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Funding Information: On behalf of the Public and Community Oversight Group (PCOG) of the Health Protection Research Unit in Chemical and Radiation Threats and Hazards: Ian Wright; John Phipps; Colette Kelly; Robert Goundry; Eve Smyth; Andrew Wood; Paul Dale (also of the Scottish Environment Protection Agency). On behalf of the Society and College of Radiographers Patient Advisory Group: Lynda Johnson; Philip Plant; Michelle Carmichael – Specialist Senior Staff Nurse Guy's and St Thomas’ NHS Foundation trust.

OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.

BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR).METHODS: Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported). Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion.RESULTS: Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0-79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0-63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0-25.2) with a median proximal neck length of 24.4 mm (IQR 15.0-34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0-35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1-19.4) and 16.2 mm (IQR 14.1-19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1).CONCLUSIONS: Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.

BACKGROUND: The hybrid room (HR) is a complex, high-risk environment, requiring teams (surgeons, anesthesiologists, nurses, technolo-gists) to master various skills, including the 'As Low As Reasonably Achievable' principle of radiation safety. This prospective single center cohort reports the first use of the Operating Room Black Box (ORBB) in a HR. This medical data recording system captures procedural and audio-visual data to facilitate structured team performance analysis.METHODS: Patients planned for endovascular repair of an infrarenal abdominal aortic aneurysm (EVAR) or treatment of symptomatic iliac-femoral-popliteal atherosclerotic disease (Peripheral Vascular Interventions or PVI) were included. Validated measures and established assess-ment tools were used to assess (non-)technical skills, radiation safety performance and environmental distractions. RESULTS: Six EVAR and sixteen PVI procedures were captured. Technical performance for one EVAR was rated 19/35 on the procedure -specific scale, below the 'acceptable' score of 21. Technical skills were rated above acceptable in all PVI procedures. Shared decision making and leadership were rated highly in 12/22 cases, whereas surgical communication and nurses' task management were rated low in 14/22 cases. Team members rarely stepped back from the C-arm during digital subtraction angiography. Radiation safety behavior was scored below 'accept-able' in 14/22 cases. A median (interquartile range) number of 12 (6-23) auditory distractions was observed per procedure. CONCLUSIONS: The ORBB facilitates holistic workplace-based assessment of endovascular performance in a HR by combining objec-tive assessment parameters and rating scale-based evaluations. Strengths and weaknesses were identified in team members' (non-)technical and radiation safety practices. This technology has the potential to improve vascular surgical practice, though human input remains crucial. (NCT04854278)

The authors regret there was a mistake in Figure 6 and 13. In Figure 6, it should read ‘Compression’ for oedema, to include inelastic compression as well (green box); in Figure 13, the pressure at the ankle should read ‘≤ 40 mm Hg’, for small and recent onset ulcer (yellow box):[Formula presented][Formula presented] The authors would like to apologise for any inconvenience caused. publishersversion published

IntroductionDue to the increased prevalence of chronic conditions, multimorbidity and an increased complexity of care, the burden on healthcare teams is high resulting in unmet needs of patients and their family and a high workload on healthcare professionals. To respond to these challenges, care models integrating nurse practitioners were introduced. Despite the proven benefits, implementation in Belgium is at an early stage. The aim of this study is to develop, implement and evaluate nurse practitioner roles in a Belgian university hospital. Insights into development and implementation processes can inform healthcare managers and policymakers for future (nationwide) implementation.Methods and analysisFor the development, implementation and (process-)evaluation of nurse practitioner roles in three departments in a Belgian university hospital, a participatory action research approach involving interdisciplinary teams of healthcare professionals, healthcare managers and researchers will be used. To investigate the effectiveness at patient (eg, quality of care), healthcare providers (eg, team effectiveness) and organisational level (eg, utility) a longitudinal (matched controlled) pre–post mixed methods study will be set up. Quantitative data (surveys, data from electronic patient files, administrative files) will be analysed using SPSS V.28.0. Qualitative data will be collected throughout the whole process and will consist of the meetings, (focus group) interviews and field notes. All qualitative data will be analysed thematically both across-case and within-case. This study is designed and will be reported based on the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement.Ethics and disseminationEthical approval for all parts of this study was obtained from the Ethics Committee of the participating university hospital (February–August 2021). All participants throughout the study parts will receive written and verbal information and will be asked written consent. All data will be stored on a secured server. Only the primary researchers will have access to the data set.Trial registration numberNCT05520203.

