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Background: Current guidelines indicate iliac-branched endografts (IBDs) as the ideal means to preserve pelvic perfusion during endovascular aortic repair. Because patient vascular anatomy represents the main limitation to extensive use of these devices, off-label application may be considered to expand the number of patients being treated. The aim of this study is to evaluate long-term outcomes obtained using the Cook ZBIS endograft in the treatment of aortoiliac aneurysms as per or outside manufacturer's instruction for use (IFU)., Methods: Data from all patients who underwent IBD implant in a single center were reviewed. Study population was divided into two subgroups: Group I treated as per manufacturer's IFU and group II treated outside IFU., Results: During the study period (2008-2018), 119 patients were treated with 130 IBDs. Eighty-six patients were treated as per IFU (group I) and 44 outside IFU (group II). Overall technical success was 99.2%. Mean follow-up was of 63.5 ± 38.3 months for group I and 58.3 ± 35.9 months for group II (P = 0.45). Freedom from reintervention at ten years was 79.8% in group I and 69.6% in group II (P = 0.29). Freedom from IBD-related reintervention rate was 98.7% and 95.3% in groups I and II, respectively (P = 0.240). Iliac-branched module thrombosis occurred significantly more in patients treated outside IFU with 4 cases in group I (4.7%) and 10 cases in group II (22.7%), (P = 0.005). Cox regression analysis identified hypogastric artery aneurysm as the only independent predictor for both IBD thrombosis and hypogastric artery occlusion during follow-up., Conclusions: When used by an experienced team, Cook IBDs are safe and effective in the treatment of aortoiliac aneurysms both inside and outside IFU. Anyway a lower target hypogastric patency rate should be expected when treating patients with hypogastric aneurysms., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: To describe a novel technique developed for the treatment of patients with thoracoabdominal aortic aneurysms having narrow aortic lumens using branched endografts., Technique: When treating patients with a narrow aortic inner diameter with branched endografts, we propose a partial graft deployment leaving the distal portion of the device inside the delivery system with the aim of spare space and facilitate target vessel cannulation., Conclusions: Partial endograft deployment could be considered in the case of expected difficulty associated with encumbrance deriving from the distal straight graft portion. This technique could be useful to avoid target vessel loss and therein save procedural and fluoroscopy time., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: To report early and mid-term results of post-aortic dissection thoracoabdominal aneurysms (pD-TAAA) treated by complex endografting in three tertiary referral hospitals., Materials and Methods: A review of all patients with pD-TAAA unfit for open surgery treated with complex endovascular repair from 2012 to 2018 was performed. Simple thoracic endografts (TEVAR) were excluded. Staged procedures in case of extensive aortic coverage were always planned., Results: In total, 21 patients (16 males, mean age 63 ± 10 years) with pD-TAAA underwent aortic repair by fenestrated or branched thoracoabdominal endografts for visceral vessels. Mean TAAA diameter was 61 ± 6.2 mm. Spinal cord drainage was performed in all patients. A staged approach was used in 12 (57%) cases. Technical success was achieved in 18 (86%) patients. No in-hospital deaths occurred. Two patients experienced transient post-procedural spinal cord ischemia. At 30 days, six type II endoleaks (29%), two type Ic endoleak (9.5%) and one type IIIc endoleak (5%) were reported. At a mean follow-up of 23 ± 13 months, no late aortic-related deaths occurred. Three patients underwent reintervention for type Ic and IIIc endoleaks. No visceral vessel occlusion was observed. Estimated freedom from reintervention at 12 and 24 months was 85.7 ± 0.7%. In 13 cases, TAAA diameter decreased at least 5 mm, while increased > 5 mm in only one case. Complete false lumen thrombosis was achieved in 18 patients (86%)., Conclusion: Complex endografting for pD-TAAA showed favorable mid-term results. Staged and carefully planned endovascular procedures may represent a safe and effective therapeutic option in patients deemed at high risk of open repair.

