Major Bleeding Predictors in Patients with Left Atrial Appendage Closure: The Iberian Registry II.

INTRODUCTION AND OBJECTIVE: Major bleeding events in patients undergoing left atrial appendage closure (LAAC) range from 2.2 to 10.3 per 100 patient-years in different series. This study aimed to clarify the bleeding predictive factors that could influence these differences. METHODS: LAAC was performed in 598 patients from the Iberian Registry II (1093 patient-years; median, 75.4 years). We conducted a multivariate analysis to identify predictive risk factors for major bleeding events. The occurrence of thromboembolic and bleeding events was compared to rates expected from CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes, stroke history, vascular disease, sex) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile INR, elderly, drugs or alcohol) scores. RESULTS: Cox regression analysis revealed that age ≥75 years (HR: 2.5; 95% CI: 1.3 to 4.8; p = 0.004) and a history of gastrointestinal bleeding (GIB) (HR: 2.1; 95% CI: 1.1 to 3.9; p = 0.020) were two factors independently associated with major bleeding during follow-up. Patients aged <75 or ≥75 years had median CHA2DS2-VASc scores of 4 (IQR: 2) and 5 (IQR: 2), respectively (p < 0.001) and HAS-BLED scores were 3 (IQR: 1) and 3 (IQR: 1) for each group (p = 0.007). Events presented as follow-up adjusted rates according to age groups were stroke (1.2% vs. 2.9%; HR: 2.4, p = 0.12) and major bleeding (3.7 vs. 9.0 per 100 patient-years; HR: 2.4, p = 0.002). Expected major bleedings according to HAS-BLED scores were 6.2% vs. 6.6%, respectively. In patients with GIB history, major bleeding events were 6.1% patient-years (HAS-BLED score was 3.8 ± 1.1) compared to 2.7% patients-year in patients with no previous GIB history (HAS-BLED score was 3.4 ± 1.2; p = 0.029). CONCLUSIONS: In this high-risk population, GIB history and age ≥75 years are the main predictors of major bleeding events after LAAC, especially during the first year. Age seems to have a greater influence on major bleeding events than on thromboembolic risk in these patients.

Contribution of interventional cardiology to the collective dose in Spain.

INTRODUCTION AND OBJECTIVES: To estimate the contribution of interventional cardiology (IC) to the collective dose in Spain. METHODS: Using the information on frequencies of examinations sourced from the Spanish Society of Cardiology and the patient dose values obtained by the national DOCCACI programme. RESULTS: The fraction of the collective dose per million inhabitants derived from IC was 34 man-Sv (a total of 1600 man-Sv in Spain with 46.5 million inhabitants). The contribution of the IC derived from the medical use of x-rays in Spain resulted in 0.66% of the procedures and 4% of the x-ray collective dose. CONCLUSIONS: Even if this collective radiation dose may seem moderate, at an individual level this medical practice delivers the greatest doses and, therefore, optimisation remains of paramount importance.

Interhospital Variability in Drug Prescription After Acute Coronary Syndrome: Insights From the ACDC Study.

INTRODUCTION AND OBJECTIVES: To analyze the rate of patients admitted for acute coronary syndrome who concomitantly received acetylsalicylic acid, statins, and angiotensin-converting enzyme inhibitors at discharge, and to analyze interhospital variability in the prescription of these drugs and its potential prognostic impact. METHODS: Interhospital variability in drug prescription was estimated using the intraclass correlation coefficient and median odds ratio (hierarchical analysis). Cox regression analysis was used to estimate the risk of death or myocardial infarction associated with prescription of all 3 agents at 2-years of follow-up. RESULTS: In total, 489 (53.3%) of 917 patients were prescribed all 3 agents. The rate was similar in patients with hypertension and diabetes (56.8%). There was significant variability among centers in the prescription of the 3 drugs at discharge (from 23% to 77% of patients). Hypertension (odds ratio=1.93; 95% confidence interval, 1.42-2.61), ejection fraction < 45% (odds ratio=2.2; 95% confidence interval, 1.44-3.37), being in a clinical trial (odds ratio=1.89; 95% confidence interval, 1.24-2.88), and renal failure (odds ratio=0.53; 95% confidence interval, 0.29-0.94) were associated with prescription of the 3 drugs. After adjustment for these factors, residual variability persisted (intraclass correlation coefficient 0.046 [95% credibility interval, 0.007 to 0.192]; median odds ratio=1.46 [95% credibility interval, 1.16-2.32]). There was no clear association between the prescription of all 3 drugs and the risk of events during follow-up (hazard ratio=0.81, 95% confidence interval, 0.55-1.18; P=.27). CONCLUSIONS: The prescription rate for acetylsalicylic acid, angiotensin-converting enzyme inhibitors, and statins after acute coronary syndrome is suboptimal, varies among centers, and is possibly related to different health care approaches.

A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results.

