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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.

Purpose to evaluate the impact of bi- and 3-dimensional preoperative aortic morphological features and their immediate postoperative variations on the outcome of abdominal aortic aneurysms (AAA) treated by endovascular exclusion with standard devices (EVAR). Materials and Methods Double centre retrospective analysis of prospectively collected registry data of EVAR patients. For all patients, preoperative and 30-day computed tomographic angiography images (CTA) were reviewed. Preoperative maximum AAA diameter >59 mm and volume >159 cm 3 , and any 30-day postoperative increasing at CTA, were considered as potentially influencing the outcome. The outcome measures were: primary technical success; 30-day, 1-year, and mean follow-up reintervention, all-cause and AAA-related mortality rates, and also endoleak-related reinterventions. Results Three hundred and thrity-three patients were enrolled. Mean preoperative and 30-day AAA diameter and volume were 50.4 mm ± 11.8 vs. 49.1 mm ± 12.1, and 112.9 cm3 ± 79.5 vs. 112.1 cm3 ± 80.5, respectively. Primary technical success was achieved in all cases. At 34.9 months follow-up, cumulative reintervention rate was 12.0%, mortality rates 7.2%, without AAA-related deaths. Endoleak-related reintervention rate was 7.5%. At uni- and multi-variate analysis, preoperative AAA diameter >59 mm, and AAA volume >159 cm 3 were significantly associated to reintervention (P = 0.012; P = 0.002), and reintervention and death (P = 0.002; P = 0.001) during follow-up. Additionally, any increase in postoperative AAA diameter or volume was significantly associated with reintervention (P = 0.001, P = 0.001) and reintervention and death (P = 0.006, P = 0.001). Endoleak-related reintervention were also significantly associated with all of the analysed morphological parameters (P = 0.019, P = 0.005, P = 0.005, and P = 0.002, respectively). Conclusions Patients with larger baseline AAA size and volume as well as unfavourable early remodelling of the sac are associated to worse long-term EVAR outcome.

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

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.

Purpose: To report the use of intravascular lithotripsy (IVL) in the treatment of calcified carotid artery lesions. Materials and Methods: The records of 21 high-surgical-risk patients (mean age 75.1±8.1 years; 17 men) who were treated at 8 centers for carotid artery stenosis ≥70% were retrospectively reviewed. Twelve patients had a history of cerebrovascular disease. All patients had heavily calcified carotid artery lesions: 19 de novo and 2 in-stent restenoses (ISR). The mean baseline stenosis was 82.3%±9.7%. IVL was utilized at the discretion of the operator, followed by balloon angioplasty. Embolic protection devices were used in all cases. Results: In 19 patients, IVL was followed by stent implantation; the 2 ISR lesions were dilated only. The mean IVL balloon diameter was 4.64±1.13 mm, and the mean number of IVL pulses applied was 67.2±61.4 (range 10–180). All procedures were technically successful (70%) in 1 asymptomatic patient at 12 months after the index procedure. No patients required reintervention during a median follow-up of 6 months (range 1–12). Conclusion: This preliminary experience demonstrates that IVL can be a safe and effective approach for the management of severely calcified carotid lesions. Further research is warranted to determine the longer-term safety and efficacy of IVL for dilation of calcified carotid artery lesions as an adjunct to carotid artery stenting.

Objectives This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). Background Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published. Methods The authors performed an individual patient–level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year. Results Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis. Conclusions This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.

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.

Objective In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. Methods A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. Results A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. Conclusion Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.