Objective: The purpose of this study was to evaluate the long term results of endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysm (AAA) and ectatic common iliac arteries (CIAs)., Methods: In a retrospective analysis of a prospectively collected database in two high volume centres, patients with AAAs undergoing elective standard EVAR were divided into two groups: those with both CIA diameters <18 mm, and those with at least one ectatic iliac artery (CIA ≥ 18 mm). Patients with an intentional external iliac artery landing zone were excluded. Primary outcomes were survival and freedom from re-intervention. Secondary end points were EVAR failure and iliac related endoleak and iliac re-intervention., Results: From 2000 to 2015, 648 patients were included in the study, 277 (43%) had at least one CIA ≥ 18 mm. Pre-operative risk factors were similar between the two groups, with the exception of chronic renal insufficiency (p = .010) and cerebrovascular events (p = .040), which were higher in the ectatic CIA group. At 30 days from primary procedure, there was a higher rate of type Ib endoleak in patients with ectatic iliacs (p = .020). A statistically significant increase in the incidence of late type Ib endoleak in patients with ectatic iliac arteries was confirmed at a mean follow up of 74.8 months (p = .01). The need for iliac related re-intervention was higher in patients with CIAs ≥18 mm (odds ratio 1.94; 95% confidence interval 1.1-3.2)., Conclusion: Ectatic iliac arteries are considered suitable landing zones for EVAR, although there is an increased risk of secondary interventions in time mainly due to late CIA dilation and secondary type Ib endoleak. Patients receiving EVAR with flared iliac limbs may benefit a more intensive surveillance to avoid late failures., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: The objective of this study was to evaluate long-term results of self-expanding vs balloon-expandable hypogastric stent grafts in conjunction with iliac branch devices (IBDs) for aortoiliac aneurysm repair in a multicenter experience (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation [pELVIS] Registry)., Methods: All patients electively treated for aortoiliac aneurysm with the Cook IBD (Cook Medical, Bloomington, Ind) in nine European centers were reviewed. Clinical and imaging data were prospectively collected in each center, and a multicenter database was created and interrogated. The primary outcome was the primary patency of the IBDs. For the purpose of this investigation, three subgroups were identified: patients receiving a hypogastric balloon-expandable stent graft (BESg); those with a self-expanding stent graft (SESg); and those with any stent graft plus relining with a bare-metal stent (RESg)., Results: Between 2005 and 2017, there were 691 patients who underwent 747 elective endovascular repairs of aortoiliac aneurysms (n = 518 [75.0%]) or isolated iliac aneurysms (n = 173 [25.0%]) with Cook IBDs (n = 56 bilateral) in nine European centers. Mean age was 72 years (range, 41-93 years); 658 (95.2%) patients were male. In 364 patients (52.7%), BESg was used; in 127 (18.4%), SESg; and in 200 (28.9%), RESg. At 30 days, there were 3 (0.4%) perioperative deaths, 3 (0.4%) technical failures, 7 (1.0%) graft thromboses, 30 (4.3%) reinterventions, and 1 (0.1%) conversion to open repair. After a mean follow-up of 32 months (range, 0-128 months), 28 (3.7%) IBD occlusions and 17 (2.3%) IBD-related endoleaks occurred. In 10 patients, iliac diameter increased >5 mm (1.4%). Overall primary patency was 99.2% at 1 month, 97.9% at 12 months, and 95.1% at 72 months. Primary patency was not significantly different in the BESg vs SESg or RESg cohorts (P = .4). During follow-up, there were 126 (18.2%) reinterventions, 93 (13.5%) of which were IBD related, including 11 (1.6%) conversions. Overall, freedom from reintervention and conversion was 90.4% at 12 months and 71.0% at 72 months. IBD-related reinterventions during follow-up in the three cohorts were not significantly different (P = .3) Overall survival was 71.3% at 72 months without differences between the subgroups. At multivariate analysis, aneurysmal hypogastric artery (P < .001; Exp [B] = 4.44) and bilateral treatment (P = .02; Exp [B] = 1.87) were associated with an increase in late failure., Conclusions: In this wide real-world experience, long-term results of endovascular treatment of aortoiliac aneurysms with the IBD are favorable, with a low rate of late graft occlusion and aneurysm-related death. No significant differences in clinical outcomes were observed in patients receiving hypogastric BESg vs SESg or endovascular relining., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: A successful case of urgent type II thoracoabdominal aneurysm repair with an inner branched endograft conducted entirely through femoral accesses without the bailout possibility to achieve an upper extremity approach for bridging stents delivery is described., Case Report: A 70-year-old male patient underwent hybrid treatment for a thoracic aortic aneurysm on complicated type B dissection in 2 steps. First, arch debranching with carotid-carotid-subclavian bypass and then ascending aortic replacement with reimplantation of the anonymous trunk plus TEVAR were performed. The scheduled 1-month control computed tomography angiography (CTA) showed a rapid increase of the false lumen thoracoabdominal aneurysm, with axial diameter measuring more than 10 cm. The repair procedure was based on the use, as off-the-shelf graft, of a prosthesis customized for another patient with inner branches for visceral vessels that well suited the characteristics of the case. A steerable guiding sheath was essential to stabilize the system in the selective and sequential cannulation of 2 of the 4 inner branches (for celiac trunk and superior mesenteric artery) and to complete the bridging stents deployment. Procedure was carried out without complications., Conclusions: In an urgent setting, total endovascular correction of a thoracoabdominal aortic aneurysm exclusively through femoral accesses appears to be feasible when the appropriate tools are available., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to report the methodology and 1-year experience of a regional service model of teleconsultation for planning and treatment of complex thoracoabdominal aortic disease (TAAD)., Methods: Complex TAADs without a feasible conventional surgical repair were prospectively evaluated by vascular surgeons of the same public health service (National Health System) located in a huge area of 22,994 km 2 with 3.7 million inhabitants and 11 tertiary hospitals. Surgeons evaluated computed tomography scans and clinical details that were placed on a web platform (Google Drive; Google, Mountain View, Calif) and shared by all surgeons. Patients gave informed consent for the teleconsultation. The surgeon who submits a case discusses in detail his or her case and proposes a possible therapeutic strategy. The other surgeons suggest other solutions and options in terms of grafts, techniques, or access to be used. Computed tomography angiography, angiography, and clinical outcomes of cases are then presented at the following telemeetings, and a final agreement of the operative strategy is evaluated. Teleconsultation is performed using a web conference service (WebConference.com; Avaya Inc, Basking Ridge, NJ) every month. An inter-rater agreement statistic was calculated, and the κ value was interpreted according to Altman's criteria for computed tomography angiography measurements., Results: The rate of participation was constant (mean number of surgeons, 11; range, 9-15). Twenty-four complex TAAD cases were discussed for planning and operation during the study period. The interobserver reliability recorded was moderate (κ = 0.41-0.60) to good (κ = 0.61-0.80) for measurements of proximal and distal sealing and very good (κ = 0.81-1) for detection of any target vessel angulation >60 degrees, significant calcification (circumferential), and thrombus presence (>50%). The concordance for planning and therapeutic strategy among all participants was complete in 16 cases. In one case, the consultation was decisive for creating an innovative therapeutic strategy; in the remaining seven cases, the strategy proposed by the patient's surgeon was changed completely after the discussion. Technical success was the same (100%) if concordance in planning was present initially or not. Overall 6-month mortality was 4%, 0% for those patients with initial concordance in planning vs 12% for those without initial concordance (P = .33). Surgery was always performed in a tertiary hospital by local surgeons, and in two cases (8%) external surgeons joined the local surgical team., Conclusions: Such a regional service of teleconsultation may be of value in standardizing the treatment and derived costs of complex TAADs in a huge region under the same health provider. The shared decision-making strategy may be of medical-legal value as well., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Recent technological developments allowed significant improvements in interventional approach to carotid artery stenosis. Tapered stents were specifically designed for extracranial carotid artery stenting (CAS) to deal with vessels mismatch with the objective of decreasing the risk of thrombosis. Nevertheless, whether the stent geometry may affect the outcomes of CAS is uncertain. This study aims to investigate the impact of stent configuration on perioperative and long-term results of this procedure., Methods: All CAS procedures performed between 2005 and 2012 at a single high-volume center were reviewed. Primary end points of the study were 30-day mortality and any ipsilateral neurological event. Secondary end points were any late (>30 days) neurological event and restenosis >50%., Results: About 1,368 procedures were performed in the period 2005-2012. 9.1% of the patients were symptomatic for recent focal neurological event. 883 patients were treated with a cylindrical stent while the others underwent a tapered design device implantation. Technical success was achieved in 96% of the procedures. No perioperative mortality was recorded; perioperative stroke occurred in 1.2% vs. 1.6% (P = not significant) in tapered and straight stent group respectively. Stent design did not predict perioperative ipsilateral neurological events neither at bivariate nor at multivariate analysis. At a mean follow-up of 30 months, late neurological events occurred in 26 cases (1.9%); conic stents resulted protective at Kaplan-Meier analysis (P = 0.027)., Conclusions: The use of conic stents appears to be associated with similar perioperative results when compared with straight stents. Late outcomes suggest a lower risk of restenosis and late neurological events in patients with conical shape stents., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Acute occlusion of the visceral arteries is a threatening complication following branched endovascular aortic repair (EVAR). Its prompt diagnosis and treatment are mandatory to restore renal function. Several techniques have been used to manage this complication. We report 2 clinical cases of patients, previously treated with implantation of an off-the-shelf thoracoabdominal aortic endograft, with acute bilateral occlusion of the renal arteries. Both patients were successfully treated with AngioJet rheolytic thrombectomy. Acute occlusion of the renal arteries can dramatically complicate the outcome of patients treated with branched EVAR. Prompt diagnosis and treatment are required. Rheolytic thrombectomy rapidly removes intra-arterial thrombus through Bernoulli effect, preventing the risk of distal embolization and rapidly restoring the renal function., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective/background: Absence of an adequate iliac seal rarely represents an absolute contraindication to endovascular abdominal aortic aneurysm repair. Iliac branch devices (IBD) are increasingly used in patients with extensive aorto-iliac aneurysmal disease, but few data are available on the long-term results of these procedures., Methods: Between 2006 and 2016, 157 consecutive IBD procedures performed at a single centre were entered into a prospective database. Indications included unilateral or bilateral common iliac artery aneurysms combined or not with abdominal aortic aneurysms. Long-term results were reported according to the Kaplan-Meier method., Results: During the study period 149 patients were treated with an iliac branched endograft. Isolated IBD was implanted in 17.8% of the cases; technical success rate was 97.5%. Peri-operative procedure failure occurred in seven patients, four during surgery and three within 30 days of the procedure. Presence of ipsilateral hypogastric aneurysm (p = .031; Exp [B] = 6.72) and intervention performed during the initial study period (p = .006; Exp [B] = 10.40) were predictive of early failure on multivariate analysis. After a mean follow-up of 44.2 months actuarial freedom from IBD related re-intervention was 97.4%, 95.6%, 94.0%, and 91.8% at 1, 3, 5, and 9 years, respectively. Hypogastric artery patency was 94.7%, 92.6%, and 90.4% at 1, 3, and 10 years, respectively. Presence of a hypogastric aneurysm was an independent predictor of target artery occlusion during follow-up on multivariate analysis (p = .007; Exp [B] = 5.93)., Conclusion: Iliac branched endografting can now be performed with a high technical success rate; long-term freedom from re-intervention is comparable with patients treated with standard aortic endografting. IBD should be considered a first-option treatment in patients with adequate vascular anatomy unsuitable for standard endovascular aortic repair., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Purpose: To evaluate the incidence and reasons for secondary procedures in patients treated with iliac branch devices (IBDs) for isolated iliac aneurysm or aortoiliac aneurysms involving the iliac bifurcation., Methods: Between January 2005 and December 2015, 575 surgical-high-risk patients (mean age 72.0±8.4 years; 558 men) with isolated iliac aneurysms (n=79) or aortoiliac aneurysms involving the iliac bifurcation (n=496) were treated with placement of 650 ZBIS or Gore IBDs (75 bilateral) in 6 European centers. The primary outcome was procedure-related reinterventions for occlusion or high-grade (>70%) stenosis of the bridging device, occlusion of the ipsilateral common or external iliac artery (EIA), type I/III endoleak, rupture, or infection following IBD implantation. Clinical and radiological data were analyzed based on preset definitions of comorbidities, aneurysm morphology, intraoperative variables, and follow-up strategies., Results: Nine (1.6%) reinterventions were performed within 30 days for occlusion or endoleak. Among 10 (1.5%) occluded EIAs ipsilateral to a deployed IBD, 6 underwent a reintervention with additional stent placement after thrombolysis (n=4) or a femorofemoral or iliofemoral crossover bypass (n=2). Three of 14 patients with early type I endoleak had a reintervention for an insufficient proximal sealing zone (stent-grafts in 2 common iliac arteries and 1 bifurcated endograft). Mean clinical and radiological follow-up were 32.6±9.9 and 29.8±21.1 months, respectively. Forty-two (7.3%) patients underwent reinterventions in the follow-up period. The overall postoperative reintervention rate was 8.9%. Both external and common iliac segments occluded in 30 (4.6%) IBDs; 2 patients had a crossover bypass and 14 were treated with endovascular techniques. In the other 14 patients, no specific treatment was performed. Seven (1.2%) patients with isolated EIA occlusion were treated during follow-up. Nineteen of the overall 28 patients with type I endoleak underwent endovascular repair. The other 9 were under radiological surveillance due to less significant (<5 mm) sac increase. No reintervention was performed to recanalize 11 (1.6%) occluded internal iliac arteries., Conclusion: Midterm experience with placement of IBDs is associated with a low incidence of secondary procedures due to type I endoleaks and occlusions. The main reasons for reinterventions seem to be short proximal sealing zone and poor conformability of the ZBIS device in elongated EIAs.

