Certification of Basic Skills in Endovascular Aortic Repair Through a Modular Simulation Course With Real Time Performance Assessment.

OBJECTIVE: Endovascular aortic repair (EVAR) is being used increasingly for the treatment of infrarenal abdominal aortic aneurysms. Improvement in educational strategies is required to teach future vascular surgeons EVAR skills, but a comprehensive, pre-defined e-learning and simulation curriculum remains to be developed and tested. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), an assessment tool for simulation based education (SBE) in EVAR, has previously been designed to assess EVAR skills, and a pass limit defining mastery level has been set. However, EVARATE was developed for anonymous video ratings in a research setting, and its feasibility for real time ratings in a standardised SBE programme in EVAR is unproven. This study aimed to test the effect of a newly developed simulation based modular course in EVAR. In addition, the applicability of EVARATE for real time performance assessments was investigated. METHODS: The European Society of Vascular Surgery (ESVS) and Copenhagen Certification Programme in EVAR (ENHANCE-EVAR) was tested in a prospective cohort study. ENHANCE-EVAR is a modular SBE programme in EVAR consisting of e-learning and hands-on SBE. Participants were rated with the EVARATE tool by experienced EVAR surgeons. RESULTS: Twenty-four physicians completed the study. The mean improvement in EVARATE score during the course was +11.8 (95% confidence interval 9.8 - 13.7) points (p < .001). Twenty-two participants (92%) passed with a mean number of 2.8 ± 0.7 test attempts to reach the pass limit. Cronbach's alpha coefficient was 0.91, corresponding to excellent reliability of the EVARATE scale. Differences between instructors' EVARATE ratings were insignificant (p = .16), with a maximum variation between instructors of ± 1.3 points. CONCLUSION: ENHANCE-EVAR, a comprehensive certifying EVAR course, was proven to be effective. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE) is a trustworthy tool for assessing performance within an authentic educational setting, enabling real time feedback.

Continuous Glucose Monitoring Reveals Perioperative Hypoglycemia in Most Patients With Diabetes Undergoing Major Surgery: A Prospective Cohort Study.

OBJECTIVE: To investigate the frequency and duration of hypo- and hyperglycemia, assessed by continuous glucose monitoring (CGM) during and after major surgery, in departments with implemented diabetes care protocols. SUMMARY BACKGROUND DATA: Inadequate glycemic control in the perioperative period is associated with serious adverse events, but monitoring currently relies on point blood glucose measurements, which may underreport glucose excursions. METHODS: Adult patients without (A) or with diabetes [non-insulin-treated type 2 (B), insulin-treated type 2 (C) or type 1 (D)] undergoing major surgery were monitored using CGM (Dexcom G6), with an electrochemical sensor in the interstitial fluid, during surgery and for up to 10 days postoperatively. Patients and health care staff were blinded to CGM values, and glucose management adhered to the standard diabetes care protocol. Thirty-day postoperative serious adverse events were recorded. The primary outcome was duration of hypoglycemia (glucose <70 mg/dL). Clinicaltrials.gov: NCT04473001. RESULTS: Seventy patients were included, with a median observation time of 4.0 days. CGM was recorded in median 96% of the observation time. The median daily duration of hypoglycemia was 2.5 minutes without significant difference between the 4 groups (A-D). Hypoglycemic events lasting ≥15 minutes occurred in 43% of all patients and 70% of patients with type 1 diabetes. Patients with type 1 diabetes spent a median of 40% of the monitoring time in the normoglycemic range 70 to 180 mg/dL and 27% in the hyperglycemic range >250 mg/dL. Duration of preceding hypo- and hyperglycemia tended to be longer in patients with serious adverse events, compared with patients without events, but these were exploratory analyses. CONCLUSIONS: Significant duration of both hypo- and hyperglycemia was detected in high proportions of patients, particularly in patients with diabetes, despite protocolized perioperative diabetes management.

Limb graft occlusion after endovascular aneurysm repair with the Cook Zenith Alpha abdominal graft.