Objective According to the angiosome concept ulcer healing and limb salvage should be superior if direct arterial flow to the source vessel of an affected angiosome is established compared to indirect flow where the angiosome is perfused by means of collaterals. The objective of this study was to evaluate the impact of direct versus indirect revascularization (DR/IR) in endovascular versus bypass surgery on ulcer healing, limb salvage and mortality. Materials and methods A retrospective analysis of both endovascular and bypass distal (below the knee) lower limb revascularizations for chronic limb-threatening ischemia (CLTI) between 1993 and 2014 was performed. Results The study population consisted of 126 endovascular and 198 bypass procedures. DR and IR were achieved in 57.4% and 42.6% limbs respectively. DR was not superior to IR regarding all three major endpoints when endovascular and bypass procedures were analyzed separately. Endovascular and bypass procedures resulted in comparable healing rates. All patients who did not achieve wound healing (HR 7.49; 95% CI 4.25-13.20, p = .0001) or needed to be treated with a bypass (HR 1.79; 95% CI 1.05-3.05, p = .034) were at an increased risk for major amputation. Increased mortality rate was noted after endovascular procedures (HR 1.45; 95% CI 1.04-2.00, p = .026). Conclusion This retrospective study with comparable results for DR and IR did not support the angiosome concept. Achieving wound healing remains critical in patients with CLTI to reduce major amputation rates. Overall the implications of the angiosome concept seem to be limited due to its feasibility in patients with CLTI.

Introduction: We present the results of the COVID-19 rule-out protocol at Ghent University Hospital, a step-wise testing approach which included repeat NFS SARS-CoV-2 rRT-PCR, respiratory multiplex RT-PCR, low-dose chest CT and bronchoscopy with BAL to confirm or rule-out SARS-CoV-2 infection in patients admitted with symptoms suggestive of COVID-19. Results: Between 19 March 2020 and 30 April 2020, 455 non-critically ill patients with symptoms suspect for COVID-19 were admitted. The initial NFS for SARS-CoV-2 rRT-PCR yielded 66.9%, the second NFS 25.4% and bronchoscopy with BAL 5.9% of total COVID-19 diagnoses. In the BAL fluid, other respiratory pathogens were detected in 65% (13/20) of the COVID-19 negative patients and only in 1/7 COVID-19 positive patients. Retrospective antibody testing at the time around BAL sampling showed a positive IgA or IgG in 42.9 % of the COVID-19 positive and 10.5% of the COVID-19 negative group. Follow-up serology showed 100% COVID-19 positivity in the COVID-19 positive group and 100% IgG negativity in the COVID-19 negative group. Conclusion: In our experience, bronchoscopy with BAL can have an added value to rule-in or rule-out COVID-19 in patients with clinical and radiographical high-likelihood of COVID-19 and repeated negative NFS testing. Furthermore, culture and respiratory multiplex PCR on BAL fluid can aid to identify alternative microbial etiological agents in this group. Retrospective analysis of antibody development in this selected group of patients suggests that the implementation of serological assays in the routine testing protocol will decrease the need for invasive procedures like bronchoscopy.

