Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial.

BACKGROUND: Observational studies support a role for oral anticoagulation to reduce the risk of dementia in atrial fibrillation patients, but conclusive data are lacking. Since dabigatran offers a more stable anticoagulation, we hypothesized it would reduce cognitive decline when compared to warfarin in old patients with atrial fibrillation. METHODS: The GIRAF trial was a 24-month, randomized, parallel-group, controlled, open-label, hypothesis generating trial. The trial was done in six centers including a geriatric care unit, secondary and tertiary care cardiology hospitals in São Paulo, Brazil. We included patients aged ≥ 70 years and CHA2DS2-VASc score > 1. The primary endpoint was the absolute difference in cognitive performance at 2 years. Patients were assigned 1:1 to take dabigatran (110 or 150 mg twice daily) or warfarin, controlled by INR and followed for 24 months. Patients were evaluated at baseline and at 2 years with a comprehensive and thorough cognitive evaluation protocol of tests for different cognitive domains including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Exam (MMSE), a composite neuropsychological test battery (NTB), and computer-generated tests (CGNT). RESULTS: Between 2014 and 2019, 5523 participants were screened and 200 were assigned to dabigatran (N = 99) or warfarin (N = 101) treatment. After adjustment for age, log of years of education, and raw baseline score, the difference between the mean change from baseline in the dabigatran group minus warfarin group was - 0.12 for MMSE (95% confidence interval [CI] - 0.88 to 0.63; P = 0.75), 0.05 (95% CI - 0.07 to 0.18; P = 0.40) for NTB, - 0.15 (95% CI - 0.30 to 0.01; P = 0.06) for CGNT, and - 0.96 (95% CI - 1.80 to 0.13; P = 0.02) for MoCA, with higher values suggesting less cognitive decline in the warfarin group. CONCLUSIONS: For elderly patients with atrial fibrillation, and without cognitive compromise at baseline that did not have stroke and were adequately treated with warfarin (TTR of 70%) or dabigatran for 2 years, there was no statistical difference at 5% significance level in any of the cognitive outcomes after adjusting for multiple comparisons. TRIAL REGISTRATION: Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF), NCT01994265 .

Comparison of high-sensitivity cardiac troponin I and T for the prediction of cardiac complications after non-cardiac surgery.

BACKGROUND: We aimed to directly compare preoperative high-sensitivity cardiac troponin (hs-cTn) I and T concentration for the prediction of major cardiac complications after non-cardiac surgery. METHODS: We measured hs-cTnI and hs-cTnT preoperatively in a blinded fashion in 1022 patients undergoing non-cardiac surgery. The primary endpoint was a composite of major cardiac complications including cardiac death, cardiac arrest, myocardial infarction, clinically relevant arrhythmias, and acute heart failure within 30 days. We hypothesized that the type of surgery may impact on the predictive accuracy of hs-cTnI/T and stratified all analyses according to the type of surgery. RESULTS: Major cardiac complications occurred in 108 (11%) patients, 58/243 (24%) patients undergoing vascular surgery and 50/779 (6%, P < .001) patients undergoing non-vascular surgery. Using regulatory-approved 99th percentile cut-off concentrations, preoperative hs-cTnI elevations were less than one-fifth as common as preoperative hs-cTnT elevations (P < .001). Among patients undergoing vascular surgery, preoperative hs-cTnI concentrations, but not hs-cTnT, was an independent predictor of cardiac complications (adjusted odds ratio (aOR) 1.5, 95% confidence interval (95% CI) 1.0-2.1). The area under the receiver-operating characteristics curve (AUC) was 0.67 (95% CI, 0.59-0.75) for hs-cTnI versus 0.59 (95% CI 0.51-0.67, P = .012) for hs-cTnT. In contrast, among patients undergoing non-vascular surgery both preoperative hs-cTnI and hs-cTnT were independent predictors of the primary endpoint (aOR 1.6, 95% CI 1.3-2.0, and aOR 3.0, 95% CI 2.0-4.6, respectively) and showed higher predictive accuracy (AUC 0.77, 95% CI, 0.71-0.83, and 0.79, 95% CI 0.73-0.85, P = ns). CONCLUSIONS: Preoperative hs-cTnI and hs-cTnT concentrations predict major cardiac complications after non-vascular surgery, while, in patients undergoing vascular surgery, hs-cTnI may have better accuracy.

