Effect of cannula insertion site during fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia on preterm prelabor rupture of membranes.

OBJECTIVE: To assess whether the cannula insertion site on the maternal abdomen during fetal endoscopic tracheal occlusion (FETO) for congenital diaphragmatic hernia (CDH) was associated with preterm prelabor rupture of membranes (PPROM) before balloon removal. METHODS: This was a multicenter retrospective study of consecutive pregnancies with isolated left- or right-sided CDH that underwent FETO in four centers between January 2009 and January 2021. The site for balloon insertion was categorized as above or below the umbilicus. One propensity score was analyzed in both groups to calculate an average treatment effect (ATE) by inverse probability of treatment weighting. Logistic regression and Cox proportional hazard regression including the ATE weights were performed to examine the effect size of entry point on the frequency and timing of PPROM before balloon removal. RESULTS: A total of 294 patients were included. The mean ± SD gestational age at PPROM was 33.45 ± 2.01 weeks and the mean rate of PPROM before balloon removal was 25.9% (76/294). Gestational age at FETO was later in the below-umbilicus group (mean ± SD, 29.47 ± 1.29 weeks vs 29.00 ± 1.25 weeks; P = 0.002) and the duration of FETO was longer in the above-umbilicus group (median, 14.49 min (interquartile range (IQR), 8.00-21.00 min) vs 11.00 min (IQR, 7.00-14.49 min); P = 0.002). After balancing for possible confounding factors, trocar entry point below the umbilicus did not increase the risk of PPROM before balloon removal (adjusted odds ratio, 1.56 (95% CI, 0.89-2.74); P = 0.120) and had no effect on the timing of PPROM before balloon removal (adjusted hazard ratio, 1.56 (95% CI, 0.95-2.55); P = 0.080). CONCLUSION: There was no evidence that uterine entry site for FETO was correlated with the risk of PPROM before balloon removal. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.

A Mathematical Model of Diel Activity and Long Time Survival in Phototrophic Mixed-Species Subaerial Biofilms.

Subaerial biofilms (SAB) are intricate microbial communities living on terrestrial surfaces, of interest in a variety of contexts including cultural heritage preservation, microbial ecology, biogeochemical cycling, and biotechnology. Here we propose a mathematical model aimed at better understanding the interplay between cyanobacteria and heterotrophic bacteria, common microbial SAB constituents, and their mutual dependence on local environmental conditions. SABs are modeled as thin mixed biofilm-liquid water layers sitting on stone. A system of ordinary differential equations regulates the dynamics of key SAB components: cyanobacteria, heterotrophs, polysaccharides and decayed biomass, as well as cellular levels of organic carbon, nitrogen and energy. These components are interconnected through a network of energetically dominant metabolic pathways, modeled with limitation terms reflecting the impact of biotic and abiotic factors. Daily cylces of temperature, humidity, and light intensity are considered as input model variables that regulate microbial activity by influencing water availability and metabolic kinetics. Relevant physico-chemical processes, including pH regulation, further contribute to a description of the SAB ecology. Numerical simulations explore the dynamics of SABs in a real-world context, revealing distinct daily activity periods shaped by water activity and light availability, as well as longer time scale survivability conditions. Results also suggest that heterotrophs could play a substantial role in decomposing non-volatile carbon compounds and regulating pH, thus influencing the overall composition and stability of the biofilm.

Long-term results of arthroscopic repair of type II SLAP lesions in sports: assessment of return to pre-injury playing level and critical risk factors for complication.

PURPOSE: The management of isolated SLAP lesions is still debated especially in athletes. Aims of the study were: 1. to analyse our algorithm to treat SLAP lesions starting from the selection of patients for surgery and 2. to correlate the familiarity for diabetes and hypothyroid disorders with post-operative results. METHODS: Seventy-eight patients with isolated SLAP lesion were arthroscopically treated using knotless anchors and microfractures. All patients had a pre-operative and post-operative clinical examination according to Walch-Duplay, Constant, Rowe and Dash scores and interviewed for familiarity to diabetes and hypothyroid disorders. RESULTS: About 68.8% of patients solved pain with rehabilitation. About 29% of patients returned to the sports activities. About 32% of patients were no responder to physiotherapy and were arthroscopically treated. About 53.9% of patients responded excellent, 34.7% good, 3.8% medium and 7.6% poor results according to Walch-Duplay score. The Constant score increased from 64 to 95, the Rowe score from 48 to 96. The outcomes were significantly worse in patients with familiarity for diabetes. CONCLUSIONS: Microfractures and knotless anchor give long-term good results for the treatment of SLAP lesions in athletes. The familiarity for diabetes is an important risk factor that can lead to decreased outcomes.

Responding to a school SARS-CoV-2 outbreak: Insights and policy implications emerging from the pandemic.

