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BACKGROUND: Little is known on the role of mismatch profile in patients undergoing early endovascular treatment (EVT). We aimed to describe pretreatment perfusion parameters and mismatch profiles in anterior circulation large vessel occlusion acute ischemic stroke undergoing EVT in the early time window and assess their association with time from stroke onset and outcomes. METHODS: Retrospective single-center study, including early (<6 hours) EVT-treated large vessel occlusion acute ischemic stroke with baseline perfusion data, assessing perfusion parameters (ischemic core volume, mismatch volume and mismatch ratio) and mismatch profiles (favorable versus unfavorable, based on criteria adopted in EXTEND-IA [Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial], SWIFT PRIME [Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment], DEFUSE 3 [Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3], and DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo] trials). We evaluated their association with time from stroke onset (rs [for parameters] or χ2 for trend [for profiles]) and association with modified Rankin Scale score >2, symptomatic intracranial hemorrhage, and mortality (multivariate regression analyses [each parameter/profile entered into a separate logistic regression model, adjusted for baseline variables associated with each outcome in the univariate analysis at the P<0.1 level]). RESULTS: Among 357 patients, unfavorable mismatch profiles ranged from 21% to 60%, depending on the criterion, and were not correlated with time from stroke onset (P=0.490). All individual perfusion parameters and unfavorable mismatch profiles were associated with poor functional outcome: ischemic core volume adjusted odds ratio (aOR), 1.49 ([95% CI, 1.13-1.97] P=0.005); penumbral volume aOR, 0.30 ([95% CI, 0.10-0.84] P=0.022); mismatch ratio aOR, 0.67 ([95% CI, 0.50-0.90] P=0.007); EXTEND-IA aOR, 2.61 ([95% CI, 1.23-5.51] P=0.012); SWIFT PRIME aOR, 2.50 ([95% CI, 1.30-4.57] P=0.006); DEFUSE 3 aOR, 2.28 ([95% CI, 1.14-4.57] P=0.020); and DAWN aOR, 4.19 ([95% CI, 2.13-8.26] P<0.001). EXTEND-IA and DEFUSE 3 unfavorable profiles were also independently associated with symptomatic intracranial hemorrhage (aOR, 3.82 [95% CI, 1.42-10.3]; P=0.008 and aOR, 2.83 [95% CI, 1.09-7.36]; P=0.033) and death (aOR, 3.26 [95% CI, 1.33-8.02]; P=0.010 and aOR, 2.52 [95% CI, 1.10-5.82]; P=0.030). CONCLUSIONS: Pretreatment perfusion parameters and mismatch profiles in early EVT-treated patients were not correlated with time from stroke onset but were independently associated with functional outcome. Mismatch assessment in the early time window may improve EVT patient selection, independently of onset-to-treatment time.

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INTRODUCTION AND OBJECTIVES: Liver stiffness measurement (LSM) by transient elastography has been validated to predict high-risk varices (HRV). We aimed to evaluate the accuracy of shear-wave elastography (SWE) and platelet count (Baveno VI criteria) to rule out HRV in patients with compensated advanced chronic liver disease (c-ACLD). METHODS: This retrospective study analyzed data of patients with c-ACLD (transient elastography ≥ 10 kPa) submitted to two-dimensional SWE (2D-SWE) (GE-LOGIQ-S8) and/or point SWE (p-SWE) (ElastPQ) who had a gastrointestinal endoscopy within 24 months. HRV definition was a large size and presence of red wale marks or sequelae from previous treatment. Optimal thresholds of SWE systems for HRV were identified. The proportion of spared gastrointestinal endoscopies and missing HRV considering a favorable SWE Baveno VI criteria were assessed. RESULTS: Eighty patients [36% male, median age = 63 (interquartile range, 57-69) years] were included. The prevalence of HRV was 34% ( n  = 27/80). The optimal thresholds to predict HRV were 10 kPa and 12 kPa for 2D-SWE and p-SWE, respectively. A favorable 2D-SWE Baveno VI criteria (LSM < 10 kPa and platelets count > 150 × 10 9 /mm 3 ) avoided 19% of gastrointestinal endoscopies without missing HRVs. A favorable p-SWE Baveno VI criteria (LSM < 12 kPa and platelets count > 150 × 10 9 /mm 3 ) spared 20% of gastrointestinal endoscopy without missing HRVs. Using a lower threshold of platelet count (<110 × 10 9 /mm 3 , expanded Baveno VI), 2D-SWE (<10 kPa) avoided 33% of gastrointestinal endoscopy with 8% of missing HRVs, while p-SWE (<12 kPa) avoided 36% of gastrointestinal endoscopy with 5% of missing HRVs. CONCLUSION: LSM by p-SWE or 2D-SWE combined with platelet count (Baveno VI criteria) can spare a considerable number of gastrointestinal endoscopies missing a negligible proportion of HRV.

