Endovascular Management for Peripheral Arterial Disease of the Upper and Lower Extremities

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(1)(E) excludes expenses for items or services which are not reasonable and necessary to carry out research conducted pursuant to §1142 of the Act.

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 1, §20.7 Percutaneous Transluminal Angioplasty (PTA) and §20.35 Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)

CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.3 Evidentiary Content

History/Background and General Information

Peripheral arterial disease (PAD) manifests as arterial insufficiency which is described as a lack of blood flow to extremity musculature relative to metabolism. The most common cause of this disorder is atherosclerotic disease of the lower extremity (LE) and less commonly, the upper extremity (UE). Atherosclerotic disease leads to peripheral arterial obstruction. The clinical manifestations result from arterial insufficiency and lack of blood flow to the musculature which can be accompanied by pain in the affected muscle groups with or without exertion. In advanced cases, chronic limb-threatening ischemia (CLTI) or acute limb ischemia (ALI) can occur.

PAD is a chronic medical condition. A comprehensive care plan for patients with PAD includes periodic clinical evaluation by a health care professional with experience in the care of patients with vascular disease and coordination of care among other clinicians. Ongoing care focuses on cardiovascular and limb risk reduction with medical therapy, optimizing functional status and quality of life (QOL) through structured exercise and, when indicated, revascularization. When recognized early and appropriately managed, complications leading to limb loss can be minimized.

The prevalence of PAD increases progressively with age, beginning after age 40. As a result, PAD is growing as a clinical problem due to the aging population in the United States and other countries. Risk factors for PAD are similar to those that promote the development of coronary atherosclerosis.

Clinical manifestations most commonly include ulcer formation, claudication, and resting pain. The underlying cause of the clinical signs of PAD must be differentiated from non-atherosclerotic and non-vascular conditions to ensure beneficiary timely referral to a vascular specialist. A multidisciplinary approach, including primary care, medical specialists, podiatry, vascular specialist, and plastic surgery, may be utilized to provide optimal medical and surgical care.

Atherosclerotic disease affecting the UE arteries is much less common and is most often asymptomatic. However, when symptomatic, it can cause exertional pain, ischemic pain, gangrene, or ulceration. Exertional pain is a reproducible discomfort of a defined group of muscles induced by exercise; the pain occurs when the demand for oxygenated blood exceeds the supply. The exertional pain is relieved with rest. Atherosclerosis is the most frequent etiology of UE arterial stenosis. It can affect any of the UE arteries, although it has the highest propensity for the proximal arteries (e.g., subclavian artery, brachiocephalic artery). Some of the risk factors associated with peripheral atherosclerosis include increased age, hypertension, dyslipidemia, and tobacco use. The prevalence of UE atherosclerotic disease is much lower than that of LE arterial disease.¹ Sex-specific data shows that males are more likely than females to be affected during their lifetime. However, due to a longer life expectancy, the prevalence of atherosclerotic disease in the population is higher in females.²

Occlusive disease affecting the digital arteries can also be due to atherosclerosis; however, symptomatic disease is more likely due to proximal embolization (e.g., atheroembolism, thromboembolism) or autoimmune disease (e.g., thromboangiitis obliterans, rheumatoid arthritis, scleroderma).²

To evaluate the presence of PAD in the LE, a standard review should always include questions related to a history of walking impairment, extremity pain that might be due to ischemia, and the presence of nonhealing wounds. Patients with risk factors for PAD who report no or few symptoms should be asked about functional capacity and decline in activity over time. Patients with compromised blood flow to the extremities because of arterial occlusive disease due to PAD may present with pain in 1 or more muscle groups, atypical pain, or no apparent symptoms.

Intermittent claudication (IC) is defined as a reproducible discomfort of a defined group of muscles that is induced by exercise and relieved with rest. This disorder results from an imbalance between supply and demand of blood flow that fails to satisfy ongoing metabolic requirements. Classic claudication is characterized by leg pain that is consistently reproduced with exercise and relieved with rest. The degree of symptoms of claudication depends upon the severity of obstruction, the collateral circulation, and the vigor of exercise. Patients with claudication can present with buttock, hip, thigh, calf, or foot pain alone or in combination.

Severe decreases in limb perfusion can result in ischemic rest pain that involves the digits and forefoot and typically occurs at night. The pain may be more localized in patients who develop an ischemic ulcer or gangrenous toe. The pain may be relieved by dependent positioning of the foot.

Some patients with PAD have atypical symptoms as a result of comorbidities, physical inactivity, and alterations in pain perception. Compared with patients with classic claudication, those with leg pain on exertion and at rest are more likely to have diabetes, neuropathy, or spinal stenosis in addition to PAD.

General Guidelines

A multi-specialty medical team approach to the management of PAD is recommended. Coordination of care is particularly important for risk factor management (i.e., diabetes, hypertension, smoking, dyslipidemia) and to optimize outcomes for these patients.

This guideline defines 4 clinical subsets of PAD: asymptomatic PAD (may have functional impairment), chronic symptomatic PAD (claudication), CLTI, and ALI.

Detection of PAD in most patients is accomplished through history, physical examination, and resting ankle-brachial index (ABI) for LEs or wrist-brachial index (WBI) for UEs.

Effective medical therapies for patients with PAD should be prescribed to prevent major adverse cardiovascular events and major adverse limb events for patients with PAD, including antiplatelet (generally single antiplatelet) and antithrombotic therapy, lipid-lowering (i.e., high-intensity statin) and antihypertensive therapy, management of diabetes, and smoking cessation. Anticoagulants combined with low-dose aspirin (81 mg daily) is effective to prevent major adverse cardiovascular events and major adverse limb events in patients with PAD who are not at increased risk of bleeding.

Structured exercise is a core component of care for patients with PAD. It includes supervised exercise therapy (SET) and community-based (including structured home-based) programs. The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover SET for beneficiaries with IC for the treatment of symptomatic PAD (National Coverage Determination [NCD] 20.35).

Revascularization (endovascular, surgical, or hybrid) should be used to prevent limb loss in those patients with CLTI and can be used to improve QOL and functional status in patients with claudication not responsive to medical therapy and structured exercise.

The PAD National Action Plan outlines 6 strategic goals (enhancing public awareness, professional education, early detection and treatment, promotion of public health, research and advocacy of PAD nationwide) to improve awareness, detection, and treatment of PAD nationwide. Implementation of this action plan is recognized as a top advocacy priority by the writing committee.³

Covered Indications:

Endovascular Revascularization for the UE

1. Asymptomatic
   • Most asymptomatic patients are found incidentally to have asymmetric UE blood pressures or during ultrasound testing in patients with carotid or coronary artery disease. Therefore, revascularization is rarely needed in patients with asymptomatic proximal UE arterial occlusive disease and would not be reasonable and necessary.
   • However, it may be warranted in patients undergoing coronary artery bypass grafting (CABG), especially when planning on using an internal mammary artery graft. Selected hemodialysis patients requiring the creation or preservation of a UE hemodialysis access may also benefit from revascularization to prevent ischemic symptoms as well as improve fistula maturation.
2. Symptomatic
   • Restoration of perfusion in a threatened UE
   • Coronary-subclavian steal syndrome with significant cardiac symptoms
   • Embolization (cerebral, peripheral) from the lesion to exclude it from the circulation and prevent future ischemia
   • Preservation of UE hemodialysis access for end-stage kidney disease
   • Traumatic injury resulting in disrupted peripheral arterial blood flow
   • End-stage kidney disease to allow the creation or preservation of UE hemodialysis access

Endovascular Techniques Indicated for the UE

The following are reasonable and necessary:

• Embolic protection— With an endovascular approach, distal embolization is possible during manipulation of the diseased vessel. With innominate lesions, it is advisable to place an embolic protection device (EPD) in the right internal carotid. If EPD deployment is not possible, primary stenting is preferred with no predilation to minimize the risk of distal embolization. Other adjunctive procedures have been described in addition to placing a filter protection device.^4,5
• Angioplasty/stenting— Percutaneous transluminal angioplasty (PTA) and stenting may be reasonable and safe in patients with appropriate anatomy (short proximal stenosis or occlusion).
• Stent-grafting— Open surgery for subclavian artery aneurysm has been the standard and provides a durable long-term repair. However, as with aneurysms at other sites, endovascular stent-grafting has been increasingly used to exclude the aneurysm from the circulation.^6-9

Endovascular Revascularization for the LE

ABI must be used to determine the presence of occlusive arterial disease. An abnormal ABI (ABI ≤0.9) has an excellent overall accuracy for detecting arterial stenosis ≥50% using arteriography as the standard. For most patients with exertional extremity pain (classic claudication, atypical symptoms), an ABI ≤0.9 is diagnostic for PAD, particularly in the context of the appropriate history. For patients with claudication, the ABI is between 0.4 and 0.9; for rest pain, the ABI is between 0.2 to 0.4; and for tissue loss (ulcer, gangrene), the ABI is between 0.0 and 0.4.

1. Asymptomatic PAD
   • It is only reasonable to perform revascularization procedures (endovascular or surgical) to reconstruct diseased arteries if needed for the safety, feasibility, or effectiveness of other procedures (e.g., transfemoral aortic valve replacement, mechanical circulatory support, endovascular aortic aneurysm repair).^10-17
   • Revascularization procedures are not reasonable and necessary when performed solely to prevent progression of disease.^18-25
2. Claudication

   All the following criteria must be met for coverage:

   • Significantly disabled by claudication, resulting in an inability to perform normal work or other activities that are important to the patient. This criterion reflects the symptom variability among patients with claudication and the impact of these symptoms on the patient's QOL. Studies have shown that successful revascularization can substantially improve the patient's QOL.^26-28
   • Documented previous failure of guideline-directed medical therapy (GDMT) which includes a statin, antiplatelet, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blocker (ARB) therapy, if hypertensive. GDMT is defined as the use of all drugs, including antithrombotic agents, renin-angiotensin-system blockers, and statins within 3 months of the PAD diagnosis.²⁹
   • Absence of OR not predicted to have an adequate response to exercise rehabilitation and/or pharmacologic therapy.
   • The anatomic characteristics of the lesion(s) permit appropriate intervention at low risk with a high likelihood of initial and long-term success. Success is defined as a more than 50% likelihood of sustained functional improvement, symptom relief, and anatomic patency for at least 2 years.³⁰
   • The projected natural history of the disease and the overall prognosis of the patient should be considered with face-to-face discussion of the inherent risks of revascularization versus conservative therapy versus open surgical treatment with the patient.
   • Benefit from an improvement in claudication (i.e., exercise is not limited by another cause, such as angina, heart failure, chronic obstructive pulmonary disease [COPD], or orthopedic problems):
     • Potential benefits with respect to QOL, walking performance, and overall functional status should be weighed against the risks and durability of intervention and possible need for repeated procedures.^31-36
     • Functionally limiting claudication and an inadequate response to GDMT (including structured exercise), revascularization is a reasonable treatment option to improve walking function and QOL.^37-44
     • Aortoiliac or femoropopliteal disease (excluding common femoral artery [CFA] disease) with functionally limiting claudication and hemodynamically significant disease AND with inadequate response to GDMT (including structured exercise), endovascular revascularization is effective to improve walking performance and QOL.^37-58
     • CFA disease with functionally limiting claudication and hemodynamically significant CFA disease with inadequate response to GDMT (including structured exercise), endovascular approaches may be considered in those at high risk for surgical revascularization AND if anatomical factors are favorable (i.e., no adverse effect on profunda femoris artery pathways).^59-66
3. Chronic Limb-Threatening Ischemia
   • Surgical, endovascular, or hybrid revascularization techniques are recommended, when feasible, to minimize tissue loss, heal wounds, relieve pain, and preserve a functional limb.^67-80
   • In patients undergoing endovascular or surgical revascularization for CLTI, AND if bypass to the popliteal or infrapopliteal arteries (i.e., tibial, pedal) is required during revascularization, this should be constructed with autogenous vein if available.^80-86
   • In CLTI due to infrainguinal disease, anatomy, available conduit, patient comorbidities, and patient preferences should be considered in selecting the optimal first revascularization strategy (surgical bypass or endovascular revascularization).^69,79
   • When indicated for revascularization, ultrasound mapping of the great saphenous vein is recommended.
   • In nonhealing wounds or gangrene, revascularization in a manner that achieves inline blood flow or maximizes perfusion to the wound bed can be beneficial.^87-93
4. Acute Limb Ischemia
   • In ischemic rest pain (i.e., without nonhealing wounds or gangrene) attributable to multilevel arterial disease, a revascularization strategy addressing inflow disease first is reasonable.^94,95
   • In ALI with a salvageable limb, revascularization (endovascular or surgical, including catheter-directed thrombolysis) is indicated to prevent amputation.^96-100
   • In ALI with a salvageable limb who are treated with catheter-directed thrombolysis, adjunctive revascularization (i.e., endovascular or surgical) procedures can be useful.
   • In ALI from chemotherapeutic or prothrombotic viral states, it may be reasonable to take a more deliberate planning strategy before engaging in a definitive revascularization or medical treatment plan.^101-109

Endovascular Techniques Indicated for the LE

The following are reasonable and necessary: Treatment options for managing occlusive vascular lesions could include balloon angioplasty (plain balloon, specialty balloon), stenting, atherectomy and percutaneous bypass techniques or combinations thereof.

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. 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%. To decrease the incidence of dissection, residual stenosis, and restenosis, a variety of specialty balloons have been used (e.g. cutting balloons, drug-coated (e.g., paclitaxel) balloons, focal pressure balloons, cryoplasty balloons).

Intravascular lithotripsy (IVL) 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 1 randomized trial, lithotripsy improved technical success rates from 50 to 66% 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 (e.g. bare metal stents, covered stents, drug-coated stents, and stent-grafts).

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 CFA, popliteal artery, ostial lesions, and for heavily calcified lesions. Available devices are classified as directional (excisional), rotational, or laser atherectomy devices (e.g. directional atherectomy devices, rotational and orbital atherectomy devices, laser atherectomy).

