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Purpose: Despite encouraging early results, mid- and long-term follow-up of endovascular aneurysm sealing (EVAS) has shown increased rates of failure mainly associated with endoleak detection and progressive bag separation with aneurysm reperfusion. Case Report: We present the first case of a Nellix endograft stent fracture detected in a 91-year-old male patient, presenting with widespread abdominal pain, 7 years after elective treatment of an abdominal aortic aneurysm by EVAS. Considering the sudden and unexpected nature of the event, an in-depth analysis of the possible causes of this structural failure has been performed. Conclusion: Material fatigue could be another significant cause of late EVAS failure and should be carefully assessed in addition to endoleak detection during follow-up. Clinical Impact: The case presented in this article further underlines the importance of a strict long term follow-up protocol in every patients who underwent EVAS. [ABSTRACT FROM AUTHOR]

Background-Aim: Several studies have been published showing conflicting results on the outcome after endovascular aneurysm sealing (EVAS). The aim of the present study is to conduct a systematic review and meta-analysis of published evidence to assess the efficacy of EVAS in the management of patients with abdominal aortic aneurysm (AAA). Methods: An electronic search of the English medical literature, from 2010 to March 2021, was conducted using MEDLINE, EMBASE, and Cochrane databases to find studies relevant to outcome after EVAS. Results: The final analysis included 12 articles published between 2011 and 2021, including 1440 patients. In total, 79.3% of the included patients underwent aneurysm treatment according to the instructions for use. Technical success was 98.8%. Overall, 30-day mortality was 1.3%. Procedure-related complications were reported in 4% of the cohort. During median follow-up of 28.1 months (range 9–72 months), the pooled estimate of endoleak type I, migration and reinterventions was 16% (95% confidence interval [CI]=7–25), 16% (95% CI=9–23), and 19% (95% CI=11–28), respectively. In a sub-analysis, 7 studies (703 patients) reported outcome with a mean follow-up of more than 2 years (range 24–72 months). In these studies, the pooled estimate of endoleak type I, migration, and reinterventions was 25% (95% CI=13–38), 22% (95% CI=19–26), and 27% (95% CI=21–33), respectively. Conclusion: Patients who have been treated with EVAS are in high risk for reintervention especially beyond 2 years following implantation. Close surveillance for patients treated with EVAS is mandatory. [ABSTRACT FROM AUTHOR]

Objective: Practice patterns and durability of parallel stent graft techniques in complex endovascular aneurysm repair (EVAR) remain poorly defined. We aimed to quantify and compare the impact of renal chimney intra-aortic stent length (IASL) on geometric deformations of renal arteries in complex EVAR. Methods: Thirty-eight nonconsecutive patients underwent EVAR utilizing parallel stent graft techniques (chimney EVAR [chEVAR], n = 28; chimney endovascular aneurysm sealing [chEVAS], n = 10) between 2010 and 2016. A total of 59 renal chimney stent grafts were used. Geometric quantification was derived from three-dimensional model-based centerline extraction. Renal chimney intra-aortic stent length (IASL) was defined as the length of chimney stent that extended from the proximal edge of the chimney stent to the ostium of the corresponding renal artery. Results: Mean IASL for both left and right renal arteries in the cohort was 35.7mm. Renal arteries containing chimney IASL <30 mm trended toward a greater branch angle (135.4 vs. 127.8°, p = .06). Left renal arteries showed significantly greater branch angle among those with IASL <40 mm (135.5 vs. 121.7°, p = .045). Mean IASL for renal arteries in chEVAR was significantly longer compared to chEVAS (39.2 vs. 26.3 mm, p = .003). No difference was noted in overall branch angle or end-stent angle based on procedure type. ChEVAR with IASL <30 mm had significantly greater end-stent angle (48.2 vs. 33.5°, p = .03). In contrast, chEVAS patients showed no difference in end-stent angle based on IASL thresholds, but did have significantly greater branch angle among those with IASL <30 mm when grouped by both all renal arteries (133.5 vs. 113.5°, p = .004) and right renal arteries (134.3 vs. 111.6°, p = .02). Conclusions: Renal chimney stents with longer IASL appear to exhibit less renal artery deformation, suggesting a more gradual and perpendicular transition of the chimney stent across the renal ostium. [ABSTRACT FROM AUTHOR]

After alerts on EndoVascular Aneurysm Seal (EVAS) failure were raised, the European Society for Vascular Surgery (ESVS) Abdominal Aortic Aneurysm (AAA) Clinical Practice Guidelines Writing Committee (WC) initiated a task force with the aim to provide guidance on surveillance and management of patients with implanted EVAS devices. Based on a scoping review of risk for late serious aortic-related adverse events in patients treated with EVAS for AAA, the ESVS AAA Guidelines WC agreed on recommendations graded according to the European Society of Cardiology (ESC) grading system. EVAS has a very high incidence of late endograft migration resulting in proximal type 1 endoleak with risk of rupture, requiring open conversion with device explantation. The reported mortality rate for elective explantation varies between 0% and 14%, while acute conversion for rupture has a very dismal prognosis with a 67 – 75% mortality rate. It is recommended that all patients in whom a Nellix device has been implanted should be identified, properly informed, and enrolled in enhanced surveillance. If device failure is detected, early elective device explantation should be considered in surgically fit patients. [ABSTRACT FROM AUTHOR]

Purpose: This technical note presents a case of a patient with a failed Nellix device (Endologix, Irvine, Calif) who was not deemed fit for open conversion. Our planned approach for repair involved an endovascular procedure utilizing a custom-made branched device., Technique: An endovascular repair was performed via a custom-made four outer branched device in conjunction with a custom-made bifurcated graft featuring inverted limbs (Cook Inc., Bloomington, Ind). All branches were connected to the target vessel with Gore Viabahn VBX balloon-expandable covered stents (Gore & Associates Inc.)., Conclusion: Endovascular conversion with branched endovascular repair in a patient not deemed fit for open surgery was successfully performed, thereby reducing the risk of a high morbid and mortal procedure., Clinical Impact: Novel useful treatment solution of failed EVAR with Nellix device., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Endovascular aneurysm sealing (EVAS) is a sac-filling device with a blunted systemic inflammatory response compared to conventional endovascular aneurysm repair (EVAR), with a suggested impact on all-cause mortality. This study compares mortality after both EVAS and EVAR. Materials and Methods: This is a retrospective observational study including data from 2 centres, with ethical approval. Elective procedures on asymptomatic infrarenal aneurysms performed between January 2011 until April 2018 were enrolled. Laboratory values (serum creatinine, haemoglobin, white blood cell count, platelet count) were measured pre- and postoperatively and at 1 and 2 years, respectively. Mortality and cause of death were recorded during follow-up. Results: A total of 564 patients were included (225 EVAS, 369 EVAR), after propensity score matching there were 207 patients in both groups. Baseline characteristics were similar, except for larger neck angulation and more pulmonary disease in the EVAR group. The median follow-up time was 49 (EVAS) and 44 (EVAR) months. No significant differences regarding creatinine and haemoglobin were observed. Preoperative white blood cell count was higher in the EVAR group (p=0.011), without significant differences during follow-up. Median platelet count was lower in the EVAR group preoperatively (p=0.001), but was significantly higher at 1 year follow-up (p=0.003). There were 43 deaths within the EVAS group (20.8%) and 52 within the EVAR group (25.1%) (p=0.293). Of these, 4 were aneurysm related (EVAS n=3, EVAR n=1; p=0.222) and 14 cardiovascular (EVAS n=6, EVAR n=8, p=0.845). For the EVAS cohort, survival was 95.5% at 1 year and 74.9% at 5 years. For the EVAR cohort, this was 93.3% at 1 year and 75.5% at 5 years. No significant differences were observed in causes of death. Conclusion: This study showed comparable survival rates through 5 years between EVAS and EVAR with a tendency toward higher inflammatory response in the EVAR patients through the first 2 years. [ABSTRACT FROM AUTHOR]

