Preventing post-contrast acute kidney injury and hypersensitivity reactions: UK national audit.

AIM: To audit UK radiology departmental protocols related to the prevention of Iodine-based contrast media (ICM) adverse drug reactions (ADRs) and to assess their compliance with the Royal College of Radiologists (RCR) endorsed Royal Australian and New Zealand College of Radiologists' 2018 Iodinated Contrast Guidelines. MATERIALS AND METHODS: Questionnaires were sent to all UK acute National Health Service (NHS) providers treating adult patients with an audit lead registered with the RCR (162 providers encompassing 211 hospital radiology departments). The questionnaire included three main sections: renal function screening, renal protection regimens, and hypersensitivity reactions prevention and follow-up. Data collection was conducted between April and July 2022. RESULTS: Sixty-one per cent (129/211) of departments responded, representing 67% of eligible providers. An independent imaging services provider supplied one additional set of data (n=130 overall). Of the responding departments, for post-contrast acute kidney injury (PC-AKI), 41% and 56% had the recommended risk assessment for inpatients and outpatients, respectively. Renal function testing was often over-utilised, and their results were applied improperly. Sixty-eight per cent of departments used the advised threshold for considering renal protection. For hypersensitivity reactions, 9% of departments had the correct risk assessment. Thirty-six per cent of departments had the correct risk mitigation protocol for identified high-risk patients. The documentation and follow-up for hypersensitivity reactions were similarly inadequate. CONCLUSION: Local protocols on preventing ICM ADRs were largely non-compliant with RCR guidelines. Departments need to update their protocols in line with current evidence to avoid iatrogenic morbidity or unnecessary tests and over-precaution.

Radiology reporting of incidental osteoporotic vertebral fragility fractures present on CT studies: results of UK national re-audit.

AIM: To describe a UK-wide re-audit of the 2019 Royal College of Radiologists (RCR) audit evaluating patient-related data and organisational infrastructure in the radiological reporting of vertebral fragility fractures (VFFs) on computed tomography (CT) studies and to assess the impact of a series of RCR interventions, initiated to raise VFF awareness, on reporting practice and outcomes. MATERIALS AND METHODS: Patient specific and organisational questionnaires largely replicated those utilised in 2019. The patient questionnaire involved retrospective analysis of between 50 and 100 consecutive, non-traumatic CT studies which included the thoracolumbar spine. All RCR radiology audit leads were invited to participate. Data collection commenced from 1 April 2022. RESULTS: Data were supplied by 129/194 (67%) departments. One thousand five hundred and eighty-six of 7,316 patients (21.7%) had a VFF on auditor review. Overall improvements were demonstrated in key initial/provisional reporting results; comment on spine/bone (93.2%, 14.4% improvement, p<0.0002); fracture severity assessment (34.7%, 8.5% improvement, p=0.0007); use of recommended terminology (67.8%, 7.5% improvement, p=0.0034); recommendations for further management (11.7%, 9.1% improvement, p<0.0002). CONCLUSIONS: The 2022 national re-audit confirms improvements in diagnostic performance and practice in VFF reporting. Continuing work is required to build on this improvement and to further embed best practice.

Accelerated implementation of remote reporting during the COVID-19 pandemic.

AIM: To assess, via a survey of UK radiological departments, if the COVID-19 pandemic led to a change in radiological reporting undertaken in a home environment with appropriate IT support. MATERIALS AND METHODS: All imaging departments in the UK were contacted and asked about the provision of home reporting and IT support before and after the first wave of the pandemic. RESULTS: One hundred and thirty-seven of the 217 departments contacted replied, producing a response rate of 61%. There was a 147% increase in the provision of remote access viewing and reporting platforms during the pandemic. Although 578 consultants had access to a viewing platform pre-pandemic, this had increased to 1,431 during the course of the first wave. CONCLUSION: This survey represents work undertaken by UK NHS Trusts in co-ordinating and providing increased home-reporting facilities to UK radiologists during the first wave of this global pandemic. The impact of these facilities has been shown to allow more than just the provision of reporting of both elective and emergency imaging and provides additional flexibility in how UK radiologists can help support and provide services. This is a good start, but there are potential problems that now need to be overcome.

