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Background Despite promising early results, mid-term failures of the Nellix endovascular aneurysm sealing (EVAS) system (Endologix Inc, Irvine, Calif) have been reported at higher than expected rates. The management of proximal endoleaks and migration differs from those after conventional endovascular aortic aneurysm repair (EVAR) owing to the peculiar design of the Nellix device. In the present study, we report a monocentric experience in the management of EVAS complications using various techniques. We also performed a comprehensive review of the relevant literature on both open surgical and endovascular management of proximal failure of EVAS from the MEDLINE database. Methods We retrospectively analyzed the reinterventions for type Ia endoleak and migration after elective infrarenal EVAS at our institution. We collected preoperative, intraoperative, and follow-up data. Open and endovascular techniques are described. Overall survival, aortic-related mortality, and the technical success rate (rate of exclusion of endoleaks) with endovascular techniques were the primary outcomes. Results We performed 101 infrarenal elective EVAS procedures from 2013 to 2018. Of the 101 patients, 20 (19.8%) had required reintervention for proximal sealing failure. The indications were type Ia (Is2, Is3) endoleak, migration >5 mm, sac expansion >5 mm, and secondary rupture. Of the 20 patients, 6 (30%) were treated with endovascular techniques—2 with a chimney Nellix-in-Nellix application and 4 with proximal relining with a covered stent. The remaining 14 patients (70%) were treated with late open conversion (OC). The average time from EVAS to reintervention was 36.1 months (range, 3-65 months). Six patients (30%) had undergone OC in an emergent setting because of secondary rupture. The technical success rate for the patients treated with endovascular reinterventions was 100%. The 30-day mortality was 20% (4 of 20), all emergent cases (four of six emergent repairs; 67%). The overall survival for the 20 patients was 75% (n = 15) at a mean follow-up of 15.1 months (range, 2-47 months). One patient had died after 7 months of non–aortic-related causes. Conclusions The high reintervention rate of the Nellix graft mandates careful evaluation for its further use with the revised instructions for use, and it should not be used off-label. OC remains the strategy of choice when managing Nellix proximal sealing failures in fit patients. Chimney Nellix-in-Nellix application and transcatheter embolization are feasible alternative techniques. Proximal relining also appears to be an effective alternative to more complex interventions, although it requires further studies for validation.

Arch pathology represents one of the last frontiers in aortic aneurysms endovascular management. Several companies recently developed dedicated branched and fenestrated endografts specifically designed for the aortic arch, aiming to overcome some of the issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomical debranching. This study aimed to evaluate early outcomes obtained with a custom-made fenestrated endograft approved for thoracic aortic aneurysms exclusion.All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in Italy were prospectively enrolled and included in the study population. Anatomical characteristics and perioperative data were retrospectively analyzed. Study endpoints were technical success, 30-day clinical success, overall survival, supra-aortic vessel patency, endoleak and need for reintervention or surgical conversion.During the period 2018-2022, seventy-six patients received a Najuta endograft in Italy and were enrolled in the study. Median age was 72 (IQR 69-76) years and 80.3% were male. Most of the patients received treatment for atherosclerotic aneurysms (80.3%) while the others for post-dissection aneurysms (7.9%), penetrating aortic ulcer (9.2%), or type I endoleak correction after previous thoracic endovascular repair (2.6%). Overall, 161 supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 74/76 (97.4%) of procedures; both failures were associated with endoleak detection at final angiography (one type I and one type III endoleak). Two distal migrations occurred during the implanting procedure. Clinical success at 30 days was 94.7%. Two early reinterventions were needed within 30 days after index procedure: in one case an aortic false lumen coils embolization was performed, since distal re-entry caused enlargement of the post dissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair. Median follow-up was 7 (IQR 3-15) months; no supra-aortic vessel occlusions occurred and no patients needed surgical conversion.Early results suggest that in selected patients with aortic arch pathology needing a proximal landing, an endovascular approach with the Najuta system is safe and effective, especially for those at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and eventual long-term complications evaluation is needed to confirm these initial experience findings.

To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment. Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months. The primary patency rate was 99(95%CI 98–100)% at 1 month, 86(80–92)% at 6 months and 81(74–88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86–96)% at 6 months and 88(82–94)% at 12 months and a secondary patency of 94(90–98)% at 6 months and 90(84–95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency. The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.

Objectives This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. Background When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque’s debris prolapsing through stent’s mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. Methods From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. Results Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. Conclusions This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Purpose: Despite encouraging early results, mid- and long-term follow-up of endovascular aneurysm sealing (EVAS) has shown increased rates of failure mainly associated with endoleak detection and progressive bag separation with aneurysm reperfusion. Case Report: We present the first case of a Nellix endograft stent fracture detected in a 91-year-old male patient, presenting with widespread abdominal pain, 7 years after elective treatment of an abdominal aortic aneurysm by EVAS. Considering the sudden and unexpected nature of the event, an in-depth analysis of the possible causes of this structural failure has been performed. Conclusion: Material fatigue could be another significant cause of late EVAS failure and should be carefully assessed in addition to endoleak detection during follow-up. Clinical Impact The case presented in this article further underlines the importance of a strict long term follow-up protocol in every patients who underwent EVAS.

Objectives: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto–iliac bifurcation in a multicenter Italian registry. Methods: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto–iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto–iliac bifurcation were included. Early (Results: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% ± 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% ± 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 ± 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% ± 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. Conclusions: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto–iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization.

