Search

Wounds in diabetic patients with peripheral arterial disease (PAD) may be poorly responsive to revascularization and conventional therapies. Background/Objective : This study's objective is to analyze the results of regenerative cell therapy with peripheral blood mononuclear cells (PBMNCs) as an adjuvant to revascularization. Methods: This study is based on 168 patients treated with endovascular revascularization below the knee plus three PBMNC implants. The follow-up included clinical outcomes at 1-2-3-6 and 12 months based on amputations, wound healing, pain, and TcPO2. Results : The results at 1 year for 122 cases showed a limb rescue rate of 94.26%, a complete wound healing in 65.59% of patients, and an improvement in the wound area, significant pain relief, and increased peripheral oxygenation. In total, 64.51% of patients completely healed at 6 months, compared to the longer wound healing time reported in the literature in the same cohort of patients, suggesting that PBMNCs have an adjuvant effect in wound healing after revascularization. Conclusions : PBMNC regenerative therapy is a safe and promising treatment for diabetic PAD. In line with previous experiences, this registry shows improved healing in diabetic patients with below-the-knee arteriopathy. The findings support the use of this cell therapy and advocate for further research.

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

Objective: Postoperative delirium (POD) is a common complication with a high health-related impact. The creation of a model (Siena posTopeRative dElirium in vaScular Surgery) to identify high-risk patients with consecutive prompt diagnosis and correct management., Methods: This is an observational retrospective study to evaluate POD incidence in patients who underwent elective vascular surgery procedures between 2018 and 2020. POD was detected using CAM and defined as the onset of an acute confusional state, clinically manifesting as a disturbed state of consciousness, cognitive dysfunction, or alteration in perception and behavior. The total population was divided in the development and validation subsamples. Multivariable logistic regression analysis was performed, identifying variables related to the occurrence of POD. An additive score was created and the STRESS score was internally validated using the Validation subgroup., Results: A total of 1067 patients were enrolled. POD occurred in 111 cases (10.4%). Multivariable logistic regression analysis for POD occurrence revealed as significant predictors: age>75 years, CKD, dyslipidaemia, psychiatric disease, CAD, hospitalization in the previous month, preoperative NLR >3.59, preoperative Hb < 12 g/dl, preoperative Barthel score <75, major amputation, CLTI revascularization, general anesthesia, and postoperative urinary catheter. These variables were used to create the STRESS score. The model was applied to both development and validation subgroups; AUC was respectively 0.7079 ( p < .0001) and 0.7270 ( p < .0001)., Conclusion: The STRESS score has a good predictive potentiality for POD occurrence in elective vascular surgery procedures. However, implementation and external validation are needed to be correctly used in everyday clinical practice., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: In this study, we evaluated the role of preoperative inflammatory markers as Neutrophil-to-Lymphocyte (NLR) and Platelet-to-Lymphocyte (PLR) ratios in relation to post-endovascular aneurysm repair (EVAR) sac shrinkage, which is known to be an important factor for abdominal aortic aneurysm (AAA) healing., Methods: This was a single-center retrospective observational study. All patients who underwent the EVAR procedure from January 2017 to December 2020 were eligible for this study. Pre-operative blood samples of all patients admitted were used to calculate NLR and PLR. Sac shrinkage was defined as a decrease of ≥5 mm in the maximal sac diameter. The optimal NLR and PLR cut-offs for aneurysmal sac shrinkage were obtained from ROC curves. Stepwise multivariate analysis was performed in order to identify independent risk and protective factors for the absence of AAA shrinkage. Kaplan-Meier curves were used to evaluate survival rates with respect to the AAA shrinkage., Results: A total of 184 patients were finally enrolled. The mean age was 75.8 ± 8.3 years, and 85.9% were male (158/184). At a mean follow-up of 43 ± 18 months, sac shrinkage was registered in 107 patients (58.1%). No-shrinking AAA patients were more likely to be older, to have a higher level of NLR and PLR, and be an active smoker. Kaplan-Meier curves highlighted a higher rate of survival for shrinking AAA patients with respect to their counterparts ( p < 0.03). Multivariate analysis outlined active smoking and NLR as independent risk factors for no-shrinking AAA., Conclusions: Inflammation emerged as a possible causative factor for no-shrinking AAA, playing a role in aneurysmal sac remodeling. This study revealed that inflammatory biomarkers, such as NLR and PLR, can be used as a preoperative index of AAA sac behavior after EVAR procedures.

Background: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI., Methods: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up., Results: A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered., Conclusions: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.

Purpose: To describe the early results and mid-term patency rates of external iliac artery (EIA) stenting using self-expanding covered stents., Methods: We conducted a multicenter retrospective study (2015-2021), including patients receiving primary endovascular treatment of external iliac artery occlusive disease with self-expanding covered stents. All patients were treated with the Viabahn (W.L Gore & Associates, Inc., Flagstaff, AZ-USA) stent. Patency and limb salvage rates were estimated with Kaplan-Meier curves., Results: Ninety-three patients (mean age, 69 ± 9 years; 81% males) were treated for disabling claudication in 44%, rest pain in 28%, and tissue loss in 28%. TASC C/D lesions were present in 72% and iliac complete occlusion in 30%. Mean lesion length was 6.9 ± 2.4 cm; 30% had moderate/severe EIA calcifications; and the mean iliac tortuosity index was 1.17 ± 0.13. Technical success was 100%. There was one perioperative death (1.4%) and procedural complication rate was 6.5%. At 42 months (mean, 25 months), primary patency was 89.8% (95%CI 83-98); the presence of EIA tortuosity (tortuosity index > 1.25, 87.7 ± 11% vs 89.9 ± 8%; P = .6) or severe calcifications (87.6 ± 9% vs 96.0 ± 8%; P = .400) had no significant impact. After univariate analysis, the use of a stent with diameter < 8 mm (HR 8.5, 95%CI 3.24-14.22; P < .001) was negatively associated with primary patency., Conclusions: The use of self-expanding covered stents provided excellent early and mid-term results in the treatment of obstructive disease of the EIA, also in cases of high EIA tortuosity and high grade of calcifications. The use of a < 8 mm-diameter stent was associated with a reduced primary patency., (© 2023. The Author(s).)

