Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Peripheral Atherectomy requires pre-authorization.

2)    Peripheral atherectomy is used to remove plaque in clogged arteries using either mechanical or laser devices and may have stents placed.

1)    Atherectomy using either mechanical means such as Simpson Atherocath (directional atherectomy) or laser (laser angioplasty) is considered medically necessary for the following criteria:

A.   Intermittent claudication: 

i) Member has symptomatic peripheral vascular disease and lifestyle-limiting disability due to intermittent claudication; and

ii) There has been an inadequate response to an exercise program of at least 6 months duration, and

iii) Trial and failure of drug therapy:

-       Antithrombotic/antiplatelet therapy (unless contraindicated),

-       LDL<70 (as documented by lipid testing) with prescribed high-dose statins and/or prescribed PCSK9 inhibition (if needed),

-       Hgb A1C <7.0 percent if diabetic,

-       BP< 130/90 if hypertensive and

iii) Efforts at smoking cessation.

Member cannot be treated by standard angioplasty techniques alone, (i.e., balloon angioplasty, etc.); and

Either:

·         Member has an eccentric lesion that does not dilate with conventional balloon angioplasty, or

·         Member has vein bypass graft stenosis.

B.   Limb Threatening ischemia.

Mechanical or laser peripheral atherectomy is considered experimental and investigational for all other indications.

Codes Used In This BI:

Peripheral Atherectomy/Atheroablation with other mechanical or rotational devices or rotational aspiration atherectomy devices (such as SilverHawk plaque excision) has not been shown to be effective.

Atherectomy was introduced in 1985 to improve upon the limitations of balloon angioplasty, primarily, abrupt reclosure and restenosis.  Atherectomy devices cut and remove atherosclerotic plaque from a vessel wall or grind the atheroma into small particles, allowing them to embolize distally.  Elastic recoil is reduced after atherectomy because the lumen is widened without stretching of the arterial wall.

Several types of atherectomy devices have been cleared by the U.S. Food and Drug Administration for peripheral use and primary success rates have been favorable with various devices; however, the Simpson Peripheral Atherocath has been the most widely used.  This device has a circular cutter that spins at 2000 rpm inside a metal housing with a window.  Balloon inflation on the opposite side of the housing forces the plaque through the window where it is cut by advancing the rotating cutter in the housing.  This device is best suited for short, discrete, eccentric stenosis.  The catheters are bulky and stiff to use in the tibial or tortuous vessels. Primary success rate have been 82-100% with few complications.

Data support the use of atherectomy as effective in the peripheral vessels in patients who meet the following criteria: have symptomatic peripheral vascular disease (limb-threatening ischemia or functionally limiting claudication); and cannot be treated by standard angioplasty techniques alone, i.e., balloon angioplasty would be ineffective or is contraindicated; and have an eccentric lesion that does not dilate with conventional balloon angioplasty, or vein bypass graft stenosis.

Until the problem of restenosis can be solved, atherectomy is a reasonable treatment for symptomatic peripheral vascular disease (limb-threatening ischemia or functionally limiting claudication) only when balloon angioplasty may be ineffective or contraindicated.

Zeller et al (2007) reported a safety and efficacy study of the first rotational aspiration atherectomy system (Pathway PV) for the treatment of arterial lesions below the femoral bifurcation.  A total of 15 patients (9 men; mean age 71 +/- 9 years) with Rutherford stage 2 to 5 lower limb ischemia were enrolled at 3 study sites.  Target lesions were in the superficial femoral (n = 7, 47 %), popliteal (n = 7, 47 %), and posterior tibial (n = 1, 6 %) arteries.  Mean diameter stenosis was 97 % +/- 10 %; mean lesion length was 61 +/- 62 mm (range of 5 - 250).  The primary study endpoint was the 30-day serious adverse event (SAE) rate.  Interventional success (residual stenosis les than 30 %) was achieved in all lesions (100 %).  Stand alone atherectomy was performed in 6 (40 %) patients, adjunctive balloon angioplasty in 7 (47 %), and stenting/endografting in 2 (13 %).  The SAE rate at 30 days was 20 % (3/15), including 1 perforation due to an unrecognized displacement of the guidewire (sealed with an endograft), 1 false aneurysm at the puncture site (successful duplex-guided compression therapy), and 1 dissection in conjunction with a distal embolism (stent implantation and aspiration thrombectomy).  Primary patency rates measured by duplex ultrasound at 1 and 6 months were 100 % and 73 %, respectively; the target lesion revascularization (TLR) rate was 0 % after 6 months.  The ankle-brachial index increased significantly from 0.54 +/- 0.3 at baseline to 0.89 +/- 0.16, 0.88 +/- 0.19, and 0.81 +/- 0.20 (p < 0.05) at discharge, 1 month, and 6 months, respectively.  Mean Rutherford categories were 2.92 +/- 1.19 (range 1 - 5), 0.64 +/- 1.12 (range 0 - 1), and 0.83 +/- 1.33 (range 0 - 3) at the same time points (p < 0.05).  The authors concluded that the application of this new atherectomy device was feasible in all cases.  The serious adverse event rate was moderate; however, all events were solved during the index procedure.  The 0 % 6-month TLR rate is promising.

