bluuebunny/crossref_metadata_2025_split huggingface dataset:
P3822Risk prediction for ASCVD in primary prevention patients on statin therapy
Authors: Pagidipati N , Wojdyla D M , Robinson J , Navar A M , Peterson E D , Pencina M 
Published: October 2019

Abstract

Background
Statins are now widely used for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). However, existing risk prediction models were developed primarily on patients not on statins. We developed a novel model to estimate the risk of ASCVD among contemporary patients taking statins.

Methods
Using combined data from 3 large NIH-sponsored cohort studies: Atherosclerosis Risk in Communities, Framingham Offspring Study, and Multi-ethnic Study of Atherosclerosis we examined adults aged 40–79 years without prior ASCVD who were on statin therapy at the baseline exam. A Cox proportional hazards model was used to identify factors associated with a 10-year risk of CV death, MI, or stroke. Age, sex, and race were forced into the model while other potential candidate predictors were retained if statistically significant at the 0.05 level. Interaction terms with age, sex, and race were retained if significant at the 0.01 level. The model was assessed with c-statistic and calibration plots of observed events versus model-based risks after cross-validation and contrasted with the Pooled Cohorts Equations (PCE) recommended by the current U.S. guidelines.

Results
Among 2333 primary prevention patients on statins at baseline, a total of 220 events occurred over a median 8.8 years of follow-up. Most risk factors retained in our final model overlapped with those included in the PCE (age, sex, race, systolic blood pressure [sBP], diabetes, smoking, high-density lipoprotein cholesterol, total cholesterol). Our model also included creatinine clearance, aspirin use, and the interaction between age and sBP. Optimism-corrected discrimination of the new model was marginally higher than PCE: 0.69 (95% CI 0.66–0.72) versus 0.68 (95% CI 0.65–0.72). Cross-validated calibration was superior on our contemporary sample, especially at the higher levels of risk (Figure), where PCE over-estimated risk.
Calibration plots

Conclusion
Accurate estimation of 10-year ASCVD risk among patients currently on statins necessitates recalibration of the current PCE model or application of our algorithm developed specifically for this cohort. This might help avoid over-estimation of risk and reduce the need for unnecessary additional lipid-lowering therapy.

Acknowledgement/Funding
Regeneron Pharmaceuticals
P3848Baseline profile of patients treated for acute venous thromboembolism (VTE) in routine clinical practice according to VTE location in the RE-COVERY DVT/PE global cohort study
Authors: Schellong S , Ageno W , Casella I B , Han C K , Schulman S , Singer D E , Desch M , Tang W , Voccia I , Zint K , Goldhaber S Z 
Published: October 2019

Abstract

Background
In contrast to randomized clinical trials, observational studies provide the opportunity to evaluate routine practice in real-world patient populations.

Purpose
Using data from the RE-COVERY DVT/PE global observational study (enrollment January 2016 to May 2017), we have explored patient characteristics and anticoagulant treatment patterns in subgroups defined according to the type and location (proximal or distal lower limb) of acute venous thromboembolism (VTE).

Methods
Baseline patient characteristics, details of hospitalization and choice of anticoagulant therapy were tabulated descriptively for three groups of patients according to the type and location of their index VTE: pulmonary embolism (PE) (± any deep vein thrombosis; DVT); proximal (± distal) lower limb DVT, including the iliac vein; or distal lower limb DVT. Anticoagulant therapy at baseline and at hospital discharge or 14 days after diagnosis (whichever was later) was recorded.

