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Aetna Aetna
Clinical Policy Bulletin:
Balloon Valvuloplasty
Number: 0477


Policy

  1. Aetna considers percutaneous balloon dilation (valvuloplasty) of severe rheumatic mitral valve stenosis medically necessary in members who meet any of the following:

    1. Members in the 2nd and 3rd trimesters of pregnancy in whom balloon valvuloplasty would be expected to achieve hemodynamic and symptomatic improvement with minimal risk to the mother and fetus, or
    2. Members with favorable valve anatomy and a cumulative score of 8 or less on echocardiographic criteria (see below), or
    3. Members with mitral valve re-stenosis after previous open surgical commissurotomy; or
    4. Members with unfavorable valve anatomy who are poor surgical candidates because of medical co-morbidities or refuse surgery.
       
  2. Aetna considers percutaneous balloon dilation of severe aortic valve stenosis medically necessary in members who meet any of the following:

    1. As a "bridge" to aortic valve replacement in members with severe heart failure who are at extremely high operative risk, or
    2. For palliative use in children with congenital critical aortic valve stenosis, until the child is old enough to have a valve replacement; or
    3. Members in the 2nd and 3rd trimesters of pregnancy with critical aortic stenosis, or
    4. Members who are not candidates for surgical valve replacement because of medical co-morbidities, but in whom balloon valvuloplasty would be expected to palliate severe symptoms or stabilize cardiogenic shock, or
    5. Members with critical aortic stenosis who have an absolute surgical contraindication or refuse surgical treatment; or
    6. Members with severe aortic stenosis who must undergo an urgent non-cardiac operation (e.g., gastrointestinal bleeding) and whose surgical risk would be reduced with the improvement in hemodynamic status afforded by balloon valvuloplasty.
       
  3. Aetna considers percutaneous balloon dilation medically necessary for pulmonary valve stenosis.

  4. Aetna considers percutaneous balloon dilation experimental and investigational for all other indications because of insufficient evidence of safety and effectiveness.

  5. Aetna considers balloon aortic valvuloplasty for selection of proper transcatheter heart valve (THV) size in persons undergoing THV implantation experimental and investigational because its effectiveness for this indication has not been established.



Background

The technique of balloon valvuloplasty (also called valvotomy or commissurotomy) involves the percutaneous transcatheter insertion of 1 or more large balloons into the aortic and/or mitral valve.  The balloons are then inflated across the stenotic valve in order to decrease the degree of obstruction within the valve.

Balloon mitral commissurotomy (BMC) has become the procedure of choice for the treatment of adult patients with rheumatic mitral stenosis.  Recent studies have shown that the long-term results of BMC are superior to open surgical commissurotomy in patients who have favorable mitral valve anatomy as determined by echocardiographic examination.  Criteria have been developed to identify which patients with symptomatic mitral stenosis are most likely to benefit from balloon valvuloplasty.  The valve is assessed on the basis of 4 characteristics, each of which is graded on a scale from 0 to 4 (favorable to unfavorable): (1) leaflet mobility; (2) valvular thickening; (3) subvalvular thickening; and (4) valvular calcification.  Good procedural results have been obtained with echocardiographic scores of 8 or less, that is the valve characteristics include a pliable, non-calcified valve with mild subvalvular disease and no or mild mitral regurgitation.

Aortic balloon valvuloplasty in adults with calcific aortic stenosis has been fraught with short-lived hemodynamic benefit and high rates of re-stenosis.  Despite disappointing intermediate-term (6 to 12 months) results, the procedure does have its role in the management of critical aortic stenosis in patients who are not surgical candidates.

Balloon valvuloplasty has been used in children with congenital critical aortic stenosis, until the child is old enough to have valve replacement (NICE, 2004).  A comparative study involving 110 neonates with critical aortic stenosis found the mean reduction in systolic gradient to be 65 % for neonates treated with balloon valvuloplasty, compared to 41 % for neonates treated with open surgery (McCrindle et al, 2001).  Aortic regurgitation rates were 18 % (15/82) in the balloon valvuloplasty group compared with 3 % (1/28) in the open surgery group.  Immediate major complications were reported in 4 % (3/82) of the balloon valvuloplasty group and 0 % (0/28) of the open surgery group.

