bluuebunny/crossref_metadata_2025_split huggingface dataset:
P6536Implementation of a mass atrial fibrillation screening program in Canadian community practice
Authors: Godin R , Nault I , Andrade J 
Published: October 2019

Abstract

Background
Atrial fibrillation is the most common arrhythmia seen in clinical practice, and is an important cause of stroke. In up to 10% of patients, stroke is the first clinical manifestation of undiagnosed atrial fibrillation (AF). Early detection of AF is therefore desirable, as it would provide an opportunity to initiate appropriate stroke prevention with anticoagulation. While European guidelines recommend screening for AF as part of routine care in patients with risk factors, the optimal modality has not yet been determined. Smartphone enabled single lead ECG devices have been shown to be highly accurate and could prove to be an effective point of care tool for uncovering AF in the community and may facilitate implementation of screening recommendations.

Purpose
We sought to describe the integration of a smartphone enabled single lead ECG device into the practice of selected Canadian community-based physicians and its impact on patient care.

Methods
Canadian community-based physicians were provided with a smartphone enabled single lead ECG device for a period of six months. Physicians were instructed to perform a single 30 second ECG recording in patients over the age of 65 who present for a regular follow-up visit. Patients with previous AF diagnosis were excluded. Outcomes related to screening, and stroke prevention-treatment initiation were prospectively ascertained and documented using a patient flow tracker.

Results
Among 612 physicians who were invited to participate in the program, 315 (51%) agreed to track and report the use of the device that was provided to them. During this program, 315 physicians screened a total of 15,538 patients. AF was detected 1103 patients (7.1%). The majority of patients with a positive screen underwent a subsequent 12-lead ECG confirmatory exam (79%). AF could not be confirmed in 277 patients (31.7% of patients undergoing 12-lead ECG). A total of 677 patients were initiated on oral anticoagulation (OAC), with 262 patients (24%) being initiated on OAC prior to ECG confirmation.

Conclusion
Undiagnosed AF is common in patients >65 years of age in community practice. The results of this program indicate that single lead mobile ECG devices can be integrated into routine point of care use for Canadian physicians and, can be a valuable tool to detect previously undiagnosed AF. While this approach identified a large number of undiagnosed AF patients eligible for OAC therapy, undertreatment with OAC remains a concern.

Acknowledgement/Funding
Bristol-Myers Squibb/Pfizer Alliance
P6538Validity of two weeks daily self pulse-palpation for opportunistic screening for atrial fibrillation among patients 65 years and older
Authors: Ghazal F , Al-Khalili F , Rosenqvist M 
Published: October 2019

Abstract

Background
Pulse-palpation is recommended (ESC IA) for single time-point screening for atrial fibrillation (AF). AF may, however, be paroxysmal which can make AF detection difficult to detect on single time-point measurement. Intermittent ECG recording is a sensitive method to detect AF. However, the role of pulse-palpation for AF detection has not been validated against simultaneous ECG recordings.

Purpose
To study the validity of AF detection using self pulse-palpation simultaneously with hand-hold ECG recording 3 times daily for two weeks for AF.

Method
Patients 65 years and older visiting four primary health care centers, four any reason, were invited to AF screening from July 2017 to December 2018. Hand-held intermittent ECG recordings, 30 seconds three times a day, was offered to participants without AF for a period of 2 weeks. Patients were instructed how to take their own pulse, simultaneously with intermittent ECG measurement and in written to note whether it was irregular or not.

Results
A total of 1010 patients (mean age 73 years, 61% women) participated in the study, 27 new cases of AF (mostly paroxysmal) were detected. Totally 53 782 simultaneous ECG-recordings and pulse-measurements were registered. AF was verified in 311 ECG-recordings but the pulse was palpated as irregular only in 77 of these recordings (25% sensitivity per measurement-occasion). Of those 27 detected AF cases, 15 cases felt their pulse as irregular at least at once occasion (56% sensitivity per individuals). 187 individuals without AF felt their pulse as irregular in at least one occasion. The specificity per measurement-occasion and per individuals were 98% and 81% respectively. Diagnostic odds ratio was 5.3.
AF 27 patients No AF 983 patients Irregular pulse 202 individuals 15 187 Regular pulse 808 individuals 12 796 Sensitivity 56% Specificity 81% Positive Predictive Value 7% Negative Predictive Value 99% AF 311 measurements No AF 53471 measurements Irregular pulse 1046 measurements 77 969 Regular pulse 52,736 measurements 234 52,502 Sensitivity 25% Specificity 98% Positive Predictive Value 7% Negative Predictive Value 99%

Conclusion
AF screening using own pulse-palpation 3 times daily for two weeks is feasible but has a low sensitivity for AF detection.

