Dexamethasone intravitreal implant in patients with cataract and naïve diabetic macular edema.

PURPOSE: To assess the feasibility and clinical effectiveness of dexamethasone intravitreal implant 0.7 mg (IDI) administered in diabetic patients to prevent the worsening of macular edema. METHODS: Forty eyes of 40 consecutive patients with naïve macular edema secondary to diabetes mellitus who were treated with IDI administered preoperative (Group A: 20 patients) or IDI administered immediately after cataract surgery (Group B: 20 patients). Best-corrected visual acuity (BCVA) and central macular thickness (CMT) changes were evaluated at baseline and at postoperative time points. RESULTS: Follow-up study was 20 weeks. In Group A and B, mean BCVA improved significantly at all post-surgery time points (p < 0.05). In Group A and B, mean CMT decreased significantly at 16 weeks (p = 0.02 and p = 0.004, respectively). At week 20, CMT failed to reach statistical significance in both groups (p = 0.5, group A and p = 0.15, group B). No statistical differences were noted between groups in term of BCVA (with the exception of week 4 for the presence of cataract in Group A), CMT and IOP. CONCLUSIONS: The use of intravitreal dexamethasone implant 1 month prior to scheduled cataract extraction or at the time of phacoemulsification appears to be safe and effective for at least 16 weeks after surgery.

Angiotensin Type 2 and Mas Receptor Activation Prevents Myocardial Fibrosis and Hypertrophy through the Reduction of Inflammatory Cell Infiltration and Local Sympathetic Activity in Angiotensin II-Dependent Hypertension.

Compound 21 (C21), an AT2 receptor agonist, and Angiotensin 1-7 (Ang 1-7), through Mas receptor, play an important role in the modulation of the protective arm of the renin-angiotensin system. The aim of this study was to investigate in an experimental model of angiotensin II-dependent hypertension whether the activation of the potentially protective arm of the renin-angiotensin system, through AT2 or Mas receptor stimulation, counteracts the onset of myocardial fibrosis and hypertrophy, and whether these effects are mediated by inflammatory mechanism and/or sympathetic activation. Sprague Dawley rats (n = 67) were treated for 1 (n = 25) and 4 (n = 42) weeks and divided in the following groups: (a) Angiotensin II (Ang II, 200 ng/kg/min, osmotic minipumps, sub cutis); (b) Ang II+Compound 21 (C21, 0.3 mg/kg/day, intraperitoneal); (c) Ang II+Ang 1-7 (576 µg/kg/day, intraperitoneal); (d) Ang II+Losartan (50 mg/kg/day, per os); (e) control group (physiological saline, sub cutis). Systolic blood pressure was measured by tail cuff method and, at the end of the experimental period, the rats were euthanized and the heart was excised to evaluate myocardial fibrosis, hypertrophy, inflammatory cell infiltration and tyrosine hydroxylase expression, used as marker of sympathetic activity. Ang II caused a significant increase of blood pressure, myocardial interstitial and perivascular fibrosis and myocardial hypertrophy, as compared to control groups. C21 or Ang 1-7 administration did not modify the increase in blood pressure in Ang II treated rats, but both prevented the development of myocardial fibrosis and hypertrophy. Treatment with losartan blocked the onset of hypertension and myocardial fibrosis and hypertrophy in Ang II treated rats. Activation of AT2 receptors or Mas receptors prevents the onset of myocardial fibrosis and hypertrophy in Ang II-dependent hypertension through the reduction of myocardial inflammatory cell infiltration and tyrosine hydroxylase expression. Unlike what happens in case of treatment with losartan, the antifibrotic and antihypertrophic effects that follow the activation of the AT2 or Mas receptors are independent on the modulation of blood pressure.

Position Paper on Young Vascular Surgeons Training of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS): State of the Art and Perspectives.

The Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS) was founded in 2018, with the aim to promote cooperation among vascular professionals within Mediterranean countries. Due to its prominent social and economic impact on national health systems, diabetic peripheral artery was selected as the very first topic to be investigated by the federation. In this second paper, different experiences from delegates of participating countries were shared to define common strategies to harmonize, standardize, and optimize education and training in the Vascular Surgery specialty.

Quantitative Lung Ultrasound: Technical Aspects and Clinical Applications.