A Prospective Randomized Controlled Trial of the Metabolic Effects of Sleeve Gastrectomy with Transit Bipartition.

PURPOSE: To compare the effects of the sleeve gastrectomy with transit bipartition (SG + TB) procedure with standard medical therapy (SMT) in mildly obese patients with type II diabetes (T2D). METHODS: This is a prospective, randomized, controlled trial. Twenty male adults, ≤ 65 years old, with T2D, body mass index (BMI) > 28 kg/m2 and < 35 kg/m2, and HbA1c level > 8% were randomized to SG + TB or to SMT. Outcomes were the remission in the metabolic and cardiovascular risk variables up to 24 months. RESULTS: At 24 months, SG + TB group showed a significant decrease in HbaA1c values (9.3 ± 2.1 versus 5.5 ± 1.1%, P = < 0.05) whereas SMT group maintained similar levels from baseline (8.0 ± 1.5 versus 8.3 ± 1.1%, P = NS). BMI values were lower in the SG + TB group (25.3 ± 2.8 kg/m2 versus 30.9 ± 2.5 kg/m2; P = < 0.001). At 24 months, none patient in SG + TB group needed medications for hyperlipidemia/hypertension. HDL-cholesterol levels increased in the SG + TB group (33 ± 8 to 45 ± 15 mg/dL, P < 0.001). After 24 months, the area under the curve (AUC) of GLP1 increased and in the SG + TB group and the AUC of the GIP concentrations was lower in the SG + TB group than in the SMT. At 3 months, SG + TB group showed a marked increase in FGF19 levels (74.1 ± 45.8 to 237.3 ± 234 pg/mL; P = 0.001). CONCLUSIONS: SG + TB is superior to SMT and was associated with a better metabolic and cardiovascular profile.

Hypertension, mitral valve disease, atrial fibrillation and low education level predict delirium and worst outcome after cardiac surgery in older adults.

BACKGROUND: Delirium is a common complication after cardiac surgery in older adult patients. However, risk factors and the influence of delirium on patient outcomes are not well established. We aimed to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery. METHODS: One hundred seventy-three consecutive patients aged ≥60 years were studied. Patients' characteristics and two cognitive function assessment tests were recorded preoperatively. Perioperative variables were blood transfusion, orotracheal intubation time (OIT), renal dysfunction, and hypoxemia. Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit. The composite outcome consisted of death, infection, and perioperative myocardial infarction until hospital discharge or 30 days after surgery, and for up to 18 months. RESULTS: One hundred six patients (61.27%) were men and the age was 69.5 ± 5.8 years. EuroSCORE II index was 4.06 ± 3.86. Hypertension was present in 75.14%, diabetes in 39.88%, and 30.06% were illiterate. Delirium occurred in 59 patients (34.1%). Education level (OR 0.81, 0.71-0.92), hypertension (OR 2.73, 1.16-6.40), and mitral valve disease (OR 2.93, 1.32-6.50) were independent predisposing factors for delirium, and atrial fibrillation after surgery (OR 2.49, 1.20-5.20) represented the potential triggering factor. Delirium (OR 2.35, 1.20-4.58) and OIT ≥ 900 min (OR 2.50; 1.30-4.80) were independently associated with the composite outcome. CONCLUSIONS: In older adult patients submitted to cardiac surgery, delirium is a frequent complication that is associated with worst outcome. Independent risk factors for delirium included education level, hypertension, mitral valve disease, and atrial fibrillation after cardiac surgery.

Prediction of major cardiac events after vascular surgery.