Background: We present a standardized protocol of endovascular revascularization for patients with acute limb ischemia due to popliteal artery aneurysm (PAA) thromboembolic complication, based on the combination of vacuum-assisted thromboaspiration to improve tibiopedal outflow and covered stent graft to exclude the PAA., Methods: All patients with a diagnosis of PAA complicated by thromboembolic events undergoing total endovascular rescue were prospectively enrolled in a dedicated database from November 2018 to November 2021. To assess vessel patency, the TIPI (Thromboaspiration In Peripheral Ischemia) classification was used. The primary end point was the primary technical success (at least one tibial vessel with a TIPI flow of 2 or 3). The 30-day overall mortality and amputation rates were considered as secondary end points. Patients' overall survival, limb salvage, freedom from reocclusion and reinterventions were reported as secondary late outcomes using Kaplan-Meier method., Results: Seventeen male patients were enrolled with a mean age of 75.7 ± 9 years. Rutherford grading score was IIa in 52.9% (9/17) and IIb in 47.1% (8/17). PAA mean diameter was 37.4 ± 11.2 mm. All patients had tibial arteries involvement, and in 9 cases (52.9%) there was also the occlusion of the PAA. Mechanical thrombectomy with Indigo/Penumbra thromboaspiration system was used in all patients. PAAs were excluded using one or more VIABAHN covered endografts (range 1-3 pieces). Technical success was achieved in 94.1%. Fasciotomy was performed in 1 case (5.9%). Mortality and amputation rates at 30-day follow-up were respectively 0% and 5.9%. Survival rates at 6, 12, and 24 months were respectively 94.1%, 86.3%, and 67.9%. Secondary patency was achieved in all cases (100%). Freedom from reintervention was 80.4%, 65.8%, and 54.8% at 6-, 12-, and 24-month follow-up. Limb salvage was 88.2% at 6-, 12-, and 24-month follow-up, respectively., Conclusions: Although preliminary, our experience of total endovascular rescue for complicated PAA with thromboembolic events highlighted promising rates of limb salvage at 30 days after intervention. The total endovascular approach seems able to maximize tibiopedal outflow offering an interesting strategy in limb salvage., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Post-operative delirium (POD) is a common complication, especially in elderly patients who underwent vascular surgery procedures. The aim of this study was to evaluate the relation of inflammatory biochemical markers as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and systemic inflammation index (SII) with POD occurrence., Methods: This was a single-center, retrospective, observational study. We analyzed the perioperative data of patients who had undergone elective vascular surgery procedures. The occurrence of delirium after procedure was used to divide the population in two groups: POD-pos and POD-neg group. ROC curves were performed to find the appropriate cut-off values of NLR, PLR and SII. Multivariate analysis was used to identify the independent predictors for POD., Results: A total of 646 patients were enrolled. Mean age was 76.2±9.8 years, 68.4% were male. Seventy-three patients (11.3%) developed POD. Mean hospital stay was significantly increased in the POD-pos group (6.1±5.4 vs 3.2±2.8 days, p=0.0001). In-hospital reinterventions were more frequent in the POD-pos group (8.2% vs 3.8%). Blood values analysis reported significant differences: Hb, NLR, PLR, SII, creatinine and RCP were strongly increased (p<0.05) in the POD-pos group. ROC curves identified cut-off values for NLR>3.57, PLR>139.2 and SII>676.4. Multivariate analysis revealed that age, Renal Failure, peripheral revascularization procedures, major amputation, general anesthesia, hospitalization in the previous month, NLR>3.57 and SII>676.4 were independent risk factors for POD., Conclusion: POD represents a common complication of vascular surgery patients. Our study demonstrated that NLR, PLR and SII are reliable and readily available laboratory predictors of POD in vascular surgery that could help in POD risk-stratification., Competing Interests: The authors have no conflict of interest to declare for this work., (© 2022 Pasqui et al.)

Our aim was to determine the predictive role of the preoperative neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in vascular access malfunctioning in patients who had undergone their first native arterio-venous fistula (AVF) for hemodialysis. Methods: This was a single-center retrospective observational study. All patients who underwent the procedure of the creation of a first native AVF for hemodialysis from January 2019 to December 2020 were considered eligible to be part of this study. Reinterventions for AVF malfunctioning were registered and the population was subdivided into two groups with respect to AVF malfunctioning. ROC curves were obtained to find the appropriate cut-off values for the NLR and PLR. A multivariate analysis was used to identify the independent predictors for an AVF malfunction. Kaplan−Meier curves were used to evaluate the AVF patency rates. A total of 178 patients were enrolled in the study, of them 70% (n = 121) were male. The mean age was 67.5 ± 12 years. Reinterventions for AVF malfunctioning were performed on 102 patients (57.3%). An NLR > 4.21 and a PLR > 208.8 was selected as the cut-off for AVF malfunctioning. The study population was divided into two groups depending on the NLR and PLR values of the individual. For the NLR < 4.21 group, the AVF patency rates were 90.7%, 85.3%, and 84% at the 3-, 6-, and 12-month follow-up, respectively, and 77.5%, 65.8%, and 39.3% at 3, 6, and 12 months for the NLR > 4.21 group, respectively (p < 0.0001). For the PLR < 208.8 group, the patency rates were 85.6%, 76.7%, and 67.7% at the 3-, 6-, and 12-month follow-up. For the PLR > 208.28 group, the patency rates were 80.8%, 71.2%, and 50.7% for the 3-, 6-, and 12-month follow-up, respectively (p = 0.014). The multivariate analysis highlighted that diabetes mellitus, the neutrophil count, the lymphocyte count, and the NLR were independent risk factors for an AVF failure. In our experience, the NLR and PLR are useful markers for the stratification of vascular access failure in hemodialysis patients. The inexpensive nature and ready availability of the values of these biomarkers are two points of strength for everyday clinical practice.

Background: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval., Objective: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience., Methods: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint., Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups., Conclusions: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label., Trial Registration: ClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892., International Registered Report Identifier (irrid): PRR1-10.2196/36995., (©Gianmarco de Donato, Edoardo Pasqui, Pasqualino Sirignano, Francesco Talarico, Giancarlo Palasciano, Maurizio Taurino, ALTAIR collaborators. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.07.2022.)

