Balloon Valvuloplasty

Number: 0477

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

1. Aetna considers percutaneous balloon dilation (valvuloplasty) of severe rheumatic mitral valve stenosis medically necessary in members who meet any of the following:

   1. Members in the second and third trimesters of pregnancy in whom balloon valvuloplasty would be expected to achieve hemodynamic and symptomatic improvement with minimal risk to the mother and fetus, or
   2. Members with favorable valve anatomy and a cumulative score of 8 or less on echocardiographic criteria (see below), or
   3. Members with mitral valve re-stenosis after previous open surgical commissurotomy; or
   4. Members with unfavorable valve anatomy who are poor surgical candidates because of medical co-morbidities or refuse surgery. 

2. Aetna considers percutaneous balloon dilation of severe aortic valve stenosis medically necessary in members who meet any of the following:

   1. As a "bridge" to aortic valve replacement in members with severe heart failure who are at extremely high operative risk, or
   2. For palliative use in children with congenital critical aortic valve stenosis, until the child is old enough to have a valve replacement; or
   3. Members in the second and third trimesters of pregnancy with critical aortic stenosis, or
   4. Members who are not candidates for surgical valve replacement because of medical co-morbidities, but in whom balloon valvuloplasty would be expected to palliate severe symptoms or stabilize cardiogenic shock, or
   5. Members with critical aortic stenosis who have an absolute surgical contraindication or refuse surgical treatment; or
   6. Members with severe aortic stenosis who must undergo an urgent non-cardiac operation (e.g., gastrointestinal bleeding) and whose surgical risk would be reduced with the improvement in hemodynamic status afforded by balloon valvuloplasty.

3. Aetna considers percutaneous balloon dilation medically necessary for pulmonary valve stenosis.

4. Aetna considers percutaneous balloon dilation experimental and investigational for all other indications because of insufficient evidence of safety and effectiveness.

5. Aetna considers balloon aortic valvuloplasty for selection of proper transcatheter heart valve (THV) size in persons undergoing THV implantation experimental and investigational because its effectiveness for this indication has not been established.

6. Aetna considers percutaneous balloon valvuloplasty for bioprosthetic tricuspid valve stenosis experimental and investigational because of insufficient evidence of safety and effectiveness.

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
Percutaneous balloon dilation of severe rheumatic mitral stenosis:
CPT codes covered if selection criteria are met:
92987	Percutaneous balloon valvuloplasty; mitral valve
Other CPT codes related to the CPB:
33476	Right ventricular resection for infundibular stenosis, with or without commissurotomy
33478	Outflow tract augmentation (gusset), with or without commissurotomy or infundibular resection
93303 - 93350	Echocardiography
ICD-10 codes covered if selection criteria are met:
I05.0	Rheumatic mitral stenosis
I05.2	Rheumatic mitral stenosis with insufficiency
I08.0	Rheumatic disorders of both mitral and aortic valves
I08.8	Other rheumatic multiple valve diseases
O99.412 - O99.413	Diseases of the circulatory system complicating pregnancy, 2nd or 3rd trimester
Percutaneous balloon dilation of severe aortic stenosis:
CPT codes covered if selection criteria are met:
92986	Percutaneous balloon valvuloplasty; aortic valve
Other CPT codes related to the CPB:
33405 - 33413	Replacement of aortic valve
ICD-10 codes covered if selection criteria are met:
I06.0	Rheumatic aortic stenosis
I06.2	Rheumatic aortic stenosis with insufficiency
I08.0	Rheumatic disorders of both mitral and aortic valves
I08.8	Other rheumatic multiple valve diseases
I35.0 - I35.9	Nonrheumatic aortic valve disorders
I70.0	Atherosclerosis of aorta
Q23.0	Congenital stenosis of aortic valve
Q25.21 - Q25.4	Congenital malformations of great arteries
Percutaneous balloon dilation of pulmonary valve:
CPT codes covered if selection criteria are met:
92990	Percutaneous balloon valvuloplasty; pulmonary valve
ICD-10 codes covered if selection criteria are met:
I09.89	Other specified rheumatic heart diseases
I37.0 - I37.9	Nonrheumatic pulmonary valve disorders
Q22.1 - Q22.2	Congenital malformations of pulmonary valve
Percutaneous balloon valvuloplasty for bioprosthetic tricuspid valve stenosis:
Other CPT codes related to the CPB:
33460	Valvectomy, tricuspid valve, with cardiopulmonary bypass
33463	Valvuloplasty, triscspid valve; without ring insertion
33464	with ring insertion

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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.

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.

Percutaneous Balloon Valvuloplasty for Bioprosthetic Tricuspid Valve Stenosis

Rana and colleagues (2017) noted that percutaneous transcatheter tricuspid balloon valvuloplasty (PTTBV) is an accepted treatment option for symptomatic severe native tricuspid valve stenosis, although surgical tricuspid valve replacement remains the treatment of choice.  There have been few reports of successful PTTBV for bioprosthetic tricuspid valve stenosis.  These researchers presented case reports of 3 patients from their hospital experience; 2 of the 3 cases were successful, with lasting clinical improvement, whereas the 3rd patient failed to show a reduction in valve gradient.  These investigators described the standard technique used for PTTBV, and presented results from a literature review that identified 16 previously reported cases of PTTBV for bioprosthetic severe tricuspid stenosis, with overall favorable results.  The authors concluded that PTTBV should perhaps be considered for a select patient population in which symptomatic improvement and hemodynamic stability are desired immediately, and particularly for patients who are inoperable or at high surgical risk.

