bluuebunny/crossref_metadata_2025_split huggingface dataset:
Up to 6-year performance and clinical outcomes of balloon expandable transcatheter aortic valve according to the implantation strategy: insight from the DIRECTAVI trial
Authors: Leclercq F , Jammoul N , Dupasquier V , Akodad M , Meunier P A , Soltani S , Moulis L , Macia J C , Robert P , Schmutz L , Piot C , Targosz F , Benkemoun H , Roubille F , Cayla G 
Published: November 2023

Abstract

Background
The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices.

Purpose
To evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVI versus BAV) with the SAPIEN 3 balloon-expandable device in patients included in the DIRECTAVI trial.

Methods
All patients included in the DIRECTAVI trial since 2016 were offered a clinical and echocardiographic follow-up until January 2023. We applied Valve Academic Research Consortium (VARC-3) criteria to define moderate/severe hemodynamic valve deterioration (HVD) as an increase in mean gradient ≥10 mm Hg resulting with a final mean gradient ≥20 mm Hg, or new/worsening aortic regurgitation (AR) of 1 grade resulting in ≥moderate AR. Survival until moderate/severe HVD between the 2 groups was the primary end-point and overall survival between direct TAVI and BAV were compared using logrank tests. Major clinical outcomes at latest follow-up were also assessed using Chi² or Fisher’s tests.

Results
Among 250 patients included in DIRECTAVI, 228 patients were followed-up during 4.5 ± 1.1 years. Mean age at follow-up was 87 ± 6.7 years. Incidence rates of moderate/severe HVD were similar in the 2 groups (1.45 versus 1.97 per 100 person-years, p=0.6) (Figure). Incidence rates for death were similar between groups (9.19 and 7.34 events per 100 persons-years for BAV and direct TAVI, respectively, p=0.4). No clinically significant differences in outcomes were observed at the latest follow-up, including major stroke (4.4% for BAV versus 2.6% for direct TAVI, p=0.7), hospitalizations for heart failure (15.8% for BAV group and 11.4% for direct TAVI group, p=0.3), permanent pacemaker implantation (37.7% for BAV and 31.6% for direct TAVI, p=0.3). Moderate/severe patient-prosthesis mismatch was also similar between groups (p=0.6).

Conclusion
Compared to systematic BAV, direct implantation of the SAPIEN 3 device was not associated with an increased risk of moderate/severe valve deterioration or adverse clinical events up to 6-year follow-up. These results encourage wide use of this simplified strategy with balloon-expandable devices, when possible.Survival without valve deterioration
Prognostic significance and outcomes of patient-reported symptoms after valve intervention in severe aortic stenosis
Authors: Ybarra-Falcon C , Garcia-Gomez M , Carnicero D , Ona A , Ruiz J , Ramos N , Vilacosta I , Nombela L , Carnero M , Carrasco M , Sevilla T , Revilla Orodea A , Amat-Santos J I , Lopez-Diaz J , San Roman J A 
Published: November 2023

Abstract

Background
Symptoms in patients with severe aortic stenosis (AS) are the main indication for intervention. The evolution of symptoms after intervention is unknown.

Objective
To describe the evolution of symptoms in patients with symptomatic AS undergoing valve replacement, the predictors of their persistence and their prognostic significance.

Methods
Retrospective analysis of 451 patients with symptoms attributed to severe isolated aortic stenosis (without other valvular heart disease or coronary disease), from two tertiary Spanish hospitals, who underwent aortic valve replacement. The presence of symptoms prior to intervention and the evolution of these after it, were evaluated. Clinical history, laboratory parameters, EKG, echocardiographic findings, total death, and cardiovascular death were also analyzed.

Results
Surgical aortic valve replacement was performed in 216 patients (57.8%) and percutaneous in 190 (42.1%). 133 patients had heart failure (29.5%), 287 dyspnea on effort (90.2%), 129 angina (40.5%) and 29 syncope (n=59). Symptoms disappeared after intervention in 192 patients (42.6%) and remained in 259 (57.4%): 193 dyspnea, 9 angina, 17 syncope and 60 heart failure (Picture 1). Age [OR 1.06 (1.04–1.09)], BMI [OR 1.09 (1.04-1.14)], previous heart failure [OR 1.67 (1.07-2.63)] and chronic obstructive pulmonary disease [OR 2.62 (1.27-5.40)] were independently related to persistence of symptoms. Over a median follow-up of 56 months (IQR: 40-73), 129 deaths were registered (28.6%), 48 cardiovascular (10.6%). Age [HR 1.04 (1.02-1.07), p=0.001], chronic obstructive pulmonary disease [HR 1.74 (1.11-2.71)], chronic kidney disease [HR 1.48 (1.01-2.19)], atrial fibrillation [HR 1.62 (1.13-2.32)], heart failure [HR 1.81(1.27-2.58)] and persistence of symptoms [HR 2.08 (1.35-3.21)] were independently associated to total death. However, persistence of symptoms was not associated to cardiovascular mortality (Picture 2).