Xin Y Choo,1 Shahab Hajibandeh,1 Shahin Hajibandeh,1 George A Antoniou1,2 1Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK; 2Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manchester, UK Background: The Nellix endovascular aneurysm sealing (EVAS) system is a novel approach for the treatment of abdominal aortic aneurysm (AAA). We aimed to evaluate the efficacy of EVAS in the management of patients with AAA. Materials and methods: We searched PubMed/MEDLINE, CINAHL, and bibliographic reference lists to identify studies reporting clinical outcomes in patients with asymptomatic, non-ruptured AAA treated with EVAS with the Nellix device. We pooled dichotomous outcome data using random-effects models. Results: We identified 14 single-arm observational studies, reporting a total of 1,510 patients. The pooled estimate of technical success was 99% (95% CI =98–100; heterogeneity: P=0.869, I2=0%). Adjunctive procedures were carried out in 39% (95% CI =19–63; heterogeneity: P

Purpose: The main objective of this work is to investigate hemodynamics phenomena occurring in EVAS (Endo Vascular Aneurysm Sealing), to understand if and how they could lead to type 1a endoleaks and following re-intervention. To this aim, methods based on computational fluid mechanics are implemented as a tool for checking the behavior of a specific EVAS configuration, starting from the post-operative conditions. Pressure and velocity fields are detailed and compared, for two configurations of the Nellix, one as attained after correct implantation and the other in pathological conditions, as a consequence of migration or dislocation of endobags. Methods: The computational fluid dynamics (CFD) approach is used to simulate the behavior of blood within a segment of the aorta, before and after the abdominal bifurcation. The adopted procedure allows reconstructing the detailed vascular geometry from high-resolution computerized tomography (CT scan) and generating the mesh on which the equations of fluid mechanics are discretized and solved, in order to derive pressure and velocity field during heartbeats. Results: The main results are obtained in terms of local velocity fields and wall pressures. Within the endobags, velocities are usually quite regular during the whole cardiac cycle for the post-implanted condition, whereas they are more irregular for the migrated case. The largest differences among the two cases are observed in the shape and location of the recirculation region in the rear part of the aorta and the region between the endobags, with the formation of a gap due to the migration of one or both of the two. In this gap, the pressure fields are highly different among the two conditions, showing pressure peaks and pressure gradients at least four times larger for the migrated case in comparison to the post-implanted condition. Conclusions: In this paper, the migration of one or both endobags is supposed to be related to the existing differential pressures acting in the gap formed between the two, which could go on pushing the two branches one away from the other, thus causing aneurysm re-activation and endoleaks. Regions of flow recirculation and low-pressure drops are revealed only in case of endobag migration and in presence of an aneurysm. These regions are supposed to lead to possible plaque formation and atherosclerosis. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the technical features and clinical results after open conversion for complications following endovascular aneurysm sealing (EVAS). Materials and Methods: From July 2013 to February 2020, 44 patients (mean age 72±8 years; 36 men) underwent an open conversion due to EVAS complications in a single center. Data were collected on patient characteristics, reasons for conversion, characteristics and duration of the procedure, condition of the polymer, blood loss, time in the intensive care unit (ICU), and intra/postoperative complications. The main outcome measure was mortality at 30 days and in follow-up. Data are presented as the median (IQR) and absolute range. Results: On average, the open conversion took place 3 years after the initial EVAS implantation [median 37 months (IQR 23, 50); range 0–64]. Most patients were converted due migration (82%), aneurysm growth (77%), and/or endoleak (75%), with 21 patients (48%) having all 3 events. Less frequent diagnoses were aneurysm rupture (n=7), aortic infection (n=3), technical failure during implantation (n=2), and graft thrombosis (n=1). The majority of patients (n=26) were asymptomatic and converted electively, but 9 were operated on urgently and 9 emergently (7 late rupture and 2 due to technical failure). The median procedure duration was 178 minutes (IQR 149, 223; range 87–417), the median blood loss was 1100 mL (IQR 600, 2600; range 300–5000). Polymer degradation was mentioned in the operative reports of 18 cases (41%). Patients stayed a median of 3 days (IQR 2, 7; range 1–35) in the ICU, while the median length of stay in the hospital was 14 days (IQR 10, 20; range 0–93). The 30-day mortality was 23% (n=10). During a median follow-up of 3 months (IQR 0, 11; range 0–38), no additional deaths occurred, but 12 patients suffered from an adverse event. There were 3 cases of wound dehiscence after laparotomy, 2 cases of leg ischemia, 2 cases of renal failure, and individual cases of urinary obstruction, urinoma, paralytic ileus, gastrointestinal bleeding, and postoperative delirium. A non-elective setting was associated with a significantly increased mortality of 33% in urgent cases and 56% in emergent cases (p=0.007). Based on these results an algorithm for the management of EVAS complications was developed. Conclusion: The significantly increased mortality associated with nonelective conversions highlights the need for active surveillance. The presented algorithm offers a structured tool to avoid emergency conversions. [ABSTRACT FROM AUTHOR]

Purpose: To assess the incidence of migration after endovascular aneurysm sealing (EVAS) in conjunction with chimney grafts (chEVAS) for repair of abdominal aortic aneurysms (AAAs). Materials and Methods: A retrospective, observational cohort study was conducted of 31 patients (mean age 75.7 years; 27 men) treated for juxtarenal AAA between April 2013 and December 2018 at single centers in New Zealand and the Netherlands. The majority of patients received >1 chimney graft (13 single, 13 double, and 5 triple) during chEVAS. Six patients had only the first postoperative scan, so the migration analysis was based on 25 patients. Results: Median seal length assessed on the first postoperative computed tomography scan was 36.5 mm. The assisted technical success rate was 93.5% with 2 technical failures. Median time to final imaging follow-up was 17 months in 25 patients. At the latest follow-up, there were no cases of caudal migration >10 mm. Freedom from caudal movement of 5 to 9 mm was estimated as 86.1% at 1 year and 73.9% at 2 years; freedom from clinically relevant migration (movement requiring reintervention) was 100% at both time intervals. However, at 3 years there were 2 cases of caudal movement of 5 to 9 mm and a type Ia endoleak warranting reintervention. No correlation between migration and aneurysm growth (p=0.851), endoleak (p=0.562), or the number of chimney grafts (p=0.728) was found. During follow-up, 2 patients (7%) had aneurysm rupture and 10 (33%) had reinterventions. Eight patients (27%) died; 2 were aneurysm-related (7%) and due to the consequences of a reintervention. Conclusion: In the 2 years following chEVAS, there was no caudal migration >10 mm, but nearly a quarter of patients had caudal movement of 5 to 9 mm. A trend was observed toward ongoing migration that required intervention at 3-year follow-up. chEVAS is technically challenging and should be considered only for patients with no viable alternative treatment option. [ABSTRACT FROM AUTHOR]

