A network meta-analysis of direct factor Xa inhibitors for the treatment of cancer-associated venous thromboembolism.

INTRODUCTION: Treatment of cancer-associated venous thromboembolism (CAVTE) remains challenging. The aim of this study was to assess the outcomes of direct acting oral anticoagulants (DOAs) for the treatment of CAVTE. MATERIALS AND METHODS: A network meta-analysis of randomized clinical trials comparing DOAs (Apixaban, Rivaroxaban, and Edoxaban) versus Dalteparin for the treatment of CAVTE was performed. Outcomes of interest included, VTE recurrence, all-cause mortality, event-free survival, major bleeding, and clinically relevant non-major bleeding (CRNMB). Analysis was based on a random effects model and Bayesian Markov-chain Monte Carlo method was used for indirect comparisons. RESULTS: Four RCTs involving 2894 patients were included. Overall certainty of evidence was moderate regarding all outcomes. DOAs exhibited lower risk of VTE (RR 0.62; 95% CI 0.44, 0.87; P = 0.007), similar risk of major bleeding (RR 1.33; 95% CI 0.84, 2.11; P = 0.23), and higher risk of CRNMB (RR 1.66, 95% CI 1.08, 2.56; P = 0.02), compared with Dalteparin. Risk of all-cause mortality and event-free survival were similar between groups with RR 0.99 (95% CI 0.84, 1.16) and RR 1.03 (95% CI 0.94, 1.13), respectively. Apixaban ranked first for recurrent VTE (42.4%) and major bleeding (62.3%) and Dalteparin ranked first for CRNMB (54.7%). Rivaroxaban ranked best considering all-cause mortality (58.7%); Apixaban ranked best for event-free survival (83.6%). CONCLUSIONS: DOAs presented a reduced risk of recurrent VTE with similar risk of major bleeding compared to Dalteparin. However, a higher risk of CRNMB is expected when this cohort of patients are treated with DOAs instead of Dalteparin.

Gene therapy for refractory angina and cell therapy for heart failure: experience of a Brazilian research group.

Cell therapy has shown impressive effects in experimental cardiomyopathy models. To a lesser extent, gene therapy has also been studied. In both cases, translation to clinical therapy has been disappointing. This paper is intended to describe the experience and achievements of a multicenter working group located in Porto Alegre, southern Brazil, in experimental and translational research projects for cell-based and gene therapy methods in the treatment of dilated and ischemic cardiomyopathies. The results of preclinical and clinical studies showed that bone marrow mononuclear stem cells indeed have an effect in improving myocardial perfusion and contractile function, but the overall results are poorly translated to the clinical level. Gene therapy studies with direct myocardial injections of naked VEGF 165 plasmid showed improvement in myocardial perfusion and function in animal models. A randomized clinical trial found that this method is safe and improved myocardial perfusion, but the benefits disappeared after 1 year. An animal experiment associating VEGF 165 with angiopoietin was undertaken in mini pigs to extend the durability of that therapy. In conclusion, our efforts to better understand the mechanisms and functions of gene and cell-based therapies in cardiology resulted in significant findings and propose a future look at cell-free therapeutic approaches.

Sexual Dysfunction in Women with Hypertension: a Systematic Review and Meta-analysis.

PURPOSE OF REVIEW: We aimed to evaluate the prevalence of sexual dysfunction in hypertensive women and compare sexual dysfunction between hypertensive and non-hypertensive women. RECENT FINDINGS: Conducted a systematic review in the following databases: PubMed, EMBASE, Scopus, Web of Science, IBECS, and Lilacs. We included articles evaluating the prevalence of sexual dysfunction in a woman and/or comparing sexual dysfunction between hypertensive and non-hypertensive women. Studies were excluded if they evaluated patients with secondary hypertension, examined sexual dysfunction caused by drugs, did not distinguish by gender, or included patients with hypertension and other comorbidities/pathologies. We conducted an I2 test to calculate heterogeneity and a meta-analysis to compare sexual dysfunction between hypertensive and non-hypertensive women. A meta-regression equation calculated the relationship between sexual dysfunction risk for hypertensive and age. Eleven articles were included: five were included in the meta-analysis (1057 hypertensive and 715 normotensive). The prevalence of sexual dysfunction in articles varied from 14.1 to 90.1%. In the meta-analysis of the sexual dysfunction, the relative risk between hypertensive and normotensive women was found to be significant and has a high heterogeneity (I2 =92.6%, p < 0.001); the pooled results revealed a significant risk ratio of 1.81 (95% CI 1.10-2.97, p < 0.05). The relative risk for hypertensive women showed an association with age (b = 0.0333, p < 0.0001). The studies analyzed presented significant limitations in relation to methodology and a small sample size. Consequently, the meta-analysis was highly heterogeneous and reinforced the need for further research in this area.

