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- Behrendt, Christian-Alexander, et al.
(författare)
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International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection
- 2018
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 56:2, s. 217-237
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Tidskriftsartikel (refereegranskat)abstract
- Objective/Background: To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries.Methods: A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions.Results: Among 31 invited experts, 25 completed five Delphi rounds via internet exchange and face to face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up.Conclusion: A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.
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- Budtz-Lilly, Jacob, et al.
(författare)
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Editor's Choice - The Impact of Centralisation and Endovascular Aneurysm Repair on Treatment of Ruptured Abdominal Aortic Aneurysms Based on International Registries
- 2018
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 56:2, s. 181-188
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Current management of ruptured abdominal aortic aneurysms (RAAA) varies among centres and countries, particularly in the degree of implementation of endovascular aneurysm repair (EVAR) and levels of vascular surgery centralisation. This study assesses these variations and the impact they have on outcomes.Materials and methods: RAAA repairs from vascular surgical registries in 11 countries, 2010-2013, were investigated. Data were analysed overall, per country, per treatment modality (EVAR or open aortic repair [OAR]), centre volume (quintiles IV), and whether centres were predominantly EVAR (>= 50% of RAAA performed with EVAR [EVAR(p)]) or predominantly OAR [OAR(p)]. Primary outcome was peri-operative mortality. Data are presented as either mean values or percentages with 95% CI within parentheses, and compared with chi-square tests, as well as with adjusted OR.Results: There were 9273 patients included. Mean age was 74.7 (74.5-74.9) years, and 82.7% of patients were men (81.9-83.6). Mean AAA diameter at rupture was 7.6 cm (7.5-7.6). Of these aneurysms, 10.7% (10.0-11.4) were less than 5.5 cm. EVAR was performed in 23.1% (22.3-24.0). There were 6817 procedures performed in OAR(p) centres and 1217 performed in EVAR(p) centres. Overall peri-operative mortality was 28.8% (27.9-29.8). Peri-operative mortality for OAR was 32.1% (31.0-33.2) and for EVAR 17.9% (16.3-19.6), p < .001, and the adjusted OR was 0.38 (0.31-0.47), p < .001. The peri-operative mortality was 23.0% in EVAR(p) centres (20.6-25.4), 29.7% in OAR(p) centres (28.6-30.8), p < .001; adjusted OR = 0.60 (0.46-0.78), p < .001. Perioperative mortality was lower in the highest volume centres (QI > 22 repairs per year), 23.3% (21.2-25.4) than in QII-V, 30.0% (28.9-31.1), p < .001. Peri-operative mortality after OAR was lower in high volume centres compared with the other centres, 25.3% (23.0-27.6) and 34.0% (32.7-35.4), respectively, p < .001. There was no significant difference in peri-operative mortality after EVAR between centres based on volume.Conclusions: Peri-operative mortality is lower in centres with a primary EVAR approach or with high case volume. Most repairs, however, are still performed in low volume centres and in centres with a primary OAR strategy. Reorganisation of acute vascular surgical services may improve outcomes of RAAA repair.
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- Conte, Michael S, et al.
(författare)
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Global vascular guidelines on the management of chronic limb-threatening ischemia.
- 2019
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Ingår i: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 69:6S, s. 3S-125S.e40
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Tidskriftsartikel (refereegranskat)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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- Grima, Matthew J., et al.
