Cooling as an Adjunctive Therapy to Percutaneous Intervention in Acute Myocardial Infarction: COOL-MI InCor Trial.

Endovascular Therapeutic hypothermia (ETH) reduces the damage caused by postischemia reperfusion injury syndrome in cardiopulmonary arrest and has already established its role in patients with sudden death; however, its role in ST-segment elevation myocardial infarction (STEMI) remains controversial. The objectives of this study were to investigate the safety, feasibility, and 30-day efficacy of rapid induction of therapeutic hypothermia as adjunctive therapy to percutaneous coronary intervention (PCI) in patients with anterior and inferior STEMIs. This was a prospective, controlled, randomized, two-arm, prospective, interventional study of patients admitted to the emergency department within 6 hours of angina onset, with anterior or inferior STEMI eligible for PCI. Subjects were randomized to the hypothermia group (primary PCI+ETH) or to the control group (primary PCI) at a 4:1 ratio. The ETH was induced by 1 L cold saline (1-4°C) associated with the Proteus™ System, by cooling for at least 18 minutes before coronary reperfusion with a target temperature of 32°C ± 1°C. Maintenance of ETH was conducted for 1-3 hours, and active reheating was done at a rate of 1°C/h for 4 hours. Primary safety outcomes were the feasibility of ETH in the absence of (1) door-to-balloon (DTB) delay; (2) major adverse cardiac events (MACE) within 30 days after randomization. The primary outcomes of effectiveness were infarct size (IS) and left ventricular ejection fraction (LVEF) at 30 days. An as-treated statistical analysis was performed. Fifty patients were included: 35 (70%) randomized to the hypothermia group and 15 (30%) to the control group. The mean age was 58 ± 12 years; 78% were men; and associated diseases were 60% hypertension, 42% diabetes, and 72% dyslipidemia. The compromised myocardial wall was anterior in 38% and inferior in 62%, and the culprit vessels were left anterior descending artery (LAD) (40%), right coronary artery (38%), and left circumflex (18%). All 35 patients who attempted ETH (100%) had successful cooling, with a mean endovascular coronary reperfusion temperature of 33.1°C ± 0.9°C. The mean ischemic time was 375 ± 89.4 minutes in the hypothermia group and 359.5 ± 99.4 minutes in the control group. The mean DTB was 92.1 ± 20.5 minutes in the hypothermia group and 87 ± 24.4 minutes in the control group. The absolute difference of 5.1 minutes was not statistically significant (p = 0.509). The MACE rates were similar between both groups (21.7% vs. 20% respectively, p = 0.237). In the comparison between the hypothermia and control groups, no statistically significant differences were observed at 30 days between mean IS (13.9% ± 8% vs. 13.8% ± 10.8%, respectively, p = 0.801) and mean final LVEF (43.3% ± 11.2% vs. 48.3 ± 10.9%, respectively; p = 0.194). Hypothermia as an adjunctive therapy to primary PCI in STEMI is feasible and can be implemented without delay in coronary reperfusion. Hypothermia was safe regarding the incidence of MACE at 30 days. However, there was a higher incidence of arrhythmia and in-hospital infection in the hypothermia group, with no increase in mortality. Regarding efficacy, there was no difference in IS or LVEF at 30 days that would suggest additional myocardial protection with ETH. ClinicalTrials.gov: NCT02664194.

Echocardiographic measurements of epicardial adipose tissue and comparative ability to predict adverse cardiovascular outcomes in patients with coronary artery disease.

