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Objective: The aim of this prospective monocentric cohort study was to analyze the risk of otolaryngologist-assessed cranial nerve injuries (CNIs) following carotid endarterectomy (CEA) in our academic center during a 15-year period, and to identify possible risk factors for CNI development., Methods: From January 2007 to December 2022, 3749 consecutive CEAs were performed and their data prospectively recorded in a dedicated database. CNIs were assessed and defined according to a standardized protocol. Instrumental ear, nose, and throat (ENT) evaluations were conducted within 30 days before intervention and before discharge. Preoperative neurological assessments were carried out in all patients with symptomatic carotid stenosis, whereas postoperative neurological evaluations were performed in all patients. Patients with newly onset CNIs underwent follow-up assessments at 30 days and, if necessary, at 6, 12, and 24 months. Perioperative results, including mortality, major central neurological events, and postoperative CNIs, were analyzed. Regression or persistence of lesions during follow-up visits was assessed, and multivariate analysis (binary logistic regression) was conducted to evaluate clinical, anatomical, and surgical technique factors influencing the occurrence of CNIs., Results: CEAs were performed more frequently in male patients (2453 interventions; 65.5%) than in females (1296 interventions; 34.5%). The interventions were performed in asymptomatic patients in 3078 cases (82%). In 66 cases, the interventions followed a previous ipsilateral CEA. At preoperative ENT evaluation, no cases of ipsilateral pre-existent CNI were recorded. The 30-day stroke and death rate was 1%. In 113 patients (3%), a postoperative neck bleeding requiring surgical revision and drainage was noted. Pre-discharge ENT evaluations identified 259 motor CNIs, accounting for 6.9% of the entire study group. Eighteen patients had lesions in more than one cranial nerve. ENT and neurological evaluations at 30 days showed the complete resolution of 161 lesions, whereas in 98 cases (2.6%), the CNI persisted. At 1 year, the rate of persistent CNI was 0.4% (10 patients), whereas at 2 years, it was 0.25% (6 cases), in all but one asymptomatic. At multivariate analysis, urgent intervention in unstable patients, secondary intervention, a clamping time >40 minutes, a hematoma requiring revision, and a postoperative stroke were independent predictors of CNIs., Conclusions: Data from this prospective monocentric cohort study showed that the occurrence of CNI following CEA was low, even when an independent multi-specialist evaluation was performed. The percentage of persistent lesions at 2 years was negligible and, in most cases, asymptomatic., Competing Interests: Disclosures None, (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: This study aims to retrospectively analyze the perioperative and long-term outcomes of carotid endarterectomy (CEA) performed in asymptomatic patients, stratifying the results by sex., Methods: Data on CEAs performed from January 2009 to December 2020 at our institution were collected. A neurologic evaluation was conducted 30 d after surgery to assess the occurrence of neurological events. Instrumental evaluations using Doppler ultrasound were performed within the first 3 mo, at 12 mo, and annually thereafter. The primary endpoints were perioperative mortality, major neurological events, and major complications. Secondary endpoints included long-term overall survival, stroke-free survival, absence of neurological symptoms, and absence of significant (>70%) restenosis., Results: Two thousand one hundred ninety-four CEAs were performed in asymptomatic patients, with 758 females and 1436 males. There were no differences in perioperative outcomes between the two groups. In the multivariate analysis, female sex was found to be a protective factor for the risk of 30-d stroke (hazard ratio: 0.2; 95% confidence interval: 0.04-0.9; P = 0.05). At a median follow-up of 24 mo, the estimated 10-y overall and stroke-free survival rates were 77.6% in males versus 62.7% in females, P = 0.2 and 70% in males versus 61% in females, P = 0.1, respectively. Also the rates of significant restenosis did not differ between males and females (82.2% versus 87.7%, P = 0.5)., Conclusions: This study suggests that female sex, by itself, does not represent a risk factor for adverse outcomes after carotid surgery and it appears to be protective in the first 30 d following surgery., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Complex endovascular procedures are now recognized as the gold standard treatments for extensive aortic diseases. Bridging stents (covered stents used to couple the aortic graft to the visceral vessels) play a pivotal role, yet there is currently no dedicated device available on the market. The aim of the study was to evaluate the midterm performance of the Gore Viabahn balloon-expandable (VBX) stent graft as a bridging stent for target visceral vessels (TVVs)., Methods: Data from all consecutive patients who underwent a fenestrated and branched endovascular aortic repair and received the VBX stent graft as a bridging stent between July 2018 and September 2022 were prospectively collected and subsequently analyzed retrospectively. Primary end points included freedom from TVV instability