Comparison of Contemporary Treatment Strategies in Patients With Cardiogenic Shock Due to Severe Aortic Stenosis.

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.

Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves.

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.

The impact of gender on outcomes of transcatheter aortic valve implantation between self-expanding valve and balloon-expandable valve.

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.

Endoscopic repeat isolated tricuspid valve surgery after left-sided valve replacement: valvuloplasty or replacement.

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.

Technical Modifications That Might Improve Long-term Outcomes of the Ross Procedure in Children.

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.

Clinical outcomes following balloon aortic valvuloplasty.

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.

Balloon aortic valvuloplasty as a palliative treatment in patients with severe aortic stenosis and limited life expectancy: a single center experience.

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.

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry.

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 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 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 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [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.

5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial.

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 cm2 vs. 1.9 ± 0.5 cm2; 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).

Utility of balloon aortic valvuloplasty in the transcatheter aortic valve implantation era.

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.

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome: A Decision Analysis.

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.

Impact of Aortic Valve Replacement for Severe Aortic Stenosis on Perioperative Outcomes Following Major Noncardiac Surgery.

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.

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

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).

Balloon Aortic Valvuloplasty as a Bridge to Aortic Valve Replacement: A Contemporary Nationwide Perspective.

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.

Reshaping bicuspid aortic valve stenosis with an hourglass-shaped balloon for transcatheter aortic valve replacement: A pilot study.

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.

Balloon-expandable transcatheter aortic valve replacement outcomes by procedure location: Catheterization laboratory versus operating room.

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.

Systematic Review and Meta-Analysis of Interventional Emergency Treatment of Decompensated Severe Aortic Stenosis.

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.

Safety of Next-Day Discharge After Transfemoral Transcatheter Aortic Valve Replacement With a Self-Expandable Versus Balloon-Expandable Valve Prosthesis.

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.