Percutaneous Bypass Techniques

Autogenous vein, generally the great saphenous vein, should be the first choice of conduit when bypass is performed for functionally limiting claudication with inadequate response to GDMT with hemodynamically significant femoropopliteal disease. Multiple randomized controlled trials (RCTs), systematic reviews, and meta-analyses have identified a clear and consistent primary patency benefit for autogenous vein versus prosthetic conduit for femoral-popliteal artery bypass.^{69,83,110,111} Approximately 20% of patients with CLTI have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation.¹¹²

Limitations for Endovascular Revascularization

The following are not considered reasonable and necessary for endovascular revascularization:

• Absence of prior interventional medical therapy to include antiplatelet therapy for IC of the UE or LE claudication including GDMT for a period of 90 days.
• Previous SET for LE claudication for less than 90 days.
• Positive response to GDMT and/or SET for claudication.
• Irreversible disease with need of a bypass due to lack of sufficient vein conduits.
• High risk for percutaneous failure that requires an open surgical revascularization procedure.
• Asymptomatic LE PAD EXCEPT if needed for the safety, feasibility, or effectiveness of other procedures.
• Asymptomatic UE PAD EXCEPT under specific circumstances where endovascular revascularization is warranted.
• In ALI with non-salvageable limb, revascularization of non-viable tissue should not be performed and is not reasonable and necessary.¹¹¹
• Endovascular procedures with high risk that are not supported by the peer-reviewed literature (Medicare Program Integrity Manual [MPIM] Chapter 13, Section 13.5.3—Evidentiary Content) are not reasonable and necessary. Available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines will be utilized to evaluate medical necessity in conducting a review of these procedures.
• Endovascular vein conduit procedures in patients with previously failed endovascular bypass procedures.
• Performance of an endovascular revascularization in a non-accredited office setting or unlicensed facility where sedation or higher levels of anesthesia are utilized.
• Functionally limiting claudication and isolated hemodynamically significant infrapopliteal disease with inadequate response to GDMT (including structured exercise), the effectiveness of revascularization is unknown and is therefore not reasonable and necessary.¹¹³
• Functionally limiting claudication and hemodynamically significant aortoiliac or femoropopliteal disease with inadequate response to GDMT and SET, and where surgical revascularization is preferred because of perioperative risk and technical factors suggest advantages over endovascular approaches, endovascular revascularization would not be considered reasonable and necessary.^114-116
• Functionally limiting claudication and hemodynamically significant CFA disease with inadequate response to GDMT and SET, and where surgical endarterectomy is reasonable, especially if endovascular approaches adversely affect profunda femoris artery pathways, endovascular revascularization would not be indicated.^59,117
• Functionally limiting claudication and isolated hemodynamically significant infrapopliteal disease with inadequate response to GDMT and SET, the effectiveness of endovascular revascularization is unknown and therefore not reasonable and necessary.

Imaging Recommendations for PAD:

1. Functionally limiting claudication with inadequate response to GDMT patients: duplex ultrasound, computed tomography angiography (CTA), magnetic resonance angiography (MRA) or catheter angiography to assess anatomy, severity of disease and to determine revascularization strategy.
2. CLTI patients: duplex ultrasound, CTA, MRA, catheter angiography should be utilized to determine revascularization strategy.
3. Suspect PAD with inconclusive ABI: duplex ultrasound, CTA, MRA, non-invasive testing should be utilized to establish the diagnosis of PAD.
4. If confirmed PAD without a plan for revascularization, duplex ultrasound, CTA, MRA or catheter angiography would not be reasonable and necessary.
5. Intraoperative imaging with intravascular ultrasound (IVUS) or extravascular ultrasound (EVUS) may be reasonable and necessary as required for successful endovascular revascularization of the affected vessel(s).

Provider Qualifications and Site of Service

Endovascular treatment for peripheral vascular disease can be considered reasonable and necessary to be performed in the following outpatient settings:

1. Ambulatory surgical center (ASC)
2. Hospital outpatient department
3. Office-based surgery center that meets state guidelines and national accreditation standards, if required by the state; AND any additional state requirements for office-based surgery when performing procedures under conscious sedation or higher levels of anesthesia. For states that allow national accreditation in lieu of state requirements or have no state requirements, national accreditation by a recognized accrediting body for office-based surgery would be sufficient for this site of service.

Provider qualifications include all the following:

1. Evidence of postgraduate training in endovascular techniques during residency or fellowship.
2. Must be a Medical Doctor or Doctor of Osteopathy licensed in the state to perform those services.
3. Residency and/or fellowship training in interventional radiology, general surgery, vascular surgery, cardiology, or cardiothoracic surgery.

Upper Extremity PAD

In a large study of extracranial arterial disease, the incidence of proximal UE arterial occlusive disease (subclavian and innominate [brachiocephalic] arteries) demonstrated a 17% association with systemic disease.¹¹⁸ Approximately 30% of such patients have subclavian artery stenosis,¹¹⁹ which most commonly occurs on the left (>75%), possibly due to a more acute origin resulting in accelerated atherosclerosis from an increased turbulence in the blood flow.^120-124 Innominate disease is also not infrequent and can lead to right-sided symptoms.

While proximal atherosclerotic disease is more commonly diagnosed, atherosclerosis is a systemic process that can also involve the distal UE arteries (e.g., brachial, radial, ulnar arteries).^125-131 This process is increasingly seen in systemic diseases affecting the medium and small vessels, such as diabetes and chronic kidney disease. These patients are at higher risk for developing calcification within the medial layer of the arterial wall, which can increase the risk for adverse outcomes and is a strong predictor of cardiovascular mortality. In studies evaluating the radial artery as a possible conduit for coronary artery bypass, creation of a forearm flap, or hemodialysis arteriovenous access, atherosclerosis is commonly encountered and should be investigated prior to moving forward with these procedures.^128-130 Severe atherosclerotic disease in the arteries below the elbow is indicative of severe, systemic widespread atherosclerotic disease. In a review of 28 patients undergoing intervention for severe hand ischemia, 68% had coronary artery disease, 86% had PAD, and 50% had a prior major lower limb amputation.¹²⁷ Typical presentations include older, dialysis-dependent patients with complaints of vascular access dysfunction, hand pain, or a nonhealing wound.

Selection of the most appropriate intervention (surgical, endovascular) is individualized based on anatomic factors (e.g., lesion severity, location, calcification, proximity to the vertebral artery), the presence of concomitant ipsilateral carotid disease, and the patient's overall medical status. For symptomatic proximal stenosis or occlusion, options include surgical and PTA and stenting.^73-75 Surgical revascularization is more durable compared with endovascular intervention. However, percutaneous angioplasty/stenting may be associated with less perioperative morbidity.

For endovascular intervention, high-quality data is limited, and a 2022 systematic review found no randomized trials comparing angioplasty alone with stenting for subclavian artery stenosis.⁷³ However, retrospective studies suggest that endovascular intervention in the subclavian artery is safe with low morbidity and mortality; one study of 110 patients who had PTA reported a 3.6% combined stroke and death rate.⁷⁶ Immediate technical success was greater than 93%, with failures usually related to an inability to cross occluded lesions.^77-79 Five-year primary patency rates are approximately 85%.⁷⁸

In a single-center retrospective review of 167 patients with left subclavian artery stents who were being evaluated for coronary artery bypass, stent patency rates were 75.2% at 10 years.⁸⁰ Freedom from reintervention for the target vessel and sustained resolution of ischemic symptoms was observed in most patients (>95%).^{76,78,79,81-83} Whether angioplasty alone has inferior outcomes compared with angioplasty and stenting depends on the nature of the lesion being treated.^84,85

Significant (>70%) recurrent stenosis or obstruction following subclavian revascularization occurs in approximately 10% of patients. In a study of 138 patients, predictors of restenosis were continued tobacco use and COPD, younger age, lack of statin use, vessel diameter <7 mm, and right-sided intervention.⁹¹ In a review of 114 patients, assisted primary patency and freedom from recurrent symptoms were worse in patients presenting with arm ischemia compared with those presenting with cardiac or posterior circulation symptoms at 5 years.⁹² Recurrent lesions are typically treated with repeat angioplasty; however, surgery may be required in up to 5% of patients.⁷⁶ Patients with a continuous (compared with intermittent) subclavian and coronary artery steal may have a higher risk of subclavian artery restenosis following endovascular intervention.⁹³

The combined stroke and death rate related to percutaneous intervention to treat UE disease was 3.6% in one study. Complications include stent thrombosis, restenosis, and stent fracture.^132-134

Good outcomes have been reported using endovascular techniques in treatment of lesions of the aortic arch (i.e., supraaortic) vessels,^135-151 but there are very few reports on the effectiveness of angioplasty for the more distal UE arterial lesions.^152-154

Immediate technical success occurs in more than 93% of patients, with failures usually related to an inability to cross an occlusive lesion.^155,156 Five-year primary patency rates are approximately 85%.⁸⁶ Sustained resolution of ischemic symptoms is observed in most patients (>95%).^155-158

Angioplasty alone has inferior outcomes compared with angioplasty and stenting, particularly when recanalizing occlusive subclavian lesions.^132,151,159 A systematic review and meta-analysis comparing angioplasty alone with angioplasty and stenting for subclavian artery stenosis found a significantly higher risk of subsequent events for angioplasty alone compared with angioplasty and stenting at 1 year (odds ratio 2.37, 95% confidence interval (CI) 1.32-4.26).¹⁶⁰ A retrospective study of 42 patients treated with angioplasty and stenting for coronary subclavian steal syndrome found that the rate of restenosis was higher in patients with a continuous (compared with intermittent) subclavian and coronary steal (41% and 7%).¹⁶¹

Symptoms due to significant (>70%) recurrent stenosis or obstruction occur in approximately 10% of patients and are typically treated with repeat angioplasty; however, surgery may be required in up to 5% of patients.¹³² Some risk factors for subclavian in-stent stenosis include younger age, smoking with history of COPD, or baseline vessel diameter ≤7 mm.¹⁶² A meta-analysis comparing open surgery with endovascular repair for subclavian atherosclerotic disease showed favorable early outcomes for both techniques, and no significant differences in survival.¹⁶³ While open repair had a better long-term patency, there were no significant differences in symptom recurrence.^164-167 Subclavian artery aneurysms can occur proximally, associated with atherosclerosis, or more distally due to injury (e.g., repetitive injury as with thoracic outlet syndrome). Each of these segments has anatomic features that make stent-graft placement challenging, and motion of the shoulder can lead to graft compression with the potential for endograft fracture.

Endovascular stent-graft repair has also been applied to treatment of penetrating¹⁶⁸ or blunt¹⁶⁹ injuries to the axillary and distal subclavian arteries with good results. A review of 223 patients with subclavian and axillary injuries from 11 trauma centers showed an excellent limb salvage (LS) rate of 97% but a 10% in-hospital mortality related to cardiac (38%), brain (21%), hemorrhage (21%), multisystem organ failure (17%), and drug-related (4%) causes. The authors of the review also emphasized the importance of early control of bleeding, typically using open exposure but noting increasing use of hybrid techniques (e.g., balloon occlusion).¹⁷⁰

Lower Extremity PAD

A low ABI is predictive of an increased risk of all-cause and cardiovascular mortality^171-173 and the development of coronary artery calcification.¹⁷⁴ A high ABI is also associated with increased cardiovascular risk.

The most common symptomatic presentation of PAD of the LE is pain. IC is a reproducible discomfort of a group of muscles induced by exercise and relieved by rest. This is caused by a mismatch of the blood supply and the increased demand induced by activity. Atypical pain is more common than classic claudication because of comorbidities, physical inactivity, and alterations in pain perceptions.^175-177

Chronic ischemia sufficient to threaten the limb is often the result of arterial stenoses or occlusions that affect more than 1 level of the arterial tree; however, isolated tibial vessel disease frequently threatens the viability of the LEs in patients with diabetes and older patients. This most often involves the aortoiliac and femoropopliteal segments or femoropopliteal and tibial segments.¹⁷⁸ Multiple levels of disease promote severe ischemia by reducing the effectiveness of collateral flow and by lowering distal systolic pressures that drive tissue perfusion. The major manifestations of chronic ischemia are ischemic rest pain, ischemic ulceration, and gangrene.

The Society for Vascular Surgery (SVS) Committee on LE treatment guidelines for claudication recommends that an intervention should be offered if there is more than a 50% likelihood of sustained functional improvement, symptom relief, and anatomic patency for at least 2 years.³⁰

For patients with CLTI and no ulcers or gangrene, improvement of inflow in those with aortoiliac disease or CFA 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 Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL)-1 trial, which randomly assigned 452 patients between 1999 and 2004 to an endovascular-first or bypass-first approach.⁶⁸ The 1- and 3-year amputation-free survival (AFS) rates were similar; however, among patients who survived more than 2 years, AFS 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 a bypass initially, suggesting a possible deleterious impact of endovascular interventions in some patients. In the BASIL-1 trial, approximately 25% of patients had infrapopliteal interventions, and the technical failure rate was 27% in this group; some had bypasses using synthetic grafts.

A subsequent phase 2 parallel trial, the Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial, identified differences in revascularization outcomes for 2 cohorts, 1 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.⁶⁹

The BASIL-2 trial differed from the BASIL-1 trial. In the BASIL-1 trial, only approximately 25% of patients had infrapopliteal interventions, some of whom had bypasses using synthetic grafts. There were similarities between the BEST-CLI and later BASIL-2 trial,⁷⁹ including technical success rate (85% and 87%), including a high number of patients with diabetes (70%), antiplatelet and statin use, and high mortality rates (approximately 10% per year). However, there were differences in the enrolled populations, with BEST-CLI including a greater difference in patients with a 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% in the vein bypass group and 18% in the best endovascular therapy groups compared with 10.4% and 14.9% in cohort I of BEST-CLI). Perioperative mortality was higher in the surgery arm in BASIL-2 (6 versus 1.7) and the main difference in AFS in BASIL-2 was due to the difference in late mortality in the surgical arm. At this time, it is unclear if the differences between the 2 study outcomes are due to differences in enrolled patient cohorts, anatomic differences, or the care delivered.

In a subgroup analysis of patients with adequate saphenous vein conduit who had tibial level interventions in cohort I of BEST-CLI (326 patients in each group), the primary endpoint (major adverse limb events or all-cause death) at 3 years was significantly lower after open bypass (48.5% versus 56.7%), with the difference being mainly due to a reduction in major adverse limb events (23.3% versus 35.0%), including major reinterventions (10.9% versus 20.2%). Freedom from amputation or all-cause death was similar (43.6% versus 45.3%), but the lower amputation rate after bypass (13.5% versus 19.3%) was borderline significant. These findings were contradictory to the BASIL-2 findings and supported BEST-CLI favoring bypass surgery in patients with CLTI who require intervention at the tibial level and who have adequate great saphenous veins.¹⁷⁹

The BASIL II and the BEST-CLI trial investigators 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 a better understanding of the approach to patients with CLTI who need infrapopliteal level revascularization.