Royal College of Radiologists national audit evaluating the provision of imaging in the severely injured patient and compliance with national guidelines.

AIM: To evaluate the provision of imaging in severely injured patients and com pliance with national guidelines. MATERIALS AND METHODS: Two data collection tools were sent to all Royal College of Radiologist audit leads in radiology departments with an emergency department throughout the UK. The first focused on configuration of radiology departments, number of patients scanned for major trauma and service configuration for major trauma. The second focused on reporting times for 30 patients scanned for major trauma. RESULTS: Eighty-five out of 191 (45%) eligible departments responded: 16 (19%) from major trauma centres, 52 (61%) from trauma units and 17 (20%) from other hospitals with an emergency department. Data were collected for 2,161 scans: 450 from major trauma centres, 1,400 from trauma units and 311 from emergency departments. Seven hundred and eighty-four (36%) scans were performed in hours and 1361 (63%) out of hours. Two hundred and forty (11%) scans had a primary survey report documented, of which 53 (22%) were unavailable to clinicians after 20 minutes. Time to final consultant report was within 1 hour for 1,033 (48%) scans and within 2 hours for an additional 540 (25%) scans. 34/85 (40%) departments have registrars first on call for major trauma who report scans out of hours and have a consultant final report the next day. CONCLUSIONS: This study highlights significant deficiencies in care and imaging of severely injured patients within major trauma centres and trauma units. Infrastructure and staffing have been underfunded and under resourced to meet rapidly changing best practice requirements in the management of major trauma.

Predicting risk of rupture and rupture-preventing reinterventions following endovascular abdominal aortic aneurysm repair.

BACKGROUND: Clinical and imaging surveillance practices following endovascular aneurysm repair (EVAR) for intact abdominal aortic aneurysm (AAA) vary considerably and compliance with recommended lifelong surveillance is poor. The aim of this study was to develop a dynamic prognostic model to enable stratification of patients at risk of future secondary aortic rupture or the need for intervention to prevent rupture (rupture-preventing reintervention) to enable the development of personalized surveillance intervals. METHODS: Baseline data and repeat measurements of postoperative aneurysm sac diameter from the EVAR-1 and EVAR-2 trials were used to develop the model, with external validation in a cohort from a single-centre vascular database. Longitudinal mixed-effects models were fitted to trajectories of sac diameter, and model-predicted sac diameter and rate of growth were used in prognostic Cox proportional hazards models. RESULTS: Some 785 patients from the EVAR trials were included, of whom 155 (19·7 per cent) experienced at least one rupture or required a rupture-preventing reintervention during follow-up. An increased risk was associated with preoperative AAA size, rate of sac growth and the number of previously detected complications. A prognostic model using predicted sac growth alone had good discrimination at 2 years (C-index 0·68), 3 years (C-index 0·72) and 5 years (C-index 0·75) after operation and had excellent external validation (C-index 0·76-0·79). More than 5 years after operation, growth rates above 1 mm/year had a sensitivity of over 80 per cent and specificity over 50 per cent in identifying events occurring within 2 years. CONCLUSION: Secondary sac growth is an important predictor of rupture or rupture-preventing reintervention to enable the development of personalized surveillance intervals. A dynamic prognostic model has the potential to tailor surveillance by identifying a large proportion of patients who may require less intensive follow-up.

Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years.

BACKGROUND: The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation. METHODS: An individual-patient data meta-analysis of four multicentre randomized trials of EVAR versus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention. RESULTS: The analysis included 2783 patients, with 14 245 person-years of follow-up (median 5·5 years). Early (0-6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P = 0·022) in the period from 6 months to 4 years after randomization. CONCLUSION: The early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5 years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle : brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1, ISRCTN55703451; DREAM (Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.

DiPOLE: a 10 J, 10 Hz cryogenic gas cooled multi-slab nanosecond Yb:YAG laser.

