scholarly journals A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms—the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e054493
Author(s):  
Shaneel R Patel ◽  
David C Ormesher ◽  
Samuel R Smith ◽  
Kitty H F Wong ◽  
Paul Bevis ◽  
...  

IntroductionIn one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: ‘What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?’Methods and analysisUK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.Ethics and disseminationThe study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.Trial registration numberISRCTN85731188.

2003 ◽  
Vol 10 (3) ◽  
pp. 453-457 ◽  
Author(s):  
Daniel F.G. Rose ◽  
Ian R. Davidson ◽  
Robert J. Hinchliffe ◽  
Simon C. Whitaker ◽  
Roger H. Gregson ◽  
...  

Purpose: To assess the anatomical suitability of ruptured abdominal aortic aneurysms (AAA) for emergency endovascular repair. Methods: All cases (46 patients [35 men; mean age 74 years, range 54–85]) in which computed tomographic angiography (CTA) confirmed AAA rupture over a 5-year period at our university hospital were reviewed for anatomical suitability for endovascular repair. Measurements were made by a radiologist experienced in anatomical assessment of CT criteria for elective endovascular aneurysm repair (EVAR). Results: The mean aneurysm neck length was 18 mm (range 0–59); 17 were conical, 13 straight, 4 barrel, and 6 reverse conical. Six cases had no proximal neck. Overall, 37 (80%) patients were unsuitable for EVAR according to our criteria. Nearly half the patients (22, 48%) had ≥2 adverse features. Unsuitable neck morphology (35, 76%) was the primary reason for exclusion, but CIA aneurysm (10, 22%) and EIA tortuosity (7, 15%) were secondary adverse features. Conclusions: With current stent-graft design, the majority of ruptured abdominal aortic aneurysms are anatomically unsuitable for endovascular repair.


2014 ◽  
Vol 18 (70) ◽  
pp. 1-66 ◽  
Author(s):  
Nigel Armstrong ◽  
Laura Burgers ◽  
Sohan Deshpande ◽  
Maiwenn Al ◽  
Rob Riemsma ◽  
...  

BackgroundPatients with large abdominal aortic aneurysms (AAAs) are usually offered reparative treatment given the high mortality risk. There is uncertainty about how to treat juxtarenal AAAs (JRAAAs) or thoracoabdominal aortic aneurysms (TAAAs). Endovascular repair of an abdominal aortic aneurysm (EVAR) is often seen as safer and easier than open surgical repair (OSR). However, endovascular treatment of JRAAAs or TAAAs requires specially manufactured stent grafts, with openings to allow blood to reach branches of the aorta. Commissioners are receiving increasing requests for fenestrated EVAR (fEVAR) and branched EVAR (bEVAR), but it is unclear whether or not the extra cost of fEVAR or bEVAR is justified by advantages for patients.Objective(s)To assess the clinical effectiveness, safety and cost-effectiveness of fEVAR and bEVAR in comparison with conventional treatment (i.e. no surgery) or OSR for two populations: JRAAAs and TAAAs.Data sourcesResources were searched from inception to October 2013, including MEDLINE (OvidSP), EMBASE (OvidSP) and the Cochrane Central Register of Controlled Trials (Wiley) and, additionally, for cost-effectiveness, NHS Economic Evaluation Database (NHS EED; Wiley) and EconLit (EBSCOhost). Conference abstracts were also searched.Review methodsStudies were included based on an intervention of either fEVAR or bEVAR and a comparator of either OSR or no surgery. For clinical effectiveness, observational studies were excluded only if they were not comparative, i.e. explicitly selected on the basis of prognosis.ResultsFor clinical effectiveness, searches retrieved 5253 records before deduplication. Owing to overlap between the databases, 1985 duplicate records were removed. Of the remaining 3268 records, based on titles and abstracts, 3244 records were excluded, leaving 24 publications to be ordered. All 24 studies were excluded as none of them satisfied the inclusion criteria. Sixteen studies were excluded on study design, six on intervention and two on comparator. Five out of 16 studies excluded on study design reported a comparison. However, all of the studies acknowledged that they had groups that were not comparable at baseline given that they had selectively assigned younger, fitter patients to OSR. Therefore, these studies were considered ‘non-comparative’. For cost-effectiveness, searches identified 104 references before deduplication. Owing to overlap between the databases, 34 duplicate records were removed. Of the remaining 70 records, seven were included for the full assessment based on initial screening. After a full-text review, no studies were included. Because of the lack of clinical effectiveness evidence and difficulty in estimating costs given the rapidly changing and variable technology, a cost-effectiveness analysis (CEA) was not performed. Instead a detailed description of modelling methods was provided.ConclusionsDespite a thorough search, no studies could be found that met the inclusion criteria. All studies that compared either fEVAR or bEVAR with either OSR or no surgery explicitly selected patients based on prognosis, i.e. essentially the populations for each comparator were not the same. Despite not being able to conduct a CEA, we have provided detailed methods for the conduct if data becomes available.Future workWe recommend at least one clinical trial to provide an unbiased estimate of effect for fEVAR/bEVAR compared with OSR or no surgery. This trial should also collect data for a CEA.Study registrationThis study is registered as PROSPERO CRD42013006051.FundingThe National Institute for Health Research Health Technology Assessment programme.


