Publications by authors named "Andreas Fuchs"

110 Publications

Bone regeneration capacity of newly developed spherical magnesium phosphate cement granules.

Clin Oral Investig 2021 Oct 23. Epub 2021 Oct 23.

Department for Functional Materials in Medicine and Dentistry, University Hospital Würzburg, Pleicherwall 2, 97070, Würzburg, Germany.

Objectives: Magnesium phosphate-based cements begin to catch more attention as bone substitute materials and especially as alternatives for the more commonly used calcium phosphates. In bone substitutes for augmentation purposes, atraumatic materials with good biocompatibility and resorbability are favorable. In the current study, we describe the in vivo testing of novel bone augmentation materials in form of spherical granules based on a calcium-doped magnesium phosphate (CaMgP) cement.

Materials And Methods: Granules with diameters between 500 and 710 μm were fabricated via the emulsification of CaMgP cement pastes in a lipophilic liquid. As basic material, two different CaMgP formulations were used. The obtained granules were implanted into drill hole defects at the distal femoral condyle of 27 New Zealand white rabbits for 6 and 12 weeks. After explantation, the femora were examined via X-ray diffraction analysis, histological staining, radiological examination, and EDX measurement.

Results: Both granule types display excellent biocompatibility without any signs of inflammation and allow for proper bone healing without the interposition of connective tissue. CaMgP granules show a fast and continuous degradation and enable fully adequate bone regeneration.

Conclusions: Due to their biocompatibility, their degradation behavior, and their completely spherical morphology, these CaMgP granules present a promising bone substitute material for bone augmentation procedures, especially in sensitive areas.

Clinical Relevance: The mostly insufficient local bone supply after tooth extractions complicates prosthetic dental restoration or makes it even impossible. Therefore, bone augmentation procedures are oftentimes inevitable. Spherical CaMgP granules may represent a valuable bone replacement material in many situations.
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http://dx.doi.org/10.1007/s00784-021-04231-wDOI Listing
October 2021

Mammary analogue secretory carcinoma of a salivary gland of the hard palate with contralateral cervical lymph node metastases: A case report.

Mol Clin Oncol 2021 Nov 6;15(5):226. Epub 2021 Sep 6.

Department of Maxillofacial and Plastic Surgery of The University of Wuerzburg, D-97070 Wuerzburg, Germany.

Mammary analogue secretory carcinoma (MASC) is a rare malignant tumour of the salivary glands, with only few cases reported in the literature to date. Initial preoperative staging is crucial for all patients with an oral malignancy to visualize the tumour, detect lymph node or distant metastases and plan therapeutic interventions. In the case presented herein, radiological imaging revealed a tumour of the right hard palate with suspected positive contralateral lymph nodes. Therefore, local tumour resection comprising hemimaxillectomy and bilateral neck dissection was performed. The diagnosis of MASC was finally based on characteristic histopathological and immunohistochemical findings, such as S100 protein and mammaglobin positivity. The diagnosis of MASC may be challenging, as such findings lack specificity. To confirm the diagnosis, molecular genetic examinations may be performed to detect a highly specific ETV6-NTRK3 fusion gene. Depending on the results of these examinations, surgery, alone or combined with adjuvant radiation or chemoradiation, is the recommended approach. In summary, MASC should be treated similarly to other low-grade salivary gland tumours, such as acinic cell carcinoma, as they exhibit biological and histopathological similarities.
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http://dx.doi.org/10.3892/mco.2021.2389DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8506652PMC
November 2021

Correction to: 10-year follow-up of the Columbus knee prostheses system in a prospective multicenter study.

Arch Orthop Trauma Surg 2021 Oct 5. Epub 2021 Oct 5.

Department of Orthopedics and Trauma Surgery, Faculty of Medicine, Medical Center, Albert-Ludwigs-University of Freiburg, Hugstetter Straße 55, 79016, Freiburg, Germany.

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http://dx.doi.org/10.1007/s00402-021-04191-6DOI Listing
October 2021

Prevalence of non-alcoholic fatty liver disease in patients with chronic kidney disease: a case-control study.

Nephrol Dial Transplant 2021 Sep 10. Epub 2021 Sep 10.

Department of Nephrology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.

Background: Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease and represents a wide spectrum ranging from mild steatosis over non-alcoholic steatohepatitis with and without fibrosis to overt cirrhosis. Patients with NAFLD have a high risk of developing cardiovascular disease and chronic kidney disease (CKD). So far, there is scarce evidence of the prevalence of NAFLD among patients with CKD. We investigated the prevalence of moderate-to-severe hepatic steatosis graded according to the definition of NAFLD in a cohort of patients with CKD.

Methods: Hepatic liver fat content was evaluated by computed tomography (CT) scan in 291 patients from the Copenhagen Chronic Kidney Disease Cohort Study and in 866 age- and sex-matched individuals with normal kidney function from the Copenhagen General Population Study. Liver attenuation density <48 Hounsfield units was used as cut-off value for moderate-to-severe hepatic steatosis.

Results: The prevalence of moderate-to-severe hepatic steatosis was 7.9% and 10.7% (P = 0.177) among patients with CKD and controls, respectively. No association between liver fat content and CKD stage was found. In the pooled data set from both cohorts, adjusted odds ratios for moderate-to-severe hepatic steatosis among persons with diabetes, overweight and obesity amounted to 3.1 (95% confidence interval (CI) 1.6-5.9), 14.8 (95% CI 4.6-47.9) and 42.0 (95% CI 12.9-136.6), respectively.

Conclusions: In a cohort of 291 patients with CKD, kidney function was not associated with the prevalence of moderate-to-severe hepatic steatosis as assessed by CT scan.
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http://dx.doi.org/10.1093/ndt/gfab266DOI Listing
September 2021

10-year follow-up of the Columbus knee prostheses system in a prospective multicenter study.

Arch Orthop Trauma Surg 2021 Sep 9. Epub 2021 Sep 9.

Department of Orthopedics and Trauma Surgery, Faculty of Medicine, Medical Center, Albert-Ludwigs-University of Freiburg, Hugstetter Straße 55, 79016, Freiburg, Germany.

