Stent-graft Exclusion Research Articles

Pre-emptive Aortic Side Branch Embolization during Endovascular Aneurysm Repair Using the Excluder Stent-Graft System: A Prospective Multicenter study

PurposeTo evaluate the effectiveness and safety of pre-emptive transcatheter arterial embolization (P-TAE) for aortic side branches (ASBs) to prevent Type 2 endoleaks (EL2) before endovascular aneurysm repair (EVAR) using the Excluder stent-graft system (Excluder). Materials and MethodsIn this prospective, multicenter study, 80 patients (mean age, 79.1 years [SD ± 6.7]; 85.0% were men; mean aneurysmal sac diameter, 48.4 mm [SD ± 7.4]) meeting the eligibility criteria were prospectively enrolled from 9 hospitals. Before EVAR, P-TAE was performed to embolize the patent ASBs originating from the abdominal aortic aneurysm. Contrast-enhanced computed tomography (CT) was performed at 1 month and 6 months after EVAR. The primary endpoint was EL2 incidence at 6 months, and the secondary endpoints were aneurysmal sac diameter changes at 6 and 12 months, P-TAE outcomes, adverse events related to P-TAE, reintervention, and aneurysm-related mortality. ResultsAll patients successfully underwent P-TAE without serious. Coil embolization was successful in 81.6% of ASBs. EL2 incidence at 6 months was identified in 18 of 70 (25.7%) patients. Aneurysmal sac diameter shrinkage (≥5 mm) was observed in 30.0% of patients at 6 months and in 40.9% at 12 months. Only 1 patient required reintervention for EL2 within 1 year of EVAR; aneurysm-related deaths were not observed. ConclusionsP-TAE for ASBs before EVAR using Excluder is a safe and effective strategy. It aids in achieving early aneurysmal sac shrinkage and reduces EL2 reintervention at 1 year after EVAR.

Effect of Dexmedetomidine on Inflammatory Response in Aortic Dissection.

To study the effect of dexmedetomidine (Dex) on perioperative inflammatory response in aortic dissection (AD) patients. From June 2020 to June 2022, 50 patients with Stanford type B AD underwent endovascular stent-graft exclusion (EVAR) at our hospital. They randomly were assigned to two groups (N = 25): the control group (C group) and the Dex group. Patients in the Dex group received 0.5ug/kg Dex intravenously 10 minutes before induction of anesthesia and 0.5µg/kg/h Dex during the intervention until 15 minutes before the end of surgery. In contrast, the C group received the same volume of normal saline at the same time points. The two groups were induced and maintained with the same anesthetic agents. Venous blood samples were taken 3 days before operation (T1), 1 day before operation (T2), 1 day after operation (T3) and 3 days after operation (T4) to detect levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and white blood cell count (WBC). At T3 and T4, CRP and ESR in the Dex group were significantly improved compared with those in the C group. Dexmedetomidine can reduce the inflammatory reaction of aortic dissection.

Abstract No. 75 Endovascular treatment of visceral artery aneurysms and pseudoaneurysms: comparing outcomes of self-expandable vs balloon-expandable stent grafts

Endovascular treatment of visceral aneurysms is effective and successful with low rates of complications. Depending on location and anatomy, endovascular treatment is either embolization or stent graft exclusion. This single-center retrospective study compares the outcomes of Self Expandable (SE) vs. Balloon Expandable (BE) stent grafts (SGs) in the treatment of visceral artery aneurysms (VAAs) and pseudoaneurysms (VAPAs).

Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort

Purpose: To compare the long-term outcomes of the most widely used third-generation stent grafts, the Endurant and Excluder stent grafts, in Japanese patients using a multicenter registry. Materials and Methods: A retrospective analysis of endovascular aneurysm repairs for abdominal aortic and iliac artery aneurysms using either the Endurant or the Excluder stent grafts from January 2012 to July 2019 at 10 Japanese hospitals was performed. Results: A total of 332 and 378 repairs using the Endurant and Excluder stent grafts, respectively, were analyzed. Although the patients’ characteristics were generally similar in the two groups, the Endurant group exhibited significantly shorter (Endurant: 31.5±18.6 mm, Excluder: 37.4±21.0 mm; p<0.001), larger (Endurant: 22.4±4.2 mm, Excluder: 21.7±3.8 mm; p=0.029), and more reversed tapered (Endurant: 12.1%, Excluder: 5.8%; p=0.003) proximal necks. The incidence of instructions for use (IFU) violations was similar between the two groups (Endurant: 59.0%, Excluder: 54.5%; p=0.223). However, the Endurant group had significantly more proximal neck-related IFU violations (54.1% and 46.3%, respectively; p=0.039), more access-related IFU violations (8.1% and 4.0%, respectively; p=0.019), and fewer bilateral hypogastric artery embolizations (5.1% and 9.3%, respectively; p=0.035) compared with the Excluder group. The incidence of intraoperative (Endurant: 3.6%, Excluder: 3.7%; p=0.950) and perioperative complications (Endurant: 3.6%, Excluder: 3.4%, p=0.899) was equivalent in the two groups. However, there was a significantly higher incidence of postoperative type II endoleaks in the Excluder group (Endurant: 28%, Excluder: 46.0%, p<0.001). Aneurysm sac regression was more frequent in the Endurant group (Endurant: 40.7%, Excluder: 31.7%, p=0.013). The Endurant group also had significantly higher rates of sac increase (Endurant: 13.0%, Excluder: 7.7%, p=0.020). Kaplan-Meier curve and log-rank analyses revealed no statistical differences in late complications (p=0.868) and overall survival (p=0.926). Conclusions: There were no statistically significant differences between the Endurant and the Excluder stent grafts in terms of intraoperative, perioperative, and late complication rates; however, the anatomical characteristics of the patients were significantly different.

Rare Cases of Bronchial Aneurysm and Comparison of Interventional Embolization in the Treatment of True Bronchial Aneurysm and Pseudobronchial Aneurysm.

BackgroundBronchial artery aneurysm (BAA) is a rare disease. Rupture of BAA can lead to life-threatening hemoptysis, and once diagnosed, treatment is needed regardless of symptoms. Transcatheter artery embolization is the first choice of treatment because it is minimally invasive and effective. This study aimed to retrospectively compare the embolization treatment of a case of true BAA and that of a pseudobranchial aneurysm and explore the choice of embolization method for BAA with short neck or no neck.Materials and MethodsEmbolization treatment and imaging characteristics of one case of true BAA and one case of pseudobronchial aneurysm admitted to our hospital were analyzed retrospectively. Embolization methods and therapeutic effects of two cases of BAAs were compared.ResultsCase 1 was that of an intact true BAA inside the mediastinum located at the opening of the bronchial artery. The distal end of the aneurysm was embolized, and tumor cavity was occluded. No recurrence of BAA was found after the operation. Case 2 was that of a ruptured and hemorrhagic pseudobronchial aneurysm of the mediastinum. Coil embolization combined with covered stent graft exclusion of the thoracic aorta were performed, and the left bronchial artery and BAA were almost occluded. Nine months postoperatively, the mediastinal hematoma was almost completely absorbed.ConclusionEndovascular embolization has become the most commonly used for the treatment of BAA. Different methods should be selected according to the location and nature of the aneurysm.

Transcatheter closure of congenital portosystemic shunts - A multicenter experience.

Background:Congenital portosystemic shunts (CPSS) are rare and present variably with hepatic encephalopathy, pulmonary arteriovenous malformations (PAVMs), and pulmonary hypertension (PH).Objective:The objective of the study was to see the feasibility of transcatheter closure of CPSS and their outcome.Materials and Methods:We analyzed the data of 24 patients of CPSS who underwent transcatheter closure from five institutions (March 2013 to April 2019). Baseline evaluation included echocardiography with bubble contrast study, ultrasound examination of the abdomen, computed tomography angiogram, and cardiac catheterization with test balloon occlusion of the CPSS. The evaluation showed cyanosis due to PAVM in 12, PH in 8, and respiratory distress in 2. Two had both cyanosis and PH. Criteria for eligibility for complete catheter closure of CPSS included demonstration of intrahepatic portal vein (PV) radicals together with a PV pressure of ≤18 mmHg on occlusion.Results:The median age and weight were 8 years (0.5–21) and 19.5 kg (4.2–73), respectively. Transcatheter closure was performed in 21 patients (22 procedures) using a variety of occlusive devices and stent-graft exclusion was done in one patient. Closure was not done in 3 in view of high portal venous pressures and hypoplastic PVs. During the follow-up (median: 42 months and range: 61 days–4.8 years), saturation normalized in 14 patients with PAVM. PH declined in all eight patients who underwent the procedure. Respiratory distress improved in two patients.Conclusions:Early and short-term follow-up results of catheter closure of CPSS appear promising. However, further, follow-up is needed to demonstrate long-term effectiveness.

