Aetna considers mechanical or laser peripheral atherectomy (atheroablation) medically necessary in members who meet all of the following criteria:

1. Member has symptomatic peripheral vascular disease (limb-threatening ischemia or functionally limiting claudication); and

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

3. Either A or B:
   1. Member has an eccentric lesion that does not dilate with conventional balloon angioplasty, or
   2. Member has vein bypass graft stenosis.

Aetna considers mechanical or laser peripheral atherectomy experimental and investigational for all other indications.

Notes: The preferred technique for mechanical atherectomy involves the use of the Simpson Atherocath (directional atherectomy). Peripheral atherectomy/atheroablation with other mechanical or rotational devices or rotational aspiration atherectomy devices has not been shown to be effective.

Peripheral laser atherectomy is also known as peripheral laser angioplasty.

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); andcannot be treated by standard angioplasty techniques alone, i.e., balloon angioplasty would be ineffective or is contraindicated; and havean 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.