Acknowledgement/Funding
This study was supported by the Swedish Heart and Lung Foundation, Pfizer, Boehringer-Ingelheim and Bayer
P6562The relationship between serum potassium concentrations and electrocardiographic characteristics in 163,547 individuals from primary care
Authors: Krogager M L , Kragholm K , Skals R K , Mortensen R N , Polcwiartek C , Graff C , Nielsen J B , Kanters J K , Holst A G , Soegaard P , Pietersen A H , Torp-Pedersen C , Hansen S M 
Published: October 2019

Abstract

Aims
Potassium disturbances are common and associated with increased morbidity and mortality, even in patients without prior cardiovascular disease. We examined six electrocardiographic (ECG) measures and their association to serum potassium levels.

Methods and results
From the Copenhagen General Practitioners' Laboratory, we identified 163,547 individuals aged ≥16 years with a first available ECG and a concomitant serum potassium measurement during 2001–2011. Restricted cubic splines curves showed a non-linear relationship between potassium and the Fridericia corrected QT (QTcF) interval, T-wave amplitude, morphology combination score (MCS), PR interval, P-wave amplitude and duration. Therefore, potassium was stratified in two intervals K: 2.0–4.1 mmol/L and 4.2–6.0 mmol/L for further analyses. Within the low potassium range, we observed: QTcF was 12.5 ms longer for each mmol/L decrease in potassium (p<0.0001); T-wave amplitude was 55.1 μV lower for each mmol/L decrease in potassium (p<0.0001); and MCS was 0.09 higher per mmol/L decrease in potassium (p<0.001). Moreover, P-wave duration and PR interval were prolonged by 3.1 and 3.3 ms for each mmol/L decrease in potassium (p<0.0001), respectively. Within the lowest potassium range (2.0–4.1 mmol/L) P-wave amplitude was 10.7 μV higher for each mmol/L decrease in potassium (p<0.0001). Within the high potassium range associations with the above-mentioned ECG parameters were much weaker.
Restricted cubic splines on adjusted lin

Conclusion
The association of potassium with six commonly measured ECG parameters was non-linear. Strong associations between ECG abnormalities and potassium were seen among individuals with lower potassium levels (≤4.1 mmol/L).

Acknowledgement/Funding
None
P6570Performance of the early clinical judgement for the diagnosis of syncope on the emergency department
Authors: Du Fay De Lavallaz J , Badertscher P B , Zimmermann T Z , Nestelberger T N , Walter J W , Strebel I S , Lohrmann J S , Boeddinghaus J B , Miro O M , Than M T , Martin-Sanchez J M S , Cullen L C , Kuehne M K , Reichlin T , Mueller C M 
Published: October 2019

Abstract

Background
Clinical judgement of the emergency department (ED) physician at time of discharge outperforms prognostic risk scores but the early clinical judgment (ECJ) regarding diagnosis has never been assessed.

Methods
We evaluated the diagnostic accuracy of the ED physicians' ECJ 90 minutes after admission of patients >40 years presenting with syncope to the ED in a prospective diagnostic multicenter study. Cardiac syncope, as adjudicated by two physicians based on information available including 1-year follow-up, was the diagnostic endpoint. Death and MACE were the prognostic endpoints. Lasso-regression was used to identify variables contributing most to the ECJ or to the diagnosis of cardiac syncope. Syncope-specific diagnostic and prognostic scores, high-sensitivity cardiac troponin I (hs-cTnI) and B-type natriuretic peptide (BNP) were used for comparison.

Results
Cardiac syncope was adjudicated in 252/1494 patients (15.2%). The diagnostic accuracy of the ECJ for cardiac syncope, as quantified by the Area Under the Curve (AUC), was 0.87 (95% CI 0.84–0.89) and was superior to the one of biomarkers and diagnostic score, constant between all centers, but poorly calibrated. 16 variables available very-early on the ED achieved a comparable performance (AUC 0.84 (95% CI 0.82–0.87), p=0.136).
The extrapolated prognostic accuracy of the ECJ was moderate for MACE (AUC 0.73–0.8) but poor for death (0.58–0.63) over two years follow-up.
Figure 1

Conclusion
The ECJ performs well for the diagnosis of cardiac syncope but a similar accuracy can be obtained using structured variables obtained very-early in the diagnostic process.

