Type III Endoleak Incidence and Outcomes in Endovascular Aortic Repair: Comparison of Anatomical and Proximal Fixation Devices.

PURPOSE: To evaluate the influence of endograft fixation type on the incidence, treatment, and outcomes of type III endoleaks (TIIIELs). MATERIALS AND METHODS: Abdominal aortic aneurysms (AAAs) treated with bifurcated endografts between 1994 and 2020 were prospectively collected and reviewed. The endograft included were classified as "Anatomical Fixation" (AF) (Powerlink [Endologix] and AFX [Endologix]) or "Proximal Fixation" (PF). The primary outcome was the incidence of TIIIEL over time, stratified by fixation type. Secondary outcomes included between-group comparisons of baseline characteristics, intraoperative details during TIIIEL correction, and survival analysis after TIIIEL diagnosis. RESULTS: A total of 2065 endovascular aneurysm repairs were performed: 872 (42.2%) with AF and 1193 (57.8%) with PF devices. The estimated incidence of TIIIEL at 1, 5, and 10 years was 0.4%, 4.2%, and 7.3%, and 0.5%, 3.2%, and 4.6% for AF and PF, respectively (p=0.157), and fixation type was not associated with TIIIEL development in the competing risk regression model (p=0.101). The cumulative overall survival rate in patients diagnosed with TIIIEL did not differ significantly between the groups (p=0.077). The rate of recurrent TIIIELs was significantly lower in the AF group (7.1% vs 22.7%; p=0.044); however, no significant difference was found in secondary reintervention between the two groups (11.9% vs 27.3%, p=0.074). Patients with angulated and calcified aortic neck (SHR 3.4, 95% CI 1.2-9.6, p=0.022) and larger aneurysms (SHR 1.2; 95% CI 1.1-1.3; p<0.001) had a higher risk of TIIIEL. Likewise, the use of three or more endograft components increased the risk of TIIIEL by 3.1 times (SHR 3.1; 95% CI 1.7-5.4; p<0.001). CONCLUSIONS: The occurrence of TIIIELs was not affected by the type of endograft fixation. For larger abdominal aortic aneurysms (AAAs) and aneurysms with angulated and calcified aortic necks, there is a higher likelihood of developing TIIIELs during follow-up, regardless of the endograft type used. CLINICAL IMPACT: The type of fixation does not influence the incidence of TIII ELs. EVAR in larger AAAs and aneurysms with angulated and calcified aortic necks have a higher risk of developing TIII EL. Moreover, the risk of TIII EL is considerably increased by the use of three or more modular components.

Effect of phospholipid curcumin Meriva® on liver histology and kidney disease in nonalcoholic steatohepatitis a randomized, double-blind, placebo-controlled trial.

BACKGROUND AIMS: Nonalcoholic steatohepatitis (NASH) confers an increased liver-related and kidney morbidity. Phospholipid curcumin (Meriva ® ) is a phospholipid formulation with ameliorated systemic curcumin absorption and delivery. We assessed safety and efficacy of Meriva ® in NASH. APPROACH: In this double-blind trial, 52 biopsy-proven NASH patients(71% with stage ≥F2 fibrosis, 58% with stage A2-G2/A2-G3a CKD) were randomized 1:1 to receive Meriva ® 2 g/day or placebo for 72 weeks. Primary end-point was NASH resolution with no worsening of fibrosis. Secondary end-points included: a ≥1 stage liver fibrosis improvement with no NASH worsening; regression of significant(i.e. stage≥F2) fibrosis and of chronic kidney disease(CKD); improvement in renal, glucose, lipid and inflammatory parameters. We also explored treatment effect on hepatic activation of Nuclear Factor(NF)-kB, a key proinflammatory transcription factor and a major target of curcumin. RESULTS: Fifty-one patients(26 on Meriva ® and 25 on placebo) completed the trial. Sixteen(62%) patients on Meriva ® vs. three(12%) patients on placebo had NASH resolution(RR=5.33[95%CI=1.76-12.13]; p=0.003). Thirteen(50%) patients on Meriva ® vs. 2(8%) patients on placebo had ≥1 stage fibrosis improvement(RR=6.50[(1.63-21.20]; p=0.008). Eleven(42%) patients on Meriva ® vs. 0(0%) on placebo had regression of significant liver fibrosis(RR=18.01[1.43-36.07]; p=0.02). Hepatic NF-kB inhibition predicted NASH resolution(AUC=0.90,95%CI=0.84-0.95) and fibrosis improvement(AUC=0.89,95%CI=0.82-0.96). Thirteen(50%) patients on Meriva ® vs. 0(0%) on placebo had CKD regression(RR=10.71[1.94-17.99)]; p=0.004). Compared with placebo, Meriva ® improved eGFR(difference in adjusted eGFR change: +3.59[2.96-4.11] mL/min/1.73 m 2 /year, p =0.009), fasting glucose(-17 mg/dL;95%CI=-22, -12), HbA1c(-0.62%;95%CI=-0.87%, -0.37%), LDL-C(-39 mg/dL; 95%CI=-45, -33), triglycerides(-36 mg/dL, 95%CI= -46, -26), HDL-C(+10 mg/dL; 95%CI=+8, +11) and inflammatory markers. Adverse events were rare, mild and evenly distributed. CONCLUSION: In NASH patients, Meriva ® administration for 72 weeks was safe, well-tolerated, improved liver histology, possibly through NF-kB inhibition, kidney disease, and metabolic profile.