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BACKGROUND: Lombardy was the epicenter in Italy of the first wave of COVID-19 pandemic. To face the contagion growth, from March 8 to May 8, 2020, a regional law redesigned the hub-and-spoke system for time-dependent diseases to better allocate resources for COVID-19 patients. METHODS: We report the reorganization of the major hospital in Lombardy during COVID-19 pandemic, including the rearrangement of its ICU beds to face COVID-19 pandemic and fulfill its role as extended hub for time-dependent diseases while preserving transplant activity. To highlight the impact of the emergently planned hub-and-spoke system, all patients admitted to a COVID-19-free ICU hub for trauma, neurosurgical emergencies and stroke during the two-month period were retrospectively collected and compared to 2019 cohort. Regional data on organ procurement was retrieved. Observed-to-expected (OE) in-ICU mortality ratios were computed to test the impact of the pandemic on patients affected by time-dependent diseases. RESULTS: Dynamic changes in ICU resource allocation occurred according to local COVID-19 epidemiology/trends of patients referred for time-dependent diseases. The absolute increase of admissions for trauma, neurosurgical emergencies and stroke was roughly two-fold. Patients referred to the hub were older and characterized by more severe conditions. An increase in crude mortality was observed, though OE ratios for in-ICU mortality were not statistically different when comparing 2020 vs. 2019. An increase in local organ procurement was observed, limiting the debacle of regional transplant activity. CONCLUSIONS: We described the effects of a regional emergently planned hub-and-spoke system for time-dependent diseases settled in the epicenter of COVID-19 pandemic in Italy.

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The effectiveness of direct-acting agents (DAAs) for hepatitis C treatment in limited-resource settings remains unclear. We estimated the pooled sustained virological response rates of DAA therapy in South America. We searched online databases for studies that reported 12-week sustained virological response (SVR12) to hepatitis C virus (HCV) treatment in individuals living in South America. Pooled SVR12 in intention-to-treat (ITT) and per-protocol were estimated. Additionally, using all studies with available data, the pooled relative risk (RR) of SVR12 using a random-effects model (DerSimonian-Laird) was estimated to compare effectiveness of DAAs in patients with or without cirrhosis, HIV co-infection or previous HCV therapy. Heterogeneity was assessed using the I2 statistics. We identified 20 studies [14 manuscripts and 6 conference abstracts] comprising 7393 individuals from five countries [Brazil (n = 11), Argentina (n = 4), Chile (n = 1), Colombia (n = 1) and Peru (n = 1)] and two South-American collaborations. The pooled overall SVR12 rates [95% confidence interval (CI)] were 92.6% [90.2-94.7] and 95.5% [94.3-96.6] by ITT (11 studies; n = 4,153; I2  = 84.2%) and per-protocol analysis (15 studies; n = 4,833; I2  = 64.5%), respectively. The RR of SVR12 was similar in patients with or without HIV co-infection [4 studies; RR = 1.03 (0.99-1.07)] and those naive compared with treatment experimented-individuals [9 studies; RR = 1.01 (1.00-1.03)], but significantly higher in patients without cirrhosis compared with those with cirrhosis [11 studies; RR = 1.04 (1.02-1.05), P < .001]. DAAs are highly effective for HCV treatment in South America. The use of DAAs should be considered in limited-resource settings to decrease the burden of liver disease in HCV-infected patients. PROSPERO[CRD 42019134603].

