bluuebunny/crossref_metadata_2025_split huggingface dataset:
P5615A randomised study comparing FFR-guided paclitaxel-coated balloon angioplasty vs. drug-eluting bioresorbable scaffolds with 9 months invasive follow-up
Authors: Otto S , Heitkamp K , Exner C , Stadler S , Franz M , Moebius-Winkler S , Schulze P C , Poerner T C 
Published: October 2019

Abstract

Background
Elimination of a permanent metallic stent from standard PCI techniques is desirable since mid- and longterm adverse reactions are attributed to an intracoronary foreign body.

Purpose
To investigate two “metal-free” PCI techniques using either drug-coated balloons (DCB) or bioresorbable scaffolds (BRS) in stable coronary artery disease regarding their safety and efficacy (NCT02607241) and clinical course.

Methods
59 patients (table 1) were prospectively randomized for elective PCI of de novo stenosis with either BRS implantation (N=28) or with DCB only angioplasty (N=31). The DCB only arm was treated by a previously implemented protocol including sequential balloon predilations and repetitive FFR (fractional flow reserve) measurements. Stenting was deferred if FFR was >0.80 and in the absence of flow-limiting dissections after final DCB dilatation. All BRS were post-dilated using a non-compliant balloon. All BVS were post-dilated (non-compliant balloon). Optical coherence tomography (OCT) was performed during index procedure and at 9-month f/u.

Results
Both groups were well balanced without significant differences in clinical characteristics (table 1). Procedural success was achieved in 89.3% in the BRS and 77.4% in the DCB group. Parameter of quantitative coronary angiography are shown in the table 2. The predefined primary end point (efficacy) net luminal gain was significantly larger in the DCB group (noninferiority t-Test, margin: 0.2mm, 80% power). Accordingly, the secondary endpoint late lumen loss indicated with −0.20±0.73 vessel enlargement at the stenotic site in the DCB group at 9-month f/u. Target lesion failure during 9-month f/u occurred much more in the BRS group (14.3% (N=4) vs. 3.2% (N=1), p=0.180) but did not reach significance in this small sample size. In detail, there were 2 scaffold thrombosis despite OCT-guided index procedure in the BRS group with subsequent myocardial infarction, and 2 restenosis in the BRS vs. 1 restenosis in the DCB group requiring repeat target lesion revascularization. Due to safety concerns of BRS and the worldwide recall of Absorb BRS the study was prematurely terminated.

Conclusion
Our data add evidence for FFR-guided “DCB only” PCI as an attractive, safe and feasible alternative by showing a favorable longterm course contrary to the late lumen loss of conventional coronary stents. The Absorb BRS is potentially harmful with a high percentage of target lesion failure including scaffold thrombosis despite OCT-guided implantation and should be avoided.
P5628Resolution of incomplete stent apposition in the early phase after stent implantation: serial optical coherence tomography analyses at 2-week and 4-month
Authors: Shimoda M , Ando H , Takashima H , Waseda K , Sakurai S , Suzuki A , Sawada H , Fujimoto M , Ohashi H , Amano T 
Published: October 2019

Abstract

Background
Previous optical coherence tomography (OCT) study demonstrated that the incomplete stent apposition (ISA) distance <355 μm immediately after an index procedure was the corresponding cut-off point for predicting the resolution of ISA at 8–12 months follow-up in the second-generation DES. However, the natural course of acute ISA in the earlier phase remains unknown. The aim of the present study is to evaluate the natural course of acute ISA in the early phase after second-generation everolimus-eluting stent (EES) using serial OCT analyses at 2-week and 4-month.

Methods
From the population of the ACS-OCT trial, we identified a total of 45 patients who successfully underwent serial OCT examinations at post-stenting, 2-week follow-up, and 4-month follow-up. The presence of ISA was assessed in the OCT images, and ISA distance was measured within the stented segment. The target site for OCT analysis was the cross-section at the proximal edge of implanted stent. Serial OCT images at post-stenting, 2-week follow-up and 4-month follow-up were reviewed side by side on the screen, and maximum ISA distance and cross-sectional ISA area were measured.

