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Background: Previous studies have focused on patient-related risk factors to explain the higher mortality risk in women undergoing elective abdominal aortic aneurysm (AAA) repair. The aim of this study was to evaluate whether hospital-related factors influence outcomes following AAA repair in women. Methods: Patients undergoing elective AAA repair in 61 hospitals in the Netherlands were identified from the Dutch Surgical Aneurysm Audit registry (2013-2018). A mixed-effects logistic regression analysis was conducted to assess the effect of sex on inhospital and/or 30-day mortality. This analysis accounted for possible correlation of outcomes among patients who were treated in the same hospital, by adding a hospital-specific random effect to the statistical model. The analysis adjusted for patient-related risk factors and hospital volume of open surgical repair (OSR) and endovascular aneurysm repair (EVAR). Results: Some 12 034 patients were included in the analysis. The mortality rate was higher in women than among men: 53 of 1780 (3.0 per cent) versus 152 of 10 254 (1.5 per cent) respectively. Female sex was significantly associated with mortality after correction for patient- and hospital-related factors (odds ratio 1.68, 95 per cent c.i. 1.20 to 2.37). OSR volume was associated with lower mortality (OR 0.91 (0.85 to 0.95) per 10-procedure increase) whereas no such relationship was identified with EVAR volume (OR 1.03 (1.01 to 1.05) per 10-procedure increase). Conclusion: Women are at higher risk of death after abdominal aortic aneurysm repair irrespective of patient- and hospital-related factors. [ABSTRACT FROM AUTHOR]

Purpose: Lifelong follow-up after endovascular abdominal aortic aneurysm repair (EVAR) is recommended due to a continued risk of complications, especially if the first postoperative imaging shows abnormal findings. We studied the long-term outcomes in patients with abnormalities on the first postoperative computed tomography angiography (CTA) following EVAR. Materials and Methods: This is a retrospective study of all consecutive patients who underwent elective EVAR for nonruptured abdominal aortic aneurysm (AAA) between January 2007 and January 2012 in 16 Dutch hospitals with follow-up until December 2018. Patients were included if the first postoperative CTA showed one of the following abnormal findings: endoleak type I–IV, endograft kinking, infection, or limb occlusion. AAA diameter, complications, and secondary interventions during follow-up were registered. Primary endpoint was overall survival, and other endpoints were secondary interventions and intervention-free survival. Kaplan-Meier analyses were used to estimate overall and intervention-free survival. Cox regression analyses were used to identify the association of independent determinants with survival and secondary interventions. Results: A total of 502 patients had abnormal findings on the first postoperative CTA after EVAR and had a median follow-up (interquartile range IQR) of 83.0 months (59.0). The estimated overall survival rate at 1, 5, and 10 years was 84.7%, 51.0%, and 30.8%, respectively. Age [hazard ratio (HR) 1.06, 95% confidence interval (CI) 1.05 to 1.10] and American Society of Anesthesiologists (ASA) classification (ASA IV HR 3.20, 95% CI 1.99 to 5.15) were significantly associated with all-cause mortality. Overall, 167 of the 502 patients (33.3%) underwent 238 secondary interventions in total. Fifty-eight patients (12%) underwent an intervention based on a finding on the first postoperative CTA. Overall survival was 38.4% for patients with secondary interventions and 44.5% for patients without (log rank; p=0.166). The intervention-free survival rate at 1, 5, and 10 years was 82.9%, 61.3%, and 45.6%, respectively. Conclusions: Patients with abnormalities on the first postoperative CTA after elective EVAR for infrarenal AAA cannot be discharged from regular imaging follow-up due to a high risk of secondary interventions. Patients who had a secondary intervention had similar overall survival as those without secondary interventions. [ABSTRACT FROM AUTHOR]

Background: The sharp decrease in open surgical repair (OSR) for abdominal aortic aneurysm (AAA) has raised concerns about contemporary postoperative outcomes. The study was designed to analyse the impact of complications on clinical outcomes within 30 days following OSR. Methods: Patients who underwent OSR for intact AAA registered prospectively between 2016 and 2019 in the Dutch Surgical Aneurysm Audit were included. Complications and outcomes (death, secondary interventions, prolonged hospitalization) were evaluated. The adjusted relative risk (aRr) and 95 per cent confidence intervals were computed using Poisson regression. Subsequently, the population-attributable fraction (PAF) was calculated. The PAF reflects the expected percentage reduction of an outcome if a complication were to be completely prevented. Results: A total of 1657 patients were analysed. Bowel ischaemia and renal complications had the largest impact on death (aRr 1244 (95 per cent c.i. 795 to 1984) at PAF 20 (95 per cent c.i. 84 to 315) per cent and aRr 507 (95 per cent c.i. 318 to 8.07) at PAF 14 (95 per cent c.i. 07 to 270) per cent, respectively). Arterial occlusion had the greatest impact on secondary interventions (aRr 1128 (95 per cent c.i. 890 to 1430) at PAF 21 (95 per cent c.i. 147 to 281) per cent), and pneumonia (aRr 252 (95 per cent c.i. 204 to 310) at PAF 13 (95 per cent c.i. 83 to 178) per cent) on prolonged hospitalization. Small effects were observed on outcomes for other complications. Conclusion: The greatest clinical impact following OSR can be made by focusing on measures to reduce the occurrence of bowel ischaemia, arterial occlusion and pneumonia. [ABSTRACT FROM AUTHOR]

