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Background: Balloon aortic valvuloplasty (BAV) has gained renewed interest as a bridge to transcatheter aortic valve replacement (TAVR) for patients with aortic stenosis (AS). However, it is unclear whether they patients should undergo TAVR directly or receive a staged bridge to BAV before TAVR is unclear. We used a national database to examine the association between BAV and TAVR in patients with TAVR and its effect on in-hospital mortality., Methods: Using the nationwide inpatient database of the Japanese registry of all cardiac and vascular diseases and the combination of the diagnosis procedure combination, we retrospectively analyzed 27,600 patients with AS who underwent TAVR between October 2013 and March 2021. Outcomes of the direct TAVR group (n = 27,387) were compared with those of the BAV bridge to TAVR group (n = 213), which received BAV at least 1 day before TAVR., Results: The median age was 85 (interquartile range: 82-88) years, with 33.3% (n = 9188) being male. Unplanned/emergent admissions increased with TAVR, whereas the use of BAV bridge to TAVR decreased. The in-hospital mortality rate was 1.3% and decreased over time. However, the BAV bridge to TAVR had a significantly higher in-hospital mortality than direct TAVR (5.6% vs. 1.3%; p < .0001). Factors associated with in-hospital mortality included age, body mass index, chronic renal disease, percutaneous coronary intervention, and BAV bridge to TAVR., Conclusions: In unplanned/emergent and planned admission settings, the in-hospital mortality rate for BAV bridge to TAVR is worse than that for direct TAVR. Practical criteria for BAV bridge to TAVR should be proposed to improve outcomes., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV)., Objectives: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes., Methods: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality., Results: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF)., Conclusions: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes., Competing Interests: Funding Support and Author Disclosures Dr Eng is a clinical proctor for Medtronic and Edwards Lifesciences. Dr Khalili has received a research grant from Edwards Lifesciences; and has received speaker fees from Abbott Vascular. Dr Vavalle is a consultant for Edwards Lifesciences. Dr Southard has received personal fees from Edwards Lifesciences and Boston Scientific. Dr Hahn has received speaker fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; has received consulting fees from Abbott Structural, Edwards Lifesciences, Gore Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity with Navigate; and is chief scientific officer of the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Wang has received research grant support from Boston Scientific; and is a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Materialise. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the TVT Registry., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking., Objectives: The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality., Methods: Using Centers for Medicare and Medicaid Services-linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement., Results: Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001)., Conclusions: Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions., Competing Interests: Funding Support and Author Disclosures Statistical analyses were supported by Edwards Lifesciences. Dr Zahr has received research and educational grants and consultation honoraria from Edwards Lifesciences, Medtronic, and Philips. Dr Elmariah is a consultant for Edwards Lifesciences and Medtronic; and has received institutional research support from Edwards Lifesciences and Medtronic. Dr Vemulapalli has received grants or contracts from the American College of Cardiology, the STS, Cytokinetics, Abbott Vascular, the National Institutes of Health (R01 and SBIR), and Boston Scientific; and has performed consultation work for and holds advisory board status with Janssen, the American College of Physicians, HeartFlow, and Edwards Lifesciences. Dr Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, and Abbott Vascular; and holds equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; holds institutional consultation contracts with no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; holds stock options with Navigate; and is the chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Davidson has received research grant support from and performed unpaid consultation for Edwards Lifesciences. Dr O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Bethea has received consultation fees from Abbott Vascular. Dr Thourani has been an advisor for Abbott Vascular, Artivion, AtriCure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave Medical. Dr Chakravarty is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. Dr Gupta is a consultant for Boston Scientific and Shockwave Medical; and holds equity in Heartbeat Health and iCardio.ai. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has received personal proctoring funds from Edwards Lifesciences; has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific; and serves as national principal investigator for the Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: While females have been found to have a higher rate of procedural complications with transcatheter aortic valve implantation (TAVI) than males, the effect of valve choice has not been fully elucidated. This study aimed to investigate the impact of gender and choice of balloon or self-expanding valve on TAVI complications., Methods: Data from patients who received a TAVI in our institution from January 2016 to September 2021 were retrospectively analyzed. A total of 971 patients were included and divided into self-expanding valve (n = 315) and balloon-expandable valve (n = 656) groups. The endpoints were 30-day mortality, need for a new pacemaker, and major adverse cardiovascular events (MACE) which is defined as cardiac arrest, stroke, myocardial infarction, major bleeding, and unplanned vascular surgery/intervention., Results: There were more females in the self-expanding valve group than in the balloon-expandable valve group (64.1 % vs. 43.6 %: p < 0.0001). There is no significant difference in the prevalence of hypertension, diabetes mellitus, current smoker, hemodialysis, and the STS risk score between the 2 groups. Females had a higher rate of major adverse cardiovascular events (3.7 % in men vs. 6.8 % in women; p = 0.043), which was driven mostly by vascular complications. This difference was particularly observed in the self-expanding valve group (2.7 % in men vs. 9.4 % in women; p = 0.036)., Conclusions: TAVI complications were more common in females than males, driven mostly by vascular complications. This difference was particularly observed in woman treated with a self-expanding valve. Particular attention should be given to access choices in females undergoing TAVI., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The aims of this study were to understand the incidence and outcomes of patients with cardiogenic shock (CS) due to severe aortic stenosis (AS), and the impact of conventional treatment strategies in this population., Methods and Results: All patients admitted to the Cleveland Clinic cardiac intensive care unit between January 1, 2010 and December 31, 2021 with CS were retrospectively identified and categorized into those with CS in the setting of severe AS versus CS without AS. The impact of various treatment strategies on mortality was further assessed. We identified 2754 patients with CS during the study period, of whom 216 patients (8%) had CS in the setting of severe AS. Medical management was associated with the highest 30-day mortality when compared with either balloon aortic valve replacement or aortic valve replacement (surgical or transcatheter aortic valve replacement) (hazard ratio, 3.69 [95% CI, 2.04-6.66]; P <0.0001). Among patients who received transcatheter therapy, 30-day mortality was significantly higher in patients who received balloon aortic valvuloplasty versus transcatheter aortic valve replacement (26% versus 4%, P =0.02). Both surgical and transcatheter aortic valve replacement had considerably lower mortality than medical management and balloon aortic valvuloplasty at 30 days and 1 year ( P <0.05 for both comparisons)., Conclusions: CS due to severe AS is associated with high in-hospital and 30-day mortality, worse compared with those with CS without AS. In suitable patients, urgent surgical aortic valvuloplasty or transcatheter aortic valve replacement is associated with favorable short- and long-term outcomes. Although balloon aortic valvuloplasty may be used to temporize patients with CS in the setting of severe AS, mortality is ≈50% if not followed by definitive aortic valve replacement within 90 days.

Introduction: Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce., Methods: We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate., Results: A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242)., Conclusions: In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV., (© 2024 Wiley Periodicals LLC.)