Background: The SARS-CoV-2 pandemic has affected also the school environment. Prolonged closures and the weakness of available data prevent a definitive answer to the question of school transmission. We report our experience of responding to COVID-19 cases in the school setting, presenting a case study of the management of an outbreak in a large school. Methods: The LHA/ASL Roma 1 has organized the School Units with a structure firmly rooted in the territory. At the local level, the District Unit mainly manages the relationship with schools, while the Hygiene and Public Health Service of the Prevention Department holds a coordinating and facilitating role. The HPHS carries out contact tracing activities facilitated by the schools, through the figure of the COVID-19 Contact Person, who is specifically trained to manage the preliminary stages of the reports. Results: Following several reports of COVID-19 suspect cases from two schools and, after a complex phase of contact tracing, it was possible to identify the major transmission chains. Furthermore, we performed a population-based screening on the entire school. Beyond the known transmission chains, for which quarantine was already in place, only five additional cases emerged, all asymptomatic, out of 1,231 swabs tested with RT-PCR. Conclusions: Our experience confirms that an active interaction between the school and the School Unit made it possible to quickly control a potentially dangerous outbreak. The large-scale screening test demonstrated the substantial absence of collateral transmission chains. Effective contact tracing allowed to set forth a successful response. Our model of intervention can be used to support public health protocols regarding school outbreaks.

Umbilical venous diameter and flow in monochorionic diamniotic twin pregnancy: association with placental sharing and fetal demise.

OBJECTIVE: To examine the association of umbilical venous diameter and flow in monochorionic diamniotic twin pregnancy with placental sharing and fetal demise. METHODS: This was a prospective longitudinal cohort study of a consecutive series of monochorionic diamniotic twin pregnancies that underwent ultrasound assessments at 12, 16, 20 and 28 weeks' gestation. Fetal biometry (crown-rump length at 12 weeks or estimated fetal weight (EFW) thereafter) and cord insertion sites were recorded at each visit, as well as the diameter of the umbilical vein (UV) in both the intra-abdominal part and a free loop of the umbilical cord. Time-averaged maximum velocity in the intra-abdominal part of the UV was measured to calculate UV-flow. Univariate and multivariate linear regression analyses were performed to assess the relationship between intertwin ratios of these variables and placental sharing at 12, 16, 20 and 28 weeks' gestation. Placental sharing was calculated by dividing the larger by the smaller placental share, as measured on placental injection studies after birth. Additionally, the Mann-Whitney U-test and receiver-operating-characteristics-curve analysis were used to explore the relationship between the occurrence of fetal demise and intertwin differences in fetal biometry, cord insertion sites, UV diameters and flow at 12, 16, 20 and 28 weeks. RESULTS: Of 200 consecutive monochorionic twin pregnancies enrolled, injection studies were performed in 165 (82.5%) placentas. On univariate analysis, intertwin differences in fetal biometry, cord insertions and UV variables were associated significantly with placental sharing at 12, 16, 20 and 28 weeks' gestation. On multivariate analysis, intertwin differences in fetal biometry, cord insertions and all three UV variables remained associated significantly with placental sharing at 12 and 16 weeks. However, at 20 and 28 weeks, only the intertwin EFW ratio was associated consistently with placental sharing. Fetal demise of one or both twins complicated 26 (13.0%) pregnancies. Differences in EFW and cord insertion sites were not associated significantly with fetal demise, while at 16 weeks, differences in intra-abdominal UV diameter and flow were associated with an increased risk of subsequent fetal demise. CONCLUSIONS: At 12 and 16 weeks' gestation, intertwin differences in UV diameter and flow reflect placental sharing more accurately than do differences in fetal growth and cord insertion sites. At 16 weeks, discordance in intra-abdominal UV diameter and flow is also associated with an increased risk of fetal demise. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.

Moderate-to-severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real-world experience.

BACKGROUND: Moderate-to-severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side-effects. Dupilumab was recently approved for treatment of adolescent AD. OBJECTIVES: A multicentre, prospective, real-world study on the effectiveness and safety of dupilumab in adolescents (aged from ≥12 to <18 years) with moderate-to-severe AD was conducted. The main AD clinical phenotypes were also examined. METHODS: Data of adolescents with moderate-to-severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes. RESULTS: One hundred and thirty-nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait-like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS-CoV-2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty-eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event. CONCLUSIONS: Dupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID-19 pandemic era.

Effect of Exoskeleton-Assisted Rehabilitation Over Prefrontal Cortex in Multiple Sclerosis Patients: A Neuroimaging Pilot Study.

Application of a passive and fully articulated exoskeleton, called Human Body Posturizer (HBP), has been demonstrated to improve mobility, response accuracy and ambulation in multiple sclerosis (MS) patients. By using functional magnetic imaging (fMRI) during a visuomotor discrimination task, we performed a pilot study to evaluate the effect of HBP over the neural correlates of motor and cognitive functions which are typically impaired in MS patients. Specifically, we tested the effect of a 6-week multidisciplinary rehabilitation intervention on two groups of MS patients: a control group who followed a standard physiotherapeutic rehabilitation protocol, and an experimental group who used the HBP during physical exercises in addition to the standard protocol. We found that, after treatment, the experimental group exhibited a significant lower activity (as compared to the control group) in the inferior frontal gyrus. This post-treatment activity reduction can be explained as a retour to a normal range, being the amount of iFg activity observed in the experimental patients very similar to that observed in healthy subjects. These findings indicate that the use of HBP during rehabilitation intervention normalizes the prefrontal activity, mitigating the cortical hyperactivity associated to MS.