Introduction: As endpoint of a prospective multicenter 10-year documentation using the Columbus system, this evaluation carried out results of clinical scores (Knee Society Score and Oxford Knee Score), an evaluation of radiological imaging, survival rates and a collection of complication statistics.

Materials And Methods: There was a multicenter prospective recruitment of consecutive patients with the indication for total knee replacement (TKR). Preoperatively and 10 years after implantation, clinical scores, range of motion and radiological imaging was performed. During this period, a detailed documentation of complications was made.

Results: A total of 210 patients were recruited in 5 centers. 140 patients were available for endpoint examination 10 years after surgery. A survival rate of 96.6% (CI 95%) for the implanted Columbus prostheses after 10 years was demonstrated. Cumulative KSS showed an improvement of 75.3 (± 38.1) points and was highly significant (p < 0.0001, t test). The average functional improvement in the Oxford score was 20.6 (± 9.5) points and was also highly significant (p < 0.0001). The ROM improved from 106.5° (± 20.5) preoperatively to 116.0° (± 11.5) (p < 0.0001, t test). There were no implant-related complications as well as no new complication documented between 5- and 10-year follow-up.

Conclusions: The endpoint analysis after an observation period of 10 years provided good clinical and radiographic results. In particular, an excellent survival rate of 96.6% after 10 years was demonstrated. The data published in this study are the first to be available in a prospective multicenter study on this system, which leads to a high level of clinical significance.
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http://dx.doi.org/10.1007/s00402-021-04156-9DOI Listing
September 2021

Computed Tomography-Based Selection of Transseptal Puncture Site for Percutaneous Left Atrial Appendage Closure.

EuroIntervention 2021 Aug 31. Epub 2021 Aug 31.

The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Background: An inferoposterior transseptal puncture (TSP) is generally recommended for percutaneous left atrial appendage (LAA) closure. However, the LAA is a highly variable anatomical structure; this may impact the preferred TSP site.

Aims: This study aimed to determine the most optimal TSP site for percutaneous LAA closure in different LAA morphologies.

Methods: In this prospective study, 182 patients undergoing percutaneous LAA closure were included. The spatial relationship of the LAA to the fossa ovalis and its consequence for TSP was assessed at pre-procedural cardiac computed tomography (CCT).

Results: Based on CCT analysis, it was predicted that co-axial alignment between delivery sheath and LAA would be obtained by an inferoposterior, -central, or -anterior TSP in 75%, 16% and 8% of cases, respectively. This was also confirmed by procedural LAA angiogram in 175 cases (96%) with <30o angle between delivery sheath and LAA central axis. Multivariate logistic regression analysis identified reverse chicken wing LAA (Odds Ratio (OR) 6.36 [1.85-29.3]; P=0.005) and posterior bending of the proximal LAA (OR 17.2 [3.3-96.2]; P<0.001) as independent predictors of a central or anterior TSP - this to increase the chance of obtaining co-axial alignment between delivery sheath and LAA.

Conclusions: An inferoposterior TSP is recommended in a majority of percutaneous LAA closure procedures in order to obtain co-axial alignment between delivery sheath and LAA. An inferior but more central/anterior TSP should be recommended in case of a reverse chicken wing LAA or posterior bending of the proximal LAA, which occurs in 20-25% of cases.
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http://dx.doi.org/10.4244/EIJ-D-21-00555DOI Listing
August 2021

Interobserver reliability is higher for assessments with 3D software-generated models than with conventional MRI images in the classification of trochlear dysplasia.

Knee Surg Sports Traumatol Arthrosc 2021 Aug 22. Epub 2021 Aug 22.

Department of Orthopedic Surgery and Traumatology, Freiburg University Hospital, Albert Ludwigs University Freiburg, Hugstetter Straße 55, 79106, Freiburg, Germany.

Purpose: Trochlear dysplasia is a significant risk factor for patellofemoral instability. The severity of trochlear dysplasia is commonly evaluated based on the Dejour classification in axial MRI slices. However, this often leads to heterogeneous assessments. A software to generate MRI-based 3D models of the knee was developed to ensure more standardized visualization of knee structures. The purpose of this study was to assess the intra- and interobserver agreements of 2D axial MRI slices and an MRI-based 3D software generated model in classification of trochlear dysplasia as described by Dejour.

Methods: Four investigators independently assessed 38 axial MRI scans for trochlear dysplasia. Analysis was made according to Dejour's 4 grade classification as well as differentiating between 2 grades: low-grade (types A + B) and high-grade trochlear dysplasia (types C + D). Assessments were repeated following a one-week interval. The inter- and intraobserver agreement was determined using Cohen's kappa (κ) and Fleiss kappa statistic (κ). In addition, the proportion of observed agreement (po) was calculated for assessment of intraobserver agreement.

Results: The assessment of the intraobserver reliability with regard to the Dejour-classification showed moderate agreement values both in the 2D (κ = 0.59 ± 0.08 SD) and in the 3D analysis (κ = 0.57 ± 0.08 SD). Considering the 2-grade classification, the 2D (κ = 0.62 ± 0.12 SD) and 3D analysis (κ = 0.61 ± 0.19 SD) each showed good intraobserver matches. The analysis of the interobserver reliability also showed moderate agreement values with differences in the subgroups (2D vs. 3D). The 2D evaluation showed correspondences of κ = 0.48 (Dejour) and κ = 0.46 (high / low). In the assessment based on the 3D models, correspondence values of κ = 0.53 (Dejour) and κ = 0.59 (high / low) were documented.

Conclusion: Overall, moderate-to-good agreement values were found in all groups. The analysis of the intraobserver reliability showed no relevant differences between 2 and 3D representation, but better agreement values were found in the 2-degree classification. In the analysis of interobserver reliability, better agreement values were found in the 3D compared to the 2D representation. The clinical relevance of this study lies in the superiority of the 3D representation in the assessment of trochlear dysplasia, which is relevant for future analytical procedures as well as surgical planning.

Level Of Evidence: Level II.
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http://dx.doi.org/10.1007/s00167-021-06697-3DOI Listing
August 2021

HIV infection is associated with thoracic and abdominal aortic aneurysms: a prospective matched cohort study.

