Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: Global Registry for Endovascular Aortic Treatment (GREAT) is an international prospective multicenter registry collecting real-world data on performance of W. L. Gore thoracic and abdominal aortic endografts. This analysis evaluated the long-term differences in patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for any thoracic aortic pathology. METHODS: From August 2010 to October 2016, 5014 patients were enrolled in GREAT. The population of interest was comprised of only patients treated for thoracic aortic pathologies. Through 5 years, primary outcomes were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, paraplegia, and any reintervention through 5 years, grouped by pathology. Secondary outcomes were reintervention rate and freedom from serious device- and aortic-related events. RESULTS: The 578 patients with thoracic aortic pathologies enrolled in GREAT and identified for this analysis were categorized by common pathologies: thoracic aneurysm (n = 239), thoracic dissection (n = 203), arch (n = 26), and other (n = 110). The mean age of this population was 66.1 ± 12.8 years, and 64.7% were male. Procedure survival was 99.7%. In the overall group, at index procedure to 30 days and 31 days to 5 years, Kaplan-Meier estimates of freedom from all-cause mortality were 99.6% and 66.4%, respectively, and for aortic-related mortality were 97.7% and 94.6%, respectively. Aortic rupture rate was 0.5% (n = 3) at 30 days and 1.4% (n = 8) through 5 years. Stroke and spinal cord ischemic events were 1.9% (n = 11) and 1.6% (n = 9) at 30 days and at 5 years were 3.6% (n = 20), 0.5% (n = 3), respectively. Reinterventions were required in 7.3% (n = 42) at 30 days and 12.4% (n = 69) through 5 years. The number of patients with endoleaks at 30 days was 2.1% (n = 12): n = 3 (1.1%) for each of types IA, 1B, and II; n = 2 (0.3%) for type III; and n = 4 (0.7%) for unspecified. Through 5 years, the percentage of patients was 8.3% (n = 40): n = 15 (3.1%) for type IA; n = 10 (2.1%) for type IB; n = 11 (2.3%) for type II; and n = 9 (1.9%) for unspecified. One patient (0.2%) had stent migration at 30 days (aneurysm group); none were reported through 5 years. There were no incidents of stent compression or fracture from index procedure through 5 years. CONCLUSIONS: Data herein demonstrates durability and support for treatment of thoracic aortic disease with the GORE TAG conformable thoracic stent graft, including no incidents of stent compression/fracture and high freedom from aortic-related mortality. The planned analysis of follow-up to 10 years in GREAT will be beneficial.

Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry.

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

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.

The Impact of the Proctor Assistance for a Safe Learning Curve in the Development of a Complex Aortic Endovascular Program.

INTRODUCTION: Initiating an endovascular aortic program for treatment of complex aortic aneurysms with fenestrated and branched grafts (FB-EVAR) is challenging. Using a Proctor is one option for training and development of the team. However, this approach has not been formally analyzed. The aim of this study was to analyze the learning curve and the effect of the Proctor regarding safety and effectiveness in FB-EVAR. METHODS: A single-center retrospective cohort study was performed, including all consecutive elective patients submitted to FB-EVAR (including both thoraco-abdominal-TAAA and complex abdominal aortic aneurysms-C-AAA) from 2013 to 2021. Patients were divided into 2 groups, the first operated with the Proctor present and the second without. Primary outcomes were 30-day mortality (safety) and technical and procedure success (efficacy). Secondary outcomes included treatment performance (procedure time, blood loss, contrast, and radiation use), re-interventions, aneurysm shrinking, target vessel patency, 30-day mortality, aneurysm-related mortality, and overall mortality. RESULTS: Overall, 105 patients were included in the study, 35 operated with Proctor and 70 operated without. The first 20 patients were operated always with the Proctor, and the remaining were operated with the Proctor selectively. Mean age was 71.8 (±7.3) years and 95 patients were male (90.5%). Overall, 62 (65%) patients had C-AAA or extent IV TAAAs and 43 (35%) had extensive TAAAs. There were no significant differences regarding 30-day mortality (Log Rank=0.99), technical success (p=0.4), or procedure success (p=0.8). Mean surgical time was longer in the non-Proctor group (p=0.005), as well as significant intra-operative blood loss (p=0.042). Contrast use (p=0.5) and radiation (p=0.53) were non-significantly different between groups. There were no significant differences regarding length of stay (p=0.4), major adverse events (p=0.6), target vessel patency (Log Rank=0.97), early (p=0.7) and late endoleaks (0.7), aneurysm shrinking (p=0.6), re-interventions (p=0.2), and overall mortality (Log Rank=0.87). CONCLUSION: In our experience, the use of a Proctor to start and accompany our complex endovascular aortic program for FB-EVAR was both safe and effective and may serve as a template by other countries and centers that aim to developing their programs.

