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Abstract: Background: The Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) is a disease-specific instrument to measure the impact of chronic venous insufficiency (CVI) on patients’ lives. The objective of this study is to test the psychometric properties of the CIVIQ, and to validate the use of the questionnaire translated into the Dutch language. Methods: A standardised questionnaire, including CIVIQ and Short Form (36) Health Survey (SF-36), was obtained before and 1 month after treatment to all new patients with varicose veins. The feasibility was tested by missing responses and response distribution. CIVIQ scores were compared to the SF-36 scores and between different levels of severity of varicose veins. The CIVIQ’s reliability was assessed using Cronbach’s alpha and test–retest reliability. The structure was studied using factor analysis. The scores before and after therapy were compared to assess responsiveness. Results: There was a response rate of 93.5%. None of 20 items missed <10% of responses, but three showed ceiling effect. The CIVIQ correlated well with the physical and moderately with the mental MCS of the SF-36, suggesting a good construct validity of the CIVIQ. The median CIVIQ scores increased significantly with the severity of varicose veins. The CIVIQ showed an excellent internal consistency and an excellent test–retest reliability. The CIVIQ score decreased in 76% of patients after treatment. The results were in accordance with the Norman’s rule and showed a median effect size. Conclusion: This study confirms the feasibility, validity, reliability and responsiveness of the CIVIQ in patients with varicose veins. The psychometric properties of the Dutch CIVIQ were comparable to the original French version. [Copyright &y& Elsevier]

Abstract: Objective: Biomechanically, rupture of an Abdominal Aortic Aneurysm (AAA) occurs when the stress acting on the wall due to the blood pressure, exceeds the strength of the wall. Peak wall stress estimations, based on CT reconstruction, may be prone to observer variation. This study focuses on the robustness and reproducibility of AAA wall stress assessment and the relation with geometrical features of the AAA. Methods: The AAAs of twenty patients were reconstructed by three operators. Both the peak and 99-percentile stress were used for intra- and inter-operator variability using the intraclass correlation coefficient (ICC). A regression analysis was performed to relate the stress parameters with the maximum diameter. Outliers were analyzed by their geometrical characteristics. Results: The intra-operator ICC was 0.73–0.79 for the peak stress and 0.94 for the 99-percentile stress. The inter-operator ICC was 0.71 for the peak stress and 0.95 for the 99-percentile stress. A significant linear relation with the diameter was found only for the 99-percentile stress. Conclusions: The 99-percentile stress is more reproducible than peak wall stress. A significant relation between wall stress and diameter was found. Other geometrical features had no statistical relation with high stress. [Copyright &y& Elsevier]

Background: Patients with abdominal aortic aneurysm (AAA) can be treated by transfemoral endovascular intervention and by conventional open surgery. Level-one evidence of the safety and efficacy of one treatment mode over the other is only provided by a randomised controlled trial (RCT). Results reported by voluntary registries are considered less valid than data from RCTs. On the other hand the outcome of a RCT may not be generalisable to the common practice because of vigorous selection of patients and institutions. Purpose: The outcomes reported by the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial were compared with the results of the EURopean collaborators on Stent-graft techniques for AAA Repair (EUROSTAR) registry. Methods: To obtain comparable study groups with regard to risk factors equal proportions of ASA I, II and III patients as observed in the endovascular arm of the DREAMtrial were selected at random from the EUROSTAR-registry. All patients had an aneurysm of at least 50mm. Only patients, who had been enrolled into the registry from 1999, were selected to avoid the influence of first generation endografts which are not longer in use. Patient characteristics and outcomes of endovascular AAA repair (EVAR) of EUROSTAR and DREAM-trial participants were compared. Differences in early findings between study groups were assessed by Chi-Square tests for discrete variables and by Wilcoxon rank sum tests for continuous variables. Follow-up variables were analysed by Kaplan-Meier and Cox proportional hazard models. Results: Data of 177 patients of the DREAM trial with randomization to EVAR and 856 patients selected in the EUROSTAR-registry were compared. Baseline characteristics were comparable between the EUROSTAR-cohort and EVAR-arm of the DREAM-trial. The 36-month survival-rate was 87.6% for EVAR-arm in the DREAM-trial similar to the 86.8% found in this EUROSTAR-study population. The freedom of secondary procedures reached after 3 years 85.7%, and 86.9% in the DREAM and EUROSTAR-cohort, respectively. Conclusion: We found comparable characteristics and outcomes between patients of comparable risk class of the EUROSTAR-registry and the EVAR-cohort of the DREAM-trial. This demonstrates the following: first, the EUROSTAR-data provide reliable information, and further comparisons of registry data with patients treated by conventional AAA surgery may be justified. Secondly, the various outcomes of the randomised DREAM trial appear generalisable, as it agrees with observations in a broad common practice derived database. [Copyright &y& Elsevier]

