Safety and usability of the MAK exoskeleton in patients with stroke.

BACKGROUND AND PURPOSE: Stroke is one of the leading causes of disability in adults worldwide, and one of the main objectives in the rehabilitation of these patients is to recover the gait. New technologies have emerged to cope with this issue, complementing conventional therapy with the use of devices such as exoskeletons. The Marsi Active Knee (MAK) exoskeleton (Marsi Bionics SL, Madrid, Spain) has already been tested, but an updated version was improved to allow the patients to perform functional exercises. The aim of this study was to assess the safety and usability of the MAK in the stroke population as well as its potential clinical effects. METHODS: A single-group open label intervention trial was conducted. The device was used twice a week for 5 weeks during 1 h per visit. During the visits, sit-to-stand transitions, walking, stair climbing, trunk rotations, and weight-transfer exercises were performed using the device. Adverse events were collected from participants and therapists to assess safety. The Quebec User Evaluation of the Satisfaction with assistive Technology (QUEST 2.0) was used by both therapists and participants to assess usability. To evaluate its clinical effects, active range of motion (ROM) and muscle strength were assessed in the lower limb. RESULTS: Six participants with stroke were recruited. The device was shown to be safe since no serious adverse events were reported neither by patients nor by therapists. Every proposed exercise was performed. Regarding clinical effects, overall muscle strength showed an increase after the treatment, although ROM measurements did not show any difference. DISCUSSION: Our results suggest that the MAK device is safe for stroke patients. Nevertheless, further changes to enhance usability are recommended, such as an improvement of the attachment system and an adaptation for the drop foot. Beneficial effects regarding increases in muscle strength were obtained. Further trials with a larger sample size, longer intervention periods, and a control group are needed to verify these results. Also, future research should focus on the usability of the MAK as an assistive technology.

Prenatal diagnosis of rhombencephalosynapsis: neuroimaging features and severity of vermian anomaly.

OBJECTIVES: To describe the prenatal neuroimaging spectrum of rhombencephalosynapsis (RES) and criteria for its classification according to the severity of vermian anomaly. METHODS: In this multicenter retrospective study of fetuses with RES between 2002 and 2020, the medical records and brain ultrasound and magnetic resonance images were evaluated comprehensively to determine the severity of the vermian anomaly and the presence of associated brain findings. RES was classified, according to the pattern of vermian agenesis and the extent of the fusion of the hemispheres, as complete RES (complete absence of the vermis) or partial RES (further classified according to the part of the vermis that was missing and, consequently, the region of hemispheric fusion, as anterior, posterior, severe or mixed RES). Findings were compared between cases with complete and those with partial RES. RESULTS: Included in the study were 62 fetuses with a gestational age ranging between 12 and 37 weeks. Most had complete absence of the vermis (complete RES, 77.4% of cases), a 'round-shaped' cerebellum on axial views (72.6%) and a transverse cerebellar diameter (TCD) < 3rd centile (87.1%). Among the 22.6% of cases with partial RES, 6.5% were classified as severe partial, 6.5% as partial anterior, 8.1% as partial mixed and 1.6% as partial posterior. Half of these cases presented with normal or nearly normal cerebellar morphology and 28.5% had a TCD within the normal limits. Infratentorially, the fourth ventricle was abnormal in 88.7% of cases overall, and anomalies of the midbrain and pons were frequent (93.5% and 77.4%, respectively). Ventriculomegaly was observed in 80.6% of all cases, being more severe in cases with complete RES than in those with partial RES, with high rates of parenchymal and septal disruption. CONCLUSIONS: This study provides prenatal neuroimaging criteria for the diagnosis and classification of RES, and identification of related features, using ultrasound and magnetic resonance imaging. According to our findings, a diagnosis of RES should be considered in fetuses with a small TCD (severe cerebellar hypoplasia) and/or a round-shaped cerebellum on axial views, during the second or third trimester, especially when associated with ventriculomegaly. Partial RES is more common than previously thought, but presents an extreme diagnostic challenge, especially in cases with normal or nearly-normal cerebellar morphobiometric features. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Corticosteroids and tocilizumab reduce in-hospital mortality in severe COVID-19 pneumonia: a retrospective study in a Spanish hospital.

