Outcomes and predictive value of the 2MACE score in patients with atrial fibrillation treated with rivaroxaban in a prospective, multicenter observational study: The EMIR study.

BACKGROUND: The aim of the study was to evaluate the performance of the 2MACE in patients with atrial fibrillation (AF) treated with rivaroxaban and to improve the accuracy of 2MACE. METHODS: This was a post-authorization and observational study of AF adults treated with rivaroxaban for ≥ 6 months. The primary endpoint was any of the major adverse cardiac events (MACE), namely, cardiovascular death, non-fatal myocardial infarction, and myocardial revascularization. The area under the curve (AUC) was calculated to evaluate the performance of 2MACE, and a new score, 2MACER to predict MACE. RESULTS: A total of 1433 patients were included (74.2 ± 9.7 years, CHA2DS2-VASc 3.5 ± 1.5, 26.9% 2MACE ≥ 3). The annual event rates (follow-up 2.5 years) were 1.07% for MACE, 0.66% for thromboembolic events and 1.04% for major bleeding. Patients with 2MACE ≥ 3 (vs. < 3) had higher risk of stroke/systemic embolism/transient ischemic attack (odds ratio [OR] 5.270; 95% CI 2.216-12.532), major bleeding (OR 4.624; 95% CI 2.163-9.882), MACE (OR 3.202; 95% CI 1.548-6.626) and cardiovascular death (OR 3.395; 95% CI 1.396-8.259). 2MACE was recalculated giving 1 more point to patients with baseline a glomerular filtration rate < 50 mL/min/1.73 m² (2MACER); 2MACER vs. 2MACE: IDI 0.1%, p = 0.126; NRI 23.9%, p = 0.125; AUC: 0.651 (95% CI 0.547-0.755) vs. 0.638 (95% CI 0.534-0.742), respectively; p = 0.361. CONCLUSIONS: In clinical practice, AF patients anticoagulated with rivaroxaban exhibit a low risk of events. 2MACE score acts as a modest predictor of a higher risk of adverse outcomes in this population. 2MACER did not significantly increase the ability of 2MACE to predict MACE.

The Maritime Declaration of Health (MDH) as a tool to detect maritime traffic-related health risks: analysis of MDH forms submitted to Spanish ports, October 2014 to March 2015.

The international maritime traffic of people and goods has often contributed to the spread of pathogens affecting public health. The Maritime Declaration of Health (MDH), according to the International Health Regulations (IHR) (2005), is a document containing data related to the state of health on board a ship during passage and on arrival at port. It is a useful tool for early detection of public health risks. The main objective of our study was to evaluate compliance with the model provided in the IHR, focusing on the format and degree of completion of MDH forms received at Spanish ports. We reviewed the content of 802 MDH forms submitted to nine Spanish ports between October 2014 and March 2015. Study results show that 22% of MDH forms presented did not comply with the recommended model and 39% were incomplete. The proportion of cargo ships with correct and complete MDH forms was lower than passenger ships; thus, the nine health questions were answered less frequently by cargo ships than passenger ships (63% vs 90%, p value < 0.001). The appropriate demand and usage of MDH forms by competent authorities should improve the quality of the document as a tool and improve risk assessment.

[Prognostic value of tumor necrosis factor-alpha in patients with ST-segment elevation acute myocardial infarction]. / Valor pronóstico del factor de necrosis tumoral alfa en pacientes con infarto agudo de miocardio con elevación del segmento ST.

INTRODUCTION AND OBJECTIVES: Tumor necrosis factor-alpha (TNFalpha in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to determine the prognostic value of TNFalpha in this clinical setting at six-month follow-up. METHODS: The levels of TNFalpha, C-reactive protein (CRP), interleukin 6 and type 1 soluble intercellular adhesion molecules measured within the first 10 h of symptom onset and at 48 h in 74 consecutive patients admitted with STEMI. The relationships between these levels and the incidence of ischemic events (i.e., angina, reinfarction, and death), heart failure (HF), or both (i.e., all cardiovascular events) were studied. RESULTS: Overall, TNFalpha levels were significantly higher in patients who had an ischemic event or HF than in those who did not (P<.02 for both). At 48 h, the adjusted odds ratios of those in the highest TNFalpha quartile (2.92 pg/mL) for the development of ischemic events, HF, and all cardiovascular events combined were 13.1, 9.59 and 9.75, respectively. A TNFalpha level of 2.04 pg/mL at 48 h had a sensitivity of 78% and a specificity of 72.5% in predicting a cardiovascular event of any form. The CRP level, but not the TNFalpha level, at admission was found to be an independent predictor of the development of a cardiovascular events. CONCLUSIONS: In patients with STEMI, the plasma TNFalpha level 48 h after symptom onset and the CRP level at admission were independent predictors of cardiovascular events.