Lung ultrasound is increasingly used in emergency departments, medical wards, and critical care units-adult, pediatric, and neonatal. In vitro and in vivo studies show that the number and type of artifacts visualized change with lung density. This has led to the idea of a quantitative lung ultrasound approach, opening up new prospects for use not only as a diagnostic but also as a monitoring tool. Consequently, the multiple scoring systems proposed in the last few years have different technical approaches and specific clinical indications, adaptable for more or less time-dependent patients. However, multiple scoring systems may generate confusion among physicians aiming at introducing lung ultrasound in their clinical practice. This review describes the various lung ultrasound scoring systems and aims to clarify their use in different settings, focusing on technical aspects, validation with reference techniques, and clinical applications.

Sodium-glucose cotransporter 2 inhibition prevents renal fibrosis in cyclosporine nephropathy.

AIMS: Sodium-glucose cotransporter 2 (SGLT2) inhibitors, a new class of antidiabetic drugs, are nephroprotective in case of diabetes, but whether a similar beneficial effect may be detectable also in case of chronic non-diabetic kidney diseases remains still unknown. The aim of this study was to evaluate the effects of empagliflozin, a SGLT-2 inhibitor, on the progression of cyclosporine nephropathy, in the absence of diabetes. METHODS: Sprague Dawley rats (n = 27) have been fed with low-salt diet starting 10 days before the beginning and finished at the end of the experimental period. Cyclosporine-A (CsA, 15 mg/kg/day, intraperitoneal injection, n = 8) and CsA plus empagliflozin (Empa, 10 mg/kg/day, per os, n = 7) were administered for 4 weeks. The control groups were treated with placebo (Control, n = 7) or empagliflozin (Control + Empa, n = 5). Blood pressure (plethysmographic method) was measured at the beginning and at the end of the experimental period. At the end of the experimental protocol, the kidneys were excised for histomorphometric analysis of renal fibrosis and for immunohistochemical evaluation of inflammatory infiltrates (monocytes/macrophages), type I and type IV collagen expression, and tyrosine hydroxylase expression, used as marker of sympathetic nerve activity. RESULTS: CsA-treated rats showed a significant increase (p < 0.01) in blood pressure, which was reduced by administration of empagliflozin (p < 0.05). CsA administration caused an increase in glomerular and tubulo-interstitial fibrosis (p < 0.05), renal inflammatory infiltrates (p < 0.05), type I and type IV collagen expression (p < 0.01), and tyrosine hydroxylase expression (p < 0.01) as compared to the control rats and control + Empa-treated rats. Treatment with empagliflozin in CsA-treated rats reduced glomerular (p < 0.01) and tubulo-interstitial fibrosis (p < 0.05), type I and type IV collagen expression (p < 0.01), inflammatory cell infiltration (p < 0.01) and tyrosine hydroxylase expression (p < 0.05), as compared to rats treated with CsA. CONCLUSION: Empagliflozin administration caused a reduction in blood pressure in CsA-treated rats and showed a protective effect on CsA nephropathy by decreasing renal fibrosis, type I and type IV collagen expression, macrophage infiltration and tyrosine hydroxylase expression. These data suggest that empagliflozin promotes nephroprotection also in non-diabetic kidney disease.

Use of Enoxaparin to Counteract COVID-19 Infection and Reduce Thromboembolic Venous Complications: A Review of the Current Evidence.

The impact of the COVID-19 pandemic has been dramatic worldwide, with China, Italy, and now US at its epicenter. Researchers and clinicians are studying and testing different approaches in the attempt to prevent the infection and minimize its severity. Major efforts are focused on optimizing mechanical ventilation, antiviral, and supportive treatment; however, the role of heparin and low molecular weight (LMW) heparin in this setting has been largely overlooked. This review summarizes the available evidence about the role of heparan sulfate as a key entry mechanism for SARS-CoV-2; the efficacy of heparin and LMW heparin in counteracting its entry into the cell, the recent experimental findings obtained in in vitro studies using the LMW heparin enoxaparin Inhixa®, the role of heparin and LMW heparin in modulating the cytokine storm, and the evidence for the use of LMW heparin in the prevention and treatment of the thromboembolic complications of COVID-19. The available evidence suggests that LMW heparin appears as a promising tool in the treatment of COVID-19. Whether its systematic use is associated with a reduction in complications and ultimately mortality of these patients is being tested in several studies starting worldwide.