Results
Incomplete stent apposition was observed in all EES at post-stenting, and it was persistent in 37.8% at 2-week follow-up and 11.1% at 4-month follow-up. Maximum ISA distance was significantly decreased over time (post-stenting, 144±150mm; 2-week follow-up, 88±146mm; 4-month follow-up, 34±111mm). Receiver-operating curve analysis identified that the best cut-off value of OCT-estimated ISA distance at post-stenting for predicting persistent ISA at 2-week follow-up and 4-month follow-up was >140μm and >215μm, respectively.
ROC curve analysis

Conclusion
ISA distance at post-stenting is an useful predictor for the resolution of ISA in the early phase after EES implantation.
P5641Impact of lethal arrhythmias on medical castration in patients with prostate cancer
Authors: Hasegawa K , Miyazaki S , Kaseno K , Hisazaki K , Ito H , Uzui H , Tada H 
Published: October 2019

Abstract

Background
Prostate cancer is the most common non-cutaneous malignancy in men and has been steadily rising in an aging society. Medical castration had been widely applied as a treatment for prostate cancer. Sex steroid hormones regulate cardiac ion channels. However, the proarrhythmic properties of medical castration have not been reported.

Methods
This prospective observational study consisted of 149 patients (75±6 years) who underwent hormonal therapy using gonadotropin-releasing hormone with or without anti-androgen for prostate cancer. The changes of electrocardiogram (ECG) findings during the therapy and the associations of ECG findings with lethal arrhythmias were studied.

Results
QT (394±32 to 406±39 ms, p<0.001) and QTc intervals (416±27 to 439±31 ms, p<0.001) significantly prolonged during the therapy as compared to baseline. Heart rate significantly increased during the therapy as compared to baseline (68±11 to 71±14 / min, p=0.006). PQ interval and QRS duration were similar before and during the therapy. During the hormonal therapy, 2 patients (1.3%) presented with torsades de pointes and ventricular fibrillation. The first patient was 71 year-old and the second patient was 70 year-old. The period of the therapy was 6 and 45 months, respectively. Both patients had no structural heart disease. The magnitude of QTc interval change during the therapy as compared to baseline (Δ QTc interval) was significantly greater in patients with VF than those without (p<0.001), however the magnitude of Δ heart rate, Δ PQ interval, and Δ QRS duration were similar between the 2 groups.

Conclusions
Medical castration significantly prolonged QT/QTc interval and could be a trigger of lethal arrhythmias in patients with prostate cancer.
P5642A clinical risk score for estimating sudden cardiac death risk in the general population
Authors: Aro A , Holkeri A , Eranti A , Kerola T , Junttila M J , Rissanen H , Heliovaara M , Knekt P , Huikuri H V 
Published: October 2019

Abstract

Background
Sudden cardiac death (SCD) remains a major cause of premature mortality worldwide, so there has been an ongoing pursuit for tools for SCD risk stratification. Coronary artery disease is the major cause for SCD in adults, but the level of risk associated with multiple cardiovascular risk factors is not well established.

Purpose
To create a clinical risk score for estimating SCD risk in the general population.

Methods
Using data from a Finnish general population cohort of 7200 adults (mean age 51y, 46% male) with a mean follow-up of 24±11 years, we assessed the incremental SCD risk associated with the presence of several cardiovascular risk factors. SCD events were adjudicated based on death certificates according to the established criteria (autopsy was performed on 48% of SCD cases). Hazard ratios (HR) for SCD and all-cause mortality were calculated using the Cox proportional hazards model. Of the multiple parameters analysed, male sex, increasing age, diabetes, hypertension, smoking and previously diagnosed cardiac disease were independently associated with SCD in a multivariable model. Based on the magnitude of risk, a SCD risk score was created (2 points: age >70y; 1 point: male sex, age 60–70y, diabetes, hypertension, smoking, cardiac disease).

Results
75.2% of the study subjects had 0–2 risk points, 12.8% 3 risk points, and 12.0% >3 risk points. During the follow-up, 400 SCDs occurred. Increasing risk score was associated with a progressively greater risk for SCD (Figure). Compared with subjects without risk factors, those with a risk score of 3 had a HR of 21.2 (95% CI 12.7–35.4, p<0.001) and those with a risk score of >3 had a HR of 52.6 (95% CI 31.3–88.3, p<0.001) for SCD. Clinical risk score predicted significantly also all-cause mortality (HR 31.5 with risk score >3 [95% CI 27.6–35.9, p<0.001]).
Risk of SCD according to the risk score

Conclusions
Accumulation of multiple cardiovascular risk factors is associated with a markedly elevated risk for SCD in the general population. This highlights the need for SCD prevention efforts with lifestyle interventions and medical therapy in the high-risk subjects. Studies on focused SCD risk stratification may be warranted in the subjects at highest risk.
P5652Catheter ablation outcome and heart failure hospitalization in atrial fibrillation patients with preserved left ventricular ejection fraction: insights from the Kansai plus atrial fibrillation (KPAF)
Authors: Tanaka N , Inoue K , Kobori A , Kaitani K , Morimoto T , Morishima I , Yamaji H , Nakazawa Y , Kusano K , Tanaka K , Hirao Y , Iwakura K , Fujii K , Kimura T , Shizuta S 
Published: October 2019

Abstract

Background
Heart failure (HF) is the leading cause of death in patients with atrial fibrillation (AF), and AF is an independent prognostic factor in HF patients with preserved left ventricular ejection fraction (LVEF). Radiofrequency catheter ablation (RFCA) for AF is effective to maintain sinus rhythm.