Pulmonary valve stenosis is a congenital heart defect in which blood flow from the heart to the pulmonary artery is blocked.  Symptoms include cyanosis, fainting, fatigue, chest pains, shortness of breath, poor weight gain or failure to strive in infants, and, in some instances, sudden death.  If the stenosis is severe, the pulmonary valve must be opened to increase blood flow to the lungs.  Based upon limited evidence from published case series, the National Institute for Health and Clinical Excellence (NICE) concluded that percutaneous balloon valvuloplasty is an established alternative to open surgical valvotomy for pulmonary valve stenosis (NICE, 2004).

Trans-esophageal echocardiogram (TEE) measurement alone of the aortic annulus may not be adequate to select a transcatheter heart valve (THV) size.  Balloon aortic valvuloplasty (BAV) can more accurately size the aortic annulus.  Babaliaros et al (2010) described the use of BAV to select proper THV size in patients undergoing THV implantation.  A total of 27 patients underwent sizing of the aortic annulus by BAV and TEE.  These researchers implanted the minimal THV size that was greater than the annulus measured by BAV.  The annulus measured by TEE was 21.3 +/- 1.6 mm and by BAV was 22.6 +/- 1.8 mm (p < 0.001).  The number of balloon inflations was 2.7 +/- 0.7 (range of 2 to 4), and the balloon sizes used were 22.0 +/- 1.8 mm (range of 20 to 25 mm).  Fourteen patients (52 %) required up-sizing of the initial balloon suggested by TEE; rapid pacing duration was 8 +/- 1.3 s (range of 6 to 11 s).  No change in aortic insufficiency or hemodynamic instability occurred with BAV.  Fifteen patients (56 %) received a 23-mm THV; 12 patients a 26-mm THV.  No coronary occlusion, annular damage, or THV embolization occurred.  Para-valvular leak was grade less than or equal to 1 in all patients.  In 7 patients (26 %), balloon sizing resulted in selection of a specific THV size that could not be done by TEE alone.  The authors concluded that BAV sizing of the aortic annulus is safe and is an important adjunct to TEE when selecting THV size.  Implanting the minimal THV greater than the BAV annulus size resulted in no adverse events.  These findings suggested that use of BAV for THV selection may improve the safety and effectiveness of THV implantation.  These preliminary findings need to be validated by well-designed studies.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Percutaneous balloon dilation of severe rheumatic mitral stenosis:
CPT codes covered if selection criteria are met:
92987
Other CPT codes related to the CPB:
33476
33478
93303 - 93350
ICD-9 codes covered if selection criteria are met:
394.0 Mitral stenosis (rheumatic)
394.2 Mitral stenosis (rheumatic) with insufficiency
396.0 Mitral valve stenosis (rheumatic) and aortic valve stenosis
396.1 Mitral valve stenosis (rheumatic) and aortic valve insufficiency
396.8 Multiple involvement of mitral and aortic valves
648.50 - 648.64 Congenital cardiovascular disorders and other cardiovascular diseases, complicating pregnancy, childbirth, or the puerperium
Percutaneous balloon dilation of severe aortic stenosis:
CPT codes covered if selection criteria are met:
92986
Other CPT codes related to the CPB:
33405 - 33413
ICD-9 codes covered if selection criteria are met:
395.0 Rheumatic aortic stenosis
395.2 Rheumatic aortic stenosis with insufficiency
396.0 Mitral valve stenosis and aortic valve stenosis
396.2 Mitral valve insufficiency (rheumatic) and aortic stenosis
396.8 Multiple involvement of mitral and aortic valves
424.1 Aortic valve disorders
440.0 Atherosclerosis of aorta
746.3 Congenital stenosis of aortic valve
747.22 Atresia and stenosis of aorta
Percutaneous balloon dilation of pulmonary valve:
CPT codes covered if selection criteria are met:
92990
ICD-9 codes covered if selection criteria are met:
397.1 Rheumatic diseases of pulmonary valve
424.3 Pulmonary valve disorders
746.02 Stenosis of pulmonary valve, congenital
746.09 Other anomalies of pulmonary valve
Other ICD-9 codes related to the CPB:
578.9 Hemorrhage of gastrointestinal tract
785.51 Cardiogenic shock
V15.1 Other personal history of surgery to heart and great vessels
V43.3 Organ or tissue replaced by other means, heart valve