The metabolic syndrome (MetS) is a cluster of cardiovascular risk factors characterised by central obesity, atherogenic dyslipidaemia, and changes in the circulating lipidome; the underlying mechanisms that lead to this lipid remodelling have only been partially elucidated. This study used an integrated "omics" approach (untargeted whole serum lipidomics, targeted proteomics, and lipoprotein lipidomics) to study lipoprotein remodelling and HDL composition in subjects with central obesity diagnosed with MetS ( vs. controls). Compared with healthy subjects, MetS patients showed higher free fatty acids, diglycerides, phosphatidylcholines, and triglycerides, particularly those enriched in products of de novo lipogenesis. On the other hand, the "lysophosphatidylcholines to phosphatidylcholines" and "cholesteryl ester to free cholesterol" ratios were reduced, pointing to a lower activity of lecithin cholesterol acyltransferase (LCAT) in MetS; LCAT activity (directly measured and predicted by lipidomic ratios) was positively correlated with high-density lipoprotein cholesterol (HDL-C) and negatively correlated with body mass index (BMI) and insulin resistance. Moreover, many phosphatidylcholines and sphingomyelins were significantly lower in the HDL of MetS patients and strongly correlated with BMI and clinical metabolic parameters. These results suggest that MetS is associated with an impairment of phospholipid metabolism in HDL, partially led by LCAT, and associated with obesity and underlying insulin resistance. This study proposes a candidate strategy to use integrated "omics" approaches to gain mechanistic insights into lipoprotein remodelling, thus deepening the knowledge regarding the molecular basis of the association between MetS and atherosclerosis.

Objective: Acute limb ischaemia is still considered a significant event, with considerable early- and long-term amputation and mortality risk. Our study aims to investigate the predictive role of pre-operative neutrophil/lymphocyte and platelet/lymphocyte ratios in terms of mortality and amputation risk in patients with acute limb ischaemia., Methods: Pre-operative blood samples of all patients admitted with acute limb ischaemia were used to calculate neutrophil/lymphocyte and platelet/lymphocyte ratios. Population was subdivided into quartiles by platelet/lymphocyte ratio and neutrophil/lymphocyte ratio values, and Kaplan-Meier life tables were obtained for overall survival and limb salvage. The optimal neutrophil/lymphocyte ratio and platelet/lymphocyte ratio cut-offs were obtained from receiver operating characteristic curves with all-cause mortality and all kinds of amputation. Stepwise multivariate analysis was performed in order to identify independent risk and protective factors for mortality and amputations., Results: A total of 168 patients were included in the analysis. Receiver operating characteristic curves identified cut-off values for neutrophil/lymphocyte ratio and platelet/lymphocyte ratio: neutrophil/lymphocyte ratio ≥5.57 for mortality; neutrophil/lymphocyte ratio ≥6.66 and platelet/lymphocyte ratio ≥269.9 for all amputations. Kaplan-Meier analysis revealed that survival rate in group neutrophil/lymphocyte ratio <5.57 was 83.4%, 78.9%, 73.7%, and 59.8%, respectively, at 12, 24, 36, and 48 months; in neutrophil/lymphocyte ratio ≥5.57 group was 62.4%, 51.3%, 47.8, and 43.7%, respectively ( p  < 0.0001). Freedom from all amputations was significantly higher in case of neutrophil/lymphocyte ratio and platelet/lymphocyte ratio below the identified cut-off values ( p  < 0.0001). Neutrophil/lymphocyte ratio and platelet/lymphocyte ratio were found as independent risk factors., Conclusion: Neutrophil/lymphocyte ratio and platelet/lymphocyte ratio are reliable markers for stratification of mortality and limb amputations in patients with acute limb ischaemia. The inexpensive nature and ready availability of these biomarkers' values reinforced their usefulness in everyday clinical practice.

Objective: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts., Methods: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate., Results: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention., Conclusions: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Anomalies in inferior vena cava represent an uncommon finding with a prevalence of 0. 3 to 0.5% among healthy patients. Specifically, the condition characterized by the agenesis of the inferior vena cava (IVC; AIVC) has been observed among the 0.0005 to 1% of the general population. AIVC is strongly related to deep vein thrombosis (DVT) of the lower limb and pelvic district, especially in young patients. The rarity of the presented condition could relate to an underestimation of its impact on a particular clinical setting leading to a delayed diagnosis and inaccurate early- and long-term management., Report: We presented a case of this anomaly regarding a 31-year-old man presenting with bilateral symptomatic proximal DVT. Duplex vascular ultrasound and subsequent CT-angiography revealed the complete occlusion of the right external and common iliac vein, as well as partial occlusion of the contralateral external iliac vein, in the patient. The exam also revealed the interruption of IVC in its infrarenal part. At the level of renal veins coalescence, IVC appeared again in its usual position. A dilatated portal system, hepatic veins, and azygos and hemiazygos systems were also highlighted. Anticoagulation was promptly started with the administration of Fondaparinux (7.5 mg/die). In addition, compression stocking was initiated within 24 h from diagnosis. After 3 weeks, the anticoagulation regimen was shifted toward the administration of a direct oral anticoagulant (Apixaban; 5 mg two times a day). At 1-month follow-up, a vascular duplex ultrasound revealed a complete resolution of the iliac veins' thrombosis., Conclusion: It is important to consider the eventuality of IVC anomalies in a young adult presenting with unexplained, extensive, or bilateral DVT. Accurate diagnostic evaluation is necessary to fully identify this condition that could represent a real challenge., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Pasqui, de Donato, Camarri, Molinari, Cascinelli, Pelini, Abate and Palasciano.)

Introduction: Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain a satisfactory erection for sexual intercourse. Many studies have highlighted that ED shares common cardiovascular risk factors with cardiovascular disease. No data are reported about the prevalence of ED in patients with the abdominal aortic aneurysm (AAA). The aim of our study was to investigate the preoperative information given about sexual functions of patients undergoing endovascular aneurysm repair (EVAR) and to compare it with the presence and severity of steno-occlusive atherosclerotic lesions of the pelvic arterial tree at pre-operative Computed Tomography Angiography (CTA)., Methods: We prospectively enrolled all men patients who underwent elective EVAR from September to November 2021. Preoperative ED was evaluated using the International Index of Erectile Function (IIEF-5) questionnaire. Preoperative imaging was routinely performed with CTA scan of the abdominal aorta and iliac-pelvic district. An innovative score of pelvic arterial disease associated to AAA was defined, dividing the iliac district in 4 zones attributing a grading of severity for each zone bilaterally (score ranges 0-24). Linear regression analysis was used to correlate IIEF-5 score to anatomical score of pelvic arterial steno-occlusive disease., Results: A total of 25 patients were enrolled. Median age was 74 ± 5.3 years. IIEF-5 average score was 14.8 ± 7.1. Eight cases (32%) had severe ED; one case (4%) had moderate, five patients (20%) had mild to moderate ED; five patients (20%) had mild ED, and 6 (24%) patients had no ED. CTA evaluation revealed an average anatomical score of 7.9 ± 4.5. Pelvic disease was considered moderate-severe in 20 cases (80%) and not significant in 20% (five cases). Linear regression analysis confirmed the hypothesis that a more diseased pelvic arterial tree was correlated to a more severe ED ( Y = -1.531 * × + 26.35 [slope CI : -1.946 to -1.117, p < 0.0001])., Conclusion: Although typically unreported, the prevalence of ED associated to AAA was found to be high. A vasculogenic origin of ED in patients with AAA is plausible and may be easily confirmed by the evaluation of pelvic arterial distribution at angio-CT performed for EVAR planning. Our proposed "MAPPING AND SCORING SHEET" may help to identify the vasculogenic origin of ED in AAA patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 de Donato, Pasqui, Gargiulo, Casilli, Ferrante, Galzerano, Cappelli and Palasciano.)

