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It is controversial whether children with isolated aortic valvular stenosis (vAS) initially undergo transcatheter or surgical aortic valvuloplasty (BAV or SAV). This multicenter retrospective case-control study aimed to explore outcomes after BAV or SAV for pediatric vAS. We studied children (aged < 15 years) with vAS treated at 4 tertiary congenital heart centers, and compared the rates of survival, reintervention, and valve replacement between patients with BAV and SAV. A total of 73 subjects (BAV: N = 52, SAV: N = 21) were studied. Age and aortic annulus z-score at the first presentation were 85 (26-530) days and - 0.45 (- 1.51-0.59), respectively. During the follow-up period of 121 (47-185) months, rates of 10-year survival (BAV: 88% vs. SAV: 92%, P = 0.477), reintervention (BAV: 58% vs. SAV: 31%, P = 0.626), and prosthetic/autograft valve replacement (BAV: 21% vs. SAV: 19%, P = 0.563) did not differ between the groups. Freedom from reintervention rate significantly correlated with aortic annulus z-score (hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.49-0.88, P = 0.005), and freedom from prosthetic/autograft valve replacement rate significantly correlated to the degree of aortic regurgitation after the first intervention (HR: 4.58, 95% CI 1.19-17.71, P = 0.027). Propensity score-matched analysis (N = 16) did not show the differences in survival and reintervention rates between the groups. Long-term survival was acceptable, and the rates of freedom from reintervention and prosthetic/autograft valve replacement were comparable between children with vAS who underwent BAV and SAV.

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OBJECTIVE: To report our experience of fetal aortic valvuloplasty (FAV) for critical aortic stenosis (AS), with a focus on the postnatal evolution of the patients. METHODS: This was a retrospective study including all fetuses with critical AS which underwent FAV in a single center between January 2011 and June 2022. FAV was performed under ultrasound guidance. Technical success was based upon balloon inflation across the aortic valve and improvement of the antegrade aortic flow across the aortic valve. At birth, a biventricular circulation (BVC) strategy was decided assuming the left ventricular (LV) systolic and diastolic function would ensure the systemic circulation. RESULTS: Sixty-three FAV procedures were performed in 58 fetuses, at a median (range) gestational age of 26.2 (20.3-32.2) weeks. The procedure was technically successful in 50/58 (86.2%) fetuses. There were 11/58 (19.0%) cases of in-utero demise and 9/58 (15.5%) terminations of pregnancy. No patient was liveborn after an unsuccessful procedure. Thirty-eight (65.5%) infants were liveborn, at a median (range) gestational age of 38.1 (29.0-40.6) weeks, of whom 21 (55.3%) required prostaglandin treatment. Twenty-eight of the 38 (73.7%) liveborn children (48.3% of the study population) entered the BVC pathway at birth. Among them, 20 (71.4%) required an aortic valvuloplasty procedure at birth (11 (55.0%) percutaneous balloon, nine (45.0%) surgical) and eight (28.6%) did not require any treatment at birth, but, of these, five (62.5%) underwent surgical valvuloplasty between day 26 and day 1200 of age. Eleven (39.3%) of the infants with BVC at birth required a second intervention and four (14.3%) of them required a third intervention. Two (7.1%) infants who entered the BVC pathway at birth underwent conversion to univentricular circulation (UVC). None of the surviving children with BVC developed pulmonary hypertension. The overall survival rate in those with BVC at birth was 22/28 (78.6%) at a median (range) follow-up of 23.3 (2.0-112.6) months. Ten of the 58 (17.2%) patients had UVC at birth. Among these, six (60.0%) received compassionate care from birth and four (40.0%) underwent surgery. Three of the 10 patients who had UVC at birth were still alive at the latest follow-up assessment, at a median (range) gestational age of 24.3 (8.3-48.7) months. CONCLUSIONS: FAV for critical AS led to increase of antegrade aortic flow in 86.2% of fetuses, with BVC being achieved in 48.3% (73.7% of the liveborn cases). Among patients with BVC at birth, the rate of reintervention was high, but 78.6% of these children were alive at the latest evaluation. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

