Ethical regulation of biomedical research in Brazil: a quality improvement initiative.

BACKGROUND: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil's national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world's largest research ethics evaluation systems.

Implementation of esophageal endoscopic submucosal dissection in Spain: Results from the nationwide registry. / Implementación de la disección endoscópica submucosa esofágica en España: resultados del registro nacional.

INTRODUCTION AND AIMS: The outcomes of endoscopic submucosal dissection (ESD) in the esophagus have not been assessed in our country. Our primary aim was to analyze the effectiveness and safety of the technique. MATERIAL AND METHODS: Analysis of the prospectively maintained national registry of ESD. We included all superficial esophageal lesions removed by ESD in 17 hospitals (20 endoscopists) between January 2016 and December 2021. Subepithelial lesions were excluded. The primary outcome was curative resection. We conducted a survival analysis and used logistic regression analysis to assess predictors of non-curative resection. RESULTS: A total of 102 ESD were performed on 96 patients. The technical success rate was 100% and the percentage of en-bloc resection was 98%. The percentage of R0 and curative resection was 77.5% (n=79; 95%CI: 68%-84%) and 63.7% (n=65; 95%CI: 54%-72%), respectively. The most frequent histology was Barrett-related neoplasia (n=55 [53.9%]). The main reason for non-curative resection was deep submucosal invasion (n=25). The centers with a lower volume of ESD obtained worse results in terms of curative resection. The rate of perforation, delayed bleeding and post-procedural stenosis were 5%, 5% and 15.7%, respectively. No patient died or required surgery due to an adverse effect. After a median follow-up of 14months, 20patients (20.8%) underwent surgery and/or chemoradiotherapy, and 9 patients died (mortality 9.4%). CONCLUSIONS: In Spain, esophageal ESD is curative in approximately two out of three patients, with an acceptable risk of adverse events.

Experience and insights from a prolonged electrocardiographic monitorization with a wearable system after an embolic stroke of unknown source.

BACKGROUND: Embolic cerebrovascular events that remain of unknown etiology after a thorough diagnostic evaluation, are known as Embolic Strokes of Undetermined Source (ESUS). Subclinical atrial fibrillation (AF) represents a significant underlying cause of ESUS. Our aims were to examine the overall diagnostic yield of a prolonged cardiac monitoring wearable system (PCMw) after an ESUS to detect AF and factors associated with it, including the time frame from the ESUS event to PCMw initiation. Additionally, to evaluate the frequency of unexpected arrhythmic events (UAE) and their prognostic implications. METHODS: We retrospectively analyzed 200 ECG recordings (3-leads, 30 days duration) by means of a PCMw in patients with an ESUS to detect AF lasting longer than 30 s, between 2017 and 2021. UAE were defined as arrhythmia events that were not correlated to the main reason of prolonged cardiac monitoring. RESULTS: AF was detected in 21 patients (10.5%). Patients with AF had more left atrial enlargement (OR = 4.22 [1.59-6.85]; p = .01) and atrial arrythmias in the initial 24-h Holter during hospitalization (OR = 5.73 [2.03-16.49]; p = .001). The detection of AF was significatively higher if the PCMw was worn within the first 30 days after the ESUS compared to beyond 30 days (17% vs. 10.3%; p = .002). Fifty three patients (26.5%) had UAE during PCMw. In six of them these findings led to targeted treatment. CONCLUSION: PCMw represents a feasible non-invasive device that could reliably detect subclinical AF episodes after an ESUS. Diagnostic yield was significatively higher when used within the first 30 days after the event, especially in selected patients. UAE were common, but did not impact prognosis.

Trapped p waves causing loss of physiological left bundle branch pacing.

We present the case of a 75-year-old woman with severe aortic stenosis and moderate left ventricular dysfunction, who underwent elective transcatheter aortic valve replacement. After the procedure, the patient developed a left bundle branch block and a long PR interval. For this reason, a dual chamber pacemaker with pacing in the left bundle branch area was implanted. On device interrogation, we confirmed the presence of functional atrial undersensing causing loss of ventricular electric resynchronization. This case highlights the importance of recognizing this problem and, by means of device reprogramming and pharmacological intervention, suggests a stepwise approach to solve it.

Temporal trends and spatial clusters of gastric cancer mortality in Brazil.