OBJECTIVE: Predicting cardiac events is essential to provide patients with the best medical care and to assess the risk-benefit ratio of surgical procedures. The aim of our study was to evaluate the performance of the Revised Cardiac Risk Index (Lee) and the Vascular Study Group of New England Cardiac Risk Index (VSG) scores for the prediction of major cardiac events in unselected patients undergoing arterial surgery and to determine whether the inclusion of additional risk factors improved their accuracy. METHODS: The study prospectively enrolled 954 consecutive patients undergoing arterial vascular surgery, and the Lee and VSG scores were calculated. Receiver operating characteristic curves for each cardiac risk score were constructed and the areas under the curve (AUCs) compared. Two logistic regression models were done to determine new variables related to the occurrence of major cardiac events (myocardial infarction, heart failure, arrhythmias, and cardiac arrest). RESULTS: Cardiac events occurred in 120 (12.6%) patients. Both scores underestimated the rate of cardiac events across all risk strata. The VSG score had AUC of 0.63 (95% confidence interval [CI], 0.58-0.68), which was higher than the AUC of the Lee score (0.58; 95% CI, 0.52-0.63; P = .03). Addition of preoperative anemia significantly improved the accuracy of the Lee score to an AUC of 0.61 (95% CI, 0.58-0.67; P = .002) but not that of the VSG score. CONCLUSIONS: The Lee and VSG scores have low accuracy and underestimate the risk of major perioperative cardiac events in unselected patients undergoing vascular surgery. The Lee score's accuracy can be increased by adding preoperative anemia. Underestimation of major cardiac complications may lead to incorrect risk-benefit assessments regarding the planned operation.

Cohort study of adult patients with haemoglobin SC disease: clinical characteristics and predictors of mortality.

Haemoglobin (Hb) SC disease is the second most common subtype of sickle cell disease and is potentially fatal. This study aimed to determine the clinical characteristics, outcome and predictors of mortality in HbSC disease patients, and to compare these findings with patients followed-up in different centres. Clinical, laboratory and outcome data were collected from a cohort of adult patients with HbSC disease followed between 1991 and 2103. Cox regression multivariate analysis was used to determine predictors of mortality. One hundred and fifty-five patients were followed-up over 20 years: 9% died and 70·8% had at least one complication. The most common complications were: painful crises (38·3%), retinopathy (33·8%), cholelithiasis (30·3%), osteonecrosis (24·8%) and sensorineural hearing disorders (9·7%). Frequency of chronic complications was similar in most studies. In multivariate analysis, hearing disorders remained an independent predictor of mortality (Odds Ratio 9·26, 95% confidence interval 1·1-74·8; P = 0·03). It was concluded that patients with HbSC disease receive a late diagnosis and there is remarkable similarity between the studies conducted in different centres around the world. Sensorineural hearing disorders were an independent predictor of mortality, suggesting that it may be useful to implement routine diagnostic screening.

Impact of cardiology referral: clinical outcomes and factors associated with physicians' adherence to recommendations.

OBJECTIVES: Cardiology referral is common for patients admitted for non-cardiac diseases. Recommendations from cardiologists may involve complex and aggressive treatments that could be ignored or denied by other physicians. The purpose of this study was to compare the outcomes of patients who were given recommendations during cardiology referrals and to examine the clinical outcomes of patients who did not follow the recommendations. METHODS: We enrolled 589 consecutive patients who received in-hospital cardiology consultations. Data on recommendations, implementation of suggestions and outcomes were collected. RESULTS: Regarding adherence of the referring service to the recommendations, 77% of patients were classified in the adherence group and 23% were classified in the non-adherence group. Membership in the non-adherence group (p<0.001; odds ratio: 10.25; 95% CI: 4.45-23.62) and advanced age (p = 0.017; OR: 1.04; 95% CI: 1.01-1.07) were associated with unfavorable outcomes. Multivariate analysis identified four independent predictors of adherence to recommendations: follow-up notes in the medical chart (p<0.001; OR: 2.43; 95% CI: 1.48-4.01); verbal reinforcement (p = 0.001; OR: 1.86; 95% CI: 1.23-2.81); a small number of recommendation (p = 0.001; OR: 0.87; 95% CI: 0.80-0.94); and a younger patient age (p = 0.002; OR: 0.98; 95% CI: 0.96-0.99). CONCLUSIONS: Poor adherence to cardiology referral recommendations was associated with unfavorable clinical outcomes. Follow-up notes in the medical chart, verbal reinforcement, a limited number of recommendations and a patient age were associated with greater adherence to recommendations.

