatives for known risks (for example, smoking cessation and dietary changes), including supervised exercise training, and pharmacological therapy (for example, anti-platelet, cilostazol) unless contraindicated; and
3. The targeted lesion has one of the following anatomic characteristics:
   1. Common iliac artery: unilateral or bilateral lesions of any length; or
   2. External iliac: unilateral or bilateral lesions less than or equal to 3 cm in length; or
   3. Femoral or popliteal artery: a single stenosis less than or equal to 10 cm in length or a single occlusion less than or equal to 5 cm in length; and
4. There is an absence of other conditions that would limit activity even if the claudication were improved (for example, angina or chronic pulmonary disease) with the endovascular intervention.

For individuals with claudication due to lower extremity occlusive arterial disease, the use of either percutaneous or open exposure primary stent placement is considered medically necessary, when the following criteria have been met:

1. Criteria above for angioplasty have been met; and
2. Stenosis or occlusion is present in the common iliac artery, external iliac artery; or
3. Stenosis or occlusion of intermediate-length (5-15 cm) is present in the femoropopliteal artery.

For individuals with claudication due to aortoiliac occlusive disease (AIOD), the use of covered stent devices is considered medically necessary in the presence of severe calcification or aneurysmal changes where the risk of rupture may be increased after unprotected dilation.

B.  Salvage (Provisional) Therapy for Claudication

For individuals with claudication due to lower extremity occlusive arterial disease, the use of either percutaneous or open exposure stents or atherectomy devices as salvage (provisional) therapy for a suboptimal or failed result from balloon angioplasty is considered medically necessary when the residual stenosis or occlusion is present in either the femoral, popliteal, or tibial artery and ANY of the following criteria have been met:

1. Residual diameter stenosis greater than 50%; or
2. Persistent translesional pressure gradient; or
3. Flow-limiting dissection is present.

C.  Critical Limb Ischemia (CLI)

For individuals with limb threatening CLI due to lower extremity occlusive arterial disease (ischemic rest pain and/or impending limb loss with skin ulceration, gangrene, infection) of the lower extremity, the use of endovascular procedures (angioplasty, stent placement, or atherectomy) is considered medically necessary as initial or salvage therapy for inflow (aorto-iliac) and outflow (infrainguinal) occlusive vascular disease.

Note: The optimal strategy for the management of an individual with CLI is determined on a case by case basis by the treating physician and influenced by the urgency of the limb threat, comorbidities, and the individual’s arterial anatomy.

Not Medically Necessary:

The use of percutaneous or open exposure angioplasty, with or without stent placement, and with or without atherectomy for the treatment of individuals with claudication due to lower extremity occlusive arterial disease is considered not medically necessary when the criteria above have not been met, including its use as prophylactic therapy in an asymptomatic individual with lower extremity PAD, or for claudication due to isolated infrapopliteal artery disease.

The use of primary stent placement for the treatment of claudication caused by isolated lesions in the infrapopliteal or tibial arteries is considered not medically necessary.

The use of peripheral vascular angioplasty, with or without stenting, and with or without atherectomy, is considered not medically necessary for treatment of occlusive arterial disease of the deep femoral artery (profunda femoris).

The use of endovascular procedures (angioplasty, stent placement, or atherectomy) for the treatment of CLI due to lower extremity occlusive arterial disease is considered not medically necessary as initial or salvage therapy for inflow (aorto-iliac) and outflow (infrainguinal) occlusive vascular disease in the absence of clinical symptoms of limb threatening CLI or when the medically necessary criteria for treatment of claudication above are not met.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses not listed; or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary.

Discussion/General Information

Background

Peripheral artery disease (PAD) affects up to 10 million people in the United States and is a significant cause of death. PAD is caused by the restriction of blood flow to the arms, legs, or internal organs due to partial or total occlusion of the blood vessels. There are two types of PAD; organic and functional. Organic PAD, which is the more common form, is due to inflammation and tissue damage in the blood vessels caused by fatty build-up in arteries that blocks normal circulation. Functional PAD is related to abnormal contractions of the blood vessels due to a disease condition (for example, Raynaud's disease). This condition may be triggered by smoking, cold temperatures, emotional stress, or working with vibrating machinery.