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Objective Abdominal aortic aneurysm patients tend to be informed inconsistently and incompletely about their disorder and the treatment options open to them. The objective of this trial was to evaluate whether these patients are better informed and experience less decisional conflict regarding their treatment options after viewing a decision aid. Design A six-centre, randomised clinical trial comparing a decision aid plus regular information versus regular information from the surgeon. Methods Included patients had recently been diagnosed with an asymptomatic abdominal aortic aneurysm at least 4 cm in diameter. The decision aid consisted of a one-time viewing of an interactive CD-ROM elaborating on elective surgery versus watchful waiting. Generally, the decision aid advised patients with aneurysms less than 5.5 cm to agree to watchful waiting, for larger aneurysms the decision aid provided insight into the balance of benefit and harm of surgical and conservative approaches, taking into account age, co-morbidity and size of the aneurysm. The primary outcome was patient decisional conflict measured at 1 month follow-up (Decisional Conflict Scale). Secondary outcomes were patient knowledge, anxiety and satisfaction. Results In 178 aneurysm patients, decisional conflict scores did not differ significantly between the decision aid and the regular information groups (22 vs. 24 on the 0-100 Decisional Conflict Scale; p = .33). Patients in the decision aid group had significantly better knowledge (10.0 vs. 9.4 out of 13 points; p = .04), whereas anxiety levels (4.4 and 5.0 on a 0-21 scale; p = .73) and satisfaction scores (74 and 73 on a 0-100 scale; p = .81) were similar in both groups. Conclusion In addition to regular patient-surgeon communication, a decision aid helps to share treatment decisions with abdominal aortic aneurysm patients by increasing their knowledge about the disorder and available treatment options without raising anxiety levels; however, it does not reduce decisional conflict, nor does it improve satisfaction. [ABSTRACT FROM AUTHOR]

Objective: Since insight into the reason for filing claims after treatment of varicose veins of the lower extremity might help prevent future claims, we determined the incidence of and reasons for medical liability insurance claims after such treatments in the Netherlands. Method: We performed a retrospective review of all medical liability insurance claims after varicose vein treatment handled by MediRisk between January 1993 and December 2007. Results: A total of 144 claims were filled of which 104 were closed by the end of the study period. Nerve injury (n = 28), skin necrosis following sclerotherapy (n = 17), deep vein injury (n = 11) and insufficient communication (n = 9) accounted for more than 60% of all claims. Claims were equally distributed among registrars and consultants. Some 41 of the 104 closed claims were accepted. In 27 of the accepted cases, the physician had obviously failed in providing the care as expected from a medical practitioner allowed to perform these treatments. The majority of these 27 claims were due to injury of nerves (n = 11) or deep veins (n = 9). Conclusion: The incidence of claims after treatment of varicose veins in the Netherlands is low. Proper knowledge of anatomy and adequate communication, along with the introduction of less invasive treatments might prevent future claims. [ABSTRACT FROM AUTHOR]

Background: Recent trials have shown promising results for the efficacy of gum chewing for the amelioration of postoperative ileus. This finding could have a major clinical impact since gum chewing is relatively harmless and cheap while postoperative ileus has a significant impact on healthcare. Methods: Systematic review and meta-analysis of randomized controlled trials comparing the efficacy of gum chewing after colorectal surgery to a standard control for the amelioration of postoperative ileus, expressed as time to flatus, time to defecation and overall hospital stay. Results: Five randomized controlled trials with a total number of 158 patients were found. The studies were homogeneous and a meta-analysis was performed. The pooled weighted mean difference (WMD) of time to flatus was significantly shorter for the gum-chewing group (20 h with a 95% confidence interval (CI) of 13–27). The pooled WMD of time to defecation was significantly shorter (29 h, 95% CI of 19–39). There was a non-significant trend towards a shorter postoperative hospital stay (1.3 days shorter, 95% CI of 3.2 days shorter to 0.6 days longer). Conclusion: This meta-analysis shows a favorable effect of gum chewing on time to flatus and defecation but no significant effect on the hospital stay. Copyright © 2008 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

