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.

[Recommendations for the specialist further training of nursing personnel on intensive care units in the treatment of abdominal aortic aneurysms: results of a modified Delphi procedure with experts]. / Empfehlungen zur Fachweiterbildung von Pflegefachpersonen der Intensivstation bei der Behandlung des Bauchaortenaneurysmas: Ergebnisse eines modifizierten Delphi-Verfahrens mit Expert:innen.

INTRODUCTION: The medical development in the previous 15 years and the changes in treatment reality of the comprehensive elective treatment of abdominal aortic aneurysms necessitate a re-evaluation of the quality assurance guidelines of the Federal Joint Committee in Germany (QBAA-RL). In the current version this requires a specialist further training quota for nursing personnel in intensive care wards of 50%. The quota was determined in 2008 based on expert opinions, although a direct empirical evidence base for this does not exist. METHODS: Representatives from the fields of patient representation, physicians, nursing personnel and other relevant interface areas were invited to participate in a modified Delphi procedure. Following a comprehensive narrative literature search, a survey and focus group discussions with national and international experts, a total of three anonymized online-based voting rounds were carried out for which previously determined key statements were assessed with a 4­point Likert scale (totally disagree up to totally agree). In addition, the expert panel had also defined a recommendation for a minimum quota for the specialist training of nursing personnel on intensive care wards in the treatment of abdominal aortic aneurysms, whereby an a priori agreement of 80% of the participants was defined as the consensus limit. RESULTS: Overall, 37 experts participated in the discussions and three successive voting rounds (participation rate 89%). The panel confirmed the necessity of a re-evaluation of the guideline recommendations and recommended the introduction of a shift-related minimum quota of 30% of the full-time equivalent of nursing personnel on intensive care wards and the introduction of structured promotional programs for long-term elevation of the quota. CONCLUSION: In this national Delphi procedure with medical and nursing experts as well as representatives of patients, the fundamental benefits and needs of professional specialist qualifications in the field of intensive care medicine were confirmed. The corresponding minimum quota for specialist further training of intensive care nursing personnel should generally apply without limitations to specific groups. The expert panel stipulates a shift-related minimum quota for intensive care nursing personnel with specialist training of 30% of the nursing personnel on intensive care wards and the obligatory introduction of structured and transparent promotion programs for the long-term enhancement.

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.

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.

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 - 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.

Mid-Term Results of Fenestrated Endovascular Repair after Prior Open Aortic Reconstruction.

This study aims to assess the mid-term results of fenestrated endovascular aneurysm repair (FEVAR) for the treatment of proximal aortic pathology after previous open surgical repair (OSR). All patients with a previous history of OSR of an abdominal aortic aneurysm undergoing a FEVAR procedure between October 2010 and November 2021 were included. The endpoints of the study were technical success, mortality, target vessel patency and reinterventions during follow-up. Thirty-five patients (34 male, mean age 72.9 ± 7 years) were included. The median interval from the primary surgery to the FEVAR procedure was 136 months (range 47-261). The indication for treatment was a para-anastomotic aneurysm in 18 (51%) patients and a true aneurysm due to progression of disease in 17 (49%) patients. Technical success was achieved in 33 (94%) patients. There was one (3%) early death due to postoperative bleeding from a renal artery. Estimated survival at 12, 24 and 36 months was 89.1% ± 6%, 84.4% ± 7.3% and 84.4% ± 7.3%, respectively. There was no aneurysm-related mortality. One (3%) target vessel occluded during follow-up and three (9%) patients underwent late reinterventions. In conclusion, FEVAR is a safe and effective alternative for the endovascular treatment of para-anastomotic aneurysms/pseudoaneurysms after OSR showing high technical success, low mortality and morbidity, and good mid-term outcomes.

Three-Dimensional Geometric Analysis of Balloon-Expandable Covered Stents Improves Classification of Complications after Fenestrated Endovascular Aneurysm Repair.