Results
Of the 6122 eligible patients, 324 who had DVT at locations other than the lower limb and no PE were excluded from this analysis (as a key objective was to compare subgroups with DVT in the lower extremities according to whether the location was distal alone or involved the proximal segment). The remaining 5798 patients had either distal DVT (17.7%), proximal (± distal) DVT (40.0%) or PE (± any DVT) (42.3%) (Table). The likelihood of being diagnosed in an emergency department and of being hospitalized for VTE increased in line with the seriousness of the index event (distal DVT to PE). There were corresponding increases in age and the proportion of patients with comorbidities and/or medical history such as hypertension, diabetes mellitus or active cancer across these subgroups. At the time of hospital discharge or 14 days after diagnosis, whichever was later, non-vitamin K antagonist oral anticoagulants were the most commonly used anticoagulants (53% of patients in the PE group and 55–56% in the two DVT groups). The use of parenteral anticoagulant therapy alone appeared to be lower in the PE group than in the DVT groups, but the total use of parenteral therapy (alone or prior to oral anticoagulation) increased across groups from distal DVT (67%) to proximal DVT (74%) to PE (79%).

Conclusion
These data provide an insight into the potential differences in patient characteristics and treatment patterns among patients with PE, proximal/iliac lower limb DVT or distal lower limb DVT.

Acknowledgement/Funding
Funded by Boehringer Ingelheim
P3855Incidence, risk factors and impact of readmission for heart failure after successful transcatheter aortic valve replacement
Authors: Guedeney P , Huchet F , Manigold F , Rouanet S , Vicaut E , Balagny P , Leprince P , Lebreton G , Letocart V , Barthelemy O , Montalescot G , Guerin P , Collet J P 
Published: October 2019

Abstract

Background
Incidence and correlates of readmission for heart failure in all-comers, after successful transcatheter aortic valve replacement (TAVR) remain unclear.

Objective
We sought to evaluate the incidence, risk factors and clinical impact of readmission for HF after successful TAVR in an unselected patient population.

Methods
All patients who underwent successful TAVR in two high-volume French tertiary centers from February 2010 to December 2016 were prospectively included and followed-up for one year. Cox multivariate model was used to assess risk factors of readmission for heart failure, evaluated a time-updated covariate and mortality.

Results
A total of 1139 patients (mean age 82.4±7.7 years, 52.2% male) were included. Readmission for heart failure occurred in 99 (8.7%) patients. Risk factors of readmission for HF were chronic pulmonary disease (adjHR 1.8; 95% CI [1.2–2.8], p=0.008), chronic kidney disease (adjHR 1.7; 95% CI [1.1–2.6], p=0.01), diabetes mellitus (adjHR 1.7; 95% CI [1.1–2.5], p=0.01), prior atrial fibrillation (adjHR 1.6; 95% CI [1.1–2.4], p=0.02) and post-TAVR left ventricular ejection fraction (LVEF) ≤35% (adjHR 2.1 95% CI 1.2–3.7, p=0.009). Readmission for HF was strongly associated with mortality (Figure) along with increased STS score (adjHR 1.07 95% CI 1.03–1.12, p=0.002), prior atrial fibrillation (adjHR 2.13 95% CI 1.53–2.96, p<0.001) and shock during the index hospitalization (adjHR 2.68 95% CI 1.48–4.87, p=0.001).
Figure 1

Conclusion
Readmission for heart failure occurs in one out of ten patients after successful TAVR and is strong risk factor of mortality. Comorbidities and post-TAVR LVEF≤35% are the main correlates of readmission for heart failure.

Acknowledgement/Funding
ACTION study group
P3858High H2FPEF score is an independent predictor of adverse outcome in patients with severe aortic stenosis and preserved ejection fraction undergoing TAVR
Authors: Ludwig S , Voigtlaender L , Ruebsamen N , Kalbacher D , Koell B , Linder M , Waldschmidt L , Schirmer J , Seiffert M , Conradi L , Schaefer U , Reichenspurner H , Blankenberg S , Westermann D , Schofer N 
Published: October 2019

Abstract

Background
Recently, the H2FPEF score has been developed in an evidence-based approach relying on simple clinical and echocardiographic variables. It enables the identification of patients with high probability of prevalent heart failure with preserved ejection fraction (HFpEF) which is associated with a dismal prognosis. Left ventricular diastolic dysfunction, a key mechanism in HFpEF, is also a common finding in patients with severe aortic stenosis.