When considering 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 QOL, rather than being purely lesion-based.

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 the disease.¹⁸⁰

Lower Extremity PAD Revascularization

Guidelines from the American Heart Association (AHA)/American College of Cardiology (ACC) and the SVS³⁰ recommend best medical treatment as the first-line treatment for claudication, with revascularization reserved for only refractory cases. These recommendations are based on data showing that there is a relatively low likelihood of limb loss associated with mild PAD¹⁸¹ and that long-term improvements in symptomatology may be limited.¹⁸² For example, recent data from the Invasive Revascularization or Not in Intermittent Claudication (IRNIC) trial demonstrated that, after 5 years of follow-up, revascularization for claudication lost any early benefit and did not result in long-term health-related QOL compared with best medical therapy.³⁰ Despite guidelines recommending medical management as the first-line therapy for claudication, recent registry data from the Vascular Quality Initiative demonstrate that 27% of all open bypass procedures and even a higher percentage of endovascular interventions are performed for claudication.¹⁸³ It is possible that many of the patients undergoing revascularization for claudication experienced severe claudication symptoms and that conservative management failed. For instance, in the CLEVER study (Claudication: Exercise Versus Endoluminal Revascularization),⁴¹ the revascularization group and the SET group had better 18-month outcomes than optimal medical care alone. Quality improvement initiatives aimed at reducing unnecessary procedures are emerging to address outlier behavior in the overuse of invasive interventions for mild disease.^184,185 The authors concluded that higher quality data about the benefits of revascularization for severe claudication symptoms is needed.

The impact of percutaneous intervention in CLTI is a subject of emergent research and the focus of active investigation. In a large observational study, percutaneous intervention compared with surgical therapy was associated with reduced in-hospital mortality (2.34% versus 2.73%, P < 0.001), length of stay (8.7 days versus 10.7 days, P < 0.001) despite similar rates of major amputation (6.5% versus 5.7%, P = 0.075).¹⁸⁶ Also, the increase in percutaneous leg revascularization has been related to a decline in leg amputation in the United States.¹⁸⁶ Although many observational studies have suggested the benefit of percutaneous intervention in decreased amputation rates and mortality, to date, only 1 trial has compared percutaneous intervention with medical or surgical therapy in patients with CLTI. In the BASIL trial, which is the only RCT on the topic to date, a bypass-first strategy had overall outcomes similar to an angioplasty-first strategy.⁶⁸ However, there was a significant overall survival benefit and a trend toward a benefit for AFS associated with open surgery among patients who survived >2 years.⁸⁶ As a result, the efficacy of endovascular versus open surgery revascularization for PAD remains unknown.

Furthermore, most studies to date have failed to account for anatomic factors that may influence patient selection toward percutaneous versus surgical intervention. The SVS has developed 2 limb-staging classification schemes to allow for more objective comparison of revascularization outcomes. The Wound, Ischemia, and foot Infection (WIfI) stage¹⁸⁷ and the Global Limb Anatomic Staging System (GLASS)¹⁸⁸ are 2 classification systems intended to permit more meaningful analysis of outcomes for various forms of therapy in heterogeneous populations with CLTI and should be reported whenever possible in major comparative studies moving forward.

With the increased use of percutaneous intervention in PAD, restenosis has been a continual obstacle. A growing proportion of patients are undergoing LE bypass for a prior failed percutaneous intervention, and these secondary revascularization procedures have been associated with inferior 1-year outcomes.³³ Although many devices lack comparative proof to support their use as a definite approach, multiple randomized studies of drug-eluting stent (DES) or drug-coated balloon (DCB) show promising results for decreasing restenosis rates in the femoral-popliteal segment.^189-195 Among the current therapeutic options, the paclitaxel-eluting or paclitaxel-coated devices consistently show a significantly higher primary patency rate, better target lesion revascularization (TLR) rate, and cost effectiveness.^196,197 Although a meta-analysis has reported an increase of mortality in patients receiving paclitaxel DCB/DES compared with controls, there is some recent evidence against this finding.¹⁹⁸ Nonetheless, the continued use of these devices should be individualized, carefully balancing the risks and benefits.¹⁹⁹

Balloon angioplasty with selective stenting for aortoiliac lesions was initially suggested as having similar outcomes compared with primary stenting.^200,201 However, early studies typically included patients with less severe disease (i.e., Trans-Atlantic inter-Society Consensus [TASC] A or B). Based on the available data, routine stenting of all iliac occlusions or long iliac stenoses, limiting plain balloon angioplasty (PBA) to only those patients with short stenoses or who have no evidence of residual stenosis or dissection following intervention is recommended by the authors. In a systematic review that included over 1300 patients, primary iliac artery stenting was associated with significantly reduced long-term failure (by 39%).²⁰²

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% with claudication), technical success was 98%.²⁰³ Stents were placed in 51%. Cumulative assisted patency was 71% at 10 years. Two-vessel femoral and 2 or more vessel tibial runoff or both were associated with improved patency. Procedure-related complications occurred in 7%.

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 external iliac artery (EIA) in combination with common femoral endarterectomy.⁷² In a small, randomized trial, Covered versus Balloon Expandable Stent Trial (COBEST trial), comparing bare metal stents to stent-grafts in patients with aortoiliac occlusive disease, the 5-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.²⁰⁴

In a metanalysis of 11 studies comprised of 1896 patients, the primary patency at 48 months was higher for covered stents compared with bare metal stents (91.2% [95% CI 84.1-99] versus 83.5% [95% CI 70.9-98.3]).²⁰⁵ For TASC C and D lesions, the 48-month primary patency for covered stents and bare metal stents was 92.4% (95% CI 84.7-100) and 80.8% (95% CI 64.5-100), respectively. Technical success, 30-day mortality, intraoperative and immediate post-operative procedure-related complications, and major amputation rates were similar, whereas the reintervention rate was lower for covered stents compared with base metal stents (risk ratio 0.59, 95% CI 0.40-0.87).

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%, and 92.1% versus 82.9%, respectively).²⁰⁶ 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%, with clinical improvement in 83 to 100% of patients. The long-term (4- or 5-year) primary patency rates ranged from 60 to 86%, and secondary patency rates ranged from 80 to 98%.²⁰⁷ 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 5-year follow-up, primary patency rates were 84, 79, 82, and 80% for stented TASC II A, B, C, and D iliac lesions in 436 patients, respectively.²⁰⁸ In a study of 413 patients who had routine iliac stenting between 1997 and 2009, the technical success rate was 99%.²⁴ Primary patency rates at 5 and 10 years were 83% and 71%, respectively, in the TASC II C/D group and 88% and 83% in the TASC II A/B group. There are no modern series with large numbers of open aortic reconstructions to directly compare these outcomes.²⁰⁹

A systematic review and meta-analysis 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 covered endovascular reconstruction of aortic bifurcation (CERAB) (n = 240).²¹⁰

Pooled outcomes for open (O), standard endovascular (SE), and CERAB, respectively, were^{72,200-204,206,207,209-211}:

Perioperative (30-day) mortality – O: 3, SE: 0.8, and CERAB: 0%.

Three-year primary patency rates – O: 93, SE: 78, and CERAB: 82%.

Three-year secondary patency rates – O: 97, SE: 93, and CERAB: 97%.

Five-year primary patency – O: 89, SE: 71, CERAB: not reported.

Five-year secondary patency – O: 95, SE: 88, CERAB: not reported.

The approach to femoropopliteal angioplasty depends on the length of the lesion. For patients with short lesions (30%) residual stenoses is recommended. For patients with lesions 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% at 3 years) was best in patients with claudication who had desired intervention completed. For lesions >10 cm in length (TASC II B/C, GLASS 2), primary stent placement can be considered. The patency for balloon angioplasty along the femoropopliteal segment is poor. In 1 review, the patency rate at 12 months for balloon angioplasty alone for 4 to 15 cm femoropopliteal lesions was 28%.²¹²

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.²¹³ 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 3-year primary patency rate of 60% 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.²¹⁴ 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). DCBs have been associated with less stent use and improved patency.

For patients with long-segment lesions (>15 cm), especially those with long-segment occlusions (>20 cm), angioplasty with nitinol stent placement is the most used treatment modality. A study that investigated the 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%.²¹⁵ In the STELLA registry,²¹⁶ “Stenting long de l’artere femorale superficielle”, a prospective monocentric register of patients, a 30-month primary patency was 62% in a cohort of patients, which included 60% 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,²¹⁷ later trials comparing heparin-bonded Viabahn with bare metal stents have shown improved midterm patency with covered stents in long femoropopliteal lesions.²¹⁸ However, these results need to be validated, and the concern remains regarding the failure mode of covered stents being more associated with limb-threatening ALI, 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.

DCBs and DESs 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. Multiple trials have evaluated the effectiveness of these devices in the superficial femoral artery.^190,219-224 While earlier studies had suggested increased mortality risk and possibly an increased risk for amputation using paclitaxel-coated devices in patients with PAD,^225,226 longer-term data from premarket randomized trials and several subsequent meta-analyses suggest that paclitaxel does not pose a risk to long-term survival. The United States Food and Drug Administration (FDA) has urged health care providers to discuss the potential benefits of paclitaxel-coated devices (i.e., reduced reinterventions) and risks in individual patients along with potential risks before using paclitaxel-coated devices for the treatment of PAD.^220,227,228

One of the advantages of DCBs is the avoidance of stents, particularly in locations associated with a high risk of in-stent restenosis, such as the popliteal arteries. DCB may also play a role in the treatment of in-stent restenosis. In a meta-analysis of 4 studies including 467 patients, TLR and recurrent in-stent restenosis were lower for DCB compared with PBA.²²¹ However, there is concern regarding the limited efficacy of DCB in heavily calcified lesions.²²⁹ Using atherectomy to debulk the plaque before treating it with DCB has been suggested to improve outcomes.²³⁰

The clinical significance of reported long-term outcomes using paclitaxel-coated devices remains unclear. Outcomes of reported trials overwhelmingly use lesion-oriented outcome measures, such as TLR or primary restenosis, rather than functional or patient-oriented measures, such as improved walking distance or increased LS rates.

In a systematic review and meta-analysis that included 4284 participants undergoing femoropopliteal revascularization, primary patency was significantly higher at 12 months in the paclitaxel-containing arm (80% versus 57.5%; relative risk [RR] 1.44, 95% CI 1.30-1 .59).²²⁰ Clinically driven target limb revascularization at 24 months (4 studies) was significantly lower for paclitaxel devices compared with controls (RR of 0.35, 95% CI, 0.26-0.48). All-cause mortality rates did not differ significantly for paclitaxel versus standard devices at 12 (17 studies), 24 (10 studies), 36 (5 studies), or 48 to 60 months (4 studies) after the intervention. There was also no statistically significant difference in target limb major amputation (7 studies) up to 60 months or thrombosis with paclitaxel drug-eluting therapy to the femoropopliteal region.

In the BASIL-3 trial, which reported on 481 patients who were randomly assigned to PBA with or without a bare stent (n = 160), DCB with or without a bare metal stent (n = 161), or DES (n = 160) between 2016 and 2021, AFS (primary endpoint) was similar between the groups (34, 40, and 42%, respectively, on intention-to-treat analysis; 35, 39, and 40%, respectively, on per-protocol analysis). Neither drug coated balloon angioplasty (DCBA) ± bare metal stenting (BMS) nor DES conferred significant clinical benefit over PBA ± BMS in the femoropopliteal segment in patients with CLTI undergoing endovascular femoropopliteal, with or without infrapopliteal, revascularization.²³¹

A systematic review and meta-analysis of 8 trials evaluated AFS (composite endpoint of death and major amputation) among patients treated with and without paclitaxel-coated balloons in the infrapopliteal arteries.²²⁶ TLR was a secondary efficacy endpoint. AFS was significantly worse for those who received paclitaxel (13.7% versus 9.4%, hazard ratio [HR] 1.52, 95% CI 1.12-2.07). However, the need for TLR was significantly reduced for paclitaxel (11.8% versus 25.6%, RR 0.53, 95% CI 0.35-0.81). The harm signal was more evident for the high dose (3 to 3.5 microgram/mm) compared with the low dose (2 microgram/mm), for which the effect was attenuated below significance.

A meta-analysis of 21 randomized trials evaluated outcomes of 3760 lower limbs treated with either a paclitaxel-coated or plain balloon for LE angioplasty in femoropopliteal and infrapopliteal arteries (IC: 52%; CLTI: 48%) at a median of 2 years follow-up.²²⁵ The rate of major amputation was significantly increased among those who received paclitaxel-coated balloons (4% versus 2.7%, 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 related only to DCBs and may not be applicable to paclitaxel-coated stents, as the mechanism of drug release and dosing are different.

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.^232-234 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 the long-term durability of these interventions along with the risk for complications (e.g., dissection, perforation, distal embolization).²³⁵ Their role in the treatment of in-stent restenosis with DCBA is under investigation, with promising early results.

The use of shockwave lithotripsy is increasingly being used, particularly in patients with severe vascular calcification. In a randomized trial, 306 patients with moderately-to-severely calcified femoropopliteal arteries were assigned to IVL (n = 153) or PTA (n = 153) prior to DCB treatment or stenting.²³⁶ Provisional stenting was required in significantly fewer patients in the IVL group (4.6% versus 18.3%). Primary patency was significantly better in the IVL group at 1 year (80.5% versus 68.0%) and 2 years (70.3% versus 51.3%), although clinically driven target vessel revascularization and restenosis rates were not significantly different between groups.

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.