Objective: To identify nationwide temporal trends and spatial patterns of gastric cancer-related mortality in Brazil. Methods: An ecological study was performed using death certificates registered from 2000 to 2019 in which gastric cancer was recorded as any cause of death (an underlying or associated cause). Trends over time were assessed using joinpoint regression models. Spatial and spatiotemporal clusters were identified by Kulldorff's space-time scan statistics to identify high-risk areas. Results: In 276 897/22 663 091 (1.22%) death certificates gastric cancer was recorded as any cause of death. Age-adjusted gastric cancer-related mortality increased significantly over time (annual percentage change [APC]: 0.7, 95% confidence interval [CI]: 0.5 to 0.8). The increase in mortality was more pronounced in the less-developed North and Northeast Regions (North Region, APC: 3.1, 95% CI: 2.7 to 3.5; Northeast Region, APC: 3.1, 95% CI: 2.5 to 3.7). Eight spatiotemporally associated high-risk clusters of gastric cancer-related mortality were identified in the North, South, Northeast and Central-West Regions, as well as a major cluster covering a wide geographical range in the South and Southeast Regions of Brazil during the first years of the study period (2000 to 2009). Conclusions: More recently, during 2010 to 2019, clusters of gastric cancer have been identified in the Northeast Region. The nationwide increase in mortality in this analysis of 20 years of data highlights the persistently high burden of gastric cancer in Brazil, especially in socioeconomically disadvantaged regions. The identification of these areas where the population is at high risk for gastric cancer-related mortality emphasizes the need to develop effective and intersectoral control measures.

Epidemiology of Chagas disease in pregnant women and congenital transmission of Trypanosoma cruzi in the Americas: systematic review and meta-analysis.

OBJECTIVE: To estimate the prevalence of Chagas disease in pregnant women and the vertical transmission of the disease. METHODS: Observational studies were identified from eight electronic databases, and details on study design, population and prevalence of Chagas disease were extracted. The data were pooled using a random-effects model, and choropleth maps were created based on geopolitical regions and countries. RESULTS: The search identified 7788 articles, of which 50 were eligible. We observed a 9% prevalence of Chagas disease among pregnant women in the Americas (95% confidence interval [CI]: 8-10, I2  = 99.96%). High disease prevalence was identified in pregnant women in South American countries (12%, 95% CI: 11-13), while lower values were identified in pregnant women in North America (2%, 95% CI: 1-3). Countries with medium Human Development Index (HDI) had a higher prevalence of Chagas disease in pregnant women (15%, 95% CI: 13-16, I2  = 99.98%) than countries with high HDI (3%, 95% CI: 2-3). The rate of vertical transmission in the continent was 2% (95% CI: 1-2). The statistical analysis showed that this heterogeneity was explained by the study design, region of the Americas and mean income of the country. CONCLUSION: South and Central American countries have a high prevalence and vertical transmission of Chagas disease. Therefore, systematic screens for this disease during the prenatal period are necessary in addition to the diagnosis and treatment of children at risk for Trypanosoma cruzi infection.

OBJECTIF: Estimer la prévalence de la maladie de Chagas chez les femmes enceintes et la transmission verticale de la maladie. MÉTHODES: Des études d'observation ont été identifiées à partir de huit bases de données électroniques et des détails sur la concept de l'étude, la population et la prévalence de la maladie de Chagas ont été extraits. Les données ont été regroupées à l'aide d'un modèle à effets aléatoires et des cartes choroplèthes ont été créées en fonction des régions et des pays géopolitiques. RÉSULTATS: La recherche a identifié 7.788 articles, dont 50 étaient éligibles. Nous avons observé une prévalence de 9% de la maladie de Chagas chez les femmes enceintes dans les Amériques (intervalle de confiance [IC] à 95%: 8-10, I2 = 99,96%). Une prévalence élevée de la maladie a été identifiée chez les femmes enceintes dans les pays d'Amérique du Sud (12%, IC95%: 11-13), tandis que des valeurs plus faibles ont été identifiées chez les femmes enceintes d'Amérique du Nord (2%, IC95%: 1-3). Les pays à indice de développement humain (IDH) moyen présentaient une prévalence plus élevée de la maladie de Chagas chez les femmes enceintes (15%, IC95%: 13-16, I2 = 99,98%) que les pays à IDH élevé (3%, IC95%: 2 -3). Le taux de transmission verticale sur le continent était de 2% (IC95%: 1-2). L'analyse statistique a montré que cette hétérogénéité s'expliquait par le concept d'étude, la région des Amériques et le revenu moyen du pays. CONCLUSION: Les pays d'Amérique du Sud et d'Amérique centrale ont une prévalence élevée et de transmission verticale de la maladie de Chagas. Par conséquent, des dépistages systématiques de cette maladie pendant la période prénatale sont nécessaires en plus du diagnostic et du traitement des enfants à risque d'infection par Trypanosoma cruzi.