We studied the predictive power at admission of troponin T and myoglobin and compared them with that of CK and CK-MB activity and ECG in 290 consecutive patients admitted for evaluation of a suspected AMI. The likelihood ratio for an ischaemic ECG at admission <4 h (between 4 and 12 h) after onset of chest pain was 2·85 (1·92), for a inconclusive ECG 1·53 (1·98) and for a normal ECG 0·27 (0·35). In patients admitted <4 h after onset of chest pain, the likelihood ratio for abnormal and normal nyoglobin concentrations (8·06 and 0·67) was considerably better for detection of AMI as defined by the WHO criteria than for the other markers, including the ECG. In patients admitted 4–12 h after onset of chest pain, the likelihood ratios for abnormal and normal myoglobin concentrations were 4·88 and 0·42; for troponin T 3·11 and 0·31, for CK activity 3·44 and 0·49 and for CK-MB activity 4·08 and 0·54 respectively. The sensitivity for troponin T (64%) was better than that of the other markers but its specificity (74%)was worse, because in patients with unstable angina troponin T was frequently elevated (37%). Stepwise logistic regression analysis showed that the best predictors of AMI within 4 h after onset of chest pain were the ECG and myoglobin and between 4–12 h after onset of chest pain the ECG, CK-MB activity and myoglobin. [ABSTRACT FROM PUBLISHER]

Little is known about the impact of standardized imaging surveillance on anxiety levels and well-being of patients after endovascular aortic aneurysm repair (EVAR). We hypothesize that patient anxiety levels increase just before receiving the imaging results compared with standard anxiety levels., Methods: Prospective cohort study from November 2018 to May 2020 including post-EVAR patients visiting the outpatient clinics of 4 Dutch hospitals for imaging follow-up. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used. Patients completed the PROMIS Anxiety v1.0 Short Form (SF) 4a, PROMIS-Global Health Scale v1.2, and PROMIS-Physical Function v1.2 SF8b at 2 time points: prior to the result of the imaging study (T1: pre-visit) and 6-8 months later (T2: reference measurement). Mean T-scores at T1 were compared to T2, and T2 to the general 65+ Dutch population., Results: Altogether 342 invited patients were eligible, 214 completed the first questionnaire, 189 returned 2 completed questionnaires and 128 patients did not participate. Out of 214 respondents, 195 were male (91.1%) and the mean (standard deviation) age was 75.2 (7.0) years. There were no significant differences between T1 and T2 in anxiety levels (0.48; 95% confidence interval[CI] -0.42-1.38), global mental health (0.27; 95% CI -0.79-0.84), global physical health (0.10; 95% CI -0.38-1.18) and physical function (0.53; 95% CI -0.26-1.32). Compared with the 65+ Dutch population, at T2 patients experienced more anxiety (3.8; 95% CI 2.96-5.54), had worse global physical health (-3.2; 95% CI -4.38 - -2.02) and physical function (-2.4; 95% CI -4.00 - -0.80). Global mental health was similar (-1.0; 95% CI -2.21 - 0.21)., Conclusions: Post-EVAR patients do not experience more anxiety just before receiving surveillance imaging results than outside this period, but do suffer from more anxiety and worse physical outcomes than the 65+ Dutch population., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: Elective abdominal aortic aneurysm (AAA) repair is performed to prevent rupture. For reasons as yet unknown, the 30-day mortality risk after elective AAA repair is higher in women than in men. We hypothesised that this higher risk might be related to differences in comorbidity., Methods: Systematic review (PROSPERO CRD42019133314) according to PRISMA guidelines. A search in the EMBASE/MEDLINE/CENTRAL databases identified 1870 studies that included patients who underwent elective AAA repair (final search February 17 th , 2021). Ultimately, 28 studies were included and all reported comorbidities were categorised into 17 comorbidity groups. Additionally, 15 groups of clearly defined comorbidities were used for sensitivity analysis. For both groups, meta-analyses of each comorbidity were performed to estimate the difference in pooled prevalence between women and men with a random effects model., Results: When analysing data of all reported comorbidities (17 groups), smoking [risk difference (RD) 11%, 95% confidence interval (CI) 4-18], diabetes (RD 3%, 95% CI 2-4), ischaemic heart disease (RD 12%, 95% CI 8-16), arrhythmia (RD 3%, 95% CI 0.4-5), liver disease (RD 0.1%, 95% CI 0.01-0.2), and cancer (RD 3%, 95% CI 2-4)) were less prevalent in women, whereas, hypertension (RD 4%, 95% CI 3-6) and pulmonary disease (RD 4%, 95% CI 3-5) were more prevalent in women. At the time of surgery women were significantly older than men (74.9 years versus 72.4; mean difference 2.4 years (95% CI 2.1-2.7)). In the sensitivity analysis of 15 comorbidity groups, the same comorbidities remained significantly different between women and men, except smoking and arrhythmia. Women had a higher mortality risk than men (RD 1%, 95% CI 1-2)., Conclusions: Although women undergoing elective AAA repair have fewer baseline comorbidities than men, their 30-day mortality risk is higher. In-depth studies on the cause of death in women after elective AAA repair are needed to explain this discrepancy in mortality., (Copyright © 2021. Published by Elsevier Inc.)

