Development of a sports technology quality framework.

Identifying tools and processes to effectively and efficiently evaluate technologies is an area of need for many sport stakeholders. This study aimed to develop a standardised, evidence-based framework to guide the evaluation of sports technologies. In developing the framework, a review of standards, guidelines and research into sports technology was conducted. Following this, 55 experts across the sports industry were presented with a draft framework for feedback. Following a two-round Delphi survey, the final framework consisted of 25 measurable features grouped under five quality pillars. These were 1) Quality Assurance & Measurement (Accuracy, Repeatability, Reproducibility, Specifications), 2) Established Benefit (Construct Validity, Concurrent Validity, Predictive Validity, Functionality), 3) Ethics & Security (Compliance, Privacy, Ownership, Safety, Transparency, Environmental Sustainability), 4) User Experience (Usability, Robustness, Data Representation, Customer Support & Training, Accessibility) & 5) Data Management (Data Standardisation, Interoperability, Maintainability, Scalability). The framework can be used to help design and refine sports technology in order to optimise quality and maintain industry standards, as well as guide purchasing decisions by organisations. It may also serve to create a common language for organisations, manufacturers, investors, and consumers to improve the efficiency of their decision-making relating to sports technology.

Healthcare cost variation in patients with heart failure: a nationwide study.

OBJECTIVE: Heart failure (HF) imposes a major economic burden; however, the individual management for patients varies, potentially leading to large cost heterogeneity. The aim of this study was to investigate the spectrum of health cost by patients with HF and factors associated with high direct health cost. STUDY DESIGN: This was a nationwide, retrospective longitudinal study. METHODS: Using Danish nationwide registries from 2012 to 2015, we identified all patients aged >18 years with a first-time diagnosis of HF. Total health costs were investigated using two perspectives-at index and during 3 years of follow-up. Patients were investigated by decile cost groups. A multivariable logistic regression was used to identify variables associated with being in the highest cost decile compared with the rest (90%). RESULTS: A total of 11,170 patients with HF were included, and those in the highest cost decile (n = 1117, 10%) were younger (69 vs. 75 years), fewer were females (34% vs. 43%), and more were inpatients (83% vs. 70%) compared with the rest of the patients with HF (n = 10,053, 90%). Patients in the highest cost decile (10%) incurred a 30 times higher cost with a mean total health cost in index year of €86,607 compared with €2893 for patients in lowest cost decile (10%). The results were similar for 3 years aggregated (€139,473 vs. €4086), corresponding to a 34 times higher cost. CONCLUSION: In patients with HF, a large total health cost heterogeneity exists with younger age, inpatient admittance, male sex, and comorbidities being associated with a higher likelihood of belonging to the highest cost group.

Return to work after COVID-19 infection - A Danish nationwide registry study.

OBJECTIVES: This study aimed to explore return to work after COVID-19 and how disease severity affects this. STUDY DESIGN: This is a Nationwide Danish registry-based cohort study using a retrospective follow-up design. METHODS: Patients with a first-time positive SARS-CoV-2 polymerase chain reaction test between 1 January 2020 and 30 May 2020, including 18-64 years old, 30-day survivors, and available to the workforce at the time of the first positive test were included. Admission types (i.e. no admission, admission to non-intensive care unit [ICU] department and admission to ICU) and return to work was investigated using Cox regression standardised to the age, sex, comorbidity and education-level distribution of all included subjects with estimates at 3 months from positive test displayed. RESULTS: Among the 7466 patients included in the study, 81.9% (6119/7466) and 98.4% (7344/7466) returned to work within 4 weeks and 6 months, respectively, with 1.5% (109/7466) not returning. Of the patients admitted, 72.1% (627/870) and 92.6% (805/870) returned 1 month and 6 months after admission to the hospital, with 6.6% (58/870) not returning within 6 months. Of patients admitted to the ICU, 36% (9/25) did not return within 6 months. Patients with an admission had a lower chance of return to work 3 months from positive test (relative risk [RR] 0.95, 95% confidence interval [CI] 0.94-0.96), with the lowest chance in patients admitted to an ICU department (RR 0.54, 95% CI 0.35-0.72). Female sex, older age, and comorbidity were associated with a lower chance of returning to work. CONCLUSION: Hospitalised patients with COVID-19 infection have a lower chance of returning to work with potential implications for postinfection follow-up and rehabilitation.

