| 1. |
- Behrendt, Christian-Alexander, et al.
(författare)
-
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
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 57:6, s. 816-821
-
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.
|
|
| 2. |
- Behrendt, Christian-Alexander, et al.
(författare)
-
International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection
- 2018
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 56:2, s. 217-237
-
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.
|
|
| 3. |
|
|
| 4. |
- Budtz-Lilly, Jacob, et al.
(författare)
-
Editor's Choice - The Impact of Centralisation and Endovascular Aneurysm Repair on Treatment of Ruptured Abdominal Aortic Aneurysms Based on International Registries
- 2018
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 56:2, s. 181-188
-
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.
|
|
| 5. |
- Grima, Matthew J., et al.
(författare)
-
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
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 59:6, s. 890-897
-
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.
|
|
| 6. |
- Grip, Olivia, et al.
(författare)
-
Contemporary Treatment of Popliteal Artery Aneurysms in 14 Countries : A Vascunet Report
- 2020
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 60:5, s. 721-729
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: Popliteal artery aneurysm (PAA) is the second most common arterial aneurysm. Vascunet is an international collaboration of vascular registries. The aim was to study treatment and outcomes. Methods: This was a retrospective analysis of prospectively registered population based data. Fourteen countries contributed data (Australia, Denmark, Finland, France, Hungary, Iceland, Italy, Malta, New Zealand, Norway, Portugal, Serbia, Sweden, and Switzerland). Results: During 2012-2018, data from 10 764 PAA repairs were included. Mean values with between countries ranges in parenthesis are given. The incidence was 10.4 cases/million inhabitants/year (2.4-19.3). The mean age was 71.3 years (66.8-75.3). Most patients, 93.3%, were men and 40.0% were active smokers. The operations were elective in 73.2% (60.0%-85.7%). The mean pre-operative PAA diameter was 32.1 mm (27.3-38.3 mm). Open surgery dominated in both elective (79.5%) and acute (83.2%) cases. A medial surgical approach was used in 77.7%, and posterior in 22.3%. Vein grafts were used in 63.8%. Of the emergency procedures, 91% (n = 2 169, 20.2% of all) were for acute thrombosis and 9% for rupture (n = 236, 2.2% of all). Thrombosis patients had larger aneurysms, mean diameter 35.5 mm, and 46.3% were active smokers. Early amputation and death were higher after acute presentation than after elective surgery (5.0% vs. 0.7%; 1.9% vs. 0.5%). This pattern remained one year after surgery (8.5% vs. 1.0%; 6.1% vs. 1.4%). Elective open compared with endovascular surgery had similar one year amputation rates (1.2% vs. 0.2%; p = .095) but superior patency (84.0% vs. 78.4%; p = .005). Veins had higher patency and lower amputation rates, at one year compared with synthetic grafts (86.8% vs. 72.3%; 1.8% vs. 5.2%; both p < .001). The posterior open approach had a lower amputation rate (0.0% vs. 1.6%, p = .009) than the medial approach. Conclusion: Patients presenting with acute ischaemia had high risk of amputation. The frequent use of endovascular repair and prosthetic grafts should be reconsidered based on these results.
|
|
| 7. |
|
|
| 8. |
- Scali, Salvatore T., et al.
(författare)
-
Optimal Threshold for the Volume-Outcome Relationship After Open AAA Repair in the Endovascular Era : Analysis of the International Consortium of Vascular Registries
- 2021
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier. - 1078-5884 .- 1532-2165. ; 61:5, s. 747-755
-
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.
|
|
| 9. |
- Baderkhan, Hassan, et al.
