Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial : Venous thromboembolism prophylAxis after gynecoLogical pElvic cancer surgery with RIvaroxaban versus enoxAparin (VALERIA trial).

Direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) prevention after major gynecological cancer surgery might be an alternative to parenteral low-molecular-weight heparin (LMWH). Patients undergoing major gynecological cancer surgery were randomized at hospital discharge to receive rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily for 30 days. The primary efficacy outcome was a combination of symptomatic VTE and VTE-related death or asymptomatic VTE at day 30. The primary safety outcome was the incidence of major or clinically relevant nonmajor bleeding. Two hundred and twenty-eight patients were enrolled and randomly assigned to receive rivaroxaban (n = 114)or enoxaparin (n = 114). The trial was stopped due to a lower-than-expected event rate. The primary efficacy outcome occurred in 3.51% of patients assigned to rivaroxaban and in 4.39% of patients assigned to enoxaparin (relative risk 0.80, 95% CI 0.22 to 2.90; p = 0.7344). Patients assigned to rivaroxaban had no primary bleeding event, and 3 patients (2.63%) in the enoxaparin group had a major or CRNM bleeding event (hazard ratio, 0.14; 95% CI, 0.007 to 2.73; P = 0.1963). In patients undergoing major gynecological cancer surgery, thromboprophylaxis with rivaroxaban 10 mg daily for 30 days had similar rates of thrombotic and bleeding events compared to parenteral enoxaparin 40 mg daily. While the power is limited due to not reaching the intended sample size, our results support the hypothesis that DOACs might be an attractive alternative strategy to LMWH to prevent VTE in this high-risk population.

Effect of psychotherapy on recurrence of events and quality of life in patients with vasovagal syncope.

Emotional distress is related to recurrence of syncope compromising patient's quality of life (QoL). The aim of this study was to determine if weekly sessions of psychotherapy reduce recurrence of events and improve QoL by SF-36 among patients with refractory vasovagal syncope. A randomised controlled pilot trial including 10 patients with recurrent vasovagal syncope and positive tilt table test was conducted. Known cardiac disease and ongoing psychotherapeutic interventions were the main exclusion criteria. All patients received standard of care treatment. Additionally, after randomisation, half of the patients underwent weekly sessions of psychotherapy for 12 months. Analysis of recurrence of events and QoL showed no significant change in the control group but, in the intervention group, there was a significant reduction in the rate of near-syncope episodes per month (5.7 ± 1.4 × 1.7 ± 1.0; P < 0.01), syncope in 1 year (4.6 ± 0.9 × 1.0 ± 0.7; P < 0.01) and a significant improvement in the overall assessment of QoL (44.1 ± 10.0 vs. 70.3 ± 10.3, P < 0.01). In conclusion, patients with refractory vasovagal syncope undergoing regular psychotherapeutic intervention had less recurrence of events and improved their quality of life in 1 year.Trial Registration: ClinicalTrials.gov number, NCT04252729.

Mortality risk prediction in high-risk patients undergoing coronary artery bypass grafting: Are traditional risk scores accurate?

BACKGROUND: The performance of traditional scores is significantly limited to predict mortality in high-risk cardiac surgery. The aim of this study was to compare the performance of STS, ESII and HiriSCORE models in predicting mortality in high-risk patients undergoing CABG. METHODS: Cross-sectional analysis in the international prospective database of high-risk patients: HiriSCORE project. We evaluated 248 patients with STS or ESII (5-10%) undergoing CABG in 8 hospitals in Brazil and China. The main outcome was mortality, defined as all deaths occurred during the hospitalization in which the operation was performed, even after 30 days. Five variables were selected as predictors of mortality in this cohort of patients. The model's performance was evaluated through the calibration-in-the-large and the receiver operating curve (ROC) tests. RESULTS: The mean age was 69.90±9.45, with 52.02% being female, 25% of the patients were on New York Heart Association (NYHA) class IV and 49.6% had Canadian Cardiovascular Society (CCS) class 4 angina, and 85.5% had urgency or emergency status. The mortality observed in the sample was 13.31%. The HiriSCORE model showed better calibration (15.0%) compared to ESII (6.6%) and the STS model (2.0%). In the ROC curve, the HiriSCORE model showed better accuracy (ROC = 0.74) than the traditional models STS (ROC = 0.67) and ESII (ROC = 0.50). CONCLUSION: Traditional models were inadequate to predict mortality of high-risk patients undergoing CABG. However, the HiriSCORE model was simple and accurate to predict mortality in high-risk patients.

