Evidences of SARS-CoV-2 virus air transmission indoors using several untouched surfaces: A pilot study.

Nowadays, there is an important controversy about coronavirus air transmission. The aim of this study was to determine aerosol transmission from patients with coronavirus infection using "COVID-19 traps" that included different untouched surfaces within them. 42 swab samples of 6 different surfaces placed in the rooms of 6 patients with a positive diagnostic of COVID-19 were analyzed with RT-PCR technique to evaluate the presence of the virus and its stability. Samples were collected at 24, 48 and 72 h. Patients were in an intensive care unit (ICU) and in a COVID-19 ward unit (CWU) at a Spanish referral hospital. None of the samples placed in the ICU unit were positive for COVID-19. However, two surfaces, placed in a CWU room with a patient that required the use of respiratory assistance were positive for coronavirus at 72 h. Surfaces could not be touched by patients or health workers, so viral spreading was unequivocally produced by air transmission. Thus, fomites should be considered as a possible mode of transmission of coronavirus and frequent disinfection of surfaces should be taken into account. Our results, although preliminary, point the importance of SARS-CoV-2 virus air transmission indoors and may shed some light in this debate.

Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial.

INTRODUCTION: Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data. METHODS: This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6-8 hours apart). RESULTS: Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days) (p = 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with ≥ 67% adherence per month demonstrated significant differences between nVNS (n = 138) and sham (n = 140) for outcomes including reduction in migraine days (2.27 vs. 1.53; p = 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common. CONCLUSIONS: Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The "sham" device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients. Study identification and registration: PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844.

Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis.

BACKGROUND: Two randomized, double-blind, sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS) as acute treatment for cluster headache. We analyzed pooled ACT1/ACT2 data to increase statistical power and gain insight into the differential efficacy of nVNS in episodic and chronic cluster headache. METHODS: Data extracted from ACT1 and ACT2 were pooled using a fixed-effects model. Main outcome measures were the primary endpoints of each study. This was the proportion of participants whose first treated attack improved from moderate (2), severe (3), or very severe (4) pain intensity to mild (1) or nil (0) for ACT1 and the proportion of treated attacks whose pain intensity improved from 2-4 to 0 for ACT2. RESULTS: The pooled population included 225 participants (episodic: n = 112; chronic: n = 113) from ACT1 (n = 133) and ACT2 (n = 92) in the nVNS (n = 108) and sham (n = 117) groups. Interaction was shown between treatment group and cluster headache subtype (p < 0.05). nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p < 0.01). Only four patients discontinued the studies due to adverse events. CONCLUSIONS: nVNS is a well-tolerated and effective acute treatment for episodic cluster headache. TRIAL REGISTRATION: The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).

Non-invasive vagus nerve stimulation for treatment of cluster headache: early UK clinical experience.

BACKGROUND: Evidence supports the use of non-invasive vagus nerve stimulation (nVNS; gammaCore®) as a promising therapeutic option for patients with cluster headache (CH). We conducted this audit of real-world data from patients with CH, the majority of whom were treatment refractory, to explore early UK clinical experience with nVNS used acutely, preventively, or both. METHODS: We retrospectively analysed data from 30 patients with CH (29 chronic, 1 episodic) who submitted individual funding requests for nVNS to the National Health Service. All patients had responded to adjunctive nVNS therapy during an evaluation period (typical duration, 3-6 months). Data collected from patient interviews, treatment diaries, and physician notes were summarised with descriptive statistics. Paired t tests were used to examine statistical significance. RESULTS: The mean (SD) CH attack frequency decreased from 26.6 (17.1) attacks/wk. before initiation of nVNS therapy to 9.5 (11.0) attacks/wk. (P < 0.01) afterward. Mean (SD) attack duration decreased from 51.9 (36.7) minutes to 29.4 (28.5) minutes (P < 0.01), and mean (SD) attack severity (rated on a 10-point scale) decreased from 7.8 (2.3) to 6.0 (2.6) (P < 0.01). Use of abortive treatments also decreased. Favourable changes in the use of preventive medication were also observed. No serious device-related adverse events were reported. CONCLUSIONS: Significant decreases in attack frequency, severity, and duration were observed in these patients with CH who did not respond to or were intolerant of multiple preventive and/or acute treatments. These real-world findings complement evidence from clinical trials demonstrating the efficacy and safety of nVNS in CH.

Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study.

Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superior to sham (6%; p < 0.01). No significant differences between nVNS (5%) and sham (13%) were seen in the cCH subgroup. Conclusions Combing both eCH and cCH patients, nVNS was no different to sham. For the treatment of CH attacks, nVNS was superior to sham therapy in eCH but not in cCH. These results confirm and extend previous findings regarding the efficacy, safety, and tolerability of nVNS for the acute treatment of eCH.

Proof of concept: short-term non-invasive cervical vagus nerve stimulation in patients with drug-refractory gastroparesis.

BACKGROUND: Gastric electric stimulation (GES) is a treatment approach to refractory gastroparesis, possibly acting centrally via afferent vagus nerve stimulation (VNS). Non-invasive VNS (nVNS) is a potential alternative to GES that could eliminate the safety risks of or identify likely responders to implantable neurostimulators. OBJECTIVE: This open-label proof-of-concept study assessed the effects of nVNS in patients with severe drug-refractory gastroparesis. METHODS: Patients used the Gastroparesis Cardinal Symptom Index (GCSI) to grade symptoms in diaries daily for 2 weeks before treatment (baseline) and during ≥3 weeks of nVNS therapy. Adverse events (AEs) were also diarised. Treatment was self-administered using an nVNS device (gammaCore, electroCore) and consisted of 120 s stimulations to the vagus nerve in the neck (two stimulations to each side three times daily during weeks 1 and 2; three stimulations to each side three times daily during week 3 and beyond). Response was defined as a ≥1 point decrease from baseline in GCSI score. RESULTS: Thirty-five patients enrolled; 23 were compliant with study procedures and were included in the analysis; 7 continued treatment beyond 3 weeks. Response rates were 35% (8/23) at 3 weeks and 43% (10/23) for the duration of therapy (3-6 weeks). For the entire cohort and the 10 responders, improvements from baseline were noted for mean total GCSI and GCSI subscale scores (nausea/vomiting, postprandial fullness/early satiety, bloating). No serious AEs were reported. CONCLUSIONS: These preliminary results provide a signal that nVNS may be useful for treating refractory gastroparesis. Larger controlled studies are warranted.

Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment.

OBJECTIVE: To report our initial experience with a novel device, designed to provide portable, noninvasive, transcutaneous stimulation of the vagus nerve, both acutely and preventively, as a treatment for cluster headache. METHODS: Patients with cluster headache (11 chronic, 8 episodic), from 2 centers, including 7 who were refractory to drug treatment, had sufficient data available for analysis in this open-label observational cohort study. The device, known as the gammaCore, was used acutely to treat individual attacks as well as to provide prevention. Patient-estimated efficacy data were collected by systematic inquiry during follow-up appointments up to a period of 52 weeks of continuous use. RESULTS: Fifteen patients reported an overall improvement in their condition, with 4 reporting no change, providing a mean overall estimated improvement of 48%. Of all attacks treated, 47% were aborted within an average of 11 ± 1 minutes of commencing stimulation. Ten patients reduced their acute use of high-flow oxygen by 55% with 9 reducing triptan use by 48%. Prophylactic use of the device resulted in a substantial reduction in estimated mean attack frequency from 4.5/24 hours to 2.6/24 hours (p < 0.0005) posttreatment. CONCLUSION: These data suggest that noninvasive vagus nerve stimulation may be practical and effective as an acute and preventive treatment in chronic cluster headache. Further evaluation of this treatment using randomized sham-controlled trials is thus warranted. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with cluster headache, transcutaneous stimulation of the vagus nerve aborts acute attacks and reduces the frequency of attacks.

Role of endoscopic ultrasound in the diagnosis of pancreatic cancer.