OBJECTIVE: Prior reports of the low profile Zenith Alpha abdominal graft (Cook Medical Inc, Bloomington, IN) have shown impaired limb graft patency to be the primary causes of reintervention. Special notices from the manufacturer have indicated certain instructions for use (IFU) violations as the main reasons for these complications. In the present study, we assessed the incidence of limb graft occlusion (LGO) and analyzed the effects of the detailed anatomic risk factors for LGO highlighted in the IFU and previously reported studies. METHODS: A retrospective study was performed of 241 patients treated with the low profile Zenith Alpha at a single institution from October 1, 2015 to September 30, 2018. All computed tomography angiograms were analyzed using three-dimensional software. Data were extracted from the electronic medical records until the end of the study period (December 31, 2020). The cumulative incidence of LGO and LGO-related reinterventions were assessed. A regression analysis was performed to evaluate the possible risk factors associated with the development of LGO at specified time points. These included aortic and iliac diameters, graft component oversizing, iliac tortuosity and calcification, overlap of graft components, proximal alignment of ipsilateral and contralateral legs, and sealing zone in the external iliac artery. Reader agreement of iliac calcification and tortuosity was assessed in patients with LGO. RESULTS: A total of 33 limbs (7%) in 27 patients (11%) had become occluded. The cumulative incidence of LGO was 7% (95% confidence interval [CI], 5%-9%) per limb up to 3 years postoperatively. The previously described risk factors for LGO were studied using regression analysis; however, no positive association with LGO was identified. Heavily calcified common iliac arteries (CIAs) and external iliac arteries were protective against LGO compared with noncalcified vessels up to 3 years postoperatively (decreased risk, 17% [95% CI, -27% to -7%]; P = .001; and 15% [95% CI, -26 to -5]; P = .005, respectively). The reader agreement of iliac calcification and tortuosity showed substantial agreement (CIA intrareader kappa = 0.75; CIA interreader kappa = 0.62) and almost perfect agreement (intrareader kappa = 0.85; interreader kappa = 0.84), respectively. CONCLUSIONS: The cumulative incidence of LGO after endovascular aneurysm repair with the Zenith Alpha graft was 7% per limb up to 3 years postoperatively. None of the analyzed risk factors suggested by the IFUs or current literature were positively associated with LGO.

Anticoagulants and reduced thrombus load in abdominal aortic aneurysms assessed with three-dimensional contrast-enhanced ultrasound examination.

OBJECTIVE: The relationship between intraluminal thrombus (ILT) and abdominal aortic aneurysm (AAA) growth and rupture risk remains ambiguous. Studies have shown a limited effect of antiplatelet therapy on ILT size, whereas the impact of anticoagulant therapy on ILT is unresolved. This study aims to evaluate an association between antithrombotic therapy and ILT size assessed with three-dimensional contrast-enhanced ultrasound (3D-CEUS) examination in a cohort of patients with AAA. METHODS: In a cross-sectional study, 309 patients with small AAAs were examined with 3D-CEUS. Patients were divided into three groups based on prescribed antithrombotic therapy: anticoagulant (n = 36), antiplatelet (n = 222), and no antithrombotic therapy (n = 51). Patient ILT size was calculated in volume and thickness and compared between the three groups. RESULTS: Patients on anticoagulants had a significantly lower estimated marginal mean ILT volume of 16 mL (standard error [SE], ±3.2) compared with 28 mL (SE, ±2.7) in the no antithrombotic group and 30 mL (SE, ±1.3) in the antiplatelet group when adjusting for AAA volume (P < .001) and comorbidities (P < .001). In addition, patients on anticoagulant therapy had significantly lower estimated marginal mean ILT thickness of 10 mm (SE, ±1.1) compared with 13 mm (SE, ±0.9) in the no antithrombotic group of and 13mm (SE, ±0.4) in the antiplatelet group when adjusting for AAA diameter (P = .03) and comorbidities (P = .035). CONCLUSIONS: A 3D-CEUS examination is applicable for ILT assessment and demonstrates that patients with AAA on anticoagulant therapy have lower ILT thickness and volume than patients with AAA on antiplatelet therapy and those without antithrombotic therapy. Causality between anticoagulants and ILT size, and extrapolation to AAA growth and rupture risk, is unknown and merits further investigations, to further nuance US-based AAA surveillance strategy.

Massed Training is Logistically Superior to Distributed Training in Acquiring Basic Endovascular Skills.

OBJECTIVE: A "PROficiency based StePwise Endovascular Curricular Training" (PROSPECT) has proven its superiority over traditional training in a randomised controlled trial to acquire basic endovascular skills outside theatre, but real life adherence is low. This study aimed to compare the original distributed training format, where trainees learn at their own pace, with a massed training format offering the same content within a limited time span while exempt from clinical duties. Secondly, long term skills retention was evaluated. METHODS: A multicentre, prospective study allocated participants to the distributed D-PROSPECT or to a massed, compact version (C-PROSPECT) based on logistics such as travel time, participant and instructor availability. A multiple choice question (MCQ) test (max. score 20) tested cognitive skills. Technical skills were assessed using a global rating scale (GRS) (max. score 55), examiner's checklist (max. score 85), and validated simulator metrics. Data were collected pre- and post-programme and at three, six, and 12 months after programme completion. RESULTS: Over four years and in two countries, D-PROSPECT was implemented in two centres and C-PROSPECT in three. A total of 22 participants completed D-PROSPECT with a 41% dropout rate, and 21 completed C-PROSPECT with 0% dropout rate. All participants showed significant improvement for all performance parameters after programme completion: MCQ test (median 14.5 vs. 18; p < .001), GRS (median 20 vs. 41; p < .001), examiner's checklist (median 49 vs. 78.5; p < .001), and simulation metrics (p < .001). Scores of C- or D-PROSPECT participants were not significantly different. No significant differences were seen between groups during the retention period. CONCLUSION: PROSPECT significantly improves the quality of simulated endovascular performances using a massed or distributed training format. A massed training format of PROSPECT may be preferred to decrease dropout during standardised training to obtain basic endovascular skills in existing surgical curricula.

Facilitators and Barriers to Implementation of Simulation Based Education in Vascular Surgery in Europe.