European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis

During the postoperative stay in the intensive care unit after kidney transplantation, the renal resistive index (RI) is routinely measured. An increased RI, measured months posttransplant, is associated with a higher mortality. We wanted to investigate the value of the RI immediately posttransplant in predicting both short- and long-term outcome.We performed a retrospective single-center study. The RI was collected48 h posttransplant in patients undergoing kidney transplantations between 2005 and 2014. Short-term outcome was evaluated by delayed graft function (DGF). The long-term endpoints were kidney function and mortality at 30 days, 1 year and 5 years.We included 478 recipients, 91.4% of whom reached the end of the 5-year follow-up. A higher RI48 h posttransplant was significantly associated with DGF. This association was particularly strong in patients receiving grafts from donors after brain death and expanded criteria donors. A higher RI also correlated with mortality and death with functioning graft but not with graft failure. After adjustment for confounders, we found an association between increased RI and DGF, but not with long-term kidney function or mortality.The RI routinely measured48 h posttransplant is an independent predictor of short-term kidney function.

Endovascular aortic aneurysm repair (EVAR) has become the most popular technique to treat infrarenal abdominal aortic aneurysms. In aneurysms with unsuitable anatomy open surgical repair remains the golden standard but fenestrated EVAR (FEVAR) or branched EVAR (BEVAR) may be an alternative to treat juxtarenal or thoracoabdominal aneurysms. The aim of this study was to report our results and to evaluate its safety and feasibility.This is a single center cohort study analyzing all consecutive patients undergoing FEVAR or BEVAR.One hundred patients underwent a procedure between June 2012 and December 2019. Forty-seven percent had a history of coronary artery disease and 31% of previous aortic repair. Sixty percent were treated for a juxtarenal and 40% for a TAAA. Primary technical success was 87%. Overall, thirty-day mortality was 6%, with 50% of the deaths resulting from a myocardial infarction. Four percent had a bowel resection for ischemia, 3% developed a stroke and 3% spinal cord ischemia. Mean follow-up was 33.6±22.4 months, freedom from all-cause mortality was 89.3±3.2% at one year and 66.4±7.6% at five years. Six intraoperative target vessel events were noted (1.7%), six early postoperative (1.7%) and three late (0.8%). A total of ten (10%) late procedure related secondary interventions were performed, among which six for endoleak.This study confirms that fenestrated and branched endovascular repair is a safe and feasible treatment for juxtarenal and thoracoabdominal aortic aneurysms with acceptable complication rates. The perioperative cardiac mortality highlights the importance of preoperative risk assessment and patient selection.

Purpose In laparoscopy, the Operating Room Black Box® (ORBB) provides insights into operative performance to improve patient safety. This technology may also enhance endovascular surgical practice; however, the use of a C-arm and X-rays pose important challenges, hindering transferability to an endovascular context. We describe the first implementation of ORBB technology in a hybrid angiosuite and illustrate its value in evaluating surgeons’ radiation safety, technical and non-technical performance. Methods Team members (surgeons, nurses, anaesthesiologists) and stakeholders were informed during several information sessions. Together with teams from Surgical Safety Technologies (Toronto, Canada), an implementation plan was developed, and video-evaluation frameworks were chosen. Radiation safety was assessed using dose measurements and video-evaluation of safety-related behaviours. Technical performance was assessed using ‘global’ (GRS) and ‘procedure-specific’ (PRS) rating scales and the ‘EndoVascular Aortic Repair Assessment of Technical Expertise’ (EVARATE) framework. Surgeons’ non-technical skills were assessed with the NOTSS framework. Results The system captures Audio-visual data from four ceiling-mounted cameras, three ceiling-array microphones, the fluoroscopy screen and anaesthesia monitor. After patient and team consent, an elective endovascular aneurysm repair was successfully analysed. Dose-Area-Product and Air Kerma were 71094 mGy.cm2 and 270 mGy, respectively. Behavioural analysis revealed deficiencies in stepping back and radiation safety communication. Technical skill assessment was feasible: GRS: 29/40; ‘PRS’: 27/35; EVARATE: 29/35. Non-technical analysis highlighted surgeons’ leadership qualities. Conclusion An innovative data capture platform has been successfully installed to evaluate overall performance during endovascular procedures. This technology may facilitate identification of (radiation) safety-related errors and instigate educational interventions based on real-world issues.

