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Background: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri‐procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI—transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri‐procedural and short‐term safety, efficacy and durability of repeated TAVI. Methods: The ReTAVI Prospective observational registry is an investigator‐initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon‐expandable SAPIEN prosthesis to evaluate procedural and short‐term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high‐volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30‐day and 12‐month follow‐up. The estimated study completion is 2025. Conclusions: The registry will collect pre‐, peri‐, postoperative and 12‐months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC‐3‐defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis. [ABSTRACT FROM AUTHOR]

This study sought to determine the degree of Evolut (Medtronic) leaflet pinning, diameter expansion, leaflet overhang, and performance at different implant depths of the balloon-expandable Sapien 3 (S3, Edwards Lifesciences LLC) transcatheter heart valve (THV) within the Evolut THV. Preservation of coronary access and flow is a major factor when considering the treatment of failed Evolut THVs. An in vitro study was performed with 20-, 23-, 26-, and 29-mm S3 THVs deployed within 23-, 26-, 29-, and 34-mm Evolut R THVs, respectively. The S3 outflow was positioned at various depths at node 4, 5, and 6 of the Evolut R. Neoskirt height, leaflet overhang, performance, and Evolut R valve housing diameter expansion were assessed under physiological conditions as per ISO 5840-3 standard. The neoskirt height for the Evolut R was shorter when the S3 outflow was positioned at node 4 compared with node 6 (node 4 height for 23 mm = 16.3 mm, 26 mm = 17.1 mm, 29 mm = 18.3 mm, and 34 mm = 19.9 mm vs node 6 height for 23 mm = 23.9 mm, 26 mm = 23.4 mm, 29 mm = 24.7 mm, and 34 mm = 27 mm Evolut R). All configurations exhibited acceptable hydrodynamic performance irrespective of the degree of leaflet overhang, except the 29-mm S3 implanted in 34-mm Evolut R at node 4 (regurgitant fraction >20%). The valve housing radius of the index Evolut R increased when the S3 was implanted, with the increase ranging from 0 to 2.5 mm. Placement of the S3 at a lower implant position within an index Evolut R reduces the neoskirt height with no significant compromise to S3 valve function despite a higher degree of leaflet overhang. Low S3 implantation may facilitate future coronary access after redo transcatheter aortic valve replacement. [Display omitted] [ABSTRACT FROM AUTHOR]

The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited. The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared. In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score–matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097). Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274). [Display omitted] [ABSTRACT FROM AUTHOR]

Background: The extent of myocardial fibrosis in patients with severe aortic stenosis might have an important prognostic value. Non-invasive imaging to quantify myocardial fibrosis by measuring extracellular volume fraction might have an important clinical utility prior to aortic valve intervention. Methods: Seventy-five consecutive patients with severe aortic stenosis, and 19 normal subjects were prospectively recruited and underwent pre- and post-contrast computed tomography for estimating myocardial extracellular volume fraction. Serum level of galectin-3 was measured and 2-dimensional echocardiography was performed to characterize the extent of cardiac damage using a recently published aortic stenosis staging classification. Results: Extracellular volume fraction was higher in patients with aortic stenosis compared to normal subjects (40.0±11% vs. 21.6±5.6%; respectively, p<0.001). In patients with aortic stenosis, extracellular volume fraction correlated with markers of left ventricular decompensation including New York Heart Association functional class, left atrial volume, staging classification of aortic stenosis and lower left ventricular ejection fraction. Out of 75 patients in the AS group, 49 underwent TAVI, 6 surgical AVR, 2 balloon valvuloplasty, and 18 did not undergo any type of intervention. At 12-months after aortic valve intervention, extracellular volume fraction predicted the combined outcomes of stroke and hospitalization for heart failure with an area under the curve of 0.77 (95% confidence interval: 0.65–0.88). A trend for correlation between serum galectin-3 and extracellular volume was noted. Conclusion: In patients with severe aortic stenosis undergoing computed tomography before aortic valve intervention, quantification of extracellular volume fraction correlated with functional status and markers of left ventricular decompensation, and predicted the 12-months composite adverse clinical outcomes. Implementation of this novel technique might aid in the risk stratification process before aortic valve interventions. [ABSTRACT FROM AUTHOR]

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm2 vs. 1.37 ± 0.5 cm2; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV). BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm2 or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm2, perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success. 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type. TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs. • TAVR can be successfully performed in severe bicuspid aortic stenosis. • However, interaction between annular size and THV type is still unclear. • We compared BEV and SEV hemodynamics by aortic annulus size in BAV patients. • In large annuli a higher rate of PVLs was observed SEVs compared to BEVs. • No differences in clinical outcomes were observed according to annular size nor THV. [ABSTRACT FROM AUTHOR]

Although bicuspid aortic valve (BAV) is not considered a "sweet spot" to trans-catheter aortic valve replacement (TAVR), a certain number of BAV underwent TAVR. Whether BAV phenotype affects outcomes following TAVR remains debated. We aimed at evaluating the impact of BAV phenotype on procedural and clinical outcomes after TAVR using new generation trans-catheter heart valves (THVs). patients included in the BEAT registry were classified according to the BAV phenotype revealed at multi-slice computed tomography (MSCT) in type 0 (no raphe) vs. type 1 (1 raphe). Primary end-point was Valve Academic Research Consortium–2 (VARC-2) device success. Secondary end-points included procedural complications, rate of permanent pacemaker implantation, clinical outcomes at 30-day and 1-year. Type 0 BAV was present in 25(7.1%) cases, type 1 in 218(61.8%). Baseline characteristics were well balanced between groups. Moderate-severe aortic valve calcifications at MSCT were less frequently present in type 0 vs. type 1 (52%vs.71.1%, p = 0.05). No differences were reported for THV type, size, pre and post-dilation between groups. VARC-2 success tended to be lower in type 0 vs. type 1 BAV (72%vs86.7%; p = 0.07). Higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 group (24%vs6%, p = 0.007). No differences were reported in the rate of post-TAVR moderate-severe aortic regurgitation and clinical outcomes between groups. Our study confirms TAVR feasibility in both BAV types, however a trend toward a lower VARC-2 device success and a higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 BAV. • Despite being a relative contraindication a certain number of BAV underwent TAVR. • We assessed the impact of BAV type on procedural and clinical outcomes post TAVR. • VARC-2 success tended to be lower in type 0 vs. type 1 BAV. • higher rate of high residual gradient was observed in type 0 compared to type 1 BAV. • No differences were noted in the rate of AR and clinical outcomes between BAV types. [ABSTRACT FROM AUTHOR]