Objective
To assess the prognostic impact of the H2FPEF score in patients with preserved ejection fraction and severe aortic stenosis undergoing Transcatheter Aortic Valve Replacement (TAVR).

Methods
Among 1148 patients with preserved ejection fraction who received TAVR at our institution between 2013 and 2018, data for calculation of the H2FPEF score was available in 535 patients. Score variables include BMI >30 kg/m2, arterial hypertension, atrial fibrillation, pulmonary hypertension >35 mmHg, age >60 years, and elevated LV filling pressure. Patients were dichotomized according to “low” (1–5 points; n=377) and “high” H2FPEF scores (6–9; n=158). Kaplan-Meier survival curves and Cox regression analyses were used to assess the prognostic impact of H2FPEF scores. Median follow-up time was 0.3 years.

Results
TAVR patients presenting with high H2FPEF scores had higher prevalence of moderate to severe mitral regurgitation (19.4% vs. 33.6%, p<0.001) as well as tricuspid regurgitation (15.2% vs. 35.1%, p<0.001), and presented with lower stroke volume index (42.2 ml/m2 vs. 36.0 ml/m2, p<0.001) compared to those with low H2FPEF scores. All-cause mortality one year after TAVR was significantly higher in patients in the high H2FPEF score group (10.5% vs. 21.0%, p=0.0019, Figure 1). Multivariate analysis revealed a high H2FPEF score to be independently predictive for 1-year all-cause mortality (HR 2.66, 95% CI: 1.41–5.02, p=0.025). Among the single H2FPEF score variables, atrial fibrillation (HR 3.45, 95% CI: 1.86–6.40, p<0.001) and systolic pulmonary hypertension >55 mmHg (HR=2.68, 95% CI: 0.97–7.40, p=0.057) were strong independent predictors of adverse outcome.
Figure 1. All-cause mortality of patients undergoing TAVR after one year stratified by low (1–5 points) and high (6–9) H2FPEF score

Conclusion
An elevated H2FPEF score of >6 is independently predictive for mortality in patients with preserved ejection fraction undergoing TAVR for severe aortic stenosis. Our findings provide evidence that the H2FPEF score, which was meant for diagnostic use originally, is able to serve as a prognostic tool in patients with preserved ejection fraction undergoing TAVR, highlighting the adverse impact of diastolic dysfunction in patients with preserved ejection fraction and aortic stenosis.
P4154MicroRNA Signatures Predict Early Major Coronary Events in Middle Aged Men and Women
Authors: Gigante B , Papa L , Bye A , Kunderfranco P , Viviani C , De Faire U , Briguori C , Bottai M , Condorelli G 
Published: October 2019

Abstract

Background
The role of microRNA as biomarkers able to predict major coronary events (MACE) has not been fully elucidated, reproducibility being a critical issue.

Aim
To identify circulating microRNA signatures able to predict MACE.

Methods
We employed a PCR-based method to screen 754 microRNAs in a cohort of 60-year-olds (60YOs) from Stockholm, using a nested case-control design (100 cases vs 100 matched controls). The association of microRNAs and their interaction with the risk of MACE (myocardial infarction (MI), angina and sudden cardiac death) was estimated with random-effect logistic regression and expressed as OR with 95% CI. A bioinformatics approach identified microRNA clusters based on predicted targets. Main findings were tested in 58 MI and 60 age and sex matched referents from the the Nord-Trøndelag Health (HUNT) Study, a longitudinal population health study conducted in Norway.

