Myocarditis and pericarditis in individuals exposed to the Ad26.COV2.S, BNT162b2 mRNA, or mRNA-1273 SARS-CoV-2 vaccines

IMPORTANCE: There is a high level of public and professional interest related to potential safety issues of the COVID-19 vaccines; however, no serious adverse cardiovascular events were reported in phase 3 randomized controlled trials of their safety and efficacy. Moreover, none of the case series from the United States (US) of these potential complications have been population-based.OBJECTIVES: To estimate the reporting rates of myocarditis and pericarditis in the US using the Vaccine Adverse Event Reporting System (VAERS), and to assess if these adverse events were disproportionally reported among the different COVID-19 vaccines.DESIGN SETTING AND PARTICIPANTS: All cases of myocarditis and pericarditis from VAERS reported up to July 28, 2021.EXPOSURE: Single-dose Ad26.COV2.S, BNT162b2 mRNA, or mRNA-1273 SARS-CoV-2 vaccinations.MAIN OUTCOMES AND MEASURES: Reporting rates were computed by dividing the total number of cases of myocarditis and pericarditis (combined) by the total number of vaccine doses administered. Disproportionality analyses were performed to evaluate disproportional reporting of myocarditis and pericarditis for the Ad26.COV2.S and mRNA-1273 vaccines vs. the BNT162b2 mRNA vaccine.RESULTS: By July 28, 2021, 1392, 699, and 68 cases of myocarditis or pericarditis had been reported out of 1.91, 1.38, and 1.33 million administered doses of the BNT162b2 mRNA, mRNA-1273, and Ad26.COV2.S COVID-19 vaccines, respectively. Median times to event were 3 days, 3 days, and 9 days for the BNT162b2 mRNA, mRNA-1273, and Ad26.COV2.S COVID-19 vaccines. The reporting rates for myocarditis or pericarditis were 0.00073 (95% confidence interval, 95% CI 0.00069-0.00077), 0.00051 (95% CI 0.00047-0.00055), and 0.00005 events per dose (95% CI 0.00004-0.00006) for the BNT162b2 mRNA, mRNA-1273, and Ad26.COV2.S COVID-19 vaccines, respectively. Myocarditis and pericarditis were disproportionally reported following the BNT162b2 mRNA vaccine when compared with the other vaccines, using both disproportionality measures.CONCLUSIONS AND RELEVANCE: We found reporting rates of myocarditis and pericarditis to be less than 0.1% after COVID-19 vaccination. Rates were highest for the BNT162b2 mRNA vaccine, followed by the mRNA-1273 and Ad26.COV2.S, respectively. However, the reporting rates of myocarditis and pericarditis secondary to vaccination remains less common than those seen for SARS-CoV-2 infection.</p

Lumbar interspinous process fixation and fusion with stand-alone interlaminar lumbar instrumented fusion implant in patients with degenerative spondylolisthesis undergoing decompression for spinal stenosis

Abstract STUDY DESIGN: Prospective cohort study. PURPOSE: To assess the ability of a stand-alone lumbar interspinous implant (interspinous/interlaminar lumbar instrumented fusion, ILIF) associated with bone grafting to promote posterior spine fusion in degenerative spondylolisthesis (DS) with vertebral instability. OVERVIEW OF LITERATURE: A few studies, using bilateral laminotomy (BL) or bilateral decompression by unilateral laminotomy (BDUL), found satisfactory results in stenotic patients with decompression alone, but others reported increased olisthesis, or subsequent need for fusion in DS with or without dynamic instability. METHODS: Twenty-five patients with Grade I DS, leg pain and chronic low back pain underwent BL or BDUL and ILIF implant. Olisthesis was 13% to 21%. Follow-up evaluations were performed at 4 to 12 months up to 25 to 44 months (mean, 34.4). Outcome measures were numerical rating scale (NRS) for back and leg pain, Oswestry disability index (ODI) and short-form 36 health survey (SF-36) of body pain and function. RESULTS: Fusion occurred in 21 patients (84%). None had increased olisthesis or instability postoperatively. Four types of fusion were identified. In Type I, the posterior part of the spinous processes were fused. In Type II, fusion extended to the base of the processes. In Type III, bone was present also around the polyetheretherketone plate of ILIF. In Type IV, even the facet joints were fused. The mean NRS score for back and leg pain decreased by 64% and 80%, respectively. The mean ODI score was decreased by 52%. SF-36 bodily pain and physical function mean scores increased by 53% and 58%, respectively. Computed tomography revealed failed fusion in four patients, all of whom still had vertebral instability postoperatively. CONCLUSIONS: Stand-alone ILIF with interspinous bone grafting promotes vertebral fusion in most patients with lumbar stenosis and unstable Grade I DS undergoing BL or BDUL