Increased long-term risk of heart failure and other adverse cardiac outcomes in dermatomyositis and polymyositis: Insights from a nationwide cohort.

BACKGROUND: Mounting evidence suggests that dermatomyositis/polymyositis (DM/PM) are associated with increased risk of atherosclerotic events and venous thromboembolism. However, data on the association between DM/PM and other cardiac outcomes, especially heart failure (HF), are scarce. OBJECTIVES: To examine the long-term risk and prognosis associated with adverse cardiac outcomes in patients with DM/PM. METHODS: Using Danish administrative registries, we included all patients ≥18 years with newly diagnosed DM/PM (1996-2018). Risks of incident outcomes were compared with non-DM/PM controls from the background population (matched 1:4 by age, sex, and comorbidity). In a secondary analysis, we compared mortality following HF diagnosis between DM/PM patients with HF and non-DM/PM patients with HF (matched 1:4 by age and sex). RESULTS: The study population included 936 DM/PM patients (median age 58.5 years, 59.0% women) and 3744 matched non-DM/PM controls. The median follow-up was 6.9 years. Absolute 10-year risks of incident outcomes for DM/PM patients vs matched controls were as follows: HF, 6.98% (CI, 5.16-9.16%) vs 4.58% (3.79-5.47%) (P = 0.002); atrial fibrillation, 10.17% (7.94-12.71%) vs 7.07% (6.09-8.15%) (P = 0.005); the composite of ICD implantation/ventricular arrhythmias/cardiac arrest, 1.99% (1.12-3.27%) vs 0.64% (0.40-0.98%) (P = 0.02); and all-cause mortality, 35.42% (31.64-39.21%) vs 16.57% (15.10-18.10%) (P < 0.0001). DM/PM with subsequent HF was associated with higher mortality compared with HF without DM/PM (adjusted hazard ratio 1.58 [CI, 1.01-2.47]). CONCLUSION: Patients with DM/PM had a higher associated risk of HF and other adverse cardiac outcomes compared with matched controls. Among patients developing HF, a history of DM/PM was associated with higher mortality.

Incidence of acute myocardial infarction-related cardiogenic shock during corona virus disease 19 (COVID-19) pandemic.

AIMS: The hospitalization of patients with MI has decreased during global lockdown due to the COVID-19 pandemic. Whether this decrease is associated with more severe MI, e.g. MI-CS, is unknown. We aimed to examine the association of Corona virus disease (COVID-19) pandemic and incidence of acute myocardial infarction with cardiogenic shock (MI-CS). METHODS: On March 11, 2020, the Danish government announced national lock-down. Using Danish nationwide registries, we identified patients hospitalized with MI-CS. Incidence rates (IR) and incidence rate ratios (IRR) were used to compare MI-CS before and after March 11 in 2015-2019 and in 2020. RESULTS: We identified 11,769 patients with MI of whom 696 (5.9%) had cardiogenic shock in 2015-2019. In 2020, 2132 MI patients were identified of whom 119 had cardiogenic shock (5.6%). The IR per 100,000 person years before March 11 in 2015-2019 was 9.2 (95% CI: 8.3-10.2) and after 8.9 (95% CI: 8.0-9.9). In 2020, the IR was 7.5 (95% CI: 5.8-9.7) before March 11 and 7.7 (95% CI: 6.0-9.9) after. The IRRs comparing the 2020-period with the 2015-2019 period before and after March 11 (lockdown) were 0.81 (95% CI: 0.59-1.12) and 0.87 (95% CI: 0.57-1.32), respectively. The IRR comparing the 2020-period during and before lockdown was 1.02 (95% CI: 0.74-1.41). No difference in 7-day mortality or in-hospital management was observed between study periods. CONCLUSION: We could not identify a significant association of the national lockdown on the incidence of MI-CS, along with similar in-hospital management and mortality in patients with MI-CS.

