Prevalence of Sinus Mucosal Abnormalities on CT of the Head Performed for Headache When Compared With Those Performed for Other Indications.

Background There is a high prevalence of mucosal abnormalities of paranasal sinuses on CT Head scans performed for all indications. The purpose of this study is to see whether or not such abnormalities are more common in scans performed on patients presenting with headaches when compared with those without headaches. Methods Images of CT scans of the brain of 100 consecutive patients from each of the two study groups (a total of 200 scans) were retrospectively reviewed for the presence of sinus mucosal abnormalities and their Lund-Mackay (LM) scores were calculated. A corrected LM score was also calculated using a correction factor for non-visualized sinuses in some scans and osteomeatal complexes in all scans. Radiological reports for these scans were also reviewed to note whether or not they contained any comments on the sinuses. All the reviewed scans were performed between January 1, 2021 and January 22, 2021. Results In the headache group, 17 patients had an LM score above 4 (which was used as the main cut-off point for this study). In the non-headache group, 16 patients had a score greater than 4. The mean LM score in the headache group was 1.24 and in the non-headache group was 1.4. There has been no significant difference in the comparison when corrected LM scores were used. In the headache group, 22 radiology reports contained comments on the sinuses compared to 11 reports in the non-headache group. Conclusion Results of this study indicate that there is no significant difference in the prevalence of clinically important sinus mucosal abnormalities in patients who had a brain CT for headache when compared with other indications. It was found that radiologists tend to comment on the sinuses more often when the indication was headache. It may be reasonable for radiologists to consider reviewing this practice. This might reduce unnecessary referrals to ENT and, more importantly, avoid missing other reasons for headaches.

Image quality in whole-body MRI using the MY-RADS protocol in a prospective multi-centre multiple myeloma study.

BACKGROUND: The Myeloma Response Assessment and Diagnosis System (MY-RADS) guidelines establish a standardised acquisition and analysis pipeline for whole-body MRI (WB-MRI) in patients with myeloma. This is the first study to assess image quality in a multi-centre prospective trial using MY-RADS. METHODS: The cohort consisted of 121 examinations acquired across ten sites with a range of prior WB-MRI experience, three scanner manufacturers and two field strengths. Image quality was evaluated qualitatively by a radiologist and quantitatively using a semi-automated pipeline to quantify common artefacts and image quality issues. The intra- and inter-rater repeatability of qualitative and quantitative scoring was also assessed. RESULTS: Qualitative radiological scoring found that the image quality was generally good, with 94% of examinations rated as good or excellent and only one examination rated as non-diagnostic. There was a significant correlation between radiological and quantitative scoring for most measures, and intra- and inter-rater repeatability were generally good. When the quality of an overall examination was low, this was often due to low quality diffusion-weighted imaging (DWI), where signal to noise ratio (SNR), anterior thoracic signal loss and brain geometric distortion were found as significant predictors of examination quality. CONCLUSIONS: It is possible to successfully deliver a multi-centre WB-MRI study using the MY-RADS protocol involving scanners with a range of manufacturers, models and field strengths. Quantitative measures of image quality were developed and shown to be significantly correlated with radiological assessment. The SNR of DW images was identified as a significant factor affecting overall examination quality. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03188172 , Registered on 15 June 2017. CRITICAL RELEVANCE STATEMENT: Good overall image quality, assessed both qualitatively and quantitatively, can be achieved in a multi-centre whole-body MRI study using the MY-RADS guidelines. KEY POINTS: • A prospective multi-centre WB-MRI study using MY-RADS can be successfully delivered. • Quantitative image quality metrics were developed and correlated with radiological assessment. • SNR in DWI was identified as a significant predictor of quality, allowing for rapid quality adjustment.

Workforce Crisis in Radiology in the UK and the Strategies to Deal With It: Is Artificial Intelligence the Saviour?