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p

Background: Good radiation safety practice in the angiosuite is essential to protect patients and healthcare workers. Most strategies aim to advance radiation safety through technological upgrades and educational initiatives. However, safety literature suggests that additional ways to improve radiation safety in the angiosuite do exist. The safety climate reflects the way team members perceive various key characteristics of their work environment and is closely related to relevant safety outcomes. A specific ‘radiation safety climate’ has not been described nor studied in the hybrid angiosuite. This study explores the radiation safety climate in the hybrid angiosuite and its relation to team members' radiation safety behavior, knowledge and motivation. Materials and Methods: Vascular surgeons, fellows/trainees and operating room nurses active in the angiosuite at five hospitals were invited to complete an online self-report questionnaire assessing the radiation safety climate (28 items); radiation safety behavior; radiation safety knowledge and radiation safety motivation. Relations between climate scores and behavior were investigated using Pearson correlations. Mediation was analyzed using the Baron and Kenny analysis. P-Values < 0.05 were considered statistically significant. Results: No major differences were identified in total radiation safety climate scores between centers or team member functions. Scale reliability for radiation safety climate was good to excellent (α > 0.663). Total radiation safety climate scores were positively related to the radiation safety behavior score (r=0.403; p=0.015). This relation was partially mediated by radiation safety knowledge (β=0.1730; 95% CI: [0.0475; 0.3512]), while radiation safety motivation did not act as a mediator: (β=0.010; 95% CI: [-0.0561; 0.0998]). Conclusion: A well-developed radiation safety climate in the hybrid angiosuite fosters positive radiation safety behaviors, which may partially be explained through improved radiation safety knowledge transfer. Further research on (radiation) safety climate and its impact on radiation safety-related outcome measures for patients is recommended.

OBJECTIVES The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial. BACKGROUND Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population. METHODS IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile. RESULTS Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile. CONCLUSIONS Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion (R) Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733) (C) 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

Corrigendum: Volume 64, Issues 2–3, 2022, 284-285

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Background This monocentric study aimed to explore whether key non-technical attributes can be reliably measured in a mixed population of candidates applying for surgical training, surgical trainees and staff and to identify any differences between these groups. Materials & methods Candidates applying for surgical training, surgical trainees and staff from four surgical specialties (general surgery, orthopedics, plastic surgery or urology) at a tertiary academic teaching hospital were all sent an online self-report questionnaire. The Communication Styles Inventory (CSI, 96 items) was used to assess a six-dimensional behavioral model of participant communication styles (expressiveness, preciseness, verbal aggressiveness, questioningness, emotionality and impression manipulativeness). Attitudes toward uncertainty and risks were assessed with the Physicians’ Reaction toward Uncertainty (PRU, 15 items) and Physician Risk Attitudes (PRA, 6 items) scales respectively. Data was encoded and analyzed using parametric testing. Results The questionnaire was completed by 177 participants (110 candidates; 42 trainees; 25 staff). All scales had very good internal consistency (Cronbach's alpha >0.80). After controlling for gender-based differences, surgical candidates scored significantly higher on ‘expressiveness’ (P = 0.012) and were significantly less risk-averse (P = 0.006) than trainees and staff. Surgical trainees scored lowest on the CSI ‘questioningness’ subscale (P = 0.019) and had significantly more difficulties dealing with uncertainty, characterized by their highest scores on the ‘concern about bad outcome’ (P = 0.021) and reluctance to disclose uncertainty to patients' (P = 0.05) subscales. Multiple subscales revealed gender-based differences in candidate and trainee groups, which were not noted for surgical staff. Conclusions Meaningful differences in non-technical attributes of surgical staff, trainees and candidates have been identified, which may be explained by differences in clinical experience and learning and may suggest that these develop over time. Further research on assessment of non-technical attributes during surgical selections and the role of both technical and non-technical attributes in surgery at large is needed.