Valor pronóstico del factor de necrosis tumoral alfa en pacientes con infarto agudo de miocardio con elevación del segmento ST / Prognostic value of tumor necrosis factor-alpha in patients with ST-segment elevation acute myocardial infarction

Introducción y objetivos. Entre la variedad de procesos inflamatorios que implican al factor de necrosis tumoral alfa (TNFα), se encuentra la enfermedad cardiovascular. Su valor pronóstico en el infarto agudo de miocardio con elevación del segmento ST (IAMEST) es poco conocido. Este estudio trata de determinar el valor pronóstico del TNFα en este marco clínico tras 6 meses de seguimiento. Métodos. Se midieron las concentraciones de TNFα, proteína C-reactiva (PCR), interleucina 6 y moléculas solubles de adhesión celular tipo 1 en las primeras 10 h tras el inicio de los síntomas y tras 48 h en 74 pacientes con IAMEST. Se correlacionaron sus valores con la incidencia de eventos isquémicos (angina, reinfarto y muerte), insuficiencia cardiaca o ambos (eventos cardiovasculares). Resultados. Los valores de TNFα fueron significativamente mayores en pacientes con eventos isquémicos o insuficiencia cardiaca que en aquellos sin eventos (p < 0,02 para todos). A las 48 h, las odds ratio (OR) ajustadas para el último cuartil de TNFα (2,92 pg/ml) eran OR = 13,1; OR = 9,59 y OR = 9,75 para el desarrollo de eventos isquémicos, insuficiencia cardiaca y eventos cardiovasculares combinados, respectivamente. La concentración de TNFα a las 48 h de 2,04 pg/ml tuvo una sensibilidad del 78% y una especificidad del 72,5% en la predicción conjunta de dichos eventos. Al ingreso, la PCR, pero no el TNFα, mostró valor predictivo independiente en el desarrollo de eventos cardiovasculares. Conclusiones. En pacientes con IAMEST, la concentración plasmática de TNFα a las 48 h y la PCR al ingreso son predictores independientes de eventos cardiovasculares (AU)

Introduction and objectives. Tumor necrosis factor-alpha (TNF-alpha) is implicated in a variety of inflammatory processes, including cardiovascular disease. Little is known about the prognostic value of TNF-alpha in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to determine the prognostic value of TNF-alpha in this clinical setting at six-month follow-up. Methods. The levels of TNF-alpha, C-reactive protein (CRP), interleukin 6 and type 1 soluble intercellular adhesion molecules measured within the first 10 h of symptom onset and at 48 h in 74 consecutive patients admitted with STEMI. The relationships between these levels and the incidence of ischemic events (i.e., angina, reinfarction, and death), heart failure (HF), or both (i.e., all cardiovascular events) were studied. Results. Overall, TNF-alpha levels were significantly higher in patients who had an ischemic event or HF than in those who did not (P<.02 for both). At 48 h, the adjusted odds ratios of those in the highest TNF-alpha quartile (2.92 pg/mL) for the development of ischemic events, HF, and all cardiovascular events combined were 13.1, 9.59 and 9.75, respectively. A TNF-alpha level of 2.04 pg/mL at 48 h had a sensitivity of 78% and a specificity of 72.5% in predicting a cardiovascular event of any form. The CRP level, but not the TNF-alpha level, at admission was found to be an independent predictor of the development of a cardiovascular events. Conclusions. In patients with STEMI, the plasma TNF-alpha level 48 h after symptom onset and the CRP level at admission were independent predictors of cardiovascular events (AU)

[Six-month intravascular ultrasound follow-up of coronary bifurcation lesions treated with rapamycin-eluting stents: technical considerations]. / Ecografía intracoronaria durante el seguimiento en la valoración de stents liberadores de rapamicina para el tratamiento de las lesiones en bifurcación: implicaciones técnicas.

