Balloon Valvuloplasty

Number: 0477

Table Of Contents

Applicable CPT / HCPCS / ICD-10 Codes


Scope of Policy

This Clinical Policy Bulletin addresses balloon valvuloplasty.

  1. Medical Necessity

    Aetna considers percutaneous balloon dilation (valvuloplasty) medically necessary for the following indications when criteria are met:

    1. Severe rheumatic mitral valve stenosis 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. Severe aortic valve stenosis 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. Pulmonary valve stenosis.
  2. Experimental and Investigational

    The following procedures are considered experimental and investigational because the effectiveness of these approaches has not been established:

    1. Balloon aortic valvuloplasty for selection of proper transcatheter heart valve (THV) size in persons undergoing THV implantation;
    2. Percutaneous balloon valvuloplasty for bioprosthetic tricuspid valve stenosis;
    3. Percutaneous balloon dilation for all other indications not listed in Section I.


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


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):
  1. leaflet mobility;
  2. valvular thickening;
  3. subvalvular thickening; and
  4. 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.

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.

Fetal Aortic Valvuloplasty for the Treatment of Aortic Stenosis

Vorisek et al (2022) stated that fetal aortic valvuloplasty (FAV) has become a therapeutic option for critical fetal aortic stenosis (AS) with the objective of preserving bi-ventricular circulation (BVC); however, to-date, it is unclear how many patients undergoing FAV achieved BVC.  In a systematic review and meta-analysis, these investigators examined the type of post-natal circulation achieved following FAV.  The PRISMA guidelines were followed.  Medline, Embase, Web of Science and the Cochrane Library were searched systematically for studies examining post-natal circulation in patients with AS following FAV.  Eligible for inclusion were original studies in the English language, published from 2000 to 2020, with at least 12 months of follow-up after birth.  Review papers, abstracts, expert opinions, books, editorials and case reports were excluded.  The titles and abstracts of all retrieved literature were screened, duplicates were excluded; and the full texts of potentially eligible articles were obtained and assessed.  The primary endpoint was type of post-natal circulation.  Additional assessed outcomes included fetal death, live-birth, neonatal death (NND), termination of pregnancy (TOP) and technical success of the FAV procedure.  The quality of articles was assessed using the Critical Appraisal Skills Program (CASP) tool.  To estimate the overall proportion of each endpoint, meta-analysis of proportions was employed using a random-effects model.  The electronic search identified 579 studies, of which 7 were considered eligible for inclusion in the systematic review and meta-analysis.  A total of 266 fetuses underwent FAV with median follow-up per study from 12 months to 13.2 years.  There were no maternal deaths and only 1case of FAV-related maternal complication was reported.  Hydrops was present in 29 (11 %) patients.  The pooled prevalence of BVC and uni-ventricular circulation (UVC) among live-born patients was 45.8 % (95 % CI: 39.2 % to 52.4 %) and 43.6 % (95 % CI: 33.9 % to 53.8 %), respectively.  The pooled prevalence of technically successful FAV procedure was 82.1 % (95 % CI: 74.3 % to 87.9 %), of fetal death it was 16.0 % (95 % CI: 11.2 % to 22.4 %), of TOP 5.7 % (95 % CI: 2.0 % to 15.5 %), of live-birth 78.8 % (95 % CI: 66. % to 87.4 %), of NND 8.7 % (95 % CI: 4.7 % to 15.5 %), of palliative care 4.0 % (95 % CI: 1.9 % to 8.4 %) and of infant death 10.3 % (95 % CI: 3.6 % to 26.1 %).  The pooled prevalence of BVC and UVC among live-born patients who had technically successful FAV was 51.9 % (95 % CI: 44.7 % to 59.1 %) and 39.8 % (95 % CI: 29.7 % to 50.9 %), respectively.  The authors concluded that the findings of this study showed a BVC rate of 46 % among live-born patients with AS undergoing FAV, which improved to 52 % when subjects underwent technically successful FAV.  These researchers stated that given the lack of randomized clinical trials, results should be interpreted with caution.  Currently, data do not suggest a true benefit of FAV for achieving BVC.