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BACKGROUND AND PURPOSE: The number of people suffering from stroke is strongly increasing, giving rise to multiple cognitive deficits which frequently prevent a full recovery. The identification of both spared and impaired cognitive domains has a key role to plan adequate interventions. However, the existing standard tests are either too expensive in terms of time and efforts for patients in acute stage or they derived from instruments addressing different pathologies such as dementia. METHODS: We developed a brief neuropsychological battery (mental performance in acute stroke, MEPS) to assess different cognitive domains (language, memory, praxis, visual perception) in acute stroke patients. MEPS was validated by enrolling a sample of 204 patients suffering from stroke in acute stage, and 263 healthy controls participants. RESULTS: The results indicated an adequate construct validity and a high ability in discriminating patients from healthy controls. CONCLUSIONS: MEPS can be considered a simple and highly valuable bedside battery, easy to administer, with values of sensitivity and specificity suitable to be proposed as a screening tool for patients with acute stroke.

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Ischaemic stroke is accompanied by important alterations of cardiac autonomic control, which have an impact on stroke outcome. In sleep, cardiac autonomic control oscillates with a predominant sympathetic modulation during REM sleep. We aimed to assess cardiac autonomic control in different sleep stages in patients with ischaemic stroke. Forty-five patients enrolled in the prospective, multicentre SAS-CARE study but without significant sleep-disordered breathing (apnea-hypopnea index < 15/hr) and without atrial fibrillation were included in this analysis. The mean age was 56 years, 68% were male, 76% had a stroke (n = 34, mean National Institutes of Health Stroke Scale [NIHSS] score of 5, 11 involving the insula) and 24% (n = 11) had a transitory ischaemic attack. Cardiac autonomic control was evaluated using three different tools (spectral, symbolic and entropy analysis) according to sleep stages on short segments of 250 beats in all patients. Polysomnographic studies were performed within 7 days and 3 months after the ischaemic event. No significant differences in cardiac autonomic control between sleep stages were observed in the acute phase and after 3 months. Predominant vagal modulation and decreased sympathetic modulation were observed across all sleep stages in ischaemic stroke involving the insula. Patients with ischaemic stroke and transitory ischaemic attack present a loss of cardiac autonomic dynamics during sleep in the first 3 months after the ischaemic event. This change could represent an adaptive phenomenon, protecting the cardiovascular system from the instabilities of autonomic control, or a risk factor for stroke, which precedes the ischaemic event.

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BACKGROUND & AIMS: Unsedated transnasal endoscopy may be used for detecting oesophageal varices. However, few studies evaluated feasibility and accuracy of this technique. We aimed to evaluate accuracy, interobserver agreement and safety of the transnasal ultrathin compared to conventional endoscopy in patients with cirrhosis. METHODS: This cross-sectional study included consecutive patients referred for screening or surveillance of oesophageal varices. Patients underwent unsedated transnasal and sedated conventional endoscopies at the same day, which were recorded in a digital video file and randomly analysed by two double-blinded endoscopists. High-risk varices were defined by the presence of large calibre or red wale marks. Accuracy, interobserver agreement and safety of transnasal were compared to conventional endoscopy. RESULTS: One hundred and thirty-three cirrhotic patients (48% male, aged of 60 ± 5, 34% Child-Pugh B/C and 71% of cases for variceal screening) were included in the study. The prevalence of oesophageal varices and high-risk oesophageal varices were 59% (n = 79) and 29% (n = 39) respectively. For the presence of oesophageal varices, transnasal GIE yielded sensitivity of 94% [95% Confidence Interval, CI 88-99], specificity of 89% [81-97] as well as positive and negative predictive value of 93% and 91% respectively. A satisfactory interobserver agreement was observed for the presence of oesophageal varices (κ = 0.89) and high-risk varices (κ = 0.65). No serious adverse events were recorded; transnasal GIE was safe and significantly associated with lower rates of hypoxaemia (P < .0001) and hypotension (P < .0001) compared to conventional endoscopy. CONCLUSIONS: Unsedated transnasal endoscopy was safe and had an excellent accuracy and high interobserver agreement for detecting oesophageal varices and for identifying high-risk varices in cirrhotic patients.