Long-term outcomes after in-hospital cardiac arrest: 30-day survival and 1-year follow-up of mortality, anoxic brain damage, nursing home admission and in-home care.

AIMS: Long-term functional outcomes after in-hospital cardiac arrest (IHCA) are scarcely studied. However, survivors are at risk of neurological impairment from anoxic brain damage which could affect quality of life and lead to need of care at home or in a nursing home. METHODS: We linked data on ICHAs in Denmark with nationwide registries to report 30-day survival as well as factors associated with survival. Furthermore, among 30-day survivors we reported the one-year cumulative risk of anoxic brain damage or nursing home admission with mortality as the competing risk. RESULTS: In total, 517 patients (27.3%) survived to day 30 out of 1892 eligible patients; 338 (65.9%) were men and median age was 68 (interquartile range 58-76). Lower age, witnessed arrest by health care personnel, monitored arrest and presumed cardiac cause of arrest were associated with 30-day survival. Among 454 30-day survivors without prior anoxic brain damage or nursing home admission, the risk of anoxic brain damage or nursing home admission within the first-year post-arrest was 4.6% (n = 21; 95% CI 2.7-6.6%) with a competing risk of death of 15.6% (n = 71; 95% CI 12.3-19.0%), leaving 79.7% (n = 362) alive without anoxic brain damage or nursing home admission. When adding the risk of need of in-home care among 343 30-day survivors without prior home care needs, 68.8% (n = 236) were alive without any of the composite events one-year post-arrest. CONCLUSION: The majority of 30-day survivors of IHCA are alive at one-year follow-up without anoxic brain damage, nursing home admission or need of in-home care.

Preheart failure comorbidities and impact on prognosis in heart failure patients: a nationwide study.

BACKGROUND: Data regarding the impact of preheart failure (HF) comorbidities on the prognosis of HF are scarce, especially in the younger HF patients. OBJECTIVES: To investigate pre-existing comorbidities in HF patients versus matched controls and to assess their impact on mortality. METHODS: We included all first-time in-hospital and outpatient diagnoses of HF from 1995 to 2017, and comorbidities antedating the HF-diagnosis in the Danish nationwide registries. HF patients were matched with up to five controls. One-year all-cause mortality rates and population attributable risk (PAR) were estimated for three separate age groups (≤50, 51-74 and >74 years). RESULTS: Totally 280 002 patients with HF and 1 166 773 controls were included. Cardiovascular comorbidities, for example, cerebrovascular disease and ischaemic heart disease were more frequent in the oldest (17.9% and 29.7% in HF vs. 9.8% and 10.7% in controls) compared to the youngest age group (3.9% and 15.2% in HF vs. 0.7% and 0.9% in controls). Amongst patients with HF, 1-year mortality rates (per 100 person-years) were highest amongst those with >1 noncardiovascular comorbidity: ≤50 years (10.4; 9.64-11.3), 51-74 years (23.3; 22.9-23.7), >74 years (58.5; 57.9-59.0); hazard ratios 245.18 (141.45-424.76), 45.85 (42.77-49.15) and 24.5 (23.64-25.68) for those ≤50, 51-74 and >74 years, respectively. For HF patients ≤50 years, PAR was greatest for hypertension (17.8%), cancer (14.1%) and alcohol abuse (8.5%). For those aged >74 years, PAR was greatest for hypertension (23.6%), cerebrovascular disease (6.2%) and cancer (7.2%). CONCLUSIONS: Heart failure patients had a higher burden of pre-existing comorbidities, compared to controls, which adversely impacted prognosis, especially in the young.

Neurological prognostication tools in out-of-hospital cardiac arrest patients in Danish intensive care units from 2005 to 2013.