Introduction: Since 2010, the Ovation Abdominal Stent Graft System has offered a new sealing concept, achieved by a sealing ring filled with polymer 13 mm from the renal arteries. In the latest version, called Ovation Alto, the sealing ring is relocated 6 mm closer to the top of the fabric. This study describes the early clinical outcomes, after CE Mark approval in August 2020, of endovascular aneurysm repair with the Alto endograft., Report: Eleven patients underwent endovascular aneurysm repair with implantation of Ovation Alto endografts. All patients were male, and the median age was 75 (IQR 5.5) years. Hostile proximal aortic neck (<10 mm) was identified in six cases (54.5%). All procedures were performed using bilateral percutaneous approaches with no groin complications. The median procedure time was 58 (IQR 7.2) minutes, the median contrast volume used was 65 (IQR 4.2) mL, and the median blood loss 40 (IQR 12.4) mL. Technical success was achieved in all cases. The median stent graft landing distance between the top of the fabric and the lowest renal artery was 1.4 (IQR 0.8) mm. No intra-operative high flow endoleaks were registered. At one and six month follow up, there was 100% clinical success (no type I/III endoleak, sac enlargement, stent graft migration, polymer leakage, abdominal aortic aneurysm related mortality, or secondary intervention)., Discussion: Initial experience confirms the early technical and clinical success of the new Ovation Alto stent graft. Technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on label. Further studies are needed to evaluate long term durability outcomes., (© 2021 The Authors.)

Intoduction: Familial cerebral cavernous malformations (FCCM) are a rare condition characterized by the multiple presences of cavernous malformations located in the central nervous system., Case Description: We present a case of FCCM incidental diagnosis in a 71-year-old male patient who underwent carotid artery stenting for high-grade carotid artery disease and subsequent reintervention for severe stent restenosis, determining neurological deficit. FCCM diagnosis was made due to the presence of hundreds of cavernous malformations located both in supra- and sub-tentorial regions highlighted by magnetic resonance and confirmed by genetic test for the mutation of the gene KRIT1, inherited also by his son., (© 2021. Fondazione Società Italiana di Neurologia.)

Introduction: Asherson's Syndrome, also defined as Catastrophic Antiphospholipid Syndrome (CAPS), represents the most severe manifestation of Antiphospholipid Antibody Syndrome. Rarely, the first CAPS diagnosis is based on macro-thrombotic event as acute limb ischemia. Case Presentation: We present a case of a 65-year-old woman admitted with an acute lower limb arterial ischemia with a complete occlusion of all the three tibial vessels. Three endovascular recanalization procedures were performed contemporary to 48 h intraarterial thrombolysis administration. The patency of tibial arteries was restored with a near-complete absence of digital arteries and microvessel perfusion of the foot. In the following days, an aggressive foot gangrene was established, leading to a major lower-limb amputation. Due to the general clinical status worsening and aggressiveness of ischemic condition, further investigations were performed leading to the diagnosis of an aggressive Asherson's Syndrome that was also complicated by a severe heparin-induced thrombocytopenia. Medical management with a high dose of intravenous steroids and nine sessions of plasma exchange led to a clinical condition stabilization. Conclusion: In our case, the presence of a "sine causa" acute arterial occlusion of a large vessel represented the first manifestation of an aggressive form of Asherson's Syndrome that could represent a fatal disease. Due to the extreme variety of manifestations, early clinical suspicion, diagnosis, and multidisciplinary management are essential to limit the life-threatening consequences of patients., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Pasqui, Camarri, de Donato, Gonnelli, Palasciano and Gennari.)

The incidence of venous and arterial thromboembolic complications in COVID-19 patients is significant. The vast majority of COVID-19 patients spend their quarantine at home in a self-isolation condition. The occurrence of Acute limb ischemia (ALI) is a dangerous event that needs prompt diagnosis and management with time-dependent recanalization outcomes. We present a case series of three COVID-19 patients who suffered from ALI that occurred during home self-isolation, and that were diagnosed and treated with a significant time-delay due to COVID-19 social implications., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: Device fracture causing intravascular foreign body (IFB) is a rare event during endovascular procedures, with potential catastrophic outcome if not promptly removed. We present two cases of retrieval of fractured devices during peripheral lower limb procedures using three guidewires tangled around the IFB., Techniques: Case 1 was a patient with critical limb ischemia. During balloon angioplasty of a high calcified peroneal artery, the balloon catheter Amphirion Deep 2.5/150 mm (Medtronic) fractured in two pieces, leaving a 20 cm distal part into the artery. Three 0.014" guides were advanced distally the IFB and twisted all together using a single torque-device. It was possible to pull back the long balloon fragment into the popliteal and to reline it inside a 5 French sheath. Case 2 was a patient with acute limb ischemia. During the mechanical thrombo-aspiration using the Indigo System (Penumbra inc.), the distal wire of the olive-shaped separator cracked in the posterior tibial artery. By crossing the IFB with three 0.014" wires and twisting them around it, this 15mm fragment was successfully recaptured., Conclusions: We named this procedure Triple Wire Twisting Technique and, in our experience, this technique is safe and effective to recapture IFB during complex peripheral procedures. This poorly known rescue technique is not complex and requires materials that are available in all cath-lab. We truly believe that physicians can take advantage of knowing it when facing with IFB in any vessel., (Copyright © 2021. Published by Elsevier Inc.)

