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Nowadays patients affected by deep vein thrombosis (DVT) and pulmonary embolism (PE) are studied widely but the challenge for physicians is when and how they are to be treated. Most patients present serious comorbidities that can potentially make treatment difficult. An increasing cohort of patients cannot be treated with systemic fibrinolysis but fortunately today, physicians can utilize a number of different instruments to resolve acute DVT and PE.

Purpose: To evaluate if jugular vein flow restoration in various venographic defects indicative of chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis (MS) patients can have positive effects on cerebral lesions identified using magnetic resonance imaging (MRI)., Materials and Methods: The Brave Dreams trial ( ClinicalTrials.gov identifier NCT01371760) was a multicenter, randomized, parallel group, double-blind, sham-controlled trial to assess the efficacy of jugular venoplasty in MS patients with CCSVI. Between August 2012 and March 2016, 130 patients (mean age 39.9±10.6 years; 81 women) with relapsing/remitting (n=115) or secondary/progressive (n=15) MS were randomized 2:1 to venography plus angioplasty (n=86) or venography (sham; n=44). Patients and study personnel (except the interventionist) were masked to treatment assignment. MRI data acquired at 6 and 12 months after randomization were compared to the preoperative scan for new and/or >30% enlargement of T2 lesions plus new gadolinium enhancement of pre-existing lesions. The relative risks (RR) with 95% confidence interval (CI) were estimated and compared. In a secondary assessment, venograms of patients who underwent venous angioplasty were graded as "favorable" (n=38) or "unfavorable" (n=30) for dilation according to the Giaquinta grading system by 4 investigators blinded to outcomes. These subgroups were also compared., Results: Of the 130 patients enrolled, 125 (96%) completed the 12-month MRI follow-up. Analysis showed that the likelihood of being free of new cerebral lesions at 1 year was significantly higher after venoplasty compared to the sham group (RR 1.42, 95% CI 1.00 to 2.01, p=0.032). Patients with favorable venograms had a significantly higher probability of being free of new cerebral lesions than patients with unfavorable venograms (RR 1.82, 95% CI 1.17 to 2.83, p=0.005) or patients in the sham arm (RR 1.66, 95% CI 1.16 to 2.37, p=0.005)., Conclusion: Expanded analysis of the Brave Dreams data that included secondary/progressive MS patients in addition to the relapsing/remitting patients analyzed previously showed that venoplasty decreases new cerebral lesions at 1 year. Secondary analysis confirmed the efficacy of the Giaquinta grading system in selecting patients appropriate for venoplasty who were more likely to be free from accumulation of new cerebral lesions at MRI.

