Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT).

BACKGROUND: The early postoperative benefits of endovascular aneurysm repair (EVAR) have been well established but questions remain regarding its durability at mid-term and long-term time points. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study used the Global Registry for Endovascular Aortic Treatment registry to explore the 5-year outcomes with the GORE EXCLUDER device in real-world clinical circumstances. METHODS: All patients within the Global Registry for Endovascular Aortic Treatment registry who underwent an infrarenal abdominal aortic aneurysm repair with the GORE EXCLUDER device were included in this study. Baseline characteristics and demographic information of the cohort were collected. End points included mortality (all-cause and aneurysm-related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events. RESULTS: A total of 3,216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson Comorbidity Index score of ≥5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Postoperative major adverse cardiovascular events occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years. CONCLUSIONS: This study supports the durability of the GORE EXCLUDER device through 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter through 5 years.

Endovascular Preservation of Segmental Arteries during Treatment of Thoracoabdominal Aortic Aneurysms with Fenestrated/Branched Stent Grafts: Feasibility and Outcomes.

PURPOSE: To evaluate the technical success, feasibility, and outcomes of endovascular preservation of segmental arteries (SAs) during fenestrated/branched endovascular aortic repair (F/B-EVAR). MATERIALS AND METHODS: A multicenter, retrospective study was conducted in consecutive patients treated with F/B-EVAR and a branch or fenestration for SA preservation. Eleven patients (median age, 57 years; range, 45-73 years; 7 men) were included. RESULTS: Twelve SAs were preserved. Stent grafts were custom made with fenestrations, branches, or a combination of both in 1, 2, and 5 patients, respectively. A t-Branch stent graft was used in 2 patients, and a physician-modified thoracic stent graft with a branch was used in 1 patient. Eight branches and 4 fenestrations were used for the preservation of 12 SAs. Four fenestrations and 1 branch for the SAs were not bridged and were left for perfusion of the corresponding SAs. Technical success was achieved in 10 of 11 (91%) patients. No early mortality occurred. Early morbidities included renal insufficiency without dialysis in 1 patient and partially delayed paraplegia in 1 patient. Before discharge, computed tomography angiography (CTA) showed patency of all the SAs. The median follow-up duration was 30 months (range, 10-88 months). Late death occurred in 1 patient. Two SAs were occluded in 1 patient with 2 unstented fenestrations, as determined using 1-year follow-up CTA. This patient did not develop spinal cord ischemia (SCI). Other SAs remained patent during follow-up. One patient with a type IIIc endoleak was treated by relining of bridging stents. CONCLUSIONS: Endovascular preservation of SAs with F/B-EVAR for thoracoabdominal aortic aneurysm is feasible and safe in select patients and may add to preventive measures for SCI.

Editor's Choice - Long Term Outcomes of the Advanta V12 Covered Bridging Stent for Fenestrated and Branched Endovascular Aneurysm Repair in 1 675 Target Vessels.

OBJECTIVE: To report outcomes of the Advanta V12 as a covered bridging stent in fenestrated and branched endovascular aneurysm repair (F/BEVAR). METHODS: Patients treated with F/BEVAR and followed in a single centre receiving the Advanta V12 as a covered bridging stent between January 2010 and May 2020 were included. RESULTS: A total of 636 patients (543 men) were analysed. A total of 1 675 target vessels (TVs) were bridged with the Advanta V12. Estimated TV patency at one, five, and eight years was 99.1% ± 0.2%, 96.9% ± 0.5% and 96.2% ± 0.7%, respectively. Estimated patency at eight years was 98.1% ± 0.5% for fenestrations and 87.3% ± 2.9% for branches (p < .001). Estimated patency of renal arteries was statistically significantly lower for those targeted with branches compared with fenestrations (p = .001). Multivariable analysis showed that targeting a TV with a branch compared with a fenestration was the only independent risk factor for occlusion during follow up (hazard ratio 6.41, 95% CI 3.4 - 11.9; p < .001). Estimated freedom from endoleak at one, five, and eight years was 99.4% ± 0.2%, 96.4% ± 0.6%, and 95.4% ± 0.8%, respectively. Estimated freedom from target vessel instability (TVI) at one, five, and eight years was 98.5% ± 0.3%, 93.0% ± 0.8%, and 91.3% ± 1%, respectively. Estimated freedom from TVI at eight years was 93.2% ± 0.9% for fenestrations and 82.7% ± 3.5% for branches (p < .001). Estimated freedom from TVI was statistically significantly lower for renal arteries targeted with branches compared with those targeted with fenestrations (p < .001) CONCLUSION: The Advanta V12 shows excellent technical success rates as a covered bridging stent in F/ΒEVAR. Late outcomes remain good with low rates of TV occlusion, endoleak, and re-intervention. Renal arteries targeted with branches demonstrated a higher risk of occlusion and instability compared with those targeted with fenestrations.