Intrapulmonary artery Doppler to predict mortality and morbidity in fetuses with mild or moderate left-sided congenital diaphragmatic hernia.

OBJECTIVES: In fetuses with isolated left-sided congenital diaphragmatic hernia (LCDH), prenatal detection of severe pulmonary hypoplasia is important, as fetal therapy can improve survival. Cases with mild or moderate lung hypoplasia still carry a considerable risk of mortality and morbidity, but there has been less interest in the accurate prediction of outcome in these cases. In this study of fetuses with mild or moderate isolated LCDH, we aimed to investigate: (1) the association between intrapulmonary artery (IPA) Doppler findings and mortality at discharge; (2) whether adding IPA Doppler findings improves the prediction of mortality based on lung size and liver herniation; and (3) the association between IPA Doppler findings and early neonatal morbidity. METHODS: This was a retrospective study of all consecutive fetuses assessed at the BCNatal and UZ Leuven hospitals between 2008 and 2020 with a prenatal diagnosis of isolated, non-severe LCDH, defined as observed-to-expected lung-to-head ratio (o/e-LHR) > 25%, that were managed expectantly during pregnancy followed by standardized neonatal management. An additional inclusion criterion was the availability of IPA Doppler measurements. The primary outcome was the association between IPA Doppler findings and mortality at discharge. Other predictors included o/e-LHR, liver herniation and gestational age at birth. Secondary outcomes were the association between IPA Doppler findings and the presence of pulmonary hypertension (PHT), need for supplemental oxygen at discharge and need for extracorporeal membrane oxygenation. IPA pulsatility index (PI) values were converted into Z-scores. Logistic regression analysis was performed to investigate the associations between predictor variables and outcome, and the best model was chosen based on the Nagelkerke R2 . RESULTS: Observations for 70 non-severe LCDH cases were available. Fifty-four (77%) fetuses survived until discharge. On logistic regression analysis, higher IPA-PI was associated with an increased risk of mortality (odds ratio (OR), 3.96 (95% CI, 1.62-9.70)), independently of o/e-LHR (OR, 0.87 (95% CI, 0.79-0.97)). An IPA-PI Z-score cut-off of 1.8 predicted mortality with a detection rate of 69% and specificity of 93%. Adding IPA-PI to o/e-LHR improved significantly the model's performance (Nagelkerke R2 , 46% for o/e-LHR + IPA-PI vs 28% for o/e-LHR (P < 0.002)), with a detection rate of 81% at a 10% false-positive rate. IPA-PI was associated with PHT (OR, 2.20 (95% CI, 1.01-4.59)) and need for oxygen supplementation at discharge (OR, 1.90 (95% CI, 1.10-3.40)), independently of lung size. CONCLUSIONS: In fetuses with mild or moderate LCDH, IPA-PI was associated with mortality and morbidity, independently of lung size. A model combining o/e-LHR with IPA-PI identified up to four in five cases that eventually died, despite being considered to have non-severe pulmonary hypoplasia. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Safety and efficacy of smart tracheal occlusion device in diaphragmatic hernia lamb model.

OBJECTIVE: To investigate the efficacy and safety of the 'smart' tracheal occlusion (Smart-TO) device in fetal lambs with diaphragmatic hernia (DH). METHODS: DH was created in fetal lambs on gestational day 70 (term, 145 days). Fetuses were allocated to either pregnancy continuation until term (DH group) or fetoscopic endoluminal tracheal occlusion (TO), performed using the Smart-TO balloon on gestational day 97 (DH + TO group). On gestational day 116, the presence of the balloon was confirmed on ultrasound, then the ewe was walked around a 3.0-Tesla magnetic resonance scanner for balloon deflation, which was confirmed by ultrasound immediately afterwards. At term, euthanasia was performed and the fetus retrieved. Efficacy of occlusion was assessed by the lung-to-body-weight ratio (LBWR) and lung morphometry. Safety parameters included tracheal side effects assessed by morphometry and balloon location after deflation. The unoccluded DH lambs served as a comparator. RESULTS: Six fetuses were included in the DH group and seven in the DH + TO group. All balloons deflated successfully and were expelled spontaneously from the airways. In the DH + TO group, in comparison to controls, the LBWR at birth was significantly higher (1.90 (interquartile range (IQR), 1.43-2.55) vs 1.07 (IQR, 0.93-1.46); P = 0.005), while on lung morphometry, the alveolar size was significantly increased (mean linear intercept, 47.5 (IQR, 45.6-48.1) vs 41.9 (IQR, 38.8-46.1) µm; P = 0.03); whereas airway complexity was lower (mean terminal bronchiolar density, 1.56 (IQR, 1.0-1.81) vs 2.23 (IQR, 2.14-2.40) br/mm2 ; P = 0.005). Tracheal changes on histology were minimal in both groups, but more noticeable in fetal lambs that underwent TO than in unoccluded lambs (tracheal score, 2 (IQR, 1-3) vs 0 (0-1); P = 0.03). CONCLUSIONS: In fetal lambs with DH, TO using the Smart-TO balloon is effective and safe. Occlusion can be reversed non-invasively and the deflated intact balloon expelled spontaneously from the fetal upper airways. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Optimal gestational age at delivery in isolated left-sided congenital diaphragmatic hernia.

