| 1. |
- Ferguson, Murdo, et al.
(författare)
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Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults
- 2024
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Ingår i: Vaccine: X. - : Elsevier. - 2590-1362. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Background: Previous phase 3 studies showed that the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) is well tolerated and efficacious in preventing RSV-associated lower respiratory tract disease in adults ≥ 60 years of age. This study evaluated lot-to-lot immunogenicity consistency, reactogenicity, and safety of three RSVPreF3 OA lots. Methods: This phase 3, multicenter, double-blind study randomized (1:1:1) participants ≥ 60 years of age to receive one of three RSVPreF3 OA lots. Serum RSVPreF3-binding immunoglobulin G (IgG) concentration was assessed at baseline and 30 days post-vaccination. Lot-to-lot consistency was demonstrated if the two-sided 95 % confidence intervals (CIs) of the RSVPreF3-binding IgG geometric mean concentration (GMC) ratios between each lot pair at 30 days post-vaccination were within 0.67 and 1.50. Solicited adverse events (AEs) within four days, unsolicited AEs within 30 days, and serious AEs (SAEs) and potential immune-mediated diseases within six months post-vaccination were recorded. Results: A total of 757 participants received RSVPreF3 OA, of whom 708 were included in the per-protocol set (234, 237, and 237 participants for each lot). Lot-to-lot consistency was demonstrated: GMC ratios were 1.06 (95 % CI: 0.94–1.21), 0.92 (0.81–1.04), and 0.87 (0.77–0.99) between the lot pairs (lot 1/2; 1/3; 2/3). For the three lots, the RSVPreF3-binding IgG concentration increased 11.84-, 11.29-, and 12.46-fold post-vaccination compared to baseline. The reporting rates of solicited and unsolicited AEs, SAEs, and potential immune-mediated diseases were balanced between lots. Twenty-one participants reported SAEs; one of these–a case of atrial fibrillation–was considered by the investigator as vaccine-related. SAEs with a fatal outcome were reported for four participants, none of which were considered by the investigator as vaccine-related. Conclusion: This study demonstrated lot-to-lot immunogenicity consistency of three RSVPreF3 OA vaccine lots and indicated that the vaccine had an acceptable safety profile. ClinicalTrials.gov: NCT05059301. © 2024 GSK
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| 2. |
- Lindberg, Terese, et al.
(författare)
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Prevalence and Incidence of Atrial Fibrillation and Other Arrhythmias in the General Older Population : Findings From the Swedish National Study on Aging and Care
- 2019
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Ingår i: Gerontology and geriatric medicine. - : SAGE PUBLICATIONS INC. - 2333-7214. ; 5
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Tidskriftsartikel (refereegranskat)abstract
- Aim: To study the prevalence and cumulative incidence of arrhythmias in the general population of adults aged 60 and older over a 6-year period. Study Design and Setting: Data were taken from the Swedish National Study on Aging and Care (SNAC), a national, longitudinal, multidisciplinary study of the general elderly population (defined as 60 years of age or older). A 12-lead resting electrocardiography (ECG) was performed at baseline and 6-year follow-up. Results: The baseline prevalence of atrial fibrillation (AF) was 4.9% (95% confidence interval [CI] = [4.5%, 5.5%]), and other arrhythmias including ventricular premature complexes (VPCs), supraventricular tachycardia (SVT), and supraventricular extrasystole (SVES) were seen in 8.4% (7.7%, 9.0%) of the population. A first- or second-degree atrioventricular (AV) block was found in 7.1% of the population (95% CI = [6.5%, 7.7%]), and there were no significant differences between men and women in baseline arrhythmia prevalence. The 6-year cumulative incidence of AF was 4.1% (95% CI = [3.5%, 4.9%]), or 6.9/1,000 person-years (py; 95% CI = [5.7, 8.0]). The incidence of AF, other arrhythmias, AV block, and pacemaker-induced rhythm was significantly higher in men in all cohorts except for the oldest. Conclusion: Our data highlight the prevalence and incidence of arrhythmias, which rapidly increase with advancing age in the general population.
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| 3. |
- Bengtsson, Viveca Wallin, et al.
