23 results on '"Campagnucci VP"'
Search Results
2. More Hospital Complications in Women after Cabg Even for Reduced Surgical Times: Call to Action for Equity in Quality Improvement.
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Lacava L, Freitas FL, Borgomoni GB, Silva PGMBE, Nakazone MA, Campagnucci VP, Tiveron MG, Lisboa LA, Jatene FB, and Mejia OAV
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- Humans, Female, Male, Middle Aged, Sex Factors, Aged, Brazil epidemiology, Length of Stay statistics & numerical data, Risk Factors, Propensity Score, Hospital Mortality, Coronary Artery Bypass adverse effects, Quality Improvement, Postoperative Complications epidemiology, Operative Time
- Abstract
Background: Analyses of extensive registries indicate adverse outcomes for women undergoing coronary artery bypass grafting (CABG) surgery, while randomized studies often lack representativeness., Objective: To compare adjusted hospital outcomes between men and women undergoing CABG., Methods: From July 2017 to June 2019, 3991 patients underwent primary isolated CABG, both electively and urgently, in 5 hospitals in the state of São Paulo, Brazil. To mitigate demographic differences between men and women, populations were adjusted using propensity score matching (PSM). The outcomes considered for analysis were those used by the STS Adult Database. The analyses were performed using R software, with a significance set at p<0.05., Results: After PSM (1:1), each group included 1089 patients. Regarding intraoperative variables, men exhibited longer cardiopulmonary bypass (CPB) time (p<0.001), surgical time (p<0.001), a higher number of distal anastomoses (p<0.001), and increased use of arterial grafts. Regarding outcomes, women had a higher incidence of deep sternal wound infection (p=0.006), prolonged Intensive Care Unit stay (p=0.002), increased need for an intra-aortic balloon pump (p=0.04), higher blood transfusion rates (p<0.001), higher 30-day hospital readmission rates after surgery (p=0.002) and higher mortality rate (p=0.03)., Conclusions: Although men had longer CPB times, a greater number of arterial grafts, and a greater number of distal anastomoses, immediate results after CABG were poorer in women.
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- 2024
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3. Age, Renal Failure and Transfusion are Risk Predictors of Prolonged Hospital Stay after Coronary Artery Bypass Grafting Surgery.
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Andrade DPG, Freitas FL, Borgomoni GB, Goncharov M, Silva PGMBE, Nakazone MA, Campagnucci VP, Tiveron MG, Lisboa LA, Dallan LAO, Jatene FB, and Mejia OAV
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- Humans, Female, Male, Middle Aged, Aged, Risk Factors, Cross-Sectional Studies, Age Factors, Brazil epidemiology, Blood Transfusion statistics & numerical data, Risk Assessment, Prospective Studies, Coronary Artery Bypass statistics & numerical data, Coronary Artery Bypass adverse effects, Length of Stay statistics & numerical data, Renal Insufficiency
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Background: Identifying risk factors in cardiovascular surgery assists in predictability, resulting in optimization of outcomes and cost reduction., Objective: This study aimed to identify preoperative and intraoperative risk predictors for prolonged hospitalization after coronary artery bypass grafting (CABG) surgery in the state of São Paulo, Brazil., Methods: A cross-sectional analysis using data from the REPLICCAR II database, a prospective, consecutive, multicenter registry that included CABG surgeries performed between August 2017 and July 2019. The primary outcome was a prolonged hospital stay (PHS), defined as a postoperative period exceeding 14 days. Univariate and multivariate logistic regression analyses were performed to identify the predictors with significance set at p <0.05., Results: The median age was 63 (57-70) years and 26.55% of patients were female. Among the 3703 patients analyzed, 228 (6.16%) had a PHS after CABG, with a median hospital stay of 17 (16-20) days. Predictors of PHS after CABG included age >60 years (OR 2.05; 95% CI 1.43-2.87; p<0.001); renal failure (OR 1.73; 95% CI 1.29-2.32; p <0.001) and intraoperative red blood cell transfusion (OR 1.32; 95% CI 1.07-2.06; p=0.01)., Conclusion: Age >60 years, renal failure, and intraoperative red blood cell transfusion were independent predictors of PHS after CABG. The identification of these variables can help in multiprofessional strategic planning aimed to enhance results and resource utilization in the state of São Paulo.
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- 2024
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4. Data-driven coaching to improve statewide outcomes in CABG: before and after interventional study.
