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Clinical Policy Bulletin:
Selected Aortic Valve Procedures: Ross Pulmonary Autograft and Aortic Valve-Sparing Re-implantation
Number: 0407


Policy

  1. Aetna considers the Ross pulmonary autograft procedure medically necessary for members undergoing aortic valve replacement secondary to either congenital anomalies or aortic valve disease, such as:

    1. Aortic incompetence (including endocarditis, rheumatism of the heart); or
    2. Aortic stenosis; or
    3. Complex left ventricular outflow tract obstruction; or
    4. Congenital lesions.

    Contraindications to this procedure are presented as an Appendix to the Background section.

    Aetna considers the Ross pulmonary autograft experimental and investigational for all other indications (e.g., middle-aged or older adults when suitable alternatives to autograft replacement of the aortic valve are available with comparable results and without the need for replacement of the right ventricular outflow tract, and individuals with bicuspid valves and aortic regurgitation or aortic dilation if other alternatives are available) because its effectiveness for indications other than the ones listed above has not been established.

  2. Aetna considers the minimally invasive approach to the aortic valve a medically necessary acceptable alternative to the conventional approach to aortic valve replacement.

  3. Aetna considers aortic valve-sparing re-implantation medically necessary for the treatment of secondary aortic regurgitation due to aortic root dilatation as occurs in Marfan syndrome as well as for the treatment of type A acute aortic dissections (i.e., dissection of the ascending and descending aorta).

    Aetna considers aortic valve sparing re-implanatation experimental and investigational for all other indications because its effectiveness for indications other than the ones listed above has not been established.



Background

Patients undergoing aortic valve replacement may consider 3 options: (i) a prosthetic valve, (ii) a homograft valve, or (iii) a pulmonary autograft (i.e., the Ross procedure).  Ross pulmonary autograft refers to essentially a double valve replacement in which the native pulmonic valve is substituted for the diseased aortic valve, while a homograft prosthetic valve replaces the pulmonic valve.  This procedure was first devised in 1967 and sought to provide a permanent aortic valve substitution, which would not degenerate like a homograft valve and would not require chronic anti-coagulation therapy like a prosthetic valve.  The risk:benefit ratio involves a balance between a more complicated surgical procedure (essentially a double valve replacement) and a potentially more durable and physiologic aortic valve replacement.  Furthermore, it is thought that the autografted pulmonary valve will grow with the young patient, thus obviating the need for re-operation.  Studies have also shown that the Ross procedure resulted in significant improvement in left ventricular wall thickness and outflow tract velocity not observed in allograft aortic valve replacements in children.  For these reasons, the Ross procedure is considered most appropriate for young adults.  Candidates for this procedure should be adequately counseled on the various valve replacement alternatives.

In a systematic review and meta-analysis, Takkenberg et al (2009) stated that the Ross procedure provides satisfactory results for both children and young adults (less than or equal to 50 years of age).  Furthermore, David (2009) noted that young adults with aortic stenosis and normal-size aortic root are the best candidates for the Ross procedure.

Aortic valve-sparing re-implantation is a valve-sparing technique employed for patients with aortic regugitation secondary to aortic root dilatation in which valvular insufficiency is due to outward displacement of the valve commissures.  This technique, which is different from aortic valve repair, has the advantages of lack of requirement for anti-coagulation and avoidance of other problems and complications associated with mechanical prosthetic valves.  Although primarily used for secondary aortic regurgitation due to root dilatation as occurs in Marfan syndrome, guidelines from the European Society of Cardiology (Erbel et al, 2001) stated that aortic valve-sparing re-implantation may also be indicated for patients with type A acute aortic dissections (i.e., dissection of the ascending and descending aorta).

The Society of Thoracic Surgeons’ “Aortic valve and ascending aorta guidelines for management and quality measures” (Svensson et al, 2013) stated that

  • The Ross procedure is not recommended for middle-aged or older adults when suitable alternatives to autograft replacement of the aortic valve are available with comparable results and without the need for replacement of the right ventricular outflow tract (RVOT), as the latter adds the additional risk of pulmonary valve dysfunction and subsequent replacement.  (Level of evidence C)
  • The Ross procedure is not recommended for patients with bicuspid valves and aortic regurgitation or aortic dilation if other alternatives are available.  (Level of evidence C)

Appendix

The pulmonary autograft procedure is contraindicated in individuals with the following conditions:

  • Extremes of age; or
  • Marfan's syndrome; or
  • Multiple pathology in which a second valve replacement device is needed; or
  • Multi-vessel coronary artery disease; or
  • Severely depressed left ventricular function.
 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
33413
Other CPT codes related to the CPB:
33400 - 33403
ICD-9 codes covered if selection criteria are met:
395.0 Rheumatic aortic stenosis
395.1 Rheumatic aortic insufficiency
424.1 Aortic valve disorders [not covered for individuals with bicuspid valves and aortic regurgitation or aortic dilation if other alternatives are available]
441.00 - 441.03 Dissection of aorta
447.70 Aortic ectasia [aortic dilation] [not covered for individuals with bicuspid valves and aortic regurgitation or aortic dilation if other alternatives are available]
747.20 - 747.29 Other anomalies of aorta
746.3 Congenital stenosis of aortic valve
746.4 Congenital insufficiency of aortic valve
Other ICD-9 codes related to the CPB:
396.0 - 396.9 Disease of mitral and aortic valve
414.00 - 414.07 Coronary atherosclerosis
745.0 Common truncus
746.89 - 746.9 Other and unspecified anomaly of heart
747.10 - 747.11 Coarctation of aorta
759.82 Marfan syndrome
V42.2 Heart valve replaced by transplant
V43.3 Heart valve replaced by other means