Systematic review and meta-analysis of cerebrospinal fluid drain-related mortality and morbidity after fenestrated-branched endovascular aortic repair.

OBJECTIVE: This study aimed to investigate the incidence of cerebrospinal fluid drainage (CSFD)-related complications specifically in patients who underwent fenestrated and branched endovascular aortic repair (F/B-EVAR). This objective was chosen considering the limitations and uncertainties surrounding its efficacy in preventing spinal cord injury. METHODS: A systematic review following Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted (PROSPERO; #CRD42022359223). Literature searches of MEDLINE, Embase, and Scopus were performed until May 1, 2023, focusing on studies published after January 1, 2000. The inclusion criteria encompassed studies reporting on F/B-EVAR, CSFD, and drain-related complications. Data extraction and quality assessment using the Newcastle-Ottawa Scale were performed by multiple reviewers to ensure accuracy and reliability. A proportion meta-analysis was conducted to calculate the pooled rate and 95% confidence interval (CI). The primary and secondary outcomes were CSFD-related mortality and morbidity, respectively. RESULTS: Six retrospective, observational, single-center studies were included, totaling 1079 patients and 730 CSFD placements (all prophylactic except for one). The Newcastle-Ottawa Scale showed a high to moderate risk of bias. The analysis revealed a CSFD-related mortality rate of 1.4% (95% CI: 0.0-4.8; I2 = 67.7%) and an overall morbidity rate of 25.6% (95% CI: 13.6-39.7; I2 = 83.2%). The overall major, moderate, and minor estimated complication rates were 6.1% (95% CI: 4.1-8.5; I2 = 0%), 4.6% (95% CI: 2.4-7.3; I2 = 33.5%), and 26.4% (95% CI: 16.5-37.7; I2 = 84.9%), respectively. Severe complications included intracranial hemorrhage (2.8%), spinal hematoma (1.4%), subarachnoid hemorrhage (1.4%), and CSFD-related neurological deficits (1.1%). A pooled estimate of 11.4% for nonfunctioning drainage was found. CONCLUSIONS: F/B-EVAR patients showed a notable incidence of CSFD-related death and substantial morbidity. This study highlights the limitations of the available data, the high prevalence of complications associated with CSFD, and the need for further research to better understand the risks and benefits of CSFD in F/B-EVAR. This calls for careful consideration regarding the routine use of prophylactic drainage due to the accumulating evidence of the risks associated with CSFD without proven benefit in this specific context.

"O.R. GOES GREEN": a first step toward reducing our carbon footprint in the operating room and hospital.

Hospitals in Europe produce approximately 6 million tons of medical waste annually, about one-third of this originating in operating rooms. Most of it is solid waste, which can be recycled if bodily fluids do not contaminate it. Only 2-3% of hospital waste must be disposed of as infectious waste, and this is much lower than the 50-70% of garbage in the biohazard waste stream. In June 2021, at the main operating room of the Department of General Surgery of the University of Turin, we began a separate collection program for materials consisting of plastic, paper, TNT (material not contaminated by bodily fluids), and biohazardous waste. We calculated the number of boxes and the weight of special waste disposed produced every month in one operating room for 18 months. The monthly number of Sanibox and the monthly weight of biohazardous waste decreased during the observation period. The reduction trend was not constant but showed variations during the 18 months. Direct proportionality between number of low-complexity procedures and production of biohazardous waste was found (p = 0.050). We observed an optimization in the collection and filling of plastic, paper and TNT boxes separated and sent for recycling. One of the barriers to recycling hospital waste, and surgical waste in particular, is the failure to separate infectious waste from clean waste. A careful separate collection of waste in the operating room is the first step in reducing environmental pollution and management costs for the disposal of hospital waste.

Design and evaluation of a smart passive dynamic arm support for robotic-assisted laparoscopic surgery.

Surgeons performing robotic-assisted laparoscopic surgery experience physical stress and overuse of shoulder muscles due to sub-optimal arm support during surgery. The objective is to present a novel design and prototype of a dynamic arm support for robotic laparoscopic surgery to evaluate its ergonomics and performance on the AdLap-VR simulation training device. The prototype was designed using the mechanical engineering design process: Technical requirements, concept creation, concept selection, 3D-design and built of the prototype. A crossover study was performed on a marble sorting task on the AdLap-VR. The first group performed four trials without the arm support, followed by four trials with the arm support, and the other group executed the sequence vice versa. The performance parameters used were time to complete (s), path length (mm), and the number of collisions. Afterward, the participants filled out a questionnaire on the ergonomic experience regarding both situations. 20 students executed 160 performed trials on the AdLap-VR Significant decreases in the subjective comfort parameters mental demand, physical demand, effort and frustration were observed as a result of introducing the novel arm support. Significant decreases in the objective performance parameters path length and the number of collisions were also observed during the tests. The newly developed dynamic arm support was found to improve comfort and enhance performance through increased stability on the robotic surgery skills simulator AdLap-VR.