Epidemiology of isolated olecranon fractures: a detailed survey on a large sample of patients in a suburban area

Background: Literature lacks data concerning several epidemiologic aspects of isolated olecranon fractures (IOFs). The few studies that have analyzed this type of fracture show a low sample size and contradicting results. Methods: This retrospective study included 165 consecutive patients (82 men and 83 women) who sustained an IOF in the past 10 years. Participants who were aged &lt;16 years or had a previous elbow fracture or had a fracture that involved other bones of the elbow joint were excluded. Data regarding age, sex, season, date, and fracture side were collected. As per the mechanism of injury, we arbitrarily distinguished 7 subgroups. IOFs were classified as per the Mayo and AO classifications using x-ray. Statistics were performed. Results: The patients' mean age was 58.5 (standard deviation [SD], 21.3) years, and men and women were aged 48.1 (SD, 19.8) years and 67.9 (SD, 18.8) years, respectively. The most frequent fracture patterns were the MAYO 2A and the AO 2U1B1(d). Low-energy mechanisms caused simple dislocated-stable fractures, whereas high-energy mechanisms caused both simple and comminuted displaced-stable fractures. Significant differences in the trauma mechanism were found between male and female patients. The former fractures showed a bimodal distribution depending on the patients' age group, whereas in women, the traumatic event was mainly represented by a low-energy mechanism. Overall, the most common cause of fracture was a low-energy accident. The seasonal distribution of fractures was different for male and female patients being more frequent in summer among young men and more frequent in winter among the elderly, both men and women. The left side was involved in 87 patients. Conclusion: IOFs occur equally in both genders, although with different age distribution. The most common fracture pattern was a simple displaced-stable fracture (MAYO 2A and AO 2U1B1[d]). Young men are more often subject to high-energy injuries that occur in road accidents, whereas with aging, they become more prone to fragility fractures as women. Female patients are usually older and are mostly affected by low-energy traumas as a fall from a standing height

Morphometric anatomical and CT study of the human adult sacroiliac region.

To identify and describe the morphometry and CT features of the articular and extra-articular portions of the sacroiliac region. The resulting knowledge might help to avoid complications in sacroiliac joint (SIJ) fusion. We analyzed 102 dry hemi-sacra, 80 ilia, and 10 intact pelves and assessed the pelvic computerized tomography (CT) scans of 90 patients, who underwent the examination for conditions not involving the pelvis. We assessed both the posterior aspect of sacrum with regard to the depressions located externally to the lateral sacral crest at the level of the proximal three sacral vertebrae and the posteroinferior aspect of ilium. Coronal and axial CT scans of the SIJ of patients were obtained and the joint space was measured. On each side, the sacrum exhibits three bone depressions, not described in anatomic textbooks or studies, facing the medial aspect of the posteroinferior ilium, not yet described in detail. Both structures are extra-articular portions situated posteriorly to the SIJ. Coronal CT scans of patients showing the first three sacral foramens and the interval between sacrum and ilium as a continuous space display only the S1 and S3 portions of SIJ, the intermediate portion being extra-articular. The S2 portion is visible on the most anterior coronal scan. Axial scans show articular and extra-articular portions and features improperly described as anatomic variations. Extra-articular portions of the sacroiliac region, not yet described exhaustively, have often been confused with SIJ. Coronal CT scans through the middle part of sacrum, the most used to evaluate degenerative and inflammatory conditions of SIJ, show articular and extra-articular portions of the region

ADDICTIONS SUBSTANCE FREE DURING LIFESPAN

The addictions substance free is an umbrella definition comprises internet addiction, sexual addiction, gambling pathological, workholism, videogames and computer addiction. Actually, the technological addictions is frequent in young adolescents. The term Digital Natives indicates the children born in an information system of learning and communication different from that of the generations previous. This temporal range was strongly characterized by growing presence of technological communication toolsin daily life. The effects of hyper-exposition to technological tools tend to create a relational virtuality without a body is born,therefore, already within the family ties and during adolescence he moved to the digital socialization network. The technological object it interacts between the adolescent and the world of peers and adults, becoming the facilitator object that as the psychotropic substance, it conveys new modes of communicatio