BACKGROUND: Neurological prognostication is an essential part of post-resuscitation care in out-of-hospital cardiac arrest (OHCA). This study aims to assess the use of computed tomography (CT) and magnetic resonance imaging (MR) of the head, electroencephalography (EEG), and somatosensory evoked potentials (SSEP) in neurological prognostication in resuscitated OHCA patients and factors associated with their use in Danish tertiary and non-tertiary centers from 2005 to 2013 and associations with outcome. METHODS: We used the Danish Cardiac Arrest Registry to identify patients ≥18 years of age admitted to intensive care units due to OHCA of presumed cardiac etiology. CT 0-20 days and MR, SSEP, and EEG ≥2-20 days post OHCA were considered related to prognostication. Incidence and factors associated with procedures were assessed by multiple Cox regression with death as competing risk. RESULTS: Use of CT, MR, EEG, and SSEP increased during the study period (CT: 51%-67%, HRCT : 1.06, CI: 1.03-1.08, MR: 2%-5%, P = .08, EEG: 6%-33%, HREEG : 1.25, CI: 1.19-1.30, SSEP: 4%-15%, HRSSEP : 1.23, CI: 1.15-1.32). EEG and SSEP were more used in tertiary centers than non-tertiary (HREEG : 1.86, CI: 1.51-2.29, HRSSEP : 4.44, CI: 2.86-6.89). Use of CT, SSEP, and EEG were associated with higher 30-day mortality, and MR was associated with lower (HRCT : 1.15, CI: 1.01-1.30, HRMR : 0.53, CI: 0.37-0.77, HRSSEP : 1.90, CI: 1.57-2.32, HREEG : 1.75, CI: 1.49-2.05). CONCLUSION: Use of neurological prognostication procedures increased during the study period. EEG and SSEP were more used in tertiary centers. CT, EEG and SSEP were associated with increased mortality.

Breastfeeding and later maternal risk of hypertension and cardiovascular disease - The role of overall and abdominal obesity.

In this study, we examined how any, full, and partial breastfeeding durations were associated with maternal risk of hypertension and cardiovascular disease (CVD), and how prepregnancy body mass index (BMI) and waist circumference 7 years postpartum influenced these associations. A total of 63,260 women with live-born singleton infants in the Danish National Birth Cohort (1996-2002) were included. Interviews during pregnancy and 6 and 18 months postpartum provided information on prepregnancy weight, height, and the duration of full and partial breastfeeding. Waist circumference was self-reported 7 years postpartum. Cox regression models were used to estimate hazard ratios of incident hypertension and CVD, registered in the National Patient Register from either 18 months or 7 years postpartum through 15 years postpartum. Any breastfeeding ≥4 months was associated with 20-30% lower risks of hypertension and CVD compared to <4 months in both normal/underweight and overweight/obese women. At follow-up starting 7 years postpartum, similar risk reductions were observed after accounting for waist circumference adjusted for BMI. Partial breastfeeding >2 months compared to ≤2 months, following up to 6 months of full breastfeeding, was associated with 10-25% lower risk of hypertension and CVD. Compared with short breastfeeding duration, additional partial breastfeeding was as important as additional full breastfeeding in reducing risk of hypertension and CVD. Altogether, longer duration of breastfeeding was associated with lower maternal risk of hypertension and CVD irrespective of prepregnancy BMI and abdominal adiposity 7 years after delivery. Both full and partial breastfeeding contributed to an improved cardiovascular health in mothers.

Plasma levels of ß2-microglobulin are associated with atherosclerosis in patients with systemic lupus erythematosus: a cross-sectional cohort study.

Objective The objective of this paper is to examine the association between plasma levels of ß2-microglobulin (ß2MG), a protein previously associated with atherosclerosis, and the presence of carotid plaque (CP) or coronary artery calcium (CAC) in a cross-sectional cohort study of patients with systemic lupus erythematosus (SLE). Methods Patients with SLE were enrolled between June 2013 and May 2014. The presence of CP and CAC was assessed with ultrasonography and computed tomography scan, respectively. The presence of CP or CAC in the SLE patients was analyzed with respect to plasma levels of ß2MG and renal function expressed as the estimated glomerular filtration rate (eGFR). Results The study cohort consisted of 147 patients, 89% women and 95% Caucasians. The median age was 46 (range: 21-75) years with a median disease duration of 14 years. CP and CAC was observed in 29 (20%) and 57 (39%) of patients, respectively. CP or CAC was seen in 62 (42%) patients and was associated with the highest quartile of plasma ß2MG in patients with eGFR ≥ 90 ml/min/1.73 m2; OR = 18 (95% CI: 1.7-181). ß2MG adjusted for eGFR was also associated with presence of CP or CAC in the total cohort. The exclusion of 25 patients with a prior history of cardiovascular disease did not change the observed associations. Conclusion In this study, we found significant associations between imaging markers of atherosclerosis and high plasma levels of plasma ß2MG. These data suggest that ß2MG is a candidate for further study as a biomarker for atherosclerosis in SLE.