Objective: The aim of our study was to identify patients' characteristics that predicted a higher chance of arteriovenous graft patency in patients undergoing Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) implantation for hemodialysis access. The GHVG is a polytetrafluroethylene (PTFE) prosthesis with a nitinol-reinforced section (NRS) at the venous end., Methods: All consecutive patients undergoing GHVG implantation for hemodialysis access at 10 tertiary referral centers between December 2013 and January 2018 were included in the study and compared with a control group of patients undergoing standard PTFE graft implantation. Selection of patients for hybrid graft implantation was based on the impossibility of autogenous vascular access creation., Results: There were 145 patients included in the GHVG group and 218 in the PTFE group. In the GHVG and the PTFE groups, the mean age was 67 ± 13 years and 65 ± 13 years, and male patients totaled 52% and 46%, respectively. The technical success was 99%. The mean duration of the intervention was 100 minutes (median, 95 minutes; interquartile range, 80-120 minutes). The brachial-axillary configuration was used in the majority of cases (n = 78 [54%]). The 5-cm NRS length was prevalent (n = 108 [75%]). The median NRS oversize was 14% (interquartile range, 0%-21%). Mean follow-up was 13 months (range, 0-55 months). Seventy-one patients (49%) underwent at least one reintervention. Primary, assisted primary, and secondary patency estimates at 12 months were 44% ± 5%, 47% ± 5%, and 65% ± 4% for the GHVG group and 41% ± 4%, 53% ± 4%, and 75% ± 3% for the control group, respectively (P = NS). One-year survival was 90% ± 3%. On multivariable Cox regression analysis, hypotension (P < .001; hazard ratio [HR], 5.8; confidence interval [CI], 2.6-13) and diabetes (P = .024; HR, 1.9; CI, 1.1-3.2) were significant predictors of GHVG loss. A larger graft size was protective against GHVG loss (P = .042; HR, 0.73; CI, 0.54-0.99). The 10-cm-long graft showed a tendency toward improved patency but did not reach statistical significance (P = .074; HR, 0.48; CI, 0.21-1.07)., Conclusions: Diabetes and hypotension were predictors of loss of hybrid arteriovenous access. Smaller diameters of NRS were more prone to thrombosis, whereas the 10-cm length seemed to perform better than the 5-cm one., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: The purpose of the following research was to provide a systematic survey on the use of additive manufacturing in vascular surgery. The survey focuses on applications of 3D printing in endovascular surgery like endovascular aneurysm repair (EVAR), a quite unexplored application domain. 3D printing is an additive production process of three-dimensional objects starting from a three-dimensional digital model. This kind of manufacturing process is getting great attention in the medical field and new applications have emerged in recent years especially thanks to the combination of additive printing with 3D imaging techniques. The purpose of the study is to reflect on additive manufacturing and its potential as an inclusive manufacturing practice which can provide benefits at economic and societal level., Evidence Acquisition: The article first introduces the use of 3D printing in surgery by summarizing the results of previous reviews which reveal three main usages of 3D printing: anatomic models, surgical tools, implants and prostheses. These studies point out that vascular surgery is still an unexplored field of application of 3D printing. Starting from this result, a new survey was carried out in databases Pubmed, Elsevier, Research Gate and ACM Digital Library for terms related to 3D printing in vascular surgery using the following keywords: 3D printing, vascular surgery, EVAR, aneurysm. The search screened articles published up to 2019 for relevance and practical application of the technology in vascular surgery, in particular the topic is related to the treatment of complex abdominal aortic aneurysm., Evidence Synthesis: Initially 437 records published up to 2019 were found, but then were narrowed down to 29 full-text articles. The findings reveal that in addition to the applications found in the previous studies, new experiments are ongoing related to the use of 3D printing in the "Off label" practice to manually fenestrate the stent to improve the accuracy of the EVAR., Conclusions: Different applications of the use of 3D printing and digital imaging in vascular surgery have been experimented with a different maturity level. Whilst the technology has increased its potential in the latest years, the number of studies documented in the literature is still quite narrow. Further research is necessary to fully test the potential of 3D printing, also in combination with other technologies (e.g. 3D imaging and CNC cutting). Early experimentations show that these technologies have the potential to radically change the vascular surgery practice in the near future, in particular in treatment like EVAR, to improve the planning and therefore the success of the surgery.

Background: The chimney technique has been developed for the treatment of complex aortic aneurysms. We analyzed the midterm to long-term outcomes of this approach from a single-center experience., Methods: From October 2008 to July 2016, 58 patients underwent endovascular aortic aneurysm repair using the chimney technique. Indications for treatment were thoracic aortic aneurysm (TAA) (N.=11), thoracoabdominal aortic aneurysm (TAAA) (N.=2), pararenal aortic aneurysm (PAAA) (N.=15), aortoiliac/isolated hypogastric artery aneurysm (N.=25), type I endoleak after previous TEVAR/EVAR (N.=4), proximal pseudoaneurysm after AAA open repair (N.=1). Elective (82.8%) and emergent (17.2%) procedures were included., Results: The immediate technical success was 100%. Single, double and triple chimneys were performed in 46, 10, and two patients, respectively. Overall, 61 target vessels (three left common carotid arteries, eight left subclavian arteries, three celiac trunks, three superior mesenteric arteries, 19 renal arteries and 25 hypogastric arteries) were involved. Postoperative mortality was 0. No neurologic complications were registered. Primary patency rate of the chimney stent/stent graft was 98.3%. Low-flow type I endoleak was observed in four patients (6.9%). Postoperative chimney graft re-intervention rate was 1.7%. The median follow-up was 32±20 months (range 3-96 months). Overall estimated survival at 12, 50, and 80 months was 100%, 89% and 44%, respectively. Estimated freedom from endoleak at 1, 12, 24, and 36 months was 96.5%, 95%, 95%, and 93%, respectively. One hypogastric artery stent-graft occluded at the 3rd month of follow-up. No reintervention was performed., Conclusions: Our experience with the chimney technique for aortic aneurysms from the aortic arch to the iliac axis shows promising and durable mid- and long-term results. Endograft oversizing, associated with the chimney graft diameter and length choice remain fundamental to reduce the risk of the most frequent procedure complications: type I endoleak and CG occlusion. The wider use of this technique should be justified in patients considered at high risk for open repair and/or not suitable for the custom-made branched/fenestrated endografts.