Background Aim of this study was to evaluate peri-procedural incidence of new diffusion-weighted-magnetic-resonance-imaging (DWMRI) brain lesions in CAS patients treated by carotid mesh stent (CGuard™) or closed-cell stent (Wallstent™). Methods Consecutive patients with asymptomatic carotid stenosis ≥ 70% were submitted to preoperative DW-MRI scan, to exclude the presence of preoperative silent cerebral lesions. Patients were randomized to CGuard or Wallstent. DWMRI was performed immediately after the intervention and at 72-hour postoperatively. Moreover, pre and postoperative Mini-Mental-State-Examination Test (MMSE) and a Montreal-Cognitive-Assessment (MoCA) test were conducted, and S100β and NSE neurobiomarkers were measured at 5-time points (preoperatively, 2, 12, 24, and 48 h postoperatively). Results From January 2015 to October 2016, sixty-one consecutive eligible patients were submitted to preoperative DWMRI scan. Three patients were excluded because of preoperative silent cerebral lesions. In 29 CGuard patients, 1 developed a minor stroke and 8 silent new lesions were observed in the 72 h-DWMRI (31%): 4 lesions were ipsilateral, and 4 lesions were contra or bilateral. In 29 Wallstent patients, 7 clinically-silent new lesions were found in the 72 h-DWMRI (24.1%; p = 0.38). In 4 cases lesions were ipsilateral and in 3 cases contra or bilateral. S100B values doubled at 48 h in 24 patients, and among them 12 presented new DWMRI lesions. 48-h S100B increase was significantly related to 72-h DWMRI lesions (p = 0.012). Conclusions In our experience both stents showed an acceptable rate of subclinical neurological events with no significant differences at 72-hour DWMRI between groups. Bilateral/contralateral lesions suggest that periprocedural neurological damage may have extra-carotid sources.

Background Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. Material and Methods a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex , clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. Results Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. Conclusions Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures’ benefit and outcome.

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.

The unibody (Powerlink/AFX/AFX2) Endovascular AAA device (Endologix Inc., CA, USA) presents a unique design with its long main body and two innate limbs. The device is designed to be deployed and sits on the native aortoiliac bifurcation and represents the only one-piece bifurcated endograft designed to use anatomical fixation for endograft stabilization. According to published literature, the unibody device seems to represent a valid choice in the treatment of abdominal aortic aneurysms. This particular device would seem to satisfactorily perform even in the treatment of more compressed aneurysms (also in off-label association with parallel grafts) and in occlusive pathologies. Ongoing studies will provide new real-life data in a large and unselected patient population to better understand the device’s advantages and limitations.

Background Small sized clinical studies evaluating one year outcomes of CAS performed with two available DLS, Roadsaver® (RS) and CGuard® (CG), have been published. Purpose To evaluate one year safety and efficacy of dual layered mesh covered carotid stent systems (DLS) for carotid artery stenting (CAS). Methods We performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. Primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at one year. Results Patients were divided in two groups according to DLS (RS N=250; CG N=306). At one year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%), 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (N=21), 11 events in the group RS (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At one year restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p=0.007). In stent thrombosis occurred in 1 patient (0.18%) of the group CG (0.32%). RS use was the only independent restenosis predictor. Conclusions This study suggests that DLS use for CAS is associated to a low one year death and stroke rate and specific DLS stent use could affect restenosis rate. Funding Acknowledgement Type of funding source: None

Objective The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. Methods To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 – 3. Safety and clinical success rate were collected at one month. Results One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 – 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 – 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. Conclusion Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.