Impact of metabolic disorders on the relation between overweight/obesity and incident myocardial infarction and ischaemic stroke in fertile women: a nationwide cohort study.

AIMS: Whether overweight is a risk factor for cardiovascular disease in the absence of metabolic disorders remains under debate and is largely unexamined in young women. We evaluated the risk of myocardial infarction and ischaemic stroke in fertile women conditional on time-dependent presence of metabolic disorders. MATERIALS AND METHODS: From nationwide registers we identified all normal weight (body mass index [BMI] ≥ 18.5 to <25 kg m(-2) and overweight (BMI ≥ 25 kg m(-2)) Danish women giving birth from 2004 to 2009. Using multivariable Poisson regression models adjusted for age, calendar year and smoking, the risk of the composite outcome of myocardial infarction and ischaemic stroke was assessed with metabolic disorders (i.e. hypertensive conditions, abnormal glucose metabolism and/or dyslipidaemia) included as time-dependent variables. RESULTS: The population comprised 261,489 women with median age of 30.5 years (interquartile range = [27.3, 33.8]). Median follow-up was 5.6 years (interquartile range = [4.0, 6.8]). Compared with normal weight women without metabolic disorders (with an incidence rate [IR] of 17.0 [95% confidence interval {CI} = 14.5-20.0] events per 100,000 person-years), overweight women without metabolic disorders had no significantly increased risk, IR 22.6 (CI = 18.3-27.8), adjusted incidence rate ratio (IRR), 1.26 (CI = 0.97-1.65). For women with metabolic disorders, IR was 30.2 (CI = 18.8-48.6) and adjusted IRR 1.77 (CI = 1.07-2.93) in normal weight, while IR was 87.1 (CI = 67.6-112.2) and IRR 4.24 (CI = 5 3.11-5.79) in overweight. CONCLUSIONS: The risk of myocardial infarction and ischaemic stroke was more strongly associated with the presence of metabolic disorders than with overweight per se in fertile women. Targeting prevention of metabolic disorders might be beneficial to reduce cardiovascular disease in overweight/obese young women.

High readmission rate after heart valve surgery: A nationwide cohort study.

BACKGROUND: After heart valve surgery, knowledge on long-term self-reported health status and readmission is lacking. Thus, the optimal strategy for out-patient management after surgery remains unclear. METHODS: Using a nationwide survey with linkage to Danish registers with one year follow-up, we included all adults 6-12 months after heart valve surgery irrespective of valve procedure, during Jan-June 2011 (n = 867). Participants completed a questionnaire regarding health-status (n = 742), and answers were compared with age- and sex-matched healthy controls. Readmission rates and mortality were investigated. RESULTS: After valve surgery, the self-reported health was lower (Short Form-36 (SF-36) Physical Component Scale (PCS): 44.5 vs. 50.6 and Mental Component Scale (MCS): 51.9 vs. 55.0, p < 0.0001) and more were physically sedentary compared with healthy controls (11.1% vs. 15.2%). Clinical signs of anxiety and depression were present in 13.6% and 13.8%, respectively (Hospital Anxiety and Depression Scale score ≥ 8). Twelve months following discharge, 483 persons (56%) were readmitted. Readmission was associated with lower self-reported health (SF-36 PCS: 46.5 vs. 43.9, and MCS 52.2 vs. 50.7). Higher age (hazard ratio (95% CI): 1.3 (1.0-1.6)), male sex (1.2 (1.0-1.5)), mitral valve surgery (1.3 (1.0-1.6)), and infective endocarditis after surgery (1.8 (1.1-3.0), p: 0.01) predicted readmission, whereas higher age (2.3 (1.0-5.4)), higher comorbidity score (3.2 (1.8-6.0)), and infective endocarditis after surgery (3.2 (1.2-8.9)) predicted mortality. CONCLUSIONS: 6-12 months after heart valve surgery the readmission rate is high and the self-reported health status is low. Readmission is associated with low self-reported health. Therefore, targeted follow-up strategies post-surgery are needed.