Editor's Choice - Single Centre Midterm Experience with Primary Fenestrated Endovascular Aortic Aneurysm Repair for Short Neck, Juxtarenal, and Suprarenal Aneurysms.

OBJECTIVE: The use of fenestrated stent grafts to treat short neck, juxta- and suprarenal aortic aneurysms is increasing worldwide, but midterm outcome reports are scarce. This study aimed to report peri-operative results and midterm outcomes after five years from a single centre. METHODS: Patients treated with primary fenestrated endovascular aortic aneurysm repair (FEVAR) for short neck, juxta- or suprarenal aortic aneurysms within the period January 2010 to May 2020 with follow up in the centre were included. Early (technical success, operative mortality, spinal cord ischaemia) and five year outcomes (cumulative survival, freedom from aortic related death, target vessel patency, target vessel instability [TVI], re-interventions) were analysed. RESULTS: A total of 349 patients (313 male, mean age 72.3 ± 7.7 years) were included in the study. Technical success was 98% (342/349). The thirty day mortality rate was 0.9% (3/349). Estimated survival at five years was 69.3 ± 3.1%. Freedom from aneurysm related death at five years was 98.8% ± 0.7%. Estimated target vessel patency at five years was 98.7 ± 0.4%. Estimated freedom from TVI at five years was 97.2 ± 0.6%. Estimated freedom from re-intervention at five years was 86.5 ± 2.3%. Survival did not differ significantly between patients with and without re-interventions (p = .088). CONCLUSION: Midterm results of FEVAR remain good as indicated by sustained target vessel patency and low aortic related mortality rates. An important proportion of patients require re-interventions, which do not have a negative impact on midterm survival.

Outcomes of Upper Extremity Access with Surgical Exposure of the Axillary Artery in Fenestrated and Branched Endovascular Aneurysm Repair.

OBJECTIVE: This study aims to assess the safety of upper extremity access with surgical exposure of the axillary artery in fenestrated and branched endovascular aneurysm repair (F/B-EVAR), evaluating neurological and local complications as well as re-interventions associated with the technique. METHODS: All patients undergoing an F/B-EVAR procedure with surgical exposure of the axillary artery between January 2010 and March 2020 were included in this retrospective single centre study. Endpoints were neurological and access related complications and re-interventions related to the upper extremity access. Complications related to the technique included stroke/transient ischaemic attack, wound infection, peripheral nerve injury, and arterial complications. RESULTS: 264 patients (192 male, mean age 70 ± 7 years) were included. Upper extremity access was performed over the left axillary artery in 257 (97%) of the cases, and over the right axillary artery in the remaining seven cases. Six (2.2%) patients had early complications related to the arterial access: four with post-operative bleeding and two with acute arm ischaemia. Two patients with post-operative bleeding and both patients with ischaemic complications required re-intervention. One of these patients with arm ischaemia died five weeks after the re-intervention due to sepsis complications related to patch infection. Sixteen (6%) patients presented with transient arm paraesthesia or sensory neurological deficit post-operatively. The symptoms completely recovered in all cases with no residual deficits. Peri-operative ischaemic stroke occurred in three (1%) patients (two minor, one major). No other access related complications were recorded during follow up in any of the patients with no cases of late stenosis/occlusion. CONCLUSION: Upper extremity access with surgical exposure of the axillary artery is a safe method for antegrade catheterisation of fenestrations and branches in complex endovascular aneurysm repair.