Eur Heart J 2021 08;42(30):2924-2931

Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Esther Møllers Vej 6, 2100 Kbh Ø, Copenhagen, Denmark.

Aims: Little is known about the prevalence of aortic aneurysms among people living with HIV (PLWH). We investigated whether HIV status is independently associated with having aortic aneurysms. Furthermore, we determined risk factors associated with aortic aneurysms in PLWH.

Methods And Results: PLWH aged ≥40 years (n = 594) were recruited from the Copenhagen Comorbidity in HIV Infection study and matched for age and sex with uninfected controls (n = 1188) from the Copenhagen General Population Study. Aortic dimensions were assessed using contrast enhanced computed tomography. Aortic aneurysms were defined according to the European Society of Cardiology guidelines, i.e. an aortic dilation of ≥50% or an infrarenal aortic diameter of ≥30 mm. Among PLWH and uninfected controls, the median (interquartile range) age was 52 (47-60) and 52 (48-61) and 88% and 90% were male, respectively. We found 46 aneurysms in 42 (7.1%) PLWH and 31 aneurysms in 29 (2.4%) uninfected controls (P < 0.001). PLWH had a significantly higher prevalence of ascending aortic aneurysms and infrarenal aortic aneurysms. In an adjusted model, HIV was independently associated with aortic aneurysms (adjusted odds ratio; 4.51 [95% confidence interval 2.56-8.08], P < 0.001). Within PLWH, obesity and hepatitis B co-infection were associated with aortic aneurysms.

Conclusion: PLWH had four-fold higher odds of aortic aneurysms compared to uninfected controls, and HIV status was independently associated with aortic aneurysms. Among PLWH, age, obesity and hepatitis B co-infection were associated with higher odds of aortic aneurysms. Our findings suggest that increased attention to aortic aneurysms in PLWH may be beneficial.
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http://dx.doi.org/10.1093/eurheartj/ehab348DOI Listing
August 2021

Aortic enlargement and coronary artery calcification in a general population cohort.

Eur Heart J Cardiovasc Imaging 2021 Jun 24. Epub 2021 Jun 24.

Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100Copenhagen, Denmark.

Aims: The role of atherosclerosis in the pathogenesis of aortic enlargement is uncertain. We aimed to evaluate the relationship between the diameters of the ascending, descending and abdominal aorta, and coronary artery calcification.

Methods And Results: Individuals in the Copenhagen General Population Study underwent thoracic and abdominal computed tomography. Maximal aortic diameters were measured in each aortic segment and coronary artery calcium scores (CACS) were calculated. Participants were stratified into five predefined groups according to CACSs and compared to aortic dimensions. The relation between aortic diameter and CACS was adjusted for risk factors for aortic dilatation in a multivariable model. A total of 2678 eligible individuals were included. In all segments of the aorta, aortic diameter was associated to CACSs, with mean increases in aortic diameters ranging from 0.7 to 3.5 mm in individuals with calcified coronary arteries compared to non-calcified subjects (P-value < 0.001). After correction for risk factors, individuals with CACS above 400 had larger ascending, descending and abdominal aortic diameter than the non-calcified reference group (P-value < 0.01).

Conclusion: Enlarged thoracic and abdominal aortic vascular segments are associated with co-existing coronary artery calcification in the general population.
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http://dx.doi.org/10.1093/ehjci/jeab122DOI Listing
June 2021

[Recommendations for the Prevention, Diagnostics and Therapy of Addiction Disorders in the Elderly].

Praxis (Bern 1994) 2021 Feb;110(2):79-93

Schweizerische Gesellschaft für Suchtmedizin (SSAM), Bern.

Recommendations for the Prevention, Diagnostics and Therapy of Addiction Disorders in the Elderly Although the chronic consumption of alcohol and sedatives, and increasingly opioids, represents a major problem in old age with consequential damage for those affected, little attention has been paid to the substance abuse disorders in old age. The aim of the present recommendations, a collaboration work of the Swiss Society for Geriatric Psychiatry and Psychotherapy (SGAP), Swiss Nurses Association (SBK) and Swiss Society of Addiction Medicine (SSAM), is to summarize the current state of knowledge in prevention, diagnostics and therapy of substance abuse disorders in old age for an interprofessional clinical team. They are intended to help strengthen prevention and early diagnosis, and consciously emphasize psychotherapy and nursing intervention options.
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http://dx.doi.org/10.1024/1661-8157/a003609DOI Listing
February 2021

Sequence and functional differences in the ATPase domains of CHD3 and SNF2H promise potential for selective regulability and drugability.

FEBS J 2021 07 5;288(13):4000-4023. Epub 2021 Feb 5.

Department of Biochemistry, Genetics and Microbiology, Biochemistry III, University of Regensburg, Germany.

Chromatin remodelers use the energy of ATP hydrolysis to regulate chromatin dynamics. Their impact for development and disease requires strict enzymatic control. Here, we address the differential regulability of the ATPase domain of hSNF2H and hCHD3, exhibiting similar substrate affinities and enzymatic activities. Both enzymes are comparably strongly inhibited in their ATP hydrolysis activity by the competitive ATPase inhibitor ADP. However, the nucleosome remodeling activity of SNF2H is more strongly affected than that of CHD3. Beside ADP, also IP inhibits the nucleosome translocation of both enzymes to varying degrees, following a competitive inhibition mode at CHD3, but not at SNF2H. Our observations are further substantiated by mutating conserved Q- and K-residues of ATPase domain motifs. The variants still bind both substrates and exhibit a wild-type similar, basal ATP hydrolysis. Apart from three CHD3 variants, none of the variants can translocate nucleosomes, suggesting for the first time that the basal ATPase activity of CHD3 is sufficient for nucleosome remodeling. Together with the ADP data, our results propose a more efficient coupling of ATP hydrolysis and remodeling in CHD3. This aspect correlates with findings that CHD3 nucleosome translocation is visible at much lower ATP concentrations than SNF2H. We propose sequence differences between the ATPase domains of both enzymes as an explanation for the functional differences and suggest that aa interactions, including the conserved Q- and K-residues distinctly regulate ATPase-dependent functions of both proteins. Our data emphasize the benefits of remodeler ATPase domains for selective drugability and/or regulability of chromatin dynamics.
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http://dx.doi.org/10.1111/febs.15699DOI Listing
July 2021

Arterial hypertension and morphologic abnormalities of cardiac chambers: results from the Copenhagen General Population Study.