Conclusions
Our work shows that symptoms putatively attributed to severe aortic stenosis may remain after valve intervention, particularly dyspnea on effort and syncope at rest. Therefore, before indicating intervention, the cause of dyspnea on effort and syncope at rest must be searched for. The persistence of symptoms was independently related to total death but not to cardiovascular death. According to these results, the recommendation of intervention based on certain symptoms, if confirmed in larger studies, should be called into question.Symptoms before and after interventionKaplan-Meier survival curve
Prognostic impact of atrial fibrillation in patients with paradoxical low-flow low-gradient aortic stenosis undergoing TAVI
Authors: Nakase M , Tomii D , Heg D , Praz F , Stortecky S , Windecker S , Pilgrim T 
Published: November 2023

Abstract

Background
Atrial fibrillation (AF) has been associated with adverse clinical outcomes after transcatheter aortic valve implantation (TAVI). However, the impact of AF on post-TAVI flow status and clinical outcomes in patients with paradoxical low-flow low-gradient aortic stenosis (PLFLG-AS) is still unclear.

Objectives
The present study aimed to investigate the effect of AF on post-TAVI flow status and clinical outcomes in patients with PLFLG-AS undergoing TAVI.

Methods
In a prospective TAVI registry, patients with preserved left ventricular ejection fraction (LVEF ≥50%) were stratified according to the flow-gradient status and presence of AF.

Results
Among 2,259 TAVI patients with preserved LVEF between August 2007 and June 2021, 765 had high-gradient AS (HG-AS) (mean gradient ≥40 mmHg) and 444 had PLFLG-AS (mean gradient &lt;40 mmHg and stroke volume index [SVi] &lt;35 ml/m2). AF was observed in 199 patients with HG-AS (26.0%) and 190 patients with PLFLG-AS (42.8%). At 1 year after TAVI, SVi was significantly improved in PLFLG-AS patients with no AF, whereas those with AF remained low-flow status (from 25.9 ± 8.5 mL/m2 to 37.2 ± 9.9 mL/m2 and from 26.8 ± 5.1 mL/m2 to 26.1 ± 9.1 mL/m2, respectively). PLFLG-AS patients had an increased risk of all-cause mortality at 1 year after TAVI compared with those without AF (HRadjust 2.79; 95% CI 1.58-4.93). Whereas PLFLG-AS patients with no AF had a similar mortality compared with HG-AS patients with no AF (HRadjust 0.84; 95% CI 0.49-1.44).

Conclusions
AF was associated with worse flow status and impaired prognosis after TAVI in patients with PLFLG-AS.
Prevalence of pulmonary hypertension in aortic stenosis and its influence on outcomes
Authors: Ratwatte S , Stewart S , Strange G , Playford D , Celermajer D 
Published: November 2023

Abstract

Background
Aortic stenosis (AS) is the commonest valve abnormality in developed countries with increasing prevalence and a long pre-symptomatic phase. Measurable variables are likely important in stratifying risk and potentially guiding management decisions. The significance of Pulmonary Hypertension (PHT) complicating AS is poorly characterised.

Purpose
We aimed to describe the prevalence and prognostic importance of PHT in a large cohort of adults with at least moderate AS.

Methods
In this retrospective study, we analysed the National Echocardiography Database of Australia (data from 2000-2019). Adults with an estimated right ventricular systolic pressure (eRVSP), left ventricular ejection fraction (LVEF) &gt;50% and with moderate or greater AS were included (n= 14980). These subjects were then categorised according to their eRVSP. The relationship between PHT severity and mortality outcomes were evaluated (median follow-up of 2.6 years, interquartile range 1.0-4.6 years).