In a retrospective study, Tulzer et al (2022) examined their experience with FAV in fetuses with critical AS (CAS) and evolving hypoplastic left heart syndrome (eHLHS), including short- and medium-term post-natal outcome, and refined selection criteria for FAV by identifying pre-procedural predictors of BV outcome.  These investigators reviewed of all fetuses with CAS and eHLHS undergoing FAV at their center between December 2001 and September 2020.  Echocardiograms and patient charts were analyzed for pre-FAV ventricular and valvular dimensions and hemodynamics and for post-natal procedures and outcomes.  The primary endpoints were type of circulation 28 days after birth and at 1 year of age.  Classification and regression-tree analysis was carried out to examine the predictive capacity of pre-FAV parameters for BV circulation at 1 year of age.  During the study period, 103 fetuses underwent 125 FAVs at the authors’ center, of which 87.4 % had a technically successful procedure.  Technical success per fetus was higher in the more recent period (from 2014) than in the earlier period (96.2 % (51/53) versus 78.0 % (39/50); p = 0.0068).  A total of 80 fetuses were liveborn after successful intervention and received further treatment.  BV outcome at 1 year of age was achieved in 55 % of live-born patients in this cohort after successful FAV, which was significantly higher than the BV-outcome rate (23.7 %) in a previously published natural history cohort fulfilling the same criteria for eHLHS (p = 0.0015).  Decision-tree analysis based on the ratio of right to left ventricular (RV/LV) length combined with LV pressure (mitral valve regurgitation maximum velocity (MR-Vmax)) had a sensitivity of 96.97 % and a specificity of 94.44 % for predicting BV outcome without signs of pulmonary arterial hypertension at 1 year of age.  The highest probability for a BV outcome was reached for fetuses with a pre-FAV RV/LV length ratio of less than 1.094 (96.4 %) and for those fetuses with a RV/LV length ratio 1.094 or greater to less than 1.135 combined with a MR-Vmax of 3.14 m/s or higher (100 %).  The authors concluded that FAV could be carried out with high success rates and an acceptable risk with improving results after a learning curve.  Pre-FAV RV/LV length ratio combined with LV pressure estimates were able to predict a successful BV outcome at 1 year of age with high sensitivity and specificity.  Moreover, these researchers stated that a prospective, controlled study is needed to confirm these findings and to examine if FAV truly improves BV outcome rates.

The authors stated that the most important drawbacks of this study were the long study period of more than 19 years, the retrospective study design, the small number of patients and the relatively short follow‐up in some patients.  The non‐standardized post-natal management strategies at the different European centers in which the patients were managed may have introduced a potential bias with regard to rates of BV outcome.  Another important drawback was that echocardiographic data obtained at other centers in patients with BV outcomes were not systematically reviewed by the authors with regard to possible pulmonary arterial hypertension.  Because these investigators did not have a control group, they chose to compare their findings with historical data from a natural history cohort in which, even though inclusion criteria were the same, left‐sided structures and physiology might have been different.  The comparison of these outcome data with those of the natural‐history control group should be considered as an observation only; and did not allow conclusions to be drawn with respect to a true benefit of FAV.  Measurements of small, weak mitral valve regurgitation jets in fetuses lying in unfavorable positions may have been under-estimated.  In addition, although their CART model showed a high sensitivity and specificity, the CIs were relatively wide because of the relatively small cohort size.  Another drawback of the CART model was a potential generalization bias of the derived predictive variables because of the non‐random selection process of patients and the selection criteria used.

In a retrospective, single-center study, Walter et al (2022) examined the course and outcome of FAV in fetuses with severe AS (SAS).  All fetuses with a prenatal diagnosis of SAS with subsequent FAV were reviewed for fetal medicine over a period of 10 years.  In the study, period fetuses with SAS were considered suitable for FAV in the presence of markedly elevated left ventricular pressures (maximum velocity of mitral regurgitation (MR Vmax)  of greater than 250 cm/s and/or maximum velocity of aortic stenosis (AS Vmax)  of greater than 250 cm/s), retrograde flow in the transverse aortic arch and a left ventricular length Z-score of greater than −1.  A total of 29 fetuses with AS were treated with 38 FAV.  If re-interventions were included 82.7 % of fetuses received a technically successful FAV . Procedure-related death occurred in 3 (10.3 %) cases, spontaneous fetal death in 2 (6.9 %), and TOP was carried out in 3 cases (10.3 %).  Among the 21 livebirths (72.4 %), 4 died in infancy.  Among the remaining survivors, 8/17 (47.1 %) had a BV outcome at the age of 1 year, 8/17 (47.1 %) were uni-ventricular and 1 infant (5.9 %) was BV at the age of 8 months.  Fetuses with BV outcome had significantly greater left ventricular (LV) length Z-scores (p = 0.031), and lower tricuspid to mitral valve (TV/MV) ratios (p = 0.003).  The authors concluded that FAV had a high technical success rate and a low rate of procedure related mortality if performed in experienced hands.  The success rate of BV circulation at the age of 1 year was moderate and appeared to depend rather on the center’s experience and post-natal surgical strategies than solely on prenatal selection criteria.  These researchers stated that in the absence of RCTs, FAV remains an experimental intervention.

