Prostate artery embolisation for benign prostatic hyperplasia: a systematic review and meta-analysis.

OBJECTIVES: Prostate artery embolisation (PAE) is a new minimally invasive treatment for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). The purpose of this study was to review the efficacy and safety of PAE in the treatment of BPH with LUTS. METHODS: A systematic review performed according to the PRISMA guidelines with a pre-specified search strategy for PubMed, Web of Science, Cochrane Library and Embase databases protocol (PROSPERO ID: CRD42017059196). Trials studying the efficacy of prostate artery embolisation to treat LUTS with more than ten participants and follow-up longer than 6 months were included by two independent authors. Outcomes investigated were International Prostate Symptom Score (IPSS), quality of life (QoL), International Index of Erectile Function (IIEF-5), prostate volume (PV), prostate-specific antigen (PSA), peak void flow (Qmax), post-void residual (PVR) and complications. To summarise mean change from baseline, a meta-analysis was done using the random-effects model. RESULTS: The search returned 210 references, of which 13 studies met the inclusion criteria, representing 1,254 patients. Patients in the included studies with data available for meta-analysis had moderate to severe LUTS and a mean IPSS of 23.5. Statistically significant (p value < 0.05) improvements of all investigated outcomes were seen at 12-month follow-up. Major complications were reported in 0.3% of the cases. CONCLUSIONS: Our findings suggest that PAE can reduce moderate to severe LUTS in men with BPH with a low risk of complications. KEY POINTS: • Prostate artery embolisation (PAE) improved International Prostate Symptom Score (IPSS) by 67%. • Major complications after PAE are very rare. • Use of cone-beam CT may reduce risk of non-target embolisation.

Administration of platelets to ruptured abdominal aortic aneurysm patients before open surgery: a prospective, single-blinded, randomised study.

BACKGROUND: In patients undergoing open surgery for a ruptured abdominal aortic aneurysm (rAAA), survivors demonstrate a high platelet count, and proactive administration of platelets (and fresh frozen plasma) appears to influence mortality. OBJECTIVES: This trial investigated the effect of platelets administered before transport to surgery. METHODS: In a prospective study design, patients were randomised to receive platelets (intervention; n = 61) or no platelets (control; n = 61) before transport to vascular surgery from 11 local hospitals. The study was terminated when one of the vascular surgical centres implemented endovascular repair for rAAA patients. RESULTS: Thirty days after surgery, mortality was 36% for patients with intervention vs 31% for controls (P = 0·32). Post-operative thrombotic events (14 vs 15; P = 0·69), renal failure (11 vs 10; P = 0·15) and pulmonary insufficiency (34 vs 39; P = 0·15) were similar in the two groups of patients. No adverse reactions to platelet administration were observed. In addition, length of stay in the intensive care unit was unaffected by intervention. CONCLUSIONS: For patients planned for open repair of a rAAA, we observed no significant effect of early administration of platelets with regard to post-operative complications and stay in the ICU or in hospital and also no significant effect on mortality.

Assessment of Competence in EVAR Stent Graft Sizing and Selection.

OBJECTIVES AND BACKGROUND: The aims of this study were to develop a test of competence in endovascular aortic repair (EVAR) stent graft sizing and selection; to examine the test for evidence of validity; and to explore the experience required for the task. METHODS: The test was developed based on a literature review resulting in 22 anatomical assessment points and a graft selection. Validity evidence was explored in an international cross sectional study. Twenty-two consultants with varying levels of experience in the field (novices, intermediates, and experts) were presented with computed tomography angiography of the aortic vessels from three patients. Test scores were based on summed z-scores using the anatomical measurements and graft choices of the experts as a reference. A proficiency score was established using the contrasting groups standard setting method. RESULTS: The assessment was shown to be reliable with an intraclass correlation coefficient of 0.83 (p<.001) and high internal consistency with a Cronbach's α of .91 (p<.001). Mann-Whitney U test showed that experts performed significantly better than novices and intermediates (p<.002 and p<.005, respectively). Regarding anatomical measurements, Mann-Whitney U test could discriminate between experts and novices (p=.002), between experts and intermediates (p=.010), and between novices and intermediates (p=.036). In stent selection the experts performed significantly better than both the novices and the intermediates (p=.002 and p=.007, respectively), while there was no significant difference between the two non-expert groups (p=1). A credible passing standard with appropriate consequences was established using the contrasting groups methods. CONCLUSION: This study presents a standardised and objective assessment tool of competence in vessel analysis and stent graft selection for endovascular aortic repair. This was supported by strong validity evidence with good internal consistency and discriminatory ability. The tool may be used to facilitate training and certification of future endovascular specialists.