EUS-Guided Gallbladder Drainage Using a Lumen-Apposing Metal Stent for Acute Cholecystitis: Results of a Nationwide Study with Long-Term Follow-Up.

BACKGROUND: Although endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using lumen-apposing metal stents (LAMS) has become one of the treatments of choice for acute cholecystitis (AC) in fragile patients, scant data are available on real-life settings and long-term outcomes. METHODS: We performed a multicenter retrospective study including EUS-guided GBD using LAMS for AC in 19 Italian centers from June 2014 to July 2020. The primary outcomes were technical and clinical success, and the secondary outcomes were the rate of adverse events (AE) and long-term follow-up. RESULTS: In total, 116 patients (48.3% female) were included, with a mean age of 82.7 ± 11 years. LAMS were placed, transgastric in 44.8% of cases, transduodenal in 53.3% and transjejunal in 1.7%, in patients with altered anatomy. Technical success was achieved in 94% and clinical success in 87.1% of cases. The mean follow-up was 309 days. AEs occurred in 12/116 pts (10.3%); 8/12 were intraprocedural, while 1 was classified as early (<15 days) and 3 as delayed (>15 days). According to the ASGE lexicon, two (16.7%) were mild, three (25%) were moderate, and seven (58.3%) were severe. No fatal AEs occurred. In subgroup analysis of 40 patients with a follow-up longer than one year, no recurrence of AC was observed. CONCLUSIONS: EUS-GBD had high technical and clinical success rates, despite the non-negligible rate of AEs, thus representing an effective treatment option for fragile patients.

Anatomical suitability for branched endovascular aortic arch repair and balloon-expandable bridging stent grafts in a cohort of patients previously treated with a hybrid approach.

OBJECTIVE: We assessed the suitability of two triple branch arch devices (aBranch) (Terumo aortic and Cook Medical) and a balloon-expandable covered stent (VBX, W. L. Gore & Associates, Johnson & Johnson) to incorporate the brachiocephalic trunk (BCT) in a cohort previously treated with hybrid thoracic endovascular repair (TEVAR). METHODS: This is a single-center, retrospective, all-comers, preclinical suitability study. We conducted an analysis of preoperative computed tomography scans in surgical patients between 1999 and 2022 in a single vascular surgery unit. The primary outcome was the aortic suitability of aBranch devices and VBX as mating stent for BCT in previous hybrid TEVAR. Hybrid repair of the aortic arch included TEVAR, fenestrated or branched TEVAR associated with any surgical debranching of the supra-aortic trunks and chimney TEVAR with proximal landing in zones 0 to 2. Secondary outcomes included (i) suitability assessment when excluding minor instruction for use (IFU) criteria, (ii) a comparison of suitable and nonsuitable patients, (iii) risk factors analysis for nonsuitability, and (iv) a description of the exclusion causes. RESULTS: During the study period, 120 patients were treated. Among elective patients (n = 73), the suitability of any aBranch was 82.2% (60/73) and VBX was suitable in 64.4% of BCTs (47/73). The aBranch suitable patients had a significantly longer sinotubular-BCT length (P = .017) and smaller distal ascending aorta (P = .043) as compared with nonsuitable ones. The suitability of Terumo Aortic and Cook Medical devices was 52.1% (38/73) and 46.6% (34/73), respectively. When minor IFU criteria were ignored, suitability increased to 82.2% (60/73) and 63.0% (46/73), respectively. Left common carotid artery diameter and sinotubular-BCT length were significant nonsuitability risk factors for Terumo Aortic aBranch in multivariable analysis. No associations were found for Cook Medical device. The outcomes were tested in the entire cohort demonstrating a global suitability of 82.9%, increasing to 86.3% when ignoring minor IFUs. VBX was anatomically suitable to use in BCT in 73.2% of patient BCTs. CONCLUSIONS: aBranch devices are anatomically suitable in a vast majority of patients (86%) undergoing hybrid TEVAR. The innominate artery seems eligible for incorporation with VBX in almost two-thirds of patients. This mating stent may help to overcome some minor IFU restrictions.

Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels.

