Editor's Choice - Two Year Results of the Randomised DISCOVER Trial Comparing Covered Versus Bare Metal Stents in the Common Iliac Artery.

OBJECTIVE: It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery. METHODS: This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381). RESULTS: One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p = .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p = .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p = .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study. CONCLUSION: No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.

Assessment of fenestrated Anaconda stent graft design by numerical simulation: Results of a European prospective multicenter study.

OBJECTIVE: A crucial step in designing fenestrated stent grafts for treatment of complex aortic abdominal aneurysms is the accurate positioning of the fenestrations. The deployment of a fenestrated stent graft prototype in a patient-specific rigid aortic model can be used for design verification in vitro, but is time and human resources consuming. Numerical simulation (NS) of fenestrated stent graft deployment using the finite element analysis has recently been developed; the aim of this study was to compare the accuracy of fenestration positioning by NS and in vitro. METHODS: All consecutive cases of complex aortic abdominal aneurysm treated with the Fenestrated Anaconda (Terumo Aortic) in six European centers were included in a prospective, observational study. To compare fenestration positioning, the distance from the center of the fenestration to the proximal end of the stent graft (L) and the angular distance from the 0° position (C) were measured and compared between in vitro testing (L1, C1) and NS (L2, C2). The primary hypothesis was that ΔL (|L2 - L1|) and ΔC (|C2 - C1|) would be 2.5 or less mm in more than 80% of the cases. The duration of both processes was also compared. RESULTS: Between May 2018 and January 2019, 50 patients with complex aortic abdominal aneurysms received a fenestrated stent graft with a total of 176 fenestrations. The ΔL and ΔC was 2.5 mm or less for 173 (98%) and 174 (99%) fenestrations, respectively. The NS process duration was significantly shorter than the in vitro (2.1 days [range, 1.0-5.2 days] vs 20.6 days [range, 9-82 days]; P < .001). CONCLUSIONS: Positioning of fenestrations using NS is as accurate as in vitro and could significantly decrease delivery time of fenestrated stent grafts.

The relation between physical fitness, frailty and all-cause mortality after elective endovascular abdominal aortic aneurysm repair.

BACKGROUND: Accurate determination of probable surgical outcomes is fundamental in decision-making regarding appropriate abdominal aortic aneurysm treatment. These outcomes depend, among other factors, on patient-related factors such as physical fitness. The primary aim of this study was to evaluate the correlation between physical fitness, measured by the metabolic equivalent of task (MET) score and the five-factor Modified Frailty Index (MFI-5), and all-cause mortality. METHODS: Four hundred twenty-nine patients undergoing elective endovascular treatment of an infrarenal aortic aneurysm (EVAR) from January 2011 to September 2018 were identified in an existing local abdominal aortic aneurysm database. Physical fitness was measured by the MFI-5 and the METs as registered during preoperative screening. The primary end point was 1-year all-cause mortality and secondary end points included 5-year all-cause mortality, freedom from aneurysm-related mortality and aneurysm-related reinterventions. Correlations were analyzed using Spearman's rho and survival was analyzed using Kaplan-Meier analyses. The effect of physical fitness on mortality was assessed by binary logistics regression analyses. RESULTS: There was a positive correlation between the MFI-5 and 1-year all-cause mortality (Rho = 0.163; P = .001), but not between the METs and 1-year all-cause mortality (Rho = -0.083; P = .124). A significant correlation between both MFI-5 and METs and 5-year all-cause mortality was observed (Rho = 0.255; P < .001 and Rho = -0.154; P = .004). When stratified by the MFI-5, the 1- and 5-year follow-up survival rates were 95.1% and 85.9%, respectively, in the group with the lowest MFI-5 and 74.5% and 33.1% in the group with the highest MFI-5 score (P = .007 and P < .001). When stratified by METs categories for 1-year follow-up, no significant differences in survival between the groups were observed (P = .090). The 5-year follow-up survival rate was 39.4% in the lowest METs category and 76.3% in the highest METs category (P = .039). Logistic regression analysis, assessing the impact of age, sex, METs, and the MFI-5 on the risk of all-cause mortality, showed that only age and the MFI-5 made a significant contribution. CONCLUSIONS: There is a significant positive association between the MFI-5 and both the 1- and 5-year all-cause mortality rates after EVAR; METs only correlated with the 5-year all-cause mortality. Only age and the MFI-5 contributed to predicting overall survival after EVAR; therefore, it could be recommended to add the MFI-5 for guidance in preoperative counselling.