Results
Fifty-five microRNAs were found to be associated with risk of MACE in the 60YO. MicroRNA-145-3p was associated with the largest estimated risk increase of MACE after adjustment for the common CV risk factors (OR: 2.18; 95% CI: 1.27–3.75). Interaction analysis revealed that increasing plasma levels of microRNA-320b modulated the association of 16 microRNAs with risk of MACE. As an example the estimated MACE risk associated with microRNA-145-3p was 1.47 (0.87–2.47) in the presence of low (<25th percentile) and 4.00 (1.79- 8.93) in the presence of high (>75th percentile) miRNA 320b expression levels. Sixteen microRNA pairs could be classified in 4 functional clusters with 492 predicted gene targets, mainly involved in the regulation of inflammation, thrombosis and lipid metabolism. Eight miRNAs interacting pairs belonging to cluster 2 and 4 showed a similar association trend with MI risk in the HUNT study.

Conclusions
We report the identification of microRNA signatures predicting risk of MACE in middle-aged Scandinavian men and women. These signatures could be a valuable tool to improve CV disease prediction in the aged.
P4166Efficacy and safety of novel biodegradable device for closure of atrial septal defect: from preclinical study to first-in-man experience
Authors: Li Y F , Xie Y M , Xie Z F , Wang S S , Li B N , Zhang Z W 
Published: October 2019

Abstract

Background
closure of atrial septal defect (ASD) has emerged as the treatment of choice for the majority of defect. The biodegradable ASD closure device is a novel, absorbable device made of poly-L_latic acid (PLLA). This study evaluates the feasibility, safety and effectiveness of PLLA biodegradable ASD closure device in a swine model and for the first time in human.

Objective
The study reports on the 24- and 36- month follow-up results of PLLA device implanted in a swine model and the first-in- man experience with 6-month follow-up.

Method
Preclinical study was done in a swine ASD model. In a clinical setting, 5 pediatric patients with a secundum ASD who a clinically left-to-right shunt were enrolled in our center. Percutaneous ASD closure procedure with PLLA device was performed with fluoroscopic and transcatheter echocardiography (TTE) guidance. Procedure results and clinical outcomes at 1 day, 30 days, 3 months and 6 months after closure procedure were analyzed.

Results
24- and 36-month follow-up results of preclinical study demonstrated that the PLLA device exhibited good endothelialization and degradability in a swine model. In clinical study, device implantation was successfully achieved in all of 5 patients (median age, 3.6 years; range, 3.1–6.5 years). The mean ASD size was (13.4±2.4)mm (range, 10–16mm). The mean pulmonary-to-systemic blood flow ratio (Qp:Qs) was (1.7±0.2):1 with a range of 1.5:1 to 2.0:1. The mean procedure time and the mean fluoroscopy time were (36.2±11.3) and (6.4±1.0)minutes, respectively. There was no evidence of short-term complications related to the device or the delivery system. No device dislodgement, significant aortic valve or mitral valve regurgitation, new onset cardiac arrhythmia, or other adverse events were reported.
Characteristics and procedure data of the 5 patients who underwent ASD closure procedure with PLLA device Patient No. Age Weight Gender Defect size Qp:Qs Mean Pulmonary Pressure Device size (mm) Sheath (Fr) Procedure time Fluoroscopy time Immediate residual shunt (years) (kg) (mm) (mmHg) (mm) (Fr) (min) (min) 1 4.9 23.5 Male 17 1.7:1 22 24 12 52 7.6 None 2 3.1 10.0 Male 14 2.0:1 19 20 12 26 5.4 None 3 6.5 21.0 Male 15 1.8:1 22 20 12 31 6.0 None 4 3.2 14.5 Female 12 1.5:1 13 18 10 44 7.3 None 5 3.6 12.5 Male 10 1.5:1 17 14 10 28 5.5 None

Conclusion
This study is the first to demonstrate the feasibility, safety and effectiveness of PLLA biodegradable device in human, with no evidence of short-term complications and a high rate of early shunt closure.

