Percutaneous balloon valvuloplasty is a method of treating stenotic pulmonary, mitral, and aortic valves without open surgery.

For pulmonary valvuloplasty, a balloon-tipped catheter is passed from the femoral or brachial vein into the right atrium. From there it is threaded just to the entrance of the right ventricle, the site of the pulmonic valve. By puncturing the atrial septum, access can also be obtained for either the mitral or aortic valves. The femoral artery can also be used to avoid septal puncture. When the balloon is positioned at the heart valve, a series of inflation-deflation cycles are required to relieve stenosis.

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 in Adolescents and Young Adults (in early 20s)
 
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.

Aortic Balloon Valvotomy for Aortic Stenosis in Adults
 
Percutaneous aortic balloon valvuloplasty may be considered medically necessary for adult patients with aortic stenosis who the following criteria:

• 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 perctaneous 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.*moderate or severe mitral stenosis is defined as mitral valve area < =1.5 cm2

BlueCard/National Account Issues

No applicable information

This policy is based on 1998 guidelines published by the American College of Cardiology in conjunction with the American Heart Association. (1) The guidelines were based on a review of the literature and additional input from an expert panel. The panel assigned their policy statements to one of three categories as follows:

Class I: Conditions for which there is evidence and/or general agreement that given procedure is useful or effective.

Class II: Conditions for which there is conflicting evidence and a divergent opinion about the usefulness/efficacy of a procedure or treatment.
 
IIa. Weight of evidence/opinion is in favor of usefulness/efficacy
 
IIb. Usefulness/efficacy is less well established by evidence/opinion.

Class III. Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful and in some cases may be harmful.

For the purposes of this policy, all indications categorized as Class I or Class IIa are considered to be medically necessary indications.

References:

1. 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.

Balloon valvuloplasty
Percutaneous balloon valvuloplasty
Valvuloplasty, percutaneous balloon