Radiology has seen rapid growth over the last few decades. Technological advances in equipment and computing have resulted in an explosion of new modalities and applications. However, this rapid expansion of capability and capacity has not been matched by a parallel growth in the number of radiologists. This has resulted in global shortages in the workforce, with the UK being one of the most affected countries. The UK National Health Service has been employing several conventional strategies to deal with the workforce situation with mixed success. The emergence of artificial intelligence (AI) tools that have the potential to increase efficiency and efficacy at various stages in radiology has made it possible for radiology departments to use new strategies and workflows that can offset workforce shortages to some extent. This review article discusses the current and projected radiology workforce situation in the UK and the various strategies to deal with it, including applications of AI in radiology. We highlight the benefits of AI tools in improving efficiency and patient safety. AI has a role along the patient's entire journey from the clinician requesting the appropriate radiological investigation, safe image acquisition, alerting the radiologists and clinicians about critical and life-threatening situations, cancer screening follow up, to generating meaningful radiology reports more efficiently. It has great potential in easing the workforce crisis and needs rapid adoption by radiology departments.

Evaluation of Clinical Case Definitions for Respiratory Syncytial Virus Lower Respiratory Tract Infection in Young Children.

BACKGROUND: Various case definitions of respiratory syncytial virus lower respiratory tract infection (RSV-LRTI) are currently proposed. We assessed the performance of 3 clinical case definitions against the World Health Organization definition recommended in 2015 (WHO 2015). METHODS: In this prospective cohort study conducted in 8 countries, 2401 children were followed up for 2 years from birth. Suspected LRTIs were detected via active and passive surveillance, followed by in-person clinical evaluation including single timepoint respiratory rate and oxygen saturation (by pulse oximetry) assessment, and nasopharyngeal sampling for RSV testing by polymerase chain reaction. Agreement between case definitions was evaluated using Cohen's κ statistics. RESULTS: Of 1652 suspected LRTIs, 227 met the WHO 2015 criteria for RSV-LRTI; 73 were classified as severe. All alternative definitions were highly concordant with the WHO 2015 definition for RSV-LRTI (κ: 0.95-1.00), but less concordant for severe RSV-LRTI (κ: 0.47-0.82). Tachypnea was present for 196/226 (86.7%) WHO 2015 RSV-LRTIs and 168/243 (69.1%) LRTI/bronchiolitis/pneumonia cases, clinically diagnosed by nonstudy physicians. Low oxygen saturation levels were observed in only 55/226 (24.3%) WHO 2015 RSV-LRTIs. CONCLUSIONS: Three case definitions for RSV-LRTI showed high concordance with the WHO 2015 definition, while agreement was lower for severe RSV-LRTI. In contrast to increased respiratory rate, low oxygen saturation was not a consistent finding in RSV-LRTIs and severe RSV-LRTIs. This study demonstrates that current definitions are highly concordant for RSV-LRTIs, but a standard definition is still needed for severe RSV-LRTI. CLINICAL TRIAL REGISTRATION: NCT01995175.

Echocardiographic Evaluation of Pulmonary Embolism: A Review.

Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States. Appropriate risk stratification is an important component of the initial evaluation for acute management of these patients. Echocardiography plays a crucial role in the risk stratification of patients with PE. In this literature review, we describe the current strategies in risk stratification of patients with PE using echocardiography and the role of echocardiography in the diagnosis of PE.

Effect of Two-Only-Meal Frequency and Exercise on HbA1C Outcomes, Weight, and Anti-Diabetic Medication in Type 2 Diabetes in a Popular Lifestyle Change Campaign in Maharashtra, Compared to Conventional Clinical Management: A Quasi-Experimental Multicenter Study in Maharashtra.

