| Coverage Policy Manual | |
| Policy #: | 1999022 |
| Category: | Surgery |
| Initiated: | November 1999 |
| Last Review: | November 2024 |
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| Percutaneous Revascularization Procedures for Lower Extremity, Abdominal Aortic & Visceral Arteries | |
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| Description: |
Revascularization (either surgical or percutaneous) is a treatment option for certain individuals with lower extremity peripheral arterial disease. Percutaneous revascularization procedures include balloon angioplasty, stent procedures, and atherectomy. Lithotripsy is proposed as a vessel preparation option to facilitate definitive endovascular treatment in heavily calcified lesions.
Guidelines recognize 4 clinical subsets of peripheral arterial disease (PAD) (Gornik, 2024).
Patients at risk for PAD are identified based on demographic features, cardiovascular risk factors, or the presence of atherosclerotic vascular disease in other vascular beds. Black race is associated with increased risk for PAD, even after adjustment for conventional risk factors, and is also associated with major adverse cardiovascular events (MACE) and major adverse limb events.
Clinical assessment, including risk factor assessment, history, physical examination, and consideration of differential diagnoses, is performed before diagnostic testing (Conte, 2015; Criqui, 2021).
For individuals at increased risk of PAD, vascular examination with a focus on the lower extremities is recommended. After the history and physical examination identify patients at risk for PAD and with history of physical examination symptoms or signs of PAD, diagnostic testing to establish the diagnosis of PAD is performed. Diagnostic testing for suspected PAD incorporates history and physical examination, ankle-brachial index (ABI), and additional physiological testing, as well as noninvasive and potentially invasive (angiography) imaging.
Measurement of the ankle-brachial index (ABI) is the primary method for establishing the diagnosis of PAD. In patients with history or physical examination findings suggestive of PAD, the resting ABI, with or without ankle pulse volume recordings (PVR) and/or Doppler waveforms, is recommended to establish the diagnosis.
The resting ABI is reported as abnormal (0.90 or less), borderline (0.91 to 0.99), normal (1.00 to 1.40), or noncompressible (more than 1.40). In individuals with suspected chronic symptomatic PAD and normal or borderline resting ABI, exercise ABI can be performed.
Standard treatment for claudication includes medical therapy, foot care, and structured exercise therapy.
Percutaneous revascularization includes catheter-based revascularization procedures using modalities such as percutaneous transluminal (balloon) angioplasty, drug-coated balloon angioplasty, stenting (bare-metal, drug-coated, or covered), and atherectomy.
Revascularization, either percutaneous or surgical, is the standard treatment for CLTI.
Stenosis of the infrarenal aorta occurs predominantly in women who are heavy smokers. Open surgical repair with either endarterectomy or bypass graft placement has been the conventional approach to treatment.
Percutaneous angioplasty of the abdominal aorta for chronic occlusive disease has been reported since the 1980's in several case report series. The advent of endovascular stents has increased the use of percutaneous treatment for the problem.
No stent is FDA approved for treatment of atherosclerotic stenosis of the abdominal aorta. Both the Wallstent and Palmaz stents for iliac artery stenosis have been used off-label for the aorta.
No randomized trials comparing percutaneous angioplasty with or without stenting to open repair have been reported. All comparisons to open repair are to historical controls. No randomized trials comparing percutaneous angioplasty to stenting of abdominal stenosis have been reported. Some studies reported only results of stenting, and others reported PTA vs. stenting, but the decision to place a stent rather than do PTA alone was at the discretion of the operator.
Despite the lack of controlled studies, percutaneous transluminal angioplasty with adjunctive or primary stenting, has been recommended as the treatment of choice for short abdominal aortic stenosis with little or no iliac involvement. The American Heart Association has a position paper recommending percutaneous transluminal angioplasty to short segment stenosis of the infra renal aorta.
Regulatory Status
In 2016, the Shockwave Medical Peripheral Lithotripsy (IVL) System received 510(k) clearance (K161384; FDA Product Code: PPN) for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, intrapopliteal, and renal arteries and is not for use in the coronary or cerebral vasculature. Initial clearance was based on a determination that the device was substantially equivalent to legally marketed predicate devices. The primary predicate for the Shockwave Medical Lithoplasty System is the Spectranetics, Inc. AngioSculpt PTA Scoring Balloon Catheter (K142983). Additional predicates were the Bard Peripheral Vascular VascuTrak PTA Dilatation Catheter (K103459) and the EKOS Corporation EKOS Lysus Micro-Infusion System (K060422).
Coding
There is no specific code for stent placement in the aorta or other vessels of the lower extremities. CPT 37205 (Transcatheter placement of an intravascular stent(s), [non-coronary vessel], percutaneous; initial vessel) is the appropriate code for the stent placement. If more than one stent is placed in the same vessel, no additional allowance will be made.
For coverage of renal artery percutaneous interventions see policy 2000015.
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Policy/ Coverage: |
Effective March 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy in individuals with chronic symptomatic lower extremity peripheral arterial disease meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when the following criteria are met:
Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for treatment of chronic limb-threatening ischemia (Rutherford classification 4-6) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for treatment of acute limb ischemia meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy in individuals with asymptomatic lower extremity peripheral arterial disease if needed for the safety, feasibility, or effectiveness of other invasive, clinically necessary, life-saving procedures (e.g., transfemoral aortic valve replacement, mechanical circulatory support, endovascular aortic aneurysm repair) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy to treat acute intestinal ischemia due to mesenteric artery occlusion meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for patients who are not surgical candidates due to severe co-morbidities.
Definition
Structured Exercise Programs for Peripheral Arterial Disease
A structured exercise program is an exercise program planned by a qualified health care professional that provides recommendations for exercise training with a goal of improving functional status over time. The program provides individualized recommendations for frequency, intensity, time, and type of exercise. Structured exercise programs are classified as supervised exercise therapy or structured community-based exercise programs. In supervised exercise therapy, training is performed for a minimum of 30 to 45 minutes per 60-minutes session. Supervised sessions are performed at least 3 times per week for a minimum of 12 weeks.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for the treatment of asymptomatic or chronic symptomatic lower extremity peripheral arterial disease does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in all other situations.