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%, with 1-year primary patency ranging from 73 to 81%.²³⁷ In 1 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%).⁶¹

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

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 (3 to 5 minutes) are used to minimize the recoil or dissections and the need for stents at this location. DCBs have been compared with balloon angioplasty for infrapopliteal arteries in a number of studies.^238-240 In a systematic review that identified 10 trials involving 1593 patients, pooled results showed no significant difference in LS (5 studies), AFS (2 studies), restenosis (4 studies), or TLR at 12 months (4 studies).²³⁹ However, a later randomized trial of 105 patients with CLTI evaluating the safety and efficacy of a DCB (Litos; paclitaxel) for below-the-knee (BTK) intervention (Rutherford class ≥4) reported significantly less late lumen loss on angiography at 6 months for those randomly assigned to drug-coated compared with PBA (0.51 ± 0.60 mm versus 1.31 ± 0.72 mm).²³⁸ At 12 months, occlusive restenosis rates were also reduced (8.6% versus 48.4%, respectively), as was clinically driven target revascularization (10% versus 41%, 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. In a meta-analysis of 12 trials (4 with DES, 8 with DCB versus PBA or stenting), when compared with plain balloon or bare metal stents, the use of DCB was associated with improved primary patency, binary restenosis, and clinically driven TLR in the short-term (6 months).²⁴¹ These outcomes were improved in the early and late (12-month) periods, with no impact on late luminal loss, mortality, and LS rates with the use of PBA and DCB or DES.

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 LS and survival.

Bare metal stents have also not been shown to improve patency over balloon angioplasty; however, DES are associated with lower rates of restenosis and amputation.^242,243 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.

The use of bioabsorbable stents following balloon angioplasty in the infrapopliteal arteries has been investigated. A drug-eluting scaffold was approved by the FDA for BTK use after failed angioplasty; however, its clinical efficacy remains to be proven. Most early studies were small cohort studies reporting on safety. A later multicenter trial, pivotal investigation of safety and efficacy of drug-eluting resorbable scaffold treatment-below the knee (LIFE-BTK trial), included 261 patients with CLTI and infrapopliteal artery disease who were randomly assigned in a 2:1 ratio to an everolimus-eluting resorbable scaffold or angioplasty.²²² At 1 year, the primary efficacy endpoint (freedom from a combination of major amputation of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, binary restenosis of the target lesion) was significantly improved for the resorbable stent (74% versus 44%). There was no significant difference in freedom from major adverse limb events or perioperative death (primary safety endpoint) between the groups (97% versus 100%, respectively). Limitations of this trial are that it included patients with involvement in only the proximal one-third of the tibial artery and with good runoff, relatively short lesions (44.1 ± 30.9 mm), and the amputation rate was very low at 2%, indicating a more favorable population. This amputation rate was much lower compared with the 18% rate seen in the endovascular arms of the BASIL-2 and 15% in BEST-CLI trials. Lastly, there was a disparity in the technical success rates of the assigned procedures at 91% in the scaffold group and 70% in the angioplasty group.

In a recent review from DeRubertis et al., the authors published their 2-year results from the LIFE-BTK Trial involving an RCT enrolling 261 patients with CLTI who were randomized 2:1 to receive either drug-eluting resorbable scaffold (DRS) or PTA. The revised primary efficacy endpoint was freedom from target limb amputation, target vessel occlusion, clinically driven TLR, or binary restenosis. The primary safety endpoint was freedom from major adverse limb events and perioperative death. Predictors of efficacy and clinically driven TLR were analyzed along with subgroup assessments. At 2 years, the primary efficacy endpoint was observed in 68.8% of the DRS group versus 45.4% of the PTA group (P=0.0004). Limb salvage rates were 94.7% for DRS and 97.3% for PTA (P=0.34). Binary restenosis occurred in 28.5% of DRS patients versus 48.2% of PTA patients (P=0.005), and clinically driven TLR rates were 9.7% versus 18.6%, respectively (P=0.034). The primary safety endpoint was observed in 91.6% of the DRS group versus 95.6% of the PTA group (P=0.16). Scaffold treatment was an independent predictor of efficacy (odds ratio, 0.27; P=0.0003) and showed a trend toward reduced risk of clinically driven TLR, though this did not reach statistical significance. Despite some of the shortcomings in the prior study noted above, it appears that the resorbable scaffold may be helpful in lessening restenosis especially for infrapopliteal disease in select patients. Limitations of this study included the addition of binary stenosis that was later added as an endpoint, the trial population included patients with noncomplex, short and mildly-to-moderately calcified lesions which may not reflect the broader population, no consideration was made for predilation prior to scaffold placement in the results and the drug resorbable scaffold was placed in the proximal two-thirds of the infrapopliteal arteries which may limit applicability to other areas.³⁰⁰ 

Various atherectomy devices have been used and are currently used to treat infrapopliteal disease (IPD); 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 is required for optimal outcomes. The authors evaluated LS, AFS, and target extremity reintervention (TER) after plain old balloon angioplasty (POBA), stenting, and atherectomy for treatment of IPD with CLTI. All index peripheral vascular interventions (PVIs) for IPD and CLTI were identified from the Vascular Quality Initiative registry. Of the multilevel procedures, the PVI type was indexed to the infrapopliteal segment. Propensity score matching was used to control for baseline differences between groups. Kaplan-Meier and Cox regression were used to calculate and compare LS and AFS. The 3-year LS for stenting versus POBA was 87.6% vs 81.9% (P = 0.006) but was not significant on Cox regression analysis (HR, 0.91; 95% CI, 0.56-0.76; P = 0.08). AFS was superior for stenting versus POBA (78.1% vs 69.5%; P = 0.001; HR, 0.73; 95% CI, 0.60-0.90; P = 0.003). LS was similar for POBA and atherectomy (81.9% vs 84.8%; P = 0.11) and for stenting and atherectomy (87.6% vs 84.8%; P = 0.23). The LS rate after propensity score matching for POBA versus stenting was 83.4% vs 88.2% (P = 0.07; HR, 0.71; 95% CI, 0.50-1.017; P = 0.062). The AFS rate for stenting versus POBA was 78.8% vs 69.4% (P = 0.005; HR, 0.69; 95% CI, 0.54-0.89; P = 0.005). No significant differences were found between stenting and atherectomy (P = 0.21 for atherectomy; P = 0.34 for POBA). The need for TER did not differ across the groups but the interval to TER was significantly longer for stenting than for POBA or atherectomy (stenting vs POBA, 12.8 months vs 7.7 months; P = 0.001; stenting vs atherectomy, 13.5 months vs 6.8 months; P < 0.001). The authors concluded that stenting and atherectomy had comparable LS and AFS for patients with IPD and CLTI. However, stenting conferred significant benefits for AFS compared with POBA but atherectomy did not. Furthermore, the interval to TER was nearly double for stenting compared with POBA or atherectomy. These factors should be considered when determining the treatment strategy for this challenging anatomic segment with comparison of outcomes for balloon angioplasty, atherectomy, and stenting in the treatment of IPD for CLTI.²⁴⁴

Angiosomes are defined as the tissue fed by a specific artery (anterior tibial, posterior tibial, or peroneal). The foot is divided into 6 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 LS and improved ulcer healing rate.^245,246 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, LS and ulcer healing rates were similar for direct revascularization compared with indirect revascularization through collaterals, and both were superior to indirect revascularization without collaterals.²⁴⁷

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 2 arteries in 1 angiosome, especially in those with incomplete pedal arch, as well as the potential of compensating for the loss of patency in 1 vessel over time. Healing time and rate were better in 2-vessel revascularization compared with single-vessel revascularization, with less effect of the angiosome concept in some studies;²⁴⁸ however, others have found no impact for multivessel revascularization.²⁴⁹ A small, randomized trial found that multivessel revascularization was associated with faster and higher healing rates with a trend for better LS in patients with tissue loss.²⁵⁰ Thus, selected patients with an incomplete pedal arch in whom indirect revascularization would not provide adequate flow to the ulcer may benefit from multivessel revascularization.

Shishehbor et al. enrolled 105 patients who had CLTI and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had AFS. According to Bayesian analysis, the posterior probability that AFS at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. LS (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan–Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. The authors found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with CLTI who were not candidates for conventional surgical or endovascular revascularization treatment options.¹¹²

Percutaneous mechanical thrombectomy (PMT) with the AngioJet Rheolytic Thrombectomy System has been developed as a therapy for patients who cannot undergo catheter directed thrombolysis (CDT). Although this treatment has also been used as an adjunct to CDT, for ALI, PMT is often used as the primary therapy, with CDT used to dissolve thrombotic material that remains after PMT.

The literature search identified a nonrandomized controlled study²⁵¹ and 5 uncontrolled studies^252-256 of PMT with the AngioJet Rheolytic Thrombectomy System for treatment of ALI. Only the Müller-Hülsbeck et al. study²⁵⁴ enrolled more than 100 patients and only the Ansel et al. study²⁵³ involved more than 3 years of follow-up.

The only controlled trial of PMT in the available literature was a retrospective, nonrandomized controlled study²⁵¹ by Hanover et al. This study reviewed hospital records for 81 patients (median age 59 years, range 32-89) who underwent PMT for acute occlusion of vein or prosthetic grafts of the femoral, popliteal, tibial, aortoiliac, or brachial arteries. All patients underwent CDT with a mean of 10 ± 5 units of reteplase, and 50 patients who seemed to have a large clot burden underwent PMT with the AngioJet System. Demographics were not reported separately for patients who did and did not undergo PMT. At 12 months of follow-up, patients who underwent PMT had higher LS, higher AFS, and lower artery patency than patients who did not undergo PMT; however, these differences were not statistically significant. For all patients combined at 12 months follow-up, primary patency was 52%, LS was 73%, survival was 91%, and AFS was 70%.²⁵¹

The largest available trial of PMT for ALI was an uncontrolled study²⁵⁴ by Müller-Hülsbeck et al. that enrolled 112 patients (56 men, 56 women; mean age 71 ± 12 years; mean symptom duration 8 ± 11 days). Of 115 vessels treated, 16 (12%) were femoropopliteal bypass grafts and 99 (88%) were occluded native leg arteries such as the iliac, superficial femoral, popliteal, and infrapopliteal arteries. Mean length of occlusion was 16 ± 11 cm for native vessels and 27 ± 12 cm for bypass grafts. In this study, all patients underwent PMT but CDT was used as adjunct treatment only if thrombus removal was incomplete after PMT. Mean amount of thrombus material removed with PMT alone was 79% (range 0% to 100%) and the mean total time of AngioJet System pump use was 280 ± 163 seconds. A total of 20 (17%) partially blocked vessels underwent treatment with urokinase or tissue plasminogen activator after PMT. In addition, 11 (10%) residual blockages underwent aspiration thrombectomy. After these procedures, 68 (59%) vessels with residual stenosis underwent angioplasty and 13 (11%) underwent stent implantation. Using < 30% stenosis as the criteria for success, 88% of revascularization procedures were successful after completion of all catheter-based procedures. For 8 (7%) patients, vascular surgery was needed to correct anastomotic strictures of bypass grafts. After 3 years of follow-up, primary patency was 58%, mortality was 19%, and AFS was 68%. These outcomes were not reported separately for patients who did and did not undergo adjunct CDT.²⁵⁴

Ansel et al. performed an uncontrolled study²⁵³ that involved a much longer period of follow-up. In this study, 57 patients (30 men, 27 women; mean age 64 ± 14 years; 53 legs treated, 4 arms treated; median lesion length range 3-10 cm) underwent PMT with the AngioJet System as the primary treatment for ALI. CDT was used only if PMT did not provide sufficient revascularization. With PMT, thrombus removal was complete for 14 (25%) patients, substantial for 22 (39%), partial for 16 (28%), and ineffectual for 5 (9%). CDT with urokinase or tissue plasminogen activator was used after PMT for 18 (32%) patients. In addition, 53 (93%) patients underwent angioplasty, atherectomy, and/or stenting, and 4 (7%) underwent surgical revision. During the first 30 days after treatment, 3 (5%) patients died and 3 (5%) required amputations. After a mean of 5 years follow-up of 54 patients, 13 (24%) patients underwent 22 endovascular reinterventions, survival was 70%, and AFS was 67%.²⁵³ NOTE: This study was sponsored by the device manufacturer.

In a smaller study²⁵⁶ with a shorter period of follow-up, Papillion et al. evaluated the AngioJet System in 43 patients (26 men, 17 women; mean age 63 ± 25 years) who had ALI in native arteries (35%), bypass grafts (56%), or stents (9%). All patients underwent PMT, and for 12 (28%) patients, PMT alone provided adequate revascularization. In another 21 (49%) patients, CDT used as an adjunct therapy provided revascularization that was deemed successful for all patients who underwent PMT followed by CDT. In addition, 28 (65%) patients underwent angioplasty and/or stent placement, 2 (5%) underwent laser atherectomy, 4 (9%) underwent surgical bypass, and 3 (7%) were converted to open thrombectomy. At 1 year of follow-up, 11 (26%) patients had undergone additional endovascular procedures, the LS rate was 81%, and the ABI was 0.95.²⁵⁶

Two uncontrolled studies^252,255 have examined short-term outcomes of PMT with the AngioJet System. Kasirajan et al. used PMT as the primary therapy in 86 patients who had acute (n = 65) or subacute (n = 21) limb ischemia with CDT used subsequently if PMT removed at least 50% of the thrombus. PMT provided successful recanalization in 51 (61%) patients and partial recanalization in 19 (23%) patients. Subsequent CDT improved angiographic results in only 7 (14%) of 50 patients.²⁵⁵ The authors used PMT as an adjunct to 30 minutes of CDT in all 49 patients who had ALI Treatment success was based on angiography and defined as full perfusion of the affected artery with partial or no delay of flow compared with normal arteries. Revascularization was successful in 45 (92%) patients. After 30 days of follow-up, the LS rate was 91%. Allie et al. also evaluated the influence of urokinase versus tenecteplase on their procedure and found that these agents provided essentially identical outcomes.²⁵²

Results of the available studies provide preliminary evidence that PMT with the AngioJet Rheolytic Thrombectomy System benefits patients who have ALI. The best evidence of efficacy was obtained in the uncontrolled studies of PMT as primary therapy, which found that 25% to 61% of patients obtained extensive recanalization with PMT.^253-256 Subsequent endovascular treatments including CDT and angioplasty improved outcomes in many patients; however, some patients cannot undergo CDT due to contraindications. Moreover, revascularization is usually obtained more quickly with PMT than with CDT, which may improve outcomes since patients who have ALI are at high risk for amputation.^251,253-257 Although a controlled study found that PMT did not improve outcomes after CDT, PMT was used only for patients who seemed to have more severe disease, which may have resulted in an underestimation of the efficacy of CDT.²⁵¹ Further studies are needed to determine whether the safest and most effective initial treatment protocol for ALI is CDT alone, CDT followed by PMT, or PMT followed by CDT.

