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In a convenience sample of 93 patients treated with monoclonal antibodies (moAbs) against SARS-CoV-2, the interleukin-62/lymphocyte count ratio (IL-62/LC) was able to predict clinical worsening both in early stages of COVID-19 and in oxygen-requiring patients. Moreover, we analysed 18 most at-risk patients with asymptomatic or mild disease treated with both moAbs and antiviral treatment and found that only 2 had clinical progression, while patients with a similar risk were reported to have an unfavourable outcome in most cases from recent data. In only one of our 18 patients, clinical progression was attributable to COVID-19, and in the other cases, clinical progression was observed despite IL-62/LC being above the risk cut-off. In conclusion, IL-62/LC may be a valuable method to identify patients requiring more aggressive treatments both in earlier and later stages of the disease; however, most at-risk patients can be protected from clinical worsening by combining moAbs and antivirals, even if levels of the IL-62/LC biomarker are lower than the risk cut-off. [ABSTRACT FROM AUTHOR]

Objective: Since there are no approved reliable biomarkers for detecting preoperatively uterine sarcoma, lactate dehydrogenase (LDH) isoenzymes are usually required. We first evaluated the role of LDH isoenzymes in detecting uterine sarcoma risk, and then we tried to introduce a model to easily interpret the biochemical results.Methods: We retrospectively retrieved records of patients who underwent surgical treatment for uterine masses from 2004 to 2016, and we compared data of 2211 patients with a definitive surgical diagnosis of uterine fibroids and 43 with uterine sarcomas. Quantitative relationships between serum LDH isoenzymes levels, as different single markers or in multiple assays, and the final diagnosis were investigated.Results: LDH isoenzymes levels significantly differed between patients with benign uterine masses or sarcomas. LDH3 isoenzyme exhibited better predictive performances than the other four isoforms. Combining LDH3 with LDH1 isoenzymes into an inverse algebraic relationship, named Uterine mass Magna Graecia (U.M.G.) risk index, the accuracy of markers in discriminating between benign and suspicious malignant uterine masses was significantly enhanced, sensitivity at 100% and specificity at 99.6%, with nine false positive over 2211 benignant cases and no false negative over 43 sarcomas.Conclusions: This retrospective analysis suggests to consider U.M.G. risk index as an inexpensive and accurate prognostic index that, once validated in a prospective study, may help clinicians in discriminating between benignant and suspicious malignant uterine masses. [ABSTRACT FROM AUTHOR]

Background: Platelet count reduction (PR) is a common but unclear phenomenon that occurs after aortic bioprosthesis valve implantation (bio-AVR). This study aimed to investigate the occurrence and clinical impact of PR in patients receiving stented, rapid deployment (RDV), or stentless bioprostheses. Methods: 1233 adult bio-AVR patients were enrolled. Platelet count variation, early post-operative adverse events, and in-hospital mortality were analysed. Results: 944 patients received a stented valve, an RDV was implanted in 218 patients, and 71 patients had a stentless bioprosthesis. In all groups, the platelet count at discharge was lower than the baseline values (p < 0.001). The percentage of PR was 27% in the stented group, 56% in the RDV group, and 55% in the stentless group. A higher platelet reduction, reaching the minimum platelet value, was observed in the RDV (mean: −30.84, standard error (SE): 5.91, p < 0.001) and stentless (mean: 22.54, SE: 9.10, p = 0.03) groups compared to the stented group. A greater PR occurred as the size of the bioprosthesis increased in RDV (p = 0.01), while platelet count variation was not directly proportional to the stented bioprosthesis size (p < 0.001). PR was not affected by cardiopulmonary bypass (mean: −0.00, SE: 0.001, p = 0.635) or cross-clamp (mean: −0.00, SE: 0.002, p = 0.051) times in any of the groups. RDV subjects experienced more in-hospital adverse events. PR was found to be associated with ischemic strokes in the overall population. Conclusions: Bio-AVR is associated with significant but transient PR. RDV patients more likely experience significant PR and related adverse clinical events. PR is associated with ischemic strokes, regardless of the bioprosthesis type. [ABSTRACT FROM AUTHOR]