For members with contracts without primary coverage criteria, percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for the treatment of asymptomatic or chronic symptomatic lower extremity peripheral arterial disease is considered investigational and is not covered in all other situations. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for the treatment of chronic or acute limb-threatening ischemia does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in all other situations.
For members with contracts without primary coverage criteria, percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for the treatment of chronic or acute limb-threatening ischemia is considered investigational and is not covered in all other situations. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Percutaneous revascularization using lithotripsy in individuals with lower extremity peripheral arterial disease does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in all situations.
For members with contracts without primary coverage criteria, percutaneous revascularization using lithotripsy in individuals with lower extremity peripheral arterial disease is considered investigational in all situations. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Percutaneous transluminal atherectomy of the abdominal aorta does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, percutaneous transluminal atherectomy of the abdominal aorta is considered investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective May 15, 2022 – February 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Angioplasty, Stenting, or Atherectomy of the Lower Extremity Arteries meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of the following conditions and using the methodologies as noted.
Angioplasty, stenting or atherectomy of the mesenteric artery to treat acute intestinal ischemia due to mesenteric artery occlusion meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for patients who are not surgical candidates due to severe co-morbidities.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous transluminal peripheral angioplasty, stenting or atherectomy, by any method, for the treatment of native vessel or in-stent stenosis in peripheral arteries in any other circumstance than those listed above as covered does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, percutaneous transluminal peripheral angioplasty, stenting or atherectomy, for any indication other than those listed above as covered, is considered not medically necessary and is not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Percutaneous transluminal atherectomy in the abdominal aorta does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, percutaneous transluminal atherectomy of the abdominal aorta is considered investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Percutaneous transluminal atherectomy of the iliac arteries does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, percutaneous transluminal atherectomy of the iliac arteries is considered investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective July 2015 through May 14, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Angioplasty, Stenting, or Atherectomy of the Lower Extremity Arteries meets primary coverage criteria for effectiveness for the treatment of the following conditions and using the methodologies as noted.
Angioplasty, stenting or atherectomy of the mesenteric artery to treat acute intestinal ischemia due to mesenteric artery occlusion meets member benefit certificate primary coverage criteria and is covered for patients who are not surgical candidates due to severe co-morbidities.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous transluminal peripheral angioplasty, stenting or atherectomy, by any method, for the treatment of native vessel or in-stent stenosis in peripheral arteries in any other circumstance than those listed above as covered does not meet member benefit certificate primary coverage criteria. For contracts without primary coverage criteria, percutaneous transluminal peripheral angioplasty, stenting or atherectomy, for any indication other than those listed above as covered, is considered not medically necessary and is not covered. Services that are considered not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
Percutaneous transluminal atherectomy in the abdominal aorta does not meet primary coverage criteria for effectiveness. No FDA approval for a device to use in the abdominal aorta was identified. No medical literature reporting on the safety and efficacy of this procedure, or long term outcomes, was identified. For contracts without primary coverage criteria, percutaneous transluminal atherectomy of the abdominal aorta is considered investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective April 2010 - June 2015
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Angioplasty meets primary coverage criteria for effectiveness for those individuals with a vocational or lifestyle-limiting disability due to intermittent claudication when clinical features suggest a reasonable likelihood of symptomatic improvement with angioplasty and
Primary stenting meets primary coverage criteria for effectiveness and is covered for common iliac artery stenosis and occlusions and in external iliac artery stenoses and occlusions.
Stenting for below-the-knee peripheral arterial stenosis (i.e., popliteal or tibial ) meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in patients that cannot tolerate open surgical repair.
Percutaneous angioplasty of the mesenteric artery meets member benefit certificate primary coverage criteria for the treatment of patients with chronic intestinal ischemia due to stenosis, not total occlusion, of the mesenteric artery. (Note: Stenting would only be allowed to salvage a suboptimal result from angioplasty)
Angioplasty/stenting of the mesenteric artery to treat acute intestinal ischemia due to mesenteric artery occlusion meets member benefit certificate primary coverage criteria and is covered for patients who are not surgical candidates due to severe co-morbidities.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The effectiveness of stents, atherectomy, cutting balloons, thermal devices and lasers in the treatment of femoral, popliteal, tibial, femoral-popliteal, and infrapopliteal arterial lesions is not known. Stents for these lesions, except to salvage a suboptimal result (persistent translesional gradient, residual diameter stenosis > 50% or flow-limiting dissection) or failed result from balloon dilatation, are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, this use would be considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Endovascular interventions do not meet primary coverage criteria that there be scientific evidence of effectiveness:
For members with contracts without primary coverage criteria, endovascular interventions are considered investigational for the indications below. Investigational services are specific contract exclusions in the member benefit certificate of coverage:
The use of stents for the treatment of aortic or lower extremity artery stenosis for any indication not listed as covered above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For contracts without primary coverage criteria, the use of stents for the treatment of aortic or lower extremity artery stenosis for any indication not listed as covered above would be considered investigational and not covered. Investigational services are exclusions in the member benefit contract.
Effective, January 2007 through March 2010
Angioplasty meets primary coverage criteria for effectiveness and is covered for those individuals with a vocational or lifestyle-limiting disability due to intermittent claudication when clinical features suggest a reasonable likelihood of symptomatic improvement with angioplasty and
Primary stenting meets primary coverage criteria for effectiveness and is covered for common iliac artery stenosis and occlusions and in external iliac artery stenoses and occlusions.
The effectiveness of stents, atherectomy, cutting balloons, thermal devices and lasers in the treatment of femoral, popliteal, tibial, femoral-popliteal, and infrapopliteal arterial lesions is not known. Stents for these lesions, except to salvage a suboptimal result (persistent translesional gradient, residual diameter stenosis > 50% or flow-limiting dissection) or failed result from balloon dilatation, are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
Percutaneous angioplasty is covered for the treatment of patients with chronic intestinal ischemia due to stenosis, not total occlusion, of the mesenteric artery. Stenting would not be covered except to salvage a suboptimal result from angioplasty. Angioplasty/stenting of the mesenteric artery to treat acute intestinal ischemia due to mesenteric artery occlusion is covered for patients who are not surgical candidates due to severe co-morbidities.