Objective: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce., Methods: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month., Results: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively., Conclusion: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The novel acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic imposed a national lockdown at the beginning of 2020. People faced social distancing, being forced to stay at home. Peripheral arterial disease (PAD) typically influences life habits and psycho-social relationship. It is now questionable how PAD can be affected by changes in lifestyle imposed by the Sars-CoV-19 Pandemic. This study's main objective is to evaluate how the limitations of social behavior set by Sars-CoV-19 Pandemic impact the perception and evolution of the disease in a group of patients with a diagnosed PAD., Methods: The changes in the in the perception and the evolution of the PAD were evaluated by comparing results of a modified VascuQol-6 quality of life (QoL) survey referring to the time frame defined "No-Sars-CoV-2 period" (from July to December 2019) with results referring to the time frame defined "Sars-CoV-2 period" (from January to June 2020). An overall score (range 4-60) was calculated, and a comparison between the two period studies was reported. Receiver Operating Characteristics (ROC) Curves evaluated a delta value for each patient with revascularization of lower limb peripheral arteries. Optimal cut-offs were chosen based on their specificity, sensitivity., Results: One-hundred-two PAD patients gave their informed consent to take part in the study. A significant general worsening of patients PAD perception in the Sars-CoV-2 period was recorded for the following items: lower limbs health status perception; overall activity limitation; walking ability limitation; overall daily walking distance; lower limbs fatigue perception; concerns about PAD worsening; pain discomfort (P < 0.05). The pain intensity changed from 4.7 ± 2.9 in the No-Sars-CoV-2 period to 6.3 ± 2.9 in the Sars-CoV-2 period significantly (P < 0.0001), even though analgesic drug intake did not increase considerably in Sars-CoV-2 period (P = 0.15). The overall score was 20.3 ± 7.4 for the No-Sars-CoV-2 period and 27.4 ± 7.6 in the Sars-CoV-2 period (P = 0.0001). The ROC curve built to analyze the relation between Delta-score and the need for revascularization identifies a cut-off > 8.5 (Area Under the Curve 0.5436; CI 95% 0.4252 to 0.6620) with a sensitivity and specificity respectively of 52.6% (CI 95% 37.26-67.52%) and 65.6% (CI 95% 53.40-76.08%)., Conclusions: Patients with PAD were significantly hit by all the restrictions and the social limitations imposed to reduce the Sars-CoV-19 virus diffusion. Our study confirms that the perception and the evolution of PAD were significantly affected during the "Sars-CoV-2 period"., (Copyright © 2021. Published by Elsevier Inc.)

We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2, P = 0.04), renal failure (HR = 2.3, P = 0.03), Rutherford class (≥5) (HR = 3.2, P = 0.01), and below-the-knee disease (HR = 2.0, P = 0.05) were significant predictors of amputation; iloprost infusion (>10 vials) (HR = 0.64, P = 0.05) was a significant protective factor. Cilostazol administration (HR = 0.77, P = 0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized. Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.

An abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta that progressively grows until it ruptures. Treatment is typically recommended when the diameter is more than 5 cm. The EVAR (Endovascular aneurysm repair) is a minimally invasive procedure that involves the placement of an expandable stent graft within the aorta to treat aortic disease without operating directly on the aorta. For years, stent grafts' essential design was based on metallic stent frames to support the fabric. More recently, a polymer-based technology has been proposed as an alternative method to seal AAA. This review underlines the two platforms that are based on a polymer technology: (1) the polymer-filled endobags, also known as Endovascular Aneurysm Sealing (EVAS) with Nellix stent graft; and (2) the O-ring EVAR polymer-based proximal neck sealing device, also known as an Ovation stent graft. Polymer characteristics for this particular aim, clinical applications, and durability results are hereby summarized and commented critically. The technique of inflating endobags filled with polymer to exclude the aneurysmal sac was not successful due to the lack of an adequate proximal fixation. The platform that used polymer to create a circumferential sealing of the aneurysmal neck has proven safe and effective.

Background: The role of carotid revascularization in women remains intensely debated because of the lower benefit and higher perioperative risks concerning the male counterpart. Carotid artery endarterectomy (CEA) and stenting (CAS) represent the two most valuable stroke prevention techniques due to large vessel disease. This study investigates the early and late outcomes in female sex in a real-world everyday clinical practice. Methods: Data were retrospectively analyzed from a single-center database prospectively compiled. A total of 234 procedures, both symptomatic and asymptomatic, were identified (98 CEAs and 136 CASs). Perioperative risks of death, cerebral ischemic events, and local complications were analyzed and compared between the two groups. Long-term outcomes were evaluated in overall survival, freedom from ipsilateral stroke/transient ischemic attack, and freedom from restenosis (>50%) and reintervention. Results: Women who underwent CAS and CEA did not differ in perioperative ischemic cerebral events (2.2 vs. 0%, p = 0.26) and death (0.8 vs. 0%, p = 1). Other perioperative and 30-day outcomes were similarly distributed within the two groups. Kaplan-Meier curves between CAS and CEA groups highlighted no statistical differences at 6 years in overall survival (77.4 vs. 77.1%, p = 0.47) of ipsilateral stroke/transient ischemic attack (94.1 vs. 92.9%, p = 0.9). Conversely, significant differences were showed in 6 years freedom from restenosis (93.1 vs. 83.3%, p = 0.03) and reinterventions (97.7 vs. 87.8%, p = 0.015). Conclusion: Our results revealed that both CEA and CAS have acceptable perioperative risk in women. Long-term outcomes highlighted favorable indications for both procedures, especially for CAS, which seemed to be an excellent alternative to CEA in female patients when performed by well-trained operators., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Pasqui, de Donato, Alba, Brancaccio, Panzano, Cappelli, Setacci and Palasciano.)