OBJECTIVE: The use of intravascular ultrasound (IVUS) reduces contrast medium use and radiation exposure during conventional endovascular aneurysm repair (EVAR). The aim of this study was to evaluate the safety and efficacy of IVUS in detecting bridging stent graft (bSG) instability during fenestrated and branched EVAR (F/B-EVAR). METHODS: This was a prospective observational multicentre study. The following outcomes were evaluated: (1) technical success of the IVUS in each bSG, (2) IVUS findings compared with intra-operative angiography, (3) incidence of post-operative computed tomography angiography (CTA) findings not detected with IVUS, and (4) absence of IVUS related adverse events. Target visceral vessel (TVV) instability was defined as any branch or fenestration issues requiring an additional manoeuvre or re-intervention. Any IVUS assessment that detected stenosis, kinking, or any geometric TVV issue was considered to be branch instability. All procedures were performed in ad hoc hybrid rooms. RESULTS: Eighty patients (69% males; median age 72 years; interquartile range 59, 77 years) from four aortic centres treated with F/B-EVAR between January 2019 and September 2021 were included: 70 BEVAR (21 off the shelf; 49 custom made), eight FEVAR (custom made), and two F/B-EVAR (custom made), for a total of 300 potential TVVs. Two TVVs (0.7%) were left unstented and excluded from the analysis. The TVVs could not be accessed with the IVUS catheter in seven cases (2.3%). Furthermore, 17 (5.7%) TVVs could not be examined due to a malfunction of the IVUS catheter. The technical success of the IVUS assessment was 91.9% (274/298), with no IVUS related adverse events. Seven TVVs (2.5%) showed signs of bSG instability by means of IVUS, leading to immediate revisions. The first post-operative CTA at least 30 days after the index procedure was available in 268 of the 274 TVVs originally assessed by IVUS. In seven of the 268 TVVs (2.6%) a re-intervention became necessary due to bSG instability. CONCLUSION: This study suggests that IVUS is a safe and potentially valuable adjunctive imaging technology for intra-operative detection of TVV instability. Further long term investigations on larger cohorts are required to validate these promising results and to compare IVUS with alternative technologies in terms of efficiency, radiation exposure, procedure time, and costs.

Comparison of bare and nonbare stent grafts during thoracic endovascular aneurysm repair of the aortic arch.

OBJECTIVE: We compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR). METHODS: We conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes. RESULTS: The median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016). CONCLUSIONS: We found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR.

Comparison of bridging stent grafts in branched endovascular aortic repair.

BACKGROUND: Endovascular treatment of thoracoabdominal aortic aneurysms has become common, with satisfactory results. Nevertheless, long-term durability remains an issue mainly because of target visceral vessel (TVV) instability. Currently, no covered stent has been approved as a bridging stent graft (BSG), demanding continuous research on this topic. METHODS: This was a multicenter observational retrospective cohort study comparing the midterm results of the Bard Covera Plus and Gore VBX as BSGs during branched endovascular aneurysm repair. The primary outcome was the comparison of the target vessel instability between the two groups. Primary patency, freedom from branch-related type I and III endoleaks and reintervention, and technical and clinical success were considered secondary outcomes. Logistic regression analysis was used to assess the association between selected baseline factors and TVV instability. TVV instability during follow-up was then evaluated using the Kaplan-Meier cumulative function. RESULTS: Three hundred forty-five TVVs in 106 patients were considered suitable for the analysis. Two hundred twenty vessels were stented with the Covera stent graft (64%) and 125 with VBX (36%). Two hundred ninety-nine TVVs received a single BSG, 45 two BSGs, and only 1 three BSGs. Bare metal stent relining was required in 36% of TVVs, mostly in the Covera group (89 [41%] vs 36 [29%]) (P = .030). The primary technical success rate was 96% (331/345), and the assisted primary technical success rate was 99% (342/345). The TVV instability rate within 30 days was 2% (one Covera and five VBX; P = .015). Three BSG occlusions (one Covera and two VBX) and three type Ic endoleaks (three VBX) were detected. The median follow-up was 13.9 months (range, 5.8-25.5 months). Sixteen TVV instabilities were detected during the follow-up. Twelve BSG occlusions (six Covera and six VBX), three type Ic endoleaks (one Covera and two VBX), and one type IIIc endoleak (VBX). The overall target vessel instability rate was 5% (16/342). TVV instability was associated with the use of Gore VBX in the univariable logistic regression (odds ratio, 3.0; 95% confidence interval, 1.1-8.0; P = .027). Aneurysm rupture and aneurysm diameter were also associated with TVV instability in the univariable analysis (P = .002 and P = .008, respectively). The only factor predisposing to TVV instability in the multivariable logistic regression analysis was the use of Gore VBX as a BSG (odds ratio, 2.9; 95% confidence interval, 1.0-8.0; P = .043). Kaplan-Meier analysis showed a significantly higher risk of TVV instability in the VBX group (P < .001). CONCLUSIONS: Overall midterm outcomes in this cohort were satisfactory. Patency rates were similar between the two stents. Nevertheless, VBX seems to be associated with worse TVV instability. These results may be correlated with a higher incidence of type Ic endoleaks, which require an extensive learning curve for correct stent selection and deployment.