Background: Rising prevalence and poor outcomes make the twin challenges of diabetes epidemiology. This study evaluates effect of 2-only-daily-meals with exercise (2-OMEX) for its effect on HbA1c, oral hypoglycaemic agents (OHA) usage, body-weight among type-2-diabetes (T2DM) subjects, compared with conventional management. Material and Methods: A quasi-experimental, multicentre study in 2-OMEX arm, and HbA1c by HPLC method. HbA1c and body-weight changes were analyzed by 'Difference in Difference' (DID) method. Meal frequency, exercise, energy intakes were based on recall. The required sample size was 20X2 for 1.1 difference in HbA1c with 95% CL and 80% power. Results: Socio-demographic and risk profile of analysed and omitted subjects were similar. Studied arms were also similar in baseline features. The results in 2-OMEX and conventional arm are: complete records analyzed 201 and 120. Mean (sd) values as follows: observation days 234 and 236, age 52.03(8.84) and 52.45(9.48) years (P=0.6977), diabetes duration 4.6(3.05) and 4.9(2.97) years, BMI 27.28(5.27), 26.90(3.74) (P = 0.1859), baseline HbA1c gm% 7.46(1.52) and 7.55(1.58), end-line proportion of subjects attaining HbA1c ≤6.5gm% was 35.3% and 19.2% (P=0.002), bodyweight loss 2.57% and 1.26%. OHA count 1.6 (1.23) and 2.7(1.06), (P=0.0003). In 2-OMEX arm log-normal HbA1c declined significantly by 0.94 (95%CI: 1.60 to - 0.56, p=0.0333), weight loss difference 0.96 kg, and statistically not significant (P=0.595). Two subjects in 2-OMEX arm showed partial remission. Mean baseline Kcal intakes in 2-OMEX arm, were 1200.4(F) and 1437.3(M) were significantly higher than conventional arm (F) and 1430 (M). Conclusion: The 2-OMEX showed a sizeable and significant reduction in HbA1c and OHA use, in 7-months, with moderate intakes, compared to the conventional arm, possibly attributable to fewer insulin surges. More studies are required for its impact and pathways.

Patient and Healthcare Professional Preferences for Characteristics of Long-Acting Injectable Antipsychotic Agents for the Treatment of Schizophrenia.

INTRODUCTION: Studies evaluating patient and healthcare professional (HCP) preferences regarding long-acting injectable (LAI) antipsychotic agent attributes are lacking. METHODS: Surveys were administered to physicians, nurses, and patients who had at least two experiences with TV-46000, an investigational subcutaneous LAI antipsychotic agent for the treatment of schizophrenia, as part of the SHINE study (NCT03893825). Survey topics included preferences for route of administration, potential LAI dosing intervals (once-weekly, twice a month, once a month [q1m], every 2 months [q2m]), injection location, ease of use, syringe type, needle length, and need for reconstitution. RESULTS: Patients (n = 63) had a mean (SD) age of 35.6 (9.6) years, age at diagnosis of 18 (10) years, and were mostly male (75%). There were 49 HCPs: 24 physicians and 25 nurses. Patients rated "a short needle" (68%), a "choice of [q1m or q2m] dosing interval" (59%), and "injection instead of oral tablet" (59%) as the most important features. HCPs rated "single injection to initiate treatment" (61%), "flexible dosing interval" (84%), and "injection instead of oral tablet" (59%) as the most important features. Subcutaneous injections were rated "easy to [receive/administer]" by 62% of patients and 84% of HCPs. When choosing between subcutaneous injections and intramuscular injections, 65% of HCPs preferred subcutaneous injections and 57% of patients preferred intramuscular injections. It was important to most HCPs to have four dose strength options (78%), a prefilled syringe (96%), and no need for reconstitution (90%). CONCLUSIONS: Patients had a range of responses, and on some issues patient and HCP preferences differed. Altogether, this suggests the importance of providing patients with a range of options and the importance of patient-HCP discussions on treatment preference for LAIs.

Several medications for treating schizophrenia are available as long-acting injections. One advantage of these medications is that patients do not need to take pills daily. In this study, patients, doctors, and nurses were asked what medication characteristics they preferred. Question topics were similar to the following: "how often should it be taken?"; "what method of delivery do you prefer?"; "where on the body should it be injected?"; "how easy was it to use?"; "what physical properties do you like?"; and "do preparation steps matter?" Patients thought that being able to be given monthly or every other month was one of the most important features of an injection (59%). Patients also liked a short needle (68%) and an injection instead of an oral pill (59%). Doctors and nurses responded that it was important to have a single injection to start treatment (61%). They also liked having options for how often the medication was given (84%), and an injection instead of an oral pill (59%). An injection was "easy to [get/give]" for most patients (62%) and doctors and nurses (84%). Most doctors and nurses (65%) liked giving injections under the skin. Most patients (57%) liked injections into the muscle. Overall, patients and doctors/nurses agreed on most topics. There were, however, a range of patient responses; therefore, it is important for patients and doctors and nurses to talk about the available treatment options. Each individual patient may have their own preferences.