Objective/background: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period., Methods: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort., Results: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; +22% [p < .001]) and INT in 44% (2009: 66%; -22% [p < .001]) of the IC population. Additional revascularisation was performed in 19% of patients in the SET group (2009: 6%; +13% [p < .001]) and also in 19% of patients in the INT group (2009: 35%; -16% [p < .001]). Later on, 29% of patients in the INT group were referred for SET (2009: 10%; +19% [p < .001]). Average costs of IC treatment per patient in 2011 were 6% lower than in 2009 (€6885 vs. €7300; p = .020)., Conclusion: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: International guidelines recommend revascularisation as the preferred treatment for patients with critical limb ischaemia (CLI). Most contemporary research focuses on the outcome of invasive procedures for CLI, but little is known about the outcome of conservative management. Amputation free survival (AFS) and overall survival (OS) was investigated in patients with CLI who did or did not receive revascularisation, and characteristics associated with clinical outcomes were explored., Methods: This was a retrospective cohort study of consecutive patients with chronic CLI between 2010 and 2014 in a Dutch university hospital. CLI was defined as the presence of ischaemic rest pain or tissue loss in conjunction with an absolute systolic ankle pressure < 50 mmHg or a toe pressure < 30 mmHg. Patients were divided into invasive (revascularisation within 6 weeks), deferred invasive (revascularisation after 6 weeks), or permanently conservative treatment groups. Univariable and multivariable survival analyses were used to identify factors associated with AFS and OS., Results: The majority (66.7%; N = 96) of the identified 144 patients with CLI (mean age 71.2 years; median follow-up 99 weeks) underwent revascularisation within 6 weeks of diagnosis. Deferred invasive treatment was provided in 18.1% (N = 26) patients and 22 patients (15.3%) were treated permanently conservatively. AFS and OS did not differ significantly between the three groups (Breslow-Wilcoxon p = .16 for AFS and p = .09 for OS). Age, chronic obstructive pulmonary disease (COPD), and heart disease were significant independent predictors of AFS. Age, COPD, and hypertension were significant independent predictors of OS. Treatment was not a significant predictor of either AFS or OS., Conclusions: Not all patients with CLI require revascularisation to achieve an AFS that is similar to patients undergoing revascularisation, although the efficacy of conservative versus invasive treatment in CLI patients is still unclear. Further prospective studies should determine subgroups of patients in whom revascularisation may be omitted., (Copyright © 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: Although commonly used to measure health related quality of life in patients with lower limb ischaemia, the measurement properties of the VascuQol and its assumed underlying health dimensions have not been studied in depth. The objective of this study was therefore to evaluate aspects of reliability and validity of the Dutch version of the VascuQol in patients with intermittent claudication (IC) and critical limb ischaemia (CLI)., Methods: Two datasets containing 195 patients with IC and 150 patients with CLI were used. Face validity of the VascuQol was examined in interviews with patients and a survey among health professionals. Homogeneity and structural validity of the VascuQol were assessed using Cronbach's α coefficients and explanatory factor analysis. Furthermore, convergent validity and known group validity were assessed., Results: During the face validity interviews, three items were indicated as less relevant. Homogeneity analysis showed that the α coefficient of the VascuQol was .93, while the symptoms and social domains had α coefficients below the threshold of .70. The original five domains of the VascuQol could not be reproduced. Instead, factor analysis yielded a three factor solution. Moderate correlations were found for the activities, social and emotional VascuQol domains and matching health domains of other patient reported outcome measures (PROMs). Lower convergent correlations were observed for the pain domain and the sumscore of the VascuQol. The VascuQol was able to distinguish between patients' level of HRQL in relation to their disease severity (IC versus CLI patients)., Conclusions: There is room for improvement of the VascuQol questionnaire. Further clinimetric studies should be performed to strengthen clinically relevant findings based on this instrument., (Copyright © 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: Biomechanical characteristics, such as wall stress, are important in the pathogenesis of abdominal aortic aneurysms (AAA) and can be visualised and quantified using imaging techniques. This systematic review aims to present an overview of all biomechanical imaging markers that have been studied in relation to AAA growth and rupture., Methods: This systematic review followed the PRISMA guidelines. A search in Medline, Embase, and the Cochrane Library identified 1503 potentially relevant articles. Studies were included if they assessed biomechanical imaging markers and their potential association with growth or rupture., Results: Twenty-seven articles comprising 1730 patients met the inclusion criteria. Eighteen studies performed wall stress analysis using finite element analysis (FEA), 13 of which used peak wall stress (PWS) to quantify wall stress. Ten of 13 case control FEA studies reported a significantly higher PWS for symptomatic or ruptured AAAs than for intact AAAs. However, in some studies there was confounding bias because of baseline differences in aneurysm diameter between groups. Clinical heterogeneity in methodology obstructed a meaningful meta-analysis of PWS. Three of five FEA studies reported a significant positive association between several wall stress markers, such as PWS and 99th percentile stress, and growth. One study reported a significant negative association and one other study reported no significant association. Studies assessing wall compliance, the augmentation index and wall stress analysis using Laplace's law, computational fluid dynamics and fluid structure interaction were also included in this systematic review., Conclusions: Although PWS is significantly higher in symptomatic or ruptured AAAs in most FEA studies, confounding bias, clinical heterogeneity, and lack of standardisation limit the interpretation and generalisability of the results. Also, there is conflicting evidence on whether increased wall stress is associated with growth., (Copyright © 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Background: Methods are required to identify abdominal aortic aneurysms (AAAs) at increased risk of rupture. Inflammatory