Urinary Bladder Test Device to Integrate Basic Ultrasound Training for Nurses.

Ultrasound is a useful tool for integrating clinical assessment with a bedside reliable imaging technique, but it requires adequate training. Ultrasonographic training involves examination performed on human models, in which many pathologic findings are not always readily available for the trainee to observe. The possibility of creating test objects that reproduce pathologic images allows the provision of training courses with those elements that are not always available. Our aims were to describe how to create a urinary bladder test object and to test its image quality and usefulness. Thus, we compared computed volume with the actual filling volume for five different devices to assess their reliability in volume estimation. Moreover, we evaluated the image quality and teaching utility using a 5-point Likert-type questionnaire among a group of learners. Computed bladder volume had excellent correlation with actual filling volume (p < 0.001, R2 = 0.9874). Trainees judged the ultrasound exploration realistic and considered the device useful in understanding ultrasound images and improving ultrasound skills. In conclusion, our device contributes to ultrasound training by providing a realistic ultrasound image, improving image understanding and skill development and allowing reliable bladder volume estimation.

Automated CO2 angiography: Injection pressure and volume settings.

The purpose of this work was to outline some practical rules for pressure and volume settings in automatic CO2 injection angiographic procedures focusing on the iliac arterial system, since, in current clinical practice, each operator uses his personal experience to obtain imaging results which are not always easy to compare. A theoretical model was thus developed and then verified by a mechanical simulator of the aortoiliac vascular system, with constant and pulsatile blood flow. The conditions of forward and reverse flows have been described, both for constant and pulsatile regimens and pressures, flows, and optical images of the bubbles in glass vessels were simultaneously acquired, analyzed and compared. Our results demonstrated that "good" radiological images (adequate to patient's conditions and clinical need) are strictly related to appropriate settings of gas injection pressure and flow, in accordance with two simple operative rules. These rules prescribe that the patient's pressure, the blood flow in the vessel, and the hydraulic resistance of the gas injection line be known: the first two parameters may be estimated, while the third must be experimentally measured. By following these rules, it is possible to obtain the best results for each clinical setting, a more standardized approach and better imaging during angiographic procedures with carbon dioxide as contrast medium.

The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft.

OBJECTIVE: The objective of this study was to evaluate adverse events occurring during the lead period of custom-made fenestrated/branched endograft for juxtarenal/pararenal abdominal aortic aneurysm (j/p-AAA) and thoracoabdominal aortic aneurysm (TAAA). METHODS: Between 2008 and 2017, patients enrolled for custom-made fenestrated/branched endograft repair were prospectively collected. Anatomic, procedural, and postoperative data were retrospectively analyzed. Lead period was defined as the time between the endograft order to the manufacturer and implantation. Aneurysm diameter, target visceral vessel (TVV) severe stenosis (>75% of ostial lumen), and number of planned TVVs were evaluated at preoperative computed tomography angiography. Patency of TVVs was evaluated intraoperatively. Aneurysm rupture and TVV occlusion during the lead period were assessed. RESULTS: There were 141 custom-made fenestrated/branched endograft repairs planned. Of these, 133 patients (male, 87%; age, 73 ± 6 years) with complete available data were considered for the study. There were 75 (56%) j/p-AAAs and 58 (44%) TAAAs. The mean aneurysm diameter was 58 ± 6 mm (j/p-AAA, 56 ± 6 mm; TAAA, 67 ± 8 mm); 15 cases (11%) had >70-mm diameter. Planned TVVs were 431 (mean, 3 ± 1 TVVs/patient). The mean lead period was 89 ± 25 days, with five (3.8%) aneurysm ruptures (j/p-AAA, one; TAAA, four) occurring, two (1.5%) during manufacture and three (2.3%) with endograft available in the hospital (all three procedures were postponed because of cardiac or pulmonary comorbidities). In one TAAA rupture, the endograft was successfully implanted and the patient survived. Four of five ruptures had >70-mm diameter. On univariate analysis, chronic obstructive pulmonary disease (P = .01; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.1-3.2) and aneurysm diameter >70 mm (P = .001; OR, 42; 95% CI, 4-411) were risk factors for aneurysm rupture during the lead period, with aneurysm diameter >70 mm being confirmed as an independent risk factor on multivariate analysis (P = .005; OR, 29.3; 95% CI, 2.8-308). Overall, eight endografts (6%) were not implanted (refusal, two; aneurysm rupture, four; death not related to aneurysm, two). In the remaining 125 patients (94%), 405 TVVs were planned. Of them, 46 (11%) had severe stenosis at preoperative computed tomography angiography. Twelve (3%) TVVs occluded in the lead period (renal arteries, five; celiac trunks, seven); six were recanalized and six were abandoned. Severe preoperative stenosis was a risk factor for TVV occlusion during the lead period (P = .000; OR, 1.3; 95% CI, 1.1-1.6). CONCLUSIONS: In our series, custom-made design required a mean lead period of 89 days, which was determined by both manufacturing time and clinical reasons. During this delay, there is a high risk of both rupture in aneurysms >70 mm and TVV occlusion in severely stenosed vessels. These factors should be considered in the indication for custom-made fenestrated/branched endograft repair.

