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

Jurisdiction: JJ Part B. States: Alabama, Georgia, Tennessee. Type: Active LCD

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 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. 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. 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 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 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 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: 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. CLTI patients: duplex ultrasound, CTA, MRA, catheter angiography should be utilized to determine revascularization strategy. Suspect PAD with inconclusive ABI: duplex ultrasound, CTA, MRA, non-invasive testing should be utilized to establish the diagnosis of PAD. If confirmed PAD without a plan for revascularization, duplex ultrasound, CTA, MRA or catheter angiography would not be reasonable and necessary. 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: Ambulatory surgical center (ASC) Hospital outpatient department 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: Evidence of postgraduate training in endovascular techniques during residency or fellowship. Must be a Medical Doctor or Doctor of Osteopathy licensed in the state to perform those services. Residency and/or fellowship training in interventional radiology, general surgery, vascular surgery, cardiology, or cardiothoracic surgery.