Acknowledgement/Funding
National Key R&D Program of China (Grant Number: 2016 YFC1100305)
P4346Religious education and midlife observance are associated with lower coronary heart disease (CHD) mortality 23 years later
Authors: Eilat-Adar S , Goldbourt U 
Published: October 2019

Abstract

Objective
To determine whether self-reported religiosity is associated with decreased coronary mortality risk in middle-aged men when rates are adjusted for known confounders.

Design
The Israeli Ischemic Heart Disease (IIHD) Project (n=10,232) was chosen by stratified sampling of civil servants and municipal male employees, men aged 40–65 in 1963. Subjects were seen upon enrollment (1963) and at two follow-up visits (1965 and 1968). Extent of religiosity according to belief and practice collected in 1965 on a scale from 1 to 5. Religiosity was defined as follow: (1) The most-strict observance of religious rules “Haredim”. (2) “Religious” (3) “Traditional” (4) “Secular” (5) The part of the latter who declared themselves to be “nonbelievers” were categorized as “agnostic”.

Main outcome measure
Coronary heart disease (CHD) death, determined from death certificates in 23 years of follow-up

Results
Among 9245 participants, 1098 died from CHD during 23 years follow up. Ever smoking, Body mass index (BMI) and socioeconomic status were significantly lower while age and diabetes were higher according to increasing religiosity. Religiosity was inversely related to CHD mortality. Demographic, anthropometric characteristics according to religion, and odds ratio (OR), 95% confidence interval (95% CI), for CHD mortality, (using agnostic as a reference group) are presented in table 1.
Characteristics according to religion Religiosity Haredim (n=2103) Religious (n=1528) Traditional (n=1782) Secular (n=2085) Agnostic (n=1747) P for trend Age years (SD) 50.2 (6.9) 48.8 (6.6) 48.4 (6.7) 48.8 (6.6) 45.9 (6.8) <0.001 Ever smoking% 58.7 67.6 70.7 71.9 72.6 0.001 Systolic blood pressure (mmHg) 136 (21) 135 (20) 135 (21) 134 (20) 135 (20) 0.115 Diabetes (%) 9.8 11.1 8.3 8.8 6.5 <0.001 Socioeconomic status 2.2 (1.3) 2.3 (1.1) 2.7 (1.1) 2.7 (1.2) 3.1 (1.4) <0.001 BMI kg/m2 (SD) 22.5 (3.6) 25.9 (3.5) 25.9 (3.2) 25.6 (3.2) 25.4 (2.9) 0.028 Cholesterol (mg%) 201 (38) 207 (41) 208 (39) 214 (40) 218 (40) 0.001 Number of death (% category) 187 (8.9) 161 (10.5) 185 (10.4) 228 (10.9) 225 (12.9) <0.001 OR (95% CI)* 0.67 (0.53–0.85) 0.85 (0.67–1.08) 0.84 (0.67–1.05) 0.87 (0.71–1.08) 1 *Adjusted for age, cigarette smoking, systolic blood pressure, diabetes, socioeconomic status, body mass index and cholesterol.

Conclusion
Religiosity was associated with lower CHD death in employed middle aged Israeli men followed up prospectively for 23 years.
P4347Automated echocardiographic quantification of left ventricular ejection fraction without volume measurements using a machine learning algorithm mimicking a human expert
Authors: Asch F M , Poilvert N , Abraham T , Jankowski M , Cleve J , Adams M , Romano N , Hong H , Mor-Avi V , Lang R M 
Published: October 2019

Abstract

Background
Echocardiographic quantification of left ventricular (LV) ejection fraction (EF) relies on either manual or automated identification of endocardial boundaries followed by standard calculation of model-based end-systolic and end-diastolic LV volumes. Recent developments in artificial intelligence resulted in computer algorithms that allow near automated detection of endocardial boundaries and measurement of LV volumes and function. However, boundary identification is still prone to errors limiting accuracy in certain patients. We hypothesized that a fully automated machine learning algorithm could be developed, which circumvents border detection and instead estimates the degree of ventricular contraction, similar to a human expert trained on tens of thousands of images.