(författare)
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Assessment of Correlation Between Mean Size of Infrarenal Abdominal Aortic Aneurysm at Time of Intact Repair Against Repair and Rupture Rate in Nine Countries
- 2020
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 59:6, s. 890-897
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Tidskriftsartikel (refereegranskat)abstract
- Objective: This study aimed to analyse the mean abdominal aortic aneurysm (AAA) diameter for repair in nine countries, and to determine variation in mean AAA diameter for elective AAA repair and its relationship to rupture AAA repair rates and aneurysm related mortality in corresponding populations. Methods: Data on intact (iAAA) and ruptured infrarenal AAA (rAAA) repair for the years 2010-2012 were collected from Denmark, England, Finland, Germany, Hungary, New Zealand, Norway, Sweden, and the USA. The rate of iAAA repair and rAAA per 100 000 inhabitants above 59 years old, mean AAA diameter for iAAA repair and rAAA repair, and the national rates of rAAA were assessed. National cause of death statistics were used to estimate aneurysm related mortality. Direct standardisation methods were applied to the national mortality data. Logistic regression and analysis of variance model adjustments were made for age groups, sex, and year. Results: There was a variation in the mean diameter of iAAA repair (n = 34 566; range Germany = 57 mm, Denmark = 68 mm). The standardised iAAA repair rate per 100000 inhabitants varied from 10.4 (Hungary) to 66.5 (Norway), p<.01, and the standardised rAAA repair rate per 100 000 from 5.8 (USA) to 16.9 (England), p<.01. Overall, there was no significant correlation between mean diameter of iAAA repair and standardised iAAA rate (r(2) = 0.04, p = .3). There was no significant correlation between rAAA repair rate (n = 12 628) with mean diameter of iAAA repair (r(2) = 0.2, p = .1). Conclusion: Despite recommendations from learned society guidelines, data indicate variations in mean diameter for AAA repair. There was no significant correlation between mean diameter of AAA repair and rates of iAAA repair and rAAA repair. These analyses are subject to differences in disease prevalence, uncertainties in rupture rates, validations of vascular registries, causes of death and registrations.
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- Scali, Salvatore T., et al.
(författare)
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Optimal Threshold for the Volume-Outcome Relationship After Open AAA Repair in the Endovascular Era : Analysis of the International Consortium of Vascular Registries
- 2021
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 61:5, s. 747-755
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Tidskriftsartikel (refereegranskat)abstract
- Objective: As open abdominal aortic aneurysm (AAA) repair (OAR) rates decline in the endovascular era, the endorsement of minimum volume thresholds for OAR is increasingly controversial, as this may affect credentialing and training. The purpose of this analysis was to identify an optimal centre volume threshold that is associated with the most significant mortality reduction after OAR, and to determine how this reflects contemporary practice.Methods: This was an observational study of OARs performed in 11 countries (2010 - 2016) within the International Consortium of Vascular Registry database (n = 178 302). The primary endpoint was post-operative in hospital mortality. Two different methodologies (area under the receiving operating curve optimisation and Markov chain Monte Carlo procedure) were used to determine the optimal centre volume threshold associated with the most significant mortality improvement.Results: In total, 154 912 (86.9%) intact and 23 390 (13.1%) ruptured AAAs were analysed. The majority (63.1%; n = 112 557) underwent endovascular repair (EVAR) (OAR 36.9%; n = 65 745). A significant inverse relationship between increasing centre volume and lower peri-operative mortality after intact and ruptured OAR was evident (p < .001) but not with EVAR. An annual centre volume of between 13 and 16 procedures per year was associated with the most significant mortality reduction after intact OAR (adjusted predicted mortality < 13 procedures/year 4.6% [95% confidence interval 4.0% - 5.2%] vs. = 13 procedures/year 3.1% [95% CI 2.8% - 3.5%]). With the increasing adoption of EVAR, the mean number of OARs per centre (intact + ruptured) decreased significantly (2010 - 2013 = 35.7; 2014 - 2016 = 29.8; p < .001). Only 23% of centres (n = 240/1 065) met the >= 13 procedures/year volume threshold, with significant variation between nations (Germany 11%; Denmark 100%).Conclusion: An annual centre volume of 13 - 16 OARs per year is the optimal threshold associated with the greatest mortality risk reduction after treatment of intact AAA. However, in the current endovascular era, achieving this threshold requires significant re-organisation of OAR practice delivery in many countries, and would affect provision of non-elective aortic services. Low volume centres continuing to offer OAR should aim to achieve mortality results equivalent to the high volume institution benchmark, using validated data from quality registries to track outcomes.
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