Endovascular Oriented Classification and Treatment of Celiac Trunk Aneurysms: 10 Years Experience

To propose an endovascular-oriented classification of celiac trunk aneurysms (CTa) and discuss single center results of this rare pathology. Data of all patients admitted to our institution for CTa from 2011 to 2021 were prospectively collected. Of them, those who underwent endovascular treatment were retrospectively analyzed. All preoperative CT scans were reviewed and CTa were classified in 4 different configurations based on progressive distal landing zone. We excluded from the classification all cases with median arcuate ligament syndrome (MALS), patients with coexistent aortic dilation or no endovascular proximal neck. Preoperative demographics, intraoperative data and post-operative complications were recorded. All-cause late mortality and complications were identified through a review of office charts and telephone assessment. During the study period 19 patients were referred to our Institution for CTa. Ten patients underwent endovascular treatment (ET). In 6 cases a watchful waiting strategy was adopted, 2 (10.5 %) patients refused ET and one patient without suitable proximal landing zone (< 10 mm) was not proposed to open surgical repair for surgical contraindication but is followed by strict instrumental and clinical evaluation. Six (60%) patients presented type 2 CTa; all of them underwent ET requiring positioning of covered stent-graft and SA embolization. Three (30%) patients presented type 3 CTa; all of them underwent ET with covered stent-graft deployment over the GDA with preliminary embolization. One (10%) patient presented type 4 CTa that was treated by means of covered stent-graft deployment along the right hepatic artery with left hepatic artery embolization. Overall, no major complications and perioperative mortality was observed. Celiac trunk aneurysms are rare, and no classifications have still been presented. Stent-graft exclusion provides excellent short-term outcome with no significant morbidity and mortality rate when technically feasible.

Iliocaval reconstruction of chronically thrombosed cylindrical inferior vena cava filters with balloon expandable covered stent-grafts

The use of a Viabahn VBX endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) to exclude chronically thrombosed inferior vena cava (IVC) filters refractory to exclusion with self-expanding stents was evaluated. The mean duration of TrapEase IVC (Cordis, Milpitas, Calif) implantation was 7.6 years (range, 2-11 years). Symptoms included leg pain, edema, color changes, and back pain. The mean Villalta score and venous clinical severity score were 17 (range, 13-23) and 13 (range, 11-15), respectively. Indirect ultrasound evidence of stent patency was demonstrated at a mean of 8 months after intervention. The mean Villalta score and venous clinical severity score had decreased by 13 and 10, respectively, at a mean of 9.5 months after intervention. Iliocaval reconstruction with Viabahn VBX balloon expandable stent-graft exclusion of chronically thrombosed TrapEase IVC filters is safe, with favorable short-term results.

The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR).

BackgroundEndovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU.PurposeTo identify whether graft selection influences outcomes following EVAR outside of IFU.MethodologyA retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff, Arizona). Analyses were performed to evaluate all-cause mortality, aneurysm-related mortality, endoleak occurrence, and surgical reintervention rates between the two cohorts.ResultsOf the 636 patients, 225 were from ENGAGE (mean age 73 years) and 411 were from GREAT (mean age 75 years). 17.8% were treated outside of IFU in the ENGAGE registry, while 12.4% were treated outside IFU in the GREAT cohort. Five-year freedom from all-cause mortality was similar in both cohorts (65.6% vs. 63.8%). The rate of type IA endoleak development was lower in the Excluder cohort, although this may have been impacted by the fact that only endoleaks that underwent reintervention were recorded within GREAT analysis (Endurant 10.6% vs. Excluder 7.0%). The reintervention rate was 16% at five years following the Endurant aortic graft while it was 13.3% at five years with the Excluder.ConclusionTreatment outside of IFU, be it with a suprarenal or an infrarenal fixation device, is associated with worse outcomes. This analysis reinforces the importance of the consideration of either fenestrated or open repair in those aneurysms that fail to satisfy IFU while endovascular repair in such a setting should be reserved as a last resort strategy.

The Impact of Endograft Selection on Mid-Term Outcomes in Female Patients Following Endovascular Aortic Aneurysm Repair (EVAR) for Abdominal Aortic Aneurysm (AAA).

