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.

1. Sanborn TA. Percutaneous peripheral atherectomy: What are its indications? J Am Coll Cardiol. 1990; 15(3):689-690. 
2. Graor RA, Whitlow PL. Transluminal atherectomy for occlusive peripheral vascular disease. J Am Coll Cardiol. 1990; 15(7):1551-1558. 
3. Kim D, Gianturco LE, Porter DH, et al. Peripheral directional atherectomy: 4-year experience. Radiology. 1992; 183(3):773-778. 
4. 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. 
5. 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. 
6. Ahn SS, Obrand DI, Moore WS. Transluminal balloon angioplasty, stents, and atherectomy. Semin Vasc Surg. 1997; 10(4):286-296. 
7. 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. 
8. 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. 
9. Tobis JM, Conroy R, Deutsch LS, et al. Laser-assisted versus mechanical recanalization of femoral arterial occlusions. Am J Cardiol. 1991; 68(10):1079-1086. 
10. Satiani B, Mohan Das B, Vaccaro PS, Gawron D. Angiographic follow-up after laser-assisted balloon angioplasty. J Vasc Surg. 1993; 17(5):960-965; discussion 965-966. 
11. Seeger JM, Kaelin LD. Limitations and pitfalls of laser angioplasty. Surg Annu. 1993; 25(Pt 2):177-192. 
12. Sculpher M, Michaels J, McKenna M, Minor J. A cost-utility analysis of laser-assisted angioplasty for peripheral arterial occlusions. Intl J Tech Assess Health Care. 1996; 12(1):104-125. 
13. Tcheng JE, Volkert-Noethen AA. Current multicentre studies with the excimer laser: Design and aims. Lasers Med Sci.  2001; 16(2):122-129. 
14. Yoffe B, Yavnel L, Altshuler A, et al. Preliminary experience with the Xtrak debulking device in the treatment of peripheral occlusions. J Endovasc Ther. 2002; 9(2):234-240.
15. Steinkamp HJ, Rademaker J, Wissgott C, et al.  Percutaneous transluminal laser angioplasty versus balloon dilation for treatment of popliteal artery occlusions.  J Endovasc Ther.  2002; 9(6):882-888.
16. Fowkes FGR, Gillespie IN. Angioplasty (versus non surgical management) for intermittent claudication. Cochrane Database Syst Rev. 1998 ;( 2):CD000017.
17. Laird Jr JR, Reiser C, Biamino G, Zeller T. Excimer laser assisted angioplasty for the treatment of critical limb ischemia. J Cardiovasc Surg (Torino). 2004; 45(3):239-248.
18. Ruef J, Hofmann M, Haase J. Endovascular interventions in iliac and infrainguinal occlusive artery disease. J Interv Cardiol. 2004; 17(6):427-435.
19. Parrella A, Mundy L. SilverHawk Peripheral Plaque Excision System: Percutaneous peripheral atherectomy for patients with peripheral vascular disease. Horizon Scanning Prioritising Summary - Volume 10. Adelaide, SA: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (HealthPACT and MSAC); 2005.
20. Gim RD, Bokhari SW, Winters RJ. Novel use of a peripheral, self-expanding nitinol stent in adjunct to excimer laser coronary atherectomy in the treatment of degenerated vein graft disease. Rev Cardiovasc Med. 2005; 6(3):173-179.
21. Bosiers M, Peeters P, Elst FV, et al. Excimer laser assisted angioplasty for critical limb ischemia: Results of the LACI Belgium Study. Eur J Vasc Endovasc Surg. 2005; 29(6):613-619.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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.
28. Slovut DP, Demaioribus CA. Hybrid revascularization using Silverhawk atherectomy and infrapopliteal bypass for limb salvage. Ann Vasc Surg. 2007; 21(6):796-800.
29. Bunting TA, Garcia LA. Peripheral atherectomy: A critical review. J Interv Cardiol. 2007; 20(6):417-424.
30. 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.
31. Biskup NI, Ihnat DM, Leon LR, Infrainguinal atherectomy: A retrospective review of a single-center experience. Ann Vasc Surg. 2008; 22(6):776-782.
32. Shrikhande GV, McKinsey JF. Use and abuse of atherectomy: Where should it be used? Semin Vasc Surg. 2008; 21(4):204-209.
33. Lumsden AB, Davies MG, Peden EK. Medical and endovascular management of critical limb ischemia. J Endovasc Ther. 2009; 16(2 Suppl 2):II31-II62.
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.