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INTRODUCTION: Fatigue is a frequent, disabling, and difficult to treat symptom in neurological disease and in other stress-related conditions; Integrated Imaginative Distention (IID) is a therapy combining muscular and imaginative relaxation, feasible also in disabled subjects; the DIMMI SI trial was planned to evaluate IID efficacy on fatigue. METHODS: The design was a parallel, randomised 1:1 (intervention:waiting list), controlled, open-label trial. Participants were persons with multiple sclerosis (pwMS), persons with insomnia (pwINS), and health professionals (HP) as conditions related to fatigue and stress. The primary outcome was the post-intervention change of fatigue; secondary outcomes were changes in insomnia, stress, and quality of life (QoL). Eight IID weekly training group sessions were delivered by a skilled psychotherapist. The study lasted 12 months. RESULTS: One hundred and forty-four subjects were enrolled, 48 for each condition. The mean change in Modified Fatigue Impact Scale (MFIS) score among exposed was 7.7 [95% CI 1.1, 14.4] (P = 0.023) in pwMS; 7.1 [1.9, 12.3] (P = 0.007) among pwINS, and 11.3 [4.3, 18.2] among HP (P = 0.002). At the last follow-up, the benefit was confirmed on physical fatigue for pwMS, on total fatigue for pwINS and HP. CONCLUSIONS: DIMMI SI is the first randomized controlled trial evaluating the efficacy of IID on fatigue. IID resulted a complementary intervention to reduce fatigue in stress-related conditions, in both health and disease status. NCT02290990ClinicalTrials.gov.

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OBJECTIVES: We explored the role of oxidative stress and inflammatory molecules as potential Parkinson (PD) biomarkers and correlated biological with non-motor abnormalities (olfactory impairment and dysautonomia), in patients with idiopathic REM behavior disorder (iRBD) (prodromal PD) and established PD. METHODS: We recruited 11 iRBD and 15 patients with idiopathic PD (Hohen&Yahr 1-3, on L-DOPA and dopamine agonists combination therapy) and 12 age- and sex-matched controls (CTRL). We measured total olfactory score (TOS), autonomic function [deep breathing (DB), lying to standing (LS) and Valsalva manoeuvre (VM) ratios], blood reduced glutathione (Br-GSH), oxidative stress and inflammatory markers (neopterin). RESULTS: Anosmia was similarly prevalent in iRBD (36%) and PD (33%) patients, but absent in CTRL. Orthostatic hypotension was more common among iRBD (73%) and PD (60%) than in CTRL (25%). By univariable ordinal logistic regression, TOS, Br-GSH, LS and VM ratio worsened from CTRL to iRBD and PD groups. Only reduced Br-GSH levels (p=0.037, OR=0.994; 95%CI 0.988-1.000) were independently associated to PD. TOS correlated with Br-GSH (R=0.34, p=0.037), VM ratio (R=0.43, p=0.015), and neopterin (rho=0.39, p=0.016). CONCLUSIONS: Reduced systemic antioxidant capacity is found in prodromal and overt PD and may represent, in association with olfactory loss and cardiovascular dysautonomia, a useful biomarker for an integrative, early diagnosis of PD.