Optical coherence tomography angiography (OCTA) is an innovative and reliable technique detecting the early preclinical retinal vascular change in patients with diabetes. We have designed our study to evaluate whether an independent relationship exists between continuous glucose monitoring (CGM)-derived glucose metrics and OCTA parameters in young adult patients with type 1 diabetes without diabetic retinopathy (DR). Inclusion criteria were age ≥ 18 years, diagnosis of type 1 diabetes from ≥ 1 year , stable insulin treatment in the last three months, use of real-time CGM, and CGM wear time ≥ 70 %. Each patient underwent dilated slit lamp fundus biomicroscopy to exclude the presence of DR. A skilled operator performed OCTA scans in the morning to avoid possible diurnal variation. CGM-derived glucose metrics from the last 2 weeks were collected through the dedicated software during OCTA. Forty-nine patients with type 1 diabetes (age 29 [18; 39] years, HbA1c 7.7 ± 1.0 %) and 34 control subjects participated in the study. Vessel density (VD) of the whole image and parafoveal retina in the superficial (SCP) and deep capillary plexus (DCP) was significantly lower in patients with type 1 diabetes compared to controls. The coefficient of variation of average daily glucose, evaluated by CGM, significantly correlated with foveal and parafoveal VD in SCP and with foveal VD in DCP. High glucose variability might be responsible for the early increase of VD in these areas. Prospective studies may help understand if this pattern precedes DR. The difference we detected between patients with and without diabetes confirms that OCTA is a reliable tool for detecting early retinal abnormalities. [ABSTRACT FROM AUTHOR]

The COVID-19 global pandemic has changed considerably the way time-sensitive disorders are treated. Home isolation, people's fear of contracting the virus and hospital reorganisation have led to a significant decrease in contacts between citizens and the healthcare system, with an expected decrease in calls to the Emergency Medical Services (EMS) of the Friuli-Venezia Giulia (FVG) region. However, mortality in clinical emergencies like acute ST-elevation myocardial infarction (STEMI), stroke and out-of-hospital cardiopulmonary arrest (OHCA) remained high. An observational retrospective cross-sectional study was carried out in FVG, taking into account the period between March 1, 2020, and May 31, 2020, the first wave of the COVID-19 pandemic, and comparing it with the same period in 2019. The flow of calls to the EMS was analysed and COVID-19 impact on time-sensitive disorders (STEMIs, ischemic strokes and OHCPAs) was measured in terms of hospitalisation, treatment and mortality. Despite a −8.01% decrease (p value ˂0.001) in emergency response, a 10.89% increase in calls to the EMS was observed. A lower number of advanced cardiopulmonary resuscitations (CPR) (75.8 vs 45.2%, p=0.000021 in April) and ROSC (39.1 vs 11.6%, p=0.0001 in April) was remarked, and survival rate dropped from 8.5 to 5%. There were less strokes (−27.5%, p value=0.002) despite a more severe onset of symptoms at hospitalisation with NHISS˃10 in 38.47% of cases. Acute myocardial infarctions decreased as well (−20%, p value=0.05), but statistical significances were not determined in the variables considered and in mortality. Despite a lower number of emergency responses, the number of calls to the EMS was considerably higher. The number of cardiac arrests treated with advanced CPR (ALS) was lower, but mortality was higher. The number of strokes decreased as well, but at the time of hospitalisation the clinical picture of the patient was more severe, thus affecting the outcome when the patient was discharged. Finally, STEMI patients decreased; however, no critical issues were observed in the variables taken into account, neither in terms of response times nor in terms of treatment times. [ABSTRACT FROM AUTHOR]

