Search

Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment.One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits.The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY.The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER€50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER£20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.

BACKGROUND: Minimal invasive laparoscopic resection of liver tumors is less traumatic compared with open surgical resection and may be a better option for many patients. However, localization of intrahepatic tumors remains a challenge. Availability of hybrid operating rooms, equipped for high performance radiologic imaging, allows for new methods of surgical navigation. METHODS: Twelve patients planned for laparoscopic resection of liver tumors were included. Before resection started, tumors were marked with radiopaque fiducials. Four fiducials were positioned with ultrasound within 1 cm of the tumor. Tumor and fiducials were localized with contrast enhanced cone beam computed tomography. Fluoroscopy with an overlay of cone beam computed tomography markings was projected side-by-side on the same screen as the laparoscopic view to visualize tumor location. The fiducials were eventually removed. Laparoscopic ultrasound, the standard method of localizing a tumor, was also used. The benefits of the 2 visualization methods were estimated by the operator. Procedure times, radiation doses and resection margins were recorded. RESULTS: Fluoroscopy with radiopaque fiducials provided valuable information, complementing the laparoscopic ultrasound, particularly during the early phase of resection. In the later phase, mobilization of the tumor-containing liver segment caused significant displacement of the fluoroscopic overlay. The technique evolved during course of the study, with decreasing procedure times and radiation doses. Radical resection was achieved for all patients. CONCLUSIONS: Radiopaque fiducials and fluoroscopy can complement laparoscopic ultrasound for guiding resection of liver tumors. Combining radiologic and optical imaging in a hybrid operating suit may facilitate development of augmented reality techniques for surgical navigation.

OBJECTIVES Patients with expanding chronic aortic dissection and patent proximal entries are sometimes poor candidates for open surgery or TEVAR. Occlusion of proximal entries with endovascular plugs has previously been suggested in selected patients, but clinical results over time are unknown. This study analyses aortic remodelling and clinical outcome after proximal entry occlusion. METHODS Between 2007 and 2016, 14 patients, with expanding chronic aortic dissection, considered poor candidates for standard treatment, were treated with endovascular plugs in proximal entries located in the arch (n = 6) or descending aorta (n = 8). The Amplatzer™ Vascular Plug II was used for entries ≤4 mm and the Amplatzer™ Septal Occluder or Amplatzer™ Muscular VSD Occluder for entries 5–16 mm. Patients were followed for 0.5–13 years (median 7.3) with clinical visits and computed tomography. Diameters and cross-sectional areas along the aorta were measured. RESULTS Occlusion of proximal entries was achieved in 10/14 patients (71%), including 4 patients with an adjunctive reintervention needed for complete seal in the segment. Unchanged or reduced maximum thoracic aortic diameter was observed in all 10 patients with successful occlusion. In 4 patients, proximal occlusion was not achieved and early conversion to FET (n = 1), FET/TEVAR (n = 2) or TEVAR (n = 1) was performed. Two aorta-related deaths occurred during follow-up, both after early conversion. CONCLUSIONS Endovascular occlusion of proximal dissection entries of expanding chronic aortic dissections can induce favourable aortic remodelling and may be considered in selected patients with expanding chronic aortic dissection who are poor candidates for open surgery or stent graft repair.

Imaging optimisation can benefit from combining structured data with qualitative data in the form of audio and video recordings. Since video is complex to work with, there is a need to find a workable solution that minimises the additional time investment. The purpose of the paper is to outline a general workflow that can begin to address this issue. What is described is a data management process comprising the three steps of collection, mining and contextualisation. This process offers a way to work systematically and at a large scale without succumbing to the context loss of statistical methods. The proposed workflow effectively combines the video and structured data to enable a new level of insights in the optimisation process.

The present study focuses on introducing the concept of optimisation and proposing a model, including evaluation of image quality, to be used in the clinical routines where image-guided intervention is being performed. The overall aim of the study was to develop a model for evaluating the use of imaging in X-ray-guided interventional procedures and its possible implications on optimisation of radiation protection. In the search for an adequate evaluation model, data from endovascular interventions of the aorta (EVAR procedures) were used. The procedure was schematically described in steps. Every imaging event was connected to the steps in the medical procedure and was also described with the purpose of the imaging event. Available technical, as well as procedural parameters, were studied and analysed. Data were collected from the X-ray equipment for 70 EVAR procedures and, out of these, 12 procedures were randomly selected to be recorded on video to understand the procedure better. It was possible to describe the EVAR procedures in a general way with explanations of the clinical purpose connected to each imaging event. Possible quality parameters of the procedure were identified for the imaging events (radiation dose, image quality). The model method still needs to be refined and will then be applied to clinical data and to other clinical procedures to test the validity.

