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- 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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| 2. |
- 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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| 3. |
- 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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| 4. |
- 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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| 6. |
- 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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