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BACKGROUND: Fetal aortic valvuloplasty (FAV) is proposed to prevent hypoplastic left heart syndrome due to fetal critical aortic stenosis. OBJECTIVE: to report our experience on FAV as the first step in a complex therapeutic strategy. METHOD: Series of patients with FAV over an 18-year period. RESULTS: 27 FAVs were performed in 26 fetuses, with technical success in 82% (22/27) and periprocedural fetal demise in 22% (6/27), decreasing to 15% in the second half-cohort. Loss to follow-up was due to birth or postnatal therapy in other centers (5) and termination of pregnancy (1), A normal-sized LV at birth was observed in 46% (6/13), 4 neonates underwent aortic valvuloplasty and 2 cardiac surgeries, with 5/6 achieving biventricular circulation at 28 days, and 3 transplant-free survival at mid-term follow-up. The 7/13 born with a borderline LV underwent LV rehabilitation strategy, with survival at 28 days in 4/7 and at mid-term in 3: one with biventricular circulation, one with a ventricle-and-a-half repair, and one lost to follow-up. CONCLUSION: FAV was feasible in most cases, with no maternal complications, and biventricular circulation at 28 days in ∼40% of survivors. After FAV, a diverse range of postnatal cardiac interventions are performed, reflecting the challenging innovation in current cardiovascular therapy.

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BACKGROUND: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. AIM: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. METHODOLOGY: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. RESULTS: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. CONCLUSION: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.

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There is conclusive evidence for relief of pulmonary valve obstruction immediately after balloon pulmonary valvuloplasty (BPV) and at follow-up. Development of infundibular obstruction is seen in more severe PS cases and in older subjects. Reappearance of PS was observed in approximately 10 % of patients following BPV. The reasons for recurrence were found to be balloon/annulus ratio less than 1.2 and immediate post-BPV pulmonary valve peak gradients greater than 30 mmHg. Recurrent stenosis is successfully addressed by repeating BPV with lager balloons than used initially. Long-term results revealed continue relief of obstruction, but with development of pulmonary insufficiency, some patients requiring replacement of the pulmonary valve. It was concluded that BPV is the treatment of choice in the management valvar PS and that balloon/annuls ratio used for BPV should be lowered to 1.2 to 1.25. It was also suggested that strategies should be developed to prevent/reduce pulmonary insufficiency at long-term follow-up.

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BACKGROUND: Severe aortic stenosis is the most common acquired valvular disorder. Balloon aortic valvuloplasty (BAV) is considered for patients who are not suitable for surgical aortic valve replacement (SAVR) and transcatheter aortic valve insertion (TAVI). The American Heart Association and European Society of Cardiology recommend BAV as a bridging procedure for SAVR and TAVI due to the significant morbidity and mortality associated with it. We aim to investigate the morbidity and mortality associated with BAV only, BAV bridged to TAVI and TAVI-only patients over 3 years in Epworth Richmond, a tertiary hospital in Victoria, Australia. METHODS: We divided patients into three groups including BAV only, BAV bridged to TAVI and TAVI only and assessed the baseline demographics, procedural complications, and mortality between the groups. RESULTS: Of 438 patients, 26 patients underwent BAV only, 36 patients bridged to TAVI post-BAV and 376 patients underwent TAVI directly. All patients had significant reductions in their mean AV pressure gradient (p<0.01). There was no significant difference in periprocedural morbidity and mortality between the groups. At 6-month follow-up, the mortality in patients undergoing only BAV was 31%, compared with 8.3% in BAV bridged to TAVI and 1.9% in TAVI-only group (p<0.01). The 12-month follow-up demonstrated a similar pattern; 42.3% vs 13.9% vs 4.5% (p<0.01). CONCLUSIONS: This study suggests no significant difference in inpatient and periprocedural morbidity and mortality between the three groups but a significant mortality benefit at 6-month and 12-month post valve insertion, either directly or post BAV.

