| 1. |
- Marconi, A., et al.
(author)
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ANDES, the high resolution spectrograph for the ELT : science case, baseline design and path to construction
- 2022
-
In: GROUND-BASED AND AIRBORNE INSTRUMENTATION FOR ASTRONOMY IX. - : SPIE - International Society for Optical Engineering. - 9781510653504 - 9781510653498
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Conference paper (peer-reviewed)abstract
- The first generation of ELT instruments includes an optical-infrared high resolution spectrograph, indicated as ELT-HIRES and recently christened ANDES (ArmazoNes high Dispersion Echelle Spectrograph). ANDES consists of three fibre-fed spectrographs (UBV, RIZ, YJH) providing a spectral resolution of similar to 100,000 with a minimum simultaneous wavelength coverage of 0.4-1.8 mu m with the goal of extending it to 0.35-2.4 mu m with the addition of a K band spectrograph. It operates both in seeing- and diffraction-limited conditions and the fibre-feeding allows several, interchangeable observing modes including a single conjugated adaptive optics module and a small diffraction-limited integral field unit in the NIR. Its modularity will ensure that ANDES can be placed entirely on the ELT Nasmyth platform, if enough mass and volume is available, or partly in the Coude room. ANDES has a wide range of groundbreaking science cases spanning nearly all areas of research in astrophysics and even fundamental physics. Among the top science cases there are the detection of biosignatures from exoplanet atmospheres, finding the fingerprints of the first generation of stars, tests on the stability of Nature's fundamental couplings, and the direct detection of the cosmic acceleration. The ANDES project is carried forward by a large international consortium, composed of 35 Institutes from 13 countries, forming a team of more than 200 scientists and engineers which represent the majority of the scientific and technical expertise in the field among ESO member states.
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| 7. |
- Beck, AW, et al.
(author)
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Variations in abdominal aortic aneurysm care : a report from the International consortium of vascular registries
- 2016
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In: Circulation. - 0009-7322 .- 1524-4539.
-
Journal article (peer-reviewed)abstract
- Background: This project by the ICVR (International Consortium of Vascular Registries), a collaboration of 11 vascular surgical quality registries, was designed to evaluate international variation in the contemporary management of abdominal aortic aneurysm (AAA) with relation to recommended treatment guidelines from the Society for Vascular Surgery and the European Society for Vascular Surgery.Methods: Registry data for open and endovascular AAA repair (EVAR) during 2010 to 2013 were collected from 11 countries. Variations in patient selection and treatment were compared across countries and across centers within countries.Results: Among 51 153 patients, 86% were treated for intact AAA (iAAA) and 14% for ruptured AAA. Women constituted 18% of the entire cohort (range, 12% in Switzerland–21% in the United States; P<0.01). Intact AAAs were repaired at diameters smaller than recommended by guidelines in 31% of men (<5.5 cm; range, 6% in Iceland–41% in Germany; P<0.01) and 12% of women with iAAA (<5 cm; range, 0% in Iceland–16% in the United States; P<0.01). Overall, use of EVAR for iAAA varied from 28% in Hungary to 79% in the United States (P<0.01) and for ruptured AAA from 5% in Denmark to 52% in the United States (P<0.01). In addition to the between-country variations, significant variations were present between centers in each country in terms of EVAR use and rate of small AAA repair. Countries that more frequently treated small AAAs tended to use EVAR more frequently (trend: correlation coefficient, 0.51; P=0.14). Octogenarians made up 23% of all patients, ranging from 12% in Hungary to 29% in Australia (P<0.01). In countries with a fee-for-service reimbursement system (Australia, Germany, Switzerland, and the United States), the proportions of small AAA (33%) and octogenarians undergoing iAAA repair (25%) were higher compared with countries with a population-based reimbursement model (small AAA repair, 16%; octogenarians, 18%; P<0.01). In general, center-level variation within countries in the management of AAA was as important as variation between countries.Conclusions: Despite homogeneous guidelines from professional societies, significant variation exists in the management of AAA, most notably for iAAA diameter at repair, use of EVAR, and the treatment of elderly patients. ICVR provides an opportunity to study treatment variation across countries and to encourage optimal practice by sharing these results.
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| 8. |
- Behrendt, C. A., et al.