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Mejia OAV, Borgomoni GB, de Freitas FL, Furlán LS, Orlandi BMM, Tiveron MG, Silva PGMBE, Nakazone MA, Oliveira MAP, Campagnucci VP, Normand SL, Dias RD, and Jatene FB
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- Humans, Female, Male, Prospective Studies, Aged, Middle Aged, Mentoring, Postoperative Complications mortality, Postoperative Complications epidemiology, Propensity Score, Coronary Artery Bypass mortality, Coronary Artery Bypass adverse effects, Quality Improvement
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Background: The impact of quality improvement initiatives program (QIP) on coronary artery bypass grafting surgery (CABG) remains scarce, despite improved outcomes in other surgical areas. This study aims to evaluate the impact of a package of QIP on mortality rates among patients undergoing CABG., Materials and Methods: This prospective cohort study utilized data from the multicenter database Registro Paulista de Cirurgia Cardiovascular II (REPLICCAR II), spanning from July 2017 to June 2019. Data from 4018 isolated CABG adult patients were collected and analyzed in three phases: before-implementation, implementation, and after-implementation of the intervention (which comprised QIP training for the hospital team). Propensity Score Matching was used to balance the groups of 2170 patients each for a comparative analysis of the following outcomes: reoperation, deep sternal wound infection/mediastinitis ≤30 days, cerebrovascular accident, acute kidney injury, ventilation time >24 h, length of stay <6 days, length of stay >14 days, morbidity and mortality, and operative mortality. A multiple regression model was constructed to predict mortality outcomes., Results: Following implementation, there was a significant reduction of operative mortality (61.7%, P =0.046), as well as deep sternal wound infection/mediastinitis ( P <0.001), sepsis ( P =0.002), ventilation time in hours ( P <0.001), prolonged ventilation time ( P =0.009), postoperative peak blood glucose ( P <0.001), total length of hospital stay ( P <0.001). Additionally, there was a greater use of arterial grafts, including internal thoracic ( P <0.001) and radial ( P =0.038), along with a higher rate of skeletonized dissection of the internal thoracic artery., Conclusions: QIP was associated with a 61.7% reduction in operative mortality following CABG. Although not all complications exhibited a decline, the reduction in mortality suggests a possible decrease in failure to rescue during the after-implementation period., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2024
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5. Position Statement on Ischemic Heart Disease - Women-Centered Health Care - 2023.
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Oliveira GMM, Almeida MCC, Rassi DDC, Bragança ÉOV, Moura LZ, Arrais M, Campos MDSB, Lemke VG, Avila WS, Lucena AJG, Almeida ALC, Brandão AA, Ferreira ADA, Biolo A, Macedo AVS, Falcão BAA, Polanczyk CA, Lantieri CJB, Marques-Santos C, Freire CMV, Pellegrini D, Alexandre ERG, Braga FGM, Oliveira FMF, Cintra FD, Costa IBSDS, Silva JSN, Carreira LTF, Magalhães LBNC, Matos LDNJ, Assad MHV, Barbosa MM, Silva MGD, Rivera MAM, Izar MCO, Costa MENC, Paiva MSMO, Castro ML, Uellendahl M, Oliveira Junior MT, Souza OF, Costa RAD, Coutinho RQ, Silva SCTFD, Martins SM, Brandão SCS, Buglia S, Barbosa TMJU, Nascimento TAD, Vieira T, Campagnucci VP, and Chagas ACP
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- Humans, Female, Delivery of Health Care, Myocardial Ischemia
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- 2023
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6. Author Correction: Performance of a novel risk model for deep sternal wound infection after coronary artery bypass grafting.
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Orlandi BMM, Mejia OAV, Sorio JL, de Barros E Silva P, Oliveira MAP, Nakazone MA, Tiveron MG, Campagnucci VP, Lisboa LAF, Zubelli J, Normand SL, and Jatene FB
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- 2022
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7. Performance of a novel risk model for deep sternal wound infection after coronary artery bypass grafting.
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Orlandi BMM, Mejia OAV, Sorio JL, de Barros E Silva P, Oliveira MAP, Nakazone MA, Tiveron MG, Campagnucci VP, Lisboa LAF, Zubelli J, Normand SL, and Jatene FB
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- Adult, Coronary Artery Bypass adverse effects, Humans, Risk Factors, Sternum surgery, Cardiac Surgical Procedures, Surgical Wound Infection etiology, Surgical Wound Infection prevention & control
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Clinical prediction models for deep sternal wound infections (DSWI) after coronary artery bypass graft (CABG) surgery exist, although they have a poor impact in external validation studies. We developed and validated a new predictive model for 30-day DSWI after CABG (REPINF) and compared it with the Society of Thoracic Surgeons model (STS). The REPINF model was created through a multicenter cohort of adults undergoing CABG surgery (REPLICCAR II Study) database, using least absolute shrinkage and selection operator (LASSO) logistic regression, internally and externally validated comparing discrimination, calibration in-the-large (CL), net reclassification improvement (NRI) and integrated discrimination improvement (IDI), trained between the new model and the STS PredDeep, a validated model for DSWI after cardiac surgery. In the validation data, c-index = 0.83 (95% CI 0.72-0.95). Compared to the STS PredDeep, predictions improved by 6.5% (IDI). However, both STS and REPINF had limited calibration. Different populations require independent scoring systems to achieve the best predictive effect. The external validation of REPINF across multiple centers is an important quality improvement tool to generalize the model and to guide healthcare professionals in the prevention of DSWI after CABG surgery., (© 2022. The Author(s).)
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- 2022
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8. The arrival of COVID-19 in Brazil and the impact on coronary artery bypass surgery.