INTRODUCTION AND OBJECTIVES: In vitro studies show that stents deform when dilated laterally to access a side branch. This phenomenon may be avoided by use of a kissing balloon at the end of the procedure. However, to date, no in vivo data are available. Our objectives were to investigate the main vessel stent using intravascular ultrasound (IVUS) at six-month follow-up in 55 patients with bifurcation lesions treated using rapamycin-eluting stents and to examine the effect of technical factors. PATIENTS AND METHOD: All patients were treated using provisional or T stents. At 6 months, IVUS measurements were made in the main vessel at both proximal and distal ends of the stent, in reference segments, immediately below the side branch ostium, and at the points where the lumen was smallest and where stent expansion was greatest. RESULTS: The lumen area immediately below the side branch ostium was significantly smaller than that at the point of maximum stent expansion (6.7 [1.8] vs 5.1 [1.3] mm2; P<.05). Underexpansion was not influenced by use of a kissing balloon (stent area immediately under the side branch ostium: 5.5 [0.9] vs 5.6 [1.6] mm2; P=NS) and only one patient experienced restenosis at this point. The lumen areas at the proximal and distal edges of the stent were almost identical in patients who did or did not undergo balloon dilation beyond the ends of the stent. CONCLUSIONS: Stent underexpansion below the side branch ostium was frequently found following provisional or T stenting of bifurcation lesions. This minor stent deformity was not prevented by use of a kissing balloon nor by any specific side branch treatment and had no significant impact on the restenosis rate.

Ecografía intracoronaria durante el seguimiento en la valoración de stents liberadores de rapamicina para el tratamiento de las lesiones en bifurcación: implicaciones técnicas / Six-month intravascular ultrasound follow-up of coronary bifurcation lesions treated with rapamycin-eluting stents: technical considerations

Introducción y objetivos. Los estudios in vitro han mostrado que el stent se deforma cuando se dilata lateralmente para acceder a un ramo colateral. Así, se han propuesto algunas técnicas para evitar este fenómeno; sin embargo, no hay información in vivo disponible. El objetivo es investigar los hallazgos ultrasónicos a los 6 meses en 55 pacientes con lesiones localizadas en bifurcación tratados mediante stents de rapamicina.Pacientes y método. Todos los pacientes fueron tratados con stent en el vaso principal y stent o dilatación con balón en el ramo colateral. Se analizaron los bordes del stent, los segmentos de referencia, el diámetro mínimo de la luz, el punto inmediatamente tras la salida del ramo colateral y el stent en el punto de máxima expansión.Resultados. El área de la luz en el punto inmediatamente tras la salida del ramo colateral fue significativamente más pequeña que en el punto de máxima expansión (6,7 ± 1,8 frente a 5,1 ± 1,3 mm²; p < 0,05). Esta inexpansión del stent no estuvo influida por el uso del inflado simultáneo de balones al final del procedimiento (área del stent inmediatamente bajo el origen del ramo colateral, 5,5 ± 0,9 frente a 5,6 ± 1,6 mm²; p = NS). El área de la luz en los bordes fue prácticamente idéntica entre pacientes con y sin inflado de balón más allá de los límites del stent.Conclusiones. Cierto grado de inexpansión del stent inmediatamente después de la salida del ramo colateral fue un hallazgo frecuente en pacientes con bifurcaciones tratados con stents en el ramo principal y stent provisional en el ramo colateral. Esta deformidad no fue prevenida por variables técnicas y no tuvo un impacto significativo en la incidencia de reestenosis

Introduction and objectives. In vitro studies show that stents deform when dilated laterally to access a side branch. This phenomenon may be avoided by use of a kissing balloon at the end of the procedure. However, to date, no in vivo data are available. Our objectives were to investigate the main vessel stent using intravascular ultrasound (IVUS) at six-month follow-up in 55 patients with bifurcation lesions treated using rapamycin-eluting stents and to examine the effect of technical factors.Patients and method. All patients were treated using provisional or T stents. At 6 months, IVUS measurements were made in the main vessel at both proximal and distal ends of the stent, in reference segments, immediately below the side branch ostium, and at the points where the lumen was smallest and where stent expansion was greatest.Results. The lumen area immediately below the side branch ostium was significantly smaller than that at the point of maximum stent expansion (6.7 [1.8] vs 5.1 [1.3] mm²; P<.05). Underexpansion was not influenced by use of a kissing balloon (stent area immediately under the side branch ostium: 5.5 [0.9] vs 5.6 [1.6] mm²; P=NS) and only one patient experienced restenosis at this point. The lumen areas at the proximal and distal edges of the stent were almost identical in patients who did or did not undergo balloon dilation beyond the ends of the stent.Conclusions. Stent underexpansion below the side branch ostium was frequently found following provisional or T stenting of bifurcation lesions. This minor stent deformity was not prevented by use of a kissing balloon nor by any specific side branch treatment and had no significant impact on the restenosis rate

Sirolimus-eluting stents for treatment of in-stent restenosis: immediate and late results.