OBJECTIVE: To evaluate the morbidity and mortality of neonates with left-sided isolated congenital diaphragmatic hernia (CDH) according to gestational age at delivery. METHODS: This was a retrospective study of fetuses diagnosed prenatally with isolated left-sided CDH that were delivered in the University Hospitals of Antoine Béclère-Bicêtre and Leuven between 1 January 2010 and 31 December 2018. The Kaplan-Meier method was used to calculate cumulative survival at 28 days after birth according to gestational age at delivery. The association between gestational age at delivery, as a continuous variable, and survival at 28 days was modeled using a fractional polynomial. Adjustment for position of the liver, management center and mode of delivery was performed. The association was also evaluated according to the severity of CDH, as defined by the observed-to-expected lung-to-head ratio (o/e-LHR), which was classified as severe (o/e-LHR < 25%), moderate (o/e-LHR between 25% and 45%) or mild (o/e-LHR > 45%). RESULTS: We included 213 fetuses with isolated left-sided CDH, with a median gestational age at delivery of 38 + 2 weeks (interquartile range, 37 + 0 to 39 + 1 weeks). The survival rates at 28 days and at 6 months were 66.7% (142/213) and 64.3% (137/213), respectively. Kaplan-Meier analysis showed a higher survival rate at 28 days for babies delivered between 37 + 0 and 38 + 6 weeks than for those delivered at or after 39 + 0 weeks (log-rank test, P < 0.001). In the subgroup of moderate CDH, the 28-day survival rate was significantly higher in newborns delivered between 37 + 0 and 38 + 6 weeks than in those delivered at or after 39 + 0 weeks (81.5% vs 61.5%; P = 0.03), and this was also the case for survival rate at 6 months. In the subgroup with moderate CDH, 28-day survival significantly increased with advancing gestational age at birth up to about 38-39 weeks (P = 0.005), and significantly decreased from 39 weeks onwards. CONCLUSION: Delivery between 37 + 0 and 38 + 6 weeks' gestation is associated with a higher survival rate at 28 days in neonates with isolated left-sided CDH and moderate lung hypoplasia, independently of intrathoracic liver, management center and mode of delivery. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Fetal endoscopic tracheal occlusion reverses the natural history of right-sided congenital diaphragmatic hernia: European multicenter experience.

OBJECTIVE: To evaluate the neonatal outcome of fetuses with isolated right-sided congenital diaphragmatic hernia (iRCDH) based on prenatal severity indicators and antenatal management. METHODS: This was a retrospective review of prospectively collected data on consecutive cases diagnosed with iRCDH before 30 weeks' gestation in four fetal therapy centers, between January 2008 and December 2018. Data on prenatal severity assessment, antenatal management and perinatal outcome were retrieved. Univariate and multivariate logistic regression analysis were used to identify predictors of survival at discharge and early neonatal morbidity. RESULTS: Of 265 patients assessed during the study period, we excluded 40 (15%) who underwent termination of pregnancy, two cases of unexplained fetal death, two that were lost to follow-up, one for which antenatal assessment of lung hypoplasia was not available and six cases which were found to have major associated anomalies or syndromes after birth. Of the 214 fetuses with iRCDH included in the neonatal outcome analysis, 86 were managed expectantly during pregnancy and 128 underwent fetal endoscopic tracheal occlusion (FETO) with a balloon. In the expectant-management group, lung size measured by ultrasound or by magnetic resonance imaging was the only independent predictor of survival (observed-to-expected lung-to-head ratio (o/e-LHR) odds ratio (OR), 1.06 (95% CI, 1.02-1.11); P = 0.003). Until now, stratification for severe lung hypoplasia has been based on an o/e-LHR cut-off of 45%. In cases managed expectantly, the survival rate was 15% (4/27) in those with o/e-LHR ≤ 45% and 61% (36/59) for o/e-LHR > 45% (P = 0.001). However, the best o/e-LHR cut-off for the prediction of survival at discharge was 50%, with a sensitivity of 78% and specificity of 72%. In the expectantly managed group, survivors with severe pulmonary hypoplasia stayed longer in the neonatal intensive care unit than did those with mildly hypoplastic lungs. In fetuses with an o/e-LHR ≤ 45% treated with FETO, survival rate was higher than in those with similar lung size managed expectantly (49/120 (41%) vs 4/27 (15%); P = 0.014), despite higher prematurity rates (gestational age at birth: 34.4 ± 2.7 weeks vs 36.8 ± 3.0 weeks; P < 0.0001). In fetuses treated with FETO, gestational age at birth was the only predictor of survival (OR, 1.25 (95% CI, 1.04-1.50); P = 0.02). CONCLUSIONS: Antenatal measurement of lung size can predict survival in iRCDH. In fetuses with severe lung hypoplasia, FETO was associated with a significant increase in survival without an associated increase in neonatal morbidity. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Debris production in bovine bone during implant site preparation. A comparative in vitro study: ultrasonic and drilling procedures.