Endovascular aneurysm sealing (EVAS) was a relatively new concept that aimed to reduce the incidence of complications after endovascular aneurysm exclusion. However, EVAS device was recently recalled from market due to high risk of graft failure beyond two years after implantation(1,2). The aim of this paper is to report a case of a post-EVAS ruptured abdominal aortic aneurysm. A 72 year-old-man underwent EVAS and a bilateral sandwich technique of the iliac bifurcation for an aorto-bi-iliac aneurysm in 2015 in another institution. Follow-up CTA at three years showed a type Ib endoleak in the left iliac bifurcation and the patient was kept under clinical and imagiological surveillance (protocol unkown, again at another institution). Four years after the initial procedure the patient was admitted in the emergency department of our hospital after syncope and with abdominal pain. The CT-angiography (CTA) revealed a post-EVAS rupture in the distal aorta suggesting an endobag rupture (Fig 1). The patient underwent open surgical repair with explantation of the EVAS device (Fig 2 and 3) and an aorto-bifemoral interposition with a Dacron graft. The procedure was uneventful and the post-operative CTA showed a patent aorto-bifemoral graft without evidence of any complications (Fig. 4). One week later the patient was discharged home in good clinical condition. Post-operative surveillance is important in any aortic aneurysm endovascular procedure. However, since the last EVAS studies, all patients submitted to this technology must be under strict surveillance to identify complications like endobag rupture that can lead, as in the reported case, to aneurysm rupture which in turn can lead to stent graft explantation in an emergency setting

Purpose: To report mid-term results of endovascular aneurysm sealing (EVAS) of abdominal aortic aneurysms (AAA) deemed unsuitable for a standard endovascular aneurysm repair (EVAR). Methods: A prospectively maintained database of 42 patients with EVAR-unfavorable anatomy treated by EVAS combined with chimney grafts in case of the proximal AAA neck shorter than 5 mm was analyzed. Early outcomes included final angiographic result, intra- and early post-operative deaths, and complications. Mid-term outcomes included all-cause mortality (ACM), aneurysm-related mortality (ARM), patency of the stents, occurrence of endoleaks, serious complications and graft failures defined as the AAA growth of more than 5 mm, type I endoleak, occlusion of the stent-graft or chimney graft, aorto-duodenal fistula, or aneurysm rupture. Results: The procedure was completed in all patients. Twenty-eight chimney grafts were implanted in 19 patients. Patients were followed for a median of 24 months (range 12-34 months). There were 2 intraoperative ruptures and 1 patient died in an early postoperative period. The cumulative ACM was 15, 21, and 36% at 12, 24, and 36 months, respectively, and the cumulative ARM was 8, 11, and 27% at 12, 24, and 36 months, respectively. Three out of 5 aneurysm-related deaths were due to a secondary aorto-duodenal fistula. The cumulative incidence of graft failure was 20, 27, and 42% at 12, 24, and 36 months, respectively. The cumulative incidence of an endoleak was 5, 9, and 23% at 12, 24, and 36 months, respectively. The graft failure increased significantly both ACM (p =.012) and ARM (p =.00003). The implantation of chimney grafts at the initial procedure increased ARM significantly (p =.008). The presence of an endoleak did not have any significant influence on ACM and ARM. Conclusion: Patients treated with EVAS for AAAs with EVAR-unfavorable anatomy, especially those with chimney grafts, exhibit a high risk of graft failure and subsequent death. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: The Nellix EndoVascular Aneurysm Sealing (EVAS) system has offered a novel approach in the treatment of abdominal aortic aneurysm (AAA). While it is currently indicated as a primary procedure in patients with infrarenal AAA with suitable anatomy according to the indications for use, a few studies aimed to address its potential interest in failed endovascular aneurysm repair (EVAR). The aim of this systematic review was to analyze the postoperative outcomes of patients with prior EVAR who underwent EVAS.Design Of the Study: A literature search was performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines in May 2019 and included patients with prior EVAR who underwent EVAS. The publications had to report at least one of the basic postoperative outcomes (technical success rate, all-cause complications, mortality, length of in-hospital stay, length of stay in intensive care unit, the need of re-intervention).Results: Eleven studies fulfilled the inclusion criteria, for a total of 46 patients. EVAS was used to treat endoleaks in 45 cases (97.8%): 29 type Ia endoleaks (63%), 6 type IIIa endoleaks (13%), and 10 type IIIb endoleaks (21.7%). Standard EVAS procedure was performed in 21 patients (45.7%), and 25 patients (54.3%) had chimney-EVAS. The technical success was achieved in all the studies. Two patients (4.9%) died during the 30-day postoperative period, but no aneurysm-related mortality was reported. The presence of endoleaks was reported in five patients (9.8%) during the follow-up.Conclusion: The results suggest the safety and the efficiency of EVAS in the treatment of complications following EVAR including type Ia, type IIIa, and type IIIb endoleaks. Further studies on larger cohorts and longer follow-up periods are required to confirm the interest of EVAS in the endovascular management of failed EVAR. [ABSTRACT FROM AUTHOR]

Chimney endovascular aneurysm sealing (ch-EVAS) could potentially minimize gutter-associated endoleaks in patients with juxtarenal abdominal aortic aneurysms resulting from the use of the conformable endobags surrounding the chimney stent grafts (ch-SGs). The aim of the present study was to quantify the (non)apposition of the endobags in the proximal aortic neck, migration of the endograft stent frames, and changes in geometry of the ch-SGs during the follow-up period. The prospective data from 20 patients undergoing elective ch-EVAS were retrospectively reviewed. The aortic anatomy was analyzed on preoperative and postoperative computed tomography scans. The (non)apposition of the endobags in the aortic neck, Nellix (Endologix, Irvine, Calif) stent frame migration, and chimney graft geometry and migration were assessed. The median preoperative infrarenal neck length was 4.0 mm (interquartile range [IQR], 0-6.0 mm). The median seal length in the juxtarenal aortic neck at the first follow-up was 23.0 mm (IQR 18.0-30.8 mm). Five type IA endoleaks were identified on postoperative imaging; one at 1 month and four newly diagnosed at 1 year. Of these five type IA endoleaks, two were type Is1 (not extending into the aneurysm sac) and did not need reintervention and other three were type Is2 (extending into the aneurysm sac). One of these patients died of malignancy before reintervention could be performed. Bilateral ch-SG occlusions in one patient were documented at the 1-month follow-up (patient needed hemodialysis) and two patients with a new single ch-SG occlusion were found at the 1-year follow-up. No reinterventions were performed for the ch-SG occlusions. An occluded Nellix stent frame in one patient was treated with femorofemoral crossover bypass. Kaplan-Meier estimate of reintervention-free survival was 85.0% after 1 year. Migration ≥5 mm of the proximal end of the Nellix stent frames was observed in 20.0% of the patients, but no reintervention was performed at the 1-year follow-up. Imaging showed 20.1% of the available sealing surface was not used, and the nonapposition surface increased to 30.6% of the preoperative aortic neck surface at 1 year. Median migration was 3.5 mm (IQR, 2.4-5.0 mm) and 3.1 mm (IQR, 2.0-4.8 mm) for the left and right proximal end of the Nellix stent frames, respectively, and was 3.0 mm (IQR, 2.2-4.8 mm) for the proximal end of the ch-SGs at 1 year of follow-up. Substantial distal migration of the Nellix endograft and positional changes of the ch-SGs in the juxtarenal aortic neck were observed at 1 year of follow-up, resulting in a 25.0% type IA endoleak rate, with three of these type IA endoleaks extending into the aneurysm sac. The reintervention-free survival rate was 85.0% at 1 year in this cohort of 20 patients. Careful follow-up after ch-EVAS is advised because changes are often subtle. The authors have stopped the ch-EVAS procedure so far. Long-term follow-up data on the stability of the Nellix endograft and the consequences of migration on ch-SGs is required before this technique should be used in clinical practice. [ABSTRACT FROM AUTHOR]