Interpreting evidence in the arteriovenous (AV) access literature is challenged by the heterogeneity in terminology and the lack of standardization in outcomes. Below some of the terms used in this guideline are listed and how they have been interpreted in the context of this document. Because guideline development necessarily relies on aggregate data from systematic reviews and other individual studies, we can only hope to provide the user with conceptual definitions for certain concepts and outcome domains. At present, there is insufficient consensus to go beyond that point and define specific outcome measures or measurements. [...]

Background The renal resistive index (RI) is routinely used for the clinical monitoring of renal transplant patients in the early postoperative period. It is a noninvasive method that allows us to detect microvascular changes in intrarenal blood flow. The aim of this study was to determine whether the RI measured in the immediate post-transplant phase during intensive care unit admission can be used to predict delayed graft function (DGF). Patients and Methods We performed a retrospective study in 1 tertiary care academic center. We measured the RI by Doppler ultrasonography within the first 2 days after kidney transplant. We included 446 transplant recipients who were transplanted between 2005 and 2014. Short-term outcome was studied by the 22 DGF definitions. Results Of the 446 kidney transplant recipients, 279 (62.6%) were men, with a median age of 55 years (interquartile range, 46-63 years). Median RI was 0.62 (interquartile range, 0.55-0.70). Depending on the definition used, DGF was present in 4.4% to 54.0% of recipients. We found that RI was associated with DGF; most of the available DGF definitions were associated with a significantly higher RI. Conclusions DGF was associated with an increased RI already within the first 2 days after kidney transplant.

BackgroundEarly 2020, a COVID-19 epidemic became a public health emergency of international concern. To address this pandemic broad testing with an easy, comfortable and reliable testing method is of utmost concern. The nasopharyngeal (NP) swab sampling is the reference method though hampered by international supply shortages. A new oropharyngeal/nasal (OP/N) sampling method was investigated using the more readily available throat swab.MethodsIn this prospective observational study 36 COVID-19 patients were tested with both a NP and combined OP/N swab for SARS-CoV-2 RNA by PCR. In hospitalized suspect patients, who tested negative on both swabs, extensive retesting was performed. The sensitivity of NP versus combined OP/N swab sampling on admission and the correlation between viral RNA loads recovered was investigated.Results35 patients were diagnosed with SARS-CoV-2 by means of either NP or OP/N sampling. The paired swabs were both positive in 31 patients. The one patient who tested negative on both NP and OP/N swab on admission, was ultimately diagnosed on bronchoalveolar lavage fluid. A strong correlation was found between the viral RNA loads of the paired swabs (r = 0.76; P < 0.05). The sensitivity of NP and OP/N analysis in hospitalized patients (n = 28) was 89.3% and 92.7% respectively.ConclusionsThis study demonstrates equivalence of NP and OP/N sampling for detection of SARS-CoV-2 by means of rRT-PCR. Sensitivity of both NP and OP/N sampling is very high in hospitalized patients.

BACKGROUND: The aim of the present study is to develop relevant quality indicators (QI) to monitor and improve quality of care in vascular surgery. METHODS: The Delphi method was used to incorporate expert opinion to reach consensus on a set of QI. A national expert panel consisting of 52 vascular surgeons was installed on a voluntary basis and endorsed by the Belgian Society of Vascular Surgery and the Flemish Hospital Network KU Leuven. A task force team consisting of 12 surgeons was created to serve as a delegation of the expert panel to discuss and filter the obtained data from the different Delphi rounds. RESULTS: A total of 3 Delphi rounds were needed to reach consensus on a set of 20 QI. Each QI had a content validity index (using a 7-point Likert scale), a feasibility index, and a target level. Twelve outcome indicators and 8 process indicators on several vascular topics were selected: overall for all vascular treatments (n = 1), arterial occlusive disease in general (n = 3), arterial occlusive disease of the lower limbs (n = 4), arterial occlusive disease of the carotid arteries (n = 5), arterial aneurysm disease in general (n = 2), arterial aneurysm disease with endovascular treatment (n = 1), and venous disease (n = 4). CONCLUSIONS: This resulted in the successful identification of 20 validated and relevant vascular QI, focusing on arterial occlusive disease, arterial aneurysm disease, and venous disease. The next step in this project will be the performance of an implementation study. ispartof: ANNALS OF VASCULAR SURGERY vol:71 pages:237-248 ispartof: location:Netherlands status: published

Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia

Summary Background The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. Methods In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of −10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov , number NCT02574481 . Findings Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI −0·66]; p Interpretation The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. Funding Boston Scientific.