Endovascular interventions are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
There is no specific code for stent placement in the aorta or other vessels of the lower extremities. CPT 37205 (Transcatheter placement of an intravascular stent(s), [non-coronary vessel], percutaneous; initial vessel) is the appropriate code for the stent placement. If more than one stent is placed in the same vessel, no additional allowance will be made.
For contracts without primary coverage criteria, the use of stents for the treatment of aortic or lower extremity artery stenosis for any indication not listed above would be considered investigational and not covered. Investigational services are exclusions in the member benefit contract.
Effective, November 1999 through December 2006
Percutaneous Transluminal Angioplasty (PTA) is covered for patients with symptomatic (intermittent claudication) stenosis or chronic occlusion of the lower extremities. Primary stenting is covered following angioplasties in which the results are considered to be suboptimal or for dissection. Stenting is covered for repeat stenosis following earlier PTA.
CPT 35472 (Transluminal balloon angioplasty, percutaneous; aortic) is the correct code for the angioplasty. There is no specific code for stent placement in the aorta. CPT 37205 (Transcatheter placement of an intravascular stent(s), [non-coronary vessel], percutaneous; initial vessel) is the appropriate code for the stent placement. The description of CPT 37205 is for stent or stents. If more than one stent is placed in the same vessel, no additional allowance will be made.
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| Rationale: |
FDA Regulation
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). This type of approval does not require results of clinical trials proving effectiveness of the specific device before marketing approval is given.
There are multiple FDA 510(k) approvals for devices used to perform peripheral atherectomies using different methods to achieve the desired outcome, at least 91 approvals since 1990. Initial devices were approved only for coronary arteries. Currently there are approved devices to perform atherectomy of infrainguinal stenoses and occlusions. There is some medical literature reporting the use of laser as treatment of in-stent stenosis though there is no FDA approval for that indication.
Several single arm studies reporting short and mid-term follow-up of atherectomy of atherosclerotic lesions of vessels of the lower extremity have shown promising results; however, other studies have shown conflicting results, and studies with longer follow-up have demonstrated failure of the procedure. In addition, no randomized controlled trial (RCT) has shown benefit compared to the control group.
A RCT comparing balloon angioplasty to atherectomy of femoral-popliteal lesions found clinical success after 2 years (success based on criteria of the Society for Vascular Surgery/International Society for Cardiovascular Surgery) was 79% for patients with balloon angioplasty and 56% for direct atherectomy (1996). The Collaborative Rotablator Atherectomy Group reported a 3 year study of 79 patients and concluded, “Peripheral atherectomy with the Auth Rotablator currently has limited application because of frequent early thromboembolic complications and poor late patency rates. Atherectomy is not generally recommended for treating peripheral arterial occlusive lesions until these problems with early thromboemboli, occlusions, and late restenoses are solved” (1994). A more recent single arm study, using a different atherectomy device, concluded, “Although high speed rotational atherectomy (HSRA) for the treatment of infrapopliteal occlusive disease yields a very high initial technical success rate, mid-term results are extremely poor. Therefore, HSRA cannot be recommended for primary treatment of this type of lesion” (2001). Another single arm study of 10 patients concluded, “These initial results demonstrate that the Xtrak device can safely debulk long segments of diffusely diseased arteries in a single pass while simultaneously retrieving the occluding material. Supplementary angioplasty may be required in the majority of cases. Larger studies are required to determine whether debulking followed by balloon dilation improves the long-term prognosis in patients with chronic lower limb occlusions” (2002). A 2003 report describes a 6-month outcome following atherectomy with a new directional atherectomy catheter. Target vessel failure was noted in 23% of patients. The authors concluded, “Plaque debulking with the Fox Hollow atherectomy device can be performed safely and effectively in relatively small vessels and complex lesions located in mid-distal artery segments with 6-month clinical outcome similar to prior atherectomy devices.” Another new device (Rotarex) was studied and reported by the same authors in two different articles in 2003 described good short-term outcomes, but neither study compared results to open surgical intervention or to balloon angioplasty.
Steinkamp et al compared PTA with PTLA in 215 patients. "Although initial recanalization may be better with PTLA, it does not appear to add any long-term benefit over balloon dilation alone." Ruef et al cited the Peripheral Excimer Laser Angioplasty (PELA) which showed no difference in patients with total occlusions of the superficial femoral artery who were treated with angioplasty alone compared to those treated with laser angioplasty. In the laser-assisted angioplasty for chronic limb ischemia the laser-assisted angioplasty was successful but the data did not indicate a significant long-term benefit compared to conventional angioplasty.
Kandzari et al, in a recent publication in J of Endovasc Therapy (2006), reported that peripheral percutaneous atherectomy had a high rate of procedural success and favorable early safety and intermediate term clinical outcomes in patients with critical limb ischemia who were not considered candidates for surgical revascularization, and who were selected for limb amputation. Further study of this modality for limb salvage in critical limb ischemia patients is warranted.
Silver Hawk plaque excision atherectomy catheter has been the subject of numerous recent case studies, but the studies have not included direct systematic comparison of atherectomy with angioplasty and or stent placement. The studies have not been standardized randomized controlled studies, and patient selection has been on the basis of clinical assessment and not protocol specific criteria. The TALON registry of Silver Hawk data defines clinical patency rate as freedom from TLR (target lesions revascularization), and this may not be an effective measure of clinical patency in patients with peripheral vascular disease.
2007 Update
Mureebe and McKinsey reported TALON registry information but concluded that questions of long-term durability and superiority or infereriority to other technologies have yet to be determined.
No reports of randomized controlled trials were found. There has been no change in American College of Cardiology guidelines for the treatment of peripheral arterial disease since the 2006 publication of the 2005 guidelines.