The aim of the present study was to evaluate early-, mid-, and long-term outcomes in an unselected population of patients treated for abdominal aortic aneurysms (AAAs) by endovascular aneurysm repair (EVAR) with different commercially available off-the-shelf devices.A retrospective study was conducted on a prospectively compiled computerized database on patients presenting an infrarenal AAA treated between January 2008 and December 2015 in a high-volume Italian tertiary referral Center. Demographic, clinical, and specific morphological features were considered as potentially influencing the outcomes and the type of the implanted device. Outcome measures were procedure-related reintervention, AAA-related, and all-cause mortality rates at 30-day, 12-month, and long-term follow-up. Reinterventions considered for the analysis were AAA rupture, graft infection, type I or III endoleaks, type II endoleaks with sac enlargement5 mm, graft stenosis or occlusions, procedures related to renal or visceral ischemia, and reintervention for access vessel injury.Of 498 EVAR procedures performed for elective infrarenal AAA treatment during the entire study period, 479 patients were enrolled, the mean age was 73.5 ± 7.34 years (range 51-91), and 416 (86.84%) were men. The mean maximum AAA diameter was 52.02 ± 8.04 mm (range 39-90.2), a maximum AAA diameter ≥59 mm was recorded in 107 patients (22.33%), and an aortic neck length was10 mm in 137 (28.60%). Technical success was achieved in all patients. At a mean follow-up of 52.97 ± 26.16 months (range 1-120), overall reintervention and death rates were 8.14% and 20.04%, respectively, without AAA-related deaths. At univariate analysis, hypertension was the only demographical variable found to be associated with higher risk of reintervention, P = 0.04 (OR: 2.34; CI 95%: 1.00-5.42). Furthermore, male sex (P = 0.02; OR: 2.62; CI 95%: 1.09-6.27) and chronic renal insufficiency (P = 0.003; OR: 2.08; CI 95%: 1.27-3.42) were associated with higher mortality rates. AAA diameter ≥59 mm was statistically associated with a higher rate of both reintervention and mortality: P 0.001 (OR: 9.05; CI 95%: 4.52-18.11) and0.001 (4.00; 2.46-6.49), respectively.Our experience seems to suggest that EVAR could be safely and effectively performed in an unselected patients' population, with encouraging results up to a ten-year follow-up.

Background Endovascular aneurysm repair (EVAR) is currently accepted as an alternative to open repair for the treatment of abdominal aortic aneurysm (AAA). Approximately 40–60% of AAA patients are not considered eligible for EVAR due to unfavorable anatomy. There is currently no consensus on the definition of “hostile” aortic neck for EVAR procedure. Methods An Expert Panel (EP), made up of 9 Italian vascular surgeons from high-volume centers (>50 EVAR procedures/year), was assembled to share their opinion about the definition of hostile aortic neck anatomy for EVAR procedure. The process included a review of the current literature by the EP, a face-to-face meeting, and an on-line survey completed by the EP prior to and following the face-to-face meeting, using the Delphi method. Results Of the 66 reviewed studies, only 38 (58%) reported at least 1 aortic neck hostility criterion. Five anatomic parameters were identified, namely, aortic neck length, aortic neck angulation, aortic neck diameter, conical neck, and presence of circumferential calcification. Based on the results of the first survey round, these criteria and related definitions were discussed in depth during the face-to-face meeting. For 3 parameters (aortic neck diameter, aortic neck angulation, conical neck), the agreement among the EP members was already high during the first survey round while for the remaining 2 (aortic neck length, circumferential calcification) it remarkably increased from the first to the second survey round. For each of these criteria, as well as combinations of at least 2 of these criteria, specific threshold values were identified above or below which a standard EVAR approach was not considered ideal by the EP due to high/moderate risk of complications. Conclusions EP agreed on the definition of 5 aortic neck hostility criteria, according to which they gave their opinion on the feasibility and risks of a standard EVAR approach. Further agreement will be needed and examined on the best nonstandard EVAR technique which may be offered in the presence of different combinations of hostility criteria.

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.

Thoracic and thoraco-abdominal aortic repair remains a challenging issue in vascular surgery, and long-term complications are well described. We report 2 cases of octogenarians with unusual long-term complications after open and endovascular thoracic aortic repair of chest wall pressure injury from the vascular prosthesis. In the first case, a computed tomographic scan of an 80-year-old man showed a pressure injury of the chest wall and rib erosion caused by a Dacron graft. The second case was an 81-year-old woman who presented with external bleeding from the left posterior chest wall. A computed tomographic scan showed a type IA endoleak and chest wall damage with rib erosion and thoracic cutaneous fistulae from the endovascular graft. Both patients were treated by relining the endovascular graft; debriding the surgical fistula was done only in the second case. In our experience, endovascular repair is a good option to avoid a complete open surgical repair.