Objective: In the last decades, life expectancy has increased worldwide considerably. Traditionally, very elderly patients have been considered too frail to undergo major vascular interventions. Considering that abdominal aortic aneurysm is an age-related disease, there is an increasing need of a correct management of the disease even in nonagenarians, but data are still scarce. The purpose of this single-centre study is to report early and mid-term outcomes of all-comer abdominal aortic aneurysm patients in their 10th decades of age., Methods: A retrospective review of our prospectively maintained database identified a total of 33 patients aged ≥ 90 presenting with abdominal aortic aneurysm between 2014 and 2019. Elective and emergency repairs were both considered. Early technical success and mortality rate at 30 days were considered as primary outcomes. Mid-term clinical success was reported, and overall survival, freedom from aneurysm-related death, re-interventions and endoleaks were estimated with the Kaplan-Meier method, stratified for elective of emergency repair and type of treatment., Results: The mean age was 91.7 (range 90-96), and 63.6% were male. Mean abdominal aortic aneurysm diameter was 67.4 ± 16.8 mm. Sixteen patients were admitted for rupture abdominal aortic aneurysm: three untreated, five underwent open and seven underwent endovascular aneurysm repair (EVAR), with an early mortality rate of 100, 100 and 42.8%, respectively. Eighteen (60%) patients were asymptomatic, and all underwent elective EVAR, with an early mortality rate of 0%. At one-month follow-up, clinical success was 84% in EVAR group. At a median follow-up of 22.4 ± 14.5 months, no abdominal aortic aneurysm-related death was registered. Freedom from all cause of mortality was 77.3, 59.4 and 40.7% at one, two and three years. Freedom from endoleaks was 95.4% at one month and 61.7% at one and three years. Freedom from reintervention was 85.8% at three years., Conclusion: Elective EVAR in nonagenarians is associated with acceptable early and mid-term outcomes. Age by itself should not be considered an exclusion criterion for treatment.

Background: Cranial and cervical nerve (CCN) injury is recognized as a possible complication after carotid endarterectomy (CEA), which may result in minor local neurologic deficiencies and significant discomfort for the patient. The aim of this study is to investigate the effect of a mini-skin incision (<5 cm) on the CCN injury after CEA in comparison to standard longitudinal incision of 12-15 cm in a high volume center, and to evaluate health-related quality of life (HRQOL) outcomes in those patients who had undergone both types of the skin incision., Methods: From January 2013 to December 2019, 446 CEAs (47.3%) were performed through a standard neck incision of 12-15 cm (group A), while 496 (52.7%) were performed through a mini-skin incision (<5 cm) (group B). Sixty-two patients underwent standard neck incision on one side and mini-skin incision on the other side (subgroup B). The main outcome measures were stroke, death, CCN injuries, cervical hematoma rates, and reinterventions. The HRQOL was assessed at baseline and after 30 days using Medical Outcomes Study Short-Form 36 and 6 disease-specific modified Likert scales., Results: The stroke and death rate at 30 days was 1.12% in group A and 1% in group B (P = 1). The incidence of CCN deficits was significantly lower in group B (5.1%) in comparison to group A (13.4%) (P < 0.001). The cervical hematoma was more common after standard incision (4.9% vs. 1.2%, P = 0.02). HRQOL at 1 month showed that the outcomes after mini-skin incision were significantly better for less difficulty with eating/swallowing and neck pain (P < 0.01)., Conclusions: CEA through a small incision (<5 cm) may reduce CCN complications without additional perioperative neurologic risks. As validated by patients with bilateral disease who experienced both surgical techniques, mini-skin incision is also associated with better HRQOL at 1 month, particularly with regard to eating/swallowing and neck pain., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: The objective of this study was to compare outcomes of patients with favorable neck angulation (FNA) and hostile neck angulation (HNA) treated with the Treovance stent graft (Terumo Aortic [formerly Bolton Medical], Sunrise, Fla)., Methods: Patients with abdominal aortic aneurysms suitable for endovascular repair with Treovance were included in the RATIONALE postmarket surveillance registry. A post hoc subgroup analysis compared patients with infrarenal neck angles <60 degrees (FNA) and ≥60 degrees (HNA)., Results: After 1 year, 179 FNA (89.5%) and 21 HNA (10.5%) patients were analyzed. Both groups were similar in terms of sex (male, 92.7% FNA and 95.2% HNA) and age (73.0 years vs 72.6 years), but the HNA group had more Asian or other race representation (7.3% vs 19.0%) and more patients assigned to American Society of Anesthesiologists class 3 and class 4 (57.6% vs 66.7%). Mean suprarenal angles (standard deviation) were 13.1 (±13.5) degrees vs 29.0 (±16.4) degrees; mean infrarenal angles were 23.2 (±16.4) degrees vs 65.4 (±4.6) degrees, respectively. Aneurysm sac size maximum diameter was 58.1 (±9.8) mm vs 62.0 (±14.1) mm. There was a significant difference in unplanned adjunctive procedures (2.2% vs 19.0%; P = .01). Mean procedural duration was also significantly different for HNA patients, who underwent protracted operations (111.3 [±47.3] minutes vs 153.5 [±44.5] minutes; P < .0001). However, there were no significant differences in rates of clinical success (96.1% vs 95.2%). The rate of reintervention was low overall but 0% in the HNA group. Changes in sac size at 1 year were significant in both groups but not as pronounced in HNA patients (relative change of -11.8% [±13.3] vs -6.6% [±11.4])., Conclusions: Patients with high neck angulation treated with Treovance underwent more complex procedures but showed equally good technical success and 1-year clinical success parameters., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: In cases of juxtarenal abdominal aortic aneurysm (jAAA), endovascular aneurysm repair (EVAR) involves the use of custom-made fenestrated stent grafts, which usually need large-diameter access vessels, superior costs, and a certain time between graft planning and delivery. We report our preliminary experience using the bare renal stent technique (called vent) in combination with the ultralow-profile stent graft Ovation (Endologix, Irvine, Calif) to seal jAAAs in patients evaluated to be unfit for open surgery and not suitable for fenestrated endograft., Methods: A single-center retrospective review of jAAAs treated by Ovation vent technique from January 2015 to December 2018 was conduced. The vent procedure consisted of a modified, off-label deployment of the sealing ring of the ultralow-profile Ovation stent graft close to renal orifices in combination with short bare-metal stents. The exclusion criterion was a diameter >31 mm at the level of the lowest renal artery. Early technical and clinical results, estimated midterm survival, renal artery patency, freedom from type IA endoleak, freedom from reintervention, and freedom from neck enlargement (>2 mm) were reported., Results: Overall, 38 patients had jAAA and were considered unfit for open repair and not eligible for fenestrated EVAR. The proximal neck was <5 mm in all cases (mean, 3.3 ± 1.2 mm). Vent renal stents were implanted bilaterally in 16 patients. Primary technical success was 94.7% (36/38), with satisfactory cannulation of all renal arteries and sealing of the aneurysm in all but two cases because of type IA endoleaks that were treated immediately with success. Primary clinical success at 1 month was 100%. During a median follow-up period of 22.4 ± 3.6 months (range, 1-46 months), no abdominal aortic aneurysm-related deaths occurred, and no patient was lost to follow-up. The survival curve at 1 year and 2 years was, respectively, 96.4% and 91.6% (standard error, 0.57%). There were no cases of neck dilation or endograft migration. Freedom from reintervention at 12 months and 24 months was 100% and 89.5%, respectively (standard error, 0.7%); freedom from type IA endoleak was 100% and patency of the renal artery was 100% at 2 years., Conclusions: The described technique includes the use of a low-profile stent graft with a polymer ring sealing technology combined with bare renal stents that are not competing for the same room. This early experience shows that the vent technique is safe and feasible and increases the range of treatment of those patients with jAAA who are unfit for open repair and for fenestrated EVAR because of several anatomic constraints., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction : Optical Coherence Tomography (OCT) is an intravascular imaging providing high-resolution images of morphological features of arterial wall. Nowadays, OCT is an accepted intravascular modality to study coronary arteries, stent implantation, and vessel injury. In the last decade, an increasing interest have been focused on the application of OCT in carotid arteries. Areas covered : Literature evidence in the application of OCT in carotid arteries still remains debated. So far, OCT has been used as a research tool, aiming to evaluate atherosclerotic plaques' features and stents' behavior after implantation. This paper is intended to summarize clinical evidences and practices in the use of OCT in carotid arteries district and during CAS procedures. Literature review was completed via Pubmed search using Keywords. Expert opinion : CAS is a safe and effective procedure when performed by trained physicians with a tailored approach. In this scenario, ambiguous pictures at ultrasound, angiography, and IVUS might be clarified using OCT.By providing unprecedented microstructural information on atherosclerotic plaques, OCT may identify the features of vulnerable carotid plaque and, by identifying possible defects after stent implantation as malapposition and plaque prolapse, it may help the tailoring approach to CAS.