Abstract: Objectives: To investigate the results following endovascular treatment of patients with inflammatory abdominal aortic aneurysms (IAAA). Design: Retrospective study based on the EUROSTAR registry. Material and methods: Patients included in the EUROSTAR registry with IAAA (n=52, 1.4%) were compared to those having aneurysms without aortic fibrosis (n=3613, 98.6%). The mean follow-up period in patients with IAAA was 23 months (range 1–60). In 11 of the patients detailed information on the effect of endovascular repair and perianeurysmal fibrosis and ureteral entrapment was obtained by a dedicated questionnaire. Results: Twelve patients (23%) with IAAA had preoperative impairment of renal function and five had known hydronephrosis. Variables that were significantly associated with IAAA included younger age (p<.0001, mean difference 5.9, CI 3.7–7.9) and lower pulmonary risks score (OR 0.38, CI 0.19–0.74). At completion of the endovascular procedure, device stenosis was more frequently observed in patients with IAAA (OR 18.1, CI 3.52–93.0). There were no differences with regard to the rates of mortality, rupture or conversion in patients with IAAA and controls. In the majority, the aneurysm size regressed irrespective of nature of aneurysm. Of the 11 patients with a detailed assessment three had deterioration of renal function and three still had ureteral entrapment during follow-up. Conclusion: Despite persistence of perianeurysmal inflammation in a proportion of patients operative and midterm results of endovascular repair were comparable in the patients with inflammatory and standard AAA. [Copyright &y& Elsevier]

Abstract: Objective: The outcomes for patients after endovascular treatment of abdominal aortic aneurysm (AAA) are determined primarily by the endpoints of death and endoleaks, the latter representing continued risk of rupture. The data of a multicentre registry were analysed with regard to the early outcome of stent-graft procedures for AAA and the complications associated with this treatment. In addition, the results during follow-up were analysed by determining mortality and endoleak development as separate endpoints and as a combined endpoint defined as endoleak-free survival. Setting: 38 European institutions of Vascular Surgery collaborating in a multicentre registry project. Patients and methods: 899 patients with AAA underwent between May 1994 and March 1998 elective endovascular repair (818 men and 81 women; mean age 69 years). 80 (8.9%) of the patients had medical conditions that excluded them from open repair. 818 (91%) of patients had a bifurcated device, 63 (7%) had a straight tube graft, and only 18 (2%) had an aorto-uni-iliac device. Clinical examination and contrast-enhanced computed tomography was performed at fixed follow-up intervals to assess increase or decrease of the maximum transverse diameter (MTD). Endoleaks observed at follow-up were discriminated into persistent endoleak and temporary endoleak. The latter is defined as single time observed endoleaks or with two or more negative imaging studies between observed endoleaks. Life-table analyses were used to calculate the rates of freedom-from-endoleak (no endoleak at any time), freedom-from-persistent endoleak (no persistent endoleak), patient survival, and persistent-endoleak-free-survival. Results: The median follow-up of this patient series was 6.2 months. The ratio between observed and expected follow-up data was 82% for the overall follow-up period. However, at 18 months of follow-up this rate was only 45%. The number of patients followed during this period was sufficient to allow statistically meaningful assessment. The MTD in patients with temporary endoleaks demonstrated a significant decrease at 6 to 12 months compared to preoperative values (mean 57 and 53 respectively, p = 0.004). In patients with persistent endoleaks there was no change between the preoperative and 6-month MTD (mean 57 and 60 mm respectively). At 6 and 18 months freedom-from-endoleak was 83% and 74% and freedom-from-persistent endoleak was 93% and 90%, respectively. The 18-month cumulative patient survival was 88% and the main outcome measure, the persistent endoleak-free-survival was 79%. Conclusions: The MTD decreases in patients with temporary endoleak, but not in patients with persistent endoleak. Therefore, the use of the rate of freedom-from-persistent endoleak, reflecting absence of persisting endoleaks to estimate the prognosis with regard to the AAA, is justified. Determining persistent endoleak-free survival appears a rational approach to provide a realistic outlook for patients with stent-grafted AAA. The observed 18-month endoleak-free survival reflects a satisfactory mid-term result. [Copyright &y& Elsevier]