The aim of this study was to compare the size and shape of bone fragments produced by the ultrasonic and drilling procedures in implant site preparation. Six pieces of rib selected as experimental animal model of 15 cm in length and at least 13 mm of thickness were used. The samples were treated and divided into 2 groups as follows: group A (GA) ultrasonic implant site preparation technique; group B (GB) traditional surgical drill technique. Ultrasonic implant site preparation (GA) was carried out using a sequence of progressive diameter (1.00 mm, 2.00 mm and 3.00 mm) conical inserts at a depth of 10 mm. Standard drill implant site procedure (GB) was carried out with a sequence of 1.00 mm, 2.00 mm, and 3.00 mm cylindrical twist drills, for preparing an implant site at a depth of 10 mm. From each group bone fragments (0.1 gr) were collected from both cortical and cancellous bone preparation and their dimensions were evaluated by optic microscope analysis. The bone debris dimensions procured by cortical bone of Group A and Group B were, respectively, 0.14×0.16 mm (±0.13) and 1.15 ×0.92 mm (±0.68). The bone debris dimensions procured by cancellous bone of Group A and Group B were, respectively, 0.15×0.10 mm (±0.10) and 1.98×1.27 mm (±0.94). Ultrasonic implant site preparation technique was able to micronize bone and to remove all debris with cooling system. Surgical drills tend to fracture bone, creating a weaker structure and fragments of larger size, which remain in considerable quantity over bone walls during site preparation. Within the limits of the present study, the ultrasonic implant preparation was able to produce reduced bone sediments and a clear bed implant favoring osseointegration.

Multiscale Modelling of De Novo Anaerobic Granulation.

A multiscale mathematical model is presented to describe de novo granulation, and the evolution of multispecies granular biofilms, in a continuously fed bioreactor. The granule is modelled as a spherical free boundary domain with radial symmetry. The equation governing the free boundary is derived from global mass balance considerations and takes into account the growth of sessile biomass as well as exchange fluxes with the bulk liquid. Starting from a vanishing initial value, the expansion of the free boundary is initiated by the attachment process, which depends on the microbial species concentrations within the bulk liquid and their specific attachment velocity. Nonlinear hyperbolic PDEs model the growth of the sessile microbial species, while quasi-linear parabolic PDEs govern the dynamics of substrates and invading species within the granular biofilm. Nonlinear ODEs govern the evolution of soluble substrates and planktonic biomass within the bulk liquid. The model is applied to an anaerobic, granular-based bioreactor system, and solved numerically to test its qualitative behaviour and explore the main aspects of de novo anaerobic granulation: ecology, biomass distribution, relative abundance, dimensional evolution of the granules and soluble substrates, and planktonic biomass dynamics within the bioreactor. The numerical results confirm that the model accurately describes the ecology and the concentrically layered structure of anaerobic granules observed experimentally, and that it can predict the effects on the process of significant factors, such as influent wastewater composition; granulation properties of planktonic biomass; biomass density; detachment intensity; and number of granules.

Transoral laser microsurgery for Tis, T1, and T2 glottic carcinoma: 5-year follow-up.

The aim of this retrospective study is to evaluate the results obtained with CO2 TOLMS in patients with Tis, T1, and T2 glottic tumors at our Department from 2004 to 2016 treated with CO2 TOLMS. One hundred eighty-five patients having a median age of 67 years (range 42-88) were included in the present analysis. The tumor stages of the patients included 134 pTis-T1a, 12 pT1b, and 39 pT2 cases. Median duration of follow-up for the whole study cohort was 55 months (range 24-108 months). At 5-year follow-up, local control was 91%, 83%, and 79.4% for T1a, T1b, and T2 respectively. Disease-specific survival was 95.5%, 91.6%, and 92.3%. Overall survival was 73.8%, 91.6%, and 82%, and larynx preservation was 96.2%, 83%, and 84.6%. This study confirms that CO2 TOLMS is a safe and standard therapy for selected T1 and T2 glottic carcinoma, and our review on T2 glottic cancer suggests that CO2 TOLMS represents a reliable option in terms of overall survival, disease-specific survival, and laryngeal preservation. However, patients with anterior commissure involvement and T2 cancer should be evaluated with a preoperative MRI in order to exclude the infiltration of the laryngeal framework and to quantify the neoplastic involvement of para-glottic space.

Promoting health and preventing non-communicable diseases: evaluation of the adherence of the Italian population to the Mediterranean Diet by using the PREDIMED questionnaire.