The Diode Pumped Optical Laser for Experiments (DiPOLE) project at the Central Laser Facility aims to develop a scalable, efficient high pulse energy diode pumped laser amplifier system based on cryogenic gas cooled, multi-slab ceramic Yb:YAG technology. We present recent results obtained from a scaled down prototype laser system designed for operation at 10 Hz pulse repetition rate. At 140 K, the system generated 10.8 J of energy in a 10 ns pulse at 1029.5 nm when pumped by 48 J of diode energy at 940 nm, corresponding to an optical to optical conversion efficiency of 22.5%. To our knowledge, this represents the highest pulse energy obtained from a cryo cooled Yb laser to date and the highest efficiency achieved by a multi-Joule diode pumped solid state laser system. Additionally, we demonstrated shot-to-shot energy stability of 0.85% rms for the system operated at 7 J, 10 Hz during several runs lasting up to 6 hours, with more than 50 hours in total. We also demonstrated pulse shaping capability and report on beam, wavefront and focal spot quality.

Uptake of tamoxifen in consecutive premenopausal women under surveillance in a high-risk breast cancer clinic.

BACKGROUND: Randomised trials of tamoxifen versus placebo indicate that tamoxifen reduces breast cancer risk by approximately 33%, yet uptake is low. Approximately 10% of women in our clinic entered the IBIS-I prevention trial. We assess the uptake of tamoxifen in a consecutive series of premenopausal women not in a trial and explore the reasons for uptake through interviews. METHODS: All eligible women between 33 and 46 years at ≥17% lifetime risk of breast cancer and undergoing annual mammography in our service were invited to take a 5-year course of tamoxifen. Reasons for accepting (n=15) or declining (n=15) were explored using semi-structured interviews. RESULTS: Of 1279 eligible women, 136 (10.6%) decided to take tamoxifen. Women >40 years (74 out of 553 (13.4%)) and those at higher non-BRCA-associated risk were more likely to accept tamoxifen (129 out of 1109 (11.6%)). Interviews highlighted four themes surrounding decision making: perceived impact of side effects, the impact of others' experience on beliefs about tamoxifen, tamoxifen as a 'cancer drug', and daily reminder of cancer risk. CONCLUSIONS: Tamoxifen uptake was similar to previously ascertained uptake in a randomised controlled trial (IBIS-I). Concerns were similar in women who did or did not accept tamoxifen. Decision making appeared to be embedded in the experience of significant others.

Long-term cost-effectiveness analysis of endovascular versus open repair for abdominal aortic aneurysm based on four randomized clinical trials.

BACKGROUND: A number of published economic evaluations of elective endovascular aneurysm repair (EVAR) versus open repair for abdominal aortic aneurysm (AAA) have come to differing conclusions about whether EVAR is cost-effective. This paper reviews the current evidence base and presents up-to-date cost-effectiveness analyses in the light of results of four randomized clinical trials: EVAR-1, DREAM, OVER and ACE. METHODS: Markov models were used to estimate lifetime costs from a UK perspective and quality-adjusted life-years (QALYs) based on the results of each of the four trials. The outcomes included in the model were: procedure costs, surveillance costs, reintervention costs, health-related quality of life, aneurysm-related mortality and other-cause mortality. Alternative scenarios about complications, reinterventions and deaths beyond the trial were explored. RESULTS: Models based on the results of the EVAR-1, DREAM or ACE trials did not find EVAR to be cost-effective at thresholds used in the UK (up to £30,000 per QALY). EVAR seemed cost-effective according to models based on the OVER trial. These results seemed robust to alternative model scenarios about events beyond the trial intervals. CONCLUSION: These analyses did not find that EVAR is cost-effective compared with open repair in the long term in trials conducted in European centres. EVAR did appear to be cost-effective based on the OVER trial, conducted in the USA. Caution must be exercised when transferring the results of economic evaluations from one country to another.

Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm.