2010 Update
A literature search was completed for the dates of January 2007 through May 2010. The coverage section was changed based on the results of the PaRADISE trial.
The PaRADISE Trial investigated the safety and efficacy of using drug-eluting stents (DES) for the treatment of patients with below-the-knee, critical limb ischemia (CLI) (Feiring, 2010). The study was a single center, single operator study with no control. Sequential patients with CLI were treated with various FDA approved coronary stents. 106 patients (108 limbs) received one or more DES. Patients were followed for 3 years. Primary endpoints were major amputation and all cause mortality. In the first year there were only 6 major amputations and none thereafter. Rest pain was relieved in 93% of patients. At three years, among those living (25 pts died during f/u) 96% were without a major amputation. Among those that died, 88% did not have a major amputation. The results were compared to historic data from the BASIL Trial and TASCII.
Prior to the procedure, PaRADISE study patients were started on a regimen of ASA 81mg, clopidogrel 75 mg or ticlopidine 250 bid. Unfractionated heparin 40-50U/kg was also given. Patients were encouraged to continue, indefinitely a regimen of ASA, thienopyridine and lipid therapy.
Although, a randomized DES versus PTA trial is needed to further support the findings of this study, drug-eluting stents may offer an alternative for the treatment of patients with CLI that cannot tolerate surgical bypass.
2012 Update
A literature search was conducted through September 2012. There was no new information identified that would prompt a change in the coverage statement. The American College of Cardiology Foundation and the American Heart Association (ACCF/AHA) published an update to their guideline for the management of patients with peripheral artery disease. The guideline offered the following updated recommendation for the endovascular treatment of critical limb ischemia: “For patients with limb-threatening lower extremity ischemia and an estimated life expectancy of less than 2 years or in patients whom an autogenous vein conduit is not available, balloon angioplasty is reasonable to perform when possible as the initial procedure to improve distal blood flow” (Class IIa; LOE: B) (Rooke, 2011). This updated recommendation does not warrant a change in the coverage statement.
2013 Update
A PubMed literature search through May 2013 was performed as well a search for specialty society practice guidelines and technology assessments. There is no body of evidence to support the treatment of in-stent restenosis in femoropopliteal arteries with atherectomy.
Shammas et al., 2012, reported a retrospective analysis of 40 consecutive patients, from a single center, who underwent excimer laser therapy for treatment of an in-stent restenosis of the FP arteries. Adjunctive balloon angioplasty was also done on all patients. Embolic filter protection (EFP) was used in 23 patients and one patient who did not have EFP and developed distal embolization. 50% required bailout stenting. Acute procedural success, defined as less than 30% angiographic residual narrowing, occurred in 92.5% of patients. At one year the target lesion revascularization rate was 48.7% and the target vessel revascularization rate was 48.7%.
Sixt, et al., 2013, reported a retrospective analysis of consecutive patients with in-stent stenosis or native restenotic vessels, treated with Silverhawk directional angioplasty DA); N=60 also had PTA (Jun-Dec 2009) and N-29 also had drug-coated balloon angioplasty (DBA) Apr-Dec 2009. Procedural success 100% in both groups. At discharge ABI improved in both groups with no difference in groups. The 1-year Kaplan-Meier estimates of freedom from restenosis (95%CI) in the DCB and PTA groups was 84.7% and 43.8% respectively. At 1 year was no difference between the groups from baseline-adjusted ABI values or regarding improvement in clinical status.
Tibial lesions
Todd et al., 2013, reported a retrospective analysis of 480 tibial interventions in 421 patient from 2008-2010. Procedures were performed for critical limb ischemia (CLI)(418) and 62 for claudication. Only the CLI group was analyzed.
CLI: PTA-333; PTA+stent-6; atherectomy-79: 33 laser, 13 directional, 33 orbital alone or with PTA 11-atherectomy only, 68 atherectomy+PTA). No significant differences existed with respect to early outcomes of loss of patency, complications or major amputation in the PTA-only group vs the atherectomy-assisted group. Kaplan-Meier analysis revealed no difference for all primary outcomes of PTA-only vs the atherectomy assisted group at 12 & 36 months: primary patency, primary assisted patency, secondary patency, limb salvage or survival.
Shammas et al., 2012 (2), reported analysis of a randomized multicenter study of 50 patients with severe peripheral artery disease (>/= 50% stenosis)(Rutherford classification 4-6) in the popliteal, tibial and/or peroneal arteries. Using 1:1 randomization patients had treatment with the Diamondback Orbital Atherectomy System follow by balloon angioplasty (BA) vs BA alone. Procedural success was 93.1% for atherectomy + BA (bailout stenting x 2) vs 82.4% for BA alone (bailout stenting x 5). The authors concluded: Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with le acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.
Cioppa et al., 2012, reported a 30 patient cohort with life limiting claudication (N=18) and critical limb ischemia (N=12) with heavily calcified lesions who received intravascular ultrasound guided DA (directional atherectomy) and DCB (drug coated balloon) using a distal protection device. Bailout stenting was allowed in case of flow limiting dissections or suboptimal result (residual stenosis greater than 50%) and was necessary in 2 cases. At 12 month follow-up Rutherford class was 2.2 +/- 1.2 (baseline 4.2 +/- 1.2) and ABI 0.8 +/- 0.1 (baseline not given). Duplex scan showed significant target restenosis requiring re-intervention in three. The authors concluded combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomized trial.
Gallagher et al., 2011, reported a retrospective, single center. Analysis of 481 patients, with claudication (N=177) or chronic limb ischemia (CLI)(N=304), with 688 CTOs (chronic total occlusion), with lesions in in SFA (193), popliteal (67), tibial (217) and multilevel (211) who were treated with angioplasty (PTA), angioplasty + stent, or atherectomy. At 2 years there were no significant differences among the treatments for the patients with claudication. CLI patients with SFA CTOs had better outcomes at 2 years with atherectomy vs angioplasty alone. Diabetics with CTOs had improved secondary patency rates with angioplasty + stent over PTA alone.