Systematic Review and Meta-Analysis of the Incidence of Rupture, Repair, and Death of Small and Large Abdominal Aortic Aneurysms under Surveillance.

BACKGROUND: The ultimate goal of treating patients with abdominal aortic aneurysms (AAAs) is to repair them when the risk of rupture exceeds the risk of repair. Small AAAs demonstrate a low rupture risk, and recently, large AAAs just above the threshold (5.5-6.0 cm) seem to be at low risk of rupture as well. The present review aims to investigate the outcomes of AAAs under surveillance through a comprehensive systematic review and meta-analysis. METHODS: PubMed, Embase, and the Cochrane Central Register were searched (22 March 2022; PROSPERO; #CRD42022316094). The Cochrane and PRISMA statements were respected. Blinded systematic screening of the literature, data extraction, and quality assessment were performed by two authors. Conflicts were resolved by a third author. The meta-analysis of prevalence provided estimated proportions, 95% confidence intervals, and measures of heterogeneity (I2). Based on I2, the heterogeneity might be negligible (0-40%), moderate (30-60%), substantial (50-90%), and considerable (75-100%). The primary outcome was the incidence of AAA rupture. Secondary outcomes included the rate of small AAAs reaching the threshold for repair, aortic-related mortality, and all-cause mortality. RESULTS: Fourteen publications (25,040 patients) were included in the analysis. The outcome rates of the small AAA group (<55 mm) were 0.3% (95% CI 0.0-1.0; I2 = 76.4%) of rupture, 0.6% (95% CI 0.0-1.9; I2 = 87.2%) of aortic-related mortality, and 9.6% (95% CI 2.2-21.1; I2 = 99.0%) of all-cause mortality. During surveillance, 21.4% (95% CI 9.0-37.2; I2 = 99.0%) of the initially small AAAs reached the threshold for repair. The outcome rates of the large AAA group (>55 mm) were 25.7% (95% CI 18.0-34.3; I2 = 72.0%) of rupture, 22.1% (95% CI 16.5-28.3; I2 = 25.0%) of aortic-related mortality, and 61.8% (95% CI 47.0-75.6; I2 = 89.1%) of all-cause mortality. The sensitivity analysis demonstrated a higher rupture rate in studies including <662 subjects, patients with a mean age > 72 years, >17% of female patients, and >44% of current smokers. CONCLUSION: The rarity of rupture and aortic-related mortality in small AAAs supports the current conservative management of small AAAs. Surveillance seems indicated, as one-fifth reached the threshold for repair. Large aneurysms had a high incidence of rupture and aortic-related mortality. However, these data seem biased by the sparse and heterogeneous literature overrepresented by patients unfit for surgery. Specific rupture risk stratified by age, gender, and fit-for-surgery patients with large AAAs needs to be further investigated.

Anatomical feasibility of a 'semi-custom' unibody single-branch endograft in previous zone 2 thoracic endovascular aortic repair.

OBJECTIVES: The aim of this study was to evaluate the suitability of a subclavian unibody single-branch endograft among patients treated with thoracic endovascular aortic repair (TEVAR) in landing zone 2 (LZ2). METHODS: This is a pre-clinical, single-centre, real-world, all-comers, retrospective cohort study. Patients treated with TEVAR in LZ2 with an available preoperative computed tomography angiography were included. The primary outcome was the anatomical feasibility of the Castor endograft in patients receiving endovascular treatment in LZ2 between 1999 and 2022. Secondary outcomes were: a comparison of feasible and unfeasible patients; frequencies and description of exclusion causes; non-feasibility risk factor analysis; and analysis of the stent graft configurations necessary to treat 75% of the patients. A logistic regression model was used to find associations between baseline morphological data and non-feasibility. RESULTS: A total of 473 procedures were performed and 72 patients fulfilling inclusion criteria were included. The mean distance between the left carotid artery and left subclavian artery (or between innominate artery and bovine trunk) was 12.4 ± 5.2 mm and its average diameter was 33.0 ± 10.6 mm. The pre-vertebral left subclavian artery's diameter and length were 11.3 ± 2.5 and 38.7 ± 10.8 mm. Forty-nine (68.1%) patients were suitable for Castor implantation. Twenty-one configurations were required to treat 75% of feasible patients and might be lowered to 12 configurations applying less strict criteria. CONCLUSIONS: The Castor endograft was anatomically feasible in several patients requiring TEVAR in LZ2. Three-quarters of feasible patients could be treated with a reasonable number of configurations, paving the path for future off-the-shelf applications.

A Systematic Review of Endovascular Repair Outcomes in Atherosclerotic Chronic Mesenteric Ischaemia.