Background Established anatomical classifications of infrapopliteal arterial lesion severity are based on assessment of only one target artery, not including all infrapopliteal arteries although multivessel revascularization is common. Purpose To investigate the reproducibility of one of these classifications and a new aggregated score. Material and Methods A total of 68 patients undergoing endovascular infrapopliteal revascularization at Sahlgrenska University Hospital during 2008–2016 were included. Preoperative magnetic resonance angiographies (MRA) and digital subtraction angiographies (DSA) were evaluated by three blinded observers in random order, using the infrapopliteal TransAtlantic Inter-Society Consensus (TASC) II classification. An aggregated score, the Infrapopliteal Total Atherosclerotic Burden (I-TAB) score, including all infrapopliteal arteries, was constructed and used for comparison. Results Inter-observer agreement on lesion severity for each evaluated artery was good; Krippendorff’s α for MRA 0.64–0.79 and DSA 0.66–0.84. Inter-observer agreement on TASC II grade, based on the selected target artery as stipulated, was poor; Krippendorff's α 0.14 (95% confidence interval [CI]=−0.05 to 0.30) for MRA and 0.48 (95% CI=0.33–0.61) for DSA. Inter-observer agreement for the new I-TAB score was good; Krippendorff's α 0.76 (95% CI=0.70–0.81) for MRA and 0.79 (95% CI=0.74–0.84) for DSA. Conclusion Reproducible assessment of infrapopliteal lesion severity can be achieved for separate arteries with both MRA and DSA using the TASC II definitions. However, poor inter-observer agreement in selecting the target artery results in low reproducibility of the overall infrapopliteal TASC II grade. An aggregated score, such as I-TAB, results in less variability and may provide a more robust evaluation tool of atherosclerotic disease severity.

Purpose: To investigate contemporary results of percutaneous transluminal renal angioplasty (PTRA).Materials and Methods: A multicentre retrospective study analysing all patients treated with PTRA ...

Objective To investigate the risk of procedure-related major amputation attributable to revascularization for intermittent claudication (IC) in a population-based observational cohort study. Methods All patients who underwent open or endovascular lower limb revascularisation for IC in Sweden between 12 May 2008 and 31 December 2012 were identified from the Swedish National Quality Registry for Vascular Surgery (Swedvasc) and data on above ankle amputations were extracted from the National Patient Registry. Any uncertainty regarding amputation level and laterality was resolved by reviewing medical charts. For the final analysis, complete medical records of all patients with IC, having ipsilateral amputation after the revascularisation procedure, were reviewed. Patients wrongly classified as having IC were excluded. Ipsilateral amputations within one year of the revascularisation were defined as procedure related. Results Altogether, 5 860 patients revascularised for IC were identified of whom 109 were registered to have undergone a post-operative ipsilateral lower limb amputation during a median follow up of 3.9 years (standard deviation 1.5 y). Seventeen were duplicate registrations and 51 were patients with chronic limb threatening ischaemia, misclassified as IC in the registry. One patient had not undergone any revascularisation, one was revascularised for a popliteal artery aneurysm, one was revascularised for acute limb ischaemia, one had a minor amputation only, and one patient was not amputated at all. Twenty-seven were amputated more than one year after the procedure. Thus, the major amputation rate within one year of revascularisation for IC was 0.2% (n = 9/5 860). Conclusion Revascularisation for IC in a contemporary setting confers a low but existing risk of procedure related major amputation within the first post-procedural year.

EndoVascular and Hybrid Trauma Management (EVTM) has been recently introduced in the treatment of severe pelvic ring injuries. This multimodal method of hemorrhage management counts on several strategies such as the REBOA (resuscitative endovascular balloon occlusion of the aorta). Few data exist on the use of REBOA in patients with a severely injured pelvic ring. The ABO (aortic balloon occlusion) Trauma Registry is designed to capture data for all trauma patients in hemorrhagic shock where management includes REBOA placement. Among all patients included in the ABO registry, 72 patients presented with severe pelvic injuries and were the population under exam. 66.7% were male. Mean and median ISS were respectively 43 and 41 (SD ± 13). Isolated pelvic injuries were observed in 12 patients (16.7%). Blunt trauma occurred in 68 patients (94.4%), penetrating in 2 (2.8%) and combined in 2 (2.8%). Type of injury: fall from height in 15 patients (23.1%), traffic accident in 49 patients (75.4%), and unspecified impact in 1 patient (1.5%). Femoral access was gained pre-hospital in 1 patient, in emergency room in 43, in operating room in 12 and in angio-suite in 16. REBOA was positioned in zone 1 in 59 patients (81,9%), in zone 2 in 1 (1,4%) and in zone 3 in 12 (16,7%). Aortic occlusion was partial/periodical in 35 patients (48,6%) and total occlusion in 37 patients (51,4%). REBOA associated morbidity rate: 11.1%. Overall mortality rate was 54.2% and early mortality rate (≤ 24 h) was 44.4%. In the univariate analysis, factors related to early mortality (≤ 24 h) are lower pH values (p = 0.03), higher base deficit (p = 0.021), longer INR (p = 0.012), minor increase in systolic blood pressure after the REBOA inflation (p = 0.03) and total aortic occlusion (p = 0.008). None of these values resulted significant in the multivariate analysis. In severe hemodynamically unstable pelvic trauma management, REBOA is a viable option when utilized in experienced centers as a bridge to other treatments; its use might be, however, accompanied with severe-to-lethal complications.