Atypical EGFR mutations occur in 10%-30% of non-small-cell lung cancer (NSCLC) patients with EGFR mutations and their sensitivity to classical epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKI) is highly heterogeneous. Patients harboring one group of uncommon, recurrent EGFR mutations (G719X, S768I, L861Q) respond to EGFR-TKI. Exon 20 insertions are mostly insensitive to EGFR-TKI but display sensitivity to exon 20 inhibitors. Clinical outcome data of patients with very rare point and compound mutations upon systemic treatments are still sparse to date. In this retrospective, multicenter study of the national Network Genomic Medicine (nNGM) in Germany, 856 NSCLC cases with atypical EGFR mutations including co-occurring mutations were reported from 12 centers. Clinical follow-up data after treatment with different EGFR-TKIs, chemotherapy and immune checkpoint inhibitors were available from 260 patients. Response to treatment was analyzed in three major groups: (i) uncommon mutations (G719X, S7681, L861Q and combinations), (ii) exon 20 insertions and (iii) very rare EGFR mutations (very rare single point mutations, compound mutations, exon 18 deletions, exon 19 insertions). Our study comprises the largest thus far reported real-world cohort of very rare EGFR single point and compound mutations treated with different systemic treatments. We validated higher efficacy of EGFR-TKI in comparison to chemotherapy in group 1 (uncommon), while most exon 20 insertions (group 2) were not EGFR-TKI responsive. In addition, we found TKI sensitivity of very rare point mutations (group 3) and of complex EGFR mutations containing exon 19 deletions or L858R mutations independent of the combination partner. Notably, treatment responses in group 3 (very rare) were highly heterogeneous. Co-occurring TP53 mutations exerted a non-significant trend for a detrimental effect on outcome in EGFR-TKI-treated patients in groups 2 and 3 but not in group 1. Based on our findings, we propose a novel nNGM classification of atypical EGFR mutations. • The EGFR-TKI efficacy of in uncommon EGFR mutations generally considered TKI sensitive was validated. • Complex EGFR mutations containing exon19del or L858R were EGFR-TKI sensitive, independent of the combination partner. • Very rare single and complex mutations, comprising 40% of atypical mutations, show a high heterogeneity of TKI sensitivity. • TP53 co-mutations may confer a detrimental outcome in TKI-treated patients with very rare EGFR mutations and exon20ins. • We propose a novel nNGM classification for atypical EGFR mutations. [ABSTRACT FROM AUTHOR]

Abstract: Currently the transverse diameter is the primary decision criterion to assess rupture risk in patients with an abdominal aortic aneurysm (AAA). To obtain a measure for more patient-specific risk assessment, aneurysm wall stress, calculated using finite element analysis (FEA), has been evaluated in literature. In many cases, initial stress, present in the AAA wall during image acquisition, is not taken into account. In the current study the effect of initial stress incorporation (ISI) is determined by directly comparing wall displacements extracted from FEA and dynamic MRI. Ten patients with an aneurysm diameter were scanned with cardiac triggered MRI. Semi-automatic segmentation of the AAA was performed on the diastolic phase. The segmented in-slice contours were propagated through the remaining cardiac phases using an active contour model as to track wall displacements on MRI. Consequently, FEA with and without ISI (no-ISI) was performed using the diastolic geometry with simultaneously measured intra-aneurysm pressure values as boundary condition. Contours extracted from FEA were compared with MRI contours at corresponding cardiac phases by distance and relative area differences. The wall displacements from FEA with ISI show significant better correspondence with wall motion from MRI data in comparison with the no-ISI FEA (deviation in wall displacement 1.7% vs. 12.4%; ). Based on these results it can be concluded that incorporation of initial stress significantly improves wall displacement accuracy of FEA and therefore it should be incorporated in future analyses. [Copyright &y& Elsevier]

Abstract: Rupture risk estimation of abdominal aortic aneurysms (AAA) is currently based on the maximum diameter of the AAA. A more critical approach is based on AAA wall stress analysis. For that, in most cases, the AAA geometry is obtained from CT-data and treated as a stress free geometry. However, during CT imaging, the AAA is subjected to a time-averaged blood pressure and is therefore not stress free. The aim of this study is to evaluate the effect of neglecting these initial stresses (IS) on the patient-specific AAA wall stress as computed by finite element analysis. Additionally, the contribution of the nonlinear material behavior of the AAA wall is evaluated. Thirty patients with maximum AAA diameters below the current surgery criterion were scanned with contrast-enhanced CT and the AAA''s were segmented from the image data. The mean arterial blood pressure (MAP) was measured immediately after the CT-scan and used to compute the IS corresponding with the CT geometry and MAP. Comparisons were made between wall stress obtained with and without IS and with linear and nonlinear material properties. On average, AAA wall stresses as computed with IS were higher than without IS. This was also the case for the stresses computed with the nonlinear material model compared to the linear material model. However, omitting initial stress and material nonlinearity in AAA wall stress computations leads to different effects in the resulting wall stress for each AAA. Therefore, provided that other assumptions made are not predominant, IS cannot be discarded and a nonlinear material model should be used in future patient-specific AAA wall stress analyses. [Copyright &y& Elsevier]

At present, the diameter of an abdominal aortic aneurysm (AAA) is considered to be the primary indicator of rupture risk. Surgical treatment is usually not considered before the diameter exceeds 5 cm, but rupture does occur for diameters less than 5 cm. We investigate if better rupture risk indicators can be obtained by patient-specific hemodynamic modeling. This paper discusses the steps involved in this modeling and describes our initial results for each of the steps. [Copyright &y& Elsevier]