Percutaneous Balloon Mitral Valvuloplasty in Patients with Mitral Stenosis and Atrial Fibrillation

In a systematic review and meta-analysis, Liu et al (2022) examined the available evidence on the effects of percutaneous balloon mitral valvuloplasty (PBMV) in patients with mitral stenosis and atrial fibrillation (AF) as opposed to sinus rhythm (SR).  Eligible studies were identified from 6 electronic databases before June 2021.  The primary outcome was mitral valve area (MVA), and secondary outcomes were hemodynamic measurements, in-hospital complications, and long-term outcomes.  Relative risks (RRs) or weighted mean differences (WMDs) with 95 % CIs were used as effect sizes.  A total of 15 studies were included entailing 6,351 patients.  For the primary outcome, the AF group obtained less favorable changes in MVA (WMD: -0.10, 95 % CI: -0.14 to -0.06) and a significantly smaller post-operative and long-term MVA (WMD: -0.13, 95 % CI: -0.18 to -0.08 and WMD: -0.10, 95 % CI: -0.17 to -0.03, respectively) compared to the SR group.  For secondary outcome, the AF group was associated with suboptimal outcomes as following (WMD/RR, [95 % CI]): higher LAP (1.37, [0.86 to 1.87]), more embolism (2.85, [1.44 to 5.63]), lower event-free survival (EFS; 0.89, [0.80 to 1.00]), higher incidences of mitral valve replacement (2.20, [1.40 to 3.46]), re-PBMV (2.28, [1.63 to 3.19]), and mortality (3.28, [2.42 to 4.44]).  No significant differences were found in other outcomes.  The authors concluded that the currently available evidence suggested that PBMV may be less effective in patients with AF than in those with SR.  However, early treatment and appropriate management of AF patients undergoing PBMV may benefit the immediate and long-term outcomes.


The above policy is based on the following references:

