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Aetna Better Health®
2000 Market Suite Ste. 850
Philadelphia, PA 19103
AETNA BETTER HEALTH®
Clinical Policy Bulletin:
Selected Aortic Valve Procedures:
Ross Pulmonary Autograft and Aortic
Valve-Sparing Re-implantation
Number: 0407
Policy
I. 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:
A. Aortic incompetence (including endocarditis, rheumatism of the
heart); or
B. Aortic stenosis; or
C. Complex left ventricular outflow tract obstruction; or
D. 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.
II. Aetna considers the minimally invasive approach to the aortic valve a
medically necessary acceptable alternative to the conventional approach to
aortic valve replacement.
III. Aetna considers aortic valve-sparing re-implantation medically necessary
for the treatment of secondary aortic regurgitation due to aortic root
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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.
IV. 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).
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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 valvesparing 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 followup is needed to learn the long-term clinical consequences of mild aortic
regurgitation early after valve-sparing aortic root replacement.
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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:
33413
Replacement, aortic valve; by translocation of autologous
pulmonary valve with allograft replacement of pulmonary valve
(Ross procedure)
33400 33403
Valvuloplasty, aortic valve
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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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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.
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JH. Clinical aspects of the Ross procedure: Indications and
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children: 10-year experience. Ann Thorac Surg. 1998;65(2):496-502.
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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.
CPT only copyright 2008 American Medical Association. All Rights Reserved.
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