AIMS: Paclitaxel drug-eluting balloons (pDEB) could be an attractive option to minimise side branch (SB) restenosis in bifurcated coronary lesions. We compared angiographic and clinical outcomes with pDEB plus bare metal stent (BMS) versus drug-eluting stents (DES) in de novo bifurcated lesions. METHODS AND RESULTS: This multicentre randomised trial included 108 patients. Sequential main branch (MB)/SB dilatation with pDEB, with provisional T-stenting with BMS in the MB was performed in the pDEB group, and with everolimus DES in the DES group. The primary endpoint was late lumen loss (LLL) at nine months. The secondary endpoint was the incidence of major adverse cardiac events (MACE: death, myocardial infarction, or target lesion revascularisation). In-segment MB LLL was 0.31±0.48 mm in the pDEB group, and 0.16±0.38 mm in the DES group (p=0.15); mean difference was 0.15 mm (upper limit one-sided 95% CI: 0.27 mm; p=0.001; non-inferiority test). LLL in SB was -0.04±0.76 mm in the pDEB group and -0.03±0.51 mm in the DES group (p=0.983). MACE and TLR were higher in the pDEB group (17.3% vs. 7.1%; p=0.105, and 15.4% vs. 3.6%; p=0.045), due to higher MB restenosis (13.5% vs. 1.8%; p=0.027). CONCLUSIONS: pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL (ns) and increased incidence of MACE compared to everolimus DES. Both strategies showed similar results in the SB.

Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries.

OBJECTIVES: This study sought to investigate the clinical impact of the use of intravascular ultrasound (IVUS) during revascularization of patients with left main coronary artery (LM) disease with drug-eluting stents (DES). BACKGROUND: Whether the use of IVUS during the procedure adds a clinical benefit remains unclear. There is only 1 previous observational study, with relevant limitations, supporting the value of this strategy. METHODS: We performed a patient-level pooled analysis of 4 registries of patients with LM disease treated with DES in Spain. A propensity score-matching method was used to obtain matched pairs of patients with and without IVUS guidance. RESULTS: A total of 1,670 patients were included, and 505 patients (30.2%) underwent DES implantation under IVUS guidance (IVUS group). By means of the matching method, 505 patients without the use of IVUS during revascularization were selected (no-IVUS group). Survival free of cardiac death, myocardial infarction, and target lesion revascularization at 3 years was 88.7% in the IVUS group and 83.6% in the no-IVUS group (p = 0.04) for the overall population, and 90% and 80.7%, respectively (p = 0.03), for the subgroups with distal LM lesions. The incidence of definite and probable thrombosis was significantly lower in the IVUS group (0.6% vs. 2.2%; p = 0.04). Finally, IVUS-guided revascularization was identified as an independent predictor for major adverse events in the overall population (hazard ratio: 0.70, 95% confidence interval: 0.52 to 0.99; p = 0.04) and in the subgroup with distal lesions (hazard ratio: 0.54, 95% confidence interval: 0.34 to 0.90; p = 0.02). CONCLUSIONS: The results of this pooled analysis show an association of IVUS guidance during percutaneous coronary intervention with better outcomes in patients with LM disease undergoing revascularization with DES.

Cardiovascular scientific production in Spain and in the European and global context (2003-2007).

INTRODUCTION AND OBJECTIVES: The publication of research articles has increased considerably in recent years in all biomedical fields. The present study examines the position of Spanish quality research in cardiology in the European and world context, and its evolution during the 5-year period 2003-2007. METHODS: Using the Science Citation Index Expanded of Thomson Reuters as data source, we compared Spanish cardiovascular scientific production with that of the rest of countries in the European Union and of the most important countries worldwide, along with relative productivity as per number of inhabitants and Gross Domestic Product, and the number of citations in the journals of the <> area of the Journal Citation Reports (CCS-JCR). RESULTS: Spain ranks sixth in the European Union and ninth worldwide in scientific production (tenth worldwide if only the journals of the first quartile of the CCS-JCR area are considered). As regards the number of citations received, Spain ranks seventh in the European Union and eleventh worldwide. In terms of relative productivity as per number of inhabitants and Gross Domestic Product, the Spanish ranking is less favorable (positions 15 and 18, respectively). CONCLUSIONS: The ranking of Spanish cardiovascular research is similar to that of other biomedical fields, though its position is less favorable in relation to certain demographic and economical indicators. In order to maintain adequate investigational levels, it is necessary for the European governments and scientific societies to regard the promotion of high-quality cardiological research as a priority concern.

La producción científica cardiovascular en España y en el contexto europeo y mundial (2003-2007) / Cardiovascular Scientific Production in Spain and in the European and Global Context (2003-2007)