There is no established technique that directly quantifies lower limb tissue perfusion. Blood oxygenation level-dependent magnetic resonance imaging (BOLD-MRI) is an MRI technique that can determine skeletal muscle perfusion. BOLD-MRI relies on magnetic differences of oxygenated and deoxygenated hemoglobin, and regional changes in oxy/deoxyhemoglobin ratio can be recorded by T2* weighted MRI sequences. We aimed to test whether BOLD-MRI can differentiate lower limb tissue perfusion in peripheral arterial occlusive disease (PAOD) patients and healthy controls. Twenty-two PAOD patients and ten healthy elderly volunteers underwent lower limb BOLD-MRI. Reactive hyperemia was provoked by transient cuff compression and images of the gastrocnemius and soleus muscles were continuously acquired at rest, during ischemia and reperfusion. Key BOLD parameters were baseline T2* absolute value and time to T2* peak value after cuff deflation (TTP). Correlations between imaging parameters and ankle-brachial index (ABI) was investigated. The mean TTP was considerably prolonged in PAOD patients compared to healthy controls (m. gastrocnemius: 111 ± 46 versus 48 ± 22 s, p = 0.000253, m. soleus: 100 ± 42 versus 41 ± 30 s, p = 0.000216). Both gastrocnemius and soleus TTP values correlated strongly with ABI (−0.82 and −0.78, p &lt, 0.01). BOLD-MRI during reactive hyperemia differentiated most PAOD patients from healthy controls. TTP was the most decisive parameter and strongly correlated with the ABI.

Lower limb peripheral artery disease is a leading cause of cardiovascular disease morbidity and mortality. Endovascular revascularization is often indicated to improve walking function and to prevent limb loss but restenosis in the treated vessel segment remains a concern that limits the overall effectiveness of the treatment. The most promising technique to prevent restenosis is the use of drug-coated devices, and the most common drug used to coat lower limb balloon angioplasty balloons and stents is paclitaxel. A systematic review and meta-analysis in 2018 reported a possible increase in late mortality attributable to paclitaxel-coated devices. Since then, their use has been brought into question. Here, we present an update of data focusing on the efficacy and safety of paclitaxel-coated devices in lower limb treatment applications. While paclitaxel-coated devices appear to reduce restenosis rates it is still unclear how these surrogate marker improvements translate to direct patient benefits and uncertainty remains as to whether paclitaxel-coated devices confer an increased risk of long-term mortality. Available randomized clinical data is hampered by trial heterogeneity, insufficient power, potential attrition bias and the lack of a plausible mechanistic explanation. An important step forward is that the ongoing trials that were temporarily halted due to the Katsanos et al. report have now both commenced recruitment and may ultimately resolve this clinical dilemma by virtue of their larger sample sizes. Other possible ways forward are the ongoing investigation of alternative anti-proliferative coating agents and use of new sophisticated vascular imaging techniques to more clearly identify patients at risk of restenosis already in the preoperative setting.

Objective To identify factors affecting the outcome after open surgical (OSR) and endovascular (ER) repair of popliteal artery aneurysm (PA) in comparable cohorts. Methods A matched comparison in a national, population based cohort of 592 legs treated for PA (2008 – 2012), with long term follow up. Registry data from 899 PA patients treated in 2014 – 2018 were analysed for time trends. The 77 legs treated by ER were matched, by indication, with 154 legs treated with OSR. Medical records and imaging were collected. Analysed risk factors were anatomy, comorbidities, and medication. Elongation and angulations were examined in a core lab. The main outcome was occlusion. Results Patients in the ER group were older (73 vs. 68 years, p = .001), had more lung disease (p = .012), and were treated with dual antiplatelet therapy or anticoagulants more often (p < .001). The hazard ratio (HR with 95% confidence intervals) for occlusion was 2.69 (1.60 – 4.55, p < .001) for ER, but 3.03 (1.26 – 7.27, p = .013) for poor outflow. For permanent occlusion, the HR after ER was 2.47 (1.35 – 4.50, p = .003), but 4.68 (1.89 – 11.62, p < .001) for poor outflow. In the ER subgroup, occlusion was more common after acute ischaemia (HR 2.94 [1.45 – 5.97], p = .003; and poor outflow HR 14.39 [3.46 – 59.92], p < .001). Larger stent graft diameter reduced the risk (HR 0.71 [0.54 – 0.93], p = .014). In Cox regression analysis adjusted for indication and stent graft diameter, elongation increased the risk (HR 1.020 per degree [1.002 – 1.033], p = .030). PAs treated for acute ischaemia had a median stent graft diameter of 6.5 mm, with those for elective procedures being 8 mm (p < .001). Indications and outcomes were similar during both time periods (2008 – 2012 and 2014 – 2018). Conclusion In comparable groups, ER had a 2.7 fold increased risk of any occlusion, and 2.4 fold increased risk of permanent occlusion, despite more aggressive medical therapy. Risk factors associated with occlusion in ER were poor outflow, smaller stent graft diameter, acute ischaemia, and angulation/elongation. An association between indication, acute ischaemia, and small stent graft diameter was identified. De två sista författarna delar sistaförfattarskapet

The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease.We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality.No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively).In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).