Purpose
We sought to clarify incidence of HF hospitalization and whether AF ablation outcome influenced incidence of HF hospitalization after the procedures in patients with preserved LVEF.

Methods
We conducted a large-scale, prospective, multicenter, observational study. A total of 4522 consecutive patients with normal LVEF (>/- 50%) who underwent an initial RFCA for AF in 26 centers were enrolled (average age, 64±10 years; non-paroxysmal AF, 33.7%). The median follow-up duration was 2.9 years.

Results
The 3-year cumulative incidence of AF recurrence after a single procedure was 40.3%. Hospitalization for HF was observed in 60 patients (1.3%) and was significantly higher in patients with AF recurrence than those without it (2.63% vs 0.44%, log-rank p<0.001). After adjustment by age ≥65 years, estimated glomerular filtration rate ≤60ml/min, history of HF, and female, all of which were statistically associated with a risk of HF hospitalization, AF recurrence after the index RFCA was an independent predictor of HF hospitalization (hazard ratio; 4.75, 95% confidence interval; 2.59–9.42, p<0.001).

Conclusions
Recurrence after RFCA for AF was a significant risk of HF hospitalization among AF patients with preserved LVEF.

Acknowledgement/Funding
This study was supported by the Research Institute for Production Development in Kyoto, Japan.
P5654Brain natriuretic peptide and left atrial volume predict the reduced flow velocity of left atrial appendage during sinus rhythm in patients with atrial fibrillation
Authors: Fukuhara E , Mine T , Kishima H , Ashida K , Ishihara M 
Published: October 2019

Abstract

Background
It remains controversial whether or not to discontinue anticoagulation therapy after catheter ablation (CA) for atrial fibrillation (AF). The reduced flow velocity of the left atrial appendage (FV-LAA) during AF causes left atrial appendage thrombus and increases the risk of stroke. However, some AF patients show reduced FV-LAA even during sinus rhythm (SR).

Methods
398 patients who showed SR during transesophageal echocardiography (TEE) before CA for AF were studied (259 males, 68±10 years, 77 with non-paroxysmal AF). Clinical factors, transthoracic echocardiography and blood samples were obtained before TEE. Reduced FV-LAA was defined as <35 cm/sec of FV-LAA.

Results
Reduced FV-LAA was observed 70/398 patients (18%). Reduced FV-LAA was significantly associated with elevated brain natriuretic peptide (BNP) (p<0.0001), increased LA volume index (p<0.0001), reduced left ventricular ejection fraction (p=0.0017), high prevalence of non-paroxysmal AF (p=0.0048), prior history of heart failure (p=0.0172), and no administration of angiotensin converting enzyme inhibitor/angiotensin II receptor blocker (ACEI/ARB) (p=0.0403), while CHADS2 factors were not significantly associated.
On multivariate analysis, LA volume index (p<0.0001, OR 1.049 for each 1 increase in LA volume index, 95% CI 1.025–1.073) and no administration of ACEI/ARB (p=0.0015, OR 0.339 for administration, 95% CI 0.173–0.662) and BNP (p=0.0048, OR 1.035 for each 10 pg/ml increase in BNP, 95% CI 1.011–1.061) and were associated with reduced FV-LAA.
Rate of reduced flow velocity

Conclusion
The elevated BNP level and large LA volume index predict reduced FV-LAA during SR. AF patients with increased BNP and larger LA volume index might require long-term anticoagulation taking after CA procedure.
P5657Fibrosis detected by late-gadolinium enhancement cardiac MRI is associated with atrial fibrillation and poorer ablation outcome: A meta-analysis
Authors: Agbaedeng T A , Emami M , Munawar D A , Rattanakosit T , Khadim K I , Elliott A , Linz D , Mahajan R , Lau D H , Sanders P 
Published: October 2019

Abstract

Background
Fibrosis is a hallmark of atrial fibrillation (AF) substrate. Recent data suggests that fibrosis detected by late-gadolinium enhancement (LGE) cardiac MRI (CMR) can predict AF. However, this relationship is not well described.