(författare)
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Periodontitis related to cardiovascular events and mortality : a long-time longitudinal study
- 2021
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Ingår i: Clinical Oral Investigations. - : Springer Science and Business Media Deutschland GmbH. - 1432-6981 .- 1436-3771. ; 25:6, s. 4085-4095
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The present study assessed if individuals ≥ 60 years of age with periodontitis are more likely to develop stroke or ischemic heart diseases, or at a higher risk of death for 17 years. Material and methods: At baseline individuals ≥ 60 received a dental examination including a panoramic radiograph. Periodontitis was defined as having ≥ 30% sites with ≥ 5-mm distance from the cementoenamel junction to the marginal bone level. Medical records were annually reviewed from 2001 to 2018. Findings from the medical records identifying an ICD-10 code of stroke and ischemic heart diseases or death were registered. Results: Associations between periodontitis and incidence of ischemic heart disease were found in this 17-year follow-up study in all individuals 60–93 years (HR: 1.5, CI: 1.1–2.1, p = 0.017), in women (HR: 2.1, CI: 1.3–3.4, p = 0.002), and in individuals 78–96 years (HR: 1.7, CI: 1.0–2.6, p = 0.033). Periodontitis was associated with mortality in all individuals (HR: 1.4, CI: 1.2–1.8, p = 0.002), specifically in men (HR: 1.5, CI: 1.1–1.9, p = 0.006) or in ages 60–72 years (HR: 2.2, CI: 1.5–3.2, p = 0.000). Periodontitis was more prevalent among men (OR: 1.8, CI: 1.3–2.4, p = 0.000). Conclusions: Individuals with periodontitis have an increased risk for future events of ischemic heart diseases and death. Clinical relevance: Improving periodontal health in older individuals may reduce overall mortality and ischemic heart diseases. Both dental and medical professionals should be aware of the associations and ultimately cooperate. © 2021, The Author(s).
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| 4. |
- Javeed, Ashir, 1989-, et al.
(författare)
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Decision Support System for Predicting Mortality in Cardiac Patients Based on Machine Learning
- 2023
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Ingår i: Applied Sciences. - : MDPI. - 2076-3417. ; 13:8
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Tidskriftsartikel (refereegranskat)abstract
- Researchers have proposed several automated diagnostic systems based on machine learning and data mining techniques to predict heart failure. However, researchers have not paid close attention to predicting cardiac patient mortality. We developed a clinical decision support system for predicting mortality in cardiac patients to address this problem. The dataset collected for the experimental purposes of the proposed model consisted of 55 features with a total of 368 samples. We found that the classes in the dataset were highly imbalanced. To avoid the problem of bias in the machine learning model, we used the synthetic minority oversampling technique (SMOTE). After balancing the classes in the dataset, the newly proposed system employed a (Formula presented.) statistical model to rank the features from the dataset. The highest-ranked features were fed into an optimized random forest (RF) model for classification. The hyperparameters of the RF classifier were optimized using a grid search algorithm. The performance of the newly proposed model ((Formula presented.) _RF) was validated using several evaluation measures, including accuracy, sensitivity, specificity, F1 score, and a receiver operating characteristic (ROC) curve. With only 10 features from the dataset, the proposed model (Formula presented.) _RF achieved the highest accuracy of 94.59%. The proposed model (Formula presented.) _RF improved the performance of the standard RF model by 5.5%. Moreover, the proposed model (Formula presented.) _RF was compared with other state-of-the-art machine learning models. The experimental results show that the newly proposed decision support system outperforms the other machine learning systems using the same feature selection module ((Formula presented.)).
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| 5. |
- Lindberg, Terese, et al.
(författare)
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Older individuals’ need for knowledge and follow-up about their chronic atrial fibrillation, lifelong medical treatment and medical controls
- 2017
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Ingår i: Scandinavian Journal of Caring Sciences. - : Wiley. - 0283-9318 .- 1471-6712. ; 31:4, s. 1022-1030
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Tidskriftsartikel (refereegranskat)abstract
- Older individuals with chronic atrial fibrillation (AF) often experience physical symptoms and feel psychologically unwell. In addition, these persons are prescribed lifelong medical treatment that requires regular monitoring. Through 11 individual interviews, this interpretive description study aimed to explore and describe lifelong medical treatment and the need for medical controls as experienced from the perspective of older individuals living with chronic AF. The interviews were performed during 2014–2015; furthermore, they were recorded, transcribed verbatim and analysed for thematic patterns using thematic analysis inspired by Braun and Clarke. Ethical standards were followed throughout the study. The findings revealed one main theme: ‘ambivalence in the need of knowledge’ showing that lifelong medical treatment and the need for medical controls, in general, meant experiencing feelings of ‘it doesn't matter, but it does matter’ and ‘being in the hands of the healthcare system’. The older persons lacked knowledge about their condition, which generated poor insight into their medical treatment and this in turn affected their daily life. They had thoughts and questions about their medication, but did not have an opportunity to ask the questions because of lack of follow-up from the healthcare system. The findings underscore the negative impact chronic AF has on older people's life and emphasises the need for follow-up and providing information from health care to these individuals.