Assessment of Competence in EVAR Procedures: A Novel Rating Scale Developed by the Delphi Technique.

OBJECTIVE/BACKGROUND: To develop a procedure specific global rating scale for assessment of operator competence in endovascular aortic repair (EVAR). METHODS: A Delphi approach was used to achieve expert consensus. A panel of 32 international experts (median 300 EVAR procedures, range 200-3000) from vascular surgery (n = 21) and radiology (n = 11) was established. The first Delphi round was based on a review of endovascular skills assessment papers, stent graft instructions for use, and structured interviews. It led to a primary pool of 83 items that were formulated as global rating scale items with tentative anchors. Iterative Delphi rounds were executed. The panellists rated the importance of each item on a 5 point Likert scale. Consensus was defined as 80% of the panel rating an item 4 or 5 in the primary round and 90% in subsequent rounds. Consensus on the final assessment tool was defined as Cronbach's alpha > .8 after a minimum of three rounds. RESULTS: Thirty-two of 35 invited experts participated. Three rounds of surveys were completed with a completion rate of 100% in the first two rounds and 91% in round three. The 83 primary assessment items were supplemented with five items suggested by the panel and reduced to seven pivotal assessment items that reached consensus, Cronbach's alpha = 0.82. The seven item rating scale covers key elements of competence in EVAR stent placement and deployment. Each item has well defined grades with explicit anchors at unacceptable, acceptable, and superior performance on a 5 point Likert scale. CONCLUSION: The Delphi methodology allowed for international consensus on a new procedure specific global rating scale for assessment of competence in EVAR. The resulting scale, EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), represents key elements in the procedure. EVARATE constitutes an assessment tool for providing structured feedback to endovascular operators in training.

Follow-up on Small Abdominal Aortic Aneurysms Using Three Dimensional Ultrasound: Volume Versus Diameter.

OBJECTIVES: Rupture risk in abdominal aortic aneurysms (AAAs) is assessed using AAA diameter; yet 10% of ruptures occur in a small aneurysm. This underlines the inadequacy of diameter as a standalone parameter. In this prospective follow-up study, ultrasound determined aneurysm diameter was compared with aneurysm volume determined by three dimensional ultrasound (3D-US) in a group of 179 AAAs. DESIGN: This was a prospective cohort study with repeated diameter and volume measurements by 3D-US. MATERIAL AND METHODS: In total, 179 patients with small infrarenal AAAs (diameter 30-55 mm) were enrolled consecutively. At enrolment and at 12 month follow-up, maximum diameter, using dual plane technique, and three dimensional volume were measured. Based on a previous accuracy study, significant change in diameter and volume were defined as an increase exceeding the known range of variability (ROV) of each US technique; ±3.7 mm and ±8.8 mL, respectively. Post-hoc Kaplan-Meier analysis was performed to estimate time to conversion to treatment after the conclusion of the follow-up period between two groups. RESULTS: In total, 125 patients (70%) had an unchanged diameter during follow-up. In this group, 50 patients (40%) had an increasing aortic volume. Forty-five (83%) of the 54 patients with an increasing aortic diameter showed a corresponding volume increase. During a median follow-up of 367 days (364-380 days), a mean increase in diameter of 2.7 mm (±2.6 mm) and a mean increase in volume of 11.6 mL (±9.9 mL) were recorded. In post-hoc analysis, it was found that more AAAs with a stable diameter and a growing volume than AAAs with a stable diameter and volume were undergoing aortic repair during follow-up, based on the maximum diameter. CONCLUSION: In this cohort of small AAAs, 40% of patients with a stable diameter had an increasing volume at 12 month follow-up. From this perspective, 3D-US could have a future supplemental role in AAA surveillance programmes.