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OBJECTIVE: Transcatheter balloon aortic valvuloplasty (BAV) remains an important alternative treatment for severe, symptomatic aortic stenosis. With increasing numbers of BAVs being performed, the need for large-scale volume-outcome relationship assessments has become evident. Here, we aimed to explain such relationships by analysing consecutive, patient-level BAV data recorded in a prospective Japanese nationwide multicentre registry. DESIGN: Prospective study. SETTING: Data of 1920 BAVs performed in 200 Japanese hospitals from January 2015 to December 2019. PARTICIPANTS: The mean patient age was 85 years, and 36.9% of procedures involved male patients. METHODS: The efficacy of BAV was assessed by reducing the mean transaortic valve gradient after the procedure. We also assessed in-hospital complication rates, including in-hospital death, bleeding, urgent surgery, distal embolism, vessel rupture and contrast-induced nephropathy. Based on the distribution of case volume (median 20, IQR 10-46), we divided the patients into high-volume (≥20) and low-volume (<20) groups. In-hospital complication risk was assessed with adjustment by logistic regression modelling. RESULTS: Indications for BAV included palliative/destination (44.2%), bridge to transcatheter aortic valve replacement (34.5%), bridge to surgical aortic valve replacement (7.4%) and salvage (9.7%). Reduction of the mean transaortic valve gradient was similar between the high-volume and low-volume groups (20 mm Hg vs 20 mm Hg, p=0.12). The proportion of in-hospital complications during BAV was 4.2%, and the incidence of complications showed no difference between the high-volume and low-volume groups (4.2% vs 4.1%, p=1.00). Rather than hospital volume, salvage procedure was an independent predictor of in-hospital complications (OR, 4.04; 95% CI, 2.03 to 8.06; p<0.001). CONCLUSION: The current study demonstrated that procedural outcomes of BAV were largely independent of its institutional volume.

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Balloon aortic valvuloplasty (BAV) is preferred by most centers over surgery for the treatment of congenital valve stenosis, due to its less invasive nature and faster recovery time. A variety of techniques have been employed to induce a transient cardiac standstill and reduce longitudinal balloon displacement during valve dilatation. Rapid right ventricular (RV) pacing is an effective method to stabilize the balloon during aortic valvuloplasty and it is regularly used in older children and adults. Despite the evidence of its feasibility and efficacy, its use in neonates and infants is still not widespread globally as it is associated with certain drawbacks in this population. We report the use of a new technique to achieve balloon stabilization during BAV in neonates and infants. Four patients with severe congenital aortic valve stenosis were treated with percutaneous BAV using rapid transesophageal atrial pacing. Rapid atrial pacing was performed in asynchronous modality at a rate which resulted in a drop of the systemic arterial pressure by 50%. The balloon was inflated only after the set pacing rate was reached. The pacing was continued until the balloon was completely deflated. No ventricular arrhythmia occurred. Fluoroscopy time was not influenced by transesophageal pacing. Mild aortic regurgitation developed in only one case. Rapid transesophageal atrial pacing was safe and allowed a significant relief of left ventricular obstruction while minimizing aortic regurgitation. Compared to RV pacing, it does not require additional vascular access. Moreover, transesophageal pacing is not at risk of cardiac or vascular perforation and ventricular arrhythmias.