The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed. [ABSTRACT FROM AUTHOR]

Purpose: To quantify deformations of renal arteries and snorkel stents after snorkel endovascular aneurysm sealing (Sn-EVAS) resulting from cardiac pulsatility and respiration and compare these deformations to patients with untreated abdominal aortic aneurysms (AAA) and snorkel endovascular aneurysm repair (Sn-EVAR). Materials and Methods: Ten Sn-EVAS patients (mean age 75±6 years; 8 men) were scanned with cardiac-gated, respiration-resolved computed tomography angiography. From 3-dimensional geometric models, changes in renal artery and stent angulation and curvature due to cardiac pulsatility and respiration were quantified. Respiration-induced motions were compared with those of 16 previously reported untreated AAA patients and 11 Sn-EVAR patients. Results: Renal artery bending at the stent end was greater for respiratory vs cardiac influences (6°±7° vs -1°±2°, p<0.025). Respiration caused a 3-fold greater deformation on the left renal artery as compared with the right side. Maximum curvature change was higher for respiratory vs cardiac influences (0.49±0.29 vs 0.24±0.17 cm-1, p<0.025), and snorkel renal stents experienced similar maximum curvature change due to cardiac pulsatility and respiration (0.14±0.10 vs 0.19±0.09 cm-1, p=0.142). When comparing the 3 patient cohorts for respiratory-induced deformation, there was significant renal branch angulation in untreated AAAs, but not in Sn-EVAR or Sn-EVAS, and there was significant bending at the stent end in Sn-EVAR and Sn-EVAS. Maximum curvature change due to respiration was ~10-fold greater in Sn-EVAR and Sn-EVAS compared to untreated AAAs. Conclusion: The findings suggest that cardiac and respiratory influences may challenge the mechanical durability of snorkel stents of Sn-EVAS; similarly, however, respiration may be the primary culprit for tissue irritation, increasing the risk for stent-end thrombosis, especially in the left renal artery. The bending stiffness of snorkel stents in both the Sn-EVAR and Sn-EVAS cohorts damped renal branch angulation while it intensified bending of the artery distal to the snorkel stent. Understanding these device-to-artery interactions is critical as they may affect mechanical durability of branch stents and quality and durability of treatment. [ABSTRACT FROM AUTHOR]

The treatment of juxtarenal abdominal aortic aneurysms is challenging. Open surgical repair is not a viable option for many patients. The use of endovascular aneurysm sealing (EVAS) with chimney grafts (Ch-EVAS) has been proposed as an immediately available, off-the-shelf option for individuals with juxtarenal aneurysms who require urgent treatment or are unsuitable for fenestrated or branched devices. This study reports the outcomes from our first patients to undergo this procedure. Data were collected prospectively for 62 consecutive patients undergoing Ch-EVAS at our institution. The procedures were undertaken for intact juxtarenal or suprarenal aneurysms in patients who were unfit for open repair or needed urgent treatment or when the aneurysm morphology was unsuitable for treatment with fenestrated or branched endografts. Between July 2013 and June 2016, there were 62 patients who were treated with Ch-EVAS; 77.4% were male, and the mean age was 73.9 years. Median aneurysm diameter was 64.5 mm. Eight suprarenal aneurysms were treated, with three chimney grafts. Of 54 juxtarenal aneurysms treated, 21 cases used two chimney grafts and 33 cases used one chimney graft. Median follow-up was 407 days. Eleven patients underwent reintervention. There were five type IA endoleaks, all successfully treated. One type IB and one type II endoleak occurred, neither requiring treatment. There were four minor strokes. Chimney patency is 97%. These results in a group of high-risk patients suggest that Ch-EVAS is a viable alternative to custom-made devices in patients who are unfit for open surgery. Longer term follow-up and data from the international registry will determine the widespread applicability and durability of this technique. [ABSTRACT FROM AUTHOR]

Endovascular treatment of a type IA endoleak was conducted using a Nellix chimney graft technique for an expanding abdominal aortic aneurysm in an 84-year-old man. During the procedure, a polymer leak occurred from one of the endobags. Postoperatively, the patient developed hemodynamic instability and a swollen leg on the side of the leaking endobag, resulting in a fatal outcome. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: To investigate in an in vitro model if secondary endobag filling can reduce gutter size during chimney endovascular aneurysm sealing (chEVAS).Materials and Methods: Nellix EVAS systems were deployed in 2 silicone juxtarenal aneurysm models with suprarenal aortic diameters of 19 and 24 mm. Four configurations were tested: EVAS with 6-mm balloon-expandable (BE) or self-expanding (SE) chimney grafts (CGs) in the renal branches of both models. Balloons were inflated simultaneously in the CGs and main endografts during primary and secondary endobag filling and polymer curing. Computed tomography (CT) was performed immediately after the primary and secondary fills. Cross-sectional lumen areas were measured on the CT images to calculate gutter volumes and percent change. CG compression was calculated as the reduction in lumen surface area measured perpendicular to the central lumen line. The largest gutter volume and highest compression were presented per CG configuration per model.Results: Secondary endobag filling reduced the largest gutter volumes from 99.4 to 73.1 mm3 (13.2% change) and 84.2 to 72.0 mm3 (27.6% change) in the BECG configurations and from 67.2 to 44.0 mm3 (34.5% change) and 92.7 to 82.3 mm3 (11.2% change) in the SECG configurations in the 19- and 24-mm models, respectively. Secondary endobag filling increased CG compression in 6 of 8 configurations. BECG compression changed by -0.2% and 5.4% and by -1.0% and 0.4% in the 19- and 24-mm models, respectively. SECG compression changed by 10.2% and 16.0% and by 7.2% and 7.3% in the 19- and 24-mm models, respectively.Conclusion: Secondary endobag filling reduced paragraft gutters; however, this technique did not obliterate them. Increased CG compression and prolonged renal ischemia time should be considered if secondary endobag filling is used. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the incidence and extent of stent frame movement after endovascular aneurysm sealing (EVAS) in the abdominal aorta and its relationships to aneurysm growth and the instructions for use (IFU) of the Nellix endograft.Methods: A retrospective single-center study was conducted to review the clinical data and computed tomography (CT) images of 75 patients (mean age 76±7.6 years; 57 men) who underwent infrarenal EVAS and had a minimum 1-year follow-up. The first postoperative CT scan at 1 month and the subsequent scans were used to measure the distances between the proximal end of the stent frames and a reference visceral vessel using a previously validated technique. Device migration was based on the Society of Vascular Surgery definition of >10-mm downward movement of either Nellix stent frame in the proximal landing zone; a more conservative proximal displacement measure (downward movement ⩾4 mm) was also recorded. Patients were categorized according to adherence to the old (2013) or new (2016) Nellix IFU. Aneurysm diameter was measured for each scan; a change ⩾5 mm was deemed indicative of aneurysm growth.Results: Over a median follow-up of 24 months (range 12-48), proximal displacement ⩾4 mm occurred in 42 (56%) patients and migration >10 mm in 16 (21%), with similar incidences in the right and left stent frames. Proximal displacement was significantly more frequent among patients whose anatomy did not conform to any IFU (p=0.025). Presence of aneurysm growth ⩾5 mm was observed in 14 (19%) patients and was significantly associated with proximal displacement ⩾4 mm (p=0.03).Conclusion: Infrarenal EVAS may be complicated by proximal displacement and migration, particularly when performed outside the IFU. The definition of migration used for endovascular aneurysm repair may be inappropriate for EVAS; a new consensus on definition and measurement technique is necessary. [ABSTRACT FROM AUTHOR]