Endograft Conformability in Fenestrated Endovascular Aneurysm Repair for Complex Abdominal Aortic Aneurysms.

Purpose: To compare the impact of 2 commercially available custom-made fenestrated endografts on patient anatomy. Materials and Methods: The records of 234 patients who underwent fenestrated endovascular aneurysm repair for abdominal aortic aneurysm from March 2002 to July 2016 in 2 hospitals were screened to identify those who had pre- and postoperative computed tomography angiography assessments with a slice thickness of ≤2 mm. The search identified 145 patients for further analysis: 110 patients (mean age 72.4±7.1 years; 94 men) who had been treated with the Zenith Fenestrated (ZF) endograft and 35 patients (mean age 72.3±7.3 years; 30 men) treated with the Fenestrated Anaconda (FA) endograft. Measurements included aortic diameters at the level of the superior mesenteric artery (SMA) and renal arteries, target vessel angles, target vessel clock positions, and the target vessel tortuosity index. Variables were tested for inter- and intraobserver agreement. Results: There was a good agreement between observers in all tested variables. The native anatomy changed in both groups after endograft implantation. In the ZF group, changes were seen in the angles of the celiac artery (p=0.012), SMA (p=0.022), left renal artery (LRA) (p<0.001), and the right renal artery (RRA) (p<0.001); the aortic diameter at the SMA level (p<0.001); and the LRA (p<0.001) and RRA (p<0.001) clock positions. In the FA group, changes were seen in the angles of the LRA (p=0.001) and RRA (p<0.001) and in the SMA tortuosity index (p=0.044). Between group differences in changes were seen for the aortic diameters at the SMA and renal artery levels (p<0.001 for both) and the LRA clock position (p=0.019). Conclusion: Both custom-made fenestrated endografts altered vascular anatomy. The data suggest a higher conformability of the Fenestrated Anaconda endograft compared with the Zenith Fenestrated.

Physiological Appearance of Hybrid FDG-Positron Emission Tomography/Computed Tomography Imaging Following Uncomplicated Endovascular Aneurysm Sealing Using the Nellix Endoprosthesis.

Purpose: To investigate the physiological uptake of hybrid fluorine-18-fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) before and after an uncomplicated endovascular aneurysm sealing (EVAS) procedure as a possible tool to diagnose EVAS graft infection and differentiate from postimplantation syndrome. Materials and Methods: Eight consecutive male patients (median age 78 years) scheduled for elective EVAS were included in the prospective study (ClinicalTrials.gov identifier NCT02349100). FDG-PET/CT scans were performed in all patients before the procedure and 6 weeks after EVAS. The abdominal aorta was analyzed in 4 regions: suprarenal, infrarenal neck, aneurysm sac, and iliac. The following parameters were obtained for each region: standard uptake value (SUV), tissue to background ratio (TBR), and visual examination of FDG uptake to ascertain its distribution. Demographic data were obtained from medical files and scored based on reporting standards. Results: Visual examination showed no difference between pre- and postprocedure FDG uptake, which was homogenous. In the suprarenal region no significant pre- and postprocedure differences were observed for the SUV and TBR parameters. The infrarenal neck region showed a significant decrease in the SUV and no significant decrease in the TBR. The aneurysm sac and iliac regions both showed a significant decrease in SUV and TBR between the pre- and postprocedure scans. Conclusion: Physiological FDG uptake after EVAS was stable or decreased with regard to the preprocedure measurements. Future research is needed to assess the applicability and cutoff values of FDG-PET/CT scanning to detect endograft infection after EVAS.

Secondary Endovascular Aneurysm (EVAS) Sealing in Combination With Chimney Grafts to Treat Failed Chimney EVAS.