Franzone et al., 2012, reported on the role of atherectomy in general in the treatment of lower extremity peripheral artery disease. The authors concluded recent technological advances have made it possible to increase the spectrum of treatable PAD lesions with high acute procedure success rates. The choice of the best endovascular strategy remains challenging because of the specific features of the vascular bed and the diffuse nature of the atherosclerotic process. Durability and long-term patency continue to be major challenges. Despite significant advances and new devices, the principal failure continues to be recurrent stenosis. Long-term outcomes need to be addressed by large, randomized trials. The Agency for Healthcare Research and Quality, in a Comparative Effectiveness Review dated May 2013, of Treatment Strategies for Patients with Peripheral Artery Disease stated: available evidence for CLI revascularization is significantly limited with regard to applicability to current practice.
NICE Interventional Procedure Guidance, 433, Nov 2012, stated current evidence is adequate to support the use of percutaneous laser atherectomy as an adjunct to balloon angioplasty (with or without stenting) for peripheral arterial disease while commenting the Committee is uncertain about whether its use confers any advantages over balloon angioplasty alone and, if so, in which patients are likely to benefit. Patient information at www.vascularweb.org (Society for Vascular Surgery), dated Jan 2010, mentions angioplasty and stenting, not atherectomy.
2015 Update
The policy was reviewed with a literature review through June 2015. Extensive revisions were made to the coverage statement based on the review of the literature. The following is a summary of the key identified studies.
The DEFINITIVE LE trial (McKensey, 2014) reported the multi-center experience on 800 subjects treated with the SilverHawk device. The investigators concluded that at 12 months the primary patency was 78% in claudicants, with a 77% patency rate in the diabetic subgroup and a 78% patency rate in the non-diabetic subgroup. In patients with critical limb ischemia, freedom from major unplanned amputation of the target limb at 12 months was 95%. There was a 3.2% bail-out stent rate. The inclusion criteria allowed patients with Rutherford classification 1-6, with >=50% stenosis or occlusion. Lesions of up to 20 cm in length were predominantly SFA, with some popliteal and infrapopliteal lesions. Adjunctive therapy was performed in 35%, with stenting in 3.2%. The investigators concluded that while direct comparisons with other technology cannot be made the DEFINITIVE LE study demonstrated that directional atherectomy has results comparable to those of other contemporary technologies treating infrainguinal PAD but with the advantage of rarely leaving a stent in place. Limitations include lack of randomization and follow-up beyond 12 months. "Studies with randomization of all FDA-approved treatment modalities such as the recent National Institutes of Health-funded BEST (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial will be required to further clarify the role for each of the treatment modalities."
The EXCITE ISR trial (Dippel, 2014) was a multicenter, prospective, randomized comparison of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) vs PTA alone for patients who had a femoropopliteal bare metal stent in-stent restenosis). The study enrolled Rutherford class 1-4 patients. The study was stopped at 250 patients because of demonstration of efficacy. The ELA+PTA patients demonstrated a 93% vs 82% success rate with fewer procedural complications. The 6-month freedom from target lesion revascularization was 73% vs 52%, and the 30-day major adverse event rates were 6% vs 20% (all statistically significant).
The Compliance 360 trial (Dattilo, 2014) compared orbital atherectomy (OA) to balloon angioplasty (BA) for calcified femoropopliteal disease in 50 patients. 65 lesions were randomized to OA plus BA vs BA alone and then followed for 12 months. The primary endpoint was freedom from target lesion revascularization (TLR) or restenosis (judged by duplex ultrasound at 6 months). The incidence of stent placement was higher in the BA group compared with the OA + BA group. Freedom from TLR was 77% in the OA group vs 11% in the BA group at 6 months (counting adjunctive stenting as TLR). At 12 months, the rate of freedom from TLR was 81% in the OA+BA group vs 78% in the BA group. It was concluded that BA and OA+BA produced similar results, but with fewer stents in the OA group.
In 2013 investigators from the Division of Vascular Surgery at Eastern Virginia Medical School (Todd, 2013) reported on 480 tibial interventions, 87% being for critical limb ischemia (CLI). Of the 418 interventions for CLI 339 underwent percutaneous transluminal angioplasty (PTA): 333 PTA alone, six PTA + stent. The remaining 79 interventions received atherectomy: 33 laser, 13 directional, and 33 orbital either alone or in conjunction with PTA. The groups did not differ significantly in terms of demographics, risk factors, or technical success. The atherectomy group had more TASC B lesions and the PTA-alone group had more TASC D lesions (25% vs 13%; P = .004). TASC A and C lesions did not differ significantly between the groups. No significant differences existed with respect to the early (30-day) outcomes of loss of patency, complications, or major amputation. Kaplan-Meier analysis revealed no difference for all primary outcomes of PTA alone vs the atherectomy-assisted group at 12 and 36 months. The authors concluded that adjunctive atherectomy offered no improvement in primary outcomes over PTA alone in either early or late outcomes of CLI patients undergoing endovascular tibial interventions.
Quevedo et al (Quevedo, 2014) from Tulane University reported a literature review of peripheral atherectomy. Only two randomized studies were found, most of the data coming from single-arm studies and registries. The group concluded that despite successful procedural outcomes reported in clinical registries, the available data do not support the use of atherectomy alone in PAD, and they opined that larger randomized controlled studies are warranted.
2017 Update
A literature search conducted through June 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
A literature search was conducted through June 2018. There was no new information identified that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through June 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.