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Mejia OAV, Borgomoni GB, Silveira LMV, Guerreiro GP, Falcão Filho ATG, Goncharov M, Dallan LRP, Oliveira MAP, de Sousa AG, Nakazone MA, Tiveron MG, Campagnucci VP, de Barros E Silva PGM, Dallan LAO, Lisboa LAF, and Jatene FB
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- Brazil, Coronary Artery Bypass, Humans, Retrospective Studies, Risk Assessment, Risk Factors, SARS-CoV-2, COVID-19, Pandemics
- Abstract
Background and Aim of the Study: This study analyzed the arrival of coronavirus disease 2019 (COVID-19) in Brazil and its impact on coronary artery bypass grafting (CABG) surgery., Methods: Patients undergoing isolated CABG in six hospitals in Brazil were divided into two periods: pre-COVID-19 (March-May 2019, N = 468) and COVID-19 era (March-May 2020, N = 182). Perioperative data were included on a dedicated REDCap platform. Patients with clinical and tomographic criteria and/or PCR (+) for severe acute respiratory syndrome coronavirus 2 infection were considered COVID-19 (+). Logistic regression analysis was performed to create a multiple predictive model for mortality after CABG in COVID-19 era., Results: Compared to 2019, in 2020, CABG surgeries had a 2.8-fold increased mortality risk (95% confidence interval [CI]: 1-7.6, p = .041), patients who evolved with COVID-19 had a 11-fold increased mortality risk (95% CI: 2.2-54.9, p < .003), rates of morbidities and readmission to the intensive care unit. The surgical volume was decreased by 60%. The model to predict mortality after CABG in the COVID-19 era was validated with good calibration (Hosmer-Lemeshow = 1.43) and discrimination (receiver operating characteristic = 0.78)., Conclusion: The COVID-19 pandemic had an adverse impact on mortality, morbidity and volume of patients undergoing CABG., (© 2021 Wiley Periodicals LLC.)
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- 2021
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9. Most deaths in low-risk cardiac surgery could be avoidable.
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Mejia OAV, Borgomoni GB, Lima EG, Guerreiro GP, Dallan LR, de Barros E Silva P, Nakazone MA, Junior OP, Gomes WJ, de Oliveira MAP, Sousa A, Campagnucci VP, Tiveron MG, Rodrigues AJ, Tineli RÂ, Rocha E Silva R, Lisboa LAF, and Jatene FB
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- Aged, Aged, 80 and over, Brazil epidemiology, Cardiac Surgical Procedures adverse effects, Cause of Death, Female, Humans, Male, Middle Aged, Patient Safety, Registries, Risk Factors, Survival Analysis, Cardiac Surgical Procedures mortality
- Abstract
It is observed that death rates in cardiac surgery has decreased, however, root causes that behave like triggers of potentially avoidable deaths (AD), especially in low-risk patients (less bias) are often unknown and underexplored, Phase of Care Mortality Analysis (POCMA) can be a valuable tool to identify seminal events (SE), providing valuable information where it is possible to make improvements in the quality and safety of future procedures. Our results show that in São Paul State, only one third of AD in low-risk cardiac surgery was related to specific surgical problems. After a revisited analysis, 75% of deaths could have been avoided, which in the pre-operative phase, the SE was related judgment, patient evaluation and preparation. In the intra-operative phase, most occurrences could have been avoided if other surgical technique had been used. Sepsis was responsible for 75% of AD in the intensive care unit. In the ward phase, the recognition/management of clinical decompensations and sepsis were the contributing factors. Logistic regression model identified age, previous coronary stent implantation, coronary artery bypass grafting + heart valve surgery, ≥ 2 combined heart valve surgery and hospital-acquired infection as independent predictors of AD.
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- 2021
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10. Validation and quality measurements for STS, EuroSCORE II and a regional risk model in Brazilian patients.
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Mejia OAV, Borgomoni GB, Zubelli JP, Dallan LRP, Pomerantzeff PMA, Oliveira MAP, Petrucci Junior O, Tiveron MG, Nakazone MA, Tineli RÂ, Campagnucci VP, Silva RRE, Rodrigues AJ, Gomes WJ, Lisboa LAF, and Jatene FB
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- Brazil, Cardiac Surgical Procedures adverse effects, Female, Humans, Male, Middle Aged, Quality Control, Registries, Risk Assessment, Safety, Cardiac Surgical Procedures statistics & numerical data, Models, Statistical
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Objectives: The objectives of this study were to describe a novel statewide registry for cardiac surgery in Brazil (REPLICCAR), to compare a regional risk model (SPScore) with EuroSCORE II and STS, and to understand where quality improvement and safety initiatives can be implemented., Methods: A total of 11 sites in the state of São Paulo, Brazil, formed an online registry platform to capture information on risk factors and outcomes after cardiac surgery procedures for all consecutive patients. EuroSCORE II and STS values were calculated for each patient. An SPScore model was designed and compared with EuroSCORE II and STS to predict 30-day outcomes: death, reoperation, readmission, and any morbidity., Results: A total of 5222 patients were enrolled in this study between November 2013 and December 2017. The observed 30-day mortality rate was 7.6%. Most patients were older, overweight, and classified as New York Heart Association (NYHA) functional class III; 14.5% of the patient population had a positive diagnosis of rheumatic heart disease, 10.9% had insulin-dependent diabetes, and 19 individuals had a positive diagnosis of Chagas disease. When evaluating the prediction performance, we found that SPScore outperformed EuroSCORE II and STS in the prediction of mortality (0.90 vs. 0.76 and 0.77), reoperation (0.84 vs. 0.60 and 0.56), readmission (0.84 vs. 0.55 and 0.51), and any morbidity (0.80 vs. 0.65 and 0.64), respectively (p<0.001)., Conclusions: The REPLICCAR registry might stimulate the creation of other cardiac surgery registries in developing countries, ultimately improving the regional quality of care provided to patients., Competing Interests: The authors have declared that no competing interests exist.