Renal Anti-Fibrotic Effect of Sodium Glucose Cotransporter 2 Inhibition in Angiotensin II-Dependent Hypertension.

BACKGROUND: Clinical trials have shown that empagliflozin (Empa), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, promotes nephroprotective effects in diabetic patients. The mechanisms underlying nephroprotection are not completely known and it is not known whether the renal beneficial action is present even in non-diabetic kidney disease. The aim of this study was to evaluate the effect of Empa administration on the development of renal fibrosis in an experimental model of angiotensin II (Ang II)-dependent hypertension. METHODS: Sprague Dawley rats (n = 31) were divided into 4 experimental groups. Ang II (200 ng/kg/min, osmotic minipumps, s.c., n = 9) or Ang II + Empa (10 mg/kg/day, per os, n = 10) were administered for 2 weeks. Control rats were treated with placebo (physiological saline, n = 6), and another group was treated with placebo plus Empa (n = 6) for the same period. Blood pressure (plethysmographic method) was measured at the beginning and at the end of the experimental protocol. After 2 weeks, the rats were euthanized and the kidneys were excised for histomorphometric evaluation of glomerular and tubulo-interstitial fibrosis and for the immunohistochemical evaluation of inflammatory infiltrates (monocytes/macrophages) and types I and IV collagen expression. RESULTS: The administration of Ang II resulted in an increase in blood pressure (p < 0.01), glomerular (p < 0.05) and tubulo-interstitial (p < 0.01) fibrosis, renal inflammatory infiltrates (p < 0.01) and type I (p < 0.01) and type IV collagen expression (p < 0.05) compared to the control group. Treatment with Empa did not significantly modify the increase in blood pressure due to Ang II, but prevented the development of renal glomerular and tubulo-interstitial fibrosis, and the increase in inflammatory infiltrates and types I and IV collagen expression in Ang II-treated rats (p < 0.01). CONCLUSIONS: These data demonstrate that the treatment with Empa prevents the development of renal fibrosis in Ang II-dependent hypertension. In Ang II-dependent hypertension, the anti-fibrotic effect due to SGLT2 inhibition is caused by the reduction of inflammatory infiltrates and it is independent on the modulation of blood pressure increase.

Is size of infarct or clinical picture that should delay urgent carotid endarterectomy? A meta-analysis.

INTRODUCTION: The best timing for carotid endarterectomy in patients with stroke is still matter of debate, particularly in case of significant cerebral ischemic lesion or neurological deterioration. The present review and meta-analysis aimed to report the best evidence in the outcome of patients submitted to urgent (<48h) or standard elapsing time (<2-week) CEA for stroke and to evaluate the impact of cerebral ischemic lesion size and clinical manifestation in the postoperative outcome. EVIDENCE ACQUISITION: A systematic review and meta-analysis was performed by searching through Scopus and PubMed all papers reporting carotid endarterectomy (CEA) outcome (stroke and stroke/death) in patients who suffered a stable stroke, treated within 48h and 2 weeks from symptoms. A subgroup analysis of studies reporting the presence and size of cerebral lesion and clinical manifestation was planned. The pooled 30-day stroke and stroke/death risk (effect size) was expressed by crude percentage and 95% confidence interval (CI), by random effect model. EVIDENCE SYNTHESIS: Sixteen studies were included in the meta-analysis, 7 reporting the CEA outcome performed <48h from stroke and 13 reporting the outcome of CEA performed <2-week. The effect size of stroke and stroke/death of CEA performed <48h from symptoms was 7.4% (95% CI: 3.7-11.2) and 7.9% (95% CI: 4.0-11.8) respectively, and for CEA <2-week was 4.5% (95% CI: 2.8-6.3) and 5.4% (95% CI: 3.4-7.4) respectively. The authors agreed in considering the severity of stroke and the volume of the cerebral ischemic lesion a risk factor for postoperative complication however, due to the extremely high heterogeneity of the studies data, the effect size was not calculated. Two studies evaluated the effect of the cerebral ischemic lesion distribution; the presence of a border-zone infarct was associated with a significant increase in the risk of postoperative stroke/death rate compared with territorial cerebral ischemic lesion (OR: 6.0; 95%CI 1.1-32.0). CONCLUSIONS: CEA for patients with a recent stroke is associated with 5.4% and 7.9% of stroke/death. A large volume of the cerebral ischemic lesion and a deteriorated neurological status are associated with a higher perioperative risk; urgent carotid revascularization seems to further increase this risk.