PAD affects three major arterial segments of the lower extremity: (1) aorto-iliac arteries, (2) femoro-popliteal (FP) arteries, and (3) infra-popliteal (primarily tibial) arteries. The disease is usually classified based on claudication (a condition characterized by cramping and pain in the leg due to exercise), resting pain, or degree of tissue loss due to chronic ischemia. One measure of the presence and severity of PAD in the extremities is the use of the Ankle Brachial Index (ABI). This test is done by measuring blood pressure at the ankle and in the arms while a person is at rest. The ABI is expressed as a ratio of the highest blood pressure measurement in the foot divided by the highest blood pressure measurement in the arms. A normal ABI is usually 1.0 to 1.4, and lower or higher measurements indicate abnormal blood flow in the extremities. A classification scheme for PAD lesion types has been proposed by the TransAtlantic Inter-Society Consensus (TASC II) working group (Norgren, 2007). This classification system has been accepted and widely used to assess the severity of PAD through consideration of the location, diameter, and length of occlusions. There are several different measurement schemes, based on the location of the occlusion. However, they all rank occlusions from Type A to Type D, with Type A occlusions being the least severe and Type D being the most severe.

More than 70% of individuals diagnosed with PAD remain stable or improve with conservative management. Those who do not improve may undergo a variety of diagnostic studies which may be used in planning for surgery or percutaneous intervention, such as computed tomography angiography (CTA) and magnetic resonance angiography (MRA) (Jens, 2013). Some of these studies also include non-invasive imaging without contrast, which helps to reduce the individual’s exposure to contrast dye. This is especially important in those individuals with significant renal insufficiency. Non-contrast MRA is a reliable alternative to non-invasive imaging with contrast (Wu, 2016).

Chronic limb-threatening ischemia (CLTI) formerly known as Critical Limb Ischemia (CLI)

CLTI, previously referred to as critical limb ischemia, is the most severe form of PAD.  CLTI exists when there is arterial insufficiencies complicated by gangrene, a nonhealing ischemic ulcer, or pain at rest. Revascularization procedures used to restore blood flow to the affected limb may involve surgical as well as endovascular approaches. The incidence of limb amputation is approximately 25% 1 year after diagnosis if revascularization to improve limb perfusion is not performed (Farber, 2022). Surgical bypass procedures involve grafting of a native autologous vein or synthetic graft prosthesis from proximal to the area of the affected artery to distal to the affected area, thus ‘bypassing’ the occluded portion of the artery. Due to complications related to bypass surgeries, the use of open and percutaneous endoluminal angioplasty, atherectomy, and stenting have been developed as primary and salvage therapy for PAD. These types of procedures act to reduce the occlusion by compressing or removing the blockage, as opposed to bypassing it. The choice of which therapy to pursue depends on many factors, including but not limited to individual’s arterial disease pattern, surgical risk, availability of an autogenous conduit for vein bypass, and individual and physician preference (Farber, 2022).

The Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial evaluated the efficacy of endovascular revascularization compared to surgical revascularization in those with CLTI caused by infrainguinal PAD who were suitable candidates for both approaches (Farber, 2023). In individuals with an adequate saphenous vein for bypass, surgery was associated with a 32% lower risk of a major adverse limb event or death. In individuals without an adequate saphenous vein for conduit, the efficacy and safety outcomes were similar between the 2 groups. Studies support revascularization for individuals with critical limb ischemia (CLI), a severe obstruction of the arteries that has progressed to the point of severe pain and even skin ulcers or sores in the extremities (Bailey, 2019; Iida, 2017; Simons, 2019).