BackgroundAbdominal aortic aneurysms (AAA) are far more common in male than female gender, although they appear to have a more aggressive pathophysiology in females. Given the lower incidence of AAA in females, it has been difficult to assess the impact of graft selection for endovascular aortic aneurysm repair (EVAR) in this cohort.PurposeTo identify whether graft selection influences outcomes following AAA endoluminal repair in female patients.MethodologyA retrospective analysis of published data for 711 female patients was conducted, collating data from three cohorts - Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE), Global Registry for Endovascular Aortic Treatment (GREAT) and U.S. Zenith multicenter trial in combination with the Zenith female registry. Patients were recruited into the ENGAGE registry between 2009 and 2011, the GREAT registry between August 2010 and October 2016, and into the Zenith registry between 2000 and 2003. Patients from ENGAGE received the Medtronic Endurant stent graft for infrarenal AAA repair, patients analysed in GREAT received the Gore Excluder stent graft and the Zenith group received the Cook Zenith stent graft. Analyses were performed to evaluate all-cause mortality, aorta-related mortality, endoleak occurrence and surgical reintervention rates between the three cohorts.ResultsOf the 711 females, 133 were from ENGAGE (mean age 76 years), 538 were from GREAT (mean age 75 years) and 40 were from Zenith (mean age 74 years). The rates of co-morbidities between the three groups were broadly similar except for atherosclerotic disease which was more commonly observed in those treated with the GORE Excluder. The rate of endoleaks was lower when the Excluder stent was utilised as compared to the other two stents (Excluder 6.7% vs. Zenith 12.5% vs. Endurant 35.3%) even considering the limited follow-up of the Zenith group to two years as compared to five years for both ENGAGE and GREAT. All-cause mortality was similar in all three groups across the period examined while aorta-related mortality was uncommon. Reintervention rate was 15% at two years following the utilisation of the Zenith aortic graft while the rate of intervention at five years was broadly similar between ENGAGE and GREAT.ConclusionThe newer generation, lower profile aortic endografts appear to have provided a safe and successful tool in the management of AAA in female patients, despite more complex aortic anatomy with shorter infrarenal neck length and larger aortic neck angulation.

Limb Occlusion Rate after EVAR With Individualized Graft Limb Selection and a Liberal Protocol of Primary Relining

This study analyses limb occlusion rates after endovascular aneurysm repair (EVAR) with a strategy including stent-graft limb selection and liberal primary stenting (relining) in anatomies at higher risk for occlusion with uncovered self-expandable or balloon-expandable stents. All patients undergoing elective EVAR with a bifurcated stent-graft between January 2010-August 2018 were included. A protocol involving personalized stent-graft selection and liberal primary relining based on preoperative imaging was followed during the whole period. Primary endpoints were technical success and primary limb patency during follow-up. Secondary endpoints included mortality and limb reintervention rates. Risk factors associated to limb patency and reintervention rates were analyzed. Six hundred and fifteen patients (548 males; mean age 72.9 ± 9 years) were included. Overall technical success was 98.5% (606/615). One (0.16%) patient died during the first 30 days. Of the 1230 limbs, 96 (8%) were deemed at risk for occlusion in view of the anatomy, and primarily relined in 62 patients. Estimated primary limb patency at 6 months, 1 year and 3 years was 99.5 ± 0.2%, 99.2 ± 0.3% and 98.5 ± 0.5%, respectively. Freedom from limb-related reintervention at 6 months, 1 year and 3 years was 98.1 ± 0.4%, 97.4 ± 0.5% and 95.6 ± 0.7%, respectively. Only one (1%) of the 96 relined limbs occluded during follow-up. No differences were found in terms of patency or freedom from reintervention between limbs at risk that were primary stented and limbs without adjunctive stents. Gore Excluder stent-grafts presented better patency (Breslow P = 0.005) and lower reintervention rates (Breslow P = 0.001) than other devices during follow-up. Peripheral artery disease was also a risk factor for reintervention (Breslow P = 0.015). Liberal use of primary limb relining in patients with iliac anatomy at higher risk for occlusion appears to be a safe and effective strategy to preserve limb patency after EVAR. Gore Excluder graft limbs present better patency and lower reintervention rates than other stent-graft types.