The above policy is based on the following references:
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  2. Elkins RC, Santangelo K, Stelzer P, et al. Pulmonary autograft replacement of the aortic valve: An evolution of technique. J Cardiac Surg. 1992;7(2):108-116.
  3. Kouchoukos NT, Davila-Roman VG, Spray TL, et al. Replacement of the aortic root with a pulmonary autograft in children and young adults with aortic-valve disease. N Engl J Med. 1994;330(1):1-6.
  4. Joyce F, Tingleff J, Pettersson G. Expanding indications for the Ross operation. J Heart Valve Dis. 1995;4(4):352-363.
  5. Reddy VM, Rajasinghe HA, Teitel DF, et al. Aortoventriculoplasty with the pulmonary autograft: The 'Ross-Konno' procedure. J Thorac Cardiovasc Surg. 1996;111(1):158-167.
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  7. Chambers JC, Somerville J, Stone S, Ross DN. Pulmonary autograft procedure for aortic valve disease. Circulation. 1997;96(7):2206-2214.
  8. Walters HL 3rd, Lobdell KW, Tantengco V, et al. The Ross procedure in children and young adults with congenital aortic valve disease. J Heart Valve Dis. 1997;6(4):335-342.
  9. Elkins RC, Knott-Craig CJ, Ward KE, Lane MM. The Ross operation in children: 10-year experience. Ann Thorac Surg. 1998;65(2):496-502.
  10. Jaggers J, Harrison JK, Bashore TM, et al. The Ross procedure: Shorter hospital stay, decreased morbidity, and cost effective. Ann Thorac Surg. 1998;65(6):1553-1557; discussion 1557-1558..
  11. Jones TK, Lupinetti FM. Comparison of Ross procedures and aortic valve allografts in children. Ann Thorac Surg. 1998;66(Suppl 6):S170-S173.
  12. Rubay JE, Buche M, El Khoury GA, et al. The Ross operation: Mid-term results. Ann Thorac Surg. 1999;67(5):1355-1358.
  13. Roughneen PT, DeLeon SY, Eidem BW, et al. Semilunar valve switch procedure: Autotransplantation of the native aortic valve to the pulmonary position in the Ross procedure. Ann Thorac Surg. 1999;67(3):745-750.
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  17. Briand M, Pibarot P, Dumesnil JG, et al. Midterm echocardiographic follow-up after Ross operation. Circulation. 2000;102(19 Suppl 3):III10-III14.
  18. Laforest I, Dumesnil JG, Briand M, et al. Hemodynamic performance at rest and during exercise after aortic valve replacement: Comparison of pulmonary autografts versus aortic homografts. Circulation. 2002;106(12 Suppl 1):I57-I62.
  19. Takkenberg JJ, Dossche KM, Hazekamp MG, et al. Report of the Dutch experience with the Ross procedure in 343 patients. Eur J Cardiothorac Surg. 2002;22(1):70-77.
  20. Al-Halees Z, Pieters F, Qadoura F, et al. The Ross procedure is the procedure of choice for congenital aortic valve disease. J Thorac Cardiovasc Surg. 2002;123(3):437-441; discussion 441-442.
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  23. Concha M, Aranda PJ, Casares J, et al. Prospective evaluation of aortic valve replacement in young adults and middle-aged patients: Mechanical prosthesis versus pulmonary autograft. J Heart Valve Dis. 2005;14(1):40-46.
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  32. Ono M, Goerler H, Kallenbach K, et al. Aortic valve-sparing reimplantation for dilatation of the ascending aorta and aortic regurgitation late after repair of congenital heart disease. J Thorac Cardiovasc Surg. 2007;133(4):876-879.
  33. Matsumori M, Tanaka H, Kawanishi Y, et al. Comparison of distensibility of the aortic root and cusp motion after aortic root replacement with two reimplantation techniques: Valsalva graft versus tube graft. Interact Cardiovasc Thorac Surg. 2007;6(2):177-181.
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  35. Hanke T, Stierle U, Boehm JO, et al; German Ross Registry. Autograft regurgitation and aortic root dimensions after the Ross procedure: The German Ross Registry experience. Circulation. 2007;116(11 Suppl):I251-I258.
  36. Kabbani S, Jamil H, Nabhani F, et al. Analysis of 92 mitral pulmonary autograft replacement (Ross II) operations. J Thorac Cardiovasc Surg. 2007;134(4):902-908.
  37. David TE. Ross procedure at the crossroads. Circulation. 2009;119(2):207-209.
  38. Takkenberg JJ, Klieverik LM, Schoof PH, et al. The Ross procedure: A systematic review and meta-analysis. Circulation. 2009;119(2):222-228.
  39. Volguina IV, Miller DC, Lemaire SA, et al; Aortic Valve Operative Outcomes in Marfan Patients study group. Valve-sparing and valve-replacing techniques for aortic root replacement in patients with Marfan syndrome: Analysis of early outcome. J Thorac Cardiovasc Surg. 2009;137(3):641-649.
  40. Alsoufi B, Al-Halees Z, Manlhiot C, et al. Mechanical valves versus the Ross procedure for aortic valve replacement in children: Propensity-adjusted comparison of long-term outcomes. J Thorac Cardiovasc Surg. 2009;137(2):362-370.
  41. Piccardo A, Ghez O, Gariboldi V, et al. Ross and Ross-Konno procedures in infants, children and adolescents: A 13-year experience. J Heart Valve Dis. 2009;18(1):76-82; discussion 83.
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  43. Kerendi F, Guyton RA, Vega JD, et al. Early results of valve-sparing aortic root replacement in high-risk clinical scenarios. Ann Thorac Surg. 2010;89(2):471-476; discussion 477-478.
  44. Forteza A, De Diego J, Centeno J, et al. Aortic valve-sparing in 37 patients with Marfan syndrome: Midterm results with David operation. Ann Thorac Surg. 2010;89(1):93-96.
  45. Alsoufi B, Al-Halees Z, Manlhiot C, et al. Superior results following the Ross procedure in patients with congenital heart disease. J Heart Valve Dis. 2010;19(3):269-277; discussion 278.
  46. El-Hamamsy I, Eryigit Z, Stevens LM, et al. Long-term outcomes after autograft versus homograft aortic root replacement in adults with aortic valve disease: A randomised controlled trial. Lancet. 2010;376(9740):524-531.
  47. Wang R, Ma WG, Tian LX, et al. Valve-sparing operation for aortic root aneurysm in patients with Marfan syndrome. Thorac Cardiovasc Surg. 2010;58(2):76-80.
  48. Liu L, Wang W, Wang X, et al. Reimplantation versus remodeling: A meta-analysis. J Card Surg. 2011;26(1):82-87.
  49. Patel ND, Arnaoutakis GJ, George TJ, et al. Valve-sparing aortic root replacement in children: Intermediate-term results. Interact Cardiovasc Thorac Surg. 2011;12(3):415-419.
  50. Benedetto U, Melina G, Takkenberg JJ, et al. Surgical management of aortic root disease in Marfan syndrome: A systematic review and meta-analysis. Heart. 2011;97(12):955-958.
  51. Shrestha M, Baraki H, Maeding I, et al. Long-term results after aortic valve-sparing operation (David I). Eur J Cardiothorac Surg. 2012;41(1):56-61; discussion 61-62.
  52. Luciani GB, Lucchese G, De Rita F, et al. Reparative surgery of the pulmonary autograft: Experience with Ross reoperations. Eur J Cardiothorac Surg. 2012;41(6):1309-1314; discussion 1314-1315.
  53. Leontyev S, Trommer C, Subramanian S, et al. The outcome after aortic valve-sparing (David) operation in 179 patients: A single-centre experience. Eur J Cardiothorac Surg. 2012;42(2):261-266; discussion 266-267.
  54. Subramanian S, Leontyev S, Borger MA, et al. Valve-sparing root reconstruction does not compromise survival in acute type A aortic dissection. Ann Thorac Surg. 2012;94(4):1230-1234.
  55. Kvitting JP, Kari FA, Fischbein MP, et al. David valve-sparing aortic root replacement: Equivalent mid-term outcome for different valve types with or without connective tissue disorder. J Thorac Cardiovasc Surg. 2013;145(1):117-126, 127.e1-e5; discussion 126-127.
  56. Svensson LG, Adams DH, Bonow RO, et al. Aortic valve and ascending aorta guidelines for management and quality measures. Ann Thorac Surg. 2013;95(6 Suppl):S1-S66. Available at: http://www.guideline.gov/content.aspx?id=47278&search=Ross+pulmonary+autograft+. Accessed March 25, 2014.


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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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