(author)
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International Variations in Amputation Practice: A VASCUNET Report
- 2018
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 56:3, s. 391-399
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Journal article (peer-reviewed)abstract
- Objectives: To study international differences in incidence and practice patterns as well as time trends in lower limb amputations related to peripheral arterial disease and/or diabetes mellitus. Methods: Data on lower limb amputations during 2010-2014 were collected from population based administrative data from countries in Europe and Australasia participating in the VASCUNET collaboration. Amputation rates, time trends, in hospital or 30 day mortality and reimbursement systems were analysed. Results: Data from 12 countries covering 259 million inhabitants in 2014 were included. Individuals aged >= 65 years ranged from 12.9% (Slovakia) to 20.7% (Germany) and diabetes prevalence among amputees from 25.7% (Finland) to 74.3% (Slovakia). The mean incidence of major amputation varied between 7.2/100,000 (New Zealand) and 41.4/100,000 (Hungary), with an overall declining time trend with the exception of Slovakia, while minor amputations increased over time. The older age group (>= 65 years) was up to 4.9 times more likely to be amputated compared with those younger than 65 years. Reported mortality rates were lowest in Finland (6.3%) and highest in Hungary (20.3%). Countries with a fee for service reimbursement system had a lower incidence of major amputation compared with countries with a population based reimbursement system (14.3/100,000 versus 18.4/100,000, respectively, p < .001). Conclusions: This international audit showed large geographical differences in major amputation rates, by a factor of almost six, and an overall declining time trend during the 4 year observation of this study. Diabetes prevalence, age distribution, and mortality rates were also found to vary between countries. Despite limitations attributable to registry data, these findings are important, and warrant further research on how to improve limb salvage in different demographic settings. (C) 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
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| 9. |
- Bäck, Hanna, et al.
(author)
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The Politics of Legislative Debates : An Introduction
- 2021
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In: The Politics of Legislative Debates. - : Oxford University Press. - 9780198849063 ; , s. 1-20
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Book chapter (other academic/artistic)abstract
- The contribution of this chapter to our volume is fourfold. First, we look at why we should study legislative debates and how scholars may benefit from representation, legislative politics, party politics, and electoral studies by incorporating debates in their analysis. In so doing, we unpack their functions in liberal democracies. Second, the chapter offers a state of the art of the burgeoning field of legislative debates. We focus on the normative scholarly discussion about legislative debates and their importance for deliberation and democratic outputs. In addition, we dwell on Proksch and Slapin's model as a watershed in the empirical study of legislative debates, particularly due to its capacity to travel and its usefulness in understanding how different institutional settings have an impact of speechmaking. Third, the chapter presents the theoretical framework, the key hypotheses guiding the volume, and our empirical approach to legislative debates. Fourth, the chapter concludes with the plan of the book.
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| 10. |
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| 11. |
- Laine, M, et al.
(author)
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Few Internal Iliac artery Aneurysms Rupture under 4 cm
- 2017
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In: Journal of Vascular Research. - : Elsevier BV. - 1018-1172 .- 1423-0135 .- 0741-5214. ; 65:1, s. 76-81
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Journal article (peer-reviewed)abstract
- ObjectiveThis study investigated the diameter of internal iliac artery (IIA) aneurysms (IIAAs) at the time of rupture to evaluate whether the current threshold diameter for elective repair of 3 cm is reasonable. The prevalence of concomitant aneurysms and results of surgical treatment were also investigated.MethodsThis was a retrospective analysis of patients with ruptured IIAA from seven countries. The patients were collected from vascular registries and patient records of 28 vascular centers. Computed tomography images taken at the time of rupture were analyzed, and maximal diameters of the ruptured IIA and other aortoiliac arteries were measured. Data on the type of surgical treatment, mortality at 30 days, and follow-up were collected.ResultsSixty-three patients (55 men and 8 women) were identified, operated on from 2002 to 2015. The patients were a mean age of 76.6 years (standard deviation, 9.0; range 48-93 years). A concomitant common iliac artery aneurysm was present in 65.0%, 41.7% had a concomitant abdominal aortic aneurysm, and 36.7% had both. IIAA was isolated in 30.0%. The mean maximal diameter of the ruptured artery was 68.4 mm (standard deviation, 20.5 mm; median, 67.0 mm; range, 25-116 mm). One rupture occurred at <3 cm and four at <4 cm (6.3% of all ruptures). All patients were treated, 73.0% by open repair and 27.0% by endovascular repair. The 30-day mortality was 12.7%. Median follow-up was 18.3 months (interquartile range, 2.0-48.3 months). The 1-year Kaplan-Meier estimate for survival was 74.5% (standard error, 5.7%).ConclusionsIIAA