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- 2020
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11. REPLICCAR II Study: Data quality audit in the Paulista Cardiovascular Surgery Registry.
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Orlandi BMM, Mejia OAV, Borgomoni GB, Goncharov M, Rocha KN, Bassolli L, Melo de Barros E Silva PG, Nakazone MA, Sousa A, Campagnucci VP, de Sousa Vilarinho KA, Katz M, Tiveron MG, Arrais Dos Santos M, Lisboa LAF, Dallan LAO, and Jatene FB
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- Brazil, Cardiovascular Surgical Procedures, Data Accuracy, Humans, Registries, Databases, Factual
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The quality of data in electronic healthcare databases is a critical component when used for research and health practice. The aim of the present study was to assess the data quality in the Paulista Cardiovascular Surgery Registry II (REPLICCAR II) using two different audit methods, direct and indirect. The REPLICCAR II database contains data from 9 hospitals in São Paulo State with over 700 variables for 2229 surgical patients. The data collection was performed in REDCap platform using trained data managers to abstract information. We directly audited a random sample (n = 107) of the data collected after 6 months and indirectly audited the entire sample after 1 year of data collection. The indirect audit was performed using the data management tools in REDCap platform. We computed a modified Aggregate Data Quality Score (ADQ) previously reported by Salati et al. (2015). The agreement between data elements was good for categorical data (Cohen κ = 0.7, 95%CI = 0.59-0.83). For continuous data, the intraclass coefficient (ICC) for only 2 out of 15 continuous variables had an ICC < 0.9. In the indirect audit, 77% of the selected variables (n = 23) had a good ADQ score for completeness and accuracy. Data entry in the REPLICCAR II database proved to be satisfactory and showed competence and reliable data for research in cardiovascular surgery in Brazil., Competing Interests: We know of no conflicts of interest associated with this publication.
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- 2020
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12. Coronary Artery Bypass Surgery in Brazil: Analysis of the National Reality Through the BYPASS Registry.
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Paez RP, Hossne Junior NA, Santo JADE, Berwanger O, Santos RHN, Kalil RAK, Jatene FB, Cavalcanti AB, Zilli AC, Bettiati LC Jr, Figueira FAMDS, D'Azevedo SSP, Soares MJF, Fernandes MP, Ardito RV, Bogdan RAB, Campagnucci VP, Nakasako D, Rodrigues CG, Rodrigues Junior AB, Cascudo MM, Atik FA, Lima EB, Nina VJDS, Heluy RA, Azeredo LG, Henrique Junior OS, Mendonça JT, Silva KKOG, Pandolfo M, Lima Júnior JD, Faria RM, Santos JGD, Coelho GHB, Pereira SN, Senger R, Buffolo E, Caputi GM, Oliveira JAB, and Gomes WJ
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- Aged, Brazil, Coronary Artery Bypass adverse effects, Cross-Sectional Studies, Female, Hospital Mortality, Humans, Intraoperative Complications, Male, Middle Aged, Treatment Outcome, Coronary Artery Bypass methods, Coronary Artery Bypass statistics & numerical data, Registries statistics & numerical data
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Introduction: Coronary artery bypass grafting (CABG) is the most frequently performed heart surgery in Brazil. Recent international guidelines recommend that national societies establish a database on the practice and results of CABG. In anticipation of the recommendation, the BYPASS Registry was introduced in 2015., Objective: To analyze the profile, risk factors and outcomes of patients undergoing CABG in Brazil, as well as to examine the predominant surgical strategy, based on the data included in the BYPASS Registry., Methods: A cross-sectional study of 2292 patients undergoing CABG surgery and cataloged in the BYPASS Registry up to November 2018. Demographic data, clinical presentation, operative variables, and postoperative hospital outcomes were analyzed., Results: Patients referred to CABG in Brazil are predominantly male (71%), with prior myocardial infarction in 41.1% of cases, diabetes in 42.5%, and ejection fraction lower than 40% in 9.7%. The Heart Team indicated surgery in 32.9% of the cases. Most of the patients underwent cardiopulmonary bypass (87%), and cardioplegia was the strategy of myocardial protection chosen in 95.2% of the cases. The left internal thoracic artery was used as a graft in 91% of the cases; the right internal thoracic artery, in 5.6%; and the radial artery in 1.1%. The saphenous vein graft was used in 84.1% of the patients, being the only graft employed in 7.7% of the patients. The median number of coronary vessels treated was 3. Operative mortality was 2.8%, and the incidence of cerebrovascular accident was 1.2%., Conclusion: CABG data in Brazil provided by the BYPASS Registry analysis are representative of our national reality and practice. This database constitutes an important reference for indications and comparisons of therapeutic procedures, as well as to propose subsequent models to improve patient safety and the quality of surgical practice in the country.