Background: The postmarket research goal is to assess "generalizability" or "external validity" to see if the early results of clinical trials with investigational devices are reproducible in everyday practice in the real world and the longer term. Registries have an important but ambivalent role in achieving this goal., Methods: Although registries are common, in practice they follow the regulatory processes that appear designed primarily for pharmaceutical clinical trials and confirmatory studies. We review the literature to assess different definitions and the role of registries in the hierarchy of scientific evidence. We analyze common characteristics affecting registry design, implementation, and governance as well as safety reporting and off-label use while describing the experience of setting up an international, prospective registry for an endovascular device used to treat abdominal aortic aneurysms., Results: Key areas in which to distinguish registries from trials are as follows: eligibility, setting (patients and institutions), device configurations and iterations, the use of design and quality "spaces," a focus on systematic quality checks (rather than source data monitoring), open-ended follow-up, flexibility in the definition of end points and sample sizes, data sharing, and publishing commitments., Conclusion: Both clinical trials and registries are essential and complementary research methods and the strengths and weaknesses of each need to be recognized. The specific characteristics of registry research deserve to be acknowledged and safeguarded in the regulations governing clinical investigations with medical devices.

Introduction: Aortic dissections classification systems have always been an argument of debate. It is well known that none of the described classifications is complete and easy at the same time. While the more used classification is currently the Stanford classification, it is clear that type A and B dissections prognosis can dramatically vary, depending on many different characteristics that they can present. The aim of this study was to propose a new severity score system that could reflect the risk of in hospital mortality of acute aortic dissections., Evidence Acquisition: Through a review of the literature, studies describing significant predictors of in hospital mortality of any type of aortic dissection were searched and selected by predefined selection criteria., Evidence Synthesis: Nine studies met the criteria and were finally analyzed. The Odds Ratios of the reported predictors were the basis to the drawing of the score system. Sixteen main in hospital mortality predictors were found, 14 of which described in more than one study. They were combined into a new severity score system that we named VI2TA2 S2C2ORE., Conclusions: This is a simple risk score that we propose as a first assessment risk-evaluating tool. We look forward to validate it and to describe specific in hospital mortality risk ranges once it will be adopted.

Background: Catastrophic events have been correlated to increased incidence of cardio-vascular events, but no correlation between RAA and seismic activities have ever been investigated., Methods: Hospital admissions related to RAA between January 2014 and December 2016 were retrospectively assessed in nine vascular centers of central Italy and correlated with date-matched seismic events. Correlation between RAA presentation and seismic event was first evaluated by Linear Regression analysis. Incidence of RAA events, mortality rate, and type of intervention were analyzed during seismic days (SD) and compared to outcomes during non-seismic days (nSD)., Results: A total of 376 patients were admitted with a diagnosis of RAA, and a total of 783 seismic events were reviewed. Twenty patients died before intervention (untreated). Open surgery was performed in 72.8%, endovascular treatment in 27.2%. General mortality at 30 days was 26.6% (30.5% for open surgery; 21.6% for endovascular treatment; P=0.24). Linear regression analysis between RAA and seismic periods revealed a significant correlation (slope=0.11±0.04, equation: y = 0.1143 x + 3.034, P=0.02). Incidence of RAA was 0.34 event per day during the entire period, 0.32 during nSD and 0.44 during SD (P=0.006). During seismic days, patients with RAA were older (80.5 years during SD vs. 77 years during nSD, P=0.12), were in poorer general condition at admission and remained untreated more frequently (8% SD vs. 4.7% nSD, P=0.3), and had a higher mortality rate at 30 days (46.2% SD vs. 27.2% nSD, P=0.012)., Conclusions: During seismic days, the incidence of RAA is higher in comparison to non-seismic days. Patients with rupture during seismic days have a higher risk of death.

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.

