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Background and aimsPortal vein thrombosis (PVT) negatively impacts the prognosis in patients with cirrhosis. The aim of our study was to evaluate the effects of transjugular intrahepatic portosystemic shunt (TIPS) placement in patients with cirrhosis complicated by PVT.MethodsSeventy consecutive cirrhotic patients with non-tumoural PVT treated with TIPS for portal hypertension complications from January 2003 to February 2010 in a tertiary-care centre were followed until last clinical evaluation, liver transplantation, or death.ResultsTIPS was successfully placed without major procedure-related complications. After TIPS, the portal venous system was completely recanalised in 57% of patients, a marked decrease in thrombosis was observed in 30%, and no improvement was seen in 13%. 95% of patients with complete recanalisation after TIPS maintained a patent portal vein. Predictors of complete recanalisation were a less severe and extensive PVT, de novo diagnosis of PVT, and absence of gastro-oesophageal varices. At follow-up, 1 patient had recurrence of bleeding, and 2 had spontaneous bacterial peritonitis. The rate of TIPS dysfunction at 12 and 24 months was 38% and 85% for bare stent and 21% and 29% for covered stent (p=0.001), respectively. Occurrence of encephalopathy at 12 and 24 months was 27% and 32%, respectively. Fifteen patients underwent liver transplantation. Survival at 1, 12 and 24 months was 99%, 89% and 81%, respectively.ConclusionLong-term outcome of non-tumoural PVT in patients with cirrhosis treated with TIPS placement is excellent. Prospective randomised studies should investigate whether TIPS placement is the best therapeutic option in patients with cirrhosis who develops non-tumoural PVT.

Additive manufacturing (AM) is a group of processes which manufacture a part by adding sequential layers of material on each other. In the last decade, these processes have been extensively applied in industry for constructing small volumes of complex, customized parts. Since parts are built layer-by-layer, the build orientation affects the surface quality and the total cost of the part. The search for optimal build orientation is not trivial since these factors are, typically, in conflict with each other. The major limitation of the methods described in the literature to choose the optimal build direction is in the insufficient accuracy of the estimates of the manufacturing cost and of the surface quality. These factors are very complex to be estimated, and accuracy in their evaluation requires methods that are very time-consuming. On the contrary, in practical use, a multi-objective optimization process requires an objective function that is reliable and easy to be evaluated. In order to overcome these problems, in this paper, original methods to estimate the manufacturing cost and surface quality as a function of build orientation are presented. They are implemented, for the fused deposition modeling (FDM) technology, in a multi-objective optimization problem that is solved by an S-metric selection evolutionary multi-objective algorithm (SMS-EMOA), obtaining an approximation of the Pareto front. The final selection of the recommended orientation is performed by the Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) method. Properly designed case studies are used to evaluate the reliability of the proposed method, and the results are compared with the state-of-the-art method to find optimal build orientation.

Abstract Introduction: Intratumoral administration of pexa-vec (pexastimogene devacirepvec), an oncolytic and immunotherapeutic vaccinia virus, given to patients with hepatocellular carcinoma (HCC), is associated with both local and distant tumor responses. We hypothesized subsequent treatment with sorafenib could demonstrate superior efficacy. Methods: This random phase III open-label study evaluated the sequential treatment with pexa-vec followed by sorafenib compared to sorafenib in patients with advanced HCC and no prior systemic treatment. The primary endpoint is overall survival (OS). Key secondary endpoints included time to progression (TTP), progression-free survival, overall response rate (ORR), and disease control rate (DCR). Safety was assessed in all patients who received ≥1 dose of study treatment. Results: The study was conducted at 142 sites in 16 countries. From December 30, 2015, to the interim analysis on August 2, 2019, 459 patients were randomly assigned (pexa-vec plus sorafenib: 234, sorafenib: 225). At the interim analysis, the median OS was 12.7 months (95% CI: 9.89, 14.95) in the pexa-vec plus sorafenib arm and 14.0 months (95% CI: 11.01, 18.00) in the sorafenib arm. This led to the early termination of the study. The median TTP was 2.0 months (95% CI: 1.77, 2.96) and 4.2 months (95% CI: 2.92, 4.63); ORR was 19.2% (45 patients) and 20.9% (47 patients); and DCR was 50.0% (117 patients) and 57.3% (129 patients) in the pexa-vec plus sorafenib and sorafenib arms, respectively. Serious adverse events were reported in 117 (53.7%) patients in the pexa-vec plus sorafenib and 77 (35.5%) patients in the sorafenib arm. Liver failure was the most frequently reported in both groups. Conclusion: Sequential pexa-vec plus sorafenib treatment did not demonstrate increased clinical benefit in advanced HCC and fared worse compared to sorafenib alone. The advent of the added value of checkpoint inhibitors should direct any further development of oncolytic virus therapy strategies.