The nasal epithelium is a key portal for infection by respiratory viruses such as SARS-CoV-2 and represents an important target for prophylactic and therapeutic interventions. In the present study, we test the safety and efficacy of a newly developed nasal spray (AM-301, marketed as Bentrio) against infection by SARS-CoV-2 and its Delta variant on an in vitro 3D-model of the primary human nasal airway epithelium. Safety was assessed in assays for tight junction integrity, cytotoxicity and cilia beating frequency. Efficacy against SARS-CoV-2 infection was evaluated in pre-viral load and post-viral load application on airway epithelium. No toxic effects of AM-301 on the nasal epithelium were found. Prophylactic treatment with AM-301 significantly reduced viral titer vs. controls over 4 days, reaching a maximum reduction of 99% in case of infection from the wild-type SARS-CoV-2 variant and more than 83% in case of the Delta variant. When AM-301 administration was started 24 h after infection, viral titer was reduced by about 12-folds and 3-folds on Day 4. The results suggest that AM-301 is safe and significantly decelerates SARS-CoV-2 replication in cell culture inhibition assays of prophylaxis (pre-viral load application) and mitigation (post-viral load application). Its physical (non-pharmaceutical) mechanism of action, safety and efficacy warrant additional investigations both in vitro and in vivo for safety and efficacy against a broad spectrum of airborne viruses and allergens. [ABSTRACT FROM AUTHOR]

Background. Screening strategies for gestational diabetes mellitus (GDM) earlier than 24-28 weeks of gestation should be considered to prevent adverse pregnancy outcomes. Nonetheless, there is uncertainty about which women would benefit most from early screening and which screening strategies should be offered to women with GDM. The Italian National Healthcare Service (NHS) recommendations on selective screening for GDM at 16-18 weeks of gestation are effective in preventing fetal macrosomia in high-risk (HR) women, but the appropriateness of timing and effectiveness of these recommendations in medium- (MR) and low-risk (LR) women are still controversial. Patients and Methods. We retrospectively enrolled 769 consecutive singleton pregnant women who underwent both anomaly scan at 19-21 weeks of gestation and screening for GDM at 16-18 and/or 24-28 weeks of gestation, in agreement with the NHS recommendations and risk stratification criteria. Comparison of maternal characteristics, fetal biometric parameters at anomaly scan (head circumference (HC), biparietal diameter (BPD), abdominal circumference (AC), femur length (FL), estimated fetal weight (EFW)), and neonatal birth weight (BW) percentile among risk groups was examined. Results. 219 (28.5%) women were diagnosed with GDM, while 550 (71.5%) were normal glucose-tolerant women. Out of 164 HR women, only 62 (37.8%) underwent the recommended early screening for GDM at 16-18 weeks of gestation. AC and EFW percentiles, as well as neonates' BW percentiles, were significantly higher in HR women diagnosed with GDM at 24-28 weeks of gestation with respect to normal glucose-tolerant women, as well as MR and LR women who tested positive for GDM. Comparative analysis between MR and LR women with GDM and women with normal glucose tolerance revealed significant differences in both AC and EFW percentiles (P < 0.05), while there was no significant difference in neonatal BW percentiles. Conclusion. In MR and LR women with GDM, a mild acceleration of fetal growth can be detected at the time of anomaly scan. However, in these at-risk categories, the NHS recommendations for screening and treatment of GDM at 24-28 weeks of gestation are still effective in normalizing BW and preventing fetal macrosomia, thus supporting a risk factor-based selective screening program for GDM. [ABSTRACT FROM AUTHOR]

Previous investigations suggested that lamin A/C gene (LMNA) mutations, which cause a variety of human diseases including muscular dystrophies and cardiomyopathies, alter the nuclear mechanical properties. We hypothesized that biomechanical changes may extend beyond the nucleus. [ABSTRACT FROM PUBLISHER]

Objective To investigate the influence of seminal leukocytes on conventional IVF and intracytoplasmic sperm injection (ICSI) outcomes, using a flow cytometry method. Design Prospective study. Setting Tertiary infertility center and research institute. Patient(s) One hundred sixty-four couples undergoing conventional IVF or ICSI. Intervention(s) Seminal leukocytes were counted by flow cytometry. Main Outcome Measure(s) Correlation between seminal leukocytes concentration and reproductive outcomes in IVF and ICSI cycles. Result(s) The median number of oocytes retrieved, the fertilization and cleavage rate, the median number and grade of embryos transferred, the median number of good-quality embryos transferred, and the median percentage of good-quality embryos from total embryos transferred, in leukocytospermic and non-leukocytospermic patients were not statistically different after either IVF or ICSI. Similarly, there were no significant differences between the two groups for implantation rate and clinical pregnancy rate. Multivariate logistic regression analysis showed that the reproductive outcomes were not influenced by adjustment for female age, infertility diagnosis, number of previous attempts, treatment protocol (GnRH agonist or antagonist), assisted reproduction procedure (IVF or ICSI), and leukocytospermia. By profiling the proper Poisson regression models, no leukocytospermia cut-off value was able to identify the subjects at risk for oocyte fertilization or embryo cleavage failure. Conclusion(s) Using a flow cytometry method, we demonstrated that leukocytospermia does not significantly influence IVF or ICSI outcomes. The same results were obtained by using lower or higher cut-off values for leukocytospermia (from 0.2 to 2 × 10 6 /mL). [ABSTRACT FROM AUTHOR]