The authors stated that there have been no randomized controlled trials (RCTs) to prove the effectiveness of PTTBV.  Although these case reports suggested that PTTBV for stenosis of bioprosthetic TVs is effective and is associated with low morbidity, isolated case reports almost certainly carry a degree of publication bias.  It is conceivable that PTTBV has been performed in a multitude of patients who had less favorable results, reports of which were not presented or not accepted for publication.  One of the 3 patients in this study failed to gain hemodynamic or symptomatic benefit from the procedure.  They stated that further evidence is needed before PTTBV can be recommended as a frontline therapy for such patients; in the meanwhile, surgical correction of stenosed bioprosthetic valves remains the preferred method of treatment.

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement

Leclercq and colleagues (2020) stated that randomized studies are lacking comparing transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) against the conventional technique of TAVR with BAV.  These researchers examined device success of TAVR using new-generation balloon-expandable prostheses with or without BAV.  The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) Trial was an open-label, non-inferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty.  The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7 % non-inferiority margin.  The secondary endpoint included procedural and 30-day adverse events (AEs).  Device success was recorded for 184 of 236 included patients (78.0 %).  The rate of device success in the direct implantation group (n = 97 [80.2 %]) was non-inferior to that in the BAV group (n = 87 [75.7 %]) (mean difference [MD] 4.5 %; 95 % confidence interval [CI]: -4.4 % to 13.4 %; p = 0.02 for non-inferiority).  No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group.  In the direct implantation group, 7 patients (5.8% ) needed BAV to cross the valve; AEs were related mainly to pacemaker implantation (20.9 % in the BAV group versus 19.0 % in the direct implantation group; p = 0.70).  No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.  The authors concluded that direct TAVR without prior BAV was non-inferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification.  BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy.

Balloon Aortic Valvuloplasty for Severe Aortic Stenosis as Rescue or Bridge Therapy

Kleczynski and colleagues (2021) examined procedural complications, patient flow and clinical outcomes following (BAV as rescue or bridge therapy, based on data from their registry.  A total of 382 BAVs in 374 patients was carried out.  The main primary indication for BAV was a bridge for TAVI (n = 185, 49.4 %).  Other indications included a bridge for aortic valve implantation (AVR; n = 26, 6.9 %) and rescue procedure in hemodynamically unstable patients (n = 139, 37.2 %).  The mortality rate at 30 days, 6 and 12 months was 10.4 %, 21.6 %, 28.3 %, respectively.  In rescue patients, the death rate increased to 66.9 % at 12 months.  A significant improvement in symptoms was confirmed after BAV, after 30 days, 6 months, and in survivors after 1 year (p < 0.05 for all).  Independent predictors of 12-month mortality were baseline Society of Thoracic Surgeons (STS) score [hazard ratio [HR] 1.42; 95 % CI: 1.34 to 2.88), p < 0.0001], baseline left ventricle ejection fraction (LVEF) of less than 20 % [HR 1.89; 95 % CI: 1.55 to 2.83), p < 0.0001] and LVEF of less than 30 % at 1 month [HR 1.97; 95 % CI: 1.62 to 3.67), p < 0.0001] adjusted for age/gender.  In everyday clinical practice in the TAVI era, there are still clinical indications to BAV a standalone procedure as a bridge to surgery, TAVI or for urgent high risk non-cardiac surgical procedures.  Patients may improve clinically following BAV with LV function recovery, allowing to perform final therapy, within limited time window, for severe AS which ameliorated long-term outcomes.  On the other hand, in patients for whom an isolated BAV becomes a destination therapy, prognosis was extremely poor.

Mini-Invasive Radial Balloon Aortic Valvuloplasty

Tumscitz and colleagues (2021) confirmed safety and feasibility of mini-invasive radial BAV; evaluated its impact in terms of quality of life (QOL) and frailty; and examined if changes in frailty following BAV are associated with death in patients undergoing transcatheter aortic valve implantation (TAVI).  A total of 330 patients undergoing BAV in 16 Italian centers were prospectively included.  The primary endpoint was the occurrence of major and minor Valve Academic Research Consortium (VARC)-2 bleeding.  Secondary endpoints were scales of QOL, frailty, evaluated at baseline and 30 days, and their relationship with the occurrence of all-cause death.  BAV was performed by radial access in 314 (95 %) patients.  No VARC-2 major and 6 (1.8 %) VARC-2 minor bleedings occurred in the study population.  QOL, as well as frailty status, significantly improved 30 days after BAV.  At 1 year, patients undergoing TAVI with baseline essential frailty toolset (EFT) of less than 3 or achieving an EFT of less than 3 after BAV had a comparable occurrence of all-cause death (15 % versus 19 %, p = 0.58).  In contrast, patients with EFT greater than or equal to 3 at 30 days despite BAV showed the worst prognosis (all-cause death: 40 % versus 15 % and 19 %, p = 0.006 and p = 0.05, respectively).  The authors concluded that mini-invasive radial BAV was safe, feasible and associated with a low rate of vascular complications.  Patients improving EFT 30 days after BAV showed a favorable outcome following TAVI.

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References