Paclitaxel-Coated Devices

Procedures such as angioplasty, atherectomy, and stenting have been established as standard procedures for the treatment of lower extremity PAD for many decades; however, in 2018, Katsanos and colleagues published the results of a systematic review and meta-analysis on the risk of death following the application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg. The systematic review yielded 28 randomized controlled trials (RCT) with 4663 participants that were included in the meta-analysis. All-cause participant death up to 1 year was reported by all 28 RCTs with a total of 4432 participants and was similar between paclitaxel-coated devices (58 deaths out of 2506 participants) and control arms (45 deaths out of 1926 participants) (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% confidence interval [CI], 0.72-1.61). Of the 28 RCTs, 12 RCTs with 2316 participants reported on all-cause death at 2 years. A significant difference was found between paclitaxel devices (101 deaths out of 1397 participants) versus control arms (35 deaths out of 919 participants) (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15-2.47; number-needed-to-harm, 29 patients [95% CI, 19-59]). There were 3 RCTs with 863 participants that reported all-cause death up to 5 years. There were 78 deaths out of 529 participants in the paclitaxel arms versus 27 deaths out of 334 participants in the control arms (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27-2.93; number-needed-to-harm, 14 patients [95% CI, 9-32]). “Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4 ± 0.1% excess risk of death per paclitaxel mg-year; p<0.001)” (Katsanos, 2018). The results of the meta-analysis are concerning; however, as noted by the investigators, the causes of the increased incidence of death are unknown mainly due to most included studies not reporting the actual causes of deaths, which could potentially help determine whether there is a link with paclitaxel devices. Another factor to consider is the paclitaxel arms had greater incidence of participant comorbidities, such as smoking, hyperlipidemia, hypertension, or diabetes mellitus. Further research with cause of death data is needed to validate these results.

In January 2019, the U.S. Food and Drug Administration (FDA) responded to these results by issuing a letter to health care providers on the treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents being potentially associated with increased mortality (FDA, 2019). The letter gave an overview of the meta-analysis and FDA actions, which included evaluation of the data to determine long-term risks associated with paclitaxel-coated devices. The FDA recommended to continue use of paclitaxel-coated devices in accordance with the indications due to the conclusion that the benefits outweigh the risks and to report any adverse events or suspected adverse events.

Also in January 2019, the Society for Cardiovascular Angiography & Interventions (SCAI) released a statement on paclitaxel devices and mortality in relation to an SCAI Vascular Disease Council expert review of the meta-analysis performed by Katsanos and colleagues (2018). The SCAI concluded that “the benefits of paclitaxel devices continue to outweigh any potential risks. However, we strongly encourage our members to discuss the findings of the meta-analysis with their patients and to report any safety concerns to FDA” (SCAI, 2019).

In July 2023, the FDA updated information associated with paclitaxel- coated devices to treat PAD. The FDA concluded that the evidence does not “support an excess mortality risk for paclitaxel-coated devices.” The FDA offered health care providers the following recommendations:

• Discuss the risks and benefits of all available PAD treatment options, including paclitaxel-coated devices, with your patients.
• Continue routine monitoring of patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
• Ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles including weight control, smoking cessation, and exercise.
• Report any adverse events or suspected adverse events to the FDA.

In response to the concerns about increased risk of death associated with paclitaxel-coated angioplasty devices, Nordanstig and associates (2020) published an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. The study compared paclitaxel-coated devices (n=1149) to uncoated devices (n=1140) when used to treat chronic limb-threatening ischemia or intermittent claudication. In the up to 4 year follow-up (mean 2.49 years), there was no difference in all-cause mortality between groups. In the Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices (SAFE-PAD) study, Secemsky and colleagues (2021) reported on a large observational data set of individuals who had undergone femoropopliteal artery revascularization procedures. Individuals received either paclitaxel-coated devices (n= 70,584) or non-coated peripheral devices (n=97,969). Follow-up of up to 5.16 years (median 2.72 years) found paclitaxel-coated devices to be non-inferior to uncoated devices in terms of mortality. The SAFE-PAD trial will continue until the median follow-up of all participants surpasses 5 years.

Specialty Society Guidance

The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) Task Force published their guideline titled, Management of Patients with Peripheral Artery Disease in 2013 (Rooke, 2013). This document updated its guidance and compiled the recommendations from earlier guidelines in 2005 and 2011.

The 2013 ACCF/AHA document supports the use of percutaneous or open exposure angioplasty for individuals with claudication and TASC type A lesions. The document specifically states, “In most claudicant patients being evaluated initially, a 6-month trial of smoking cessation, risk factor modification, exercise, or cilostazol, or a combination, should be initiated before any invasive therapy.”

Please refer to Hirsch (2005) for further details on the ACCF/AHA TASC recommendations (see page e517, Figure 8). The use of these procedures is not supported for more severe lesions.

In 2015, Jaff and others reported an update of the 2007 TASC II classification. This publication reiterated support for the existing TASC II classifications for aortoiliac and femoropopliteal segments, and added a new classification for the infrapopliteal segment. The authors also provided an overview of the current state of evidence addressing various treatment methodologies. They concluded that, despite the years that have passed since the TASC II publication in 2007, there remains a paucity of trial data comparing open and endovascular approaches for the treatment of CLI or claudication.