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.

Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients.

BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR). METHODS: Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported). Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion. RESULTS: Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0-79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0-63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0-25.2) with a median proximal neck length of 24.4 mm (IQR 15.0-34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0-35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1-19.4) and 16.2 mm (IQR 14.1-19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1). CONCLUSIONS: Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.

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 - Multicentre Outcomes of Redo Fenestrated/Branched Endovascular Aneurysm Repair to Rescue Failed Fenestrated Endografts.

OBJECTIVE: To report the outcomes of redo fenestrated and/or branched endovascular aortic repair (F/BEVAR in FEVAR) to rescue previous failed FEVAR. METHODS: Retrospective review of all consecutive patients undergoing F/BEVAR in FEVAR at eight aortic centres including pre-, intra-, and post-operative data according to a pre-established protocol. Follow up consisted of at least yearly computed tomography angiography. Values are presented as median and interquartile range, and survival as estimate ± standard error in percentage. RESULTS: 18 male patients (76 years old; range 69 - 78 years) receiving FEVAR involving two (two or three) target vessels between 2006 and 2016 underwent F/BEVAR in FEVAR between 2012 and 2019 (aneurysm diameter of 63 mm; range 56 - 69 mm). Median interval between the procedures was 53 (29 - 103) months. The indication for F/BEVAR in FEVAR was type Ia endoleak in 16 cases (eight isolated and eight combined with graft migration), one graft migration without endoleak and one migration with significant proximal aortic expansion. F/BEVAR in FEVAR involved all patent renovisceral arteries and had an operating time of 260 (204 - 344) minutes. Technical success was achieved in 15 (83%) cases. There was a failure to bridge one renal artery, one renal capsular bleed with the subsequent need for renal artery embolisation within 24 hours and one persistent type Ib endoleak despite iliac extension. There was no peri- or in hospital death. Two patients developed spinal cord ischaemia, one transient paraparesis and one permanent paraplegia. The latter occurred in a non-staged procedure where spinal drainage was used. During a follow up of 27 (7 - 39) months, three (17%) patients underwent late re-interventions. Overall survival at 24 months was 70 ± 11% with no aneurysm related death and a secondary clinical success at 24 months of 84 ± 11%. CONCLUSION: F/BEVAR in FEVAR is a technically challenging but feasible solution to rescue failed FEVAR. The outcomes are promising in many aortic centres but need to be confirmed by further studies with longer follow up.

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.

Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results.

BACKGROUND: The utilisation rate of endovascular aortic aneurysm repair has increased continuously over the past 2 decades. Endovascular aortic aneurysm repair is still performed frequently in patients with an unfavourable proximal seal zone, despite the associated late complications. PURPOSE: We aimed to evaluate the mid-term durability of the GORE® EXCLUDER® AAA Endoprosthesis, featuring the C3 delivery system, in patients with a proximal neck anatomy outside the instructions for use (IFU). METHODS: A retrospective sub-analysis of the Global Registry for Endovascular Aortic Treatment including patients treated for abdominal aortic aneurysms with the GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) was performed. A "challenging neck" was defined as those treated outside the IFU with an aortic neck length <15 mm and/or aortic neck angle >60°. Cox proportional analyses were used to test for time-to-event differences between those treated within and outside the IFU while accounting for covariates, specifically proximal neck length and neck angle. The main outcomes assessed were 5-year all-cause mortality, 5-year endoleak development (type I or III), and 5-year device-related reinterventions. FINDINGS: Of the 3,324 patients included in the analysis, 411 (12.4%) had a challenging neck and 2,913 (87.6%) did not. The patients in the challenging neck group were significantly older (74.9 years vs. 73.2 years, p≤0.0001) and had a significantly larger aortic aneurysm diameter at the time of the intervention than those treated within the IFU (61.2 mm vs. 56.4 mm, P< 0.0001), shorter proximal neck length (18 mm vs. 30 mm, P< 0.0001) and larger infrarenal neck angle (60.8° vs. 25.8°, P< 0.0001). In the multivariate analysis, brachial access site and challenging neck were not independent risk factors; increased age was associated with a shorter time to mortality (hazard ratio 1.051, 95% confidence interval 1.039-1.062, P< 0.0001), as was the use of tobacco (hazard ratio 1.329, 95% confidence interval 1.124-1.571, P= 0.0009). The 5-year all-cause mortality (36.2% vs. 27.5%, P= 0.002) and aorta-related mortality (3.8% vs. 1.1%, P= 0.002) were significantly higher in the challenging neck group. The risk of death within 5 years also increased significantly at 1.1% per millimetre increase in the abdominal aortic aneurysm diameter (P= 0.0005). Furthermore, the rates of type Ia endoleak development (7% vs. 1.2%, P< 0.001) and requirement for reintervention (13.3% vs. 9.7%, P< 0.001) were higher in those treated outside the IFU (challenging neck group). CONCLUSIONS: Treatment with the Excluder AAA Endograft outside the IFU was associated with higher 5-year mortality values, increased type Ia endoleak development rates, and a greater need for reintervention compared with treatment within the IFU. This reiterates that fenestrated and open treatments should be strongly considered in cases with aortic neck anatomies outside the IFU. Infrarenal endovascular intervention outside the IFU should only be used when there is no alternative, with meticulous procedural planning and intervention to promote satisfactory outcomes.

Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

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.

Gender Related Access Complications After TEVAR: Analysis from the Retrospective Multicentre Cohort GORE® GREAT Registry Study.

OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT), a retrospective sponsored registry, was queried to determine the incidence and identify potential predictors of access related complications after TEVAR. METHODS: This is a multicentre, observational cohort study. For the current study, all patients were treated only with the Conformable GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Thoracic Endoprosthesis devices for any kind of thoracic aortic disease. All serious adverse events within 30 days of the procedure were documented by sites. The following were considered access related complications: surgical site infection, pseudoaneurysm, avulsion, dissection, arterial bleeding, access vessel thrombosis/occlusion, seroma, and lymphocoele. RESULTS: A total of 887 patients was analysed: most of the cases had an operative indication for TEVAR of degenerative atherosclerotic aneurysm (n = 414, 46.7%) and type B dissection (n = 270, 30.4% either complicated or uncomplicated). Two hundred and ninety-five patients (33.3%) were female. The overall access related complication rate was 2.8% (n = 25): 4.7% (n = 14) in women and 1.8% (n = 11) in men (p = .013). After adjustment for age, urgency, device diameter, introducer sheath (≥24Fr vs. ≤ 24Fr), access vessel diameters, and access method, female gender was significantly associated with the risk of access complications (OR 2.85; p = .038). Brachial artery for access was also found to be an independent predictor of access related complications (OR 8.32; p < .001). CONCLUSION: This analysis suggests that women may have a higher access related complication rate after TEVAR, irrespective of the clinical setting, type of aortic disease, and device sizing.

The Relationship Between Operative Volume and Peri-operative Mortality After Non-elective Aortic Aneurysm Repair in Australia.

OBJECTIVE: Hospital and surgeon operative caseload is thought to be associated with peri-operative mortality following the non-elective repair of aortic aneurysms; however, whether such an association exists within the Australian healthcare setting is unknown. METHODS: The Australasian Vascular Audit was interrogated to identify patients undergoing non-elective (emergency [EMG] or semi-urgent [URG]) aortic aneurysm repair between 2010 and 2016, as well as their treating surgeon and hospital. Hierarchal logistic regression modelling was used to assess the impact of caseload on outcomes after both endovascular (EVAR) and open surgical repair (OSR). RESULTS: Volume counts were determined from 14 262 patients (4 121 OSR and 10 141 EVAR). After exclusion of elective procedures and duplicates, 1 153 EVAR (570 EMG and 583 URG) and 1 245 OSR (946 EMG and 299 URG) non-elective cases remained for the analysis. Crude mortality was 24.0% following OSR (EMG 29.2%; URG 7.7%) and 7.5% following EVAR (EMG 12.6%; URG 2.4%). Univariable analysis demonstrated an association between OSR mortality and hospital volume (quintile [Q] 1: 25.3%, Q2: 27.8%, Q3: 23.9%, Q4: 27.0%, Q5: 16.2%; p = .030), but not surgeon (Q1: 25.2%, Q2: 27.4%, Q3: 26.0%, Q4: 21.4%, Q5: 19.5%, p = .32). Multivariable analysis confirmed this association (odds ratio (OR) [95% CI]; Q1 vs 5: 1.91 [1.13-3.21], Q2 vs. 5: 2.01[1.24-3.25], Q3 vs. 5: 1.41 [0.86-2.29], Q4 vs. 5: 1.92 [1.17-3.15]; p = .020). The difference was most pronounced in the EMG OSR group [Q1 - 3 vs. 4-5] (OR 1.63 [1.07-2.48]; p = .020). Mortality after EVAR was not associated with either hospital (Q1: 6.3%, Q2: 10%, Q3: 6.8%, Q4: 4.5%, Q5: 10%; p = .14) or surgeon volume (Q1: 9.3%, Q2: 5.7%, Q3: 8.1%, Q4: 7.0%, Q5: 7.3%; p = .67). CONCLUSION: There is an inverse correlation between hospital volume and peri-operative mortality following EMG open repair of aortic aneurysm. These data support restructuring Australian pathways of care to direct suspected ruptured aneurysm to institutions that reach a minimum volume threshold.