Purpose: To report the use of the Nellix endovascular aneurysm sealing (EVAS) system in the management of proximal stent-graft collapse associated with thrombosis following endovascular aneurysm repair (EVAR).Case Report: A 76-year-old man was admitted for proximal collapse of an aortic extension following bifurcated AFX stent-graft implantation associated with chimney grafts in both renal arteries and the superior mesenteric artery 1 month prior. Imaging identified thrombosis of the aortic stent-graft and the iliac limbs. A Nellix EVAS was placed into the AFX stent-graft to recanalize the aneurysm lumen and address the aortic thrombosis. There was no endoleak, and the renovisceral chimney stent-grafts remained patent over a follow-up of 25 months.Conclusion: While further studies are required to generalize its use, EVAS appears to be feasible in the management of aortic stent-graft collapse. [ABSTRACT FROM AUTHOR]

Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU).Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3).Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690).Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology.Methods: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95% confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 - Q1).Results: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95% CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47% (IQR 43) vs 49% (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066).Conclusion: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the impact of the revised Nellix instructions for use (IFU) from 2016 on clinical outcomes and anatomic applicability by retrospectively applying them to a cohort treated with endovascular aneurysm sealing according to the original IFU 2013.Methods: A single-center study was conducted of 100 consecutive patients (mean age 72±8 years, range 46-91; 89 men) treated electively with standard bilateral EVAS from July 2013 to August 2015 and followed through December 2017. Procedures previously classified within and outside the original IFU from 2013 (75 and 25, respectively) were reclassified according to the revised IFU 2016 (34 and 66, respectively). Stepwise backward logistic regression analysis was performed to evaluate the prognostic value of specific anatomic features for the development of endoleak and/or migration.Results: The single most important morphologic feature disqualifying patients from being within IFU 2016 was a thrombus ratio >1.4 (36 of 41 reclassified patients). Overall technical success was 98% (100% within vs 97% outside IFU 2016, p=0.323) and 30-day mortality was 3% (0% within vs 5% outside IFU 2016, p=0.251). During a median follow-up of 31 months (range 0-53), overall mortality was 21% (15% within vs 24% outside IFU 2016, p=0.469); aneurysm-related mortality was 8% (3% within vs 11% outside IFU 2016, p=0.533). Twenty-six patients developed an endoleak (6 within vs 20 outside IFU 2016, p=0.172) and 23 had migration (4 within vs 19 outside IFU 2016, p=0.088). Both proximal neck length <10 mm and neck angulation >60° were positive predictors for the development of endoleak and/or migration. A reintervention was performed in 26 patients (7 within vs 19 outside IFU 2016, p=0.376). While a significant difference was found between the within vs outside IFU 2016 groups with regard to freedom from migration (p=0.026) and the composite freedom from endoleak and/or migration (p=0.021), there were no significant differences in survival (p=0.201) or freedom from reintervention (p=0.505), suggesting a limited effectiveness of the new IFU 2016.Conclusion: The IFU 2016 reduced the anatomic applicability to 34% from 75% for the original IFU 2013. The lack of significant intergroup differences in terms of survival and reinterventions suggests a limited effectiveness of the new IFU 2016. [ABSTRACT FROM AUTHOR]

Objective: Late complications after previous endovascular aneurysm repair (EVAR) procedures include type I/III endoleaks causing aneurysm growth and rupture. We reviewed our results from the management of such complications with endovascular aneurysm sealing (EVAS) techniques.Methods: Analysis of our prospectively maintained aneurysm database was performed (December 2013-May 2017). Primary outcomes were: (1) success of the procedure in excluding the primary complication, (2) perioperative mortality, (3) post-operative complications and (4) survival.Results: Ten consecutive patients were treated for complications of EVAR procedures performed 2-12 years previously. All patients underwent EVAS with/without chimney grafts for 6 type Ia,1 type IIIb and 3 undetermined (but presumed type IIIb) endoleaks. Overall, 19 Nellix® devices were used. The technical success with type Ia endoleaks was 100%. All sealed using proximal extension through chimney EVAS with 1 target vessel loss. There were no perioperative deaths. All but 1 type Ia endoleak remained eliminated at follow-up (range 2-29 months) as did the proven type IIIb endoleak. Two of the 3 undetermined endoleaks demonstrated continued sac expansion requiring surgical exploration by laparotomy, during which type II endoleaks were identified.Conclusions: EVAS provides effective short-term treatment of type Ia/IIIb endoleaks after EVAR. However, late complications may occur due to disease progression.Level Of Evidence: Level 4, case series. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the 2-year outcomes of endovascular aneurysm sealing (EVAS) according to 2 versions of the instructions for use (IFU). Methods: A retrospective study was conducted involving 355 consecutive patients treated with the first-generation EVAS device from April 2013 to December 31, 2015, at 3 high-volume centers. Out of 355 patients treated with EVAS, 264 were elective asymptomatic infrarenal EVAS procedures suitable for analysis. In this cohort, 168 (63.3%) patients were treated within the IFU 2013 criteria; of these 48 (18.2%) were in compliance with the revised IFU 2016 version. Results: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year freedom from reintervention estimates were 89.7% (IFU 2013) and 95.7% (IFU 2016), with significantly more reinterventions in the first 45 cases (p=0.005). The stenosis/occlusion estimates were 6.5% (IFU 2013) and 4.2% (IFU 2016; p=0.705). Nine (5.4%) endoleaks (8 type Ia and 1 type Ib) were observed within the IFU 2013 cohort; 3 (2.1%) were in the IFU 2016 subgroup (p=0.583). Migration ≥10 mm or ≥5 mm requiring intervention was reported in 12 (7.1%) patients in the IFU 2013 cohort but none within the IFU 2016 subgroup. Ten (6.0%) patients demonstrated aneurysm growth in the IFU 2013 cohort, of which 2 (4.2%) were in the IFU 2016 subgroup. Overall survival and freedom from aneurysm-related death estimates at 2 years were 90.9% and 97.6% in the IFU 2013 cohort (IFU 2016: 95.5% and 100.0%). The prevalence of complications seemed lower within IFU 2016 without significant differences. Conclusion: This study shows acceptable 2-year results of EVAS used within the IFU, without significant differences between the 2 IFU versions, though longer follow-up is indicated. The refined IFU significantly reduced the applicability of the technique. [ABSTRACT FROM AUTHOR]