Objective: To develop consensus definitions of image-guided surgery, computer-assisted surgery, hybrid operating room, and surgical navigation systems. Summary Background Data: The use of minimally invasive procedures has increased tremendously over the past 2 decades, but terminology related to image-guided minimally invasive procedures has not been standardized, which is a barrier to clear communication. Methods: Experts in image-guided techniques and specialized engineers were invited to engage in a systematic process to develop consensus definitions of the key terms listed above. The process was designed following review of common consensus-development methodologies and included participation in 4 online surveys and a post-surveys face-to-face panel meeting held in Strasbourg, France. Results: The experts settled on the terms computer-assisted surgery and intervention, image-guided surgery and intervention, hybrid operating room, and guidance systems and agreed-upon definitions of these terms, with rates of consensus of more than 80% for each term. The methodology used proved to be a compelling strategy to overcome the current difficulties related to data growth rates and technological convergence in this field. Conclusions: Our multidisciplinary collaborative approach resulted in consensus definitions that may improve communication, knowledge transfer, collaboration, and research in the rapidly changing field of image-guided minimally invasive techniques., This study gathered experts with multiple backgrounds and used common consensus-development methodologies in 2 phases (online and panel meeting). It resulted in definitions that may improve communication, knowledge transfer, collaboration, and research in the field of image-guided minimally invasive techniques.

This paper aimed to study the agreement and repeatability, both intra- and interobserver, of infrapopliteal lesion assessment with magnetic resonance angiography (MRA), using the TransAtlantic Inter-Society Consensus (TASC) II criteria, with perioperative digital subtraction angiography (DSA) as a reference. Sixty-eight patients with an MRA preceding an endovascular infrapopliteal revascularization were included. Preoperative MRAs and perioperative DSAs were evaluated in random order by three independent observers using the TASC II classification. The results were analyzed using visual grading characteristics (VGC) analysis and Krippendorff’s α. No systematic difference was found between modalities: area under the VGC curve (AUCVGC) = 0.48 (p = 0.58) or intraobserver; AUCVGC for Observer 1 and 2 respectively, 0.49 (p = 0.85) and 0.53 (p = 0.52) for MRA compared with 0.54 (p = 0.30) and 0.49 (p = 0.81) for DSA. Interobserver differences were seen: AUCVGC of 0.63 (p < 0.01) for DSA and 0.80 (p < 0.01) for MRA. These results were confirmed using Krippendorff’s α for the three observers showing 0.13 (95% confidence interval (CI) −0.07–0.31) for MRA and 0.39 (95% CI 0.23–0.53) for DSA. Poor interobserver agreement was also found in the choice of a target vessel on preoperative MRA: Krippendorff’s α = 0.19 (95% CI 0.01‒0.36). In conclusion, infrapopliteal lesions can be reliably determined on preoperative MRA, but interobserver variability regarding the choice of a target vessel is a major concern that appears to affect the overall TASC II grade.

Chronic limb threatening ischaemia (CLTI) has a high risk of amputation and mortality. Increased knowledge on how sex, comorbidities, and medication influence these outcomes after revascularisation may help optimise results and patient selection.This population based observational cohort study included all individuals revascularised for CLTI in Sweden during a five year period (10,617 patients in total). Data were retrieved and merged from mandatory national healthcare registries, and specifics on amputations were validated with individual medical records.Mean age at revascularisation was 76.8 years. Median follow up was 2.7 years (range 0-6.6 years). Male sex (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.09-1.33), renal insufficiency (HR 1.57, 95% CI 1.32-1.87), diabetes (HR 1.45, 95% CI 1.32-1.60), and heart failure (HR 1.17, 95% CI 1.05-1.31) were independently associated with an increased amputation rate, whereas the use of statins (HR 0.71, 95% CI 0.64-0.78) and low dose acetylsalicylic acid (HR 0.77, 95% CI 0.70-0.86) were associated with a reduced amputation rate. For the combined end point of amputation or death, an association with increased rates was found for male sex (HR 1.25, 95% CI 1.18-1.32), renal insufficiency (HR 1.94, 95% CI 1.75-2.14), heart failure (HR 1.50, 95% CI 1.40-1.60), and diabetes (HR 1.31, 95% CI 1.23-1.38). The use of statins (HR 0.74, 95% CI 0.67-0.82) and low dose acetylsalicylic acid (HR 0.82, 95% CI 0.77-0.88]) were related to a reduced risk of amputation or death.Renal insufficiency is the strongest independent risk factor for both amputation and amputation/death in revascularised CLTI patients, followed by diabetes and heart failure. Men with CLTI have worse outcomes than women. These results may help govern patient selection for revascularisation procedures. Statin and low dose acetylsalicylic acid are associated with an improved limb outcome. This underlines the importance of preventive medication to reduce general cardiovascular risk and increase limb salvage.