Sex-Related Outcomes After Endovascular Aneurysm Repair Within the Global Registry for Endovascular Aortic Treatment (GREAT)

Retrospective analysis from the Global Registry for Endovascular Aortic Treatment (GREAT) between August 2010 and October 2016 Of 3758 patients (3220 male, 538 female) who received Gore Excluder stent grafts (W. L. Gore & Associates, Flagstaff, Ariz) and underwent endovascular infrarenal abdominal aortic aneurysm repair (EVAR), women had shorter, more angulated necks and more reintervention for device-related issues than men did but not more endoleaks. Women had lower mortality rates but higher rates of reintervention and morbidity after EVAR.

Gutter Characteristics and Stent Compression of Self-Expanding vs Balloon-Expandable Chimney Grafts in Juxtarenal Aneurysm Models

Purpose: To assess in silicone juxtarenal aneurysm models the gutter characteristics and compression of different types of chimney graft (CG) configurations. Materials and Methods: Fifty-seven combinations of Excluder C3 or Conformable Excluder stent-grafts (23, 26, and 28.5 mm) were deployed in 2 silicone juxtarenal aneurysm models with 3 types of CGs: Viabahn self-expanding (VSE; 6 and 13 mm) or Viabahn balloon-expandable (VBX; 6, 10, and 12 mm) stent-grafts and Advanta V12 balloon-expandable stent-grafts (ABX; 6 and 12 mm). Setups were divided into 4 groups on the basis of increasing CG and main graft (MG) diameters. Two independent observers assessed gutter size and type as well as CG compression on computed tomography scans using postprocessing software. Results: In the smaller diameter combinations (6-mm CG and 23-, 26-, and 28.5-mm MGs), both VSE (p=0.006 to 0.050) and ABX (p=0.045 to 0.050) showed lower gutter areas and volumes compared with VBX. In turn, the VBX showed a nonsignificant tendency to decreased compression, especially compared to ABX. Use of the Excluder C3 showed a 6-fold increase in type A1 gutters (related to type Ia endoleak) as compared to the Conformable Excluder (p=0.018). Balloon-expandable stent-grafts (both ABX and VBX) showed a 3-fold increase in type A1 gutters in comparison with self-expanding stent-grafts (p=0.008). Conclusion: The current study suggests that use of the Conformable Excluder in combination with VSE chimney grafts is superior to the other tested CG/MG combinations in terms of gutter size, gutter type, and CG compression.

Sex-Related Outcomes After Endovascular Aneurysm Repair Within the Global Registry for Endovascular Aortic Treatment

Abdominal aortic aneurysms (AAAs) are more common in men. However, women have been shown to have more short- and long-term adverse outcomes after endovascular aneurysm repair. This disparity is thought to be multifactorial, including anatomical differences, hormonal differences, older age of presentation, and a greater degree of preoperative comorbidities. A retrospective analysis that included data for 3,758 patients from the Global Registry for Endovascular Aortic Treatment (GREAT) was conducted. Patients were recruited into GREAT between August 2010 and October 2016 and received the Gore Excluder stent graft for infrarenal AAAs repair. Cox multivariate regression analyses were performed to analyze any reintervention and device-related intervention rates. Of the 3,758 patients, 3,220 were male (mean age 73years) and 538 were female (mean age 75years). Women had higher prevalence rates of chronic obstructive pulmonary disease (P<0.0001) and renal insufficiency (P=0.03), whereas men had higher rates of cardiovascular comorbidities. The AAAs in women were smaller in diameter with shorter and more angulated necks. Women did not experience a significantly higher rate of endoleaks but did exhibit higher reintervention rates, including reintervention for device-related issues. In terms of mortality, aorta-related mortality was most prevalent within the first 30days after procedure in both sexes. Women were treated at an older age and had a more hostile aneurysmal anatomy. Although the mortality rates were lower in women, they had significantly higher rates of reintervention, and thus higher morbidity rates after endovascular aneurysm repair.

Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts

ObjectiveMany endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. MethodsPatients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. ResultsThe study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (β-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). ConclusionsThis study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.

Mid-term outcomes of endovascular aneurysm repair in challenging aortic neck anatomy based on experience from the GREAT C3 registry.