Endovascular aneurysm sealing (EVAS) using the Nellix Endovascular Sealing System was introduced commercially in 2013 with the aim of reducing the incidences of reintervention and late complications observed after conventional endovascular aneurysm repair (EVAR). In the 5 years since its commercial launch, the Nellix system has evolved in terms of its structure, instructions for use, and delivery technique. Complications, including migration and proximal endoleak, have been recognized and treatment strategies developed, although durability remains to be demonstrated. Prospective multicenter trials have shown a low incidence of type I endoleak and reintervention at 1-year follow-up, comparable to conventional EVAR with modern devices. Since the aneurysm sac is “actively managed” with EVAS, similar to open surgical repair, type II endoleaks are rare with the Nellix system. Unexpected benefits of active sac management with EVAS include reduced incidences of postimplantation syndrome and cardiac complications, with low all-cause mortality at 1 year. Less neck dilatation compared to EVAR has also been observed. The Nellix device and procedure continue to evolve, and further prospective studies are indicated. This article analyzes the current EVAS evidence to update our knowledge of this technique in the management of abdominal aortic aneurysm. [ABSTRACT FROM AUTHOR]

Purpose: To report bailout treatment of a thoracoabdominal aortic aneurysm using a single Nellix stent and parallel stents.Case Report: A 74-year-old man with multiple comorbidities and a previous fenestrated Anaconda stent-graft for a 60-mm juxtarenal aneurysm was diagnosed with a type IV thoracoabdominal aneurysm on the 2-year computed tomography angiography (CTA) scans. The imaging showed >10-mm downward migration of the proximal Anaconda stent with a massive type Ia endoleak and aneurysmal evolution of the distal descending thoracic aorta; the superior mesenteric artery (SMA) and renal artery covered stents were patent and intact. Open conversion or a second custom-made endograft was not feasible. A plan was devised to use off-the-shelf materials, including the deployment of a single Nellix stent extending from the descending thoracic aorta into the stented area of the fenestrated endograft, with parallel chimney stent-grafts into the SMA and right renal artery; the left renal artery was treated with a bare stent in a periscope configuration. Transient paraparesis was resolved with cerebrospinal fluid drainage. At 6-month CTA, ongoing aneurysm exclusion with patent SMA and renal arteries was confirmed.Conclusion: Thoracic endovascular aneurysm sealing with visceral and renal stenting seems to be a feasible bailout alternative treatment for urgent, complex cases without reconstruction options. [ABSTRACT FROM AUTHOR]

Purpose: To explore whether or not there are temporal changes in the abdominal aortic aneurysm (AAA) and intraluminal thrombus (ILT) volumes between planning and implantation of the endovascular aneurysm sealing (EVAS) device and how these changes influence lumen volume.Methods: A retrospective review was conducted of 51 AAA patients (mean age 76±7.1 years; 36 men) in whom 2 serial preoperative computed tomography angiograms (CTAs) had been performed within 1 to 18 months before fenestrated endovascular repair. The 2 preoperative CTAs were analyzed to identify changes in total sac, ILT, and lumen volumes.Results: Over a median 7.0 months (interquartile range 4, 10), 46 (90%) of 51 AAAs increased in volume between the 2 CTAs. ILT volume increased in 44 aneurysms. In contrast, lumen volume increased in 31 and decreased in 20 AAAs. There was a strong correlation between changes in AAA volume and ILT volume (rs=0.859, p<0.001), which remained significant after adjustment for initial volumes (rs=0.815; p<0.001). There was no correlation between the time interval separating the 2 CTAs and changes in AAA volume (rs=0.115; p=0.421), changes in ILT volume (rs=0.084; p=0.599), or changes in lumen volume (rs=0.060; p=0.676). The AAA growth rate (defined as the change in AAA size/days between CTAs) showed a weak correlation with ILT volume (rs=0.272, p=0.054), which disappeared after adjustment for initial AAA size (rs=-0.002, p=0.991). Between the 2 CTAs, 12 aneurysms crossed the new <1.4 Nellix maximum aorta/lumen diameter ratio.Conclusion: As AAAs grow, the increase in aortic volume is largely occupied by additional ILT formation, with minimal change in lumen volume. These changes may alter the suitability of the aneurysm for the Nellix device and could have implications for EVAS planning and device deployment. [ABSTRACT FROM AUTHOR]

Purpose: To describe and validate a new methodology for visualizing and quantifying 3-dimensional (3D) displacement of the stent frames of the Nellix endosystem after endovascular aneurysm sealing (EVAS).Methods: The 3D positions of the stent frames were registered to 5 fixed anatomical landmarks on the post-EVAS computed tomography (CT) scans, facilitating comparison of the position and shape of the stent frames between consecutive follow-up scans. Displacement of the proximal and distal ends of the stent frames, the entire stent frame trajectories, as well as changes in distance between the stent frames were determined for 6 patients with >5-mm displacement and 6 patients with <5-mm displacement at 1-year follow-up. The measurements were performed by 2 independent observers; the intraclass correlation coefficient (ICC) was used to determine interobserver variability.Results: Three types of displacement were identified: displacement of the proximal and/or distal end of the stent frames, lateral displacement of one or both stent frames, and stent frame buckling. The ICC ranged from good (0.750) to excellent (0.958). No endoleak or migration was detected in the 12 patients on conventional CT angiography at 1 year. However, of the 6 patients with >5-mm displacement on the 1-year CT as determined by the new methodology, 2 went on to develop a type Ia endoleak in longer follow-up, and displacement progressed to >15 mm for 2 other patients. No endoleak or progressive displacement was appreciated for the patients with <5-mm displacement.Conclusion: The sac anchoring principle of the Nellix endosystem may result in several types of displacement that have not been observed during surveillance of regular endovascular aneurysm repairs. The presented methodology allows precise 3D determination of the Nellix endosystems and can detect subtle displacement better than standard CT angiography. Displacement >5 mm on the 1-year CT scans reconstructed with the new methodology may forecast impaired sealing and anchoring of the Nellix endosystem. [ABSTRACT FROM AUTHOR]

Objective/Background Proximal type I endoleaks are associated with abdominal aortic aneurysm (AAA) growth and rupture and necessitate repair. The Nellix™ EndoVascular Aneurysm Sealing (EVAS) system is a unique approach to AAA repair, where the appearance and treatment of endoleaks is also different. This study aimed to analyse and categorise proximal endoleaks in an EVAS treated cohort. Methods All patients, treated from February 2013 to December 2015, in 15 experienced EVAS centres, presenting with proximal endoleak were included. Computed tomography scans were analysed by a core laboratory. A consensus meeting was organised to discuss and qualify each case for selection, technical aspects, and possible causes of the endoleak. Endoleaks were classified using a novel classification system for EVAS. Results During the study period 1851 patients were treated using EVAS at 15 centres and followed for a median of 494 ± 283 days. Among these, 58 cases (3.1%) developed a proximal endoleak (1.5% early and 1.7% late); of these, 84% of 58 patients were treated outside the original and 96% outside the current, refined, instructions for use. Low stent positioning was the most likely cause in 44.6%, a hostile anatomy in 16.1%, and a combination of both in 33.9%. Treatment, by embolisation or proximal extension, was performed in 47% of cases, with a technical success of 97%. Conclusion The overall incidence of proximal endoleak after EVAS is 3.1% after a mean follow-up period of 16 months, with 1.5% occurring within 30 days. Their occurrence is related to patient selection and stent positioning. Early detection and classification is crucial to avoid the potential of sac rupture. [ABSTRACT FROM AUTHOR]