Relationship between local presence and density of Aedes aegypti eggs with dengue cases: a spatial analysis approach.

OBJECTIVES: To analyze the relationship between the occurrence of dengue and ovitrap positivity and dengue egg density in two Amazonas municipalities (Brazil) in 2016. METHODS: We performed a case-control study using secondary data from the dengue fever surveillance system. Ovitraps distributed regularly in the urban area of two cities were used to monitor the presence of the vector. The relationship between egg positivity, egg density and the location of dengue cases was evaluated using two approaches as follows: (i) based on the result of the nearest neighbour ovitrap and (ii) based on the results of the set of ovitraps within the influence area of 300 m from the location of each case and control. RESULTS: During the study period, 229 confirmed cases of dengue fever were reported in Tabatinga and 89 cases in Itacoatiara. In this study, we found that the positivity of ovitraps was related to the occurrence of dengue in Tabatinga and Itacoatiara. An association between egg density of Ae. aegypti and dengue occurrence was also observed in Itacoatiara. The temporal lags for ovitrap positivity measurements were predominantly 15 or 30 days. A dengue association for egg density for a 15-day time lag was detected for one of the case-control approaches. CONCLUSIONS: The location of dengue cases is related to ovitrap egg positivity, while a less evident possible association may exist for egg density. This indicates that these traps could be used to improve vector control actions.

Tuberculosis incidence inequalities and its social determinants in Manaus from 2007 to 2016.

BACKGROUND: Brazil is among the 30 countries with high-burden of tuberculosis worldwide, and Manaus is the capital with the highest tuberculosis incidence. The accelerated economic and population growth in Manaus in the last 30 years has strengthened the process of social stratification that may result in population groups that are less favored in terms of healthcare and are vulnerable to infection and illness due to tuberculosis. This study aimed to characterize inequalities associated with tuberculosis incidence in relation to the socioeconomic and demographic characteristics of the resident population of Manaus and to identify their determinants from 2007 to 2016. METHODS: An ecological study was conducted using the data from the Diseases Notification Information System. Tuberculosis incidence rates by population characteristics (gender, ethnicity, and socioeconomic level) were calculated for each year, studied, and represented in equiplot charts. To measure the disparity of tuberculosis incidence in the resident population in Manaus, the Gini index of tuberculosis in each neighborhood was calculated based on the incidence rates of the census sectors. A thematic map was constructed to represent the spatial distribution of tuberculosis incidence inequality. Linear regression models were used to identify the relationship between the tuberculosis incidence inequality and its social determinants. RESULTS: From 2007 to 2016, there was an increase in the tuberculosis incidence in Manaus, together with an increase in incident inequality among genders, ethnic groups, and socioeconomic level. The incidence of tuberculosis inequality was associated with the inequalities of its possible determinants (Gini of the proportion of male population, Gini of the proportion of indigenous population, Gini of the proportion of illiteracy, Gini of income, Gini of the proportion of households connected to the water network, and Gini of the mean number of bathrooms per inhabitant), the per capita income, and the proportion of cases with laboratory confirmation. CONCLUSIONS: Disparities in tuberculosis incidence in the resident population in neighborhoods can be explained by the sociodemographic and economic heterogeneity. Our findings recommend that public policies and tuberculosis control strategies consider differences in the determinants of tuberculosis inequality for the development of specific actions for each population group.

Dengue epidemic typology and risk factors for extensive epidemic in Amazonas state, Brazil, 2010-2011.

BACKGROUND: Dengue is the most prevalent arboviral disease affecting humans. The frequency and magnitude of dengue epidemic have significantly increased over recent decades. This study aimed to identify dengue epidemic types and risk factors for the extensive epidemics that occurred in 2010-2011, across the municipalities of Amazonas state, Brazil. METHODS: Using an ecological approach, secondary data were obtained from the dengue fever surveillance system. Epidemic waves were classified according to three indices: duration, intensity, and coverage. A hierarchical model of multiple logistic regression was used for the identification of risk factors, with the occurrence of extensive dengue epidemic. RESULTS: During the study period, dengue virus affected 49 of the 62 Amazonas municipalities. In 22 of these, the epidemics were of high intensity, wide range, and long time span, and therefore categorized as "extensive epidemics". The final multivariable model revealed a significant association between extensive dengue epidemics occurrence and the average number of days with precipitation (adjusted OR = 1.40, 95% CI: 1.01-1.94) and the number of years with infestation (adjusted OR = 1.53, 95% CI: 1.18-1.98). CONCLUSIONS: Our results indicate that it is crucial to integrate vector control, case management, epidemiological investigation, and health education, in order to respond to the growing threat of multiple mosquito-borne diseases, such as dengue, Zika and chikungunya, which are highly prevalent in the South America region.