and freedom from TVV-related reinterventions, both overall and in comparison between branched and fenestrated graft configurations. Secondary end points were overall survival, procedure and TVV-related (in an intent-to-treat basis) technical success, freedom from type IC/IIIC endoleak, and freedom from TVV patency loss., Results: Sixty-three patients were treated with a fenestrated and branched endovascular aortic repair using the VBX stent graft as a bridging stent, of whom 47 (74.6%) presented an atherosclerotic aneurysm, 7 (11.1%) a post-dissecative aneurysm, and 9 (14.3%) an anastomotic pseudoaneursym or a type IA endoleak in a previous endovascular aortic repair. Included in the aortic repair were 231 of 243 (95.1%) total visceral vessels. The intraoperative requirement of 13 additional VBX stent grafts determined a TVV-related technical success of 94.4%. The mean follow-up was 26.1 ± 16.4 months. The estimated overall survival at 36 months was 73% ± 7.5%. The estimated rates at 36 months for freedom from type IC/IIIC endoleaks and TVV primary patency were 90.6% ± 3.9% and 99% ± 0.7%, respectively. The estimated rate at 36 months for freedom from TVV instability was 92.1% ± 3% and did not differ between branched and fenestrated configurations, whereas freedom from TVV-related reinterventions was 90.6% ± 3.1% and significantly in favor of fenestrations (69.4% vs 96.8%, P < .001). Multivariate analyses confirmed fenestrated configuration as a protective factor against TVV-related reinterventions (hazard ratio: 0.079; 95% confidence interval: 0.016-0.403)., Conclusions: The VBX stent graft proves to be a reliable bridging stent for complex aortic procedures involving both fenestrated and branched endografts. Although immediate results are deemed satisfactory, they favor fenestrations regarding the need of reinterventions through 3 years. The success of the procedure heavily relies on a thorough understanding of the unique characteristics of this stent., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Carbon dioxide (CO 2 ) angiography has emerged as a viable alternative to regular iodinated contrast medium (ICM) for guiding endovascular aneurysm repair (EVAR) procedures. This study aimed to evaluate the feasibility and safety of a standardised EVAR procedure using only CO 2 angiography., Methods: A prospective, multicentre, national study enrolled consecutive patients between January 2023 and January 2024 with asymptomatic abdominal aortic aneurysms measuring ≥ 55 mm and for whom standard endovascular graft (instructions for use) was anatomically feasible. The study involved the use of an automatic CO 2 injector to standardise intra-operative imaging. A strategy comprising five standardised steps was devised to visualise a target vessel (TV) that could not be seen during the first CO 2 angiography. The five steps were: (A) place the introducer closer to the TV; (B) tilt the table by 5 - 10° in the direction opposite to the TV; (C) selectively cannulate the TV; (D) cannulate the contralateral gate (only for repositionable devices); CO 2 angiography was repeated in steps 1 - 2; and (E) use ICM., Results: A total of 293 patients were enrolled (10 centres), with a median age of 78 (interquartile range [IQR] 72, 83) years; 256 (87.4%) were male. The overall procedure time, fluoroscopy time, and injected CO 2 volume were 90 (IQR 65, 125) minutes, 15 (IQR 10, 22) minutes, and 600 (IQR 400, 800) mL, respectively. The 30 day mortality, complication, and re-intervention rates were 0.3% (n = 1), 6.8% (n = 20), and 2.4% (n = 7), respectively. CO 2 related adverse events were rare (1%) and minor. A zero iodine contrast EVAR procedure was feasible in 240 (patients 81.9%). The five standardised steps were used extensively: step A, 170 procedures (58.0%); step B, 109 procedures (37.2%); step C, 21 procedures (7.2%); step D, 14 procedures (4.8%); and step E, 53 procedures (18.1%), with a median volume of 20 (IQR 10, 35) mL. Significant predictors for ICM use were aneurysm diameter > 70 mm and a position of the lowermost renal artery between 3 and 9 o'clock., Conclusion: This study demonstrated that the standardised zero iodine contrast EVAR protocol reported here is both safe and feasible and is applicable to 82% of consecutive non-selected patients. Limitations primarily arose from anatomical factors, and adjunctive standardised manoeuvres can effectively address these challenges in most cases., (Copyright © 2024 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Purpose: The study investigated the association between cell-stent area and cerebrovascular events incidence in asymptomatic patients undergoing carotid artery stenting (CAS)., Materials and Methods: This is an observational, retrospective, multicenter, cohort study. Between 2012 and 2022, all patients undergoing primary CAS for severe asymptomatic carotid artery stenosis were evaluated. Three groups were defined on the basis of the cell area (open cell, OC; closed cell, CC; double layer, DL). Periprocedural primary outcomes were 30-day stroke, mortality, myocardial infarction (MI), and major adverse event (MAE, stroke/mortality composite outcome) rates. Follow-up primary outcomes included overall survival, stroke-free survival (SFS), freedom from ipsilateral stroke (FFiS), and freedom from stroke-related mortality (FF-SRM). Data were analyzed at short-term (1 year) and mid-term (2.5 