is an uncommon condition and mostly coexists with other aortoiliac aneurysms. Follow-up until a diameter of 4 cm seems justified, at least in elderly men, although lack of surveillance data precludes firm conclusions. The mortality was low compared with previously published figures and lower than mortality in patients with ruptured abdominal aortic aneurysm.Abdominal aortic aneurysm (AAA) is the most common and studied aneurysm. Aneurysms of the iliac arteries are found considerably less often, and epidemiologic data on these do not exist. In many cases iliac artery aneurysms coexist with aortic aneurysms: ∼10% to 20% of patients with AAA also have a concomitant aneurysm in the iliac arteries.1 The artery most often affected is the common iliac artery (CIA), followed by the internal iliac artery (IIA), also called the hypogastric artery. In the case of isolated aneurysms in the iliac arteries, without involvement of the aorta, the most common location is the IIA.2 Aneurysms of the external iliac artery are extremely rare, possibly because these arteries originate later in development from a different cell population than the distal aorta and the CIA and IIA. Studies on IIA aneurysms (IIAAs) are scarce owing to the rarity of the condition. The existing literature consists primarily of case reports and small patient series. No prospective studies on IAAs exist.According to the literature, IAAs have a high rupture and mortality rate even in elective cases, possibly because of their deep location in the pelvis.3 The etiology and risk factors of IAA seem to be the same as AAA.4 Iliac aneurysms are mostly degenerative but can also be mycotic or caused by genetic disorders such as Marfan or Ehlers-Danlos syndromes. Traumatic aneurysms in the iliac arteries have also been described; for example, caused by iatrogenic trauma from hip, lumbar, or gynecologic operations. A mainly historical subpopulation of young women with IIAA caused by trauma from pregnancy and delivery has been described.5 and 6IAAs cause symptoms more often than AAA because of compression of pelvic structures such as ureters, bladder, veins, or lumbar nerves. Wilhelm et al7 reported that 53% of published isolated IIAA cases were symptomatic, not including the ruptured ones (31%). The high proportion of symptomatic patients in these older reports may partly be explained, however, by the fact that most of these cases were from time before widespread use of modern imaging. IIAA are not easily discovered with clinical examination because of their location8 but are detected increasingly often as a result of imaging and screening programs.Because the studies on IIAAs are scarce, the natural history is virtually unknown. A widely used threshold for elective repair is 3 cm, originally suggested by McCready et al9 because their series did not include any ruptures under that diameter. However, only seven ruptures were included in that report. The reference list of this article illustrates that most of the papers on this subject were published when open repair was the only treatment option. Nowadays endovascular treatment is the first option in many centers.10The aim of this study was to investigate at what diameter IIAAs tend to rupture and whether the current operative threshold of 3 cm is rational. Secondary aims were to assess the prevalence of concomitant aortoiliac aneurysms, treatment patterns, and the results of treatment.
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| 12. |
- Budtz-Lilly, Jacob, et al.
(author)
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Editor's Choice - Assessment of International Outcomes of Intact Abdominal Aortic Aneurysm Repair over 9 Years
- 2017
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In: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 54:1, s. 13-20
-
Journal article (peer-reviewed)abstract
- Background: Case mix and outcomes of complex surgical procedures vary over time and between regions. This study analyses peri-operative mortality after intact abdominal aortic aneurysm (AAA) repair in 11 countries over 9 years. Methods: Data on primary AAA repair from vascular surgery registries in 11 countries for the years 2005-2009 and 2010-2013 were analysed. Multivariate adjusted logistic regression analyses were carried out to adjust for variations in case mix. Results: A total of 83,253 patients were included. Over the two periods, the proportion of patients >= 80 years old increased (18.5% vs. 23.1%; p < .0001) as did the proportion of endovascular repair (EVAR) (44.3% vs. 60.6; p < .0001). In the latter period, 25.8% of AAAs were less than 5.5 cm. The mean annual volume of open repairs per centre decreased from 12.9 to 10.6 between the two periods (p < .0001), and it increased for EVAR from 10.0 to 17.1 (p < .0001). Overall, peri-operative mortality fell from 3.0% to 2.4% (p < .0001). Mortality for EVAR decreased from 1.5% to 1.1% (p < .0001), but the outcome worsened for open repair from 3.9% to 4.4% (p = .008). The peri-operative risk was greater for octogenarians (overall, 3.6% vs. 2.1%, p < .0001; open, 9.5% vs. 3.6%, p < .0001; EVAR, 1.8% vs. 0.7%, p < .0001), and women (overall, 3.8% vs. 2.2%, p < .0001; open, 6.0% vs. 4.0%, p < .0001; EVAR, 1.9% vs. 0.9%, p < .0001). Peri-operative mortality after repair of AAAs <5.5 cm was 4.4% with open repair and 1.0% with EVAR, p < .0001. Conclusions: In this large international cohort, total peri-operative mortality continues to fall for the treatment of intact AAAs. The number of EVAR procedures now exceeds open procedures. Mortality after EVAR has decreased, but mortality for open operations has increased. The peri-operative mortality for small AM treatment, particularly open surgical repair, is still considerable and should be weighed against the risk of rupture.