J Hypertens 2021 04;39(4):703-710

Department of Cardiology, The Heart Center, Rigshospitalet.

Objectives: In patients with arterial hypertension (AH), hypertension-mediated organ damage may be manifested by cardiac chamber enlargement and/or remodeling. Cardiac computed tomography imaging has emerged as an important method for morphological assessment of cardiac chambers. We tested the hypothesis that prevalence of cardiac chamber abnormalities is specifically related to clinical categories of AH in the general population.

Methods: We studied 4747 individuals, mean age was 60 years (range: 40-93), 46% were men, undergoing 320-detector computed tomography in the Copenhagen General Population Study. Clinical categories of AH were: normotensive (n = 2484), untreated hypertensive (n = 1301), treated controlled hypertensive (n = 412) and treated uncontrolled hypertensive (n = 550). Chamber abnormalities in the form of left ventricular (LV) concentric remodeling, LV eccentric hypertrophy, LV concentric hypertrophy or left atrial enlargement were assessed, in addition to LV or right ventricular enlargement.

Results: Chamber abnormalities were present in 23% of all individuals. Combined LV and left atrial abnormalities were rare (<2%). LV concentric remodeling (10%) was the most prevalent abnormality, and most commonly found in individuals with treated hypertension. LV and right ventricular enlargements were unrelated to hypertension. The highest frequencies of chamber abnormalities were found in individuals of elevated blood pressure (BP) with (40%) or without (32%) treatment, as opposed to individuals of normal BP with (27%) or without (14%) treatment, P less than 0.0001.

Conclusion: In a general population cohort, untreated or inadequately treated AH was associated with the highest prevalence of cardiac chamber enlargement and remodeling. These observations suggest a strong link between elevated BPs and development of hypertension-mediated organ damage.
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http://dx.doi.org/10.1097/HJH.0000000000002705DOI Listing
April 2021

Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography.

JACC Cardiovasc Interv 2020 11;13(21):2528-2538

Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Objectives: The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography.

Background: Expanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR.

Methods: In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility.

Results: After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005).

Conclusions: Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.
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http://dx.doi.org/10.1016/j.jcin.2020.06.016DOI Listing
November 2020

[Cardiac CT].

Ugeskr Laeger 2020 09;182(39)

Cardiac CT has become a frequently used diagnostic modality in Denmark, especially for the evaluation of coronary artery disease indicated by angina pectoris/dyspnoea. Indications have recently expanded to include evaluation of valvular heart disease, pre- and post-procedural evaluation related to several invasive procedures as well as some congenital and pediatric cardiac conditions. As described in this review, improved image quality and reduced radiation, owing to technological advances as well as a high number of well-performed scientific studies, have paved the way for this development.
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September 2020

Diabetes-Related Effectiveness and Cost of Liraglutide or Insulin in German Patients with Type 2 Diabetes: A 5-Year Retrospective Claims Analysis.

Diabetes Ther 2020 Oct 2;11(10):2357-2370. Epub 2020 Sep 2.

Novo Nordisk Region Europe, 3 City Place, Beehive Ring Road, West Sussex, Gatwick, RH6 0PA, UK.

Introduction: Liraglutide is a glucagon-like peptide-1 analogue used to treat type 2 diabetes mellitus (T2DM). To date, limited long-term data (> 2 years) exist comparing real-world diabetes-related effectiveness and costs for liraglutide versus insulin treatment.

Methods: This retrospective claims data analysis covered the period from 1 January 2010 to 31 December 2017 and included continuously insured patients with T2DM who initiated insulin or liraglutide and had 3.5 or 5 years' follow-up data, identified using the German AOK PLUS dataset. Propensity score matching (PSM) was used to adjust for patient characteristics.

Results: After PSM, there were 825 and 436 patients in the liraglutide and insulin groups at 3.5 and 5 years' follow-up, respectively. Baseline characteristics were similar between compared cohorts. The respective change from baseline to follow-up in mean glycated haemoglobin for liraglutide and insulin patients was - 0.88% and - 0.81% (p > 0.100) after 3.5 years and - 1.15%/ - 1.02% (p > 0.100) after 5 years. Mean respective changes in body mass index (kg/m) were - 1.21/+ 1.14 (p < 0.001) after 3.5 years and - 1.29/+ 1.13 after 5 years (p < 0.001). Liraglutide- versus insulin-treated patients were less likely to have an early T2DM-related hospitalisation (3.5-year hazard ratio [HR]: 0.414 [95% confidence interval (CI) 0.263-0.651]; 5-year HR: 0.448 [95% CI 0.286-0.701]). At 5 years' follow-up, there was no statistically significant difference in total direct costs between treatment groups (cost ratio: 1.069 [95% CI 0.98-1.13]; p > 0.100).

Conclusion: The clinical effectiveness of liraglutide is maintained long term (up to 5 years). Liraglutide treatment is not associated with higher total direct healthcare costs.
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http://dx.doi.org/10.1007/s13300-020-00903-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509007PMC
October 2020

Pulmonary Arterial Enlargement in Well-Treated Persons With Human Immunodeficiency Virus.

J Infect Dis 2021 01;223(1):94-100

Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Background: Pulmonary artery enlargement is a marker of pulmonary hypertension. We aimed to determine the proportion with pulmonary artery enlargement among well-treated persons with human immunodeficiency virus HIV (PWH) and uninfected controls.

Methods: PWH with a chest computed tomography were included from the ongoing Copenhagen Comorbidity in HIV Infection (COCOMO) study. Age and sex-matched uninfected controls were recruited from the Copenhagen General Population Study. Pulmonary artery enlargement was defined as a ratio of >1 between the diameter of the main pulmonary artery (at the level of its bifurcation) and the diameter of the ascending aorta.

