Pulmonic Balloon Valvotomy for Pulmonary Stenosis 
Percutaneous balloon valvuloplasty may be considered medically necessary in symptomatic patients or in patients with right ventricular to pulmonary artery peak gradient of 40 mm Hg or greater.

Aortic Balloon Valvotomy for Aortic Stenosis 

1. Percutaneous aortic balloon valvuloplasty may be considered medically necessary for adolescent patients and young adults in their early 20s with aortic stenosis who meet any one of the following criteria:
   • Symptoms of angina, syncope and dyspnea on exertion, with catheterization peak gradient ≥ 50 mm Hg.
   • Catheterization peak gradient >60 mm Hg.
   • New-onset ischemic or repolarization changes on EKG at rest or with exercise (ST depression, T-wave inversion over left precordium) with a gradient >50 mm Hg.
   • Catheterization peak gradient >50 mm Hg if patient wants to play competitive sports or desires to become pregnant.
   • For palliative use in children with congenital critical aortic valve stenosis, until the child is old enough to have a valve replacement.
2. Percutaneous aortic balloon valvuloplasty may be considered medically necessary for adult patients with aortic stenosis as a bridge to surgery in hemodynamically unstable patients who are at high risk for aortic valve replacement.

Mitral Balloon Valvotomy for Mitral Valve Stenosis
Percutaneous balloon valvuloplasty may be considered medically necessary for patients with mitral valve stenosis who meet any of the following criteria:

• Symptomatic patients (NYHA functional Class II, III or IV), moderate or severe mitral stenosis and valve morphology favorable for percutaneous balloon valvotomy in the absence of left atrial thrombus or moderate to severe mitral regurgitation.
• Asymptomatic patients with moderate or severe mitral stenosis* and valve morphology favorable for percutaneous balloon valvotomy who have pulmonary hypertension (pulmonary artery systolic pressure >50 mm Hg at rest or 60 mm Hg with exercise) in the absence of left atrial thrombus or moderate to severe mitral regurgitation.
• Patients with NYHA functional Class III-IV symptoms, moderate or severe mitral stenosis* and a nonpliable calcified valve who are at high risk for surgery in the absence of left atrial thrombus or moderate to severe mitral stenosis.
• Patients 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.
• Patients with favorable valve anatomy and a cumulative score of 8 or less on echocardiographic criteria (e.g., a pliable, non-calcified valve with mild subvalvular disease and no or mild mitral regurgitation).

*Moderate or severe mitral stenosis is defined as mitral valve area ≤=1.5 cm2.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Place of Service: Inpatient

Description

The technique of percutaneous balloon valvuloplasty involves the percutaneous insertion of one or more large balloons into the aortic, mitral, or pulmonary valve. The balloons are then inflated across the stenotic valve in order to decrease the degree of obstruction within the valve.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

Percutaneous balloon mitral valvuloplasty in patients with mitral restenosis after previous surgical commissurotomy, European Heart Journal, 1996

One year outcome of cardioversion of atrial fibrillation in patients with mitral stenosis after percutaneous balloon mitral valvuloplasty, American Journal of Cardiology, Vol. 97, No. 7, 04/2006

Comparison of long-term outcome after mitral valve replacement or repeated balloon mitral valvotomy in patients with restenosis after previous balloon valvotomy, American Journal of Cardiology, Vol. 99, No. 11, 06/2007

Percutaneous mitral valvuloplasty versus surgical treatment in mitral stenosis with severe tricuspid regurgitation, Circulation, Vol. 116, 09/2007

Bonow RO, Carabello B, de Leon AC Jr, et al. Guidelines for the management of patients with valvular heart disease: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 1998;98(18):1949-84.

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.

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.

Blue Cross and Blue Shield Association. Percutaneous Balloon Valvuloplasty. Medical Policy Reference Manual 7.01.17. Issued March, 2003.

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 October 27, 2010.

InterQual® Level of Care Criteria 2010. Acute Care Adult. McKesson Health Solutions, LLC.