Significance of serum Myostatin in hemodialysis patients

Background: Malnutrition and muscle wasting are common in haemodialysis (HD) patients. Their pathogenesis is complex and involves many molecules including Myostatin (Mstn), which acts as a negative regulator of skeletal muscle. The characterisation of Mstn as a biomarker of malnutrition could be useful in the prevention and management of this condition. Previous studies have reported no conclusive results on the actual relationship between serum Mstn and wasting and malnutrition. So, in this study, we evaluated Mstn profile in a cohort of regular HD patients. Methods: We performed a cross-sectional study, enrolling 37 patients undergoing bicarbonate-HD (BHD) or haemodiafiltration (HDF) at least for six months. 20 sex-matched healthy subjects comprised the control group. Mstn serum levels were evaluated by ELISA before and after HD. We collected clinical and biochemical data, evaluated insulin resistance, body composition, malnutrition [by Malnutrition Inflammation Score (MIS)] and tested muscle function (by hand-grip strength, six-minute walking test and a questionnaire on fatigue). Results: Mstn levels were not significantly different between HD patients and controls (4.7 \ub1 2.8 vs 4.5 \ub1 1.3 ng/ml). In addition, while a decrease in Mstn was observed after HD treatment, there were no differences between BHD and HDF. In whole group of HD patients Mstn was positively correlated with muscle mass (r = 0.82, p &lt; 0.001) and inversely correlated with age (r = - 0.63, p &lt; 0.01) and MIS (r = - 0.39, p = 0.01). No correlations were found between Mstn and insulin resistance, such as between Mstn levels and parameters of muscle strength and fatigue. In multivariate analysis, Mstn resulted inversely correlated with fat body content (\u3b2 = - 1.055, p = 0.002). Conclusions: Circulating Mstn is related to muscle mass and nutritional status in HD patients, suggesting that it may have a role in the regulation of skeletal muscle and metabolic processes. However, also considering the lack of difference of serum Mstn between healthy controls and HD patients and the absence of correlations with muscle function tests, our findings do not support the use of circulating Mstn as a biomarker of muscle wasting and malnutrition in HD

A functional gene expression analysis in epithelial sinonasal cancer: Biology and clinical relevance behind three histological subtypes

Epithelial sinonasal cancers (SNCs) are rare diseases with overlapping morphological features and a dismal prognosis. We aimed to investigate the expression differences among the histological subtypes for discerning their molecular characteristics. We selected 47 SNCs: (i) 21 nonkeratinizing squamous cell carcinomas (NKSCCs), (ii) 13 sinonasal neuroendocrine cancers (SNECs), and (iii) 13 sinonasal undifferentiated cancers (SNUCs). Gene expression profiling was performed by DASL (cDNA-mediated annealing, selection, extension, and ligation) microarray analysis with internal validation by quantitative RT-PCR (RT-qPCR). Relevant molecular patterns were uncovered by sparse partial-least squares discriminant analysis (sPLS-DA), microenvironment cell type (xCell), CIBERSORT, and gene set enrichment (GSEA) analyses. The first two sPLS-DA components stratified samples by histological subtypes. xCell highlighted increased expression of immune components (CD8 + effector memory cells, in SNUC) and \u201cother cells\u201d: keratinocytes and neurons in NKSCC and SNEC, respectively. Pathway enrichment was observed in NKSCC (six gene sets, proliferation related), SNEC (one gene set, pancreatic \u3b2-cells), and SNUC (twenty gene sets, some of them immune-system related). Major neuroendocrine involvement was observed in all the SNEC samples. Our high-throughput analysis revealed a good diagnostic ability to differentiate NKSCC, SNEC, and SNUC, but indicated that the neuroendocrine pathway, typical and pathognomonic of SNEC is also present at lower expression levels in the other two histological subtypes. The different and specific profiles may be exploited for elucidating their biology and could help to identify prognostic and therapeutic opportunities

Effective Neutralizing Antibody Response Against SARS-CoV-2 Virus and Its Omicron BA.1 Variant in Fully Vaccinated Hematological Patients

SARS-CoV-2 and its variants cause CoronaVIrus Disease 19 (COVID-19), a pandemic disease. Hematological malignancies increase susceptibility to severe COVID-19 due to immunosuppression. Anti-SARS-CoV-2 neutralizing antibodies protect against severe COVID-19. This retrospective real-life study aimed to evaluate seropositivity and neutralizing antibody rates against SARS-CoV-2 and its Omicron BA.1 variant in hematological patients. A total of 106 patients with different hematologic malignancies, who have mostly received three or more vaccine doses (73%), were included in this study. Serum was collected between May and June 2022. The primary endpoint was anti-SARS-CoV-2 antibody response against ancestral (wild type; wt) and Omicron BA.1 virus, defined as a neutralizing antibody titer ≥ 1:10. Adequate neutralizing antibody response was observed in 75 (71%) and 87 (82%) of patients for wt and Omicron BA.1 variants, respectively.However, patients with B-cell lymphoproliferative disorders and/or those treated with anti-CD20 monoclonal antibodies in the prior 12&nbsp;months showed a lower seropositivity rate compared to other patients against both Omicron BA.1 variant (73% vs 91%; P = 0.02) and wt virus (64% vs 78%; P = 0.16). Our real-life experience confirmed that full vaccination against SARS-CoV-2 induces adequate neutralizing antibody protection for both the wt virus and Omicron BA.1 variants, even in hematological frail patients. However, protective measures should be maintained in hematological patients, especially those with B-cell lymphoproliferative diseases treated with anti-CD20 monoclonal antibodies, because these subjects could have a reduced neutralizing antibody production