Impact of cardiology referral: clinical outcomes and factors associated with physicians' adherence to recommendations

OBJECTIVES: Cardiology referral is common for patients admitted for non-cardiac diseases. Recommendations from cardiologists may involve complex and aggressive treatments that could be ignored or denied by other physicians. The purpose of this study was to compare the outcomes of patients who were given recommendations during cardiology referrals and to examine the clinical outcomes of patients who did not follow the recommendations. METHODS: We enrolled 589 consecutive patients who received in-hospital cardiology consultations. Data on recommendations, implementation of suggestions and outcomes were collected. RESULTS: Regarding adherence of the referring service to the recommendations, 77% of patients were classified in the adherence group and 23% were classified in the non-adherence group. Membership in the non-adherence group (p<0.001; odds ratio: 10.25; 95% CI: 4.45-23.62) and advanced age (p = 0.017; OR: 1.04; 95% CI: 1.01-1.07) were associated with unfavorable outcomes. Multivariate analysis identified four independent predictors of adherence to recommendations: follow-up notes in the medical chart (p<0.001; OR: 2.43; 95% CI: 1.48-4.01); verbal reinforcement (p = 0.001; OR: 1.86; 95% CI: 1.23-2.81); a small number of recommendation (p = 0.001; OR: 0.87; 95% CI: 0.80-0.94); and a younger patient age (p = 0.002; OR: 0.98; 95% CI: 0.96-0.99). CONCLUSIONS: Poor adherence to cardiology referral recommendations was associated with unfavorable clinical outcomes. Follow-up notes in the medical chart, verbal reinforcement, a limited number of recommendations and a patient age were associated with greater adherence to recommendations. .

Diabetes and cardiovascular disease: from evidence to clinical practice - position statement 2014 of Brazilian Diabetes Society.

There is a very well known correlation between diabetes and cardiovascular disease but many health care professionals are just concerned with glycemic control, ignoring the paramount importance of controlling other risk factors involved in the pathogenesis of serious cardiovascular diseases. This Position Statement from the Brazilian Diabetes Society was developed to promote increased awareness in relation to six crucial topics dealing with diabetes and cardiovascular disease: Glicemic Control, Cardiovascular Risk Stratification and Screening Coronary Artery Disease, Treatment of Dyslipidemia, Hypertension, Antiplatelet Therapy and Myocardial Revascularization. The issue of what would be the best algorithm for the use of statins in diabetic patients received a special attention and a new Brazilian algorithm was developed by our editorial committee. This document contains 38 recommendations which were classified by their levels of evidence (A, B, C and D). The Editorial Committee included 22 specialists with recognized expertise in diabetes and cardiology.

Perioperative cardiovascular evaluation: heads or tails?

When dealing with surgical patients, a perioperative evaluation is essential to anticipate complications and institute measures to reduce the risks. Several algorithms and exams have been used to identify postoperative cardiovascular events, which account for more than 50% of perioperative mortality. However, they are far from ideal. Some of these algorithms and exams were proposed before important advances in cardiology, at a time when pharmacological risk reduction strategies for surgical patients were not available. New biomarkers and exams, such as C-reactive protein, brain natriuretic peptide, and multislice computed tomography have been used in cardiology and have provided important prognostic information. The ankle-brachial index is another significant marker of atherosclerosis. However, specific information regarding the perioperative context of all these methods is still needed. The objective of this article is to evaluate cardiovascular risk prediction models after noncardiac surgery.

Perioperative cardiovascular evaluation: heads or tails?