The above policy is based on the following references:
  1. Braunwald E, ed. Heart Disease: A Textbook of Cardiovascular Medicine. 5th ed. St. Louis, MO: W.B. Saunders Co.; 1997.
  2. Cheng TO, Holmes DR Jr. Percutaneous balloon mitral valvuloplasty by the Inoue balloon technique: The procedure of choice for treatment of mitral stenosis. Am J Cardiol. 1998;81(5):624-628.
  3. Lau KW, Ding ZP, Hung JS. Percutaneous transvenous mitral commissurotomy versus surgical commissurotomy in the treatment of mitral stenosis. Clin Cardiol. 1997;20(2):99-106.
  4. Piovaccari G, Marzocchi A, Marrozzini C, et al. Percutaneous aortic valvuloplasty in the adult. When and why is now useful? Ann Ital Med Int. 1996;11(4):258-262.
  5. Lau KW, Ding ZP, Gao W, et al. Percutaneous balloon mitral valvuloplasty in patients with mitral restenosis after previous surgical commissurotomy. A matched comparative study. Eur Heart J. 1996;17(9):1367-1372.
  6. Elliott JM, Tuzcu EM. Recent developments in balloon valvuloplasty techniques. Curr Opin Cardiol. 1995;10(2):128-134.
  7. Reyes VP, Raju BS, Wynne J, et al. Percutaneous balloon valvuloplasty compared with open surgical commissurotomy for mitral stenosis. N Engl J Med. 1994;331:961-967.
  8. Vahanian A. Balloon valvuloplasty. Heart. 2001;85(2):223-228.
  9. Mickleborough LL. Is mitral valvuloplasty always indicated in patients with poor left ventricular function and ischemic cardiomyopathy? J Thorac Cardiovasc Surg. 2001;121(1):97.
  10. Zaki A, Salama M, El Masry M, et al. Immediate effect of balloon valvuloplasty on hemostatic changes in mitral stenosis. Am J Cardiol. 2000;85(3):370-375.
  11. Zeymer U, Neuhaus K. Percutaneous balloon valvuloplasty - the first line treatment for mitral stenosis and restenosis. Eur Heart J. 2000;21(20):1643-1644.
  12. Cheng TO. Percutaneous inoue balloon valvuloplasty is the procedure of choice for symptomatic mitral stenosis in pregnant women. Catheter Cardiovasc Interv. 2000;50(4):418.
  13. Marzo K, Prigent FM, Steingart RM. Interventional therapy in heart failure management. Clin Geriatr Med. 2000;16(3):549-566.
  14. Vahanian A, Luxereau P, Brochet E. Valvular stenosis: Treatment by percutaneous dilatation. Rev Prat. 2000;50(15):1679-1683.
  15. Azpitarte J, Alonso AM, Garcia Gallego F, et al. Guidelines of the Spanish Society of Cardiology on valve heart disease. Rev Esp Cardiol. 2000;53(9):1209-1278.
  16. de Souza JA, Martinez EE Jr, Ambrose JA, et al. Percutaneous balloon mitral valvuloplasty in comparison with open mitral valve commissurotomy for mitral stenosis during pregnancy. J Am Coll Cardiol. 2001;37(3):900-903.
  17. Prendergast BD, Shaw S. Percutaneous balloon mitral valvuloplasty. Hosp Med. 001;62(9):564-566.
  18. Iung B, Vahanian A. The long-term outcome of balloon valvuloplasty for mitral stenosis. Curr Cardiol Rep. 2002;4(2):118-124.
  19. Palacios IF, Sanchez PL, Harrell LC, et al. Which patients benefit from percutaneous mitral balloon valvuloplasty? Prevalvuloplasty and postvalvuloplasty variables that predict long-term outcome. Circulation. 2002;105(12):1465-1471.
  20. McCrindle BW. Independent predictors of immediate results of percutaneous balloon aortic valvotomy in children. Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) Registry Investigators. Am J Cardiol. 1996;77(4):286-293.
  21. McCrindle BW, Blackstone EH, Williams WG, et al. Are outcomes of surgical versus transcatheter balloon valvotomy equivalent in neonatal critical aortic stenosis? Circulation. 2001;104(12 Suppl 1):I152-I158.
  22. Berger M. Natural history of mitral stenosis and echocardiographic criteria and pitfalls in selecting patients for balloon valvuloplasty. Adv Cardiol. 2004;41:87-94.