The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry.DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year.From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion.At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence.This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

Objective: We compared the early and mid-term outcomes of polytetrafluoroethylene covered stents (CSs) vs bare metal stents (BMSs) used in the kissing conformation for the reconstruction of the aortic bifurcation in aortoiliac obstructive disease. Methods: A multicenter cohort registry (2015-2019) collected data from 1306 patients who had undergone endovascular treatment of aortoiliac arterial obstructive disease. Only patients who had received bilateral iliac kissing stents for TransAtlantic Inter-Society Consensus (TASC) class C and D lesions were included in the present analysis. The 30-day outcomes, mid-term primary patency, and limb salvage rates were compared between the CSs and BMSs in matched patient cohorts after propensity score matching. The follow-up results were analyzed using Kaplan-Meier curves. Cox proportional hazards models were used to identify the predictors of primary patency. Results: A total of 336 patients were treated with kissing stents, 201 with CSs (60%) and 135 with BMSs (40%). In the unmatched cohort, patients receiving CSs were more likely to have critical limb ischemia (41% vs 30%; P = .038), complex iliac lesions, such as TASC D (90% vs 56%; P < .01), and iliac occlusions (59% vs 44%; P < .01). After propensity score matching, 220 patients were selected (110 with CSs and 110 with BMSs), without differences in the clinical presentation (critical limb ischemia, 41% vs 33%; P = .167), or anatomic complexity (TASC D, 66% vs 60%, P = .21; iliac occlusion, 48% vs 49%, P = .89). The 30-day mortality was 0%. The early medical (unmatched, 5% vs 4%, P = 1.00; matched, 5% vs 4%, P = .75) and surgical (unmatched, 5% vs 5%, P = 1.00; matched, 5% vs 3%, P = .72) complication rates were similar between the CSs and BMSs. However, the CSs resulted in a lower risk of intraoperative iliac rupture (0% vs 3.5%; P = .013) and greater ankle-brachial index improvement (0.43 ± 0.22 vs 0.36 ± 0.24; P = .02). At 36 months, the overall primary patency (92% ± 7% vs 92% ± 8%; P = .38), secondary patency (98% ± 3% vs 98% ± 4%; P = .50), and limb salvage (93% ± 9% vs 97% ± 5%; P = .20) rates were similar. In cases of moderate to severe iliac calcification, the CSs showed better results in the matched cohort (100% vs 89% ± 9%; P = .048). On multivariate analysis, CS use (hazard ratio [HR], 1.67; P = .45) did not significantly affect primary patency, but older age (HR, 0.93; P = .03) and kissing stent diameter ≥8 mm (HR, 0.25; P = .03) were significantly associated. Conclusion: In the present multicenter study, the use of kissing stents for the treatment of the aortic bifurcation provided good early and mid-term results. CSs were preferred for more complex lesions, were protective from iliac rupture, and allowed for greater ankle-brachial index improvement. The 3-year patency rates were similar between the CSs and BMSs. However, CSs showed improved results in the case of moderate to severe calcification.

Objectives: This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. Background: When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. Methods: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. Results: Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. Conclusions: This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Aims The aim of the present study was to evaluate periprocedural and 30-day outcomes in a prospective series of patients treated with the CGuard Embolic Prevention System (EPS). Methods and results From April 2015 to June 2016, a physician-initiated prospective multicentre study was performed in 200 consecutive patients admitted for protected carotid artery stenting (CAS) and treated using the CGuard EPS in twelve vascular centres. Outcome measures were: technical success, periprocedural (0-24 hours) and post-procedural (24 hours-30 days) major and minor strokes, death, acute myocardial infarction (AMI), transient ischaemic attack (TIA), and external carotid occlusion. In three centres, consecutive diffusion-weighted magnetic resonance cerebral imaging (DW-MRI) was performed ≤72 hours prior to and within 72 hours after the intervention. A distal embolic protection device was employed in 182 patients (91%). Technical success was 100%. No death, AMI or major stroke occurred periprocedurally. There were two TIAs and five periprocedural minor strokes (2.5%), including one thrombosis solved by surgery. In the remaining patients (199/200; 99.5%) one-month follow-up duplex ultrasound revealed optimal technical results. Post-procedural clinical follow-up was uneventful. No external carotid artery occlusion occurred. New post-procedural DW-MRI lesions were detected in 12 patients out of 61 (19.6%), including bilateral in five (8.2%) and isolated ipsilateral in six (9.8%), whereas one patient (1.6%) had contralateral only lesions. Conclusions Multicentre multi-specialty use of the CGuard EPS in routine clinical practice was associated with no major periprocedural neurologic complications and a total elimination of post-procedural neurologic complications by 30 days.

