bluuebunny/crossref_metadata_2025_split huggingface dataset:
Conflicts of interest among authors of the ESC guidelines for the management of atrial fibrillation
Authors: Schneider B , Stoellberger C 
Published: November 2020

Abstract

Background
In 2011, the Institute of Medicine (IOM) published standards for developing trustworthy clinical practice guidelines. It is recommended that “Whenever possible guideline development group members should not have conflicts of interest (COIs). In some circumstances, a guideline development group may not be able to perform its work without members who have COIs, such as relevant clinical specialists. Members with COIs should represent not more than a minority of the guideline development group members. The chair or cochairs should not be a person with COIs.”

Aim
Aim of the present study was to assess if the ESC guidelines for the management of atrial fibrillation are in accordance with the standards proposed by the IOM.

Methods
The declaration of COIs from task force members (TFM) and reviewers of the 2010 and 2016 ESC atrial fibrillation guidelines were retrieved from the ESC homepage. The number and the type of COIs were assessed for each guideline and compared.

Results
Regarding the 2010 guidelines, 8 of the 25 TFM (32%) reported no COI. In the remaining 17 TFM, 148 COIs were reported (8.7±10.2 per member, range 1–44). The chairperson declared 11 COIs. Consulting and advising was reported by 15 and research contacts by 13 TFM. Among the guideline reviewers, 12/26 (46%) reported no COI, and 14 reviewers declared 72 COIs (5.1±3.3 per reviewer, range 2–14).
Regarding the 2016 guidelines, 3 of the 17 TFM (18%) reported no COI. The remaining 14 TFM declared 182 COIs (13.0±10.4 per member, range 1–32). The chairperson of the task force had the second most COIs (n=30). Direct personal payment was reported by 14 and research funding of the department by 10 TFM. Among the guideline reviewers, 16/79 (20%) reported no COI, and 63 reviewers declared 473 COIs (7.5±6.8 per reviewer, range 1–34).
Comparing the 2010 and the 2016 guidelines, there was an increase of TFM with COIs (from 68% to 82%), of the number of COIs per TFM (from 8.7±10.2 to 13.0±10.4) and the COIs of the chairperson (from 11 to 30). Moreover, the proportion of TFM receiving personal payment (60% vs 82%) and the number of COIs due to personal payment (5.9±7.3 vs 7.7±7.4) were higher in the 2016 guidelines. In addition, more guideline reviewers had COIs in 2016 (54% vs 80%).

Conclusion
The high and increasing rate of TFM and reviewers with COIs is not in accordance with the recommendations of the IOM. Since COIs can influence healthcare decision makers and may consciously or unconsciously influence choices made throughout the guideline development process, the ESC should follow the standards of the IOM.

Funding Acknowledgement
Type of funding source: None
Cardio-vascular risk factors according to different profiles of night work and shift work
Authors: Esquirol Y , Bourgkard E , Dziurlac M , Ferrieres J , Ribet C , Boini S 
Published: November 2020

Abstract

Background
The shift-night work concerns around 17% workers in our modern society with evident need of this type of organisation for productivity and economic reasons for the companies. if the impact of this global organisation pattern on cardiovascular disease or risk factors is more and more documented, it remains unclear which types of rotating or night work are really involved and which are the impact on cardiovascular risk of being exposed currently or in the past to these different types of shift-night work.

Purpose
To study possible relationships between arterial blood pressure, anthropometric markers, fasting biomarkers, and sleep disturbances, and different exposure profiles of night work and/or shift work.

Methods
A cross-sectional study was conducted among 65.126 workers aged 18–70 at baseline in the French random population-based Constances cohort. Four exposure groups were defined: (1) workers with current permanent night work, (2) current night shift workers 3x8, (3) day workers with past night and/or shift work, (4) day workers without night and/or shift work during their work history (reference group). Logistic regression models adjusted for age, sex, socio-economic position, and personal history of ischemic cardiovascular disease (CVD) were performed to assess associations between clinical risk markers for CVD at baseline and these exposure groups.