The literature search identified 2 prospective uncontrolled studies (n = 36 to 100) and 3 retrospective uncontrolled studies (n = 12 to 61) that evaluated the safety and efficacy of external iliac atherectomy for treatment of symptomatic PAD in patients with angiographic stenoses and/or occlusions involving the iliac and other arteries. Many patients were treated for recurrent disease following prior revascularization. Overall, recanalization of stenosed or occluded iliac arteries was technically successful by atherectomy with and without balloon angioplasty and stenting. In studies that reported on clinical outcomes, patients experienced symptom relief. In 1 prospective study that included 24 occlusions in iliac vessels and examined immediate postoperative results, recanalization was achieved in 91% of the lesions overall and in 87.5% of the iliac artery lesions. However, all 4 failures (9%) in this study were attributed to inability to access an iliac occlusion due to excessive tortuosity of the vessel, so the failure rate was higher in iliac vessels. In a retrospective study that included 11 aortoiliac lesions, the technical success rate was high (84%) for recanalization of chronic total occlusions (CTOs), as was the clinical success rate at 6 months (93%). The cumulative clinical patency rate at 1 year was 83%. Two older studies evaluated atherectomy in patients with obstructed iliac stents. One retrospective study reported a high rate of cumulative patency at 1 year (87%) after atherectomy for stenotic lesions, but patency was significantly lower in previously occluded lesions (57%), and recurrent obstruction was observed in 33% of the successfully treated lesions after a mean of 15.5 months. Another retrospective study reported a primary patency rate of 79% following initial atherectomy for stent restenosis or occlusion and a secondary patency rate of 92% at a mean of 11.5 months after the initial atherectomy. An older prospective study involving 100 patients treated with directional atherectomy reported an acute success rate of 94% overall (96% for stenoses and 91% for occlusions). Although sufficient revascularization could not be achieved with the largest available catheter in 3 of 22 iliac lesions, successfully treated iliac stenoses showed superior results compared with LE lesions, with minimal narrowing at the 6-month follow-up. The complication rate related to atherectomy was low, and no procedure-related deaths were reported. While endovascular iliac atherectomy appears to confer some clinical benefits in patients with symptomatic PAD and appears to be relatively safe, the overall quality of the evidence is very low. All the studies lacked controls; most were small in size, had a retrospective design, and had incomplete reporting of angiographic and clinical follow-up. There are no large, well-designed, long-term comparative studies on external iliac atherectomy, and no RCTs. Few studies were conducted in the era of modern antiplatelet agents. Some studies included patients with lesions in the LEs and did not separately report results in iliac or EIAs. While the available evidence seems promising, it is preliminary. Additional studies are needed to assess the safety and efficacy of external iliac atherectomy for PAD, and to determine patient selection criteria.^258-262

Diamond Atherectomy has minimal evidentiary support. An overall very low-quality body of evidence suggests that treatment of LE PAD with Diamondback 360 peripheral orbital atherectomy combined with balloon angioplasty is reasonably safe but provides limited inconsistent improvements relative to angioplasty alone. Most of the benefits obtained with Diamondback atherectomy were statistically significant in only 1 of up to 5 studies. In addition, all but 2 of the benefits were assessed during or immediately after completion of treatment, and the studies involved limited or no comparison with cutting/scoring balloon angioplasty, rotational atherectomy, excimer laser atherectomy, or IVL.^233,263-266 

Carr et al. recently published a meta-analysis which showed that peripheral atherectomies, including orbital atherectomies, prompted favorable outcomes with high 1-year patency rate compared to POBA and DCBs. While not specific to orbital atherectomy with the Diamond Atherectomy, the orbital atherectomy rates were favorable, similar to previously published studies. However, only 5.9% of the studies included RCTs and only looked at 12-month patency. While the data included orbital atherectomy, the authors noted that given these factors, as well as variations in imaging use (e.g., IVUS) and adjunctive therapies (POBA or DCB), comparison of results between atherectomy classes across inherently noncomparative studies must be interpreted with caution.³⁰¹

In general, outcomes were similar across the 4 classes of devices. Despite the limitations in the studies, since Diamondback orbital atherectomy was included in all orbital atherectomy devices and has FDA approval, it may be reasonable and necessary when done with the proper medical documentation.

Delivery Setting/Site of Service

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 combine 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.

Endovascular treatments for PAD are frequently performed in outpatient or ambulatory settings, which may offer patients the advantage of shorter recovery times and reduced hospital stays compared with traditional hospital-based surgical approaches.²⁶⁷

PAD represents a high volume, high-cost burden on the health care system. CMS has developed the Bundled Payments for Care Improvement-Advanced program, in which a single payment is provided for all services administered in a postsurgical 90-day episode of care. Factors associated with 30- and 90-day reinterventions after PAD interventions would represent useful data for both payors and stakeholders. A national cohort study of adults 65 years and older in the Vascular Quality Initiative and CMS linked dataset who underwent an open, endovascular, or hybrid revascularization procedure for PAD between January 1, 2010, to December 31, 2018, was conducted. Procedures for ALI and aneurysms were excluded. The primary outcome was 90-day reintervention. Reintervention at 30-days was a secondary outcome. Covariates of interest included demographic, comorbidities, and patient- and facility-level characteristics. Multivariable Cox regression was used to determine the association between patient- and facility-level characteristics and the risk of 30- and 90-day reinterventions. Among 42,429 patients (71.3% endovascular, 23.3% open, and 5.4% hybrid), median [IQR] age was 74 [69-80], 57.9% were male, and 84.3% were White. CLTI was the operative indication in 40.4% of the procedures. Overall, 42.8% were completed in the outpatient setting (40.3% outpatient, 2.5% office-based laboratory [OBL]). Over 70% of procedures for CLTI were completed as inpatient while 60% of the claudication interventions were done as outpatient. The 90-day reintervention rate was 14.5% and the 30-day reintervention rate was 5.5%. Compared to inpatient procedures, PAD interventions completed in the outpatient or OBL setting had significantly higher 90- and 30-day reintervention rates (ref - inpatient; outpatient 90-day reintervention [HR 1.41 (95% CI 1.25-1.60)]; outpatient 30-day reintervention [HR 1.90 (95% CI 1.62-2.24)]; OBL 90-day reintervention [HR 2.09 (95% CI 1.82-2.41)]; OBL 30-day reintervention [HR 3.54 (95% CI 3.17-3.94)]). Open and hybrid approaches demonstrated lower risk of reintervention compared to endovascular procedures at 30 and 90 days and, compared to aortoiliac disease, all other anatomic segments of disease were associated with higher 90-day reintervention, but no difference was noted at 30 days. While outpatient PAD interventions may be convenient for patients and providers, the outpatient setting is associated with a significant risk of subsequent reintervention. Additional work is needed to understand how to improve the longevity of outpatient PAD interventions.²⁶⁸

To compare outcomes of outpatient tibial artery procedures between an office endovascular center and a hospital angiography suite, D'Souza et al. conducted a retrospective review of 204 outpatient tibial interventions performed on 161 patients (mean age 72 ± 11.5 years; 81 men) in either an office (n = 100) or hospital (n = 104) angiography suite from April 2011 through September 2013. Patients who had an existing ipsilateral bypass that was completely proximal to the tibial trifurcation were eligible, as were patients with prior proximal endovascular interventions. Exclusion criteria included previous ipsilateral bypass involving the infrapopliteal vessels, in-patient status at the time of the procedure, planned admission after the procedure, and infrapopliteal stenting. Treatment included PTA or PTA with atherectomy. Primary outcomes were unplanned admission, emergency room visits, acute complications, and patency. The authors reported no significant differences in demographics or baseline Rutherford category between patients treated in an office endovascular suite versus a hospital angiography suite. Factors more prevalent in the hospital group included COPD (16% vs 8%, p = 0.045), renal insufficiency (37% vs 25%, p = 0.017), and previous proximal bypass (12% vs 4%, p = 0.045). Of the 100 office procedures, 25 involved PTA and 75 were PTA with atherectomy, while in the 104 hospital procedures, PTA was applied in 68 patients and PTA with atherectomy in 36. Thirty-day local complication rates (7% vs 11%, p = 0.368), systemic complication rates (4% vs 8%, p = 0.263), and mortality (1% vs 2%, p = 0.596) in the office versus hospital setting were not statistically different. Unplanned post-procedure hospital admission rates for medical reasons were lower in the office group (2% vs 11%, p = 0.01). Kaplan-Meier estimates of the 1-year follow-up data were better in the office group for primary patency (69% vs 53%, p = 0.050), assisted primary patency (90% vs 89%, p = 0.646), and AFS (89% vs 83%, p = 0.476), but the differences were not statistically significant. Efficacy and safety of outpatient endovascular tibial artery interventions between office and hospital settings were similar, with lower unplanned admission rates and better patency. The authors found with appropriate patient selection; the office endovascular suite can be a safe alternative to the hospital angiography suite.²⁶⁹

Few data are available on the safety of interventions for PAD performed in the OBL setting. Giannopoulos et al. performed a study to investigate the short- and late-term outcomes of patients treated in OBL versus hospital settings. They included patients with PAD treated with any United States FDA approved or cleared devices for distal femoropopliteal and/or IPD. Data were retrieved from the LIBERTY 360 study. A propensity-scored, matched analysis was conducted and HRs with the respective 95% CIs were synthesized to examine the outcomes after interventions at OBL versus non-OBL settings. A total of 710 propensity-scored patients (355 OBL patients and 355 non-OBL patients) with 907 treated lesions (454 OBL lesions and 453 non-OBL lesions), were included. For almost all subjects, balloon angioplasty was the preferred treatment approach (341 [96.1%] in the OBL group vs 353 [99.4%] in the non-OBL group; P < 0.01), with bail-out stenting necessary in 5.1% of the OBL group and 3.1% of the non-OBL group. Overall, significant angiographic complications occurred in 7.8% of all patients treated, with no differences between the 2 groups. The risk for all-cause death, target-vessel revascularization, and major amputation and death combined was similar between the 2 groups during 3-year follow-up. The authors concluded that peripheral artery endovascular interventions in patients with chronic threatening ischemia or claudication, performed in the OBL setting, are safe and associated with favorable outcomes at 3 years of follow-up. These results demonstrate that treatment at OBLs is comparable to non-OBL settings. Further comparative studies and larger registries are needed to benchmark procedural quality and long-term outcomes.²⁷⁰

Outpatient use of atherectomy for PAD has grown rapidly and outcomes are poorly understood. The outcomes of atherectomy done for claudication, comparing office and hospital outpatient settings were analyzed. Analysis of Medicare Part B claims data was performed for incident femoral-popliteal or tibial-peroneal atherectomy from 2012 to 2014. Longitudinal analysis assessed services 18 months before, during, and up to 18 months after the incident PVI. Differences between office-based and hospital outpatient-based settings were assessed using χ²and Fisher’s exact tests. Comparing procedure settings, significant differences in race (femoral-popliteal: P = 0.04, tibial-peroneal: P = 0.001), chronic renal failure (femoral-popliteal: P = 0.002), and hypertension (femoral-popliteal: P = 0.01, tibial-peroneal: P = 0.006) were found. Nine hundred twenty-four patients undergoing femoral-popliteal atherectomy were analyzed (262 office-based, 662 hospital outpatient-based); 42.7% of office-based and 36.9% of hospital outpatient-based femoral-popliteal atherectomy patients had repeat PVI within 18 months (P = 0.10). Major amputation was performed in 2.3% and 3.2% of patients in office and hospital outpatient settings, respectively (P = 0.47). Four hundred twenty-three patients undergoing tibial-peroneal atherectomy were analyzed (202 office-based, 221 hospital outpatient-based); 46.5% of office-based and 38.9% of hospital outpatient-based tibial-peroneal atherectomy patients had repeat PVI within 1 year (P = 0.11). Major amputation was performed in 5.0% and 8.1% of patients in office and hospital outpatient settings, respectively (P = 0.19). The study demonstrated higher than expected rates of major amputation for patients undergoing peripheral arterial atherectomy regarding previously reported rates. No significant differences in outcomes were noted between office-based and hospital-based procedures. However, further studies may be required to prove the efficacy and safety of atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments to ensure outcomes are not worse than the natural history of medically managed claudicants.²⁷¹

The development of minimally invasive devices to treat PAD led to a reduction of complications, particularly of the puncture or access site. Subsequently, the number of ambulatory procedures increased, saving costs and resources. An analysis was performed to provide data on patients treated with 4 French (F) compatible devices in ambulatory and in-hospital settings. This is a single-center retrospective analysis of prospectively collected data. Consecutive patients who received PVIs from 2013 to 2015 were included. Data were extracted from electronic patients' files; data until the time of last contact were collected. Arterial puncture was performed under ultrasound guidance; 4F compatible devices ought to be selected and compression devices were used to seal the puncture site. The primary outcome was the rate of ambulatory failure in the ambulatory group. A total of 219 patients (68.5% male, 69.5 ± 12.8 years) were included in the analysis. Thereof 71 patients with 80 procedures were hospitalized, predominantly for social reasons (42/80, 52.5%) or emergency conditions (18/80, 22.5%). In the ambulatory group (148 patients), 183 procedures were performed, thereof 92.9% (170/183) with 4F compatible equipment. Procedural success was 91.8% (168/183) in the ambulatory group and 82.5% (66/80) in the hospitalized group (P = 0.027). Patients in an ambulatory setting were younger and more frequently males. Ambulatory success was 99.2% (181/183). One puncture site complication was observed in each group but no other procedural complications, and all patients were alive after 1 month. In the ambulatory group, the mean follow-up was of 148 ± 260 days and in the hospitalized group, the mean follow-up was of 126 ± 199 days; no patient died during follow-up in the ambulatory group, but 3 patients died in the hospitalized group. The authors concluded that ambulatory endovascular procedures can be safely performed in a large proportion of patients with PAD.²⁷²

