Funding Source, Quality of Publications and Outcome in Genetic Damage in Mammalian Cells Exposed to Non-Ionizing Radiofrequency Fields

2019 ◽  
Vol 192 (4) ◽  
pp. 353 ◽  
Author(s):  
. Vijayalaxmi ◽  
Thomas J. Prihoda
2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Deaton ◽  
F Forsyth ◽  
J Mant ◽  
D Edwards ◽  
R Hobbs ◽  
...  

Abstract Aims Patients with heart failure with preserved ejection fraction (HFpEF) are usually older and multi-morbid and diagnosis can be challenging. The aims of this cohort study were to confirm diagnosis of HFpEF in patients with possible HFpEF recruited from primary care, to compare characteristics and health status between those with and without HFpEF, and to determine factors associated with health status in patients with HFpEF. Methods Patients with presumed HFpEF were recruited from primary care practices and underwent clinical assessment and diagnostic evaluation as part of a longitudinal cohort study. Health status was measured by Montreal Cognitive Assessment (MOCA), 6-minute walk test, symptoms, and the Kansas City Cardiomyopathy Questionnaire (KCCQ), and quality of life (QoL) by EQ-5D-5L visual analogue scale (VAS). Results 151 patients (mean age 78.5±8.6 years, 40% women, mean EF 56% + 9.4) were recruited and 93 (61.6%) were confirmed HFpEF (those without HFpEF had other HF and cardiac diagnoses). Patients with and without HFpEF did not differ by age, MOCA, blood pressure, heart rate, NYHA class, proportion with atrial fibrillation, Charlson Comorbidity Index, or NT-ProBNP levels. Patients with HFpEF were more likely to be women, overweight or obese, frail, and to be more functionally impaired by 6 minute walk distance and gait speed than those without. Although not statistically significant, patients with HFpEF had clinically significant differences (>5 points) on the physical limitations, symptom burden and clinical summary subscales of the KCCQ, but did not differ by other subscales or by EQ-5D-5L VAS (70±17 vs 73±19, p=0.385). More patients with HFpEF reported daytime dyspnoea (63% vs 46%, p=0.035) and fatigue (81% vs 61%, p=0.008), but not other symptoms compared to those without HFpEF. For both groups BMI was moderately negatively correlated with KCCQ subscale scores, and 6 minute walk distance was positively correlated with KCCQ subscales. Conclusions Nearly 40% were not confirmed as HFpEF indicating the challenges of diagnosis. Patients with confirmed HFpEF differed by sex, overweight/obesity, frailty, functional impairment, and symptoms but not by age or comorbidities from those without HFpEF. These differences were reflected in some subscale scores of the KCCQ, but not how patients reported their quality of life on the KCCQ QoL subscale and EQ-5D-5L VAS. Older patients with HFpEF reported relatively high QoL despite poor health status by functional impairment, frailty and symptoms. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institute of Health Research School of Primary Care Research


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Raparelli ◽  
L Pilote ◽  
H Behlouli ◽  
J Dziura ◽  
H Bueno ◽  
...  

Abstract Background The quality of care among young adults with acute myocardial infarction (AMI) may be related to biological sex, psycho-socio-cultural (gender) determinants or healthcare system-level factors. Purpose To examine whether sex, gender, and the type of healthcare system influence the quality of AMI care among young adults. Methods A total of 4,564 AMI young adults (<55 years) (59% women, 47 years, 66% US) were analyzed from the VIRGO and GENESIS-PRAXY studies consisting of single-payer (Canada, Spain) versus multipayer (US) systems. For each patient treated in each system we calculated a quality of care score (QCS) for pre-AMI (1-year pre admission), in-hospital, and post-AMI (1-year post discharge) phases of care (number of quality indicators received divided by the total number [range=0–100%], with higher scores indicating better quality). Ordinal logistic or linear regression models, and 2-way interactions between sex, gender and healthcare system were tested. Results Women in the multipayer system had the highest risk factor burden. Across the phases of care for AMI, 20% of quality indicators were missed in both sexes. High stress, earner status, and social support were associated with a higher QCS in the pre-AMI phase, whereas only employment and earner status were associated with QCS in all other phases. In the pre-AMI phase, women had higher QCS than men, mainly in the single-payer system (adjusted-OR=1.85, 95% CI 1.46,2.35 vs. 1.07, 95% CI 0.84,1.36, P-interaction= 0.002). Regardless of sex, only employment status had a greater effect in the multipayer system (adjusted-OR=0.59, 95% CI 0.44,0.78 vs 1.13, 95% CI 0.89,1.44, P-interaction <0.001). In the in-hospital phase, women had a lower QCS than men, especially in the multipayer system (adjusted-mean-difference: −2.48, 95% CI-3.87, −1.08). Employment was associated with a higher QCS (2.0, 95% CI 0.9–3.17, P-interaction >0.05). Finally, in the post-AMI phase, men and women had a lower QCS, predominantly in the multipayer system. However, primary earners had higher QCS regardless of system. Conclusion Sex, gender, and healthcare system affected the quality of care after AMI. Women had a poorer in-hospital than men and both women and men had suboptimal post-discharge care. Being unemployed lowered the quality of care, more so in the multipayer system. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Canadian Institutes of Health and Research (CIHR)


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Houben ◽  
J.A Snoek ◽  
E Prescott ◽  
N Mikkelsen ◽  
A.E Van Der Velde ◽  
...  