Results
Subjects were aged 77±13years and 57.4% were female. Overall, 2049 (13.7%), 5085 (33.9%), 4380 (29.3%), 1956 (13.1%) and 1510 (10.1%) patients had no (eRVSP&lt;30.00mmHg), borderline (30.00-39.99mmHg), mild (40.00-49.99mmHg), moderate (50.00-59.99mmHg) and severe PHT (&gt;60.00mmHg), respectively. A echocardiographic phenotype was evident with worsening PHT, showing rising E:e’ ratio and right and left atrial sizes (p&lt;0.0001, for all). After adjustment for age and sex, the risk of long-term mortality increased as eRVSP increased (adjusted hazard ratio (aHR) 1.15, 95% confidence interval 1.05-1.26 in borderline PHT, to aHR3.04, 95%CI 2.74-3.36 in severe PHT) (Figure 1). These trends were maintained on a sensitivity analysis excluding patients with ≥moderate mitral and/or aortic regurgitation (n=12005), (aHR 1.12, 95% CI 1.002-1.24 in borderline PHT, to aHR3.00, 95%CI 2.66-3.39 in severe PHT). A mortality threshold was identified in the 4th decile of eRVSP categories (35.01–38.00mmHg; HR1.20, P=0.005), with risk progressively increasing through to the 10th decile (HR2.95 p &lt;0.0001).

Conclusions
Both AS and PHT confer an increased risk of mortality as they progress. In this large cohort study, we find that PHT is common in ≥moderate AS and mortality increases as PHT becomes more severe. A threshold for higher mortality lies within the range of "borderline-mild" PHT.Adjusted Risk for All-Cause MortalityThreshold for Mortality
Dobutamine stress echocardiography in low-gradient aortic stenosis
Authors: Borg Mogensen N , Ali M , Carter-Storch R , Annabi M S , Grenier-Delaney J , Moeller J E , Oevrehus K A , Pellikka P A , Pibarot P , Clavel M A , Dahl J S 
Published: November 2023

Abstract

Background
Dobutamine stress echocardiography (DSE) is recommended to distinguish between true-severe and pseudo-severe aortic stenosis (AS) in patients with low flow low-gradients and left ventricular ejection fraction (LVEF) &lt;50%. However, DSE has mostly been tested in the setting of LVEF&lt;35%.

Purpose
The purpose of this study was to examine the diagnostic accuracy of DSE according to aortic valve calcification (AVC) score, in patents with low-flow, low-gradient AS across a wide range of LVEF.

Methods
Patients with aortic mean gradient &lt;40 mmHg, aortic valve area (AVA) &lt;1.0 cm2, and stroke volume index (SVi) ≤35 mL/m2 undergoing DSE were identified from three prospectively collected patient cohorts, and stratified according to LVEF; &lt;35%, 35-50% and &gt;50%.
Severe AS was defined as AVC score ≥2000 AU among men, and ≥1200 AU for women. Recommendation for severe AS according to DSE, are an AVA &lt;1.0 cm2 combined with an aortic mean gradient ≥40 mmHg or peak velocity ≥4 m/s.
Receiver operating characteristic curves for DSE-derived AVA, mean gradient and Vmax were used to identify optimal cut-off points for each LVEF subgroup.

Results
Of the 221 patients included in the study, 78 (35%) presented with LVEF &lt;35%, 67 (30%) with LVEF 35-50%, and 76 (34%) with LVEF &gt;50%. Baseline characteristics are presented in the table. Based on AVC, severe AS was present in 102 (46%) of patients.
Using recommended thresholds for severe AS for AVC and DSE, led to a sensitivity of 49%, a specificity of 84% and an accuracy of 67% for DSE for all patients with LVEF &lt;50%, but with significant heterogeneity between groups figure.
AVA performed rather uniformly across LVEF subgroups; (AUC =0.68 vs 0.62 vs 0.54, p=0.36) LVEF&lt;35%, LVEF 35-50%, LVEF&gt;50% respectively and displayed a rather uniform optimal cut-off (1.0 cm2 vs 0.9 cm2 vs 0.8 cm2).
However, mean gradient and Vmax during DSE, both showed significantly diagnostic heterogeneity across LVEF groups (AUC= 0.90 vs 0.67 vs 0.65, p=&lt;0.001 and AUC= 0.90 vs 0.66 vs 0.60, p=&lt;0.001) with different optimal thresholds (30 mmHg & 3.8 m/s, 45 mmHg & 4.3 m/s and 37mmHg & 4 m/s, LVEF&lt;35%, LVEF 35-50%, LVEF&gt;50%, respectively).