Objective: Staged endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with temporary perfusion of the sac through a branch left unstented or a dedicated branch is a strategy intended to reduce the risk of postoperative spinal cord ischemia (SCI). However, potential complications of this approach are aneurysm sac progression between stages, visceral embolism, and occlusion or displacement of components. We here present the "bare branch" technique, a safe adjunct to TAAA repair in terms of interstage complications., Methods: In the first step, one branch, preferentially the one for the celiac trunk, is stented by a bare stent; in the second step, the bare branch is relined with a covered stent. There were 32 TAAAs (5 type I, 6 type II, 16 type III, 5 type IV) treated by this approach at our center from January 2015 to December 2017 (median follow-up, 13 months [range, 2-24 months]). Data were prospectively collected and retrospectively analyzed. Primary end points were aneurysm sac exclusion and freedom from major adverse events, which included SCI. Secondary end points were freedom from aneurysm growth between the stages and freedom from minor adverse events., Results: Preoperative mean maximum diameter was 68.4 mm; 32 endografts (8 off-the-shelf and 24 custom-made devices) were used. The mean aortic coverage was 364 mm. The mean interval time between the two stages was 10.5 weeks (range, 7-20 weeks). In-hospital mortality was 0%. Type I or type III endoleak rate was 3.2%, whereas one type II endoleak was registered (3.2%). Two patients showed paraparesis, one after the first stage and one after the second stage, both noted at 4/5 on the Tarlov scale, and fully recovered so that the SCI rate was 6.4% with 0% permanent neurologic deficit. Interstage mean maximum diameter was 68.6 mm (P > .05). After the second step, there was an average of 4.7 spinal arteries (standard deviation, 1.4; P < .05) per patient with an increase in visibility and of diameter by 0.7 mm (standard deviation, 0.4 mm)., Conclusions: This is a reproducible adjunct to staged TAAA endovascular repair. The use of a bare branch instead of a branch left completely open has the clear advantage of an easy catheterization in the second step. Furthermore, by having the target vessel stented with a bare stent, the risk of embolism is avoided. In this experience, there was no significant aneurysm sac growth in between the steps. Further comparative studies may determine whether there are different hemodynamic forces with this technique with respect to those already described in the literature., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The aim of this study is to report the Destino-guided branched endovascular aortic repair approach as a valid alternative to catheterization downward branches in complex aortic arch/descending thoracic anatomies., Methods & Results: A 53-year-old woman with Marfan syndrome underwent a thoracoabdominal aortic aneurysm (TAAA) repair for a type III dissecting aneurysm. A custom repair with an endograft having 3 fenestrations (for renal arteries and superior mesenteric artery) and 1 branch for the celiac trunk was planned. The right axillary artery was chronically occluded; the left subclavian artery (LSA) was aneurysmatic. The catheterization of the celiac trunk branch was demanding but ultimately a bare stent was used as a bridging component between the graft and the target vessel, for spinal cord preconditioning. At the 2-month computed tomography angiography, when planning the relining of the bare metal stent, a 1 cm increase in diameter of the LSA aneurysm was documented and therefore a Destino-guided branched endovascular aortic repair was planned. This approach consists of branch catheterization via femoral access using the Destino steerable guiding sheath inside which, after bending, a smaller Cook Flexor is placed to easily deliver the stent, while maintaining stability., Conclusions: The Destino-guided branched endovascular aortic repair is a reproducible and effective alternative to the classic catheterization of side branches via brachial/axillary access allowing their completion from a femoral access., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Acute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis., Objective: The devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions., Methods: This study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month., Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints., Conclusions: These new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future., International Registered Report Identifier (irrid): DERR1-10.2196/9972., (©Gianmarco de Donato, Edoardo Pasqui, Giovanni Giannace, Francesco Setacci, Domenico Benevento, Giancarlo Palasciano, Carlo Setacci, INDIAN Registry Collaborators. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.03.2019.)

Objectives: The aim of this study was to evaluate the clinical efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: The need to minimize the risk for plaque debris prolapsing between stent struts following CAS has resulted in the development of DLS. Small clinical studies evaluating 2 available devices, Roadsaver and CGuard, have been recently published; none of these studies is sufficiently powered to test the role of common risk factors on the occurrence of stroke at 30 days post-CAS., Methods: A search was performed of multiple electronic databases for studies larger than 100 cases of CAS with DLS. Four single-arm prospective studies were identified, and individual patient data were collected. The primary endpoint was the occurrence of stroke at 30 days; secondary endpoints were technical and procedural success, periprocedural stroke, and in-hospital and 30-day rates of death., Results: The Roadsaver and CGuard stents were used in similar proportions, and technical success was achieved in all procedures (100% [n = 556]). There were 6 periprocedural strokes (1.08%; all minor). During 30-day follow-up, there was 1 death (0.17%) from myocardial infarction and 1 additional minor stroke (0.17%). The cumulative 30-day mortality rate was 0.17%, and the incidence of stroke at 30 days was 1.25%. No predictors of stroke at 30 days could be identified., Conclusions: This meta-analysis suggests that DLS can be safely used for CAS, and their use minimizes the incremental risk related to symptomatic status and other risk factors., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose:: To evaluate the safety and performance of the Treovance stent-graft., Methods:: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes., Results:: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related., Conclusion:: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