  1. Abu Rmilah AA , Tahboub MA, Alkurashi AK, et al. Efficacy and safety of percutaneous mitral balloon valvotomy in patients with mitral stenosis: A systematic review and meta-analysis. Int J Cardiol Heart Vasc. 2021;33:100765.
  2. Azpitarte J, Alonso AM, Garcia Gallego F, et al. Guidelines of the Spanish Society of Cardiology on valve heart disease. Rev Esp Cardiol. 2000;53(9):1209-1278.
  3. Babaliaros VC, Junagadhwalla Z, Lerakis S, et al. Use of balloon aortic valvuloplasty to size the aortic annulus before implantation of a balloon-expandable transcatheter heart valve. JACC Cardiovasc Interv. 2010;3(1):114-118.
  4. Badheka AO, Shah N, Ghatak A, et al. Balloon mitral valvuloplasty in the United States: A 13-year perspective. Am J Med. 2014;127(11):1126.e1-e12.
  5. Berger M. Natural history of mitral stenosis and echocardiographic criteria and pitfalls in selecting patients for balloon valvuloplasty. Adv Cardiol. 2004;41:87-94.
  6. Bouhout I, Ba PS, El-Hamamsy I, Poirier N. Aortic valve interventions in pediatric patients  Semin Thorac Cardiovasc Surg. 2019:31(2):277-287.
  7. Braunwald E, ed. Heart Disease: A Textbook of Cardiovascular Medicine. 5th ed. St. Louis, MO: W.B. Saunders Co.; 1997.
  8. Chaara J, Meier P, Ellenberger C, et al. Percutaneous aortic balloon valvuloplasty and intracardiac adrenaline in electromechanical dissociation as bridge to transcatheter aortic valve implantation. Medicine (Baltimore). 2015;94(26):e1061.
  9. Cheng TO, Holmes DR Jr. Percutaneous balloon mitral valvuloplasty by the Inoue balloon technique: The procedure of choice for treatment of mitral stenosis. Am J Cardiol. 1998;81(5):624-628.
  10. Cheng TO. Percutaneous inoue balloon valvuloplasty is the procedure of choice for symptomatic mitral stenosis in pregnant women. Catheter Cardiovasc Interv. 2000;50(4):418.
  11. Cubeddu RJ, Palacios IF. Percutaneous techniques for mitral valve disease. Cardiol Clin. 2010;28(1):139-153.
  12. 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.
  13. Elliott JM, Tuzcu EM. Recent developments in balloon valvuloplasty techniques. Curr Opin Cardiol. 1995;10(2):128-134.
  14. Himbert D. Percutaneous cardiac valvular interventions. Rev Prat. 2009;59(2):207-212.
  15. Iung B, Vahanian A. The long-term outcome of balloon valvuloplasty for mitral stenosis. Curr Cardiol Rep. 2002;4(2):118-124.
  16. Karakaya O, Turkmen M, Bitigen A, et al. Effect of percutaneous mitral balloon valvuloplasty on left atrial appendage function: A Doppler tissue study. J Am Soc Echocardiogr. 2006;19(4):434-437.
  17. Khambadkone S, Nordmeyer J, Bonhoeffer P. Percutaneous implantation of the pulmonary and aortic valves: Indications and limitations. J Cardiovasc Med (Hagerstown). 2007;8(1):57-61.
  18. Kleczynski P, Kulbat A, Brzychczy P, et al. Balloon aortic valvuloplasty for severe aortic stenosis as rescue or bridge therapy. J Clin Med. 2021;10(20):4657.
  19. Konishi A, Iwasaki M, Omori T, Shinke T. The effect of multiple-inflation balloon aortic valvuloplasty. Heart Vessels. 2020;35(11):1557-1562.
  20. Lanjewar C, Phadke M, Singh A, et al. Percutaneous balloon valvuloplasty with Inoue balloon catheter technique for pulmonary valve stenosis in adolescents and adults. Indian Heart J. 2017;69(2):176-181.
  21. Lau KW, Ding ZP, Gao W, et al. Percutaneous balloon mitral valvuloplasty in patients with mitral restenosis after previous surgical commissurotomy. A matched comparative study. Eur Heart J. 1996;17(9):1367-1372.
  22. Lau KW, Ding ZP, Hung JS. Percutaneous transvenous mitral commissurotomy versus surgical commissurotomy in the treatment of mitral stenosis. Clin Cardiol. 1997;20(2):99-106.
  23. Leclercq F, Robert P, Akodad M, et al. Prior balloon valvuloplasty versus direct transcatheter aortic valve replacement: Results from the DIRECTAVI Trial. JACC Cardiovasc Interv. 2020;13(5):594-602.
  24. Lee SP, Kim HK, Kim KH, et al. Prevalence of significant tricuspid regurgitation in patients with successful percutaneous mitral valvuloplasty for mitral stenosis: Results from 12 years' follow-up of one centre prospective registry. Heart. 2013;99(2):91-97.
  25. Liu B, Wang Y, Liu Y, et al. Effects of percutaneous balloon mitral valvuloplasty in patients with mitral stenosis and atrial fibrillation: A systematic review and meta-analysis. 2022;77(10):890-899.
  26. Martin GP, Sperrin M, Bagur R, et al. Pre-implantation balloon aortic valvuloplasty and clinical outcomes following transcatheter aortic valve implantation: A propensity score analysis of the UK registry. J Am Heart Assoc. 2017;6(2).
  27. Marzo K, Prigent FM, Steingart RM. Interventional therapy in heart failure management. Clin Geriatr Med. 2000;16(3):549-566.
  28. McCrindle BW, Blackstone EH, Williams WG, et al. Are outcomes of surgical versus transcatheter balloon valvotomy equivalent in neonatal critical aortic stenosis? Circulation. 2001;104(12 Suppl 1):I152-I158.
  29. McCrindle BW. Independent predictors of immediate results of percutaneous balloon aortic valvotomy in children. Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) Registry Investigators. Am J Cardiol. 1996;77(4):286-293.