Background: Failure of the pulmonary valve autograft (PVA) after the Ross procedure (RP) has discouraged its widespread use and has led to modifications or alternatives to the procedure. We sought to analyze whether certain technical modifications could improve results of the RP in children., Methods: Sixty-nine patients (median age, 12 years; range, 0.25-17.9) underwent the RP between January 1996 and December 2018. A concomitant Konno procedure was performed on 20 of 69 patients (29%). Prior interventions included balloon valvuloplasty in 30 (44%) and/or surgical valvuloplasty in 39 (57%). Technical modifications included using the native aortic root for external annuloplasty, implanting the autograft using uniplanar horizontal sutures through the aortic wall, normalizing the sinotubular junction, and wrapping the native root remnant around the PVA., Results: Operative mortality was 1 of 69 patients (1.5%), with no late deaths. No patient had neoaortic valvar stenosis and 7 of 68 (10%) had mild regurgitation on discharge echocardiogram. At latest follow-up (median, 9.4 years; range, 0.4-21.3) there was no significant change in Z scores of annulus, sinus, or sinotubular junction diameters when compared with those at discharge. Three patients (4.4%) required late autograft replacement, 2 PVA repair, and 2 resection of a pseudoaneurysm. Actuarial freedom from PVA replacement was 87% at 20 years. Freedom from right ventricular outflow tract catheter reintervention or reoperation was 83% and 80%, respectively., Conclusions: Technical modifications of the RP used in this cohort might successfully prolong the life of the PVA without compromising its growth, an important advantage in pediatric patients., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The strategy of isolated tricuspid valve surgery has undergone innovations in recent years. This study aimed to summarize our experience using an endoscopic approach to repeat isolated tricuspid valve surgery (RITS) after left-sided valve replacement (LSVR)., Methods: From June 2013 to May 2019, 79 patients underwent endoscopic RITS after LSVR at our institution. Patients were divided into the tricuspid valvuloplasty (TVP) group (N.=49) and the tricuspid valve replacement (TVR) group (N.=30); perioperative outcomes and follow-up results were compared., Results: There were seven postoperative deaths (8.9%). In-hospital mortality was higher in the TVR group than in the TVP group, although this difference was not statistically significant (13.3% vs. 6.1%, P=0.417). More patients experienced residual moderate-to-severe tricuspid regurgitation (TR) at discharge in the TVP group than in the TVR group (26.7% vs. 0%, P=0.003). Five patients died from heart, and multiorgan failure during follow-up; the overall 3- and 5-year survival rates were 93.8% [95% confidence interval (CI): (87.1-99.9%)] and 85.3% (95% CI: 73.3-99.2%), respectively, and no significant differences were found between the two groups (P=0.103). The overall rates of the 3- and 5-year freedom from severe recurrent TR were 93.2% (95% CI: 85.9-99.9%) and 89.0% (78.7-99.9%), respectively, and no significant difference was found between groups (P=0.176)., Conclusions: Repeat isolated tricuspid valve surgery after left-sided valve replacement is associated with adverse perioperative outcomes. Endoscopic access offers an alternative approach for RITS after LSVR with acceptable results. TVP results in lower surgical mortality than TVR while carrying a higher risk of residual moderate-to-severe TR.

Background: Balloon aortic valvuloplasty (BAV) remains a treatment option for the selected patients with severe aortic stenosis. We examined clinical outcomes and predictors of prognosis in patients undergoing BAV for severe aortic stenosis., Methods: We identified all patients undergoing BAV from January 2010 to March 2018 (n=167) at a single transcatheter aortic valve implantation (TAVI) centre. Patient demographics, investigations, subsequent interventions and clinical outcomes were obtained from electronic health records., Results: Patients undergoing BAV were elderly (median age 80, IQR 73-86 years) and half (n=87, 52%) were male. All-cause mortality at 30 days and 12 months was 11% and 43%, respectively. Reduce ejection fraction (EF 30%-50%: HR 1.76, 95% CI 1.05 to 2.94; EF <30%: HR 1.90, 95% CI 1.12 to 3.20) was the only independent predictor at baseline of overall mortality. Median survival was 212 (IQR 54-490) days from the index procedure. Mortality at 1 year was lowest in patients who subsequently underwent TAVI or SAVR but high among those who had no further interventions or those who had a repeat BAV (14%, 19%, 60%, 89% respectively, log-rank p<0.001)., Conclusion: BAV as a bridge to definitive aortic valve intervention in carefully selected patients offers acceptable outcomes. These contemporary observational findings demonstrate the ongoing potential utility of BAV in the TAVI era., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Whether balloon aortic valvuloplasty (BAV) may provide an effective palliation in symptomatic high-risk patients is uncertain. Therefore, we aimed to evaluate outcomes in symptomatic high-risk patients with severe aortic stenosis (AS), who underwent BAV. All-cause mortality and length of hospitalization for heart failure (HF) up to death or to 1-year follow up were collected after BAV. One hundred thirty-two (132) patients (62% women), mean age 85±7 years, underwent BAV with a substantial reduction of the peak-to-peak aortic gradient from 53±21 to 29±15 mmHg (p<0.001). The median of days of HF hospitalization prior to BAV was 9 (0-19), and decreased after BAV to 0 (0-9), p<0.001. During 1-year follow-up patients with untreated CAD (85, 64%) had a higher mortality compared to patients with insignificant/treated CAD (47, 36%): 1-year survival: 45±7% vs. 66± 7%; p=0.02. After adjustment for STS risk score and severity of residual AS, patients with untreated CAD remained at higher risk of mortality (adjusted HR 1.74 [1.01-2.91]; p=0.04). Thus, in this series of symptomatic high-risk patients, BAV was associated with a significant reduction in aortic valve gradient and hospitalization time for HF post-BAV. In patients with significant CAD, percutaneous intervention might be considered in order to improve survival.

Background: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement., Methods: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported., Results: Median aortic annulus area and perimeter were 617 mm 2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm 2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P =0.001), with a higher rate of significant paravalvular leak ( P =0.004), second valve implantation ( P =0.013), and valve embolization ( P =0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group., Conclusions: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

Competing Interests: Competing interests: None declared.

Objectives: The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years., Background: The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV., Methods: The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability., Results: After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm 2 vs. 1.9 ± 0.5 cm 2 ; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63)., Conclusions: Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Balloon aortic valvuloplasty (BAV) has seen renewed interest since the advent of transcatheter aortic valve implantation (TAVI). The study aimed to characterise a contemporary BAV cohort and determinants of clinical outcomes., Methods: Patients undergoing BAV at a single tertiary centre were retrospectively reviewed over a 10-year period, and functional and mortality outcomes were reported with up to a 2-year follow-up., Results: 224 patients (aged 82.5±8.3 years; 48% female) underwent BAV over the study period. Indications were either destination treatment (39%) or bridge-to-valve replacement (61%)-including bridge-to-decision (29%), symptom relief while on the waitlist (27%), and temporary contraindications to TAVI/aortic valve replacement (AVR) (5%). The mean reduction of aortic mean pressure gradient was 38%. Procedural mortality occurred in 0.5%, stroke in 1.3%, and major bleeding in 0.9%. Twelve-month mortality was 36% overall, and 26% and 50% in the bridging and destination groups, respectively. New York HeartAssociation (NYHA) class improved by ≥1 at 30 days in 50%. Among the bridge-to-TAVI/AVR group, 40% proceeded to TAVI/AVR within 12 months following BAV. In multivariate analysis, active malignancy at baseline (OR: 4.4, 95% CI: 1.3 to 15.1, p=0.02), smoking history (OR: 3.3, 95% CI: 1.3 to 7.9, p<0.01), LVEF ≤30% at baseline (OR: 3.2, 95% CI: 1.3 to 7.6, p<0.01), destination treatment (OR: 2.2, 95% CI: 1.0 to 4.9, p=0.04) were all associated with 12-month mortality., Conclusions: BAV remains a useful procedure with relatively low rates of complications, however, 1-year mortality rates are high. Contemporary indications for BAV include a bridge to definitive valve replacement or destination treatment., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Fetal aortic valvuloplasty (FAV) may prevent progression of midgestation aortic stenosis to hypoplastic left heart syndrome. However, FAV has well-established risks, and its survival benefit remains unknown. Our primary aim was to determine whether FAV for midgestation aortic stenosis increases survival from fetal diagnosis to age 6 years., Methods and Results: We performed a retrospective analysis of 143 fetuses who underwent FAV from 2000 to 2017 and a secondary analysis of the Pediatric Heart Network Single Ventricle Reconstruction trial. Using these results, we developed a decision model to estimate probability of transplant-free survival from fetal diagnosis to age 6 years and postnatal restricted mean transplant-free survival time. FAV was technically successful in 84% of 143 fetuses with fetal demise in 8%. Biventricular circulation was achieved in 50% of 111 live-born infants with successful FAV but in only 16% of the 19 patients with unsuccessful FAV. The model projected overlapping probabilities of transplant-free survival to age 6 years at 75% (95% CI, 67%-82%) with FAV versus 72% (95% CI, 61%-82%) with expectant fetal management, resulting in a restricted mean transplant-free survival time benefit of 1.2 months. When limiting analyses to the improved FAV experience since 2009 to reflect current practice, (probability of technical success [94%], fetal demise [4%], and biventricular circulation [66%]), the model projected that FAV increased the probability of survival to age 6 years to 82% (95% CI, 73%-89%). Expectant management is favored if risk of fetal demise exceeded 12% or probability of biventricular circulation fell below 26%, but FAV remained favored over plausible recent range of technical success., Conclusions: Our model suggests that FAV provides a modest, medium-term survival benefit over expectant fetal management. Appropriate patient selection and low risk of fetal demise with FAV are critical factors for obtaining a survival benefit.