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| 6. |
- Lindberg, Terese, et al.
(författare)
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Prevalence of unknown and untreated arrhythmias in an older outpatient population screened by wireless long-term recording ECG
- 2016
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Ingår i: Clinical Interventions in Aging. - 1176-9092 .- 1178-1998. ; 11, s. 1083-1090
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: With longer life expectancies, the prevalence of arrhythmias is increasing; thus, there is a need for new methods to screen the older outpatient population. This population-based study describes the prevalence of arrhythmias in 200 outpatients aged ≥66 years. We also investigated the feasibility of wireless long-term recording (LTR) using the ECG-BodyKom®. Methods: Two hundred elderly persons aged 66–93 years were recruited from the Swedish National Study on Aging and Care in 2010–2013, and data were collected via wireless LTR ECG-BodyKom. Results: Screening with the LTR ECG revealed that persistent atrial fibrillation (AF) occurred in 10% of the outpatient population aged ≥66 years. Paroxysmal AF occurred in 5.5% of the population, with no difference between younger (60–80 years) and older (≥80 years) elderly participants. Furthermore, all patients with paroxysmal AF had a CHA2DS2VASc score of ≥2 and were therefore potential candidates for follow-up and medical examination. LTR ECG-BodyKom can be considered a feasible method to screen for arrhythmias in older outpatient populations. This simple method requires little of the user, and there was high satisfaction with the equipment and a good overall experience wearing it. Conclusion: The increasing occurrence of arrhythmias in the older population, as well as the high number of untreated cases of arrhythmias such as persistent AF and paroxysmal AF, poses a challenge for health care. Therefore, it is essential to develop effective strategies for their prevention and treatment.
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| 7. |
- Olsson, Anki, et al.
(författare)
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Better platelet function, less fibrinolysis and less hemolysis in re-transfused residual pump blood with the Ringer’s chase technique : a randomized pilot study
- 2018
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Ingår i: Perfusion. - : Sage Publications. - 0267-6591 .- 1477-111X. ; 33:3, s. 185-193
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Residual pump blood from the cardiopulmonary bypass (CPB) circuit is often collected into an infusion bag (IB) and re-transfused. An alternative is to chase the residual blood into the circulation through the arterial cannula with Ringer’s acetate. Our aim was to assess possible differences in hemostatic blood quality between these two techniques.Methods: Forty adult patients undergoing elective coronary artery bypass graft surgery with CPB were randomized to receive the residual pump blood by either an IB or through the Ringer’s chase (RC) technique. Platelet activation and function (impedance aggregometry), coagulation and hemolysis variables were assessed in the re-transfused blood and in the patients before, during and after surgery. Results are presented as median (25-75 quartiles).Results: Total hemoglobin and platelet levels in the re-transfused blood were comparable with the two methods, as were soluble platelet activation markers P-selectin and soluble glycoprotein VI (GPVI). Platelet aggregation (U) in the IB blood was significantly lower compared to the RC blood, with the agonists adenosine diphosphate (ADP) 24 (10-32) vs 46 (33-65), p<0.01, thrombin receptor activating peptide (TRAP) 50 (29-73) vs 69 (51-92), p=0.04 and collagen 24 (17-28) vs 34 (26-59), p<0.01. The IB blood had higher amounts of free hemoglobin (mg/L) (1086 (891-1717) vs 591(517-646), p<0.01) and D-dimer 0.60 (0.33-0.98) vs 0.3 (0.3-0.48), p<0.01. Other coagulation variables showed no difference between the groups. Conclusions: The handling of blood after CPB increases hemolysis, impairs platelet function and activates coagulation and fibrinolysis. The RC technique preserved the blood better than the commonly used IB technique.
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| 8. |
- Olsson, Anki, et al.