Pentraxin-3 level at admission is a strong predictor of short-term mortality in a community-based hospital setting.

BACKGROUND: The pattern recognition molecule pentraxin-3 (PTX3) is a novel potential marker of prognosis, as elevated levels are associated with both disease severity and mortality in patients with a wide range of conditions. However, the usefulness of PTX3 as a prognostic biomarker in a general hospital setting is unknown. PATIENTS AND METHODS: The study cohort consisted of 1326 unselected, consecutive patients (age >40 years) admitted to a community hospital in Copenhagen, Denmark. Patients were followed until death or for a median of 11.5 years after admission. The main outcome measure was all-cause mortality. Serum samples collected from patients at admission and from 192 healthy control subjects were quantified for PTX3 level by enzyme-linked immunosorbent assay. RESULTS: PTX3 was elevated in patients (median 3.7 ng mL(-1) , range 0.5-209.8) compared with healthy nonhospitalized subjects (median 3.5 ng mL(-1) , range 0.0-8.3; P = 0.0003). Elevated PTX3 levels, defined as above the 95th percentile of the concentration in healthy subjects, were associated with increased overall mortality during the study (P < 0.0001). This increase in mortality was greatest in the short term, with an unadjusted hazard ratio (HR) of 6.4 [95% confidence interval (CI) 3.8-11.0] at 28 days after admission, compared to 1.7 (95% CI 1.4-2.0) at the end of follow-up. These results were still significant after adjustment for age, gender and glomerular filtration rate: adjusted HR of 5.0 (95% CI 2.9-8.8) and 1.4 (95% CI 1.2-1.8), respectively. CONCLUSION: These results suggest that PTX3 could be a widely applicable marker of short-term mortality in hospitalized patients and may be useful in the initial risk stratification.

Hyponatraemia at hospital admission is a predictor of overall mortality.

BACKGROUND: Hyponatraemia is a prognostic marker of increased mortality and morbidity in selected groups of hospitalised patients. The aim of the present study was to examine the prevalence and prognostic significance of hyponatraemia at hospital admission in an unselected population with a broad spectrum of medical and surgical diagnoses. METHODS: Consecutive patients >40 years of age admitted to a general district hospital in Greater Copenhagen between 1 April 1998 and 31 March 1999. Median follow-up time was 5.16 years (range 0-4372 days). Plasma sodium measurements were available in 2960 patients, and hyponatraemia defined as P-Na(+) <137 mmol/L at hospital admission was present in 1105 (37.3 %) patients. RESULTS: One-year mortality was higher for hyponatraemic patients than for normonatraemic patients: 27.5% versus 17.7%. Moreover, hyponatraemia was an independent predictor of short and long-term all-cause mortality after 1 year and after the entire observation period respectively: hazard ratio (HR) 1.6 (95 % confidence interval (CI) 1.4-1.9, P < 0.0001) and HR 1.4 (95 % CI 1.3-1.6, P < 0.0001). Patients with hyponatraemia had longer hospitalisations than patients with normonatraemia: 7.6 (±0.38) days vs 5.6 (±0.21) days, P < 0.001. There was no interaction between hyponatraemia at admission and any admission diagnoses (P > 0.05 for all interaction analyses). CONCLUSION: Hyponatraemia is associated with increased all-cause mortality and longer admission length independently of diagnosis and clinical variables.

Antipsychotics and associated risk of out-of-hospital cardiac arrest.