OBJECTIVE: This study explored the status and availability of simulation based education (SBE) for learning vascular surgical procedures identified in the 2019 General Needs Assessment in vascular surgery in Europe (GNA-2019) and identified facilitators and barriers to SBE implementation in vascular surgery. METHODS: A three round iterative survey was distributed via the European Society for Vascular Surgery and the Union Européenne des Médecins Spécialistes. Members from leading committees and organisations within the European vascular surgical community were invited to participate as key opinion leaders (KOLs). Three online survey rounds explored demographics, SBE availability, and facilitators and barriers to SBE implementation. RESULTS: Overall, 147 KOLs (target population 338) accepted invitation to round 1, representing 30 European countries. The dropout rates for rounds 2 and 3 were 29% and 40%, respectively. Most respondents (88%) were senior, consultant level or higher. No mandatory SBE training was required in their department before training on patients, according to 84% of the KOLs. There was high consensus on the need for structured SBE (87%) and mandatory SBE (81%). SBE is available for the top three prioritised procedures in GNA-2019 (basic open skills, basic endovascular skills, and vascular imaging interpretation) in 24, 23, and 20 of the 30 represented European countries, respectively. The highest ranking facilitators were structured SBE programmes, availability of simulation equipment locally and regionally, good quality simulators, and having a dedicated person running the SBE. The highest ranked barriers were lack of structured SBE curriculum, equipment costs, lack of SBE culture, no or limited dedicated time for faculty to teach in SBE, and clinical work overload. CONCLUSION: Based largely on the opinions of KOLs in vascular surgery in Europe, this study revealed that SBE is needed in vascular surgery training and that systematic and structured programmes are required to ensure successful implementation.

Continuous wireless pre- and postoperative vital sign monitoring reveal new, severe desaturations after vascular surgery.

OBJECTIVES: Postoperative deviating physiologic values (vital signs) may represent postoperative stress or emerging complications. But they can also reflect chronic preoperative values. Distinguishing between the two circumstances may influence the utility of using vital signs in patient monitoring. Thus, we aimed to describe the occurrence of vital sign deviations before and after major vascular surgery, hypothesising that preoperative vital sign deviations were longer in duration postoperatively. METHODS: In this prospective observational study, arterial vascular patients were continuously monitored wirelessly - from the day before until 5 days after surgery. Recorded values were: heart rate, respiration rate, peripheral arterial oxygen saturation (SpO2 ) and blood pressure. The outcomes were 1. cumulative duration of SpO2 < 85% / 24 h, and 2. cumulative duration per 24 h of vital sign deviations. RESULTS: Forty patients were included with a median monitoring time of 21 h preoperatively and 42 h postoperatively. The median duration of SpO2 < 85% preoperatively was 14.4 min/24 h whereas it was 28.0 min/24 h during day 0 in the ward (p = .09), and 16.8 min/24 h on day 1 in the ward (p = 0.61). Cumulative duration of SpO2 < 80% was significantly longer on day 0 in the ward 2.4 min/24 h (IQR 0.0-4.6) versus 6.7 min/24 h (IQR 1.8-16.2) p = 0.01. CONCLUSION: Deviating physiology is common in patients before and after vascular surgery. A longer duration of severe desaturation was found on the first postoperative day in the ward compared to preoperatively, whereas moderate desaturations were reflected in postoperative desaturations. Cumulative duration outside thresholds is, in some cases, exacerbated after surgery.

A cross-sectional national study of burnout and psychosocial work environment in vascular surgery in Denmark.

OBJECTIVE: Little is known about burnout among European vascular surgeons (VSs). In this study, the prevalence of burnout and its associated risk factors were investigated among all VSs and vascular surgeons in training (VSTs) in Denmark. METHODS: An anonymous electronic survey was distributed to all clinical active VSs and VSTs on January 1, 2020. Validated assessment tools were used to measure burnout and aspects of the psychosocial work environment. RESULTS: A total of 104 VSs and VSTs were invited to participate, and 82% (n = 85) completed the survey. The majority of the respondents were male (60%; n = 50) and VSs (67%; n = 61). Of the respondents, 82% (n = 70) reported either light (54%; n = 46), moderate (22%; n = 19), or severe (6%; n = 5) personal burnout. More than 50% (n = 47) reported work-related burnout, light (39%; n = 33), moderate (9%; n = 8), and severe (7%; n = 6), respectively, whereas 35% (n = 30) reported patient-related burnout, light (31%; n = 26), moderate (2%; n = 2), and severe (2%; n = 2), respectively. Respondents with more than four 24-hour on-call shifts per month had significantly higher work-related burnout scores, whereas respondents with home-living children and those aged 45 to 59 years showed significantly higher personal and patient-related burnout, respectively. There were strong associations between personal and work-related burnout and the psychosocial work environment, especially work organization and interpersonal relations, but not job demands. The prevalence of burnout was unevenly distributed across departments, with the most affected department having a burnout occurrence twice the least affected department. CONCLUSIONS: Based on a national survey conducted among all clinical active VSs and VSTs in Denmark, more than 80% (n = 70) suffered from burnout, of whom 28% (n = 24) suffered from moderate to severe personal burnout. The strong association with the psychosocial work environment, and the significant differences between departments, suggest that burnout is modifiable through changes in the work environment.

Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft.

OBJECTIVE: Outcome reports after endovascular aneurysm repair (EVAR) using the low-profile Zenith Alpha Abdominal Endovascular grafts (Cook Medical, Bjæverskov, Denmark) are sparse. We present results from a single-center cohort treated with the Zenith Alpha, from a period where the graft was the primary EVAR device choice. The aim of the study was to evaluate short- and midterm outcomes of patients treated with the Zenith Alpha. METHODS: A retrospective single-center study was performed including all patients treated with the Zenith Alpha graft from October 1, 2015 to September 30, 2018. All patients underwent computed tomography angiography (CTA) imaging preoperatively as well as at 3 and 12 months postoperatively. Hereafter, patients were followed yearly with duplex ultrasound and clinical exams. Additional imaging was performed on indication. All CTAs were analyzed using three-dimensional reconstruction software (Aquarius, TeraRecon, Durham, NC). Data was extracted from electronic charts according to a protocol that remained unchanged until the end of the study (December 31, 2020). The following outcomes were assessed according to Society for Vascular Surgery/International Society of Cardiovascular Surgeons reporting criteria: aortic-related and all-cause mortality, reinterventions, instruction for use (IFU) violations, endoleaks (ELs), and aneurysm shrinkage. RESULTS: A total of 241 patients were treated with the Zenith Alpha, and 214 (89%) were asymptomatic repairs. Technical success was achieved in 238 patients (99%). One hundred fifty-seven patients (65%) received implantation outside IFU. The median hospital length of stay was 2 days (interquartile range, 2-3 days). The median clinical follow-up was 35.1 months (interquartile range, 28.8-47.5 months). The 4-year Kaplan-Meier estimate of freedom from reintervention was 66% (95% confidence interval, 59%-73%). The main reasons for reinterventions were iliac limb stenosis and occlusion (n = 30; 12%) and type 2 EL (n = 13; 5%). Overall, significantly more patients with grafts implanted outside distal IFU developed type 1B ELs (n = 10/11; P = .009). Aneurysm sac shrinkage was observed in 48 patients (25%) 1 year postoperatively. The Kaplan-Meier estimate of freedom from aortic-related mortality was 99% (95% confidence interval, 98%-100%) 4 years postoperatively. CONCLUSIONS: EVAR with the Zenith Alpha shows acceptable freedom from aortic-related mortality up to 4 years postoperatively. The majority of patients were treated outside IFU, and significantly more type 1B ELs appeared in this subgroup of patients. The leading cause for reintervention was impaired limb patency. The root cause for impaired limb patency requires further investigation.

Hyperoxia and Antioxidants for Myocardial Injury in Noncardiac Surgery: A 2 × 2 Factorial, Blinded, Randomized Clinical Trial.

BACKGROUND: Hyperoxia and oxidative stress may be associated with increased risk of myocardial injury. The authors hypothesized that a perioperative inspiratory oxygen fraction of 0.80 versus 0.30 would increase the degree of myocardial injury within the first 3 days of surgery, and that an antioxidant intervention would reduce degree of myocardial injury versus placebo. METHODS: A 2 × 2 factorial, randomized, blinded, multicenter trial enrolled patients older than 45 yr who had cardiovascular risk factors undergoing major noncardiac surgery. Factorial randomization allocated patients to one of two oxygen interventions from intubation and at 2 h after surgery, as well as antioxidant intervention or matching placebo. Antioxidants were 3 g IV vitamin C and 100 mg/kg N-acetylcysteine. The primary outcome was the degree of myocardial injury assessed by the area under the curve for high-sensitive troponin within the first 3 postoperative days. RESULTS: The authors randomized 600 participants from April 2018 to January 2020 and analyzed 576 patients for the primary outcome. Baseline and intraoperative characteristics did not differ between groups. The primary outcome was 35 ng · day/l (19 to 58) in the 80% oxygen group; 35 ng · day/l (17 to 56) in the 30% oxygen group; 35 ng · day/l (19 to 54) in the antioxidants group; and 33 ng · day/l (18 to 57) in the placebo group. The median difference between oxygen groups was 1.5 ng · day/l (95% CI, -2.5 to 5.3; P = 0.202) and -0.5 ng · day/l (95% CI, -4.5 to 3.0; P = 0.228) between antioxidant groups. Mortality at 30 days occurred in 9 of 576 patients (1.6%; odds ratio, 2.01 [95% CI, 0.50 to 8.1]; P = 0.329 for the 80% vs. 30% oxygen groups; and odds ratio, 0.79 [95% CI, 0.214 to 2.99]; P = 0.732 for the antioxidants vs. placebo groups). CONCLUSIONS: Perioperative interventions with high inspiratory oxygen fraction and antioxidants did not change the degree of myocardial injury within the first 3 days of surgery. This implies safety with 80% oxygen and no cardiovascular benefits of vitamin C and N-acetylcysteine in major noncardiac surgery.

