Balloon Aortic Valvuloplasty Group Research Articles

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Direct vs. staged TAVI in the acute management of decompensated severe aortic stenosis

Abstract Funding Acknowledgements None. Background Transcatheter aortic valve implantation (TAVI) has emerged as a preferred treatment for severe aortic stenosis across a spectrum of surgical risks, potentially diminishing the role of balloon aortic valvuloplasty (BAV) as a transient solution or a bridge to definitive intervention. With advancements in TAVI technology and expertise, patients even in unstable conditions are increasingly receiving direct, definitive TAVI, avoiding the risks associated with staged, multiple procedures. Aims The study set out to assess whether immediate TAVI is safer and more effective than BAV followed by elective aortic valve replacement (AVR) in acute severe aortic stenosis. Methods Conducted as a retrospective analysis at a single center, this study encompassed a cohort of consecutive patients who received either urgent or emergency BAV, as bridge to AVR, or TAVI to manage decompensated severe aortic stenosis from May 2012 to May 2023. The primary outcomes were mortality rates at both 30 days and one year following the procedures. Results In this cohort, 258 cases of urgent or emergent percutaneous aortic valvuloplasty were evaluated. BAV was performed in 47 patients, whereas 211 received direct TAVI. A significantly higher proportion of the BAV group (36%) was treated due to cardiogenic shock as the primary indication, compared with just 11% in the TAVI group (p< 0.001). Demographic parameters and comorbid condition profiles were equivalently balanced across both groups. The median age was 81 years (interquartile range: 74-85, p= 0.40), and males constituted 56% of the patient population (p= 0.72). Most patients (65%) presented with left ventricular systolic dysfunction, and nearly half (49%) were diagnosed with obstructive coronary artery disease. The reduction in peak aortic valve gradient was significantly more pronounced in the TAVI group (-56±25 mmHg) compared to the BAV group (-27±19 mmHg, p< 0.001). TAVI recipients also had a higher incidence of VARC-2 minor and major bleeding events (26% versus. 6% for BAV, p<0.001), and a greater occurrence of advanced atrioventricular block necessitating temporary pacing (19% vs. 9% for BAV, p= 0.02). Thirty-day survival rates favored the TAVI group (93%) over BAV (86%). This trend persisted at the one-year mark, with survival rates of 84% for TAVI and 70% for BAV. Furthermore, the one-year hazard ratio for mortality among patients undergoing BAV was 2.01 (95% confidence interval: 1.34–3.01, p< 0.001). Conclusion The data from this retrospective analysis indicate that for patients with decompensated severe aortic stenosis, immediate TAVI may confer a mortality benefit over BAV followed by elective procedures. Despite a higher rate of procedural complications, the direct TAVI approach was associated with better survival rates at both 30 days and one year. These outcomes suggest a potential reevaluation of treatment strategies in acute settings may be warranted.

Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial

BackgroundSafety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR versus BAV pre TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519). MethodsClinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n=228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation). ResultsMedian follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ±6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, p=0.6). Prevalence of predicted prothesis-patient mismatch was low (n=13 [11.4%] in the direct TAVR group versus n=15 [13.2%] in BAV group) and similar between both groups (p=0.7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (p=0.4, p=0.7, p=0.3 and p=0.3 respectively). ConclusionDirect implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible. Clinical Trials Registration numberNCT05140317

Aortic insufficiency following balloon aortic valvuloplasty does not impact long-term autograft durability after the Ross procedure

ObjectivePreoperative aortic insufficiency (AI) is associated with inferior autograft durability after the Ross procedure. However, many patients with aortic stenosis (AS) undergo balloon aortic valvuloplasty (BAV) early and present with longstanding AI before Ross. We studied how BAV and subsequent valvular pathology impacts autograft durability. MethodsPatients undergoing the Ross operation from 1993 to 2020 were identified. Those who underwent BAV before Ross were compared with patients who did not undergo BAV and underwent Ross for predominant AI (AI group) or AS (AS group). Those who underwent previous open surgical aortic valve intervention were excluded. Primary outcome of interest was autograft failure, defined as a composite of autograft reintervention or severe insufficiency. ResultsA total of 198 patients were included. Seventy-nine (39.9%) underwent BAV and subsequently underwent the Ross for predominant AI (45.6%) or AS (54.4%). Of patients who did not undergo BAV, 66 (33.3%) presented with predominant AI and 53 (26.8%) with AS. Freedom from autograft failure at 15 years was 90%, 92%, and 62% in BAV, AS, and AI groups, respectively. The AI group was at significantly increased risk of long-term autograft failure (hazard ratio, 5.6; P = .01), whereas the AS and BAV groups had similar, low risk (hazard ratio, 1.1; P = .91). Autograft durability was similar among patients who received BAV and presented with AS or AI before the Ross (P = .84). ConclusionsBAV before the Ross procedure is common in patients with AS. These patients have excellent long-term autograft durability regardless of preoperative valvular pathology and should strongly be considered for the Ross operation.