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Outcomes of Advanta V12 Covered Stents After Fenestrated Endovascular Aneurysm Repair.

PURPOSE: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established endovascular treatment option for pararenal abdominal aortic aneurysms in which balloon-expandable covered stents (BECS) are used to bridge the fenestration to the target vessels. This study presents midterm clinical outcomes and patency rates of the Advanta V12 BECS used as a bridging stent. METHODS: All patients treated with FEVAR with at least 1 Advanta V12 BECS were included from 2 large-volume vascular centers between January 2012 and December 2015. Primary endpoints were freedom from all-cause reintervention, and freedom from BECS-associated complications and reintervention. BECS-associated complications included significant stenosis, occlusion, type 3 endoleak, or stent fracture. Secondary endpoints included all-cause mortality in-hospital and during follow-up. RESULTS: This retrospective study included 194 FEVAR patients with a mean age of 72.2±8.0 years. A total of 457 visceral arteries were stented with an Advanta V12 BECS. Median (interquartile range) follow-up time was 24.6 (1.6, 49.9) months. The FEVAR procedure was technically successful in 93% of the patients. Five patients (3%) died in-hospital. Patient survival was 77% (95% CI 69% to 84%) at 3 years. Freedom from all-cause reintervention was 70% (95% CI 61% to 78%) at 3 years, and 33% of all-cause reinterventions were BECS associated. Complications were seen in 24 of 457 Advanta V12 BECSs: type 3 endoleak in 8 BECSs, significant stenosis in 4 BECSs, occlusion in 6 BECSs, and stent fractures in 3 BECSs. A combination of complications occurred in 3 BECSs: type 3 endoleak and stenosis, stent fracture and stenosis, and stent fracture and occlusion. The freedom from BECS-associated complications for Advanta V12 BECSs was 98% (95% CI 96% to 99%) at 1 year and 92% (95% CI 88% to 95%) at 3 years. The freedom from BECS-associated reinterventions was 98% (95% CI 95% to 100%) at 1 year and 94% (95% CI 91% to 97%) at 3 years. CONCLUSION: The Advanta V12 BECS used as bridging stent in FEVAR showed low complication and reintervention rates at 3 years. A substantial number of FEVAR patients required a reintervention, but most were not BECS related.

Editor's Choice - Fenestrated or Branched Endovascular versus Open Repair for Complex Aortic Aneurysms: Meta-Analysis of Time to Event Propensity Score Matched Data.

OBJECTIVE: The aim of this review was to investigate comparative outcomes of fenestrated or branched endovascular aneurysm repair (F/BEVAR) with open repair for juxta/para/suprarenal or thoraco-abdominal aortic aneurysms. METHODS: Electronic bibliographic sources (MEDLINE and Embase) were interrogated using the Healthcare Databases Advanced Search interface. Eligible studies compared F/BEVAR with open repair for complex aortic aneurysms using propensity score or Cox regression modelling/multivariable logistic regression analysis. Pooled estimates of peri-operative outcomes were calculated using the odds ratio (OR) and 95% confidence interval (CI). The result of time to event analysis was reported as summary hazard ratio (HR) and 95% CI. Random effects models and the inverse variance method were applied. The quality of evidence was graded using the system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group. RESULTS: Eleven studies published between 2014 and 2019 were selected for inclusion in qualitative and quantitative synthesis reporting a total of at least 7 061 patients. The odds of peri-operative mortality after F/BEVAR were lower, although not significantly, than after open repair (OR 0.56, 95% CI 0.28-1.12), whereas the hazard of overall mortality during follow up was higher following F/BEVAR, but, again, without reaching statistical significance (HR 1.25, 95% CI 0.93-1.67). The hazard of re-intervention was significantly higher after endovascular therapy (HR 2.11, 95% CI 1.39-3.18). The certainty for the body of evidence for peri-operative and overall mortality during follow up was judged to be very low and moderate, respectively, and for re-intervention it was judged to be high. CONCLUSION: The evidence is uncertain about the effect of F/BEVAR on peri-operative mortality when compared with open repair. There is probably no difference in overall survival, but F/BEVAR results in an increased re-intervention hazard. There is a need for high level evidence to inform decision making and vascular/aortic service provision.

