| 1. |
- Aktaa, Suleman, et al.
(author)
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Data standards for transcatheter aortic valve implantation : the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart).
- 2023
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In: European Heart Journal - Quality of Care and Clinical Outcomes. - : Oxford University Press. - 2058-5225 .- 2058-1742. ; 9:5, s. 529-536
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Journal article (peer-reviewed)abstract
- AIMS: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI).METHODS AND RESULTS: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform.CONCLUSION: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices and pharmacotherapies.
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| 2. |
- Andersson, Charlotte, et al.
(author)
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A risk score for predicting 30-day mortality in heart failure patients undergoing non-cardiac surgery
- 2014
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In: European Journal of Heart Failure. - : Wiley. - 1879-0844 .- 1388-9842. ; 16:12, s. 1310-1316
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Journal article (peer-reviewed)abstract
- BackgroundHeart failure is an established risk factor for poor outcomes in patients undergoing non-cardiac surgery, yet risk stratification remains a clinical challenge. We developed an index for 30-day mortality risk prediction in this particular group. Methods and resultsAll individuals with heart failure undergoing non-cardiac surgery between October 23 2004 and October 31 2011 were included from Danish administrative registers (n=16827). In total, 1787 (10.6%) died within 30days. In a simple risk score based on the variables from the revised cardiac risk index, plus age, gender, acute surgery, and body mass index category the following variables predicted mortality (points): male gender (1), age 56-65years (2), age 66-75years (4), age 76-85years (5), or age >85years (7), being underweight (4), normal weight (3), or overweight (1), undergoing acute surgery (5), undergoing high-risk procedures (intra-thoracic, intra-abdominal, or suprainguinal aortic) (3), having renal disease (1), cerebrovascular disease (1), and use of insulin (1). The c-statistic was 0.79 and calibration was good. Mortality risk ranged from <2% for a score <5 to >50% for a score 20. Internal validation by bootstrapping (1000 re-samples) provided c-statistic of 0.79. A more complex risk score based on stepwise logistic regression including 24 variables at P<0.05 performed only slightly better, c-statistic=0.81, but was limited in use by its complexity. ConclusionsFor patients with heart failure, this simple index can accurately identify those at low risk for perioperative mortality.
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| 3. |
- Azawi, Nessn, et al.
(author)
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suPARnostic : an advanced predictive tool for detecting recurrence in renal cell carcinoma
- 2023
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In: BMC Urology. - 1471-2490. ; 23:1
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Journal article (peer-reviewed)abstract
- Background: Plasma soluble urokinase-type Plasminogen Activator Receptor (suPAR) predicts disease aggressiveness in renal cell carcinoma (ccRCC), but its prognostic accuracy has not been investigated. To investigate the prognostic accuracy of preoperative plasma suPAR in patients who received curative treatment for initially localized ccRCC. Methods: We retrospectively analyzed plasma samples stored in the Danish National Biobank between 2010 and 2015 from 235 patients with ccRCC at any stage. Relationships with outcome analyzed using univariate and multiple logistic Cox regression analysis. Results: There were 235 patients with ccRCC. The median follow-up period was 7.7 years. In univariate analysis suPAR ≥ 6 ng/mL was significantly associated with overall survival (OS) and recurrence-free survival (RFS). Patients with elevated suPAR were more likely to recur, with a Hazard Ratio (HR) of 2.3 for RFS. In multiple logistic regression, suPAR ≥ 6 ng/mL remained a negative predictor of OS and RFS. Limitations include retrospective study design, wide confidence intervals, and tumor subtype heterogeneity bias. Conclusions: ccRCC patients with high plasma suPAR concentrations are at an elevated risk of disease recurrence and see lower OS. suPAR is a promising surveillance tool to more precisely follow up with ccRCC patients and detect future recurrences. Patient Summary: In this study, we showed that new type of liquid marker in blood plasma, called suPAR, is associated to a higher risk of kidney cancer recurrence when elevated above 6ng/mL. We also showed suPAR to independently be able to predict patients overall and recurrence free survival in patient with any stage of kidney cancer.
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| 4. |
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| 5. |
- Elkoumy, Ahmed, et al.
(author)
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ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty : direct ACURATE neo2
- 2024
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In: International Journal of Cardiology. - 0167-5273 .- 1874-1754. ; 400
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Journal article (peer-reviewed)abstract
- Background: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice. Aim: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV. Methodology: This is a retrospective multicentre analysis of 499 patients with severe aortic stenosis who underwent TAVI using Neo2. The comparison was done according to the performance or omission of BAV. Echocardiography and computed tomography were analysed by an independent Core Lab. Propensity score matching (PSM) was performed based on the annular diameter and AV calcium volume, which identified 84 matched pairs. Results: Among the cohort included, 391 (78%) patients received BAV (BAV-yes) and 108 (22%) were not attempted (BAV-no or Direct TAVI). Patients in BAV-no cohort had smaller annular diameter (22.6 vs 23.4 mm; p < 0.001) and lower calcium volume (163 vs 581 mm3; p < 0.001) compared to BAV-yes cohort. In the matched cohort, VARC-3 device technical success was similar (95%) and all other outcome measures were statistically comparable between cohorts. Conclusion: Direct TAVI using ACURATEneo2 without pre-TAVI balloon aortic valvuloplasty in patients with mild or less valve calcifications might be feasible and associated with comparable early outcomes compared to patients with similar anatomical features undergoing systematic balloon valvuloplasty.