Guidelines for the use of magnetic resonance imaging in diagnosing and monitoring the treatment of multiple sclerosis: recommendations of the Swedish Multiple Sclerosis Association and the Swedish Neuroradiological Society.

Multiple sclerosis (MS) is associated with inflammatory lesions in the brain and spinal cord. The detection of such inflammatory lesions using magnetic resonance imaging (MRI) is important in the consideration of the diagnosis and differential diagnoses of MS, as well as in the monitoring of disease activity and predicting treatment efficacy. Although there is strong evidence supporting the use of MRI for both the diagnosis and monitoring of disease activity, there is a lack of evidence regarding which MRI protocols to use, the frequency of examinations, and in what clinical situations to consider MRI examination. A national workshop to discuss these issues was held in Stockholm, Sweden, in August 2015, which resulted in a Swedish consensus statement regarding the use of MRI in the care of individuals with MS. The aim of this consensus statement is to provide practical advice for the use of MRI in this setting. The recommendations are based on a review of relevant literature and the clinical experience of workshop attendees. It is our hope that these recommendations will benefit individuals with MS and guide healthcare professionals responsible for their care.

Red blood cell storage duration and long-term mortality in patients undergoing cardiac intervention: a Danish register study.

OBJECTIVES: To study the effect of red blood cell (RBC) storage duration on long-term mortality in patients undergoing cardiac intervention. BACKGROUND: RBCs undergo numerous structural and functional changes during storage. Observational studies have assessed the association between RBC storage duration and patient outcomes with conflicting results. METHODS: Between January 2006 and December 2014, 82 408 patients underwent coronary angiography. Of these, 1856 patients received one to four RBC units within 30 days after this procedure. Patients were allocated according to length of RBC storage duration: short-term (≤11 days), intermediate (IM)-term (12-23 days) and long-term (≥24 days). The study endpoints were 30-day and long-term all-cause mortality. RESULTS: A total of 4168 RBC units were given to 1856 patients. The mean RBC storage duration was 8.5 ± 2.1, 17.7 ± 3.4 and 29.9 ± 3.4 days in the short-term, IM-term and long-term storage groups, respectively. There was no difference in baseline characteristics between the groups. The long-term storage group received significantly more units (2.4 ± 1.0 units) as compared to the short-term (2.0 ± 1.0 units; P < 0.001) and IM-term storage group (2.2 ± 1.0 units; P < 0.01). In the survival analysis, there was no significant difference in all-cause mortality between the groups (log-rank: 0.509 for 30-days mortality; 0.493 for 5-year mortality). Additional stratified analysis demonstrated no association between RBC storage duration and long-term mortality. CONCLUSION: This study did not find an association between RBC storage duration and 30-days or long-term mortality in patients undergoing cardiac intervention.

Contrast Enhanced Ultrasound can Replace Computed Tomography Angiography for Surveillance After Endovascular Aortic Aneurysm Repair.

OBJECTIVE/BACKGROUND: Surveillance after endovascular aortic aneurysm repair (EVAR) is mandatory and computed tomography angiography (CTA) is considered the standard imaging modality, although patients are exposed to ionizing radiation and nephrotoxic contrast medium. The primary aim of this study was to determine the diagnostic efficacy of duplex ultrasound (DUS) and contrast enhanced ultrasound (CEUS) using CTA as the gold standard. The secondary aim was to determine the clinical consequences of endoleaks missed by DUS and CEUS, or CTA. METHODS: All patients with EVAR for an aorto-iliac aneurysm between 1 August 2011 and 31 October 2014 were prospectively and consecutively enrolled. CEUS was added to the existing surveillance protocol, which included DUS, plain abdominal X-ray, and CTA at 3 and 12 months after stent implantation. RESULTS: In 278 patients, endoleaks were detected in 68, 69, and 46 cases by CTA, CEUS, and DUS, respectively. The sensitivity and specificity of DUS and CEUS were 46% and 93%, and 85% and 95%, respectively. CEUS and CTA were diagnostically equivalent, as opposed to DUS and CTA (p = .002). Endoleaks detected by CTA led to re-intervention in 11 (4%) patients. These endoleaks were also detected by CEUS; however, three out of 11 patients were missed by DUS and underwent re-intervention: limb extension, re-cuff, and attempt to coil lumbar leaks. Endoleaks missed by CEUS or CTA were type II endoleaks without sac expansion. CONCLUSION: In surveillance programs after EVAR a diagnostic CEUS examination may replace CTA.