Adverse Events Reported with Therapies Targeting the CGRP Pathway During the First 6 Months Post-launch: A Retrospective Analysis Using the FDA Adverse Events Reporting System.

INTRODUCTION: Through 2018, three calcitonin gene-related peptide pathway-targeted monoclonal antibodies (CGRP mAbs) had received US Food and Drug Administration (FDA) approval for migraine prevention: erenumab, fremanezumab, and galcanezumab. METHODS: This retrospective analysis evaluated adverse events (AEs) spontaneously reported to the FDA Adverse Event Reporting System (FAERS) safety surveillance database during the first 6 months post-approval of erenumab (May 2018 to November 2018), fremanezumab (September 2018 to March 2019), and galcanezumab (September 2018 to March 2019). Reporting rates (RR) per 1000 exposed patients were calculated from number of reported events (when product classified as "primary suspect") in each AE category and estimated number of treated patients based on de-identified prescription data (IQVIA database) and were ranked on the basis of frequency for each product. RESULTS: RR per 1000 exposed patients for "migraine" (erenumab, 4.89; fremanezumab, 1.01; galcanezumab, 2.99), "headache" (3.32, 1.27, 3.07), and "drug ineffective" (3.68, 1.14, 1.69) were commonly reported for all three products, as were migraine-associated symptoms ("nausea": 2.94, 0.91, 1.09) and "injection-site" reactions ("pain": 2.94, 0.8, 4.9; "swelling": 0.56, 0.53, 1.25; "pruritus": 0.26, 0.63, 1.14; "erythema": 0.58, 0.71, 1.58). "Constipation" ranked second for erenumab (4.90) but did not make the top ten events for fremanezumab (0.46) or galcanezumab (0.76); cardiovascular events did not rank in the top ten AEs for any product. The frequency of serious outcomes was low, with ≤ 2% of AEs categorized as serious across the CGRP mAbs. CONCLUSION: These results aid in supporting the safety profile of CGRP mAbs in the real-world setting and may provide clinicians and patients with additional insight when considering migraine preventive treatments.

Pattern Recognition of Abdominal Vasculature on Color Doppler in the Fetus as a Tool for Early Diagnosis of Bladder Exstrophy in the First and Early-Second Trimester: Initial Observations.

Early prenatal diagnosis of bladder exstrophy is challenging because of its variable size and presentation. This article brings forth new signs on color Doppler (CD) to help establish the diagnosis in a suspected case. Two cases of omphalocele-exstrophy-imperforate anus-spinal defects complex presenting as a solid-cystic ventral mass at 11 weeks and a solid lower abdominal wall mass at 20 weeks, with nonvisualization of the urinary bladder, were studied by gray-scale and CD in sagittal and transverse-bladder views of the abdomen. The sagittal view on CD revealed an altered intrafetal course of umbilical artery (UA), widened UA-aorta angle (K angle), a break in the intersection of UA, and umbilical vein (UV) at the umbilicus-broken "X-sign" with distortion of the equilateral triangle normally formed by aorta, UA, and UV. The transverse-bladder view showed an altered divergent course of single-UA. Combination of these findings substantiated early diagnosis of bladder exstrophy, thus facilitating prenatal counseling. Key Messages Early prenatal diagnosis of bladder exstrophy is possible by pattern recognition of abdominal vasculature on color Doppler.The new signs-"X" and "Y" derived on color Doppler, as a clue to early diagnosis of bladder exstrophy-have not been identified in the current literature that makes this article unique.