Reasons for and Outcomes of Open Abdominal Aortic Repair in the Endovascular Era.

BACKGROUND: Endovascular aortic aneurysm repair (EVAR) has become the treatment of choice for most patients with abdominal aortic aneurysm (AAA). Open aneurysm repair (OAR) is still being used in a number of patients for specific reasons. The aim of the present study was to investigate the reasons and perioperative outcomes of OAR in a high-volume endovascular center. METHODS: All patients who underwent OAR in a single center institution during the period April 2010 to July 2019 were retrospectively analyzed. RESULTS: During the study period, 222 patients underwent OAR. One hundred and forty-one (63.5%) patients underwent elective surgery, and eighty-one (36.5%) patients were treated acutely. The reasons for the decision to perform OAR instead of EVAR were as follows: anatomical in 89 (40.1%) cases, rupture in unstable patient in 57 (25.7%) cases, AAA with concomitant iliac arterial occlusive disease in 44 (19.8%) cases, previous EVAR with complications in 14 (6.3%) cases, large pararenal aneurysm considered risky to wait for a customized fenestrated stent graft in 7 (3.2%) cases, young patient age in 4 (1.8%) cases, the patient's preference in 3 (1.4%) cases, infected/mycotic AAA in 2 (0.9%) cases, and simultaneous OAR with colon cancer resection (n = 1, 0.5%) and renal transplantation (n = 1, n = 0.5). Thirty-day mortality in elective cases was 5% (7/141) and in acute cases 34.6% (28/81). CONCLUSIONS: This study shows that OAR is still used for selected patients despite improvements in EVAR technology. The most common reason for OAR was an unsuitable anatomy for EVAR. Perioperative mortality of OAR both for acute and elective cases as observed in this study is in line with published outcomes of other centers.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Vascular e-Learning During the COVID-19 Pandemic: The EL-COVID Survey.

BACKGROUND: The corona virus disease (COVID-19) pandemic has radically changed the possibilities for vascular surgeons and trainees to exchange knowledge and experience. The aim of the present survey is to inventorize the e-learning needs of vascular surgeons and trainees as well as the strengths and weaknesses of vascular e-Learning. METHODS: An online survey consisting of 18 questions was created in English, with a separate bilingual English-Mandarin version. The survey was dispersed to vascular surgeons and trainees worldwide through social media and via direct messaging from June 15, 2020 to October 15, 2020. RESULTS: Eight hundred and fifty-six records from 84 different countries could be included. Most participants attended several online activities (>4: n = 461, 54%; 2-4: n = 300, 35%; 1: n = 95, 11%) and evaluated online activities as positive or very positive (84.7%). In deciding upon participation, the topic of the activity was most important (n = 440, 51.4%), followed by the reputation of the presenter or the panel (n = 178, 20.8%), but not necessarily receiving accreditation or certification (n = 52, 6.1%). The survey identified several shortcomings in vascular e-Learning during the pandemic: limited possibility to attend due to lack of time and increased workload (n = 432, 50.5%), no protected/allocated time (n = 488, 57%) and no accreditation or certification, while technical shortcomings were only a minor problem (n = 25, 2.9%). CONCLUSIONS: During the COVID-19 pandemic vascular e-Learning has been used frequently and was appreciated by vascular professionals from around the globe. The survey identified strengths and weaknesses in current e-Learning that can be used to further improve online learning in vascular surgery.

A systematic review of outcomes of upper extremity access for fenestrated and branched endovascular aortic repair.

