Balloon Valvuloplasty

Number: 0477

Table Of Contents

Policy

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 implantation (TAVI) or surgical aortic valve replacement (SAVR) 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, Investigational, or Unproven

   The following procedures are considered experimental, investigational, or unproven 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. Combined balloon pulmonary valvuloplasty and conal artery occlusion for the treatment of right ventricular outflow tract obstruction in individuals with tetralogy of Fallot;
   3. Percutaneous balloon valvuloplasty woulfor bioprosthetic tricuspid valve stenosis;
   4. Percutaneous balloon dilation for all other indications not listed in Section I;
   5. Simultaneous transcatheter aortic valve replacement (TAVR) and percutaneous balloon pulmonary valvuloplasty for the treatment of multiple valvular diseases.

3. Related Policies

   1. CPB 0407 - Selected Aortic Valve Procedures: Ross Pulmonary Autograft and Aortic Valve-Sparing Re-implantation
   2. CPB 0821 - Transcatheter Pulmonary Valve Implantation
   3. CPB 0826 - Transcatheter Aortic Valve Implantation
   4. CPB 0880 - Percutaneous Mitral Valve and Tricuspid Valve Repair

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 thrive 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).

Transesophageal 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 the 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 received a 26-mm THV. No coronary occlusion, annular damage, or THV embolization occurred. Paravalvular leak was grade less than or equal to 1 in all patients. In 7 patients (26%), balloon sizing resulted in the 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 the 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 the development of less invasive endovascular therapies. These investigators compared outcomes of concomitant PABV and percutaneous coronary intervention (PCI) with PABV alone during the same hospitalization using the 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 the Nationwide Inpatient Sample database from 1998 to 2010. Only patients greater than 60 years with aortic stenosis were included. The primary outcome included in-hospital mortality, and secondary outcomes included procedural complications, length of stay (LOS), and cost of hospitalization. A total of 2,127 PABV procedures were identified, with 247 in the PABV + PCI group and 1,880 in the PABV group. The utilization rate of concomitant PABV + PCI during the 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 the PABV + PCI group were similar to those of the PABV group (10.3% versus 10.5% and 23.4% versus 24.7%, respectively). The PABV + PCI group had similar LOS but higher hospitalization costs (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 a change in in-hospital mortality, complication rates, or LOS compared with PABV alone; however, it increases the cost of hospitalization.

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

The American College of Cardiology/American Heart Association (Otto et al., 2020) issued a clinical practice guideline to provide recommendations for the management of adult patients with valvular heart disease across diagnostic, medical, surgical, and transcatheter approaches. The guideline scope encompassed evaluation and treatment strategies for native and prosthetic valve disease in adult patients, based on evidence reviewed through March 1, 2020. The guideline stated that in critically ill patients with severe aortic stenosis, percutaneous aortic balloon dilation may be considered as a bridge to surgical aortic valve replacement or transcatheter aortic valve implantation. This recommendation was assigned a Class of Recommendation 2b and a Level of Evidence C‑EO. The supportive text noted; however, that this approach is used less frequently given the availability and success of immediate transcatheter aortic valve implantation (TAVI), even in very high-risk patients.

Kawsara et al. (2020) conducted a retrospective observational study utilizing a national representative database to evaluate the incidence, predictors, timing, and in-hospital outcomes of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve replacement (TAVR) in the contemporary United States. The study analyzed data from the Nationwide Readmission Database for patients who underwent BAV between January 1, 2015, and December 31, 2016, excluding those under 50 years, with missing procedure dates, or who had BAV and TAVR on the same day, resulting in a final cohort of 3,691 patients with a mean age of 81.1 years, of whom 53.6% were male. Among these, 1,426 patients (38.6%) subsequently underwent TAVR, with the majority (over 80%) occurring within 90 days post-BAV. The study identified several negative predictors for subsequent TAVR, including prior defibrillator implantation, dementia, malnutrition, malignancy, private insurance, prolonged BAV hospitalization, and nonhome discharge. A propensity score-matched comparison of 1,315 patients who underwent TAVR after BAV and 1,315 who had direct TAVR revealed similar in-hospital mortality and complication rates, although hospitalization costs were higher for the direct TAVR group. The authors concluded that nearly 40% of BAV patients proceeded to TAVR, primarily within 90 days, and that in-hospital outcomes for TAVR after BAV were comparable to those of direct TAVR. They acknowledged limitations such as potential coding inaccuracies in claims data, inability to track patients across years, lack of granular clinical data such as hemodynamics and imaging, inability to capture out-of-hospital deaths, and the potential for residual selection bias despite propensity score matching. The authors report that further investigations are needed to define the role of BAV in contemporary practice.

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.