Objective: To compare the incidence of major adverse cardiac events and death among severe aortic stenosis patients with and without aortic valve replacement (AVR) before noncardiac surgery., Patients and Methods: We retrospectively evaluated 491 severe aortic stenosis patients undergoing non-emergency/non-urgent elevated-risk noncardiac surgery between January 1, 2000, and December 31, 2013, including 203 patients (mean age, 74±10 years, 63.5% men) with previous AVR and 288 patients (mean age, 77±12 years, 55.6% men) without prior AVR., Results: The incidence of major adverse cardiac events was significantly lower in the AVR group (5.4% vs 20.5%; P<.001), primarily because of the lower incidence of new or worsening heart failure (2.5% vs 17.7%; P<.001), compared with the non-AVR group. No significant differences were observed between the groups with and without AVR in the incidence of death (2.5% vs 3.5%; P=.56), myocardial infarction (0.5% vs 1.4%; P=.48), ventricular arrhythmia (0.0% vs 0.7%; P=.51), or stroke (0.0% vs 0.7%; P=.51) at 30-days. At a median follow-up of 4.2 (interquartile range,1.3-7.5) years, overall mortality was significantly worse in patients without versus with AVR (5-year rate: 57.0% vs 32.7%; P<.001). Symptomatic patients without AVR (n=35) had the worst outcomes overall, including increased 30-day and overall mortality rates, compared with the AVR-group and asymptomatic non-AVR patients., Conclusion: In patients with severe aortic stenosis, AVR before noncardiac surgery was associated with decreased incidence of heart failure after noncardiac surgery and improved overall survival without differences in 30-day survival, myocardial infarction, ventricular arrhythmia, or stroke. Preoperative AVR should be considered in symptomatic patients for whom the benefit of AVR is greatest., (Copyright © 2019 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to use a national representative database to assess the incidence, predictors, and outcomes of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve replacement (TAVR) in contemporary practice., Background: Nationwide data on the use and outcomes of BAV as a bridge to TAVR are limited., Methods: Patients who underwent BAV between January and June in 2015 and 2016 were identified in the National Readmission Database. We assessed rate of subsequent TAVR following BAV, and predictors and timing of subsequent TAVR. We then identified a group of patients who had direct TAVR (without prior BAV) in the original 2015 to 2016 National Readmission Database dataset. We compared in-hospital outcomes following TAVR between patients with prior bridging BAV and those undergoing direct TAVR., Results: Among the 3,691 included patients 1,426 (38.6%) had subsequent TAVR. Timing of TAVR was pre-discharge in 7.4%, within 30 days in 35%, between 31 and 90 days in 47%, between 91 and 180 days in 14%, and >180 days in 4%. Negative predictors of subsequent TAVR included prior defibrillator (odds ratio [OR]: 0.56; 95% confidence interval [CI]: 0.36 to 0.85), dementia (OR: 0.60; 95% CI: 0.46 to 0.79), malnutrition (OR: 0.64; 95% CI: 0.45 to 0.90), and malignancy (OR: 0.62; 95% CI: 0.47 to 0.82). In propensity-score matched cohorts of patients who underwent direct TAVR versus those with prior BAV, in-hospital mortality during TAVR admission was similar (3.7% vs. 3.5%; p = 0.91). Major complications, length of stay, and discharge disposition were also comparable. However, cost of the hospitalization was higher in the direct TAVR group., Conclusions: About 40% of BAV patients undergo subsequent TAVR mostly within 90 days. In-hospital outcomes of TAVR in these patients were comparable with propensity-score matched patients who underwent TAVR without prior BAV. Further investigations are needed to define the role of BAV in contemporary practice., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The 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)., Background: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV., Methods: DIRECTAVI (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., Results: 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 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., Conclusions: Direct 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)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The impact of procedure location on clinical outcomes after TAVR remains unclear. We aimed to compare short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) in the catheterization laboratory (CATH) versus surgical operating room (OR)., Methods: A retrospective review of 63,581 trans-femoral TAVR patients using balloon-expandable valves from 2015 to 2018 were captured utilizing the TVT Registry. Propensity score matching was performed using 24 covariates resulting in 2 risk-adjusted groups. Patients were further stratified by STS Risk Score with outcomes compared., Results: Propensity score matching resulted in 24,160 risk-matched CATH and OR patient pairs. Short-term clinical outcomes including all-cause mortality, stroke, major vascular complications, life-threatening bleeding, and new dialysis were similar between CATH and OR (p = all ns). There was no difference in conversion to open heart surgery between CATH and OR with both occurring at a very low rate (0.4% vs. 0.5%, p = 0.07). Moreover, the 30-day survival post-conversion was similar whether TAVR was performed in CATH versus OR (43.3% and 49.7%, p = 0.28). When stratified by STS Risk Score, there was no difference in conversion to surgery or 30-day mortality in low and intermediate risk patients between CATH and OR. For high risk patients, however, conversion to surgery was lower in CATH vs. OR (0.2% vs. 0.4%, p = 0.04) with no difference in 30-day survival (46% vs. 43%, p = 0.94)., Conclusions: Procedure location has minimal impact on TAVR procedural and 30-day outcomes with a very low conversion to open surgery rate between CATH versus OR for low, intermediate, and high-risk patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: We evaluated the safety and usefulness of preparatory anatomical reshaping with a geometric hourglass-shaped balloon to optimize transcatheter aortic valve replacement (TAVR) outcomes in bicuspid aortic valve (BAV) stenosis., Background: TAVR has been increasingly performed for BAV stenosis; however, technical challenges remain. Procedural results are suboptimal given unfavorable valvular anatomies., Methods: Eligible patients with BAV stenosis were enrolled to undergo aortic valve predilatation with the hourglass-shaped TAV8 balloon before TAVR using the self-expandable Venus A-Valve. Procedural details and outcomes were compared to a sequential group of patients with BAV who underwent TAVR with the same device following preparatory dilatation using a cylindrical balloon., Results: A total of 22 patients were enrolled in the TAV8 group and 53 were included in the control group. Valve downsizing was less common in the TAV8 group (36.4 vs. 67.9%; p = .012). Stable valve release and optimal implant depth were consistently achieved in the TAV8 group with no requirement for a second valve (0 vs. 17.0%; p = .039) and with higher device success rates (100.0 vs 77.4%; p = .014). Residual aortic regurgitation graded as ≥mild was less common in the TAV8 group (13.6 vs 45.3%; p = .009). Mortality was similar (0 vs. 3.8%; p = 1); no major/disabling stroke or conversion to open-heart surgery was seen in either group within 30 days., Conclusions: Compared with standard cylindrical balloon valvuloplasty, preparatory reshaping with the hourglass-shaped balloon before self-expandable TAVR in BAV was associated with significantly better procedural results and may encourage more promising outcomes., (© 2020 Wiley Periodicals, Inc.)