In 2015 Conte and others representing the Society for Vascular Surgery Lower Extremity Guidelines Writing Group published the Society for Vascular Surgery (SVS) practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. In this document they provide the following recommendations:

Recommendations: Interventions for aortoiliac occlusive disease (AIOD) in intermittent claudication (IC):

5.6. We recommend the use of covered stents for treatment of AIOD in the presence of severe calcification or aneurysmal changes where the risk of rupture may be increased after unprotected dilation.

Recommendations: Intervention for femoropopliteal occlusive disease (FPOD) in intermittent claudication (IC):

5.18. For intermediate-length lesions (5-15 cm) in the SFA, we recommend the adjunctive use of self-expanding nitinol stents (with or without paclitaxel) to improve the midterm patency of angioplasty.
5.20. We recommend against EVT of isolated infrapopliteal disease for IC because this treatment is of unproven benefit and possibly harmful.
5.21. We recommend surgical bypass as an initial revascularization strategy for patients with diffuse FP disease, small caliber (<5 mm), or extensive calcification of the SFA, if they have favorable anatomy for bypass (popliteal artery target, good runoff) and have average or low operative risk.

Additionally, this publication by the SVS also states that, “IC rarely results from isolated profunda femoral disease unless there is associated CFA or SFA disease. Endovascular intervention on the profunda femoral artery for claudication symptoms is of unproven value and may carry substantial risk to this most important source of collateral flow in the limb.”

The American College of Cardiology (ACC) and the American Heart Association (AHA) published a joint guideline on the management of patients with lower extremity peripheral artery disease (Gerhard-Herman, 2016). In this document they provided the following recommendations:

• In patients with claudication, a supervised exercise program is recommended to improve functional status and quality of life and to reduce leg symptoms (Class I, Level A)
• A supervised exercise program should be discussed as a treatment option for claudication before possible revascularization (Class I, Level B-R)
• Endovascular procedures are effective as a revascularization option for patients with lifestyle-limiting claudication and hemodynamically significant aortoiliac occlusive disease (Class I, Level A)
• Endovascular procedures are reasonable as a revascularization option for patients with lifestyle-limiting claudication and hemodynamically significant femoropopliteal disease (Class IIa, Level B-F)
• The usefulness of endovascular procedures as a revascularization option for patients with claudication due to isolated infrapopliteal artery disease is unknown (Class IIb, Level C-LD)
• Endovascular procedures should not be performed in patients with PAD solely to prevent progression to CLI (Class III: HARM, Level B-NR)
• When surgical revascularization is performed, bypass to the popliteal artery with autogenous vein is recommended in preference to prosthetic graft material (Class I, Level A)
• Surgical procedures are reasonable as a revascularization option for patients with lifestyle-limiting claudication with inadequate response to GDMT, acceptable perioperative risk, and technical factors suggesting advantages over endovascular procedures (Class II-a, Level B-NR)
• Femoral-tibial artery bypasses with prosthetic graft material should not be used for the treatment of claudication (Class III-HARM, Level B-R)
• Surgical procedures should not be performed in patients with PAD solely to prevent progression to CLI (Class III-HARM, Level B-R)
• In patients with CLI, revascularization should be performed when possible to minimize tissue loss (Class I Level B-nR)
• An evaluation for revascularization options should be performed by an interdisciplinary care team (Table 9) before amputation in the patient with CLI (Class I Level C-EO)
• Endovascular procedures are recommended to establish in-line blood flow to the foot in patients with nonhealing wounds or gangrene (Class I, Level B-R)
• A staged approach to endovascular procedures is reasonable in patients with ischemic rest pain (Class IIa Level C-LD)
• Evaluation of lesion characteristics can be useful in selecting the endovascular approach for CLI (Class IIa Level B-R)
• Use of angiosome-directed endovascular therapy may be reasonable for patients with CLI and nonhealing wounds or gangrene (Class IIb Level B-R)
• When surgery is performed for CLI, bypass to the popliteal or infrapopliteal arteries (ie, tibial, pedal) should be constructed with suitable autogenous vein (Class I Level A)
• Surgical procedures are recommended to establish in-line blood flow to the foot in patients with nonhealing wounds or gangrene (Class I Level C-LD)
• In patients with CLI for whom endovascular revascularization has failed and a suitable autogenous vein is not available, prosthetic material can be effective for bypass to the below-knee popliteal and tibial arteries(Class IIa Level B-NR)
• A staged approach to surgical procedures is reasonable in patients with ischemic rest pain (Class IIa Level C-LD)