Dall’Ara et al. (2021) reviewed contemporary balloon aortic valvuloplasty (BAV) and described its evolving indications and technical refinements in patients with symptomatic severe aortic stenosis, stating that although BAV did not improve long-term prognosis, it was used in selected patients as a bridge to surgical or transcatheter aortic valve replacement (AVR or TAVI) or as a triage strategy when indications were uncertain. The authors reported that international guidelines recommended BAV as a bridge to AVR or TAVI, as a trial in patients with undetermined symptoms, or as a bridge-to-decision in the presence of comorbidities, and they noted that in clinical practice BAV was also performed as a palliative measure to improve hemodynamics and quality of life in patients excluded from AVR or TAVI. The review further described the use of BAV during TAVI procedures to facilitate prosthesis delivery, optimize frame expansion, or enable bioprosthetic valve fracture in selected valve-in-valve procedures. The authors stated that technical innovations, including a mini-invasive approach using transradial access and pacing delivered through the wire, had led to a decrease in complications over time, and they indicated that the review focused on new indications, innovative techniques, and specific complex patient subgroups.

Balloon Aortic Valvuloplasty for the Treatment of Cardiogenic Shock Due to Decompensated Aortic Stenosis

Kuhne et al. (2025) noted that cardiogenic shock (CS) induced by severe aortic stenosis (AS) is a life-threatening condition with high mortality. Despite advancements in emergency interventions, the optimal therapeutic approach remains uncertain. In a systematic review and meta-analysis, these investigators examined the available evidence on outcomes of emergency transcatheter aortic valve implantation (eTAVI) and emergency balloon aortic valvuloplasty (eBAV) in CS patients. The primary endpoint was mortality at 30 days. Secondary endpoints were in-hospital mortality, 1-year mortality, bleeding, major vascular complications, myocardial infarction (MI), stroke, incidence of pacemaker implantation, acute kidney injury (AKI), and aortic regurgitation (AR). A total of 17 studies (2,811 patients) were included. The analysis showed a 30-day mortality pooled estimated rate for eTAVI of 19% (CI: 0.17 to 0.20) and for eBAV 39% (CI: 0.32 to 0.46). In-hospital mortality pooled estimated rates were 11% for eTAVI (CI: 0.06 to 0.18) and for eBAV 40% (CI: 0.28 to 0.54). One-year mortality pooled estimated rates for eTAVI were 29% (CI: 0.20 to 0.40) and for eBAV 67% (CI: 0.58 to 0.74). Pooled estimated rates of any bleeding were 12% for eTAVI (CI: 0.06 to 0.20) and 15% for eBAV (CI: 0.10 to 0.21). The rate of major vascular complications for eTAVI was 8% (CI: 0.07 to 0.10) and 3% for eBAV (CI: 0.0 to 0.23). The authors concluded that this meta-analysis was the first study analyzing the totality of available evidence on emergency interventions in CS patients due to decompensated AS. Despite its limitations, this meta-analysis of real-world evidence suggested that eTAVI is a viable option in this complex clinical scenario; however, the overall mortality in AS patients presenting with CS remains high. These researchers stated that further larger comparative studies with a prospective, randomized design and standardized outcome reporting are needed to substantiate evidence and guide clinical decision-making.

The authors stated that this study had several drawbacks. First, the studies included in this meta-analysis were carried out over a wide time range, contributing to heterogeneity and potentially impacting the reliability of pooled estimates. Second, the studies incorporated into this analysis covered an extensive historical period, reflecting the comprehensive nature of the research. However, the three oldest studies from the 1990s had a limited weight in the pooled rates, primarily due to their small sample sizes. Despite this, the evolution in clinical practice and patient management over time introduced another layer of variability, which may impact the study’s conclusions. Of note, the leave-one-out sensitivity analyses did not detect any differences. Third, CS is a condition with a wide range of severity, which is difficult to harmonize and compare. The studies included in this meta-analysis were characterized by relevant heterogeneity and did not report outcomes according to the Society for Cardiovascular Angiography and Interventions (SCAI) classification. Fourth, there was a lack of information concerning the strategy used to achieve valve sizing in eTAVI. In elective cases, CT scan was the gold standard to examine access site and annulus size. However, anecdotal cases of urgent TAVI with sizing using TEE or BAV have been reported. The absence of high-resolution anatomical data from CT scans could have influenced acute outcomes and prognosis, further complicating the interpretation of these findings.