There are important questions surrounding the potential contribution of outdoor and indoor air quality in the transmission of SARS-CoV-2 and perpetuation of COVID-19 epidemic waves. Environmental health may be a critical component of COVID-19 prevention. The public health community and health agencies should consider the evolving evidence in their recommendations and statements, and work to issue occupational guidelines. Evidence coming from the current epidemiological and experimental research is expected to add knowledge about virus diffusion, COVID-19 severity in most polluted areas, inter-personal distance requirements and need for wearing face masks in indoor or outdoor environments. The COVID-19 pandemic has highlighted the need for maintaining particulate matter concentrations at low levels for multiple health-related reasons, which may also include the spread of SARS-CoV-2. Indoor environments represent even a more crucial challenge to cope with, as it is easier for the SARS-COV2 to spread, remain vital and infect other subjects in closed spaces in the presence of already infected asymptomatic or mildly symptomatic people. The potential merits of preventive measures, such as CO 2 monitoring associated with natural or controlled mechanical ventilation and air purification, for schools, indoor public places (restaurants, offices, hotels, museums, theatres/cinemas etc.) and transportations need to be carefully considered. Hospital settings and nursing/retirement homes as well as emergency rooms, infectious diseases divisions and ambulances represent higher risk indoor environments and may require additional monitoring and specific decontamination strategies based on mechanical ventilation or air purification. • Outdoor and indoor air quality play a potential role in SARS-COV2 transmission. • Environmental health may be a critical component of COVID-19 prevention. • Particulate matter concentrations should be maintained at low levels. • Indoor environments represent a crucial challenge for SARS-COV2 spreading. • Preventive measures should include indoor CO2 monitoring & mechanical ventilation. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the role of uterine fundal pressure during the second stage of labor (Kristeller maneuver) on pelvic floor dysfunction (urinary and anal incontinence, genital prolapse, pelvic floor strength). Methods: 522 primiparous women, enrolled 3 months after vaginal delivery, were divided in two groups: group A (297 women) identifies the women who received Kristeller maneuvers with different indications (e.g. fetal distress, failure to progress, mother exhaustion), group B (225 women) the women without maneuver. Participants were questioned about urogynecological symptoms and examined by Q-tip test, digital test, vaginal perineometry and uroflowmetric stop test score. Results: Mediolateral episiotomies, dyspareunia and perineal pain were significantly higher in Kristeller group, whereas urinary and anal incontinence, genital prolapse and pelvic floor strength were not significantly different between the groups. Conclusions: Kristeller maneuver does not modify puerperal pelvic floor function but increases the rate of episiotomies. [ABSTRACT FROM AUTHOR]