BACKGROUND: Single-centre series of the management of patients with ruptured abdominal aortic aneurysm (AAA) are usually too small to identify clinical factors that could improve patient outcomes. METHODS: IMPROVE is a pragmatic, multicentre randomized clinical trial in which eligible patients with a clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair (EVAR) or to open repair. The influences of time and manner of hospital presentation, fluid volume status, type of anaesthesia, type of endovascular repair and time to aneurysm repair on 30-day mortality were investigated according to a prespecified plan, for the subgroup of patients with a proven diagnosis of ruptured or symptomatic AAA. Adjustment was made for potential confounding factors. RESULTS: Some 558 of 613 randomized patients had a symptomatic or ruptured aneurysm: diagnostic accuracy was 91·0 per cent. Patients randomized outside routine working hours had higher operative mortality (adjusted odds ratio (OR) 1·47, 95 per cent confidence interval 1·00 to 2·17). Mortality rates after primary and secondary presentation were similar. Lowest systolic blood pressure was strongly and independently associated with 30-day mortality (51 per cent among those with pressure below 70 mmHg). Patients who received EVAR under local anaesthesia alone had greatly reduced 30-day mortality compared with those who had general anaesthesia (adjusted OR 0·27, 0·10 to 0·70). CONCLUSION: These findings suggest that the outcome of ruptured AAA might be improved by wider use of local anaesthesia for EVAR and that a minimum blood pressure of 70 mmHg is too low a threshold for permissive hypotension.

Temporal trends in imaging and associated radiation exposure in inflammatory bowel disease.

OBJECTIVES: Increasing use of diagnostic imaging in inflammatory bowel disease (IBD) has led to concerns about the malignant potential of ionising radiation in a cohort that have an increased lifetime risk of gastrointestinal malignancy. The aim was to quantify radiation exposure in IBD patients referred from primary care, determine predictors of high exposure and evaluate temporal trends in diagnostic imaging over a 20-year period. METHODS: This was a retrospective cohort study whereby IBD patients were recruited from the outpatient clinic and evaluated retrospectively. The total cumulative effective dose (CED) received from tests was calculated for each subject. Cox regression was performed to assess factors associated with potentially harmful levels of ionising radiation defined as total CED > 50 milli-sieverts (mSv; equivalent to five CT abdomen scans). RESULTS: The cohort included 415 patients. Median total CED was 7.2 mSv (IQR: 3.0-22.7) in Crohn's disease and 2.8 mSv (IQR: 0.8-8.9) in ulcerative colitis patients, respectively. A total of 32 patients (8%) received a CED > 50 mSv. A history of IBD-related surgery was associated with high exposure (HR 7.7). During the study period, usage of abdominal CT increased by 310%. CONCLUSION: Approximately 1 in 13 patients in the study cohort were exposed to potentially harmful levels of ionising radiation. Strategies to minimise exposure to diagnostic medical radiation in IBD patients are required.

Explaining the decrease in mortality from abdominal aortic aneurysm rupture.

BACKGROUND: A steady rise in mortality from abdominal aortic aneurysm (AAA) was reported in the 1980s and 1990 s, although this is now declining rapidly. Reasons for the recent decline in mortality from AAA rupture are investigated here. METHODS: Routine statistics for mortality, hospital admissions and procedures in England and Wales were investigated. All data were age-standardized. Trends in smoking, hypertension and treatment for hypercholesterolaemia (statins), together with regression coefficients for mortality, were available from public sources for those aged at least 65 years. Deaths from ruptured AAA avoided in this age group were estimated by using the IMPACT equation: deaths avoided = (deaths in index year) × (risk factor decline) × ß-coefficient. RESULTS: From 1997, deaths from ruptured AAA have decreased sharply, almost twofold in men. Hospital admissions for elective AAA repair have increased modestly (from 40 to 45 per 100,000 population), attributable entirely to more procedures in those aged 75 years and over (P < 0.001). Admissions for ruptured AAA have declined from 18.6 to 13.5 per 100,000 population, across all ages, with the proportion offered and surviving emergency repair unchanged. From 1997, mortality from ruptured aneurysm in those aged at least 65 years has fallen from 65.9 to 44.6 per 100,000 population. An estimated 8-11 deaths per 100,000 population were avoided by a reduced prevalence of smoking and a similar number from an increase in the number of elective AAA repairs. Estimates for the effects of blood pressure and lipid control are uncertain. CONCLUSION: The reduction in incidence of ruptured AAA since 1997 is attributable largely to changes in smoking prevalence and increases in elective AAA repair in those aged 75 years and over.

