ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2.

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.

Clinical Outcomes Associated With Balloon Aortic Valvuloplasty in the Contemporary Era.

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.

Volume-outcome relationship in balloon aortic valvuloplasty: results of a consecutive, patient-level data analysis from a Japanese nationwide multicentre registry (J-SHD).

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.

Rapid transesophageal atrial pacing for balloon aortic valvuloplasty in neonates and infants: A new technique for balloon stabilization.

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.

The outcomes of fetal aortic valvuloplasty in critical aortic stenosis: A systematic review and meta-analysis.

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.

Safety and efficacy of repeated balloon aortic valvuloplasty in patients with symptomatic severe aortic stenosis.

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.

The Outcomes of PBMV in Pregnancy, and When is the Best Time?

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.

Integrative echocardiographic assessment of post-operative obstruction severity and restenosis after balloon valvuloplasty in 81 dogs with pulmonary stenosis.

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.

Which is the best time to perform balloon valvuloplasty in critically fetal aortic stenosis: Prenatally or after birth?

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.

Pulmonary artery dissection following pulmonary balloon valvuloplasty in dogs.

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.

Simultaneous Dual Distal Radial Balloon Aortic Valvuloplasty for Larger Aortic Annuli.

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.

Fetal echocardiography and early neonatal balloon valvuloplasty improved overall survival in prenatally detected aortic stenosis over 25 years of tertiary center experience.

PURPOSE: This article aimed to present the factors determining survival and prognosis in fetuses and newborns with critical prenatal aortic stenosis (AS) and to present 26 years of tertiary center experience. METHODS: Study included 87 fetuses with critical AS requiring surgical intervention during neonatal period. All results were expressed as means ± SD, in numbers and percentages. The statistically significant results were those with p < 0.05. RESULTS: An increase in the number of cases of AS was observed in our center along with a decrease in gestational age of our patients during the first echocardiographic exam. The survival rate of newborns was considerably higher when born in due time (p < 0.05) with body weight > 2500 g (p < 0.05). Balloon valvuloplasty performed in the first days after birth occurred to be an optimal solution in these cases. CONCLUSIONS: Fetal echocardiography and special perinatal care with transplacental maternal pharmacotherapy in selected cases and an early neonatal aortic balloon valvuloplasty have shown improvement in survival rate. The most dangerous for the newborn with AS was the first week of postnatal life. It is vital to refer the fetuses with AS to the reference centers which offer the possibility of invasive cardiac intervention on the first day after birth, and it might be an optimal solution.

Hemodynamic and anatomic changes after fetal aortic valvuloplasty are associated with procedural success and postnatal biventricular circulation.

BACKGROUND: There are minimal data characterizing the trajectory of left heart growth and hemodynamics following fetal aortic valvuloplasty (FAV). METHODS: This retrospective study included patients who underwent FAV between 2000 and 2019, with echocardiograms performed pre-FAV, immediately post-FAV, and in late gestation. RESULTS: Of 118 fetuses undergoing FAV, 106 (90%) underwent technically successful FAV, of which 55 (52%) had biventricular circulation. Technically successful FAV was associated with improved aortic valve growth (p < 0.001), sustained antegrade aortic arch (AoA) flow (p = 0.02), improved mitral valve (MV) inflow pattern (p = 0.002), and favorable patent foramen ovale (PFO) flow pattern (p = 0.004) from pre-FAV to late gestation. Compared to patients with univentricular outcome, patients with biventricular outcome had less decrement in size of the left ventricle (LV) (p < 0.001) and aortic valve (p = 0.005), as well as more physiologic PFO flow (p < 0.001) and antegrade AoA flow (p < 0.001) from pre-FAV to late gestation. In multivariable analysis, echocardiographic predictors of biventricular outcome were less decline in LV end diastolic dimension (p < 0.001), improved PFO flow (p = 0.004), and sustained antegrade AoA flow (p = 0.002) from pre-FAV to late gestation. CONCLUSION: Stabilization of left heart growth and improved hemodynamics following successful FAV through late gestation are associated with postnatal biventricular circulation.

Temporal Trends in the Utilization and Outcomes of Balloon Aortic Valvuloplasty in the Pre-Transcatheter Aortic Valve Implantation (TAVI) and TAVI Eras.