Conclusion
Our study shows, that the association between DSE gradients and AS severity assessed by AVC demonstrates important heterogeneity depending on LVEF. While DSE had the highest accuracy in patients with LVEF&lt;35% both patients with LVEF 35-50%, and patients with LVEF&gt;50% showed significantly less concordance between DSE and AVC.
Left ventricular early diastolic strain rate predicts mortality after transcatheter aortic valve implantation
Authors: Anwer S , Zuercher D , Benz D C , Winkler N E , Donati T G , Tsiourantani G , Wilzeck V , Michel J , Kasel A M , Tanner F C 
Published: November 2023

Abstract

Introduction
Speckle-tracking echocardiography is an increasingly important tool for assessing degenerative aortic valve stenosis (AS). This study aims to analyse left ventricular early diastolic strain rate (eSR) in patients with severe AS undergoing transcatheter aortic valve implantation (TAVI) and explore its association with mortality during long-term follow-up.

Methods
From our prospective AS cohort study, 100 patients with severe AS and a comprehensive echocardiographic examination prior to TAVI were identified and eSR was determined using TomTec ImageArena v.4.6 (Figure A). All-cause five-year mortality was defined as the endpoint.±

Results
Baseline characteristics were comparablebetween non-survivors (14%) and survivors (86%) except for a higher STS-Score among the former (non-survivors: 3.6 [2.7–7.4]%; survivors: 2.6 [1.8–3.7]%; P=0.024). There was no significant difference between non-survivors and survivors with regard to LVEF (54 [50–58]% vs 58 [52–63]%; P=0.069) and LVGLS (-14.8 [-15.8 to -12.7]% vs -15.4 [-15.8 to -14.7]%; P=0.339). In contrast, eSR was significantly lower in non-survivors (0.72 [0.67–0.87]s-1) than survivors (0.88 [0.73–1.22]s-1); P=0.013; Figure B). Patients with an eSR ≤ 0.72 s-1 (ROC AUC 71%; P=0.008) exhibited a lower survival probability as revealed by Kaplan-Meier survival analysis (P=0.001; Figure C). Inclusion of eSR improved the fitness (2) of a multivariable logistic regression model for LV systolic function (LVEF and LVGLS; Figure D). A similar effect was observed when eSR was included in a model for LV diastolic function (E/A and E/e’; Figure D). These improvements in 2 were significant for both models (ANOVA P=0.026, and P=0.037, respectively).

Conclusions
eSR differentiated non-survivors from survivors and was associated with long-term mortality after TAVI. This association was independent of and improved outcome prediction by LV systolic or diastolic function parameters. These findings highlight the potential value of eSR for assessing long-term mortality after TAVI.Figures
Predictors of futility outcomes after TAVI: insights from the France TAVI Registry
Authors: Suc G , Boureau A , Gouysse M , Gilard M , Iung B , Eltchaninoff H 
Published: November 2023

Abstract

Background
Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of aortic stenosis and provides a significant symptom relief and mortality reduction. However, a substantial group of patients fail to derive a benefit from TAVI, whether in terms of mortality, quality of life (QoL) or functional benefit.

Objectives
The aim of the present analysis was to report factors associated with a futility outcome one year after TAVI, in a national real-life registry.

Methods
This prospectively designed France TAVI-QoL substudy included patients from the national France TAVI registry between February the 12th 2018 and February the 12th 2019. Patient’s QoL was assessed at baseline and one year after TAVI using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Vital status was collected from the SNDS ("Systeme Natiobal des donnees de sante"). Factors associated with a futility outcome, defined by death or significant degradation of QoL one-year after a TAVI, were analyzed through a multivariable logistic regression.

Results
The mean age of the 3159 included patients was of 83 years old, and 51,1% were male.
At follow-up, a total of 1055 patients (33.4%) met the primary outcome of procedure futility: 596 (18.9%) died and 459 (14.5%) had a significant decrease in QoL. The independent factors associated with procedure futility were general conditions (diabetes under insulin (RR 1.7, 95CI[1.2-2.3]; p=0.001), estimated glomerular filtration rate (odds-ratio [OR] 0.9 per 1 ml/min increase, 95CI[0.9-1.0]; p&lt;0.001), chronic pulmonary disease (OR 1.6, 95CI[1.2-1.9]; p&lt;0.001)), geriatric values (severe reduction in mobility (OR 1.5, 95CI[1.1-2.1]; p=0.003)), cardiologic values (supraventricular arrhythmia (OR 1.5, 95CI[1.2-1.8]; p&lt;0.001), anticoagulation therapy at discharge (OR 1.3, 95CI[1.1-1.6]; p=0.01)), and procedural features (immediate complications (OR 1.5, 95CI[1.2-1.7]; p&lt;0.001), and time to discharge (OR 1.1, 95CI[1.1-1.1]; p&lt;0.001)).