Background Revascularization is a treatment option for patients with intermittent claudication. However, there is a lack of evidence to support its long-term benefits and cost-effectiveness. The aim of this study was to compare the cost-effectiveness of revascularization and best medical therapy (BMT) with that of BMT alone. Methods Data were used from the IRONIC (Invasive Revascularization Or Not in Intermittent Claudication) RCT where consecutive patients with mild-to-severe intermittent claudication owing to aortoiliac or femoropopliteal disease were allocated to either BMT alone (including a structured, non-supervised exercise programme) or to revascularization together with BMT. Inpatient and outpatient costs were obtained prospectively over 24 months of follow-up. Mean improvement in quality-adjusted life-years (QALYs) was calculated based on responses to the EuroQol Five Dimensions EQ-5D-3 L™ questionnaire. Cost-effectiveness was assessed as the cost per QALY gained. Results A total of 158 patients were randomized, 79 to each group. The mean cost per patient in the BMT group was €1901, whereas it was €8280 in the group treated with revascularization in addition to BMT, with a cost difference of €6379 (95 per cent c.i. €4229 to 8728) per patient. Revascularization in addition to BMT resulted in a mean gain in QALYs of 0·16 (95 per cent c.i. 0·06 to 0·24) per patient, giving an incremental cost-effectiveness ratio of €42 881 per QALY. Conclusion The costs associated with revascularization together with BMT in patients with intermittent claudication were about four times higher than those of BMT alone. The incremental cost-effectiveness ratio of revascularization was within the accepted threshold for public willingness to pay according to the Swedish National Guidelines, but exceeded that of the UK National Institute for Health and Care Excellence guidelines.

Background Symptomatic renal artery stenosis (RAS) is mainly treated with pharmacological blood pressure control, sometimes with percutaneous transluminal renal angioplasty (PTRA). It is unclear if PTRA benefits these patients over time. Purpose To determine long-term renal function, morbidity, and mortality in patients with symptomatic RAS treated with PTRA, and whether long-term outcomes are associated with angiographic restenosis. Material and Methods Retrospective single-center, long-term follow-up of 57 patients with atherosclerotic RAS treated with PTRA with stent during 1995–2004 and investigated for restenosis with angiography after one year. Outcomes were retrieved from medical records and from mandatory healthcare registries. Mortality rates were related to expected survival in an age- and gender-matched population, using a life-table database. Surviving patients were assessed with blood pressures, laboratory tests, duplex ultrasonography, and radioisotope renography. Results Median follow-up was 11 years 7 months. Major indications for PTRA were therapy-resistant hypertension and declining renal function. Angiographic restenosis at one year was found in 21 of 57 patients (37%). Thirty-six patients (60%) died during follow-up. Main cause of death was cardiovascular events (54%). Mortality was significantly increased, and morbidity and healthcare utilization were high. Hypertension control during follow-up was stable with persistent need for anti-hypertensive medication, and renal function remained moderately reduced with no long-term difference between patients with vs. without restenosis. Conclusion Long-term prognosis after PTRA for atherosclerotic RAS is dismal, with high mortality and morbidity and reduced renal function, despite maintained hypertension control. Restenosis does not appear to affect late outcome.

Objectives Patient reported outcomes are increasingly used to assess outcomes after peripheral arterial disease (PAD) interventions. VascuQoL-6 (VQ-6) is a PAD specific health-related quality of life (HRQoL) instrument for routine clinical practice and clinical research. This study assessed the minimum important difference for the VQ-6 and determined thresholds for the minimum important difference and substantial clinical benefit following PAD revascularisation. Materials and methods This was a population-based observational cohort study. VQ-6 data from the Swedvasc Registry (January 2014 to September 2016) was analysed for revascularised PAD patients. The minimum important difference was determined using a combination of a distribution based and an anchor-based method, while receiver operating characteristic curve analysis (ROC) was used to determine optimal thresholds for a substantial clinical benefit following revascularisation. Results A total of 3194 revascularised PAD patients with complete VQ-6 baseline recordings (intermittent claudication (IC) n = 1622 and critical limb ischaemia (CLI) n = 1572) were studied, of which 2996 had complete VQ-6 recordings 30 days and 1092 a year after the vascular intervention. The minimum important difference 1 year after revascularisation for IC patients ranged from 1.7 to 2.2 scale steps, depending on the method of analysis. Among CLI patients, the minimum important difference after 1 year was 1.9 scale steps. ROC analyses demonstrated that the VQ-6 discriminative properties for a substantial clinical benefit was excellent for IC patients (area under curve (AUC) 0.87, sensitivity 0.81, specificity 0.76) and acceptable in CLI (AUC 0.736, sensitivity 0.63, specificity 0.72). An optimal VQ-6 threshold for a substantial clinical benefit was determined at 3.5 scale steps among IC patients and 4.5 in CLI patients. Conclusions The suggested thresholds for minimum important difference and substantial clinical benefit could be used when evaluating VQ-6 outcomes following different interventions in PAD and in the design of clinical trials.