BACKGROUND: There is an urgent need to reduce mortality of COVID-19. We examined if corticosteroids and tocilizumab reduce risk for death in patients with severe pneumonia caused by SARS-CoV-2. METHODS: A retrospective cohort study was performed in a single university hospital. All adult patients admitted with confirmed severe COVID-19 pneumonia from 9 March to 9 April 2020 were included. Severe pneumonia was defined as multi-lobar or bilateral pneumonia and a ratio of oxygen saturation by pulse oximetry to the fraction of inspired oxygen (SpFi)<315. All patients received antiviral and antibiotic treatment. From March 26, patients also received immunomodulatory treatment with corticosteroids (methylprednisolone 250 mg/day for 3 days), or tocilizumab or both. In-hospital mortality in the entire cohort and in a 1:1 matched cohort sub-analysis was evaluated. RESULTS: 255 patients were included, 118 received only antiviral and antibiotic treatment while 137, admitted after March 26, also received immunomodulators. In-hospital mortality of patients on immunomodulatory treatment was significantly lower than in those without [47/137(34.3%) vs. 69/118(58.5%), (p < .001)]. The risk of death was 0.44 (CI, 0.26-0.76) in patients receiving corticosteroids alone and 0.292 (CI, 0.18-0.47) in those treated with corticosteroids and tocilizumab. In the sub-analysis with 202 matched patients, the risk of death was 0.356 (CI 0.179-0.707) in patients receiving corticosteroids alone and 0.233 (0.124-0.436) in those treated with the combination. CONCLUSIONS: Combined treatment with corticosteroids and tocilizumab reduced mortality with about 25% in patients with severe COVID-19 pneumonia. Corticosteroids alone also resulted in lower in-hospital mortality rate compared to patients receiving only antiviral and antibiotic treatment. Corticosteroids alone or combined with tocilizumab may be considered in patients with severe COVID-19 pneumonia.

Quantitative bone SPECT analysis of mandibular condyles in an asymptomatic population: an approach to normal reference values.

Bone scintigraphy is an extremely valuable technique in diagnosis and treatment planning for patients with condylar hyperplasia (CH). The main objective of this study was to develop an approach to determine normal activity values in the mandibular condyles, adjusted to age and sex, through quantitative analysis of bone single-photon emission computed tomography (SPECT) on a condyle-by-condyle basis and to compare these values with those of a control group comprising patients with confirmed CH. Technetium 99 m-methylene diphosphonate (99mTc-MDP) SPECT studies of the mandibular condyles were performed in patients with no mandibular pathology for quantitative analysis. Regions of interest were drawn on slices representing the upper, middle, and inferior thirds of each condyle and on the summation of transaxial slices representing the whole condyle (three-dimensional approach). The clivus was used for internal validation and the condyle to clivus ratios were calculated. These ratios were compared between 'normal' and 'diseased' condyles. A total 144 condyles in normal patients and 25 in confirmed CH patients were analysed. Differences between the ratios were evaluated through the coefficient of variation. In normal patients, the ratios to the clivus on the summed condyle image showed the lowest variability: range 0.3-1.28 (median 0.74). The quantile regression model showed significant differences with respect to sex, but not to age. The Mann-Whitney test showed significant differences in the ratios to clivus between normal and diseased condyles (P<0.0001).

Identification of bacteriophages in the vagina of pregnant women: a descriptive study.

OBJECTIVE: To determine the presence and identity of extracellular bacteriophage (phage) families, genera and species in the vagina of pregnant women. DESIGN: Descriptive, observational cohort study. SETTING: São Paulo, Brazil. POPULATION: Pregnant women at 21-24 weeks' gestation. METHODS: Vaginal samples from 107 women whose vaginal microbiome and pregnancy outcomes were previously determined were analysed for phages by metagenomic sequencing. MAIN OUTCOME MEASURES: Identification of phage families, genera and species. RESULTS: Phages were detected in 96 (89.7%) of the samples. Six different phage families were identified: Siphoviridae in 69.2%, Myoviridae in 49.5%, Microviridae in 37.4%, Podoviridae in 20.6%, Herelleviridae in 10.3% and Inviridae in 1.9% of the women. Four different phage families were present in 14 women (13.1%), three families in 20 women (18.7%), two families in 31 women (29.1%) and one family in 31 women (29.1%). The most common phage species detected were Bacillus phages in 48 (43.6%), Escherichia phages in 45 (40.9%), Staphylococcus phages in 40 (36.4%), Gokushovirus in 33 (30.0%) and Lactobacillus phages in 29 (26.4%) women. In a preliminary exploratory analysis, there were no associations between a particular phage family, the number of phage families present in the vagina or any particular phage species and either gestational age at delivery or the bacterial community state type present in the vagina. CONCLUSIONS: Multiple phages are present in the vagina of most mid-trimester pregnant women. TWEETABLE ABSTRACT: Bacteriophages are present in the vagina of most pregnant women.