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| 16. |
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| 17. |
- Behrendt, Christian-Alexander, et al.
(author)
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Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia : A Delphi Consensus from the International Consortium of Vascular Registries
- 2019
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In: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 57:6, s. 816-821
-
Journal article (peer-reviewed)abstract
- Objective: To develop a minimum core data set for evaluation of acute limb ischaemia (ALI) revascularisation treatment and outcomes that would enable collaboration among international registries. Methods: A modified Delphi approach was used to achieve consensus among international multidisciplinary vascular specialists and registry members of the International Consortium of Vascular Registries (ICVR). Variables identified in the literature or suggested by the expert panel, and variables, including definitions, currently used in 15 countries in the ICVR, were assessed to define both a minimum core and an optimum data set to register ALI treatment. Clinical relevance and practicability were both assessed, and consensus was defined as >= 80% agreement among participants. Results: Of 40 invited experts, 37 completed a preliminary survey and 31 completed the two subsequent Delphi rounds via internet exchange and face to face discussions. In total, 117 different items were generated from the various registry data forms, an extensive review of the literature, and additional suggestions from the experts, for potential inclusion in the data set. Ultimately, 35 items were recommended for inclusion in the minimum core data set, including 23 core items important for all registries, and an additional 12 more specific items for registries capable of capturing more detail. These 35 items supplement previous data elements recommended for registering chronic peripheral arterial occlusive disease treatment. Conclusion: A modified Delphi study allowed 37 international vascular registry experts to achieve a consensus recommendation for a minimum core and an optimum data set for registries covering patients who undergo ALI revascularisation. Continued global harmonisation of registry infrastructure and definition of items allows international comparisons and global quality improvement. Furthermore, it can help to define and monitor standards of care and enable international research collaboration.
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| 18. |
- Bäck, Hanna, et al.
(author)
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Sweden : Biased Debate Participation with Nearly Equal Gender Representation
- 2021
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In: The Politics of Legislative Debates. - 9780198849063 ; , s. 713-733
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Book chapter (other academic/artistic)abstract
- The Swedish Riksdag is often regarded as an ideal type for Scandinavian or Nordic parliamentarism. This relates to institutional features and party cohesion, but more often so to descriptive representation in terms of gender—an aspect where Sweden's parliament has consistently occupied the top position among European parliaments during the last decades. However, and despite an unlikely-case-character, previous research has shown that gender biases exist in Nordic parliaments and the Riksdag in particular. This chapter follows this research and evaluates how gender and seniority determine legislators' opportunities to speak in plenary debates. Our results show that the gender biases found in previous research persist to date and extend further to the past. Furthermore, low seniority amplifies the effect of gender; junior female legislators have the slimmest chances to speak in plenary debates.
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| 19. |
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| 20. |
- Conte, Michael S, et al.
(author)
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Global vascular guidelines on the management of chronic limb-threatening ischemia.
- 2019
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In: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 69:6S, s. 3S-125S.e40
-
Journal article (peer-reviewed)abstract
- Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.
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| 21. |
- Conte, Michael S., et al.
(author)
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Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia
- 2019
-
In: European Journal of Vascular and Endovascular Surgery. - : Saunders Elsevier. - 1078-5884 .- 1532-2165. ; 58:1, s. S1-S109
-
Journal article (peer-reviewed)abstract
- Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.
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| 22. |
- Dickie, B., et al.