Background The objective of the study was to report immediate and midterm results of an unselected population of patients treated for abdominal aortic aneurysms (AAAs) by endovascular aneurysm repair (EVAR) using the Ovation stent graft. Methods A double-center retrospective study was conducted on a prospectively collected database between 2012 and 2015. One hundred fifty-six elective patients were included. The outcome measures considered for analysis were primary technical success, 30-day and midterm reinterventions, and all-cause and AAA-related mortality rates. The presence of an aortic neck ≤10 mm, and of a noncylindrical aortic neck, as well as a narrowed aortic bifurcation was defined as an aortic bifurcation average diameter (AB average ) ≤ 18 mm or an AB area ≤ 20 mm 2 , and an external iliac artery diameter ≤5 mm was considered as independent factors potentially influencing the outcome. Results Male patients totaled 128 (82.1%), and mean age was 74.83 ± 6.76 years (range: 56–91). Mean aortic diameter was 57.15 ± 8.77 mm, mean diameter at inferior renal artery level + 13 was 24.44 ± 3.31 mm, and mean aortic neck length was 18.77 ± 8.45 mm. Fifty-four patients (34.6%) had an aortic neck ≤10 mm, and cylindrical aortic neck shape was present in 34 patients (21.8%). Regarding the aortic bifurcation (AB), 31 patients (19.9%) presented AB average ≤ 18 mm, and 35 (22.4%) an AB area ≤ 20 mm 2 . Technical success was achieved in all cases. At 30-day follow-up, 2 type I endoleaks (1.3%) were detected. One patient was successfully treated endovascularly by proximal aortic cuff implantation, while the other patient refused further treatment. Three-month unscheduled computed tomographic angiography shows endoleak resolution and complete aneurysm seal. One patient suffered from a limb graft occlusion, managed by medical treatment. At a mean follow-up time of 20.4 ± 8.8 (1–60) months, 6 reinterventions were reported, including 2 embolizations for type II endoleak and 4 for iliac and femoral vessel occlusive disease. Log-rank test on preoperative anatomical features showed no significant differences in terms of freedom from reinterventions, and P values were 0.653 for aortic neck length ≤10 mm, 0.309 for noncylindrical aortic neck length shape, 0.520 for AB average ≤ 18 mm, 0.604 for AB area ≤ 20 mm 2 , and 0.421 for external iliac artery diameter ≤5 mm. Conclusions Our initial experience suggests that in an unselected patient population undergoing AAA repair, EVAR by Ovation stent graft can be performed safely with satisfactory immediate and midterm outcomes.

The aim of the present study was to evaluate the impact of the aortic bifurcation (AB) morphological characteristics, analyzed on computed tomography angiography (CTA), on outcomes of patients with abdominal aortic aneurysms (AAAs), treated by endovascular aneurysm repair (EVAR) in a single-center experience. A retrospective analysis was conducted using a prospectively collected database. Morphological features considered as potentially impacting outcomes were maximum AB diameter (ABmax), minimum diameter (ABmin), mean diameter (ABaverage), AB area (ABarea), and AB calcification (ABcalcification) and thrombosis (ABthrombosis). Outcome measures were perioperative, 30-day, and midterm AAA-related reinterventions and all-cause mortalities. Investigators reviewed 306 preoperative CTA scans. Maximum aortic diameter was 51.4 ± 12.4 mm (range 40–110), and mean ABmax was 24.2 ± 8.8 mm (range 10–60), ABmin 17.0 ± 5.4 mm (range 4–40), ABaverage 20.6 ± 6.5 mm (range 9–47.5), and ABarea 35.2 ± 24.2 mm2 (range 6–176). ABcalcification ≥ 50% was present in 63 patients (20.6%), and ABthrombosis ≥ 50% in 102 patients (33.3%). Technical success was obtained in all cases, without perioperative reintervention or death. At 30-day follow-up, the reintervention rate was 3.3%, and mortality rate was 1.3%. At a mean follow-up period of 35 ± 28.6 (range, 1–72) months, reintervention and mortality rates were 6.5 and 4.9%, respectively. None of the analyzed thresholds were predictive of adverse outcomes. At multivariate analysis, association of a narrowed AB with severe calcification of the distal aorta showed a significant differences in terms of reinterventions (p = 0.009). Our limited experience seems to reveal that a cutoff of ≤ 20 mm for AB diameter, as in current guidelines, is ineffective in predicting outcomes after EVAR.