Background: The treatment of mycotic abdominal aortic aneurysm requires surgery and antimicrobial therapy. Since prosthetic reconstructions carry a considerable risk of reinfection, biological grafts are noteworthy alternatives. The current study evaluated the durability, infection resistance, and midterm outcome of biological grafts in treatment of mycotic abdominal aortic aneurysm., Methods and Results: All patients treated with biological graft in 6 countries between 2006 and 2016 were included. Primary outcome measures were 30- and 90-day survival, treatment-related mortality, and reinfection rate. Secondary outcome measures were overall mortality and graft patency. Fifty-six patients (46 males) with median age of 69 years (range 35-85) were included. Sixteen patients were immunocompromised (29%), 24 (43%) had concomitant infection, and 12 (21%) presented with rupture. Bacterial culture was isolated from 43 (77%). In-situ aortic reconstruction was performed using autologous femoral veins in 30 patients (54%), xenopericardial tube-grafts in 12 (21%), cryopreserved arterial/venous allografts in 9 (16%), and fresh arterial allografts in 5 (9%) patients. During a median follow-up of 26 months (range 3 weeks-172 months) there were no reinfections and only 3 patients (5%) required assistance with graft patency. Thirty-day survival was 95% (n=53) and 90-day survival was 91% (n=51). Treatment-related mortality was 9% (n=5). Kaplan-Meier estimation of survival at 1 year was 83% (95% confidence interval, 73%-94%) and at 5 years was 71% (52%-89%)., Conclusions: Mycotic abdominal aortic aneurysm repair with biological grafts is a durable option for patients fit for surgery presenting an excellent infection resistance and good overall survival., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

The history of the recognition and surgical treatment of lower limb ischemia dates back to the Middle Ages. The twin Saints Comas and Damian were ascribed to have saved a gangrenous limb in the 13 th century and became patrons of future surgeons. The physicians that followed developed the theories of blood flow, anatomy of the arterial circulation, and recognition that occlusive disease was the cause of limb ischemia and gangrene. Innovative physicians developed the techniques of arterial surgery and bypass grafting to restore limb blood flow and allow healing of lesions. In the 1960s, the era of endovascular intervention by the pioneering work of Charles Dotter, who developed techniques to image diseased arteries during a recanalization procedure. The development of guide wires, angioplasty balloons, and stents quickly followed. Management of lower limb ischemia and the diabetic foot will continue to evolve, building on the history and passion of preceding physicians and surgeons., (Copyright © 2019 Elsevier Inc. All rights reserved.)

After the invention of the balloon catheter by Fogarty in 1963, surgical thromboembolectomy was considered the gold standard treatment for many years in patients with acute lower limb ischemia (ALLI). ALLI is a dramatic event, carrying a high risk of amputation and perioperative morbidity and mortality. The evolution of endovascular technologies has resulted in a variety of therapeutic options to establish arterial patency. In the 1970s, Dotter first introduced the idea of clot lysis in the treatment of ALLI, which was modified to catheter-directed thrombolysis, and now clot aspiration techniques. Currently, the majority of ALLI (about 70%) is arterial thrombosis, which generally occurs in the setting of preexisting vascular lesion. This condition is very common in patients with diabetes. Clinical presentation in case of thrombosis on atherosclerotic stenosis (so called "acute on chronic ischemia") may be less severe, but treatment is generally more challenging than ALLI due to embolism, considering the complexity in device trackability through the diseased vessels, potential vessel injury, incomplete revascularization, and need of correction of underlying vascular lesions. Although surgery is still a treatment option, especially for ALLI, endovascular interventions have assumed a prominent role in restoring limb perfusion. In this review, the treatment options for ALLI are detailed from surgical thromboembolectomy to thrombolysis and current endovascular techniques, including mechanical fragmentation, rheolytic thrombectomy, and aspiration thrombectomy. The evolution to endovascular therapies has resulted in improved clinical outcomes and lower rates of morbidity., (Copyright © 2018 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.)

Multicenter clinical trials level 1 evidence favors the application of carotid endarterectomy in symptomatic patients, especially the in the elderly cohort. Carotid artery stenting has been proposed as a possible early alternative in selected patients after onset of ipsilateral neurologic symptoms. It is well known that treatment of acute stroke is time-dependent in patients with acute ischemic stroke caused by high-grade stenosis of the internal carotid artery, but intensive medical treatment in conjunction with intervention to improve stroke severity and clinical outcomes has not been established. Two major clinical concerns exist: (1) the risk of hemorrhagic infarction after cerebral revascularization in the acute stage and (2) application of carotid stenting in the acute embolic stage, which may be associated with continued embolic risk after carotid artery stenting compared to carotid endarterectomy, which removes the symptomatic plaque. This review summarizes the indications and results of early carotid artery stenting after onset of neurologic symptoms, considering the new carotid stents and cerebral protection systems available for clinical use and enhanced stenting techniques., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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.