Orthodontic and orthopaedic treatment for anterior open bite in children.

BACKGROUND: Anterior open bite occurs when there is a lack of vertical overlap of the upper and lower incisors. The aetiology is multifactorial including: oral habits, unfavourable growth patterns, enlarged lymphatic tissue with mouth breathing. Several treatments have been proposed to correct this malocclusion, but interventions are not supported by strong scientific evidence. OBJECTIVES: The aim of this systematic review was to evaluate orthodontic and orthopaedic treatments to correct anterior open bite in children. SEARCH METHODS: The following databases were searched: the Cochrane Oral Health Group's Trials Register (to 14 February 2014); the Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library 2014, Issue 1); MEDLINE via OVID (1946 to 14 February 2014); EMBASE via OVID (1980 to 14 February 2014); LILACS via BIREME Virtual Health Library (1982 to 14 February 2014); BBO via BIREME Virtual Health Library (1980 to 14 February 2014); and SciELO (1997 to 14 February 2014). We searched for ongoing trials via ClinicalTrials.gov (to 14 February 2014). Chinese journals were handsearched and the bibliographies of papers were retrieved. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of orthodontic or orthopaedic treatments or both to correct anterior open bite in children. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of all reports identified. Risk ratios (RRs) and corresponding 95% confidence intervals (CIs) were calculated for dichotomous data. The continuous data were expressed as described by the author. MAIN RESULTS: Three randomised controlled trials were included comparing: effects of Frankel's function regulator-4 (FR-4) with lip-seal training versus no treatment; repelling-magnet splints versus bite-blocks; and palatal crib associated with high-pull chincup versus no treatment.The study comparing repelling-magnet splints versus bite-blocks could not be analysed because the authors interrupted the treatment earlier than planned due to side effects in four of ten patients.FR-4 associated with lip-seal training (RR = 0.02 (95% CI 0.00 to 0.38)) and removable palatal crib associated with high-pull chincup (RR = 0.23 (95% CI 0.11 to 0.48)) were able to correct anterior open bite.No study described: randomisation process, sample size calculation, there was not blinding in the cephalometric analysis and the two studies evaluated two interventions at the same time. These results should be therefore viewed with caution. AUTHORS' CONCLUSIONS: There is weak evidence that the interventions FR-4 with lip-seal training and palatal crib associated with high-pull chincup are able to correct anterior open bite. Given that the trials included have potential bias, these results must be viewed with caution. Recommendations for clinical practice cannot be made based only on the results of these trials. More randomised controlled trials are needed to elucidate the interventions for treating anterior open bite.

Comparison of hemodynamic instability among continuous, intermittent and hybrid renal replacement therapy in acute kidney injury: A systematic review of randomized clinical trials.

PURPOSE: To compare hemodynamic instability during continuous, intermittent and hybrid renal replacement therapy (RRT) in critically ill patients, and its association with renal recovery and mortality. MATERIALS AND METHODS: The search was conducted in accordance with the PRISMA guidelines which was registered at the PROSPERO Database (CRD42018086504). Randomized clinical trials (RCTs) involving critically ill patients with acute kidney injury (AKI) treated with continuous, intermittent or hybrid RRT were included. The search was performed using PubMed, Embase and Cochrane databases. RESULTS: Out of 3442 citations retrieved, 12 RCTs were included in the systematic analysis, representing 1419 patients. Most studies (n = 8) did not report differences in hemodynamic parameters across different RTT modalities. The incidence of hypotensive episodes varied from 5 to 60% among the studies. Punctual differences on heart rate and blood pressure were observed among studies. However, studies presented high heterogeneity in terms of outcome definitions and measurement, thus making the conduction of meta-analysis impossible. CONCLUSIONS: There is very few information available regarding hemodynamic tolerance of renal replacement therapy methods. A better standardization of hemodynamic tolerance and further reports are needed before conclusions can be drawn.