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| 6. |
- Hedström, Anna Karin, et al.
(author)
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The interaction between smoking and HLA genes in multiple sclerosis : replication and refinement
- 2017
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In: European Journal of Epidemiology. - : Springer Science and Business Media LLC. - 0393-2990 .- 1573-7284. ; 23:1, s. 37-37
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Journal article (peer-reviewed)abstract
- Interactions between environment and genetics may contribute to multiple sclerosis (MS) development. We investigated whether the previously observed interaction between smoking and HLA genotype in the Swedish population could be replicated, refined and extended to include other populations. We used six independent case-control studies from five different countries (Sweden, Denmark, Norway, Serbia, United States). A pooled analysis was performed for replication of previous observations (7190 cases, 8876 controls). Refined detailed analyses were carried out by combining the genetically similar populations from the Nordic studies (6265 cases, 8401 controls). In both the pooled analyses and in the combined Nordic material, interactions were observed between HLA-DRB*15 and absence of HLA-A*02 and between smoking and each of the genetic risk factors. Two way interactions were observed between each combination of the three variables, invariant over categories of the third. Further, there was also a three way interaction between the risk factors. The difference in MS risk between the extremes was considerable; smokers carrying HLA-DRB1*15 and lacking HLA-A*02 had a 13-fold increased risk compared with never smokers without these genetic risk factors (OR 12.7, 95% CI 10.8-14.9). The risk of MS associated with HLA genotypes is strongly influenced by smoking status and vice versa. Since the function of HLA molecules is to present peptide antigens to T cells, the demonstrated interactions strongly suggest that smoking alters MS risk through actions on adaptive immunity.
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| 7. |
- Larsen, Lars Bruun, et al.
(author)
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Digital Recruitment and Acceptance of a Stepwise Model to Prevent Chronic Disease in the Danish Primary Care Sector : Cross-Sectional Study
- 2019
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In: Journal of Medical Internet Research. - : JMIR Publications Inc.. - 1438-8871. ; 21:1
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Journal article (peer-reviewed)abstract
- BACKGROUND: During recent years, stepwise approaches to health checks have been advanced as an alternative to general health checks. In 2013, we set up the Early Detection and Prevention project (Tidlig Opsporing og Forebyggelse, TOF) to develop a stepwise approach aimed at patients at high or moderate risk of a chronic disease. A novel feature was the use of a personal digital mailbox for recruiting participants. A personal digital mailbox is a secure digital mailbox provided by the Danish public authorities. Apart from being both safe and secure, it is a low-cost, quick, and easy way to reach Danish residents. OBJECTIVE: In this study we analyze the association between the rates of acceptance of 2 digital invitations sent to a personal digital mailbox and the sociodemographic determinants, medical treatment, and health care usage in a stepwise primary care model for the prevention of chronic diseases. METHODS: We conducted a cross-sectional analysis of the rates of acceptance of 2 digital invitations sent to randomly selected residents born between 1957 and 1986 and residing in 2 Danish municipalities. The outcome was acceptance of the 2 digital invitations. Statistical associations were determined by Poisson regression. Data-driven chi-square automatic interaction detection method was used to generate a decision tree analysis, predicting acceptance of the digital invitations. RESULTS: A total of 8814 patients received an invitation in their digital mailbox from 47 general practitioners. A total of 40.22% (3545/8814) accepted the first digital invitation, and 30.19 % (2661/8814) accepted both digital invitations. The rates of acceptance of both digital invitations were higher among women, older patients, patients of higher socioeconomic status, and patients not diagnosed with or being treated for diabetes mellitus, chronic obstructive pulmonary disease, or cardiovascular disease. CONCLUSIONS: To our knowledge, this is the first study to report on the rates of acceptance of digital invitations to participate in a stepwise model for prevention of chronic diseases. More studies of digital invitations are needed to determine if the acceptance rates seen in this study should be expected from future studies as well. Similarly, more research is needed to determine whether a multimodal recruitment approach, including digital invitations to personal digital mailboxes will reach hard-to-reach subpopulations more effectively than digital invitations only.
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| 8. |
- Larsen, Lars Bruun, et al.