Aims: Patients in cardiogenic shock (CS) due to decompensated aortic stenosis (AS) evidence poor prognosis. Both emergency transcatheter aortic valve replacement (eTAVR) and emergency balloon aortic valvuloplasty (eBAV) have been reported in CS patients. We aimed to summarize and compare available studies on eBAV and eTAVR in patients suffering from CS due to decompensated AS with regard to safety and efficacy., Methods and Results: Study-level data were analyzed. Heterogeneity was assessed using the I2 statistic. Pooled proportions, ie, event rates, were calculated and obtained using a random-effects model (DerSimonian and Laird). Eight studies were found suitable for the final analysis, including 311 patients. Primary endpoint was mortality at 30 days. For eBAV (n = 238), 30-day mortality rate was 46.2% (95% confidence interval [CI], 30.3%-62.5%; I²=74%), major bleeding rate was 10% (95% CI, 5.4%-15.7%; I²=13%), and stroke rate was 0.7% (95% CI, 0.0%-2.7%; I²=0%). Aortic regurgitation (AR) ≥II was present in 8.6% (95% CI, 0.4%-23.5%; I²=86%). For eTAVR (n = 73), 30-day mortality rate was 22.6% (95% CI, 12.0%-35.2%; I²=26%), major bleeding rate was 5.8% (95% CI, 0.5%-14.7%; I²=0%), and stroke rate was 5.8% (95% CI, 0.5%-14.7%; I²=0%). AR ≥II was present in 4% (95% CI, 0.0%-12.1%; I²=0%)., Conclusion: Mortality in CS patients due to decompensated severe AS is high, regardless of interventional treatment strategy. Both eBAV and eTAVR seem feasible. As eTAVR is associated with better initial improvements in hemodynamics and simultaneously avoids sequential interventions, it might be favorable to eBAV in select patients. If eTAVR is not available, eBAV might serve as a "bridge" to elective TAVR.

Background: A differential impact of sex has been observed in balloon aortic valvuloplasty (BAV) outcomes from small observational studies. Accordingly, we sought to compare mortality in men and women undergoing BAV and identify sex-specific predictors of mortality., Methods: The Nationwide Inpatient Sample was screened for hospitalizations involving adults who underwent BAV between 2006 and 2014. Demographic data and clinical history were recorded. In-hospital mortality and predictors of death after BAV were assessed in men and women., Results: Among an estimated national cohort of 18,415 adults undergoing BAV, 8871 (48.2%) were women and 9543 (51.8%) were men. Compared with male patients, women were older, with a lower prevalence of coronary artery disease, prior myocardial infarction, diabetes mellitus, chronic kidney disease, chronic obstructive lung disease, and peripheral arterial disease but a higher rate of hypertension and obesity. In-hospital mortality rates were 6.7% and 9.4% in women and men respectively (p = 0.004). In multivariable regression analysis, female sex was independently associated with lower mortality [odds ratio (OR) 0.73, 95% confidence interval (CI) 0.57-0.93) following BAV. Sex-specific risk-adjusted predictors of mortality included atrial fibrillation in women and younger age, congestive heart failure, chronic kidney disease, and absence of prior myocardial infarction, hypertension, and peripheral arterial disease in men., Conclusions: Women undergoing BAV had a different risk profile compared to men. Risk-adjusted in-hospital mortality was lower in women, and disparate predictors of risk-adjusted mortality exist in men and women undergoing BAV. Further studies are warranted to determine whether preventive interventions can improve outcomes in both men and women in this high-risk population., (Published by Elsevier Inc.)

Objectives: This study aimed to assess the value of low transvalvular flow rate (FR) for the prediction of mortality compared with low stroke volume index (SVi) in patients with low-gradient (mean gradient: <40 mm Hg), low aortic valve area (<1 cm 2 ) aortic stenosis (AS) following aortic valve intervention., Background: Transaortic FR defined as stroke volume/left ventricular ejection time is also a marker of flow; however, no data exist comparing the relative prognostic value of these 2 transvalvular flow markers in patients with low-gradient AS who had undergone valve intervention., Methods: We retrospectively followed prospectively assessed consecutive patients with low-gradient, low aortic valve area AS who underwent aortic valve intervention between 2010 and 2014 for all-cause mortality., Results: Of the 218 patients with mean age 75 ± 12 years, 102 (46.8%) had low stroke volume index (SVi) (<35 ml/m 2 ), 95 (43.6%) had low FR (<200 ml/s), and 58 (26.6%) had low left ventricular ejection fraction <50%. The concordance between FR and SVi was 78.8% (p < 0.005). Over a median follow-up of 46.8 ± 21 months, 52 (23.9%) deaths occurred. Patients with low FR had significantly worse outcome compared with those with normal FR (p < 0.005). In patients with low SVi, a low FR conferred a worse outcome than a normal FR (p = 0.005), but FR status did not discriminate outcome in patients with normal SVi. By contrast, SVi did not discriminate survival either in patients with normal or low FR. Low FR was an independent predictor of mortality (p = 0.013) after adjusting for age, clinical prognostic factors, European System for Cardiac Operative Risk Evaluation II, dimensionless velocity index, left ventricular mass index, left ventricular ejection fraction, heart rate, time, type of aortic valve intervention, and SVi (p = 0.59)., Conclusions: In patients with low-gradient, low valve area aortic stenosis undergoing aortic valve intervention, low FR, not low SVi, was an independent predictor of medium-term mortality., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background The safety of next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR) with a self-expandable valve is unknown. We investigated the safety of NDD after TAVR in patients who received a self-expandable valve or balloon-expandable valve. Methods and Results We retrospectively evaluated consecutive patients who underwent elective minimalist TAVR between January 2017 and July 2018. We investigated the success rates and predictors of NDD after TAVR. Ninety-day and 1-year outcomes in patients managed with NDD after self-expandable ACURATE neo or balloon-expandable SAPIEN 3 replacement were compared. In 315 TAVRs, 249 patients received an ACURATE neo (n=146) or SAPIEN 3 (n=103) valve. There were no differences in baseline characteristics. In the ACURATE neo and SAPIEN 3 groups, NDD was achieved in 60% (n=87) and 55% (n=57) of patients, respectively ( P>0.50). Predictors of NDD included chronic obstructive pulmonary disease (odds ratio, 0.49; 95% CI, 0.25-0.94) and low pre-TAVR hemoglobin (odds ratio, 0.98; 95% CI, 0.96-0.99) but not type of valve (odds ratio, 1.20; 95% CI, 0.71-1.98 for ACURATE neo). After excluding non-NDD cases, there were no significant differences in 90-day mortality (0% versus 0%; P>0.90) or new pacemaker implantation (1% versus 0%; P>0.40) between ACURATE neo and SAPIEN3, respectively. No significant difference in 1-year mortality between ACURATE neo and SAPIEN 3 groups after NDD (8% versus 10%; log-rank, P>0.80) was observed. Conclusions The safety of NDD using ACURATE neo was similar that using SAPIEN 3, with comparable 90-day and 1-year outcomes.