Foot ulcers associated with Diabetes mellitus require immediate attention due to risk of amputation if left untreated. Herein we focus on the mitigating risk factors and physiopathology of the diabetic foot, recounting our own surgical approach and revascularization procedures.

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.

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: 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.)

Background: The comparative effectiveness of treatment with angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or their combination in people with albuminuria and cardiovascular risk factors is unclear., Methods: In a multicenter, randomized, open label, blinded end point trial, we evaluated the effectiveness on cardiovascular events of ACE or ARB monotherapy or combination therapy, targeting BP<130/80 in patients with moderate or severe albuminuria and diabetes or other cardiovascular risk factors. End points included a primary composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for cardiovascular causes and a revised end point of all-cause mortality. Additional end points included ESRD, doubling of serum creatinine, albuminuria, eGFR, BP, and adverse events., Results: Because of slow enrollment, the trial was modified and stopped 41% short of targeted enrollment of 2100 participants, corresponding to 35% power to detect a 25% reduced risk in the primary outcome. Our analysis included 1243 adults, with median follow-up of 2.7 years. Efficacy outcomes were similar between groups (ACE inhibitor versus ARB, ACE inhibitor versus combination, ARB versus combination) as were rates of serious adverse events. The rate of permanent discontinuation for ARB monotherapy (6.3%) was significantly lower than for ACE inhibitor monotherapy (15.7%) or combined therapy (18.3%)., Conclusions: Patients may tolerate ARB monotherapy better than ACE inhibitor monotherapy. However, data from this trial and similar trials, although as yet inconclusive, show no trend suggesting differences in mortality and renal outcomes with ACE inhibitors or ARBs as dual or monotherapy in patients with albuminuria and diabetes or other cardiovascular risk factors., (Copyright © 2018 by the American Society of Nephrology.)

Aims: Metabolic syndrome (MS) is a cluster of cardio-metabolic risk factors associated with atherosclerosis and low-grade inflammation. Using unbiased expression screenings in peripheral blood mononuclear cells, we depict here a novel expression chart of 678 genes and 84 microRNAs (miRNAs) controlling inflammatory, immune and metabolic responses. In order to further elucidate the link between inflammation and the HDL cholesterol pathway in MS, we focussed on the regulation of the ATP-binding cassette transporter A1 (ABCA1), a key player in cholesterol efflux (CE)., Methods and Results: ABCA1 mRNA levels are suppressed in CD14+ cells of MS patients and are negatively correlated to body mass index (BMI), insulin-resistance (HOMA-IR) and cardiovascular risk, and positively to HDL cholesterol and CE. miRNA target in silico prediction identified a putative modulatory role of ABCA1 for the nuclear factor kappa-light-chain-enhancer of activated B cell (NF-κB) target miR-9-5p, whose expression pattern was up-regulated in CD14+ cells of MS patients, positively correlated to BMI, HOMA-IR, and triglycerides, and negatively to ABCA1 mRNA levels, HDL cholesterol and CE. Ectopic gain and loss of miR-9-5p function in macrophages modulated ABCA1 mRNA and protein levels, ABCA1 miRNA 3'-untranslated region target sequence reporter assay, and CE into HDL, thus confirming ABCA1 as a target of miR-9-5p., Conclusions: We identified the NF-κB target miR-9-5p as a negative regulator of ABCA1 adding a novel target pathway in the relationship between inflammation and HDL-driven reverse cholesterol transport for prevention or treatment of atherosclerosis in MS.

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.)

Celiac disease (CD) is a systemic disorder characterized by an immune-mediated reaction to gluten and a wide spectrum of clinical manifestations. Currently, the main treatment of CD is represented by adherence to a gluten-free diet (GFD) which determines the resolution of symptoms, and the normalization of the serology and of the duodenal villous atrophy. In the present study, we aimed to identify changes in gene expression in peripheral blood mononuclear cells (PBMCs) of celiac patients on GFD for at least 2 years, in order to identify novel disease biomarkers and candidate targets for putative therapeutic approaches. Microarray analysis was performed on PBMCs from 17 celiac patients on long-term GFD and 20 healthy controls. We identified 517 annotated genes that were significantly modulated between celiac patients and controls. Significant biological pathways were functionally clustered using the Core Function of Ingenuity System Pathway Analysis (IPA). Intriguingly, despite being on a GFD, celiac patients exhibited a peculiar PBMC profile characterized by an aberrant expression of genes involved in the regulation of immunity, inflammatory response, metabolism, and cell proliferation. Random forest algorithm was then used to validate the prediction ability of core genes as classifiers of the "celiac status". In conclusion, our study identified a characteristic PBMCs signature profile in clinically asymptomatic celiac patient., Competing Interests: The authors have declared that no competing interests exist.

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.)

