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To evaluate all-cause mortality in ViV-TAVI versus redo SAVR in patients with failed bioprostheses.Study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of non-randomized studies published by September 30, 2021.Ten studies met our eligibility criteria and included a total of 3345 patients (1676 patients underwent ViV-TAVI and 1669 patients underwent redo SAVR). Pooling all the studies, ViV-TAVI showed a lower risk of all-cause mortality in the first 44 days [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49-0.93, P = 0.017], with an HR reversal after 197 days favoring redo SAVR (HR 1.53; 95% CI 1.22-1.93; P 0.001). Pooling only the matched populations (1143 pairs), ViV-TAVI showed a lower risk of all-cause mortality in the first 55 days [hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.45-0.89, P 0.001], with a reversal HR after 212 days favoring redo SAVR (HR 1.57; 95% CI 1.22-2.03; P 0.001). The Cox regression model showed a statistically significant association of prosthesis-patient mismatch (PPM) with all-cause mortality during follow-up for ViV-TAVI (HR 1.03 per percentage increase in the study- and treatment arm-level proportion of PPM, 95% 1.02-1.05, P 0.001).ViV-TAVI is associated with a strong protective effect immediately after the procedure in comparison with redo SAVR, however, this initial advantage reverses over time and redo SAVR seems to be a protective factor for all-cause mortality after 6 months. Considering that these results are the fruit of pooling data from observational studies, they should be interpreted with caution and trials are warranted.

OBJECTIVES Incidence and prognosis of ST-segment elevation myocardial infarction (STEMI) vary according to ambient temperature and season. We sought to assess whether season and temperature on the day of STEMI are associated with infarct size, microvascular obstruction (MVO), left ventricular ejection fraction (LVEF) and clinical outcomes after primary percutaneous coronary intervention (PCI). METHODS Individual patient data from 1598 patients undergoing primary PCI in six randomized clinical trials were pooled. Infarct size was evaluated by cardiac magnetic resonance within 30 days in all trials. Patients were categorized either by whether they presented on a day of temperature extremes (minimum temperature 25 °C) or according to season. RESULTS A total of 558/1598 (34.9%) patients presented with STEMI on a day of temperature extremes, and 395 (24.7%), 374 (23.4%), 481 (30.1%) and 348 (21.8%) presented in the spring, summer, fall and winter. After multivariable adjustment, temperature extremes were independently associated with larger infarct size (adjusted difference 2.8%; 95% CI, 1.3-4.3; P

Background Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). Objectives The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. Methods Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. Results A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). Conclusions In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

After 15 years of successive randomized, controlled trials, indications for transcatheter aortic valve replacement (TAVR) are rapidly expanding. In the coming years, this procedure could become the first line treatment for patients with a symptomatic severe aortic stenosis and a tricuspid aortic valve anatomy. However, randomized, controlled trials have excluded bicuspid aortic valve (BAV), which is the most frequent congenital heart disease occurring in 1% to 2% of the total population and representing at least 25% of patients 80 years of age or older referred for aortic valve replacement. The use of a less invasive transcatheter therapy in this elderly population became rapidly attractive, and approximately 10% of patients currently undergoing TAVR have a BAV. The U.S. Food and Drug Administration and the “European Conformity” have approved TAVR for low-risk patients regardless of the aortic valve anatomy whereas international guidelines recommend surgical replacement in BAV populations. Given this progressive expansion of TAVR toward younger and lower-risk patients, heart teams are encountering BAV patients more frequently, while the ability of this therapy to treat such a challenging anatomy remains uncertain. This review will address the singularity of BAV anatomy and associated technical challenges for the TAVR procedure. We will examine and summarize available clinical evidence and highlight critical knowledge gaps regarding TAVR utilization in BAV patients. We will provide a comprehensive overview of the role of computed tomography scans in the diagnosis, and classification of BAV and TAVR procedure planning. Overall, we will offer an integrated framework for understanding the current role of TAVR in the treatment of bicuspid aortic stenosis and for guiding physicians in clinical decision-making.

Objectives The aim of this study was to evaluate early results of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) versus redo surgical aortic valve replacement (SAVR) fo...