Antipsychotic drugs have been associated with sudden cardiac death, but differences in the risk of out-of-hospital cardiac arrest (OHCA) associated with different antipsychotic drug classes are not clear. We identified all OHCAs in Denmark (2001-2010). The risk of OHCA associated with antipsychotic drug use was evaluated by conditional logistic regression analysis in case-time-control models. In total, 2,205 (7.6%) of 28,947 OHCA patients received treatment with an antipsychotic drug at the time of the event. Overall, treatment with any antipsychotic drug was associated with OHCA (odds ratio (OR) = 1.53, 95% confidence interval (CI): 1.23-1.89), as was use with typical antipsychotics (OR = 1.66, CI: 1.27-2.17). By contrast, overall, atypical antipsychotic drug use was not (OR = 1.29, CI: 0.90-1.85). Two individual typical antipsychotic drugs, haloperidol (OR = 2.43, CI: 1.20-4.93) and levomepromazine (OR = 2.05, CI: 1.18-3.56), were associated with OHCA, as was one atypical antipsychotic drug, quetiapine (OR = 3.64, CI: 1.59-8.30).

Cardiovascular safety of combination therapies with incretin-based drugs and metformin compared with a combination of metformin and sulphonylurea in type 2 diabetes mellitus--a retrospective nationwide study.

AIM: Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 (GLP-1) agonists are widely used in combinations with metformin in the treatment of type 2 diabetes; however, data on long-term safety compared with conventional combination therapies are limited. METHODS: Danish individuals without prior myocardial infarction or stroke that initiated combinations of metformin with sulphonylurea (SU), DPP-4 inhibitors, GLP-1 agonists or insulin between 9 May 2007 and 31 December 2011 were followed up for the risk of all-cause mortality, cardiovascular (CV) mortality or a combined end point of myocardial infarction, stroke and CV mortality. Rate ratios (RR) were calculated using time-dependent multivariable Poisson regression analysis. RESULTS: A total of 40 028 patients (59% men, mean age 60 ± 13 years) used metformin with SU (n = 25 092), DPP-4 inhibitor (n = 11 138), GLP-1 agonist (n = 4345) or insulin (n = 6858). Crude incidence rates per 1000 patient years for the combined end point were 18 (SU), 10 (DPP-4 inhibitor), 8 (GLP-1 agonist) and 21 (insulin). In adjusted analyses with metformin + SU as reference, metformin + DPP-4 inhibitor was associated with an RR of 0.65 (0.54-0.80) for mortality, an RR of 0.57 (0.40-0.80) for CV mortality and an RR of 0.70 (0.57-0.85) for the combined end point. For metformin + GLP-1 agonist, the RR for mortality was 0.77 (0.51-1.17), for CV mortality 0.89 (0.47-1.68), and for the combined end point 0.82 (0.55-1.21). CONCLUSION: Incretin-based drugs combined with metformin were safe compared with conventional combinations of glucose-lowering therapy. Use of incretin-based therapy may be target for strategies to lower CV risk in type 2 diabetes, although it should be recognized that the multivariable analysis may not have fully accounted for important baseline differences.

Ocular, bulbar, limb, and cardiopulmonary involvement in oculopharyngeal muscular dystrophy.

OBJECTIVES: To assess skeletal muscle weakness and progression as well as the cardiopulmonary involvement in oculopharyngeal muscular dystrophy (OPMD). MATERIALS AND METHODS: Cross-sectional study including symptomatic patients with genetically confirmed OPMD. Patients were assessed by medical history, ptosis, ophthalmoplegia, facial and limb strength, and swallowing capability. Cardiopulmonary function was evaluated using forced expiratory capacity in 1 s (FEV1), electrocardiogram (ECG), Holter monitoring, and echocardiography. RESULTS: We included 13 symptomatic patients (six males, mean age; 64 years (41-80) from 8 families. Ptosis was the first symptom in 8/13 patients followed by limb weakness in the remaining 5 patients Dysphagia was never the presenting symptom. At the time of examination, all affected patients had ptosis or had previously been operated for ptosis, while ophthalmoplegia was found in 9 patients. Dysphagia, tested by cold-water swallowing test, was abnormal in 9 patients (17-116 s, ref <8 s). Six patients could not climb stairs of whom two were wheelchair bound and one used a rollator. Six patients had reduced FEV1 (range 23%-59%). No cardiac involvement was identified. CONCLUSIONS: Limiting limb weakness is common in OPMD and can even be the presenting symptom of the disease. In contrast, dysphagia was not the initial symptom in any of our patients, although it was obligatory for diagnosing OPMD before genetic testing became available. Mild respiratory dysfunction, but no cardiac involvement, was detected.