Introduction The aim of this review is to assess if late mortality after endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) is a real problem, and whether it could be an issue in the case of medical litigation. Material and methods A review of all English language literature was performed on PubMed web-site, looking for all papers reporting EVAR long-term mortality rate. EVAR performances were reviewed also from an ethical and medico-legal point of view, based on current Italian laws. Results Mono-centric studies, and international registers suggest that today EVAR offers similar (if not better) results than open repair (OR) in the treatment of AAAs with standard and complex anatomies, even if performed outside the devices-specific instructions for use. In contrast, large randomized trials, and consequently current guidelines, suggest that EVAR still has an ancillary role compared to OR, only to be used for highly selected patients. Recently, specific litigation cases on surgical options related to the treatment of aortic aneurysms has developed. The informed consent process needs to include not only mortality and major complications related to the procedure but also the chance of patients' outcomes. For those reasons, the generic nature of informed consent has been criticized. Conclusions No conclusive data is currently available to assess the initial question of late mortality after EVAR but results are still improving. In the meantime, widespread use of EVAR as first choice for treating AAA may only be acceptable in high-volume centres validating their results by a strict follow up protocol., Highlights • The long-term results after endovascular repair (EVAR) for abdominal aortic aneurysms (AAA) are still considered one of the main limitations of this treatment option. • This paper is a comprehensive review of the current literature on long-term mortality after EVAR procedures. • An analysis on informed consent for EVAR from a non-surgical point of view is reported for the very first time.

Background To evaluate the impact of iliac artery's diameters, tortuosity, and peripheral vascular patency on outcome of elective endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) in 2 high volume vascular centers' experience. Methods A retrospective study was conducted on a prospectively collected database between 2010 and 2012. Anatomical features at pre-operative computed tomography (CTA) considered as potentially influencing outcomes were: iliac diameters, tortuosity (expressed as a ratio), and calcifications, bilateral internal iliac artery (IIA) patency, and presence of Trans-Atlantic Inter-Societies Consensus (TASC) II C/D femoro-popliteal occlusive disease (PAD). Outcome measures were reintervention and mortality rates at follow-up. Results Two-hundred-eighty-nine patients' CTA preoperative images were reviewed with a mean of 1148±328 images per patient analyzed. Mean common iliac artery (CIA) diameters calculated in the narrowest point were 12.8±4 mm and 12.9±3.9 mm, and mean external iliac artery (EIA) diameters were 7.7±1.6 mm 7.8±1.7 mm, respectively on right and left side. Mean tortuosity ratios were 0.8±0.1 (0.40-0.91) and 0.8±0.1 (0.49-0.99), respectively on right and left side. PAD was present in 31 patients (10.7%). Technical success was achieved in all case, and bilateral IIA patency was preserved in 229 (79.2%) patients. No in hospital and 30-day mortality and complications were recorded. At a mean follow-up of 26 months, 30 reinterventions were required in 26 patients (8.9%), and 22 (7.6%) non AAA-related deaths were noted. Right EIA diameter ≤5 mm (P=0.0012, OR 5.2, 95% CI 1.73-15.57), and femoro-popliteal steno-obstructive disease (P=0.03, OR 3.06, 95% CI 1.02-9.20) were significantly related to reinterventions during follow-up. Iliac tortuosity ratio and calcification were not significant predictors of adverse events. Conclusions This preliminary experience suggests that diameters of access vessels and the presence of femoro-popliteal steno-obstructive disease could affect the outcome of EVAR.