Objective/Background Proximal type I endoleaks are associated with abdominal aortic aneurysm (AAA) growth and rupture and necessitate repair. The Nellix™ EndoVascular Aneurysm Sealing (EVAS) system is a unique approach to AAA repair, where the appearance and treatment of endoleaks is also different. This study aimed to analyse and categorise proximal endoleaks in an EVAS treated cohort. Methods All patients, treated from February 2013 to December 2015, in 15 experienced EVAS centres, presenting with proximal endoleak were included. Computed tomography scans were analysed by a core laboratory. A consensus meeting was organised to discuss and qualify each case for selection, technical aspects, and possible causes of the endoleak. Endoleaks were classified using a novel classification system for EVAS. Results During the study period 1851 patients were treated using EVAS at 15 centres and followed for a median of 494 ± 283 days. Among these, 58 cases (3.1%) developed a proximal endoleak (1.5% early and 1.7% late); of these, 84% of 58 patients were treated outside the original and 96% outside the current, refined, instructions for use. Low stent positioning was the most likely cause in 44.6%, a hostile anatomy in 16.1%, and a combination of both in 33.9%. Treatment, by embolisation or proximal extension, was performed in 47% of cases, with a technical success of 97%. Conclusion The overall incidence of proximal endoleak after EVAS is 3.1% after a mean follow-up period of 16 months, with 1.5% occurring within 30 days. Their occurrence is related to patient selection and stent positioning. Early detection and classification is crucial to avoid the potential of sac rupture.

Background Endovascular aneurysm sealing (EVAS) is an innovative alternative to conventional endovascular aneurysm repair (EVAR). EVAS relies on sac anchoring without proximal fixation to achieve sealing and should have allowed for the treatment of a broader range of anatomic features compared with standard EVAR. Despite the encouraging early reports, the mid- and long-term follow-up data have shown increased rates of failure. To address the issue, the manufacturer introduced revised instructions for use (IFU) in 2016. The present study reports the outcomes of this system after a median follow-up of 45 months. Methods Data for all patients electively treated with EVAS at our institution were retrospectively collected. The patients were retrospectively reclassified according to the 2016 revised IFU of the device. All patients in the present series had undergone EVAS for the treatment of infrarenal abdominal aortic aneurysms (AAAs). The primary end point was therapeutic failure: graft migration >5 mm, sac expansion >5 mm, type IA endoleak (Is2 and Is3 using the Van den Ham classification), type Ib endoleak, and secondary rupture. The overall mortality, aortic-related mortality, and reintervention rates were also analyzed. Results A total of 101 patients had undergone elective treatment by EVAS from 2013 to 2018 for infrarenal AAAs. The median follow-up was 3.75 years. Therapeutic failure was observed in 31 of the 101 patients (30.7%), with no significant difference between the in-IFU and off-IFU 2016 subgroups. Failure occurred at a median interval of 34 months from the index procedure. Of the 101 patients, 6.9% had presented with secondary rupture. Freedom from aneurysm-related mortality was 96.9% at 1 and 2 years and 89.9% at 5 years. Freedom from reintervention decreased over time: 94.7% at 1 year, 77% at 4 years, and 52.1% at 6 years. Of the 101 patients, 14 (13.9%) had undergone emergent or elective graft explantation. Conclusions EVAS performed worse than conventional endografts for several critical end points, regardless of any preoperative anatomic parameter s . The incidence of therapeutic failures tended to increase over time, especially 4 years after the index procedure.

Objective The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR). Methods Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up. Results One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively. Conclusion The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies.

Purpose: To report the results of endovascular treatment of iliac and complex aortoiliac occlusive disease (AIOD) in a multicenter Italian registry. Materials and Methods: A retrospective, multicenter, observational cohort study analyzed 713 patients (mean age 68±10 years; 539 men) with isolated iliac and complex aortoiliac lesions treated with primary stenting between January 2015 and December 2017. Indications for treatment were claudication in 406 (57%) patients and critical limb ischemia in 307 (43%). According to the TransAtlantic Inter-Society Consensus II (TASC) classification, the lesions were categorized as type A (104, 15%), type B (171, 24%), type C (170, 24%), and type D (268, 37%). Early (

Background Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis. Objective The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions. Methods This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month. Results The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints. Conclusions These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future. International Registered Report Identifier (IRRID) DERR1-10.2196/9972

Objective The objective of this study was to assess early and midterm results after endovascular aortic arch repair using a double inner branch stent graft (DIBSG) in patients with aortic arch aneurysm or dissection unfit for open surgery. Methods Between 2012 and 2018, there were 24 patients with aortic arch disease who were treated with a single model of a DIBSG (Terumo Aortic, Glasgow, United Kingdom) in nine Italian cardiovascular centers. We investigated technical success, mortality, occurrence of major complications, and need for reintervention in a multicenter, nonrandomized, retrospective fashion. Results The in-hospital mortality rate was 16.7%. Cerebrovascular events occurred in 25% of patients and major strokes in 12.5%. Two patients experienced a retrograde dissection (8.3%), whereas none reported any type I or type III endoleak. During a mean follow-up of 18 months (range, 1-60 months), one patient died of a nonaortic cause and one reported a nonarch-related major stroke. No late secondary intervention was needed during the follow-up. Excluding from the analysis the first six patients treated until 2014 as part of the learning curve, in-hospital mortality, major stroke, and retrograde dissection rates were 11.1%, 11.1%, and 5.6%, respectively. Conclusions Endovascular aortic arch repair using this model of DIBSG is feasible, and results are acceptable for a new technique in a high-risk subset of patients. Operative mortality suffers the effect of a learning curve, whereas midterm aorta-related survival is promising. Endovascular repair of aortic arch disease with a DIBSG should always be considered to give high-risk patients a chance of repair. Large-scale studies are needed to assess the long-term durability of this technique.