Implementation of Whole-Body MRI (MY-RADS) within the OPTIMUM/MUKnine multi-centre clinical trial for patients with myeloma.

BACKGROUND: Whole-body (WB) MRI, which includes diffusion-weighted imaging (DWI) and T1-w Dixon, permits sensitive detection of marrow disease in addition to qualitative and quantitative measurements of disease and response to treatment of bone marrow. We report on the first study to embed standardised WB-MRI within a prospective, multi-centre myeloma clinical trial (IMAGIMM trial, sub-study of OPTIMUM/MUKnine) to explore the use of WB-MRI to detect minimal residual disease after treatment. METHODS: The standardised MY-RADS WB-MRI protocol was set up on a local 1.5 T scanner. An imaging manual describing the MR protocol, quality assurance/control procedures and data transfer was produced and provided to sites. For non-identical scanners (different vendor or magnet strength), site visits from our physics team were organised to support protocol optimisation. The site qualification process included review of phantom and volunteer data acquired at each site and a teleconference to brief the multidisciplinary team. Image quality of initial patients at each site was assessed. RESULTS: WB-MRI was successfully set up at 12 UK sites involving 3 vendor systems and two field strengths. Four main protocols (1.5 T Siemens, 3 T Siemens, 1.5 T Philips and 3 T GE scanners) were generated. Scanner limitations (hardware and software) and scanning time constraint required protocol modifications for 4 sites. Nevertheless, shared methodology and imaging protocols enabled other centres to obtain images suitable for qualitative and quantitative analysis. CONCLUSIONS: Standardised WB-MRI protocols can be implemented and supported in prospective multi-centre clinical trials. Trial registration NCT03188172 clinicaltrials.gov; registration date 15th June 2017 https://clinicaltrials.gov/ct2/show/study/NCT03188172.

Incidence of Respiratory Syncytial Virus Lower Respiratory Tract Infections During the First 2 Years of Life: A Prospective Study Across Diverse Global Settings.

BACKGROUND: The true burden of lower respiratory tract infections (LRTIs) due to respiratory syncytial virus (RSV) remains unclear. This study aimed to provide more robust, multinational data on RSV-LRTI incidence and burden in the first 2 years of life. METHODS: This prospective, observational cohort study was conducted in Argentina, Bangladesh, Canada, Finland, Honduras, South Africa, Thailand, and United States. Children were followed for 24 months from birth. Suspected LRTIs were detected via active (through regular contacts) and passive surveillance. RSV and other viruses were detected from nasopharyngeal swabs using PCR-based methods. RESULTS: Of 2401 children, 206 (8.6%) had 227 episodes of RSV-LRTI. Incidence rates (IRs) of first episode of RSV-LRTI were 7.35 (95% confidence interval [CI], 5.88-9.08), 5.50 (95% CI, 4.21-7.07), and 2.87 (95% CI, 2.18-3.70) cases/100 person-years in children aged 0-5, 6-11, and 12-23 months. IRs for RSV-LRTI, severe RSV-LRTI, and RSV hospitalization tended to be higher among 0-5 month olds and in lower-income settings. RSV was detected for 40% of LRTIs in 0-2 month olds and for approximately 20% of LRTIs in older children. Other viruses were codetected in 29.2% of RSV-positive nasopharyngeal swabs. CONCLUSIONS: A substantial burden of RSV-LRTI was observed across diverse settings, impacting the youngest infants the most. Clinical Trials Registration. NCT01995175.

A Case Report of Double Positive Peripheral T Cell Lymphoma­ Not Otherwise Specified in A Young Pregnant Female.

Peripheral T-cell lymphoma (PTCL) comprises 5-20% of all non-Hodgkin lymphomas (NHL). These all have different morphological patterns, phenotypes, and clinical presentations making it a diverse group of lymphomas. PTCL, not otherwise specified (PTCL-NOS), is a subtype considered to have a poor prognosis and a low overall survival rate of only about 30-40%. We report a case of primary cutaneous PTCL-NOS presenting in a young pregnant female with multiple progressive, tender, and necrosed nodules all over her body for 3 months. Her skin biopsy findings led us to suspect malignancy, and via immunohistochemistry (IHC), her diagnosis was confirmed. Cutaneous lymphoma is a dangerous albeit rare entity and should be kept in mind when the commoner differentials have been ruled out.