Up to 6-year performance and clinical outcomes of balloon expandable transcatheter aortic valve according to the implantation strategy: insight from the DIRECTAVI trial

Abstract Background The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. Purpose To evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVI versus BAV) with the SAPIEN 3 balloon-expandable device in patients included in the DIRECTAVI trial. Methods All patients included in the DIRECTAVI trial since 2016 were offered a clinical and echocardiographic follow-up until January 2023. We applied Valve Academic Research Consortium (VARC-3) criteria to define moderate/severe hemodynamic valve deterioration (HVD) as an increase in mean gradient ≥10 mm Hg resulting with a final mean gradient ≥20 mm Hg, or new/worsening aortic regurgitation (AR) of 1 grade resulting in ≥moderate AR. Survival until moderate/severe HVD between the 2 groups was the primary end-point and overall survival between direct TAVI and BAV were compared using logrank tests. Major clinical outcomes at latest follow-up were also assessed using Chi² or Fisher’s tests. Results Among 250 patients included in DIRECTAVI, 228 patients were followed-up during 4.5 ± 1.1 years. Mean age at follow-up was 87 ± 6.7 years. Incidence rates of moderate/severe HVD were similar in the 2 groups (1.45 versus 1.97 per 100 person-years, p=0.6) (Figure). Incidence rates for death were similar between groups (9.19 and 7.34 events per 100 persons-years for BAV and direct TAVI, respectively, p=0.4). No clinically significant differences in outcomes were observed at the latest follow-up, including major stroke (4.4% for BAV versus 2.6% for direct TAVI, p=0.7), hospitalizations for heart failure (15.8% for BAV group and 11.4% for direct TAVI group, p=0.3), permanent pacemaker implantation (37.7% for BAV and 31.6% for direct TAVI, p=0.3). Moderate/severe patient-prosthesis mismatch was also similar between groups (p=0.6). Conclusion Compared to systematic BAV, direct implantation of the SAPIEN 3 device was not associated with an increased risk of moderate/severe valve deterioration or adverse clinical events up to 6-year follow-up. These results encourage wide use of this simplified strategy with balloon-expandable devices, when possible.Survival without valve deterioration

Surgical aortic valvuloplasty is a better primary intervention for isolated congenital aortic stenosis in children with bicuspid aortic valve than balloon aortic valvuloplasty

ObjectivesSurgical aortic valvuloplasty (SAV) and balloon aortic valvuloplasty (BAV) are two main treatments for children with isolated congenital aortic stenosis (CAS). We aim to compare the two procedures' midterm outcomes, including valve function, survival, reintervention, and replacement. MethodsFrom January 2004 to January 2021, children with isolated CAS undergoing SAV (n = 40) and BAD (n = 49) at our institution were included in this study. Patients were also categorized into subgroups based on the aortic leaflet number(Tricuspid = 53, Bicuspid = 36) to compare the two procedures’ outcomes. Clinical and echocardiogram data were analyzed to identify risk factors for suboptimal outcomes and reintervention. ResultsPostoperative peak aortic gradient (PAG) and PAG at follow-up in the SAV group were lower compared with the BAV group (p < 0.001, p = 0.001, respectively). There was no difference in moderate or severe AR in the SAV group compared with the BAV group before discharge (5.0% vs 12.2%, p = 0.287) and at the last follow-up (30.0% vs 32.7%, p = 0.822). There were no early death but three late deaths (SAV = 2, BAV = 1). Kaplan-Meier estimated survivals were 86.3% and 97.8% in SAV and BAV groups respectively at 10 years (p = 0.54). There was no significant difference in freedom from reintervention (p = 0.22). For patients with bicuspid aortic valve morphology, SAV achieved higher freedom from reintervention (p = 0.011) and replacement (p = 0.019). Multivariate analysis indicated that residual PAG was a risk factor for reintervention (p = 0.045). ConclusionsSAV and BAV achieved excellent survival and freedom from reintervention in patients with isolated CAS. SAV performed better in PAG reduction and maintenance. For patients with bicuspid AoV morphology, SAV was the preferred choice.