The objective of this study was to evaluate the results of the off-label use of the Nellix endograft (Endologix, Irvine, Calif) for the treatment of short-neck aneurysms and juxtarenal aortic aneurysms (JAAs) compared with the outcomes of patients with infrarenal abdominal aortic aneurysms treated in accordance with the manufacturer's instructions for use.Data available from patients treated with the Nellix endograft from September 2013 to January 2016 were reviewed to create a case-control analysis (1:2). Fourteen elective patients with a short-neck aneurysm or JAA (10 mm) and mild aortic neck angulation (35 degrees) were included. As a control group, 28 elective patients who had been treated in accordance with instructions for use were included. Patients were matched for age, sex, aortic diameter, and aortic neck angulation. The final cohort group included 42 patients: 14 in the JAA off-label group (5 with aortic neck length ≤4 mm and 9 with necks of 5 to 10 mm) and 28 in the control group. Technical and clinical success, freedom from any secondary intervention, any type of endoleak, and aneurysm-related death were evaluated.There were no significant differences between the two groups in terms of comorbidity, intraoperative time, radiation time, contrast agent volume, and perioperative mortality and morbidity. Two patients of the JAA group subsequently underwent open repair (14%), both with aortic neck length 4 mm (2/5; 40%), for type Ia endoleak. Two of the control group also subsequently underwent open repair (7%). At a mean follow-up of 22 ± 3.9 months, freedom from any reintervention was 85% for the JAA off-label group vs 92% for the control group (log-rank test, P = .33).The off-label use of the Nellix endograft for the treatment of JAA showed a higher rate of subsequent conversion to open repair for JAA patients (aortic neck length ≤4 mm), underlining the need for a proximal sealing zone. Longer term data are needed to verify the possible use of the Nellix endograft in selected short-neck aneurysms with aortic neck length5 mm.

Despite the improvement in diagnostic and therapeutic strategies, the treatment of thoracoabdominal aneurysms is still burdened with a high incidence of peri/postoperative morbidity and mortality. The multilayer flow modulator is a new and promising technique for the treatment of such disease; however, some limits are still evident. We report the case of a 76-year-old woman affected by a symptomatic thoracoabdominal aneurysm treated with multiple Cardiatis multilayer flow modulators complicated by aortic arch rupture on the fifth postoperative day, with subsequent patient death.

Background The endovascular treatment of an abdominal aortic aneurysm (AAA) is a treatment with low risk and good reported results. This retrospective study analyzed experience with patients requiring surgical conversion after endovascular abdominal aortic aneurysm repair (EVAR). Methods A total of 26 patients underwent open conversion (OC) after EVAR (18 endografts implanted at the authors' center and 8 in other centers). Patients were divided into 2 groups: early conversion if OC was performed within 30 days from the primary EVAR, and late conversion if OC was performed at least 30 days after EVAR. The authors analyzed all data on OC and the postoperative course. Results In this series, OC was performed for 22 endoleaks (13 type I, 5 type II, 2 type III, and 2 type V, which in 5 cases these were associated with AAA ruptures), 2 renal artery coverages, and 2 endograft infections. Six (23%) patients underwent early conversion with a mortality rate of 50%, and 20 (77%) had late conversion with a mortality rate of 20%. The overall mortality rate after OC, occurring before hospital discharge or within 30 days, was 26.9% (7 of 26). Conclusions Endoleaks remain the weak point of endografts and can result in aneurysm rupture/death. Urgent OC and infections engender a high mortality. Elective OC can be performed with very low mortality and acceptable morbidity. Lifelong surveillance is necessary to detect and treat endoleaks.

To report midterm failure of tandem peripheral multilayer stents used to treat a common hepatic artery aneurysm (HAA) that had a good early result.A 71-year-old man with multiple comorbidities had a 3.4-cm HAA treated with 2 Cardiatis peripheral multilayer stents (8×100 and 9×60 mm) that overlapped by 3 cm. At the 12-month follow-up, the stents were patent, with signs of collateral patency and full thrombosis of the aneurysm sac without expansion. At the 18-month visit, the sac had expanded to 4.5 cm without signs of revascularization, but there was an initial stent dislocation; a wait and watch approach was elected. On the 24-month imaging, the HAA had enlarged to 6 cm, with disconnection of the 2 stents. A new multilayer stent (9×100 mm) was positioned to "bridge" the gap; however, the proximal part of the new stent did not correctly expand despite multiple attempts to overcome the infolding. The 3 stents became completely thrombosed, but thanks to rich mesenteric collaterals, perfusion of the proper hepatic artery was adequate.The multilayer peripheral stent appears to be an alternative for the treatment of visceral aneurysms in patients with a high surgical risk, but it is not a conventional stent. There are unknowns about its function, behavior, and application. Therefore, more experience is needed to validate the effectiveness of the multilayer stent.

Objective Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. Methods This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. Results From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. Conclusions The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data.

Purpose: To report midterm outcomes of the Nellix Endovascular Aneurysm Sealing (EVAS) System in the treatment of abdominal aortic aneurysm (AAA). Methods: Between September 2013 and July 2014, 64 AAA patients (mean age 76.6±6.8 years; 61 men) were treated with the EVAS system at 2 centers (only procedures performed at least 12 months prior to the analysis were included). Most patients were treated for a stable AAA, while 1 patient was treated for a ruptured aneurysm. Mean aneurysm diameter was 57.3±9.3 mm. The proximal neck measured a mean 21.5±3.3 mm in diameter and 27.0±12.1 mm long; the neck angle was 16.9°±19.3°. Eleven (17.2%) patients were treated outside the instructions for use (IFU). Results: Technical success was achieved in 63 (98.4%) of 64 patients; 1 type Ia endoleak was treated intraoperatively. One (1.6%) aneurysm-related death occurred at 4 months due to a secondary aortoenteric fistula. Overall, endoleaks occurred in 3 (4.7%) patients (2 type Ia, 1 type II). The estimated rates for 18-month overall survival, freedom from aneurysm-related death, and freedom from secondary interventions were 92.7%, 98.4%, and 95.0%, respectively. Patients treated outside the IFU had a significantly higher incidence of device-related complications (p=0.03). Conclusion: The use of the Nellix device in everyday clinical practice is safe and offers promising midterm results. The risk of secondary aortoenteric fistula requires further analysis. Longer follow-up is needed to assess the actual efficacy of the device, although the risk of migration with late endoleak seems low.