Background: The aim of this paper was to develop a scoring system to grade the risk of rupture of an abdominal aortic aneurysm (AAA) in individual patients., Methods: Computed tomography angiography of an AAA were coupled with computational fluid dynamics (CFD) evaluation performed using open source software (ElmerSolver, Institute of Technology, Espoo, Finland). CFD criteria studied were: Oscillatory Shear Index (OSI), time averaged wall shear stress (TAWSS) and residence relative time (RRT) on both two-dimensional (2D) and three-dimensional (3D) models. AAA rupture predictors were analyzed and a scoring system was generated using Arabic numerals for all significant variables in order to grade the individual patient risk of rupture., Results: There were 143 patients examined. Ninety-one AAAs (18 ruptured AAAs), and 52 had a non-aneurysmal aorta. The 2D OSI was the best CFD criterion following multivariate analysis and ROC curves evaluation. An AAA was deemed respectively at low, moderate, or high risk of rupture, according to whether the risk score was defined as AAA I (total score <2.3), AAA II (2.3-6.5) or AAA III (>6.5). The only protective factor was found in diabetes (OR=0.775; CI: 0.665-0.902)., Conclusions: The Florence Risk Score for AAA rupture based on this report may be a useful tool to predict AAA rupture. A prospective multicenter registry will need to confirm its validity.

Aims: The aim of this study was to identify the findings (by optical coherence tomography [OCT]) after carotid artery stenting (CAS) with two different types of new-generation mesh-covered stent., Methods and Results: Sixteen consecutive patients undergoing CAS with mesh-covered stents and highdefinition OCT image acquisition were enrolled in the study. Cross-sectional OCT images for the presence of strut malapposition (SM) and plaque prolapse (PP) were evaluated using a proximal or distal embolic protection device (EPD). CGuard stents were used in 11 patients (68.8%) and RoadSaver stents in five (31.2%). With OCT analysis, the incidence of SM was 20.5% for CGuard vs. 26.8% for RoadSaver, p=0.26, and the incidence of PP was 10.8% for CGuard vs. 20.7% for RoadSaver, p=0.05. No neurological complications (stroke/TIA) occurred during the procedural and post-procedural periods., Conclusions: The OCT findings of two different types of mesh-covered stent after CAS were obtained safely. Our work indicates that current mesh-covered carotid stents may show differences in SM and PP. The effect of stent design and implantation technique on OCT findings post CAS, and their relation to longterm clinical outcomes, require further evaluation.

Introduction: Carotid artery stenting (CAS) has recently changed the status in the treatment of the extracranial carotid atheromasic disease. In recent years, evolution in both stents and protection devices as well as in carotid stenting techniques, has resulted in an important reduction in the rate of stroke in patients undergoing CAS procedures. Areas covered: The purpose of this article is reviewing the literature and summarizing the current evidence of the new available materials to underline the importance of the correct choice of the devices during the procedure. Expert commentary: Certainly a key issue in order to limit the periprocedural events to the lowest possible, is to select the appropriate device for the appropriate patient anatomy and clinical syndrome, the so called 'tailored approach'.

Background: The endovascular correction (EC) has emerged in recent years as a possible alternative to surgical revision (SR) in case of bleeding complications after peripheral bypass (PB). The purpose of this study is to evaluate the efficacy and safety of EC compared to SR in case of bleeding complications of PB., Methods: From January 2004 to December 2014, we have submitted 32 patients to surgery for acute bleeding in previous PB (25 venous bypass, in situ or reversed, 6 PTFE bypass and 1 composite bypass). The cause of the bleeding was the dehiscence of proximal anastomosis in 14 patients, the dehiscence of distal anastomosis in 11 patients and the rupture of the graft in 7 patients. All patients postoperatively underwent anticoagulation or antiplatelet therapy, antibiotic therapy and close ultrasound follow-up. Patency rate, limb salvage rate and survival rate in the short term were assessed by Kaplan-Meier curves., Results: Of the 32 patients treated for acute bleeding in previous PB, 11 underwent endovascular correction with a technical success of 100% (no need for reintervention), while in 21 patients a surgical revision was performed. Among the latter, in 4 cases (19.1%) an early bleeding occurred, and endovascular correction was promptly performed solving the bleeding in the absence of sequelae (then a total of 15 patients were treated by endovascular correction). The 12-month patency, limb salvage and survival rates were respectively 71.4%, 88.2% and 88.2% in the SR group and 80%, 93.3% and 100% in the EC., Conclusions: This topic underlines that endovascular correction after peripheral bypass bleeding is an attractive alternative to surgery, but there are still a few data to change the gold standard treatment. Randomized clinical trials comparing the two treatment options are warranted.