We used a nationwide cohort to (1) compare characteristics and outcomes of patients who underwent balloon aortic valvuloplasty (BAV) in pre-transcatheter aortic valve transplantation (TAVI) and TAVI eras, (2) examine trends in utilization and outcomes of BAV from 2005 to 2017, (3) assess the association of BAV procedural volume with hospital-based TAVI volume, and (4) understand trends and outcomes of BAV in TAVI and non-TAVI centers in the TAVI era. Pre-TAVI era included hospitalizations from 2005 to 2011, and TAVI era included hospitalizations from 2012 to 2017. In the TAVI era, hospitals were classified into quartiles based on the number of TAVI procedures performed. Trends in volume of BAV procedures from 2012 to 2017 were assessed in non-TAVI and TAVI centers (based on TAVI volume). Between 2005 and 2017, a total of 6,962 hospitalizations for BAV were identified. There were no significant differences in in-hospital mortality or stroke between pre-TAVI and TAVI eras (mortality: pre-TAVI, 8.5% vs TAVI era, 9.3%, p = 0.354; stroke: pre-TAVI, 1.9% vs TAVI era, 1.3%, p = 0.083). However, acute kidney injury was more prevalent in the TAVI era and blood transfusion in the pre-TAVI era. Importantly, patients who underwent BAV in the TAVI era were more likely to have a greater number of co-morbidities and to undergo nonelective procedures. From 2005 to 2017, there was 10-fold increase in utilization of BAV. In the TAVI era, the maximum increase in number of BAV procedures was seen in hospitals with highest TAVI volume. In conclusion, although BAV procedural volume increased approximately 10-fold between 2005 and 2017, with concomitant expansion of TAVI, rates of mortality and stroke have remained stable. Despite this, the rate of BAV utilization continues to increase, thereby indicating a significant opportunity to improve outcomes in this patient population.

Balloon aortic valvuloplasty: current status and future prospects.

INTRODUCTION: Balloon aortic valvuloplasty (BAV) improves hemodynamic and clinical status of patients with severe aortic stenosis (AS) for a limited period of 6-12 months. However, there is a high number of procedures performed worldwide and an upward trend over the last decades. AREAS COVERED: Epidemiology of AS and the advent of transcatheter aortic valve implantation (TAVI) contribute to the extensive referral of patients. The expansion of recommendations for TAVI has occasionally led to financial reimbursement-related problems that do not exist for BAV. BAV is indicated as a bridge to valve replacement, to decision in complex cases, and to extracardiac surgery. BAV may play a role in preparing for TAVI and optimizing procedural results. The minimalist approach and reduced complication rate make it applicable in fragile patients. EXPERT OPINION: In the near future, BAV will continue to be a useful asset in managing patients with AS given the multiple indications, broad applicability, safety profile, low cost, and repeatability. Specific studies are necessary to explore technical solutions, stronger indications, the finest technique, and to standardize the procedural result. Pending the development of potential competitive devices, the role that BAV plays will remain closely intertwined with the one played by TAVI.

Long-term Results of Perfusion-Balloon Valvuloplasty, Without Rapid Pacing, in High-Risk Elderly Patients With Severe Aortic Stenosis: A New Space Oddity.

BACKGROUND: Percutaneous balloon aortic valvuloplasty (BAV) is actually recommended as a bridge to surgery or transcatheter aortic valve replacement in patients with severe aortic stenosis (AS) in particular clinical settings. In this pilot study, for the first time, we report our experience utilizing a nonocclusive balloon for BAV, which does not require rapid ventricular pacing (RVP), in high-risk symptomatic elderly patients with severe AS. METHODS AND RESULTS: From 2018 to 2020, a total of 30 high-risk elderly patients with heart failure due to severe AS were treated with BAV and were all prospectively included in the study. We used a perfusion-balloon valvuloplasty without RVP (True Flow; BD/Bard). Hemodynamic parameters were invasively evaluated during catheterization, before and immediately after BAV. All patients were regularly followed to detect the rate of mortality. The patients were 87.56 ± 4.10 years old and 23% were males. In the catheterization laboratory, the peak left ventricular to aortic pressure gradient significantly decreased from 55 mm Hg (interquartile range [IQR], 48.75-66.25) to 26 mm Hg (IQR, 15.7-30) immediately after balloon inflation (P<.001). The median value of percentage decrease of transaortic gradient was 56% (IQR, 50-74). At a median of 12 months (IQR, 5-27) follow-up, 12 patients (40%) died. The median time between BAV and mortality was 10.5 months (IQR, 1.75-15.5). At multivariable analysis, the only predictor of mortality was the New York Heart Association class at admission (odds ratio, 3.29; 95% confidence interval, 2.4-298.4; P<.01). CONCLUSION: This single-center pilot study represents the first evidence that perfusion-balloon valvuloplasty without RVP is a safe, valid, and durable option in high-risk, symptomatic, elderly patients with severe AS.