Additional 2024 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Percutaneous Revascularization for Chronic Symptomatic Lower Extremity Peripheral Artery Disease Using Balloon Angioplasty, Stent Procedures, or Atherectomy
Wardle et al conducted a systematic review and meta-analysis of studies investigating atherectomy in individuals with symptomatic PAD (Wardle, 2020). The review included 7 studies (N=527; number of treated lesions=581), comparing atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. The evidence from this review was of very low certainty due to high risk of bias, imprecision, and inconsistency. The key findings indicated no clear difference between atherectomy and BA in primary patency rates at six months (RR: 1.06; 95% CI: 0.94 to 1.20; 3 studies, N=186) or at 12 months (RR: 1.20; 95% CI: 0.78 to 1.84; 2 studies, N=149), mortality rates (RR: 0.50; 95% CI: 0.10 to 2.66; 3 studies, N=210), initial technical failure rates (RR: 0.48; 95% CI: 0.22 to 1.08; 6 studies; number of treated vessels=425), and target vessel revascularization (TVR) rates at six months (RR: 0.51; 95% CI: 0.06 to 4.42; 2 studies, number of treated vessels=136) or at 12 months (RR: 0.59; 95% CI: 0.25 to 1.42; 3 studies, number of treated vessels=176). Complication rates (RR: 0.69; 95% CI: 0.28 to 1.68; 6 studies; N=387) and embolization events (RR: 2.51; 95% CI: 0.64 to 9.80; 6 studies; N=387) also showed no clear difference between atherectomy and BA. However, atherectomy may be less likely to cause dissection (RR: 0.28; 95% CI: 0.14 to 0.54; 4 studies; N=290) and may be associated with a reduction in bailout stenting (RR: 0.26; 95% CI: 0.09 to 0.74; 4 studies, number of treated vessels=315). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. Subgroup analysis comparing plain balloons/stents and drug-eluting balloons/stents did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, reporting one death (RR: 0.38; 95% CI: 0.04 to 3.23; N=155) and three complication events (RR: 7.04; 95% CI: 0.80 to 62.23; N=155), both with very low-certainty evidence. There was no clear difference in cardiovascular events (RR: 0.38; 95% CI: 0.04 to 3.23; N=155) and no initial technical failure events. TVR rates at 6 and 24 months showed little difference between treatment arms (RR: 2.27; 95% CI: 0.95 to 5.46; N=155, and RR: 2.05; 95% CI 0.96 to 4.37; N=155, respectively). The authors concluded that the evidence is very uncertain about the effect of atherectomy on patency, mortality, and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. Larger studies powered to detect clinically meaningful, patient-centered outcomes are required.
Gornik et al conducted a systematic review to support clinical practice guidelines for the management of lower extremity PAD (Gornik, 2024). Given the benefits of the less invasive measures of guideline-directed management and therapy and structured exercise, revascularization is a second-tier treatment for most patients with claudication.
The reviewers concluded that revascularization (open and endovascular) has shown effectiveness in mitigation of pain with walking and improving walking distance as well as QOL although tradeoffs in durability need to be considered. The reviewers noted that most studies of revascularization for individuals with chronic symptomatic PAD enrolled participants with claudication. They noted that the potential effects of revascularization on individuals with chronic symptomatic PAD with leg symptoms other than claudication is an area in need of further study.
Guidelines recommend selection of procedures based on lesion characteristics (e.g., anatomic location, lesion length, degree of calcification), operator experience, and the range of available technologies. Evaluation of the comparative effectiveness of different endovascular procedures was beyond the scope of this review.
Percutaneous Revascularization Procedures for Chronic Limb Threatening Ischemia Using Balloon Angioplasty, Stent Procedures, or Atherectomy
Abouzid et al conducted a systematic review and meta-analysis comparing endovascular therapy and surgical revascularization for CLTI (Abouzid, 2024). The analysis included 16 studies (N=47,609). The results showed that surgery is associated with a lower risk of major adverse limb events (MALE) (odds ratio (OR): 1.13; 95% CI: 1.01 to 1.28, P:.04), while endovascular therapy is linked to lower rates of major adverse cardiovascular events (MACE) (OR: 0.62; 95% CI: 0.51 to 0.76; P less than .00001), bleeding, wound complications, readmission, unplanned reoperation, acute renal failure, and shorter hospital stays. There was no significant difference in 30-day mortality between the two groups (OR: 0.94; 95% CI: 0.79 to 1.12; P=.52). The authors conclude the results suggest that the choice between endovascular therapy and surgery should be based on a multidisciplinary team approach, considering patient characteristics and anatomy.
In 2024 the American College of Cardiology/American Heart Association Joint Committee conducted a systematic review to inform clinical practice guidelines, citing the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLI) and BASIL-2 (Bypass versus Angioplasty for Severe Ischaemia of the Leg) trials as further informing revascularization strategy in patients with CLTI (Gornik, 2024; Farber, 2022; Bradbury, 2023). The contrasting findings of the BEST-CLI and BASIL-2 trials highlight the need to consider patient clinical and anatomic characteristics when selecting the initial revascularization strategy for patients with CLTI, including consideration of patient risk estimation, staging of the limb for severity and anatomic pattern of disease, previous vascular interventions, and availability of conduit.
The guidelines additionally cite a systematic review of 13 studies looking at the natural history of patients with CLTI enrolled in medical and angiogenic therapy trials who did not receive revascularization in which a 22% all-cause mortality rate and a 22% rate of major amputation at a median follow-up of 12 months were observed (Abu Dabrh, 2015). Thus, all patients with CLTI should undergo assessment for revascularization. Data from RCTs and observational evidence inform revascularization strategy in CLTI. Both endovascular and surgical revascularization have been demonstrated to be effective treatments for preventing amputation in CLTI.
Bradbury et al conducted the BASIL-2 trial (N=345) comparing the effectiveness of vein bypass versus best endovascular treatment for patients with CLTI requiring infra-popliteal revascularization (Bradbury, 2023). The trial was conducted at 41 vascular surgery sites in the UK, Sweden, and Denmark, and followed participants for a minimum of 2 years. The primary outcome was amputation-free survival, defined as the time to the first major amputation above the ankle or death from any cause, using the intention-to-treat population. Results showed that major amputation or death occurred in 63% of the vein bypass group compared to 53% of the best endovascular treatment group (adjusted hazard ratio (HR): 1.35; 95% CI: 1.02 to 1.80; p=.037). Additionally, 53% of the vein bypass group and 45% of the best endovascular treatment group died (adjusted HR: 1.37; 95% CI: 1.00 to 1.87). The authors concluded that a best endovascular treatment first revascularization strategy was associated with better amputation-free survival, suggesting that more patients with CLTI should be considered for this approach. A limitation of the trial was that the planned enrollment was not met due to recruitment challenges.