Abstract: A health promotion program was conducted in the Veneto Region in Italy. Participants were screened for non-communicable diseases and were referred to the nutrition clinic. The aim of this study was to assess the adherence to the Mediterranean diet in the Italian population by using the "PREvención con DIeta MEDiterránea" questionnaire. The data showed that 63% of the participants were overweight, 57% presented hypercholesterolemia, 36% were hypertensive and 43% had high blood glucose levels. The results highlighted a low consumption of protective foods against non-communicable diseases such as fruit, vegetables, fresh fish, legumes and oily dried fruit. Overall, only 6% of the subjects who visited the nutritional clinic had the maximum adherence to the Mediterranean diet, 73% had an average adherence, followed by 21% with low adherence. Multivariable analysis between risk factors and socio-demographic characteristics and the adherence to Mediterranean diet revealed that male gender relates directly (p =0.002, AOR = 2.95) to a low adherence. There are three criteria in the questionnaire for a point in favour of Mediterranean diet which we believe to be inadequate, as they are not in accordance with the Italian guidelines for healthy eating. The "PREvención con DIeta MEDiterránea" questionnaire, if associated with a food frequency questionnaire or a food intake record, could become a useful tool for nutritional counseling in our Country.

New device permitting non-invasive reversal of fetal endoscopic tracheal occlusion: ex-vivo and in-vivo study.

OBJECTIVE: One of the drawbacks of fetal endoscopic tracheal occlusion (FETO) for congenital diaphragmatic hernia is the need for a second invasive intervention to re-establish airway patency. The 'Smart-TO' device is a new balloon for FETO that deflates spontaneously when placed in a strong magnetic field, therefore overcoming the need for a second procedure. The safety and efficacy of this device have not yet been demonstrated. The aim of this study was to investigate the reversibility, local side effects and occlusiveness of the Smart-TO balloon, both in a simulated in-utero environment and in the fetal lamb model. METHODS: First, the reversibility of tracheal occlusion by the Smart-TO balloon was tested in a high-fidelity simulator. Following videoscopic tracheoscopic balloon insertion, the fetal mannequin was placed within a 1-L water-filled balloon to mimic the amniotic cavity. This was held by an operator in front of their abdomen, and different fetal and maternal positions were simulated to mimic the most common clinical scenarios. Following exposure to the magnetic field generated by a 1.5-T magnetic resonance (MR) machine, deflation of the Smart-TO balloon was assessed by tracheoscopy. In cases of failed deflation, the mannequin was reinserted into a water-filled balloon for additional MR exposure, up to a maximum of three times. Secondly, reversibility, occlusiveness and local effects of the Smart-TO balloon were tested in vivo in fetal lambs. Tracheal occlusion was performed in fetal lambs on gestational day 95 (term, 145 days), either using the balloon currently used in clinical practice (Goldbal2) (n = 5) or the Smart-TO balloon (n = 5). On gestational day 116, the presence of the balloon was assessed by tracheoscopy. Deflation was performed by puncture (Goldbal2) or MR exposure (Smart-TO). Six unoccluded fetal lambs served as controls. Following euthanasia, the lung-to-body-weight ratio (LBWR), lung morphometry and tracheal circumference were assessed. Local tracheal changes were measured using a hierarchical histologic scoring system. RESULTS: Ex vivo, Smart-TO balloon deflation occurred after a single MR exposure in 100% of cases in a maternal standing position with the mannequin at a height of 95 cm (n = 32), 55 cm (n = 8) or 125 cm (n = 8), as well as when the maternal position was 'lying on a stretcher' (n = 8). Three out of eight (37.5%) balloons failed to deflate at first exposure when the maternal position was 'sitting in a wheelchair'. Of these, two balloons deflated after a second MR exposure, but one balloon remained inflated after a third exposure. In vivo, all Smart-TO balloons deflated successfully. The LBWR in fetal lambs with tracheal occlusion by a Smart-TO balloon was significantly higher than that in unoccluded controls, and was comparable with that in the Goldbal2 group. There were no differences in lung morphometry and tracheal circumference between the two balloon types. Tracheal histology showed minimal changes for both balloons. CONCLUSIONS: In a simulated in-utero environment, the Smart-TO balloon was effectively deflated by exposure of the fetus in different positions to the magnetic field of a 1.5-T MR system. There was only one failure, which occurred when the mother was sitting in a wheelchair. In healthy fetal lambs, the Smart-TO balloon is as occlusive as the clinical standard Goldbal2 system and has only limited local side effects. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Learning curves of open and endoscopic fetal spina bifida closure: systematic review and meta-analysis.

