Effective Date: 03/04/2011
Title: Peripheral Atherectomy
Revision Date: 11/01/2019
CPT Code(s): 37225, 37227, 37229, 37231, 37233, 37235
will apply to all services performed on or after the above revision date which
will become the new effective date.
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
Atherectomy requires pre-authorization.
atherectomy is used to remove plaque in clogged arteries using either mechanical
or laser devices and may have stents placed.
Atherectomy using either
mechanical means such as Simpson Atherocath (directional atherectomy) or laser
(laser angioplasty) is considered medically necessary for the following
i) Member has symptomatic
peripheral vascular disease and
lifestyle-limiting disability due to intermittent claudication;
There has been an inadequate response to an exercise
program of at least 6 months duration, and
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
Efforts at smoking cessation.
cannot be treated by standard angioplasty techniques alone, (i.e., balloon
Member has an eccentric
lesion that does not dilate with conventional balloon angioplasty,
Member has vein bypass
Limb Threatening ischemia.
Mechanical or laser
peripheral atherectomy is considered experimental and investigational for all
Used In This BI:
Fem/popl revas w/ather
Fem/popl revasc stnt & ather
Tib/per revasc w/ather
Tib/per revasc stent & ather
Tibper revasc w/ather add-on
Tib/per revasc stnt & ather
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.
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
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
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
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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atherectomy: What are its indications? J Am Coll Cardiol. 1990;
Graor RA, Whitlow PL. Transluminal
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Kim D, Gianturco LE, Porter DH, et al.
Peripheral directional atherectomy: 4-year experience. Radiology. 1992;
Dorros G, Iyer S, Lewin R, et al.
Angiographic follow-up and clinical outcome of 126 patients after
percutaneous directional atherectomy for occlusive peripheral vascular
disease. Cathet Cardiovasc Diagn. 1991; 22(2):79-84.
Desbrosses D, Petit H, Torres E, et al.
Percutaneous atherectomy with the Kensey Catheter: Early and midterm results
in femoropopliteal occlusions unsuitable for conventional angioplasty. Ann
Vasc Surg. 1990; 4(6):550-552.
Ahn SS, Obrand DI, Moore WS. Transluminal
balloon angioplasty, stents, and atherectomy. Semin Vasc Surg. 1997;
White CJ. Peripheral atherectomy with the
Pullback atherectomy catheter: Procedural safety and efficacy in a
multicenter trial. J Endovasc Surg. 1998; 5(1):9-17.
Huppert PE, Duda SH, Helber U, et al.
Comparison of pulsed laser-assisted angioplasty and balloon angioplasty in
femoropopliteal artery occlusions. Radiology. 1992; 184(2):363-367.
Tobis JM, Conroy R, Deutsch LS, et al.
Laser-assisted versus mechanical recanalization of femoral arterial
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Satiani B, Mohan Das B, Vaccaro PS, Gawron D.
Angiographic follow-up after laser-assisted balloon angioplasty. J Vasc
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Sculpher M, Michaels J, McKenna M, Minor J. A
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Tcheng JE, Volkert-Noethen AA. Current
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Yoffe B, Yavnel L, Altshuler A, et al.
Preliminary experience with the Xtrak debulking device in the treatment of
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Steinkamp HJ, Rademaker J, Wissgott C, et
al. Percutaneous transluminal laser angioplasty versus balloon dilation for
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Laird Jr JR, Reiser C, Biamino G, Zeller T.
Excimer laser assisted angioplasty for the treatment of critical limb
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Ruef J, Hofmann M, Haase J. Endovascular
interventions in iliac and infrainguinal occlusive artery disease. J Interv
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Plaque Excision System: Percutaneous peripheral atherectomy for patients
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Gim RD, Bokhari SW, Winters RJ. Novel use of
a peripheral, self-expanding nitinol stent in adjunct to excimer laser
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Cardiovasc Med. 2005; 6(3):173-179.
Bosiers M, Peeters P, Elst FV, et al. Excimer
laser assisted angioplasty for critical limb ischemia: Results of the LACI
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Laird JR, Zeller T, Gray BH, et al. Limb
salvage following laser-assisted angioplasty for critical limb ischemia:
Results of the LACI multicenter trial. J Endovasc Ther. 2006; 13(1):1-11.
Yancey AE, Minion DJ, Rodriguez C, et al.
Peripheral atherectomy in TransAtlantic InterSociety Consensus type C
femoropopliteal lesions for limb salvage. J Vasc Surg. 2006; 44(3):503-509.
Zhou W, Bush RL, Lin PH, et al. Laser
atherectomy for lower extremity revascularization: An adjunctive
endovascular treatment option. Vasc Endovascular Surg. 2006; 40(4):268-274.
Keeling WB, Shames ML, Stone PA, et al.
Plaque excision with the Silverhawk catheter: Early results in patients with
claudication or critical limb ischemia. J Vasc Surg. 2007; 45(1):25-31.
Zeller T, Krankenberg H, Rastan A, et al.
Percutaneous rotational and aspiration atherectomy in infrainguinal
peripheral arterial occlusive disease: A multicenter pilot study. J Endovasc
Ther. 2007; 14(3):357-364.
Mahmud E, Cavendish JJ, Salami A. Current
treatment of peripheral arterial disease: Role of percutaneous
interventional therapies. J Am Coll Cardiol. 2007; 50(6):473-490.
Slovut DP, Demaioribus CA. Hybrid
revascularization using Silverhawk atherectomy and infrapopliteal bypass for
limb salvage. Ann Vasc Surg. 2007; 21(6):796-800.
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atherectomy: A critical review. J Interv Cardiol. 2007; 20(6):417-424.
McKinsey JF, Goldstein L, Khan HU, et al.
Novel treatment of patients with lower extremity ischemia: Use of
percutaneous atherectomy in 579 lesions. Ann Surg. 2008; 248(4):519-528.
Biskup NI, Ihnat DM, Leon LR, Infrainguinal
atherectomy: A retrospective review of a single-center experience. Ann Vasc
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Garcia LA, Lyden SP. Atherectomy for
infrainguinal peripheral artery disease. J Endovasc Ther. 2009; 16(2 Suppl
Removed CPT codes no longer applicable to the policy under Codes Used in
This BI section.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.