Causes of Erythema Nodosum in Patients Admitted to a Tertiary Care Hospital in Spain. / Causas de eritema nudoso en pacientes ingresados en un hospital español de tercer nivel.

Erythema nodosum (EN) is the most frequent panniculitis, and although it can be idiopathic, it presents multiple causal processes. We made a retrospective, observational and descriptive study about causes of EN in patients admitted to a third-level Spanish hospital over a period of 11 years, and we compared the results obtained with those published in other studies. We compared the analytical markers of inflammation between inflammatory and non-inflammatory causes of EN. The final cohort was composed by 52 patients, with 20% of idiopathic cases, 34% of cases secondary to infections and another 34% of cases secondary to autoimmune diseases. There were no cases secondary to drugs or lymphomas. We did not observe significant differences in the analytical parameters of inflammation between inflammatory or non-inflammatory cause of EN.

Necrotizing Sarcoid Granulomatosis: A Disease Not to be Forgotten.

Sarcoidosis is a systemic granulomatous disease of unknown aetiology characterised by the appearance of noncaseifying epithelioid granulomas in the affected organs, most commonly the lungs, skin, and eyes (Iannuzzi et al. 2007). Necrotizing Sarcoid Granulomatosis (NGS) is a rare and little-known form of disease, which also presents nodular lung lesions, and it shares pathologic and clinical findings with sarcoidosis, where the presence of necrosis may lead to misdiagnosis of tuberculosis (TB), leading to a consequent delay in treatment of the underlying entity (Chong et al. 2015). This is exactly what happened with the two cases that we present here.

Comparison of the defined daily dose and days of treatment methods for evaluating the consumption of antibiotics and antifungals in the intensive care unit.

OBJECTIVE: To compare the measurement of antimicrobial consumption by defined daily dose (DDD) versus by days of therapy (DOT). DESIGN: Retrospective analysis of clinical and administrative data from patients admitted to a polyvalent ICU. SETTING: ICU at a University Hospital in Spain. PATIENTS: All patients admitted to the ICU. INTERVENTIONS: None. MAIN VARIABLES OF INTEREST: For the DDD method, the World Health Organization (WHO)-assigned DDD was determined for the all the prescribed antimicrobials. For the DOT method, one DOT represented the administration of a single agent on a given day regardless of the number of doses administered. To express aggregate use, total DDDs and total DOTs were normalized to 100 patient-days. RESULTS: During the study period, 2393 adult patients were admitted to the ICU. Total median antimicrobial drugs measured by DDDs was 535.3 (IQR 319.8-845.5) vs. 344.0 (IQR 117.2-544.5) when measured by DOTs, p<0.001. When antimicrobial consumption was normalized to 100 patient-days, median antimicrobial consumption was also higher when measured by DDDs [2.98/100 patient-days (IQR 1.76-5.25) vs. 1.89/100 patient-days (IQR 0.64-3.0) when measured by DOTs, p<0.001]. CONCLUSIONS: For most antibacterial and antifungal drugs used in critically ill patients, estimates of aggregate antibiotic use by DDDs per 100 patient-days and DOTs per 100 patient-days are discordant because the administered dose is dissimilar from the WHO-assigned DDD. DOT methods should be recommended to avoid the overestimation that occurs with DDDs in adult critically ill patients.

Renal function at admission as a prognostic marker for patients hospitalised for a first episode of heart failure. Results of the PREDICE study. / Función renal al ingreso como marcador pronóstico en pacientes hospitalizados por un primer episodio de insuficiencia cardíaca. Resultados del estudio PREDICE.