OBJECTIVE: Chronic mesenteric ischaemia (CMI) treatment focuses on symptom relief and prevention of disease progression. Endovascular repair represents the main treatment modality, while data on the associated antiplatelet regimen are scarce. The aim of this meta-analysis was to assess the early and midterm outcomes of endovascular repair in patients with CMI. DATA SOURCES: Randomised controlled trials and observational studies (1990 - 2022) reporting on early and midterm endovascular repair outcomes in patients with atherosclerotic CMI. REVIEW METHODS: The PRISMA guidelines and PICO model were followed. The protocol was registered to PROSPERO (CRD42023401685). Medline, Embase (via Ovid), and Cochrane databases were searched (end date 21 February 2023). The Newcastle-Ottawa Scale was used for risk of bias assessment, and GRADE for evidence quality assessment. Primary outcomes were technical success, 30 day mortality, and symptom relief, assessed using prevalence meta-analysis. The role of dual antiplatelet therapy (DAPT) was investigated using meta-regression analysis. RESULTS: Sixteen retrospective studies (1 224 patients; mean age 69.8 ± 10.6 years; 60.3% female) reporting on 1 368 target vessels (57.8% superior mesenteric arteries) were included. Technical success was 95.0% (95% CI 93 - 97%, p = .28, I2 19%, low certainty), the 30 day mortality rate was 2.0% (95% CI 2 - 4%, p = .93, I2 36%, low certainty), and immediate symptom relief was 87.0% (95% CI 80 - 92%, p < .010, I2 85%, very low certainty). At mean follow up of 28 months, the mortality rate was 15.0% (95% CI 9 - 25%, p = .010, I2 86%, very low certainty), symptom recurrence 25.0% (95% CI 21 - 31%, p < .010, I2 68%, very low certainty) and re-intervention rate 26.0% (95% CI 17 - 37%, p < .010, I2 92%, very low certainty). Single antiplatelet therapy (SAPT) and DAPT performed similarly in the investigated outcomes. CONCLUSION: Endovascular repair for CMI appears to be safe as first line treatment, with a low peri-operative mortality rate and acceptable immediate symptom relief. During midterm follow up, symptom recurrence and need for re-intervention are not uncommon. SAPT appears to be equal to DAPT in post-operative outcomes.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Acute perioperative complications after arterial and venous femoral access in major vascular and cardiac procedures: Ischemic or hemorrhagic patterns and how to solve them.

A direct percutaneous arterial and venous approach to the common femoral vessel has become the first option in most large-bore percutaneous vascular and cardiac procedures, making the issue of access site-related complications (ASCs) a pressing clinical concern. ASCs represent a potentially limb-threating and/or life-threatening scenario that alters the clinical success of the procedure and contributes to increased length of stay and resource utilization. Preoperative assessment of risk factors for ASCs should be well known before planning an endovascular percutaneous procedure and early diagnosis is necessary for prompt treatment. Several percutaneous and surgical approaches have been reported in case of ASCs, according to the different etiologies of these complications. The aim of this review was to report the incidence of ASCs in vascular and cardiac large-bore procedures, diagnosis, and available treatments according to the latest available literature.

Colorectal cancer with synchronous unresectable liver metastases: resecting the primary tumor improves survival.

PURPOSE: The optimal treatment strategy of patients affected by colorectal cancer (CRC) with synchronous unresectable liver metastases (SULM) is at present undefined. It is not known if a palliative primary tumor resection followed by chemotherapy could have a survival benefit compared to upfront chemotherapy (CT). The aim of the study is to analyze the safety and effectiveness of both therapeutic strategies in a group of patients treated at one institution. METHODS: A prospectively collected database was queried for patients affected by colorectal cancer with synchronous unresectable liver metastases between January 2004 and December 2018, defining and comparing 2 groups: patients treated by chemotherapy alone (group 1) vs patients who underwent primary tumor resection with or without a first line chemotherapy (group 2). The primary end point was Overall Survival (OS), estimated by the Kaplan-Meier method. RESULTS: One hundred sixty-seven patients were included: 52 in group 1 and 115 in group 2, median follow-up 48 months (range 25-126). A difference of 14 months in overall survival was observed between group 2 compared to group 1 (28 vs 14 months respectively; p < 0.001). Furthermore, overall survival increased in patients who underwent liver metastases resection (p < 0.001) or percutaneous radiofrequency ablation after surgery (p < 0.001). CONCLUSION: With the limits of a retrospective analysis, the study shows that surgical resection of the primary tumor has a significant impact on survival compared to chemotherapy alone. Randomized controlled trials are needed to confirm these data.

Anatomical Feasibility of an Off-the-shelf Single-Renal Scalloped Stent-Graft for Hostile Neck Abdominal Aortic Aneurysm: A Preclinical Study.