We analyzed the clinical, angiographic, and late intravascular ultrasonographic findings from 140 patients whose in-stent restenosis was treated with sirolimus-eluting stents. In-stent restenosis remains the main limitation to percutaneous coronary revascularization and has a high recurrence rate after bare stent implantation. From May 2002 through July 2003, we studied 140 patients with clinical restenosis after bare-stent treatment. In 107 patients, in-stent restenosis occurred de novo; in 28 patients, this was the 2nd restenosis; and in another 5, it was the 3rd occurrence. A sirolimus-eluting stent was implanted directly after angiographic evaluation of the in-stent restenosis in 79 patients and after pre-dilation in 61 patients. All patients were given the following antithrombotic regimen: low-molecular-weight heparin, ticlopidine, and aspirin for 1 month, followed by clopidogrel and aspirin for 1 year. Primary success was achieved in 137 patients. Three patients had a non-Q wave myocardial infarction. At the 1-month evaluation, 2 patients had died: 1 due to subacute stent thrombosis and another due to acute mesenteric ischemia. After a mean follow-up of 16 +/- 4 months, the major adverse cardiac events were acute myocardial infarction due to late stent thrombosis in 2 patients and the need for target lesion revascularization in 15 patients. Late angiographic evaluation was performed in 97 patients (69%), 16 of whom had new restenosis: 14 of the restenoses were intrastent, and 2 were at the edges of the stent. Our results suggest that sirolimus-eluting stents are effective in the prevention of in-stent restenosis and, therefore, may become the leading treatment alternative for patients with in-stent restenosis.

Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy.

BACKGROUND: Rapamycin-eluting stents (RES) have been shown to reduce restenosis in many types of lesions. However, the ideal strategy for the treatment of coronary bifurcated lesions has not been established to date. This randomized study compares 2 strategies for the RES treatment of bifurcation lesions: a simple approach (stenting the main vessel and balloon dilatation for the side branch [SB]) versus a complex approach (stents for both vessels). METHODS: To compare both strategies, a randomized study was conducted in 91 patients with true coronary bifurcation lesions. All patients received an RES at the main vessel, covering the SB. Patients from group A (n = 47) were assigned to balloon dilation of the involved SB (simple strategy); patients in group B (n = 44) were randomized to receive a second stent at the SB origin (complex strategy). There were no differences between groups regarding baseline clinical and angiographic data. RESULTS: Major adverse cardiac events occurred in 3 patients from group A (2 non-Q-wave myocardial infarctions and 1 target lesion revascularization). Six-month angiographic reevaluation was obtained in 80 patients (88%). Restenosis of the main vessel was observed in 1 (2%) patient from group A and in 4 (10%) from group B. Restenosis of the SB appeared in 2 (5%) patients from group A and in 6 (15%) from group B. CONCLUSIONS: Both strategies are effective in reducing the restenosis rate, with no differences in terms of clinical outcome. Elective SB stenting seems to provide no advantages over the simpler stent jail followed by SB balloon dilation.

Rapamycin-eluting stents for the treatment of unprotected left main coronary disease.

BACKGROUND: Conventional bare stents have been used to treat unprotected left main (LM) coronary artery stenosis. However, restenosis remains the main limitation. Since rapamycin-eluting stents (RES) appear to inhibit neointimal proliferation, their application to this specific site seems promising. METHODS: Since May 2002, we have studied a series of 52 patients with LM lesions treated with RES. Forty-seven patients presented with de novo stenoses, and 5 had in-stent restenosis; 19 patients required combined stent treatment for other remote lesions in the coronary tree, 6 of them at the level of proximal right coronary artery. The RES was implanted directly at the LM in 39 patients; 13 others needed predilation. Once deployed, the RES was overexpanded with short balloons adjusted to the LM length in 44 patients. Quantitative coronary angiograms were analyzed in the same view before and immediately after treatment and at follow-up. Patients were followed-up closely and new cardiac catheterization was scheduled at 6-month evaluation or earlier in the presence of symptoms. At follow-up study, quantitative coronary angiography and motorized intravascular ultrasound analyses were performed in 35 (67%) patients. RESULTS: Primary success was obtained in 50 patients (96%). Two patients (4%) developed a non-Q-wave myocardial infarction. All patients were symptom-free at discharge. After a mean follow-up of 12 +/- 4 months, 50 patients (96%) remain asymptomatic. No late death or acute thrombosis have been recorded. Two patients became symptomatic 2 and 4 months after treatment, respectively. One had restenosis at a remote site, while the other had in-segment restenosis. None of the remaining 33 angiographically evaluated patients developed restenosis at any site. Target lesion revascularization was 1/52 (2%). CONCLUSIONS: Although longer-term follow-up studies are needed, the tailored treatment of coronary lesions located at the LM by overexpanded RES is feasible and safe. Midterm results seem promising, which might help to shift the orientation of patient management from surgical to percutaneous revascularization.