Endoscopic ultrasonography (EUS) with or without fine needle aspiration has become the main technique for evaluating pancreatobiliary disorders and has proved to have a higher diagnostic yield than positron emission tomography, computed tomography (CT) and transabdominal ultrasound for recognising early pancreatic tumors. As a diagnostic modality for pancreatic cancer, EUS has proved rates higher than 90%, especially for lesions less than 2-3 cm in size in which it reaches a sensitivity rate of 99% vs 55% for CT. Besides, EUS has a very high negative predictive value and thus EUS can reliably exclude pancreatic cancer. The complication rate of EUS is as low as 1.1%-3.0%. New technical developments such as elastography and the use of contrast agents have recently been applied to EUS, improving its diagnostic capability. EUS has been found to be superior to the recent multidetector CT for T staging with less risk of overstaying in comparison to both CT and magnetic resonance imaging, so that patients are not being ruled out of a potentially beneficial resection. The accuracy for N staging with EUS is 64%-82%. In unresectable cancers, EUS also plays a therapeutic role by means of treating oncological pain through celiac plexus block, biliary drainage in obstructive jaundice in patients where endoscopic retrograde cholangiopancreatography is not affordable and aiding radiotherapy and chemotherapy.

Metástasis pancreática única de carcinoma renal / Solitary pancreatic metastasis from renal carcinoma

Presentamos el caso de un varón de 60 años, con antecedentes de nefrectomía radical izquierda por carcinoma renal, en grado nuclear II de Fuhrman, 8 años atrás. Por traumatismo abdominal cerrado se solicitó una TC abdominal en la que se observó una lesión sólida, hipervascular en la cabeza pancreática de 4cm de diámetro. Con la sospecha diagnóstica de metástasis pancreática de carcinoma renal se realizó duodenopancreatectomía cefálica con preservación pilórica. El estudio anatomopatológico confirmó la presunción diagnóstica. A los 23 meses de seguimiento el paciente está libre de enfermedad (AU)

We present the case of a 60-year-old man with a history of left radical nephrectomy due to Fuhrman nuclear grade II renal carcinoma 8 years previously. Abdominal computed tomography was performed due to a closed abdominal injury, revealing a solid, 4-cm hypervascular mass in the head of the pancreas. The suspected diagnosis was pancreatic metastasis from renal carcinoma. Cephalic duodenopancreatectomy was performed. The diagnosis was confirmed by histopathological analysis. At 23 months of follow-up, the patient remains disease free (AU)

[Solitary pancreatic metastasis from renal carcinoma]. / Metástasis pancreática única de carcinoma renal.

We present the case of a 60-year-old man with a history of left radical nephrectomy due to Fuhrman nuclear grade II renal carcinoma 8 years previously. Abdominal computed tomography was performed due to a closed abdominal injury, revealing a solid, 4-cm hypervascular mass in the head of the pancreas. The suspected diagnosis was pancreatic metastasis from renal carcinoma. Cephalic duodenopancreatectomy was performed. The diagnosis was confirmed by histopathological analysis. At 23 months of follow-up, the patient remains disease free.

Causa poco frecuente de úlcera gástrica / A rare cause of gastric ulcer

Las lesiones del tracto gastrointestinal inducidas por fármacos son cada vez más frecuentes, pero en general poco reconocidas. Aunque hay un número elevado de fármacos que se asocian con efectos adversos gastrointestinales, hay limitados patrones característicos de los mismos. La gastritis aguda isquémica es una entidad poco común que rara vez se distingue de otras formas de isquemia intestinal. Presentamos el caso de una mujer de 69 años que en el contexto de una reagudización de su anemia, encontramos una lesión gástrica poco común (AU)

Drug-induced gastrointestinal tract lesions are becoming more frequent but are generally little known. Although a large number of drugs have gastrointestinal adverse effects, there are few characteristic patterns. Acute ischemic gastritis is an uncommon entity that is rarely distinguished from other forms of intestinal ischemia. We report the case of a 69-year-old woman who was diagnosed with an unusual gastric lesion in the context of an acute exacerbation of her anemia (AU)

[A rare cause of gastric ulcer]. / Causa poco frecuente de úlcera gástrica.

Drug-induced gastrointestinal tract lesions are becoming more frequent but are generally little known. Although a large number of drugs have gastrointestinal adverse effects, there are few characteristic patterns. Acute ischemic gastritis is an uncommon entity that is rarely distinguished from other forms of intestinal ischemia. We report the case of a 69-year-old woman who was diagnosed with an unusual gastric lesion in the context of an acute exacerbation of her anemia.

Glutamatergic fine tuning with ADX-10059: a novel therapeutic approach for migraine?