Coronary obstruction is a major complication of transcatheter aortic valve replacement (TAVR). Rapid and growing demand for TAVR procedures is accompanied by interest in techniques that may prevent...

Bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF) may be caused by structural or nonstructural valve dysfunction. Both surgical and transcatheter bioprosthetic valves have limited durability because of structural valve deterioration. The main objective of this summary of experts participating in a virtual workshop was to propose standardized definitions for nonstructural and structural BVD and BVF following aortic or mitral biological valve replacement with the goal of facilitating research reporting and implementation of these terms in clinical practice. Definitions of structural BVF, based on valve reintervention or death, underestimate the true incidence of BVF. However, definitions solely based on the presence of high transprosthetic gradient at a given echocardiogram during follow-up overestimate the incidence of structural BVD and BVF. Definitions of aortic or mitral structural BVD must therefore include the confirmation by imaging of permanent structural changes to the leaflets alongside evidence of deterioration in valve hemodynamic function at echocardiography follow-up.

IMPORTANCE: The outcome and interpretation of noninferiority trials depend on the magnitude of the noninferiority margin and whether a relative or absolute noninferiority margin is used and may be affected by imprecision in event rate estimation. OBJECTIVE: To assess the consequence of imprecise event rate estimations on interpretation of peer-reviewed randomized clinical trials. DATA SOURCES: PubMed/MEDLINE was searched for articles published between January 1, 2015, and April 30, 2021. STUDY SELECTION: Noninferiority randomized clinical trials of coronary stents published in selected journals with clinical events as the primary end point. DATA EXTRACTION AND SYNTHESIS: Two reviewers (M.S. and F.V.) independently extracted data on trial characteristics, noninferiority assumptions, primary end point clinical outcomes, and study conclusions. Overestimation or underestimation of the control event rate was evaluated by dividing the assumed control event rate by the observed control event rate. For noninferiority end points with absolute margins, the assumed corresponding relative margin was defined as the ratio of the absolute margin and the assumed event rate, and the observed corresponding relative margin as the ratio between the absolute margin and the observed event rate in the control arm. Noninferiority comparisons with absolute margins were reanalyzed using the assumed corresponding relative margin and the Farrington-Manning score test for relative risk. MAIN OUTCOMES AND MEASURES: Overestimation or underestimation, assumed and observed corresponding relative margins, and relative reanalysis of the primary end points of trials with absolute margins. RESULTS: A total of 106 989 patients from 58 trials were included. The event rate in the control arms was overestimated by a median (IQR) of 28% (2%-74%). Most noninferiority trials used absolute rather than relative margins (55 of 58 trials [94.8%]). Owing to overestimation, absolute noninferiority margins became more permissive than originally assumed (median [IQR] of observed relative noninferiority margin, 1.62 [1.50-1.80] vs assumed relative noninferiority margin, 1.47 [1.39-1.55]; P

Aims Baseline renal dysfunction (RD) adversely impacts outcomes among patients with heart failure (HF) and severe secondary mitral regurgitation (MR). Heart failure and MR, in turn, accelerate progression to end-stage renal disease (ESRD), worsening prognosis. We sought to determine the impact of RD in HF patients with severe MR and the impact of transcatheter mitral valve repair (TMVr) on new-onset ESRD and the need for renal replacement therapy (RRT). Methods and results The COAPT trial randomized 614 patients with HF and severe MR to MitraClip plus guideline-directed medical therapy (GDMT) vs. GDMT alone. Patients were stratified into three RD subgroups based on baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2): none (≥60), moderate (30–60), and severe ( Conclusion Baseline RD was common in the HF patients with severe MR enrolled in COAPT and strongly predicted 2-year death and HFH. MitraClip treatment reduced new-onset ESRD and the need for RRT, contributing to the improved prognosis after TMVr.

Background: The management of patients with asymptomatic, severe aortic stenosis (AS) is controversial. We performed a meta-analysis to examine the impact on outcomes of early aortic valve ...