TAVR vs balloon aortic valvotomy for severe aortic stenosis and cardiogenic shock: An insight from the National Inpatient Sample database

BackgroundSevere Aortic stenosis (AS) complicated by cardiogenic shock (CS) represents a grave clinical condition with limited treatment options. Evidence from small observation studies favors that Transcatheter Aortic Valve Replacement (TAVR) might be a feasible option in these patients in contrast to emergent Balloon Aortic Valvuloplasty (BAV) which is associated with very high short and long-term mortality. Methods11,405 hospitalizations with severe AS complicated by CS between 2016 and 2020 were identified using the National Inpatient Sample (NIS) Database, and patients were then stratified according to whether they received TAVR or BAV. Propensity-score matching was used to account for differences in the baseline characteristics. Primary and secondary outcomes were then compared between 3485 hospitalizations in direct TAVR group and with 3485 matched hospitalizations in the BAV group. The primary outcome was a composite of all-cause in-hospital death, acute cerebrovascular accident (CVA), and myocardial infarction (MI). Secondary outcomes and safety outcomes were also compared between the two groups. ResultsTAVR was associated with fewer primary outcomes events as compared to BAV {36.8 % vs 56.8 %, aOR (95%CI) = 0.38(0.30–0.47)}, due to fewer all-cause in-hospital deaths {17.8 % vs 38.9 %, aOR (95%CI) =0.34 (0.26–0.43)} and MI {12.3 % vs 32.4 %, aOR (95%CI) = 0.29 (0.22–0.39)}. TAVR was associated with higher rates of acute CVA {6.17 % vs 3.44 %, aOR (95%CI) = 1.84 (1.08–3.21)} and pacemaker implantation post procedure {11.9 % vs 6.03 %, aOR (95%CI) = 2.10 (1.41–3.18)}. ConclusionDirect TAVR in shock and severe Aortic stenosis is a better strategy than rescue Balloon aortic valvotomy.

Use of left ventricular support devices during transcatheter aortic valve replacement and balloon aortic valvuloplasty: a single center experience

Abstract Background Transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV) are definitive and bridging therapies in patients with aortic stenosis. Data on utilization of mechanical circulatory support (MCS) in this population is scarce. This study sought to evaluate the clinical outcomes of the use of Impella (Abiomed, Danvers, MA) in patients undergoing TAVR or BAV at a tertiary-care center. Methods We reviewed all TAVRs and BAVs that required Impella from 2012 and 2020. Patient demographics, procedural outcomes, complications, and 30-day mortality were analyzed. Results A total of 1,965 TAVR and 715 BAV cases were performed in the study period. 30 TAVR and 94 BAV cases required an Impella. 65% of these cases were due to cardiogenic shock (CS) (100% of TAVR and 55% of BAV). 31% were performed in female patients. Transfemoral access was utilized in 98% of cases. Impella CP was used in 98% of cases, other types of MCS were used in 8.7% of cases. 32.2% of cases required MCS for more than 24 hours. In the TAVR population the indication for MCS was 46.6% profound hypotension post valve deployment requiring vasopressors, 16.6% cardiac arrest, 10% sustained ventricular arrhythmia, 10% cardiac tamponade [Office1] and 10% coronary occlusion. In the BAV group the indication was 44% high-risk PCI and 56% CS. The 30-day mortality in TAVR was 40% and 28% in BAV; from the BAV group in CS the mortality was 45%. VARC-2 vascular complications and bleeding complications were observed in 4.8% and 1.5%, respectively. 0.7% of the total cohort required conversion to open-heart surgery. Conclusions Impella support is required in a minority of TAVR or BAV cases. In those who require MCS with Impella for either BAV or TAVR, the total mortality remains high especially in those experiencing CS. Funding Acknowledgement Type of funding sources: None.