We report a case of an 18-year-old woman who developed a delayed pseudoaneurysm of the right anterior tibial artery (ATA), 14 days after a knife accidental trauma. The patient was admitted to our emergency department for acute onset of pain in the right limb after a domestic trauma. At a physical examination, the limb was tense and tender, with a pulsatile mass in the anterior compartment. Femoral, popliteal, and distal pulses were palpable on both limbs. Duplex ultrasound scan (DUS) and computed tomography angiography showed the presence of an ATA pseudoaneurysm. An urgent endovascular treatment was performed under local anesthesia via percutaneous access. Pseudoaneurysm was excluded implanting 2 coronary covered balloon-expandable stents (BeGraft; Bentley Innomed GmbH, Hechingen, Germany). Postoperative course was uneventful and the patient was discharged on the second postoperative day under dual antiplatelet therapy. One- and 13-month scheduled follow-up visits and DUS revealed the presence of a normal pedal pulse, complete pseudoaneurysm exclusion, and patency of the stent grafts and the entire ATA with triphasic waveforms. In conclusion, endovascular treatment of an ATA pseudoaneurysm seems to be a feasible option. Further experience with this technique is needed to validate its safety and long-term patency, especially in young and healthy subjects.

Background The aim of this work is describing incidence and fate of type 2 endoleaks (T2ELs) in a multicentric cohort of patients treated by endovascular aneurysms repair using the Ovation device (Endologix) and comparing them with a group treated using the Excluder (W. L. Gore & Associates). Methods This is a retrospective study conducted on 261 patients treated using the Ovation device and 203 using the Excluder. Outcomes were intraprocedural, 30-day, 12-month, and mean time follow-up T2EL incidence and related reinterventions. Patent inferior mesenteric artery (IMA), ≥3 lumbar arteries (LAs), intrasac thrombus volume, the mean diameter of common and external iliac arteries, external iliac artery stenosis (>70%), diameter ≤5 mm, iliac tortuosity ratio ≤0.5, thrombosis, and calcification were noted and considered as potentially influencing outcomes. Results Patients of the Ovation group presented significantly more thrombosed, calcified, and tortuous iliac vessels than those in the Excluder group. No significant differences were noted in sac thrombosis, IMA, and LA patency. At completion angiography, T2EL was evident in 57 Ovation and 46 Excluder patients (P = 0.832). At 1 month, it was evident in 33 Ovation group and 28 Excluder group patients (P = 0.726). At 12-month and mean time (30.14 months) follow-up, no differences were evident between the 2 groups (P = 0.940 and 0.951, respectively). The log-rank test showed that the rate of T2EL-related reintervention was not different between the 2 groups (P = 0.46). Regarding anatomical characteristics, a statistically significant difference was not observed between patients presenting or not with T2EL (P > 0.05). Conclusions Data showed no significant differences in terms of T2EL incidence between the 2 study groups. None of preoperative anatomical features were found to be significantly associated with the appearance of T2EL.

In 1885, Osler described the infected peripheral aneurysms, resulting from endocarditis embolism for the first time. Over the years, many authors have reported different classification and pathophysiological mechanisms of infected aortic aneurysms. Those conditions are rare and aneurysms involving visceral arteries even more so.

Purpose: To compare outcomes of patients treated for pararenal aortic aneurysms using fenestrated endovascular aneurysm repair (fEVAR) vs open surgical repair (OSR) in 3 high-volume centers. Materials and Methods: A multicenter retrospective analysis was conducted of 200 pararenal abdominal aortic aneurysm patients electively treated with OSR (n=108) or fEVAR (n=92) from 1998 to 2015 at 3 tertiary institutions. Endpoints were 30-day morbidity and mortality, late reinterventions, visceral artery occlusion, and mortality. Analysis was conducted on the entire population and on a propensity score–matched population constructed on age, gender, coronary artery disease (CAD), and chronic renal failure. Results: In the total cohort, fEVAR patients were significantly (p