Abstract Background and purpose Although participation in cardiac rehabilitation (CR) improves quality of life (QoL), participation in CR, especially among elderly, is limited. We conducted this study to assess whether mobile home-based CR (mCR) increases QoL in elderly (≥65 years old) patients with coronary artery disease (CAD) or a valvular intervention who decline participation in conventional CR. Methods It is designed as a randomised multi-centre study with two parallel arms. Randomisation assigned patients either to mCR or a control group. mCR Consisted of six months of home-based CR with telemonitoring and coaching. Control-group patients did not receive any form of CR throughout the study period. Quality of life was measured with the SF-36v2 questionnaire at 0, 6 and 12 months. Results A total of 179 patients were included in this study (90 control, 89 mCR). A flowchart of the trial is presented in Figure 1. Patients were predominantly male (81.1%). Baseline characteristics can be found in Table 1. Patients using mCR improved on physical QoL after 6 (p=0.026) and 12 (p=0.008) months. There was no difference on mental QoL for both groups (mCR 6 months p=0.563, 12 months p=0.945; control 6 months p=0.589, 12 months p=0.542). No difference existed in QoL between the mCR and control group (physical: 6 months p=0.070, 12 months p=0.150; mental: 6 months p=0.355, 12 months p=0.625). Conclusion Although there is no significant difference in QoL between the control and mCR group, mCR increases physical QoL after 6 and 12 months in elderly patients who decline participation in conventional CR. Therefore E-Health tools should be considered as an alternative for conventional CR when (elderly) patients decline to participate in conventional CR. Figure 1. Flow chart of all eligible patients Funding Acknowledgement Type of funding source: Public grant(s) – EU funding. Main funding source(s): European Union's Horizon 2020 research and innovation programme


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Perings ◽  
C Wolff ◽  
A Wilk ◽  
A Witthohn ◽  
R Voss ◽  
...  

Abstract Introduction In 30% of patients with syncope, the underlying cause remains unexplained after clinical investigations. Unexplained syncope tends to recur, significantly impacting patients' quality of life of patients and mortality. Thus, there is a need for timely and more accurate diagnosis to initiate treatment. Dedicated care pathways are recommended by ESC guidelines. Purpose Patients with recurrent syncope were followed over time and patient outcomes with ILR were compared to patients with the same syncope burden, age, gender and mortality risk score who did not receive an ILR. Method A representative database of 4.9 million patients insured by German company statuary health insurances (BKK) was analysed over a time period of 10 years, 2007–17. Patients with recurrent syncope (two times ICD-10 GM diagnosis codes R55), age between 45–84 and no diagnosis code for the syncope were included in the analysis and followed for at least 2 years. Patients with ILR were matched to patients without ILR based on age, gender and Charlson Comorbidity index (CCI) using mahalanobis distances. The index event was the device implant in the ILR group and the second syncope event in the control group. Life expectancy, syncope hospitalisations, fall related injuries, health care costs, diagnoses and treatment rates were compared between the groups. Results A total of 412 patients with ILR for recurrent unexplained syncope were matched to the control group. Overall mean age was 68, mean was CCI 2.7, 42% were females. The risk of death was 2.35 times higher in the control group during follow up as shown in Figure 1 (p-value logrank test <0.0001). Cardiovascular related diagnosis and treatment rates were higher in the ILR group with 69% of patients having a cardiology diagnosis compared to 41% in the control group. Over a quarter (27%) of ILR patients received an implantable cardiac device compared to 5% in the control group. Ablation rates were 7% in the ILR group compared to 0% in the control group. Median health care costs were € 3,847 higher in the ILR group including the costs of the ILR implant, follow up and higher rates of cardiac treatments. These extra costs appear moderate given the substantially higher mortality risk in the control group. Conclusion This study of patients with recurrent unexplained syncope shows a remarkable difference in life expectancy in patients with ILR compared to a matched control group. Two large claim data analysis have recently shown higher rates of cardiovascular death as well as all-cause mortality in patients with unexplained syncope. A more vigilant cardiac workup might be needed to identify a possible underlying cardiac condition. Higher rates of cardiac device therapy in the ILR group were likely to play an important role for their better life expectancy. Cardiac therapies such as pacemakers, defibrillators and ablation have also been shown to significantly improve patients' quality of life. Life Expectancy Comparison Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The data analysis was funded by Medtronic


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Barco ◽  
L Valerio ◽  
M Jankowski ◽  
M.M Hoeper ◽  
F.A Klok ◽  
...  