Readmission following urgent transcatheter aortic valve implantation versus urgent balloon aortic valvuloplasty in patients with decompensated heart failure or cardiogenic shock.

Urgent transcatheter aortic valve implantation (TAVI) is a feasible option for aortic stenosis (AS) patients with decompensated heart failure (HF) and cardiogenic shock (CS) as compared to the more traditional urgent balloon aortic valvuloplasty (BAV). We conducted a retrospective analysis to compare risk and cause of readmission in these two high-risk groups. Nationwide Readmission Database (NRD) 2011-2014 was retrospectively analyzed to identify patients with AS having either urgent TAVI or urgent BAV using appropriate ICD-9 codes. Propensity scores were used to match patients with urgent TAVI as compared to patients with urgent BAV. Statistical analysis was performed using the Stata 15.1 software. We identified a weighted sample of 6,670 patients with urgent BAV and 6,964 patients with urgent TAVI. The all-cause 30- and 90-day readmission was lower in the urgent TAVI group compared to urgent BAV (15.4 vs. 22.5%, (aHR): 0.92 [0.90-0.95] p < .001). 30-day readmission due to CV cause and HF was also lower in the urgent TAVI group (aHR, 0.93: p < .001 and aHR, 0.98: p=.040, respectively). The 30-day gastrointestinal (GI) bleed readmission rate was three times higher in urgent TAVI group (aHR, 3.00:95% CI (1.23-7.33), p=.016), but was not statistically significant at 90-days. Cardiac causes of readmission were the predominant cause of readmission in both groups, but more pronounced in urgent BAV group (60.3 vs. 40.5%, p < .001). Urgent TAVI appears beneficial in patients with AS and decompensated HF or CS driven by roughly 10 and 25% reductions in overall readmissions at 30 and 90 days, and marked reductions in reintervention, although offset partially by higher risk of readmission due to GI bleeding at 30 days.

Small balloon strategy associated with low pacemaker implantation rate after self-expanding transcatheter valve implantation.

This study aims to investigate whether small balloon aortic valvuloplasty (BAV) reduces the need for permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI). This was a retrospective analysis using data from our local TAVI database. Small BAV was defined as a small balloon size (=18 mm) pre-dilatation. Normal BAV was defined as a balloon size >18 mm. The primary endpoint was the incidence of new PPMI. Of 99 consecutive TAVI patients, five patients were excluded due to pre-existing permanent pacemaker. Patients in the small BAV group (n=57) had a significantly lower PPMI rate compared with the normal BAV group (n=37) (3.5% vs. 18.9%, P=0.026). Moderate or severe aortic valve regurgitation post-procedure was similar between the small BAV and normal BAV groups (5.3% vs. 8.1%, P=0.480); likewise, the mean aortic gradient post-procedure did not differ significantly (11.5±5.2 mmHg vs. 12.2±7.3 mmHg, 1 mmHg=0.133 kPa, P=0.580) between the groups. Device success rates were also similar (94.7% vs. 91.8%, P=0.680). In multivariable analysis, small BAV (P=0.027), the ratio of prosthesis diameter to annulus diameter (P=0.048), and mean aortic gradient by echo in the basement (P=0.021) were independent predictors of PPMI. The small BAV strategy is associated with a low rate of permanent pacemaker implantation after transcatheter self-expanding valve implantation in this single-center observational study.

Is preoperative balloon aortic valvuloplasty of interest for severe aortic stenosis in hip fracture surgery?

In elderly patients, the discovery and management of a severe aortic stenosis (AS) prior to emergency non-cardiac surgery is a frequent and controversial issue. The objective of this study was to evaluate preoperative balloon aortic valvuloplasty (BAV) for severe AS in hip fracture surgery. We conducted an observational, monocentric, retrospective study from 2011 to 2018. Survival (30-day, 90-day and 180-day mortality) and the occurrence of perioperative complications were analyzed and compared between control (i.e. no BAV prior to surgery) and preoperative BAV groups in patients with hip fracture surgery and a formal transthoracic echocardiographic diagnosis of severe AS (aortic valve area < 1 cm²). Patients' allocation to the intervention and control groups was after a discussion between cardiologist, anesthesiologist and the surgeon. Among the 8506 patients who underwent hip fracture surgery, 29 patients in the control group and 30 patients in the BAV group were finally included. Kaplan-Meier survival analysis demonstrated a significant decrease in mortality in the BAV group (p=0.014) despite an increase in median time to operation of about 48 hours (p<0.0001). Multivariate analysis (stepwise logistic regression) showed that postoperative delirium (OR [95%CI]: 17.5 [1.8-168]; p=0.013) and postoperative acute congestive heart failure (OR [95%CI]: 59.4 [5.0-711.1]; p=0.0013) were predictive factors of 30-day mortality with an area under ROC curve of 0.90 (95%CI: 0.80-0.97; p<0.0001). preoperative BAV for severe AS could reduce the mortality of hip fracture patients despite an increase in time to operation. This improved survival could be linked to the decrease in cardiologic and neurologic adverse events. A larger prospective randomized study is necessary before generalizing our results.