The European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT) evaluates the outcome and deployment mechanism of the C3 Gore Excluder stent-graft. We aimed to assess the mid- to long-term durability of the C3 Gore Excluder stent-graft in the management of challenging aortic neck morphology, outside the instruction of use (IFU). The prospectively collected data from GREAT were retrospectively analyzed. For each subject demographic, pre/intra- and postoperative variables were collected. The main outcomes measured were serious adverse events (device-related, cerebrovascular, cardiac, pulmonary, pulmonary embolism, limb ischemia, and renal complications) and re-intervention at the 6-year follow-up. In this study, outside IFU was defined as aortic neck length <15 mm and/or aortic neck angle >60°. A total of 399 subjects (86.7% male, mean age 73.9 years) were identified. Sixty-eight subjects (17%) from 11 recruiting sites underwent endovascular aneurysm repair (EVAR) outside IFU, and 399 devices were implanted. Of these, 47% had neck length <15 mm, 72.3% had neck angulation > 60°, and 21% had both. Mean follow-up duration was 53.5 months (SD=22.3). At the 6-year follow-up, the group with challenging anatomy required significantly more re-interventions (23.5% vs. 13.3%, P<0.05) and reported more serious adverse events (42.6% vs. 30.6%, P<0.005) than those within IFU. Midterm outcomes of the C3 Gore Excluder stent-graft are safe and effective within IFU. Outside IFU patients required significantly more all or device related re-interventions; however, they did not sustain significantly more serious adverse events.

Deployment of stent graft in an excessively higher position above the renal artery induces a flow channel to the aneurysm in chimney endovascular aortic aneurysm repair: an in vitro study.

We aimed to investigate the influences of the sealing length above the renal artery (RA) on gutter formation, non-apposed regions between the aortic wall, stent graft (SG), and chimney graft and incidence of flow channel to the aneurysm in chimney endovascular aortic aneurysm repair (Ch-EVAR) using a juxtarenal abdominal aortic aneurysm model. Neck diameter and length of the silicone model were 24 and 4mm, respectively. In double Ch-EVAR configuration using Advanta V12, 12 combinations were tested three times with two sizes [28.5 (20%-oversize) and 31 (30%-oversize) mm] of Excluder SG, three sealing lengths above the RA (10, 20, and 30mm), and two deployment positions (anatomical and cross-leg). Gutter area, non-apposed region, and flow channels to the aneurysm were analyzed using micro-computed tomography. Average gutter area and non-apposed region of 30%-oversize SG were significantly smaller than those of 20%-oversize SG (p = 0.05). Furthermore, the non-apposed region of 30%-oversize SG with a 30-mm sealing length was significantly larger than that of the other sealing lengths. For 20%-oversize SGs, flow channel to the aneurysm was observed, except for the anatomical deployment with the sealing length of 10mm. For 30%-oversize SGs, flow channel was absent, except for the SG with a 30-mm sealing length in both deployment positions. These flow channels were frequently formed through a valley space, existing in the lower unibody above the two limbs. Our data indicated that the optimal sealing length should be chosen in consideration of the device design difference due to the device diameter in Ch-EVAR.

Influence of Proximal Aortic Neck Diameter on Durability of Aneurysm Sealing and Overall Survival in Patients Undergoing Endovascular Aneurysm Repair. Real World Data from the Gore Global Registry for Endovascular Aortic Treatment (GREAT)

Aortic neck diameter is an independent anatomical feature that is poorly understood, yet potentially linked to proximal seal failure and adverse outcome following standard EVAR. The aim of this study was to assess whether large proximal aortic neck (LAN) diameter is associated with adverse outcome using prospectively collected individual patient data from The Global Registry for Endovascular Aortic Treatment (GREAT). A total of 3166 consecutive patients, from 78 global centres, receiving Gore Excluder stent grafts for infrarenal abdominal aortic aneurysm repair between 2011 and 2017 were included. Patient demographics, biometrics, operative details, and clinical outcome were analysed. Patients were divided into two groups: normal baseline proximal aortic neck (NAN) diameter (<25 mm on computed tomography aortography), and LAN (≥25 mm). Clinical follow up (including imaging) was available for 76.5% of patients 5 years post-intervention. Primary endpoints analysed were Type IA endoleak and any aortic re-intervention up to 5 years post-procedure. A composite endpoint of Type IA endoleak, re-intervention, aortic rupture, or aortic related mortality was also assessed. A total of 1977 (62.4%) patients were classified NAN and 1189 (37.6%) were LAN. Immediate technical success was achieved in 3164 out of 3166 (>99.9%) of cases. Freedom from Type IA endoleak was achieved in 99.3% at 1 year and 97.3% at 5 years (lower in LAN vs. NAN: 96.8% [CI 93.7–98.4] vs. 98.6% [CI 94.5–99.6], p = .007). Freedom from aortic re-intervention was 93.7% at 1 year and 83.2% at 5 years (78.6% [CI 66.0–87.0] LAN vs. 86.0% [CI 81.8–89.3] NAN, p = .11). Freedom from primary composite endpoint was 95.9% at 1 year and 84.9% at 5 years (81.3% [CI 69.2–89.0] LAN vs. 87.0% [CI 81.6–91.0] NAN, p = .066). Five year survival was lower in the LAN group; 64.6% (CI 50.1–75.7) vs. 76.5% (CI 70.7–81.3), p = .03). LAN is associated with delayed Type IA endoleak occurrence and lower overall survival.