[Clinical characteristics and medium-term prognosis of patients with heart failure and preserved systolic function. Do they differ in systolic dysfunction?]. / Características clínicas y pronósticos a medio plazo de la insuficiencia cardíaca con funcón sistólica conservada. ¿Es diferente de la insuficienca cardíaca sistólica?

OBJECTIVES: To assess the prevalence, clinical profile and medium-term prognosis in patients with heart failure and preserved systolic ventricular function compared to those with systolic dysfunction. PATIENTS AND METHOD: 153 patients were included, 62 with preserved systolic ventricular function (left ventricular ejection fraction > or = 45%) and 91 with impaired systolic ventricular function (left ventricular ejection fraction < 45%). The mean follow-up period was 25 10 months. RESULTS: Mean age was similar (66 10 vs. 65 10; p = 0.54). There was a higher proportion of women among patients with preserved systolic function (53% vs. 28%; p < 0.01). Ischemic and idiopathic cardiomyopathy were the most common causes of heart failure in patients with systolic dysfunction, whereas valvular disease and hypertensive cardiopathy were the most common in patients with preserved systolic function. Angiotensin-converting enzyme inhibitors and beta-blockers were more often prescribed in patients with impaired systolic ventricular function (86% vs. 52%; p < 0.01 and 33% vs. 11%; p < 0.01, respectively). There were no differences between the groups in terms of mortality rate (37% vs. 29%), readmission rate for other causes (29% vs. 23%), readmission rate for heart failure (45% vs. 45%), cumulative survival (51% vs. 62%) and the likelihood of not being readmitted for heart failure (50% vs. 52%). In the multivariate analysis, left ventricular ejection fraction was not a predictor of death or readmission because of heart failure. CONCLUSIONS: In a large proportion of patients with heart failure, systolic ventricular function is preserved. Despite the clinical differences between patients with preserved and impaired systolic ventricular function, the medium-term prognosis was similar in both groups.

Características clínicas y pronóstico a medio plazo de la insuficiencia cardíaca con función sistólica conservada. ¿Es diferente de la insuficiencia cardíaca sistólica? / Clinical characteristics and medium-term prognosis of patients with heart failure and preserved systolic function. Do they differ in systolic dysfunction?

Objetivos. Analizar la prevalencia, las características clínicas y el pronóstico a medio plazo de los pacientes con insuficiencia cardíaca y función sistólica conservada, y compararlos con los que presentan disfunción ventricular. Pacientes y método. Se incluyó a un total de 153 pacientes, 62 con función sistólica conservada (fracción de eyección ventricular izquierda 45 por ciento) y 91 con disfunción ventricular (fracción de eyección < 45 por ciento). El seguimiento medio fue de 25 ñ 10 meses. Resultados. Las edades medias fueron similares (66 ñ 10 frente a 65 ñ 10 años; p = 0,54). La proporción de mujeres fue mayor entre los pacientes con función sistólica conservada (53 frente a 28 por ciento; p < 0,01). Las miocardiopatías isquémica e idiopática fueron las causas más prevalentes en pacientes con disfunción sistólica, y las valvulopatías y la cardiopatía hipertensiva, en los que tenían una función sistólica conservada. Los pacientes con función sistólica deprimida recibieron inhibidores de la enzima de conversión de la angiotensina y bloqueadores beta en mayor proporción (86 frente a 52 por ciento; p < 0,01 y 33 frente a 11 por ciento; p < 0,01). Las tasas de mortalidad (37 frente a 29 por ciento), reingresos por insuficiencia cardíaca (45 frente a 45 por ciento) y reingresos por otras causas (29 frente a 23 por ciento) fueron similares entre ambos grupos, y tampoco difirieron la supervivencia actuarial (51 frente a 62 por ciento) ni la probabilidad de no reingresar por insuficiencia cardíaca (50 frente a 52 por ciento). La fracción de eyección ventricular izquierda no fue predictora de mortalidad o reingresos por insuficiencia cardíaca. Conclusiones. Una importante proporción de pacientes con insuficiencia cardíaca presentan una función ventricular sistólica conservada. Aunque las características clínicas de estos pacientes son distintas de las de aquellos con disfunción ventricular sistólica, el pronóstico a medio plazo fue similar (AU)