Simulation-Based Education of Endovascular Scrub Nurses Reduces Stress and Improves Team Performance.

INTRODUCTION: Endovascular procedures have become commonplace in vascular surgery. This development calls for new training strategies for future specialists. Most simulation-based education (SBE) programs have a monodisciplinary focus on physicians, although successful surgery is a multidisciplinary team effort. Mental stress impairs the learning process and surgical performance and heart rate variability (HRV) can be measured as a proxy for both mental and physical stress. This study aims to assess how SBE of endovascular scrub nurses affects team performance and HRV during endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Prospective interventional study in which EVAR-inexperienced scrub nurses followed a focused SBE EVAR program. During real-life EVAR procedures, HRV was continuously recorded with a wireless electrocardiogram patch and multidisciplinary team performance was assessed with the Imperial College Error CAPture (ICECAP) tool, before and after the SBE program, allowing each scrub nurse to serve as their own control. Eight scrub nurses with experience in lower limb endovascular procedures, but not EVAR, were invited to participate. RESULTS: Seven participants completed the study. In five of seven scrub nurses, HRV-derived stress levels during real-time EVAR procedures were lower after SBE compared to before SBE. Mean HRV increased from 24 msec to 35 msec (P < 0.001), indicating stress level reduction. Before SBE, the mean number of errors/hour was 7.3 (standard deviation ± 1.8) compared to 3.6 (standard deviation ± 2.7) after SBE. Most errors were categorized as technical (58 %) and communicative (23 %). CONCLUSIONS: SBE of scrub nurses may improve team performance and may lower mental stress during EVAR procedures. In this small study, we suggest using mental stress, as evaluated with HRV, and multidisciplinary team performance, as evaluated with ICECAP, to assess SBE effectiveness in real-case EVAR procedures. This SBE program and live ICECAP observations and electrocardiogram patches was well-accepted by scrub nurses and the entire team.

Transcutaneous blood gas monitoring and tissue perfusion during common femoral thromboendarterectomy.

BACKGROUND: Improving tissue perfusion can improve clinical outcomes in surgical patients, where monitoring may aid clinicians in detecting adverse conditions and guide interventions. Transcutaneous monitoring (TCM) of oxygen (tcpO2) and carbon dioxide (tcpCO2) is a well-proven technology and could potentially serve as a measure of local circulation, perfusion and metabolism, but the clinical use is not thoroughly explored. The purpose of this proof-of-concept study was to investigate whether TCM of blood gasses could detect changes in perfusion during major vascular surgery. METHODS: Ten patients with peripheral arterial disease scheduled for lower limb major arterial revascularization under general anaesthesia were consecutively included. TcpO2 and tcpCO2 were continuously recorded from anaesthesia induction until skin closure with a TCM monitor placed on both legs and the thorax. Peripheral oxygen saturation was kept ≥94% and mean arterial blood pressure ≥65 mmHg. The primary outcomes were changes in tcpO2 and tcpCO2 related to arterial clamping and declamping during the procedure and analyzed by paired statistics. RESULTS: Femoral artery clamping resulted in a significant decrease in tcpO2 (-2.1 kPa, IQR-4.2; -0.8), p=.017)), followed by a significant increase in response to arterial declamping (5.5 kPa, IQR 0-7.3), p=.017)). Arterial clamping resulted in a statistically significant increase in tcpCO2 (0.9 kPa, IQR 0.3-5.4), p=.008)) and a significant decrease following declamping (-0.7 kPa, IQR -2.6; -0.2), p=.011)). CONCLUSION: Transcutaneous monitoring of oxygen and carbon dioxide is a feasible method for detection of extreme changes in tissue perfusion during arterial clamping and declamping, and its use for improving patient outcomes should be explored. Clinical Trials identifier: NCT04040478. Registered on July 31, 2019.

Cancer should not contravene the revascularization of chronic limb-threatening ischaemia.

OBJECTIVES: This study aimed to examine the frequency of cancer among patients with chronic limb-threatening ischaemia (CLTI) due to peripheral artery disease (PAD) and to determine how active cancer affected outcomes after open or endovascular revascularization. In addition, we aimed to investigate all-cause mortality and cause of death in the PAD population. DESIGN: Observational single-centre cohort study based on a retrospective analysis of prospectively entered registry data. MATERIALS: All consecutive patients treated for CLTI due to PAD at a single university centre between the 1st of January 2011 and the 31st of December 2015 were included. Data from the Danish Vascular Registry (Karbase) regarding demographics, surgical procedure, and complications were linked with data from the Danish Cancer Registry and Cause of Death Registry. METHODS: The primary endpoint was major amputation-free survival. Secondary endpoints were postoperative complications within 30 days, cancer-free survival, all-cause mortality and cause of death in the cohort. Major amputation-free survival, cancer-free survival and mortality were described with Kaplan-Meier (KM) survival estimates. RESULTS: We included 920 patients, of which 116 (13%) were in the active cancer group at the time of revascularization. There was no difference in amputation-free survival between those with cancer (86.8% 1-year KM estimate) and those without cancer (85.2% 1-year KM estimate) (p = 0.50). Likewise, we found no difference in 30-day postoperative complication rate. The risk of developing cancer in the included CLTI cohort was similar to the age-matched background population (6.1% vs 6.4%) (p = 0.69). All-cause mortality was higher in CLTI patients with cancer, mainly due to cancer, compared with CLTI patients without cancer who mainly died from cardiovascular disease. Three-year KM survival estimates were 48.3% (95% CI 40.0%-58.3%) and 64.4% (95% CI 61.2%-67.8%) (p = 0.014) for cancer and non-cancer patients, respectively. CONCLUSIONS: Although cancer in patients with CLTI is related to higher medium- to long-term mortality, active cancer per se should not contravene revascularization, as postoperative complications and risk of amputation are not overrepresented.