Results
Compared with the reference group, current and past night workers had a significant higher risk of obesity (Body Mass Index≥30). Permanent night workers had a significant higher risk of metabolic syndrome, mostly due to abdominal obesity, hypertriglyceridemia (&gt;1.7 mmol/l) and low level of high density lipoprotein. Even if day workers with past night/shift work had no statistically significant over-risk of metabolic syndrome, they presented significantly higher risks for the same three criteria as observed for the permanent night workers. However, only hypertriglyceridemia was significantly more frequent among 3x8 workers. Among current night workers, 3x8 had a higher risk of sleep disturbances while permanent had not. Sleep disturbances over-risk was also observed among day workers with past night/shift work. No over-risk of hypertension, hypercholesterolemia, hyperglycemia, and elevated levels of gamma-glutamyl-transferase was observed among the three groups.

Conclusion
The results support the need for enhanced cardiovascular follow-up of workers exposed to night and/or shift work. However, it is also necessary to follow regularly and specifically current day workers with a past night and/or shift work history.

Funding Acknowledgement
Type of funding source: Public Institution(s). Main funding source(s): INRS: institut National de Recherche et de Sécurité
TAVI In South Africa's resource-constrained economy: the role of local data in overcoming funding resistance
Authors: Schaafsma E , Scherman J , Weich H , Ntsekhe M 
Published: November 2020

Abstract

The South African (SA) prospective multi-centre observational SHARE-TAVI registry aims to provide local outcomes data on all TAVIs in State & Private sectors, to support local evidence-based policy evaluations, comparing outcomes to international data & identifying local variations.

Methods and results
All 14 implants centres voluntarily capture data into the web-based SHARE-TAVI registry. 1375 patients from Sept 2014-Jan 2020 had pre-TAVI clinical evaluations, 998 proceeded to TAVI & procedural data & complications recorded (VARC-2 criteria), 30d & annual follow up. State sector hospitals provide limited tertiary cardiac care due to severe resource constraints. 13% of TAVIs in SA are in State teaching hospitals, 6.2% of State implants are 2nd generation (2G) devices. In the Private sector the roll-out of TAVI is inhibited by funding resistance, particularly to higher-cost 2G valves. 1st generation (1G) implants comprise 30% of 2019 implants, funding policies leave patients with unaffordable co-payments for 2G valves. Local data (Table 1) shows peri- & 1-year mortality, & procedural success (average 95.4%, & in 2019 98.91%), which are comparable with international data. TAVI in SA is successful despite low volumes & resource limitations. Local data supports superiority of 2G over 1G i.t.o this data and hospital stay length, & unplanned valve-in-valves. No significant differences between 1G & 2G in re-admissions in year 1, but improved quality of life patients experience with TAVI implantation is notable in the NYHA class.

Funding Acknowledgement
Type of funding source: Other. Main funding source(s): SA Heart Association registry project funding. Unrestricted educational grants by Medtronic and Edwards Life Sciences
Cost-effective analysis of atorvastatin based on outcome data from a large cohort undergoing PCI before and after the availability of atorvastatin for patients with social health insurance
Authors: Nuehrenberg T , Giesel-Kiefer A , Neumann F.-J , Mossialos E 
Published: November 2020

Abstract

Background
After market introduction of atorvastatin in Germany, the Institute for quality and efficiency in health care (IQWiG) concluded that atorvastatin, as compared to other less potent statins, was not associated with added value and levelled reimbursement to that of other statins. This decision being highly controversial, we hypothesized that a cost-effectiveness analysis based on real-world outcome data may have proven cost-effectiveness of atorvastatin, favouring corresponding reimbursement.