OBJECTIVE: Upper extremity access (UEA) is an important component of complex fenestrated and branched endovascular aneurysm repair (F/BEVAR). Open and percutaneous UEA approaches have been reported during these procedures. The aim of this review was to assess the outcomes of UEA done to facilitate F/BEVAR. METHODS: A systematic review of studies focusing on upper extremity arterial access during F/BEVAR was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Three databases including PubMed MEDLINE, Embase, and Cochrane Library were queried. Outcomes of interest included UEA-related and other unrelated early and late morbidity and mortality, such as arterial occlusion, neurologic deficit, bleeding complications, and stroke, in patients undergoing UEA during F/BEVAR. RESULTS: Five full-text manuscripts and one abstract met criteria to be included, accounting for a total of 495 patients. The median age of patients who underwent UEA during F/BEVAR was 73.4 years. Predominantly male patients (371 [74.9%]) were treated. Indications for F/BEVAR were thoracoabdominal aortic aneurysms in 325 (65.6%), pararenal aneurysms in 96 (19.4%), juxtarenal aneurysms in 44 (8.9%), and suprarenal aortic aneurysms in 30 (6.1%). Axillary conduits were created in 29 (5.8%) patients. A total of 41 (8.2%) UEA-related complications were reported. Of those 41 complications, 17 (41.5%) were access bleeding, 10 (24.4%) were ischemic strokes, 7 (17.1%) were arterial occlusions, 4 (9.7%) were upper extremity neurologic deficits, 2 (4.9%) were arterial stenoses, and 1 (2.4%) was pseudoaneurysm. UEA-related complications were reported in 15 of 56 (26.8%) patients undergoing percutaneous UEA and 26 of 439 (5.9%) undergoing open UEA (P < .001). CONCLUSIONS: The overall complication rate associated with UEA during F/BEVAR is low, with 2% stroke rate reported. The percutaneous approach showed a higher UEA-related complication rate compared with open UEA. More studies on percutaneous UEA and randomized studies comparing open vs percutaneous UEA during F/BEVAR are warranted to determine the safest and most efficient UEA approach strategy during complex aortic procedures.

Aneurysm Rupture and Mortality During the Waiting Time for a Customised Fenestrated/Branched Stent Graft in Complex Endovascular Aortic Repair.

OBJECTIVE: Treatment of complex aortic pathologies with customised fenestrated/branched stent grafts (F/BEVAR) is associated with a longer waiting time to the procedure. This study aimed to investigate the prevalence of aneurysm rupture and mortality during the waiting time for a fenestrated/branched stent graft in a single centre. METHODS: All patients with a pararenal (PAA), thoraco-abdominal (TAAA), or aortic arch aneurysm planned to be treated with a customised F/BEVAR between January 2010 and December 2018 were included. Patients planned for F/BEVAR who in the end did not undergo the procedure were analysed. RESULTS: 906 patients were planned to undergo F/BEVAR during the study period. Of those, 862 (95.1%) underwent the procedure as planned (FEVAR for PAA; n = 494, F/BEVAR for TAAA; n = 348, F/BEVAR for arch aneurysm; n = 20). In 44 (4.9%) patients, the procedure was cancelled. Thirty-seven (4.1%) patients died before the procedure, four (0.4%) patients turned down the procedure, two (0.2%) were cancelled because of worsened general condition, and one (0.1%) ruptured but underwent emergency open repair in another institution. Causes of death during the waiting time were: aneurysm rupture, n = 15 (1.7%); cardiac, n = 7 (0.8%); stroke, n = 3 (0.3%); gastrointestinal, n = 3 (0.3%); death after complete arch debranching, n = 2 (0.2%); infection, n = 2 (0.2%); death after transcatheter aortic valve implantation, n = 1 (0.1%); death after urological surgery, n = 1 (0.1%); unknown, n = 3 (0.3%). Aneurysm diameter was larger in patients who died of aneurysm rupture compared with patients who died as a result of other causes (79.2 ± 13 mm vs. 66.7 ± 12 mm, respectively, p = .005). CONCLUSION: Aneurysm rupture during the waiting time for F/BEVAR can occur but is rare. Patients with a larger aneurysm diameter may be at higher risk of rupture. Measures to reduce the risk of rupture during the waiting time might include the use of off the shelf devices for larger aneurysms, quicker measurement and graft plan order processes, and quicker graft construction and delivery.

Use of Bilateral Cook Zenith Iliac Branch Devices to Preserve Internal Iliac Artery Flow During Endovascular Aneurysm Repair.