In balloon-expandable covered stent (BECS) associated complications after fenestrated endovascular aneurysm repair (FEVAR), geometric analysis may determine the cause of failure and influence reintervention strategies. This study retrospectively classifies BECS-associated complications based on computed tomographic angiography (CTA) applied geometric analysis. BECS-associated complications of FEVAR-patients treated in two large vascular centers between 2012 and 2021 were included. The post-FEVAR CTA scans of complicated Advanta V12 BECSs were analyzed geometrically and complications were classified according to its location in the BECS. BECS fractures were classified according to an existing classification system. In 279 FEVAR-patients, 34 out of the 683 included Advanta V12 BECS (5%) presented with a complication. Two Advanta V12 complications occurred during the FEVAR procedure and 32 occurred during follow-up of which five post-FEVAR CTA scans were missing or not suitable for analysis. In the remaining 27 BECSs complications were classified as (endoleaks (n = 8), stenoses (n = 4), occlusions (n = 6), fractures (n = 3), and a combination of complications (n = 6)). All BECSs associated complications after FEVAR with available follow up CTA scans could be classified. Geometric analysis of BECS failure post-FEVAR can help to plan the reintervention strategy.

Fenestrated and branched stent grafts for the treatment of post-dissection thoracoabdominal aortic aneurysms.

The present study aims to analyze fenestrated/branched endovascular aneurysm repair (F/BEVAR) in the treatment of post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). Focus is given on indication, anatomic suitability, device planning, and clinical outcomes. PD-TAAAs present with additional challenges in F/BEVAR. These include true lumen compression and visceral arteries originating from the false lumen. These technical challenges limited the use of F/BEVAR in PD-TAAAs to a few institutions in the beginning, but the good results reported with this approach have led to an increase in its use in a growing number of centers. Our current single-center experience includes 75 patients treated with F/BEVAR for a PD-TAAA between October 2010 and October 2021. Technical success was achieved in 74 cases (98.7%). Two patients (2.6%) died in the first 30 postoperative days. Ten patients (13.3%) had postoperative symptoms of spinal cord ischemia: 9 (12%) with transient limb weakness and 1 (1.3%) with permanent paraplegia. There was only 1 death (1.3%) related to the aneurysm during follow-up. Mean ± SD estimated primary patency rates of the target vessels at 12, 24, and 36 months were 97.9% ± 1%, 96.1% ± 1.6%, and 95.2% ± 1.9%, respectively. The estimated freedom from re-intervention rates at these time points were 81.4% ± 5.3%, 56.9% ± 7.3%, and 53.9% ± 7.5%, respectively. In conclusion, F/BEVAR can be performed in PD-TAAAs with high rates of technical success and good mid-term results with regard to mortality and morbidity. The additional technical challenges posed by PD-TAAAs need to be considered to prevent complications and decrease the high rate of re-interventions.

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.

The influence of narrow aortic bifurcation on limb graft patency: a two-center retrospective study.

BACKGROUND: Narrow aortic bifurcation (NAB) has been considered as a potential risk factor for graft limb thrombosis after endovascular aortic repair (EVAR). The aim of this study was to compare mid- and long-term outcome of EVAR in patients with NAB and standard aortic bifurcation (SAB). METHODS: Data from patients receiving EVAR were prospectively collected and retrospectively analyzed. In case of angiographic limb stenosis (>50%), additional stenting was performed. Patients with a NAB (≤20mm) were included in the NAB group, the remaining patients in the SAB group. Primary endpoints were limb thrombosis rate and technical success. RESULTS: A total of 902 patients were included; 18.3% (N.=165/902) in the NAB and 81.7% (N.=737/902) in the SAB group. Mean follow-up time was 43 months (range 0-198 months). Bilateral stenting of the aortic bifurcation was performed in 2.7% (N.=27/902), 8.5% (N.=14/165) in the NAB and 1.4% (N.=10/737) in the SAB group (P=0.001). Limb thrombosis was found in 2.8% (N.=25/902), 3.6% (N.=6/165) in the NAB and 2.6% (N.=19/737) in the SAB group (P=0.55). Technical success was 97.8%, 98.8% in the NAB and 97.6% in the SAB group (P=0.33). Device related reintervention rate was 16% (N.=144/902), 15.2% in the NAB and 16.1% in the SAB group (P=0.75). CONCLUSIONS: Standard EVAR could safely be performed in patients with NAB (≤20mm) when a low threshold for additional stenting was applied. This resulted in no significant higher incidence of limb thrombosis. Additional stent deployment did not increase the complication rate.

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.

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.

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.

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.

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.