bluuebunny/crossref_metadata_2025_split huggingface dataset:
The distribution of anti-factor Xa activity value, PT and APTT at peak and trough times in patients with direct anti-factor Xa inhibitors
Authors: Ono R , Fukushima K , Yamazaki T , Takahashi H , Hori Y 
Published: November 2020

Abstract

Background
Although patients taking direct oral anticoagulants (DOACs) do not require routine coagulation monitoring, the distribution of anti-factor Xa activity (AXA) values, prothrombin time (PT), PT-international normalized ratio (INR) and activated partial thromboplastin time (APTT) in patients on apixaban, edoxaban and rivaroxaban therapy is still not clear.

Purpose
The aim is to set the standard values of AXA values, PT, PT-INR and APTT in patients using DOACs.

Methods
We measured AXA, using chromogenic assay with the HemosIL Liquid Heparin kit, PT, PT-INR and APTT at trough and peak times in 224 patients with non-valvular atrial fibrillation and venous thromboembolism, of whom 90 received apixaban, 100 received edoxaban and 34 received rivaroxaban. The peak time was defined as 3 hours after the intake of apixaban or rivaroxaban, and 2 hours after the intake of edoxaban. The trough time was defined as that immediately before the intake. The AXA values, PT, PT-INR and APTT were measured at least 72 hours after the start of treatment. The dosage of DOACs is defined according to the prescribing information in Japan.

Results
(The order of results below is apixaban, edoxaban and rivaroxaban, respectively.) The average AXA values were 2.29, 0.23 and 0.39 (IU/mL) at trough time, and 3.04, 1.01 and 1.70 (IU/mL) at peak time. The average PT values were 17.9, 12.9 and 13.1 (s) at trough time, and 19.7, 15.5 and 17.5 (s) at peak time. The average PT-INR values were 1.49, 1.07 and 1.08 at trough time, and 1.65, 1.29 and 1.45 at peak time. The average APPT values were 34.5, 31.3 and 32.0 (s) at trough time, and 39.5, 35.9 and 39.8 (s) at peak time.

Conclusion
Our findings reveal the standard values of AXA, PT, PT-INR and APTT in patients using apixaban, edoxaban and rivaroxaban in each dosage. The DOACs should be changed if the measured value is out of those standard values in 90% confidence interval.

Funding Acknowledgement
Type of funding source: None
The usefulness of total thrombus-formation analysis system for predicting high bleeding risk in coronary artery disease patients taking anticoagulants who underwent percutaneous coronary intervention
Authors: Nakanishi N , Kaikita K , Mitsuse T , Tsujita K 
Published: November 2020

Abstract

Background
Although anticoagulants are widely used for prevention of cerebral infarction in patients with atrial fibrillation (AF), venous thrombosis, and valvular disease, it is possible that anticoagulants increase bleeding events in daily medical practices. Recently, we reported that the total thrombus-formation analysis system (T-TAS) was useful for evaluating bleeding risk in coronary artery disease (CAD) patients.

Aim
We examined whether T-TAS was practical for predicting bleeding risk in CAD patients taking anticoagulants who underwent percutaneous coronary intervention (PCI).

Methods
This study was the retrospective analysis of the 500 consecutive CAD patients who underwent PCI. Blood samples obtained on the day of PCI were used in T-TAS to compute the thrombus formation area under the curve (AUC) (AR10-AUC30, AUC for AR chip). We divided the total number of study patients into two groups according to the presence of anticoagulants; 53 CAD patients with triple therapy (TT) and 447 CAD patients with dual antiplatelet therapy (DAPT). We compared clinical characteristics and prognosis between the two groups. The primary endpoint was 1-year bleeding events that were defined by ISTH bleeding criteria. We excluded the CAD patients who underwent emergency PCI, and who were treated for hemodialysis.

Results
All patients took aspirin and clopidogrel, or aspirin and prasugrel at baseline. Compared to the patients with DAPT, the patients with TT had atrial fibrillation and history of stroke. The AR10-AUC30 levels were significantly lower in the patients with TT than the patients with DAPT (median [interquartile range] 1402.6 [1095.1–1609.8] vs. 1679.8 [1526.4–1783.3], p&lt;0.001). Thirty-five patients (7%) had bleeding events during follow-up [11 cases (20.8%) in the patients with TT, 24 cases (5.4%) in the patients with DAPT]. Kaplan-Meier curve analysis showed a worse 1-year bleeding event-free survival rate in the patients with TT compared with the patients with DAPT (p&lt;0.001). Receiver operating characteristic analysis showed that AR10-AUC30 levels significantly predicted bleeding events (AUC 0.653, 95% CI 0.555–0.751; p=0.003) and the cut-off point was 1586.4 by Youden index in the present study. In multivariate Cox hazards analysis, low AR10-AUC30 level (≤1586.4) (hazard ratio 2.99; 95% CI 1.46–6.11; p=0.003) and taking warfarin (hazard ratio 3.02; 95% CI 1.24–7.34; p=0.015) were significant predictors for 1-year bleeding events.