Results: In total, 900 PWH were included, and 44 (5%) had a pulmonary artery-aorta ratio (PA:A) >1. After adjustment for age, sex, and body mass index, obesity (adjusted odds ratio, 4.33; 95% confidence interval, 1.76-10.65; P = .001) and injection drug use (IDU) (4.90; 1.00-18.46; P = .03) were associated with higher odds of having a PA:A >1, and pulmonary indices and smoking status were not. HIV seropositivity was borderline associated with a PA:A >1 (adjusted odds ratio, 1.89; 95% confidence interval, .92-3.85; P = .08).

Conclusions: A PA:A >1 was common in PWH. Obesity and IDU were independently associated with this finding and HIV serostatus was borderline associated with it, but HIV-related factors were not. Increased awareness may be appropriate in obese PWH and those with IDU.
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http://dx.doi.org/10.1093/infdis/jiaa339DOI Listing
January 2021

Prevalence and Risk Factors of Moderate-to-Severe Hepatic Steatosis in Human Immunodeficiency Virus Infection: The Copenhagen Co-morbidity Liver Study.

J Infect Dis 2020 09;222(8):1353-1362

Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.

Background: People with human immunodeficiency virus (PWH) may be at risk of nonalcoholic fatty liver disease. We compared the prevalence of moderate-to-severe hepatic steatosis (M-HS) in PWH with human immunodeficiency virus (HIV)-uninfected controls and determined risk factors for M-HS in PWH.

Methods: The Copenhagen Co-Morbidity in HIV Infection study included 453 participants, and the Copenhagen General Population Study included 765 participants. None had prior or current viral hepatitis or excessive alcohol intake. Moderate-to-severe hepatic steatosis was assessed by unenhanced computed tomography liver scan defined by liver attenuation ≤48 Hounsfield units. Adjusted odds ratios (aORs) were computed by adjusted logistic regression.

Results: The prevalence of M-HS was lower in PWH compared with uninfected controls (8.6% vs 14.2%, P < .01). In multivariable analyses, HIV (aOR, 0.44; P < .01), female sex (aOR, 0.08; P = .03), physical activity level (aOR, 0.09; very active vs inactive; P < .01), and alcohol (aOR, 0.89 per unit/week; P = .02) were protective factors, whereas body mass index (BMI) (aOR, 1.58 per 1 kg/m2; P < .01), alanine transaminase (ALT) (aOR, 1.76 per 10 U/L; P < .01), and exposure to integrase inhibitors (aOR, 1.28 per year; P = .02) were associated with higher odds of M-HS.

Conclusions: Moderate-to-severe hepatic steatosis is less common in PWH compared with demographically comparable uninfected controls. Besides BMI and ALT, integrase inhibitor exposure was associated with higher prevalence of steatosis in PWH.
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http://dx.doi.org/10.1093/infdis/jiaa246DOI Listing
September 2020

Left ventricular trabeculation and major adverse cardiovascular events: the Copenhagen General Population Study.

Eur Heart J Cardiovasc Imaging 2021 01;22(1):67-74

Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.

Aims: Prominent left ventricular trabeculations is a phenotypic trait observed in cardiovascular diseases. In the general population, the extent of left ventricular trabeculations is highly variable, yet it is unknown whether increased trabeculation is associated with adverse outcome.

Methods And Results: Left ventricular trabeculated mass (g/m2) was measured with contrast-enhanced cardiac computed tomography in 10 097 individuals from the Copenhagen General Population Study. The primary endpoint was a composite of major adverse cardiovascular events and defined as death, heart failure, myocardial infarction, or stroke. The secondary endpoints were the individual components of the primary endpoint. Cox regression models were adjusted for clinical parameters, medical history, electrocardiographic parameters, and cardiac chamber sizes. The mean trabeculated mass was 19.1 g/m2 (standard deviation 4.9 g/m2). During a median follow-up of 4.0 years (interquartile range 1.5-6.7), 710 major adverse cardiovascular events occurred in 619 individuals. Individuals with a left ventricular trabeculated mass in the highest quartile had a hazard ratio for major adverse cardiovascular events of 1.64 [95% confidence interval (CI) 1.30-2.08; P < 0.001] compared to those in the lowest quartile. Corresponding hazard ratios were 2.08 (95% CI 1.38-3.14; P < 0.001) for death, 2.63 (95% CI 1.61-4.31; P < 0.001) for heart failure, 1.08 (95% CI 0.56-2.08; P = 0.82) for myocardial infarction, and 1.07 (95% CI 0.72-1.57; P = 0.74) for stroke.

Conclusion: Increased left ventricular trabeculation is independently associated with an increased rate of major adverse cardiovascular events in the general population.
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http://dx.doi.org/10.1093/ehjci/jeaa110DOI Listing
January 2021

Alignment of Transcatheter Aortic-Valve Neo-Commissures (ALIGN TAVR): Impact on Final Valve Orientation and Coronary Artery Overlap.

JACC Cardiovasc Interv 2020 05 16;13(9):1030-1042. Epub 2020 Mar 16.

Division of Cardiac Surgery, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York.

Objectives: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries.

Background: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated.

Methods: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut "Hat" marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation.

Results: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut "Hat" at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut "Hat" at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases.

Conclusions: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR.
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http://dx.doi.org/10.1016/j.jcin.2020.02.005DOI Listing
May 2020

Left ventricular myocardial crypts: morphological patterns and prognostic implications.

Eur Heart J Cardiovasc Imaging 2021 01;22(1):75-81

Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.

Aims: Left ventricular (LV) myocardial crypts are considered a subtle marker of hypertrophic cardiomyopathy. However, crypts have also been observed in seemingly healthy individuals and it is unknown whether myocardial crypts are associated with adverse outcome.