Along with these recommendations, the ACC and AHA provided key components of supervised exercise programs, also referred to as supervised exercise therapy:

• Program takes place in a hospital or outpatient facility
• Program uses intermittent walking exercise as the treatment modality
• Program can be standalone or within a cardiac rehabilitation program
• Program is directly supervised by qualified healthcare provider(s)
• Training is performed for a minimum of 30-45 minutes per session; sessions are performed at least 3 times per week for a minimum of 12 weeks
• Training involves intermittent bouts of walking to moderate-to-maximum claudication, alternating with periods of rest
• Warm-up and cool-down periods precede and follow each session of walking

In addition to the hospital or outpatient facility, a supervised exercise program may take place in a physician office setting.

In 2019, the American College of Cardiology Appropriate Use Criteria Task Force, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine issued a joint report on the Appropriate Use Criteria for peripheral artery intervention (Bailey, 2019). In this document, they provided the following recommendations:

• Lower extremity disease
  • Intermittent claudication; no prior guideline-directed medical therapy
    • Any lower extremity disease
      • Initiate medical therapy (Appropriate)
      • Endovascular treatment (Rarely appropriate)
      • Surgical treatment (Rarely appropriate)
  • Intermittent claudication despite guideline-directed medical therapy – stenotic lesions
    • Aortoiliac
      • Continue or intensify medical therapy (Appropriate)
      • Endovascular treatment (Appropriate)
      • Surgical treatment (May be appropriate)
    • SFA and popliteal artery
      • Continue or intensify medical therapy (Appropriate)
      • Endovascular treatment (Appropriate)
      • Surgical treatment (May be appropriate)
    • Below the knee
      • Continue or intensify medical therapy (Appropriate)
      • Endovascular treatment (May be appropriate)
      • Surgical treatment (Rarely appropriate)
  • Intermittent claudication despite guideline-directed medical therapy – chronic total occlusion
    • Aortoiliac
      • Continue or intensify medical therapy (Appropriate)
      • Endovascular treatment (Appropriate)
      • Surgical treatment (May be appropriate)
    • SFA and popliteal artery
      • Continue or intensify medical therapy (Appropriate)
      • Endovascular treatment (May be appropriate)
      • Surgical treatment (May be appropriate)
    • Below the knee
      • Continue or intensify medical therapy (Appropriate)
      • Endovascular treatment (May be appropriate)
      • Surgical treatment (Rarely appropriate)
• Critical limb ischemia
  • Aortoiliac
    • Continue or intensify medical therapy (No recommendation)
    • Endovascular treatment (Appropriate)
    • Surgical treatment (Appropriate)
  • SFA and popliteal artery
    • Continue or intensify medical therapy (No recommendation)
    • Endovascular treatment (Appropriate)
    • Surgical treatment (Appropriate)
  • Below the knee
    • Continue or intensify medical therapy (No recommendation)
    • Endovascular treatment (Appropriate)
    • Surgical treatment (Appropriate)
• Options for endovascular treatment when deemed appropriate or may be appropriate
  • Isolated common iliac artery
    • Discrete stenosis
      • Artherectomy (Rarely appropriate)
      • Balloon angioplasty (Appropriate)
      • Stent (Appropriate)
    • Diffuse disease or multiple stenoses of the CIA
      • Artherectomy (Rarely appropriate)
      • Balloon angioplasty (May be appropriate)
      • Stent (Appropriate)
  • Isolated external iliac artery
    • Discrete stenosis
      • Artherectomy (Rarely appropriate)
      • Balloon angioplasty (Appropriate)
      • Stent (Appropriate)
  • Diffuse common iliac artery and external iliac artery
    • Unilateral EIA stenosis with multiple CIA stenoses
      • Artherectomy (Rarely appropriate)
      • Balloon angioplasty (May be appropriate)
      • Stent (Appropriate)
    • Chronic total occlusion
      • Artherectomy (Rarely appropriate)
      • Balloon angioplasty (May be appropriate)
      • Stent (Appropriate)
  • SFA and popliteal artery
    • Length <100 mm
      • Artherectomy (May be appropriate)
      • Balloon angioplasty (Appropriate)
      • Drug-coated balloon (Appropriate)
      • Bare metal stent (Appropriate)
      • Drug-eluting stent (Appropriate)
      • Covered stent (May be appropriate)
    • Length ≥100 mm
      • Artherectomy (May be appropriate)
      • Balloon angioplasty (May be appropriate)
      • Drug-coated balloon (Appropriate)
      • Bare metal stent (Appropriate)
      • Drug-eluting stent (Appropriate)
      • Covered stent (May be appropriate)
  • Below the knee
    • Length <100 mm
      • Artherectomy (May be appropriate)
      • Balloon angioplasty (Appropriate)
      • Drug-coated balloon (May be appropriate)
      • Bare metal stent (May be appropriate)
      • Drug-eluting stent (Appropriate)
      • Covered stent (Rarely appropriate)
    • Length ≥100 mm
      • Artherectomy (May be appropriate)
      • Balloon angioplasty (Appropriate)
      • Drug-coated balloon (May be appropriate)
      • Bare metal stent (May be appropriate)
      • Drug-eluting stent (May be appropriate)
      • Covered stent (Rarely appropriate)
• Secondary treatment options for lower-extremity disease
  • In-stent restenosis
    • Recurrent symptoms
      • Focal stenosis
        • Continue or intensify medical therapy (Appropriate)
        • Endovascular treatment (Appropriate)
        • Surgical treatment (May be appropriate)
      • Diffuse stenosis
        • Continue or intensify medical therapy (Appropriate)
        • Endovascular treatment (Appropriate)
        • Surgical treatment (May be appropriate)
    • Asymptomatic
      • Focal stenosis
        • Continue or intensify medical therapy (Appropriate)
        • Endovascular treatment (May be appropriate)
        • Surgical treatment (Rarely appropriate)
      • Diffuse stenosis
        • Continue or intensify medical therapy (Appropriate)
        • Endovascular treatment (May be appropriate)
        • Surgical treatment (Rarely appropriate)