Conclusions
The present findings suggested that the AR10-AUC30 level determined by T-TAS could be a useful marker for predicting high bleeding risk in CAD patients taking anticoagulants who underwent PCI.

Funding Acknowledgement
Type of funding source: None
Favorable therapeutic index of an orally-active small-molecule antagonist of the platelet protease-activated receptor-4, BMS-986141, compared with the P2Y12 antagonist ticagrelor in cynomolgus monkeys
Authors: Wong P , Banville J , Wexler R , Priestley E , Marinier A , Bouvier M , Gordon D , Yang J 
Published: November 2020

Abstract

Introduction
BMS-986141 is an orally-active small-molecule platelet thrombin receptor antagonist selective for the protease-activated receptor-4 (PAR4), a human platelet thrombin receptor.

Purpose
This study assessed effects of BMS-986141 vs. the P2Y12 antagonist ticagrelor, a standard of care antiplatelet agent, on arterial thrombosis (AT), mesenteric bleeding time (MBT) and platelet aggregation in monkeys.

Methods
Studies were conducted in models of electrically-mediated carotid artery thrombosis and MBT in anesthetized monkeys. Monkeys were given a single oral dose of BMS-986141 (0.05, 0.1, 0.5 mg/kg) or vehicle (n=8/group). At 2 hr post-dose, in vivo AT, MBT as well as ex vivo platelet aggregation were monitored in the same animal. Ticagrelor was studied as a comparator and given as IV bolus plus infusion at 0.0023+0.017 to 0.075+0.6 (mg/kg+mg/kg/h) (n=5–6/group). Thrombus weight reduction, MBT increase over vehicle, and platelet aggregation inhibition were determined. Peak platelet aggregation responses to activation peptides selective for PAR4 (PAR4-AP, 12.5 μM) and PAR1 (PAR1-AP, 18 μM), to collagen (5 μg/ml) and to ADP (20 μM) were determined by whole blood aggregometry.

Results
BMS-986141 inhibited platelet aggregation induced by PAR4-AP in human and monkey blood in vitro with comparable IC50 of 1.8±0.3 and 1.2±0.3 nM, respectively. BMS-986141 at 0.5 mg/kg completely inhibited platelet aggregation induced by PAR4-AP but not PAR1-AP, ADP and collagen, suggesting PAR4 receptor selectivity. In the AT model, BMS-986141 at 0.05, 0.1 and 0.5 mg/kg reduced thrombus weight by 36±7*, 63±8*, and 88±3%*, respectively (*P&lt;0.05 vs. vehicle). BMS-986141 increased MBT by up to 1.2-fold. In a separate study, ticagrelor at 0.0023+0.017, 0.0068+0.055, 0.0255+0.18 and 0.075+0.6 (mg/kg+mg/kg/h IV) reduced thrombus weight by 19±8, 36±5*, 76±6* and 89±1%*, and increased MBT by respectively by 1.7-, 6.4-*, &gt;10-*, and &gt;10-fold*, respectively (*P&lt;0.05 vs. vehicle).

Conclusion
Comparable antithrombotic efficacy was observed between BMS-986141 and ticagrelor in monkeys. BMS-986141 exhibited lower MBT compared with ticagrelor at equivalent antithrombotic doses. This study suggests that PAR4 antagonism provides a potentially safer antiplatelet therapy.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Research was supported by Bristol-Myers Squibb
Enhancing nurses self-efficacy by high-fidelity resuscitation simulation training: a pre-post study
Authors: Al Kalaldeh M 
Published: November 2020

Abstract

Introduction
Recent evidence support the use of High-fidelity simulation (HFS) among health care professional. Self-efficacy towards resuscitation competency is assumed to be influenced by HFS training that low fidelity simulation.

Purpose
This study aimed to examine the impact of the high-fidelity Resuscitation Simulation Training (RST) program on the nurse's self-efficacy.