Acknowledgement/Funding
Swiss National Science Foundation, Swiss Heart Foundation, Cardiovascular Research Foundation, Basel (Switzerland), University Basel (Switzerland)
P6601Low miR-19b-1-5p expression in ACS patients is related to aspirin resistance and major adverse cardio-cerebrovascular event (MACCE)
Authors: Singh S , Ronde M W J , Creemers E E , Chan M Y , Hwee T S , Chin C T , Richards A M , Troughton R W , Fong A Y , Yan B P , Pinto S J 
Published: October 2019

Abstract

Aim
Despite aspirin therapy, acute coronary syndrome (ACS) patients are at risk of developing re-events owing to the aspirin resistance. This study sought to explore the possibility of utilizing miR-19b-1-5p as a suitable biomarker for aspirin resistance and future major adverse cardio-cerebrovascular (MACCE) events in the ACS patients.

Methods
Buffy coat from ACS (n=945) patients was used to measure the miR-19b-1-5p expression by RT-qPCR and Platelets function was determined by Multiplate® aggregometry testing. Furthermore, MACCE was collected over a mean follow-up time of 1.01±0.43 years. Linear regression concerning the relationship between miR-19b-1-5p expression and Multiplate® data and cox regression concerning MACCE were used for the analysis, to be able to adjust for confounding.

Results
Low miR-19b-1-5p expression was found to be related to aspirin resistance as could be observed from sustained platelet aggregation in the presence of aspirin (-Log-miR-19b-1-5p, (B (95% CI); 41.51 (5.09–77.93); p<0.05), even after adjusting for several confounders. The Cox regression analysis, showed that with lower miR-19b-1-5p expression, was independently associated to a higher risk of MACCE (-Log-miR-19b-1-5p, (HR (95% CI); 2.41 (1.51–3.84); p<0.05). Furthermore, both a sustained platelet aggregation on aspirin and lower miR-19b-1-5p expression, were related to an increased leukocyte count (B (95% CI); 3.85 (0.95–6.75) for platelet aggregation and 1.44 (0.41–2.46), for -Log-miR-19b-1-5p; p<0.05).

Conclusions
Lower miR-19b-1-5p expression was found to be associated with sustained platelet aggregation on aspirin, an increased leucocyte count and the risk of MACCE in ACS patients. Therefore, miR-19b-1-5p could be a suitable marker for aspirin resistance and might predict future MACCE in ACS patients.
86Coronary CT angiography as the first-line diagnostic strategy in patients with non-ST-segment Elevation Acute Coronary Syndrome - The VERDICT trial
Authors: Kofoed K F , Kelbaek H , Sigvardsen P , Torp-Pedersen C , Riis-Hansen P , Holmvang L , Elming H , Hofsten D , Engstroem T , Gislason G , Kober L , Linde J 
Published: October 2019

Abstract

Background
In patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) coronary pathology may range from structurally normal vessels to severe coronary artery disease. Current guidelines recommend early invasive coronary angiography (ICA) to guide management strategy.

Purpose
We tested the hypothesis that a strategy of first-line coronary computed tomography angiography (CCTA) may be used to differentiate between significant and nonsignificant coronary artery stenosis in patients with NSTE-ACS.

Methods
We included patients with NSTE-ACS confirmed by ischaemic ECG changes and/or elevated biomarkers of myocardial ischaemia, in whom ICA was feasible within 12 hours. Patients were randomised 1:1 to ICA within 12 hours (Very Early) or 48–72 hours (Standard) and CCTA was conducted prior to ICA. The primary endpoint was the ability of CCTA to rule out significant coronary artery stenosis (≥50% stenosis) expressed as the negative predictive value (NPV) using ICA as the reference standard. The VERDICT trial is registered with ClinicalTrials.gov number NCT02061891.

Results
CCTA was conducted in 1023 patients – Very Early, 2.5 (IQR 1.8, 4.2) hours, N=583 and Standard, 59.9 (IQR 38.9, 86.7) hours, N=440 after establishment of the diagnosis. Significant coronary stenosis was found by ICA in 67.4% of the patients. NPV of CCTA (95% CI) was 90.9% (86.8%-94.1%) and the positive predictive value, sensitivity and specificity were 87.9% (85.3–90.1%), 96.5 (94.9–97.8%) and 72.4 (67.2–77.1%), respectively. False negative patients (24/1023, 2.3%) mostly had lesions in coronary segments with a luminal diameter ≤2.5 mm. NPV was not influenced by patient characteristics or clinical risk profile, including abnormal cardiac troponin, ischaemic ECG changes, or a GRACE risk score>140. CCTA accuracy parameters were similar in Very Early and the Standard strategy group.