Background: Hypoxemia in acute lung injury/acute respiratory distress syndrome (ALI/ARDS) patients represents a common finding in the intensive care unit (ICU) and frequently does not respond to standard ventilatory techniques. Objective: To study whether the early short-term application of high-frequency percussive ventilation (HFPV) can improve gas exchange in hypoxemic patients with ALI/ARDS or many other conditions in comparison to conventional ventilation (CV) using the same mean airway pressure (Paw), representing the main determinant of oxygenation and hemodynamics, irrespective of the mode of ventilation. Methods: Thirty-five patients not responding to CV were studied. During the first 12 h after admission to the ICU the patients underwent CV. Thereafter HFPV was applied for 12 h with Paw kept constant. They were then returned to CV. Gas exchange was measured at: 12 h after admission, every 4 h during the HFPV trial, 1 h after the end of HFPV, and 12 h after HFPV. Thirty-five matched patients ventilated with CV served as the control group (CTRL). Results: Pao2/Fio2 and the arterial alveolar ratio (a/A Po2) increased during HFPV treatment and a Pao2/Fio2 steady state was reached during the last 12 h of CV, whereas both did not change in CTRL. Paco2 decreased during the first 4 h of HFPV, but thereafter it remained unaltered; Paco2 did not vary in CTRL. Respiratory system compliance increased after HFPV. Conclusions: HFPV improved gas exchange in patients who did not respond to conventional treatment. This improvement remained unaltered until 12 h after the end of HFPV. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Purpose: Ineffective respiratory efforts during expiration (IEE) are a problem during mechanical ventilation (MV). The goal of this study is to validate mathematical algorithms that automatically detect IEE in a computerized (Better Care) system that obtains and processes data from intensive care unit (ICU) ventilators in real time. Methods: The Better Care system, integrated with ICU health information systems, synchronizes and processes data from bedside technology. Algorithms were developed to analyze airflow waveforms during expiration to determine IEE. Data from 2,608,800 breaths from eight patients were recorded. From these breaths 1,024 were randomly selected. Five experts independently analyzed the selected breaths and classified them as IEE or not IEE. Better Care evaluated the same 1,024 breaths and assigned a score to each one. The IEE score cutoff point was determined based on the experts' analysis. The IEE algorithm was subsequently validated using the electrical activity of the diaphragm (EAdi) signal to analyze 9,600 breaths in eight additional patients. Results: Optimal sensitivity and specificity were achieved by setting the cutoff point for IEE by Better Care at 42%. A score >42% was classified as an IEE with 91.5% sensitivity, 91.7% specificity, 80.3% positive predictive value (PPV), 96.7% negative predictive value (NPV), and 79.7% Kappa index [confidence interval (CI) (95%) = (75.6%; 83.8%)]. Compared with the EAdi, the IEE algorithm had 65.2% sensitivity, 99.3% specificity, 90.8% PPV, 96.5% NPV, and 73.9% Kappa index [CI (95%) = (71.3%; 76.3%)]. Conclusions: In this pilot, Better Care classified breaths as IEE in close agreement with experts and the EAdi signal. [ABSTRACT FROM AUTHOR]

Purpose: To demonstrate in a two-compartment heterogeneous mechanical model of the lung how different loads applied to one compartment, while the other is kept constant, would modify gas distribution between the two pathways under high-frequency percussive ventilation (HFPV). Additionally, these results were compared with those generated in the same model by pressure-controlled ventilation (PCV). Methods: Analysis was based on a Siemens lung simulator, representing a fixed branch of the system with an elastance equal to 45 cmHO/L and a resistance of 20 cmHO/L/s, and a single-compartment lung simulator, representing a variable pathway of the model, presenting three elastic loads varying between 35 and 85 cmHO/L and three resistive loads varying between 5 and 50 cmHO/L/s. Each simulator represented one compartment of the model connected to a central airway that was ventilated with either a volumetric diffusive respirator (VDR-4; Percussionaire Corporation, Sandpoint, ID, USA) or a Siemens Servo 900c ventilator. Flow and pressures were measured in each branch of the model under nine conditions representing the combinations of three elastic and three resistive loads (variable branch) while the loads in the other pathway were kept constant. Results: HFPV was able to avoid hyperinflation and reduce tidal volume in a bicompartmental heterogeneous lung model. Under HFPV, gas distribution between the two compartments was not constrained by their time constants. PCV yielded gas distribution as determined by the time constant of each compartment. Conclusions: HFPV accommodated volume distribution without overinflating compartments with low time constants, thus possibly presenting a potential protective behavior in mechanically heterogeneous lungs. [ABSTRACT FROM AUTHOR]

The article focuses a randomized prospective study which explores the ability of high-frequency percussive ventilation (HFPV) to improve pulmonary resection and reduce hospital length of stay of patients. The study enrolled fifty-three patients undergoing elective pulmonary partial resection. It found that HFPV can improve oxygenation in one-lung ventilation during pulmonary resection.