Background: Sex differences in presentation and outcomes of abdominal aortic aneurysms (AAA) with increased mortality rates in women are suggested. This study aimed to assess mortality risk after repair of ruptured AAA (rAAA) in women in the endovascular abdominal aortic repair (EVAR) era., Methods: Patients treated between 2006 and 2015 for rAAA were included in a prospective database. Characteristics at presentation and outcomes were compared between women and men. Multivariable logistic regression and Cox proportional analyses were performed to identify the effect of sex adjusted for other predictors on mortality., Results: One hundred thirteen patients were identified; of these, 17.7% (20/113) of the patients were women. Forty-four procedures (38.9%) were by EVAR, with comparable rates in women (45%) and men (37.6%, P = 0.62). On admission, women and men shared similar comorbidities and presentation (shock 45% vs. 43.0%, P = 0.81; free rupture 65.0% vs. 67.7%, P = 0.80) and comparable mean aneurysm diameter (76.5 vs. 78.8 mm, P = 0.68), but women were older (mean age 86.4 + 5.5 vs. 75.2 ± 10.6 years, P < 0.0001) and octogenarian women were twice as likely as men (90% vs. 40%, P < 0.0001). Perioperative mortality was comparable between women and men (40.0% vs. 38.7%) either after EVAR (22.2% vs. 40.0% in women and men respectively; odds ratio [OR] 0.45, 95% confidence interval [CI] 0.77-2.37) or after open surgery (54.5% vs. 37.9%; OR 2.0, 95% CI 0.54-7.21), even though there was a trend for lower mortality in women with EVAR. In adjusted analyses, female sex was not associated with perioperative mortality as it was for older age (octogenarians: OR 6.6, 95% CI 2.08-20.82, P = 0.001) and free rupture (OR 4.2, 95% CI 1.29-13.73, P = 0.02). Mean follow-up was 34.32 months. After controlling for age, surgical repair, free rupture, cardiac disease, and shock at presentation, female sex was not a predictor of late mortality., Conclusions: AAA repair is often delayed in women and applied at older age; nevertheless, currently women do not show increased perioperative mortality risks from rAAA treatment after the introduction of EVAR., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience., Methods: Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention., Results: Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034)., Conclusions: EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Repair of isolated iliac aneurysm with stent-graft implantation and internal iliac coverage may induce significant type II endoleak from patent internal iliac refilling leading to ongoing aneurysm growth. Subsequent treatment of such complication can be challenging especially in case of bilateral iliac involvement. Open repair is technically demanding and often a high risk procedure, while embolization via transfemoral approach is unviable due to the stent-graft coverage precluding direct antegrade access between the common and the internal iliac lumen. Percutaneous retrograde embolization from superior gluteal artery is a feasible technique in case of impossible access through the origin of internal iliac artery., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aims: Conflicting data exist on the impact on outcome of the use of different stent types during carotid artery stenting (CAS). The aim of this study was to evaluate clinical outcomes according to different carotid stent design among the population of the European Registry of Carotid Artery Stenting (ERCAS)., Methods and Results: The present study was conducted in 1,604 patients who underwent neuroprotected CAS in ERCAS. All types of commercially available carotid stent were used. Open-cell design stents were classified according to free cell area into <7.5 mm2 or >7.5 mm2. A total of 713 closed-cell, 456 hybrid-cell, 238 <7.5 mm2 open-cell, and 197 >7.5 mm2 open-cell stents were implanted. Overall, the 30-day stroke and death rate was 1.37%. At 30 days, 19 strokes occurred (1.18%): eight in the group of patients treated with a closed-cell (1.12%), two in those with a hybrid-cell (0.44%), three in those with a <7.5 mm2 open-cell (1.26%), and six in those treated with a >7.5 mm2 open-cell stent (3.05%) (p=0.045)., Conclusions: Data of the present study suggest that, in the setting of neuroprotected CAS performed in high-volume centres by properly trained operators, the use of an open-cell design stent with a free cell area >7.5 mm2 may be associated with an increased 30-day stroke risk.