AIMS The aim of this study was to evaluate transcatheter aortic valve-in-valve (ViV) implantation performance in rapid deployment (ViVr) vs. conventional (ViVc) surgical heart valves. METHODS AND RESULTS A multicentre registry was developed as part of the VIVID international registry. A total of 30 ViVr patients (Perceval, n=24, ATS 3f Enable™, n=5, and the INTUITY, n=1) were evaluated and compared with 2,288 ViVc patients. Propensity score (PS) matching was performed to adjust further for bias. Compared with ViVc, ViVr patients presented twice as early after surgical heart valve (SHV) implantation (55.2±36.1 vs. 118.4±57.7 months, p

BACKGROUND There is a rising trend for transcatheter aortic valve implantation (TAVI) in bicuspid aortic stenosis patients. Data on the use of self-expandable (SEV) vs. balloon-expandable (BEV) valves in these patients are scarce. Therefore, we systematically compared clinical outcomes in bicuspid aortic stenosis patients treated with SEV and BEV. METHODS Data were extracted from PubMed/MEDLINE, EMBASE, CENTRAL/CCTR, ClinicalTrials.gov, SciELO, LILACS, Google Scholar and reference lists of relevant articles. Eight studies published from 2013 to 2020 including a total of 1,080 patients (BEV: n = 620; SEV: n = 460) were selected. Primary endpoints were procedural, 30-day and 1-year mortality. Secondary endpoints were new pacemaker implantation, annular rupture, coronary obstruction, moderate-to-severe paravalvular leak, need of second valve, stroke and acute kidney injury. RESULTS We found no statistically significant difference in mortality between patients treated with BEV vs. SEV during index procedure, at 30 days and at 1 year. BEVs showed a statistically significant higher risk of annulus rupture (2.5%) in comparison with SEV (0%) (OR 5.81 [95% CI, 3.78-8.92], p

Coronavirus disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), is an ongoing global pandemic with high morbidity and mortality.1 Patients with preexist...

Introduction Few data exist regarding the late clinical impact of the Selvester score prediction of myocardial fibrosis after transcatheter aortic valve replacement (TAVR). This study evaluated the predictive power of the Selvester score on survival in patients with aortic stenosis (AS) undergoing TAVR. Methods and results Patients with severe AS who had preoperative electrocardiograms were included. Clinical follow-up was obtained retrospectively. The primary endpoint was all-cause mortality. Secondary endpoints were cardiovascular death and major adverse cardiac events (MACE). Two hundred twenty-eight patients were included (mean age, 81.5±7.4 years; women, 58.3%). Deceased patients had a higher mean score (4.6±3.2 vs. 1.4±1.3; p Conclusions Elevated Selvester scores increase the risk of poor outcomes in patients with AS undergoing TAVR. The involvement of the anterior or lateral wall presents worse prognosis. Kaplain Meier and ROC Curve Funding Acknowledgement Type of funding source: None

Introduction Transcatheter aortic valve replacement (TAVR) is increasingly utilized in treatment of aortic stenosis (AS). AS is commonly associated to pulmonary hypertension (PH) and tricuspid regurgitation (TR). We aimed to evaluate the long-term post-TAVR course of PH and TR. Methods Patients undergoing TAVR were screened for 24-month echocardiographic data on PH and TR. All echocardiograms were performed by a single team. Patients were divided in groups according to TR and PH (pulmonary systolic pressure ≥ or Results 156 and 151 patients were selected for PH and TR follow-up, respectively. Mean follow-up was 42.23±17.53 months and 42.60±17.67 months for PH and TR groups. Maximum follow-up was 96 months. PH was reduced post-TAVR (32.7% pre-TAVR vs. 20.5% post-TAVR, p Conclusions TAVR was able to reduce the severity of PH, but not TR, in this cohort. Additionally, long-term survival was affected by PH, diastolic dysfunction and LA sizing. Kaplan-Meier survival curve Funding Acknowledgement Type of funding source: None

Aortic stenosis (AS) remains one of the most common valvular heart diseases, with enormous impact on patient survival. Over the past years, transcatheter aortic valve implantation (TAVI) has become a reality worldwide, offering a less invasive method to treat AS. Apart from the classical indications for aortic valve disease, recent studies tried to address unanswered questions for TAVI - asymptomatic severe AS, bicuspid aortic valves and moderate AS in patients with heart failure. This review discusses the rationale of those possible indications, pitfalls and current evidence in the medical literature.