The aim of this study is to report the outcome of immediate and direct revascularization by mechanical thrombectomy in acute limb ischemia due to thrombosed popliteal artery aneurysm (PAA). Two patients with acute limb ischemia due to PAA thrombosis were admitted at our hospital, and immediately treated by mechanical thrombectomy (Indigo System). The first patient had a complete recanalization after thrombectomy, while the second one required urokinase infusion (12 hr) due to a suboptimal result. After revascularization, both patients were treated by a polytetrafluoroethylene bypass to definitively exclude PAA. Follow-up showed the patency of the femoropopliteal bypass with good distal outflow. In these 2 reported cases, the Indigo System® has proven to be safe and effective, allowing an immediate limb reperfusion, reducing the necessity for thrombolytic drug infusion.

To report our experience in treating severely claudicant patients, employing a “nitinol-constrained” balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA—USA) before drug-coated balloon (DCB) in a standardized protocol. Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up. Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p = 0.725). CTO length impacted early results: in cases of CTOs 150 mm, it was 83.3% (p = 0031). ABI at 12-month was significantly higher with respect to preoperative values (p

Acute limb ischemia (ALI) is a pathological condition resulting from a sudden blood interruption (or, at least, from an important reduction in flow) limiting tissues’ survival. ALI is always a serious event requiring immediate diagnosis and treatment, also considering the high associated amputation risk. The most frequent causes of acute limb ischemia are embolism, thrombosis, and trauma. Clinical findings are grouped together in a series mnemonic note as “6P of Pratt”: pain, pallor, pulselessness, poikilothermia, paresthesia, and paralysis. Those in concert with duplex ultrasound assume a primary and crucial role in diagnostic and preoperative evaluation of ALI patients. Treatment for ALI largely depends on the clinical presentation according to Rutherford’s classification. When indication for surgery is posed, several open, endovascular, and hybrid procedures are developed to restore blood flow in acute patients.

To describe results of AFX unibody stent-graft treatment for TransAtlantic Inter-Society Consensus (TASC) D aortoiliac occlusive disease (AIOD) with coexistent abdominal aortic aneurysm (AAA).A retrospective analysis was conducted of 21 consecutive patients (mean age 73.6±6.4 years; 17 men) with TASC D AIOD plus AAA (diameter3.5 cm) treated electively using the AFX stent-graft. Common iliac artery (CIA) and external iliac artery (EIA) stenosis or occlusion was reported. Outcome measures were technical and clinical success, improvement in ankle-brachial index (ABI), and improvement in Rutherford category. Immediate and midterm patency, AAA exclusion, major adverse events (MAE), and mortality were also evaluated.After AFX deployment (100% technical success), 18 EIAs required adjunctive stenting (none required in the CIA). One patient required a reintervention for closure device failure. At 30-day follow-up, no death or MAE was recorded. Improvement in ABI was registered in all patients (mean 0.91±0.11), with 100% primary patency. At a mean follow-up of 25.2±11.1 months, primary patency was maintained in all cases. No death or amputation occurred; 2 patients had a myocardial infarction. Improvement in ABI was maintained (0.88±0.13) as well as Rutherford category.This study examined the use of the AFX unibody stent-graft for the treatment of TASC D AIOD with concomitant AAA. The AFX stent-graft appears to be a safe and effective solution for these complex lesions, with low morbidity and mortality.

To report our experience in treating severely claudicant patients, employing a "nitinol-constrained" balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA-USA) before drug-coated balloon (DCB) in a standardized protocol.Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up.Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150 mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC = 0). Mean follow-up was 12.3 ± 5.6 months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p = 0.725). CTO length impacted early results: in cases of CTOs 150 mm, PP was 100%, while in CTOs 150 mm, it was 83.3% (p = 0031). ABI at 12-month was significantly higher with respect to preoperative values (p 0.001).In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.

To report a case of pararenal aortic aneurysm (PAAA) with narrowed iliac arteries treated by the chimney technique combined with the INCRAFT