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BACKGROUND: Critical aortic stenosis that appears in mid-gestation tends to develop to growth retardation of left ventricle, known as hypoplastic left heart syndrome (HLHS). Despite better clinical management of HLHS, the morbidity and mortality rates of univentricular circulation patients remain high. In this paper, we sought to perform a systematic review and meta-analysis to know the outcomes of fetal aortic valvuloplasty in critical aortic stenosis patients. METHODS: This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. A systematic search on fetal aortic valvuloplasty procedure for critical aortic stenosis was performed through PubMed, Scopus, EBSCOhost, ProQuest, and Google Scholar. The primary endpoint of each group was overall mortality. We used R software (version 4.1.3) to estimate the overall proportion of each outcome using random-effects model of proportional meta-analysis. RESULTS: A total of 389 fetal subjects from 10 cohort studies were included in this systematic review and meta-analysis. Fetal aortic valvuloplasty (FAV) was successfully performed in 84% of patients. It revealed a successful conversion to biventricular circulation rate of 33% with a mortality rate of 20%. Bradycardia and pleural effusion requiring treatment were two most common fetal complications, whereas maternal complication reported was only placental abruption in one patient. CONCLUSIONS: FAV has a high technical success rate with the ability to achieve biventricular circulation and a low rate of procedure-related mortality if carried out by experienced operators.

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Background: Percutaneous balloon mitral valvuloplasty (PBMV) is considered the most suitable option for managing symptomatic severe mitral valve stenosis (MS) during pregnancy with favorable anatomy. We do not know the best time to perform PBMV during pregnancy to achieve the best maternal and fetal outcomes. Therefore, we conducted this study to clarify the best procedure timing. Methods: This prospective, observational, single-center study involved 44 pregnant patients suffering from symptomatic MS who underwent PBMV from May 2017 to May 2020. A detailed history is taken, full clinical examination, laboratory assessment, 2 D echocardiography, and follow-up during the hospital stay and monthly until labor. Results: We found that the mean mitral valve area (MVA) had significantly increased from 1.12 ± 0.24 to 2.09 ± 0.46 cm2 (P < 0.001). The mean pressure gradient across the mitral valve reduced from 17.22 ± 5.55 to 8.94 ± 3.75 mmHg (P < 0.001). The procedures were successful in 91% of the patients. Regarding obstetric outcomes, the incidence of preterm labor, fetal death, and composite adverse outcomes was significantly lower in patients who had the procedure during the second trimester than those who had the procedure during the third trimester. All preterm deliveries and intrauterine fetal deaths occurred at least 21 days after PBMV. The patients showed a statistically significant improvement in NYHA functional classification. Conclusion: We can conclude that PBMV performed in pregnant patients is an effective and safe treatment modality, and we observed better obstetric outcomes achieved with early intervention during the second trimester.

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INTRODUCTION/OBJECTIVES: Pulmonary stenosis (PS) is a congenital defect in the dog that is managed with balloon valvuloplasty (BV). Obstruction severity is routinely assessed using transthoracic echocardiography. The objectives of this study were to describe the short-term changes and long-term restenosis by retrospectively evaluating flow-dependent and flow-independent echocardiographic variables for dogs with PS after BV. ANIMALS, MATERIALS, AND METHODS: Medical records and stored echocardiographic images were reviewed from dogs that received BV for PS. The following echocardiographic variables were measured or calculated: maximum systolic ejection velocity (VmaxPV) and velocity-derived maximal pressure gradient (PV maxPG) across the pulmonary valve; ratio of aortic to pulmonary velocity time integral (VTIAV/VTIPV); ratio of aortic to pulmonary maximal velocity. RESULTS: Eighty-one dogs with PS that had a BV were included. Each of these dogs had pulmonary obstruction severity assessed in at least three timepoints. Forty-nine dogs had at least one additional examination performed, the last of which occurred a median of 504 days after the BV. Echocardiographic variables at the first follow-up had increased by a clinically relevant quantity in 20-34% of the dogs when comparing to the immediate post-BV examination. The last follow-up examination identified valve restenosis in 18-38% of the dogs in this study. Valve type and pre-BV obstruction severity did not have a significant effect (P > 0.1). CONCLUSIONS: For the assessment of BV efficacy, the immediate post-BV echocardiogram may not be as useful as the first follow-up examination several months later. Pulmonary restenosis after BV may be more prevalent than previously reported.