Methods And Results: Myocardial crypts were defined as invaginations traversing >50% of the myocardial wall and assessed using contrast-enhanced cardiac computed tomography in 10 097 individuals from the Copenhagen General Population Study. Number of crypts, location, shape, penetrance, and volume were assessed. The endpoint was a composite of major adverse cardiovascular events and defined as death, myocardial infarction, heart failure, or stroke. Cox regression models were adjusted for clinical variables, medical history, electrocardiographic parameters, and cardiac chamber sizes. A total of 1199 LV myocardial crypts were identified in 915 (9.1%) individuals. Seven hundred (6.9%) had one crypt and 215 (2.1%) had multiple crypts. During a median follow-up of 4.0 years (interquartile range 1.5-6.7), major adverse cardiovascular events occurred in 619 individuals. Individuals with one or multiple crypts had a hazard ratio for major adverse cardiovascular events of 1.00 [95% confidence interval (CI): 0.72-1.40; P = 0.98] and 0.90 (95% CI: 0.47-1.75; P = 0.76), respectively, compared with those with no crypts. No specific pattern of crypt location, shape, penetrance, or volume was associated to an increased hazard ratio for major adverse cardiovascular events.

Conclusion: LV myocardial crypts are frequent in the general population and are not associated with intermediate-term major adverse cardiovascular events.
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http://dx.doi.org/10.1093/ehjci/jeaa020DOI Listing
January 2021

Pericardial Adipose Tissue Volume Is Independently Associated With Human Immunodeficiency Virus Status and Prior Use of Stavudine, Didanosine, or Indinavir.

J Infect Dis 2020 06;222(1):54-61

Department of Infectious Diseases 8632, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Background: Increased pericardial adipose tissue is associated with higher risk of cardiovascular disease. We aimed to determine whether human immunodeficiency virus (HIV) status was independently associated with larger pericardial adipose tissue volume and to explore possible HIV-specific risk factors.

Methods: Persons with HIV (PWH) were recruited from the Copenhagen Comorbidity in HIV Infection (COCOMO) Study and matched 1:1 on age and sex to uninfected controls. Pericardial adipose tissue volume was measured using cardiac computed tomography.

Results: A total of 587 PWH and 587 controls were included. Median age was 52 years, and 88% were male. Human immunodeficiency virus status was independently associated with 17 mL (95% confidence interval [CI], 10-23; P < .001) larger pericardial adipose tissue volume. Larger pericardial adipose tissue volume was associated with low CD4+ nadir and prior use of stavudine, didanosine, and indinavir. Among PWH without thymidine analogue or didanosine exposure, time since initiating combination antiretroviral treatment (per 5-year use) was associated with l6 mL (95% CI, -6 to -25; P = .002) lower pericardial adipose tissue volume.

Conclusions: Human immunodeficiency virus status was independently associated with larger pericardial adipose tissue volume. Severe immunodeficiency, stavudine, didanosine, and indinavir were associated with larger pericardial adipose tissue volume. Persons with HIV with prior exposure to these drugs may constitute a distinct cardiovascular risk population.
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http://dx.doi.org/10.1093/infdis/jiaa057DOI Listing
June 2020

Mechanisms governing the pioneering and redistribution capabilities of the non-classical pioneer PU.1.

Nat Commun 2020 01 21;11(1):402. Epub 2020 Jan 21.

Department of Internal Medicine III, University Hospital Regensburg, 93053, Regensburg, Germany.

Establishing gene regulatory networks during differentiation or reprogramming requires master or pioneer transcription factors (TFs) such as PU.1, a prototype master TF of hematopoietic lineage differentiation. To systematically determine molecular features that control its activity, here we analyze DNA-binding in vitro and genome-wide in vivo across different cell types with native or ectopic PU.1 expression. Although PU.1, in contrast to classical pioneer factors, is unable to access nucleosomal target sites in vitro, ectopic induction of PU.1 leads to the extensive remodeling of chromatin and redistribution of partner TFs. De novo chromatin access, stable binding, and redistribution of partner TFs both require PU.1's N-terminal acidic activation domain and its ability to recruit SWI/SNF remodeling complexes, suggesting that the latter may collect and distribute co-associated TFs in conjunction with the non-classical pioneer TF PU.1.
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http://dx.doi.org/10.1038/s41467-019-13960-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6972792PMC
January 2020

Prevalence of and Risk Factors for Low Bone Mineral Density Assessed by Quantitative Computed Tomography in People Living With HIV and Uninfected Controls.

J Acquir Immune Defic Syndr 2020 02;83(2):165-172

Viro-immonology Research Unit, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Background: Low bone mineral density (BMD) has been described in people living with HIV (PLWH). We examined the prevalence of low BMD measured by quantitative computed tomography (QCT), a method that allows 3-dimensional volumetric density measures at the thoracic spine, in well-treated PLWH and uninfected controls and assessed risk factors for reduced BMD.

Methods: Cross-sectional study including 718 PLWH from the Copenhagen Co-Morbidity in HIV infection (COCOMO) study and 718 uninfected controls matched on age and sex from the Copenhagen General Population Study (CGPS). Trabecular BMD was determined by QCT.

Results: Median BMD was 144.2 mg/cm in PLWH vs. 146.6 mg/cm in controls (P = 0.580). HIV status was not associated with BMD in univariable or multivariable linear analyses. However, a higher prevalence of very low BMD (T-score ≤ -2.5) was found in PLWH (17.2% vs. 11.0% in controls, P = 0.003). In unadjusted analysis, HIV was associated with very low BMD (odds ratio 1.68 [95% confidence interval: 1.24-2.27], P = 0.001), but this association was not significant after adjusting for age, sex, smoking, alcohol, body mass index, physical activity, and ethnicity. Previous AIDS-defining disease was associated with lower BMD, but no other associations with HIV-specific variables were identified.

Conclusion: Using QCT, we found a higher prevalence of very low BMD in PLWH than in controls. However, HIV status was not independently associated with BMD indicating that traditional risk factors contribute to the difference in prevalence of very low BMD. Focus on improvement of lifestyle factors, especially in PLWH with previous AIDS-defining disease, may prevent very low BMD in PLWH.
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http://dx.doi.org/10.1097/QAI.0000000000002245DOI Listing
February 2020

Real-World Treatment of Patients with Multiple Sclerosis per MS Subtype and Associated Healthcare Resource Use: An Analysis Based on 13,333 Patients in Germany.

Neurol Ther 2020 Jun 12;9(1):67-83. Epub 2019 Dec 12.

Institute for Pharmacoeconomics and Medication Logistics (IPAM), University of Wismar, Alter Holzhafen 19, 23966, Wismar, Germany.