Objective/background: A consistent number of elderly patients with ruptured abdominal aortic aneurysms (rAAAs) are deemed unfit for repair and excluded from any treatment. The objective of this study was to examine the impact on survival of endovascular repair and open surgery with restricted turndown in acute AAA repair., Methods: A prospective database for patients treated for rAAA was established. None of the patients admitted alive with rAAA were denied treatment. Multivariate regression models, the predictive risk assessment Glasgow Aneurysm Score (GAS), and subgroup analyses in older patients were applied to identify indicators of excessive 30 day mortality risk that could affect the decision for turndown., Results: From 2006 to 2015, 113 consecutive patients (93 males; mean age 77.2 years) with rAAAs were treated (69 open surgery; 44 EVAR). Overall peri-operative (30 day) mortality was 38.9% (44/113): 40.6% (28/69), and 36.4% (16/44) after open surgery and EVAR, respectively (p = .70). Multivariate logistic regression identified old age as an indicator of increased peri-operative mortality (odd ratio [OR] 1.2, 95% confidence interval [CI] 1.1-1.3; p = .001), as well as free aneurysm rupture (OR 5.0, 95% CI 1.3-19.9; p = .02). GAS was higher in patients who died (97.75 vs. 86.62), but the score failed to identify increased peri-operative mortality risk in adjusted analyses (OR 1.0; p = .06). Almost two thirds of the patients (n = 71) were older than 75 at the time of aneurysm rupture (48.6% octogenarians) and EVAR was more commonly applied than open surgery (86.4% vs. 47.8%; p < .0001). Peri-operative mortality in > 75 year old patients was 46.5% compared with 26.2% in younger patients (p = .05), with rates increased after open surgery (54.5% vs. 27.8%, p = .03) but not after EVAR (39.5% vs. 16.7%; p = .39). According to Kaplan-Meier estimates, mean survival was 39.7 ± 4.8 months. Patients older than 75 years of age survived for a mean of 23.0 ± 4.47 months after rupture., Conclusion: In this study aggressive treatment with a very restricted or no turndown strategy for any rAAA, also applied to older patients, allowed for an additional mean 40 months of survival after aneurysm rupture. In the contemporary endovascular era the decision to deny repair arbitrarily to older patients with rAAAs must be revisited., (Copyright © 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Background: Age is a main risk factor for stroke and perioperative risk. This study aims to analyze the effect of age by symptomatic status in young patients receiving carotid revascularization., Methods: Consecutive carotid revascularization procedures performed during the period 2001-2009 were reviewed. Patients were analyzed by age using the 70-year threshold as suggested by trials. Primary end point was perioperative stroke or death rate. Secondary end points included survival and late stroke incidence at 6 years., Results: A total of 2,196 procedures (1,080 by carotid artery stenting [CAS] and 1,116 by carotid endarterectomy [CEA]) were analyzed. Symptomatic patients (n = 684) showed higher perioperative stroke or death risks (24 of 684 [3.5%] versus 29 of 1,512 [1.9%], odds ratio [OR] 1.8; 95% confidence interval [CI] 1.07-3.22; P = 0.034) and lower 6-year survival (74% vs. 82%, P < 0.0001) or freedom from late stroke (93% vs. 97%, P = 0.001) when compared with asymptomatic patients with similar differences detected within CEA or CAS procedure. Overall 949 procedures were in patients with 70 years or less at the time of intervention (500 CEA and 449 CAS); 282 were in patients symptomatic for minor stroke or transient ischemic attack within 6 months before revascularization. For young symptomatic patients, primary end point rates were <2.5% after both CEA and CAS procedure. Perioperative stroke or death rates were 2.4% in symptomatic versus 1.5% in asymptomatic (4 of 170 vs. 5 of 330; OR 1.57; 95% CI 0.42-5.91; P = 0.50) within the CEA group and 1.8% in symptomatic versus 1.2% in asymptomatic (2 of 112 vs. 4 of 337; OR 1.51; 95% CI 0.27-8.38; P = 0.64) within the CAS group. At 6 years, symptomatic young patients showed survival (89.5% vs. 89%, P = 0.76) and freedom from late stroke (97% vs. 98%, P = 0.56) rates comparable to those found in asymptomatic patients, with similar incidences after CAS or CEA procedure., Conclusions: Outcomes after carotid revascularization are related to patients' age. At younger ages (<70 years), after carotid revascularization, symptomatic patients show low perioperative risks of stroke or death, comparable with those in asymptomatic patients. The same, 2.5% or lower, threshold for perioperative stroke or death risk related to asymptomatic carotid procedures must be applied today to symptomatic patients when younger than age of 70 years., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: To evaluate the late results of endovascular aneurysm repair (EVAR) with the endografts currently in use and compare outcomes to older devices., Methods: Clinical, demographic, and imaging data on consecutive patients undergoing elective EVAR from January 1997 to December 2011 at a single center were retrieved from an electronic database and reviewed. Newer stent-grafts (NSG) were defined as those introduced after 2004 (second-generation Excluder and Anaconda) or currently in use without modifications (Zenith, Endurant). Of the 1412 consecutive patients (1290 men; mean age 73 years) who underwent elective EVAR in a tertiary university hospital, 882 were treated with NSGs and 530 with older stent-grafts (OSGs)., Results: In the NSG group, the abdominal aortic aneurysms (AAA) were larger (55.7 vs. 53.2 mm, p<0.0001) and the patients were older (p<0.0001) and less frequently smokers or had pulmonary disease, while hypertension and diabetes were more frequent (all p<0.0001). Thirty-day mortality was 0.8% in the NSG group vs. 1.1% in the OSG group (p=NS). Follow-up ranged from 1 to 174 months (mean 54.1±42.4); the OSG patients had longer mean follow-up compared to the NSG group (80.2±47.9 vs. 38.4±29.1 months, p<0.0001). All-cause survival rates were comparable in both groups. Freedom from late conversion (96.1% vs. 89.1% at 7 years, p<0.0001) or reintervention (83.6% vs. 74.2% at 7 years, p=0.015) and freedom from AAA diameter growth >5 mm (p=0.022) were higher in the NSG group. In adjusted analyses, the use of a new-generation device was a negative independent predictor of reintervention [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49 to 0.93, p=0.015] and aneurysm growth (HR 0.63, 95% CI 0.45 to 0.89, p=0.010)., Conclusion: Newer-generation endografts can perform substantially better than the older devices. In the long term, incidences of reintervention, conversion, and AAA growth are decreased in patients treated with devices currently in use. However, the need for continuous surveillance is still imperative for all endografts.

Background: This study analyzed predictors and the long-term consequence of type II endoleak in a large series of elective endovascular abdominal aneurysm repairs (EVARs)., Methods: Baseline characteristics and operative and follow-up data of consecutive patients undergoing EVAR were prospectively collected. Patients who developed type II endoleak according to computed tomography angiography and those without type II endoleak were compared for baseline characteristics, mortality, reintervention, conversion, and aneurysm growth after repair., Results: In 1997-2011, 1412 consecutive patients (91.4% males; mean age, 72.9 years) underwent elective EVAR and were subsequently followed up for a median of 45 months (interquartile range, 21-79 months). Type II endoleak developed in 218. Adjusted analysis failed to identify significant independent predictors for type II endoleak with the exception of age (odds ratio, 1.03; 95% confidence interval, 1.01-1.05; P = .003) and intraluminal thrombus (odds ratio, 0.69; 95% confidence interval, 0.53-0.92; P = .010). Type II endoleak rates were comparable regardless of the device model. Late aneurysm-related survival was comparable (98.4% vs 99.5% at 60 months; P = .73) in patients with and without type II endoleak. However, at 60 months after EVAR, rates of aneurysm sac growth >5 mm (35.3% vs 3.3%; P < .0001) were higher in patients with type II endoleak. Cox regression identified type II endoleak as an independent predictor of aneurysm growth along with age and cardiac disease. The presence of type II endoleak led to reinterventions in 40% of patients and conversion to open surgery in 8%. However, assessment of these patients after reintervention showed similar 60-month freedom rates of persisting type II endoleak (present in more than two after computed tomography angiography scan studies) among those with and without reinterventions (49.8% vs 45.6%; P = .639). Aneurysm growth >5 mm persisted with comparable rates in type II endoleak patients after reintervention and in those who remained untreated (42.9% vs 57.4% at 60 months; P = .117)., Conclusions: Reintervention for type II endoleak was common in our practice, yet such intervention did not reliably prevent the continued expansion of the abdominal aortic aneurysm. Our data indicate type II endoleak appears to be a marker of EVAR failure that is difficult to predict and treat effectively., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Visceral aneurysms are rare in the general population (<2%), and the most serious complication is represented by aneurysm rupture. The use of stent grafts to exclude visceral aneurysms is described in several reports but is reserved for patients with favorable anatomy. We report here on a hepatic artery pseudoaneurysm in a liver transplant patient and a patient with an aneurysmal vein graft degeneration of a renal bypass, both with no suitable proximal neck for standard stent grafting. Both patients were successfully treated with a custom-made aortic endograft with a single fenestration for the hepatic or renal artery, together with a visceral covered stent. Although initial results are promising, long-term follow-up is required to assess durability., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: This study aims to investigate the impact of diabetes in the management of patients with small abdominal aortic aneurysms (AAA)., Methods: Three-hundred sixty patients with small AAA (4.1-5.4 cm), enrolled in a randomized trial comparing early endovascular repair versus surveillance and delayed repair (after achievement of >5.5 cm or growth>1 cm/yr), were analyzed with standard survival methods to assess the relation between diabetes and risk of all-cause mortality, complications, and aneurysm growth (on computed tomography as per trial protocol) at 36 months. Baseline covariates were selected with partial likelihood stepwise method to investigate factors (demographic, morphologic, medications) associated with risk of aneurysm growth during surveillance., Results: Prevalence of diabetes was 13.6%. The hazard ratio (HR) for all-cause mortality at 36 months was higher in diabetic compared with nondiabetic patients: (HR, 7.39; 95% confidence interval [CI], 1.55-35.13; P=.012). Baseline aneurysm diameter was comparable between diabetic and nondiabetic patients enrolled in the surveillance arm and was related to subsequent aneurysm growth in covariance analyses adjusted for diabetes (49.3 mm for nondiabetic; 50.2 mm for diabetic). Cox analyses found diabetes as the strongest independent negative predictor of 63% lower probability of aneurysm growth>5 mm during surveillance (HR, 0.37; 95% CI, 0.15-0.92; P=.003). Kaplan-Meier cumulative probability of aneurysm growth>5 mm at 36 months was 40.8% in diabetics versus 85.1% in nondiabetics (HR, 0.32; 95% CI, 0.17-0.61)., Conclusions: Progression of small AAA seems to be more than 60% lower in patients with diabetes. This may help to identify high-risk subgroups at higher likelihood of AAA enlargement, such as nondiabetics, for surveillance protocols in patients with small AAA., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers., Methods: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events., Results: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%., Conclusions: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: Paradoxical pulmonary embolisms are uncommon emergencies and can occur as a consequence of an aortocaval fistula due to unrecognized dislodgement of thrombus from aortic sac into pulmonary circulation. This study reviewed current literature and therapeutic options in this emergency condition requiring prompt management and repair., Methods: Literature was systematically searched for paradoxical pulmonary embolism associated with aortocaval rupture., Results: Eight published cases were identified. However, many other paradoxical pulmonary emboli could have remained undiagnosed due to challenging clinical presentation. Symptoms of high-output cardiac failure and respiratory distress in the presence of large aortoiliac aneurysm and venous hypertension are findings of a possible major abdominal arteriovenous fistula with paradoxical pulmonary embolism. Successful treatment depends on prevention of new embolism and proper management of perioperative hemodynamics and massive bleeding during fistula repair. Endovascular procedures have been recently used as useful tools in this field. Cava filter placement may be a first step to prevent further thrombus dislodgements during aortocaval repair. Immediate subsequent aortic stent-grafting can allow repair of aortocaval communication and exclusion of the abdominal aortic aneurysm from circulation with successful reversal of altered hemodynamic features. However, experience (especially in the long-term) is limited., Conclusions: Paradoxical pulmonary embolism from aortocaval fistula represents an extremely rare but true clinical emergency with high fatality rate. Recent advances in diagnostic technology and endovascular techniques can substantially improve outcomes of the disease. Clinical competence in early detection and diagnosis is essential for appropriate emergent management., (Copyright © 2012 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

