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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.

  4. Aetna considers aortic valve-sparing procedures medically necessary for the treatment of aortic root ectasia, and dissection and aneurysms of the ascending aorta.

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)

Guidelines from the European Society of Cardiology (Erbel, et al., 2014) state that In most cases of aortic insufficiency associated with acute Type A dissection, the aortic valve is essentially normal and can be preserved by applying an aortic valve-sparing repair of the aortic root. In cases of aneurysms of the ascending aorta, where total replacement is indicated, the choice between a valve-sparing intervention and a composite graft with a valve prosthesis depends on the analysis of aortic valve function and anatomy, the size and site of TAA, life expectancy, desired anticoagulation status, and the experience of the surgical team.

Similarly, guidelines from the American College of Cardiology (Hiratzka, et al., 2010) state that extensive dissection of the aortic root should be treated with aortic root replacement with a composite graft or with a valve sparing root replacement.

Stephens et al (2014) examined if recurrent or residual mild aortic regurgitation, which occurs after valve-sparing aortic root replacement, progresses over time.  Between 2003 and 2008, a total of 154 patients underwent Tirone David-V valve-sparing aortic root replacement; 96 patients (62 %) had both 1-year (median of 12 ± 4 months) and mid-term (62 ± 22 months) transthoracic echocardiograms available for analysis.  Age of patients averaged 38 ± 13 years, 71 % were male, 31 % had a bicuspid aortic valve, 41 % had Marfan syndrome, and 51 % underwent aortic valve repair, predominantly cusp free margin shortening.  A total of 41 patients (43 %) had mild aortic regurgitation on 1-year echocardiogram.  In 85 % of patients (n = 35), mild aortic regurgitation remained stable on the most recent echocardiogram (median of 57 ± 20 months); progression to moderate aortic regurgitation occurred in 5 patients (12 %) at a median of 28 ± 18 months and remained stable thereafter; severe aortic regurgitation developed in 1 patient, eventually requiring re-operation.  Five patients (5 %) had moderate aortic regurgitation at 1 year, which did not progress subsequently.  Two patients (2 %) had more than moderate aortic regurgitation at 1 year, and both ultimately required re-operation.  The authors concluded that although mild aortic regurgitation occurs frequently after valve-sparing aortic root replacement, it is unlikely to progress over the next 5 years and should not be interpreted as failure of the valve-preservation concept.  Further, these investigators suggested that mild aortic regurgitation should not be considered non-structural valve dysfunction, as the 2008 valve reporting guidelines would indicate.  The authors noted that 10- to 15-year follow-up is needed to learn the long-term clinical consequences of mild aortic regurgitation early after valve-sparing aortic root replacement.

In a retrospective study, Gamba and colleagues (2015) evaluated their experience of using a simplified aortic valve sleeve procedure to treat aortic root ectasia and aneurysms with or without aortic regurgitation.  In experienced hands, 2 aortic valve-sparing procedures, namely, Yacoub and David, have yielded excellent long-term results in the treatment of aortic root aneurysms, with or without aortic regurgitation.  However, these techniques are demanding and not widely used.  Recently, a new and simplified valve-sparing technique, named "sleeve procedure", has been proposed, and has yielded encouraging early results.  A total of 90 consecutive patients with aortic root aneurysms underwent sleeve procedures from October 2006 to October 2012.  Follow-up data (clinical 100 % complete and echocardiographic 93 % complete) were acquired from the authors’ out-patient clinic or from the referring cardiologist.  The mean age of the patients was 61.5 ± 12.5 years, 79 % were male, 16 (18 %) had a bicuspid valve, 3 had Marfan syndrome, and 2 had aortic dissection.  Over a mean clinical follow-up of 34 ± 19 months, 2 patients died from non-cardiac causes and 1 was re-operated on for the recurrence of aortic regurgitation.  On follow-up echocardiography after a mean of 18 ± 9 months, aortic regurgitation was absent/negligible, mild or moderate in 62 %, 37 %, and 1 % of patients, respectively, and the diameters of the annulus, Valsalva sinuses, and sino-tubular junction were 27.3 + 2.2, 37.0 + 3.4, and 30.6 + 3.1 mm, respectively.  The authors concluded that these encouraging early and medium term results suggested that the sleeve procedure is a safe and effective aortic valve-sparing technique for the treatment of aortic root ectasia and aneurysm.  However, they stated that longer follow-up is needed in order to draw definitive conclusions.