Adherence to instruction for use after endovascular repair of popliteal artery aneurysm.

OBJECTIVES: Endovascular repair (ER) of popliteal artery aneurysm (PAA) is an alternative to open repair. However, there is no standardized protocol for when to opt for ER and the decision is therefore at the discretion of the clinician. This study aims to evaluate the adherence to the Instruction For Use (IFU) in patients undergoing ER for PAA and factors associated with stent graft patency at one year. METHODS: The adherence to IFU provided by the manufacturer in 55 patients treated with Gore Viabahn® Endoprosthesis with Heparin Bioactive Surface for PAA between 2009 and 2019 were retrospectively analyzed. Duplex follow-up was performed at 30 days and one year. RESULTS: The two groups of patients treated within (n = 10) and not within (n = 45) IFU did not differ in patient demographics, diagnostic assessment, treatment or outcome. Forty-five patients (81.8%) received stent graft placement with at least one deviation according to IFU. Distal oversizing >20% was the most frequent deviation against IFU (n = 22, 40.0%). Primary patency at one year was 72%. Diameter size difference >1 mm between overlapping stent grafts (6/14 [43%], p = 0.013) and renal insufficiency (5/12 [42%], p = 0.0086) were associated with lower primary patency at one year. Age-adjusted analysis of tortuosity index (HR 1.78/SD, 95% CI 1.17-2.71; p = 0.0071) and maximal PAA angle (HR 1.73/SD, 95% CI 1.018-2.95; p = 0.043) were associated with major amputation/mortality at end of follow-up. CONCLUSION: The majority of patients undergoing ER for PAA were not treated within IFU. Diameter size difference >1 mm between overlapping stent grafts was associated with a higher loss of primary patency at one year. Multi-center studies with larger sample size and long-term follow up of patency are warranted.

Three-dimensional ultrasound improves identification of patients with abdominal aortic aneurysms reaching the threshold for repair.

OBJECTIVE: Conventional two-dimensional ultrasound (2D-US) has been the recommended and preferred modality for the diagnosis and surveillance of abdominal aortic aneurysms (AAAs). Measurement of the aneurysm diameter using three-dimensional ultrasound (3D-US) has shown promising results in a research setting, improving agreement and reproducibility. However, studies evaluating 3D-US in a clinical context are lacking, which could hinder the optimal usage of this new modality. In the present study, we investigated the clinical value of 3D-US for AAA surveillance compared with the current standard 2D-US examination. METHODS: Data from 126 patients with infrarenal AAAs <50 mm and 55 mm (female and male, respectively) were available for analysis. Eligibility was determined using the standard 2D-US anteroposterior (AP) diameter with a dual-plane technique. All the patients had subsequently undergone additional 3D-US and computed tomography angiography (CTA). Using CTA as the reference standard, the maximal standard 2D-US AP diameter was compared with that from 3D-US. RESULTS: All 126 AAAs were, per the inclusion criteria, small, with no intervention indicated. With the addition of 3D-US imaging to the 2D-US-based surveillance program, the AAA diameter threshold (50 and 55 mm) was exceeded for 31 of the 126 patients (25%). These 31 patients were withdrawn from the present study and referred for treatment planning. Compared with the CTA AP diameter (mean, 49 ± 7.2 mm), the mean 3D-US AP diameter (mean, 49 ± 6.7 mm) was significantly more accurate than the standard mean 2D-US AP diameter (45 ± 6.2 mm; kappa value, 0.86 ± 0.05; 95% confidence interval, 0.76-0.96; kappa value, 0.01 ± 0.04; 95% confidence interval, -0.05 to 0.09, respectively). CONCLUSIONS: For clinical use, the AAA diameter assessment using 3D-US was significantly more accurate than that with 2D-US and can substantially change the clinical management, from surveillance to operative treatment, for approximately one fourth of patients with an AAA. Further studies evaluating the clinical consequences of the 2D to 3D paradigm shift in AAA diagnostics are warranted, including sensitivity, specificity, agreement, and reproducibility estimation.

Three-dimensional ultrasound is a reliable alternative in endovascular aortic repair surveillance.