  23. Vassiliades TA Jr, Block PC, Cohn LH, et al. The clinical development of percutaneous heart valve technology. J Thorac Cardiovasc Surg. 2005;129(5):970-976.
  24. Thiem A, Cremer J, Lutter G. Percutaneous valve replacement: Weird or wonderful? Minerva Cardioangiol. 2006;54(1):23-30.
  25. Karakaya O, Turkmen M, Bitigen A, et al. Effect of percutaneous mitral balloon valvuloplasty on left atrial appendage function: A Doppler tissue study. J Am Soc Echocardiogr. 2006;19(4):434-437.
  26. National Institute for Health and Clinical Excellence (NICE). Percutaneous balloon fetal valvuloplasty for aortic stenosis. Interventional Procedure Guidance 175. London, UK: NICE; May 2006. Available at: http://www.nice.org.uk/page.aspx?o=IPG175guidance. Accessed June 22, 2006.
  27. National Institute for Health and Clinical Excellence (NICE). Percutaneous fetal balloon valvuloplasty for pulmonary atresia with intact ventricular septum. Interventional Procedure Guidance 176. London, UK: NICE; May 2006. Available at: http://www.nice.org.uk/page.aspx?o=ipg176guidance. Accessed June 22. 2006.
  28. National Institute for Health and Clinical Excellence (NICE). Balloon dilatation for pulmonary valve stenosis. Interventional Procedure Guidance 67. London, UK: NICE; June 2004. Available at: http://www.nice.org.uk/page.aspx?o=ipg067guidance. Accessed June 22, 2006.
  29. National Institute for Health and Clinical Excellence (NICE). Balloon valvuloplasty for aortic valve stenosis in adults and children. Interventional Procedure Guidance 78. London, UK: NICE; July 2004. Available at: http://www.nice.org.uk/page.aspx?o=ipg078guidance. Accessed June 22, 2006.
  30. Soltesz EG, Cohn LH. Minimally invasive valve surgery. Cardiol Rev. 2007;15(3):109-115.
  31. Khambadkone S, Nordmeyer J, Bonhoeffer P. Percutaneous implantation of the pulmonary and aortic valves: Indications and limitations. J Cardiovasc Med (Hagerstown). 2007;8(1):57-61.
  32. Rao PS. Percutaneous balloon pulmonary valvuloplasty: State of the art. Catheter Cardiovasc Interv. 2007;69(5):747-763.
  33. Presbitero P, Lisignoli V, Zavalloni D, et al. Endovascular intervention in the treatment of congenital heart disease in adults. Minerva Cardioangiol. 2007;55(5):669-679.
  34. Nobuyoshi M, Arita T, Shirai S, et al. Percutaneous balloon mitral valvuloplasty: A review. Circulation. 2009;119(8):e211-e219.
  35. Himbert D. Percutaneous cardiac valvular interventions. Rev Prat. 2009;59(2):207-212.
  36. Cubeddu RJ, Palacios IF. Percutaneous techniques for mitral valve disease. Cardiol Clin. 2010;28(1):139-153.
  37. Song JK, Kim MJ, Yun SC, et al. Long-term outcomes of percutaneous mitral balloon valvuloplasty versus open cardiac surgery. J Thorac Cardiovasc Surg. 2010;139(1):103-110.
  38. Palaniswamy C, Selvaraj DR, Guleria R, et al. Respiratory muscle strength in rheumatic mitral stenosis improves after balloon valvotomy. J Cardiovasc Med (Hagerstown). 2010;11(6):440-443.
  39. Babaliaros VC, Junagadhwalla Z, Lerakis S, et al. Use of balloon aortic valvuloplasty to size the aortic annulus before implantation of a balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv. 2010;3(1):114-118.
  40. Lee SP, Kim HK, Kim KH, et al. Prevalence of significant tricuspid regurgitation in patients with successful percutaneous mitral valvuloplasty for mitral stenosis: Results from 12 years' follow-up of one centre prospective registry. Heart. 2013;99(2):91-97.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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