Ten-Year Trends in Patient Characteristics, Treatments, and Outcomes in Myocardial Infarction From National Cardiovascular Data Registry Chest Pain-MI Registry.

BACKGROUND: The Chest Pain-MI registry affords a 10-year perspective of the acute myocardial infarction (MI) patient characteristics, management, and clinical outcomes in the United States. We report the changes in the treatment and cardiovascular outcomes of acute MI patients over 10 years. METHODS: Annual trends in patient characteristics, in-hospital treatment, and outcomes of 604 936 ST-segment-elevation MI (STEMI) and 933 755 non-ST-segment-elevation MI (NSTEMI) patients at 1230 hospitals from 2009 to 2018 were analyzed. Using the validated Acute Coronary Intervention and Outcomes Network mortality risk model, trends in in-hospital risk-adjusted mortality rates were tested between 2011 and 2018. RESULTS: Over 10 years, the prevalence of diabetes (22.8%-28.3% [STEMI] and 35.7%-41.3% [NSTEMI]) and atrial fibrillation (4.1%-6.1% and 9.4%-11.7%) increased, whereas the prevalence of smoking decreased (43.5%-37.9% and 30.2%-27.5%, P<0.001 for all) in patients with STEMI and NSTEMI, respectively. Among eligible patients with STEMI, primary percutaneous coronary intervention use increased (82.3%-96.0%) with shorter median first medical contact to device time (90 to 82 minutes, P<0.001). Among patients with NSTEMI, percutaneous coronary intervention use increased significantly (43.9%-54.5%, P<0.001). Adherence to guideline-directed medical therapies improved in both groups. From 2011 to 2018, risk-adjusted mortality rate (2.8%-2.7%, P=0.46) was stable in STEMI and declined significantly in patients with NSTEMI (1.9%-1.3%, P=0.0001). CONCLUSIONS: Risk factors of patients presenting with acute MI have changed modestly while treatment improved over time. Risk-adjusted mortality rates remained stable for patients with STEMI and declined significantly for patients with NSTEMI.

Redo-aortic valve replacement in prior stentless prosthetic aortic valves: Transcatheter versus surgical approach.

OBJECTIVES: The objective was to compare outcomes of redo-aortic valve replacement (AVR) via surgical or transcatheter approach in prior surgical AVR with large percentage of prior stentless surgical AVR. BACKGROUND: With the introduction of transcatheter aortic valve replacement (TAVR), patients with increased surgical risks now have an alternative to redo surgical AVR (SAVR), known as valve-in-valve (ViV) TAVR. Stentless prosthetic aortic valves present a more challenging implantation for ViV-TAVR given the lack of structural frame. METHODS: We performed a retrospective study of 173 subjects who have undergone SAVR (N = 100) or ViV-TAVR (N = 73) in patients with prior surgical AVR at Wake Forest Baptist Medical Center from 2009 to 2019. Our study received the proper ethical oversight. RESULTS: The average ages in redo-SAVR and ViV-TAVR groups were 58.03 ± 13.86 and 66.57 ± 13.44 years, respectively (p < 0.0001). The redo-SAVR had significantly lower STS (2.78 ± 2.09 and 4.68 ± 5.51, p < 0.01) and Euroscores (4.32 ± 2.98 and 7.51 ± 8.24, p < 0.05). The redo-SAVR group had higher percentage requiring mechanical support (8% vs. 0%, p < 0.05) and vasopressors (53% vs. 0%, p < 0.0001), longer length of stay (13.65 ± 11.23 vs. 5.68 ± 7.64 days, p < 0.0001), and inpatient mortality (16% vs. 2.78%, p < 0.005). At 30-day follow-up, redo-SAVR group had higher rates of acute kidney injury (10% vs. 0%, p < 0.01), however ViV-TAVR group had more new left bundle branch blocks (6.85% vs. 0%, p < 0.05). No significant differences regarding re-hospitalization rates, stroke, or death up to 1-year. CONCLUSION: Although the ViV-TAVR group had higher risk patients, there were significantly fewer procedural complications, shorter length of stay, and similar mortality outcomes up to 1-year follow-up.

