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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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- Heinola, Ivika, et al.
(författare)
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Open Repair of Mycotic Abdominal Aortic Aneurysms With Biological Grafts : An International Multicenter Study
- 2018
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Ingår i: Journal of the American Heart Association. - : John Wiley & Sons. - 2047-9980 .- 2047-9980. ; 7:12
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Tidskriftsartikel (refereegranskat)abstract
- Background- The treatment of mycotic abdominal aortic aneurysm requires surgery and antimicrobial therapy. Since prosthetic reconstructions carry a considerable risk of reinfection, biological grafts are noteworthy alternatives. The current study evaluated the durability, infection resistance, and midterm outcome of biological grafts in treatment of mycotic abdominal aortic aneurysm.Methods and Results- All patients treated with biological graft in 6 countries between 2006 and 2016 were included. Primary outcome measures were 30- and 90-day survival, treatment-related mortality, and reinfection rate. Secondary outcome measures were overall mortality and graft patency. Fifty-six patients (46 males) with median age of 69 years (range 35-85) were included. Sixteen patients were immunocompromised (29%), 24 (43%) had concomitant infection, and 12 (21%) presented with rupture. Bacterial culture was isolated from 43 (77%). In-situ aortic reconstruction was performed using autologous femoral veins in 30 patients (54%), xenopericardial tube-grafts in 12 (21%), cryopreserved arterial/venous allografts in 9 (16%), and fresh arterial allografts in 5 (9%) patients. During a median follow-up of 26 months (range 3 weeks-172 months) there were no reinfections and only 3 patients (5%) required assistance with graft patency. Thirty-day survival was 95% (n=53) and 90-day survival was 91% (n=51). Treatment-related mortality was 9% (n=5). Kaplan-Meier estimation of survival at 1 year was 83% (95% confidence interval, 73%-94%) and at 5 years was 71% (52%-89%).Conclusions- Mycotic abdominal aortic aneurysm repair with biological grafts is a durable option for patients fit for surgery presenting an excellent infection resistance and good overall survival.
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- Strøm, Michael, et al.
(författare)
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Assessment of EVAR Competence : Validity of a Novel Rating Scale (EVARATE) in a Simulated Setting
- 2018
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884. ; 56:1, s. 137-144
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aims of this study were to investigate the validity evidence for a novel procedure specific assessment tool of competence in endovascular aortic repair (EVAR) and to establish a pass/fail level for the assessment. Methods: Computed tomography angiography data of a 55 mm in diameter infrarenal aortic aneurysm was implemented into an endovascular simulator. Twenty-three physicians with varying EVAR experiences were video-recorded when performing a standard EVAR procedure on the simulator. Two experienced EVAR operators assessed the participants using the novel rating scale, “EndoVascular Aortic Repair Assessment of Technical Expertise” (EVARATE). Validity was studied according to the framework endorsed by the American Educational Research Association. Results: The EVARATE scale had a high internal consistency (Cronbach's alpha =.90). The inter-rater reliability was acceptable (Intraclass Correlation Coefficient =.68, p =.005). Specific EVAR experience correlated significantly with the EVARATE score (Spearman's rho =.62, p =.002), but general endovascular experience did not. Consequence analysis showed that the EVARATE assessment could distinguish novices from intermediates (p <.01) and from experts (p <.001). A pass/fail score was determined using the contrasting groups’ method. Conclusion: This paper presents the initial validity evidence for a novel procedure specific assessment tool, EVARATE, for operator competence in endovascular aortic repair investigated in a simulated setting. The assessment tool can be used to provide structured formative feedback to trainees.
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