OBJECTIVE: The Management of Myelomeningocele Study (MOMS) trial demonstrated the safety and efficacy of open fetal surgery for spina bifida aperta (SBA). Recently developed alternative techniques may reduce maternal risks without compromising the fetal neuroprotective effects. The aim of this systematic review was to assess the learning curve (LC) of different fetal SBA closure techniques. METHODS: MEDLINE, Web of Science, EMBASE, Scopus and Cochrane databases and the gray literature were searched to identify relevant articles on fetal surgery for SBA, without language restriction, published between January 1980 and October 2018. Identified studies were reviewed systematically and those reporting all consecutive procedures and with postnatal follow-up ≥ 12 months were selected. Studies were included only if they reported outcome variables necessary to measure the LC, as defined by fetal safety and efficacy. Two authors independently retrieved data, assessed the quality of the studies and categorized observations into blocks of 30 patients. For meta-analysis, data were pooled using a random-effects model when heterogeneous. To measure the LC, we used two complementary methods. In the group-splitting method, competency was defined when the procedure provided results comparable to those in the MOMS trial for 12 outcome variables representing the immediate surgical outcome, short-term neonatal neuroprotection and long-term neuroprotection at ≥ 12 months of age. Then, when raw patient data were available, we performed cumulative sum analysis based on a composite binary outcome defining successful surgery. The composite outcome combined four clinically relevant variables for safety (absence of extreme preterm delivery < 30 weeks, absence of fetal death ≤ 7 days after surgery) and efficacy (reversal of hindbrain herniation and absence of any neonatal treatment of dehiscence or cerebrospinal fluid leakage at the closure site). RESULTS: Of 6024 search results, 17 (0.3%) studies were included, all of which had low, moderate or unclear risk of bias. Fetal SBA closure was performed using standard hysterotomy (11 studies), mini-hysterotomy (one study) or fetoscopy by either exteriorized-uterus single-layer closure (one study), percutaneous single-layer closure (three studies) or percutaneous two-layer closure (one study). Only outcomes for standard hysterotomy could be meta-analyzed. Overall, outcomes improved significantly with experience. Competency was reached after 35 consecutive cases for standard hysterotomy and was predicted to be achieved after ≥ 57 cases for mini-hysterotomy and ≥ 56 for percutaneous two-layer fetoscopy. For percutaneous and exteriorized-uterus single-layer fetoscopy, competency was not reached in the 81 and 28 cases available for analysis, respectively, and LC prediction analysis could not be performed. CONCLUSIONS: The number of cases operated is correlated with the outcome of fetal SBA closure, and the number of operated cases required to reach competency ranges from 35 for standard hysterotomy to ≥ 56-57 for minimally invasive modifications. Our observations provide important information for institutions looking to establish a new fetal center, develop a new fetal surgery technique or train their team, and inform referring clinicians, potential patients and third parties. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Curvas de aprendizaje del cierre de la espina bífida fetal mediante cirugía abierta y endoscópica: revisión sistemática y metaanálisis OBJETIVO: El ensayo del Estudio sobre la Gestión del Mielomeningocele (MOMS, por sus siglas en inglés) demostró la seguridad y eficacia de la cirugía fetal abierta para la espina bífida aperta (EBA). Las técnicas alternativas recientemente desarrolladas pueden reducir los riesgos de la madre sin comprometer los efectos neuroprotectores del feto. El objetivo de esta revisión sistemática fue evaluar la curva de aprendizaje (CA) de diferentes técnicas de cierre de la EBA fetal. MÉTODOS: Se realizaron búsquedas en las bases de datos de MEDLINE, Web of Science, EMBASE, Scopus y Cochrane, así como en la literatura gris, para identificar artículos relevantes sobre cirugía fetal para la EBA, sin restricción de idioma, publicados entre enero de 1980 y octubre de 2018. Se examinaron sistemáticamente los estudios identificados y se seleccionaron los que informaban de todos los procedimientos consecutivos y con seguimiento postnatal ≥12 meses. Los estudios se incluyeron sólo si informaban sobre las variables de resultado necesarias para medir la CA, definidas por la seguridad y la eficacia para el feto. Dos autores recuperaron los datos de forma independiente, evaluaron la calidad de los estudios y clasificaron las observaciones en bloques de 30 pacientes. Para el metaanálisis, los datos se agruparon mediante un modelo de efectos aleatorios cuando fueron heterogéneos. Para medir la CA, se usaron dos métodos complementarios. En el método de división de grupos, la competencia se definió cuando el procedimiento proporcionó resultados comparables a los del ensayo MOMS para 12 variables de resultados que representaban el resultado quirúrgico inmediato, la neuroprotección neonatal a corto plazo y la neuroprotección a largo plazo a ≥12 meses de edad. Luego, cuando se dispuso de los datos brutos de los pacientes, se realizó un análisis de suma acumulada basado en un resultado binario compuesto que definió el éxito de la cirugía. El resultado compuesto combinó cuatro variables clínicamente relevantes en cuanto a la seguridad (ausencia de parto pretérmino extremo <30 semanas; ausencia de muerte fetal a ≤7 días después de la cirugía) y eficacia (reducción de la hernia del rombencéfalo y ausencia de cualquier tratamiento neonatal de dehiscencia o derrame de líquido cefalorraquídeo en el lugar del cierre). RESULTADOS: De los 6024 resultados de la búsqueda, se incluyeron 17 (0,3%) estudios, todos ellos con un riesgo de sesgo bajo, moderado o incierto. El cierre de la EBA fetal se realizó mediante histerotomía estándar (11 estudios), mini histerotomía (un estudio) o fetoscopia, ya fuera mediante el cierre exteriorizado del útero de una sola capa (un estudio), el cierre percutáneo de una sola capa (tres estudios) o el cierre percutáneo de dos capas (un estudio). Sólo se pudieron metaanalizar los resultados de la histerotomía estándar. En general, los resultados mejoraron significativamente con la experiencia. Se alcanzó la competencia después de 35 casos consecutivos para la histerotomía estándar y se predijo que se alcanzaría después de ≥57 casos para la mini histerotomía y ≥56 para la fetoscopia percutánea de dos capas. En el caso de las fetoscopias percutánea y exteriorizada del útero de una sola capa, no se alcanzó la competencia en los 81 y 28 casos disponibles para el análisis, respectivamente, y no se pudo realizar el análisis de predicción de la CA. CONCLUSIONES: El número de casos operados está correlacionado con el resultado del cierre de la EBA fetal, y el número de casos operados necesarios para alcanzar la competencia estuvo entre 35 para la histerotomía estándar y ≥56-57 para las operaciones con mínima agresividad. Las observaciones realizadas proporcionan información importante para las instituciones que buscan establecer un nuevo centro fetal, desarrollar una nueva técnica de cirugía fetal o entrenar a su equipo, e informar a los médicos que remiten a especialistas a los posibles pacientes y a terceros. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Weil osteotomy for the treatment of grade III hallux rigidus: a case series.