Abstract Background It is unclear to which extent persistence of symptoms and/or residual haemodynamic impairment clinical course of pulmonary embolism are associated with worse quality of life (QoL). Aims To study the correlation between symptoms and haemodynamic impairment with QoL during the first year after acute pulmonary embolism (PE). Methods The Follow-Up after acute pulmonary embolism (FOCUS) study prospectively enrolled and followed consecutive adult patients diagnosed with acute symptomatic objectively diagnosed PE. In the present analysis, we considered patients who completed the Pulmonary Embolism QoL (PEmb-QoL) Questionnaire at predefined visits 3 and 12 months after acute PE. The PEmb-QoL score ranges from 0% (best QoL) to 100% (worst QoL). We evaluated at these two time points the correlation between persisting symptoms (group: symptoms), elevation of natriuretic peptides or residual right ventricular dysfunction (group: RVD), or their combination (group: symptoms + RVD) and QoL. Results A total of 617 patients were included; their median age was 62 years, 44% were women; 8% had active cancer, and 21% previous venous thromboembolism. At 3 months, patients with neither symptoms nor RVD (n=302) had the highest quality of life (median score 18%, 25th–75th percentile: 8%–34%), followed by those without symptoms but with RVD (n=255; median score 19%, 25th–75th percentile: 7%–34%), and by those with symptoms only (n=131; median PEmb-QoL 31%, 25th–75th percentile: 18%–49%). Patients with both symptoms and RVD (n=170) had the worst quality of life (median score 38%, 25th–75th percentile: 19%–53%); Figure 1A. At 12 months, we found an overall improvement of PEmb-QoL score. The degree of this QoL improvement varied across groups, being largest for patients who recovered from having symptoms + RVD at 3 months to normalization of at least one at 12 months. The change in QoL from 3 to 12 months was smaller both in patients who had neither symptoms nor RVD and in patients who had no recovery in either symptoms or RVD; Figure 1B. Conclusions Persistent symptoms after PE, especially in patients with elevated biomarkers or residual echocardiographic dysfunction, were the main drivers of QoL at 3 months as well as of the course of QoL over time. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): University Medical Center of the Johannes Gutenberg University, Mainz, Germany; German Federal Ministry of Education and Research


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Safstrom ◽  
T.J Jaarsma ◽  
L.N Nordgren ◽  
M.L Liljeroos ◽  
A.S Stomberg

Abstract Background Since healthcare systems are increasingly complex and often fragmented, continuity of care after hospitalization is a priority to increase patient safety and satisfaction. Aim Describe factors related to continuity of care in patients hospitalized due to cardiac conditions. Methods This cross-sectional multicenter study enrolled patients 6 weeks after hospitalization due to cardiac conditions. A total of 993 patients were included (mean age 72.2 (SD 10.4), males 66%) with AMI (35%), AF (25%), angina (21%) and HF (17.3%). Patients completed the Patient Continuity of Care Questionnaire, a questionnaire based on the definition that continuity of care is “the extent to which a series of health care services is experienced as connected and coherent and is consistent with a patient's health needs and personal circumstances”. The total score of the questionnaire ranges from 6 to 30, higher score indicating higher continuity and a score <24 indicating insufficient continuity. Cronbach's alpha on the total PCCQ was 0.94. Correlations between PCCQ and quality of life, depression, anxiety, perceived control and health care utilization were estimated using spearman rang correlation. Results Insufficient continuity of care ranged between 47% to 59% in the different diagnosis groups, which the highest continuity in the AMI group and lowest in patients with atrial fibrillation. In patients hospitalized due to AMI (n=355, mean age 71 (± 11), 70% men), continuity of care was related to higher perceived control, higher quality of life, a good financial situation, being a man, no symptoms of anxiety or depression (ᚹ range 0.17–0.26 p≤0.002). A low score on the PCCQ were associated with follow-up visit to a nurse in primary care after hospitalization (ᚹ −0.12 p=0.033). In patients hospitalized due to angina (n=210, mean age 73 (± 9), 74% men), continuity of care was related to higher perceived control, higher quality of life and no depressive symptoms (ᚹ range between 0.20 and 0.26 p=0.005). In patients with AF, (n=255, mean age 71 (± 10.), 58% men), continuity of care was related to having had contact by telephone with a nurse-led AF clinic, higher perceived control, higher quality of life and not being depressed (ᚹ range between 0.14–0.25 p=0.03). In patients with HF, (n=173, mean age 77 (±8) 59% men), continuity was related to male ender, younger age, follow-up in a nurse-led HF clinic and not being anxious (ᚹ range between 0.16 and 0.22 p=0.004–0.047). Low total score on PCCQ correlated to having had telephone contact with nurse in primary care (ᚹ −0.24 p=0.002). Conclusion Almost half of all patient reported insufficient continuity of care. Perceived control, quality of life, and symptoms of depression were related to higher continuity of care in all diagnose groups except heart failure. Further, there was a correlation between continuity and follow-up visits or contact by telephone with nurse-led clinics in all diagnose groups except angina. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Medical Research Council of Southeast Sweden, Centre for Clinical Research Sörmland


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