Conclusions
First-line CCTA may be used to rule out clinically significant coronary artery disease in patients with NSTE-ACS and thus potentially guide patient management.

Acknowledgement/Funding
This study was funded by the Danish Agency for Science, Technology, and Innovation and the Danish Council for Strategic Research (grant no. 09–066994)
87Effects of the chymase inhibitor fulacimstat on adverse cardiac remodelling after acute myocardial infarction - Results of the CHIARA MIA 2 trial
Authors: Duengen H D , Kim R J , Zahger D , Orvin K , Admon D , Kettner J , Shimony A , Otto C , Becka M , Kanefendt F , Iniguez Romo A , Hasin T , Ostadal P , Calvo Rojas G , Senni M 
Published: October 2019

Abstract

Introduction
Adverse cardiac remodelling represents the most important risk factor for the development of heart failure (HF) after myocardial infarction (MI). Chymase is a protease that generates locally pro-fibrotic factors such as angiotensin II, TGFβ, and matrixmetallproteases that contribute to tissue remodelling.

Purpose
This phase IIa study examined the effects of the chymase inhibitor fulacimstat on functional parameters of adverse cardiac remodelling after acute MI.

Methods
A double-blind, multinational, randomized, placebo-controlled study was performed in patients after first STEMI who were treated with primary percutaneous coronary intervention within 24h of symptom onset. To enrich for patients at risk of adverse remodelling, main inclusion criteria were a left-ventricular ejection fraction (LVEF)≤45% and an infarct size>10% on day 5 to 9 post MI as measured by cardiac MRI. On day 6 to 12 post MI, patients were randomized to treatment with either 25 mg fulacimstat (n=54) or placebo (n=53) twice daily on top of standard of care. The changes in LVEF, LVEDVI, and LVESVI from baseline to 6 months of treatment were analyzed by a central blinded cardiac MRI core laboratory.

Results
Fulacimstat was safe and well tolerated, 64.8% of patients treated with fulacimstat and 75.5% of patients treated with placebo reported treatment emergent adverse events. Fulacimstat achieved exposures that were approximately 10-fold higher than those predicted to be required for minimal therapeutic activity. After six months of treatment, there were no effects of fulacimstat compared to placebo on the changes in LVEF, LVEDVI, and LVESVI (see Table).
Analysis of primary efficacy parameters Parameter Placebo Fulacimstat p-value LVEF (%) baseline 37.2±6.1 39.1±5.5 0.15 6 months 41.2±8.4 42.6±8.4 0.45 delta 4.0±5.0 3.5±5.4 0.69 LVEDVI (mL/m2) baseline 80.0±17.1 77.4±18.2 0.51 6 months 85.1±19.1 84.7±23.4 0.94 delta 5.1±18.9 7.3±13.3 0.54 LVESVI (mL/m2) baseline 50.5±13.0 47.3±12.3 0.26 6 months 51.1±16.9 49.6±18.1 0.71 delta 0.6±14.8 2.3±11.2 0.56 Data are given as mean ± standard deviation.

Conclusion
Fulacimstat was safe and well tolerated in patients with left-ventricular dysfunction (LVD) after first STEMI but had no effect on adverse cardiac remodelling in the experimental setting of this study.

Acknowledgement/Funding
The study was funded by its sponsor BAYER AG
107Diagnostic accuracy of optical coherence tomography for the identification of in-stent fibroatheroma following stent implantation: an ex-vivo histological validation study
Authors: Shibutani H , Fujii K , Kawakami R , Imanaka T , Kawai K , Hirota S , Shiojima I 
Published: October 2019

Abstract

Background
Previous histopathological studies have demonstrated that new atherosclerotic formation within the neointima, called neoatherosclerosis, is one of the most important mechanisms leading to both very late in-stent restenosis and stent thrombosis after stent implantation. Therefore, to distinguish lipid-containing atherosclerotic neointima from other tissues using intracoronary imaging modalities is clinically important to prevent late stent failures.

Purpose
This study evaluated the diagnostic performance of optical coherence tomography (OCT) for the detection of “in-stent fibroatheroma” following stent implantation by comparing cross-sections of the model with the corresponding histological images.