OBJECTIVE: Three-dimensional ultrasound (3D-US) has already demonstrated improved reproducibility with a high degree of agreement (intermodality variability), reproducibility (interoperator variability), and repeatability (intraoperator variability) compared with conventional two-dimensional ultrasound (2D-US) when estimating the maximum diameter of native abdominal aortic aneurysms (AAAs). The aim of the present study was, in a clinical, multicenter setting, to evaluate the accuracy of 3D-US with aneurysm model quantification software (3D-US abdominal aortic aneurysm [AAA] model) for endovascular aortic aneurysm repair (EVAR) sac diameter assessment vs that of computed tomography angiography (CTA) and 2D-US. METHODS: A total of 182 patients who had undergone EVAR from April 2016 to December 2017 and were compliant with a standardized EVAR surveillance program were enrolled from five different vascular centers (Rigshospitalet, Copenhagen, Denmark; Catharina Ziekenhuis, Eindhoven, Netherlands; L'hospital de la Timone, Paris, France; Cleveland Clinic, Cleveland, Ohio; and The Christ Hospital, Cincinnati, Ohio) in four countries. All image acquisitions were performed at the local sites (ie, 2D-US, 3D-US, CTA). Only the 2D-US and CTA readings were performed both locally and centrally. All images were read centrally by the US and CTA core laboratory. Anonymized image data were read in a randomized and blinded manner. RESULTS: The sample used to estimate the accuracy of the 3D-US AAA model and 2D-US included 164 patients and 177 patients, respectively. The Bland-Altman analysis revealed that the mean difference between CTA and 3D-US was -2.43 mm (95% confidence interval [CI], -5.20 to 0.14; P = .07) with a lower and upper limit of agreement of -8.9 mm (95% CI, -9.3 to -8.4) and 2.7 mm (95% CI, 2.3-3.2), respectively. For 2D-US and CTA, the mean difference was -3.62 mm (95% CI, -6.14 to -1.10; P = .002), with a lower and upper limit of agreement of -10.3 mm (95% CI, -10.8 to -9.8) and 2.5 mm (95% CI, 2-2.9), respectively. CONCLUSIONS: The 3D-US AAA model showed no significant difference compared with CTA for measuring the anteroposterior diameter, indicating less bias for 3D-US compared with 2D-US. Thus, 3D-US with AAA model software is a viable modality for anteroposterior diameter assessment for surveillance after EVAR.

International Implementation of a PROficiency based StePwise Endovascular Curricular Training (PROSPECT) in Daily Practice.

OBJECTIVE: A randomised controlled trial (RCT) showed superior real life endovascular performance of trainees after PROficiency based StePwise Endovascular Curricular Training (PROSPECT) compared with traditional training. This study aimed to determine whether PROSPECT can be implemented routinely in surgical training (registry) and to identify the associated effects, facilitators, and barriers to implementation. METHODS: This was a multicentre prospective registry to evaluate real life PROSPECT implementation effects. Cognitive ability was tested with a Multiple Choice Question test (MCQ) (max. score 20 points), while technical skills were assessed with a Global Rating Scale (GRS) (max. score 55 points), Examiner's Checklist (max, score 85 points), and simulator metrics. A cross sectional anonymous survey for both trainees and faculty evaluated the programme's implementation. RESULTS: The PROSPECT registry was implemented in five centres in four countries over a period of three years. Only 17 of 48 starting trainees completed PROSPECT, resulting in a dropout rate of 65%. Participants who completed the programme showed significant improvement in the GRS (median 26 vs. 44, p = .018) and Examiner's Checklist (median 53.5 vs. 80, p = .028) after the programme. The survey was completed by 13/17 faculty members (76%) and 38/57 trainees who participated either in the initial PROSPECT RCT or the registry (67%). PROSPECT was perceived to provide more endovascular training opportunities, but non-availability of logistical/technical support, lack of training time within the working schedule, and little trainee motivation hindered broad implementation. CONCLUSION: PROSPECT has a significant effect on performance, and trainees and faculty agree that PROSPECT is a valuable addition to surgical training. However, external and internal factors pose significant barriers to integration of this simulation based programme into daily practice leading to a high dropout rate. To integrate PROSPECT into contemporary surgical training, it should be a prerequisite to treating real patients and protected training time should be provided, combined with accessible support.

Endovascular Treatment of Chronic and Acute on Chronic Mesenteric Ischaemia: Results From a National Cohort of 245 Cases.