Hallux rigidus (HR) is one of the most common pathologies of the forefoot. The conservative treatment is indicated for early stages, while surgical treatment is required for advanced osteoarthritis and rigidity. Surgical treatment of advanced stages of HR is still controversial and includes joint-destructive procedures such as arthrodesis and arthroplasty, Weil osteotomy for decompression of the joint space may be a safe and effective procedure for the treatment of grade III HR. Twenty-four patients that underwent Weil osteotomy for Grade III HR were retrospectively reviewed. American Orthopedic Foot and Ankle Score (AOFAS), ROM and a subjective 5-point satisfaction scale were evaluated preoperatively, at 1 year, and at a minimum follow-up of 2 years. Joint space width and metatarsal length were assessed through radiographic examination preoperatively, immediately postoperatively and at 2 years follow up. AOFAS score was 45.1±3.9 preoperatively, 84.9±6.4 at 1 year and 73.7±6.2 at two years of follow up. All patients were satisfied with the procedure at 2 years follow up. Mean ROM increased from 35.1° (range, 10°- 50°) preoperatively to 80.3° (range, 60°-90°) at 1 year. Mean dorsiflexion increased from 5° (range 0° to 10°) preoperatively to 15° (range 7° to 23°) at 1 year. Both total ROM and dorsiflexion values remained constant at 2 years. The joint space was 0.5±0.9 mm preoperatively, 2.0±1.9 mm at 1 year and 1.5±1.2 mm at 2 years. The average metatarsal shortening was 2±1.4 mm. Weil osteotomy alone can be beneficial for the treatment of patients affected by advanced HR. It can improve clinical and radiological outcomes at 2 years follow up in a series of patients affected by grade III HR. Therefore, the sliding oblique osteotomy represent a valid alternative to delay more aggressive procedures.

Validation of a novel smart drilling system to monitor bone impedance during transpedicular screw placement: a pilot study.

Transpedicular screw placement is a high-risk procedure routinely performed in spine surgery. To decrease the rate of complications, it is necessary to find innovative solutions to assist the surgeon during screw insertion so as to avoid the chance of mispositioning. In this study, we developed a new drilling system able to estimate the mechanical properties of drilled tissues. Several investigations show that cortical bone requires a high level of thrust force and torque during drilling compared to trabecular bone. To implement an algorithm for bony breakthrough detection, a new drilling system has been built together with a mechanical support to drill the pedicle along a pre-planned trajectory. The mechanical support is equipped with a smart rotative drill that embeds force and position sensors. Ten human vertebral segments have been used to test the surgical platform, for percutaneous bone drilling. 10 transpedicular holes from L1 to L5 have been performed bilaterally. The holes were further evaluated by computed tomographic scans to measure bone density in the cortical and in the trabecular layers. To compare bone density with the bony mechanical impedance two new parameters (DHU and DPAI) have been introduced. The results show that in 18 out of 20 cases the D values of bone density and mechanical impedance, related to the same bone transition, differ less than 10%. The proposed system is thus able to evaluate the variation of bone density of the cortical and the trabecular layer using impedance. Therefore, it is possible to use the described system to increase the accuracy of transpedicular screw placement.

Adipose-derived stromal vascular fraction processed with different systems for the treatment of knee osteoarthritis: a pilot study on cell proliferation and clinical results.

In recent years, the interest in stromal vascular fraction (SVF) therapy for conservative treatment of osteoarthritis has grown significantly. This study aims to assess three different processing systems (micro-fragmentation, filtration, or slow centrifugation) in terms of cell proliferation in vitro and clinical results of intraarticular injections for the treatment of knee OA. From December 2017 to June 2018, 25 procedures were performed using three different systems. A considerable improvement of the clinical condition in almost all patients already one month after the treatment with a stable effect at 6 and 12 months was recorded. Patients treated with SVF, obtained by the micro-fragmentation system, had better outcomes one month after the treatment with a mean improvement of the symptomatology higher than that found in patients treated with the filtration or slow centrifugation system. The SVF product from the same system had a higher cell proliferation capacity in vitro.