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:
33400 - 33403 Valvuloplasty, aortic valve
33413 Replacement, aortic valve; by translocation of autologous pulmonary valve with allograft replacement of pulmonary valve (Ross procedure)
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 - 441.9 Aortic aneurysm and dissection
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:
    1. Ross D, Jackson M, Davies J. The pulmonary autograft - a permanent aortic valve. Eur J Cardiothorac Surg. 1992;6(3)113-116; discussion 117.
    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.
    6. Oury JH. Clinical aspects of the Ross procedure: Indications and contraindications. Semin Thorac Cardiovasc Surg. 1996;8(4):328-335.
    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.
    14. Oswalt JD. Acceptance and versatility of the Ross procedure. Curr Opin Cardiol. 1999;14(2):90-94.
    15. Legarra JJ, Concha M, Casares J, et al. Left ventricular remodeling after pulmonary autograft replacement of the aortic valve (Ross operation). J Heart Valve Dis. 2001;10(1):43-48.
    16. Linden PA, Cohn LH. Medium-term follow up of pulmonary autograft aortic valve replacement: Technical advances and echocardiographic follow up. J Heart Valve Dis. 2001;10(1):35-42.
    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.
    21. Dalshaug DB, Caldarone CA, Camp P. Aortic valve disease and the Ross operation. eMedicine Pediatrics Topic 2823. Omaha, NE: eMedicine.com; updated July 18, 2003. Available at: http://www.emedicine.com/ped/topic2823.htm. Accessed June 24, 2004.
    22. Raja SG, Pozzi M. Growth of pulmonary autograft after Ross operation in pediatric patients. Asian Cardiovasc Thorac Ann. 2004;12(4):285-290.
    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.
    24. Jamieson WRE, Cartier PC. Surgical management of valvular heart disease 2004. Canadian Cardiovascular Society Consensus Conference. Can J Cardiol. 2004;20(Suppl E):7E-120E.
    25. Erbel R, Alfonso F, Boileau C, et al; Task Force on Aortic Dissection, European Society of Cardiology. Diagnosis and management of aortic dissection. Eur Heart J. 2001;22(18):1642-1681.
    26. David TE, Ivanov J, Armstrong S, et al. Aortic valve-sparing operations in patients with aneurysms of the aortic root ro ascending aortia. Ann Thorac Surg. 2002;74(5):S1758-S1761; discussion S1792-S1799.
    27. Karck M, Kallenbach K, Hagl C, et al. Aortic root surgery in Marfan syndrome: Comparison of aortic valve-sparing reimplantation versus composite grafting. J Thorac Cardiovasc Surg. 2004;127(2):391-398.
    28. Kallenbach K, Karck M, Pak D, et al. Decade of aortic valve sparing reimplantation: Are we pushing the limits too far? Circulation. 2005;112(9 Suppl):I253-I259.
    29. Pacini D, Settepani F, De Paulis R, et al. Early results of valve-sparing reimplantation procedure using the Valsalva conduit: A multicenter study. Ann Thorac Surg. 2006;82(3):865-871; discussion 871-872.
    30. Kallenbach K, Baraki H, Khaladj N, et al. Aortic valve-sparing operation in Marfan syndrome: What do we know after a decade? Ann Thorac Surg. 2007;83(2):S764-S768; discussion S785-S790.
    31. Settepani F, Szeto WY, Pacini D, et al. Reimplantation valve-sparing aortic root replacement in Marfan syndrome using the Valsalva conduit: An intercontinental multicenter study. Ann Thorac Surg. 2007;83(2):S769-S773; discussion S785-S790.
    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.
    34. Raja SG, Pollock JC. Current outcomes of Ross operation for pediatric and adolescent patients. J Heart Valve Dis. 2007;16(1):27-36.
    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.
    42. David TE, Woo A, Armstrong S, Maganti M. When is the Ross operation a good option to treat aortic valve disease? J Thorac Cardiovasc Surg. 2010;139(1):68-73; discussion 73-75.
    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.
    57. Erbel R, Aboyans V, Boileau C, et al; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014;35(41):2873-926.
    58. Hiratzka LF, Bakris GL, Beckman JA, et al.; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American College of Radiology; American Stroke Association; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society of Thoracic Surgeons; Society for Vascular Medicine. 2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM guidelines for the diagnosis and management of patients with Thoracic Aortic Disease: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, American Association for Thoracic Surgery, American College of Radiology, American Stroke Association, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Thoracic Surgeons, and Society for Vascular Medicine. Circulation. 2010;121(13):e266-e369.
    59. Hu R, Wang Z, Hu X, et al. Effect of native aortic valve sparing aortic root reconstruction surgery on short- and long-term prognosis in Marfan syndrome patients: A meta-analysis. Zhonghua Xin Xue Guan Bing Za Zhi. 2014;42(5):433-438.
    60. Saczkowski R, Malas T, Mesana T, et al. Aortic valve preservation and repair in acute Type A aortic dissection. Eur J Cardiothorac Surg. 2014;45(6):e220-226.
    61. Stephens EH, Liang DH, Kvitting JP, et al.  Incidence and progression of mild aortic regurgitation after Tirone David reimplantation valve-sparing aortic root replacement. J Thorac Cardiovasc Surg. 2014;147(1):169-177.
    62. Gamba A, Tasca G, Giannico F, et al. Early and medium term results of the sleeve valve-sparing procedure for aortic root ectasia. Ann Thorac Surg. 2015 Feb 3 [Epub ahead of print].


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