Influence of immediate/delayed implant placement and implant platform on the peri-implant bone formation.

AIM: To determinate the influence of the timing and position of the implant placement, as well as the presence and absence of a buccal gap, associated with different implant platforms on bone formation around implants. METHODS AND MATERIALS: In a first surgical stage, two premolars in one side of the mandibular arch of 07 mongrel dogs were extracted. After a 120-day healing period, a second-stage surgery was performed, in which a full flap was raised and two implants were installed. At this same stage, two contralateral premolars were extracted and two immediate implants were placed into the fresh sockets, through the "palatal approach technique" without flap elevation, totaling four implants per animal. The 28 installed implants constituted groups according to the timing (Immediate or delayed) of placement and the type of surface treatment. After 4 months, samples were collected and histomorphometric analysis was performed to determinate buccal surface BIC, lingual surface BIC, total BIC, buccal area, and lingual area of all implants. Kruskal-Wallis and pared Wilcoxon (P < 0.05) tests were performed for statistical analysis. RESULTS: After 4-month healing period, the groups of immediate implants presented better BIC scores, mainly on the buccal surface. Data also suggest better bone area formation around the implants of these same groups. Concerning the type of implant platform, better results were found using Morse taper. CONCLUSION: The flapless technique with "palatal approach," Morse taper implants, and immediate implant placement all have favorable influence on the bone formation around the implants.

Deforestation, drainage network, indigenous status, and geographical differences of malaria in the State of Amazonas.

BACKGROUND: Malaria is a major public health problem worldwide. In Brazil, an average of 420,000 cases of malaria have been reported annually in the last 12 years, of which 99.7 % occurred in the Amazon region. This study aimed to analyse the distribution of malaria in the State of Amazonas and the influence of indigenous malaria in this scenario, to evaluate the correlation between incidence rates and socio-economic and environmental factors, and to evaluate the performance of health surveillance services. METHODS: This ecological study used secondary data obtained from the SIVEP-MALARIA malaria surveillance programme. The relationship between demographic, socio-economic and environmental factors, the performance of health surveillance services and the incidence of malaria in Amazonas, a multiple linear regression model was used. RESULTS: The crude rate of malaria in Amazonas was 4142.72 cases per 100,000 inhabitants between 2003 and 2012. The incidence rates for the indigenous and non-indigenous populations were 12,976.02 and 3749.82, respectively, with an indigenous population attributable fraction of only 8 %. The results of the linear regression analysis indicated a negative correlation between the two socio-economic indicators (municipal human development index (MHDI) and poverty rate) and the incidence of malaria in the period. With regard to the environmental indicators (average annual deforestation rate and percentage of areas under the influence of watercourses), the correlation with the incidence rate was positive. CONCLUSIONS: The findings underscore the importance of implementing economic and social development policies articulated with strategic actions of environmental protection and health care for the population.

"Floating" Stent in a Coronary Aneurysm Presenting as ST-Elevation Myocardial Infarction.

Coronary artery aneurysm (CAA) presenting as an ST-elevation myocardial infarction (STEMI) represents a clinical challenge due to the technical difficulties in the percutaneous management of this specific situation. Appropriate treatment for CAA depends on the precise clinical situation and consists of medical management, surgical resection, or/and stent placement. The high rate of complications during percutaneous intervention (distal thrombus embolization, no-reflow phenomenon, stent malposition, or dissection) makes emergent surgery a frequent situation in these cases. We present the case of a 50-year-old man with a STEMI due to thrombotic occlusion of CAA. Specific angiographic techniques and intracoronary imaging help with the percutaneous management of acute thrombotic occlusions in CAA, providing a less invasive approach than emergent surgery.

Hemolytic Anemia After an Aortic Dissection Treated With a Valve-Sparing Aortic Root Replacement.

A 46-year-old man with a personal history of a repaired aortic dissection was admitted because of hemolytic anemia. The transesophageal echocardiogram displayed an accelerated flow and a residual intimal flap in the proximal descending aorta. A total arch replacement was performed, the flap was removed, and his hemolytic anemia was resolved. (Level of Difficulty: Advanced.).