Safety and efficacy of baroreflex activation therapy for heart failure with reduced ejection fraction: a rapid systematic review.

To retrieve and assess the available data in the literature about the safety and efficacy of baroreflex activation therapy (BAT) in heart failure with reduced ejection fraction (HFrEF) patients, through a rapid systematic review of clinical studies. Rapid systematic review of literature. Searched electronic databases included PubMed, EMBASE, CENTRAL, Scopus, and Web of Science using Mesh and free terms for heart failure and BAT. No language restriction was used for the searches. We included full peer reviewed publications of clinical studies (randomized or not), including patients with HFrEF undergoing BAT, with or without control group, assessing safety and efficacy outcomes. One reviewer conducted the analysis of the selected abstracts and the full-text articles, performed data extraction, and evaluated the methodological quality of the selected articles. The methodological quality was assessed according to the Cochrane Collaboration instruments. A descriptive summary of the results is provided. Of the 441 citations screened, 10 publications were included (three were only conference abstracts), reporting data from three studies. Only one study was a randomized clinical trial. Two studies reported a 6 month following, and the other study analysed outcomes up to 41 months. The procedure seems to be safe when performed by a well-trained multi-professional team. An 86% rate of system and procedure-related complication-free was reported, with no cranial nerve injuries. Improvements in New York Heart Association class of heart failure, quality of life, 6 min walk test, and hospitalization rates, as well as in muscle sympathetic nerve activity. No meta-analysis was conducted because of the lack of homogeneity across studies; the results from each study are reported individually. BAT procedure seems to be safe if appropriate training is provided. Improvements in clinical outcomes were described in all included studies. However, several limitations do not allow us to make conclusive statements on the efficacy of BAT for HFrEF. New well-designed trials are still needed.

Nursing Guidelines on Cardiac Surgery and Parents' Anxiety: Randomized Clinical Trial.

OBJECTIVE: The preparation of parents of children who should undergo cardiac surgery requires special treatment such as the explanations about the event. This study aims to compare the effects of standardized nursing guidelines with routine institutional orientation on the anxiety of parents of children undergoing cardiac surgery. METHODS: Randomized clinical trial. The sample consisted of parents of children who underwent cardiac surgery from December 2010 to April 2011. Twenty-two parents were randomized to the intervention group (IG) and received the standard nursing guidelines and 22 participated in the control group (CG) and received the routine guidelines from the institution. Anxiety was assessed by the State-Trait Anxiety Inventory (STAI) applied in the preoperative period, between 12 and 20 hours before surgery and before receiving standard or institutional guidelines and 48 hours after surgery. The analysis of variance (ANOVA) for repeated measures was performed to evaluate the differences between the variations in STAI scores between the groups during the studied period. The level of significance was 0.05. RESULTS: There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18). Likewise, the variation in score after 48 hours was similar between groups (STAI-trait P=0.77; STAI-state P=0.61). CONCLUSION: There were no significant differences in the parents' anxiety levels when comparing the two types of guidelines: the standard nursing and the institutional orientation.

Creation and Implementation of a Prospective and Multicentric Database of Patients with Acute Myocardial Infarction: RIAM. / Criação e Implementação de um Banco de Dados Prospectivo e Multicêntrico de Pacientes com Infarto Agudo do Miocárdio: RIAM.