Purpose
This study was designed to test the feasibility and accuracy of this approach.

Methods
Machine learning algorithm was developed and trained on a database of >50,000 echocardiographic studies, including multiple apical 2- and 4-chamber views, to automatically estimate LVEF (AutoEF, BayLabs). Testing was performed on an independent group of 99 unselected patients, whose automated EF values were compared to reference values obtained by averaging measurements by 3 experts using conventional volume-based technique. Inter-technique agreement was assessed using linear regression and Bland-Altman analysis of bias and limits of agreement (LOA). Consistency was assessed by mean absolute deviation (MAD) among automated estimates based on different combinations of apical views. Finally, sensitivity and specificity of detecting of EF≤35% was calculated. These metrics were compared side-by-side against the same reference standard to those obtained from conventional EF measurements by clinical readers.

Results
Automated estimation of LVEF was feasible in all 99 patients. AutoEF values showed high consistency (MAD=2.9%) and excellent agreement with the reference values: r=0.95, bias=1.0%, LOA=±11.8%, with sensitivity 0.90 and specificity 0.92 for detection of EF≤35%. This was similar to clinicians' measurements: r=0.94, bias=1.4%, LOA=±13.4%,sensitivity 0.93, specificity 0.87.

Conclusions
Machine learning algorithm for volume-independent LVEF estimation is highly feasible and similar in accuracy to conventional volume-based measurements, when compared to reference values provided by an expert panel.

Acknowledgement/Funding
Bay Labs, Inc.
P4371Right ventricular remodeling during the first weeks of life in healthy neonates
Authors: Sandoe A , Silesen A S , Raja A A , Pihl C , Vejlstrup N , Iversen K , Bundgaard H 
Published: October 2019

Abstract

Background
The right ventricle (RV) serves as the dominant ventricle in utero. The transition from fetal to post-natal circulation at birth involves marked structural and functional cardiac changes including a large increase in pulmonary blood flow and closure of fetal shunts. Little is known about how the transitional circulation influences RV structure and function in healthy neonates during the first weeks of life. The purpose of this study was to systematically assess RV remodeling in a large, unselected cohort of healthy neonates.

Methods
Transthoracic echocardiograms of unselected neonates <26 days old without any signs of structural cardiac abnormalities performed between April 1st, 2016 and August 12th, 2017, were consecutively included from the Copenhagen Baby Heart study until at least 90 neonates per day were included. Left parasternal long-axis RV anterior end-diastolic wall thickness and short-axis RV outflow tract end-diastolic diameter were measured offline by one sonographer according to recommendations by the American Society of Echocardiography. RV parameters were corrected for body surface area (BSA). Comparisons were made by T-tests and correlations were computed using univariate linear regression.

Results
A total of 3,412 echocardiograms were assessed, of which 414 were excluded due to age ≥26 days (n=159), presence of cardiac abnormality (n=179), or suboptimal parasternal views (n=76). Thus, a total of 2,998 (48% male) were included for analysis. Age, weight, and length at examination were (mean±SD) 11.1±7.5 days, 3.6±0.6 kg, and 52±2.6 cm, respectively. BSA-corrected mean (95% CI) end-diastolic outflow tract diameter and end-diastolic anterior wall thickness according to age are presented (Figure). There was a small age-related reduction in end-diastolic RV outflow tract diameter (r2=0.018, p<0.001), whereas the BSA-corrected end-diastolic anterior wall thickness decreased by 35% (from 14.2 to 9.2 mm/m2, p<0.001) from birth to day 25.
Figure 1. Mean (95% CI) BSA-corrected end-diastolic RV anterior wall thickness and end-diastolic RV outflow tract diameter. P-value for correlation.

Conclusion
RV remodeling during the first 25 days of life in unselected neonates included a small decrease in RV outflow tract diameter and a 35% decrease in anterior wall thickness.