OBJECTIVES: Iliac branch devices (IBD) have become a widespread option to preserve antegrade internal iliac artery (IIA) flow during endovascular aneurysm repair (EVAR). Reported experience with bilateral implantation of IBDs is limited. This study aimed to describe the indications, technical options, and outcomes with the use of bilateral IBDs. METHODS: All patients undergoing elective implantation of bilateral Cook Zenith IBD between January 2010 and September 2017 in a single centre were included. Bilateral IBD was indicated in physically active, anatomically suitable patients and those with previous or concomitant surgery for a thoraco-abdominal aortic aneurysm or impaired collateral circulation to the IIA. Data were collected prospectively. RESULTS: Twenty-nine patients (29 male, mean age 64.1 ± 10 years) were included. Of the 58 IBDs, 48 (83%) were implanted in one procedure and 10 (17%) in two procedures (mean time between procedures 30.4 ± 9 months). Nineteen patients (65%) had a previous or simultaneous EVAR and the remaining 10 (35%) a previous or simultaneous complex aortic repair. Mean CIA diameter was 35.2 ± 8 mm. Technical success was achieved in 55 of the 58 IBDs (95%) with no mortality. Axillary artery access was used in 13 (38%) procedures. During follow up, four (7%) IIA branches occluded (1 bilateral occlusion and 2 unilateral). Estimated IIA branch patency at one and three years was 97.8% ± 2% and 88.5% ± 7%, respectively. All patients with late IIA occlusion remained asymptomatic. Re-intervention was needed in four patients (14%): two bridging stent graft extensions for type Ib endoleak, one relining of the external iliac artery because of mural in-stent thrombus and one femoro-femoral crossover bypass to treat an external iliac limb occlusion. CONCLUSIONS: Bilateral implantation of IBDs is a safe and effective technique to preserve IIA flow in selected patients with suitable anatomy, showing similar technical success and mid-term outcomes to the unilateral use of the device.

Mid-Term Results of Fenestrated/Branched Stent Grafting to Treat Post-dissection Thoraco-abdominal Aneurysms.

OBJECTIVES: Patients surviving acute aortic dissection are at risk of developing a post-dissection thoraco-abdominal aortic aneurysm (PD-TAAA) during follow up, regardless of the type of treatment in the acute setting. Fenestrated and branched stent grafting (F/B-TEVAR) has been used with success to treat PD-TAAA, albeit reported only with short-term results. The aim of this study was to report mid-term results in a cohort of 71 patients. METHODS: This was a retrospective analysis of a prospectively maintained database including all patients with PD-TAAAs who underwent F/B-TEVAR within the period January 2010 - April 2017 at two vascular institutions experienced in endovascular techniques. RESULTS: A total of 71 consecutive patients (56 male, mean age 63.8 ± 10.6 years) were treated. Technical success was achieved in 68/71 (95.8%) patients. In hospital mortality was four (5.6%) patients. Peri-operative morbidity was 19.6%. Three (4.2%) patients developed severe spinal cord ischaemia, one of these patients 12 months post-operatively. Mean follow up was 25.3 months (1-77 months). Cumulative survival rates at 12, 24, and 36 months were 84.7 ± 4.5%, 80.7 ± 5.1%, and 70.0 ± 6.7%, respectively. Estimated freedom from re-intervention at 12, 24, and 36 months was 80.7 ± 5.3%, 63.0 ± 6.9%, and 52.6 ± 8.0%, respectively. The main reasons for re-intervention were endoleak from visceral/renal arteries and iliac endoleak requiring extension. Target vessel occlusion occurred in 8/261 (3.1%) vessels (renal artery n = 4; superior mesenteric artery n = 2; coeliac artery n = 2). Mean aneurysm sac regression during follow up was 9.2 ± 8.8 mm, with a false lumen thrombosis rate of 85.4% for patients with a follow up longer than 12 months. No ruptures occurred during follow up. CONCLUSION: F/B-TEVAR for post-dissection TAAA is feasible and associated with low peri-operative mortality and peri-operative morbidity. Mid-term results demonstrate a high rate of aneurysm sac regression. Rigorous follow up is required because of the significant re-intervention rate. Longer bridging covered stents for target vessels are advised.