Methods
A quasi-experiment, one-group pretest-posttest design was used. A total of 62 nurses enrolled the RST. Self-efficacy was assessed in both pretest and posttest phases using the Resuscitation Self-Efficacy Scale (RSES). Changes occurred in self-efficacy after conducting the study program and the potential influence of demographic characteristics were examined using descriptive and inferential statistics.

Results
Self-efficacy has significantly improved after the RST considering all self-efficacy dimensions; Recognition, Debriefing and recording, Responding and rescuing, and Reporting (P&lt;0.05). This was also consistent with RSES assessment by the course instructors (t=−1.5, p=0.11). A moderate positive correlation was found between the RSES and the ACLS posttest written exam (r=0.303, p=0.017). While minimal influence of demographic characteristic was reported, nurses who had never been involved in resuscitation in the past had shown a significant improvement in their self-efficacy after the RSE.

Conclusion
The utilization of high-fidelity simulation training can improve nurse's self-efficacy regardless personal characteristics or experience.

Funding Acknowledgement
Type of funding source: None
Nurse management of glycemia in cardiac intensive care
Authors: Cappannelli S , Cosmi D , Rey L , Murrone A 
Published: November 2020

Abstract

Introduction
Scientific studies have shown that hypoglycaemia is an important risk factor for adverse events in cardiac intensive care. Nursing management of blood glucose, via protocol, is an important tool to avoid cases of hypoglycaemia.

Objective
We evaluate the efficacy and safety of a glycemia control protocol based on nursing management in diabetic patients in Intensive Care Unit.

Material and methods
We conducted a retrospective analysis on 500 patients hospitalized for acute coronary syndrome or heart failure, with an average age of 75±12 years, clinically stable. The protocol used provides, on medical indication, the suspension of home therapy (both oral hypoglycemic agents and insulin) and the introduction of insulin therapy according to the scheme 0.2/0.5 IU/kg/day. The dosage lower than 0.2 IU/kg/day is used for patients in home therapy with oral hypoglycemic agents and basal blood sugar &lt;150 mg/dl and the dose greater than 0.5 IU/kg/day for patients already on home insulin therapy and basal blood sugar&gt; at 200 mg/dl. The intermediate dosage. 3–0.4 IU/kg/day is instead used in patients with glycaemia between 150 and 200 mg/dl regardless of home therapy. On the basis of the dosage schedule, the daily insulin requirement is obtained which is then administered at 50% as a slow analogue at 10 pm and at 50% as a rapid analogue, further divided into three doses with each main meal.
Once the initial therapy has been set, the nurse acts autonomously according to a correction algorithm (based on the calculation of the correction factor (FC) according to the formula FC = 3000/body weight in kg or FC = 1700/total daily dose of insulin &gt; FC = reduction in blood glucose in mg/dl determined by 1 IU of insulin) which provides for the modification of insulin therapy based on the patient's weight and the blood glucose values measured with sticks at 8, 12, 18 and 22. If during hospitalization and/or discharge, inadequately controlled glycemic values persist, the patient is sent to diabetes advice and the current home therapy is resumed upon discharge or according to diabetes advice.

Results
We observed an excellent pre and post prandial glucose control with extremely reduced incidence of hypoglycaemia which occurred in only 3 cases, one of which with severe hypoglycaemia (glucose detected &lt;40 mg/dl, resolved with the administration of glucose 33 20ml% followed by infusion of 10% glucose solution and glycemic stick after 15') for administration error and two with moderate hypoglycaemia (glucose detected between 40–70 mg/dl resolved with the reduction of 2 IU of rapid analogue and repeated stick post prandial).

Conclusions
A nursing management protocol for blood glucose values in patients with diabetes mellitus hospitalized for acute coronary syndrome or heart failure is safe and allows good control of blood glucose values.

Funding Acknowledgement
Type of funding source: None
Symptoms of depression at discharge after PCI are associated with an increased risk of 1-year mortality: findings from the national DenHeart study
Authors: Borregaard B , Nielsen S.N , Lassen J.F , Jensen L.O , Thrysoe L , Berg S.K , Moller J.E , Christensen A.V , Ekholm O , Mols R.E , Thorup C.B , Rasmussen T.B 
Published: November 2020

Abstract

Background
Although survival rates among patients with coronary artery disease have increased since the introduction of treatment with percutaneous coronary intervention, PCI, the effect of psychological factors such as symptoms of anxiety and depression on adverse outcomes are sparsely described.

Purpose
The objective of the current study was to investigate the association between symptoms of anxiety and depression and 1-year mortality after PCI.