Purpose Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a technique for temporary stabilization of patients with non-compressible torso hemorrhage. This technique has been increasingly used worldwide during the past decade. Despite the good outcomes of translational studies, clinical studies are divided. The aim of this multicenter-international study was to capture REBOA-specific data and outcomes. Methods REBOA practicing centers were invited to join this online register, which was established in September 2014. REBOA cases were reported, both retrospective and prospective. Demographics, injury patterns, hemodynamic variables, REBOA-specific data, complications and 30-days mortality were reported. Results Ninety-six cases from 6 different countries were reported between 2011 and 2016. Mean age was 52 ± 22 years and 88% of the cases were blunt trauma with a median injury severity score (ISS) of 41 (IQR 29–50). In the majority of the cases, Zone I REBOA was used. Median systolic blood pressure before balloon inflation was 60 mmHg (IQR 40–80), which increased to 100 mmHg (IQR 80–128) after inflation. Continuous occlusion was applied in 52% of the patients, and 48% received non-continuous occlusion. Occlusion time longer than 60 min was reported as 38 and 14% in the non-continuous and continuous groups, respectively. Complications, such as extremity compartment syndrome (n = 3), were only noted in the continuous occlusion group. The 30-day mortality for non-continuous REBOA was 48%, and 64% for continuous occlusion. Conclusions This observational multicenter study presents results regarding continuous and non-continuous REBOA with favorable outcomes. However, further prospective studies are needed to be able to draw conclusions on morbidity and mortality.

Objectives To quantify the deformation of the common iliac artery caused by stiff guide wires and delivery systems during abdominal endovascular aortic repair (EVAR). Methods Twenty-two patients treated with abdominal EVAR were included. The following three image data-sets were acquired for each patient: (1) a preoperative computed tomography angiography (CTA), (2) an intraoperative contrast-enhanced cone beam CT (CBCT) obtained after the main trunk of the bifurcated stent graft was released and both iliac limbs were engaged with stiff guide wires, and (3) the first postoperative CTA. These data-sets were merged and compared in an image analysis work station. The length and the tortuosity index of the common iliac artery, the Euclidian displacement of the aortic and the iliac bifurcations, and the optimal C-arm angulation for projection of the iliac bifurcation were computed. Results The common iliac artery was on average 6.4 mm shorter ( p Conclusion Stiff guide wires and delivery systems cause significant deformation of the common iliac arteries during EVAR. The aortic bifurcation is more cranial, the common iliac arteries are shorter, and optimal C-arm angulation is more contralateral oblique when the iliac limbs are to be deployed compared to baseline measurements from preoperative CTA. This affects image fusion accuracy and stent graft selection.

Little is known about the relative impact of the preoperative symptoms rest pain and tissue loss, and of the arterial segment revascularized, on amputation rate and mortality in patients with chronic limb-threatening ischemia (CLTI). We wanted to investigate this topic further.This population-based observational cohort study involved 10 419 patients revascularized for CLTI in Sweden, 2008 to 2013. Data were collected from health-care registries and medical records. The effect of preoperative symptoms and revascularized arteries was determined using Cox regression models. A competing risk analysis was used to determine the effect of symptoms on the combined endpoint "amputation or death".The amputation rate during a mean follow-up of 2 years was 7.5% in patients with rest pain, 15.6% in patients with tissue loss only, and 20.1% when both symptoms were present. Mortality was 39% lower in patients with rest pain only than in those with both symptoms. Revascularizations targeted the aortoiliac, femoropopliteal, and infrapopliteal segments in 19.4%, 76.8%, and 30.6%, respectively. Distal revascularizations were associated with a higher amputation rate, but this difference disappeared after adjustment for comorbidities. Aortoiliac revascularizations were associated with high mortality. Competing risk analysis showed that mortality became the major determinant of amputation-free survival outcomes from 1 year after revascularization.Tissue loss implies a clearly worse prognosis compared to rest pain for patients with CLTI. Most revascularizations for CLTI are done in the femoropopliteal segment. Infrapopliteal procedures are associated with a higher amputation rate, whereas aortoiliac revascularizations are associated with higher mortality.

Background Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) may improve Systolic Blood Pressure (SBP) in hypovolemic shock. It has, however, not been studied in patients with impending traumatic cardiac arrest (ITCA). We aimed to study the feasibility and clinical outcome of REBOA in patients with ITCA using data from the ABOTrauma Registry. Methods Retrospective and prospective data on the use of REBOA from 16 centers globally were collected. SBP was measured both at pre- and post-REBOA inflation. Data collected included patients' demography, vascular access technique, number of attempts, catheter size, operator, zone and duration of occlusion, and clinical outcome. Results There were 74 patients in this high-risk patient group. REBOA was performed on all patients. A 7-10Fr catheter was used in 66.7% and 58.5% were placed on the first attempt, 52.1% through blind insertion and 93.2% inflated in Zone I, 64.8% for a period of 30 to 60 min, 82.1% by ER doctors, trauma surgeons, or vascular surgeons. SBP significantly improved to 90 mm Hg following the inflation of REBOA. 36.6% of the patients survived. Conclusions Our study has shown that REBOA may be performed in patients with ITCA, SBP can be elevated, and 36.6% of the patients survived if REBOA placement is successful.