Methods
We investigated the introduction of highly potent statins in a cohort of 10,875 patients undergoing percutaneous coronary intervention (PCI) in a high-volume single centre in Germany between 2010 and 2017 and whether this conferred a clinical benefit as compared to statins with low potency. Routine clinical follow-up was performed at 30 days, 1 and 3 years after intervention with assessment of death, repeat revascularisations and myocardial infarction. Cox proportional hazards regression analyses were performed to adjust for differences in baseline patient characteristics. Based on the outcome data, a cost-effectiveness analysis of atorvastatin was performed, complemented by scenario analyses.

Results
Clinical benefit was present for high potency statins but was limited to all-cause death and not present in rates of myocardial infarction or revascularisations. Regarding cost-effectivenesss, an incremental cost-effectiveness ratio (ICER) of €6,311 / quality-adjusted life year (QUALY) was obtained for atorvastatin in the base case with life time horizon. In scenario analyses, the highest ICERs was €12,216 / QUALY (Figure 1).

Conclusions
We demonstrate that cost-effectiveness analysis can be performed based on routine treatment data. Hence, when there is uncertainty regarding cost-effectiveness analyses based on data from RCTs, timely restricted reimbursement could be a novel way of accumulating such treatment data and serve for evaluation of cost-effectiveness in real-world treatment conditions.
Figure 1

Funding Acknowledgement
Type of funding source: None
Contemporary predictors of readmission outcomes in patients with infective endocarditis: analysis from a national readmission database
Authors: Khayata M , Addoumieh A , Alkharabsheh S , Collier P , Klein A , Griffin B , Xu B 
Published: November 2020

Abstract

Background/Introduction
Infective endocarditis (IE) remains a serious illness that is associated with remarkable morbidity and mortality in the United States (US). There are limited studies that investigated predictors of 30-day readmission risk in this population.

Purpose
We aimed to perform a contemporary analysis to investigate predictors of 30-day readmission in IE patients in the US.

Methods
We used the 2017 national readmission database to identify index admissions among adults (age ≥18) with the diagnosis of IE. Appropriate International Statistical Classification (ICD-10) codes were used to identify patients with IE. Primary outcome of interest was 30-day readmission, and hospital cost was the secondary outcome.

Results
Out of 49,692 admissions for IE, 5,743 (11.6%) patients were readmitted within 30 days. Patients who had 30-day readmission were younger (55±20 vs 61±19 years, P&lt;0.001), 44.8% were females (P=0.08), 27.9% had diabetes mellitus (DM), 56.8% had hypertension, 37.9% had heart failure (HF), 31.3% had chronic kidney disease (CKD), 12.2% had end stage renal disease, and 47.8% had Medicare insurance. Patients who had readmissions within 30 days were more likely to have non-elective index admission (96.9% vs 93.4%, P&lt;0.001), more likely to have hepatitis C (19.5% vs 12.2%, P&lt;0.001), human immunodeficiency virus (HIV) (1.7% vs 1.2%, P&lt;0.001), substance abuse (8.6% vs 5.4%, P&lt;0.001), opioid abuse (24% vs 14.7%, P&lt;0.001), and cocaine use (7.4% vs 4.3%, P&lt;0.001). Overall, 5,393 (10.9%) patients died during index admission. Median cost for readmissions within 30 days was $83,217 [$41,457-$165,487], compared to the index admission cost of $90,257 [$41,945- $208,851] (P&lt;0.001). After adjusting for age, DM, HF, and CKD, substance abuse (odds ratio (OR): 1.19 [1.07–1.33]; P 0.001), opioid abuse (OR: 1.37, [1.26- 1.48]; P&lt;0.001), cocaine use (OR: 1.33 [1.18- 1.48]; P&lt;0.001), HIV (OR: 1.25 [1.01–1.56]; P=0.04), and hepatitis C (OR: 1.34 [1.24–1.45]; P&lt;0.001) correlated with higher odds of readmissions within 30 days (Figure 1).