Methods
A national cross-sectional survey at hospital discharge (responders, n=3,366) with register-based follow-up among patients having undergone elective or emergency PCI. Mental health was measured using the Hospital Anxiety and Depression Scale, HADS, and divided into symptoms of anxiety (HADS-A) and symptoms of depression (HADS-D). The association between mental health (HADS-A and HADS-D) and 1-year all-cause mortality were investigated with Cox Proportional Hazard models with time to death as the underlying time scale. The results are presented as hazard ratios (HR) with 95% confidence intervals (CI) and adjusted for sex, age and Tu-comorbidity score.

Results
At discharge, 32% of the population reported symptoms of anxiety (HADS-A ≥8) and 19% reported symptoms of depression (HADS-D ≥8). After one year, the mortality rate among patients being alive at discharge was 2.1%. All-cause mortality did not differ among patients reporting symptoms of anxiety compared to patients without symptoms of anxiety (2.3% vs 1.9%, p=0.454), whereas all-cause mortality was higher among patients reporting symptoms of depression compared to those, who did not (4.3% vs 1.6%, p≤0.001).
In the regression analyses, symptoms of anxiety (HADS-A ≥8) was not associated with 1-year mortality (HR 1.16 95% CI 0.70–1.92); however, symptoms of depression was (HADS-D ≥8, HR 2.27 95% CI 1.38–3.73, adjusted analyses). Based on the continuous scores of HADS-D, a one-point increase in scores was associated with a 12% higher risk of 1-year mortality (HR 1.12 95% CI 1.05–1.18) (Figure 1).

Conclusion
After PCI, nearly one-third of patient report symptoms of anxiety and one-fifth symptoms of depression. Symptoms of anxiety was not associated with 1-year mortality, whereas symptoms of depression increased the risk of 1-year mortality.
Figure 1

Funding Acknowledgement
Type of funding source: None
Clinical determinants and prognostic impact of osteoporosis in patients with chronic heart failure
Authors: Katano S , Yano T , Tsukada T , Kouzu H , Honma S , Inoue T , Takamura Y , Nagaoka R , Ohori K , Koyama M , Nagano N , Nishikawa R , Hashimoto A , Katayose M , Miura T 
Published: November 2020

Abstract

Background
Despite accumulating evidence of a close association between orthopedic fractures and chronic heart failure (CHF), the clinical risk factors of osteoporosis, defined as reduction in bone mineral densities (BMDs), in CHF patients have not been systematically analyzed. In addition, the impact of osteoporosis on prognosis of CHF remains unclear.

Aims
We aimed to clarify the prevalence, clinical risk factors, and prognostic impact of osteoporosis in CHF patients.

Methods
We retrospectively examined 303 CHF patients (75 years, [interquartile range (IQR), 66–82 years]; 41% female). BMDs at the lumber spine, femoral neck, and total femur were measured by dual-energy X-ray absorptiometry (DEXA), and osteoporosis was diagnosed when BMD at any of the three sites was less than 70% of Young Adult Mean.

Results
The prevalence of osteoporosis in the CHF patients was 40%. Patients with osteoporosis were older (79 [IQR, 74–86] vs. 72 [IQR, 62–80] years), included a large percentage of females, had slower gait speed and had lower body mass index (BMI). Loop diuretics and warfarin were used more frequently and direct oral anticoagulants (DOACs) were used less frequently in patients with osteoporosis than in patients without osteoporosis. Multivariate logistic regression analysis indicated that sex (odds ratio [OR] 5.07, 95% Confidence Interval [CI] 2.68–9.61, p&lt;0.01), BMI (OR, 0.83; 95% CI, 0.75–0.91; p&lt;0.01), gait speed (OR, 0.80; 95% CI, 0.70–0.92; p&lt;0.01), loop diuretics use (OR, 2.52; 95% CI, 1.20–5.27; p=0.01) and no DOACs use (OR, 0.43; 95% CI, 0.19–0.96; p=0.04) were independently associated with osteoporosis. During the mean follow-up period of 290±254 days, 92 patients (30.4%) had adverse events. When patients with osteoporosis were divided into subgroups according to the number of sites with BMD of an osteoporosis level, Kaplan-Meier survival curves showed that the rate of adverse events (death and cardiovascular events) was higher in patients with osteoporotic BMD at two or more sites than in patients without osteoporosis (51% vs. 23%, p=0.03) (Figure). In multivariate Cox regression analyses, osteoporotic BMD at two or more sites was an independent predictor of adverse events after adjustment for age, sex, and NT-proBNP level (Hazard ratio, 1.74; 95% CI, 1.01–2.99; p=0.04).