Modifications in reimbursement rates by Medicare in 2008 have led to PVIs being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. Using a 100% national sample of Medicare beneficiaries from 2010 to 2012, we examined 30-day and 1-year rates of all-cause mortality, major LE amputation, repeat revascularization, and all-cause hospitalization by clinical care location of index PVI. A total of 218,858 Medicare beneficiaries underwent an index PVI between 2010 and 2012. Index PVIs performed in inpatient settings were associated with higher 1-year rates of all-cause mortality (23.6% vs 10.4% and 11.7%; p < 0.001), major LE amputation (10.1% vs 3.7% and 3.5%; p < 0.001), and all-cause repeat hospitalization (63.3% vs 48.5% and 48.0%; p < 0.001), but lower rates of repeat revascularization (25.1% vs 26.9% vs 38.6%; p < 0.001) when compared with outpatient hospital settings and office-based clinics, respectively. After adjustment for potential confounders, patients treated in office-based clinics remained more likely than patients in inpatient hospital settings to require repeat revascularization within 1 year across all specialties. There was also a statistically significant interaction effect between location of index revascularization and geographic region on the occurrence of all-cause hospitalization, repeat revascularization, and LE amputation. Index PVI performed in office-based settings was associated with a higher hazard of repeat revascularization when compared with other settings. Differences in clinical outcomes across treatment settings and geographic regions suggest that inconsistent application of PVI may exist and highlights the need for studies to determine optimal delivery of PVI in clinical practice.²⁷³

Between May 22, 2007 and December 31, 2012, 2822 patients underwent 6458 percutaneous procedures in an office-based endovascular suite. Demographics of the patients, complications, hospital transfers, and 30-day mortality were documented in a prospective manner. Follow-up calls were made, and a satisfaction survey was conducted. Almost all dialysis procedures were done under local anesthesia and peripheral arterial procedures under conscious sedation. All patients, except those undergoing catheter removals, received hydrocodone and acetaminophen (5/325 mg), diazepam (5-10 mg), and 1 dose of an oral antibiotic pre-procedure and 3 doses post-procedure. Patients who required conscious sedation received fentanyl and midazolam. Conscious sedation was used almost exclusively in patients having an arterial procedure. Measurements of blood urea nitrogen, creatinine, international normalized ratio, and partial thromboplastin time were performed before peripheral arteriograms. All other patients had no preoperative laboratory tests. Patients considered high risk (American Society of Anesthesiologists physical status classification 4), those who could not tolerate the procedure with mild-to-moderate conscious sedation, patients with a previous bad experience, or patients who weighed >400 pounds were not candidates for office-based procedures. There were 54 total complications (0.8%): venous, 2.2%; aortogram without interventions, 1%; aortogram with interventions, 2.7%; fistulogram, 0.5%; catheters, 0.3%; and venous filter-related, 2%. Twenty-six patients required hospital transfer from the office. Ten patients needed an operative intervention because of a complication. No procedure-related deaths occurred. There were 18 deaths in a 30-day period. Of patients surveyed, 99% indicated that they would come back to the office for needed procedures.²⁴⁷

The success rate for arterio-venous fistula (AVF) related interventions was 90%, and including partially successful interventions it was 93%. The success rate for PAD-related interventions was 82%, and including partially successful interventions it was 92%. The procedure success rate for miscellaneous interventions was 89%. Five AVF-related procedures suffered an adverse event (1.49%). Two PAD-related procedures suffered an adverse event (1.3%) while no adverse events were noted among miscellaneous procedures. One patient required immediate post-procedure hospitalization due to iliac artery perforation. Peripheral vascular procedures performed in the outpatient setting are safe and effective. A comparison of outcomes between outpatient and inpatient facilities when performing similar PVIs is needed in order to determine whether a transition of further vascular procedures into an outpatient setting is justified.²⁷⁵

Treatment outcomes of 5134 consecutive procedures performed in office-based endovascular suites from 2006 to 2013 were analyzed. Five sequential groups (group I–V) of 1000 consecutive interventions were compared with regard to technical success and treatment outcomes. The patients included 2856 (56%) females and 2267 (44%) males. Procedures performed included diagnostic arteriogram, arterial interventions, venous interventions, dialysis access interventions, and venous catheter management, which were 1024 (19.9%), 1568 (30.6%), and 3073 (60.0%), 621(12.1%), and 354 (6.9%), respectively. The complication rates for group I, II, III, IV, and V were 3%, 1.5%, 1%, 1.1%, and 0.7%, respectively. The complication rate was higher in group I when compared to each of the remaining 4 groups (p < 0.05). Nine patients (0.18%) died within the 30-day period following their procedures, and none were procedure related. The authors concluded that endovascular procedure could be performed safely in an office-based facility with excellent outcomes.²⁷⁶

Intravascular Ultrasound

IVUS is an imaging technique commonly used as an adjunctive tool during endovascular treatment options for PAD. Unlike traditional angiography-based guidance, which uses x-rays to generate two-dimensional images of vessels, IVUS generates detailed three-dimensional, cross-sectional images of vessels using a catheter equipped with an ultrasound transducer. As an adjunct to endovascular treatment options, such as angioplasty and stenting, IVUS can provide information about vessel and lesion morphology to help guide optimal device placement. Information obtained through IVUS may include vessel dimensions (e.g., diameter, wall thickness, length, shape, etc.), plaque location/buildup, plaque characteristics (e.g., fibrous tissue, fibro fatty plaques, necrotic cores, or calcification), arterial dissections, and/or plaque ulceration, among other information. IVUS may be used alongside endovascular treatment options for PAD to aid in diagnosis, treatment planning, and guiding device selection and placement, with the goal of improving endovascular outcomes.^277-279

Divakaran et al. reported on IVUS for use in PAD procedures. IVUS was shown in limited prospective studies to improve procedural outcomes for patients undergoing LE PVI. The authors aimed to study temporal trends, practice variation, and associated outcomes with the use of IVUS during PVI among Medicare beneficiaries. All PVIs performed from 2016 to 2019 among Medicare beneficiaries aged >65 years were included. Temporal trends in IVUS use were stratified by procedural location (inpatient, outpatient, or ASC/OBL) and physician specialty. The primary outcome was major adverse limb events (MALE). Inverse probability weighting was used to account for differences in baseline characteristics. Cox regression with competing risks was used to estimate weighted HRs. During the study period, 543,488 PVIs were included, of which 63,372 (11.7%) used IVUS. A substantial growth in IVUS use was observed, which was driven by procedures performed in ASCs/OBLs (23.6% increase from quarter 1 of 2016 through quarter 4 of 2019). Among operators who used IVUS, there was also notable variation in use (median operator use 5.4% of cases; IQR: 2.2%-15.0%; range, < 0.0001). In contemporary nationwide data, IVUS use during PVI has increased since 2016, driven by growth in the ASC/OBL setting. However, there remains substantial variation in operator practice. When used during PVI, IVUS was associated with a lower risk of short- and long-term MALE.²⁸⁰

Fujihara et al. assessed the utility of IVUS during BTK interventions for patients with CLTI. The retrospective single-center study included 216 symptomatic patients (mean age 74.2 ± 9.5 years; 167 men) with CLTI and BTK steno-occlusive disease who underwent successful balloon angioplasty between January 2016 and August 2018. Data from 88 vessels (58 patients) treated with IVUS-guided procedures were compared with corresponding values from 242 vessels (158 patients) treated with angiography-guided procedures. The primary outcomes included procedure-related variables of balloon size, contrast dose, and complication rates, as well as changes in ABI and skin perfusion pressure (SPP). Secondary outcomes included IVUS determination of vessel size, wire route, and calcification severity, as well as technical success and clinically driven TLR, LS, and wound healing rates in the Rutherford category 5/6 patients as evaluated by propensity score matching analysis. The patient and lesion characteristics were similar in both groups. The mean balloon size for IVUS-guided procedures was significantly larger (2.45 ± 0.4 mm) compared with that for angiography-guided procedures (2.23 ± 0.4 mm; p0.99, respectively). IVUS-guided interventions for BTK lesions were safe and effective in accurately assessing the lesions. The results suggest that IVUS guidance of endovascular procedures has the potential to influence better clinical outcomes than angiography-guided angioplasty.²⁸¹

Iida et al. investigated whether the use of IVUS improved primary patency following nitinol stenting for TASC II A-C femoropopliteal lesions. Using a retrospective multicenter database of 1198 limbs from 965 patients (695 men; mean age 72 ± 9 years) with TASC II A-C lesions (28% critical limb ischemia) treated by provisional stenting from April 2004 to December 2011, primary patency rate was compared between 234 propensity score-matched pairs with versus without IVUS use. IVUS was used in 22% (n = 268) of the overall population. It was more likely to be used in cases with generally more complicated femoropopliteal lesions (e.g., more severe TASC II class, longer lesion length, and narrower reference diameter). Analysis of the 234-propensity score-matched pairs (mean follow-up 1.9 ± 1.5 years; 142 events) revealed higher 5-year primary patency with than without IVUS use (65% ± 6% vs 35% ± 6%, p < 0.001), and event-free survival (p < 0.001). IVUS use in femoropopliteal stenting for TASC II A-C lesions appeared to be associated with higher primary patency rate.²⁸²

Krishnan et al. looked at nitinol interwoven bare metal stents placement with IVUS assistance, and this represents an advancement in stent technology. However, nominal deployment remains an area of focus. This study aims to determine the effect of IVUS when used adjunctively with nitinol interwoven bare metal stents in the management of femoropopliteal lesions. This retrospective study included a cohort of 200 consecutive patients with PAD. All patients were treated with ≥1 Supera bare metal stent, and 91 received adjunctive IVUS imaging prior to stent deployment. Deployment conditions of nominal, compressed, and elongated were measured, and the primary clinical outcomes included target lesion reintervention, amputation, and mortality. This study also showed that 8.3 number needed to treat (NNT) patients must be treated with IVUS to avoid an additional revascularization event. The patients who received IVUS had a significantly greater number of nominally deployed stents (p < 0.001). Patients who had IVUS imaging also had significantly lower reintervention rates compared with those who did not receive IVUS imaging (p = 0.047). The IVUS and angiography decreases clinically driven target lesion reintervention and increases nominal deployment compared with angiography alone in femoropopliteal lesions treated with interwoven bare metal nitinol stents. Endovascular surgeons may consider the adjunctive use of IVUS when using the Supera stent for the treatment of infrainguinal superficial femoral artery lesions. The authors concluded that the adjunct use of IVUS may lead to improved sizing, vessel prep, deployment, and ultimately reduction in clinically driven target lesion revascularization (CD-TLR).²⁸³

Although angiography has been the primary imaging modality used in PVI, this technique has major limitations due to the evaluation of three-dimensional vessels in 2 dimensions. IVUS is an important adjunctive tool that can address some of these limitations. This systematic review assesses the appropriateness of IVUS as an imaging modality for guiding peripheral intervention through evidence collection and clinical appraisal of studies. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a cohort of 48 studies (29 arterial; 19 venous) detailing IVUS use in PVI were extracted. Qualitative assessment of the studies evaluated pre- and post-procedure efficacy of IVUS and revealed that IVUS-guided peripheral intervention in arterial and venous diagnosis and treatment was superior to other imaging techniques alone. Each study in the cohort was further assessed for reliability and validity using the Oxford Centre for Evidence Based Medicine (CEBM) level of evidence scale. The majority of both arterial (79.3%) and venous (73.7%) studies received a 2b rating, the second highest level of evidence rating. According to the authors, the evidence to date indicates that IVUS results in better clinical outcomes overall and should be more widely adopted as an adjunctive imaging modality during peripheral intervention.²⁸⁴

Soga et al. performed a study to compare outcomes and costs between IVUS and contrast angiography alone in patients undergoing peripheral revascularization procedures in Japan. This retrospective comparative analysis was performed using the Japanese Medical Data Vision insurance claims database. All patients undergoing revascularization for PAD between April 2009 and July 2019 were included. Patients were followed until July 2020, death, or a subsequent revascularization procedure for PAD. Two patient groups were compared: 1 undergoing IVUS imaging and the other contrast angiography alone. The primary endpoint was major adverse cardiac and limb events, including all-cause-mortality, endovascular thrombolysis, subsequent revascularization procedures for PAD, stroke, acute myocardial infarction, and major amputations. The study included 3956 patients in the IVUS group and 5889 in the angiography alone group. IVUS was significantly associated with reduced risk of a subsequent revascularization procedure (adjusted HR: 0.25 [0.22-0.28]) and major adverse cardiac and limb events (0.69 [0.65-0.73]). The total costs were significantly lower in the IVUS group, with a mean cost saving over follow-up of $18,173 [$7,695-$28,595] per patient. The use of IVUS during peripheral revascularization provides superior long-term clinical outcomes. IVUS guidance during peripheral vascular revascularization has been introduced to improve the precision of the procedure. However, questions over the benefit of IVUS in terms of long-term clinical outcome have limited its use in everyday clinical practice. This study, performed in a Japanese health insurance claims database, demonstrates that use of IVUS provides a superior clinical outcome over the long-term compared to angiography alone. These findings should encourage clinicians to use IVUS in routine peripheral vascular revascularization procedures and encourage providers to reduce barriers to use.¹³⁶

Treatment with a fluoropolymer-based drug-eluting stent (FP-DES) has been widely applied to the contemporary femoropopliteal practice with durable outcomes. Nevertheless, the impact of IVUS utilization on clinical outcomes after FP-DES implantation has not been determined. This study aimed to investigate the impact of IVUS on 1-year clinical outcomes after FP-DES implantation for femoropopliteal lesions in patients with symptomatic PAD. As a sub analysis of the CAPSICUM (contemporary outcomes after paclitaxel-eluting peripheral stent implantation for symptomatic lower limb ischemia with superficial femoral or proximal popliteal lesion) study, the present investigation analyzed 1,091 patients with symptomatic PAD who underwent endovascular therapy with FP-DES for femoropopliteal lesions. One-year clinical outcomes were compared between patients treated with IVUS and those treated without IVUS after propensity score matching. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed. A total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation. After propensity score matching, the 1-year restenosis was not significantly different between the groups (11.5% [95% CI: 9.1%-14.0%] vs 15.5% [95% CI: 10.9%-20.1%]; P = 0.22). The frequency of aneurysmal degeneration at 1 year was significantly higher in the IVUS group than in the non-IVUS group (19.8% [95% CI: 16.3%-23.4%] vs 7.1% [95% CI: 3.3%-11.0%]; P < 0.001). IVUS use was associated with a lower restenosis risk in patients with CTO but not in those without (P for interaction = 0.044). The present study revealed that 1-year restenosis risk was not significantly different between the 2 groups, whereas the incidence of aneurysmal degeneration was significantly higher in the IVUS group.²⁸⁵