Incidence of cardiovascular events and death after open or endovascular repair of abdominal aortic aneurysm in the randomized EVAR trial 1.

BACKGROUND: The aim was to compare rates of myocardial infarction, stroke and cardiovascular death in patients with a large abdominal aortic aneurysm who had endovascular (EVAR) or open repair to determine whether cardiovascular mortality explains the convergence in survival curves after these procedures. METHODS: Between 1999 and 2004, 1252 patients were randomized to EVAR or open repair in the UK EVAR trial 1. All patients were followed for death, myocardial infarction or stroke until September 2009. Cox regression was used to compare cardiovascular events and deaths between the randomized groups during different time intervals. RESULTS: Over 5 years of follow-up, a total of 187 first non-fatal or fatal cardiovascular events (98 myocardial infarctions and 89 strokes) and 256 cardiovascular deaths occurred. Although the endovascular group had a lower cardiovascular event rate than the open repair group (2·6 versus 3·2 per 100 person-years respectively) this was not statistically significant (adjusted hazard ratio (HR) 0·83, 95 per cent confidence interval 0·62 to 1·10; P = 0·199). Overall, there was little difference in cardiovascular mortality between the randomized groups (adjusted HR 1·06, 0·83 to 1·36; P = 0·638), but a non-significant excess of cardiovascular deaths was apparent in the endovascular group during the 6-24-month interval (adjusted HR 1·44, 0·79 to 2·62; P = 0·237). CONCLUSION: Patients who had EVAR appeared to have a lower subsequent cardiovascular event rate during all time intervals. Cardiovascular mortality was similar between the two groups overall, but more cardiovascular deaths in the EVAR group appeared to contribute to the convergence in all-cause mortality during the first 2 years.

Use of baseline factors to predict complications and reinterventions after endovascular repair of abdominal aortic aneurysm.

BACKGROUND: It is uncertain which baseline factors are associated with graft-related complications and reinterventions after endovascular aneurysm repair (EVAR) in patients with a large abdominal aortic aneurysm. METHODS: Patients randomized to elective EVAR in EVAR Trial 1 or 2 were followed for serious graft-related complications (type 2 endoleaks excluded) and reinterventions. Cox regression analysis was used to investigate whether any prespecified baseline factors were associated with time to first serious complication or reintervention. RESULTS: A total of 756 patients who had elective EVAR were followed for a mean of 3.7 years, by which time there were 179 serious graft complications (rate 6.5 per 100 person years) and 114 reinterventions (rate 3.8 per 100 person years). The highest rate was during the first 6 months, with an apparent increase again after 2 years. Multivariable analysis indicated that graft-related complications increased significantly with larger initial aneurysm diameter (P < 0.001) and older age (P = 0.040). There was also evidence that patients with larger common iliac diameters experienced higher complication rates (P = 0.011). CONCLUSION: Graft-related complication and reintervention rates were common after EVAR in patients with a large aneurysm. Younger patients and those with aneurysms closer to the 5.5-cm threshold for intervention experienced lower rates.

Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2.

OBJECTIVES: To investigate whether endovascular aneurysm repair (EVAR) influences the rate of cardiovascular events (fatal or non-fatal myocardial infarction or stroke) in patients with abdominal aortic aneurysm (AAA) considered unfit for open repair. DESIGN: Randomised controlled trial. MATERIALS: Between 1999 and 2004, 404 patients with large AAA considered unfit for open repair were randomised to EVAR or no surgical intervention across 33 UK hospitals and followed until July 2009. METHODS: The Customised Probability Index was used to determine fitness for each patient and Cox regression was used to compare time to first cardiovascular event between randomised groups and levels of fitness. RESULTS: During an average of 2.8 years of follow-up, 67 first cardiovascular events occurred with a non-significantly higher event rate in the EVAR group compared to the no intervention group (6.6 versus 5.1 events per 100 person years); adjusted hazard ratio 1.42 [95% CI 0.87-2.34], p=0.156. There was no evidence to suggest that the hazard ratio between randomised groups changed with level of fitness (p=0.378). CONCLUSIONS: Cardiovascular event rates were high in these unfit patients and medical therapy was sub-optimal. Events rates were slightly higher in the EVAR group but this was not statistically significant.