Conclusion
Approximately 1 in 4 patients admitted for IE in the US had a history of opioid abuse and almost one fifth had hepatitis C. The 30-day readmission rate remains significant in IE with high financial burden on the health system. Both opioid abuse and hepatitis C were among the highest predictors of readmission within 30 days. Identifying modifiable predictors of readmission in this population may reduce readmission risk and healthcare cost.
Figure 1

Funding Acknowledgement
Type of funding source: None
Economic impact of sudden cardiac arrest
Authors: Paratz E , Rowsell L , Ball J , Zentner D , Parsons S , Morgan N , Thompson T , James P , Pflaumer A , Semsarian C , Stub D , Liew D , Smith K , La Gerche A 
Published: November 2020

Abstract

Background
Each year, there are approximately 5,000 out-of-hospital cardiac arrests (OHCAs) in the state of Victoria, Australia (population 6.4 million, state healthcare budget AUD$2.9 billion / €1.8billion). Mortality from OHCA approaches ninety percent. High mortality rates and survivors not returning to work is likely to have an adverse effect on the Victorian economy but this has not been previously investigated.

Purpose
To model the economic impact of OHCA mortality and survivors not returning to work.

Methods
Data on all OHCAs transported by Ambulance Victoria from July 2017- June 2018 in Victoria, Australia was collected, including age, gender, survival to hospital, survival to discharge, and survival to 12 months. Cases were excluded if arrest was precipitated by trauma, exsanguination, overdose, terminal illness, hanging, SIDS, electrocution, sepsis, respiratory causes, drowning, or neurological causes. Pre-arrest employment status of patients was modelled using the Australian Bureau of Statistics Economic Security dataset, which provides contemporary employment rates for gender-matched five-year cohorts for Australians aged 15–79 years. For survivors to 12 months, pre-arrest and post-arrest work status were confirmed. Economic impact was then calculated to a five year horizon utilizing a Markov model with probabilistic sensitivity analysis.

Results
4,934 arrests meeting the inclusion criteria were transported by Ambulance Victoria in twelve months, of whom 4,639 were determined to be cardiac arrests without any exclusion criteria as a precipitant. 695 patients survived to hospital (15.0%), and 325 to discharge (7.0%). At 12 months, 303 patients were alive (6.5% of overall cases, 93.2% of those discharged from hospital). Economic modelling of age and gender-matched data indicated that 1516 patients (35%) would have been employed pre-cardiac arrest, but only 216 survivors (4.7%) would be employed at five years post-arrest. Using Markov modelling incorporating estimated earnings and the pre-determined value of a statistical life, the annual economic burden of cardiac arrest approximated AUD$4 billion (€2.5 billion) at a five-year horizon.

Conclusion
The annual economic impact of cardiac arrest in Victoria, Australia is approximately AUD$4 billion (€2.5 billion) in a five-year horizon. As the annual Victorian state budget for all healthcare is AUD$2.93 billion (€1.8 billion), our data suggests that the economic impact of cardiac arrest is under-appreciated. Therefore, research in this area and providing state-of-the-art care for all cardiac arrest patients should be a healthcare priority.

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): NHMRC/NHF Postgraduate Scholarship, RACP JJ Billings Scholarship
Resource utilization and costs associated with achieved LDL-C levels in patients following a myocardial infarction treated with lipid-lowering therapies in Spain
Authors: Escobar Cervantes C , Campos Tapias I , Sorio Vilela F , Lozano J , Kahangire D.A , Sicras-Mainar A 
Published: November 2020

Abstract

Background/Introduction
Reduction in low-density lipoprotein cholesterol (LDL-C) significantly reduces cardiovascular (CV) risk, especially in patients with atherosclerotic CV disease. There is, however, a lack of evidence on the association between achieved LDL-C and resource utilization and costs.

Purpose
Assess the association of achieved LDL-C levels and resource use and costs in patients treated with lipid-lowering therapies (LLT) following a myocardial infarction (MI).