PURPOSE: To describe a proximal extension of a failed chimney endovascular aneurysm sealing repair (chEVAS) using a chEVAS-in-chEVAS procedure in 2 cases with successful treatment outcome at 2-year follow-up. CASE REPORT: Two patients with an infrarenal abdominal aortic aneurysm were treated with an elective chEVAS procedure with 1 chimney stent for a unilateral renal artery. At 18 and 24 months, respectively, both patients showed aneurysm growth with an associated decrease in proximal seal. Both patients were treated with a secondary chEVAS procedure, consisting of chimney stent-graft placement in the contralateral renal and the superior mesenteric arteries combined with proximal extension of the in situ chimney stent-graft and the Nellix stents. Two-year follow-up demonstrated successful aneurysm exclusion with a patent stent configuration. CONCLUSION: A type Ia endoleak after chEVAS can be successfully repaired with a chEVAS-in-chEVAS procedure.

Systematic Review of Results of Kissing Stents in the Treatment of Aortoiliac Occlusive Disease.

BACKGROUND: Endovascular treatment of aortoiliac occlusive disease (AIOD) involving the aortic bifurcation is challenging. The gold standard is open surgery with patency rates up to 90% at 5 years, but has considerable morbidity and mortality. The kissing stent (KS) technique was introduced as an alternative. The goal of this review is to give an overview of the current results and role of the KS technique in AIOD treatment. METHODS: The Cochrane guidelines were used to assure a systematic method. A search query designed in the Scopus search interface was used to identify relevant studies. Abstracts from the search were screened against the inclusion and exclusion criteria. During full-text reading, methodological quality was scored using a critical review list tailored to the topic of AIOD. Thereafter, study data were extracted and pooled for further analysis. RESULTS: In total, 143 abstracts were retrieved using Scopus, 116 were rejected and 7 more were rejected after full-text screening. One study was included after cross referencing. Twenty-one studies presented 1,390 patients. Rutherford classification 1/2/3 was the indication in 76.2% of patients, and 48.4% of the lesions were classified as Trans-Atlantic Inter-Society Consensus C or D. The technical success rate was 98.7%, and the complication rate was 10.8%. Clinical improvement at 30 days was achieved in 89.9%. Primary patency at 12, 24, and 60 months was 89.3%, 78.6%, and 69.0%, respectively. CONCLUSIONS: KS treatment of AIOD yields acceptable mid-term results, with high technical success rates and mostly minor complications occur. The long-term patency cannot yet match that of open surgery, underlining the need for further research that provides insight into factors related to reocclusion.

The Nellix™ EndoVascular sealing system in patients with abdominal aortic aneurysms in conjunction with iliac artery occlusive disease.

Introduction Concomitant abdominal aortic aneurysm formation and aortoiliac occlusive disease is a challenging combination, often requiring open reconstructive surgery. In this study, we have assessed a single center experience of the Nellix EndoVascular Aneurysm Sealing System in the treatment of an abdominal aortic aneurysm in conjunction with iliac artery occlusive disease. Methods Retrospectively case files of patients treated with Nellix EndoVascular Aneurysm Sealing System in a single center were reviewed. The primary endpoints of the study were the technical success of Nellix EndoVascular Aneurysm Sealing System in patients with coincidental iliac artery occlusive disease and the successful exclusion of the aneurysm during follow-up. Results Of the 96 patients that were treated with Nellix EndoVascular Aneurysm Sealing System, five were identified that had an abdominal aortic aneurysm in conjunction with iliac artery occlusive disease. Treated patients had either unilateral (n = 4) or bilateral (n = 1) common iliac artery occlusive disease varying from 70% stenosis to complete occlusions. The lesion length varied from 5 to 50 mm and in two cases it involved an occluded bare metal stent. The indication for surgery was the abdominal aortic aneurysm in all patients, including three also suffering from claudication. In all patients the iliac artery occlusive disease was pretreated with balloon-expandable covered stents. Technical success was achieved in all five patients. After a median follow-up of nine months all stents were patent with no signs of endoleak and stable aneurysm diameters. All patients were free of intermittent claudication or ischemic wounds. Conclusion Nellix EndoVascular Aneurysm Sealing System seems feasible and safe in patients with a combination of abdominal aortic aneurysm and iliac artery occlusive disease.