Elective versus rescue balloon aortic valvuloplasty for critical aortic stenosis.

Balloon aortic valvuloplasty (BAV) may be considered a bridge to further intervention in hemodynamically unstable patients or patients with symptomatic severe aortic stenosis (AS). This study aimed to retrospectively compare periprocedural and in‑hospital outcomes of AS patients treated with elective BAV (group 1) and rescue BAV (group 2). We identified 35 patients in whom BAV was performed between 2010 and 2018. Among them, 16 were treated electively (group 1) and 19 urgently (group 2). Overall, BAV resulted in a significant decrease in the mean transaortic gradient by a median (interquartile range [IQR]) value of 5 (1-10) mm Hg (P <0.01) and the maximal transaortic gradient by a median (IQR) value of 13.5 (2.5-23.2) mm Hg (P <0.01). Postprocedural grade II aortic regurgitation rates increased from 8.6% to 17.1% (P = 0.48). Periprocedural death occurred in 4 patients (11.4%)-all from group 2 (21%) (P = 0.1). In‑hospital death occurred in 15 patients (42.8%)-3 patients (18.7%) from group 1 and 12 patients (63.1%) from group 2 (P <0.01). During follow‑up, a single patient underwent surgical aortic valve replacement, and transcatheter aortic valve implantation was performed in 4 individuals. A single patient died 22 months after BAV. Periprocedural and in‑hospital mortality in patients with critical AS treated with BAV remains very high, especially in patients treated urgently.

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial

ObjectivesThe aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BackgroundRandomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. MethodsDIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority 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% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. ResultsDevice 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 noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 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. ConclusionsDirect TAVR without prior BAV was noninferior 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. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519)

Percutaneous Aortic Valve Intervention in Patients Scheduled for Noncardiac Surgery: A Japanese Multicenter Study

BackgroundThe optimal management of preexisting severe aortic stenosis (AS) in patients undergoing noncardiac surgery (non-CS) remains uncertain. This study aimed to investigate the safety and effectiveness of percutaneous aortic valve intervention (PAVI) in patients with AS before non-CS. MethodsWe analyzed pooled data within a multicenter Japanese registry from 118 patients with severe AS who underwent PAVI before non-CS. Sixty patients underwent percutaneous balloon aortic valvuloplasty (BAV) and 58 patients underwent transcatheter aortic valve replacement (TAVR). The groups' baseline characteristics, perioperative complications, and 30-day mortality and midterm mortality after non-CS were compared. ResultsThe postprocedural mean pressure gradient was higher in the BAV group than in the TAVR group (35.0 ± 11.5 mmHg vs. 11.5 ± 4.8 mmHg, p < 0.001). The non-CS operation risk did not differ between the groups (p = 0.69). One patient in each group experienced a noncardiac death (p = 0.74), and the 30-day mortality rate after non-CS was 1.7%. Heart failure occurred in 2 patients in each group (p = 0.68). One patient in the TAVR group experienced a non-disabling stroke, and no myocardial infarctions occurred. Consequently, the combined adverse events were 5.0% and 6.9% in the 2 groups (p = 0.48). The bleeding rates during the non-CS were similar in both groups (33.3% vs. 25.9%, p = 0.25). There were no differences between the groups regarding midterm mortality (p = 0.60), whereas 53.3% of the patients in the BAV group required invasive treatment of their AS during follow-up. ConclusionsAmong patients with severe AS, PAVI before non-CS reduces the AS severity and may contribute to procedural safety during non-CS.