Predictors of survival in malignant aortic tumors.

OBJECTIVE: Malignant aortic tumors (MATs) are exceedingly rare, and a comprehensive review of clinical and therapeutic aspects is lacking in the literature. The aim of this study was to analyze all known cases of MATs and to identify predictors of patients' survival. METHODS: All patients diagnosed with an aortic tumor treated in a single center along with all case reports and reviews available in the literature through a specific PubMed search using keywords such as "malignant" and "aorta" or "aortic," "tumor," or "sarcoma" or "angiosarcoma" were analyzed. The tumor's primary location, clinical presentation, histologic subtype, and treatment choice were examined. Survival at 1 year, 3 years, and 5 years and the possible preoperative and operative outcome predictors were evaluated using Kaplan-Meier analysis with a log-rank test and by Cox regression for multivariate analysis. RESULTS: In addition to the 5 cases treated in our center, 218 other cases of MAT were reported in the literature from 1873 to 2017. The mean age of the patients was 60.1 ± 11.9 years, and the male to female ratio was 1.59:1. The median overall survival from diagnosis was 8 (7-9) months; 1-, 3-, and 5-year survival rates were 26%, 7.6%, and 3.5%, respectively. Chronic hypertension (P = .03), fever (P = .03), back pain (P = .01), asthenia (P = .04), and signs of peripheral embolization (P = .007) were significant predictors of a poor result. Histologic subtypes had a different impact on survival, with no statistical significance. Compared with other treatment strategies, combined surgical-medical therapy had the best impact on the median survival rate (surgical-medical, 12 [8-24] months; medical, 8 [5-10] months; surgical 7 [2-16] months; no treatment, 2 [0.5-15] months; P = .001). Analyzing exclusively medical approaches, chemotherapy and radiotherapy had the best impact on median survival rate compared with untreated patients (chemotherapy-radiotherapy, 18 [10-26] months; radiotherapy, 16 [8-20] months; chemotherapy, 10 [7-24] months; no medical treatment, 6 [2-16] months; P = .005); these data were not sustained by multivariate analysis. CONCLUSIONS: Aortic tumors are a malignant pathologic condition with a short survival rate after initial diagnosis. Survival is further diminished in the presence of clinical factors such as hypertension, fever, back pain, asthenia, and signs of peripheral embolization. Combined surgical and medical treatment, particularly with chemotherapy and radiotherapy, has shown the highest survival rate.

Incidental Findings Identified on Head MRI for Investigation of Cognitive Impairment: A Retrospective Review.