The article presents a study that examines the effect of positive expiratory pressure on cuffs of different tracheal tubes on intensive care unit (ICU) patients. Forty patients recovering in the ICU were ventilated in volume-controlled mode, 20 were randomly intubated with Hi-Lo tubes and the other twenty were intubated with SealGuard tubes. It found that 5 cm H20 positive expiratory pressure was effective for the delay in passing fluid around the cuffs of tracheal tubes.

The article evaluates the prognostic value of different dead space indices to predict survival in mechanically ventilated patients with acute lung injury (ALI) and acute respiratory disease syndrome (ARDS) by researchers in the U.S. It is revealed that interaction between noninvasive measures of alveola ejection volume/tidal volume ratio (VAE/VT) at intensive care unit (ICU) admission and after 48 hour of mechanical ventilation provides useful information on outcome in ALI patients.

Despite promising results obtained in the early diagnosis of several pathologies, breath analysis still remains an unused technique in clinical practice due to the lack of breath sampling standardized procedures able to guarantee a good repeatability and comparability of results. The most diffuse on an international scale breath sampling method uses polymeric bags, but, recently, devices named Mistral and ReCIVA, able to directly concentrate volatile organic compounds (VOCs) onto sorbent tubes, have been developed and launched on the market. In order to explore performances of these new automatic devices with respect to sampling in the polymeric bag and to study the differences in VOCs profile when whole or alveolar breath is collected and when pulmonary wash out with clean air is done, a tailored experimental design was developed. Three different breath sampling approaches were compared: (a) whole breath sampling by means of Tedlar bags, (b) the end-tidal breath collection using the Mistral sampler, and (c) the simultaneous collection of the whole and alveolar breath by using the ReCIVA. The obtained results showed that alveolar fraction of breath was relatively less affected by ambient air (AA) contaminants (p-values equal to 0.04 for Mistral and 0.002 for ReCIVA Low) with respect to whole breath (p-values equal to 0.97 for ReCIVA Whole). Compared to Tedlar bags, coherent results were obtained by using Mistral while lower VOCs levels were detected for samples (both breath and AA) collected by ReCIVA, likely due to uncorrected and fluctuating flow rates applied by this device. Finally, the analysis of all data also including data obtained by explorative analysis of the unique lung cancer (LC) breath sample showed that a clean air supply might determine a further confounding factor in breath analysis considering that lung wash-out is species-dependent. [ABSTRACT FROM AUTHOR]

The burden of COVID-19 was extremely severe in Northern Italy, an area characterized by high concentrations of particulate matter (PM), which is known to negatively affect human health. Consistently with evidence already available for other viruses, we initially hypothesized the possibility of SARS-CoV-2 presence on PM, and we performed a first experiment specifically aimed at confirming or excluding this research hyphotesys. We have collected 34 PM10 samples in Bergamo area (the epicenter of the Italian COVID-19 epidemic) by using two air samplers over a continuous 3-weeks period. Filters were properly stored and underwent RNA extraction and amplification according to WHO protocols in two parallel blind analyses performed by two different authorized laboratories. Up to three highly specific molecular marker genes (E, N, and RdRP) were used to test the presence of SARS-CoV-2 RNA on particulate matter. The first test showed positive results for gene E in 15 out of 16 samples, simultaneously displaying positivity also for RdRP gene in 4 samples. The second blind test got 5 additional positive results for at least one of the three marker genes. Overall, we tested 34 RNA extractions for the E, N and RdRP genes, reporting 20 positive results for at least one of the three marker genes, with positivity separately confirmed for all the three markers. Control tests to exclude false positivities were successfully accomplished. This is the first evidence that SARS-CoV-2 RNA can be present on PM, thus suggesting a possible use as indicator of epidemic recurrence. • COVID-19 burden seems more severe in areas with high concentrations of PM. • Particulate matter is already known to have negative effects on human health. • This is the first evidence that SARS-CoV-2RNA can be found on particulate matter. [ABSTRACT FROM AUTHOR]

A response by Umberto Lucangelo and colleagues to a letter to the editor about their article "Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit," is presented.

A correction to the article "Validation of the Better Care system to detect ineffective efforts during expiration in mechanically ventilated patients: a pilot study," by J. Villar and colleagues in the November 14, 2012 online issue is presented.