Introduction: The aim of this study was to describe the real-word treatment and associated healthcare resource use (HCRU) of multiple sclerosis (MS) patients, as stratified by different MS subtypes.

Methods: All patients with MS continuously insured by two German statutory healthcare insurance funds from 2011 to 2015 were enrolled. These patients were categorized into four subgroups according to their MS type as follows: clinically isolated syndrome (CIS); relapsing remittent MS (RRMS); primary progressive MS (PPMS); and secondary progressive MS (SPMS). Sociodemographic characteristics, treatments, and HCRU for 2015 were analyzed. Treatment cascades for treatment-naïve patients were also determined.

Results: A total of 13,333 patients with MS were identified. The largest proportion of patients had RRMS (41.9%), followed by PPMS (17.1%). Mean age of the enrolled patients was 50.2 years, and 70.7% were female. Among all patients, 38.3% of those with CIS, 22.4% with PPMS, 69.6% with RRMS, and 33.9% with SPMS received a prescription of a disease-modifying immunomodulatory agent, with interferon beta-1a being the most frequently prescribed agent. Likewise, 14.5, 18.5, 19.9, and 21.5% of patients with CIS, PPMS, RRMS, and SPMS, respectively, received a flare-up treatment with glucocorticoids. MS-associated overall costs, including indirect costs for MS-associated days absent from work, were € 16,433, with costs related to MS medication (€ 8770; 53.4%) being the main driver of costs in all subgroups. MS-associated costs according to MS subtypes were € 12,427 for CIS patients, € 14,459 for PPMS patients, € 20,583 for RRMS patients, and € 17,554 for SPMS patients.

Conclusion: Among the four MS subtypes, RRMS patients most often received a disease-modifying immunomodulatory treatment. Consequently, healthcare costs were highest for patients with this MS subtype. Contrary to the treatment guideline, a substantial percentage of patients with CIS, RRMS, and SPMS did not receive any disease-modifying immunomodulatory treatment.
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http://dx.doi.org/10.1007/s40120-019-00172-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229080PMC
June 2020

Persistence with Biologic Treatment in Patients with Inflammatory Bowel Disease: A German Claims Data Analysis.

Digestion 2021 22;102(2):216-226. Epub 2019 Oct 22.

Gastroenterologische Gemeinschaftspraxis Minden, Minden, Germany.

Objectives: This study aimed to assess the real-world rates of treatment discontinuation and switching of biologic therapies in patients with inflammatory bowel disease (IBD).

Methods: A retrospective claims data analysis on all continuously insured adult IBD patients with initiation of a biologic therapy was conducted. Observation started with the date of the first prescription of index tumor necrosis factor α-inhibitors (anti-TNFα) or vedolizumab (VDZ) therapy and lasted 12 months. Non-persistence was assumed in case of a switch to another biologic or a treatment gap of >90 days.

Results: We included 1,248 IBD biologic treatment starters (502 adalimumab, 77 golimumab, 441 infliximab, 228 VDZ); 837/411 were biologic-naïve (bio-naïve)/ biologic-experienced (bio-experienced). Mean age of bio-naïve/bio-experienced anti-TNFα patients was 39.2/38.1 years (54.9%/56.7% female) and 42.6/37.8 years for VDZ patients (56.3%/54.9% female). Seven hundred and seventy-two patients (61.9%) were persistent with their index biologic therapy after 12 months (61.9%/61.8% bio-naïve/bio-experienced). Percentage of persistent patients was 69.7% for VDZ (65.6%/71.3%) and 60.1% for anti-TNFα (61.4%/55.5%). VDZ was associated with later non-persistence in a multivariable Cox regression analysis (hazard ratio 0.675; p = 0.003) compared to anti-TNFα.

Conclusions: Only 60-70% of IBD -patients are still persistent with their biologic therapy after 12 months. VDZ therapy is associated with a higher persistence than anti-TNFα therapy in this analysis.
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http://dx.doi.org/10.1159/000503859DOI Listing
August 2021

Identifying Disparities in the Management of Hip Fractures Within Europe: A Comparison of 3 Health-Care Systems.

Geriatr Orthop Surg Rehabil 2019 4;10:2151459319872941. Epub 2019 Sep 4.

Department of Orthopedics and Trauma Surgery, Medical Center-Albert-Ludwigs-University of Freiburg, Faculty of Medicine, Albert-Ludwigs-University of Freiburg, Freiburg im Breisgau, Germany.

Introduction: This study investigates the management of hip fractures in a German maximum care hospital and compares these data to evidence-based standard and practice in 180 hospitals participating in the UK National Hip Fracture Database (NHFD) and 16 hospitals participating in the Irish Hip Fracture Database (IHFD). This is the first study directly comparing the management of hip fractures between 3 separate health-care systems within Europe.

Methods: Electronic medical data were collected retrospectively describing the care pathway of elderly patients with a hip fracture admitted to a large trauma unit in the south of Germany "University Hospital Freiburg" (UHF). The audit evaluated demographics, postoperative outcome, and the adherence to the 6 "Blue Book" standards of care. These data were directly compared with the data from the UK NHFD and the IHFD acquired from 180 and 16 hospitals, respectively.

Results: At 36 hours, 95.8% of patients had received surgery in UHF, compared to 71.5% in the NHFD and 58% of patients in the IHFD. The rate of in-hospital mortality was 4.7% compared to 7.1% in the NHFD and 5% in the IHFD. The mean average acute length of stay was 13.4 days compared to 16.4 days in the NHFD and 20 days in the IHFD. Reoperation rates are 3.3% compared to 1% in the NHFD and 1.1% in the IHFD; 50.5% of patients were discharged on bone protection medication, compared to 47% in the IHFD and 79.3% in the UK NHFD.

Discussion: Despite uniformly acknowledged evidence-based treatment guidelines, the management of hip fractures remains heterogeneous within Europe.

Conclusion: These data show that different areas of the hip fracture care pathway in Germany, England, and Ireland, respectively, show room for improvement in light of the growing socioeconomic burden these countries are expected to face.
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http://dx.doi.org/10.1177/2151459319872941DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6728671PMC
September 2019

Prevalence and risk factors of prolonged QT interval and electrocardiographic abnormalities in persons living with HIV.