BACKGROUND: Multicenter registries representing the real world can be a significant source of information, but few studies exist describing the methodology to implement these tools. OBJECTIVE: To describe the process of implementing a database of ST-segment elevation acute myocardial infarction (STEMI) at a reference hospital, and the application of this process to other centers by means of an online platform. METHODS: In 2009, our institution implemented an Registry of Acute Myocardial Infarction (RIAM), with the prospective and consecutive inclusion of every patient admitted to the institution who received a diagnosis of STEMI. From March 2014 to April 2016, the registries were uploaded to a web-based system using the REDCap software and the registry was expanded to other centers. Upon subscription, the REDCap platform is a noncommercial software made available by Vanderbilt University to institutions interested in research. RESULTS: The following steps were taken to improve and expand the registry: 1. Standardization of variables; 2. Implementation of institutional REDCap (Research Electronic Data Capture); 3. Development of data collection forms (Case Report Form - CRF); 4. Expansion of registry to other reference centers using the REDCap software; 5. Training of teams and participating centers following an SOP (Standard Operating Procedure). CONCLUSION: The description of the methodology used to implement and expand the RIAM may help other centers and researchers to conduct similar studies, share information between institutions, develop new health technologies, and assist public policies regarding cardiovascular diseases. (Arq Bras Cardiol. 2020; 114(3):446-455).

FUNDAMENTO: Registros multicêntricos representativos do mundo real podem fornecer informações importantes, mas existem poucos estudos descrevendo como implementar estas ferramentas. OBJETIVO: Descrever o processo de implementação de um banco de dados em infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCST) em um hospital de referência e sua aplicação para outros centros com uma plataforma online . MÉTODOS: Nossa instituição implementou em 2009 um Registro de Infarto Agudo do Miocárdio (RIAM), com a inclusão prospectiva e consecutiva de todos os pacientes com diagnóstico de IAMCST que internaram na instituição. No período de março de 2014 a abril de 2016 foi realizada a migração para o sistema online com o software REDCap e expansão do registro para outros centros. A plataforma REDCap é um software de uso gratuito disponibilizado pela Universidade Vanderbilt a instituições interessadas em pesquisa, mediante cadastramento prévio. RESULTADOS: Foram realizadas as seguintes etapas do aprimoramento e expansão do registro: 1. Padronização das variáveis; 2. Implementação do software REDCap ( Research Electronic Data Capture ) institucional; 3. Desenvolvimento de formulários de coleta de dados ( Case Report Form - CRF); 4. Expansão do registro para outros centros de referência utilizando o software REDCap; 5. Treinamento da equipe e dos centros participantes pelo POP (Procedimento Operacional Padrão). CONCLUSÕES: A descrição da metodologia utilizada para implementar e expandir o RIAM pode auxiliar outros centros e pesquisadores a realizar estudos semelhantes, compartilhar informações entre instituições, o desenvolvimento de novas tecnologias em saúde e auxiliar nas políticas públicas em doenças cardiovasculares. (Arq Bras Cardiol. 2020; 114(3):446-455).

Using a 3D printer in cardiac valve surgery: a systematic review.

BACKGROUND: The use of the 3D printer in complex cardiac surgery planning. OBJECTIVES: To analyze the use and benefits of 3D printing in heart valve surgery through a systematic review of the literature. METHODS: This systematic review was reported following the Preferred Reporting Items for Systematic Review and registered in the Prospero (International Prospective Register of Systematic Reviews) database under the number CRD42017059034. We used the following databases: PubMed, EMBASE, Scopus, Web of Science and Lilacs. We included articles about the keywords "Heart Valves", "Heart Valve Prosthesis Implantation", "Heart Valve Prosthesis", "Printing, Three-Dimensional", and related entry terms. Two reviewers independently conducted data extraction and a third reviewer solved disagreements. All tables used for data extraction are available at a separate website. We used the Cochrane Collaboration tool to assess the risk of bias of the studies included. RESULTS: We identified 301 articles and 13 case reports and case series that met the inclusion criteria. Our studies included 34 patients aged from 3 months to 94 years. CONCLUSIONS: Up to the present time, there are no studies including a considerable number of patients. A 3D-printed model produced based on the patient enables the surgeon to plan the surgical procedure and choose the best material, size, format, and thickness to be used. This planning leads to reduced surgery time, exposure, and consequently, lower risk of infection.

Coronary Artery Bypass Surgery in Brazil: Analysis of the National Reality Through the BYPASS Registry.

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.

Central hemodynamic parameters to predict cardiovascular outcomes and mortality among the elderly: protocol for a systematic review.