BACKGROUND AND OBJECTIVE: Heart failure (HF) is a frequent condition that deteriorates quality of life and results in high morbidity and mortality. A considerable number of studies have been implemented in recent years to determine the factors that affect the prognosis of HF; however, few studies have assessed the prognosis of patients hospitalised for their first episode of HF. The aim of our study was to analyse the prognostic impact of renal function on patients hospitalised for a first episode of HF. MATERIAL AND METHODS: We recruited 600 patients hospitalised for a first episode of HF in 3 tertiary Spanish hospitals. We analysed the mortality risk during the first year of follow-up according to renal function at the time of admission. RESULTS: The patients with the highest degree of kidney failure at admission were older (P<.001), were more often women (p=.01) and presented a higher degree of dependence (P<.05), as well as a higher prevalence of arterial hypertension (P<.001), chronic renal failure (P<.001) and anaemia (P<.001). In the multivariate analysis, the degree of kidney failure at admission remained an independent predictor of increased mortality risk during the first year of follow-up. CONCLUSIONS: The presence of kidney failure at admission was a marker of poor prognosis in our cohort of patients hospitalised for a first episode of HF.

Time for radioimmunotherapy: an overview to bring improvements in clinical practice.

Harnessing the patient's own immune system against an established cancer has proven to be a successful strategy. Within the last years, several antibodies blocking critical "checkpoints" that control the activation of T cells, the immune cells able to kill cancer cells, have been approved for the use in patients with different tumours. Unfortunately, these cases remain a minority. Over the last years, radiotherapy has been reported as a means to turn a patient's own tumour into an in situ vaccine and generate anti-tumour T cells in patients who lack sufficient anti-tumour immunity. Indeed, review data show that the strategy of blocking multiple selected immune inhibitory targets in combination with radiotherapy has the potential to unleash powerful anti-tumour responses and improve the outcome of metastatic solid tumours. Here, we review the principal tumours where research in this field has led to new knowledge and where radioimmunotherapy becomes a reality.

Perinatal outcomes after open fetal surgery for myelomeningocele repair: a retrospective cohort study.

OBJECTIVE: Describe outcomes of open fetal surgery for myelomeningocele (MMC) repair in two Brazilian hospitals and the impact of surgical experience on outcome. DESIGN: Retrospective cohort study. SETTING: Sao Paulo, Brazil. POPULATION: 237 pregnant women carrying a fetus with an open spinal defect. METHODS: Surgical details, and maternal and fetal outcomes collected from all patients. MAIN OUTCOME MEASURES: Analysis of surgical and perinatal outcome parameters. RESULTS: Total surgical time was 119 ± 7.6 minutes. Preterm labour occurred in 24.2%, premature rupture of membranes in 26.7%, placental abruption in 0.8%, need for a blood transfusion at delivery in 2.1%, and dehiscence at the repair site in 2.5%. Reversal of hindbrain herniation at birth occurred in 71.4%. There were no maternal deaths or severe maternal morbidities. The failure rate with the patient anaesthetised was 0.42% and perinatal mortality was 2.1% (three intrauterine demises and two neonatal deaths). Comparing results from our study in the first 3 years with the last 3 years demonstrated improvement in the total surgical time (121.2 ± 6.4 versus 118.5 ± 8.2 minutes, P = 0.005) and an increase in reversal of hindbrain herniation at birth (64.0 versus 77.1%, P = 0.042). CONCLUSION: Our open fetal surgical approach for MMC was effective and results were comparable to past studies. Improvements in surgical performance and perinatal outcome increased as the surgical team became more familiar with the procedure. FUNDING: The study was funded solely by institutional funds. TWEETABLE ABSTRACT: Brazilian experience of in utero open surgery for myelomeningocele repair.

Amniotic fluid lactic acid and matrix metalloproteinase-8 levels at the time of fetal surgery for a spine defect: association with subsequent preterm prelabour rupture of membranes.