Hybrid Immunity Results in Enhanced and More Sustained Antibody Responses after the Second Sinovac-CoronaVac Dose in a Brazilian Cohort: DETECTCoV-19 Cohort.

We measured anti-SARS-CoV-2 antibody responses before and after CoronaVac (inactivated) vaccination in a case-control study performed in CoronaVac-immunized individuals participating in a longitudinal prospective study of adults in Manaus (DETECTCoV-19). Antibody responses were measured by standard serological immunoassays. Peak anti-S-RBD and neutralizing RBD-ACE2 blocking antibody responses after two doses of CoronaVac vaccine were similar in vaccine breakthrough cases (n = 9) and matched controls (n = 45). Individuals with hybrid immunity resulting from prior SARS-CoV-2 infection followed by vaccination (n = 22) had elevated levels of anti-N, anti-S-RBD and RBD-ACE2 blocking antibodies after the second vaccine dose compared to infection-naïve individuals (n = 48). Post-vaccination SARS-CoV-2-specific antibody responses rapidly waned in infection-naïve individuals. Antibody responses wane after vaccination, making individuals susceptible to infection by SARS-CoV-2 variants. These findings support the need for booster doses after primary vaccination. Population antibody serosurveys provide critical information toward implementing optimal timing of booster doses.

Pediatric central nervous system infections in the Amazon: clinical and laboratory profiles.

Background: Central nervous system (CNS) infections are important causes of mortality and morbidity in children, and they are related to severe problems such as hearing loss, neurological sequelae, and death. The objective was to describe clinical and laboratory exam profiles of children who were diagnosed with CNS infections. Methods: We conducted a cross-sectional study based on medical records, which included pediatric patients aged from 3 months to 15 years, with a clinical suspicion of CNS infection between January 2014 to December 2019. The pathogens were confirmed in cerebrospinal fluid (CSF) samples using Gram staining, cell culture, molecular diagnostics (PCR and qPCR), and serology. Results: Out of the 689 enrolled patients, 108 (15.6%) had laboratory-confirmed infections in CSF. The most common bacterial pathogens isolated from the culture were Neisseria meningitidis serogroup C in 19, Streptococcus pneumoniae in 11, and Haemophilus influenzae in seven samples. The viruses identified were Enterovirus, Cytomegalovirus, Varicella-zoster virus, Epstein-Barr virus, and arbovirus. No patient was found to be positive for Herpes simplex virus 1 and 2. Patients with viral infections showed altered levels of consciousness (p = 0.001) when compared to bacterial infections. Conclusion: This study shows the presence of important vaccine-preventable pathogens, and different families of viruses causing CNS infections in the pediatric patients of Manaus.

Multiple introductions and country-wide spread of DENV-2 genotype II (Cosmopolitan) in Brazil.

Dengue virus serotype 2, genotype Cosmopolitan (DENV-2-GII), is one of the most widespread DENV strains globally. In the USA, DENV-2 epidemics have been dominated by DENV-2 genotype Asian-American (DENV-2-GIII), and the first cases of DENV-2-GII were only described in 2019, in Peru, and in 2021 in Brazil. To gain new information about the circulation of DENV-2-GII in Brazil, we sequenced 237 DENV-2 confirmed cases sampled between March 2021 and March 2023 and revealed that DENV-2-GII is already present in all geographic regions of Brazil. The phylogeographic analysis inferred that DENV-2-GII was introduced at least four times in Brazil, between May 2020 and August 2022, generating multiple clades that spread throughout the country with different success. Despite multiple introductions of DENV-2-GII, analysis of the country-wide laboratory surveillance data showed that the Brazilian dengue epidemic in 2022 was dominated by DENV-1 in most states. We hypothesize that massive circulation of DENV-2-GIII in previous years in Brazil might have created a population immune barrier against symptomatic homotypic reinfections by DENV-2-GII, leading to sustained cryptic circulation in asymptomatic cases and localized outbreaks of this new genotype. In summary, our study stresses the importance of arboviral genomic surveillance to close monitoring and better understanding the potential impact of DENV-2-GII in the coming years.

Acute Post-Traumatic Aortic Regurgitation.

A 16-year-old girl with a history of blunt chest trauma was admitted because of heart failure symptoms. Transthoracic echocardiography showed severe eccentric aortic regurgitation. Cardiac computed tomography revealed a pseudoaneurysm of the right sinus of Valsalva. We present a rare clinical presentation of a life-threatening condition. (Level of Difficulty: Intermediate.).