Introducción y objetivos. La publicación de artículos de investigación ha aumentado de manera considerable en los últimos años en todas las áreas biomédicas. El objetivo de este trabajo es determinar el lugar que ocupa la investigación cardiológica española de calidad en el contexto europeo y mundial y su evolución durante el quinquenio 2003-2007. Métodos. Utilizando como fuente de datos la base de datos Science Citation Index Expanded de Thomson Reuters, se comparó la producción científica cardiovascular española con la de los países de la Unión Europea y los más destacados del mundo, así como la productividad relativa respecto al número de habitantes y producto interior bruto y el número de citas recibidas en las revistas del área «Cardiac & Cardiovascular Systems» del Journal Citation Reports (CCS-JCR). Resultados. España ocupa el sexto puesto en el ranking europeo y el noveno en el mundial de la producción científica, pasando al décimo mundial si se consideran únicamente las revistas del primer cuartil del área CCS-JCR. En número de citas recibidas, España ocupa el séptimo lugar europeo y undécimo mundial. En la productividad relativa respecto al número de habitantes y el producto interior bruto, la posición española es menos favorable, ocupando la decimoquinta y la decimoctava posición, respectivamente. Conclusiones. En investigación cardiovascular, España ocupa posiciones similares a otras áreas biomédicas, si bien su situación es menos ventajosa respecto a algunos indicadores demográficos y económicos. Para que se mantengan los niveles adecuados de investigación, es necesario que los gobiernos y las sociedades científicas europeas consideren el fomento de la investigación cardiológica de alta calidad como un objetivo primordial (AU)

Introduction and objectives. The publication of research articles has increased considerably in recent years in all biomedical fields. The present study examines the position of Spanish quality research in cardiology in the European and world context, and its evolution during the 5-year period 2003-2007. Methods. Using the Science Citation Index Expanded of Thomson Reuters as data source, we compared Spanish cardiovascular scientific production with that of the rest of countries in the European Union and of the most important countries worldwide, along with relative productivity as per number of inhabitants and Gross Domestic Product, and the number of citations in the journals of the «Cardiac & Cardiovascular Systems» area of the Journal Citation Reports (CCS-JCR). Results. Spain ranks sixth in the European Union and ninth worldwide in scientific production (tenth worldwide if only the journals of the first quartile of the CCS-JCR area are considered). As regards the number of citations received, Spain ranks seventh in the European Union and eleventh worldwide. In terms of relative productivity as per number of inhabitants and Gross Domestic Product, the Spanish ranking is less favorable (positions 15 and 18, respectively). Conclusions. The ranking of Spanish cardiovascular research is similar to that of other biomedical fields, though its position is less favorable in relation to certain demographic and economical indicators. In order to maintain adequate investigational levels, it is necessary for the European governments and scientific societies to regard the promotion of high-quality cardiological research as a priority concern (AU)

Ámbito de actuación de la cardiología en los nuevos escenarios clínicos. Documento de consenso de la Sociedad Española de Cardiología / The scope of cardiological competence in new clinical settings. Spanish Society of Cardiology Consensus Document

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[Myocardial infarction with ST segment elevation and angiographically normal coronary arteries: epidemiology and mid-term follow-up]. / Infarto de miocardio con elevación del segmento ST y arterias coronarias angiográficamente normales: epidemiología y evolución a medio plazo.

BACKGROUND AND OBJECTIVE: The myocardial infarction (MI) with ST elevation and angiographically normal coronary arteries isn't frequent. The aim of this study is to describe clinical characteristic and mid-term follow-up of those patients. PATIENTS AND METHOD: Between January 1997 and December 2004 we identified 75 patients with MI and normal coronary arteries in a coronary angiography performed within one month of the AMI. All had criteria of MI and their coronary arteries were smooth and without obstructive lesions. RESULTS: The incidence was 3%, and mean age (standard deviation): 49 (11) years; 63% of patients were males and 47% were smokers, 33% had hypertension, 24% dislipemia and 9% diabetes. No patient had previous angina. MI location was anterior in 43%, inferior in 40% and lateral in 17%. The peak of creatine phosphokinase was 700 U/dl (range: 431-1,115) and the ejection fraction was 65% (14%). After a medium follow up of 30 months (range: 12-84) the events were: one death and 2 new MI. CONCLUSIONS: MI with normal coronary arteries is rare, is associated with a relative low rate of coronary risk factors, and with a good initial outcome, low rate of recurrent events and preservation of left ventricular function.

Guías de práctica clínica de la Sociedad Española de Cardiología en miocardiopatías y miocarditis / Guidelines of the Spanish Society of Cardiology on Cardiomyopathy and Myocarditis

Las miocardiopatías constituyen un conjunto extraordinariamente heterogéneo de procesos que sólo tienen en común que afectan el músculo cardíaco y que causan un amplio espectro de formas de disfunción del mismo. El enfoque del manejo y tratamiento de las miocardiopatías es objeto permanente de discusión porque la mayor parte de alternativas en este campo no se han basado en la mejor evidencia científica posible, puesto que con la excepción del tratamiento de la insuficiencia cardíaca en el contexto de la miocardiopatía dilatada, la mayoría de las diferentes opciones no han sido estudiadas mediante amplios (ni reducidos) ensayos clínicos. Pese a ello, este capítulo ha intentado proporcionar al lector las diversas formas de enfocar los problemas clínicos de mayor importancia en la miocardiopatía dilatada, hipertrófica y restrictiva, así como en la miocarditis. Se ha empleado para ello la información más relevante que ha podido localizarse, en consonancia con nuestro propio juicio clínico, aun admitiendo que muchas de las recomendaciones puedan resultar controvertidas (AU)