Tsujimura et al. investigated the effect of IVUS imaging use on clinical outcomes after aortoiliac stenting in patients with PAD. Subjects for this retrospective analysis were derived from the OMOTENASHI registry database, which contained 803 symptomatic PAD patients (Rutherford categories 2-4) who were treated with self-expanding stent implantation for aortoiliac atherosclerotic lesions at 61 centers in Japan between January 2014 and April 2016. Of the 803 patients, 545 (67.9%) patients (mean age 73 ± 9 years; 453 men) underwent IVUS-supported stent implantation and were compared with the 258 patients (mean age 73 ± 8 years; 217 men) treated without IVUS. A propensity score analysis of 138 matched pairs was conducted to compare treatment strategies and clinical outcomes between patients having IVUS-supported endovascular therapy and those treated without IVUS. Endovascular strategies and postoperative medications were not significantly different between the IVUS and no-IVUS groups. A procedure time under 1 hour was less frequent in the IVUS group, which had a longer fluoroscopy time. The 12-month restenosis rate was not significantly different between the 2 groups (10.2% [95% CI 6.9 to 14.9%] vs 10.3% [95% CI 5.4 to 18.6%], p = 0.99). There was no interaction between baseline characteristics and the association of IVUS use with restenosis risk. Propensity-score matching analysis revealed that duration and fluoroscopy time during IVUS-supported procedures were significantly longer than in cases without IVUS use, whereas the 12-month restenosis rate was not significantly different between the groups. However, the authors concluded that the IVUS use in aortoiliac lesions may be unnecessary.²⁸⁶

Thus, IVUS has been increasingly adopted as an adjunct to catheter-based techniques in the peripheral arteries owing to its ability to produce detailed diagnostic information regarding the lumen size, plaque morphology, degree of stenosis, and residual lumen area. The limitations of IVUS include its requirement for intraluminal access and having a wire across the lesion, which is the primary mode of immediate endovascular technical failure. Furthermore, it is a side-looking device and cannot assess total occlusions or vessels <2 mm. Compared with optical coherence tomography (OCT) and magnetic resonance imaging (MRI), IVUS images contain more artifact and lower frame rates and are inherently user dependent.²⁸⁷

Health Care Disparities

Evidence suggests pathophysiological drivers of the clinical expression of PAD differ across self-reported race and ethnicity. Several studies document accentuation of vascular aging with reduced endothelial function, increased arterial stiffness, and increased oxidative stress in Black American patients (and in some studies of Hispanic American patients). In healthy adults, Black American women display reduced skeletal muscle mitochondrial function that may reflect increased oxidative injury. Systemic inflammation associates with poor functional capacity in PAD and biomarkers, including C-reactive protein and fibrinogen, are elevated in Black compared with White Americans. Microvascular disease is a key predictor of amputation risk and is more prevalent in Black than in White Americans in the Veterans Aging Cohort Study. Racial differences in vascular health reflect, in part, a higher burden of cardiovascular risk factors, including diabetes, smoking, and hypertension. Emerging evidence also links social determinants of health to alternations in vascular health. Limited data suggest that genetic determinants of PAD may be distinct across ancestry, but more information is needed from diverse samples.²⁸⁸

Despite advances in medical, endovascular, and open surgical techniques, there is striking variation in care among population subgroups defined by sex, race and ethnicity, and socioeconomic status, with concomitant differences in preoperative medication optimization, amputation risk, and overall health outcomes. Higher amputation rates and poorer outcomes were associated with lower socioeconomic status, rural locations and minorities due to limited access and greater extent of PAD in these subpopulations.²⁸⁸

Social Determinants of Health

Social determinants of health are linked to the development of PAD. Prevalence studies show higher rates of PAD with lower income, lower education levels, and less social support with higher risk for amputation with lower socioeconomic status. Current frameworks link structural health elements, including economic status, built environment, education access, health care access, food quality, and community resilience to chronic stressors and downstream adverse physiological effects, including chronic inflammation. Racial discrimination is associated with elevated biomarkers of systemic inflammation and vasoconstrictor responses in Black American men related to higher sympathetic nerve activity, potentially reflecting influence of chronic stress. Accelerated vascular aging related to adverse social determinants of health may also be driven by epigenetic alterations, including DNA methylation and shortened telomere length. Public health interventions targeted at the social determinants of health are likely to improve the clinical status of patients with PAD across diverse racial groups.²⁸⁸

The social and clinical effect of PAD includes higher rates of individual disability, depression, minor and major limb amputation along with cardiovascular and cerebrovascular events. The reasons behind the inequitable burden of PAD and inequitable delivery of care are both multifactorial and complex in nature, including systemic and structural inequity that exists within our society.²⁸⁸

Even so, a comprehensive review of the literature has identified key ways in which vascular specialists can help optimize health outcomes by applying principles of culturally informed and inclusive care. To make a difference in outcomes, providers should aim to (1) provide care that is informed by an awareness of differences in sex, race and ethnicity, and socioeconomic status that can have significant impacts on disease presentation, medical management, and operative outcomes; (2) provide comprehensive care, working collaboratively with primary care practitioners and enlisting resources to address unique patient circumstances, and (3) be willing to develop and employ new technological tools that can bridge the gap between patients and providers and ultimately improve vascular outcomes across all patient subgroups.²⁸⁹

Health disparities in PAD are associated with poor limb and cardiovascular outcomes and must be addressed at the individual patient and population levels, with interventions coordinated between multiple stakeholders across the cardiovascular community and public health infrastructure.¹¹¹

Societal Guidelines

PAD LE:

The following are key points from the Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease (PAD)²⁹⁰:

1. Patients at increased risk for PAD include patients aged ≥65 years, those with other risk factors for atherosclerosis (e.g., diabetes, any smoking history, hyperlipidemia, hypertension), a family history of PAD, or other known forms of atherosclerosis (e.g., coronary or carotid atherosclerosis, renal or mesenteric atherosclerosis, abdominal aortic aneurysms).²⁹⁰
2. In patients with possible PAD, a resting ABI, with or without segmental pressures and waveforms, is recommended to establish a diagnosis. ABI readings (the higher of each arterial pressure in each limb) are categorized as abnormal (ABI ≤0.90), borderline (ABI 0.91-0.99), normal (ABI 1.00-1.40), or noncompressible (ABI >1.40).²⁹⁰
3. A toe-brachial index (TBI) should be measured to diagnose patients suspected of PAD when the resting ABI is >1.40. An exercise ABI should be performed in patients with exertional nonjoint-related leg symptoms and normal or borderline resting ABI (0.90-1.40).²⁹⁰
4. In patients suspected of having critical limb ischemia (CLI; e.g., rest pain, nonhealing wound, or gangrene), an anatomic study, such as duplex ultrasound, CTA, MRA, or invasive angiogram should be performed when arterial pressures are abnormal (ABI or TBI).²⁹⁰
5. Patients with symptomatic PAD should be initiated on antiplatelet therapy (aspirin 75-325 mg daily or clopidogrel 75 mg daily) and statin therapy, preferably atorvastatin 80 mg daily. Antihypertensive therapy, smoking cessation, and coordinated diabetes management should also be initiated.²⁹⁰
6. Use of cilostazol may improve symptoms and increase walking distance in patients with claudication. Cilostazol is contraindicated in patients with congestive heart failure. Pentoxifylline is not effective for treatment of claudication.²⁹⁰
7. Supervised exercise is recommended to improve functional status and QOL as well as to reduce leg symptoms. This should be discussed prior to possible revascularization treatment options. Structured community-based or home-based exercise programs are an alternative to supervised exercise for patients with claudication.²⁹⁰
8. Revascularization is a reasonable treatment option for patients with lifestyle-limiting claudication and an inadequate response to medical management and exercise.²⁹⁰
9. Endovascular intervention is effective for patients with lifestyle-limiting claudication and hemodynamically significant aortoiliac occlusive disease (Class I—strong benefit>risk) or femoropopliteal disease (Class IIa—moderate benefit>risk). Endovascular procedures should not be performed in patients with PAD solely to prevent progression to CLI (Class III: Harm).²⁹⁰
10. When surgical revascularization is performed, bypass to the popliteal artery with autogenous vein is recommended over prosthetic graft material. Femoral-tibial artery bypasses with prosthetic graft material should not be used to treat claudication (Class III: Harm). Surgical procedures should not be performed in patients with PAD solely to prevent progression to CLI (Class III: Harm).²⁹⁰
11. In patients with CLI, revascularization should be performed to minimize tissue loss. Evaluation should be performed by an interdisciplinary care team prior to amputation. Endovascular or surgical procedures are recommended to establish in-line blood flow to the foot in patients with nonhealing wounds or gangrene.²⁹⁰
12. Patients with ALI should be emergently evaluated by a clinician experienced in assessing limb viability and revascularization techniques. Imaging is not necessary if clinical findings are highly suggestive of ALI. Instead, patients should proceed to revascularization and anticoagulation should be initiated. If the limb is found to be irreversible, then amputation should be performed.²⁹⁰
13. Patients with PAD should be followed periodically to assess cardiovascular risk factors, limb symptoms, functional status, and ABI testing.²⁹⁰

Guidelines have been issued in recent years by the European Society of Cardiology (ESC), by the European Society of Vascular Surgery (ESVS) and by the European Stroke Organization (ESO)²⁹¹:

1. Healthcare centers are strongly recommended to establish multidisciplinary vascular teams to make decisions and manage patients with PAD, including public awareness efforts.²⁹¹
2. For patients with carotid artery disease, surgery or stenting (with EPDs) is recommended (Class IIa—should be considered based upon weight of evidence) for high stroke risk patients, while stenting alone can be considered (Class IIb—may be considered with less well-established evidence) for average surgical risk patients.²⁹¹
3. Routine prophylactic carotid revascularization of asymptomatic carotid disease (70-99%) is not recommended (Class III—treatment not recommended due to potential harm or not effective) in patients undergoing CABG surgery.²⁹¹
4. Stenting is no longer recommended (Class III) for patients with symptomatic atherosclerotic renal artery stenosis of >60%.²⁹¹
5. Patients with aorto-iliac or aorto-bifemoral occlusions are recommended for surgical intervention (Class IIa) or endovascular revascularization in experienced centers (Class IIb).²⁹¹
6. Patients with intrapopliteal lesions should be treated with bypass surgery (Class I) or endovascular therapy (Class IIa).²⁹¹
7. All patients with LE artery disease should be treated with statins to improve walking distance (Class I—is recommended based upon evidence that treatment is beneficial or effective) as well as SET, even after revascularization.²⁹¹
8. In patients with symptomatic PAD, clopidogrel can be considered over aspirin therapy (Class IIb). Antiplatelet therapy is not recommended in asymptomatic PAD patients (Class III).²⁹¹
9. Patients with LE artery disease and concurrent atrial fibrillation should receive anticoagulation if the CHA₂DS₂-VASc score is >2 (Class I).²⁹¹
10. Patients with coronary artery disease or heart failure should be considered for LE PAD screening (Class IIb).²⁹¹

The following 2024 societal recommendations are taken directly from the ACC/AHA/Multisociety PAD Guideline for the treatment of lower extremity PAD²⁹²:

PAD continues to grow in global prevalence and consumes an increasing number of resources in the United States health care system. Overall rates of intervention for PAD have been rising steadily in recent years. Changing demographics, evolution of technologies, and an expanding database of outcome studies are primary forces influencing clinical decision-making in PAD. The management of PAD is multidisciplinary, involving primary care physicians and vascular specialists with varying expertise in diagnostic and treatment modalities. PAD represents a broad spectrum of disease from asymptomatic through severe limb ischemia. The SVS LE Practice Guidelines committee reviewed the evidence supporting clinical care in the treatment of asymptomatic PAD and IC. The committee made specific practice recommendations using the GRADE (Grades of Recommendation Assessment, Development and Evaluation) system. There are limited Level I data available for many of the critical questions in the field, demonstrating the urgent need for comparative effectiveness research in PAD. Emphasis is placed on risk factor modification, medical therapies, and broader use of exercise programs to improve cardiovascular health and functional performance. Screening for PAD appears of unproven benefit at present. Revascularization for IC is an appropriate therapy for selected patients with disabling symptoms, after careful risk-benefit analysis. Treatment should be individualized based on comorbid conditions, degree of functional impairment, and anatomic factors. Invasive treatments for IC should provide predictable functional improvements with reasonable durability. A minimum threshold of a >50% likelihood of sustained efficacy for at least 2 years is suggested as a benchmark. Anatomic patency (freedom from restenosis) is considered a prerequisite for sustained efficacy of revascularization in IC. Endovascular approaches are favored for most candidates with aortoiliac disease and for selected patients with femoropopliteal disease in whom anatomic durability is expected to meet this minimum threshold. Conversely, caution is warranted in the use of interventions for IC in anatomic settings where durability is limited (extensive calcification, small-caliber arteries, diffuse infrainguinal disease, poor runoff). Surgical bypass may be a preferred strategy in good-risk patients with these disease patterns or in those with prior endovascular failures. CFA disease should be treated surgically, and saphenous vein is the preferred conduit for infrainguinal bypass grafting. Patients who undergo invasive treatments for IC should be monitored regularly in a surveillance program to record subjective improvements, assess risk factors, optimize compliance with cardioprotective medications, and monitor hemodynamic and patency status.³⁰

PAD UE

Although symptoms due to PAD are more common in the LEs, UE exertional pain, pain at rest, and tissue loss may also manifest in the UEs due to atherosclerotic disease. Atherosclerosis is predominantly localized to the subclavian artery, but distal vessels can also be affected. While no specific societal guidelines exist, evidence-based studies as above suggest similar considerations should be made when treating PAD of the UE.