Patient preference for surgical method of abdominal aortic aneurysm repair: postal survey.

OBJECTIVES: To determine whether men with small abdominal aortic aneurysm have a preference between either endovascular or open aneurysm repair for future treatment. DESIGN: Prospective study of self-declared treatment preference following receipt of a validated patient information pack. PARTICIPANTS: Men aged 65-84 years (n=237) with asymptomatic aneurysm (4.0-5.4 cm) detected by population-based screening. METHODS: An unbiased, validated patient information pack and questionnaire were developed to conduct a postal survey. RESULTS: One hundred sixty seven participants (70%) returned a completed questionnaire; 24 (10%) did not respond at all. Initially, only 38 (23%) declared a treatment preference. After reading the information pack, 130 participants (80%) declared a treatment preference: 30 preferred open repair (18%), 77 endovascular repair (46%), 23 were happy with either option (14%) and only 34 remained without any preference (20%). Nearly all (92%) thought that the information pack had prepared them well for future discussions with clinicians and with no single feature identified as influencing the preference-making process, 66 respondents (40%) still opted to 'take the advice of the doctor'. CONCLUSION: The patient information pack facilitated the development of treatment preferences with endovascular repair being preferred to open repair. Nevertheless for patient-centred care, vascular centres must continue to safely provide both open and endovascular repair.

MRI of small bowel Crohn's disease: determining the reproducibility of bowel wall gadolinium enhancement measurements.

This study aims to determine inter- and intra-observer variation in MRI measurements of relative bowel wall signal intensity (SI) in Crohn's disease. Twenty-one small bowel MRI examinations (11 male, mean age 40), including T1-weighted acquisitions acquired 30 to 120s post-gadolinium, were analysed. Maximal bowel wall SI (most avid, conspicuous contrast enhancement) in designated diseased segments was measured by two radiologists and two trainees using self-positioned "free" regions of interest (ROIs) followed by "fixed" ROIs chosen by one radiologist, and this procedure was repeated 1 month later. Relative enhancement (post-contrast SI minus pre-contrast SI/pre-contrast SI) was calculated. Data were analysed using Bland-Altman limits of agreement and intra-class correlation. Inter-observer agreement for relative enhancement was poor (spanning over 120%) using a free ROI-95% limits of agreement -0.69, 0.70 and -0.47, 0.74 for radiologists and trainees, respectively, only marginally improved by use of a fixed ROI -0.60, 0.67 and -0.59, 0.49. Intra-class correlation ranged from 0.46 to 0.72. Intra-observer agreement was slightly better and optimised using a fixed ROI-95% limits of agreement -0.52, 0.50 and -0.34, 0.28 for radiologists and trainees, respectively. Intra-class correlation ranged from 0.49 to 0.86. Relative bowel wall signal intensity measurements demonstrate wide limits of observer agreement, unrelated to reader experience but improved using fixed ROIs.

Three-dimensional imaging core laboratory of the endovascular aneurysm repair trials: validation of methodology.