The present study aimed to compare echocardiography measurements of epicardial adipose tissue (EAT) thickness and other risk factors regarding their ability to predict adverse cardiovascular outcomes in patients with coronary artery disease (CAD). Outcomes of 107 patients (86 males, 21 females, mean age 63.6 years old) submitted to diagnostic echocardiography and coronary angiography were prospectively analyzed. EAT (measures over the right ventricle, interventricular groove and complete bulk of EAT) and left ventricle ejection fraction (LVEF) were performed by echocardiography. Coronary complexity was evaluated by Syntax score. Primary endpoints were major adverse cardiovascular events (MACE's), composite of cardiovascular death, myocardial infarction, unstable angina, intra-stent re-stenosis and episodes of decompensate heart failure requiring hospital attention during a mean follow up of 15.94 ± 3.6 months. Mean EAT thickness was 4.6 ± 1.9 mm; and correlated with Syntax score and body mass index; negatively correlated with LVEF. Twenty-three cases of MACE's were recorded during follow up, who showed higher EAT. Diagnostic ability of EAT to discriminate MACE's was comparable to LVEF (AUROC > 0.5); but higher than Syntax score. Quartile comparison of EAT revealed that measurement of the complete bulk of EAT provided a better discrimination range for MACE's, and higher, more significant adjusted risk (cutoff 4.6 mm, RR = 3.91; 95% CI 1.01-15.08; p = 0.04) than the other risk factors. We concluded that echocardiographic measurement of EAT showed higher predicting ability for MACE's than the other markers tested, in patients with CAD. Whether location for echocardiographic measurement of EAT impacts the diagnostic performance of this method deserves further study.

Características clínicas de pacientes con falla cardiaca aguda según la función ventricular izquierda / Clinical characteristics of acute heart failure patients according to left ventricular function

Resumen Introducción: la insuficiencia cardiaca aguda es la causa más frecuente de hospitalización en pacientes mayores de 65 años. A la fecha se han publicado pocos estudios descriptivos en la población colombiana, por lo que se realizó un estudio observacional que expone las características clínicas de los pacientes con diagnóstico de falla cardiaca aguda en Colombia. Métodos: se hizo un estudio observacional tipo corte-transversal con información obtenida de historias clínicas de pacientes con diagnóstico de falla cardiaca aguda entre los años 2011 a 2015 en la Fundación Santa Fe de Bogotá. Estos datos se recolectaron a través del Registro Colombiano de Enfermedad Cardiovascular (RECODEC). Resultados: se analizaron los datos de 550 pacientes, con un promedio de edad de 77 años. El análisis univariado evidenció mayor prevalencia de la enfermedad en hombres (55%) y una importante relación con hipertensión arterial (78,2%), enfermedad coronaria (31,8%) y fibrilación auricular (29,6). En cuanto a la estancia hospitalaria, se observó un promedio de 8 días en hospitalización general y de 1 día en la unidad de cuidado intensivo. En el análisis bivariado se dividieron los pacientes en tres grupos según la fracción de eyección del ventrículo izquierdo: disminuida (<40%), limítrofe (41-49%) y preservada (>50). Como desenlaces finales se evaluaron mortalidad (8,4%) y aparición de arritmias (22,5%). Conclusiones: el análisis de la base de datos de RECODEC se ha utilizado para evaluar los aspectos epidemiológicos y clínicos de la enfermedad cardiovascular. Existe la necesidad de crear registros nacionales que en general permitan analizar el comportamiento de la población colombiana.

Abstract Introduction: Acute heart failure is the most frequent cause of hospital admissions in patients over 65 years-old. Only few descriptive studies have been published on the Colombian population. The aim is to carry out an observational study that determines the clinical characteristics of patients with acute heart failure in a hospital in Colombia. Methods: An observational, cross-sectional study was conducted using information from clinical records of patients diagnosed with acute heart failure between 2011 and 2015 in our Foundation. These data were collected using the Colombian Registry of Cardiovascular Disease (RECODEC). Results: The analysis was performed on the data from 550 patients, with a median age of 77 years. The univariate analysis showed a higher prevalence of the disease in men (55%), and a significant association with hypertension (78.2%), coronary disease (31.8%), and atrial fibrillation (29.6%). In the bivariate analysis, the patients were divided into three groups according to their left ventricular ejection fraction: decreased (<40%), restricted (41%-49%), and preserved (> 50%), with the preserved ejection fraction being the most prevalent. The main outcomes were mortality (8.4%) and the occurrence of arrhythmias (22.5%). Conclusions: It is important to take into account that the analysis of the RECODEC database has been used to evaluate the epidemiological and clinical aspects of cardiovascular disease. However, there is a need to create registries at a national level in order to analyse the general characteristics of the Colombian population.