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- 2019
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13. The Brazilian Registry of Adult Patient Undergoing Cardiovascular Surgery, the BYPASS Project: Results of the First 1,722 Patients.
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Gomes WJ, Moreira RS, Zilli AC, Bettiati LC Jr, Figueira FAMDS, D' Azevedo SSP, Soares MJF, Fernandes MP, Ardito RV, Bogdan RAB, Campagnucci VP, Nakasako D, Kalil RAK, Rodrigues CG, Rodrigues AB Junior, Cascudo MM, Atik FA, Lima EB, Nina VJDS, Heluy RA, Azeredo LG, Henrique OS Junior, Mendonça JT, Silva KKOG, Pandolfo M, Lima JD Júnior, Faria RM, Santos JG, Paez RP, Coelho GHB, Pereira SN, Senger R, Buffolo E, Caputi GM, Santo JADE, Oliveira JAB, Berwanger O, Cavalcanti AB, and Jatene FB
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- Adult, Aged, Brazil epidemiology, Cardiovascular Surgical Procedures mortality, Coronary Artery Bypass mortality, Coronary Artery Bypass statistics & numerical data, Coronary Disease mortality, Coronary Disease surgery, Female, Heart Valves surgery, Humans, Male, Middle Aged, Prospective Studies, Treatment Outcome, Cardiovascular Surgical Procedures statistics & numerical data, Databases, Factual statistics & numerical data, Multicenter Studies as Topic statistics & numerical data, Registries statistics & numerical data
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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 systems; and 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.
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- 2017
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14. Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial.
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Cavalcanti AB, Bozza FA, Machado FR, Salluh JI, Campagnucci VP, Vendramim P, Guimaraes HP, Normilio-Silva K, Damiani LP, Romano E, Carrara F, Lubarino Diniz de Souza J, Silva AR, Ramos GV, Teixeira C, Brandão da Silva N, Chang CC, Angus DC, and Berwanger O
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- Brazil, Catheter-Related Infections mortality, Female, Hospitalization statistics & numerical data, Humans, Intensive Care Units statistics & numerical data, Male, Middle Aged, Odds Ratio, Pneumonia, Ventilator-Associated mortality, Time Factors, Checklist, Goals, Hospital Mortality, Intensive Care Units standards, Quality Improvement, Teaching Rounds
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Importance: The effectiveness of checklists, daily goal assessments, and clinician prompts as quality improvement interventions in intensive care units (ICUs) is uncertain., Objective: To determine whether a multifaceted quality improvement intervention reduces the mortality of critically ill adults., Design, Setting, and Participants: This study had 2 phases. Phase 1 was an observational study to assess baseline data on work climate, care processes, and clinical outcomes, conducted between August 2013 and March 2014 in 118 Brazilian ICUs. Phase 2 was a cluster randomized trial conducted between April and November 2014 with the same ICUs. The first 60 admissions of longer than 48 hours per ICU were enrolled in each phase., Interventions: Intensive care units were randomized to a quality improvement intervention, including a daily checklist and goal setting during multidisciplinary rounds with follow-up clinician prompting for 11 care processes, or to routine care., Main Outcomes and Measures: In-hospital mortality truncated at 60 days (primary outcome) was analyzed using a random-effects logistic regression model, adjusted for patients' severity and the ICU's baseline standardized mortality ratio. Exploratory secondary outcomes included adherence to care processes, safety climate, and clinical events., Results: A total of 6877 patients (mean age, 59.7 years; 3218 [46.8%] women) were enrolled in the baseline (observational) phase and 6761 (mean age, 59.6 years; 3098 [45.8%] women) in the randomized phase, with 3327 patients enrolled in ICUs (n = 59) assigned to the intervention group and 3434 patients in ICUs (n = 59) assigned to routine care. There was no significant difference in in-hospital mortality between the intervention group and the usual care group, with 1096 deaths (32.9%) and 1196 deaths (34.8%), respectively (odds ratio, 1.02; 95% CI, 0.82-1.26; P = .88). Among 20 prespecified secondary outcomes not adjusted for multiple comparisons, 6 were significantly improved in the intervention group (use of low tidal volumes, avoidance of heavy sedation, use of central venous catheters, use of urinary catheters, perception of team work, and perception of patient safety climate), whereas there were no significant differences between the intervention group and the control group for 14 outcomes (ICU mortality, central line-associated bloodstream infection, ventilator-associated pneumonia, urinary tract infection, mean ventilator-free days, mean ICU length of stay, mean hospital length of stay, bed elevation to ≥30°, venous thromboembolism prophylaxis, diet administration, job satisfaction, stress reduction, perception of management, and perception of working conditions)., Conclusions and Relevance: Among critically ill patients treated in ICUs in Brazil, implementation of a multifaceted quality improvement intervention with daily checklists, goal setting, and clinician prompting did not reduce in-hospital mortality., Trial Registration: clinicaltrials.gov Identifier: NCT01785966.
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- 2016
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15. A cluster-randomised trial of a multifaceted quality improvement intervention in Brazilian intensive care units (Checklist-ICU trial): statistical analysis plan.