Mahmud et al (2007) noted that over the past decade, percutaneous revascularization therapies for the treatment of patients with peripheral arterial disease (PAD) have evolved tremendously, and a great number of patients can now be offered treatment options that are less invasive than traditional surgical options.  With the surgical approach, there is significant symptomatic improvement, but the associated morbidity and mortality preclude its routine use.  Although newer percutaneous treatment options are associated with lower procedural complications, the technical advances have outpaced the evaluation of these treatments in adequately designed clinical studies, and therapeutic options are available that may not have been rigorously investigated.

Bunting and Garcia (2007) stated that atherectomy is experiencing increased interest from endovascular specialists as a therapeutic treatment in the peripheral arteries.  Long studied in the coronary vasculature, atherectomy has several theoretical advantages that make it uniquely suited for the peripheral circulation.  In particular, infra-inguinal PAD experiences physiological stresses and forces that have made traditional percutaneous coronary treatments such as angioplasty and stenting not as successful.  Re-stenosis has been a major problem for angioplasty and stenting alone.  The SilverHawk atherectomy device has favorable short-term data but important longer-term data are limited and need further study.  Laser atherectomy also has favorable applications in niche patients but the number of studies is limited.  Unfortunately, athero-ablative technologies for PAD require more definitive objective data regarding 12-month and longer-term outcomes in order to obtain widespread scientific acceptance.

Biskup et al (2008) noted that a new atherectomy device (SilverHawk) has recently been approved by the Food and Drug Administration, but the results with its use are unclear. These investigators analyzed a series of consecutive patients undergoing atherectomy. They retrospectively reviewed the charts of 35 patients undergoing infra-inguinal (IF) atherectomy in 38 limbs. The Trans-Atlantic Inter-Society Consensus (TASC) classification and Society of Vascular Surgery run-off scores were calculated. Time to event analysis was performed using Kaplan-Meier estimates. Risk factors affecting patency were analyzed with a multi-variate Cox model. Mean patient age was 70 +/- 9.6 years. Indications for intervention were claudication (26 %), rest pain (21 %), and tissue loss (53 %). Femoro-popliteal (FP) atherectomy was performed in 68 % and tibial atherectomy in 32 %. For FP lesions, the TASC distribution was A, 42 %; B, 23 %; C, 4 %; and D, 15 %. The average lesion treatment length was 9.4 +/- 10.6 cm (range of 1 to 40), and the run-off score was 5.1 +/- 3.5. For tibial lesions, the TASC distribution was A, 0 %; B, 17 %; C, 8 %; and D, 75 %. The average lesion treatment length was 9.2 +/- 6.0 cm (range of 2 to 20), with a run-off score of 5.4 +/- 2.4. A total of 39 % of patients had prior IF interventions. Adjunctive angioplasty of the atherectomized lesion was performed in 55 % of cases, stenting in 0 %, and adjunctive therapy for tandem lesions in 39 %. The post-operative ankle-brachial index increased by 0.30 +/- 0.14 and toe pressures increased by 40 +/- 32.4 mm Hg. Mean follow-up was 10 +/- 8 months (range of 0.3 to 23). During the studied period, 7 patients required major limb amputation and 5 open surgical re-vascularization. Total primary and secondary patency rates were 66 % and 70 % at 1 year, respectively. Primary and secondary patency rates for FP atherectomy were 68 % and 73 % at 1 year, respectively. The limb salvage rate was 74 % at 6 months. Patients with prior interventions in the atherectomized segment had an almost 10-fold decrease in primary patency. Atherectomy produces acceptable results, similar to those in reported series of conventional balloon angioplasty/stenting. Patients with prior IF interventions had a nearly 10-fold decrease in primary patency. A greater than 6-fold decrease in patency rates was noted in patients who underwent simultaneous inflow or outflow procedures, but this finding did not reach statistical significance (p = 0.082). The authors stated that future studies should focus on cost comparisons with other treatments such as angioplasty and stenting, and prospective randomized trials should be performed to compare these treatment alternatives.

Garcia and Lyden (2009) noted that compared to conventional percutaneous transluminal angioplasty (PTA) and stent implantation for arterial occlusive diseases, atherectomy offers the theoretical advantages of eliminating stretch injury on arterial walls and reducing the, rate of restenosis. Historically, however, neither rotational nor directional atherectomy, whether used alone or with adjunctive PTA, has shown any significant long-term benefit over PTA alone in the coronary or peripheral arteries. However, the SilverHawk Plaque Excision System has produced positive results in single-center prospective registries of patients with FP and IF lesions, with reduced adjunctive PTA, minimal adjunctive stenting, and competitive 6-month and 12-month patency rates. In the observational non-randomized TALON (Treating Peripherals with SilverHawk: Outcomes Collection) registry, freedom from target lesion re-vascularization was 80 % for 87 patients at 12 months. Questions remaining for further research with this device include more accurate determination of an event rate for distal embolization, the appropriate use of distal protection, the value of and appropriate circumstances for adjunctive angioplasty, and definitive patency and clinical outcomes.

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34. Garcia LA, Lyden SP. Atherectomy for infrainguinal peripheral artery disease. J Endovasc Ther. 2009; 16(2 Suppl 2):II105-II115.

 Addendum:

1. Effective 01/01/2017: Removed CPT codes no longer applicable to the policy under Codes Used in This BI section.