Balloon-expandable transcatheter aortic valve implantation with or without pre-dilation \u2013 results of a meta-analysis of 3 multicenter registries

BackgroundTo evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis.MethodsThe meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes.ResultsMedian procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30.ConclusionsThis patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.

Outcomes of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty Using a New Generation Valve.

We investigated the outcomes of patients who underwent Transcatheter Aortic Valve Replacement (TAVR) with and without Balloon Aortic Valvuloplasty (BAV) using the SAPIEN 3 (S3) valve. All patients who underwent TAVR using S3 valve were included. The primary outcomes were the incidence of stroke and significant paravalvular leak (PVL). Secondary outcomes were the incidence of mortality, balloon post dilation, and need for permanent pacemaker. From July-2014 to April-2018, 34 (9%) patients underwent BAV prior to TAVR and 344 (91%) patients underwent direct TAVR without BAV using the S3 valve. The Society of Thoracic Surgeons (STS) risk score was similar between two groups; 5.8 ± 3.5 in no BAV group and 5.4 ± 3.3 in BAV group, p = 0.53. After TAVR, 6 (1.7%) patients in no BAV group but no patient in BAV group developed stroke (p = 1.0). No patient had severe PVL and only 5 patients (1.3%) had moderate PVL at 30-day; 4 (1.2%) in no BAV group and 1 (2.9%) in BAV group (p = 0.38). Forty-six patients (13.4%) in the no BAV group and 4 (11.8%) patients in the BAV group needed balloon post dilation (p = 1.0). Six (1.6%) patients died during hospitalization, all in the no BAV group (p = 1.0). Forty-five (11.9%) patients needed new pacemaker implantation; 44 (12.8%) patients in no BAV group and 1 (2.9%) patient in BAV group (p = 0.1). Two-year survival rate was 85% in no BAV group and 84% in BAV group (p = 0.46). TAVR using S3 valves is associated with very low rates of post-TAVR stroke and significant PVL. Outcomes of direct TAVR are similar to the outcomes of TAVR with BAV, without an increased rate of stroke, significant PVL, or balloon post dilation.

Trend and Outcomes of Direct Transcatheter Aortic Valve Replacement from a Single-Center Experience.

IntroductionWhen transcatheter aortic valve replacement (TAVR) was introduced, pre-implantation balloon aortic valvuloplasty (BAV) was a routine part of the procedure. Smaller device profiles have resulted in selective use of BAV; however, there is a paucity of data about the trend in use of direct TAVR and the safety of this strategy.MethodsAll patients who underwent TAVR at a Veterans Affairs Medical Center from September 2013 to November 2016 were included in this retrospective analysis. We reviewed angiography films and verified with procedure reports to assess if direct TAVR was performed. Troponin T was assessed within 72 h after the TAVR. Multivariate analysis examined the association between direct TAVR and periprocedural myocardial infarction (MI) or 1-year mortality.ResultsOverall, 207 patients were available for analysis. The mean follow-up was 13.3 months. A balloon-expandable valve was used 93.2% of the time, and 35.3% of patients were treated with conscious sedation. Periprocedural MI or 1-year mortality occurred in 12.5% of the direct TAVR group versus 18.3% of the pre-implantation BAV group (p = 0.30). After controlling for potential confounding variables, direct TAVR was not associated with periprocedural MI or 1-year mortality.ConclusionsDirect TAVR appears to be safe and is not associated with periprocedural MI or 1-year mortality. With current generation devices, this strategy can be considered for most patients undergoing TAVR.

Cronología y evolución de los trastornos de conducción asociados con el implante percutáneo de válvula aórtica: impacto de la valvuloplastia aórtica con balón