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: Familial Mediterranean Fever (FMF) is an autosomal recessive autoinflammatory disorder characterised by recurrent attacks of fever and serositis (peritonitis, pleuritic or synovitis) affecting mainly populations of Mediterranean origin., Aim: To describe a relatively new cluster of FMF subjects from Apulia and Basilicata regions (southern Italy)., Patients and Methods: Subjects were screened for FMF using the Tel-Hashomer criteria and genetic analysis. Demographic data were taken from patients' files and direct interviews. Patients were investigated about attack duration, intensity and site, body temperature, skin manifestations and overall quality of life before and after treatment with colchicine. Inflammatory parameters were also measured between these periods., Results: Forty-nine subjects had FMF (M : F = 26 : 23, age 38 years ± 2 SE) and followed-up up to 8 years. The age at disease onset was 22·1 years ± 1·2SE and the diagnostic delay was 15·5 years ± 1·9SE. The majority of patients (82%) suffered from abdominal pain, and 35% had undergone prior abdominal surgery or laparotomy. Severity score (ISSF) was mild in 43% of patients and intermediate in 57% of patients. Serum amyloid A (SAA) was increased in 20% of patients (16·9 ± 3·7, normal range < 6·4 mg/dL). In over 95% of patients, inflammation markers, duration and intensity of febrile painful attacks, quality of life and ISSF score improved dramatically following colchicine treatment., Conclusion: The Apulia region represents a new endemic area for FMF. Clinical presentation of FMF can be misleading and requires a complete and early workup to recognise the disease and avoid unjustified surgery. Colchicine remains the gold standard therapy to prevent FMF attacks and fatal long-term complications., (© 2017 Stichting European Society for Clinical Investigation Journal Foundation.)

Inflammatory pseudotumor (IPT) of the liver is a rare, benign lesion of unclear etiology, which may be misdiagnosed as hepatocellular carcinoma, cholangiocarcinoma, secondary tumor or abscess, because of its non-specific clinical, biochemical and radiologic findings. We present the case of a 48-old-year male in whom diagnosis of liver IPT was suspected by contrast enhanced ultrasound (CEUS) and confirmed by fine-needle liver biopsy. The diagnosis is in contrast to most of the literature reports in which the diagnosis was made only based on a surgical specimen., Learning Points: The inflammatory pseudotumor (IPT) of the liver is a rare benign disease that may be misdiagnosed as a malignant primary or secondary tumor.The diagnosis of IPT may be improved by the use of contrast enhanced ultrasound (CEUS) and the fine-needle liver biopsy without surgical intervention.The therapy of IPT may be monitored by ultrasonography (US) and CEUS., Competing Interests: Conflicts of Interests: The Authors declare that there are no competing interests.

The Mediterranean diet (MeD) is believed to promote health; nevertheless, changes in the nutritional patterns in the Mediterranean area (increased intake of refined carbohydrates/saturated fats; reduced fibers intake; main calorie load shifted to dinner) led to reduced MeD benefits in recent decades. We retrospectively investigated the effects of a MeD with a low intake of refined carbohydrates in the evening ("MeDLowC") on body weight (BW) and metabolic profile of overweight/obese subjects. According to their adherence to MeDLowC, subjects were classified into 44 (41%) individuals with "excellent" adherence and 63 (59%) with "poor" adherence. Nutritional counseling induced an improvement in BW, glucose metabolism and liver transaminases in both groups, with an increased magnitude of these effects in the "Excellent" adherence group. "Excellent" adherence to MeDLowC improved insulin sensitivity and lipid metabolism. In conclusion, MeD with a restriction of carbohydrates in the evening significantly ameliorates obesity and associated metabolic complications.

Extra virgin olive oil (EVOO) consumption has been associated with reduced cardiovascular risk but molecular mechanisms underlying its beneficial effects are not fully understood. Here we aimed to identify genes and miRNAs expression changes mediated by acute high- and low-polyphenols EVOO intake. Pre- and post-challenge gene and miRNAs expression analysis was performed on the peripheral blood mononuclear cells (PBMCs) of 12 healthy subjects and 12 patients with metabolic syndrome (MS) by using microarray and RT-qPCR. In healthy subjects, acute intake of EVOO rich in polyphenols was able to ameliorate glycaemia and insulin sensitivity, and to modulate the transcription of genes and miRNAs involved in metabolism, inflammation and cancer, switching PBMCs to a less deleterious inflammatory phenotype; weaker effects were observed in patients with MS as well as in healthy subjects following low-polyphenol EVOO challenge. Concluding, our study shows that acute high-polyphenols EVOO intake is able to modify the transcriptome of PBMCs through the modulation of different pathways associated with the pathophysiology of cardio-metabolic disease and cancer. These beneficial effects are maximized in healthy subjects, and by the use of EVOO cultivars rich in polyphenols. Nutrigenomic changes induced by EVOO thus legitimate the well-known beneficial effects of EVOO in promoting human health and, potentially, preventing the onset of cardiovascular disease and cancer., (Copyright © 2016. Published by Elsevier B.V.)

Previous studies have shown the antiinflammatory, antioxidant and antiangiogenic properties by pure olive oil polyphenols; however, the effects of olive oil phenolic fraction on the inflammatory angiogenesis are unknown. In this study, we investigated the effects of the phenolic fraction (olive oil polyphenolic extract, OOPE) from extra virgin olive oil and related circulating metabolites on the VEGF-induced angiogenic responses and NADPH oxidase activity and expression in human cultured endothelial cells. We found that OOPE (1-10 μg/ml), at concentrations achievable nutritionally, significantly reduced, in a concentration-dependent manner, the VEGF-induced cell migration, invasiveness and tube-like structure formation through the inhibition of MMP-2 and MMP-9. OOPE significantly (P<0.05) reduced VEGF-induced intracellular reactive oxygen species by modulating NADPH oxidase activity, p47phox membrane translocation and the expression of Nox2 and Nox4. Moreover, the treatment of endothelial cells with serum obtained 4 h after acute intake of extra virgin olive oil, with high polyphenol content, decreased VEGF-induced NADPH oxidase activity and Nox4 expression, as well as, MMP-9 expression, as compared with fasting control serum. Overall, native polyphenols and serum metabolites of extra virgin olive oil rich in polyphenols are able to lower the VEGF-induced angiogenic responses by preventing endothelial NADPH oxidase activity and decreasing the expression of selective NADPH oxidase subunits. Our results provide an alternative mechanism by which the consumption of olive oil rich in polyphenols may account for a reduction of oxidative stress inflammatory-related sequelae associated with chronic degenerative diseases., (Copyright © 2015 Elsevier Inc. All rights reserved.)