Objectives: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limitin...

Background Kidney autotransplantation (KAT) is the ultimate way to salvage kidneys with complex renovascular, ureteral, or malignant pathologies that are not amenable to in situ reconstruction. A minimally invasive approach could broaden its adoption. Objective To describe operative technique, perioperative complications, and early functional outcomes of robot-assisted kidney autotransplantation (RAKAT). Design, setting, and participants Retrospective review of prospectively collected data regarding consecutive patients undergoing RAKAT between March 2017 and February 2018 at two university hospitals. Intervention RAKAT. Outcome measurements and statistical analysis Technical feasibility, perioperative complications, and early functional results. Results and limitations Seven patients underwent RAKAT (three male and four female; five left and two right; one totally intracorporeal) for complex ureteral strictures (n = 5), severe left renal vein nutcracker (n = 1), and loin pain hematuria syndrome (n = 1). Two patients underwent bench vascular reconstruction and one patient underwent ex vivo flexible ureterorenoscopy. No patient needed open conversion. Median operative and console time was 370 and 255 min, respectively, with median vascular and ureteral anastomosis time of 28 and 23 min, respectively. Median warm, cold, and rewarming ischemia time was 2, 178, and 44 min, respectively. One major postoperative complication occurred—wound dehiscence needing wound revision (grade 3b). Median hospital stay was 5 d. At 3 mo, all patients were free of indwelling stents, pain, or hematuria. Median serum creatinine at 3 mo was 0.80 mg/dl and median calculated autotransplant glomerular filtration rate did not drop significantly. Conclusions RAKAT is feasible, safe, and results in good functioning of the autotransplant in selected patients with complex ureteral strictures, loin pain hematuria, or severe nutcracker syndrome. Larger studies with longer follow-up are needed to confirm these findings and to test whether RAKAT is feasible for other KAT indications. Patient summary We describe the first series worldwide of a minimally invasive technique for kidney autotransplantation. Robot-assisted kidney autotransplantation is a safe and feasible approach to prevent nephrectomy for intractable symptoms in selected patients with complex ureteral or renal pathology.