Aims The aim of this meta-analysis was to evaluate the evidence regarding the rates of procedural success and the incidence of adverse outcomes following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in patients with failed bioprosthetic aortic valves. Methods and results A systematic search of major electronic databases was conducted for studies relevant to patients with failed bioprosthetic aortic valves undergoing VIV-TAVR. The primary outcome was procedural success. A total of 5,553 patients from 24 studies were included. The mean Society of Thoracic Surgeons (STS) score was 7.84±5.14. The procedural success rate was high (97%, 95% confidence interval [CI]: 94-98%). At 30 days, all-cause mortality was 5% (95% CI: 3-6%), stroke 2% (95% CI: 1-2%), myocardial infarction 1% (95% CI: 1-2%), permanent pacemaker placement 6% (95% CI: 5-8%), and aortic regurgitation 7% (95% CI: 5-10%). At one year, the incidence of all-cause mortality was 12% (95% CI: 10-14%), stroke 3% (95% CI: 2-4%), myocardial infarction 1% (95% CI: 0-2%), and permanent pacemaker placement 7% (95% CI: 5-11%). At three years, the incidence of all-cause mortality was 29% (95% CI: 25-34%) and stroke 6% (95% CI: 5-9%). Conclusions VIV-TAVR appears to be associated with high procedural success rates and low adverse outcomes during the short-term and midterm follow-up period.

Aims Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. Methods and results A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2–12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02–1.13)], age [HR 1.21 (95% CI 1.01–1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11–1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis–patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31–14.39)], device malposition [SHR 3.75 (95% CI 1.36–10.35)], EBEV [SHR 3.34 (95% CI 1.26–8.85)], and age [SHR 0.59 (95% CI 0.44–0.78)]. Conclusions The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.

INTRODUCTION Few data exist regarding the late clinical impact of the Selvester score prediction of myocardial fibrosis after transcatheter aortic valve replacement (TAVR). This study evaluated the predictive power of the Selvester score on survival in patients with aortic stenosis (AS) undergoing TAVR. METHODS AND RESULTS Patients with severe AS who had preoperative electrocardiograms were included. Clinical follow-up was obtained retrospectively. The primary endpoint was all-cause mortality. Secondary endpoints were cardiovascular death and major adverse cardiac events (MACEs). Two-hundred twenty-eight patients were included (mean age, 81.5 ± 7.4 years; women, 58.3%). Deceased patients had a higher mean score (4.6 ± 3.2 vs. 1.4 ± 1.3; p

Objective: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). Methods: Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL. Results: Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%. Conclusion: Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.

Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the "off-label" use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

OBJECTIVES A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses.BACKGROUND Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis.METHODS Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses).RESULTS Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 +/- 10% for stentless ViV-TAVR vs. 6 +/- 9% for stented ViV-TAVR (and 8 +/- 10% for stentless ViV-TAVR vs. 3 +/- 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR.CONCLUSIONS Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome. (C) 2019 by the American College of Cardiology Foundation.

Objectives This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. Background Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. Methods S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%. Results A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p Conclusions Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.