Conclusion
One third of patients treated in the TAVI Qol Substudy presented with a futility outcome. Certain risk factors are potentially reversible (e.g. severe reduction in mobility or supraventricular arrhythmia), and their management might attenuate the risk of treatment futility and improve TAVI outcomes. Futility outcomes should be assessed with the growing number of patients with aortic stenosis and increasing concerns in the allocation of resources.
Survival in moderate and severe aortic stenosis patients with and without symptoms: a multicenter clinical cohort study
Authors: Playford D , Schwarz N , Chowdhury E , Williamson A E , Duong M , Kearney L , Stewart S , Strange G 
Published: November 2023

Abstract

Background
Untreated moderate and severe aortic stenosis (AS) is associated with poor long-term survival, however the association of symptom status with mortality risk remains unknown.

Methods
Echocardiography report data from an 80-site national cardiology service was extracted and classified into: No AS (mean AV gradient&lt;10.0mmHg or peak AV velocity&lt;2.0m/s, and AVA&gt;1.5cm²), moderate AS (20.0-39.9mmHg/3.0-3.9m/s and AVA&gt;1.0cm2) or severe AS (≥40.0mmHg/≥4.0m/s and/or ≤1.0cm2). Symptom status was extracted using Natural Language Processing of cardiologist reviews and mortality extracted from the National Deaths Index. Native valve AS severity, symptoms and survival were examined during a fixed 2-year follow-up.

Results
29,368 individuals (mean age 60.9±17.4 years, 50.3% male) experienced 1,140 fatal events, more likely in severe than moderate AS, but not increased by the presence of symptoms: 16.8 deaths per 1000 person-years in no AS, 35.4 per 1000 person-years in asymptomatic moderate AS, 32.5 per 1000 person-years in symptomatic moderate AS, 68.7 per 1000 person-years in asymptomatic severe AS and 56.1 per 1000 person-year in symptomatic severe AS (p&lt;0.001 compared with no AS). In adjusted models (including age, sex and cardiac damage score), symptomatic moderate and severe AS had similar mortality to asymptomatic moderate AS, with only asymptomatic severe AS showing increased mortality (HR 1.67, 95% CI 1.17-2.38, p=0.005).

Conclusions
Mortality is increased in both moderate and severe AS, with and without symptoms. The high rates of mortality in asymptomatic severe AS warrants re-examination of the role of symptoms in management decisions, including clinical trials to address whether earlier AVR in asymptomatic moderate and severe AS improves mortality.
Aortic stenosis drives the differential in survival in patients with concomitant moderate aortic and mitral valves diseases
Authors: Hajj Ali A , Gaballa A , El Dahdah J , Popovic Z , Wang T K M , Reed G , Rodriguez L , Griffin B , Roselli E , Gillinov A M , Kapadia S , Svensson L G , Desai M 
Published: November 2023

Abstract

Background
Valvular heart diseases are common causes of morbidity and mortality worldwide. In this study we sought to assess the long-term outcomes of patients diagnosed with concomitant moderate aortic and mitral valves diseases at a tertiary center.

Methods
All 3257 patients (aged 71.7 ± 12.9 years old, 55.2% male, 83.1% white) who presented to the Cleveland Clinic between 1/2010 and 1/2018 and were diagnosed with concomitant moderate aortic and mitral valves diseases were included in this study. The patients were categorized into groups on the basis of aortic and mitral stenosis/regurgitation (AS/AR and MS/MR). The primary endpoint of the study was the composite event defined as heart failure hospitalization or all-cause mortality. The data was analyzed via Kaplan Meier and Cox proportional hazards regression analysis on SPSS.

Results
The median follow-up period was 21.8 months (range 1-155.8). All-causes mortality occurred in 1611 patients (49.5%), heart failure hospitalization in 1119 (34.4%) and the composite event in 1926 patients (59.1%). AR/MR was the most frequent group with 2090 patients (64.2%) followed by AS/MR with 866 (26.6%), AS/MS with 179 (5.5%) and AR/MS with 122 (3.7%). As presented in figure 1, patients with AS/MR had the worst outcome followed by AS/MS, AR/MR and finally AR/MS (p-value &lt;0.001). However, when dividing the comparison on the basis of one valve only, and even after adjusting for aortic and mitral valve interventions, no significance difference in outcomes is noted between MR and MS (p=0.755) while AS had significantly poorer outcome than AR with p&lt;0.001.

Conclusion
In our cohort, patients with concomitant moderate aortic and mitral valves diseases had an overall high rate of death and heart failure hospitalization. Patients with AS had significantly poorer outcomes than patients with AR but no difference was noted when comparing MS to MR.Figure 1Figure 2