Aim: To validate the feasibility of high resolution computed tomography (HRCT) of the lung prior to computed tomography angiography (CTA) in assessing incidental thoracic findings during endovascular aortic aneurysm repair (EVAR) planning or follow-up., Methods: We conducted a retrospective study among 181 patients (143 men, mean age 71 years, range 50-94) referred to our centre for CTA EVAR planning or follow-up. HRCT and CTA were performed before or after 1 or 12 mo respectively to EVAR in all patients. All HRCT examinations were reviewed by two radiologists with 15 and 8 years' experience in thoracic imaging. The results were compared with histology, bronchoscopy or follow-up HRCT in 12, 8 and 82 nodules respectively., Results: There were a total of 102 suspected nodules in 92 HRCT examinations, with a mean of 1.79 nodules per patient and an average diameter of 9.2 mm (range 4-56 mm). Eighty-nine out of 181 HRCTs resulted negative for the presence of suspected nodules with a mean smoking history of 10 pack-years (p-y, range 5-18 p-y). Eighty-two out of 102 (76.4%) of the nodules met criteria for computed tomography follow-up, to exclude the malignant evolution. Of the remaining 20 nodules, 10 out of 20 (50%) nodules, suspected for malignancy, underwent biopsy and then surgical intervention that confirmed the neoplastic nature: 4 (20%) adenocarcinomas, 4 (20%) squamous cell carcinomas, 1 (5%) small cell lung cancer and 1 (5%) breast cancer metastasis); 8 out of 20 (40%) underwent bronchoscopy (8 pneumonia) and 2 out of 20 (10%) underwent biopsy with the diagnosis of sarcoidosis., Conclusion: HRCT in EVAR planning and follow-up allows to correctly identify patients requiring additional treatments, especially in case of lung cancer., Competing Interests: Conflict-of-interest statement: None.

Although proof-based medicine has generated much valid evidence for the drawing up of guidelines and recommendations for best clinical practice in symptomatic and asymptomatic carotid stenosis, whether and when it is better to employ endarterectomy or stenting as the intervention of choice still remain matters of debate. Moreover, guidelines have been targeted up to now to the 'representative' patient, as resulting from the statistical analyses of the studies conducted on the safety and efficacy of both interventions as well as on medical therapy alone. The Italian Stroke Organization (ISO) and Stroke Prevention and Awareness Diffusion (SPREAD) group has thus decided to update its statements for an 8th edition. To this end, a multidisciplinary team of authors representing Italian scientific societies in the neurology, neuroradiology, vascular and endovascular surgery, interventional cardiology, and general medicine fields re-examined the literature available on stroke. Analyses and considerations on patient subgroups have allowed to model the risks/benefits of endarterectomy and stenting in the individual. Accordingly, the guideline's original methodology has been revised to follow the new SIGN (Scottish Intercollegiate Guideline Network) Grade-like approach, integrating it with new considerations on Precision, or Personalized Medicine. Therefore, this guideline offers recommendations on precision medicine for the single patient, and can be followed in addition to the more standard guidelines.

Aims: The miR-17-92 cluster and the HDAC9 gene are involved in inflammatory, apoptotic, and angiogenic processes that are activated in the vulnerable carotid plaque. The aim of this research was to determine whether expression of one or more of the miRs of the miR-17-92 cluster and/or HDAC9 expression could represent biomarkers for patients with unstable atherosclerotic carotid plaques., Materials and Methods: Plasma levels of miRs and HDAC9 expression in peripheral blood were analyzed by real-time PCR in patients with histologically classified stable or unstable plaques., Results: No differences were observed between the two groups., Discussion and Conclusions: Levels of the miR-17-92 cluster in plasma and HDAC9 gene expression in peripheral blood cannot be considered appropriate biomarkers to identify patients with unstable plaques at risk of rupture.

Restenosis is one of the main complications in patients undergoing coronary or peripheral revascularization procedures and is the leading cause for their long-term failures. Cilostazol is the only pharmacotherapy that showed an adequate efficacy for preventing restenosis in randomized, controlled studies after coronary or peripheral revascularization procedures. The present review sums up the main clinical evidence supporting the use of cilostazol after revascularization interventions, focusing on all its benefits, warnings, and administration schedules., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long., Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm)., Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group., Conclusion: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.

Objectives: The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR)., Methods: Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country., Results: Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7)., Conclusions: Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world., (Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

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.