AIDS 2019 11;33(14):2205-2210

aDepartment of Infectious Diseases bDepartment of Cardiology cDepartment of Radiology, Rigshospitalt, University of Copenhagen, Copenhagen, Denmark dInstitute for Global Health, UCL., Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), London, United Kingdom eThe Copenhagen General Population Study, Department of Clinical Biochemistry, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev fFaculty of Health and Medical Sciences, University of Copenhagen gDepartment of Infectious Diseases, Hvidovre Hospital, Copenhagen hDepartment of Health Science and Technology, Aalborg University, Aalborg iCHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Objective: Abnormal ECGs are associated with increased risk of arrhythmias and sudden cardiac death. We aimed to investigate the prevalence and associated risk factors of prolonged QTc and major ECG abnormalities, in persons living with HIV (PLWH) and uninfected controls.

Design: PLWH aged at least 40 years were recruited from the Copenhagen comorbidity in HIV infection (COCOMO) study and matched on sex and age to uninfected controls from the Copenhagen General Population Study.

Methods: ECGs were categorized according to Minnesota Code Manual of ECG Findings definition of major abnormalities. A QT interval corrected for heart rate (QTc) greater than 440 ms in men and greater than 460 ms in women was considered prolonged. Pathologic Q-waves were defined as presence of major Q-wave abnormalities.

Results: ECGs were available for 745 PLWH and 2977 controls. Prolonged QTc was prevalent in 9% of PLWH and 6% of controls, P = 0.052. Pathologic Q-waves were more common in PLWH (6%) than in controls (4%), P = 0.028. There was no difference in prevalence of major ECG abnormalities between PLWH and controls, P = 0.987.In adjusted analyses, HIV was associated with a 3.6 ms (1.8-5.4) longer QTc interval, P < 0.001, and HIV was independently associated with prolonged QTc [adjusted odds ratio: 1.59 (1.14-2.19)], P = 0.005. HIV was borderline associated to pathologic Q-waves after adjusting, P = 0.051.

Conclusion: HIV was associated with higher odds ratio of prolonged QTc after adjustment for cardiovascular risk factors, but analyses were not adjusted for QT-prolonging medication. Although evidence indicated more pathologic Q-waves in PLWH, the risk seemed to be associated mainly with an adverse risk profile.
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http://dx.doi.org/10.1097/QAD.0000000000002327DOI Listing
November 2019

Real-world biologic treatment and associated cost in patients with inflammatory bowel disease.

Z Gastroenterol 2019 Jul 9;57(7):843-851. Epub 2019 Jul 9.

Gastroenterologische Gemeinschaftspraxis Minden, Germany.

Objectives:  This study aimed to describe biologic treatment of German inflammatory bowel disease (IBD) patients, including biologics' dosage, health care resource use, and treatment-associated cost.

Methods:  In this retrospective claims data analysis, all continuously insured adult IBD patients (Crohn's disease [CD] or ulcerative colitis [UC]) who started a new therapy with an anti-tumor necrosis factor alpha (anti-TNF-α) or vedolizumab (VDZ) were included. Observation started with the date of the first prescription of index biologic therapy and lasted 12 months.

Results:  In the database, 1248 out of 57 296 IBD patients started a biologic treatment of interest (1020 anti-TNF-α, 228 VDZ), and 837 patients were bio-naïve (773 anti-TNF-α, 64 VDZ). The mean age of bio-naïve/bio-experienced anti-TNF-α patients was 39.2/38.1 years (54.9 %/56.7 % female) and 42.6/37.8 years for VDZ patients (56.3 %/54.9 % female). The proportion of patients receiving a maintenance dosage > 150 % compared to SmPC was 15.1 % for Adalimumab, 5.2-39.0 % for Golimumab, 14.7-34.5 % for Infliximab, and 19.7 % for VDZ patients. During the maintenance phase, up to 58.8 % of patients received at least 1 prescription of any CS, and 41.7 %/47.1 % (anti-TNF-α/VDZ) were treated in a hospital due to IBD. The mean IBD-related direct health care cost per patient year was € 30 246 (anti-TNF-α)/ € 28 227 (VDZ) for bio-naïve patients (p = 0.288) and € 34 136 (anti-TNF-α)/ € 32 112 (VDZ) for bio-experienced patients (p = 0.011).

Conclusions:  A substantial percentage of patients receive a high biologic dosage in the maintenance phase. Despite biologic therapy, 30-40 % receive a CS therapy and/or experience at least 1 IBD-associated hospitalization within a year, possibly indicating a remaining disease activity.
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http://dx.doi.org/10.1055/a-0903-2938DOI Listing
July 2019

Development and Bone Regeneration Capacity of Premixed Magnesium Phosphate Cement Pastes.

Materials (Basel) 2019 Jul 1;12(13). Epub 2019 Jul 1.

Department of Oral & Maxillofacial Plastic Surgery, University Hospital Würzburg, Pleicherwall 2, 97070 Würzburg, Germany.

Magnesium phosphate cements (MPC) have been demonstrated to have a superior bone regeneration capacity due to their good solubility under in vivo conditions. While in the past only aqueous MPC pastes have been applied, the current study describes the fabrication and in vitro/in vivo testing of an oil-based calcium doped magnesium phosphate (CaMgP) cement paste. Premixed oil-based pastes with CaMgP chemistry combine the advantages of conventional MPC such as high mechanical strength and good resorbability with a prolonged shelf-life and an easier clinical handling. The pastes set in an aqueous environment and predominantly form struvite and achieve a compressive strength of ~8-10 MPa after setting. The implantation into a drill-hole defect at the distal femoral condyle of New Zealand white rabbits over a course of 6 and 12 weeks demonstrated good biocompatibility of the materials without the formation of soft connective tissue or any signs of inflammation. In contrast to a hydroxyapatite forming reference paste, the premixed CaMgP pastes showed subsequent degradation and bony regeneration. The CaMgP cement pastes presented herein are promising bone replacement materials with excellent material properties for an improved and facilitated clinical application.
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http://dx.doi.org/10.3390/ma12132119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6651064PMC
July 2019
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