2016 ◽  
Vol 23 (6) ◽  
pp. 919-927 ◽  
Author(s):  
Hassan Baderkhan ◽  
Frederico M. Bastos Gonçalves ◽  
Nelson Gomes Oliveira ◽  
Hence J. M. Verhagen ◽  
Anders Wanhainen ◽  
...  

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.


BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020066 ◽  
Author(s):  
Manuela Deidda ◽  
Kathleen Anne Boyd ◽  
Helen Minnis ◽  
Julia Donaldson ◽  
Kevin Brown ◽  
...  

IntroductionChildren who have experienced abuse and neglect are at increased risk of mental and physical health problems throughout life. This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors. Evidence suggests that early intervention can mitigate the negative consequences of child maltreatment, exerting long-term positive effects on the health of maltreated children entering foster care. However, evidence on cost-effectiveness of such complex interventions is limited. This protocol describes the first economic evaluation of its kind in the UK.Methods and analysisAn economic evaluation alongside the Best Services Trial (BeST?) has been prospectively designed to identify, measure and value key resource and outcome impacts arising from the New Orleans intervention model (NIM) (an infant mental health service) compared with case management (CM) (enhanced social work services as usual). A within-trial economic evaluation and long-term model from a National Health Service/Personal Social Service and a broader societal perspective will be undertaken alongside the National Institute for Health Research (NIHR)–Public Health Research Unit (PHRU)-funded randomised multicentre BeST?. BeST? aims to evaluate NIM compared with CM for maltreated children entering foster care in a UK context. Collection of Paediatric Quality of Life Inventory (PedsQL) and the recent mapping of PedsQL to EuroQol-5-Dimensions (EQ-5D) will facilitate the estimation of quality-adjusted life years specific to the infant population for a cost–utility analysis. Other effectiveness outcomes will be incorporated into a cost-effectiveness analysis (CEA) and cost-consequences analysis (CCA). A long-term economic model and multiple economic evaluation frameworks will provide decision-makers with a comprehensive, multiperspective guide regarding cost-effectiveness of NIM. The long-term population health economic model will be developed to synthesise trial data with routine linked data and key government sector parameters informed by literature. Methods guidance for population health economic evaluation will be adopted (lifetime horizon, 1.5% discount rate for costs and benefits, CCA framework, multisector perspective).Ethics and disseminationEthics approval was obtained by the West of Scotland Ethics Committee. Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal as well as published in the peer-reviewed NIHR journals library (Public Health Research Programme).Trial registration numberNCT02653716; Pre-results.