Background: The aim of this study was to compare the adverse effects of iodixanol and iopamidol in terms of patient's discomfort in subjects undergoing carotid artery stenting (CAS)., Methods: We retrospectively analyzed data of all successful CAS procedures performed in our department during a 15-year period study. All patients judged to be collaborative were included. From December 2000 to December 2005, we adopted iopamidol as contrast media (CM), thereafter iodixanol. Any transient unpleasant sensation of bitter taste or warmth perceived by the patient after intra-arterial injection of CM was recorded. Injection-associated discomfort was assessed by visual analog scale (VAS) score. Comparison between the 2 CMs with regard to the overall discomfort was carried out by using the Mann-Whitney test. Spearman correlation was performed to assess the correlation among discomfort, age, and CM used. A univariate analysis was performed for slightly bitter taste and warmth sensation to compare these clinical outcomes and CM used; subsequently, a logistic multivariate analysis regression was performed with the "backward elimination.", Results: Data from 1,633 patients were evaluated. A total of 608 patients underwent CAS procedure using iopamidol, and 1,025 using iodixanol. The total amount of CM used during a single procedure was 85 ± 17 mL/patient (range 60-135). The median VAS value was statistically significantly lower in the iodixanol group than in the iopamidol group (P < 0.001). A significant Spearman correlation coefficient was found between age and discomfort for both CMs used (Spearman rho 0.18 for iodixanol, 0.17 for iopamidol). The univariate analysis showed that patients undergoing CAS with iopamidol had an odds ratio (OR) of 8.48 (P < 0.001) to perceive warmth sensation. When adjusted for age and gender, the multivariate analysis still showed an OR of 8.03. For slightly bitter taste sensation, the crude analysis showed an OR of 1.31 (P = 0.018); adjusting for age and gender, OR became 1.15 and the difference was not statistically significant (P = 0.257)., Conclusions: During CAS, less overall discomfort was reported in patients receiving iodixanol than iopamidol; in terms of warmth sensation, patients undergoing procedure using iopamidol as CM have a higher risk to perceive this clinical symptom than iodixanol. Slightly bitter taste seems to have a statistically significant relation with age and gender, and not with CM used., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Data from randomized controlled trials (RCTs) demonstrated significant differences between carotid artery stenting (CAS) and carotid endarterectomy (CEA) in terms of early neurological outcomes (from 0 to 30 days), although mid- and long-term neurological results are indistinguishable. CAS in symptomatic standard risk patients is coupled with a higher risk of any stroke, and death or any stroke at 30 days, while the rates of disabling or major stroke do not vary remarkably between treatments. Since the micro-embolization through the stent struts is the primary suspected cause of suspected early postoperative neurological complications (i.e., non-disabling stroke), surgical technology has focused on the production of a new generation of stents with a double layer of mesh to reduce the "free area" of the cells, and on new cerebral protection devices. Another major determinant of early negative outcomes is believed to be the intraluminal manipulation occurring during carotid engagement from the aortic arch, the crossing maneuvers at the level of the culprit lesion and vessel trauma during angioplasty. To address these subject matters, new embolic protection devices and innovative strategies have been developed, consequently. This review is designed to furnish the current status of CAS results, to update the ongoing RCTs comparing CAS vs. CEA outcomes, and to recapitulate the features and clinical outcomes for a new carotid stent design, the so called "mesh-stents", and new embolic protection tools.

Endovascular aneurysm repair (EVAR) is largely the most adopted strategy for aneurysmal disease of the aorta. Nevertheless, the high incidence of reintervention makes it difficult to identify EVAR as a definitive solution; in particular, the most frequent indication of reintervention is endoleak, which is defined as persistent flow into the aneurysmal sac from different sources. Several treatment strategies are described. A contemporary literature search was performed with the intent of describing techniques and outcomes of endovascular and open strategies to type I, II, and III endoleak. Described techniques and outcomes were organized by indication (type I, II, and III endoleak) and by type of approach (endovascular, open, and laparoscopic) to give an overview of the current status of the treatment for the three most frequent types of endoleak. Several endovascular means are described in the literature for the treatment of endoleak.

Aims: The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation., Methods and Results: The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use., Conclusions: The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.

Aims: Carotid artery stenting (CAS) is still associated with higher periprocedural cerebrovascular events (CEs) compared to vascular surgery. The Roadsaver carotid artery stent is a double layer micromesh stent which reduces plaque prolapse and embolisation by improving plaque coverage. Its clinical impact on neurological outcome was unknown. The aim of this study was therefore to report the clinical results of a large real-world population from three different centres receiving a Roadsaver stent to treat carotid artery disease., Methods and Results: One hundred and fifty (150) patients (age 74±8 yrs, 75% male, symptomatic 29%) treated with CAS using the Roadsaver carotid stent in three high-volume Italian centres were included in the study. Intraprocedural optical coherence tomography (OCT) evaluation was performed in 26 patients, with an off-line analysis by a dedicated core laboratory. All patients underwent duplex ultrasound and neurological evaluation at 24 hours and at 30 days. CAS was technically successful in all cases (stent diameter: 8.6±0.8 mm, stent length: 25.0±4.5 mm). No in-hospital or 30-day CEs were observed. OCT evaluation detected a low rate of plaque prolapse (two patients, 7.7%). Duplex ultrasound showed stent and external carotid artery patency in all cases both before discharge and at 30-day follow-up., Conclusions: The Roadsaver stent is a safe and promising technology for CAS, with a low percentage of plaque prolapse and good short-term clinical outcome. Larger studies with longer follow-up are necessary to confirm this favourable clinical outcome.