Aortic valve (AV) disease in pediatric patients requires a complex decision process that has an impact on decades of life. The aim of this review is to summarize the current evidence surrounding AV interventions in this patient population. In neonates with critical aortic stenosis, the relative merit of surgical vs balloon valvuloplasty is debated and practices vary depending on centers' experience with little comparative literature. In children and adolescents, AV repair has regained interest in the last decades with encouraging early and mid-term results. The Ross procedure represents the best AV replacement option as it offers growth potential, excellent hemodynamics, low rates of endocarditis, and thromboembolism without the risks of anticoagulation. Based on contemporary literature, we propose a management algorithm for children AV disease., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Transcatheter pulmonary valvuloplasty in neonates with pulmonary atresia and intact ventricular septum (PA-IVS) or duct-dependent pulmonary valve stenosis (DD-PVS) has become a reasonable alternative to surgical right ventricle decompression., Aim: To investigate mid-term outcomes following pulmonary valvuloplasty., Methods: Sixty-five neonates with PA-IVS (n=29) or DD-PVS (n=36) (median age 4 days; mean weight 3.0kg) undergoing pulmonary valvuloplasty were reviewed retrospectively. Procedural data and clinical outcomes were assessed., Results: Pulmonary valvuloplasty was successful in 59 patients (90.8%). Preterm birth, larger tricuspid valve annulus diameter and PA-IVS correlated with procedural failure. Eleven patients (18.6%) required a Blalock-Taussig shunt during early follow-up, despite valvuloplasty. These neonates had smaller tricuspid and pulmonary valve annulus Z-scores (-1.9 vs. -0.8 [p=0.04] and -2.5 vs. -0.9 [P=0.005], respectively) and a higher incidence of "bipartite" right ventricle (P=0.02). Mean follow-up was 5.4±3.3 years. Mortality after successful valvuloplasty was 8.5% (n=5). Among the 54 survivors, biventricular repair was achieved in 52 patients (96.3%), including nine with a previous Blalock-Taussig shunt. The cumulative rate of subsequent surgery (excluding Blalock-Taussig shunt) was 13.7% (95% confidence interval 6.8-26.7%) and 16.4% (95% confidence interval 8.5-30.4%) at 2 and 4 years, respectively. Secondary surgery was significantly more frequent in PA-IVS compared with DD-PVS, and in neonates with a Blalock-Taussig shunt (P=0.003 and 0.01, respectively)., Conclusions: Selected neonates with DD-PVS or PA-IVS managed by transcatheter pulmonary valvuloplasty had a good mid-term outcome. In neonates with a borderline small right ventricle, a hybrid strategy with a supplementary source of pulmonary blood flow can be efficient to achieve biventricular repair., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Objectives: The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial., Background: There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV., Methods: Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach., Results: A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: -8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths., Conclusions: Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the safety and the feasibility of balloon aortic valvuloplasty (BAV) procedure made by trained operators in centers not performing transcatheter aortic valve implantation (TAVI)., Background: BAV is a valuable therapeutic tool for patients with symptomatic severe aortic valve stenosis (AS) at prohibitive risk for TAVI or surgery., Methods: Consecutive high-risk AS patients underwent BAV in five non-TAVI centers, where BAV operators had completed a 6-month training period in high-volume TAVI centers (Group A). All clinical, echocardiographic, and procedural data were prospectively collected and compared with data of patients treated in TAVI center (Group B)., Results: Between June 2016 and June 2017, 55 patients (83.9 ± 7.0 years) were enrolled: 25 in Group A and 30 in Group B. After BAV, a substantial reduction of the peak-to-peak aortic valve gradient was obtained in both groups (-35.3 ± 15.2 vs -28.8 ± 13.9 mmHg, P =0.25). No major bleeding or vascular complications occurred. In-hospital death was observed in three patients of Group A and two patients of Group B (P =0.493). The mean follow-up time was 303 ± 188 days; no patients were lost. The 1-year survival free from overall death (Group A 75.8% vs Group B 68.8%; P =0.682) and heart failure rehospitalization (Group A 73.0% vs Group B 66.8%; P =0.687) was similar in the two groups. At multivariable analysis, low left ventricular (LV) ejection fraction (HR: 0.943; P = 0.011) and cardiogenic shock (HR: 5.128; P = 0.002) at admission were independent predictors of mortality., Conclusions: BAV is a safe and effective procedure that can be performed by trained operators in centers not performing TAVI., (© 2018 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV)., Background: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy., Methods: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years., Results: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n = 1,438). Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to 0.99; p = 0.045), Wilkins score ≤8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p = 0.02) and age (odds ratio: 0.97; 95% CI: 0.96 to 0.99; p = 0.006). Very long term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall mortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to 9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p < 0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to 0.98; p = 0.028), and mitral valve area ≤1.75 cm 2 after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11; p = 0.028) were independent predictors of the primary endpoint., Conclusions: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to understand the effects of balloon post-dilatation on outcomes following transcatheter aortic valve replacement with the SAPIEN 3 valve., Background: Hemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported., Methods: The effects of balloon post-dilatation (BPD) in 1,661 intermediate (S3i cohort) and high surgical risk (S3HR cohort) patients with aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) 2, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed., Results: 208 of 1,661 patients (12.5%) had BPD during the initial transcatheter aortic valve replacement. Baseline characteristics were similar except BPD had higher STS score (p < 0.001), significantly less % oversizing (p = 0.004), significantly more ≥moderate left ventricular outflow tract calcification (p = 0.005), and severe annular calcification (p = 0.006). BPD patients had no increase in permanent pacemaker, annular rupture, or valve embolization. Following transcatheter aortic valve replacement, BPD patients had significantly larger aortic valve area (1.72 ± 0.41 cm 2 vs. 1.66 ± 0.37 cm 2 ; p = 0.04) with no significant difference in prosthesis-patient mismatch (p = 0.08) or transvalvular aortic regurgitation (p = 0.65), but significantly more paravalvular regurgitation (p < 0.01). There was no significant difference in 30-day or 1-year outcomes of all-cause death (p = 0.65 to 0.76) or stroke (p = 0.28 to 0.72). However, at 1 year, there was a significantly higher incidence of minor stroke in BPD patients (p = 0.02). Adjusting for baseline differences, including calcium burden, minor strokes were no longer significantly different between the BPD and NoBPD groups (p = 0.21)., Conclusions: BPD is performed more frequently in patients with lower % oversizing and greater calcium burden. BPD is not associated with procedural complications or an increase in 1-year adverse events of death, rehospitalization, or stroke., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Balloon aortic valvuloplasty (BAV) is often utilized as a bridge prior to surgical or transcatheter aortic valve replacement. Chronic kidney disease (CKD) is commonly present in patients with aortic stenosis, however, its association with outcomes following BAV has not been well studied. Accordingly, we sought to assess the impact of CKD on mortality in adults undergoing BAV., Methods: The Nationwide Inpatient Sample was screened for hospitalizations involving adults undergoing BAV from 2006 to 2012. Demographic data and clinical history were recorded. Patients were divided into those with and without CKD as a documented comorbidity and were compared for adjusted in-hospital mortality risk., Results: Among a national cohort of 10,845 adults undergoing BAV, 3842 (35.4%) adults had CKD while 7003 (64.6%) did not. Patients with CKD were older, more often male, and had higher rates of coronary disease, heart failure, diabetes mellitus, hypertension, peripheral artery disease, obesity, obstructive sleep apnea, and atrial fibrillation. Adults with CKD undergoing BAV had significantly higher in-hospital mortality rates (10.2% vs 6.3%, p=0.0005). In multivariable analysis, CKD was independently associated with a nearly 2-fold higher odds of in-hospital mortality (odds ratio 1.98, 95% confidence interval 1.45-2.70, p<0.0001). Other predictors of mortality included presence of atrial fibrillation and absence of prior myocardial infarction, hypertension, peripheral arterial disease, and smoking., Conclusions: CKD was independently associated with a nearly 2-fold higher odds of in-hospital mortality in adults undergoing BAV. Further studies are warranted to determine whether preventive interventions can improve outcomes in this high-risk population., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD)., Background: VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes., Methods: All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device., Results: A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC., Conclusions: VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD., (© 2017 Wiley Periodicals, Inc.)

Objectives: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates., Methods: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI., Results: A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment., Conclusions: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.