(author)
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Step-wise approach to prevention of chronic diseases in the Danish primary care sector with the use of a personal digital health profile and targeted follow-up- A n assessment of attendance
- 2019
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In: BMC Public Health. - : Springer Science and Business Media LLC. - 1471-2458. ; 19
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Journal article (peer-reviewed)abstract
- Background: Current evidence on chronic disease prevention suggests that interventions targeted at high-risk individuals represents the best way forward. We implemented a step-wise approach in the Danish primary care sector, designed for the systematic and targeted prevention of chronic disease. The intervention centered on a personal digital health profile for all participants, followed by targeted preventive programs for high-risk patients. The present paper examines individual characteristics and health-care usage of patients who took up the targeted preventive programs in response to their personal digital health profile. Methods: A sample of patients born between 1957 and 1986 was randomly selected from the patient-list system of participating general practitioners in two Danish municipalities. The selected patients received a digital invitation to participate. Consenting patients received a second digital invitation for a personal digital health profile based on questionnaire and electronic patient record data. The personal digital health profile contained individualized information on risk profile and personalized recommendations on further actions. If at-risk or presenting with health-risk behaviour a patient would be advised to contact either their general practitioner or municipal health centre for targeted preventive programs. Attendance at the targeted preventive programs was examined using Poisson regression and chi-squared automatic interaction detection methods. Results: A total of 9400 patients were invited. Of those who participated (30%), 22% were advised to get a health check at their general practitioner. Of these, 19% did so. Another 23% were advised to schedule an appointment for behaviour-change counselling at their municipal health centre. A total of 21% took the advice. Patients who had fair or poor self-rated health, a body mass index above 30, low self-efficacy, were female, non-smokers, or lead a sedentary lifestyle, were most likely to attend the targeted preventive programs. Conclusions: A personal digital health profile shows some promise in a step-wise approach to prevention in the Danish primary care sector and seems to motivate people with low self-efficacy to attend targeted preventive programs.
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| 9. |
- Larsen, Lars Bruun, et al.
(author)
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Targeted prevention in primary care aimed at lifestyle-related diseases : A study protocol for a non-randomised pilot study
- 2018
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In: BMC Family Practice. - : Springer Science and Business Media LLC. - 1471-2296. ; 19:1
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Journal article (peer-reviewed)abstract
- Background: The consequences of lifestyle-related disease represent a major burden for the individual as well as for society at large. Individual preventive health checks to the general population have been suggested as a mean to reduce the burden of lifestyle-related diseases, though with mixed evidence on effectiveness. Several systematic reviews, on the other hand, suggest that health checks targeting people at high risk of chronic lifestyle-related diseases may be more effective. The evidence is however very limited. To effectively target people at high risk of lifestyle-related disease, there is a substantial need to advance and implement evidence-based health strategies and interventions that facilitate the identification and management of people at high risk. This paper reports on a non-randomized pilot study carried out to test the acceptability, feasibility and short-term effects of a healthcare intervention in primary care designed to systematically identify persons at risk of developing lifestyle-related disease or who engage in health-risk behavior, and provide targeted and coherent preventive services to these individuals. Methods: The intervention took place over a three-month period from September 2016 to December 2016. Taking a two-pronged approach, the design included both a joint and a targeted intervention. The former was directed at the entire population, while the latter specifically focused on patients at high risk of a lifestyle-related disease and/or who engage in health-risk behavior. The intervention was facilitated by a digital support system. The evaluation of the pilot will comprise both quantitative and qualitative research methods. All outcome measures are based on validated instruments and aim to provide results pertaining to intervention acceptability, feasibility, and short-term effects. Discussion: This pilot study will provide a solid empirical base from which to plan and implement a full-scale randomized study with the central aim of determining the efficacy of a preventive health intervention. Trial registration: Registered at Clinical Trial Gov (Unique Protocol ID: TOFpilot2016). Registered 29 April 2016. The study adheres to the SPIRIT guidelines.
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| 10. |
- Ludwig, Sebastian, et al.
(author)
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Transcatheter Mitral Valve Replacement versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison.
- 2023
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In: Circulation. Cardiovascular interventions. - 1941-7632. ; 16:6
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Journal article (peer-reviewed)abstract
- Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry included patients with MR undergoing TMVR using dedicated devices. Patients with MR etiologies other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial. We compared outcomes between the TMVR and GDMT groups, using propensity score (PS)-matching to adjust for baseline differences. Results: After PS-matching, 97 patient pairs undergoing TMVR (72.9±8.7 years, 60.8% male, transapical access 91.8%) versus GDMT (73.1±11.0 years, 59.8% male) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared to 6.9% and 7.7%, respectively, in those receiving GDMT alone (both p<0.001). The 2-year rate of HF hospitalization was significantly lower in the TMVR group (32.8% vs. 54.4%, HR 0.59, 95% CI 0.35-0.99; p=0.04). Among survivors, a higher proportion of patients were in NYHA functional class I or II in the TMVR group at 1 year (78.2% vs. 59.7%, p=0.03) and at 2 years (77.8% vs. 53.2%, p=0.09). Two-year mortality was similar in the two groups (TMVR vs. GDMT, 36.8% vs. 40.8%, HR 1.01, 95% CI 0.62-1.64; p=0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for HF and similar mortality compared with GDMT.
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