Editor's Choice – Influence of Proximal Aortic Neck Diameter on Durability of Aneurysm Sealing and Overall Survival in Patients Undergoing Endovascular Aneurysm Repair. Real World Data from the Gore Global Registry for Endovascular Aortic Treatment (GREAT)

Aortic neck diameter is an independent anatomical feature that is poorly understood, yet potentially linked to proximal seal failure and adverse outcome following standard EVAR. The aim of this study was to assess whether large proximal aortic neck (LAN) diameter is associated with adverse outcome using prospectively collected individual patient data from The Global Registry for Endovascular Aortic Treatment (GREAT). A total of 3166 consecutive patients, from 78 global centres, receiving Gore Excluder stent grafts for infrarenal abdominal aortic aneurysm repair between 2011 and 2017 were included. Patient demographics, biometrics, operative details, and clinical outcome were analysed. Patients were divided into two groups: normal baseline proximal aortic neck (NAN) diameter (<25mm on computed tomography aortography), and LAN (≥25mm). Clinical follow up (including imaging) was available for 76.5% of patients 5 years post-intervention. Primary endpoints analysed were Type IA endoleak and any aortic re-intervention up to 5 years post-procedure. A composite endpoint of Type IA endoleak, re-intervention, aortic rupture, or aortic related mortality was also assessed. A total of 1977 (62.4%) patients were classified NAN and 1189 (37.6%) were LAN. Immediate technical success was achieved in 3164 out of 3166 (>99.9%) of cases. Freedom from Type IA endoleak was achieved in 99.3% at 1 year and 97.3% at 5 years (lower in LAN vs. NAN: 96.8% [CI 93.7-98.4] vs. 98.6% [CI 94.5-99.6], p=.007). Freedom from aortic re-intervention was 93.7% at 1 year and 83.2% at 5 years (78.6% [CI 66.0-87.0] LAN vs. 86.0% [CI 81.8-89.3] NAN, p=.11). Freedom from primary composite endpoint was 95.9% at 1 year and 84.9% at 5 years (81.3% [CI 69.2-89.0] LAN vs. 87.0% [CI 81.6-91.0] NAN, p=.066). Five year survival was lower in the LAN group; 64.6% (CI 50.1-75.7) vs. 76.5% (CI 70.7-81.3), p=.03). LAN is associated with delayed Type IA endoleak occurrence and lower overall survival.

Cross-wire technique for difficult contralateral limb cannulation during endovascular abdominal aneurysm repair for tortuous proximal aortic neck.

In selected cases of endovascular aortic repair (EVAR) of an abdominal aortic aneurysm, such as patients with tortuous proximal aortic neck, achieving a successful cannulation can sometimes be difficult. Herein, we described a novel cross-wire technique to help overcome such anatomical variations. During the EVAR procedure among our 5 cases, the main body of the Gore Excluder Stent Graft was deployed through an ipsilateral guidewire. Because of a large angle between the contralateral guidewire and the contralateral short limb of the main body, a successful traditional cannulation was unfeasible. Therefore, the contralateral guidewire was cannulated into the ipsilateral long limb, and the ipsilateral guidewire was cannulated into the contralateral short limb. The contralateral and ipsilateral iliac limb components of the stent graft were deployed through the ipsilateral and contralateral guidewires, respectively. All 5 patients receiving this technique during EVAR of an abdominal aortic aneurysm were free of mortality or any kind of complication at the 1-year follow-up. In conclusion, the cross-wire technique might be safe and effective for EVAR of an abdominal aortic aneurysm when a traditional cannulation is unachievable in selected cases without creating additional percutaneous access or using extra devices.