Safe and effective protocol for discharge 3 days after cardiac surgery.

The Enhanced Recovery After Surgery (ERAS) protocol affected traditional cardiac surgery processes and COVID-19 is expected to accelerate its scalability. The aim of this study was to assess the impact of an ERAS-based protocol on the length of hospital stay after cardiac surgery. From January 2019 to June 2020, 664 patients underwent consecutive cardiac surgery at a Latin American center. Here, 46 patients were prepared for a rapid recovery through a multidisciplinary institutional protocol based on the ERAS concept, the "TotalCor protocol". After the propensity score matching, 46 patients from the entire population were adjusted for 12 variables. Patients operated on the TotalCor protocol had reduced intensive care unit time (P < 0.025), postoperative stay (P ≤ 0.001) and length of hospital stay (P ≤ 0.001). In addition, there were no significant differences in the occurrence of complications and death between the two groups. Of the 10-central metrics of TotalCor protocol, 6 had > 70% adherences. In conclusion, the TotalCor protocol was safe and effective for a 3-day discharge after cardiac surgery. Postoperative atrial fibrillation and renal failure were predictors of postoperative stay > 5 days.

Atypical chest pain due to multiple coronary arteries fistulas occluded with percutaneous interlock coils: A case report.

Coronary artery fistulas, although rare, should be included in the differential diagnosis of atypical chest pain, generally unveiled by cardiac catheterization or multidetector computed tomography. Such anatomical findings in conjunction with detectable ischemia and severe symptoms should prompt their closure. Transcatheter closure of fistulas is an attractive alternative to surgery, especially with the novel devices such as the interlock fibered detachable coils, which can be safely and effectively performed in a variety of circumstances, including the coronary arteries with tortuous anatomies. We present a case of atypical chest pain and large burden of ischemia in the stress scintigraphy, due to multiple coronary fistulas to the bronchial arteries successfully occluded with percutaneous interlock coils. .

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: clinicaltrials.gov Identifier: NCT01448642.

Application of BAROS' questionnaire in obese patients undergoing bariatric surgery with 2 years of evolution / Aplicação do questionário BAROS em pacientes obesos submetidos à cirurgia bariátrica com 2 anos de evolução

ABSTRACT BACKGROUND -In recent decades, the high prevalence of obesity in the general population has brought serious concerns in terms of public health. Contrarily to conventional treatment involving dieting and physical exercising, often ineffective in generating long term results, bariatric opera­tions have been an effective method for sustained weight loss in morbidly obese individuals. The Bariatric Analysis and Reporting Outcome System (BAROS) is an objective and recognized system in the overall evaluation of results after bariatric surgery. OBJECTIVE To investigate results concerning a casuistic of morbidly obese patients undergoing bariatric surgery over a 2-year follow-up in terms of weight loss, related medical conditions, safety and changes in quality of life. METHODS A total of 120 obese (17 male and 103 female) patients, who underwent bariatric surgery, were assessed and investigated using the BAROS system after a 2- year follow-up. RESULTS Patients obtained a mean excess weight loss of 74.6 (±15.9) % and mean body mass index reduction of 15.6 (±4.4) Kg/m2. Pre-surgical comorbidities were present in 71 (59%) subjects and they were totally (86%) or partially (14%) resolved. Complications resulting specifically from the surgical procedure were observed in 4.2% of cases (two bowel obstructions requiring re-operation, and three stomal stenosis treated with endoscopic dilation). Sixteen subjects (13% of total number of patients) presented minor clinical complications managed through outpatient care. The final scores for the BAROS questionnaire showcased excellent to good results in 99% of cases (excellent 44%, very good 38%, good 23%, acceptable 1%). CONCLUSION According to the BAROS questionnaire, bariatric surgery is a safe and effective method for managing obesity and associated clinical comorbidities, allowing for satisfactory results after a 2-year follow-up. Future studies should address other clinical and psychosocial variables that impact outcome as well as allow for longer follow-ups.