Editor's choice. A randomized controlled trial of the fascia suture technique compared with a suture-mediated closure device for femoral arterial closure after endovascular aortic repair.

OBJECTIVES: The aim was to investigate whether the fascia suture technique (FST) can reduce access closure time and procedural costs compared with the Prostar technique (Prostar) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcomes of both techniques. METHODS: In this two center trial, 100 patients were randomized to access closure by either FST or Prostar between June 2006 and December 2009. The primary endpoint was access closure time. Secondary outcome measures included access related costs and evaluation of the short- and mid-term complications. Evaluation was performed peri- and post-operatively, at discharge, at 30 days and at 6 months follow up. RESULTS: The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar (p < .001). Prostar required a 54% greater procedure time than FST, mean ratio 1.54 (95% CI 1.25-1.90, p < .001) according to regression analysis. Adjusted for operator experience the mean ratio was 1.30 (95% CI 1.09-1.55, p = .005) and for patient body mass index 1.59 (95% CI 1.28-1.96, p < .001). The technical failure rate for operators at proficiency level was 5% (2/40) compared with 28% (17/59) for those at the basic level (p = .003). The proficiency level group had a technical failure rate of 4% (1/26) for FST and 7% (1/14) for Prostar, p = 1.00, while corresponding rates for the basic level group were 27% (6/22) for FST and 30% (11/37) for Prostar (p = .84). There was a significant difference in cost in favor of FST, with a median difference of €800 (95% CI 710-927, p < .001). CONCLUSIONS: In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique.

Three-dimensional ultrasound evaluation of small asymptomatic abdominal aortic aneurysms.

OBJECTIVE: Non-invasive and reproducible size measurements that correlate well with computed tomography (CT) are desirable in the management of small abdominal aortic aneurysms (AAA). Three dimensional ultrasound (3D-US) technology may reduce inaccuracy because of variations in orientation of the image planes and axis. This study aimed to determine any differences in paired size estimation associated with three 3D-US derived methods using 3D-CT as the gold standard. When CTA was not available, the patients were enrolled anyway to assess 3D-US reproducibility in terms of agreement between two physicians. METHODS: In the period from 1 March 2013 to 27 February 2014, consecutive patients with a small AAA, <5.5 cm for men and <5.2 cm for women, underwent 3D-US examination and three AAA size measures were obtained: dual plane diameter, diameter perpendicular to the residual sac's centreline and a partial volume. RESULT: In all, 122 consecutive US examinations were performed. Patients were excluded because of inadequate AAA size (n = 11) and for technical reasons (n = 11). Thus, 100 patients (F/M; 20/80) with a median maximum AAA diameter of 46 (range 31-55) mm were analysed. The mean US dual plane diameter and the 3D-US centreline diameter were 2.6 mm and 1.8 mm smaller than the mean 3D-CT centreline diameter, respectively (p = .003). The inter-observer reproducibility coefficient was 3.7 mm for the US dual plane diameter and 3.2 mm for the 3D-US centreline diameter (p = 0.222). For the partial volume, the reproducibility was 8-12%, corresponding to a diameter variability of ±3 mm. The median time used for post-processing of the 3D-US acquisition was 72 (range 46-108) seconds per examination. CONCLUSION: 3D-US demonstrated an acceptable reproducibility and a good agreement with 3D-CT, and has the potential to improve future AAA management through more reliable ultrasound guided size estimates.

Endograft limb occlusion in EVAR: iliac tortuosity quantified by three different indices on the basis of preoperative CTA.

