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| 2. |
- Acosta, Stefan, et al.
(författare)
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Open Abdomen Therapy with Vacuum and Mesh Mediated Fascial Traction After Aortic Repair : An International Multicentre Study
- 2017
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 54:6, s. 697-705
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Open abdomen therapy may be necessary to prevent or treat abdominal compartment syndrome (ACS). The aim of the study was to analyse the primary delayed fascial closure (PDFC) rate and complications after open abdomen therapy with vacuum and mesh mediated fascial traction (VACM) after aortic repair and to compare outcomes between those treated with open abdomen after primary versus secondary operation. Methods: This was a retrospective cohort, multicentre study in Sweden, Finland, and Norway, including consecutive patients treated with open abdomen and VACM after aortic repair at six vascular centres in 2006-2015. The primary endpoint was PDFC rate. Results: Among 191 patients, 155 were men. The median age was 71 years (IQR 66-76). Ruptured abdominal aortic aneurysm (RAAA) occurred in 69.1%. Endovascular/hybrid and open repairs were performed in 49 and 142 patients, respectively. The indications for open abdomen were inability to close the abdomen (62%) at primary operation and ACS (80%) at secondary operation. Duration of open abdomen was 11 days (IQR 7-16) in 157 patients alive at open abdomen termination. The PDFC rate was 91.8%. Open abdomen initiated at primary (N=103), compared with secondary operation (N=88), was associated with less severe initial open abdomen status (p=.006), less intestinal ischaemia (p=.002), shorter duration of open abdomen (p=.007), and less renal replacement therapy (RRT, p<.001). In hospital mortality was 39.3%, and after entero-atmospheric fistula (N=9) was 88.9%. Seven developed graft infection within 6 months, 1 year mortality was 28.6%. Intestinal ischaemia (OR 3.71, 95% CI 1.55-8.91), RRT (OR 3.62, 95% CI 1.72-7.65), and age (OR 1.12, 95% CI 1.06-1.12), were independent factors associated with in hospital mortality, but not open abdomen initiated at primary versus secondary operation. Conclusions: VACM was associated with a high PDFC rate after prolonged open abdomen therapy following aortic repair. Patient outcomes seemed better when open abdomen was initiated at primary, compared with secondary operation but a selection effect is possible.
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- Arndt, Helene, et al.
(författare)
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A Delphi Consensus on Patient Reported Outcomes for Registries and Trials Including Patients with Intermittent Claudication: Recommendations and Reporting Standard.
- 2022
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Ingår i: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1532-2165 .- 1078-5884. ; 64:5, s. 526-533
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Tidskriftsartikel (refereegranskat)abstract
- This study aimed to develop a core set of patient reported outcome quality indicators (QIs) for the treatment of patients with intermittent claudication (IC), that allow a broad international implementation across different vascular registries and within trials.A rigorous modified two stage Delphi technique was used to promote consensus building on patient reported outcome QIs among an expert panel consisting of international vascular specialists, patient representatives, and registry members of the VASCUNET and the International Consortium of Vascular Registries. Potential QIs identified through an extensive literature search or additionally proposed by the panel were validated by the experts in a preliminary survey and included for evaluation. Consensus was reached if ≥ 80% of participants agreed that an item was both clinically relevant and practical.Participation rates in two Delphi rounds were 66% (31 participants of 47 invited) and 90% (54 of 60), respectively. Initially, 145 patient reported outcome QIs were documented. Following the two Delphi rounds, 18 quality indicators remained, all of which reached consensus regarding clinical relevance. The VascuQoL questionnaire (VascuQoL-6), currently the most common patient reported outcome measurement (PROM) used within vascular registries, includes a total of six items. Five of these six items also matched with high rated indicators identified in the Delphi study. Consequently, the panel recommends the use of the VascuQoL-6 survey as a preferred core PROM QI set as well as an optional extension of 12 additional patient reported QIs that were also identified in this study.The current recommendation based on the Delphi consensus building approach, strengthens the international harmonisation of registry data collection in relation to patient reported outcome quality. Continuous and standardised quality assurance will ensure that registry data may be used for future quality benchmarking studies and, ultimately, positively impact the overall quality of care provided to patients with peripheral arterial occlusive disease.
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| 5. |
- Behrendt, Christian-Alexander, et al.
(författare)
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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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Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 57:6, s. 816-821
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Tidskriftsartikel (refereegranskat)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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| 6. |
- 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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| 10. |
- Boyle, Jonathan R., et al.
(författare)
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Editor's Choice - Variation in Intact Abdominal Aortic Aneurysm Repair Outcomes by Country : Analysis of International Consortium of Vascular Registries 2010-2016
- 2021
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 62:1, s. 16-24
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Outcomes for intact abdominal aortic aneurysm (AAA) repair vary over time and by healthcare system, country, and surgeon. The aim of this study was to analyse peri-operative mortality for intact AAA repair in 11 countries over time and compare outcomes by gender, age, and geographical location. Methods: Prospective data on primary repair of intact AAAwere collected from11 countries through the International Consortium of Vascular Registries (ICVR) and analysed for two time periods, 2010 - 2013 and 2014 - 2016. The primary outcome was peri-operative mortality after endovascular aneurysm repair (EVAR) and open surgical repair (OSR). Multivariable logistic regression models were used to adjust for differences in patient characteristics. Results: A total of 103 715 patients were included. The percentage of patients undergoing EVAR increased from 63.6% to 71.2% (p < .001) over the study period. This proportion varied by country from 35% in Hungary to 81% in the United States. Overall peri-operative mortality decreased from 2.1% to 1.6 % (p < .001). Mortality also declined significantly over time for both OSR 4.2% to 3.6 % (p = .002) and EVAR 1.0% to 0.7% (p = .002). Mortality was significantly higher for female than male patients (3.0% vs. 1.6% p < .001). The percentage of patients > 80 years old undergoing AAA repair remained constant at 23.6% (p = .91). Peri-operative mortality was higher for patients > 80 years than for those < 80 years old (2.7% vs. 1.6% p < .001). Forty-six per cent (n = 275) of all EVAR deaths occurred in the over 80s. Conclusion: The proportion of AAA repairs performed using EVAR has increased over time. Peri-operative mortality continues to decline for both OSR and EVAR. Outcomes however were significantly worse for both women and those aged over 80, so efforts should be focused on these patient groups to further reduce elective AAA mortality rates.
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