A multicenter randomized phase 4 trial comparing sodium picosulphate plus magnesium citrate vs. polyethylene glycol plus ascorbic acid for bowel preparation before colonoscopy. The PRECOL trial

Background: Adequate bowel preparation before colonoscopy is crucial. Unfortunately, 25% of colonoscopies have inadequate bowel cleansing. From a patient perspective, bowel preparation is the main obstacle to colonoscopy. Several low-volume bowel preparations have been formulated to provide more tolerable purgative solutions without loss of efficacy. Objectives: Investigate efficacy, safety, and tolerability of Sodium Picosulphate plus Magnesium Citrate (SPMC) vs. Polyethylene Glycol plus Ascorbic Acid (PEG-ASC) solutions in patients undergoing diagnostic colonoscopy. Materials and methods: In this phase 4, randomized, multicenter, twoarm trial, adult outpatients received either SPMC or PEG-ASC for bowel preparation before colonoscopy. The primary aims were quality of bowel cleansing (primary endpoint scored according to Boston Bowel Preparation Scale) and patient acceptance (measured with six visual analogue scales). The study was open for treatment assignment and blinded for primary endpoint assessment. This was done independently with videotaped colonoscopies reviewed by two endoscopists unaware of study arms. A sample size of 525 patients was calculated to recognize a difference of 10% in the proportion of successes between the arms with a two-sided alpha error of 0.05 and 90% statistical power. Results: Overall 550 subjects (279 assigned to PEG-ASC and 271 assigned to SPMC) represented the analysis population. There was no statistically significant difference in success rate according to BBPS: 94.4% with PEG-ASC and 95.7% with SPMC (P = 0.49). Acceptance and willing to repeat colonoscopy were significantly better for SPMC with all the scales. Compliance was less than full in 6.6 and 9.9% of cases with PEG-ASC and SPMC, respectively (P = 0.17). Nausea and meteorism were significantly more bothersome with PEG-ASC than SPMC. There were no serious adverse events in either group. Conclusion: SPMC and PEG-ASC are not different in terms of efficacy, but SPMC is better tolerated than PEG-ASC. SPMC could be an alternative to lowvolume PEG based purgative solutions for bowel preparation

Progressive myoclonus epilepsies-Residual unsolved cases have marked genetic heterogeneity including dolichol-dependent protein glycosylation pathway genes

Progressive myoclonus epilepsies (PMEs) comprise a group of clinically and genetically heterogeneous rare diseases. Over 70% of PME cases can now be molecularly solved. Known PME genes encode a variety of proteins, many involved in lysosomal and endosomal function. We performed whole-exome sequencing (WES) in 84 (78 unrelated) unsolved PME-affected individuals, with or without additional family members, to discover novel causes. We identified likely disease-causing variants in 24 out of 78 (31%) unrelated individuals, despite previous genetic analyses. The diagnostic yield was significantly higher for individuals studied as trios or families (14/28) versus singletons (10/50) (OR = 3.9, p value = 0.01, Fisher's exact test). The 24 likely solved cases of PME involved 18 genes. First, we found and functionally validated five heterozygous variants in NUS1 and DHDDS and a homozygous variant in ALG10, with no previous disease associations. All three genes are involved in dolichol-dependent protein glycosylation, a pathway not previously implicated in PME. Second, we independently validate SEMA6B as a dominant PME gene in two unrelated individuals. Third, in five families, we identified variants in established PME genes; three with intronic or copy-number changes (CLN6, GBA, NEU1) and two very rare causes (ASAH1, CERS1). Fourth, we found a group of genes usually associated with developmental and epileptic encephalopathies, but here, remarkably, presenting as PME, with or without prior developmental delay. Our systematic analysis of these cases suggests that the small residuum of unsolved cases will most likely be a collection of very rare, genetically heterogeneous etiologies.Peer reviewe