Background Limited data exist on clinical valve thrombosis after transcatheter aortic valve-in-valve (ViV) implantation. Our objective was to determine the incidence, timing, clinical characteristics, and treatment outcomes of patients diagnosed with clinical ViV thrombosis. Methods and Results Centers participating in the Valve-in-Valve International Data Registry were surveyed for thrombosis cases, and clinical valve thrombosis was defined based on a combination of the presence of new valve dysfunction and an imaging evidence of leaflet thrombosis. Three hundred ViV implantations were included. The surgical valve was stented in 86.3% and stentless in 13.7% of cases; and the transcatheter heart valve was self-expanding in 50%, balloon-expandable in 49%, and mechanically expanding in 1.0%. The incidence of clinical valve thrombosis was 7.6% (n=23), diagnosed at a median time of 101 days (interquartile range, 21–226) after the procedure. Fifteen patients (65%) presented with worsening symptoms and 21 (91%) with transvalvular mean gradient elevation. The mean gradient at the time of diagnosis (median 39 mm Hg; interquartile range, 30–44) was significantly higher than immediately post-ViV (13 mm Hg; interquartile range, 8–20.5; P P P =0.011), surgical valve true internal diameter indexed to body surface area (0.537 [0.331–0.873], P =0.012), and Mosaic or Hancock II stented porcine bioprostheses (4.01 [1.287–12.485], P =0.017). Conclusions Clinical valve thrombosis after transcatheter aortic ViV implantation is common, especially in patients not on oral anticoagulation. Although aortic ViV is commonly associated with elevated gradients, valve thrombosis should be ruled out if gradients increase compared with early postprocedural values. A higher incidence was observed after treatment of certain stented porcine surgical valve types, suggesting a specific adjustment of the adjunctive antithrombotic therapy in this subset of ViV patients.

An ageing population and increased utilisation of tissue valves in younger patients imply that the number of patients receiving transcatheter aortic valve implantation within failed bioprostheses will continue to increase. There are two major adverse events associated with aortic valve-in-valve procedures that may temper the enthusiasm for these appealing interventions. Residual stenosis is the "Achilles' heel" of aortic valve-in-valve, while coronary obstruction is an uncommon but life-threatening adverse event. Prevention of these adverse events is essential. Emerging tools and techniques enable operators to manipulate existing devices and to implant new ones inside them safely. Considering the available evidence, it seems that bioprosthetic valve ring fracture and bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) may enable some solution. Until we have prosthetic valves that are both very durable and non-thrombogenic, we can expect that techniques and tools chosen to treat failed bioprosthetic valves effectively will continue to be designed and utilised.

Aims Transcatheter valve-in-valve implantation (VinV) is established for the treatment of degenerated surgical bioprostheses in patients at high operative risk. Our aim was to report on the first large assessment of VinV with next-generation balloon-expandable transcatheter heart valves. Methods and results After SAPIEN XT or SAPIEN 3 VinV, 514 patients were analysed using an inverse probability of treatment weighting. Standardised clinical and haemodynamic outcomes were compared, and core laboratory evaluation of implantation depth was performed. Thirty-day all-cause mortality was 0.6% and 3.5% for SAPIEN 3 and SAPIEN XT (p=0.077). Residual transprosthetic gradient ≥20 mmHg was observed in 38.3% (SAPIEN 3) and 35.7% (SAPIEN XT) of patients (p=0.627) with increased rates in small bioprostheses (≤21 mm true ID). In SAPIEN 3 VinV, low implantation depth >20% THV stent frame length was associated with a higher rate of elevated transaortic gradients (p=0.048). Similarly, an implantation depth >5 mm was linked to more pacemaker implantations (p=0.01). Overall, a trend towards higher pacemaker implantation rates was observed after SAPIEN 3 VinV (6% vs. 2.5% in SAPIEN XT, p=0.071). Conclusions Transcatheter aortic VinV with the balloon-expandable SAPIEN XT or SAPIEN 3 was similarly safe and effective. However, residual stenosis remains a concern, particularly in smaller bioprostheses and with increasing implantation depth.

Background Recent findings suggest an association between attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD). Thus, we evaluated the clinical associated features of ADHD in a large sample of adult OCD patients. Methods A cross-sectional study including 955 adult patients with OCD from the Brazilian Research Consortium of Obsessive-Compulsive Spectrum Disorders (C-TOC). Clinical characteristics in adult OCD patients with and without comorbid ADHD were compared using Fisher's exact test, t-tests or Mann-Whitney tests. Bivariate analyses were followed by logistic regression analysis to identify clinical characteristics independently associated with ADHD comorbidity. Results The lifetime prevalence of ADHD in adult OCD patients was 13.7%. The current results indicate that OCD + ADHD patients were more severe, had an earlier onset of the obsessive-compulsive symptoms, a higher history of rheumatic fever, with higher frequencies of sensory phenomena and comorbidity with Tourette syndrome. They also had an increased risk for academic impairment and suicide attempts. Conclusion Adult OCD patients with ADHD present some specific clinical features and may represent a special subgroup of adult OCD. Future studies should focus on the development of interventions more tailored to the phenotype of this subgroup of patients.