Use of Coronary Intravascular Lithotripsy: A Comprehensive Review of Literature.

Severe coronary artery calcification (CAC) is associated with high rate of procedural complications. The current techniques that facilitate percutaneous coronary interventions in moderate to severe CAC have significant risk of complications, including periprocedural myocardial infarction , dissection, perforation and transient atrioventricular block. Coronary Intravascular lithotripsy (IVL) is a novel technology for the treatment of moderate to severe calcified lesions. IVL uses sonic pressure waves to break down the calcium deposits with no to minimal impact on the blood vessel tissues, which makes IVL a safe option with high procedural success and minimal complications. Here, we discuss coronary IVL as a treatment option for CAC and summarize the major clinical trials performed evaluating the safety and outcome of IVL.

The Burden of Acute Febrile Illness Attributable to Dengue Virus Infection in Sri Lanka: A Single-Center 2-Year Prospective Cohort Study (2016-2019).

We performed a 2-year prospective cohort study to determine the incidence of dengue in Angoda, Colombo district, Sri Lanka (NCT02570152). The primary objective was to determine the incidence of acute febrile illness (AFI) because of laboratory confirmed dengue (LCD). Secondary objectives were to determine AFI incidence because of non-LCD, describe AFI symptoms, and estimate AFI incidence because of LCD by dengue virus (DENV)-type and age group. Participants from households with at least one minor and one adult (≤50 years) were enrolled and followed with scheduled weekly visits and, in case of AFI, unscheduled visits. Blood was collected for DENV detection at AFI visits, and symptoms recorded during the 7-day period following AFI onset. A total of 2,004 participants were enrolled (971 children, and 1,033 adults). A total of 55 LCD episodes were detected (overall incidence of 14.2 per 1,000 person-years). Incidence was the highest among children < 5 years (21.3 per 1,000 person-years) and 5-11 years (22.7 per 1,000 person-years), compared with adults ≥ 18 years (9.2 per 1,000 person-years). LCD was mostly (83.6%) caused by DENV-2 (n = 46), followed by DENV-1 (n = 6) and DENV-3 (n = 3). Common symptoms of LCD were headache, fatigue, myalgia, loss of appetite, and arthralgia. Incidence of AFI because of non-LCD was 47.3 per 1,000 person-years. In conclusion, this study reports the LCD incidence for a DENV-2 dominated epidemic that is comparable to the incidence of suspected dengue reported passively for 2017, one of the worst outbreaks in recent history.

Echocardiography and EuroSCORE II for the stratification of low-gradient severe aortic stenosis and preserved left ventricular ejection fraction.

The purpose of this study was to explore the utility of echocardiography and the EuroSCORE II in stratifying patients with low-gradient severe aortic stenosis (LG SAS) and preserved left ventricular ejection fraction (LVEF ≥ 50%) with or without aortic valve intervention (AVI). The study included 323 patients with LG SAS (aortic valve area ≤ 1.0 cm2 and mean pressure gradient < 40 mmHg). Patients were divided into two groups: a high-risk group (EuroSCORE II ≥ 4%, n = 115) and a low-risk group (EuroSCORE II < 4%, n = 208). Echocardiographic and clinical characteristics were analyzed. All-cause mortality was used as a clinical outcome during mean follow-up of 2 ± 1.3 years. Two-year cumulative survival was significantly lower in the high-risk group than the low-risk patients (62.3% vs. 81.7%, p = 0.001). AVI tended to reduce mortality in the high-risk patients (70% vs. 59%; p = 0.065). It did not significantly reduce mortality in the low-risk patients (82.8% with AVI vs. 81.2%, p = 0.68). Multivariable analysis identified heart failure, renal dysfunction and stroke volume index (SVi) as independent predictors for mortality. The study suggested that individualization of AVI based on risk stratification could be considered in a patient with LG SAS and preserved LVEF.