years) period., Results: A total of 1096 CAS were considered (787 men, 71.8%, median age = 74 years). Technical success was achieved in 99.5% procedures. Periprocedural 30-day stroke rate was 1.5% (OC: 1.1%, CC: 2.3%, DL: 1%, p=0.27), mortality was 0.7% (OC: 1.1%, CC: 0.3%, DL: 0.5%, p=0.35), and no MI was recorded. The MAE rate was 2.1% (OC: 2%, CC: 2.6%, DL: 1.5%, p=0.66). Median follow-up was 46 months. At 1 and 2.5 years, estimated overall survival was 96.1% and 91% (p=0.41), SFS was 99.1% and 98.2% (p=0.007, CC stroke rates 2.9% and 4.2% at timepoints), FFiS was 99.4% and 99% (p=0.014, CC FFiS rates 1.7% and 2.6% at timepoints) and FF-SRM was 99.5% and 99% (p=0.28). During follow-up, no stroke events occurred in DL group. CC design showed higher rates of any (4.2%) and ipsilateral stroke (2.6%) within 2.5 years., Conclusion: In asymptomatic patients undergoing CAS, the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. The DL stents may offer the best available performances in terms of mid-term stroke prevention., Clinical Impact: The study analyzed the contemporary results of carotid artery stenting (CAS) focusing on the impact of cell-stent area on peri- and post-operative cerebrovascular events in a multicenter real-world experience. In asymptomatic patients undergoing CAS the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. DL stents may offer the best available performances in terms of mid-term stroke prevention., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objectives: To evaluate gender-related outcomes during endovascular treatment of thoracic and thoraco-abdominal aortic diseases (TEVAR)., Methods: Multicentre, retrospective, observational cohort study. All TEVARs between January 2005 and April 2023 were identified. Primary outcomes were 30-day mortality and cumulative survival. Secondary outcomes were vascular access complications, and freedom from TEVAR-related reintervention. Interventions performed in male patients were matched to females on the basis of a one-to-one coarsened exact matching., Results: We identified 151 males who were matched with 151 females. Mortality at 30 days was not statistically different between females and males (11.2% vs 11.2%; P = 1.0). At binary logistic regression analysis, duration of intervention (P = 0.001) and emergency TEVAR (P = 0.001) were associated with mortality at 30 days. Gender did not impact the access vessel complication rate [n = 6 (4.0%) vs n = 5 (3.3%); P = 1.0]. The median follow-up was 46 (interquartile range, 7-84) months with no difference between males and females [median 50 (11-95) vs 37.5 (3.5-71.2); P = 0.153]. Estimated survival was not statistically different between females and males [log-rank χ2 = 0.6, P = 0.442; 95% confidence interval (CI) 110.7-207.3]. At Cox's regression analysis, gender did not impact overall survival (hazard ratio 0.8; 95% CI 0.6-1.3; P = 0.450). Estimated freedom from TEVAR-related reinterventions was not statistically different between females and males (log-rank χ2 = 0.4, P = 0.837; 95% CI 187.8-219.3)., Conclusions: Female gender itself was not associated with worse 30-day mortality and late survival than males with similar access vessel complication as well as TEVAR-related reintervention rate., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: To evaluate the results of isolated left subclavian artery in-situ fenestration (ISF) during 'zone 2' thoracic endovascular aortic repair (TEVAR) using a new adjustable needle puncturing device system., Methods: It is a multicentre, retrospective, physician-initiated cohort study of patients treated from 28 July 2021 to 3 April 2024. Inclusion criteria were isolate left subclavian artery revascularization for elective or urgent/emergent 'zone 2' TEVAR. The primary outcome was technical success and freedom from ISF TEVAR-related reintervention or endoleak., Results: We treated 50 patients: 28 (56.0%) atherosclerotic thoracic aneurysms, 12 (24.0%) type B aortic dissection and 10 (20.0%) penetrating aortic ulcers. Elective intervention was carried out in 46 (92.0%) cases. ISF was successful in all cases, with a procedural primary technical success in 47 (94.0%) cases. The median time of intervention was 184 min (interquartile range 135-220) with a median fenestration time of 20 min (interquartile range 13-35). Operative mortality did not occur. We observed 1 case of spinal cord ischaemia and 2 cases of bilateral posterior non-disabling stroke. Mortality at 30 days occurred in 1 (2.0%) patient (not aorta-related). The median follow-up was 4 months (interquartile range 1-12.25). Bridging stent graft patency was 100% with no ISF-related endoleak. ISF-related reintervention was never required., Conclusions: ISF TEVAR using the Ankura™-II device with the self-centring adjustable needle system showed high technical success, promising stability and stable aortic-related outcomes. Owing to these results, it represents a safe and effective alternative for standard 'zone 2' TEVAR., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Purpose: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers., Materials and Methods: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility., Results: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy., Conclusion: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria., Clinical Impact: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.