INTRODUCTION: Incidental findings are common in presumed healthy volunteers but are infrequently studied in patients in a clinical context. OBJECTIVE: To determine the prevalence, nature, and management implications of incidental findings on head MRI in patients presenting with cognitive symptoms, and to quantify and describe unexpected MRI abnormalities that are of uncertain relevance to the patient's cognitive symptoms. METHODS: A single-centre retrospective review of patients attending a regional early-onset cognitive disorders clinic between March 2012 and October 2018. Medical records of consecutive patients who underwent head MRI were reviewed. Unexpected MRI findings were classified according to their severity and likelihood of being incidental. Markers of small vessel disease and cerebral atrophy were excluded. RESULTS: Records of 694 patients were reviewed (median age 60 years, 49.9% female), of whom 514 (74.1%) underwent head MRI. 54% of the patients received a diagnosis of a neurodegenerative disorder. Overall 111 incidental findings were identified in 100 patients of whom 18 patients (3.5%, 95% CI 2.2-5.6%) had 18 incidental findings classified as requiring additional medical evaluation. 82 patients (16%, 95% CI 13.0-19.5%) had 93 incidental findings without clearly defined diagnostic consequences. 17 patients (3.3%) underwent further investigations, 14 patients (2.7%) were referred to another specialist clinic and 3 patients (0.6%) were treated surgically. Two patients had MRI findings of uncertain relevance to their cognitive symptoms, necessitating prolonged clinic follow-up. CONCLUSION: Incidental findings are common in patients with cognitive impairment from this large clinic-based series; however, few required additional medical evaluation. These data could help inform discussions between clinicians and people with cognitive symptoms regarding the likelihood and potential implications of incidental imaging findings.

Endovascular repair of thoraco-abdominal aortic aneurysms by fenestrated and branched endografts†.

OBJECTIVES: Our objective was to report the outcomes of fenestrated/branched endovascular aneurysm repair of thoraco-abdominal aortic aneurysms (TAAAs) with endografts. METHODS: Between January 2010 and April 2018, patients with TAAAs, considered at high surgical risk for open surgery and treated by Cook-Zenith fenestrated/branched endovascular aneurysm repair, were prospectively enrolled and retrospectively analysed. The early end points were 30-day/hospital mortality rate, spinal cord ischaemia and 30-day cardiopulmonary and nephrological morbidity. Follow-up end points were survival, patency of target visceral vessels and freedom from reinterventions. RESULTS: Eighty-eight patients (male: 77%; mean age: 73 ± 7 years; American Society of Anesthesiologists 3/4: 58/42%) were enrolled. Using Crawford's classification, 43 (49%) were types I-III and 45 (51%) were type IV TAAAs. The mean aneurysm diameter was 65 ± 15 mm. Custom-made and off-the-shelf endografts were used in 60 (68%) and 28 (32%) cases, respectively. Five (6%) patients had a contained ruptured TAAA. The procedure was performed in multiple steps in 42 (48%) cases. There was 1 (1%) intraoperative death. Five (6%) patients suffered spinal cord ischaemia with permanent paraplegia in 3 (3%) cases. Postoperative cardiac and pulmonary complications occurred in 7 (8%) and 12 (14%) patients, respectively. Worsening of renal function (≥30% of baseline level) was detected in 11 (13%) cases, and 2 (2%) patients required haemodialysis. The 30-day and hospital mortality rates were 5% and 8%, respectively. The mean follow-up was 36 ± 22 months. Survival at 12, 24 and 36 months was 89%, 75% and 70%, respectively. The patency of target visceral vessels at 12, 24 and 36 months was 92%, 92% and 92%, respectively. Freedom from reinterventions at 12, 24 and 36 months was 85%, 85% and 83%, respectively. CONCLUSIONS: The endovascular repair of TAAAs with fenestrated/branched endovascular aneurysm repair is feasible and effective with acceptable technical/clinical outcomes at early/midterm follow-up.

Planning and Endograft Related Variables Predisposing to Late Distal Type I Endoleaks.