(författare)
-
Challenging Anatomy Predicts Mortality and Complications After Endovascular Treatment of Ruptured Abdominal Aortic Aneurysm
- 2016
-
Ingår i: Journal of Endovascular Therapy. - : SAGE Publications. - 1526-6028 .- 1545-1550. ; 23:6, s. 919-927
-
Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: To analyze the effects of aortic anatomy and endovascular aneurysm repair (EVAR) inside and outside the instructions for use (IFU) on outcomes in patients treated for ruptured abdominal aortic aneurysms (rAAA).METHODS: All 112 patients (mean age 73 years; 102 men) treated with standard EVAR for rAAA between 2000 and 2012 in 3 European centers were included in the retrospective analysis. Patients were grouped based on aortic anatomy and whether EVAR was performed inside or outside the IFU. Data on complications, secondary interventions, and mortality were extracted from the patient records. Cox regression analysis was performed to assess predictors of mortality and complications; results are presented as the hazard ratio (HR) with 95% confidence interval (CI). Survival was analyzed using the Kaplan-Meier method.RESULTS: Of the 112 patients examined, 61 (54%) were treated inside the IFU, 43 (38%) outside the IFU, and 8 patients lacked adequate preoperative computed tomography scans for determination. Median follow-up of those surviving 30 days was 2.5 years. Mortality at 30 days was 15% (95% CI 6% to 24%) inside the IFU vs 30% (95% CI 16% to 45%) outside (p=0.087). Three-year mortality estimates were 33.8% (95% CI 20.0% to 47.5%) inside the IFU vs 56% (95% CI 39.7% to 72.2%) outside (p=0.016). At 5 years, mortality was 48% (95% CI 30% to 66%) inside the IFU vs 74% (95% CI 54% to 93%) outside (p=0.015). Graft-related complications occurred in 6% (95% CI 0% to 13%) inside the IFU and 30% (95% CI 14% to 42%) outside (p=0.015). The rate of graft-related secondary interventions was 14% (95% CI 4% to 22%) inside the IFU vs 35% (95% CI 14% to 42%) outside (p=0.072). In the multivariate analysis, neck length <15 mm (HR 8.1, 95% CI 3.0 to 21.9, p<0.001) and angulation >60° (HR 3.1, 95% CI 1.0 to 9.3, p=0.045) were independent predictors of late graft-related complications. Aneurysm neck diameter >29 mm (HR 2.5, 95% CI 1.1 to 5.9, p=0.035) was an independent predictor of overall mortality.CONCLUSION: Long-term mortality and complications after rEVAR are associated with aneurysm anatomy. The role of adjunct endovascular techniques and the outcome of open repair in cases with challenging anatomy warrant further study.
|
|
| 10. |
- Baderkhan, Hassan, et al.
(författare)
-
Detection of Late Complications After Endovascular Abdominal Aortic Aneurysm Repair and Implications for Follow up Based on Retrospective Assessment of a Two Centre Cohort
- 2020
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 60:2, s. 171-179
-
Tidskriftsartikel (refereegranskat)abstract
- Objective. Endovascular aortic aneurysm repair (EVAR) is associated with the risk of late complications and mandates follow up. This retrospective study assessed post-EVAR complications in a two centre cohort. The study evaluated the rate of complications presenting with symptoms vs. those detected by imaging follow up. Additionally, the agreement between DUS and CTA in detecting complications was assessed in patients with both. Methods: All EVAR patients from 1998 to 2012 in two centres were included. Complications were classified based on whether they were symptomatic or detected by imaging, as well as based on imaging detection modality (DUS or CTA). For patients who had undergone DUS and CTA within three months of each other, the kappa coefficient of agreement was assessed. Results: Four hundred and fifty-four patients treated by EVAR were identified. The median follow up time was 5.2 (IQR 2.8-7.6) years. One hundred and eighteen patients (26%) developed 176 complications. One hundred and six (60.2%) of the complications were asymptomatic, and 70 (39.8%) were symptomatic. Two hundred and fifty-three patients had imaging with both modalities within three months of each other; the kappa coefficient for agreement between CTA and DUS for detecting clinically significant complications was 0.91. Regarding CTA as the standard modality, DUS had a sensitivity of 88.8% (95% CI 77.3-95.8%) and a specificity of 99.4% (95% CI 97.1-99.9%). Three of the complications missed by DUS were related to loss of proximal and distal seal, all occurring in patients with short sealing length on first post-operative CT scan. Conclusion: Approximately a quarter of the patients developed complications, the majority of which were asymptomatic, underlining the importance of adequate surveillance. There was good agreement between CTA and DUS in detecting complications. Clinically significant complications related to inadequate seal were missed by DUS, suggesting that CTA still plays an important role in EVAR surveillance.
|
|