Fenestrated Endografts for Complex Abdominal Aortic Aneurysm Repair.

Since the introduction of fenestrated endovascular aneurysm repair (FEVAR) in 1996, great advances have been made in endograft development. Custom-made and off-the-shelf fenestrated and branched endografts have been used to treat patients with complex abdominal aortic and thoraco-abdominal aneurysms. Most experience has been gained with the Cook Zenith® fenestrated endograft (Cook Medical Inc., Limerick, Ireland). The Cook Zenith® endograft is customized with fenestrations, (fixed) inner or outer branches, or a combination of them, to cover a wide range of complex aneurysms. There are limitations to the number, location, and size of the fenestrations and to the maximal angulation of the aorta. Because the production of a custom-made fenestrated endograft takes several weeks, and is therefore not available for emergency cases, off-the-shelf fenestrated endograft were developed. One of these grafts was the Endologix Ventana™ (Endologix, Inc., Irvine, California). This endograft was withdrawn from enrollment due to a high reintervention rate. Vascutek Ltd. developed the custom-made Vascutek Fenestrated Anaconda™ endograft (Vascutek Ltd., Inchinnan, Scotland) to treat patients where other endografts were not suitable-like in a more tortuous aorta with an angulation up to 90°. Additionally, the unsupported proximal body enables a high number and large size of fenestrations if needed. First reports of custom-made fenestrated and (inner and outer) branched JOTEC E-xtra DESIGN ENGINEERING (JOTEC GmbH, Hechingen, Germany) for aortic aneurysms seem promising, but larger series need to be reported to be able to draw conclusions. Both custom-made Cook Zenith® and Vascutek Fenestrated Anaconda™ endografts have good reported clinical outcomes with a perioperative mortality between 4.1 and 6.7% and a reintervention rate of <10% at one year. Knowledge on the long-term outcome of both devices is still limited.

Endovascular repair of a ruptured pararenal aortic aneurysm using the Nellix endovascular aneurysm sealing system and chimney grafts.

PURPOSE: To demonstrate the feasibility of emergent endovascular repair of a ruptured pararenal aneurysm using chimney grafts and the Nellix endovascular aneurysm sealing (EVAS) system to reduce the potential for endoleak from the gutters around the chimney grafts. CASE REPORT: A 74-year-old patient presented with a ruptured pararenal aneurysm. Because of anatomical considerations after previous aortic surgery, conventional endovascular aneurysm repair was deemed impossible. It was decided to exclude the aneurysm with a Nellix EVAS system in conjunction with two chimneys to the renal arteries, even though this was outside the instructions for use of the device. Active bleeding was stopped directly after positioning the chimneys and filling the endobags with polymer. Completion angiography showed aneurysm exclusion and patent renal arteries. Renal function remained stable, and the patient was discharged at the third postoperative day. At 6 months, duplex ultrasound and computed tomography showed patent stents and chimneys and no evidence of endoleak. CONCLUSION: Using chimney grafts in combination with the Nellix endoprosthesis in a ruptured pararenal aneurysm is feasible. However, more robust data on both chimney-EVAS and EVAS in ruptured cases are required.

Evaluation of Electrocardiogram-Gated Computed Tomography Angiography to Quantify Changes in Geometry and Dynamic Behavior during the Cardiac Cycle of the Nellix Endovascular Sealing System.