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Damiani LP, Cavalcanti AB, Moreira FR, Machado F, Bozza FA, Salluh JI, Campagnucci VP, Normilio-Silva K, Chiattone VC, Angus DC, Berwanger O, and Chou H Chang C
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- Adult, Bias, Brazil, Humans, Outcome Assessment, Health Care, Checklist, Cluster Analysis, Critical Care, Data Interpretation, Statistical, Quality Improvement, Research Design
- Abstract
Background: The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (Checklist- ICU) trial is a pragmatic, two-arm, cluster-randomised trial involving 118 intensive care units in Brazil, with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist, definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality., Objective: To describe our trial statistical analysis plan (SAP)., Methods: This is an ongoing trial conducted in two phases. In the preparatory observational phase, we collect three sets of baseline data: ICU characteristics; patient characteristics, processes of care and outcomes; and completed safety attitudes questionnaires (SAQs). In the randomised phase, ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ., Results: Our SAP includes the prespecified model for the primary and secondary outcome analyses, which account for the cluster-randomised design and availability of baseline data. We also detail the multiple mediation models that we will use to assess our secondary hypothesis (that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist, but also through changes in safety culture). We describe our approach to sensitivity and subgroup analyses and missing data., Conclusion: We report our SAP before closing our study database and starting analysis. We anticipate that this should prevent analysis bias and enhance the utility of results.
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- 2015
16. A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol.
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Machado F, Bozza F, Ibrain J, Salluh F, Campagnucci VP, Guimarães HP, Normilio-Silva K, Chiattone VC, Vendramim P, Carrara F, Lubarino J, da Silva AR, Viana G, Damiani LP, Romano E, Teixeira C, da Silva NB, Chang CC, Angus DC, and Berwanger O
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- Brazil, Checklist, Clinical Protocols, Hospital Mortality, Humans, Intensive Care Units organization & administration, Outcome and Process Assessment, Health Care, Patient Safety, Intensive Care Units standards, Quality Improvement organization & administration
- Abstract
Background: The uptake of evidence-based therapies in the intensive care environment is suboptimal, particularly in limited-resource countries. Checklists, daily goal assessments, and clinician prompts may improve compliance with best practice processes of care and, in turn, improve clinical outcomes. However, the available evidence on the effectiveness of checklists is unreliable and inconclusive, and the mechanisms are poorly understood. We aim to evaluate whether the use of a multifaceted quality improvement intervention, including the use of a checklist and the definition of daily care goals during multidisciplinary daily rounds and clinician prompts, can improve the in-hospital mortality of patients admitted to intensive care units (ICUs). Our secondary objectives are to assess the effects of the study intervention on specific processes of care, clinical outcomes, and the safety culture and to determine which factors (the processes of care and/or safety culture) mediate the effect of the study intervention on mortality., Methods/design: This is a cluster randomized trial involving 118 ICUs in Brazil conducted in two phases. In the observational preparatory phase, we collect baseline data on processes of care and clinical outcomes from 60 consecutive patients with lengths of ICU stay longer than 48 h and apply the Safety Attitudes Questionnaire (SAQ) to 75% or more of the health care staff in each ICU. In the randomized phase, we assign ICUs to the experimental or control arm and repeat data collection. Experimental arm ICUs receive the multifaceted quality improvement intervention, including a checklist and definition of daily care goals during daily multidisciplinary rounds, clinician prompting, and feedback on rates of adherence to selected care processes. Control arm ICUs maintain usual care. The primary outcome is in-hospital mortality, truncated at 60 days. Secondary outcomes include the rates of adherence to appropriate care processes, rates of other clinical outcomes, and scores on the SAQ domains. Analysis follows the intention-to-treat principle, and the primary outcome is analyzed using mixed effects logistic regression., Discussion: This is a large scale, pragmatic cluster-randomized trial evaluating whether a multifaceted quality improvement intervention, including checklists applied during the multidisciplinary daily rounds and clinician prompting, can improve the adoption of proven therapies and decrease the mortality of critically ill patients. If this study finds that the intervention reduces mortality, it may be widely adopted in intensive care units, even those in limited-resource settings., Trial Registration: ClinicalTrials.gov NCT01785966.
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- 2015
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17. Recurrent giant left ventricular aneurysm of tuberculous etiology in a child: case report.
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Campagnucci VP, Pinto E Silva AM, Catani LH, and Rivetti LA
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- Child, Female, Heart Aneurysm diagnostic imaging, Heart Ventricles diagnostic imaging, Humans, Pericarditis diagnostic imaging, Radiography, Treatment Outcome, Tuberculosis diagnosis, Heart Aneurysm etiology, Heart Aneurysm surgery, Heart Ventricles surgery, Pericarditis etiology, Pericarditis surgery, Tuberculosis complications, Tuberculosis surgery
- Abstract
We report a case of myocardial tuberculosis in a 10-year-old girl, diagnosed after recurrence of left ventricular aneurysm, treated surgically.
- Published
- 2012
- Full Text
- View/download PDF
18. Seven years' outcome of simultaneous surgical treatment of atrial septal defect and atrial flutter in 2 children: case reports.