Early Experience with the Use of Inner Branches in Endovascular Repair of Complex Abdominal and Thoraco-abdominal Aortic Aneurysms.

OBJECTIVES: Visceral arteries in fenestrated and branched endovascular repair (F/BEVAR) have been addressed by fenestrations or directional side branches. Inner branches, as used in the arch branched device, could provide an extra option for visceral arteries "unsuitable" for fenestrations or directional side branches. Early experience with the use of inner branches for visceral arteries in F/BEVAR is described. METHODS: All consecutive patients treated by F/BEVAR for complex abdominal aortic aneurysm (AAA) or thoraco-abdominal aneurysm (TAAA) using stent grafts with inner branches were included. Data were collected prospectively. RESULTS: Thirty-two patients (28 male, mean age 71.6 ± 8.3 years) were included. Seven (21.9%) patients had a complex AAA and 25 (78.1%) had a TAAA. A stent graft with inner branches only was used in four (12.5%) patients. The remaining 28 (87.5%) patients received a stent graft with fenestrations and inner branches. In total 52 vessels were targeted with inner branches. Technical success was achieved in all 32 (100%) patients. All 38 inner branch target vessels in grafts including fenestrations and inner branches were instantly catheterised (<1 minute), whereas catheterisation of target vessels in "inner branch only" grafts proved more difficult (<1 minute, n = 3; 1-3 min, n = 4; and >3 min, n = 7). The 30 day operative mortality was 3.1% (1/32). Estimated survival at 1 year was 80.0% ± 8.3%. During follow-up, four renal inner branches occluded in three patients. The estimated inner branch target vessel stent patency at 1 year was 91.9 ± 4.5%. The estimated freedom from re-intervention at 1 year was 78.4% ± 8.9%. CONCLUSIONS: Early data suggest that visceral inner branches might represent a feasible third option to address selected target vessels in F/BEVAR. Stent grafts with inner branch(es) in combination with fenestrations seem to be a better configuration than stent grafts with inner branches alone. Durability of the inner branch design needs further investigation.

Comparison of outcomes for double fenestrated endovascular aneurysm repair versus triple or quadruple fenestrated endovascular aneurysm repair in the treatment of complex abdominal aortic aneurysms.

OBJECTIVE: This study compared outcomes of standard fenestrated endovascular aneurysm repair (St-FEVAR) with renal artery fenestrations only with more complex FEVAR (Co-FEVAR) with additional fenestrations for the superior mesenteric artery or the celiac trunk, or both. METHODS: All consecutive patients treated with FEVAR for short-necked, juxtarenal, or suprarenal aortic aneurysms between January 2010 and July 2016 were included. Patients with stent grafts with a combination of fenestrations and branches were excluded. Data were collected prospectively. All stent grafts used were customized based on the Zenith system (William A. Cook Australia, Ltd, Brisbane, Queensland, Australia). RESULTS: A total of 384 patients (345 men; mean age, 72.7 ± 7.8 years) were treated. St-FEVAR was used in 199 patients (51.8%) and Co-FEVAR in 185 (48.2%), including 30 patients with a quadruple FEVAR. Overall technical success was 373 of 384 (97.1%), and the difference between the St-FEVAR group (195 of 199 [98%]) and the Co-FEVAR group (178 of 185 [96.2%]) was not statistically significant (P = .37). Mean operative time was 135 ± 46 minutes for St-FEVAR and 176 ± 53 minutes for Co-FEVAR (P < .001). Mean fluoroscopy time was 45 ± 17 minutes for St-FEVAR and 57 ± 21 minutes for Co-FEVAR (P < .001). Overall 30-day mortality was two of 384 (0.5%), and the difference between the two groups was not statistically significant (St-FEVAR: 1 of 199 [0.5%] vs Co-FEVAR: 1 of 185 [0.5%]; P = 1.0). Major perioperative complications between St-FEVAR group (22 of 199 [11.1%]) and Co-FEVAR group (24 of 185 [13%]) were similar (P = .64). Mean follow-up was 20 ± 17.1 months. Estimated survival at 1 and 3 years was 95% ± 1.7% and 83.4% ± 3.6% for St-FEVAR vs 94% ± 2.4% and 89.4% ± 3.5%, respectively, for Co-FEVAR (P = .96). Estimated freedom from reintervention at 1 and 3 years was 97.9% ± 1.2% and 90.5% ± 3.1% for St-FEVAR vs 95.4% ± 2.0% and 89.1% ± 4.2%, respectively, for Co-FEVAR (P = .5). Estimated target vessel patency at 1 and 3 years was 99.2% ± 0.4% and 98.6.0% ± 0.6% for St-FEVAR vs 98.6% ± 0.6% and 97.9% ± 0.9%, respectively, for Co-FEVAR (P = .48). CONCLUSIONS: Co-FEVAR is not associated with an increase in perioperative mortality and morbidity compared with St-FEVAR. Co-FEVAR requires longer procedure and fluoroscopy duration, but technical success rates are as high as in St-FEVAR. A liberal use of Co-FEVAR is therefore justified whenever a longer and higher proximal sealing zone is needed.