Background: The Nellix endovascular sealing system (EVAS) was a unique concept with regard to its sealing concept that failed, related to high migration rates. We investigated the changes in aortoiliac morphology during the cardiac cycle before and after EVAS using electrocardiography (ECG)-gated CT. Methods: Eight patients scheduled for EVAS were prospectively enrolled. ECG-gated CT scans were made pre- and postoperatively. Measurements were performed in the mid-systolic and mid-diastolic phases. Endpoints were changes in infrarenal aortoiliac morphology postoperatively compared to preoperatively and their changes in the cardiac cycle. Results: Both pre- and postoperatively, there were no changes during the cardiac cycle. EVAS caused an increase in neck diameter and surface in both phases (p < 0.001). EVAS increased the luminal AAA volume (p < 0.001), with a decrease in thrombus volume (p < 0.001) in both phases and an increase in total volume (p < 0.001) in the systolic phase. During follow-up, one patient presented with >5 mm migration. There were no differences in the movements of this patient compared to the remaining patients. Conclusion: The cardiac cycle had a very limited effect on the aortoiliac dynamics before and after EVAS and, therefore, there is probably not a role for ECG-gated CT in enhanced surveillance programs. EVAS itself has a significant impact on anatomy, particularly the neck diameter, length, and volumes of the AAA.

Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry.

INTRODUCTION: Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease. METHODS AND ANALYSIS: This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1-3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient and vascular surgeon). For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CT angiography or magnetic resonance angiography). Changes in walking performance (treadmill tests, 6 min walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, WHO QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Freedom from revascularisation and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared using Kaplan-Meier survival curves. ETHICS AND DISSEMINATION: This study has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United 'MEC-U' (W17.071). Results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally. TRIAL REGISTRATION NUMBER: NTR7332; Pre-results.

Guideline adherence of mediastinal staging of non-small cell lung cancer: A multicentre retrospective analysis.

OBJECTIVES: Mediastinal lymph node staging of NSCLC by initial endosonography and confirmatory mediastinoscopy is recommended by the European guideline. We assessed guideline adherence on mediastinal staging, whether staging procedures were performed systematically and unforeseen N2 rates following staging by endosonography with or without confirmatory mediastinoscopy. MATERIAL AND METHODS: We performed a multicentre (n = 6) retrospective analysis of NSCLC patients without distant metastases, who were surgical candidates and had an indication for mediastinal staging in the year 2015. All patients who underwent EBUS, EUS and/or mediastinoscopy were included. Surgical lymph node dissection was the reference standard. Guideline adherence was based on the 2014 ESTS guideline. RESULTS: 330 consecutive patients (mean age 69 years; 61% male) were included. The overall prevalence of N2/N3 disease was 42%. Initial mediastinal staging by endosonography was done in 84% (277/330; range among centres 71-100%; p < .01). Confirmatory mediastinoscopy was performed in 40% of patients with tumour negative endosonography (61/154; range among centres 10%-73%; p < .01). Endosonography procedures were performed 'systematically' in 21% of patients (57/277) with significant variability among centres (range 0-56%; p < .01). Unforeseen N2 rates after lobe-specific lymph node dissection were 8.6% (3/35; 95%-CI 3.0-22.4) after negative endosonography versus 7.5% (3/40; 95% CI 2.6-19.9) after negative endosonography and confirmatory mediastinoscopy. CONCLUSION: Although adherence to the European NSCLC mediastinal staging guideline on initial use of endosonography was good, 30% of endosonography procedures were performed insufficiently. Confirmatory mediastinoscopy following negative endosonography was frequently omitted. Significant variability was found among participating centres regarding staging strategy and systematic performance of procedures. However, unforeseen N2 rates after mediastinal staging by endosonography with and without confirmatory mediastinoscopy were comparable.

Treating complex femoropopliteal lesions.

Peripheral artery disease affects 202 million patients worldwide and may cause disabling intermittent claudication and critical limb ischemia. Next to life style changes, best medical treatment and supervised exercise therapy, it can be necessary to re-vascularize the limb. Treatment of femoropopliteal lesions poses a challenge and a surgical bypass remains recommended in the guidelines for longer and more complex lesions. Bypass surgery is associated with substantial morbidity and even mortality. Endovascular alternatives are quickly evolving from plain balloon angioplasty to drug-eluting stents, drug-coated balloons, polytetrafluoroethylene-covered stents and atherectomy. These developments might challenge the gold standard in the near future. This article focuses on which technique can be used for which femoropopliteal lesion, particularly complex lesions, and summarizes the most recent and important literature on this topic.