Methods
Fifty stented coronary arteries from the 31 autopsy hearts were imaged by OCT. Coronary arterial histopathological specimens, all of which included more than 30% of %neointimal hyperplasia, were compared with the corresponding OCT cross-sections. Histological in-stent fibroatheroma was defined as neointima containing large necrotic core and inflammatory cells. OCT-derived in-stent fibroatheroma comprised a low-intensity tissue containing a poorly delineated region with invisible stent strut behind low signal intensity.

Results
A total of 122 OCT cross-sections were compared with histological images. OCT examination revealed that 24 images (20%) contained low-intensity tissue inside the neointima. Of those, 5 images, in which stent strut behind low signal intensity was invisible, were diagnosed as OCT-derived in-stent fibroatheroma (4%) (Figure A). By histological analysis, only 4 images were classified as in-stent fibroatheroma (3%) (Figure B). With histology as the gold standard, the sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy for OCT-derived in-stent fibroatheroma were 100%, 99%, 80%, 100%, and 99%, respectively. The only histological finding underlying the false-positive-diagnosis of OCT-derived in-stent fibroatheroma was foam cells accumulation without necrotic core on the neointimal surface (Figure C and D). Most tissue that showed low-intensity tissue with visible stent strut by OCT contained proteoglycan matrix and organized thrombus in the absence of an underlying necrotic core.
Coregistration of OCT with histology

Conclusion
This study showed the potential capability of OCT based on the visualization of stent struts behind low-intensity regions for discriminating in-stent fibroatheroma from other neointimal tissues following stent implantation.
192Effect of dapagliflozin on cardiovascular outcomes in patients with type 2 diabetes according to baseline renal function and albuminuria status: Insights from DECLARE-TIMI 58
Authors: Zelniker T A , Raz I , Mosenzon O , Dwyer J P , Heerspink H J L , Cahn A , Im K , Bhatt D L , Leiter L A , McGuire D K , Wilding J P H , Gause-Nilsson I A M , Langkilde A M , Sabatine M S , Wiviott S D 
Published: October 2019

Abstract

Background
Renal dysfunction including both reduced estimated glomerular filtration rate (eGFR) and the presence of albuminuria have each been shown to predict cardiovascular (CV) outcomes. Sodium glucose co-transporter 2 inhibitors (SGLT2i), which promote glucose excretion in the kidneys, reduce CV events and hospitalizations for heart failure (HHF) in patients with type 2 diabetes mellitus (T2DM).

Purpose
To analyze the CV efficacy of dapagliflozin according to baseline renal function and albuminuria status in DECLARE-TIMI 58.

Methods
The DECLARE-TIMI 58 trial compared dapagliflozin vs. placebo in 17,160 patients with T2DM and a creatinine clearance >60 ml/min/1.73m2 at enrollment. The dual primary endpoints were CV death/HHF and MACE (MI, stroke, CV death). We categorized patients according baseline eGFR [<60 vs. ≥60 ml/min/1.73m2 according to the CKD-EPI formula] and urinary albumin:creatinine ratio (UACR) [<30 vs. ≥30 mg/g]. Cox regression models with interaction testing were applied. The Gail-Simon test was used to test for interaction of the absolute risk differences.

Results
In total, 5198 (30.3%) patients had albuminuria (UACR 30–300: n=4029; UACR >300: n=1169) and 1265 (7.4%) had an eGFR <60 ml/min/1.73m2. Accordingly, 10958 (63.9%) patients had no manifestation of CKD, 5367 (31.3%) had either an eGFR <60 ml/min/1.73m2 or albuminuria, and 548 (3.2%) patients had both manifestations. Patients with more abnormal markers had higher event rates for CV death/HHF (KM event rates at 4 years of 3.9%, 8.3%, 17.4%) and MACE (7.5%, 11.7%, and 18.9%) for no, 1, or 2 markers of CKD, respectively. The relative risk reductions for CV death/HHF and MACE were generally consistent across the subgroups (both P-interaction >0.29), though numerically greatest (42%) in patients with reduced eGFR and albuminuria. However, the absolute risk difference increased substantially in patients with greater kidney damage (absolute risk difference of CV death/HHF: −0.5%, −1.0%, and −8.3%, respectively; P-INT for ARD 0.002; Figure). See figure for MACE and component outcomes.

Conclusions
Patients with baseline renal disease had higher rates of adverse CV outcomes. Dapagliflozin reduced events with generally consistent relative risk, but reduced the absolute risk of CVD/HHF by the greatest amount in patients with kidney disease evidenced by both reduced eGFR and albuminuria.

Acknowledgement/Funding
AstraZeneca, Deutsche Forschungsgemeinschaft (ZE 1109/1-1)