Objective Evaluation of orthogonal rings, fiducial markers, and overlay accuracy when image fusion is used for endovascular aortic repair (EVAR). Methods This was a prospective single centre study. In 19 patients undergoing standard EVAR, 3D image fusion was used for intra-operative guidance. Renal arteries and targeted stent graft positions were marked with rings orthogonal to the respective centre lines from pre-operative computed tomography (CT). Radiopaque reference objects attached to the back of the patient were used as fiducial markers to detect patient movement intra-operatively. Automatic 3D-3D registration of the pre-operative CT with an intra-operative cone beam computed tomography (CBCT) as well as 3D-3D registration after manual alignment of nearby vertebrae were evaluated. Registration was defined as being sufficient for EVAR guidance if the deviation of the origin of the lower renal artery was less than 3 mm. For final overlay registration, the renal arteries were manually aligned using aortic calcification and vessel outlines. The accuracy of the overlay before stent graft deployment was evaluated using digital subtraction angiography (DSA) as direct comparison. Results Fiducial markers helped in detecting misalignment caused by patient movement during the procedure. Use of automatic intensity based registration alone was insufficient for EVAR guidance. Manual registration based on vertebrae L1-L2 was sufficient in 7/19 patients (37%). Using the final adjusted registration as overlay, the median alignment error of the lower renal artery marking at pre-deployment DSA was 2 mm (0–5) sideways and 2 mm (0–9) longitudinally, mostly in a caudal direction. Conclusion 3D image fusion can facilitate intra-operative guidance during EVAR. Orthogonal rings and fiducial markers are useful for visualization and overlay correction. However, the accuracy of the overlaid 3D image is not always ideal and further technical development is needed.

Background: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. Methods: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. Results: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P =0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P =0.02). Conclusions: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01219842.

Objective The purpose of this multicentre study was to analyse the outcome of thoracic endovascular aortic repair (TEVAR) in patients with ruptured descending thoracic aortic aneurysm (rDTAA). Methods This is a nationwide retrospective study including all patients who underwent TEVAR for rDTAA at six major vascular university centres in Sweden between January 2000 and December 2015. Outcome measures were analysed using Kaplan–Meier estimator and multivariable Cox regression. Results There were 140 patients (age [mean ± SD] 74.1 ± 8.8 years; 56% men; aneurysm size 64.8 ± 19 mm), with rDTAA. In 53 patients (37.9%), the left subclavian artery was covered, and in 25 patients (17.9%) arch vessel revascularisation was performed. In total, 61/136 patients (45%) had a major complication within 30 days post TEVAR. Stroke (n = 20; 14.7%) was the most common complication, followed by paraplegia (n = 13; 9.6%) and major bleeding (n = 13; 9.6%). TEVAR related complications during follow up included endoleaks 22.1% (30/136; 14 type 1a, six type 1b, 10 not defined). In total, re-interventions (n = 31) were required in 27/137 (19.7%) patients. The median follow up time was 17.0 months (range 0–132 months). The Kaplan–Meier estimated survival was 80.0% at one month, 71.7% at three months, 65.3% at one year, 45.9% at three years, and 31.9% at five years. Age (HR 1.03; 95% CI 1.00–1.07; p = .046), history of stroke (HR 2.35; 95% CI 1.19–4.63; p = .014), previous aortic surgery (HR 2.11; 95% CI 1.15–3.87; p = .016) as well as post-operative major bleeding (HR 4.40; 95% CI 2.20–8.81; p = .001), stroke (HR 2.63; 95% CI 1.37–5.03; p = .004), and renal failure (HR 8.25; 95% CI 2.69–25.35; p = .001) were all associated with mortality. Conclusions This nationwide multicentre study of patients with rDTAA undergoing TEVAR showed acceptable short- but poor long-term survival. Adequate proximal and distal aortic sealing zones are important for technical success. High risk patients and post-operative complications need to be further addressed in an effort to improve outcome.