characteristics of AAA can be visualised using advanced imaging techniques and have been proposed as potential predictors of aneurysm progression. The objective of this review was to determine which inflammatory imaging biomarkers are associated with AAA growth and rupture., Methods: A systematic review was carried out in accordance with the PRISMA guidelines. The electronic databases of Medline (PubMed), Embase, and the Cochrane Library were searched up to January 1, 2016 for studies to determine the potential association between inflammatory imaging biomarkers and AAA growth or rupture., Results: Seven studies were included, comprising 202 AAA patients. (18)F-fluoro-deoxy-glucose positron emission tomography ((18)F-FDG PET-CT) was evaluated in six studies. Magnetic resonance imaging with ultrasmall superparamagnetic particles of iron oxide (USPIO-MRI) was evaluated in one study. Two of six (18)F-FDG PET-CT studies reported a significant negative correlation (r=.383, p = .015) or a significant negative association (p = .04). Four of six (18)F-FDG PET-CT studies reported no significant association between (18)F-FDG uptake and AAA growth. The single study investigating USPIO-MRI demonstrated that AAA growth was three times higher in patients with focal USPIO uptake in the AAA wall compared to patients with diffuse or no USPIO uptake in the wall (0.66 vs. 0.24 vs. 0.22 cm/y, p = .020). In the single study relating (18)F-FDG uptake results to AAA rupture, the association was not significant., Conclusions: Current evidence shows contradictory associations between (18)F-FDG uptake and AAA growth. Data on the association with rupture are insufficient. Based on the currently available evidence, neither (18)F-FDG PET-CT nor USPIO-MRI can be implemented as growth or rupture prediction tools in daily practice. The heterogeneous results reflect the complex and partially unclear relationship between inflammatory processes and AAA progression., (Copyright © 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: Shared decision making (SDM) is a process in which patients and their doctors collaborate in choosing a suitable treatment option by incorporating patient values and preferences, as well as the best available evidence. Particularly in vascular surgery, several conditions seem suitable for SDM because there are multiple treatment options. The objective of this study was to assess the degree of SDM behaviour in vascular surgery., Methods: Vascular surgeons of four Dutch hospitals selected consultations with patients who were facing a treatment decision. Immediately after the consultation, patients and surgeons completed the (subjective) SDM Q-9 and SDM Q-doc questionnaires respectively, to appreciate the perceived level of SDM behaviour. Two evaluators independently and objectively rated SDM behaviour in the audiotaped consultations, using the Observing Patient Involvement (OPTION-12) scale., Results: Nine vascular surgeons and three vascular surgeons in training conducted 54 consultations. The patients' median SDM Q-9 score was high, 93% (IQR 79-100%), and 16/54 (29.6%) of them gave the maximum score. The surgeons' median score was also high, 84% (IQR 73-92%), while 4/54 (7.4%) gave the maximum score. In contrast, mean OPTION score was 31% (SD 11%). Surgeons hardly ever asked the patients for their preferred approach to receive information, whether they had understood the provided information, and how they would like to be involved in SDM., Conclusions: Currently, objective SDM behaviour among vascular surgeons is limited, even though the presented disorders allow for SDM. Hence, SDM in vascular surgical consultations could be improved by increasing the patients' and surgeons' awareness and knowledge about the concept of SDM., (Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: The VascuQol is a questionnaire for health related quality of life (HRQL) in patients with intermittent claudication (IC), and is frequently used to evaluate treatment effects. Yet, the interpretation of change in score on a questionnaire is not always obvious. The minimally important difference (MID) represents the smallest change in score on a questionnaire that is considered relevant by patients. This study aims to determine the MID for the VascuQol sumscore and its different domains for patients with IC., Methods: A total of 118 participants were recruited from the SUPER study, a multicenter randomized controlled trial comparing angioplasty with supervised exercise therapy for alleviation of IC due to an iliac artery stenosis or occlusion. All patients completed the VascuQol and the Short Form 36 (SF-36) questionnaires at baseline and after 12 months of follow up. Two anchor based methods for MID calculation were applied. Two anchors were used: six global rating of change questions aimed at the VascuQol sumscore and subscales and the health transition item of the SF-36, both recorded at 12 months of follow up., Results: The MID for the VascuQol sumscore ranged between 1.19 and 1.66 for improvement and 0.08 and 0.41 for deterioration. For the pain domain, MID values ranged from 1.48 to 1.91 for improvement and 0.19 to 0.34 for deterioration. Finally, for the activities domain MID values ranging from 1.55 to 2.2 and from 0.12 to 0.26 for improvement and deterioration were found, respectively. Since the correlations between the anchors and the symptom, social and emotional subscales were below the threshold of 0.3, the MID was not calculated for these subscales., Conclusions: The range of MID values found in this study is an indication of the smallest change score on the VascuQol questionnaire score that is considered relevant by patients with IC. They may help to better interpret trial results and set treatment goals., (Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Physicians are legally and ethically compelled to present their patients with available evidence on the potentially beneficial and harmful effects of a proposed medical or surgical treatment.