BACKGROUND: Central blood pressure is a factor that may predict cardiovascular events. However, its use in clinical practice is not well consolidated. Therefore, the aim of our study will be to summarize the use of central hemodynamic parameters to predict cardiovascular-related outcomes and all-cause mortality. DESIGN AND SETTING: Protocol for systematic review of longitudinal observational studies conducted in healthcare institutions, as presented in the studies included. METHODS: We will perform a systematic search in the electronic databases MEDLINE (via PubMed), EMBASE and LILACS (via Virtual Health Library (VHL)), using health descriptors terms for elderly people and for hemodynamic indices of central blood pressure. We will include articles that evaluated hemodynamic indices and at least one of the following outcomes: all-cause mortality, total cardiovascular death, total non-cardiovascular death, myocardial infarction, stroke, coronary artery restenosis after percutaneous coronary intervention, revascularization and aortic syndromes. Two independent reviewers will conduct analysis on the abstracts selected and on the full-text articles. Two reviewers will independently perform data extraction and evaluate the methodological quality of the articles selected, and a third reviewer will evaluate any divergences. The methodological quality of the studies will be assessed in accordance with the ROBINS-I tool (Risk Of Bias In Non-randomized Studies of Interventions). RESULTS AND CONCLUSIONS: Through this systematic review, we intend to summarize evidence that supports the use of central hemodynamic parameters for central blood pressure to diagnose and perform prognostics on arterial hypertension in elderly patients within clinical practice and predict future cardiovascular events in this population. REGISTRATION: Prospero - CRD42018085264.

Quality of life in patients with implantable cardioverter-defibrillator: systematic review of randomized controlled trials.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy significantly improves the survival of patients who are at high risk for sudden cardiac death. However, it is unclear whether this survival is accompanied by impairment on quality of life (QoL). OBJECTIVES: This systematic review sought to describe whether ICD therapy, as compared with standard treatment, can have an impact on QoL outcomes. METHODS: Extensive literature searches were carried out in PubMed, EMBASE, LILACS and Cochrane Library. Eligible studies were randomized controlled trials (RCTs) of ICD versus medical therapy that reported valid and reliable measures of QoL. Included studies were reviewed to determine baseline patient characteristics, mean duration of follow-up, questionnaires used to assess QoL and association between QoL scores and ICD shock therapy. RESULTS: Seven studies, enrolling a total of 5,701 patients, were included in this review. The analyzed trials showed conflicting results about the impact of ICD on QoL outcomes. Among the secondary prevention studies, CIDS reported a clear benefit from ICD and AVID showed no difference between ICD and amiodarone groups. Of the primary prevention trials, AMIOVIRT, MADIT II, DEFINITE, and SCD-HeFT found no evidence of impaired QoL in patients with an ICD. Evidence for an association between ICD shocks and QoL was mixed and seemed to depend on the interval between shocks and QoL assessment. CONCLUSION: There was no evidence of impaired QoL in patients with an ICD. However, ICD patients must be educated of all possible risks and benefits, including transitory declines in QoL after ICD shocks.

Oral healthcare management practices in Brazil: systematic review and metasummary

Universal health coverage is a global target included in the United Nations Sustainable Development Goals agenda for 2030. Healthcare in Brazil has universal coverage through the Unified Health System (SUS), which guarantees health as basic right to the Brazilian population. Considering the principles of SUS, public oral healthcare management is a huge challenge. Aim: To identify good management practices for quality care adopted by local public oral healthcare managers and teams around Brazil. Methods: This study was registered with PROSPERO (CRD42017051639). Five databases (PubMed, Embase, Web of Science, Scopus and Lilacs) as well as the reference lists and citations of the included publications were searched according to PRISMA guidelines. Results:A total of 30,895 references were initially found, which were evaluated according to the defined eligibility criteria. Twenty qualitative studies, eight surveys and two mixed-model studies were selected. The practices (codes) were organized into three main groups (families), and the Frequency of the Effect Size (FES) of each code was calculated. Among the 20 codes identified, the most relevant ones were: Diagnosis and Health Planning (FES=80%) and Family Health Strategy(FES=66,7). The Intensity of the Effect Size of each study was also calculated to demonstrate the individual contribution of each study to the conclusions. Conclusion: The evidence emerging from this review showed that healthcare diagnosis, planning, and performance based on the family health strategy principles were the most relevant practices adopted by public oral healthcare managers in Brazil. The widespread adoption of these practices could lead to improved oral healthcare provision and management in Brazil

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 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.

