| Coverage Policy Manual | |
| Policy #: | 1999022 |
| Category: | Surgery |
| Initiated: | November 1999 |
| Last Review: | February 2024 |
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| Percutaneous Angioplasty, Stenting & Atherectomy of the Lower Extremity, Abdominal Aortic & Visceral Arteries | |
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| Description: |
Stenotic or occluded lower extremity vessels can be bypassed surgically or opened using endovascular techniques including balloon angioplasty, stenting, or atherectomy. Successful balloon angioplasty results in plaque fracture, arterial wall stretching, and ‘controlled’ intimal dissection. Atherectomy removes plaque from the vessel and increases lumen size. Methods of performing atherectomy include laser (also called laser angioplasty), mechanical (directional or rotational/orbital) and radiofrequency. Orbital atherectomy has the potential advantage of removing fibrotic or calcified plaque with minimal dissection and elastic recoil. Stenting can be used to treat a suboptimal result of angioplasty or atherectomy; stenting is also appropriate primary therapy for focal lesions in the common and external iliac arteries.
Percutaneous atherectomy of peripheral artery disease, especially of the lower extremities has been studied for several years, mostly in phase II prospective studies, but a few randomized controlled trials have been reported (see below, Rationale). The effectiveness of stents, atherectomy, cutting balloons, thermal devices, and lasers for the treatment of femoral – popliteal arterial lesions (except to salvage a suboptimal result from balloon dilatation) is not well established. However, there is evidence that endovascular plaque excision with atherectomy catheters in patients with critical limb ischemia, who are not candidates for surgical revascularization, may have early and intermediate term favorable clinical outcomes.
It is universally recommended that patients with claudication should first be treated with lifestyle modifications, diet, exercise, smoking cessation, lipid control, and in many cases drug therapy such as antiplatelet therapy, lipid-lowering therapy, phosphodiesterase inhibitors, and others. Those patients with critical limb ischemia or with substantial lifestyle or vocational limitations are considered for surgical or endovascular therapy of peripheral arterial disease.
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.
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 MAY 15, 2022
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.
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| References: |
Audet P, Therasse E, Oliva VL, et al.(1998) Infrarenal aortic stenosis: long-term clinical and hemodynamic results of percutaneous transluminal angioplasty. Radiology 1998; 208:357-363. BASIL Trial Participants.(2005) Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomized controlled trial. The Lancet. 3 Dec. 2005; 366(9501):1925-1934. Dattilo R, Himmelstein S, Cuff RF. J Invasive Cardiol. 2014 Aug;26(8):355-60.(2014) The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014 Aug;26(8):355-60. Dippel EJ, Makam P, Kovach R, et al.(2015) Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8 (1 Pt A):92-101 Epub 2014 Dec 10. Feiring AJ, Krahn M, Nelson L, et al.(2010) Preventing Leg Amputations in Critical Limb Ischemia With Below-the Knee Drug-Eluting Stents: The PaRADISE (Preventing Amputations using Drug eluting StEnts) Trial. J. Am. Coll. Cardiol. 2010;55;1580-1589. Haider SN, Kavanagh EG, et al.(2006) Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg, 2006; 43:504-12. Hans SS, DeSantis D, Siddiqui R, Khoury M.(2008) Results of endovascular therapy and aortobifemoral grafting for Transatlantic Inter-Society type C and D aortoiliac occlusive disease. Surgery. 2008 Oct;144(4):583-9. Hirsch AT, Haskal ZJ, et al.(2006) ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): Executive Summary. J Am Coll Cardiol, 2006; 47:1239-1312. 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