Background: Diabetes is prevalent in most patients undergoing carotid revascularization and is suggested as a marker of poor outcome after carotid endarterectomy (CEA). Data on outcome of diabetic patients undergoing carotid artery stenting (CAS) are limited. The aim of this study was to investigate early and 6-year outcomes of diabetic patients undergoing carotid revascularization with CAS and CEA., Methods: The database of patients undergoing carotid revascularization for primary carotid stenosis was queried from 2001 to 2009. Diabetic patients were defined as those with established diagnosis and/or receiving oral hypoglycemic or insulin therapy. Multivariate and Kaplan- Meier analyses, stratified by type of treatment, were performed on perioperative (30 days) and late outcomes., Results: A total of 2196 procedures, 1116 by CEA and 1080 by CAS (29% female, mean age 71.3 years), were reviewed. Diabetes was prevalent in 630 (28.7%). Diabetic patients were younger (P < .0001) and frequently had hypertension (P = .018) or coronary disease (P = .019). Perioperative stroke/death rate was 2.7% (17/630) in diabetic patients vs 2.3% (36/1566) in nondiabetic, (P = .64); the rate was 3.4% in diabetic CEA group and 2.1% in diabetic CAS group (P = .46). At multivariate analyses, diabetes was a predictor of perioperative stroke/death in the CEA group (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.05-7.61; P = .04) but not in the CAS group (P = .72). Six-year survival was 76.0% in diabetics and 80.8% in nondiabetics (P = .15). Six-year late stroke estimates were 3.2% in diabetic and 4.6% in nondiabetic patients (P = .90). The 6-year risk of restenosis was similar (4.6% % vs 4.2%) in diabetic and nondiabetic patients (P = .56). Survival, late stroke, and restenosis rates between diabetics and nondiabetics were similar in CAS and CEA groups., Conclusions: Diabetic patients are not at greater risk of perioperative morbidity and mortality or late stroke after CAS, however, the perioperative risk can be higher after CEA. This may help in selecting the appropriate technique for carotid revascularization in patients best suited for the type of procedure., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1-5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance., Methods: Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey., Results: Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 (p = 0.18), Physical domain: 71.4 versus 73.3 (p = 0.33); Mental health domain: 70.9 versus 72.7 (p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (-3.9 in EVAR, -6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38., Conclusions: Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar., (Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: This study sought to evaluate long-term outcomes of carotid stenting (CAS) versus carotid endarterectomy (CEA) based on physician-guided indications., Background: The issue regarding long-term outcome of CAS versus CEA in patients with carotid stenosis is clinically relevant but remains unsettled., Methods: Consecutive patients (71% men, mean age 71.3 years) treated by CEA (n = 1,118) or CAS (n = 1,084) after a training phase were reviewed. Selection of treatment was based on better-suitability characteristics (morphology and clinical). Data were adjusted with propensity score analysis and stratified by symptoms, age, and sex., Results: Thirty-day stroke/death rates were similar: 2.8% in CAS and 2.0% in CEA (p = 0.27). The risk was higher in symptomatic (3.5%) versus asymptomatic (2.0%) patients (p = 0.04) but without significant difference between CAS and CEA groups. Five-year survival rates were 82.0% in CAS and 87.7% in CEA (p = 0.05). Kaplan-Meier estimates of the composite of any periprocedural stroke/death and ipsilateral stroke at 5 years after the procedure were similar in all patients (4.7% vs. 3.7%; p = 0.4) and the subgroups of symptomatic (8.7% vs. 4.9%; p = 0.7) and asymptomatic (2.5% vs. 3.3%; p = 0.2) patients in CEA versus CAS, respectively. Cox analysis, adjusted by propensity score, identified statin treatment (p = 0.016) and symptomatic disease (p = 0.003) associated with the composite end point. There were no sex- or age-related significant outcome differences., Conclusions: When physicians use their clinical judgment to select the appropriate technique for carotid revascularization CAS can offer efficacy and durability comparable to CEA with benefits persisting at 5 years., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Management of anti-platelet therapy during carotid artery stenting (CAS) is mainly based on indirect evidence from coronary stenting experience. There is common agreement on the use of thienopyridine (mainly second-generation) during CAS, but some patients are unsuitable for clopidogrel treatment and data on the benefit of its use in large CAS populations are lacking. The aim of this study was to investigate whether clopidogrel was associated with reduced perioperative morbidity in patients undergoing CAS., Methods: Consecutive patients undergoing CAS for primary carotid stenosis from 2004 to 2009 were reviewed. The independent association of clopidogrel and perioperative morbidity was assessed using multivariable analysis., Results: A total of 1083 patients were treated (29% females, mean age 71.6 years); 825 (76%) patients were given clopidogrel starting before treatment. Clopidogrel use was associated with a non-significant reduction of perioperative stroke/death (4.3% vs. 2.4%; p = 0.13) and disabling stroke (1.2% vs. 1.0%; p = 1) rates. The non-significant stroke/death difference was similar in symptomatic (5.8% vs. 4.0%, p = 0.37) and asymptomatic (3.7% vs. 1.9%; p = 0.17) patients. After adjusting for demographics, co-morbidities and other therapies with multivariable analysis, clopidogrel use failed to show any significant independent association in decreasing operative risks. The only independent protective factor was use of statins (p = 0.010). The additional use of dual anti-platelet therapy did not add any advantage to the use of clopidogrel alone., Conclusions: The suggested benefit of clopidogrel in decreasing the incidence of complications in patients undergoing CAS may be overestimated due to the overlapping effect of other more relevant factors (e.g., pleiotropy and plaque stabilisation from statins). More data and level I evidence are needed to understand which is the best medical management of CAS that will help improve outcomes of the procedure., (Copyright © 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Objectives: Increasing data suggest that statins can significantly decrease cardiovascular and cerebrovascular events due to a plaque stabilization effect. However, the benefit of statins in patients undergoing carotid angioplasty and stenting (CAS) for carotid stenosis is not well defined. The aim of this study was to investigate whether statins use was associated with decreased perioperative and late risks of stroke, mortality, and restenosis in patients undergoing CAS., Methods: All patients undergoing CAS for primary carotid stenosis from 2004 to 2009 were reviewed. The independent association of statins and perioperative morbidity was assessed using multivariable analysis. Survival curves and Cox regression models were used to assess late morbidity and restenosis. Propensity score adjustment was employed., Results: A total of 1083 consecutive CAS were performed (29% females, mean age 71.5 years; 24.7% symptomatic); 465 (43%) were on statins medication before treatment that was not discontinued at discharge. Statins use was associated with a reduction of perioperative stroke and death (odds ratio [OR] 0.327, 95% confidence interval [CI] 0.13-0.80, P = .016) according to multivariable analysis. Statins effect was more significant in reducing stroke and death in symptomatic patients (OR 0.13; P = .032) and in males (OR 0.27, P = .01). At 5 years, survival (87.2% vs 78.3%; P = .009) and ischemic stroke-free interval (88.9% vs 99.7%; P = .02) rates were higher in the statins group of patients. Adjusting for propensity score and covariates in Cox regression analyses, statins use was independently associated with reduced long-term mortality risk (HR 0.56, 95% CI 0.32-0.97; P = .039) and borderline associated with decreased late ischemic stroke risk (HR 0.14; 95% CI 0.018-1.08, P = .059). There was no effect on restenosis rates., Conclusions: These data suggest that statins use is associated with decreased perioperative and late ischemic strokes risk and reduced mortality rates in patients undergoing CAS. Statins therapy should be considered part of the best medical treatment in current CAS practice., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Nine completed randomized clinical trials (RCTs) failed to show any advantage of carotid angioplasty and stenting (CAS) over carotid surgery, whereas a number of larger trials were recently developed and are still ongoing or have just released interim data analysis. These new RCTs, giving emphasis to CAS carried out with appropriate credentialing and updated technology should be appropriately powered. According to last published data, carotid revascularization performed by highly qualified surgeons and interventionalists might be safe and effective; nevertheless, stroke is more likely after carotid stenting, whereas myocardial infarction is more likely after surgery, and the 2 risks need to be balanced in selecting the indication for treatment in specific patients. It is hoped that ongoing RCTs will clarify a couple of other issues: (1) the benefit of CAS in "asymptomatic" patients with respect not only to surgery but also to medical therapy alone and (2) which subgroups of patients at "average risk" would benefit more from CAS. Final results from pending RCTs are eagerly awaited to manage the common practice with CAS.