Monophasic and biphasic shock for transthoracic conversion of atrial fibrillation: Systematic review and network meta-analysis.

OBJECTIVES: Conduct a systematic review of the literature to compare the efficacy of different biphasic and monophasic shock waveforms technologies for transthoracic cardioversion of Atrial Fibrillation (AF). METHODS: We searched PubMed, EMBASE, The Cochrane Library, LILACS and ClinicalTrials.gov databases for randomized clinical trials comparing two or more defibrillation waveforms when performing elective transthoracic cardioversion of AF. The outcomes assessed were 1st shock success, overall success, cumulative energy and number of shocks to restore Normal Sinus Rhythm. RESULTS: Were included 23 trials involving 3046 patients, 5 biphasic and the monophasic waveform. Direct meta-analysis revealed that Biphasic waveforms have higher chance to achieve cardioversion in the 1st shock (OR: 3.2; 95% CI 2.2-4.7) and after a sequence of attempts (OR:2.4; 95% CI 1.5-3.9), requiring 296 less Joules (95% CI 356-237) and 0.74 less shocks (95%CI 1.03-0.44) when compared to Monophasic. Network meta-analysis showed no significant differences between the Biphasic technologies of PhysioControl ADAPTIV, Philips SMART and ZOLL Rectilinear, in any of the four outcomes. CONCLUSION: The evidences points to a Biphasic waveform superiority over Monophasic to perform AF cardioversion, supporting current guidelines to use less energy when using a Biphasic defibrillator. It is suggested that the Biphasic defibrillators from PhysioControl ADAPTIV, Philips SMART and ZOLL Rectilinear have similar efficacy and the use of any of them may result in similar chances, energy and number of shocks to achieve successful AF cardioversion.

Criação e Implementação de um Banco de Dados Prospectivo e Multicêntrico de Pacientes com Infarto Agudo do Miocárdio: RIAM / Creation and Implementation of a Prospective and Multicentric Database of Patients with Acute Myocardial Infarction: RIAM

Resumo Fundamento Registros multicêntricos representativos do mundo real podem fornecer informações importantes, mas existem poucos estudos descrevendo como implementar estas ferramentas. Objetivo Descrever o processo de implementação de um banco de dados em infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCST) em um hospital de referência e sua aplicação para outros centros com uma plataforma online . Métodos Nossa instituição implementou em 2009 um Registro de Infarto Agudo do Miocárdio (RIAM), com a inclusão prospectiva e consecutiva de todos os pacientes com diagnóstico de IAMCST que internaram na instituição. No período de março de 2014 a abril de 2016 foi realizada a migração para o sistema online com o software REDCap e expansão do registro para outros centros. A plataforma REDCap é um software de uso gratuito disponibilizado pela Universidade Vanderbilt a instituições interessadas em pesquisa, mediante cadastramento prévio. Resultados Foram realizadas as seguintes etapas do aprimoramento e expansão do registro: 1. Padronização das variáveis; 2. Implementação do software REDCap ( Research Electronic Data Capture ) institucional; 3. Desenvolvimento de formulários de coleta de dados ( Case Report Form - CRF); 4. Expansão do registro para outros centros de referência utilizando o software REDCap; 5. Treinamento da equipe e dos centros participantes pelo POP (Procedimento Operacional Padrão). Conclusões A descrição da metodologia utilizada para implementar e expandir o RIAM pode auxiliar outros centros e pesquisadores a realizar estudos semelhantes, compartilhar informações entre instituições, o desenvolvimento de novas tecnologias em saúde e auxiliar nas políticas públicas em doenças cardiovasculares. (Arq Bras Cardiol. 2020; 114(3):446-455)