OBJECTIVE: Late distal type I endoleak (ELIB) hampers the outcome of endovascular repair (EVAR) for abdominal aortic aneurysm (AAA); however, only few dedicated experiences have been reported in the literature. The aim of the study was to evaluate the incidence, presentation and treatment of late ELIB and to identify possible anatomical and technical predictors. METHODS: All patients undergoing elective EVAR between 2008 and 2013 were collected prospectively. Follow up was by post-operative computed tomography angiography (CTA) performed within 30 days and CTA and/or duplex ultrasound (DUS) at six or 12 months and yearly thereafter. Patients with late ELIB, defined as distal type I endoleak detected more than six months after the primary intervention without endoleak on the intra-operative completion angiogram and on the post-operative CTA, were retrospectively selected (G1) and compared with a control group with no ELIB (G2) homogeneous for clinical conditions, endograft implanted, and timing of follow up. The minimum follow up required for inclusion in the study was 24 months. Pre-operative morphological aorto-iliac features and EVAR implant details were evaluated, and measurements performed after centre lumen line reconstructions using dedicated software. The differences between G1 and G2 were analysed using the chi-square test, the Student t test, and logistic regression. RESULTS: Six hundred and sixteen patients were submitted to EVAR. ELIB was detected in 14 cases (2.3%) (G1) at a median follow up of 32.8 (IQR 48) months. In three of the 14 cases ELIB was symptomatic (AAA rupture, 2; pain, 1); in the remaining 11 cases it was asymptomatic and found incidentally at routine follow up. Treatment was by open repair in one case and by endovascular iliac leg extension in 13 cases. Hypogastric exclusion was necessary in two of 14 cases. Thirty patients were included in G2, with a median follow up of 41.2 (25) months. Common iliac artery length <4 cm (OR 5.3, 95% CI 1.1-29.5, p = .05), diameter > 15 mm (OR 3.5, 95% CI 1.2-10.9, p = .03), and severe thrombotic apposition (>50% of circumference) (OR 5, 95% CI 1.2-19.2, p = .02), at the iliac sealing zone were significant predictors of ELIB, on univariable analysis; oversizing of the iliac leg diameter < 10% and distal sealing > 1 cm above the hypogastric origin were independently associated with ELIB (OR 5.4, 95% CI 1.3-21.5, p = .01 and OR 6.6, 95% CI 1.1-39.3, p = .03, respectively), on multivariable analysis. CONCLUSION: The present data underline that ELIB is a non-negligible occurrence during long term EVAR follow up and requires further interventions, most often by endovascular solutions. According to the ELIB risk factors identified in this study, an iliac leg diameter oversize >10% and extensive common iliac artery coverage (<1 cm above the hypogastric origin) would be suggested to prevent this complication.

Anatomical Predictors of Flared Limb Complications in Endovascular Aneurysm Repair.

Purpose: To evaluate possible predictors of complications with flared iliac stent-graft limbs for ectatic common iliac arteries (CIAs) associated with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). Materials and Methods: A retrospective comparative analysis was conducted of 533 EVAR patients (mean age 75 years; 442 men) treated between 2012 and 2017 who had complications associated with the stent-graft limbs (n=1066). Complications, including type Ib endoleak, type IIIa endoleak, and limb occlusion, were compared between patients with nondilated (<16 mm) CIAs treated with standard iliac limbs (SLs, n=808) vs patients with ectatic CIAs treated with flared limbs (FLs, n=258). Follow-up included a duplex scan at 3, 6, and 12 months and yearly thereafter; computed tomography angiography was performed in case of iliac complications. Risk factors for iliac complications in FLs were investigated using Cox regression and Kaplan-Meier analyses; results of the regression analysis are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: Overall, no iliac complications occurred at 30 days, but over a mean follow-up of 38±8 months, there were 10 (1%) events (4 limb occlusions, 6 type Ib endoleaks): 7 (3%) in FLs and 3 (0.4%) in SLs (p=0.20). Kaplan-Meier analysis found no differences at 5 years in SLs vs FLs for freedom from limb occlusion (99%±1% vs 98%±1%, respectively; p=0.30) or type Ib endoleak (96%±3% vs 97%±1%, respectively; p=0.44). Similarly, the overall 5-year iliac complication rates were similar in SLs vs FLs (96%±3% vs 95%±2%, p=0.21). Regression analysis found CIA length ≤30 mm (HR 4.7, 95% CI 1.02 to 21.6, p=0.04) and a diameter ≥20 mm (HR 7.8, 95% CI 1.05 to 64.8, p=0.03) to be independent predictors of iliac complications in FLs. Kaplan-Meier estimates of iliac complication-free survival in FLs were significantly worse when the CIA length was ≤30 mm (79%±9% vs 98%±1%, p=0.003) or the diameter was ≥20 mm (85%±7% vs 99%±1%, p=0.02). The combination of both risk factors produced significantly poorer iliac complication-free survival compared with cases in which there was one or no risk factor (67%±19% vs 96%±2% vs 99%±1%, respectively; p<0.001). Conclusion: Iliac limb complications are infrequent in EVAR, regardless of the type of iliac limb chosen; however, CIAs ≤30 mm in length or ≥20 mm in diameter significantly increased the risk of late iliac complications in FLs. If both characteristics were present, this risk was further elevated.

A prognostic score for clinical success after revascularization of critical limb ischemia in hemodialysis patients.