Endoleak is a common and unique complication of endovascular aortic repair (EVAR) and its persistence represents a failure of the endovascular treatment. Accurate detection and classification is essential for the proper management since the method of endoleak treatment is determined by the different source. In general, high-pressure leaks (type I and type III) require urgent management because of the relatively high short-term risk of sac rupture. Although precise differentiation between type I and type III endoleaks may not be possible at cross- sectional imaging, differentiation is often unnecessary because both lesions are considered high-risk and require angiographic evaluation and subsequent treatment. Low-pressure lesions (types II and V or endotension) are considered less urgent but may warrant continued endovascular evaluation if there is impending growth of the aneurysm sac or if the patient presents with symptoms. Once detected, endoleaks warranting correction (all type I and III; persistent endotension and type II associated with aneurysm enlargement) are usually treated by endovascular route. A variety of techniques including extension endografts or cuff, balloon angioplasty, bare stents and a combination of transvascular and direct sac puncture embolization techniques has allowed to treat the vast majority of these endoleaks without conversion to open surgical repair. Type II endoleak continues to be the most common but also the most controversial in terms of evaluation, the need of treatment, and methods of treatment. Careful and rigorous postoperative lifelong follow-up with computed tomography (CT) and high quality imaging continue to be essential for all patients after EVAR.

Objective: Randomized controlled trials (RCTs) of carotid endarterectomy (CEA) advised little benefit from surgery in women because of high operative risk. Whether these findings are also applicable to carotid angioplasty and stenting (CAS) is subject of investigation. Our aim was to determine the risk of perioperative and late complications related to CAS and CEA in women., Methods: Data from a single-center carotid surgery database including 1065 individuals with CAS (306 women and 759 men) and 1131 with CEA (325 women and 806 men) were analyzed in a consecutive series of patients. Perioperative risks of death, stroke, and local complications in women undergoing CAS and CEA were compared. Rates of restenosis >50% and stroke at 5 years in symptomatic and asymptomatic women were also assessed., Results: The perioperative risks of stroke or death were no different in women who underwent CAS and CEA women (1.9% vs 3.0%; odds ratio [OR] = 0.63; 95% confidence interval [CI], 0.20-1.7; P = .45) whether they were symptomatic or not. Other perioperative complications were also similarly distributed between the two groups of women. Life-table estimates of any periprocedural stroke/death and ipsilateral stroke at 5 years after the procedure did not differ between women with CAS and CEA (4.1% vs 8.1%; P = .18). Five-year rates of restenosis >50% were nonsignificantly higher in women after CEA than after CAS (1.8% vs 8.1%; P = .058)., Conclusion: Women with carotid stenosis might have favorable early and late outcomes from CAS with complication rates similar and even lower than those attained with CEA. CAS, performed by trained operators, may be a valid primary choice for treatment of carotid stenosis, particularly in asymptomatic women for whom the risk of surgery seems to be higher. However, before claiming CAS for women, these results need to be confirmed by large RCTs., (Copyright 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

The emerging role of stent-graft strategies for the management of thoracic aortic diseases has attracted growing acceptance, especially in considering the sobering results of open repair in thoracic high-risk settings (e.g., acute dissection, trauma, rupture). Aortic endograft technology for thoracic diseases has rapidly improved after the early use of first generation devices, and the new models show very promising early and mid-term success rates. To date there is no evidence of the superiority of any single device model over the others. Indeed, each device has some peculiarities that makes it more useful in specific settings. Current limitations in thoracic stent-grafts will hopefully be addressed with new designs of highly-individualized low-profile devices in order to extend the applicability of stent-graft technology in the thoracic aorta. Despite progress in configuration and flexibility and the greater availability of different devices compared to a decade ago, shortcomings of specific endovascular grafts including collapse, migration, or dislodgment have not been fully resolved. Nowadays the selection of patients on the basis of favourable anatomy and pathology is the key for the success of the procedure. Not all patients have lesions amenable to stent-graft repair (contraindications for endovascular treatment of thoracic aorta are still not marginal and mainly defined by anatomical constraints) and thoracic endografting is technically challenging, requiring dedicated facilities and experienced specialists. This paper discusses the different configurations and models of stent-graft for thoracic aortic disease as well as the still existing shortcomings.

Open repair of abdominal aortic aneurysm (AAA) is considered a stable and durable vascular procedure when compared with the more recent endovascular approach. A process of remodeling and progressive degeneration may occur after open surgery in the aorta proximal to the repair, predisposing to proximal recurrent aneurysm formation. Surgical repair of the false aneurysm carries a high rate of perioperative complications, including spinal cord ischemia and renal insufficiency. The literature is conflicting on the frequency of proximal false-aneurysm formation, but an average neck dilation of between .2 and .6 mm per year has been reported. Importantly, disease progression may be the most common underlying culprit for proximal false-aneurysm formation. These findings argue for careful follow-up after aneurysm repair using high-quality imaging studies to detect failures and the potential for false-aneurysm formation.

Objective: To analyze early and mid-term outcome of endovascular treatment in patients with iliac aneurysms, comparing the results of hypogastric revascularization by branch endografting with those of hypogastric occlusion., Methods: Consecutive patients with iliac aneurysms receiving side branch endograft (Group I) were compared with those receiving endograft with hypogastric exclusion (Group II) during the interval from January 2000 to May 2008. Procedural details and outcomes were prospectively collected and were analyzed at one year to avoid mismatch in follow-up length., Results: A total of 74 patients (mean age, 75.8 years, 95% males) were treated: 32 in Group I and 42 in Group II. No differences in baseline risk factors and aneurysm diameter (40.2 +/- 7.9 mm in Group I vs. 38.4 +/- 10.8 in Group II) were found. Concurrent treatment of aortic aneurysm was performed in 25/32 (78%) of Group I and 36/42 (86%) of Group II. Fluoro time was 48 minutes (interquartile range [IQR] 31-57) in Group I vs. 31 minutes (IQR 23-38) in Group II (P = .04). The amount of contrast was similar in both Groups: 184 ml (IQR 155-210) in Group I vs. 183 ml (IQR 155-200) in Group II. No intestinal ischemia or deaths occurred. There were no significant differences in failures of hypogastric side branch deployment (2/32) compared with hypogastric coiling (3/42). Limb occlusions all occurring in the external iliac artery side were 2/32 in Group I vs. 3/42 in Group II. Reintervention rates were similar (5/32 vs. 4/42) at one year. Shrinkage of 5 mm or more was detected in 7/23 (30%) of Group I and in 13/37 (34%) of Group II. Iliac endoleak was present in eight patients (19%) in Group II and in one patient in Group I (4%) (P = .1). Similarly, buttock claudication or impotence were more frequent after hypogastric exclusion, recorded in eight patients in Group II and in one patient in Group I (P = .1)., Conclusions: Endovascular treatment of iliac aneurysm with hypogastric revascularization through side branched endografts is feasible and safe in the mid-term. When compared with hypogastric embolization, this option leads to similar technical success and reintervention rates. Endoleak and buttock claudication occur frequently in patients with iliac aneurysm treated with hypogastric exclusion, while are uncommon in those with hypogastric revascularization. Side branch endografting for iliac aneurysm may be considered a primary choice in younger, active patients with suitable anatomy, but larger studies and longer postoperative observation periods are needed.