ObjectivesTo evaluate short-term clinical efficacy, complications and possible passive stent expansion of transjugular intrahepatic portosystemic shunt (TIPS) creation using the new controlled expansion ePTFE covered stent (VCX), for portal hypertension complications.MethodsBetween 7/2016 and 3/2018, 75 patients received TIPS using VCX. Thirty-nine patients with VCX dilated with an 8-mm angioplasty balloon underwent computed tomography (CT) study during follow-up and CT data were used to measure stent diameter. The CT measurement technique was validated by ex vivo experiment.ResultsTIPS indications were: refractory ascites (n = 45), variceal bleeding (n = 22), other (n = 8). Mean follow-up was 5.8 months (± 4.5, range 1–20). In 69 patients, TIPS was dilated to 8 mm of diameter reaching the hemodynamic target of a portosystemic pressure gradient (PSG) < 12 mmHg. In six patients, not reaching the hemodynamic target the stent was dilated to 10 mm of diameter during the same session with a final PSG < 12 mmHg. Overall clinical success was achieved in 66/75 (88%) patients (80% in refractory ascites, 95% variceal bleeding, 100% other). Grade II–III encephalopathy was observed in five patients (6%). TIPS revision with stent dilatation to 10 mm was performed in seven patients: in three patients with ascites persistence, without evidence of stent dysfunction and in four patients for stent stenosis. One patient underwent stent reduction. Fourteen patients (18%) died during follow-up of causes not related to TIPS. Five patients (6%) underwent liver transplant. No passive stent expansion was detected by CT measurements.ConclusionVCX for TIPS creation retains its diameter over a short-term period and is associated with a good clinical outcome with a reasonably low complication rate.

PurposeThe primary aim of this study is to provide a summary of operators’ radiation doses during hepatobiliary fluoroscopic guided procedures. In addition, patient dose in these procedures was also documented.Materials and MethodsA total of 283 transarterial chemoembolisation (TACE) and 302 biliary procedures, including 52 percutaneous transhepatic cholangiogram (PTC), 36 bilioplasty and 214 biliary catheter changes (BCC) performed over 14 months, were included. Electronic personal dosimeters were used to measure operator radiation doses. Effective dose (E) was calculated using modified Niklason algorithm. Patient dose was measured as dose area product (DAP) and fluoroscopy time (FT).ResultsFor TACE, E for radiologist ranged between 0 and 9.96 µSv, for radiographer 0–0.99 µSv and for nurse 0–4.65 µSv. The patient DAP and FT ranged between 1.5 and 421.9 Gy cm2 and 1.91–67.25 min. For PTC, E for the radiologist ranged between 0.33 and 55.89 µSv, for radiographer 0–38.61 µSv and for nurse 0–3.18 µSv. Patient DAP and FT ranged between 1.7 and 218.4 Gy cm2 and 2.07–71.53 min. For bilioplasty, E ranged between 0.09 and 9.24 µSv for radiologist, 0–0.84 µSv for radiographer and 0–1.38 µSv for nurse. The patients’ DAP and FT ranged from 0.7 to 52.54 Gy cm2 and 1.13–24.47 min. For BCC, E ranged from 0 to 12.78 µSv for radiologist, 0–8.43 µSv for radiographer and 0–4.05 µSv for nurse. Patient DAP and FT ranged between 0.12 and 117.3 Gy cm2 and 0.57–15.83 min.ConclusionsThis study shows that doses to all operators performing hepatobiliary interventional procedures can be very low.