OBJECTIVE: To assess the incidence and outcome of graft limb occlusions after endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) in a high volume single centre. To quantify iliac artery tortuosity in patients with AAA and correlate this with limb occlusion. DESIGN: Data were collected consecutively and prospectively, and analyzed retrospectively. MATERIALS: Patients treated with Zenith bifurcated stent grafts from January 2000 to December 2010 at a tertiary referral vascular unit were analyzed. Routine regular office follow-up with computed tomography angiography (CTA) and, subsequently, duplex ultrasound imaging was performed. Patients with limb occlusions were identified. For each index patient, two controls were obtained, one immediately preceding and one following the index patient in the consecutive cohort of EVAR patients. METHODS: Demographics and CTA data on limb graft occlusions were recorded and compared with a defined control group. Three different indices were used to describe the tortuosity of the iliac vessels based on preoperative CTA: pelvic artery index of tortuosity (PAI), common iliac artery index of tortuosity (CAI), and a visual description of vessel tortuosity - the double iliac sign (DIS). Demographic data and indices were correlated for later occurring limb occlusion. RESULTS: 504 patients underwent EVAR and 18 patients experienced graft limb occlusion during a median follow-up of 28 months (range 0-133). Primary graft patency was 97% at 1 year and 96% at 3 years. Logistic regression showed that iliac artery tortuosity (DIS) (p = .001) and body mass index (p = .007) had a significant impact on graft patency. CONCLUSION: A tortuous vessel on the preoperative CTA is associated with an increased risk of limb occlusion after EVAR. Adjunctive stenting of iliac segments deemed at risk is suggested, which is achieved without compromise of the aneurysm repair.

Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial.

OBJECTIVES: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. METHODS: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. RESULTS: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). CONCLUSIONS: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.

Cortisol metabolism after weight loss: associations with 11 ß-HSD type 1 and markers of obesity in women.

OBJECTIVE: Increased glucocorticoid metabolite excretion and enhanced expression and activity of 11ß-hydroxysteroid dehydrogenase type 1 in adipose tissue are closely correlated with obesity and its detrimental consequences. Weight loss ameliorates the latter. The aim of this study was to explore whether increased glucocorticoid exposure in obesity is improved with substantial weight loss and thus is a consequence rather than a cause of obesity. DESIGN AND PATIENTS: A prospective cohort study in 31 women. MEASUREMENTS: 11ß-HSD type 1 expression and activity, urinary glucocorticoid metabolite excretion, body composition including regional adipose tissue depots and insulin resistance by HOMA-IR before and 2 years after gastric bypass surgery. RESULTS: After weight loss, excretion of cortisol and cortisone metabolites decreased. Both cortisol and cortisone metabolite excretion correlated with central obesity, where the intraabdominal fat depot showed the strongest association. Cortisol metabolites correlated with 11ß-HSD type 1 activity in abdominal subcutaneous adipose tissue. The ratio of cortisol to cortisone metabolites [(5α-tetrahydrocortisol (5αTHF) + tetrahydrocortisol (THF) + α-cortol)/(tetrahydrocortisone (THE) + α-cortolone)] and the ratio of 5α-THF/THF both decreased after stable weight loss, reflecting a downregulation of the net activities of 11ß-HSD type 1 and 5α-reductase. CONCLUSION: Long-term weight loss in women is not only followed by reduced glucocorticoid production, but also favourably decreases the global and tissue-specific activity of the cortisol-activating enzyme 11 ß-HSD type 1, possibly contributing to the health benefits of bariatric surgery.

Outcomes after elective aortic aneurysm repair: a nationwide Danish cohort study 2007-2010.

OBJECTIVE: To assess outcomes after treatment for asymptomatic abdominal aortic aneurysm (AAA) in Denmark in a period when both open surgery (OR) and endoluminal repair (EVAR) have been routine procedures. METHODS: We performed a retrospective nationwide cohort study of patients treated for asymptomatic AAA between 2007 and 2010. Data on demographics, procedural data, perioperative complications, length of stay (LOS), 30-day reinterventions and readmissions, late aneurysm and procedure-related complications and mortality were obtained from the Danish Vascular Registry and the Danish National Patient Register. RESULTS: 525 EVAR and 1176 OR for asymptomatic AAA were identified. LOS was shorter after EVAR than OR (4 vs. 7 days, p < .001). During primary hospitalization procedure-related complications (12% vs. 6%) and general complications (21% vs. 8%) were more common after OR than EVAR (p < 0.001). The 30-day reintervention rate was higher for OR than EVAR (18% vs. 6%, p < 0.001), but there was no difference in readmissions within 30 days. During follow-up (mean 29 ± 15 months) aneurysm-related complications after EVAR were outweighed by procedure-related complications after OR. CONCLUSION: Elective AAA repair in Denmark is overall comparable with international results and both perioperative and late outcomes after EVAR of elective AAA are better than the results after OR.