Objectives: Although the Vascular Quality of Life Questionnaire (VascuQol) is a widely used instrument to assess quality of life in patients with peripheral arterial disease (PAD), data on its reliability are scarce and its measurement error is unknown. The aim of this study was to determine test-retest reliability and measurement error of the Dutch version of the VascuQol in patients with intermittent claudication (IC)., Methods: Patients with intermittent claudication due to PAD presenting between October 2013 and April 2014 completed the VascuQol twice, with a 1 week interval. Test-retest reliability was expressed as the intraclass correlation coefficient (ICC) with 95% confidence interval (CI), and measurement error as a standard error of measurement (SEM)., Results: Sixty-one patients completed two VascuQol questionnaires sufficiently. The ICC for the VascuQol sumscore was 0.91 (95% CI 0.86-0.95). The ICC for the different VascuQol domains ranged between 0.77 (95% CI 0.64-0.86) and 0.87 (95% CI 0.79-0.92). The SEM of the sumscore was 0.34 and ranged between 0.44 and 0.76 for the different VascuQol domains., Conclusions: The test-retest reliability of the Dutch version of the VascuQol is excellent, both for the sumscore and for its different domains. The VascuQol has a measurement error that is sufficiently small to allow detection of clinically relevant changes., (Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: The aim was to critically appraise, compare, and summarize the quality of the measurement properties of all available disease specific patient reported outcome measures (PROMs) on health related quality of life and functional status validated in patients with intermittent claudication (IC)., Methods: A systematic search was carried out in Embase and Medline (last search November 18, 2013). The quality of the identified studies was assessed per measurement property according to the COnsensus-based Standards for the selection of health Measurements Instruments (COSMIN) checklist. Data on the measurement properties were extracted to determine a level of evidence per measurement property per instrument., Results: Forty three studies were found evaluating 10 health related quality of life and two functional status PROMs. Evidence for the existence of subscales (structural validity) and for internal consistency (interrelatedness of items within subscales) for PROMs was generally poor. Evidence for construct validity was limited. Accuracy and reproducibility of PROMs were often uncertain, since reliability studies were mostly performed in small patient samples. Responsiveness, or the ability of PROMs to detect change over time, was hardly ever studied., Conclusion: The quality of the validation of most disease specific PROMs for IC is alarming, hampering all conclusion based on these PROMs. Considering the results, the PAD quality of life questionnaire (PADQOL), Intermittent claudication questionnaire (ICQ) and the Vascular quality of life questionnaire (VascuQol) might be appropriate PROMs for health related quality of life, while the Walking impairment questionnaire (WIQ) and Estimate ambulation capacity by history questionnaire (EACH-Q) appear suitable PROMs for functional status. However, all PROMs require further validation studies to fill the gaps in their measurement properties. The shortcomings highlighted in this review should be taken into account when interpreting PROM results., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective/background: Arterial calcification may render the ankle-brachial index (ABI) unreliable in diabetic patients. Although guidelines recommend the toe-brachial index (TBI) for patients with falsely elevated ABI arbitrarily defined as an ABI > 1.4, arterial calcification is also common among diabetic patients with an ABI ≤ 1.4. This could result in a "falsely normalized" ABI and under-diagnosis of peripheral arterial disease (PAD). We investigated whether diabetes invalidates the ABI as opposed to the TBI, and if the TBI may therefore be more suitable for detecting PAD in diabetic patients., Methods: The difference between ABI and TBI was compared between diabetic and non-diabetic patients with an ABI ≤ 1.4 referred to the vascular laboratory. A Bland-Altman plot was constructed to assess whether ABI-TBI differences were dependent on the magnitude of the measurements. Subgroup analyses were performed for patients with a normal ABI, and for patients with critical ischemia., Results: The population comprised 161 diabetic (252 limbs) and 160 non-diabetic (253 limbs) patients (mean age 67). Median ABIs (0.79 vs. 0.80) were similar, while median TBI was 0.07 higher in diabetics (p = 0.024). The ABI-TBI difference in diabetics and non-diabetics was similar (0.32 vs. 0.35; p = .084), and was also similar for patients with a normal ABI. Moreover, ABI-TBI differences in diabetic- and non-diabetic patients overlapped, irrespective of the magnitude of the measurements. Diabetes was not associated with larger differences between ankle and toe pressures (mean difference -0.9 mmHg, 95% confidence interval -15 to 13 mmHg) among patients with critical ischemia., Conclusion: No evidence was found that the TBI may overcome the potentially invalidated ABI in diabetic patients with an ABI ≤ 1.4. ABI and TBI are strongly associated, and this relationship is not influenced by diabetes. Therefore, the TBI does not allow for earlier detection of ischemia in diabetes., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: International guidelines recommend supervised exercise therapy (SET) as primary treatment for intermittent claudication (IC). The aim of this study was to calculate treatment costs in patients with IC and to estimate nationwide annual savings if a stepped care model (SCM, primary SET treatment followed by revascularization in case of SET failure) was followed., Methods: Invoice data of all patients with IC in 2009 were obtained from a Dutch health insurance company (3.4 million members). Patients were divided into three groups based on initial treatment after diagnosis (t0). The SET group received SET initiated at any time between 12 months before and up to 3 months after t0. The intervention group (INT) underwent endovascular or open revascularization between t0 and t+3 months. The third group (REST) received neither SET nor any intervention. All peripheral arterial disease related invoices were recorded during 2 years and average costs per patient were calculated. Savings following use of a SCM were calculated for three scenarios., Results: Data on 4954 patients were analyzed. Initial treatment was SET (n = 701, 14.1%), INT (n = 1363, 27.5%), or REST (n = 2890, 58.3%). Within 2 years from t0, invasive revascularization in the SET group was performed in 45 patients (6.4%). Additional interventions (primary at other location and/or re-interventions) were performed in 480 INT patients (35.2%). Some 431 REST patients received additional SET (n = 299, 10.3%) or an intervention (n = 132, 4.5%). Mean total IC related costs per patient were €2,191, €9851 and €824 for SET, INT, and REST, respectively. Based on a hypothetical worst, moderate, and best case scenario, some 3.8, 20.6, or 33.0 million euros would have been saved per annum if SCM was implemented in the Dutch healthcare system., Conclusion: Implementation of a SCM treatment for patients with IC may lead to significant savings of health care resources., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: A systematic review of randomized clinical trials (RCTs) to assess the additional value of hyperbaric oxygen therapy (HBOT) in promoting the healing of diabetic foot ulcers and preventing amputations was performed., Methods: MEDLINE, Embase, and the Cochrane Library were searched to identify RCTs in patients with diabetic foot ulcers published up to August 2013. Eligible studies reported the effectiveness of adjunctive HBOT