Abstract Background Multicenter registries representing the real world can be a significant source of information, but few studies exist describing the methodology to implement these tools. Objective To describe the process of implementing a database of ST-segment elevation acute myocardial infarction (STEMI) at a reference hospital, and the application of this process to other centers by means of an online platform. Methods In 2009, our institution implemented an Registry of Acute Myocardial Infarction (RIAM), with the prospective and consecutive inclusion of every patient admitted to the institution who received a diagnosis of STEMI. From March 2014 to April 2016, the registries were uploaded to a web-based system using the REDCap software and the registry was expanded to other centers. Upon subscription, the REDCap platform is a noncommercial software made available by Vanderbilt University to institutions interested in research. Results The following steps were taken to improve and expand the registry: 1. Standardization of variables; 2. Implementation of institutional REDCap (Research Electronic Data Capture); 3. Development of data collection forms (Case Report Form - CRF); 4. Expansion of registry to other reference centers using the REDCap software; 5. Training of teams and participating centers following an SOP (Standard Operating Procedure). Conclusion The description of the methodology used to implement and expand the RIAM may help other centers and researchers to conduct similar studies, share information between institutions, develop new health technologies, and assist public policies regarding cardiovascular diseases. (Arq Bras Cardiol. 2020; 114(3):446-455)

Nursing guidelines on cardiac surgery and parents anxiety: randomized clinical trial

Abstract Objective: The preparation of parents of children who should undergo cardiac surgery requires special treatment such as the explanations about the event. This study aims to compare the effects of standardized nursing guidelines with routine institutional orientation on the anxiety of parents of children undergoing cardiac surgery. Methods: Randomized clinical trial. The sample consisted of parents of children who underwent cardiac surgery from December 2010 to April 2011. Twenty-two parents were randomized to the intervention group (IG) and received the standard nursing guidelines and 22 participated in the control group (CG) and received the routine guidelines from the institution. Anxiety was assessed by the State-Trait Anxiety Inventory (STAI) applied in the preoperative period, between 12 and 20 hours before surgery and before receiving standard or institutional guidelines and 48 hours after surgery. The analysis of variance (ANOVA) for repeated measures was performed to evaluate the differences between the variations in STAI scores between the groups during the studied period. The level of significance was 0.05. Results: There were no significant differences in baseline anxiety scores between groups with regard to trait anxiety as well as state anxiety: STAI-trait (CG 42.6±4.9 vs. IG 41.4±6.0, P=0.48); STAI-state (CG 42.3±5.7 vs. IG 45.6±8.3, P=0.18). Likewise, the variation in score after 48 hours was similar between groups (STAI-trait P=0.77; STAI-state P=0.61). Conclusion: There were no significant differences in the parents' anxiety levels when comparing the two types of guidelines: the standard nursing and the institutional orientation.

Applicability of two international risk scores in cardiac surgery in a reference center in Brazil.

BACKGROUND: The applicability of international risk scores in heart surgery (HS) is not well defined in centers outside of North America and Europe. OBJECTIVE: To evaluate the capacity of the Parsonnet Bernstein 2000 (BP) and EuroSCORE (ES) in predicting in-hospital mortality (IHM) in patients undergoing HS at a reference hospital in Brazil and to identify risk predictors (RP). METHODS: Retrospective cohort study of 1,065 patients, with 60.3% patients underwent coronary artery bypass grafting (CABG), 32.7%, valve surgery and 7.0%, CABG combined with valve surgery. Additive and logistic scores models, the area under the ROC (Receiver Operating Characteristic) curve (AUC) and the standardized mortality ratio (SMR) were calculated. Multivariate logistic regression was performed to identify the RP. RESULTS: Overall mortality was 7.8%. The baseline characteristics of the patients were significantly different in relation to BP and ES. AUCs of the logistic and additive BP were 0.72 (95% CI, from 0.66 to 0.78 p = 0.74), and of ES they were 0.73 (95% CI; 0.67 to 0.79 p = 0.80). The calculation of the SMR in BP was 1.59 (95% CI; 1.27 to 1.99) and in ES, 1.43 (95% CI; 1.14 to 1.79). Seven RP of IHM were identified: age, serum creatinine > 2.26 mg/dL, active endocarditis, systolic pulmonary arterial pressure > 60 mmHg, one or more previous HS, CABG combined with valve surgery and diabetes mellitus. CONCLUSION: Local scores, based on the real situation of local populations, must be developed for better assessment of risk in cardiac surgery.