- Author
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Campagnucci VP, Rocha Pinto AM, Neto AS, Catani LH, Passarelli ML, Gandra SM, and Rivetti LA
- Subjects
- Atrial Flutter complications, Atrial Flutter diagnosis, Child, Preschool, Echocardiography, Doppler, Color, Electrocardiography, Female, Follow-Up Studies, Heart Atria diagnostic imaging, Heart Atria physiopathology, Heart Rate physiology, Heart Septal Defects, Atrial complications, Heart Septal Defects, Atrial diagnosis, Humans, Infant, Male, Suture Techniques, Time Factors, Atrial Flutter surgery, Cardiac Surgical Procedures methods, Heart Atria surgery, Heart Septal Defects, Atrial surgery
- Abstract
We describe 2 children who had long-standing type 1 atrial flutter and atrial septal defect. The simultaneous surgical treatment of these 2 conditions consisted of transmural incision from the inferior edge of the septal defect to the tricuspid ring, transmural incision from the medial-superior edge of the septal defect to the tricuspid ring, and closure of the septal defect with a bovine pericardial patch. There was no arrhythmia recurrence during a 7-year follow-up period.
- Published
- 2010
- Full Text
- View/download PDF
19. EuroSCORE and the patients undergoing coronary bypass surgery at Santa Casa de São Paulo.
- Author
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Campagnucci VP, Pinto E Silva AM, Pereira WL, Chamlian EG, Gandra SM, and Rivetti LA
- Subjects
- Adult, Aged, Aged, 80 and over, Brazil, Chi-Square Distribution, Coronary Disease diagnosis, Female, Hospital Mortality, Humans, Logistic Models, Male, Middle Aged, Retrospective Studies, Risk Factors, Coronary Artery Bypass mortality, Coronary Disease surgery, Risk Assessment methods
- Abstract
Objective: The aim of this study was to assess the performance of the European Risk System in Cardiac Operations (EuroSCORE) model to predict mortality in patients undergoing myocardial revascularization at the Division of Cardiovascular Surgery of Santa Casa de São Paulo Medical School., Methods: From May 2005 to November 2006, 100 consecutive patients undergoing coronary artery bypass surgery were retrospectively analyzed. The records of these patients were reviewed in order to retrieve those variables included in the EuroSCORE risk scoring method. The correlation of predicted and observed mortality was compared. Statistical analysis was performed using chi-square test for univariate analysis and Hosmer-Lemeshow Test for logistic regression model., Results: Hospital mortality was 5%. For EuroSCORE univariate analysis, findings were as follows: score 0-2 predicted mortality 0.40%, observed 0.00%; score 3-5 predicted mortality 1.45%, observed 0.00%; score greater than 6 predicted mortality 3.15%, observed 7.94%. Although these differences, p-value was 0.213 with no statistical significance. The p-value for the Hosmer-Lemeshow Test was < 0.001 indicating poor calibration of the model for this sample., Conclusion: The EuroSCORE model is a simple, objective system to estimate hospital mortality. However, to validate the logistic regression analysis, it is necessary hundreds of patients, which limit its widespread application.
- Published
- 2008
- Full Text
- View/download PDF
20. [Off-pump myocardial revascularization in the elderly: analysis of morbidity and mortality].
- Author
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Pinto E Silva AM, Campagnucci VP, Pereira WL, Rosa RF, Franken RA, Gandra SM, and Rivetti LA
- Subjects
- Aged, Aged, 80 and over, Anastomosis, Surgical, Angina, Unstable etiology, Brazil epidemiology, Coronary Artery Disease mortality, Female, Humans, Length of Stay, Male, Mammary Arteries transplantation, Morbidity, Myocardial Infarction etiology, Postoperative Complications, Postoperative Period, Preoperative Care, Saphenous Vein transplantation, Treatment Outcome, Coronary Artery Bypass adverse effects, Coronary Artery Bypass mortality, Coronary Artery Disease surgery
- Abstract
Objective: To analyze the in-hospital outcome of elderly patients aged 70 years and older who underwent off-pump coronary artery bypass graft surgery with an intraluminal shunt in urgent, emergent, and elective coronary revascularizations., Methods: From July 1989 to July 2005, we analyzed 87 patients ranging in age from 70 to 92 years. Of the 87 patients enrolled, 50 (57.5%) patients had unstable angina, with three (3.4%) acute myocardial infarction; thirty-one (35.6%) patients underwent urgent and emergent surgery; thirteen (14.9%) patients had myocardial infarction in less than 30 days, and 34 (39.1%) in more than 30 days., Results: The main postoperative complications were: atrial fibrillation (32.2%), heart failure (12.6%), pneumonia (10.3%), septicemia (3.4%), acute myocardial infarction (2.3%), mediastinitis (1.1%) transient ischemic attack (1.1%), and pneumothorax (1.1%). The mean extubation time was 18.50+/-19.09 hours, the length of stay in the intensive care unit was 2.92+/-2.03 days, and hospital length of stay was 10.55+/-7.16 days. Packed red cells were given to nine (10.34%) patients and none of them was operated due to bleeding. The in-hospital mortality was 4.6%., Conclusions: In patients over 70 years-old, elective and non-elective off-pump coronary artery bypass grafting with intracoronary shunt showed to be safe and effective, associated with low rates of postoperative complications and mortality in relation to the studied population.