with regard to wound healing, amputations, and additional interventions., Results: Seven of the 669 identified articles met the inclusion criteria, comprising 376 patients. Three trials included 182 patients with ischaemic ulcers, two trials studied 64 patients with non-ischaemic ulcers, and two trials comprising 130 patients did not specify ulcer type. Two trials were of good methodological quality. Pooling of data was deemed inappropriate because of heterogeneity. Two RCTs in patients with ischaemic ulcers found increased rates of complete healing at 1-year follow-up (number needed to treat (NNT) 1.8 (95% CI: 1.1 to 4.6) and 4.1 (95% CI: 2.3 to 19)), but found no difference in amputation rates. A third trial in ischaemic ulcers found significantly lower major amputation rates in patients with HBOT (NNT 4.2, 95% CI: 2.4 to 17), but did not report on wound healing. None of the RCTs in non-ischaemic ulcers reported differences in wound healing or amputation rates. Two trials with unknown ulcer types reported beneficial effects on amputation rates, although the largest trial used a different definition for both outcomes. HBOT did not influence the need for additional interventions., Conclusion: Current evidence shows some evidence of the effectiveness of HBOT in improving the healing of diabetic leg ulcers in patients with concomitant ischaemia. Larger trials of higher quality are needed before implementation of HBOT in routine clinical practice in patients with diabetic foot ulcers can be justified., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: To evaluate 1 to 36 month follow-up outcomes of different endovascular treatment strategies in above-the-knee (ATK) arterial segments in patients with intermittent claudication (IC) and critical limb ischemia (CLI)., Methods: Studies indexed in Medline and Embase from 1980 to November 2013 of randomized controlled trials comparing balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another were included. Methodological quality of each trial was assessed using the Cochrane Collaboration tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were quality of life, walking capacity evaluated by treadmill or questionnaire, change in Rutherford classification, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, amputation, death, major adverse cardiac events, or event-free survival with follow-up periods of at least 1 month., Results: Twenty-three trials including 3314 patients in total were identified. Eighty-five per cent patients had IC and 15% CLI. Fifteen trials showed no systematic benefit of BS over PTA. One trial comparing DES and PTA reported no significant differences in walking capacity or Rutherford classification. Four trials showed a beneficial effect on TLR rate, but not on Rutherford classification of DEB compared with PTA. In four trials DES did not systematically perform better than BS., Conclusion: In general, performing PTA with optional bailout stenting for ATK lesions is the preferred strategy in patients with IC. For CLI, more studies are needed for recommending an optimal treatment strategy., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: To evaluate 1 to 48 month follow-up outcomes of different endovascular treatment strategies in below-the-knee (BTK) arterial segments in critical limb ischemia (CLI) patients., Methods: Medline and Embase were searched (last searched on 5 November 2013) for studies of randomized controlled trials comparing either balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another. Methodological quality of each trial was assessed using a Cochrane Collaboration's tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were wound healing, quality of life, change in Rutherford classification, amputation, death, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, and event-free survival with follow-up periods of at least 1 month., Results: Twelve trials including 1145 patients were identified, with 90% of patients having CLI. Six BS versus PTA and two DES versus PTA trials showed low-quality evidence of equal efficacy. One trial, comparing DEB with PTA, showed moderate-quality evidence of improved wound healing (RR 1.28; 95% CI: 1.05 to 1.56; p=.01), improvement in Rutherford classification (RR 1.32; 95% CI: 1.08 to 1.60; p=.008), and lower TLR (RR 0.41; 95% CI 0.23 to 0.74; p=.002) and binary restenosis (RR 0.36; 95% CI 0.24 to 0.54; p<.0001) in diabetic patients after 12 months. Amputation and death rate did not differ significantly. For DES versus BS, most trials showed equal efficacy between strategies., Conclusion: Based on low- to moderate-quality evidence, PTA with optional bailout stenting using BS should remain the preferred strategy in treating CLI patients with BTK arterial lesions. Before other strategies can be implemented, larger and high-quality RCTs assessing clinically relevant outcomes are needed., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: Interpreting whether changes in quality of life (Qol) in patients with peripheral arterial disease (PAD) are not only statistically significant but also clinically relevant, may be difficult. This study introduces the concept of the minimally important difference (MID) to vascular surgeons using Qol outcomes of patients treated for chronic critical limb ischemia (CLI)., Methods: The Vascular Quality of Life (VascuQol) questionnaire was recorded at baseline before treatment and after 6 months follow-up in consecutive patients with CLI treated between May 2007 and May 2010. Statistical significance of change in VascuQol score was tested with the Wilcoxon Signed Rank test. The MID for the VascuQol score was determined using a clinical anchor-based method and a distribution-based method., Results: A total of 127 patients with CLI completed the VascuQol after 6 months. The VascuQol sum scores improved from 3.0 (range 1.1-5.9) at baseline to 4.0 (range 1.2-6.7) at 6 months (p < .001). The MID on the VascuQol sumscore indicating a clinically important change determined with the anchor-based method was 0.36, and with the distribution-based method was 0.48. On an individual level, depending on the method of determining the MID, this resulted in 60% to 68% of the patients with an important benefit., Conclusions: Expression of changes in Qol by means of the MID provides better insight into clinically important changes than statistical significance., (Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: To evaluate the diagnostic accuracy of computed tomography angiography (CTA) in detecting arterial lesions in patients with suspected arterial injury of the upper or lower extremity due to trauma., Methods: A systematic review and meta-analysis was carried out. Medline and Embase were searched on August 13, 2012, for studies comparing CTA with surgery, digital subtraction angiography (DSA), or follow-up, which allowed extraction of data into two-by-two tables. The methodological quality of included studies was assessed