Objectifs Le thrombus libre flottant de l'artere carotide interne (TLF-ACI) est rare et sa vraie incidence est inconnue. L'etiologie la plus commune est la complication d'une plaque atheromateuse, mais plusieurs conditions medicales peuvent etre responsables. Le but de cette etude etait d'analyser retrospectivement notre experience de l'endarteriectomie carotidienne dans la gestion des TLF-ACI et d'analyser les resultats. Methodes Une revue retrospective a ete faite sur tous les patients admis pendant les 9 dernieres annees avec un diagnostic de TLF-ACI. La demographie, les manifestations cliniques, les modalites diagnostiques, les indications chirurgicales, les details operatoires, les suites postoperatoires, et le suivi ont ete enregistres dans la base de donnees de l'hopital. Resultats Entre janvier 2000 et decembre 2008, dans notre unite, 2.572 endarteriectomies carotidiennes ont ete faites pour lesion de l'artere carotide. Un total de 16 patients (16 sur 2.572 ; 0,62%) ont ete traites pour un TLF-ACI. En tout, 87,5% (14 sur 16) patients avaient eu des symptomes neurologiques. Tous les patients ont eu un examen duplex. Dans 75% (12 de 16) de cas, des examens diagnostiques additionnels ont ete faits : angiographie numerique en soustraction (ANS), angiographie par resonance magnetique, ou scanner. Le duplex et l'ANS ont detecte le TLF-ACI dans 62,5% et 100% des cas, respectivement. Le scanner et l'angiographie par resonance magnetique n'ont pas fourni de diagnostic chez la majorite des patients (33,4% et 66,7%, respectivement). La presence d'un TLF-ACI a ete confirmee en peroperatoire dans tous les cas. Le taux cumulatif d'AVC apres chirurgie etait de 6,3% (un sur 16). Parmi tous les patients sortis, 68,75% montraient une amelioration des symptomes neurologiques, 12,5% etaient asymptomatiques, 12,5% n'avaient aucun changement des symptomes, et 6,25% des cas etaient aggraves. Au suivi de 30 jours, le taux de survie etait de 93,7% et 75% des patients avaient une amelioration des symptomes neurologiques, 12,5% etaient asymptomatiques, et 6,25% etaient morts. En tout, 6,25% des patients ont ete perdus de vue. Conclusion Les patients avec TLF-ACI sont habituellement symptomatiques et se presentent en urgence. Le duplex demeure l'examen diagnostic de reference pour detecter les TLF-ACI. Nous ne pouvons pas affirmer que la chirurgie precoce est superieure a l'anticoagulation provisoire et/ou a l'intervention differee en raison de l'absence d'un groupe controle. Cependant, nos resultats retrospectifs suggerent que l'intervention rapide est une alternative sure dans le traitement des TLF-ACI.

Introduction Cette etude retrospective unicentrique sequentielle comparait les resultats de l’endarteriectomie carotidienne (EAC) sous anesthesie generale a l’EAC sous anesthesie generale. Methodes De Novembre 2002 a Octobre 2004, 428 EACs etaient realisees dans notre unite vasculaire. Deux groupes etaient formes : groupe AG (anesthesie generale) : 219 patients operes sous anesthesie generale ; groupe AL (anesthesie locale) : 209 patients operes sous anesthesie locale. Resultats Il n’y avait aucun deces dans les deux groupes. Apres chirurgie, trois accidents vasculaires constitues etaient notes dans le groupe AG et trois dans le groupe AL (AG 1,36% vs. AL 1,43%, p = 0,9540) ; Apres EAC, il y avait trois AITs dans le groupe AG et aucun dans le groupe AL (AG 0,42% vs. AL 0%, p = 0,2634). Conclusion La morbi-mortalite n’etait pas influencee par le type d’anesthesie utilisee en chirurgie carotidienne. Aucune difference statistique n’etait detectee en termes de taux de complications neurologiques et cardio-pulmonaires entre l’AG et l’AL.