Objective
To delineate the association of cardiac fibrosis detected by LGE CMR with AF prevalence, AF recurrence after catheter ablation.

Methods
PubMed, Embase, Web of Science and Ovid MEDLINE were searched through November 2018, using the keywords: LGE AND Fibrosis AND CMR AND AF. Inclusion criteria: 1. LGE CMR of left atrial (LA LGE), ventricular wall (LV LGE) or right ventricular wall (RV LGE); 2. Studies reporting AF or recurrent arrhythmia after ablation; 3. Patient ≥18 years; and 4. ≥50 participants. Included studies were pooled in a random effects meta-analysis and reported as: mean difference (MD); unadjusted risk ratios (RR); adjusted hazard ratios (HR); and 95% confidence intervals (95% CI).

Results
After exclusions, we identified 9 studies (2,307 patients [65.9% males, 34.1% females]) conducted between 2003 and 2015 for LGE and AF. Fibrosis was present in 666 (35.1%) and detected by LV LGE in 7 (78%) and RV LGE in 2 (22%). The presence of AF was higher in patients positive for ventricular LGE than those negative, trending towards significance (RR: 1.51, 95% CI: 0.94–2.45, p=0.09). Pooled LV fibrosis associated with AF progression (RR [NPAF vs. PAF]: 2.2, 95% CI: 1.22–3.94, p=0.009). We identified 8 studies (2,041 patients [65.8% males, 34.2% females]) conducted between 2006 and 2016 reporting LGE and AF recurrence after catheter ablation, with fibrosis detected in 644 (31.6%) by LA LGE in 8 (88.9%, biased towards one centre). After 17.8±14.2 follow-up years, atrial fibrosis was significantly greater in recurrent AF than controls (MD: 4.97%, 95% CI: 1.23–8.7, p<0.01), and predicted 16% increased risk of AF recurrence (RR: 1.16, 95% CI: 1.07–1.26, p<0.05).

Conclusion
Myocardial fibrosis detected by LGE associates with prevalence and progress of AF and is predictive of AF recurrence post ablation. This further supports the proarrhythmic role of fibrosis and selection of patients for ablation therapy based on LGE.
P5662Development of a prognostic model for prevalent atrial fibrillation using individual patient data: Results of CATCH ME
Authors: Chua W , Easter C L , Guasch E , Sitch A , Casadei B , Haase D , Hatem S , Kaab S , Mont L , Schotten U , Sinner M , Hemming K , Deeks J J , Kirchhof P , Fabritz L 
Published: October 2019

Abstract

Background/Introduction
Atrial fibrillation (AF) can be challenging to diagnose due to asymptomatic and paroxysmal presentation. Identifying prognostic factors of AF would elucidate potential mechanisms causing AF and refine screening for at risk patients.

Purpose
To identify the main predictors of AF and to develop a prognostic model for prevalent AF.

Methods
Data of 120 potential predictors were harmonised in individual patient data from 4 independent European studies. A three stage Delphi expert consensus process identified predictors based on clinical knowledge. The predictors were further reduced using statistical selection (backward elimination), and a logistic regression model was fitted. We calculated odds ratios (OR) for each of the selected predictors and evaluated model performance using the C-statistic.

Results
Overall, 2420 patients (mean [standard deviation] age = 62.7 [14.5] years, 35.6% female, 43.1% with AF) were included in the analysis. Thirty-one potential predictors identified from the Delphi process which had sufficient data across all datasets were modelled. Of these 14 were deemed prognostic in predicting AF (age, sex, BMI, height, hypertension, diabetes, history of coronary artery disease, left atrial volume, left ventricular end systolic diameter, abnormality on echo, tricuspid valve disease of at least moderate intensity, aldosterone-antagonists, beta-blockers and P2Y12 blockers; see Figure 1). There was a clear interaction between age and sex indicating that males are at higher risk than females early in life, while females are at increased risk of AF at older age (Figure 1). The risk prediction model combining these prognostic factors performed well (C-statistic 0.79; 95% CI 0.77–0.81).
Figure 1. (a) Forest plot; (b) Interaction

Conclusion(s)
Our preliminary analysis identified important prognostic factors and a complex relationship between age and sex, which predicts prevalent AF, highlighting the different potential causes of AF in different patients. There is a clear need to validate these factors in external datasets and for further investigation into the molecular mechanism underlying these factors.