Also in 2019, the SVS released joint guidelines with the European Society for Vascular Surgery and the World Federation of Vascular Societies on the management of chronic limb-threatening ischemia (CLTI) (Conte, 2019). Conte and colleagues describe CLTI as a new term that encompasses the full spectrum of individuals with varying degrees of limb-threatening ischemia, including those with a critical level of obstruction of the arteries. The guidelines propose CLTI should be evaluated using two relatively newer staging systems: Global Anatomic Staging System (GLASS) for classifying the pattern of arterial disease in CLTI and Wounds, Ischemia, and foot Infection (WIfI) for staging severity of limb threat. The authors acknowledge that these staging systems are being evaluated in multicenter trials and may require some adjustments. Currently, these staging systems have not been endorsed by most major authoritative organizations. However, the following recommendations were issued:

• Use an endovascular-first approach for treatment of CLTI patients with moderate to severe (eg, GLASS stage IA) aorto-iliac (AI) disease, depending on the history of prior intervention. [Grade: 1(Strong); Level of Evidence: B(Moderate)]
• Consider endovascular treatment of significant common femoral artery disease in selected patients who are deemed to be at high surgical risk or to have a hostile groin. [Grade: 2(Weak); Level of Evidence: C(Low)]
• In average-risk CLTI patients with infrainguinal disease, base decisions of endovascular intervention vs open surgical bypass on the severity of limb threat (eg, Wounds, Ischemia, and foot Infection [WIfI]), the anatomic pattern of disease (eg, GLASS), and the availability of autologous vein. [Grade: 1(Strong); Level of Evidence: C(Low)]
• Offer endovascular revascularization when technically feasible for high-risk patients with advanced limb threat (eg, WIfI stage 4) and significant perfusion deficits (eg, WIfI ischemia grades 2 and 3). [Grade: 2(Weak); Level of Evidence: C(Low)]
• Consider endovascular revascularization for high-risk patients with intermediate limb threat (eg, WIfI stages 2 and 3) and significant perfusion deficits (eg, WIfI ischemia grades 2 and 3). [Grade: 2(Weak); Level of Evidence: C(Low)]
• Consider endovascular revascularization for high-risk patients with advanced limb threat (eg, WIfI stage 4) and moderate ischemia (eg, WIfI ischemia grade 1) if the wound progresses or fails to reduce in size by greater than or equal to 50% within 4 weeks despite appropriate infection control, wound care, and offloading, when technically feasible. [Grade: 2(Weak); Level of Evidence: C(Low)]
• Consider endovascular revascularization for high-risk patients with intermediate limb threat (eg, WIfI stages 2 and 3) and moderate ischemia (eg, WIfI ischemia grade 1) if the wound progresses or fails to reduce in size by greater than or equal to 50% within 4 weeks despite appropriate infection control, wound care, and offloading, when technically feasible. [Grade: 2(Weak); Level of Evidence: C(Low)]

Further study is needed to validate the new staging systems before they can be broadly used to guide treatment decisions.