RESUMO CONTEXTO Nas últimas décadas, a alta prevalência de obesidade na população geral trouxe grandes preocupações para a saúde pública. Contrariamente ao tratamento convencional envolvendo dieta e atividade física, quase sempre inefetivo em gerar resultados a longo prazo, a cirurgia bariátrica vem se mostrando um método efetivo de perda de peso mantida em indivíduos com obesidade mórbida. O Bariatric Analysis and Reporting Outcome System (BAROS) é um sistema reconhecido e objetivo para a avaliação global de resultados depois de cirurgia bariátrica. OBJETIVO Investigar os resultados referentes à casuística de pacientes obesos mórbidos submetidos à cirurgia bariátrica em um período de 2 anos em termos de perda de peso, condições clínicas relacionadas, segurança e qualidade de vida. MÉTODOS Um total de 120 pacientes obesos (17 masculinos e 103 femininos) admitidos consecutivamente durante período de 4 meses para cirurgia bariátrica foram avaliados e investigados usando o sistema BAROS após 2 anos de evolução. RESULTADOS Os pacientes apresentaram redução média percentual de excesso de peso de 74,6 (±15,9) % e redução média de índice de massa corporal de 15,6 (±4,4) Kg/m2. Comorbidades pré-cirúrgicas estavam presentes em 71 (59%) pacientes e em todos eles foram total (86%) ou parcialmente (14%) resolvidas. Complicações resultantes especificamente do procedimento cirúrgico foram observadas em 4,2% dos casos (duas obstruções intestinais exigindo reoperação e três estenoses anastomóticas resolvidas com dilatação endoscópica). Dezesseis (13%) pacientes apresentaram complicações clínicas menores resolvidas com manejo clínico ambulatorial. Os escores totais do BAROS classificaram os resultados como excelente até bom em 99% dos casos (44% excelente, 38% muito bom e 23% bom) e aceitável em 1% dos casos. CONCLUSÃO De acordo com o questionário BAROS, a cirurgia bariátrica se mostrou segura e efetiva no controle da obesidade e de comorbidades clínicas associadas, permitindo satisfação geral dos pacientes após 2 anos de seguimento. Estudos futuros deverão também investigar outras variáveis clínicas e psicossociais de possível impacto na evolução e por períodos de seguimento mais longos.

Application of BAROS' questionnaire in obese patients undergoing bariatric surgery with 2 years of evolution.

BACKGROUND:: -In recent decades, the high prevalence of obesity in the general population has brought serious concerns in terms of public health. Contrarily to conventional treatment involving dieting and physical exercising, often ineffective in generating long term results, bariatric opera-tions have been an effective method for sustained weight loss in morbidly obese individuals. The Bariatric Analysis and Reporting Outcome System (BAROS) is an objective and recognized system in the overall evaluation of results after bariatric surgery. OBJECTIVE: - To investigate results concerning a casuistic of morbidly obese patients undergoing bariatric surgery over a 2-year follow-up in terms of weight loss, related medical conditions, safety and changes in quality of life. METHODS: - A total of 120 obese (17 male and 103 female) patients, who underwent bariatric surgery, were assessed and investigated using the BAROS system after a 2- year follow-up. RESULTS: - Patients obtained a mean excess weight loss of 74.6 (±15.9) % and mean body mass index reduction of 15.6 (±4.4) Kg/m2. Pre-surgical comorbidities were present in 71 (59%) subjects and they were totally (86%) or partially (14%) resolved. Complications resulting specifically from the surgical procedure were observed in 4.2% of cases (two bowel obstructions requiring re-operation, and three stomal stenosis treated with endoscopic dilation). Sixteen subjects (13% of total number of patients) presented minor clinical complications managed through outpatient care. The final scores for the BAROS questionnaire showcased excellent to good results in 99% of cases (excellent 44%, very good 38%, good 23%, acceptable 1%). CONCLUSION: - According to the BAROS questionnaire, bariatric surgery is a safe and effective method for managing obesity and associated clinical comorbidities, allowing for satisfactory results after a 2-year follow-up. Future studies should address other clinical and psychosocial variables that impact outcome as well as allow for longer follow-ups.