using the QUADAS tool. Summary estimates of sensitivity and specificity of CTA in identifying or excluding arterial lesions were obtained using a bivariate model., Results: This review included 11 studies making up a total of 891 trauma patients. The included studies were of moderate methodological quality and at risk of misclassification and verification bias. Some 4.2% of all CTA studies were non-diagnostic. The summary estimates of sensitivity and specificity of CTA were 96.2% (95% CI 93.5-97.8%) and 99.2% (95% CI 96.8-99.8%), respectively., Conclusion: Despite methodological flaws, the excellent estimates of sensitivity and specificity indicate that CTA is an accurate modality for evaluating arterial lesions in patients with extremity trauma and can replace DSA., (Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Introduction: Treatment of intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improving walking distance and includes secondary prevention of cardiovascular disease. Both supervised exercise therapy (SET) and percutaneous transluminal angioplasty (PTA) have proven to be effective in increasing maximum and pain-free walking distance in IC. However, the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear., Objective: To compare the (cost-) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction., Design: In a multicentre randomised controlled trial 400 consecutive patients with IC will be randomly assigned to PTA (with additional stent placement on indication) or SET. Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year. Secondary outcomes are pain-free walking distance, functional status, generic quality of life, complications related to each of the interventions, additional interventions, treatment failures and costs (cost-effectiveness and cost-utility) after 1 year., Conclusion and Implications: Based on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented (Clinical Trials.gov NCT01385774; Nederlands Trial Register NTR2776)., (Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

The results of the recently published PeriOperative ISchemic Evaluation (POISE) trial show that perioperative use of metoprolol in patients with atherosclerosis undergoing major non-cardiac surgery reduces the risk of cardiovascular complications. This effect was primarily produced by a 1.5% reduction in non-fatal myocardial infarction (MI), but this advantage was outweighed by a 0.8% increase in total mortality and a 0.5% increase in nonfatal stroke. These results, combined with previous meta-analyses, confirm that non-fatal MI is reduced at the cost of a statistically significant increase in stroke rate and a near significant increase in mortality. It is likely that the increase in complications is due to a high dose of metoprolol being given too shortly before the operation. These findings call for judicious perioperative use of adrenergic beta-antagonists in cardiac-high-risk patients undergoing high risk non-cardiac surgery. Dosage should be lower and administration should be implemented longer before the operation.

Objectives: To assess the mortality of patients with ruptured abdominal aortic aneurysms undergoing open surgery and examine changes in mortality over time., Methods: Literature databases were searched for relevant articles published between 1991 and 2006. Two reviewers independently performed study inclusion and data extraction. Primary outcome measure was 30 day or in-hospital mortality. Subgroup analyses were performed examining the effect of population- and hospital-based studies, hospital volume and type of surgeon., Results: From a total of 1419 identified studies, 145 observational studies met the inclusion criteria of which 116 were included in the systematic review comprising 60,822 patients. Overall mortality was 48.5% (95% CI: 48.1-48.9%) and did not change significantly over the years. Age increased over the years. For overall mortality a trend was seen in favour of high-volume hospitals., Conclusions: This meta-analysis suggests that mortality of patients with RAAA treated by open surgery has not changed over the past 15 years. This could be explained by increased age of patients undergoing RAAA repair.

Objective: To review the evidence for the effectiveness of exercise therapy and to estimate the additional effect of supervision on exercise therapy in patients with intermittent claudication., Materials and Methods: A systematic review was performed of all randomised controlled trials (RCTs) comparing supervised exercise therapy to unsupervised exercise regimens or observation in patients with intermittent claudication. Main endpoints were pain free walking distance (PWD) and absolute walking distance (AWD). Quality assessment and data extraction were performed independently by two observers., Results: Fifteen manuscripts, published between 1990 and May 2006, were eligible for analysis, evaluating 761 patients. In the studies comparing supervised exercise to standard care the weighted mean difference in pain free walking distance (PWD) and absolute walking distance (AWD) was 81.3meters (95% CI; 35.5-127.1) and 155.8meters (95% CI; 80.8-230.7), respectively. In the studies comparing supervised to unsupervised exercise therapy, the weighted mean difference in PWD and AWD was 143.8meters (95% CI; 5.8-281.8) and 250.4meters (95% CI; 192.4-308.5)., Conclusion: Exercise therapy increases the PWD and AWD in patients with intermittent claudication. Supervised exercise therapy increases the PWD and AWD more than standard care. However, the additional value of supervision over unsupervised exercise regimens needs further clarification.

Objectives: Our aim was to analyse the relation between hospital volume and peri-operative mortality in abdominal aortic aneurysm surgery., Design: Systematic review., Method: The Medline, Embase and Cochrane databases were searched to identify all population based studies reporting on the volume outcome relationship published between 1966 and 2006. Two independent observers performed methodological quality assessment and data extraction. Outcome was 30-day or in-hospital mortality in relation to hospital volume., Results: Twenty-four articles were included. Overall peri-operative mortality ranged from 2.3 to 9.9%. The cut-off values for a high- or low-volume hospital appeared to range from 8 to 50 operations annually. The peri-operative mortality in low volume hospitals (LVH) ranged from 3.0 to 13.8% (median 6.2%) and from 1.8 to 7.4% in high volume hospitals (HVH) (median 4.3%). In 14 studies a significantly lower mortality was found in HVH as opposed to LVH; in 10 articles no such difference between HVH and LVH could be proved., Conclusion: We found some evidence for a relation between the volume of AAA surgery and peri-operative mortality. There seems to be a nonsignificant trend in favour of high volume hospitals. However we could not derive an unequivocal volume threshold for safely performing AAA surgery.