OBJECTIVE: Endovascular treatment of chronic mesenteric ischaemia (CMI) is linked to low early morbidity and mortality but a higher risk of recurrence than open repair. Mid and long term outcomes after endovascular treatment remain to be proven in larger series. The aim of this study was to assess short and mid term outcome after first line endovascular revascularisation of CMI and acute on chronic mesenteric ischaemia (AoCMI). METHODS: This was a prospective population and registry based cohort study supplemented by a retrospective review of medical records and imaging files. A national cohort was created based on data extracted from the Danish National Registry for Vascular Surgery (Karbase) for all patients treated endovascularly for CMI or AoCMI between 2011 and 2015 in Denmark. Survival data, bowel resection, complications, re-intervention rate, and improvement of clinical symptoms were analysed, as were potential risk factors. RESULTS: In total, 245 patients had an endovascular intervention for CMI (n = 178; 72.6%) and AoCMI (n = 67; 27.3%). One and three year survival estimates were 85% (95% confidence interval [CI] 79 - 90) and 74% (95% CI 67 - 80) in the CMI-group, and 67% (95% CI 54 - 77) and 54% (95% CI 41 - 65) in the AoCMI group. The hazard ratio for death was 1.89 (95% CI 1.23 - 2.9) for AoCMI, relative to patients with CMI. Superior mesenteric artery (SMA) stenosis, rather then occlusion, significantly increased the success of SMA recanalisation: OR 19.4 (95% CI 6.2 - 61.4) and 9.3 (95% CI 1.6 - 53.6) in the CMI and AoCMI groups, respectively. The proportion of patients reporting clinical improvement was 71% (n = 127) in the CMI group and 59% (n = 39) in the AoCMI group. Five patients (3%) in the CMI and 30 (45%) in the AoCMI groups underwent bowel resection (p < .001), and the overall length of hospital stay (LoS) was a median of two days (interquartile range [IQR] 1 - 3 days) in the CMI group and seven days (IQR 3 - 23 days) in the AoCMI group. Within the first year, re-intervention was performed in 14 patients (5.7%). CONCLUSION: First line endovascular treatment of CMI carries a three year mortality rate of 25%, and low risk of re-occurrence of symptomatic ischaemia. Relative to CMI, patients suffering AoCMI have significantly higher morbidity and mortality, more bowel resections, and longer LoS.

Simulation Based Training and Assessment in Open Vascular Surgery: A Systematic Review.

OBJECTIVE: The aim of this study was to systematically review the literature and give evidence based recommendations for future initiatives for simulation based training (SBT) and assessment in open vascular surgery. DATA SOURCES: PubMed, Embase, and the Cochrane Library. REVIEW METHODS: A systematic review of PubMed, Embase, and the Cochrane Library was performed, with the last search on 31 March 2020, to identify studies describing SBT and assessment in open vascular surgery. Kirkpatrick's levels for efficacy of training were evaluated. Validity evidence for assessment tools was evaluated according to the recommended contemporary framework by Messick. RESULTS: Of 2 844 studies, 51 were included for data extraction. A high degree of heterogeneity in reporting standards and varying types of simulation was found. Vascular anastomosis was the most frequently simulated technical skill (43%). Assessment was mostly carried out using the Objective Structured Assessment of Technical Skills (55%). Validity evidence for assessment tools was found using outdated frameworks, and only one study used Messick's framework. Self directed training is valuable, the low trainer to trainee ratio is important to maximise efficiency, and experienced vascular surgeons are the most effective trainers. CONCLUSION: Carefully designed and structured SBT is effective and can improve technical skills, especially in less experienced trainees. However, the supporting evidence lacks homogeneity in the reporting standards and types of simulations. Pass/fail standards that support proficiency based learning and studies investigating skills transfer should be the focus in future studies. Validity evidence of assessment tools needs to be addressed using contemporary frameworks.

Low Risk of Neurological Recurrence while Awaiting Carotid Endarterectomy: Results From a Danish Multicentre Study.

OBJECTIVE: The risk of ipsilateral neurological recurrence (NR) was assessed in patients awaiting carotid endarterectomy (CEA) due to symptomatic carotid artery stenosis and whether current national guidelines of performing CEA within 14 days are adequate in present day practice. METHODS: This was a retrospective multicentre observational cohort study. Patients scheduled for CEA due to symptomatic carotid artery stenosis in a five year period, 1 January 2014 to 31 December 2018, from four centres were included. Data from the Danish Vascular Registry (www.karbase.dk), operative managing systems, and electronic medical records were reviewed. RESULTS: In total, 1 125 patients scheduled for CEA were included and 1 095 (97%) underwent the planned surgery. During a median delay from index event to CEA of 11 days (interquartile range 8-16 days), 40 patients (3.6%; 95% confidence interval [CI] 2.5%-5%) experienced a NR. One third were minor strokes (n = 12, 30%); half were transient ischaemic attacks (TIA) (n = 22, 55%); and amaurosis fugax accounted for 15% (n = 6). Twenty-six (2%) CEA procedures was cancelled, of which one was due to a disabling recurrent ischaemic event (aphasia). There were no deaths or major strokes in the waiting time for CEA. Best medical treatment (BMT) with platelet inhibitory or anticoagulation drugs and a statin was initiated in nearly all patients (98%) at first assessment. The overall 30 day risk of a post-operative major event (death or stroke) was (Kaplan-Meier [KM] estimate) 2.7% (95% CI 1.8-3.8), and not significantly correlated with the timing of surgery. Most (69%) occurred within the first three days. One, two, and three year mortality rate for CEA patients was (KM estimate) 4.8%, 7.8%, and 11.5% respectively. CONCLUSION: In symptomatic carotid artery stenosis patients awaiting CEA, very few NRs occurred within 14 days. Institution of immediate BMT in specialised TIA/stroke units followed by early, but not necessarily urgent, CEA is a reasonable course of action in patients with high grade symptomatic carotid artery stenosis.