Background To evaluate incidence, risk factors, and outcomes of postoperative neurological complications in patients undergoing cardiac surgery. Methods A total of 2121 patients underwent cardiac surgery between August, 2008 and December, 2013; 91/2121 (4.3%) underwent brain computed tomography (70/91, 77%) or magnetic resonance imaging (21/91, 23%) scan because of major stroke (37/2121, 1.7%) and a spectrum of transient neurological episodes as well as transient ischemic attacks and delirium /psychosis/seizures (54/2121, 2.5%). The mean age was 65.3 ± 12.1 years and 60 (65.9%) were male. Variables were compared among study- and matched-patients ( n  = 113) without neurological deficits. Results A total of 37/2121 (1.7%) patients had imaging evidence of stroke. Radiological examinations were done 5.72 ± 3.6 days after surgery. Patients with and without imaging evidence of stroke had longer intensive care unit length of stay (LOS) (13.8 ± 14.7 and 12.9 ± 15 days vs. 5.7 ± 12.1 days, respectively ( p  < 0.001) and hospital LOS (53 ± 72.8 and 35.5 ± 29.8 days vs. 18.4 ± 29.2 days, respectively (p < 0.001) than the control group. The hospital mortality of patients with and without imaging evidence of stroke was higher than the control group (7/37 patients [19%], and 12/54 patients [22%] vs. 4/115 patients [3%], respectively (p < 0.001). Multivariate analysis showed that bilateral internal carotid artery stenosis of any grade ( p  < .001), and re-do operations ( p  = .013) increased the risk of postoperative neurological complications. Conclusions Neurological complications after cardiac surgery increase hospitalization and mortality even in patients without radiologic evidence of stroke. Bilateral internal carotid artery stenosis of any grade, suggesting a diffuse patient propensity toward atherosclerosis, and re-do operations increase the risk of postoperative neurological complications.

By additive manufacturing technologies, an object is produced deposing material layer by layer. The piece grows along the build direction, which is one of the main manufacturing parameters of Additive Manufacturing (AM) technologies to be set-up. This process parameter affects the cost, quality, and other important properties of the manufactured object. In this paper, the Objective Functions (OFs), presented in the literature for the search of the optimal build direction, are considered and reviewed. The following OFs are discussed: part quality, surface quality, support structure, build time, manufacturing cost, and mechanical properties. All of them are distinguished factors that are affected by build direction. In the first part of the paper, a collection of the most significant published methods for the estimation of the factors that most influence the build direction is presented. In the second part, a summary of the optimization techniques adopted from the reviewed papers is presented. Finally, the advantages and disadvantages are briefly discussed and some possible new fields of exploration are proposed.

Selective laser melting (SLM) is the most widely used laser powder-bed fusion (L-PBF) technology for the additive manufacturing (AM) of parts from metallic powders. The surface quality of the SLM parts is highly dependent on many factors and process parameters. These factors include the powder grain size, the layer thickness, and the building angle. This paper conducted an experimental analysis of the effects of SLM process parameters on the surface quality of CuCrZr cubic specimens. Thanks to its excellent thermal and mechanical properties, CrCrZr has become one of the most widely used materials in SLM technology. The specimens have been produced with different combinations of layer thickness, laser patterns, building angles, and scanning speed, keeping the energy density constant. The results show how different combinations of parameters affect the surface quality macroscopically (i.e., layer thickness, building angle, and scanning speed); in contrast, other parameters (i.e., laser pattern) do not seem to have any contributions. By varying these parameters within typical ranges of the AM machine used, variations in surface quality can be achieved from 10.4 µm up to 40.8 µm. These results represent an important basis for developing research activities that will further focus on implementing a mathematical/experimental model to help designers optimize the surface quality during the AM pre-processing phase.

The aim of this study is to investigate the integration of Shape Memory Alloy (SMA) torque tubes into SmallSats’ thermal management systems to passively deploy radiator panels in an autonomous manner. Specific aspects of the investigation are related to material production, thermomechanical characterization, structural integration, and assessment of overall prototype functionalities. Implementation feasibility was evaluated through a 12U CubeSat test case. Starting with NiTi tubes (50.8% at Ni.) intended for pseudoelastic applications, a combined aging and shape-setting heat treatment process was selected to achieve both SME characteristics and an S-shaped geometric configuration. Comprehensive material characterization was conducted using differential scanning calorimetry (DSC) and mechanical testing to evaluate post-treatment phase transformation temperatures (PTTs) and torsional load response. Experimental results demonstrated the actuator’s capacity to fully recover imposed rotations exceeding 90° against resisting torques up to 0.1 Nm. Material cyclic stability analysis revealed rapid stabilization after four cycles, with maintained performance through 80 cycles. The experimental validation culminated in benchtop prototype testing, which achieved an 85° deployment rotation, evidencing the viability of the proposed mechanism.