Percutaneous Balloon Valvuloplasty

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, Twave 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 . Policy Guidelines 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. Benefit Application BlueCard/National Account Issues Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage. Background The technique of balloon valvuloplasty (also called valvotomy or commissurotomy) involves the percutaneous transcatheter insertion of 1 or more large balloons into the aortic and/or mitral valve.  The balloons are then inflated across the stenotic valve in order to decrease the degree of obstruction within the valve. Balloon mitral commissurotomy (BMC) has become the procedure of choice for the treatment of adult patients with rheumatic mitral stenosis.  Recent studies have shown that the long-term results of BMC are superior to open surgical commissurotomy in patients who have favorable mitral valve anatomy as determined by echocardiographic examination.  Criteria have been developed to identify which patients with symptomatic mitral stenosis are most likely to benefit from balloon valvuloplasty.  The valve is assessed on the basis of 4 characteristics, each of which is graded on a scale from 0 to 4 (favorable to unfavorable): leaflet mobility; valvular thickening; subvalvular thickening; and valvular calcification. leaflet mobility; valvular thickening; subvalvular thickening; and valvular calcification. Good procedural results have been obtained with echocardiographic scores of 8 or less, that is the valve characteristics include a pliable, non-calcified valve with mild subvalvular disease and no or mild mitral regurgitation. Aortic balloon valvuloplasty in adults with calcific aortic stenosis has been fraught with short-lived hemodynamic benefit and high rates of re-stenosis.  Despite disappointing intermediate-term (6 to 12 months) results, the procedure does have its role in the management of critical aortic stenosis in patients who are not surgical candidates. Balloon valvuloplasty has been used in children with congenital critical aortic stenosis, until the child is old enough to have valve replacement (NICE, 2004).  A comparative study involving 110 neonates with critical aortic stenosis found the mean reduction in systolic gradient to be 65 % for neonates treated with balloon valvuloplasty, compared to 41 % for neonates treated with open surgery (McCrindle et al, 2001).  Aortic regurgitation rates were 18 % (15/82) in the balloon valvuloplasty group compared with 3 % (1/28) in the open surgery group.  Immediate major complications were reported in 4 % (3/82) of the balloon valvuloplasty group and 0 % (0/28) of the open surgery group. Pulmonary valve stenosis is a congenital heart defect in which blood flow from the heart to the pulmonary artery is blocked.  Symptoms include cyanosis, fainting, fatigue, chest pains, shortness of breath, poor weight gain or failure to strive in infants, and, in some instances, sudden death.  If the stenosis is severe, the pulmonary valve must be opened to increase blood flow to the lungs.  Based upon limited evidence from published case series, the National Institute for Health and Clinical Excellence (NICE) concluded that percutaneous balloon valvuloplasty is an established alternative to open surgical valvotomy for pulmonary valve stenosis (NICE, 2004). Trans-esophageal echocardiogram (TEE) measurement alone of the aortic annulus may not be adequate to select a transcatheter heart valve (THV) size.  Balloon aortic valvuloplasty (BAV) can more accurately size the aortic annulus.  Babaliaros et al (2010) described the use of BAV to select proper THV size in patients undergoing THV implantation.  A total of 27 patients underwent sizing of the aortic annulus by BAV and TEE.  These researchers implanted the minimal THV size that was greater than the annulus measured by BAV.  The annulus measured by TEE was 21.3 +/- 1.6 mm and by BAV was 22.6 +/- 1.8 mm (p < 0.001).  The number of balloon inflations was 2.7 +/- 0.7 (range of 2 to 4), and the balloon sizes used were 22.0 +/- 1.8 mm (range of 20 to 25 mm).  Fourteen patients (52 %) required up-sizing of the initial balloon suggested by TEE; rapid pacing duration was 8 +/- 1.3 s (range of 6 to 11 s).  No change in aortic insufficiency or hemodynamic instability occurred with BAV.  Fifteen patients (56 %) received a 23-mm THV; 12 patients a 26-mm THV.  No coronary occlusion, annular damage, or THV embolization occurred.  Para-valvular leak was grade less than or equal to 1 in all patients.  In 7 patients (26 %), balloon sizing resulted in selection of a specific THV size that could not be done by TEE alone.  The authors concluded that BAV sizing of the aortic annulus is safe and is an important adjunct to TEE when selecting THV size.  Implanting the minimal THV greater than the BAV annulus size resulted in no adverse events.  These findings suggested that use of BAV for THV selection may improve the safety and effectiveness of THV implantation.  These preliminary findings need to be validated by well-designed studies. Singh et al (2015) stated that the use of percutaneous aortic balloon valvotomy (PABV) in high surgical risk patients has resurged because of development of less invasive endovascular therapies.  These investigators compared outcomes of concomitant PABV and percutaneous coronary intervention (PCI) with PABV alone during same hospitalization using nation's largest hospitalization database.  They identified patients and determined time trends using the International Classification of Diseases, Ninth Revision, Clinical Modification, procedure code for valvulotomy from Nationwide Inpatient Sample database 1998 to 2010.  Only patients greater than 60 years with aortic stenosis were included.  Primary outcome included in-hospital mortality, and secondary outcomes included procedural complications, length of stay (LOS), and cost of hospitalization.  A total 2,127 PABV procedures were identified, with 247 in PABV + PCI group and 1,880 in the PABV group.  Utilization rate of concomitant PABV + PCI during same hospitalization increased by 225 % from 5.1 % in 1998 to 1999 to 16.6 % in 2009 to 2010 (p < 0.001).  Overall in-hospital mortality rate and complication rates in PABV + PCI group were similar to that of PABV group (10.3 % versus 10.5 % and 23.4 % versus 24.7 %, respectively).  PABV + PCI group had similar LOS but higher hospitalization cost (median [interquartile range] $30,089 [$21,925 to $48,267] versus $18,421 [$11,482 to $32,215], p < 0.001) in comparison with the PABV group.  Unstable condition, occurrence of any complication, and weekend admission were the main predictors of increased LOS and cost of hospital admission.  The authors concluded that concomitant PCI and PABV during the same hospitalization are not associated with change in in-hospital mortality, complications rate, or LOS compared with PABV alone; however, it increases the cost of hospitalization.