Objectif Le risque precoce de survenue d’un accident vasculaire cerebral apres un accident ischemique transitoire (AIT)/accident vasculaire cerebral (AVC) varie entre 5 et 10% a une semaine et 10 et 20% a trois mois. Bien que l’endarteriectomie carotidienne (EAC) soit le traitement de choix des stenoses symptomatiques de l’artere carotide interne, le delai de realisation des interventions carotidiennes apres un accident vasculaire aigu n’est toujours pas codifie. Les auteurs ont voulu determiner si une EAC precoce pouvait etre realisee de maniere sure au cours des premieres heures ( Methodes En quatre ans, les auteurs ont effectue 1184 EAC (285 symptomatiques). Cinq groupes ont ete formes a partir des 285 patients symptomatiques, selon l’intervalle separant la survenue de l’AIT (accident cerebral) et la realisation de l’EAC : G1, moins de 48 heures ; G2, 48 heures-2 semaines ; G3, 2-4 semaines ; G4, 4-8 semaines ; G5, 8-24 semaines. La chirurgie n’a jamais ete effectuee lorsque les patients presentaient des deficits neurologiques invalidants (echelle de Rankin modifiee, 5) a l’admission, des lesions cerebrales superieures a 3 cm sur l’IRM ou le scanner, presence ou suspicion d’hemorragie parenchymateuse associee aux lesions ischemiques, patients consideres comme mauvais candidats a la chirurgie (classification de l’American Society of Anesthesiology grade V) et en cas d’occlusion de l’artere cerebrale moyenne. Des examens neurologiques et diagnostiques (echographie Doppler et scanner/IRM) ont ete utilises pour selectionner les candidats a l’EAC precoce. Resultats Le taux cumulatif AIT/AVC/deces apres EAC a ete de 3,8% (11/285) et de 2,8% (8/285) a 30 jours. Le taux cumulatif d’AIT apres EAC et a 30 jours a ete de 0% (0/285). Le taux cumulatif d’AVC apres EAC a ete de 3,5% (10/285) et a 30 jours de 2,4% (7/285). Le taux cumulatif de deces apres EAC et a 3 jours a ete de 0,3% (1/285). Le taux d’AVC apres EAC dans chaque groupe a ete : G1 4,2% (3/70) ; G2 3,2% (2/61) ; G3 0% (0/22) ; G4 3,4% (1/29) ; G5 3,8% (4/103). Il n’a pas ete montre de difference statistiquement significative entre les groupes G1 et les quatre autres groupes concernant la survenue d’un AVC post-operatoire : G1 (4,2%) versus G2 (3,2%), p = 0,7641 ; G1 (4,2%) versus G3 (0%), p = 0,7648 ; G1 (4,2%) versus G4 (3,4%), p = 0,8473 ; G1 (4,2%) versus G5 (3,8%), p = 0,8952. Il n’y a eu aucun accident hemorragique compliquant une EAC precoce. Le type d’anesthesie et l’utilisation d’un shunt n’etaient pas significativement differents entre les 5 groupes. Conclusions L’analyse de ces donnees suggere qu’une EAC precoce dans la phase suivant un evenement neurologique aigu, chez les patients cliniquement selectionnes, ne semble pas augmenter le risque de complications comparee a la chirurgie retardee ou differee. De plus, l’avantage de l’EAC precoce est de reduire les taux de recidive d’evenement neurologique, les patients non traites en presentant une plus forte incidence.

The early risk of stroke after transient ischemic attack (TIA)/stroke is of the order of 5-10% at 1 week and 10-20% at 3 months. Even if carotid endarterectomy (CEA) is the treatment of choice in symptomatic internal carotid artery stenosis, the timing of carotid intervention after acute stroke is not yet codified. The authors want to determinate whether early CEA is safely carried out in the first few hours (48 hours) successive to the nondebilitating neurological event and whether the outcome (TIA/stroke/death) in these cases is comparable with the results of those treated by delayed/deferred surgery (range, 48 hours-24 weeks).In 4 years, the authors performed 1,184 CEA (285 symptomatic). Five groups were formed from 285 symptomatic patients, according to interval between TIA/stroke onset and performance of CEA: G1, less than 48 hours; G2, 48 hours-2 weeks; G3, 2-4 weeks; G4, 4-8 weeks; G5, 8-24 weeks. Surgery was never performed on patients with disabling neurological deficit (modified Rankin Scale, 5) at the time of admittance, cerebral lesions greater than 3 cm at magnetic resonance/computed tomography scan, presence or suspect of parenchymal hemorrhage associated with ischemic damage, condition considered unfit for surgery (American Society of Anesthesiology classification grade V), and occlusion of the cerebral middle artery. Neurological and diagnostic examinations (duplex-scanning and computed tomography/magnetic resonance scan) were used in determining the selection for early CEA.Cumulative TIA/stroke/death rate after CEA was 3.8% (11/285) and at 30 days was 2.8% (8/285). The cumulative TIA rate after CEA and at 30 days was 0% (0/285). The cumulative stroke rate after CEA was 3.5% (10/285) and at 30 days was 2.4% (7/285). The cumulative death rate after CEA and at 30 days was 0.3% (1/285). Stroke rate after CEA in each group was: G1 4.2% (3/70); G2 3.2% (2/61); G3 0% (0/22); G4 3.4% (1/29); G5 3.8% (4/103). Any statistically significant difference between G1 and the other four groups was not detected with regard to postoperative stroke: G1 (4.2%) versus G2 (3.2%), p = 0.7641; G1 (4.2%) versus G3 (0%), p = 0.7648; G1 (4.2%) versus G4 (3.4%), p = 0.8473; G1 (4.2%) versus G5 (3.8%), p = 0.8952. No hemorrhagic stroke was detected after early CEA. The type of anesthesia and the use of a shunt didn't show any significant difference between the five groups.The analysis of these records suggests that early CEA in the acute post stroke phase, for patients clinically selected, does not result in greater complications than when performed delayed or deferred . Furthermore, the advantage of early CEA is the reduction of recurrent strokes, as untreated patients present a higher incidence of neurological events.