Acknowledgement/Funding
European Commission H2020 framework
P5666Impact of metabolic syndrome on the incidence of atrial fibrillation; a nationwide longitudinal cohort study in South Korea
Authors: Kwon C H 
Published: October 2019

Abstract

Background/Introduction
There is a lack of studies for the association between the status of metabolic syndrome (MetS) and the risk of atrial fibrillation (AF)

Purpose
The present study aimed to evaluate the impact of MetS status for the incidence of AF in Korean population.

Methods
We used the data obtained from the Korean National Health Insurance Service from 2009 to 2016. This study enrolled a total of 7,830,602 men and women aged between 30 and 69 years without baseline AF who underwent national health examination between January 2009 and December 2009. They were evaluated to determine the risk of AF based on the status of MetS until December 2016. Based on the criteria of the National Cholesterol Education Program Adult Treatment Panel III, the status of MetS was defined into three groups according to number of MetS components: the normal (0), Pre-MetS (1–2), and MetS (3–5).

Results
During follow-up, 20,708 subjects (0.26%) were diagnosed with AF. After multivariable adjustment, the risk of AF was significantly higher according to the status of MetS (hazard ratios [HR] 1.391, 95% confidence interval [CI] 1.322–1.464 in Pre-MetS and HR 1.722, 95% CI 1.621–1.829 in MetS). Among the components of MetS, central obesity (HR 1.316, P<0.001), elevated blood pressure (HR 1.451, P<0.001), and elevated fasting glucose (HR 1.163, P<0.001) were associated with an increased risk of AF.

Conclusion
MetS and pre-MetS are significantly associated with an increased risk of AF in Korean adults. Of the components of MetS, central obesity, elevated blood pressure, and elevated fasting glucose are potent risk factors for the risk of AF in this population.
P5672Diagnostic accuracy and clinical utility of point-of-care ultrasound among syncope patients in the emergency department
Authors: Pivetta E , Moretto F , Bianchi G , Masellis S , Bovaro F , Manasievska M , Maule M M , Lupia E 
Published: October 2019

Abstract

Background/Introduction
Syncope is still a challenge for risk stratification in the Emergency Department (ED), and the indication to discharge is not well established for all patients.

Purpose
To evaluate diagnostic accuracy and clinical utility of integration of clinical assessment and point-of-care ultrasound (POCUS) in evaluating non high-risk syncopes in the ED.

Methods
This observational prospective cohort study enrolled patients between February 2016 and January 2019.
All adult patients presenting in the ED for a non-high risk syncope were eligible (defined according to the 2015 ESC consensus on management of syncope in the ED). Subject for whom event etiology was identified right after the clinical assessment (i.e. history, physical exam, and EKG) or showing a clinical high risk for short term serious outcomes or refuse to participate in the study were excluded.
After the initial clinical assessment, the physician responsible for patient care was asked to categorize the syncope as low or neither high nor low risk. Immediately after, the same physician performed POCUS, and a new risk assessment, based on the results of both clinical and sonographic findings, was recorded. Thirty days after the ED evaluation, all participants were telephonically followed up by the investigators in order to assess the risk of short-term outcomes as defined in the San Francisco Syncope Rule cohorts. Both diagnostic accuracy, defined as sensitivity (SE) and specificity (SPE), and clinical utility, evaluated as net reclassification index (NRI) and net benefit were evaluated for clinical and POCUS-integrated assessment.

Results
A total of 415 patients with a syncope were eligible. Of these, 194 were enrolled (107 women - 55.2%). Median age was 63 years (interquartile range, IQR, 30 years). During the follow up, 21 patients experienced 28 events.
SE and SPE of the clinical evaluation were 33.3% (95% confidence interval, CI, 14.6–57%) and 79.5% (95% CI 72.7–85.3%), and they were 42.9% (95% CI 21.8–66%), and 92.4% (95% CI 87.4–95.9) for the POCUS-integrated evaluation (p<0.01 for SE and 0.05 for SPE).
NRI for events and non-events during follow up was 9.5% and 12.7%, respectively.
Using the prevalence of events in our cohort (10.8%) as the threshold probability, the use of the POCUS-integrated approach would reduce the diagnostic error of the clinical evaluation by 4.6 cases/100 patients.
The median time between clinical and POCUS-integrated evaluation was 15 minutes (iqr 20 minutes).

Conclusion
The results of our study suggest that the integration of the clinical evaluation with POCUS for patients presenting to the ED for non high-risk syncope might be able to increase the diagnostic accuracy and the utility of the clinical assessment alone.