OBJECTIVE: In utero fetal surgery to correct incomplete closure of the spinal cord lessens the extent of permanent damage but is associated with preterm prelabour rupture of membranes (PPROM). We determined whether compounds in amniotic fluid collected at the time of surgery predicted subsequent development of PPROM. DESIGN: Prospective study. SETTING: Hospitals in Sao Paulo, Brazil. POPULATION: Twenty-four consecutive pregnant women at 24-26 weeks of gestation seen between February and October 2017 with a singleton pregnancy underwent in utero surgery to correct an open spinal defect in their fetus. METHODS: Amniotic fluid was tested for lactic acid, matrix metalloproteinase 2 (MMP-2), MMP-8, MMP-9 and interleukin-6 (IL-6) by enzyme-linked immunosorbent assay. Clinical data were collected after completion of all laboratory studies. MAIN OUTCOME MEASURE: Amniotic fluid concentration of compounds in women with or without PPROM. RESULTS: Preterm prelabour rupture of membranes occurred in seven (29.2%) women. There were no differences in maternal age, gravidity, parity, race, history of caesarean sections or fetal gender between women with or without PPROM. Length of surgery, days of wound healing and length of hospital stay were also indistinguishable. The median concentrations of MMP-8 (1.7 versus 0.6 ng/ml; P = 0.0041) and lactic acid (7.1 versus 5.9 mm; P = 0.0181) were higher in women with PPROM. The amniotic fluid MMP-8 level was also negatively correlated with gestational age at delivery (Spearman r = -0.4217, P = 0.0319). CONCLUSION: Differences in susceptibility to develop PPROM are present before fetal surgery. An increase in anaerobic glycolysis, evidenced by the intra-amniotic lactic acid level, may enhance MMP-8 production and weaken maternal and fetal membranes. TWEETABLE ABSTRACT: Matrix metalloproteinase-8 and lactic acid in amniotic fluid predict preterm prelabour rupture of membranes.

Incidence and evolution of sepsis-induced cardiomyopathy in a cohort of patients with sepsis and septic shock. / Incidencia y evolución de la miocardiopatía séptica en una cohorte de pacientes con sepsis y shock séptico.

OBJETIVE: The aim of this study was to establish the incidence of septic cardiomyopathy (SM) in patients with sepsis and septic shock, to describe its characteristics and testing its evolution. DESIGN: Prospective cohort study. PARTICIPANTS: We included 57 consecutive patients admitted to Intensive Care Unit, who met criteria of sepsis and septic shock. PRINCIPAL VARIABLES OF INTEREST: Clinical and biochemical variables were analyzed. An echocardiogram was performed in the first 24hours of admission, determining myocardial function parameters, and if the patients had left ventricular ejection fraction (LVEF)<50%) a second echocardiogram was performed. AMBIT: Intensive medical and surgical Care Service for Adults in University Hospital. RESULTS: The mean age of the patients was 62,1±16,3 years. 58% were males. 22.8% had left ventricular dysfunction. The mean LVEF in patients with MS was lower than those without SM (34.1±10.6 vs 60.7±6.94%, P<.001), with complete recovery, in survivors, after the acute event (LVEF at discharge 56.1±6.3%, P=.04). Patients with SM had higher levels of procalcitonin (47.1±35.4 vs 18.9±24.5; P=.02) and higher score on the Sequential Organ Failure Assessment (SOFA score) (9.91±3.82 vs 7.47±3.41; P=.037). Mortality was not significantly different between both groups [4 (30.8%) vs 4 (9.1%); P=.07]. CONCLUSIONS: SM is not uncommon and is related to a higher scores on the severity scales. In the survivors, LVEF normalized after the recovery of the acute event.

Effects of cervical cerclage on cervical length and the impact of changes in cervical length on pregnancy prognosis.

OBJECTIVE: To identify any cervix-related morphological and functional marker that can be correlated with pregnancy prognosis in patients who have undergone cerclage for cervical incompetence. DESIGN: An observational and prospective study. SETTING: Department of Obstetrics, Paulista School of Medicine - Federal University of São Paulo (UNIFESP-EPM). METHODS: Patients with cervical incompetence who underwent cervical cerclage using a modified version of the McDonald procedure during or before the 22nd week of pregnancy. The patients were examined by transvaginal ultrasound in the preoperative period, the immediate postoperative period, and between 20 and 24 weeks, 24 weeks + 1 day and 28 weeks, and 28 weeks + 1 day and 32 weeks. Cervical length and the presence of funneling were evaluated during all examinations. Changes in cervical length, presence or absence of funneling, percent increase or decrease in cervical length, and cervical length of less than established values (.