Assessment of coronary artery disease using coronary computed tomography angiography in patients with aortic valve stenosis referred for surgical aortic valve replacement.

BACKGROUND: In patients referred for aortic valve replacement (AVR) a pre-surgical assessment of coronary artery disease is mandatory to determine the possible need for additional coronary artery bypass grafting. The diagnostic accuracy of coronary computed tomography angiography (coronary CTA) was evaluated in patients with aortic valve stenosis referred for surgical AVR. METHODS: Between March 2008 and March 2010 a total of 181 consecutive patients were included. All patients underwent pre-surgical coronary CTA (64- or 320-detector CT scanner) and invasive coronary angiography (ICA). The analyses were performed blinded to each other. RESULTS: The mean ± SD age of the included patients was 71 ± 9 years and 59% were male. The prevalence of significant coronary artery stenosis >70% by ICA was 36%. Average heart rate during coronary CTA was 65 ± 16 b pm. In a patient based analysis 94% of the patients (171/181) were considered fully evaluable. Coronary CTA had a sensitivity of 68%, a specificity of 91%, a positive predictive value of 81%, and a negative predictive value of 83%. Advanced age, obstructive lung disease, NYHA function class III/IV, and high Agatston score were found to be significantly associated with disagreement between ICA and coronary CTA in univariate analysis. CONCLUSION: In patients with aortic valve stenosis referred for surgical AVR the diagnostic accuracy of coronary CTA to identify significant coronary artery disease is moderate. Coronary CTA may be used successfully in a subset of patients with low age, no chronic obstructive lung disease, NYHA function class

The inflammatory biomarker YKL-40 at admission is a strong predictor of overall mortality.

OBJECTIVES: YKL-40 is an inflammatory biomarker associated with disease activity and mortality in patients with diseases characterized by inflammation and tissue remodelling. The aim of this study was to describe the prognostic value of YKL-40 in an unselected patient population. DESIGN: In consecutive patients admitted to hospital during a 1-year period, blood was collected and information regarding final diagnosis and mortality was collected. Median follow-up time was 11.5 years. SETTING: District hospital, Copenhagen, Denmark. PATIENTS: A total of 1407 patients >40 years of age were admitted acutely. MAIN OUTCOME MEASURE: All-cause mortality. RESULTS: Median YKL-40 was increased in patients (157 µg L(-1) , range 13-7704 µg L(-1) ) compared to healthy controls (40 µg L(-1) , range 29-58 µg L(-1) ; P < 0.001). Patients with YKL-40 in the highest quartile had a hazard ratio (HR) of 7.1 [95% confidence interval (CI) 4.2-12.0] for all-cause mortality in the first year and 3.4 (95% CI 2.8-4.2) in the total study period, compared to those in the lowest quartile (HR = 1). The HR for death for all patients with YKL-40 above the normal age-corrected 95th percentile was 2.1 (95% CI 1.6-2.7) after 1 year and 1.5 (95% CI 1.3-1.7) during the total study period, compared to patients with YKL-40 below the age-corrected 95th percentile. The results of multivariable analysis showed that YKL-40 was an independent biomarker of mortality; this was most significant in the first year. YKL-40 was a marker of prognosis in all disease categories. The HR for death was increased in patients with YKL-40 above the normal age-corrected 95th percentile in healthy subjects independent of type of disease (all P < 0.001). CONCLUSION: The level of YKL-40 at admission is a strong predictor of overall mortality, independent of diagnosis and could be useful as a biomarker in the acute evaluation of all patients.