OBJECTIVE: The revascularization of critical limb ischemia (CLI) in hemodialysis (HD) patients features poor results in terms of patient survival and limb salvage. Recent predictive models in CLI revascularization did not specifically address HD patients. The aim of this study was to define risk factors for clinical success (CS) after revascularization of CLI in HD patients and to transform findings in a prognostic score. METHODS: A retrospective study was conducted of prospectively gathered data, including consecutive HD patients treated for CLI from January 2004 to December 2012. Patients' demographics, comorbidities, CLI stage (Rutherford classification), tissue loss (Texas University Wound classification [TUWC]), and type of revascularization were assessed. End points were CS after revascularization (amputation-free and reintervention-free survival) and a prognostic score for CS based on significant risk factors (multivariable analysis). RESULTS: In the study period, 131 patients (mean age, 70.2 ± 9.9 years; male, 76.3%) with a total of 180 limbs were treated. Endovascular (52.8%), surgical (28.9%), or hybrid (10.6%) revascularization was performed in 163 (90.6%) limbs in 117 patients. The mean (± standard deviation) follow-up was 20.8 ± 21.1 months. Considering revascularized patients, CS was 47.9%, 30.8%, and 17.8% at 6, 12, and 24 months, respectively. On multivariable analysis, age (hazard ratio [HR], 1.03; 95% confidence interval [CI], 1.01-1.05; P = .005), coronary artery disease (CAD; HR, 1.55; 95% CI, 1.04-2.32; P = .032), and TUWC stage D (HR, 1.80; 95% CI, 1.22-2.67; P = .003) were independent negative factors. Type of revascularization had no influence on CS. The score for predicting CS was 0.026 × age (years) + 0.441 × CAD + 0.59 × TUWC stage D. CAD and TUWC stage D were 1 in the presence of disease and 0 in the absence of disease. The score has a significant discrimination power of 75.5% (P = .036), with a best cutoff value of 2.07. Patients with a CS score <2.07 would have a low risk of clinical failure, whereas patients with a CS score >2.07 would have a high risk. There were 31 (26.5%) cases of low-risk score and 86 (73.5%) cases of high-risk score. Cases with low-risk score had a CS at 1 year of 51.6% compared with 23.3% in cases with high-risk score. CONCLUSIONS: CS after revascularization in HD patients remains poor independent of the type of revascularization. A prognostic model based on age, history of CAD, and severity of CLI (TUWC stage D lesion) can estimate an individual's chances of CS and may help in the decision-making process.

Early and Late Outcome of Common Iliac Aneurysms Treated by Flared Limbs or Iliac Branch Devices during Endovascular Aortic Repair.

PURPOSE: To compare perioperative and long-term outcomes of endovascular aneurysm repair (EVAR) with flared limbs (FLs) vs iliac branch devices (IBDs) for common iliac artery aneurysm to determine possible differences in outcome. MATERIALS AND METHODS: From 2012 to 2017, all patients with standard EVAR with FLs and aortoiliac anatomy fit for implantation of IBDs were retrospectively selected and compared with patients with standard EVAR and IBDs. The study included 150 patients with 162 iliac treatments: 105 (65%) FLs and 57 (35%) IBDs. Iliac complications (ICs), including internal iliac artery (IIA) loss, limb thrombosis, and type 1b or type 3 endoleak, were considered at 30 days and in the follow-up period. RESULTS: Procedural time and volume of contrast medium were significantly higher in IBD vs FL procedures (90 min ± 33 vs 70 min ± 25, P = .01; 130 mL ± 40 vs 80 mL ± 20, P = .01). Perioperative rate of ICs was similar between IBDs and FLs (0% vs 3.8% [4 IIA loss], P = .25). During 35-month median follow-up, there were 10 ICs, all in FLs group (4 IIA perioperative loss, 4 type 1b endoleak, 2 limb occlusion). By Kaplan-Meier analysis, survival free of ICs was significantly higher in IBD group after 4 years of follow-up (1 y 100% vs 96%, P = .36; 2 y 100% vs 94%, P = .14; 3 y 100% vs 91%, P = .07; 4 y 100% vs 87%, P = .03; 5 y 100% vs 78%, P = .02). CONCLUSIONS: IBDs and FLs have similar perioperative results. IBDs require longer procedural time and greater contrast medium volume; however, they are associated with lower ICs after 4 years of follow-up.