Farber et al conducted the BEST-CLI trial (N=1830) investigating the effectiveness of endovascular therapy versus surgical revascularization for patients with CLTI (Farber, 2022). Cohort 1 included patients with an adequate single segment of great saphenous vein that could be used for surgery. In Cohort 1, the incidence of major adverse limb events or death was significantly lower in the surgical group compared to the endovascular group (42.6% vs 57.4%; HR: 0.68; 95% CI: 0.59 to 0.79; P less than .001). Cohort 2 included patients who needed an alternative bypass conduit. In Cohort 2, the outcomes were similar between the surgical group and the endovascular group (42.8% vs 47.7%; HR: 0.79; 95% CI: 0.58 to 1.06; P=.12). The incidence of adverse events was similar in both groups across the two cohorts. A limitation of this study was selection bias because participant eligibility was determined locally and varied by site.
Nugteren et al conducted a retrospective analysis of prospectively collected data from 29 consecutive participants with CLTI who were enrolled in the Disrupt PAD III Trial (Nugteren, 2023). All consecutive patients treated with lithotripsy at 4 Dutch hospitals were included. The primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. The primary safety endpoint was the freedom from a composite of major adverse events (MAEs) through 30 days, defined as abrupt closure, distal embolization, perforation, emergency revascularization, major amputation, and death. The primary patency, limb salvage, and AFS for CLTI patients were 68.8%, 83.9%, and 57.1% at 12 months, respectively. During follow-up, 3 major amputations were performed due to progressive foot ulceration without infection, all within 3 months of intervention. A total of 5 patients died, whose causes of death were acute coronary syndrome (ACS), acute mesenteric ischemia, and in 3 patients a palliative course, including 1 due to progressive foot ulceration. The rate of MAE at 30 days was 13.3%. In 1 patient, the closure device failed and led to an acute occlusion, after which a femoral endarterectomy was performed to remove the closure device. Another patient was amputated after 16 days due to progressive foot ulceration. Two patients died within 30 days after the intervention because of an ACS and a palliative course due to treatment-requiring multi-morbidity and lack of perspective. The study was limited by a low sample size, heterogeneity in post-dilatation technique, lack of a control group, and lack of an independent core laboratory adjudication.
Percutaneous Revascularization Procedures for Acute Limb Ischemia Using Balloon Angioplasty, Stent Procedures, or Atherectomy
Veenstra et al conducted a systematic review and meta-analysis on the safety and effectiveness of surgical revascularization versus catheter-driven thrombolysis (CDT) for treating acute limb ischemia (Veenstra, 2020). A meta-analysis of 25 studies (N=4689) found no significant differences in limb salvage between thrombectomy and thrombolysis. However, thrombolysis was associated with a higher incidence of major vascular events compared to surgical treatment, (6.5% vs 4.4%; odds ratio (OR): 0.33; 95% CI: 0.13 to 0.87; P=.02; I2=20%). Both CDT and surgery have comparable limb salvage rates, but CDT carries a higher risk of hemorrhagic complications. There was a lack of randomized controlled trials and future trials should ensure comparable study groups and standardized outcome reporting practices.
Percutaneous Revascularization for Lower Extremity Peripheral Artery Disease Using Lithotripsy
Lithotripsy using the Shockwave system has been evaluated in 1 RCT, known as the Disrupt PAD III Trial (NCT02923193) (Tepe, 2021). The trial compared vessel preparation with lithotripsy versus percutaneous transluminal angioplasty prior to drug-coated balloon in 306 individuals with symptomatic PAD. The primary endpoint was core-lab adjudicated procedural success. Secondary outcomes, evaluated at 30 days, included clinically driven target lesion revascularization, change in ABI, change in Rutherford class, health utility based on response to the EQ-5D questionnaire, and walking capacity on the Walking Impairment Questionnaire. Major adverse events assessed included unplanned surgical revascularization or major amputation (above ankle) of the target limb, symptomatic thrombus or embolus requiring treatment, and perforations requiring provisional stent placement or other treatment. The powered secondary endpoint was primary patency at 12 months, reported in a subsequent publication (Tepe, 2022).
Procedural success was achieved in 65.8% of individuals in the lithotripsy group, compared to 54.0% in the control group (P=.01) (Tepe, 2021). Tepe et al reported primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization (CD-TLR) plus freedom from restenosis determined by duplex ultrasound (Tepe, 2022). Acute PTA failure requiring stent placement during the index procedure was prespecified as a loss of primary patency. Primary patency at 1 year was superior in the lithotripsy group compared to the control group (80.5% vs 68.0%, P=.017). The difference was driven by the freedom from provisional stent placement rate; freedom from the individual endpoints of CD-TLR and restenosis at 1 year were similar between the 2 groups. The MAE rate at 12 months was similar in both groups. Both groups demonstrated improvement in ABI index, WIQ, EQ-5D, and Rutherford category, but there were no differences in the change from baseline to 1 year between treatment groups.
A major limitation of the study was a lack of comparison to other percutaneous revascularization procedures.
A number of nonrandomized studies have reported outcomes in consecutive patients undergoing lithotripsy for chronic symptomatic PAD or CLTI. These studies are limited by lack of a control group, small sample sizes, and heterogeneity in clinical and procedural characteristics (Adams, 2022; Shammas, 2024).
Percutaneous Revascularization Procedures for Asymptomatic Lower Extremity Peripheral Artery Disease
A systematic review conducted to support the ACC/AHA guideline for the management of lower extremity PAD identified no evidence that invasive treatment while PAD is asymptomatic will alter its natural history, and evidence showing that individuals who have undergone a revascularization procedure are at increased risk of subsequent complications, particularly MALE, including the need for additional subsequent revascularization procedures (Gornik, 2024). The reviewers concluded that no evidence supports a recommendation for early revascularization for asymptomatic individuals.