Purpose: To report the results of the ASCEND Registry of cases involving endovascular aneurysm sealing (EVAS) in combination with chimney grafts (chEVAS) for the treatment of para- and juxtarenal aortic aneurysms (AAA).Methods: A retrospective, multicenter registry established in 8 vascular centers between 2013 and 2016 recorded the treatment results and follow-up of chEVAS procedures for nonruptured AAAs; data were analyzed using standardized outcome measures. In the observation period, 154 patients (mean age 72.3±7.7 years; 124 men) underwent elective treatment for de novo juxtarenal and pararenal aneurysms and formed the study group.Results: Sixty-two (40.3%) of the cohort were treated using a single parallel graft, 54 (35.1%) with double chimneys, 27 (17.5%) with triple chimneys, and 11 (7.1%) with 4 chimneys. The 30-day mortality was 2.8%, and there were 4 perioperative strokes (1 fatal). At 1 year, the freedom from all-cause mortality was 89.8% and the freedom from aneurysm-related mortality was 94.3%. There were 3 endoleaks within 90 days of the procedure, one type Ia and 2 type Ib. The freedom from type Ia endoleaks was 95.7% at 1 year. There were no types II or III endoleaks in this series; the freedom from all endoleaks was 94.2% at 1 year. Freedom from reintervention at 1 year was 89.2%. Target vessel patency rates at 1 year were 97.7%, 99.3%, 100%, and 100% for the left renal, right renal, superior mesenteric artery, and celiac axis stents, respectively.Conclusion: The ASCEND Registry supports a proof of concept for the use of polymer technology and EVAS with parallel grafts in managing patients with complex aortic disease. The future role of chEVAS will be defined by studies that assess mid- to long-term durability. [ABSTRACT FROM AUTHOR]

Purpose: To report endovascular treatment of a symptomatic type V thoracoabdominal aortic aneurysm (TAAA) using the combined techniques of endovascular aneurysm sealing and parallel stent-grafts.Case Report: A 70-year-old man was referred with a symptomatic type V TAAA. The Nellix EndoVascular Aneurysm Sealing (EVAS) System was used in combination with 2 chimney grafts for the celiac artery (CA) and the superior mesenteric artery (SMA); one periscope graft perfused the right renal artery. Completion angiography showed exclusion of the aneurysm and patency of all 3 parallel grafts but occlusion of the left renal artery (LRA) due to unintentional coverage of its ostium by the Nellix endobags. Antegrade catheterization of the LRA failed, requiring implantation of an aortorenal vein bypass. The postoperative course was complicated by acute kidney injury. Imaging at 6 months showed sustained exclusion of the aneurysm, patency of the CA and SMA parallel grafts and left aortorenal bypass but occlusion of the right renal artery periscope graft. Serum creatinine at 6 months was 1.5 mg/dL.Conclusion: The combination of EVAS with parallel grafts for preservation of the visceral vessels may be a feasible technique to treat selected TAAAs in the acute setting when other options are not applicable. [ABSTRACT FROM AUTHOR]

Purpose: To determine how many endovascular aneurysm sealing (EVAS) procedures with/without off-label use of chimneys (ChEVAS) could have been performed in a cohort of patients who had undergone fenestrated endovascular aneurysm repair (FEVAR).Methods: Sixty patients (median age 76.3 years; 54 men) who underwent FEVAR in our institution between 2013 and 2015 were selected for the study. The median aneurysm diameter was 62.0 mm (interquartile range 59.3, 69.0). Preoperative computed tomography angiograms (CTA) were anonymized and sent to 2 physicians with experience of more than 40 ChEVAS interventions. These ChEVAS planners were blinded to the study purpose and asked to agree upon an EVAS/ChEVAS plan. The primary outcome was the percentage of the FEVAR patients in whom an EVAS/ChEVAS was technically possible. The secondary outcomes were a comparison of seal zones, number of target vessels, and device cost.Results: An EVAS-based intervention would have been technically possible in 56 (93.3%) of the FEVAR patients. The median proximal aortic seal zone was significantly more distal in the EVAS/ChEVAS procedures vs the FEVAR cases (zone 8 vs zone 7, p<0.001) and fewer target vessels were involved (median 2 vs 3, p<0.001). The cost of the EVAS/ChEVAS device was 66% of the FEVAR device. Planners would not currently advocate an EVAS-based intervention in 43 (76.8%) of these 56 patients due to concerns regarding the risk of migration associated with the lumen thrombus ratios observed.Conclusion: EVAS is technically feasible in the majority of patients undergoing FEVAR in our institution but currently advocated in only 23.2%. The seal zone was more distal, fewer target vessels were involved, and the device cost was lower in the planned EVAS/ChEVAS interventions. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the risk of postimplantation syndrome associated with endovascular aneurysm sealing (EVAS) and endovascular aneurysm repair (EVAR) in patients treated for abdominal aortic aneurysm (AAA).Methods: From December 2013 to May 2015, 41 AAA patients treated with EVAS (mean age 72±9 years; 38 men) and 63 with EVAR (mean age 74±10 years; 55 men) at a single center were retrospectively reviewed. To control for treatment selection bias, propensity score matching was used to compare outcomes by treatment mode. Main outcomes were postimplantation syndrome (defined as temperature >38°C and leukocyte count >12,000/µL), inflammatory response markers [platelets and high-sensitivity C-reactive protein (hs-CRP)], and clinical complications through 30 days.Results: In 39 matched patients per group, the incidences of postimplantation syndrome (p=0.07), mean body temperature (p=0.05), mean leukocyte count (p=0.003), and mean hs-CRP (p<0.001) were proportionally lower with EVAS vs EVAR. Serious adverse events (0% vs 12.8%, p=0.05) and endoleaks (0% vs 10.3%, p=0.13) through 30 days were less frequent with EVAS, but the group differences were not significantly different. The choice of endovascular graft material influenced postoperative and 30-day clinical outcomes, with greater overall risk observed with polyester stent-grafts.Conclusion: Endovascular aneurysm sealing is associated with a blunted systematic inflammatory response compared with EVAR. Polyester stent-grafts induce the greatest periprocedural inflammatory response. [ABSTRACT FROM AUTHOR]

Purpose: To examine the influence of device positioning and infrarenal neck diameter on flow patterns in the Nellix endovascular aneurysm sealing (EVAS) system.Methods: The transition of the aortic flow lumen into two 10-mm-diameter stents after EVAS creates a mismatched area. Flow recirculation may affect local wall shear stress (WSS) profiles and residence time associated with atherosclerosis and thrombosis. To examine these issues, 7 abdominal aortic aneurysm flow phantoms were created, including 3 unstented controls and 3 stented models with infrarenal neck diameters of 24, 28, and 32 mm. Stents were positioned within the instructions for use (IFU). Another 28-mm model was created to evaluate lower positioning of the stents outside the IFU (28-mm LP). Flow was visualized using optical particle imaging velocimetry (PIV) and quantified by time-averaged WSS (TAWSS), oscillatory shear index (OSI), and relative residence time (RRT) in the aorta at the anteroposterior (AP) midplane, lateral midplane, and renal artery AP midplane levels.Results: Flow in the aorta AP midplane was similar in all models. Vortices were observed in the stented models in the lateral midplane near the anterior and posterior walls. In the 32-mm IFU and 28-mm LP models, a steady state of vortices appeared, with varying location during a cycle. In all models, a low TAWSS (<10-2 Pa) was observed at the anterior wall of the aorta with peak OSI of 0.5 and peak RRT of 104 Pa-1. This region was more proximally located in the stented models. The 24- and 28-mm IFU models showed flow with a higher velocity at the renal artery inflow compared to controls. TAWSS in the renal artery was lower near the orifice in all models, with the largest area in the 24-mm IFU model. OSI and RRT in the renal artery were near zero for all models.Conclusion: EVAS enhances vorticity proximal to the seal zone, especially with lower positioning of the device and in larger neck diameters. Endobags just below the renal artery affect the flow profile in a minor area of this artery in 24- and 28-mm necks, while lower stent positioning does not influence the renal artery flow profile. [ABSTRACT FROM AUTHOR]