Conclusion
The risk of osteoporosis may be increased in users of loop diuretics and may be decreased in users of DOACs in CHF patients. Extent of osteoporosis is a novel predictor of adverse events in CHF patients.

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): The Japan Society for the Promotion of Science KAKENHI
Influence of long-term swimming exercises on cardiac index, life duality and level of depression in patients with heart failure with pEF and diabetes mellitus type 2
Authors: Shorikova D , Shorikov E.I , Khukhlina O.S , Shorikov P 
Published: November 2020

Abstract

Introduction
In the number of studies it was proved that specific physical activity can significantly improve the control of Heart Failure (HF). Physical exercises improve mobility, strength and cardiovascular fitness, can easily be performed in patients with HF.

Purpose
To investigate the effect of regular swimmings on cardiac output, life duality, anxiety and depressive symptoms in patients with HF and DM type 2.

Material and methods
62 patients (20 women and 42 men, mean age 55.3±7.9 years) with HFpEF and DM type 2 were included in prospective observation during 6 months. The intensity of physical activity was 6 points due to Borg scale (60–70.0%). Hospital Anxiety and Depression Scale (HADS), MLHFO and SF-36 surveys were used. The water temperature was 32°C throughout the study.

Results
It was set that lowest scores QL in patients with HF and DM type 2 were obtained on the scales of physical (PF, GH and RP) and psychological (RE, VE and SF) health components (p&lt;0.05). The life duality in patients with HF and DM type 2 depended on the degree of physical activity. The reliable improvement of both physical (p&lt;0.05) and psychological components (p&lt;0.05) of health after regular swimming is proved (table). According to MLHFQ was set reducing the restriction of physical and social activity after regular swimming. Water exercises increased efficacy of pharmacological therapy on 61.8% (p&lt;0.001) according to MLHFQ. According to the HADS scale anxiety and depression disorders were reduced from higher to lower level in 88.0% patients. After 6 months of swimming exercises it was set increasing of cardiac index by 12.0% (p&lt;0.05).

Conclusions
It has been established that regular swimming exercises in patient with Heart Failure and Diabetes Mellitus type 2 has favourable effect for cardiac index by 12.0% (p&lt;0.05), life duality (p&lt;0.05) and decrease the level of anxiety and depression disorders (p&lt;0.05).

Funding Acknowledgement
Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Health Service of Ukraine
Change in health-related quality of life among patients with a reduced ejection fraction initiating guideline-directed medical therapy
Authors: Burch A , Sears S.F , Doring M , Gummadi S , Robertson M , Sanchez R , Shroff G , Veltmann C 
Published: November 2020

Abstract

Background
Management of patients with heart failure (HF) should include patient reported outcomes (PROs). The Kansas City Cardiomyopathy Questionnaire is self-administered with subscales to evaluate HF symptom burden, physical limitations, social limitations (recreational participation), and quality of life (QoL). Change in PROs among newly diagnosed patients with HF and reduced ejection fraction (HFrEF) prescribed a wearable cardioverter defibrillator (WCD) and initiating guideline-directed medical therapy (GDMT) has not been assessed.

Purpose
Examine PROs over 180 days of receiving GDMT for newly diagnosed HFrEF.

Methods
Patients (n=93, 75.3% male) were enrolled ≤10 days post-hospitalization for new onset HF; all patients had an EF ≤35% and were prescribed a WCD. Health status, as measured by PRO was assessed at baseline, day 90, and day 180. Controlling for age and EF at baseline, changes in PROs over the 180-day study period were evaluated using repeated measures modeling. Pairwise comparisons with Bonferroni adjustments were used to compare adjacent timepoints. Higher scores reflect better health status.

Results
After controlling for age (mean 56±13.4) and baseline EF (mean 22±7.7) improvements in health status were observed. From baseline to day 90, physical limitation, symptom frequency, QoL, and the summary score all increased (Δ: 17.8, 23.7, 28.4, 23.7, respectively; all p's &lt;0.05). From day 90 to day 180, only QoL continued to improve (Δ 7.5, p=0.001). Change in social limitations over time was not significant (p=0.42).

Conclusion
Patients report improved health status in the months following a new diagnosis of HFrEF when prescribed a WCD and GDMT.
Change in Quality of Life

Funding Acknowledgement
Type of funding source: None