Introduction and Objectives: Transcatheter aortic-valve implantation (TAVI) is an accepted treatment for patients with severe aortic stenosis and high surgical risk. However, there is lack in data about TAVI in low-risk patients that are already being treated with this therapy in some clinical contexts., Methods: A retrospective analysis of patients treated with transfemoral TAVI using Edwards Sapien prosthesis in one center was performed, classifying the patients into three groups according to the surgical risk (high/intermediate/low risk for STS score>8/4-8/<4). Clinical characteristics, procedure and follow-up outcomes were collected, comparing the results between low and high surgical risk groups., Results: 89 TAVIs using Edwards balloon expandable prosthesis were performed (9 Sapien XT and 80 Sapien 3 valves were implanted). 40 patients (45%) presented a STS score<4, while 33 (37%) had a STS>8. Low-risk patients were significantly younger and had lower rates of coronary artery disease, peripheral vascular disease, pulmonary lung disease and atrial fibrillation. There were no significant differences in most of the technical variables of the procedure, apart from vascular complications and complete left bundle branch block after valve implant, which were higher in the group with STS>8. Patients of low risk presented shorter hospital stay (2,91±1,6, vs 4,8±3,9 days), with lower rates of mortality at mid- and long follow-up (death from any cause 15,2% vs 0%, p 0,04)., Conclusions: TAVI in low-risk patients is safe and associated with better outcome at mid and long-term follow-up compared to high-risk patients., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The prognosis of patients with cardiogenic shock (CS) or refractory pulmonary edema because of severe aortic stenosis remains poor. The purpose of this study was to assess the outcomes of rescue percutaneous balloon aortic valvuloplasty (PBAV) in the transcatheter aortic valve implantation (TAVI) era. Patients were consecutively included between 2008 and 2016. CS was defined as ≥1 sign of systemic hypoperfusion and need of catecholamines. Refractory pulmonary edema was defined as not controlled by optimal medical treatment. A total of 40 patients, 22 men (55%), aged 79 ± 9 years, were included: 17 with CS (42.5%), 23 with refractory pulmonary edema (57.5%). After PBAV, mean transaortic gradient decreased from 47 ± 16 mm Hg to 32 ± 10 mm Hg (p < 0.001), aortic valve area increased from 0.60 ± 0.18 cm 2 to 0.88 ± 0.22 cm 2 (p < 0.0001), left ventricular ejection fraction increased from 35 ± 15 to 37 ± 14% (p = 0.02), and systolic pulmonary artery pressure decreased from 61 ± 15 to 48 ± 12 mm Hg (p = 0.002). There was no procedural death. Early death occurred in 12 patients (30%). After PBAV, 16 of the 28 survivors (57%) were bridged to surgical aortic valve replacement (SAVR; n = 7) or TAVI (n = 9), and 12 (43%) were denied definitive therapy. The 2-year estimated survival rate was 71 ± 17% after SAVR, 36 ± 19% after TAVI, and 8 ± 8% after PBAV alone. In conclusion, rescue PBAV is safe in patients with CS and high-risk aortic stenosis or refractory pulmonary edema and may improve their dismal prognosis when followed by TAVI or SAVR., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to investigate whether minimising trauma to the aortic annulus and left ventricular outflow tract reduces the occurrence of new conduction disorders and the need for permanent pacemakers., Methods and Results: A total of 175 patients (58% female, mean age 83±6 years) underwent transfemoral TAVI with the Boston Scientific ACURATE neo at three centres in Europe. Prosthesis size selection was based on perimeter-derived annular diameter. Predilatation was performed in all with a balloon 1.9±0.9 mm smaller than the perimeter-derived annular diameter. Post-dilatation was performed in 46 (26.3%) with a balloon 1.2±0.9 mm smaller than the perimeter-derived annular diameter. Eighteen patients (10.3%) developed a new left bundle branch block, 13 (7%) a new first-degree AV block, and four (2.3%) received a new permanent pacemaker. Paravalvular regurgitation was none/trace in 66 (37.7%), mild in 101 (57.7%) and moderate in eight (4.6%). At 30 days, the rate of any stroke was 1.7% (3/175), and one patient (0.6%) had died., Conclusions: With careful selection of the balloon and the ACURATE neo prosthesis size, very low rates of new conduction disorders and permanent pacemaker implantation may be achieved without increasing the amount of paravalvular regurgitation.

Objectives: To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV)., Background: BAV was considered a mandatory previous step in TAVR procedures., Methods: A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained., Results: Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups., Conclusions: Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Some patients who are at high surgical risk because of multiple co-morbidities undergo balloon aortic valvuloplasty (BAV) as a bridge therapy towards transcatheter aortic-valve implantation (TAVI)., Aim: The aim of this study was to compare the clinical course of patients with or without previous BAV who underwent TAVI and were included in the FRANCE 2 registry., Methods: From January 2010 to December 2011, 3953 patients underwent TAVI. Survival analysis was done by multivariable regression and propensity-score analysis to adjust for confounders., Results: Patients in the previous BAV group (n=664, 16.8%) were older than patients in the primary TAVI group. The logistic EuroSCORE I and the rates of co-morbidities and symptoms were higher in the previous BAV group. Procedural success was similar in both groups, as was postprocedural aortic regurgitation grade≥2/4. The 1-month mortality rates from all causes were 12.5 and 8.7%, respectively, in the previous BAV and primary TAVI groups (P=0.001). The 1-month to 1-year mortality rates were similar in both groups. Previous BAV was not an independent predictor of 1-month mortality (hazard ratio 1.44, 95% confidence interval 0.90-2.34; P=0.14) or 1-month to 1-year mortality., Conclusions: Crude 1-month mortality was higher in patients with previous BAV. Nevertheless, precarious preoperative status, but not previous BAV, was associated with mortality, and is the only marker that should be considered as detrimental at the time of preTAVI reassessment., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Objectives: The aim of this study was to evaluate practice patterns and outcomes of a contemporary group of patients undergoing balloon aortic valvuloplasty (BAV) for congenital aortic stenosis (AS)., Background: BAV is the most common treatment for isolated congenital AS., Methods: Within the IMPACT (Improving Pediatric and Adult Congenital Treatments) Registry, all BAV procedures performed between January 2011 and March 2015 were identified. Procedures were separated into those performed for critical versus noncritical AS. Outcomes were stratified into optimal, adequate, and inadequate, with optimal and adequate outcomes defining "successful" procedures. Multivariate logistic regression was used to identify patient and procedural characteristics associated with unsuccessful BAV. Mortality and adverse events rates were compared across patient cohorts., Results: Of the 1,026 isolated BAV procedures captured in IMPACT, 718 (70%) were "successful." Success rates were 70.9% for noncritical AS (n = 916) and 62.7% for critical AS (n = 110). Multivariate analysis revealed that prior cardiac catheterization, mixed valve disease, baseline aortic valve gradient >60 mm Hg, baseline aortic insufficiency greater than mild, presence of a trainee, and multiple balloon inflations were associated with unsuccessful BAV in the noncritical AS cohort. There were no factors associated with unsuccessful procedures in the critical AS group. No procedural deaths occurred, but 2.4% of patients did not survive to hospital discharge. Adverse events occurred in 15.8% of all cases and were more frequent in procedures performed for critical AS (30.0% vs. 14.1%; p < 0.001)., Conclusions: BAV is an effective treatment for congenital AS with low rates of mortality and adverse events. Patients with critical AS have a higher risk for procedure-related adverse events., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to evaluate the indications, short- and long-term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe aortic stenosis (AS)., Methods: A cohort of 112 patients with AS underwent 114 BAV procedures between October 2012 and July 2015 in two Polish interventional cardiology centers. Clinical and echocardiographic data were prospectively collected within 1, 6, and 12 months follow-up., Results: BAV was performed as a bridge to TAVI (51.8%), surgical aortic valve replacement (AVR, 5.4%), before urgent noncardiac surgery (8.0%), for symptom relief (33.0%) and cardiogenic shock (1.8%). Periprocedural, in-hospital, 1-, 6-, 12-month mortality were 2.7%; 8.9%; 8.9%; 16.9%; 22.3%, respectively. Serious periprocedural adverse events occurred in 18.8% of patients. After the procedure, mean aortic valve area (AVA) increased from 0.59 ± 0.18 to 0.82 ± 0.24 cm 2 , mean peak aortic valve gradient (pAVG) decreased from 94.0 ± 27.6 to 65.4 ± 20.0 mm Hg, mean aortic gradient decreased from 58.0 ± 17.8 to 40.5 ± 14.6 mm Hg, P < 0.05 for all. Left ventricular ejection fraction (LVEF) increased from median (interquartile range) of 53.5 (30 - 64) to 60 (45 - 65)% after 1 month (P < 0.05). In patients with impaired left ventricle function (LVEF <40%), LVEF significantly improved (median increase of 16%) after 1 and 6 months (P < 0.05). At 12 months patients had higher AVA, pAVG, and LVEF as compared to baseline (P < 0.05)., Conclusions: BAV is a useful procedure in high-risk AS patients, where achieved effects can be sufficient in bridging patients for TAVI/AVR. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Aims: This study aimed (1) to evaluate the impact of preprocedural two-dimensional speckle-tracking echocardiography (2D-STE) on long-term outcome after successful percutaneous mitral balloon valvotomy (PMBV) in patients with mitral stenosis (MS) and (2) to determine whether 2D-STE detects underlying diastolic dysfunction as defined by invasive haemodynamic study., Methods and Results: Sixty-four consecutive MS patients with preserved left ventricular ejection fraction (LVEF ≥50%) and who underwent successfully PMBV were studied. Successful immediate result was defined as post-procedural mitral valve area ≥1.5 cm2 and ≤2/4 mitral regurgitation by catheterization. During a follow-up of 4.2 ± 3.0 years, there were 7 deaths (11%) and 21 late mitral valve reintervention (33%). Univariate predictors of death were global longitudinal strain (GLS), age, LVEF, and pre- and post-procedural pulmonary artery pressures. In the multivariate Cox model, GLS was the strongest predictor of death [hazard ratio (HR) (95% CI), 1.45 (1.07-2.04); P= 0.01]. For the composite endpoint, GLS and post-procedural left atrial pressure (LAP) were univariate predictors of death or reintervention. At multivariable analysis, GLS and post-procedural LAP remained in the final model with strong trend towards significance [GLS HR (95% CI), 1.17 (0.99-1.37); P= 0.056]. There was no correlation between diastolic dysfunction identified at catheterization and standard echocardiographic and 2D-STE indexes, even after adjustments for age, left ventricular mass, effective arterial elastance (afterload), and end-diastolic volume indexes (preload)., Conclusion: GLS is a powerful predictor of long-term outcome after successful PMBV and provides incremental prognostic value over traditional parameters. Echocardiographic diagnosis of concomitant diastolic dysfunction in MS patients remains elusive., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions, please email: journals.permissions@oup.com.)

