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

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.

Scope of Policy

This Clinical Policy Bulletin addresses balloon valvuloplasty.

Medical Necessity

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

Experimental and Investigational

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