Poor inter-observer agreement in anatomical classifications of infrapopliteal arterial disease due to mandatory selection of only one target artery.

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.

Endovascular plugs to occlude proximal entries in chronic aortic dissection.

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.

Radiopaque Fiducials Guiding Laparoscopic Resection of Liver Tumors.

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.

Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

A Reperfusion BOLD-MRI Tissue Perfusion Protocol Reliably Differentiate Patients with Peripheral Arterial Occlusive Disease from Healthy Controls.

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 < 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.

ALIGNING VIDEO-AND STRUCTURED DATA FOR IMAGING OPTIMISATION.

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.

Results After Open and Endovascular Repair of Popliteal Aneurysm: A Matched Comparison Within a Population Based Cohort.

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.

The current status of drug-coated devices in lower extremity peripheral artery disease interventions.

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.

Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.).

Comparison of Magnetic Resonance Angiography and Digital Subtraction Angiography for the Assessment of Infrapopliteal Arterial Occlusive Lesions, Based on the TASC II Classification Criteria.

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.

Results of renal artery revascularization in the post-ASTRAL era with 4 years mean follow-up.

Purpose: To investigate contemporary results of percutaneous transluminal renal angioplasty (PTRA).Materials and Methods: A multicentre retrospective study analysing all patients treated with PTRA for primary symptomatic renal artery stenosis (RAS) between 2010 and 2013 at four tertiary centres. Procedures during the preceding four years were counted to evaluate for change in PTRA frequency.Results: The number of PTRA procedures decreased by approximately 50% from 2006 to 2013. Patients treated in the post-ASTRAL period (n = 224) had a significant reduction in mean systolic pressure (168 to 146 mmHg, p < 0.01), diastolic pressure (84 to 76 mmHg, p < 0.01), number of anti-hypertensive drugs (3.54 to 3.05, p < 0.01), and anti-hypertensive treatment index (21.75 to 16.92, p < 0.01) compared to before PTRA. These improvements were maintained at one year and at the last clinical evaluation after a mean follow-up of 4.31 years. Renal function increased transiently without sustained improvement, or deterioration, during later follow-up. Thirteen patients (5.8%) eventually required dialysis, nine of these had eGFR <20 ml/min/1.73 m2 before PTRA. There was no difference in outcomes between subgroups differentiated by different indications for PTRA.Conclusion: The frequency of PTRA has decreased, indicating a higher threshold for invasive treatment of RAS in recent years. The reduction in blood pressures, the reduced need for anti-hypertensive medication, and stabilization of renal function over time suggest a clinical benefit for most patients who are now being treated with PTRA.

Aortic balloon occlusion (REBOA) in pelvic ring injuries: preliminary results of the ABO Trauma Registry.

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.

Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial.

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.

Definitions of Computer-Assisted Surgery and Intervention, Image-Guided Surgery and Intervention, Hybrid Operating Room, and Guidance Systems: Strasbourg International Consensus Study.

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.

Feasibility and Clinical Outcome of Reboa in Patients with Impending Traumatic Cardiac Arrest.

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.

Low Risk of Procedure Related Major Amputation Following Revascularisation for Intermittent Claudication: A Population Based Study.

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.

Correction to: Performance of a feature-based algorithm for 3D-3D registration of CT angiography to cone-beam CT for endovascular repair of complex abdominal aortic aneurysms.

In the original version of this article [1], published on 8 November 2018, there was an error in the name of the 2nd author.

Outcome After Endovascular Repair of Ruptured Descending Thoracic Aortic Aneurysm: A National Multicentre Study.

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.

Impact of Preoperative Symptoms and Revascularized Arterial Segment in Patients With Chronic Limb-Threatening Ischemia.

BACKGROUND: 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. METHOD: 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". RESULTS: 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. CONCLUSIONS: 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.