Supplemental Information
In 2024, the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines published a Guideline for the Management of Lower Extremity PAD (Gornik, 2024). The Guideline was developed in collaboration with and endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Podiatric Medical Association, Association of Black Cardiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, Society of Interventional Radiology, and Vascular & Endovascular Surgery Society. The Guideline included the following statements relevant to this evidence review:
Revascularization for Asymptomatic Peripheral Artery Disease
Revascularization for Claudication (Chronic Symptomatic Peripheral Artery Disease)
1. In patients with functionally limiting claudication who are being considered for revascularization, 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 Class of Recommendation 1; Level of Evidence B-NR
2. In patients with functionally limiting claudication and an inadequate response to GDMT (including structured exercise), revascularization is a reasonable treatment option to improve walking function and QOL Class of Recommendation 2a; Level of Evidence B-R
3. In patients with claudication who have had an adequate clinical response to GDMT (including structured exercise), revascularization is not recommended. Class of Recommendation 3: No Benefit; Level of Evidence C-EO
4. In patients with functionally limiting claudication and hemodynamically significant aortoiliac or femoropopliteal disease with inadequate response to GDMT (including structured exercise), endovascular revascularization is effective to improve walking performance and QOL. Class of Recommendation 1; Level of Evidence A
5. In patients with functionally limiting claudication and hemodynamically significant aortoiliac or femoropopliteal disease with inadequate response to GDMT (including structured exercise), surgical revascularization is reasonable if perioperative risk is acceptable and technical factors suggest advantages over endovascular approaches Class of Recommendation 2a; Level of Evidence B-NR
6. In patients with functionally limiting claudication and hemodynamically significant common femoral artery disease with inadequate response to GDMT (including structured exercise), surgical endarterectomy is reasonable, especially if endovascular approaches adversely affect profunda femoris artery pathways Class of Recommendation 2a; Level of Evidence B-R
7. In patients with functionally limiting claudication and hemodynamically significant common femoral artery disease with inadequate response to GDMT (including structured exercise), endovascular approaches may be considered in those at high risk for surgical revascularization and/or if anatomical factors are favorable (ie, no adverse effect on profunda femoris artery pathways). Class of Recommendation 2b; Level of Evidence B-R
8. In patients with functionally limiting claudication and isolated hemodynamically significant infrapopliteal disease with inadequate response to GDMT (including structured exercise), the effectiveness of endovascular revascularization is unknown Class of Recommendation 2b; Level of Evidence C-LD
9. In patients with functionally limiting claudication and isolated hemodynamically significant infrapopliteal disease with inadequate response to GDMT (including structured exercise), the effectiveness of surgical revascularization is unknown. Class of Recommendation 2b; Level of Evidence C-LD
In 2018, the American College of Cardiology, American Heart Association/Society for Cardiovascular Angiography and Intervention, Society of Interventional Radiology, and Society for Vascular Medicine published Appropriate Use Criteria for Peripheral Artery Intervention (Bailey, 2019). Appropriate use scores for endovascular treatment of relevant indications are shown below.
Appropriate Use Criteria for Peripheral Artery Intervention
The document also includes appropriateness criteria for choice of endovascular procedure (atherectomy, balloon angioplasty, or stent) for different clinical situations, but does not mention lithotripsy.
In 2020, the Society for Interventional Radiology published guidelines on device selection in aorto-iliac arterial interventions (Feldman, 2020). The guidelines provide recommendations for the use of balloon angioplasty, stent procedures, and atherectomy in different clinical situations. Although specific guidelines for lithotripsy are not mentioned, the document mentions lithotripsy under the "Adjunctive Therapies" section and note that long-term data is needed.
In 2015, the Society for Vascular Surgery published guidelines for the management of asymptomatic PAD and intermittent claudication (Conte, 2015). Relevant recommendations are summarized below.
Asymptomatic Peripheral Artery Disease
3.1. We recommend multidisciplinary comprehensive smoking cessation interventions for patients with asymptomatic PAD who use tobacco (repeatedly until tobacco use has stopped). 1A
3.2. We recommend providing education about the signs and symptoms of PAD progression to asymptomatic patients with PAD. 1 Ungraded
3.3. We recommend against invasive treatments for PAD in the absence of symptoms, regardless of hemodynamic measures or imaging findings demonstrating PAD. 1B
Intermittent Claudication- Invasive Treatments
5.1. We recommend endovascular therapy or surgical treatment of IC for patients with significant functional or lifestyle-limiting disability when there is a reasonable likelihood of symptomatic improvement with treatment, when pharmacologic or exercise therapy, or both, have failed, and when the benefits of treatment outweigh the potential risks. 1B
5.2. We recommend an individualized approach to select an invasive treatment for IC. The modality offered should provide a reasonable likelihood of sustained benefit to the patient (>50% likelihood of clinical efficacy for at least 2 years). For revascularization, anatomic patency (freedom from hemodynamically significant restenosis) is considered a prerequisite for sustained efficacy.
In 2022, the Society published Appropriate Use Criteria for Management of Intermittent Claudication (Woo, 2022). Revascularization was rated as B greater than R (benefit outweighs risk) for selected patients with severe lifestyle-limiting intermittent claudication symptoms despite treatment with optimal medical therapy and an adequate trial of exercise. The panel noted, "specific types of endovascular interventions (e.g., angioplasty, stenting, atherectomy) were not included in these AUC owing to the large number of additional scenarios that would be required. Furthermore, the amount and quality of data available regarding the outcomes of interventions for multilevel disease and specific types of endovascular interventions are limited. Thus, if included, the ratings would have relied primarily on expert opinion." Lithotripsy was not mentioned in the document.
In 2018, the USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for PAD and cardiovascular disease risk with the ankle-brachial index (ABI) in asymptomatic adults.
Some currently unpublished trials that might influence this review are listed below.
Summary of Ongoing Key Trials
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