OBJECTIVES: We sought to determine the impact of aortic root calcium on the risk of significant paravalvular regurgitation (sPAR) in transcatheter aortic valve replacement (TAVR).METHODS: In 302 consecutive patients from 3 centers, aortic root calcium was quantified volumetrically on pre-TAVR multidetector computed tomography (MDCT) in three regions: 1) the aortic valve region, 2) the overall left ventricular outflow tract (LVOT) and 3) the upper LVOT. Transcathether heart valve (THV) oversizing was calculated as (THV nominal area/MDCT annular area-1) × 100. The study endpoint sPAR was a composite of post-dilatation (PD) and PAR > mild.RESULTS: sPAR occurred in 15% (46/302) of patients. Upper LVOT calcium volume was more predictive of sPAR than overall LVOT calcium volume, with an area under the receiver operating curve (AUC) (95% confidence interval [CI]) of 0.80 (0.67-0.89) vs. 0.60 (0.51-0.70); p = 0.0001. The optimal cut-off calcium volume thresholds determined from receiver operating curves were 21 mm3 and 30 mm3 for upper LVOT and overall LVOT calcium, respectively. Upper LVOT calcium ≥ 21 mm3, but not overall LVOT calcium ≥ 30 mm3, independently predicted sPAR, odds ratio (95%CI): 9.5 (4.1-22.3) vs 1.6 (0.6-2.7). Upper LVOT calcium was more predictive of sPAR in patients with THV oversizing ≥ 13% compared to patients with THV oversizing CONCLUSIONS: Upper LVOT calcium predicts more-than-mild paravalvular regurgitation following TAVR or the need for postdilatation. Upper LVOT calcium is most predictive of paravalvular regurgitation in the event of THV oversizing ≥ 13%.

Aims: There are limited data on coronary obstruction following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The objectives of this study were to determine the incidence, predictors, and clinical outcomes of coronary obstruction in transcatheter ViV procedures. Methods and results: A total of 1612 aortic procedures from the Valve-in-Valve International Data (VIVID) Registry were evaluated. Data were subject to centralized blinded corelab computed tomography (CT) analysis in a subset of patients. The virtual transcatheter valve to coronary ostium distance (VTC) was determined. A total of 37 patients (2.3%) had clinically evident coronary obstruction. Baseline clinical characteristics in the coronary obstruction patients were similar to controls. Coronary obstruction was more common in stented bioprostheses with externally mounted leaflets or stentless bioprostheses than in stented with internally mounted leaflets bioprostheses (6.1% vs. 3.7% vs. 0.8%, respectively; P

Aims Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Diverse prostheses are currently under investigation. The aim of this study was the clinical, safety and efficacy assessment of Braile Inovare Transcatheter Aortic Prosthesis usage. Methods and results Ninety high-risk or inoperable patients underwent transcatheter aortic valve implantation. The mean logistic EuroSCORE was 39.3%. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through the transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included. Implantation was feasible in 87 cases. There was only one case of operative mortality, and 30-day mortality was 13.3%. The median transvalvular aortic gradient was reduced from 44.8±15.3 to 14.1±8.0 mmHg. Left ventricular function improved in the first seven postoperative days. Paravalvular aortic regurgitation was present in 29.7% of cases, mostly trace. One case presented a major vascular complication, and there were two cases of permanent pacemaker implantation. Two cases of major stroke occurred. Conclusions Transcatheter aortic valve replacement using the Braile Inovare prosthesis is able to provide encouraging results with significant functional and structural cardiac improvement. It is mandatory to continue follow-up to measure the benefits of this device as well as to improve selection criteria of patients.

ObjectiveWe aimed to analyse the incidence of prosthesis–patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event.MethodsA total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls).ResultsModerate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta −0.023; 95% CI −0.032 to –0.014; PConclusionsSevere PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.