INTRODUCION Indications for reinterventions after endovascular aneurysm repair (EVAR), as well as their occurrence in number and time, are important to establish in order to optimize patient selection, postprocedure surveillance and also to guide improvements in endograft designs. The aim of this report was to present an overview of current data on reinterventions after elective EVAR. EVIDENCE ACQUISITION Qualitative review of studies reporting on reinterventions after elective EVAR, identified by a systematic literature search in MEDLINE, EMBASE and the Cochrane Library for publications from 2010 to 13th of November 2017. EVIDENCE SYNTHESIS Twenty-three studies reporting on 83,307 patients met the inclusion criteria. Index procedures were performed between 1996-2014. There was wide heterogeneity in reporting standards. Type I endoleaks were reported in 0.6%-13% and type III endoleaks in 0.9-2.1% with a significant improvement for newer devices. Migration rates varied between 0-4%. Endoleak type II was the most common indication for re-intervention ranging from 14-25.3% although the majority resolved without intervention. Rupture rates ranged from 0-5.4% and carried a high mortality (60-67%). Ruptures occurred at any time after the index procedure. Limb ischemia rates were reported at 0.4-11.9% with re-intervention rates between 0.06-11.9%. Wound related complications and related re-interventions were the indication in 0.5-14% and 0.3-6.5%, respectively. Endograft infection carried a high risk of mortality and was described in 0.3-3.6%, often related to graft-enteric fistula and the majority had an open explantation of the endograft. CONCLUSIONS This review showed that the rates of complications and techniques for reintervention developed over time with a tendency towards better outcomes considering the aneurysm related indications. Significant factors that led to subsequent secondary interventions were migration, rupture, infections and type I and II endoleaks. Patients treated with earlier generation endografts are still alive and need continued surveillance to detect these severe complications before they lead to rupture.

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

Aims: Data on long-term healthcare costs of patients with peripheral artery disease (PAD) is limited, and the aim of this study was to investigate healthcare costs for PAD patients at a nationwide level. Methods and results: A cohort study including all incident patients diagnosed with PAD in the Swedish National Patient Register between 2006-2014, and linked to cause of death- and prescribed drug registers. Mean per-patient annual healthcare costs (2015 Euros [€]) (hospitalisations and out-patient visits) were divided into cardiovascular (CV), lower limb and non-CV related cost. Results were stratified by high and low CV risk. The study included 66,189 patients, with 221,953 observation-years. Mean total healthcare costs were €6,577, of which 26% was CV-related (€1,710), during the year prior to the PAD diagnosis. First year after PAD diagnosis, healthcare costs were €12,549, of which €3,824 (30%) was CV-related and €3,201 (26%) lower limb related. Highrisk CV patients had a higher annual total healthcare and CV related costs compared to low risk CV patients during follow-up €7,439 and €1,442 versus €4,063 and €838). Annual lower limb procedure costs were €728 in the PAD population, with lower limb revascularisations as key cost driver (€474). Conclusion: Non-CV related hospitalizations and outpatient visits were the largest cost contributors for PAD patients. There is a substantial increase in healthcare costs in the first year after being diagnosed with PAD, driven by PAD follow-up and lower limb related procedures. Among the CV-related costs, hospitalisations and outpatient visits related to PAD represented the largest costs. Keywords Nationwide register data • peripheral artery disease • healthcare resource use • healthcare costs

Purpose: Embolic stroke is a dreaded complication of thoracic endovascular aortic repair. The prevailing theory about its cause is that particulate debris from atherosclerotic lesions in the aortic wall are dislodged by endovascular instruments and embolize to the brain. An alternative source of embolism might be air trapped in the endograft delivery system. The aim of this experimental study was to determine whether air is released during deployment of a thoracic endograft. Methods: In an experimental benchtop study, eight thoracic endografts (five Medtronic Valiant Thoracic and three Gore TAG) were deployed in a water-filled transparent container drained from air. Endografts were prepared and deployed according to their instructions for use. Deployment was filmed and the volume of air released was collected and measured in a calibrated syringe. Results: Air was released from all the endografts examined. Air volumes ranged from 0.1 to 0.3 mL for Medtronic Valiant Thoracic and from Conclusion: Air bubbles are released from thoracic endografts during deployment. Air embolism may be an alternative cause of stroke during thoracic endovascular aortic repair.

Background Renal artery duplex ultrasound (RADUS) is an established method for diagnosis of renal artery stenosis (RAS), but there is no consensus regarding optimal RADUS criteria. Purpose To define optimal cutoff values for RADUS parameters when screening for RAS using intra-arterial trans-stenotic pressure gradient measurement (PGM) as reference. Material and Methods The renal arteries of 58 consecutive patients evaluated for renovascular hypertension were examined by RADUS and PGM. Conclusive measurements with both methods were obtained in 76 arteries. Hemodynamically significant RAS was defined as PGM ≥15 mmHg and was found in 43 of the 76 arteries. RADUS parameters included renal artery peak systolic velocity (PSV) and the renal–aortic ratio (RAR) of flow velocities. Receiver operating characteristic curves (ROCs) and Youden’s index were used to calculate optimal RADUS criteria for RAS. Results When traditional RADUS criteria for RAS were used, with a combination of PSV ≥180 cm/s and RAR ≥3.5, the sensitivity was 62% and the specificity was 91%. When RADUS criteria were optimized for sensitivity, then RAR ≥2.6 alone resulted in a sensitivity of 89% and a specificity of 69%. Conclusion The RAR ≥2.6 is a more sensitive criterion than traditional RADUS criteria when screening patients with clinical suspicion of RAS.