  30. Mickleborough LL. Is mitral valvuloplasty always indicated in patients with poor left ventricular function and ischemic cardiomyopathy? J Thorac Cardiovasc Surg. 2001;121(1):97.
  31. National Institute for Health and Clinical Excellence (NICE). Balloon dilatation for pulmonary valve stenosis. Interventional Procedure Guidance 67. London, UK: NICE; June 2004.
  32. 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.
  33. National Institute for Health and Clinical Excellence (NICE). Percutaneous balloon fetal valvuloplasty for aortic stenosis. Interventional Procedure Guidance 175. London, UK: NICE; May 2006.
  34. National Institute for Health and Clinical Excellence (NICE). Percutaneous fetal balloon valvuloplasty for pulmonary atresia with intact ventricular septum. Interventional Procedure Guidance 176. London, UK: NICE; May 2006.
  35. Nobuyoshi M, Arita T, Shirai S, et al. Percutaneous balloon mitral valvuloplasty: A review. Circulation. 2009;119(8):e211-e219.
  36. Nwaejike N, Mills K, Stables R, Field M. Balloon aortic valvuloplasty as a bridge to aortic valve surgery for severe aortic stenosis. Interact Cardiovasc Thorac Surg. 2015;20(3):429-435.
  37. 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.
  38. Palaniswamy C, Selvaraj DR, Guleria R, et al. Respiratory muscle strength in rheumatic mitral stenosis improves after balloon valvotomy. J Cardiovasc Med (Hagerstown). 2010;11(6):440-443.
  39. Piovaccari G, Marzocchi A, Marrozzini C, et al. Percutaneous aortic valvuloplasty in the adult. When and why is now useful? Ann Ital Med Int. 1996;11(4):258-262.
  40. Pranata R, Vania R, Alkatiri AA, Firman D. Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement -- Systematic review and meta-analysis of randomized controlled trials and prospective-matched cohorts. J Card Surg. 2020;35(7):1498-1507.
  41. Prendergast BD, Shaw S. Percutaneous balloon mitral valvuloplasty. Hosp Med. 001;62(9):564-566.
  42. Presbitero P, Lisignoli V, Zavalloni D, et al. Endovascular intervention in the treatment of congenital heart disease in adults. Minerva Cardioangiol. 2007;55(5):669-679.
  43. Rana G, Malhotra R, Sharma A, Kakouros N. Percutaneous valvuloplasty for bioprosthetic tricuspid valve stenosis. Tex Heart Inst J. 2017;44(1):43-49.
  44. Rao PS. Percutaneous balloon pulmonary valvuloplasty: State of the art. Catheter Cardiovasc Interv. 2007;69(5):747-763.
  45. Reyes VP, Raju BS, Wynne J, et al. Percutaneous balloon valvuloplasty compared with open surgical commissurotomy for mitral stenosis. N Engl J Med. 1994;331:961-967.
  46. Singh V, Patel NJ, Badheka AO, et al. Comparison of outcomes of balloon aortic valvuloplasty plus percutaneous coronary intervention versus percutaneous aortic balloon valvuloplasty alone during the same hospitalization in the United States. Am J Cardiol. 2015;115(4):480-486.
  47. Soltesz EG, Cohn LH. Minimally invasive valve surgery. Cardiol Rev. 2007;15(3):109-115.
  48. Song JK, Kim MJ, Yun SC, et al. Long-term outcomes of percutaneous mitral balloon valvuloplasty versus open cardiac surgery. J Thorac Cardiovasc Surg. 2010;139(1):103-110.
  49. Sreerama D, Surana M, Moolchandani K, et al. Percutaneous balloon mitral valvotomy during pregnancy: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2021;100(4):666-675.
  50. Thiem A, Cremer J, Lutter G. Percutaneous valve replacement: Weird or wonderful? Minerva Cardioangiol. 2006;54(1):23-30.
  51. Tulzer A, Arzt W, Gitter R, et al. Valvuloplasty in 103 fetuses with critical aortic stenosis: Outcome and new predictors for postnatal circulation. Ultrasound Obstet Gynecol. 2022;59(5):633-641.
  52. Tumscitz C, Di Cesare A, Balducelli M, et al. Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty. Heart. 2021;107(11):874-880.
  53. Vahanian A, Luxereau P, Brochet E. Valvular stenosis: Treatment by percutaneous dilatation. Rev Prat. 2000;50(15):1679-1683.
  54. Vahanian A. Balloon valvuloplasty. Heart. 2001;85(2):223-228.
  55. Vassiliades TA Jr, Block PC, Cohn LH, et al. The clinical development of percutaneous heart valve technology. J Thorac Cardiovasc Surg. 2005;129(5):970-976.
  56. Vorisek CN, Zurakowski D, Tamayo A, et al. Postnatal circulation in patients with aortic stenosis undergoing fetal aortic valvuloplasty: Systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2022;59(5):576-584.
  57. Walter A, Strizek B, Weber EC, et al. Intrauterine valvuloplasty in severe aortic stenosis -- A ten years single center experience. J Clin Med. 2022;11(11):3058.
  58. Wernly B, Jirak P, Lichtenauer M, et al. Systematic review and meta-analysis of interventional emergency treatment of decompensated severe aortic stenosis. J Invasive Cardiol. 2020:32(1):30-36.
  59. Zaki A, Salama M, El Masry M, et al. Immediate effect of balloon valvuloplasty on hemostatic changes in mitral stenosis. Am J Cardiol. 2000;85(3):370-375.
  60. Zeymer U, Neuhaus K. Percutaneous balloon valvuloplasty - the first line treatment for mitral stenosis and restenosis. Eur Heart J. 2000;21(20):1643-1644.