(författare)
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Protamine reduces whole blood platelet aggregation after cardiopulmonary bypass
- 2016
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Ingår i: Scandinavian Cardiovascular Journal. - : TAYLOR & FRANCIS LTD. - 1401-7431 .- 1651-2006. ; 50:1, s. 58-63
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Tidskriftsartikel (refereegranskat)abstract
- Platelet dysfunction is an important cause of postoperative bleeding after cardiac surgery. Protamine is routinely used for reversal of heparin after cardiopulmonary bypass (CBP), but may affect platelet aggregation. We assessed changes in platelet function in relation to protamine administration. Design: Platelet aggregation was analyzed by impedance aggregometry before and after protamine administration in 25 adult cardiac surgery patients. Aggregation was also studied after in vitro addition of heparin and protamine. The activators adenosine diphosphate (ADP), thrombin receptor activating peptide-6 (TRAP), arachidonic acid (AA) and collagen (COL) were used.Results: Platelet aggregation was reduced by approximately 50% after in vivo protamine administration; ADP 640 +/- 230 (AU*min, mean +/- SD) to 250 +/- 160, TRAP 939 +/- 293 to 472 +/- 260, AA 307 +/- 238 to 159 +/- 143 and COL 1022 +/- 350 to 506 +/- 238 (all p<0.001). Aggregation was also reduced after in vitro addition of protamine alone with activators ADP from 518 +/- 173 to 384 +/- 157 AU*min p<0.001, and AA 449 +/- 311 to 340 +/- 285 (p<0.01) and protamine combined with heparin (1:1 ratio) with activators ADP to 349 +/- 160 and AA to 308 +/- 260 (both p<0.001); and COL from 586 +/- 180 to 455 +/- 172 (p<0.05). Conclusions: Protamine given after CPB markedly reduces platelet aggregation. Protamine added in vitro also reduces platelet aggregation, by itself or in combination with heparin.
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| 9. |
- Widen, Cecilia, et al.
(författare)
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Systemic inflammatory impact of periodontitis on acute coronary syndrome
- 2016
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Ingår i: Journal of Clinical Periodontology. - : Wiley. - 0303-6979 .- 1600-051X. ; 43:9, s. 713-719
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Tidskriftsartikel (refereegranskat)abstract
- AimA causative relationship between acute coronary syndrome (ACS) and periodontitis has yet to be defined. The aim of this study was to assess differences in levels of serum cytokines between individuals with or without ACS or periodontal comorbidity. Material and MethodsIn a case-control study, individuals with ACS (78 individuals, 10.3% females) and matching healthy controls (78 individuals, 28.2% females) were included. Medical and dental examinations were performed to diagnose ACS and periodontitis. Serum levels of cytokines were assessed, using Luminex technology. ResultsA diagnosis of periodontitis in the ACS and control group was diagnosed in 52.6% and 12.8% of the individuals, respectively. The unadjusted odds-ratio that individuals with ACS also had periodontitis was 7.5 (95% CI: 3.4, 16.8, p<0.001). Independent of periodontal conditions, individuals with ACS had significantly higher serum levels of IL8 (mean: 44.3 and 40.0pg/ml) and vascular endothelial growth factor (VEGF) (mean: 82.3 and 55.3pg/ml) than control individuals. A diagnosis of periodontitis made no difference in serum cytokine expressions. ConclusionElevated serum levels of VEGF were associated with ACS. Serum cytokine expression in individuals with ACS is unrelated to periodontal conditions.
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| 10. |
- Olsson, Anki, Medicine doktor, et al.
(författare)
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Activated platelet aggregation is transiently impaired also by a reduced dose of protamine
- 2019
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Ingår i: Scandinavian Cardiovascular Journal. - : TAYLOR & FRANCIS LTD. - 1401-7431 .- 1651-2006. ; 53:6, s. 355-360
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Protamine reduces platelet aggregation after cardiopulmonary bypass (CPB). We studied the inhibitory effect of a reduced protamine dose, the duration of impaired platelet function and the possible correlation to postoperative bleeding. Design: Platelet function was assessed by impedance aggregometry in 30 patients undergoing cardiac surgery with CPB at baseline, before protamine administration, after 70% and 100% of the calculated protamine dose, after 20 minutes and at arrival to the intensive care unit. Adenosine diphosphate (ADP), thrombin receptor activating peptide-6 (TRAP), arachidonic acid (AA) and collagen (COL) were used as activators. Blood loss was measured during operation and three hours after surgery. Results are presented as median (25th-75th percentile). Results: Platelet aggregation decreased markedly after the initial dose of protamine (70%) with all activators; ADP 89 (71-110) to 54 (35-78), TRAP 143 (116-167) to 109 (77-136), both p < .01; AA 25 (16-49) to 17 (12-24) and COL 92 (47-103) to 60 (38-81) U, both p < .05. No further decrease was seen after 100% protamine. The effect was transient and after twenty minutes platelet aggregation had started to recover; ADP 76 (54-106), TRAP 138 (95-158), AA 20 (10-35), COL 70 (51-93) U. Blood loss during operation correlated to aggregometry measured at baseline and after protaminization. Conclusions: Protamine after CPB induces a marked decrease in platelet aggregation already at a protamine-heparin ratio of 0.7:1. The impairment seems to be transient and recovery had started after 20 minutes.
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