Aims: We aimed to evaluate the effect of omitting predilation on feasibility, procedural results and safety in balloon-expandable TAVI., Methods and Results: We performed an analysis of all 680 patients scheduled for a balloon-expandable TAVI prosthesis between January 2011 and August 2016. Patients treated with or without predilation were compared. Procedure times decreased from 85.6±42.9 to 56.7±26.1 minutes (p<0.001), fluoroscopy times from 9.5±5.7 to 6.2±3.9 minutes (p<0.001) and contrast volume from 131.9±60.8 to 85.4±37.4 ml (p<0.001) without predilation. Intraprocedural CPR was significantly more frequent in the predilation group (5.3% vs. 1.4%, p=0.01). Stroke rate was low at 1.5% and with no detectable difference. Applying VARC-2 definitions, the combined endpoints device success (88.3% vs. 92.4%, p=0.07) and clinical efficacy (88.7% vs. 92.4%, p=0.11) were comparable with or without prior valvuloplasty, while early safety was less frequent with predilation (85.2% vs. 90.2%, p=0.04). At 30 days, all-cause mortality and cardiovascular mortality were 6.8% with predilation vs. 2.9% without predilation (p=0.03) and 5.3% vs. 1.4% (p=0.01)., Conclusions: TAVI without prior valvuloplasty is feasible without apparent adverse impact in patients receiving a balloon-expandable TAVI prosthesis. The omission of predilation is associated with shorter procedure time, less radiation exposure and lower rates of intraprocedural resuscitation.

This study aimed to review our 30-year, single-center experience of neonates admitted with Ebstein anomaly. Between January 1985 and August 2015, 80 neonates with Ebstein anomaly were managed. The primary outcome measures were early and late survival, freedom from reoperation, and functional status. Pulmonary atresia or critical stenosis occurred in 18 neonates. Twenty-seven (34%) patients required intervention: 13 systemic-to-pulmonary shunts, 5 balloon pulmonary valvotomy, 3 relief of right ventricular outflow tract obstruction, 3 Starnes procedures, and 3 other procedures. Sixty-nine (86%) of the neonates survived to hospital discharge. Overall 15-year survival estimate was 67% (SE = 6.5), with a superior prognosis for those able to be managed medically (15-year survival of 79%, SE = 7.0) compared with those in whom surgical or catheter intervention was undertaken (15-year survival of 45%, SE = 11.2, P = 0.005). For early survivors of neonatal surgery, freedom from reoperation at 10 years was 16% (SE = 8.5). For long-term survivors, 96% were classified as New York Heart Association Class I or II. Neonates with Ebstein anomaly who can be managed without intervention have a good prognosis. Substantial mortality risk remains in those who require intervention, especially those complicated by pulmonary atresia., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: There has been a revival of balloon aortic valvuloplasty (BAV) for severe aortic stenosis, as a result of an increasing number of patients undergoing trans-catheter aortic valve implantation (TAVI). However, there has not been universal adoption of BAV as a standalone, nor bridging therapy., Methods: A retrospective analysis of the practice at our institution between June 2009 and May 2016 was performed. Demographic, clinical, procedural, and follow-up data on all patients were collected., Results: A total of 200 patients with a median age of 82 years and severe symptomatic aortic stenosis underwent BAV from June 2009 to May 2016. All patients had appreciable comorbidity with a mean logistic Euro SCORE of 48 ± 11 and mean standard Euro SCORE 15 ± 4. BAV was performed for palliation in 118 (59%), as a bridging therapy for TAVI in 55 (27.5%) and bridging to surgical AVR in 27 patients (13.5%), respectively. Major complications occurred in 14 patients (7%) including 2 in-patient deaths (1%). A statistically significant improvement in symptoms and a decrease in trans-valvular gradient were observed., Conclusion: BAV is an effective treatment strategy, either as a bridge to definitive therapy or as a palliative procedure, with an acceptable mortality. BAV is associated with a significant improvement in symptoms and is valuable as a palliative treatment in high-risk patients, where no other invasive option is available., (© 2017, Wiley Periodicals, Inc.)

Background: New generation devices for transfemoral aortic valve replacement were optimized on valve positioning and reduction of residual aortic regurgitation. We compared 30-day, 12-month, and 24-month outcomes of the Boston Scientific Lotus valve (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) valve. Primary end point was all-cause mortality or disabling stroke within 12 months., Methods and Results: Between 2014 and 2016, 537 patients were enrolled at our center, and 202 patients received Lotus and 335 ES3. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation was lower with the repositionable and retrievable Lotus valve compared with the ES3. Rate of pacemaker implantation was significantly higher with the Lotus valve compared with the ES3 valve (36.1% versus 14.9%, P <0.01). Valve Academic Research Consortium-2 early safety end point at 30 days was 7.4% with both devices with no difference in all-cause mortality (Lotus, 1.9%; ES3, 1.8%; P =0.87), rate of disabling stroke (Lotus, 1.5%; ES3, 2.1%; P =0.62), or major vascular complications (Lotus, 2.9%; ES3, 2.4%; P =0.69). The primary end point at 12 months was similar between groups. In a propensity score-matched comparison, there was no difference in the primary end point within 12 months (Lotus, 15.5%; ES3, 18.6%; P =0.69) and 24 months (Lotus, 21.9%; ES3, 26.4%; P =0.49)., Conclusions: Transfemoral aortic valve replacement with the ES3 and the Lotus were associated with similar 30-day, 12-month, and 24-month clinical outcomes. Need for permanent pacemaker implantation was significantly higher with the repositionable Lotus device., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02162069., (© 2017 American Heart Association, Inc.)