We report a case of a metachronous common iliac artery and the internal iliac artery (IIA) aneurysm developed 8 years after an aortobi-femoral bypass for treatment of abdominal aortic aneurysm associated at chronic occlusion of the right iliac axis. To exclude the metachronous aneurysm on the left iliac axis and to maintain the pelvic circulation, an external to IIA endografts were positioned ("U stent-graft technique"). At 6-month follow-up, the computed tomography scan showed patency of the endografts, of the bypass and of the IIA, without endoleak, or other adverse events.

Objective We compared the outcomes and the durability of endovascular recanalization (EVR) with the Viabahn (W. L. Gore and Associates, Flagstaff, Ariz) covered stent graft vs traditional aortobifemoral or aortofemoral bypass grafting for complex aortoiliac occlusions. Methods Between 2008 and 2014, 11 unilateral iliac occlusions and 11 aortobiiliac occlusions were treated by EVR. Also collected were data from the last 21 consecutive patients treated in the same period by aortofemoral (n = 6) or aortobifemoral (n = 15) bypass grafting. In accordance with the TransAtlantic Inter-Society Consensus II (TASC II) document, only patients with type D lesions were considered. Kaplan-Meier estimates for patency were calculated, and Cox proportional hazard modeling was performed. Results The difference in risk factors between the groups was not significant. General anesthesia was required in 100% of the surgical group, and local or locoregional anesthesia was used for EVR. Suprarenal aortic cross-clamping was required in nine of the open surgical procedures (41%). A brachial percutaneous approach was performed in all patients undergoing EVR, and technical success was 100% in both groups. All of the attempts at EVR were successful. At the 2-year follow-up, primary patency did not differ significantly between the endovascular (91%) and surgical (95%) groups. This was seen in the univariate model (hazard ratio [HR], 0.27; 95% confidence interval [CI], 0.02-2.95; P = .28) and in the multivariate model (HR, 0.77; 95% CI, 0.06-10.07; P = .84) for group (HR, 0.58; 95% CI, 0.04-7.72; P = .68), age (HR, 0.89; 95% CI, 0.73-1.08; P = .24), symptoms (HR, 1.98; 95% CI, 0.42-9.46; P = .39), and occlusion (HR, 3.22; 95% CI, 0.51-20.35; P = .21). The average hospital length of stay was shorter for patients treated with ERV than for those treated with open surgery (3.9 ± 2.2 vs 5.8 ± 3.1 days, respectively; P = .03). The complication rate was 4% for EVR vs 18% in the surgical group (P = .32). Conclusions At 2 years of follow-up, the results of endoluminal bypass grafting with the Viabahn stent to treat complex aortoiliac disease are promising. Longer-term results are needed to fully evaluate the potential benefits and longer-term patency.

Objective The objective of this multicenter registry was to review current treatments and late results of repair of aneurysm of aberrant right subclavian artery (AARSA). Methods All consecutive AARSA repairs from 2006 to 2013 in seven centers were reviewed. End points were 30-day and late mortality, reintervention rate, and AARSA-related death. Results Twenty-one AARSA repairs were included (57% men; mean age, 67 years); 3 ruptures (14%) required emergent treatment; 12 (57%) were symptomatic for dysphagia (33%), dysphonia (24%), or pain (19%). Eight cases (38%) presented with thoracic aortic aneurysm, two with intramural hematoma, and one with acute type B aortic dissection. Mean AARSA diameter was 4.2 cm; a single bicarotid common trunk was present in 38% of cases. The majority of patients underwent hybrid intervention (n = 15; 71%) consisting of single (n = 2) or bilateral (n = 12) subclavian to carotid transposition or bypass or ascending aorta to subclavian bypass (n = 1) plus thoracic endovascular aortic repair (TEVAR); 19% of cases underwent open repair and 9% simple TEVAR with AARSA overstenting. Perioperative death occurred in two patients (9%): in one case after TEVAR in ruptured AARSA, requiring secondary sternotomy and aortic banding; and in an elective case due to multiorgan failure after a hybrid procedure. Median follow-up was 30 (interquartile range, 15-46) months. The Kaplan-Meier estimate of survival at 36 months was 90% (standard error, 0.64). Late AARSA-related death in one case was due to AARSA-esophageal fistula presenting with continuing backflow from distal AARSA and previous TEVAR. At computed tomography controls, one type I endoleak and one type II endoleak were detected; the latter required reintervention by aneurysm wrapping and ligature of collaterals. AARSA-related death was more frequent after TEVAR, a procedure reserved for ruptures, compared with elective open or hybrid repair. Conclusions Hybrid repair is the preferred therapeutic option for patients presenting with AARSA. Midterm results show high rates of clinical success with low risk of reintervention. Simple endografting presents high risk of related death; these findings underline the importance of achieving complete sealing to avoid treatment failures.

We compared the intra-operative diagnostic value of CDS vs IA-DSA in identifying major and minor technical defects after CEA. Between August 1997 and December 1998, 138 consecutive patients undergoing 141 carotid endarterectomies were intra-operatively investigated with colour duplex scan and intra-arterial digital subtraction angiography. Thirty-six (25.5%) technical defects were identified. Four (11.1%) major defects were detected by both methods and they were immediately corrected. Fifteen (41.6%) minor defects were detected by both methods, thirteen (36.1%) minor defects were detected by colour duplex but ignored by angiography. Angiography detected four (11.1%) kinkings missed with the colour duplex. The overall sensitivity of both methods for major defect was 100%. The sensitivity of colour duplex for minor defects was 87% vs 59% for angiography. On the basis of our study, colour duplex could be considered the choice method for quality control after carotid endarterectomy.