Combined Balloon Pulmonary Valvuloplasty and Conal Artery Occlusion for the Treatment of Right Ventricular Outflow Tract Obstruction in Patients with Tetralogy of Fallot

Das et al. (2024) noted that tetralogy of Fallot (TOF) is the most common congenital cyanotic heart disease and is characterized by an antero-superior deviation of the infundibular septum, with a consequent large mal-aligned ventricular septal defect (VSD) and pulmonary and sub-pulmonary (infundibular) stenosis. Surgical repair has been the cornerstone of treatment, which is electively performed early in their lives, between 3 and 6 months of age. With advancements in transcatheter interventions, the complete percutaneous repair of TOF, a complex disease with multiple treatable lesions, is becoming a conceivable possibility. These investigators reported the case of total transcatheter correction of an 18-year-old boy with TOF, conducted in 2 stages. The 1st stage entailed addressing the right ventricular outflow tract (RVOT) obstruction with balloon pulmonary valvuloplasty (BPV) and occluding the conal artery using absolute alcohol and a coil. In the 2nd stage, the VSD was closed with a multi-functional occluder (MFO) Konar device (Lifetech, China). The authors concluded that while surgical treatment remains the gold standard for total correction of TOF, transcatheter total correction of TOF was feasible and effective in a selected group of patients who were surgically turned down. Moreover, these researchers stated that whether the same technique could be applied to the pediatric population is unclear, and the long-term risks of conal occlusion and future arrhythmia are unknown.

In a pilot study, Das et al. (2025) examined the effectiveness of combined BPV and conal artery occlusion for the treatment of RVOT obstruction. A total of 35 patients completed the study. The mean age was 19.8 ± 4.2 years, with a male-to-female ratio of 4:3. A total of 25 patients had uncorrected TOF, and 10 had undergone intra-cardiac repair. After the procedure, patients with uncorrected TOF demonstrated a significant increase in oxygen saturation from 84.7% ± 1.4% to 94.6% ± 1.2%. Procedural success was 91.4%, with 3 patients experiencing significant re-stenosis. No procedural complications were observed. There were no arrhythmic events until the 1st year of follow-up. At 1-year follow-up, the mean RVOT pressure gradient was significantly reduced, and all subjects remained symptom-free. The authors concluded that combined BPV and conal artery occlusion was a safe and effective method for alleviating RVOT obstruction in patients with TOF, showing promising intermediate-term outcomes with minimal complications.

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 the 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 one case 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 a 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: 66.0% 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 outcomes, and refined selection criteria for FAV by identifying pre-procedural predictors of BVC outcome. These investigators reviewed 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 the 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 BVC 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 live born after successful intervention and received further treatment. BVC 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 BVC 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 left ventricular pressure (mitral valve regurgitation maximum velocity (MR-Vmax)) had a sensitivity of 96.97% and a specificity of 94.44% for predicting BVC without signs of pulmonary arterial hypertension at 1 year of age. The highest probability for a BVC 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 an RV/LV length ratio of 1.094 or greater to less than 1.135 combined with an 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 left ventricular pressure estimates were able to predict a successful BVC 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 BVC 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 BVC outcome. Another important drawback was that echocardiographic data obtained at other centers in patients with BVC 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 underestimated. In addition, although their CART model showed a high sensitivity and specificity, the confidence intervals 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 FAVs. 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 live births (72.4%), 4 died in infancy. Among the remaining survivors, 8/17 (47.1%) had a BVC outcome at the age of 1 year, 8/17 (47.1%) were uni-ventricular, and 1 infant (5.9%) was BVC at the age of 8 months. Fetuses with BVC 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 BVC at the age of 1 year was moderate and appeared to depend more 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.

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.

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 three patients from their hospital experience; two of the three cases were successful, with lasting clinical improvement, whereas the third 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 tricuspid valves 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 three 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.

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.

Simultaneous Transcatheter Aortic Valve Replacement (TAVR) and Percutaneous Balloon Pulmonary Valvuloplasty (PBPV)

Zhang and Zhang (2025) stated that transcatheter aortic valve replacement (TAVR) and percutaneous balloon pulmonary valvuloplasty (PBPV) are the 1st-line treatments for aortic stenosis and pulmonary stenosis. These researchers presented the case of a 72-year-old woman who suffered from severe aortic stenosis with pulmonary stenosis, treated with simultaneous TAVR and PBPV. Post-procedural echocardiography showed significant improvement in valve stenosis, with no complications. The authors concluded that this case demonstrated the feasibility and safety of performing TAVR and PBPV together, offering a new therapeutic approach. Moreover, these researchers stated that this combination of valvular diseases is rare, and further investigations are needed to better understand the etiology and mechanisms involved. Similarly, procedural strategies for combining TAVR with PBPV require further examination.

The authors stated that this procedure had 2 main drawbacks. First, these investigators did not adequately monitor the pressure in the pulmonary artery and ventricle, which prevented them from observing critical changes in intra-cardiac pressure over time and delayed their response to abnormal pressure. Second, post-operative examination showed a residual gradient in the pulmonary valve, indicating that pulmonary stenosis may not be fully resolved by PBPV. Although the patient’s hemodynamics were stable 30 days after the procedure, annual ultrasound (US) monitoring is still needed as a consequence of the residual stenosis. If the stenosis progresses, then surgical pulmonary valve replacement may need to be considered for this patient.

References