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AIM: Application of microcurrents of bioresonance may allow protein aggregates lysis and a related enhancement of lymphatic drainage. Combining bioresonance with transcutaneous passage of active principles, by means of skin electroporation, microcirculation and clearance of connective tissues may be theoretically activated. A pilot study on an electro-medical device which includes these two technologies (Transponder(®)), has been performed on patients affected by lymphedema (LYM) and/or lipedema (LIP) of the lower limbs. METHODS: Eight patients affected by primary or secondary unilateral LYM or LIP were submitted to six consecutive daily sessions with the medical device; the first two sessions were performed by a trained physiotherapist, whilst the following four sessions were self-administered by the patients themselves at home (who were educated about the technique). Magnesium silicate was delivered transcutaneously by means of the device at each session. Pre-post-treatment assessment included: 1) limb volumetry by means of tape measurement; 2) segmental multifrequency bioimpedance spectroscopy for fluid changes, with L-DEX measurement; 3) visual analogue scale (VAS) (0-10 score) questionnaire for related symptoms. RESULTS: All the patients completed the scheduled treatment. After the treatment the mean volume of the whole limb decreased from 9462.85 (±3407.02) to 9297.37 cc (±3393.20), which accounts for a 165.48 cc (2%) reduction after six days of treatment. The pre/post-treatment VAS mean score changes were: heaviness from 4.57±3.46 to 2.43±2.57 (-47%), dysesthesias from 1.71±2.63 to 0.71±1.50 (-58%), pain from 1.57±2.57 to 0.57±0.79 (-64%). Diuresis VAS measurement passed from 7.43±1.81 to 8.57±0.98 (15% increase). The average L-DEX percentage reduction was 21%. No side effects were reported and a good patients' compliance was recorded. CONCLUSIONS: The preliminary data of this pilot study show that the combination of microcurrents of bioresonance with transdermal delivery of active principles indicate that it could result in edema decrease and symptom improvement in patients affected by LYM and/or LIP of the lower limbs. Self-administered modality of the electrical device is possible and effective; no side effects have been reported.

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AIM: The aim of the study was to assess efficacy and safety of a new medical device, based on electric microcurrents and vacuum mechanism, on lymphedema of the lower limbs. METHODS: This was an observational clinical and instrumental study was performed on eight patients (2 males and 6 females, mean age 40.5 years), affected by secondary (3) or primary (5) lymphedema of the lower limbs. Ten daily sessions with an electro-sound wave and vacuum medical device were performed. Patients did not discontinue antecedently worn compression stockings. Lymphoscintigraphy of the lower limbs was performed before and after the treatment and an independent observer scored the images. Circumference tape measurement and relative volumetry were calculated before and after the treatment. RESULT: Total limb mean volumetry decreased from 9145 cc (±3439 SD) to 8714 (±3307) after 10 sessions (5% improvement); reduction in the lower leg volumetry was 8%. Ankle and mid calf mean circumference (in cm) decreased from 27.7 to 27.2 and from 36.2 to 35.2. Popliteal and inguinal lymph node visualisation at lymphoscintigraphy improved of 72%, 41%, 95% and 192% and of 0%, 33%, 110% and 245% respectively, 5', 45',120' and 180' after the injection. Radiotracer ascension along the leg and the thigh increased respectively of 48% and 33%, 39% and 64%, 50% and 62% and finally of 55% and 78% at the same intervals. Dermal back flow did not significantly vary till 45', whereas it improved of 25% both 120' and 180' after injection. No side effects were highlighted during the treatment. CONCLUSION: In this observational study the application of a medical device, based on bioresonance and vacuum mechanisms, on limbs with lymphedema proved to be both safe and effective in terms of limb volume reduction and of lymphoscintigraphy parameters.

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Accurate measurement of limb volume is considered crucial to lymphedema management. Various non-invasive methods may be used and have been validated in recent years, though suboptimal standardisation has been highlighted in different publications.

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