When dealing with surgical patients, a perioperative evaluation is essential to anticipate complications and institute measures to reduce the risks. Several algorithms and exams have been used to identify postoperative cardiovascular events, which account for more than 50% of perioperative mortality. However, they are far from ideal. Some of these algorithms and exams were proposed before important advances in cardiology, at a time when pharmacological risk reduction strategies for surgical patients were not available. New biomarkers and exams, such as C-reactive protein, brain natriuretic peptide, and multislice computed tomography have been used in cardiology and have provided important prognostic information. The ankle-brachial index is another significant marker of atherosclerosis. However, specific information regarding the perioperative context of all these methods is still needed. The objective of this article is to evaluate cardiovascular risk prediction models after noncardiac surgery.

Acute pericarditis with transient constriction: surgical impetus must be contained.

Constrictive pericarditis is typically a chronic and progressive condition characterised by debilitating chronic right heart failure and surgical pericardiectomy remains the treatment of choice. Although most cases of acute pericarditis are self-limiting, an uncommon but known complication is a transient form of constrictive pericarditis that shares the same clinical features with the chronic form but resolves without surgical intervention.We report a case of a 29-year-old man with acute idiopathic pericarditis complicated with overt signs of constriction with complete recovery after medical treatment. The knowledge of this transient pattern of cardiac constriction complicating acute pericarditis may avoid unnecessary morbidity and mortality related to surgical procedure in a pericardium with acute inflammatory reaction.

Cardiovascular prevention in HIV patients: results from a successful intervention program.

OBJECTIVES: To analyze the effect of a prevention program on the estimated cardiovascular risk calculated by three risk scores. METHODS: We prospectively evaluated 87 HIV+patients with elevated cardiovascular risk estimation. Framingham (FRS), PROCAM and National Cholesterol Education Program (ATP-III) were applied. Cardiovascular risk was defined as elevated if >10%. All patients received non-pharmacological (diet, exercise, smoking cessation) and, when appropriate, pharmacological therapy. RESULTS: Mean age was 52 years, 92% were male, 39.1% were smokers, 70.1% had hypertension, 18.4% had diabetes. All patients were under HAART, 56.3% were receiving protease inhibitors (PI). After 6 months, intervention was associated to significant changes on triglycerides (298+/-242 and 206+/-135 mg/dL, p<0.05), total-cholesterol (224+/-47 and 189+/-38 mg/dL, p<0.001), LDL-cholesterol (129+/-44 and 109+/-30 mg/dL, p<0.001). Frequencies of patients with elevated cardiac risk before and 6 months after intervention were 92% x 27.6% (p<0.0001), 80.5% x 50.6% (p<0.0002), and 25.3% x 14.9% (p=0.12), for FRS, ATP III and PROCAM, respectively. CONCLUSIONS: An intervention program focused on reduction of traditional risk factors was able to decrease the frequency of patients with HIV infection and elevated cardiovascular risk estimation. FRS showed greater sensitivity than the other scores.

Complicações cardiopulmonares das doenças falciformes / Cardiopulmonary complications of sickle cell disease

O pulmão é um dos principais alvos de complicações agudas e crônicas nas doenças falciformes (DF). A síndrome torácica aguda é a segunda causa de internação hospitalar apresentando considerável morbimortalidade. O suporte clínico de alta qualidade é a base do tratamento bem sucedido. A administração adequada de fluidos, a analgesia, a oxigenioterapia, a fisioterapia respiratória ativa e o uso criterioso de transfusões sanguíneas são elementos essenciais do tratamento. A hipertensão pulmonar (HP), por sua vez, tem sido recentemente reconhecida como uma das complicações mais graves e freqüentes destes pacientes. A pressão de artéria pulmonar deve ser medida periodicamente por meio de ecocardiografia. Se o diagnóstico de HP for confirmado, o uso de hidroxiuréia, anticoagulação, transfusões e oxigênio deveriam ser considerados. As manifestações cardíacas nas DF incluem cardiomegalia, isquemia miocárdica, disfunção ventricular e cor pulmonale. O tratamento destas complicações deve seguir as recomendações das diretrizes atuais.