Volume estimation of the aortic sac after EVAR using 3-D ultrasound - a novel, accurate and promising technique.

OBJECTIVES: Volume estimation is more sensitive than diameter measurement for detection of aneurysm growth after endovascular aneurysm repair (EVAR), but this has only been confirmed on three-dimensional, reconstructed computer tomography (3-D CT). The potential of 3-D ultrasound (3-D US) for volume estimation in EVAR surveillance is unknown. DESIGN: Prospective validation study comparing 3-D US with 3-D CT, using 3-D CT as the gold standard. MATERIALS AND METHODS: From August 2011 to March 2012, 93 consecutive EVAR patients were enrolled and examined with both 3-D US and CT angiography (CTA). Image data were analysed in a mutual blinded setup using a 3-D interactive segmentation technique. RESULTS: The technical success rate of 3D-US was 98% (91/93). In 91 EVAR patients (F/M; 10/81) eligible for further analysis, the mean maximum volume (SD) was 126 (58) ml using 3-D US and 128 (58) ml using 3-D CT. The mean difference was 1 ml (0.4%) and the limits of agreement were -14 to 16 ml (-11; 12%). CONCLUSION: Volume estimation of the aortic sac after EVAR using 3-D US is a feasible and accurate method using 3-D CT as the gold standard.

Three-dimensional ultrasound improves the accuracy of diameter measurement of the residual sac in EVAR patients.

OBJECTIVES: Discrepancy between maximum diameters obtained with two-dimensional ultrasound and computed tomography (CT) after endovascular aneurysm repair (EVAR) is well known. The maximal diameter is ideally measured perpendicular to the centerline, a methodology so far only feasible with three-dimensional (3D) CT and magnetic resonance angiography (MRA). We aimed to investigate the agreement between 3D ultrasound and 3D CT and to determine reproducibility measures. METHODS: Prospective study comparing 3D ultrasound with 3D CT in 124 consecutive patients seen 3 or 12 month after EVAR. RESULTS: Replacing 2D with 3D ultrasound, the mean difference was improved from 6.0 mm to -1.3 mm (p < .001), and the range of variability was reduced from 9.4 mm to 6.6 mm (p = .009) using 3D CT as the gold standard. The mean difference between 3D ultrasound and 3D CT maximum diameter of the residual sac was -1.3 mm with upper and lower limits of agreement of 5.2 mm and -7.9 mm, respectively. Reproducibility measures of 3D ultrasound were ± 4 mm. CONCLUSION: 3D ultrasound correlate significantly better to 3D CT than the currently used 2D ultrasound method when assessing maximum diameter of the residual sac after EVAR, and reproducibility measures were within clinical acceptable values.

Construct validity and reliability of structured assessment of endoVascular expertise in a simulated setting.

OBJECTIVES: To study the construct validity and reliability of a novel endovascular global rating scale, Structured Assessment of endoVascular Expertise (SAVE). DESIGN: A Clinical, experimental study. MATERIALS: Twenty physicians with endovascular experiences ranging from complete novices to highly experienced operators performed a video-recorded simulated contra-lateral iliac-artery-stenting procedure. The virtual-patient case was a novel technically challenging procedure presenting the distal arteries below the knee. METHODS: Three experts assessed the performances blinded to operator identity. Validity was analysed by correlating experience with performance results. Reliability was analysed according to generalisability theory. RESULTS: The mean score on the 29 items of the SAVE scale correlated well with clinical experience (R = 0.84, P < 0.01) and was found discriminative even among the more experienced participants having performed up to 500 endovascular procedures in total. Only the most experienced participants (>5000 procedures) obtained maximum scores. The inter-rater reliability was high (G = 0.94 and G = 0.95). The procedure time (median 69 min, range 32-86) correlated moderately with clinical experience (R = -0.53, P < 0.05), whereas the fluoroscopy time and amount of contrast fluid did not correlate. CONCLUSIONS: The construct validity and reliability of assessment with the SAVE scale was high when applied to performances in a simulation setting with advanced realism. No ceiling effect was present in the assessment situation.