2021 ◽  
Vol 12 ◽  
Author(s):  
Ming Qing ◽  
Yue Qiu ◽  
Jiarong Wang ◽  
Tinghui Zheng ◽  
Ding Yuan

Objectives: Cross-limb stent grafts for endovascular aneurysm repair (EVAR) are often employed for abdominal aortic aneurysms (AAAs) with significant aortic neck angulation. Neck angulation may be coronal or sagittal; however, previous hemodynamic studies of cross-limb EVAR stent grafts (SGs) primarily utilized simplified planar neck geometries. This study examined the differences in flow patterns and hemodynamic parameters between crossed and non-crossed limb SGs at different spatial neck angulations.Methods: Ideal models consisting of 13 cross and 13 non-cross limbs were established, with coronal and sagittal angles ranging from 0 to 90°. Computational fluid dynamics (CFD) was used to capture the hemodynamic information, and the differences were compared.Results: With regards to the pressure drop index, the maximum difference caused by the configuration and angular direction was 4.6 and 8.0%, respectively, but the difference resulting from the change in aneurysm neck angle can reach 27.1%. With regards to the SAR-TAWSS index, the maximum difference caused by the configuration and angular direction was 7.8 and 9.8%, respectively, but the difference resulting from the change in aneurysm neck angle can reach 26.7%. In addition, when the aneurysm neck angle is lower than 45°, the configuration and angular direction significantly influence the OSI and helical flow intensity index. However, when the aneurysm neck angle is greater than 45°, the hemodynamic differences of each model at the same aneurysm neck angle are reduced.Conclusion: The main factor affecting the hemodynamic index was the angle of the aneurysm neck, while the configuration and angular direction had little effect on the hemodynamics. Furthermore, when the aneurysm neck was greatly angulated, the cross-limb technique did not increase the risk of thrombosis.


2014 ◽  
Vol 96 (1) ◽  
pp. 27-31 ◽  
Author(s):  
J Cross ◽  
T Richards

INTRODUCTION The aim of this study is to establish the current practice of aneurysm management, to assess the introduction of fenestrated endovascular aneurysm repair (FEVAR) and to establish the criteria for its use and its role in the UK. METHODS All UK centres performing FEVAR and centres with an established interest in infra-renal endovascular aneurysm repair (EVAR) were invited to respond to an open-ended questionnaire about abdominal aortic aneurysm (AAA) management. RESULTS A response was obtained from over 90% of UK FEVAR centres. Results showed marked regional differences in aneurysm management, in particular with regard to indications for complex aneurysm management. CONCLUSION The trend in the UK is towards endovascular repair. However, there are still variations in unit policies, indicating regional differences in patient management.


2021 ◽  
Vol 18 (3) ◽  
Author(s):  
Zeinab Dolatshahi ◽  
Fateme Mezginejad ◽  
Shahin Nargesi ◽  
Moslem Saliminejad

Context: If the diameter of an aneurysm increases by more than 6 cm, the risk of aortic rupture increases by 50% within 10 years. Therefore, rupture of aneurysm, which is usually asymptomatic, can lead to severe complications and increase the risk of mortality. The current study aimed to systematically review studies comparing the cost-effective endovascular aneurysm repair (EVAR) and open surgical repair (OSR) as the primary treatment options for patients with ruptured abdominal aortic aneurysms (AAAs). Methods: An electronic search was conducted in PubMed, EMBASE, Science Direct, Scopus, and other scientific economic databases. Relevant articles were searched from 1999 to 2020 using keywords, such as “abdominal aortic aneurysm”, “endovascular”, “open surgery”, “rupture”, “economic evaluation”, and “cost-effectiveness”. The quality of articles was assessed using the Quality of Health Economic studies (QHES) checklist; finally, five articles were included in this review. Results: The results of the QHES checklist showed that most studies had a good quality. A third-party payer’s perspective was the dominant perspective in all selected studies, comparing EVAR with OSR. All studies considered the direct medical costs and did not disclose any discount rates, except for one study, reporting a 3.5% discount rate. Almost all included studies found EVAR to be a cost-effective intervention; only one study concluded that EVAR, with a cost-effectiveness ratio of €424,542, was not the best treatment option. Conclusion: In patients with ruptured AAAs, the EVAR intervention improved the quality of life, decreased the mortality rate, and shortened the hospital stay as compared to OSR.


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