Diagnostic testing for suspected PAD requires a multifaceted approach that incorporates history and physical examination, ABI, and additional physiological testing, as well as noninvasive and potentially invasive (angiography) imaging. Understanding the indications for the use of these testing modalities can help to efficiently direct resources such as revascularization to patients who may be in urgent need of therapy. Further, and more commonly, understanding the indications for the use of these testing modalities can help to avoid unnecessary testing for patients for whom further delineation of arterial anatomy will not impact plans for therapy (e.g., for patients with asymptomatic PAD or chronic symptomatic PAD who are treated with medical therapy and structured exercise).¹¹¹

The decision to perform endovascular revascularization for PAD in the UEs and LEs should be based upon the underlying symptoms of the patient as well as the risk of potential limb loss and effects on the QOL. In the absence of ALI and for many patients who present with claudication, physiological studies and ABI with exercise should be the primary diagnostic measures employed. Conservative therapy and adjunctive therapy including the use of platelet inhibitors, exercise therapy medical management of preexisting comorbidities such as tobacco abuse, hypertension, diabetes, etc. and other noninvasive modalities should be considered prior to any surgical intervention. For patients with CLTI, early physiological studies including ABI and TBI for LEs should provide the indications for further vascular studies and the need for interventional vascular procedures if warranted by those preoperative imaging techniques. Endovascular intervention for PAD should follow the published guidelines recommended by the ACC/AHA (American College of Cardiology/American Heart Association), Vascular Society and Interventional radiologists. Peer-reviewed literature should support the exact modality of the endovascular procedure that is being performed by the qualified and appropriately trained physician.

The purpose of preoperative diagnostic imaging is to confirm the anatomic location for the site of PAD to be treated prior to undergoing the endovascular revascularization of the affected extremity(ies). Such modalities may include CTA, MRA, and color doppler sonography (CDS). Once the need for endovascular revascularization is established, the use of intraoperative imaging with digital subtraction angiography (DSA), IVUS or EVUS may be reasonable and necessary to improve the outcome. Despite remarkable advancements in endovascular devices and techniques, endovascular procedures still have a remarkable immediate failure rate (15%-20%), and the early failure rate remains high. The main reason for this can be attributed to the challenge of effectively crossing CTOs, arterial plaque composition and calcification, which plays a major role in the ability to intervene and in the success of the intervention. Invasive and noninvasive imaging methods which can accurately predict plaque characteristics have been shown to improve endovascular outcomes.²⁸⁷

The choice of site of service should be conducted in a location that can best meet the needs of the patient who typically has several comorbidities that place the patient at an increased risk for complications. Therefore, the site of service should be equipped with the necessary supporting personnel and safety equipment. Due to the requirements of the patient to have some degree of sedation or above, the site should be certified and/or state licensed so that quality of care issues can be addressed as well as outcomes monitoring and reporting. The site of service should have provisions in place for the immediate transfer to an acute care facility so equipped that in the event of an emergency, further LS procedures can be immediately initiated as well as other life-saving issues to be addressed for the safety of the patient.

Revascularization Lower Extremity PAD

Based upon an extensive review of the literature, endovascular revascularization of the LEs would not be considered reasonable and necessary for most patients with asymptomatic PAD. Some patients with asymptomatic PAD can progress to symptomatic disease during longitudinal follow-up, emphasizing the need for longitudinal care of these patients.²⁹³ However, no data suggests that invasive treatment while PAD is asymptomatic will alter its natural history. Data have shown that patients who have undergone a revascularization procedure are at increased risk of subsequent complications, particularly male sex, including the need for additional subsequent revascularization procedures. Consequently, the risk-benefit assessment of revascularization in a patient with asymptomatic PAD argues against revascularization in this setting. Therefore, no evidence supports a recommendation for early revascularization for asymptomatic individuals [Grade 3; harm (not recommended)].¹¹¹

For patients with claudication (chronic symptomatic PAD), endovascular revascularization for patients with functionally limiting claudication and inadequate response to GDMT (including structured exercise) is a reasonable treatment option to improve walking function and QOL [Grade 2a, moderate (reasonable)]. For those patients who have responded to GDMT including structured exercise, endovascular revascularization is not recommended.¹¹¹

Based upon the literature and society guidelines, patients with CLTI, endovascular revascularization or hybrid techniques are recommended, when feasible to minimize tissue loss, heal wounds, relieve pain and preserve a functional limb [Grade 1, strong (recommended)]. Additionally, an evaluation for revascularization should be discussed prior to recommendations for amputation [Grade 1]. The strategy for revascularization may include a conduit to bypass the popliteal or infrapopliteal arteries and should be constructed with autogenous vein, if available. Ultrasound mapping of the great saphenous vein is also recommended [Grade 1].¹¹¹

For patients with ALI and a salvageable limb, revascularization is indicated to prevent amputation [Grade 1]. For those patients with ALI and a nonsalvageable limb, endovascular revascularization should not be performed [Grade 3, harm (not recommended)].¹¹¹

Revascularization Upper Extremity PAD

For most asymptomatic patients, no specific intervention is generally necessary, other than cardiovascular risk reduction. However, intervention may be needed prior to CABG that will use an internal mammary (thoracic) artery graft or in selected hemodialysis patients to allow the creation or preservation of a UE hemodialysis access.

For symptomatic patients, in addition to cardiovascular risk reduction, vascular intervention is required for those with a threatened UE (e.g., acute limb ischemia, CLTI) to restore perfusion, alleviate symptoms, and heal any ulcers; significant cardiac symptoms related to coronary-subclavian steal syndrome; embolization (cerebral, peripheral) related to the lesion to prevent future ischemia; and end-stage kidney disease to allow the creation or preservation of UE hemodialysis access.

For patients with UE ischemia with indications for emergency revascularization, a bedside WBI should suffice to document the deficit prior to vascular intervention. Under elective circumstances, the relationship between symptoms and suspected arterial stenosis/occlusion can be confirmed with noninvasive UE physiological studies including a WBI. Arterial imaging should be performed prior to revascularization to confirm the location of the lesion. CTA or MRA is sufficient for imaging the proximal UE vasculature; however, digital subtraction arteriography is superior for imaging the distal UE vessels. Vascular imaging should also include the aortic arch branch vessels (i.e., supraaortic) and neck vessels.

Arterial disorders of the UE that require endovascular revascularization are much less common than those of the LE. The main indications for UE revascularization are ALI typically due to traumatic injury or cardiogenic emboli, and chronic extremity ischemic pain or tissue loss due to arterial stenosis, most commonly atherosclerotic disease but also from the late sequelae of traumatic injuries. Other less common etiologies include UE aneurysmal disease, arterial thoracic outlet syndrome, and the need for subclavian coverage to accommodate thoracic endovascular repair, among others.

Observational studies suggest that PTA and stenting is safe in patients with appropriate anatomy (short proximal stenosis or occlusion). The combined stroke and death rate related to percutaneous intervention to treat UE disease was 3.6% in one study.¹³² Complications include stent thrombosis, restenosis, and stent fracture.^132-134 Good outcomes have been reported using endovascular techniques in treatment of lesions of the aortic arch (i.e., supraaortic) vessels,^135-151 but there are very few reports on the effectiveness of angioplasty for the more distal UE arterial lesions.^152-154 Immediate technical success occurs in more than 93% of patients, with failures usually related to an inability to cross an occlusive lesion.^155,156 Five-year primary patency rates are approximately 85%.¹⁵⁶ Sustained resolution of ischemic symptoms is observed in most patients (>95%).^155-158 Therefore, the data is sufficient to treat UE PAD with endovascular techniques in symptomatic patients where conservative therapy has failed, and diagnostic imaging corroborates the site of anatomic obstruction or compromise.

Endovascular Revascularization Treatments

Selection of the most appropriate UE intervention (surgical, endovascular) is individualized based upon anatomic factors (e.g., lesion severity, location, calcification, proximity to the vertebral artery), the presence of concomitant ipsilateral carotid disease, and the patient's overall medical status. For proximal lesions (subclavian artery, innominate artery), extra-anatomic reconstruction is more durable compared with endovascular intervention. However, percutaneous angioplasty/stenting may be associated with less perioperative morbidity.

Endovascular intervention involves accessing typically the femoral artery with an arterial sheath and passing various wires or catheters to guide the placement of an expandable balloon and/or stent, a cutting device, or other devices at the presumed culprit lesion in the leg. Balloon angioplasty results in a "controlled" dissection of the arterial media, widening the lumen of the stenosed vessel. Atherectomy involves removal, morcellation, or evaporation of the plaque. Sculpting or cutting balloons allow for plaque modification to enhance balloon angioplasty and are often used as adjuncts to drug-eluting balloon angioplasty therapy. Adjunctive stenting might be needed if the vessel has a recalcitrant stenosis without appropriate luminal gain, develops elastic recoil or a flow-limiting dissection. It is common for several modalities to be combined to achieve a satisfactory result.

A hybrid approach (endovascular intervention combined with an open procedure) was initially described in patients undergoing bypass procedures (e.g., femoro-femoral, femoropopliteal) with endovascular intervention used to treat an inflow lesion (e.g., focal aorto-iliac artery lesion). Endovascular intervention of the inflow lesion can be done before the planned bypass or simultaneously with the bypass procedure. Hybrid procedures have evolved to include endovascular treatment of complex lesions (e.g., long occlusions) involving the inflow (iliac artery) and/or outflow (superficial femoral or deep femoral [profunda]) vessels, with femoral endarterectomy combined with a prosthetic patch being the most common open reconstruction.

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 CFA. Femoral endarterectomy should include a profundoplasty if significant disease is present at the profunda femoris orifice.

Endovascular interventions can be performed in any patient with aortoiliac occlusive disease, even those with more complex anatomy. However, juxta renal occlusions, hypoplastic aortic syndrome, or concomitant aortic aneurysmal dilation (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 for good-risk surgical patients.²⁹⁴

Lesions in the EIA 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 EIA occlusions, stent-grafting has better patency rates compared with bare stents.

Common iliac artery (CIA) lesions are typically treated with balloon-expandable stents or stent-grafts. Stenting would still be required for a focal lesion if there is flow limiting dissection or residual stenosis of >30%. If the lesions in the CIA 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 LEs.

For patients with aortoiliac occlusions and small iliac arteries, the CERAB technique can be used.²⁹⁵ In this technique, a large balloon-expandable stent-graft is placed in the aorta extending to above the bifurcation, and 2 covered stents are placed to both CIAs in a kissing fashion, recreating the flow divider. The presence of an aortic aneurysm with concomitant iliac occlusions was once considered a strong indication for open repair or endovascular revascularization using an aorto-iliac stent-graft with femoro-femoral bypass; however, bifurcated stent-grafts are increasingly used in these cases, decreasing overall morbidity.

For patients with 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 EIA occlusions and patent internal iliac arteries (IIAs), antegrade crossing from the contralateral femoral access preserves the IIA and is particularly safer in those who will need a femoral endarterectomy distal to the EIA occlusion.

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. IPD 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 2 or more runoff vessels.

Site of Service

Many states in the United States have guidelines for office-based surgery; some states such as New York, California, Florida and Massachusetts have more extensive requirements. Other states have limited or no specific guidelines. In addition, ASCs are licensed in most states and where no additional guidelines exist must follow CMS guidelines for payment and reimbursement if they participate in the Medicare Ambulatory Surgery Center conditions for coverage. There has been an increase in the number of procedures performed in an office-based surgery atmosphere and hence issues of quality and safety have arisen as a result of this risk in procedures performed at this site of service.²⁹⁶

The rise in office-based interventional vascular laboratories in recent years was prompted in part by expedient ambulatory patient experience and favorable outpatient procedural reimbursement. While studies have shown that clinical safety and treatment efficacy can be achieved in office-based vascular facilities, critics have raised various concerns due to inconsistent patient care standards and lack of organizational oversight to ensure optimal patient outcome. Available literature showed widely varied clinical outcomes which were partly attributable to nonuniform standards in reporting clinical efficacy and adverse events. Strategies to improve patient care delivery in OBLs include accreditations which serve as external validation of processes to ensure patient care and safety.

Most endovascular procedures require some level of anesthesia beyond local anesthesia and therefore patients undergoing sedation and above in the office surgery setting may be at increased risk when comorbidities and underlying disease status are not considered. Therefore, it is necessary to have patients assessed by qualified individuals prior to the induction of anesthesia. Consequently, standards of care have been established by various accrediting bodies for patients undergoing anesthesia in an office-based setting.

An office-based practice is distinct from other ambulatory practices and has unique considerations for an effective administrative structure to support its operations. National guidelines have been promulgated by various entities addressing both management and clinical care aspects of the practice. Specific regulations vary by practice location, and practitioners need to comply with the pertinent accreditation and licensing requirements. Anesthesiologists have been at the forefront of promoting the culture of safety in the office-based setting. Specific practice considerations include provider credentialing, maintenance of documentation, quality assessment, professional liability, facility safety, patient health information, billing, and finance. Office-based practice will continue to evolve with the national emphasis on patient safety, cost reduction, value-based care, and outcomes measurement and reporting. Each practice must comply with the state and national regulations that could limit the types of procedures being performed and who can administer sedation or anesthesia and require the facility to be accredited by a nationally recognized accrediting agency.²⁹⁷

Safe office-based anesthesia practices dictate proper patient and procedure selection, appropriate provider qualifications, adequately equipped facilities, and effective administrative infrastructure. Accreditation is an area that provides evaluation of office-based surgery centers to review quality of care, peer review and outcome reviews of patients treated at those centers.²⁹⁸ There are significant benefits to accreditation, in addition to fulfilling federal and individual state requirements.²⁹⁹

NCD 20.35: Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)

Research has shown SET to be an effective, minimally invasive method to alleviate the most common symptom associated with PAD – intermittent claudication (IC). SET has been shown to be significantly more effective than unsupervised exercise and could prevent the progression of PAD and lower the risk of cardiovascular events that are prevalent in these patients. SET has also been shown to perform at least as well as more invasive revascularization treatments that are covered by Medicare.

NCD 20.7: Percutaneous Transluminal Angioplasty (PTA)

This procedure involves inserting a balloon catheter into a narrow or occluded blood vessel to recanalize and dilate the vessel by inflating the balloon. The objective of PTA is to improve the blood flow through the diseased segment of a vessel so that vessel patency is increased, and embolization is decreased. With the development and use of balloon angioplasty for treatment of atherosclerotic and other vascular stenoses, PTA (with and without the placement of a stent) is a widely used technique for dilating lesions of peripheral, renal, and coronary arteries.

U.S. Food and Drug Administration. 510(k) Summary: K151313. Published 9/21/15. Accessed 2/2/26.

U.S. Food and Drug Administration. 510(k) Summary: P130005c. Published 2013. Accessed 2/2/26.

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• Peripheral Arterial Disease
• PAD
• Upper Extremity
• Lower Extremity
• Endovascular