Use of the Nellix Endovascular Aneurysm Sealing System in Combination With Parallel Grafts for the Treatment of a Symptomatic Type V Thoracoabdominal Aortic Aneurysm.

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.

A Systematic Review of Proximal Neck Dilatation After Endovascular Repair for Abdominal Aortic Aneurysm.

PURPOSE: To provide an updated systematic literature review and summarize current evidence on proximal aortic neck dilatation (AND) after endovascular aneurysm repair (EVAR). METHODS: A review of the English-language medical literature from 1991 to 2015 was conducted using MEDLINE and EMBASE to identify studies reporting AND after EVAR. Studies considered for inclusion and full-text review fulfilled the following criteria: (1) reported AND after EVAR, (2) included at least 5 patients, and (3) provided data on AND quantification. The search identified 26 articles published between 1998 and 2015 that encompassed 9721 patients (median age 71.8 years; 9439 men). RESULTS: AND occurred in 24.6% of patients (95% CI 18.6% to 31.8%) over a period ranging from 15 months to 9 years after EVAR. No significant dilatation of the suprarenal part of the aorta was reported by most studies. The incidence of combined clinical events (endoleak type I, migration, reintervention during follow-up) was higher in the AND group (26%) when compared with 2% in the group without AND (OR 28.7, 95% CI 5.43 to 151.67, p<0.001). CONCLUSION: AND affects a considerable proportion of EVAR patients and was related to worse clinical outcome, as indicated by increased rates of type I endoleak, migration, and reinterventions. Future studies should focus on a better understanding of the pathophysiology, predictors, and risk factors of AND, which could identify patients who may warrant a different EVAR strategy and/or a closer post-EVAR surveillance strategy.

"Snare-Ride": A Bailout Technique to Catheterize Target Vessels With Unfriendly Anatomy in Branched Endovascular Aortic Repair.

PURPOSE: To describe a novel endovascular bailout technique for successful completion of target vessel stenting during branched stent-graft repair of thoracoabdominal aortic aneurysms (TAAA) after encountering difficulties with standard catheterization techniques. TECHNIQUE: Technical difficulties when using fenestrated and branched grafts should be expected, especially in difficult anatomy or when an off-the-shelf device (eg, standard 4-branch device) is used that does not perfectly "match" the anatomy. The "snare-ride technique" facilitates antegrade transaxillary side branch catheterization and stent placement during TAAA branched grafting using a snare via a transfemoral approach. The branch of the graft is catheterized from an axillary access. The respective target vessel is then catheterized via a femoral access. An Indy snare is advanced over the transfemoral wire and positioned near the entrance of the target vessel. The transaxillary wire inside the branch of the graft is then advanced, snared, and pushed inside the target vessel with the snare. The procedure is thereafter continued with antegrade bridging of the target vessel in routine fashion. CONCLUSION: The snare-ride technique can be a useful maneuver to catheterize target vessels with difficult anatomy in TAAA branched stent-graft repair. Early experience shows safety and feasibility.