Tucuxi-BLAST: Enabling fast and accurate record linkage of large-scale health-related administrative databases through a DNA-encoded approach.

Background: Public health research frequently requires the integration of information from different data sources. However, errors in the records and the high computational costs involved make linking large administrative databases using record linkage (RL) methodologies a major challenge. Methods: We present Tucuxi-BLAST, a versatile tool for probabilistic RL that utilizes a DNA-encoded approach to encrypt, analyze and link massive administrative databases. Tucuxi-BLAST encodes the identification records into DNA. BLASTn algorithm is then used to align the sequences between databases. We tested and benchmarked on a simulated database containing records for 300 million individuals and also on four large administrative databases containing real data on Brazilian patients. Results: Our method was able to overcome misspellings and typographical errors in administrative databases. In processing the RL of the largest simulated dataset (200k records), the state-of-the-art method took 5 days and 7 h to perform the RL, while Tucuxi-BLAST only took 23 h. When compared with five existing RL tools applied to a gold-standard dataset from real health-related databases, Tucuxi-BLAST had the highest accuracy and speed. By repurposing genomic tools, Tucuxi-BLAST can improve data-driven medical research and provide a fast and accurate way to link individual information across several administrative databases.

Impact of SARS-Cov-2 infection in patients with hypertrophic cardiomyopathy: results of an international multicentre registry.

AIMS: To describe the natural history of SARS-CoV-2 infection in patients with hypertrophic cardiomyopathy (HCM) compared with a control group and to identify predictors of adverse events. METHODS AND RESULTS: Three hundred and five patients [age 56.6 ± 16.9 years old, 191 (62.6%) male patients] with HCM and SARS-Cov-2 infection were enrolled. The control group consisted of 91 131 infected individuals. Endpoints were (i) SARS-CoV-2 related mortality and (ii) severe clinical course [death or intensive care unit (ICU) admission]. New onset of atrial fibrillation, ventricular arrhythmias, shock, stroke, and cardiac arrest were also recorded. Sixty-nine (22.9%) HCM patients were hospitalized for non-ICU level care, and 21 (7.0%) required ICU care. Seventeen (5.6%) died: eight (2.6%) of respiratory failure, four (1.3%) of heart failure, two (0.7%) suddenly, and three (1.0%) due to other SARS-CoV-2-related complications. Covariates associated with mortality in the multivariable were age {odds ratio (OR) per 10 year increase 2.25 [95% confidence interval (CI): 1.12-4.51], P = 0.0229}, baseline New York Heart Association class [OR per one-unit increase 4.01 (95%CI: 1.75-9.20), P = 0.0011], presence of left ventricular outflow tract obstruction [OR 5.59 (95%CI: 1.16-26.92), P = 0.0317], and left ventricular systolic impairment [OR 7.72 (95%CI: 1.20-49.79), P = 0.0316]. Controlling for age and sex and comparing HCM patients with a community-based SARS-CoV-2 cohort, the presence of HCM was associated with a borderline significant increased risk of mortality OR 1.70 (95%CI: 0.98-2.91, P = 0.0600). CONCLUSIONS: Over one-fourth of HCM patients infected with SARS-Cov-2 required hospitalization, including 6% in an ICU setting. Age and cardiac features related to HCM, including baseline functional class, left ventricular outflow tract obstruction, and systolic impairment, conveyed increased risk of mortality.

Faecal immunochemical test outside colorectal cancer screening?

Faecal immunochemical tests (FITs) are the most widely colorectal cancer (CRC) diagnostic biomarker available. Many population screening programmes are based on this biomarker, with the goal of reducing CRC mortality. Moreover, in recent years, a large amount of evidence has been produced on the use of FIT to detect CRC in patients with abdominal symptoms in primary healthcare as well as in surveillance after adenoma resection. The aim of this review is to highlight the available evidence on these two topics. We will summarize the evidence on diagnostic yield in symptomatic patients with CRC and significant colonic lesion and the different options to use this (thresholds, brands, number of determinations, prediction models and combinations). We will include recommendations on FIT strategies in primary healthcare proposed by regulatory bodies and scientific societies and their potential effects on healthcare resources and CRC prognosis. Finally, we will show information regarding FIT-based surveillance as an alternative to endoscopic surveillance after high-risk polyp resection. To conclude, due to the coronavirus disease 2019 pandemic, FIT-based strategies have become extremely relevant since they enable a reduction of colonoscopy demand and access to the healthcare system by selecting individuals with the highest risk of CRC.