Introduction Intravascular ultrasound (IVUS) can be used as a quality control technique following carotid artery stenting (CAS). Report An asymptomatic 79-year-old female, with 70% right internal carotid artery (ICA) stenosis, underwent CAS. ICA IVUS evaluation was performed before and after CAS. Angiogram post-CAS showed good results while IVUS detected a flap protrusion across the stent. We treated the flap protrusion with another stent placement. A second IVUS evaluation did not show any further procedural defects. Discussion IVUS can be a useful tool to perform quality control following CAS.

We wished to analyze our initial experience with the Cardiatis Multilayer Stent for visceral artery aneurysms. Two males with a hepatic artery aneurysm (34 mm and 48 mm in diameter, respectively) were treated, via a percutaneous femoral approach, with multilayer stents. We deployed the stent in front of the aneurysm neck, covering the hepatic artery branches. At 12 months, a computed tomography scan showed thrombosis of the aneurysmal sac and patency of all the branches of the hepatic artery. The Multilayer Stent appears to be a viable alternative for the treatment of visceral artery aneurysms in patients at high surgical risk, but long-term follow-up is needed.

Percutaneous closure of an atrial septal defect has been increasingly used, and complications have been rare. We report the case of a 63-year-old man who had undergone endovascular closure of a secundum atrial septal defect months earlier. The occluder was later found in the abdominal aorta.

OBJECTIVE: Thoracic, arch, and proximal descending thoracic aorta diseases are still considered an enormous challenge. The hybrid approach developed in recent years (supra-aortic trunks debranching and thoracic endovascular repair aortic repair; TEVAR) may improve the morbidity and mortality of the population at risk. The aim of this study was to analyze retrospectively our experience in the hybrid treatment of aortic-arch aneurysms and dissections. METHOD: We carried out a retrospective review of 27 patients who required a surgical debranching of the supra-aortic trunks and a TEVAR in the management of the aortic arch and proximal descending thoracic aortic disease. The aortic lesions included 18 degenerative arch-aortic aneurysms, four complicated aortic dissections, two subclavian artery aneurysms, and three penetrating atherosclerotic ulcers. Technical success was achieved in all patients. RESULTS: The 30-day mortality rate was 11.1% (3/27). Mean follow-up was 16.7 months (range, 1–56), and the survival rate was 77.8%. The endoleaks’ rate was 3.7% (1/27), due to a stent-graft migration. CONCLUSION: Hybrid approaches may represent an alternative option in the treatment of complex aortic lesions involving the arch and the proximal descending thoracic aorta in high-risk patients and emergency cases. However, the promising early results need to be confirmed by longer follow-up and larger comparative series.

Atherosclerosis can be thought of as a complex process involving many aspects of the patient’s life, ranging from sex, age, and genetics to lifestyle and nutrition. In the last 10 years, there has been a wide expansion of the “-omics” sciences. Such sciences have proven very effective and accurate in the analysis of complex systems, where the analysis of many factors might help a better understanding of the system itself. Among all the “-omics” sciences, metabolomic and metabonomic are gaining increasing interest. Metabonomics quantitatively measures living systems undergoing the effects of diseases. Unlike genomics and proteomics, metabonomics focuses on the multiparameter evaluation of a living complex system by studying its overall physiological profile. Metabonomics can be thought of as a multiparameter profiling technique of each individual.

A 69-year-old man was referred to our facility owing to the sudden onset of a compression-like pain in the right leg, without limb-threatening acute ischemia. The duplex scan examination, followed by a selective leg angiography, showed the presence of a peroneal artery aneurysm. A diagnosis of mycotic aneurysm was made on the basis of the patient’s clinical condition, positive blood cultures, and the unusual location of the lesion. Endovascular repair was performed by using a coil embolization and covered stent release. The patient was discharged in good general condition with complete pain relief. In previously published data, only four cases of peroneal artery aneurysm with a mycotic etiology have been reported. In this case, the endovascular treatment was safe and resolutive.

Surgical treatment for steno-obstructive pathology of the extracranial carotid artery is today the gold standard for the prevention of cerebral ischemic disease associated to the manifestation of atherosclerosis. During the 1990s, a number of randomised trials incontrovertibly demonstrated the advantages which are derived from carotid endarterectomy with respect to medical therapy alone, in patients with symptomatic or asymptomatic stenosis. As a whole, these ­trials ­indicated a perioperative rate of major adverse events (stroke, mortality and MACE) of about 9%. Many projects have since been conducted in the field of carotid surgery, and today the reported complication rates are lower than 3%, with excellent long-term results (North American Symptomatic Carotid Endarterectomy Trial Collaborators, N Engl J Med 325(7):445–534, 1991; Mayberg et al., JAMA 266(23):3289–945, 1991). The results of new arising techniques, such as carotid stenting, must be compared with these complication rates in order to have a clear benchmark for a more objective future dissemination.

Five patients were treated for ruptured visceral artery aneurysms during the last 9 years, including two splenic and three pancreaticoduodenal aneurysms. The average size of aneurysm was 2.6 cm (range: 1.5-5 cm). All patients underwent open surgical treatment. There was one operative death. After a mean follow-up of 46.6 months, there were no cases of mortality or secondary complications. The authors conclude that operative treatment of ruptured visceral artery aneurysms is durable.