The lung is a major target organ for acute and chronic complications in sickle cell disease. Acute chest syndrome is the second most common cause of hospital admission resulting in considerable morbidity and mortality. The mainstay of successful treatment remains high quality supportive care. Fluid management, analgesia, oxygenation, bronchodilators, incentive spirometry and judicious use of transfusion therapy are essential elements of supportive care management. Pulmonary hypertension (PHT) has emerged as one of the most frequent and serious complications in these patients. The pulmonary artery pressure should be evaluated periodically by echocardiography. If the PHT diagnosis is positive the use of hydroxiurea, anticoagulation, transfusions and oxygen therapy should be considered. Cardiac manifestations are common including enlargement of the heart, myocardial ischaemia, ventricular dysfunction and cor pulmonale. The management of these complications follows the current guidelines.

Multicenter study of perioperative evaluation for noncardiac surgeries in Brazil (EMAPO).

INTRODUCTION: The accuracy of perioperative evaluation methods available is better than chance, but their performance is not ideal. OBJECTIVES: To compare a new evaluation method (EMAPO) to the American College of Physicians method for determining the risk of cardiovascular complications in noncardiac surgeries and to look for new influencing variables. METHODS: Evaluations through EMAPO and the American College of Physicians method were employed for 700 patients. Cardiac events and deaths were recorded, the risk variables related to the occurrence of complications were verified, and the models were compared by analyzing the areas under the receiver operating characteristic curves. RESULTS: Mortality rate was 3.4%, and the incidence of cardiovascular complications was 5.3%. Renal failure (P = 0.01), major surgery (P = 0.004), and emergency surgery (P = 0.003) were independently related to the occurrence of cardiovascular complications. The two methods produced similar results. CONCLUSION: EMAPO is as good as the American College of Physicians method in determining the risk of cardiovascular complications in noncardiac surgeries. New variables related to surgical risk were identified.

Multicenter study of perioperative evaluation for noncardiac surgeries in Brazil (EMAPO)

INTRODUCTION: The accuracy of perioperative evaluation methods available is better than chance, but their performance is not ideal. OBJECTIVES: To compare a new evaluation method (EMAPO) to the American College of Physicians method for determining the risk of cardiovascular complications in noncardiac surgeries and to look for new influencing variables. METHODS: Evaluations through EMAPO and the American College of Physicians method were employed for 700 patients. Cardiac events and deaths were recorded, the risk variables related to the occurrence of complications were verified, and the models were compared by analyzing the areas under the receiver operating characteristic curves. RESULTS: Mortality rate was 3.4 percent, and the incidence of cardiovascular complications was 5.3 percent. Renal failure (P = 0.01), major surgery (P = 0.004), and emergency surgery (P = 0.003) were independently related to the occurrence of cardiovascular complications. The two methods produced similar results. CONCLUSION: EMAPO is as good as the American College of Physicians method in determining the risk of cardiovascular complications in noncardiac surgeries. New variables related to surgical risk were identified.

INTRODUÇÃO: A precisão dos métodos de avaliação perioperatória disponíveis é melhor que o acaso, porém está longe do ideal. OBJETIVOS: Comparar um novo método de avaliação perioperatória (EMAPO) ao método do American College of Physicians para determinar o risco cardíaco em cirurgias não cardíacas e buscar novas variáveis envolvidas na determinação deste risco. MÉTODOS: O EMAPO e o método do American College of Physicians foram aplicados em 700 pacientes. A ocorrência de eventos cardíacos e de mortes foi documentada, a relação entre as variáveis de risco e as complicações foi estabelecida e os métodos foram comparados analisando as áreas sob a curva ROC. RESULTADOS: A mortalidade foi 3.4 por cento e a incidência de complicações cardiovasculares 5.3 por cento. A presença de insuficiência renal (p=0.01), cirurgia de grande porte (p=0.004) e cirurgia de emergência (p=0.003) se correlacionaram com a ocorrência de complicações cardiovasculares na análise multivariada. Não houve diferença entre os dois métodos. CONCLUSÕES: O EMAPO é tão eficaz quanto o método do American College of Physicians para determinar o risco de complicações cardiovasculares em cirurgias não cardíacas. Novas variáveis relacionadas com o risco perioperatório foram encontradas.