OBJECTIVES: To evaluate the feasibility of a standardized single-renal scallop stent-graft. DESIGN: Preclinical, single-center, real-world, all-comers, retrospective cohort study. METHODS: A total of 1347 abdominal aortic aneurysm (AAA) repairs (endovascular and open) performed between 2010 and 2020 were screened for elective treatment and retrievable preoperative high-quality computed tomography angiography (CTA) performed <6 months of the surgical procedure. Six hundred of the included CTAs involved prespecified measurements and a morphological assessment protocol (NCT05150873). The proximal sealing zones suitable for standard stent-graft implantations were further analyzed (N=547). The primary outcome assessed the feasibility of 2 single-renal scallop designs (10×10 mm and 15×10 mm, height × width). The feasibility was the inter-renal length ≥10 mm and ≥15 mm for prototypes #10 and #15, respectively. The secondary outcome quantified hypothetical length and surface improvements comparing those suitable for investigational devices implantation (study group) versus those not (control group). RESULTS: Of the total, 24.7% (n=135) was feasible with prototype #10. The study versus control group sealing zones were shorter (p=0.008), with a smaller surface (p=0.009) and a higher alpha angle (p=0.039). The length and surface area increased by about 25% and 23%, respectively, (both p<0.001) within the study group and became significantly better versus the control group (standard stent-graft; both p<0.001). Of the total, 7.1% (n=39) was suitable for prototype #15. The study versus control group sealing zones were shorter (p=0.148), with a smaller surface (p=0.077) and a higher alpha angle (p=0.027). The length and surface area increased by about 34% and 31%, respectively, (both p<0.001) within the study group and became significantly higher versus the control group (standard stent-graft; both p<0.001). CONCLUSIONS: The use of single-renal scalloped stent-graft might be feasible in a considerable number of AAA patients. The breakthrough stands in treating hostile AAAs presenting in mismatched renal arteries, keeping the complexity of the repair as similar as possible to standard endovascular repair with a remarkable improvement in sealing. CLINICAL IMPACT: The anatomic feasibility of a single renal stent graft for the treatment of "hostile" abdominal aortic aneurysm (AAA) with mismatched renal arteries was evaluated. The experimental device could be feasible in a considerable number of patients with AAA, approaching 25%, and demonstrate significant improvements in sealing. As far as we know, this is the first paper to report the prevalence of mismatched renal arteries in a large cohort of AAA patients in the real world, while proposing a dedicated device. The breakthrough is to keep the complexity of the repair as close as possible to standard endovascular repair.

Comprehensive Learning Curve Analysis of a Long-Term Experience With Thoracic Endovascular Aneurysm Repair.

PURPOSE: To analyze the learning curve for thoracic endovascular aortic repair (TEVAR) in a single center over a period of 25 years. MATERIALS AND METHODS: In total, 390 consecutive standard TEVAR procedures undertaken between 1996 and 2021 were included in a retrospective, observational, single-center study. Cumulative sum charts were elaborated for the entire center experience (primary outcome) as well as for the first and second implanting physicians. Data on procedural variables (contrast volume, operative and fluoroscopy time), 30-day major adverse events (MAEs) and clinical success, and endoleak and reintervention rates were secondary outcomes and subdivided into 4 quartiles of experience (Q1-Q4) or presented as first 2 versus latest 2 quartiles (Q1-Q2 vs Q3-Q4). RESULTS: The mean follow-up was 4.3±4.0 years. The center's learning curve was achieved after 75 procedures, and it was similar for the first implanting physician. The surgeon coming thereafter had a significantly shorter curve (10 TEVARs). Comparing Q1-Q2 with Q3-Q4, 30-day MAEs (16.1 vs 11.3%, p=0.164), 30-day mortality (11.4% vs 3.6%, p=0.003), and intraoperative additional maneuvers (21.5% vs 13.3%, p=0.033) were reduced along with an improvement in clinical success (85.9% vs 90.3%, p=0.190). From Q1 to Q4, operative time (139.8±65.5 to 76.7±43.7 min, p=0.001), fluoroscopy time (15.1±8.8 to 7.1±5.1 min, p<0.001), and contrast volume (244.0±112.1 to 104.3±46.1 mL, p<0.001) showed a considerable reduction. Late endoleak and aortic-related mortality declined significantly from Q1-Q2 to Q3-Q4 (24.1% to 15.5%, p=0.033 and 18.6% vs 8.2%, p=0.006, respectively). Operative time (p=0.021), contrast volume (p=0.016), and fluoroscopy time (p=0.004) were independent risk factors for endoleak, causing a 1.3-fold risk increase for both each 60 minutes of additional operative time (p=0.021) and every 100 mL of additional contrast medium (p=0.016). Each 10-minute increase in fluoroscopy time determined a 1.4-fold risk increment (p=0.004). CONCLUSION: The learning curve shortened significantly over time with non-negligible clinical outcome improvements, suggesting that specific endovascular training is mandatory to become an effective TEVAR performer. CLINICAL IMPACT: For the first time in literature, the standard TEVAR's learning curve has been evaluated at a single vascular surgery center over a period of 25 years. The learning curve for the center and the first physician historically undertaking TEVAR was achieved at the 75th treated patient. The learning curve of the surgeons coming thereafter was significantly shorter (10 cases). This quarter-century demonstrated that intraoperative learning-related variables were associated with long-term clinical outcomes and all have improved over time. Centers approaching TEVAR for the first time and training program providers could use these data to aim to offer better clinical outcomes.