- Published
- 2008
- Full Text
- View/download PDF
21. Approach of the pulmonary valve using right heart bypass and bicaval cannula: experimental study.
- Author
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Silva AM, Dallan LA, Campagnucci VP, Caruso J, Gandra SM, and Rivetti LA
- Subjects
- Animals, Blood Pressure physiology, Body Temperature physiology, Carbon Monoxide analysis, Catheterization instrumentation, Catheterization standards, Disease Models, Animal, Heart Rate physiology, Minimally Invasive Surgical Procedures methods, Oxygen blood, Pulmonary Artery surgery, Pulmonary Valve abnormalities, Swine, Time Factors, Cardiopulmonary Bypass instrumentation, Pulmonary Valve surgery, Pulmonary Valve Stenosis surgery
- Abstract
Objective: To reproduce the surgery for correction of pulmonary valve anomalies using right heart bypass and a new bicaval cuffed venous cannula for minimal access surgery., Methods: Fifteen Large-White pigs were used for this study. The standard technique model was established with the first five pigs, the experiment was done with nine animals by sternotomy, and one was submitted to a minimally invasive procedure, but has been excluded of the sample. Bicaval drainage by a single cannula was obtained through the internal jugular vein. The cuffs were inflated to increase blood flow to the machine. The return was established by putting the arterial cannula into the pulmonary artery trunk. Pre-bypass parameters were measured and compared with the parameters during the right bypass: Median Arterial Tension (MAT); Heart Rate (HR); O2 Saturation (SAT O2); end-tidal CO2 measures (etCO2); Temperature (T). The statistical analysis was done comparing the pre-bypass and during bypass values., Results: Pre-bypass values: MAT: 90.8 mmHg; HR = 101.6 beat/min; O2 SAT = 93.8%; PetCO2 = 28.4 mmHg; T = 36.1 degrees C. During bypass the obtained values were: MAT: 88.1 mmHg; HR = 98.0 beat/min; O2 SAT = 93.1%; PetCO2 = 25.3 mmHg; T = 36.9 degrees C. Comparing the average values between the two abovementioned moments, no significant difference occurred in MAT, HR and O2 SAT; PetCO2 and T presented significant differences., Conclusions: The bicaval cuffed venous cannula showed efficient drainage of both venae cavae with appropriate hemodynamic parameters during right bypass allowing access to the pulmonary valve.
- Published
- 2007
- Full Text
- View/download PDF
22. [Thrombolytic therapy in thrombosis of prosthesis].
- Author
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Campagnucci VP, Suzuki HY, Franken RA, and Rivetti LA
- Subjects
- Adult, Coronary Thrombosis etiology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Coronary Thrombosis drug therapy, Heart Valve Prosthesis adverse effects, Plasminogen therapeutic use, Streptokinase therapeutic use, Thrombolytic Therapy
- Abstract
Purpose: To relate our experience with thrombolytic therapy in 8 patients with cardiac metal prosthesis complicated with thrombosis., Methods: Eight patients with clinical and echocardiographic diagnosis of cardiac valvar prosthesis thrombosis were treated., Results: The treatment efficacy was evaluated by clinical and echocardiographic improvement. The authors recognized improvement in all 8 patients. One case of hemorrhage was observed (coxo-femoral articulation). Late death were observed twice: 24 months after, sudden death and 30 months later by hemorrhagic stroke., Conclusion: The results indicated that thrombolytic therapy is best way to treat patients with cardiac valve thrombosis, instead of surgical treatment.
- Published
- 1994
23. [Mitral valve replacement with porcine bioprosthesis in children. Evaluation of 29 patients during 12 years].
- Author
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Gandra SM, Rivetti LA, Pinto AM, Marinelli I, Campagnucci VP, and Franken RA
- Subjects
- Actuarial Analysis, Adolescent, Child, Female, Follow-Up Studies, Heart Valve Diseases surgery, Humans, Male, Mitral Valve surgery, Bioprosthesis, Heart Valve Prosthesis mortality
- Abstract
Purpose: To analyze the clinical result of the mitral valve substitution for the porcine bioprostheses, the incidence of dysfunction caused by calcification and its importance related to the durability of bioprostheses and also the patients' survival., Methods: Twenty-nine children of about seven to sixteen years old were operated on from November 1977 to August 1982 and all of them received porcine bioprostheses of low profile., Results: There were three (10.34%) hospital deaths and nine other late mortalities. The follow-up period varied from 4 to 128 months with average of 58.17 months and with the loss of nine patients. An actuarial survival rate of 46.08% has been observed at 11 years after surgery. Calcification of 21 bioprostheses occurred in 14 out of 17 follow-up patients; 47.6% of them happened until the third year of pos-operative and 85.7% until the fifth year. Eleven patients were reoperated on with 9.09% of hospital mortality. There were no cases of thromboembolism., Conclusion: Porcine bioprostheses works well with an evident clinical improvement of patients, with no thromboembolic accidents. However, its durability has been affected by the high incidence of calcification, which is responsible for an increase in late morbidity and mortality. Mitral valve disease treatment in children must be conservative, in an attempt to solve the problem with the different available plastic technics and leave the valve substitution to be a last option. In that case, the preference is given to the homologous bioprostheses.
- Published
- 1992
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