(author)
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A community-endorsed open-source lexicon for contrast agent-based perfusion MRI: A consensus guidelines report from the ISMRM Open Science Initiative for Perfusion Imaging (OSIPI)
- 2024
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In: Magnetic Resonance in Medicine. - 0740-3194. ; 91:5, s. 1761-1773
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Journal article (peer-reviewed)abstract
- This manuscript describes the ISMRM OSIPI (Open Science Initiative for Perfusion Imaging) lexicon for dynamic contrast-enhanced and dynamic susceptibility-contrast MRI. The lexicon was developed by Taskforce 4.2 of OSIPI to provide standardized definitions of commonly used quantities, models, and analysis processes with the aim of reducing reporting variability. The taskforce was established in February 2020 and consists of medical physicists, engineers, clinicians, data and computer scientists, and DICOM (Digital Imaging and Communications in Medicine) standard experts. Members of the taskforce collaborated via a slack channel and quarterly virtual meetings. Members participated by defining lexicon items and reporting formats that were reviewed by at least two other members of the taskforce. Version 1.0.0 of the lexicon was subject to open review from the wider perfusion imaging community between January and March 2022, and endorsed by the Perfusion Study Group of the ISMRM in the summer of 2022. The initial scope of the lexicon was set by the taskforce and defined such that it contained a basic set of quantities, processes, and models to enable users to report an end-to-end analysis pipeline including kinetic model fitting. We also provide guidance on how to easily incorporate lexicon items and definitions into free-text descriptions (e.g., in manuscripts and other documentation) and introduce an XML-based pipeline encoding format to encode analyses using lexicon definitions in standardized and extensible machine-readable code. The lexicon is designed to be open-source and extendable, enabling ongoing expansion of its content. We hope that widespread adoption of lexicon terminology and reporting formats described herein will increase reproducibility within the field.
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| 23. |
- Fernandes, Jorge M., et al.
(author)
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Unpacking the politics of legislative debates
- 2021
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In: European Journal of Political Research. - : Wiley. - 0304-4130 .- 1475-6765. ; 60:4, s. 1032-1045
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Journal article (peer-reviewed)abstract
- Legislative debates are a thriving field in comparative politics. They make representation work by offering legislators the opportunity to take the floor and represent their constituents. In this paper, we review the key theoretical concepts and empirical findings in a maturing field. We begin by addressing what legislative debates are and why we should study them to learn about inter- and intra-party politics. Next, we look at the contributions springing from Proksch and Slapin's ground-breaking model. In so doing, our review suggests that recent work extends the original model to include further dimensions of legislative debates. Third, we examine the role of legislative debates as mechanisms of representation, focusing on gender. Four, we examine the challenges of the comparative analysis of legislative debates. Finally, we map the road ahead by discussing four avenues of future research and some key questions that remain unanswered.
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| 24. |
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| 25. |
- Govsyeyev, Nicholas, et al.
(author)
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Rivaroxaban in Patients with Symptomatic Peripheral Artery Disease after Lower Extremity Bypass Surgery with Venous and Prosthetic Conduits
- 2023
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In: Journal of Vascular Surgery. - : Elsevier. - 0741-5214 .- 1097-6809. ; 77:4, s. 1107-1118.e2
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Journal article (peer-reviewed)abstract
- BACKGROUND: Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. VOYAGER PAD demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit in patients undergoing surgical revascularization; however, the efficacy and safety in those treated by surgical bypass including stratified by bypass conduit (venous or prosthetic) has not been described.METHODS: In the VOYAGER PAD trial, patients with PAD after surgical and endovascular infrainguinal LER were randomized to rivaroxaban 2.5 mg twice daily or placebo and followed for a median of 28 months. The primary endpoint was a composite of acute limb ischemia (ALI), major amputation of vascular etiology, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Index procedure details including conduit type (venous or prosthetic) were collected at baseline.RESULTS: Among 6564 randomized, 2185 (33%) underwent surgical LER. Of these, surgical bypass was performed in 1448 (66%), using prosthetic conduit in 773 (53%) and venous in 646 (45%). Adjusting for baseline differences and anatomic factors, the risk for unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving prosthetic versus venous conduits (adjHR 2.53, 95% CI 1.65-3.90; p<0.001) while the risk for ALI was 3 times greater (adjHR 3.07, 95% CI 1.84-5.11; p<0.001). Rivaroxaban reduced the primary outcome in patients treated with bypass surgery (HR 0.78, 95% CI 0.62-0.98) with consistent benefits in those receiving venous (HR 0.66, 95% CI 0.49-0.96) and prosthetic (HR 0.87, 95% CI 0.66-1.15) conduits (pinteraction 0.254). In the overall trial, TIMI major bleeding was increased with rivaroxaban; however, numbers in those treated with bypass surgery were low (5 with rivaroxaban, 9 with placebo, HR 0.55, 95% CI 0.18-1.65) and not powered to show statistical significance.CONCLUSIONS: Surgical bypass with prosthetic conduit is associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjusting for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduces this risk, increases bleeding, but has a favorable benefit risk in patients treated with bypass surgery and regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.
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