Incidence of cancer following bariatric surgery: systematic review and meta-analysis.

Obesity is linked to the development of cancer. Previous studies have suggested that there is a relationship between bariatric surgery and reduced cancer risk. Data sources were from Medline, Embase, and Cochrane Library. From 951 references, 13 studies met the inclusion criteria (54,257 participants). In controlled studies, bariatric surgery was associated with a reduction in the risk of cancer. The cancer incidence density rate was 1.06 cases per 1000 person-years within the surgery groups. In the meta-regression, we found an inverse relationship between the presurgical body mass index and cancer incidence after surgery (beta coefficient -0.2, P < 0.05). Bariatric surgery is associated with reduced cancer risk in morbidly obese people. However, considering the heterogeneity among the studies, conclusions should be drawn with care.

Using a 3D printer in cardiac valve surgery: a systematic review

SUMMARY BACKGROUND: The use of the 3D printer in complex cardiac surgery planning. OBJECTIVES: To analyze the use and benefits of 3D printing in heart valve surgery through a systematic review of the literature. METHODS: This systematic review was reported following the Preferred Reporting Items for Systematic Review and registered in the Prospero (International Prospective Register of Systematic Reviews) database under the number CRD42017059034. We used the following databases: PubMed, EMBASE, Scopus, Web of Science and Lilacs. We included articles about the keywords "Heart Valves", "Heart Valve Prosthesis Implantation", "Heart Valve Prosthesis", "Printing, Three-Dimensional", and related entry terms. Two reviewers independently conducted data extraction and a third reviewer solved disagreements. All tables used for data extraction are available at a separate website. We used the Cochrane Collaboration tool to assess the risk of bias of the studies included. RESULTS: We identified 301 articles and 13 case reports and case series that met the inclusion criteria. Our studies included 34 patients aged from 3 months to 94 years. CONCLUSIONS: Up to the present time, there are no studies including a considerable number of patients. A 3D-printed model produced based on the patient enables the surgeon to plan the surgical procedure and choose the best material, size, format, and thickness to be used. This planning leads to reduced surgery time, exposure, and consequently, lower risk of infection.

RESUMO INTRODUÇÃO: A impressora 3D é utilizada como coadjuvante no planejamento de cirurgias de cardiopatias complexas. OBJETIVOS: Analisar o uso e os benefícios da impressão 3D em cirurgias de válvula cardíaca por meio de revisão sistemática da literatura. MÉTODOS: Esta revisão sistemática foi conduzida de acordo com os itens do Preferred Reporting for Systematic Reviews e registrada no banco de dados Prospero (Registro Prospectivo Internacional de Revisão Sistemática) sob o número CRD42017059034. Foram utilizados os seguintes bancos de dados: PubMed, Embase, Scopus, Web of Science e Lilacs. Incluídos artigos com os termos de busca "Heart Valves", "Heart Valve Prosthesis Implantation", "Heart Valve Prosthesis", "Printing, Three-Dimensional" e termos relacionados. Dois revisores independentes conduziram a extração dos dados e um terceiro (revisor) solucionou as discordâncias. Todas as tabelas usadas para a extração de dados estão disponibilizadas em site próprio. A ferramenta Cochraine Collaboration foi utilizada para avaliar o risco de viés na inclusão de estudos. RESULTADOS: Identificados 301 artigos e 13 relatos de casos e séries de casos que atenderam aos critérios de inclusão. A amostra envolveu 34 pacientes, com idade de 3 meses a 94 anos. CONCLUSÃO: Até o presente momento, não há estudos que contemplem um número considerável de pacientes. A impressão de um modelo 3D produzida a partir do protótipo do paciente permitirá ao cirurgião planejar a cirurgia, bem como escolher o melhor material, tamanho, formato e espessura da válvula a ser utilizada. Esse planejamento reduz o tempo de cirurgia, a exposição e, consequentemente, a redução do risco de infecção.