Introduction and objectivesLittle is known about the timing of onset and outcome of conduction abnormalities (CA) following balloon-expandable transcatheter aortic valve implantation. The aim of this study was to examine the timing of CA and determine the impact of balloon aortic valvuloplasty (BAV) on the persistence of these abnormalities. MethodsA total of 347 patients were included. Of these, 75 had a continuous electrocardiogram recording and a 6-lead electrocardiogram at each step of the procedure. ResultsIn the transcatheter aortic valve implantation population undergoing continuous electrocardiogram monitoring, new-onset left bundle branch block (LBBB) or third-degree atrioventricular block occurred in 48 (64%) and 16 (21.3%) patients, with 51.5% of CA occurring before valve implantation. Left bundle branch block persisted more frequently at hospital discharge (53.8 vs 22.7%; P=.028) and at 1-month follow-up (38.5 vs 13.6%; P=.054) when occurring before valve implantation. Balloon aortic valvuloplasty prior to valve implantation was used in 264 (76.1%) patients, and 78 (22.5%) had persistent LBBB or complete atrioventricular block requiring pacemaker implantation. Persistent LBBB or unresolved atrioventricular block at 1 month occurred more frequently in the BAV group (76.1 vs 47.6%; P=.021), and the use of BAV was associated with a lack of CA resolution (OR, 3.5; 95%CI, 1.17-10.43; P=.021). ConclusionsIn patients undergoing a balloon-expandable transcatheter aortic valve implantation, more than half of CA occurred before valve implantation. Early occurrence of CA was associated with a higher rate of persistence at 1-month follow-up. The use of BAV was associated with an increased risk of CA persistence.Full English text available from:www.revespcardiol.org/enFull English text available from:www.revespcardiol.org/en

Randomized comparison of balloon aortic valvuloplasty performed with or without rapid cardiac pacing: The pacing versus no pacing (PNP) study.

To compare the effectiveness and safety of balloon aortic valvuloplasty (BAV) performed with or without rapid ventricular pacing (RP). BAV technique is poorly standardized. One hundred consecutive patients were randomly assigned 1:1 between BAV performed with or without RP. Exclusion criteria were an immediate indication for surgical or transcatheter aortic valve replacement, presentation in cardiogenic shock or pulmonary edema refractory to medical stabilization. There were 51 patients in the BAV group performed with RP, 49 in the BAV group without RP (noRP). Procedural success (50% hemodynamic gradient reduction) was achieved in 37.3% and 55.1%, respectively (P = 0.16). Fewer people in the noRP group complained of poor tolerance to the procedure (16% vs 41%). The primary efficacy endpoint, a 50% reduction in the mean echocardiographic trans-aortic gradient, was met in 21/49 patients in the noRP group compared to 20/51 in the RP (42.9% vs 39.2%; P = 0.84). No significant difference between the groups was observed in the primary safety endpoint, a 30-day composite of death, myocardial infarction, stroke, acute aortic regurgitation, and BARC bleeding ≥3 (8.2% noRP vs 13.7%; P = 0.53). The noRP group required fewer bailout temporary pacemakers (P = 0.048) and had a lower incidence of moderate/severe renal function worsening (4.1% vs 17.6%; P = 0.052). Rapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse.

Timing of Onset and Outcome of New Conduction Abnormalities Following Transcatheter Aortic Valve Implantation: Role of Balloon Aortic Valvuloplasty

Introduction and objectivesLittle is known about the timing of onset and outcome of conduction abnormalities (CA) following balloon-expandable transcatheter aortic valve implantation. The aim of this study was to examine the timing of CA and determine the impact of balloon aortic valvuloplasty (BAV) on the persistence of these abnormalities. MethodsA total of 347 patients were included. Of these, 75 had a continuous electrocardiogram recording and a 6-lead electrocardiogram at each step of the procedure. ResultsIn the transcatheter aortic valve implantation population undergoing continuous electrocardiogram monitoring, new-onset left bundle branch block (LBBB) or third-degree atrioventricular block occurred in 48 (64%) and 16 (21.3%) patients, with 51.5% of CA occurring before valve implantation. Left bundle branch block persisted more frequently at hospital discharge (53.8 vs 22.7%; P=.028) and at 1-month follow-up (38.5 vs 13.6%; P=.054) when occurring before valve implantation. Balloon aortic valvuloplasty prior to valve implantation was used in 264 (76.1%) patients, and 78 (22.5%) had persistent LBBB or complete atrioventricular block requiring pacemaker implantation. Persistent LBBB or unresolved atrioventricular block at 1 month occurred more frequently in the BAV group (76.1 vs 47.6%; P=.021), and the use of BAV was associated with a lack of CA resolution (OR, 3.5; 95%CI, 1.17-10.43; P=.021). ConclusionsIn patients undergoing a balloon-expandable transcatheter aortic valve implantation, more than half of CA occurred before valve implantation. Early occurrence of CA was associated with a higher rate of persistence at 1-month follow-up. The use of BAV was associated with an increased risk of CA persistence.