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BACKGROUND: Long-term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe symptomatic aortic stenosis (AS) are poor, and this procedure needs to be repeated in selected cases. AIMS: We aimed to investigate the safety and efficacy of repeated BAV (reBAV). METHODS: We included consecutive patients who underwent reBAV in three Polish centers between 2010 and 2019. Baseline clinical, echocardiographic, procedural, and outcome data were analyzed. RESULTS: Thirty-five patients (median age 81.5 years, 57.1% women) who underwent reBAV were enrolled. In 42.9% of the patients, index BAV was considered a palliative treatment, and in 54.3% a bridge to definitive treatment. Index BAV decreased peak aortic valve gradient (pAVG) from a median of 78.0 mm Hg to 46.0 mm Hg (P <0.001). After a mean of 255.8 days, reBAV was performed. In most cases (71.4%), the reason for reBAV was the worsening of heart failure symptoms and in 54.3% of patients, reBAV was still considered a palliative option. A decrease in pAVG max from a median of 73.0 mm Hg to 45.0 mm Hg (P <0.001), comparable to index BAV, was observed. The frequency of complications were numerically higher for repeated procedures. During the median (IQR) follow-up of 403.0 (152.0-787.0) days from the index procedure, 80.0% of the patients died. CONCLUSIONS: Acute hemodynamic results of reBAV are comparable to those achieved during index BAV. However, reBAV may carry an increased risk of complications. Moreover, mortality is high due to unfavorable risk profiles or delays in receiving definitive therapy.

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Fetal aortic valvuloplasty may prevent the progression of severe fetal aortic stenosis to hypoplastic left heart syndrome at birth. Since it is an high risk procedure a careful selection of fetuses that can benefit from the prenatal treatment instead of waiting for postnatal intervention.

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INTRODUCTION/OBJECTIVES: Pulmonary artery dissection is a rare complication following balloon valvuloplasty for pulmonic stenosis. We sought to report the rate of this complication in dogs and describe the demographic, clinical, procedural, and outcome data in affected dogs. ANIMALS, MATERIALS AND METHODS: Medical records at a single academic institution between 2002 and 2021 were reviewed for dogs with pulmonic stenosis treated by a balloon valvuloplasty. Dogs were included for evaluation if there was evidence of pulmonary artery dissection on echocardiography or necropsy following balloon valvuloplasty. The demographic, clinical, surgical, and follow-up information were then recorded. RESULTS: Six dogs were included from 210 balloon valvuloplasty procedures for pulmonic stenosis giving a 3.9% rate of pulmonary dissection. There was a variety of signalment, pulmonary valve morphologies, and balloon catheter types used in each dog. All dogs had severe pulmonic stenosis (median pressure gradient of 208 mmHg, range 94-220 mmHg) with 5/6 dogs having a pressure gradient >144 mmHg. The median balloon to pulmonary valve annulus ratio was 1.35 (range 1.25-1.5). Three dogs died perioperatively, and three dogs were alive at follow up 3.3, 4.0, and 4.1 years postoperatively. CONCLUSION: Pulmonary artery dissection is a rare complication following balloon valvuloplasty for pulmonic stenosis. Extreme elevations in preoperative pulmonary valve flow velocity were common. Prognosis is variable, with a potential 50% perioperative survival rate, but extended survival times were noted in those patients discharged from hospital.

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Dual distal mini-balloon aortic valvuloplasty stabilized an 85-year-old patient with severe aortic stenosis. Puncturing both radial arteries solves the issue of large diameters at the aortic ring, introducing a feasible strategy in selected cases of fragile octogenarian patients with a high hemorrhagic risk. Moving at the anatomical snuffbox offers better postprocedural occlusion rates and better workspace ergonomics during the procedure.

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