A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants.

The human rotavirus vaccine (HRV; Rotarix, GSK) is available as liquid (Liq) and lyophilized (Lyo) formulations, but only Lyo HRV is licensed in India. In this phase III, randomized, open-label trial (NCT02141204), healthy Indian infants aged 6-10 weeks received 2 doses (1 month apart) of either Liq HRV or Lyo HRV. Non-inferiority of Liq HRV compared to Lyo HRV was assessed in terms of geometric mean concentrations (GMCs) of anti-RV immunoglobulin A (IgA), 1-month post-second dose (primary objective). Reactogenicity/safety were also evaluated. Seroconversion was defined as anti-RV IgA antibody concentration ≥20 units [U]/mL in initially seronegative infants (anti-RV IgA antibody concentration <20 U/mL) or ≥2-fold increase compared with pre-vaccination concentration in initially seropositive infants. Of the 451 enrolled infants, 381 (189 in Liq HRV and 192 in Lyo HRV group) were included in the per-protocol set. The GMC ratio (Liq HRV/Lyo HRV) was 0.93 (95% confidence interval [CI]: 0.65-1.34), with the lower limit of the 95% CI reaching ≥0.5, the pre-specified statistical margin for non-inferiority. In the Liq HRV and Lyo HRV groups, 42.9% and 44.3% (baseline) and 71.4% and 73.4% (1-month post-second dose) of infants had anti-RV IgA antibody concentration ≥20 U/mL, and overall seroconversion rates were 54.5% and 50.0%. Incidences of solicited and unsolicited adverse events were similar between groups and no vaccine-related serious adverse events were reported. Liq HRV was non-inferior to Lyo HRV in terms of antibody GMCs and showed similar reactogenicity/safety profiles, supporting the use of Liq HRV in Indian infants.

PLAIN LANGUAGE SUMMARYWhat is the context?Rotavirus is the most common cause of acute gastronenteritis and contributes to the high number of hospitalizations and deaths in young children worldwide.Vaccination against rotavirus has led to a significant decrease in rotavirus-related infections.The human rotavirus vaccine Rotarix (GSK) is currently used as a liquid or lyophilized formulation.In clinical trials conducted in European and North American infants, the liquid vaccine showed ability to induce immune response and safety comparable to the lyophilized formulation.Only the lyophilized vaccine is currently marketed in india.What is new?We compared the 2-dose liquid and lyophilized human rotavirus vaccines in indian infants in a phase III clinical trial:The ability to induce immune response for thw liquid formulation was not inferior to that observed for the lyophilized vaccine.The safety profiles of the 2 formulations were comparable.Why is this important?This study shows that the liquid human rotavirus vaccine can be administrated to infants from india.

Oral Anticoagulant Use in Morbid Obesity and Post Bariatric Surgery: A Review.

Bariatric surgery has emerged as a therapy for obesity and the associated comorbidities. Obesity has been shown to be a risk factor for atrial fibrillation as well as venous thromboembolism, both of which are conditions that warrant anticoagulation. There is significant underrepresentation of the morbidly obese population in prospective trials that evaluated direct oral anticoagulants and vitamin K antagonists in atrial fibrillation and venous thromboembolism. We aim to review all the available data that assessed these oral anticoagulants in the morbidly obese population (body mass index >40 kg/m2 and weight >120 kg) and in the post-bariatric surgery population. Our findings suggest that direct oral anticoagulants may be safe and effective for anticoagulation in morbidly obese patients for both atrial fibrillation and venous thromboembolism. However, warfarin is the preferred agent in the post-bariatric surgery population, given the limited number of studies on direct oral anticoagulants in this population. Further adequately powered randomized control trials are needed to confirm the safety and efficacy of these oral anticoagulants in the morbidly obese and post-bariatric surgery population.