Mortality reduction with use of oral beta-blockers in patients with acute coronary syndrome

OBJECTIVES: Recent studies have revealed a relationship between beta-blocker use and worse prognosis in acute coronary syndrome, mainly due to a higher incidence of cardiogenic shock. However, the relevance of this relationship in the reperfusion era is unknown. The aim of this study was to analyze the outcomes of patients with acute coronary syndrome that started oral beta-blockers within the first 24 hours of hospital admission (group I) compared to patients who did not use oral beta-blockers in this timeframe (group II). METHODS: This was an observational, retrospective and multicentric study with 2,553 patients (2,212 in group I and 341 in group II). Data regarding demographic characteristics, coronary treatment and medication use in the hospital were obtained. The primary endpoint was in-hospital all-cause mortality. The groups were compared by ANOVA and the chi-square test. Multivariate analysis was conducted by logistic regression and results were considered significant when p<0.05. RESULTS: Significant differences were observed between the groups in the use of angiotensin-converting enzyme inhibitors, enoxaparin, and statins; creatinine levels; ejection fraction; tabagism; age; and previous coronary artery bypass graft. Significant differences were also observed between the groups in mortality (2.67% vs 9.09%, OR=0.35, p=0.02) and major adverse cardiovascular events (11% vs 29.5%, OR=4.55, p=0.02). CONCLUSIONS: Patients with acute coronary syndrome who underwent early intervention with oral beta-blockers during the first 24 hours of hospital admission had a lower in-hospital death rate and experienced fewer major adverse cardiovascular events with no increase in cardiogenic shock or sustained ventricular arrhythmias compared to patients who did not receive oral beta-blockers within this timeframe.

Impact of Chest Pain Protocol with Access to Telemedicine on Implementation of Pharmacoinvasive Strategy in a Private Hospital Network.

BACKGROUND: Brazilian registries have shown a gap between evidence-based therapies and real treatments. We aim to compare the use of the pharmacoinvasive strategy and mortality in patients with ST elevation myocardial infarction (STEMI) transferred pre- and post-chest pain protocol with access to telemedicine (CPPT) in a private hospital network. MATERIALS AND METHODS: A CPPT was implemented in 22 private emergency departments in 2012. Emergency physicians and nurses of all facilities were trained to disseminate the information to comply with a chest pain protocol focusing on reperfusion therapy (pharmacoinvasive strategy) for STEMI. To conduct clinical discussions using telemedicine, a cardiologist from a reference hospital in cardiology (RHC) was available 24 h/day, 7 days/week. Using the database of all consecutive admissions, we compared the data of patients with STEMI transferred to the RHC in 2011 (pre-CPPT) and 2013-2014 (post-CPPT). RESULTS: We included 376 patients (113 pre-CPPT and 263 post-CPPT) with STEMI. All patients admitted in the RHC were transferred from the 22 emergency departments. Comparing pre-CPPT and post-CPPT, we did not find differences regarding age, gender, hypertension, dyslipidemia, diabetes, smoking, previous myocardial infarction, or Killip classification. However, the use of CPPT was associated with a greater use of pharmacoinvasive strategy (55.8% versus 38%; p = 0.002) and a trend toward lower in-hospital mortality (3% versus 8%; p = 0.06). CONCLUSIONS: The implementation of a CPPT was associated with a significant increase in the use of pharmacoinvasive strategy in patients with STEMI and a trend toward reduced in-hospital mortality in a private hospital network.