Introduction:Despite improvements in endograft design, operator skills, and patient selection, late endovascular abdominal aortic aneurysm repair (EVAR) associated complications and need for reinterventions remains the Achilles heel. These complications erode the early benefit over open aneurysm repair during long-term follow-up. The recently introduced endovascular aneurysm sealing (EVAS) is an innovative technology with the intention to lower these EVAR related complications. Areas covered:In this review the EVAS technique, indications, and possible applications, will be discussed, as well as a critical appraisal of clinical outcomes. Expertcommentary: EVAS is a promising technique for treating abdominal aortic aneurysms, and early efficacy data are encouraging in very suitable straight forward anatomy. The Nellix device is still in development. Longterm results are awaited. [ABSTRACT FROM PUBLISHER]

Purpose: To describe the feasibility and technical aspects of a proximal Nellix-in-Nellix extension to treat caudal stent-graft migration after endovascular aneurysm sealing (EVAS) in the in vitro and in vivo settings.Methods: In vitro studies were designed (1) to assess inner diameters of Nellix-in-Nellix extensions after postdilation with 12-mm balloons and (2) to test wall apposition in tubes with different diameters using a Nellix-in-Nellix stent-graft that extended out of the original Nellix stent-graft lumen by 10, 20, 30, and 40 mm. Simulated-use experiments were performed using silicone models in conjunction with a pulsatile flow pump. In the clinical setting, 5 patients (median age 74 years, range 73-83) presented at 2 centers with type Ia endoleak secondary to caudal Nellix stent-graft migration measuring a median 9 mm (range 7-15) on the left and 7 mm (range 0-11) on the right. Median polymer fill volume at the initial EVAS procedure was 42.5 mL (range 25-71). The median time to reintervention with a proximal Nellix extension was 15 months (range 13-32).Results: In vitro, the inner diameters of the Nellix-in-Nellix extensions were consistent after postdilation. Cases with 10 and 20 mm of exposed endobag resulted in a poor seal with endoleak, while cases with 30 and 40 mm of exposed endobag length exhibited angiographic seal. Fill line pressures of the second Nellix were higher than expected. In the 5 clinical cases, chimney grafts were required in each case to create an adequate proximal landing zone. The Nellix-in-Nellix procedure was successful in all patients. There were no procedure-related complications, and no endoleaks were observed during a median 12-month follow-up. Reinterventions were performed in 2 patients because of in-stent stenosis and chimney graft compression, respectively.Conclusion: Proximal Nellix-in-Nellix extension can be used to treat caudally migrated Nellix stent-grafts and to treat the consequent type Ia endoleak, but the technique differs from primary EVAS. The development of dedicated proximal extensions is desirable. [ABSTRACT FROM AUTHOR]

Purpose: To report a heretofore undescribed complication seen on imaging after endovascular aortic sealing (EVAS).Case Report: A 77-year-old woman was treated with the Nellix EVAS device for an infrarenal aortic aneurysm. After a normal computed tomography (CT) scan at 15 days, the 6-month CT showed the onset of perianeurysmal inflammatory tissue. The patient was asymptomatic, and blood tests were normal. Imaging suggested a nonaggressive inflammatory process, so a conservative approach was adopted with close follow-up. The periaortic tissue remitted without any treatment after a further 9 months (16 months after EVAS).Conclusion: The cause of this nonacute complication is unclear. Some clues suggest that interaction between the endobags and aneurysm wall could be involved. Imaging and clinical data led to a successful conservative strategy. [ABSTRACT FROM AUTHOR]

Purpose: To assess short-term stability and conformational changes of the Nellix EndoVascular Aneurysm Sealing (EVAS) System using 3-dimensional (3D) analysis.Methods: Postoperative computed tomography (CT) scans obtained at 0, 3, and 12 months in 24 patients (mean age 75±7 years; 22 men) who underwent EVAS between December 2013 and December 2014 for intact abdominal aortic aneurysm (within the instructions for use) were evaluated for stent-graft deviation in multiple planes using dedicated 3D analysis software. In addition, 2D analysis using an anatomically fixed reference landmark was performed to assess craniocaudal migration. Clinical and follow-up data of the patients were recorded and matched with results of the imaging analysis.Results: Overall stability of the Nellix endografts was promising. Relevant conformational changes in the majority of cases were limited to the iliac graft segment and were clinically benign in all cases. Conversely, the only deviation of the proximal stent-graft segment was found in a patient with type Ia endoleak. Additional 2D analysis found relevant (≥5 mm) caudal migration of the Nellix stent-graft in 6 patients, including the one with the type Ia endoleak. In 3 patients, 3D analysis demonstrated the absence of relevant conformational changes of the endografts despite caudal migration.Conclusion: Overall stability of the separate EVAS stent-grafts is promising in the short term. Relevant conformational changes (stent-graft deviation) in the majority of cases were benign and confined to the iliac segment. [ABSTRACT FROM AUTHOR]

Purpose: To assess the technical success and clinical outcome of reinterventions using the Nellix Endovascular Aneurysm Sealing (EVAS) System to treat complications after endovascular aneurysm repair (EVAR).Methods: Fifteen consecutive patients (mean age 79 years; 14 men) with prior EVAR were treated with EVAS between March 2014 and December 2015 at 2 institutions. The failed prior EVARs included 13 bifurcated endografts, 1 bifurcated graft plus fenestrated cuff, and 1 tube endograft. Endoleaks were the predominant indications: type Ia in 10 and type III in 5 (3 type IIIa and 2 type IIIb). All patients presented with progressive aortic aneurysms (median 7.85-cm diameter; range 6.5-11). Eight patients were treated on an urgent or emergency basis (6 symptomatic aneurysms and 2 contained ruptures). All patients underwent Nellix relining of the failed stent-graft; 10 had chimney (Ch) procedures in combination with EVAS (chEVAS) because the proximal landing zones were inadequate.Results: Technical success was 100%. All endoleaks were successfully sealed, and no additional intervention was required. No further endoleak after EVAS or chEVAS was recorded. Endobag protrusion occurred in 1 case without sequelae. One elderly patient with ruptured aneurysm died from multiple organ failure 2 months postoperatively. One renal artery guidewire injury led to nephrectomy because of active bleeding. No reinterventions, aneurysm-related mortalities, graft thrombosis, endoleaks, or chimney graft occlusions were observed during a median follow-up of 8 months (range 3-24).Conclusion: The present preliminary experience demonstrates that the use of EVAS/chEVAS is feasible for treatment of failed EVAR. This technique may be used as bailout or an alternative treatment when other established methods are infeasible or not available. [ABSTRACT FROM AUTHOR]