Background/objective: Durability is the main concern of aortic endografting, but it is not clear to what extent trial results are applicable to "real world" patients. The purpose of this study was to assess the durability of a single model of aortic endograft in an unselected population with core lab analysis of morphological changes., Methods: Computed tomography (CT) images of patients treated with Talent Unidoc (Medtronic, Santa Rosa, Calif) endografts from 2002 to 2006 in nine European centers with more than 1 year follow-up were centrally reviewed using a dedicated software with multiplanar and volume reconstructions. Images were checked for aneurysm growth >/=5 mm, neck enlargement >3 mm, graft migration >/=10 mm, endoleak, structural integrity. Morphological changes were defined clinically relevant when associated with reintervention or aneurysm-related death., Results: A total of 349 patients (mean age 73.8 years, 90% males) were available for analysis; 1187 CT examinations were reviewed. Median abdominal aortic aneurysm (AAA) diameter was 56 mm (interquartile range [IQR] 49-62), neck length 20 mm (IQR 16-30), and neck diameter 25 mm (IQR 23-26). Mean follow-up was 25 months (range 12-60 months). During the study period, 10 late deaths (1 aneurysm-related, 0.3%) with a survival rate of 89.2% at 48 months and 33 reinterventions including 8 conversions (2.2%), 2 AAA ruptures (0.6%) and 1 (0.3%) loss of graft integrity were recorded. Cumulative reintervention rate was 6%, 8%, 13%, and 16% at 1, 2, 3, and 4 years, respectively. According to core lab analysis, 22 AAA grew, 169 were unchanged, and 158 shrunk, with a growing AAA rate of 3.1% patients/year. Five growths required reintervention, one for rupture. Forty-seven (6.5% patients/year) neck enlargements, three clinically relevant, 17 migrations (2.4% patients/year), five clinically relevant, and 70 endoleaks (9.7 % patients/year), 11 clinically relevant, were detected., Conclusion: Data from this real world experience monitored with a centralized imaging review show that endovascular repair of abdominal aortic aneurysm with the latest generation of a single model of endograft is associated with low graft thrombosis and graft fatigue, and low late aneurysm rupture and related death risks. Neck enlargement although common after EVAR, is almost always without clinical consequences but a longer follow-up and prospective clinical studies are advisable to confirm the present results.

Major criticism of randomized clinical trials comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA) focused on the incomplete learning curve of interventionists and the inadequate and outdated technology employed, which might have contributed to the high stroke and death rates in the CAS arm. The effect of the learning curve related to technical expertise and patient selection strongly influences the results of CAS. Due to the devastating potential complications when compared with other endovascular minimally invasive procedures, CAS requires a more strict analysis of operator training and outcome, because improvement in the learning curve is accompanied by a comparative reduction in complication rates. Today, there is a general agreement that requirements for training in CAS are higher than in other fields. In contrast to many endovascular peripheral arterial interventions, CAS represents a more challenging procedure because it involves complex catheter-based skills. Training experience attempts to sensibly reduce strokes that may occur during the unprotected phases of catheterization/approach to the target vessel and the protected phase of ballooning/stenting and cerebral protection device retrieval. Mandatory training, familiarity with the indications and contraindications, and knowledge of the technology and devices are paramount for the success of CAS, and preprocedure, intraprocedure, and postprocedure patient management is essential for reducing morbidity and mortality. These prerequisites are essential to allow CAS to be accepted as a potential alternative to CEA.

Aim: To compare the results of endovascular repair (EVAR) in large and small (diameter < 5.5cm) abdominal aortic aneurysms (AAA)., Methods: A systematic review was performed to identify studies comparing the outcomes after EVAR of large and small aneurysms. Outcomes considered were: risk of death (perioperative, all cause, aneurysm-related), ruptures, and complications (conversion, reintervention). Weighted pooled estimates of outcomes in patients with small versus large aneurysms were calculated. The inverse variance method was used (random-effect model). Subgroup analyses by a follow-up longer or shorter than 24 months were performed., Results: Five studies, with published and unpublished data, totallying 7,735 patients, were included. Overall, the weighted pooled estimates were: OR 0.68; 95% CI 0.51-0.90 for operative mortality, OR 0.77; 95% CI 0.69 to 0.86 for all cause mortality, OR 0.58; 95% CI 0.40 to 0.87 for aneurysm-related mortality and OR 0.61; 95% CI 0.47 to 0.79 for rupture in favour of small AAA group. Pooled estimates were not influenced by follow-up length. Conversion and reintervention rates were not significantly lower for small AAA., Conclusions: EVAR in small versus large AAA might be associated with lower operative mortality, aneurysm-related mortality and aneurysm rupture. Better evidence is needed to support these suggestions.

Objectives: Cerebral embolism is the first cause of neurologic complications of carotid artery stenting (CAS). A large debate has been raised to identify the caseload necessary for an appropriate learning curve before systematic use of CAS. This study examined (1) the timing of periprocedural complications during CAS and how these complications vary over time to identify factors that contribute to neurologic morbidity and (2) a sufficient number of procedures for adequate training., Methods: During 2001 to 2006, 627 CAS procedures with cerebral protection devices (CPD) were performed in a single vascular surgery center by a team including a vascular surgeon and an interventional radiologist. These represented 38% of a total of 1598 carotid revascularizations performed in the same interval. CAS procedures were divided into two groups according to time interval: the first period, 2001 to 2003, included 195 CAS procedures, and the second period, 2004 to 2006, included 432 CAS procedures. During each CAS procedure, five major steps were considered: phase 1, or the catheterization phase, included the passage of the aortic arch, catheterization of the target vessel, and introduction of a guiding catheter or sheath. Phase 2, or the crossing stenosis phase, included the placement of a CPD. Phase 3, or the stent ballooning phase, included predilation (when indicated), stent implantation, postdilation, and recovery of the protection system. Phase 4, or the early postinterventional phase, included the first 24 hours after leaving the catheterization table. Phase 5, or the late postinterventional phase, included the interval from the first postoperative day to 30 days., Results: At 30 days, 10 major strokes (2 of which were fatal) and 1 cardiac death occurred, for an overall major stroke/death rate of 1.75%. Furthermore, 18 minor strokes (2.9%) were recorded. By analyzing the occurrence of major strokes according to the three intraprocedural phases, four occurred in phase 1 and six in phase 3. All strokes but one were ischemic; six were ipsilateral, three were contralateral, and one was posterior. Minor strokes occurred prevalently after the procedure (11 in phase 4, 5 in phase 5, and 1 for phases 1 and 3). Comparing the first with the second interval of the study period, the 30-day major stroke and death rate decreased from 3.1% to 0.9% (P = .047), and the 30-day any stroke and death rate decreased from 8.2% to 2.7% (P = .005). According to multivariate analysis, study interval (hazard ratio, 3.68; 95% confidence interval, 1.49-9.01; P = .005) and age (hazard ratio, 1.06; 95% confidence interval, 1.00-1.12; P = .05) were significant predictors of stroke., Conclusions: A large proportion of major strokes (4/10) from CAS cannot be prevented by using CPD, because these strokes occur during catheterization (phase 1). This finding, together with the significant decrease in the overall stroke/death rate between the first and the last interval of the study period, enhances the importance of an appropriate learning curve that involves a caseload larger than that generally accepted for credentialing. The noticeable number of postprocedural cerebral embolizations leading to minor strokes and occurring in the early and late postinterventional phases (16/18) is likely due to factors less strictly related to the learning-curve effect, such as stent design and medical therapy. Moreover, expertise in selecting material and design of the stents according to different vessel morphology, in association with correct medical treatment, may be useful in reducing the number of minor strokes that occur in the later postinterventional phases of CAS.

Carotid artery stenting (CAS) is becoming increasingly common for the treatment of carotid stenosis. Accumulating data, but not randomised data, suggest that CAS has promising efficacy in preventing stroke with an acceptable rate of procedure-related complications when compared to carotid endarterectomy (CEA). However, CAS procedures can carry a risk of non-negligible complications such as cerebral embolization, cerebral hemorrhage, severe hypotension and bradycardia. These may occur after the first 24 hours. Lessons may be learned from the timing of occurrence of CAS adverse events. The most severe neurological complications are generally due to embolism and occur intraprocedurally especially during catheter, wire or sheath manipulation in the aortic arch and common carotid. These strokes, obviously, cannot be prevented by using cerebral protection devices and enhance the importance of an appropriate learning curve that includes proper material choice, patient selection, good technique and the skill of "know when to quit".

