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 .

Acute heart failure after non-cardiac surgery: incidence, phenotypes, determinants and outcomes.

AIMS: Primary acute heart failure (AHF) is a common cause of hospitalization. AHF may also develop postoperatively (pAHF). The aim of this study was to assess the incidence, phenotypes, determinants and outcomes of pAHF following non-cardiac surgery. METHODS AND RESULTS: A total of 9164 consecutive high-risk patients undergoing 11 262 non-cardiac inpatient surgeries were prospectively included. The incidence, phenotypes, determinants and outcome of pAHF, centrally adjudicated by independent cardiologists, were determined. The incidence of pAHF was 2.5% (95% confidence interval [CI] 2.2-2.8%); 51% of pAHF occurred in patients without known heart failure (de novo pAHF), and 49% in patients with chronic heart failure. Among patients with chronic heart failure, 10% developed pAHF, and among patients without a history of heart failure, 1.5% developed pAHF. Chronic heart failure, diabetes, urgent/emergent surgery, atrial fibrillation, cardiac troponin elevations above the 99th percentile, chronic obstructive pulmonary disease, anaemia, peripheral artery disease, coronary artery disease, and age, were independent predictors of pAHF in the logistic regression model. Patients with pAHF had significantly higher all-cause mortality (44% vs. 11%, p < 0.001) and AHF readmission (15% vs. 2%, p < 0.001) within 1 year than patients without pAHF. After Cox regression analysis, pAHF was an independent predictor of all-cause mortality (adjusted hazard ratio [aHR] 1.7 [95% CI 1.3-2.2]; p < 0.001) and AHF readmission (aHR 2.3 [95% CI 1.5-3.7]; p < 0.001). Findings were confirmed in an external validation cohort using a prospective multicentre cohort of 1250 patients (incidence of pAHF 2.4% [95% CI 1.6-3.3%]). CONCLUSIONS: Postoperative AHF frequently developed following non-cardiac surgery, being de novo in half of cases, and associated with a very high mortality.

Hemodynamic depression after carotid surgery: Incidence, risk factors and outcomes.

INTRODUCTION: Hemodynamic Depression (HD) characterized by hypotension and bradycardia is a complication of carotid surgery due to direct autonomic stimulation in the carotid sinus. The authors believe the incidence of HD is high and possibly related to major cardiac complications. METHODS: Analysis of patient records during admissions for carotid surgery between January 2014 and December 2018 in two hospitals. HD was defined as bradycardia or hypotension in the first 24 postoperative hours. Bradycardia was defined as heart rate < 50bpm; hypotension as systolic blood pressure < 90 mmHg, continuous use of vasopressors, or a drop in SBP > 20% compared to preoperative values. Myocardial infarction, stroke, and cardiovascular death were defined as adverse events. RESULTS: Overall, 237 carotid surgeries (178 endarterectomies, 59 angioplasties) were studied, and the global incidence of HD was 54.4% (hypotension in 50.2%, bradycardia in 11.0%, and hypotension and bradycardia in 6.8%). The independent predictors of HD were asymptomatic carotid stenosis (OR = 1.824; 95% CI 1.014-3.280; p = 0.045), endovascular surgery (OR = 3.319; 95% CI 1.675-6.576; p = 0.001) and intraoperative hypotension or bradycardia (OR = 2.144; 95% CI 1.222-3.762; p = 0.008). Hypotension requiring continuous vasopressor infusion was the only factor independently associated with adverse cardiovascular events (OR = 5.504; 95% CI 1.729-17.529; p = 0.004). DISCUSSION/CONCLUSION: Incidence of Hemodynamic Depression after carotid surgery is high and independently associated with surgical technique, symptomatic repercussion of the carotid stenosis, and intraoperative hypotension or bradycardia. Hypotension requiring the continuous infusion of vasopressors was independently associated with the occurrence of MACE.

Cardiovascular imaging following perioperative myocardial infarction/injury.

Patients developing perioperative myocardial infarction/injury (PMI) have a high mortality. PMI work-up and therapy remain poorly defined. This prospective multicenter study included high-risk patients undergoing major non-cardiac surgery within a systematic PMI screening and clinical response program. The frequency of cardiovascular imaging during PMI work-up and its yield for possible type 1 myocardial infarction (T1MI) was assessed. Automated PMI detection triggered evaluation by the treating physician/cardiologist, who determined selection/timing of cardiovascular imaging. T1M1 was considered with the presence of a new wall motion abnormality within 30 days in transthoracic echocardiography (TTE), a new scar or ischemia within 90 days in myocardial perfusion imaging (MPI), and Ambrose-Type II or complex lesions within 7 days of PMI in coronary angiography (CA). In patients with PMI, 21% (268/1269) underwent at least one cardiac imaging modality. TTE was used in 13% (163/1269), MPI in 3% (37/1269), and CA in 5% (68/1269). Cardiology consultation was associated with higher use of cardiovascular imaging (27% versus 13%). Signs indicative of T1MI were found in 8% of TTE, 46% of MPI, and 63% of CA. Most patients with PMI did not undergo any cardiovascular imaging within their PMI work-up. If performed, MPI and CA showed high yield for signs indicative of T1MI.Trial registration: https://clinicaltrials.gov/ct2/show/NCT02573532 .

Hemodynamic depression after carotid surgery: Incidence, risk factors and outcomes

Abstract Introduction: Hemodynamic Depression (HD) characterized by hypotension and bradycardia is a complication of carotid surgery due to direct autonomic stimulation in the carotid sinus. The authors believe the incidence of HD is high and possibly related to major cardiac complications. Methods: Analysis of patient records during admissions for carotid surgery between January 2014 and December 2018 in two hospitals. HD was defined as bradycardia or hypotension in the first 24 postoperative hours. Bradycardia was defined as heart rate < 50bpm; hypotension as systolic blood pressure < 90 mmHg, continuous use of vasopressors, or a drop in SBP > 20% compared to preoperative values. Myocardial infarction, stroke, and cardiovascular death were defined as adverse events. Results: Overall, 237 carotid surgeries (178 endarterectomies, 59 angioplasties) were studied, and the global incidence of HD was 54.4% (hypotension in 50.2%, bradycardia in 11.0%, and hypotension and bradycardia in 6.8%). The independent predictors of HD were asymptomatic carotid stenosis (OR = 1.824; 95% CI 1.014 −3.280; p = 0.045), endovascular surgery (OR = 3.319; 95% CI 1.675−6.576; p = 0.001) and intraoperative hypotension or bradycardia (OR = 2.144; 95% CI 1.222−3.762; p = 0.008). Hypotension requiring continuous vasopressor infusion was the only factor independently associated with adverse cardiovascular events (OR = 5.504; 95% CI 1.729-17.529; p = 0.004). Discussion/conclusion: Incidence of Hemodynamic Depression after carotid surgery is high and independently associated with surgical technique, symptomatic repercussion of the carotid stenosis, and intraoperative hypotension or bradycardia. Hypotension requiring the continuous infusion of vasopressors was independently associated with the occurrence of MACE.