IMPORTANCE OF THE FIELD: Migraine is an episodic, substantially inherited brain disorder affecting 15% of adults in Western Europe and North America, and is one of the commonest reasons for patients to see their physicians. While the World Health Organization considers that severe migraine can be as disabling as quadriplegia, unfortunately the condition remains undertreated. Until the 1990s, specific migraine therapies were limited to ergot derivatives. AREAS COVERED IN THIS REVIEW: The triptans, serotonin 5-HT(1B/1D) receptor agonists, revolutionized the acute management of migraine patients. However, although the triptans are generally effective and safe, not all patients can take them and many do not respond especially to oral therapies. Recently, progress has been made on the therapeutic front, particularly with new acute treatments. This review will focus on the therapeutic potential of ADX10059, a metabotropic glutamate receptor 5, negative allosteric modulator (mGluR5 NAM), in migraine. Data from a proof-of-concept study in episodic migraineurs demonstrated a significant improvement following acute treatment. A large European multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study is currently investigating the efficacy, safety and tolerability of the compound for migraine prevention. WHAT THE READER WILL GAIN: The reader will have the basic principles of migraine management and the potential for glutamate-targeted approaches. TAKE HOME MESSAGE: Targeting glutamatergic transmission in migraine may provide a novel preventive therapy that is effective and well-tolerated.

[Primary esophageal melanoma]. / Melanoma esofagico primario.

Primary Esophageal Melanoma (PEM) is an extremely rare neoplasm, with less than 270 cases described. Although clinical presentation is similar to any other esophageal neoplasm, MEP's behavior is more aggressive and fatal in most cases. We report two new cases of MEP diagnosed through endoscopy and anatomical-pathological analysis of collected biopsies. Both samples were positive for HMB-45 and S100, so the presence of primary melanoma in other location was ruled out. The form of presentation as left miosis with no eyelid ptosis or enophthalmos should be highlighted in the first case, which was described by this early manifestation. Unfortunately, the neoplasm could not be excised when diagnosed because the thoracic artery was found to be affected through echoendoscopy. In the second case, in spite of the fact that the neoplastic extension was only local, and neoplasm was subject to transhiatal esophagectomy, the patient had multiple post-surgical complications and died nineteen days after the surgical procedure. Furthermore, bibliographic review is applied to diagnosis, treatment options, and prognosis of this exceptional neoplasm.

Melanoma esofágico primario / Primary esophageal melanoma

El melanoma esofágico primario (MEP) es una neoplasia extremadamente rara, con menos de 270 casos descritos. Aunque la presentación clínica es similar a cualquier otra neoplasia esofágica, su comportamiento es más agresivo y fatal en la mayoría de los casos. Presentamos dos nuevos casos de MEP diagnosticados mediante endoscopia y estudio anatomopatológico de las biopsias obtenidas, siendo en ambos casos las muestras positivas para HMB-45 y S100, descartando así mismo la presencia de melanoma primario en otra localización. En el primer caso merece destacar la forma de presentación como miosis izquierda sin ptosis palpebral ni enoftalmos, siendo el primer caso descrito con esta manifestación inicial, lamentablemente al momento del diagnóstico fue irresecable, demostrando así mismo por ecoendoscopia afectación de la aorta torácica. El segundo caso a pesar de ser una neoplasia sin extensión locorregional y sometido a esofaguectomía transhiatal presentó múltiples complicaciones postoperatorias falleciendo al decimo noveno día de la intervención. Así mismo se hace una revisión bibliográfica sobre diagnóstico, opciones de tratamiento y pronóstico de esta excepcional neoplasia.

Primary Esophageal Melanoma (PEM) is an extremely rare neoplasm, with less than 270 cases described. Although clinical presentation is similar to any other esophageal neoplasm, MEP's behavior is more aggressive and fatal in most cases. We report two new cases of MEP diagnosed through endoscopy and anatomical-pathological analysis of collected biopsies. Both samples were positive for HMB-45 and S100, so the presence of primary melanoma in other location was ruled out. The form of presentation as left miosis with no eyelid ptosis or enophthalmos should be highlighted in the first case, which was described by this early manifestation. Unfortunately, the neoplasm could not be excised when diagnosed because the thoracic artery was found to be affected through echoendoscopy. In the second case, in spite of the fact that the neoplastic extension was only local, and neoplasm was subject to transhiatal esophagectomy, the patient had multiple post-surgical complications and died nineteen days after the surgical procedure. Furthermore, bibliographic review is applied to diagnosis, treatment options, and prognosis of this exceptional neoplasm.