Objective: To evaluate frequency, causes and results of conversion to Open repair (OR) after endovascular repair (EVAR) in a single centre during an 8-year period., Design: Six hundred and forty-nine consecutive patients undergoing EVAR were followed up prospectively for endograft-related complications., Outcomes: Early conversion was any OR during or within 30 days from the primary EVAR. Late conversion was any OR with removal of the endograft after 30 days since a completed EVAR procedure., Results: Median patient follow-up was 38 months (1-93 months). Conversion to OR was performed in 38 patients; nine early and 29 late. Most (7/9) early conversions were due to extensive vessel calcification. Peri-operative mortality was 22% (2/9). Late conversions occurred at a median of 33 months after primary EVAR: 29 were elective and 4 urgent. During the same interval, 79 secondary endovascular interventions were performed, 7 of which failed. The risk of conversion to OR was 9% at 6 years. At multivariate logistic regression analysis, no single factor (short, large or angulated neck, suprarenal fixation, large pre-operative diameter, iliac aneurysms, ASA score risk) was associated with the risk of late failure requiring conversion to OR., Conclusion: The risk of death after early conversion should be recognized, to avoid forcing morphological indications for primary EVAR. Occurrence of late conversion after EVAR is not negligible, affecting almost 1 out of 10 patients after 6 years. In the presence of an expanding aneurysm after EVAR, especially after a failed secondary endovascular correction, an aggressive attitude in fit patients allows outcomes at similar to those of primary OR.

We describe a case of severe acute bleeding from an arterio-duodenal fistula between the duodenum and a hepato-hepatic by-pass. Emergency ligation of the common hepatic artery was successfully achieved. After hepatic artery ligation, revascularization of the liver in human subjects occurs through inferior phrenic, pancreatico-duodenal and intercalary de novo arteries.

Objective: We compared the effectiveness and clinical outcome of open repair versus endovascular aortic aneurysm repair (EVAR) in achieving prevention of abdominal aortic aneurysm (AAA)-related death and graft-related complications., Methods: Over 7 years from 1997 to 2003, 1119 consecutive patients underwent elective treatment of infrarenal AAAs, 585 with open repair and 534 with EVAR. Patients were regularly followed up at 1, 6, 12 months, and every 6 months thereafter, in EVAR group, and at 3 and 12 months, and yearly thereafter after open repair. Preoperative, intraoperative, and follow-up data were stored in a prospective database., Results: Median follow-up was similar in the 2 groups: 33 months (interquartile range [IQR], 13-50 months) in the EVAR group vs 35 months (IQR, 15-54 months) in the open repair group. EVAR group patients were older than patients in the open repair group: 73 years vs 72 years (P = .04). There were statistical significant differences between the EVAR group and the open repair group with respect to AAA median diameter (52 mm vs 56 mm), coronary disease rate (46% vs 37%; P = .001), pulmonary disease rate (56% vs 38%; P < .0001), and American Society of Anesthesiologists IV score rate (16% vs 6%; P < .0001). Thirty-day mortality in the EVAR group was 0.9% (5 of 534 patients), compared with 4.1% (24 of 585 patients; P = .001) in the open repair group, and major morbidity was 9.1% (49 of 534 patients) vs 18.6% (109 of 585 patients; P < .0001), respectively. The incidence of secondary procedures in the EVAR group was 15.7%, compared with 3% in the open repair group (P < .0001). There were no deaths related to secondary procedures in either group. Six AAAs (1.1%) ruptured after EVAR, 3 of which were fatal; in the open repair group 1 patient (0.2%) underwent successful repeat operatation to treat iliac pseudoaneurysm rupture 5 years after the original procedure. Kaplan-Meier estimates for freedom from aneurysm-related death at 84 months were 97.5% in the EVAR group and 95.9% in the open repair group (log rank test, P = .008). Kaplan-Meier survival estimates at 84 months were 67.1% in the open repair group and 66.9% in the EVAR group (P = NS). At the same interval the risk for secondary procedures was 49.4% for the EVAR group and 7.1% for the open repair group. Of the 11 variables analyzed with logistic analysis, open surgery (hazard ratio [HR], 11; 95% confidence interval [CI], 2.5-54.2; P = .002), American Society of Anesthesiologists IV score (HR, 7.1; 95% CI, 2.7-18.8; P = .0001), and age (HR, 1.06; 95% CI, 1.04-1.13; P = .04) were positive independent predictors of perioperative mortality., Conclusion: Our data suggest that at a maximum follow-up of 7 years, patients who undergo EVAR show lower perioperative and late aneurysm-related mortality compared with a younger and substantially healthier group of patients with aneurysms treated with open repair. The higher need for secondary procedures in the endovascular group did not affect superiority of the overall performance of EVAR in the early and late intervals.

Among the hospital related complications the nosocomial infections are a major source of problems, especially in the Intensive Care and in the Surgery Units. It has been clearly demonstrated that infection control programs, in Surgery Units, have a large benefit in the reduction of surgical site infections (SSIs) rates. The surveillance method, sponsored by the Centers for Diseases Control of Atlanta, is the most consolidated system and it is active since '70 years. We used this method in the Vascular Surgery Unit of Perugia Hospital. During a 12-month period, 668 consecutive patients were enrolled and followed, after surgery, for 30 days (without implantable devices) or 1 year (with prosthesis). A total of 14 (2.1%) patients had SSIs: 4 superficial, 4 deep, 6 organ-space. We isolated 13 pathogens: 8 gram-positive, 4 gram-negative, and one Candida albicians. The most prevalent pathogen isolated was Staphylococcus aureus methicillin-susceptible. This first positive experience will be used for further more generalized work involving the principal surgical Unit of the Umbria Region.

Objective: Several studies have suggested that proximal aortic neck dilatation (AND) is a frequent event after balloon-expandable endografting. Yet few data are available on AND after repair with self-expandable stent grafts. To investigate incidence, predictive factors, and clinical consequences of AND, computed tomography (CT) scans obtained at intervals during follow-up of 230 patients who had undergone endoluminal abdominal aortic aneurysm (AAA) repair with self-expandable stents were reviewed., Subjects: Between April 1997 and March 2001, 318 patients underwent endoluminal AAA repair with a self-expandable endograft at our unit. CT scans obtained at 1 and 12 months after surgery and yearly thereafter were prospectively stored in a computer imaging data base. Two hundred thirty patients were available for minimum 1-year assessment. Two vascular surgeons with tested interobserver agreement reviewed 686 CT scans. Diameter of the proximal aortic neck was measured as the minor axis of the first CT section that contained at least half of the proximal portion of the endograft. For endografts with suprarenal attachment the first scan below the lowest renal artery was considered. Diameter change of 3 mm or more between the CT scan at 1 month and subsequent evaluations was defined as AND. Nine possible independent predictors of AND were analyzed with Cox regression analysis., Results: Median follow-up was 24 months (range, 12-54 months). In 2 patients, AAA ruptured during follow-up. CT scans for 65 patients (28%) showed AND. Thirteen patients with AND (5.6%) underwent repeat intervention, including positioning of the proximal cuff in 8 patients and late conversion to open repair in five patients. Of the nine variables examined with multivariate analysis, only 3, ie, presence of neck circumferential thrombus (hazard ratio [HR], 2.51; 95% confidence interval [CI], 1.26-5.01; P =.008), preoperative proximal neck diameter (HR, 1.21; 95% CI, 1.07-135; P =.001), and preoperative AAA diameter (HR, 1.03; 95% CI, 1.00-1.06; P =.046) were positive independent predictors of AND, whereas the other 6, ie, neck angulation more than 60 degrees, neck length, suprarenal fixation, oversizing more than 15%, endoleak at 30 days, and increased AAA diameter during follow-up, showed no significant correlation. Probability of AND at 48 months was 59 +/- 6.1 at analysis with the Kaplan-Meier method., Conclusions: AND is a frequent sequela of endoluminal repair in the mid-term. Severe AND developed in a small percentage of our patients, compromising integrity of AAA repair. Patients with large aneurysms and aortic necks and patients with aortic neck circumferential thrombus are at high risk for aortic neck enlargement after endoluminal repair of AAA.