The Brazilian Registry of Adult Patient Undergoing Cardiovascular Surgery, the BYPASS Project: Results of the First 1,722 Patients

Objective: To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Methods: Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. Results: 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systemsand 7.3% from private (out-of-pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%for CABG was 2.6%, and for valve operations, 4.4%. Conclusion: This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols.Univ Fed Sao Paulo UNIFESP EPM, Hosp Sao Paulo, Sao Paulo, SP, BrazilHosp Caridade Sao Vicente Paulo, Jundiai, SP, BrazilInst Med Integral Prof Fernando Figueira IMIP, Recife, PE, BrazilHosp Base FUNFARME & FAMERP, Sao Jose Do Rio Preto, SP, BrazilIMC, Sao Jose Do Rio Preto, SP, BrazilIrmandade Santa Casa Sao Paulo INCT HPV, Fac Ciencias Med Santa Casa Sao Paulo, Sao Paulo, SP, BrazilFundacao Univ Cardiol, Inst Cardiol Rio Grande do Sul, Porto Alegre, RS, BrazilInst Coracao Natal, Natal, RN, BrazilInst Cardiol Dist Fed, Brasilia, DF, BrazilUniv Fed Maranhao HU UFMA, Univ Hosp, Sao Luis, MA, BrazilHosp Evangelico, Cachoeiro De Itapemirim, ES, BrazilHosp Coracao Sergipe, Aracaju, SE, BrazilHosp Nossa Senhora Salete, Inst Cirurgia Cardiovasc ICCV, Cascavel, PR, BrazilHosp Wilson Rosado, Mossoro, RN, BrazilHosp Bosque Saude, Sao Paulo, SP, BrazilHosp Univ Santa Maria, Santa Maria, RS, BrazilHosp Coracao HCor, Sao Paulo, SP, BrazilHosp Coracao IP HCor, Ins Pesquisa, Sao Paulo, SP, BrazilInst Coracao InCor, Sao Paulo, SP, BrazilUniv Fed Sao Paulo UNIFESP EPM, Hosp Sao Paulo, Sao Paulo, SP, BrazilWeb of Scienc

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

Comparison of two technics of extracorporeal circulation (Conventional and Mini ECC), in the trans and post-operative periods of cardiac surgery

Abstract Objective: This study aimed to compare the effects of two different perfusion techniques: conventional cardiopulmonary bypass and miniature cardiopulmonary bypass in patients undergoing cardiac surgery at the University Hospital of Santa Maria - RS. Methods: We perform a retrospective, cross-sectional study, based on data collected from the patients operated between 2010 and 2013. We analyzed the records of 242 patients divided into two groups: Group I: 149 patients undergoing cardiopulmonary bypass and Group II - 93 patients undergoing the miniature cardiopulmonary bypass. Results: The clinical profile of patients in the preoperative period was similar in the cardiopulmonary bypass and miniature cardiopulmonary bypass groups without significant differences, except in age, which was greater in the miniature cardiopulmonary bypass group. The perioperative data were significant of blood collected for autotransfusion, which were higher in the group with miniature cardiopulmonary bypass than the cardiopulmonary bypass and in transfusion of packed red blood cells, which was higher in cardiopulmonary bypass than in miniature cardiopulmonary bypass. In the immediate, first and second postoperative period the values of hematocrit and hemoglobin were higher and significant in miniature cardiopulmonary bypass than in the cardiopulmonary bypass, although the bleeding in the first and second postoperative days was higher and significant in miniature cardiopulmonary bypass than in the cardiopulmonary bypass. Conclusion: The present results suggest that the miniature cardiopulmonary bypass was beneficial in reducing the red blood cell transfusion during surgery and showed slight but significant increase in hematocrit and hemoglobin in the postoperative period

Elaboração e desenvolvimento de um website sobre o teste da linguinha

RESUMO Objetivo: desenvolver um website sobre o “Teste da Linguinha”. Métodos: pesquisa aplicada, baseada no desenvolvimento ativo de um website com a finalidade de disponibilizar informações sobre o Teste da Linguinha. O desenvolvimento desse estudo consistiu de 3 etapas: conceituação, desenvolvimento e implementação. Para a etapa de conceituação foi definido o público-alvo, o objetivo, a análise e a definição do conteúdo por meio de revisão de literatura sobre anquiloglossia, avaliação do frênulo lingual em bebês e frenotomia. A etapa de desenvolvimento do website foi realizada por meio de editor de texto, digitalizador e editor de imagens. Para a construção das páginas Web foi utilizado o editor de texto Sublime. Para o teste das páginas em ambiente Internet foi selecionado o navegador Chrome. A fase de implementação envolveu a publicação do website na rede mundial de computadores. Resultados: o website “Teste da Linguinha” encontra-se implementado com domínio já registrado. O conteúdo desse website é destinado a pais/cuidadores e profissionais da saúde, orientando sobre o teste e sobre a língua presa, com base em estudos científicos. O referido website foi elaborado com layout responsivo, podendo ser acessado em tablet, telefones celulares com acesso à internet e/ou em computadores, independentemente do sistema operacional, por meio dos principais navegadores disponíveis, sem perder a funcionalidade. Conclusão: o website “Teste da linguinha” foi finalizado e pode ser acessado pelo endereço eletrônico www.testedalinguinha.com

Impact of autologous blood transfusion on the use of pack of red blood cells in coronary artery bypass grafting surgery

OBJECTIVE: To evaluate the impact of Cell Saver autologous blood transfusion system (CS) on the use of packed red blood cells (pRBC) in coronary artery bypass grafting (CABG) surgery. METHODS: We carried out a retrospective cross-sectional study in 87 patients undergoing primary elective CABG with miniaturized cardiopulmonary bypass (miniCPB), divided in two groups: 44 without-CS and 43 with-CS. We investigated the necessity of absolute use and the volume of packed red blood cells (pRBC) in each group, as well as cardiovascular risk factors, presurgical variables and intraoperative surgical parameters. All data were collected from medical records and there was no randomization or intervention on group selection. Statistical analysis was performed with Student t-test, Mann-Whitney U-test and χ² test, with a 5% significance level. RESULTS: There were no significant differences between the two groups in terms of cardiovascular risk factors and pre and intraoperative variables. Evaluating the absolute use of pRBC during surgery, there was a statistically significant difference (P=0.00008) between the groups without-CS (21/44 cases; 47.7%) and with-CS (4/43 cases; 9.3%). There was also a statistically significant difference (P=0.000117) in the volumes of pRBC between the groups without-CS (198.651258.65ml) and with-CS (35.061125.67ml). On the other hand, in the early postoperative period (up to 24h) there was no difference regarding either the absolute use or the volumes of pRBC between both studied groups. CONCLUSION: Autologous erythrocyte transfusion with CS use reduces the use of intraoperative homologous pRBC in coronary artery bypass grafting surgeries associated with miniCPB