Incidence, Long Term Clinical Outcomes, and Risk Factor Analysis of Type III Endoleaks Following Endovascular Repair of Abdominal Aortic Aneurysm.

OBJECTIVE: To assess the real world incidence, outcomes, and risk factors of type III endoleaks (TIIIEL) after endovascular aneurysm repair (EVAR). METHODS: This was a single centre, retrospective, observational, cohort study. All patients with abdominal aortic aneurysms (AAAs) receiving EVAR between 1994 and 2020 were collected prospectively and reviewed. The primary outcome was the cumulative incidence and impact on survival of TIIIELs, either defined as disconnections of modular graft components (TIIIaEL) or fabric defects (TIIIbEL). Secondary outcomes included risk factor analysis evaluating baseline morphological and stent graft details, as well as a comparison of TIIIaEL and TIIIbEL. RESULTS: In total, 2 565 EVARs were performed and 95 (3.7%) TIIIELs were diagnosed at a median interval of 49.5 months (interquartile range [IQR] 19.4, 67.6). Estimated TIIIEL incidence at five years was 6.8%, 2.2%, and 3.6% for first and second generation, third and fourth generation, and fifth and sixth generation, respectively. The survival rate in patients without any high flow endoleak was 88.0%, 67.9%, 56.9%, and 52.1%, while in TIIIEL patients it was 98.6%, 77.2%, 49.8%, and 32.3% at one, five, 10, and 15 years, respectively (p = .77). The distribution of TIIIaEL and TIIIbEL was 70.5% and 29.5%, respectively. TIIIbEL received a higher rate of open treatment (28.6% vs. 7.5%; p = .005) and device or procedure related re-interventions (35.7% vs. 13.4%; p = .013). Fourteen (15.4%) recurrent TIIIELs were diagnosed at a median of 16.8 months (IQR 7.6, 32.1). Old generation endografts (hazard ratio [HR] 2.1, 95% confidence interval [CI] 1.3 - 3.4; p = .002) and non-proprietary extensions (HR 3.6, 95% CI 1.9 - 6.8; p < .001), and angulated and calcified aneurysm neck (HR 3.6, 95% CI 1.2 - 10.6; p = .017) were risk factors for TIIIEL. Every 10 mm maximum AAA diameter increase presented a 1.4 fold higher risk of TIIIEL. CONCLUSION: TIIIEL is a severe condition that is often fatal if left untreated. Old endografts, the implantation of non-proprietary extensions, large AAAs, and angulated and calcified necks are risk factors for TIIIEL that require careful follow up due to the high rate of recurrence.

Systematic review and meta-analysis of long-term reintervention following thoracic endovascular repair for blunt traumatic aortic injury.

OBJECTIVE: To investigate the long-term reinterventions of thoracic endovascular repair (TEVAR) after blunt traumatic aortic injury. METHODS: MEDLINE, EMBASE, and Cochrane databases were interrogated until June 2021. Inclusion criteria were blunt traumatic aortic injury treated with TEVAR and mean follow-up of more than 60 months. A systematic review was conducted and data were pooled using a random effects model of proportions applying the Freeman-Tukey transformation. Late reintervention was the primary outcome. Secondary outcomes were procedure-related complications (endoleak, in-stent thrombosis, occlusion, infolding/collapse, bird-beak, migration, and left arm claudication), overall and aortic-related mortality, and aortic diameter changes. RESULTS: Eleven studies with a low quality assessment were included. Four hundred eight patients were collected and the 389 surviving more than 30 days were included. The mean follow-up was 8.2 years (95% confidence interval [CI], 5.7-10.8; I2 = 40.2%). Late reintervention was 2.1% (95% CI, 0.6-3.9; I2 = 0.0%; 11/389 cases) with 0.1% (95% CI, 0.0-1.2; I2 = 0.0%; 3/389) occurring after 5 years. Bird-beak was identified in 38.7% (95% CI, 16.4-63.6; I2 = 86.6%). Left arm claudication occurring after 30 days was 3.1% (95% CI, 0.1-8.6; I2 = 26.9%; 11/140 cases). In-stent thrombosis was 1.9% (95% CI, 0.1-5.2; I2 = 51.8%; 11/389 cases). Endoleak was 0.5% (95% CI, 0.0-1.9; I2 = 0.0%; 5/389 cases). Infolding, occlusion, and migration were reported in 2 of 389, 1 of 389, and 0 of 389 patients, respectively. Overall late survival was 95.6% (95% CI, 88.1-99.8; I2 = 84.7%; 358/389 patients) and only one patient accounted for aortic related mortality. The increase in proximal and distal aortic diameters was estimated at 2.7 mm (95% CI, 1.2-4.3; I2 = 0.0%) and 2.5 mm (95% CI, 1.1-3.9; I2 = 0.0%), respectively. CONCLUSIONS: TEVAR demonstrates remarkably good long-term results and reinterventions are rarely required. Aortic reinterventions tend to occur within the first and after the fifth year.