Background: Treatment for patients with end-stage renal disease (ESRD) and severe aortic stenosis (AS) includes balloon aortic valvuloplasty (BAV), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. We compared outcomes among these strategies., Methods: A retrospective review of patients with ESRD undergoing treatment for severe AS between 07/2007 and 06/2015 was performed at our center. Patients were classified based on treatment: BAV-only, TAVR, or SAVR. Baseline characteristics and 30-day outcomes were compared among groups. A 1-year survival analysis was performed., Results: Of 85 patients, 25 (29.4%) underwent BAV, 30 (35.3%) TAVR, and 30 (35.3%) SAVR. Patients in the SAVR group, compared to the BAV or TAVR patients, were younger (63 vs. 74 vs. 71 years, P = 0.02) and had less prior stroke (3.3% vs. 12.0% vs. 30.0%, P = 0.008). While all BAV patients had NYHA class III/IV, 93.3% and 76.7% of patients had NYHA class III/IV in the TAVR and SAVR group, respectively (P = 0.001). BAV patients were less likely to have atrial fibrillation than TAVR or SAVR patients (16.0% vs. 43.3% vs. 50.0%, P = 0.03). All patients were high risk, but there was a statistical trend to lower STS scores in the SAVR group (8.6% vs. 13.5% vs. 13.5%, P = 0.08). There was no significant difference in 30-day mortality (16.7% vs. 10.0% vs. 10.0%, P = 0.74), but BAV treated patients had an increased 1-year mortality compared to those treated with TAVR or SAVR (87.0% vs. 32.0%, vs. 36.7%, P=<0.001). Independent predictors of 1-year mortality were a higher STS score (HR 1.026, 95%CI 1.002-1.051) and BAV-only strategy (BAV vs. TAVR: HR 3.961, 95%CI 1.595-9.840), but dialysis duration and type, and SAVR versus TAVR were not., Conclusions: Patients with ESRD and severe AS have a similar and higher survival with TAVR or SAVR when compared to BAV at 1-year. These results may influence patient care decisions favoring valve replacement in AS patients with ESRD. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: The introduction of transcatheter aortic valve replacement (TAVR) led to renewed interest in balloon aortic valvuloplasty (BAV). We sought to assess contemporary trends in BAV utilization and their outcomes., Methods and Results: The Nationwide Inpatient Sample was used to identify patients who underwent BAV between 2004 and 2013. In-hospital morbidity and mortality, and predictors of death after BAV were assessed. Outcomes of propensity-matched groups of patients undergoing elective BAV or TAVR were evaluated. BAV utilization increased from 707 cases in 2004 to 3715 cases in 2013 (national estimates). Procedural and in-hospital mortality were 1.4% and 8.5%, respectively. Vascular complications occurred in 7.0% of cases, blood transfusion in 17.5%, clinical stroke in 1.8%, and pacemaker implantation in 3.0%. The strongest predictors of in-hospital death were cardiogenic shock (odds ratio, 6.01; 95% confidence interval, 4.19-8.61; P <0.001), need for left ventricular assist device (odds ratio, 3.48; 95% confidence interval, 2.25-5.36; P <0.001), coagulopathy (odds ratio, 2.19; 95% confidence interval, 1.51-3.18; P <0.001), and low institutional volume of BAV (odds ratio, 1.58; 95% confidence interval, 1.06-2.37; P =0.03). In propensity-matched patients undergoing elective BAV or TAVR, rates of in-hospital mortality (2.9% versus 3.5%; P =0.60), clinical stroke (1.6% versus 3.1%; P =0.10), and vascular complications (8.2% versus 10.9%; P =0.14) were similar. However, BAV was associated with lower rates of pacemaker implantation (2.9% versus 8.0%; P <0.001) and blood transfusion (12.8% versus 22.9%; P <0.001)., Conclusions: In a contemporary national registry, BAV is associated with significant morbidity and mortality that are similar to TAVR. With the substantial increase in BAV utilization and the continuous improvement in TAVR outcomes, these data have important implications to aid clinicians in the selection of appropriate BAV candidates., (© 2017 American Heart Association, Inc.)

Background: Balloon aortic valvuloplasty (BAV) is resurging as a bridge treatment in patients with severe aortic stenosis (AS) with a dissemination of transcatheter aortic valve implantation. However, the significantly high periprocedural mortality and complication rates still limit the indications of BAV. Further efforts are needed to improve the safety and efficacy of BAV.Methods and Results:We retrospectively investigated the safety and efficacy of simultaneous biplane mode of 3-dimensional transesophageal echocardiography (biplane-TEE) guided antegrade transseptal multiple-inflation BAV, with gradual upsizing of the balloon, by enrolling 20 consecutive AS patients who underwent BAV. The median age was 83 years, and there were 6 male patients (30.0%). The clinical frailty scale was 4, and the Society of Thoracic Surgeon score was 14.5%. The balloon was inflated at a median of 18 times, which improved the mean aortic valve pressure gradient from 43.0 to 15.2 mmHg (P<0.001). We safely performed BAV in all patients, without periprocedural death or symptomatic stroke, although asymptomatic stroke was detected in 8 patients (42.1%) on diffusion-weighted magnetic resonance imaging. Kaplan-Meier estimates showed that the survival rate was 84.0% and cardiovascular death-free survival was 88.9% at 1-year., Conclusions: Biplane-TEE guided antegrade multiple-inflation BAV might have the potential to improve periprocedural survival without increasing complications, compared with conventional retrograde BAV in patients with severe AS.

Objective: Coronary obstruction remains a challenging complication of transcatheter aortic valve replacement; however, a new self-expanding transapical prosthesis may reduce this risk. The purpose of this study was to evaluate the early 1-year outcomes of patients with low coronary heights who received the Acurate TA bioprosthesis (Symetis, Ecublens, Switzerland)., Methods: Between May 2014 and April 2015, 30 consecutive patients (aged 85 ± 6 years, 63% were female, Society of Thoracic Surgeons score 8.4 ± 6.0) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the Acurate TA bioprosthesis. Relevant patient characteristics included reoperation in 47% (n = 14), peripheral vascular disease in 43% (n = 13), and porcelain aorta in 30% (n = 9). The mean left and right coronary heights were 10.8 ± 1.5 mm and 16.4 ± 4.1 mm, respectively, with a sinus of Valsalva : annular ratio of 1.3 ± 0.8., Results: All 30 device implants were successful. The 30-day in-hospital mortality was 3.3% (n = 1), and no patients had coronary obstruction or stroke. One patient (3.3%) had apical rupture requiring cardiopulmonary bypass for repair, 1 patient (3.3%) had a localized femoral artery dissection, and 1 patient (3.7%) required a new pacemaker. There were no other complications. Mean and peak transaortic valve gradients decreased from 59 ± 17 and 84 ± 31 mm Hg to 14 ± 7 and 28 ± 12 mm Hg, respectively (P < .0005). No patients had more than mild paravalvular aortic insufficiency. At 30 days, there were no further complications and 96.7% (n = 29) were in New York Heart Association class I/II. Survival at 30 days and 1 year was 97% and 89%, respectively., Conclusions: The Symetis Acurate TA device demonstrates high procedural success and excellent acute and 1-year patient outcomes. The device allows safe implantation in patients at higher risk for coronary artery obstruction., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)