Methods
Retrospective observational study using the BIG-PAC® database, with anonymized electronic medical records from 1.9 million inhabitants from 7 regions in Spain.
Eligible patients were adults (≥18 years), hospitalized for an MI (index date) between January 2015 and December 2017, treated with LLTs (statins and/or ezetimibe) during follow-up (up to 18 months), and with recorded LDL-C values at baseline and follow-up.
Direct (related to health care interventions) and indirect (related to loss of productivity) costs were estimated in 2018€.
Costs incurred during follow-up were computed by achieved LDL-C. Achieved LDL-C was obtained in the year following the MI and at least 2 months after the index date. LDL-C categories were defined as per the 2016 and 2019 ESC/EAS guidelines for dyslipidaemias management: &lt;55 mg/dL, 55–69 mg/dL, 70–99 mg/dL, 100–129 mg/dL and ≥130 mg/dL. Results were adjusted for age, gender, CV disease history and comorbidities.

Results
6025 patients were included. Mean age (SD) was 69.7 (12.2) and 77% were male.
Resource use (not reported in this abstract) and costs monotonically increased with achieved LDL-C. Mean total costs ranged from 5044€ for patients with LDL-C &lt;55 mg/dL to 7567€ for patients with LDL-C ≥130 mg/dL (Table 1).
Only 11% (641/6025) of patients reached recommended LDL-C levels for very-high-risk patients as per 2016 ESC/EAS guidelines (&lt;70 mg/dL), and 1% (68/6025) the LDL-C levels (&lt;55 mg/dL) proposed in the 2019 guidelines.

Conclusions
Achieving lower LDL-C levels following an MI may be associated to lower resource use and costs. Many patients do not achieve recommended LDL-C levels despite treatment with LLT. These data suggest that use of more intense LLT, with a greater reduction in LDL-C, would be beneficial from a clinical and economic perspective.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Amgen (Europe) GmbH
Measuring the systolic and the diastolic properties of single human pluripotent stem-cell cardiomyocyte for drug testing and disease modeling
Authors: Ballan N , Shaheen N , Keller G , Gepstein L 
Published: November 2020

Abstract

Background
The advent of human pluripotent stem cell–derived cardiomyocytes (hPSC-CMs) provided exciting tools for cardiovascular physiological studies, disease modeling and drug testing applications. Current platforms for studying the mechanical properties of human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) as single-cells do not measure forces directly, require numerous assumptions, and cannot study cell mechanics at different loading conditions.

Objective
To establish a novel platform to assess the active and passive mechanical properties of single-cell hPSC-CMs at different loading conditions and to demonstrate the potential of this approach for drug testing and disease modeling applications.

Methods and results
To allow morphological maturation, hPSC-CMs were treated with Tri-iodo-thyronine hormone, dexamethasone and Insulin-like growth factor-1. The hPSC-CM were then lifted and attached to a highly sensitive optical-force transducer and a piezoelectric length controller and electrically-stimulated. The attached hPSC-CM remained intact and contractile allowing evaluation of their passive and active mechanical properties. Utilizing this technique, single-cell hPSC-CMs exhibited positive length-tension (Frank-Starling) relationships, and appropriate inotropic, klinotropic, and lusitropic changes in response to treatment with isoproterenol. The unique potential of the approach for drug testing and disease modeling was exemplified by treating the cells with doxorubicin (a potential cardiotoxic anti-cancer agent) and omecamtiv mecarbil (a positive ionotropic drug currently in stage 3 clinical trial). The results of these studies recapitulated the drugs' known actions to suppress (doxorubicin) and augment (omecamtiv mecarbil at low dose) cardiomyocyte contractility. Finally, novel insights were gained regarding the cellular effects of these drugs as doxorubicin treatment led to cellular mechanical alternans and high doses of omecamtiv mecarbil suppressed contractility and worsened the cellular diastolic properties.

Conclusion
A novel method that allows direct active and passive force measurements from single hPSC-CMs at different loading conditions for the first time was established and validated. Our results highlight the potential implications of this novel approach for pharmacological studies and disease modeling studies.

Funding Acknowledgement
Type of funding source: Public grant(s) – EU funding. Main funding source(s): European Research Council