OBJECTIVE: The aim of this study was to establish and validate a three-dimensional imaging protocol for the assessment of Computed Tomography (CT) scans of abdominal aortic aneurysms in UK EVAR trials patients. Quality control and repeatability of anatomical measurements is important for the validity of any core laboratory. METHODS: Three different observers performed anatomical measurements on 50 preoperative CT scans of aortic aneurysms using the Vitrea 2 three-dimensional post-imaging software in a core laboratory setting. We assessed the accuracy of intra and inter observer repeatability of measurements, the time required for collection of measurements, 3 different levels of automation and 3 different automated criteria for measurement of neck length. RESULTS: None of the automated neck length measurements demonstrated sufficient accuracy and it was necessary to perform checking of the important automated landmarks. Good intra and limited inter observer agreement were achieved with three-dimensional assessment. Complete assessment of the aneurysm and iliacs took an average (SD) of 17.2 (4.1) minutes. CONCLUSIONS: Aortic aneurysm anatomy can be assessed reliably and quickly using three-dimensional assessment but for scans of limited quality, manual checking of important landmarks remains necessary. Using a set protocol, agreement between observers is satisfactory but not as good as within observers.

Vascular training and endovascular practice in Europe.

OBJECTIVE: To evaluate the influence of the status of vascular surgery (VS) training paradigms on the actual practice of endovascular therapy among the European countries. METHODS: An email-based survey concerning vascular surgery training models and endovascular practices of different clinical specialties was distributed to a VS educator within 14 European countries. European Vascular and Endovascular Monitor (EVEM) data also were processed to correlate endovascular practice with training models. RESULTS: Fourteen questionnaires were gathered. Vascular training in Europe appears in 3 models: 1. Mono-specialty (independence): 7 countries, 2. Subspecialty: 5 countries, 3. An existing specialty within general surgery: 2 countries. Independent compared to non-independent certification shortens overall training length (5.9 vs 7.9 years, p=0.006), while increasing overall training devoted specifically to VS (3.9 vs 2.7 years, p=0.008). Among countries with independent certification an average of 76% of aortic and 50% of peripheral endovascular procedures are performed by vascular surgeons, while the corresponding values, for countries with a non-independent certification, are 69% and 36% respectively. Countries with independent vascular certification, despite their lower average endovascular index (procedures per 100,000 population), reported a higher growth rate of aortic endovascular procedures (VS independent 132% vs VS non-independent 87%), within a four-year period (2003-2007). Peripheral endovascular procedures, though, have similar growth rates in both country groups (VS independent 62% vs VS non-independent 60%). CONCLUSIONS: In European countries with VS as an independent specialty, vascular surgeons have a shorter total training period but spend more time in VS training, although they may not undertake a greater proportion of the endovascular procedures their countries appear to have adopted endovascular technologies more rapidly compared to the ones with non-independent VS curricula. Whether such differences influence patient outcomes requires investigation in future studies.

The Immediate Management of the Patient with Rupture: Open Versus Endovascular repair (IMPROVE) aneurysm trial--ISRCTN 48334791 IMPROVE trialists.

BACKGROUND: Systematic reviews have suggested a survival advantage for patients with ruptured abdominal aortic aneurysm (AAA), who are managed by endovascular repair. These reviews are based on single centre experiences of selected patients. OBJECTIVE: To determine whether a policy of endovascular repair improves the survival of all patients with ruptured AAA. METHODS: A randomized controlled trial, IMPROVE (ISRCTN 48334791) will randomize patients with a clinical diagnosis of rAAA, made in hospital, either to immediate CT scan and endovascular repair whenever anatomically suitable (endovascular first), or to open repair, with CT scan being optional (normal care), The trial is set on a background of guidelines for emergency care, CT scanning and anaesthesia, which incorporate the protocol of permissive hypotension. Recruitment started in October 2009 and 600 patients are required to show a 14% survival benefit at 30 days (primary outcome) for the endovascular first policy. Recruitment will be from the UK and Europe. Secondary outcomes include 24h, in-hospital and 1 year survival, complications, major morbidities, costs and quality of life. DISCUSSION: This is a "real life" trial that will answer the fundamental relevant clinical dilemma, namely, do patients who present with ruptured AAA derive benefit from treatment in a system, which offers a preferential strategy of endovascular repair? The trial addresses whether the anticipated reduced mortality and morbidity associated with endovascular repair is offset by the relatively greater ease of access and speed to conventional surgery. This issue is pivotal to future patient care and provision of services.