Objectives: Radiation protection training courses currently focus on broad knowledge topics which may not always be relevant in daily practice. The goal of this study was to determine the key competencies in radiation protection that every endovascular team member should possess and apply routinely, through multispecialty clinical content expert consensus.Methods: Consensus was obtained through a two round modified Delphi methodology. The expert panel consisted of European vascular surgeons, interventional radiologists, and interventional cardiologists/angiologists experienced in endovascular procedures. An initial list of statements, covering knowledge skills, technical skills and attitudes was created, based on a literature search. Additional statements could be suggested by the experts in the first Delphi round. Each of the statements had to be rated on a 5-point Likert scale. A statement was considered to be a key competency when the internal consistency was greater than alpha = 0.80 and at least 80% of the experts agreed (rating 4/5) or strongly agreed (rating 5/5) with the statement. Questionnaires were emailed to panel members using the Surveymonkey service.Results: Forty-one of 65 (63.1%) invited experts agreed to participate in the study. The response rates were 36 out of 41 (87.8%): overall 38 out of 41(92.6%) in the first round and 36 out of 38 (94.7%) in the second round. The 71 primary statements were supplemented with nine items suggested by the panel. The results showed excellent consensus among responders (Cronbach's alpha = 0.937 first round; 0.958 s round). Experts achieved a consensus that 30 of 33 knowledge skills (90.9%), 23 of 27 technical skills (82.1%), and 15 of 20 attitudes (75.0%) should be considered as key competencies.Conclusions: A multispecialty European endovascular expert panel reached consensus about the key competencies in radiation protection. These results may serve to create practical and relevant radiation protection training courses in the future, enhancing radiation safety for both patients and the entire endovascular team. (C) 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Abstract. Background: Fibromuscular dysplasia (FMD) is an idiopathic, non-inflammatory, non-atherosclerotic vascular disease, resulting in focal narrowing of small and medium-sized arteries. Systematic recording of clinical data in central databases as in the US and France provided new insights into FMD. The main objectives of this multicentre study were to explore the epidemiology, pattern of vascular involvement, clinical manifestations, and management of FMD patients in Flanders. Patients and methods: Multicentre, retrospective registry of patients diagnosed with FMD based on medical imaging. Results: Hundred-twenty-three FMD patients (83.7 % female) were included. Mean age at FMD diagnosis was 57.3 years (SD 15.8). More than half of patients (59.5 %) were hypertensive at the time of diagnosis. Neurological complaints such as headache (26.4 %) and dizziness (23.1 %) were also frequently reported. FMD was discovered incidentally in 10 patients (8.3 %). Nearly one quarter (22.8 %) of patients experienced a cerebrovascular event. Aneurysms were found in one-fifth (20.3 %) of patients and 11.4 % had an arterial dissection. FMD affected most frequently the renal (85.3 %), carotid (74.7 %), and vertebral (39.8 %) arteries. Renovascular FMD was more prevalent in men, whereas cerebrovascular FMD was more frequent in women. Multiple affected sites were documented in 25 of 61 (41.0 %) patients, having two or more vascular beds imaged. Digital subtraction angiography was most frequently used for detecting FMD. One third (32.9 %) of patients received an interventional treatment, mainly patients with renovascular FMD (32.8 % underwent percutaneous transluminal angioplasty) and patients with an intracranial carotid aneurysm (36.4 % were treated by means of coiling). Conclusions: Although differences existed, results of the Flemish registry were broadly in line with the US and French registries. Patient databases help to learn more about the natural history, progression, and management of FMD, based on real life clinical evidence.

Objective Bioresorbable stents are an emerging technology in the endovascular treatment of femoropopliteal lesions. They address the issue of leaving permanent stents in the treated arterial segment that are only temporarily needed to treat dissection or recoil. The REMEDY stent (Kyoto Medical Planning Co, Kyoto, Japan) was the first commercially available biodegradable scaffold for peripheral use. We evaluated its performance and safety in the treatment of short femoropopliteal stenosis or occlusion. Methods A prospective, multicenter, observational registry was set up of patients in Rutherford-Becker categories 2 to 5 with femoropopliteal lesions that could be treated with one REMEDY stent. Clinical examination and duplex ultrasound imaging were performed at 1, 6, and 12 months. The primary end point was absence of clinically driven target lesion revascularization at 12 months. Secondary end points were technical and clinical success, primary and secondary patency rate, clinically driven target vessel revascularization, major complications, and Rutherford-Becker classification at 6 and 12 months. Results The registry enrolled 99 patients between January 2011 and July 2013 in 12 centers in Belgium. Most lesions were determined as TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A (n = 80) and located in the superficial femoral artery (n = 91). There were 19 total occlusions (mean length, 41.3 mm) and 80 stenoses (mean length, 37.5 mm). Technical success was achieved in 96 patients, and clinical success was obtained in 95. Target lesion revascularization, which equalled target vessel revascularization, was 19% at 6 months and rose to 33% at 12 months. Primary patency was 68% at 6 months and 58% at 12 months. Secondary patency was 85% at 6 months and 86% at 12 months. After 12 months, two patients had undergone an amputation. Conclusions The 1-year follow-up results of the REMEDY stent do not meet current standards set by nitinol stents. Given the significant issues concerning bioresorbable stents in femoropopliteal arteries, their use outside clinical trials should be withheld until improvements are made and better data are available.

Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.