Incidence of systemic inflammatory response syndrome after endovascular aortic repair.

AIM: The aim of this study was to estimate the incidence of the post-implantation syndrome/systemic inflammatory response syndrome (SIRS) after endovascular aortic repair. METHODS: All patients, undergoing elective primary endovascular repair of an asymptomatic infrarenal abdominal aortic aneurysm during 2007, were retrospectively evaluated for SIRS within the first 5 postoperative days. The only exclusion-criteria were missing data. SIRS was assessed using the criteria defined by the American College of Chest Physicians and Society of Critical Care Medicine Consensus Conference Committee. RESULTS: Sixty-six patients were included, 40 (60%) met the SIRS criteria within the first 5 postoperative days (95% of the 40 patients met the criteria within 3 days). We found no significant differences between the SIRS and the non-SIRS group in baseline characteristics or other data including volume of the contrast media used, type of groin access, adjunctive procedures and duration of surgery. In total, 11 (28%) patients in the SIRS group and 4 (15%) patients in the non-SIRS group underwent re-interventions. Median follow-up period was 26 (range 20-32) months. Thirty-day mortality did not differ in the groups (3% in the SIRS group vs. none in the non-SIRS group). CONCLUSION: The high incidence of SIRS after EVAR is unexpected considering the minimally invasive procedure. Further studies on the cause of this response and measures to attenuate the response seem appropriate.

Capturing the essence of developing endovascular expertise for the construction of a global assessment instrument.

OBJECTIVES: To explore what characterises the development of endovascular expertise and to construct a novel global assessment instrument. DESIGN: Literature review and an experimental study. MATERIALS AND METHODS: The literature was searched for information regarding available global rating scales (GRSs); scientific societies' official statements on endovascular competence; and task analyses of endovascular procedures. In the experimental study, clinicians performed a video-recorded simulated iliac-artery stenting procedure. Subsequently, by using the method of retrospective verbalisation, the clinicians were interviewed while watching their performance on video commenting on key issues of the construct. Data from all sources were analysed, categorised and synthesised into a novel rating scale. RESULTS: Available GRSs primarily included technical aspects of performance, whereas the competence statements, task analyses and clinicians' perceptions added a range of non-technical aspects. The novel rating scale SAVE (Structured Assessment of endoVascular Expertise) differs from prior scales by including issues of pre-planning; prediction of challenges; preparation of tools; management of imaging presentation; distinction of technical skills into external and internal control according to operator focus of visual attention; adaptation of strategy; clinical decision making; use of assistant; complications; inter-personal skills; and post-procedural planning. CONCLUSIONS: The essence of developing endovascular expertise goes far beyond mere technical aspects.

Celiac trunk coverage in endovascular aneurysm repair.

BACKGROUND AND AIMS: This retrospective study was undertaken to examine the risks associated with obstruction of the coeliac trunk in the process of treating aneurysms with endografting. MATERIAL AND METHODS: 120 patients were treated by endografting for aneurysmal disease. Of these, a subgroup of 9 patients had their celiac trunk covered. If possible, a preoperative angiography was performed to evaluate collateral flow from the superior mesenteric artery. This was considered to predict the risk for ischemia. RESULTS: None of the patients had any severe clinical event of the celiac trunk occlusion or clinical signs of intestinal ischemia. Three patients had transient increase of liver enzymes. CONCLUSIONS: In cases where the distal landing zone of the descending thoracic aorta is to short for endografting, covering of the celiac trunk may be an option if no other surgical alter-native is apparent. Preoperative angiography to visualise the presence of collateral vessels from the superior mesenteric artery is recommended.