In 2022, the SVS Appropriateness Committee convened a panel consisting of SVS and ACC members to develop appropriate use criteria (AUC) regarding intermittent claudication (IC) (Woo, 2022). Key principles include:

• Exercise therapy is a preferred initial management strategy for all patients with IC.
•  For patients who have not completed exercise therapy, invasive therapy might provide a net benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and are experiencing severe lifestyle limitations and/or a short walking distance.
• Considering the long-term durability of currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance.
• In the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC.
• In the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.

Definitions

Angioplasty: A catheter-based procedure involving a percutaneous endovascular approach to access an area of vessel stenosis (obstruction). Balloons within the catheter are sequentially inflated, in order to clear the stenosed lesion within the vessel.

Atherectomy: This term refers to a minimally invasive endovascular technique where atherosclerotic plaque is percutaneously removed from the walls of a blood vessel.

Claudication: A condition characterized by pain in the legs. This condition is usually caused by obstruction of the arteries and commonly triggered by exercise. Claudication can be intermittent, usually caused by exercise, or persistent.

Common iliac artery: A large blood vessel originating at the bifurcation of the descending aorta and ending at the bifurcation into the external and internal iliac arteries.

Chronic limb-threatening ischemia (CLTI): Arterial insufficiency with gangrene, a nonhealing ischemic ulcer, or pain at rest. Previously referred to as critical limb ischemia (CLI).

Deep femoral artery (profunda femoris): A branch of the femoral artery that passes closer to the femur than the rest of the femoral artery.

External iliac artery: A branch of the iliac artery that originates at the bifurcation of the common iliac artery and ends where it passes through the pubic tubercle, at which point it is referred to as the femoral artery.

Femoral artery: A major blood vessel in the thigh that originates where the external iliac artery passes through the pubic tubercle. This vessel gives rise to the deep femoral and superficial femoral arteries.

Popliteal artery: A continuation of the superficial femoral artery, beginning where it passes through the distal portion of the adductor magnus muscle, above the knee joint.

Provisional Stenting: Stenting use when balloon angioplasty has been attempted and failed or inadequate results were obtained.

Superficial femoral artery: A continuation of the femoral artery after it gives rise to the deep femoral artery. It extends to just above the knee, where it is then referred to as the popliteal artery.

Supervised exercise training: A structured exercise program that is directly supervised by a qualified healthcare provider and takes place in a hospital or outpatient facility in which intermittent walking exercise is used as the treatment modality.

Tibial artery: A continuation of the popliteal artery, beginning below the knee, where it bifurcates into the anterior and posterior tibial arteries.

References

Peer Reviewed Publications:

1. Di Mario C, Pijls NH. An introduction to provisional stenting. Int J Cardiovasc Intervent. 2001; 4(2):59-65.
2. Farber A, Menard MT, Conte MS, et al; BEST-CLI Investigators. Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med. 2022; 387(25):2305-2316.
3. Iida O, Takahara M, Soga Y, et al; SPINACH Investigators. Three-year outcomes of surgical versus endovascular revascularization for critical limb ischemia: The SPINACH study (Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischemia). Circ Cardiovasc Interv. 2017; 10(12):e005531.
4. Katsanos K, Spiliopoulos S, Kitrou P, et al. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018; 7(24):e011245.
5. Jens S, Koelemay MJ, Reekers JA, Bipat S. Diagnostic performance of computed tomography angiography and contrast-enhanced magnetic resonance angiography in patients with critical limb ischaemia and intermittent claudication: systematic review and meta-analysis. Eur Radiol. 2013; 23(11):3104-3114.
6. Majmundar M, Patel KN, Doshi R, ET AL. Comparison of 6-month outcomes of endovascular vs surgical revascularization for patients with critical limb ischemia. JAMA Netw Open. 2022;5 (8):e2227746.
7. Nordanstig J, James S, Andersson M, et al. Mortality with Paclitaxel-coated devices in peripheral artery disease. N Engl J Med. 2020; 383(26):2538-2546.
8. Secemsky EA, Shen C, Schermerhorn M, Yeh RW. Longitudinal assessment of safety of femoropopliteal endovascular treatment  with Paclitaxel-coated devices among Medicare beneficiaries: The SAFE-PAD study. JAMA Intern Med. 2021:e212738.
9. Simons JP, Schanzer A, Flahive JM, et al. Survival prediction in patients with chronic limb-threatening ischemia who undergo infrainguinal revascularization. J Vasc Surg. 2019; 69(6S):137S-151S.e3.
10. Wu G, Yang J, Zhang T, et al. The diagnostic value of non-contrast enhanced quiescent interval single shot (QISS) magnetic resonance angiography at 3T for lower extremity peripheral arterial disease, in comparison to CT angiography. J Cardiovasc Magn Reson. 2016; 18(1):71.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bachoo P, Thorpe PA, Maxwell H, Welch K. Endovascular stents for intermittent claudication. Cochrane Database Syst Rev. 2010;(1):CD003228.
2. Bailey SR, Beckman JA, Dao TD, et al. ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for peripheral artery intervention: a report of the American College of Cardiology Appropriate Use Criteria Task Force, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine. J Am Coll Cardiol. 2019; 73(2):214–237.
3. Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014;(6):CD006767.
4. Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019; 69(6S):3S-125S.e40.
5. Conte MS, Pomposelli FB, Clair DG, et al. Society for Vascular Surgery Lower Extremity Guidelines Writing Group. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. J Vasc Surg. 2015; 61(3 Suppl):2S-41S.
6. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. J Am Coll Cardiol. 2017; 69(11):e71-e126.
7. Hirsch AT, Haskal ZJ, Hertzer NR, et al.; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006; 113(11):e463-654.
8. Jaff MR, White CJ, Hiatt WR, et al.; TASC Steering Committee. An update on methods for revascularization and expansion of the TASC Lesion Classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Endovasc Ther. 2015; 22(5):663-677.
9. Klein AJ, Jaff MR, Gray BH, et al. SCAI appropriate use criteria for peripheral arterial interventions: an update. Catheter Cardiovasc Interv. 2017; 90(4):E90-E110.
10. Norgren L, Hiatt WR, Dormandy JA, et al.; TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007; 45 Suppl S:S5-67.
11. Rooke TW, Hirsch AT, Misra S, et al.; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA Focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011; 58(19):2020-2045.
12. Rooke TW, Hirsch AT, Misra S, et al.; American College of Cardiology Foundation Task Force; American Heart Association Task Force. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; 61(14):1555-1570.
13. Society for Cardiovascular Angiography and Intervention (SCAI). SCAI statement on paclitaxel devices and mortality. Last updated: January 25, 2019. Available at: https://scai.org/scai-statement-association-between-paclitaxel-devices-and-mortality.Accessed on July 21, 2023.
14. U.S. Food and Drug Administration (FDA). Circulatory System Devices Panel of the Medical Devices Advisory Committee. Paclitaxel-coated drug coated balloon and drug-eluting stent late mortality executive summary. Last updated: June 20, 2019. Available at: https://www.fda.gov/media/127698/download. Accessed on July 21, 2023.
15. U.S. Food and Drug Administration (FDA). Paclitaxel-coated balloons and stents for peripheral arterial disease. Published December 2, 2021. Available at: https://www.fda.gov/medical-devices/cardiovascular-devices/paclitaxel-coated-balloons-and-stents-peripheral-arterial-disease. Accessed on July 21, 2023.
16. U.S. FDA. Update: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality- Letter to Health Care Providers. July 11, 2023. Available at: https://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality. Accessed on July 21, 2023.
17. Woo K, Siracuse JJ, Klingbeil K, et al; Society for Vascular Surgery Appropriateness Committee. Society for Vascular Surgery appropriate use criteria for management of intermittent claudication. J Vasc Surg. 2022; 76(1):3-22.e1.

Index

Angioplasty
Atherectomy
Endarterectomy
Femoropopliteal
Stenting

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History

Status

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