Outcomes and factors associated with mortality in patients with atrial fibrillation and heart failure: FARAONIC study

Background: Heart failure (HF) and atrial fibrillation (AF) are common and coexistent conditions. Hypothesis: To investigate the adverse events and mortality risk factors in patients with AF and HF treated with rivaroxaban in Spain. Methods: Multicenter, prospective and observational study with a follow-up of 2 years, that included adults, with a diagnosis of nonvalvular AF and chronic HF, anticoagulated with rivaroxaban at least 4 months before being enrolled. Results: A total of 672 patients from 71 Spanish centers were recruited, of whom 658 (97.9%) were included in the safety analysis and 552 (82.1%) in the per protocol analysis. At baseline, the mean age was 73.7 +/- 10.9 years, 65.9% were male, 51.3% had HF with preserved ejection fraction and 58.7% were on New York Heart Association functional class II. CHA2DS2-VASc was 4.1 +/- 1.5. During the follow-up, 11.6% of patients died and around one-quarter of patients were hospitalized or visited the emergency department, being HF worsening/progression the main cause (51.1%), with a 2.9% of thromboembolic events and 2.0% of acute coronary syndromes. Major bleeding occurred in 3.1% of patients, with 0.5% experiencing intracranial bleeding but no fatalities. Compliance with HF treatment was associated with a lower risk of death (hazard ratio: 0.092; 95% confidence interval: 0.03-0.31). Conclusions: Among patients with HF and AF anticoagulated with rivaroxaban, incidences of thromboembolic or hemorrhagic complications were low. The most important factor for improving survival was compliance with HF drugs, what strengths the need for early treatment with HF disease-modifying therapy and anticoagulation

Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol.

Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. Methods We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. Conclusions The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice

Impact of heart failure on the clinical profile and outcomes in patients with atrial fibrillation treated with rivaroxaban. Data from the EMIR study

Background: The aim of this study was to analyze the impact of the presence of heart failure (HF) on the clinical profile and outcomes in patients with atrial fibrillation (AF) anticoagulated with rivaroxaban. Methods: Observational and non-interventional study that included AF adults recruited from 79 Spanish centers, anticoagulated with rivaroxaban ≥ 6 months before inclusion. Data were analyzed according to baseline HF status. Results: Out of 1,433 patients, 326 (22.7%) had HF at baseline. Compared to patients without HF, HF patients were older (75.3 ± 9.9 vs. 73.8 ± 9.6 years; p = 0.01), had more diabetes (36.5% vs. 24.3%; p < 0.01), coronary artery disease (28.2% vs. 12.9%; p < 0.01), renal insufficiency (31.7% vs. 22.6%; p = 0.01), higher CHA2DS2-VASc (4.5 ± 1.6 vs. 3.2 ± 1.4; p < 0.01) and HAS-BLED (1.8 ± 1.1 vs. 1.5 ± 1.0; p < 0.01). After a median follow-up of 2.5 years, among HF patients, annual rates of stroke/systemic embolism/transient ischemic attack, MACE-non-fatal myocardial infarction, revascularization and cardiovascular death-, cardiovascular death, and major bleeding were 1.2%, 3.0%, 2.0%, and 1.4%, respectively. Compared to those patients without HF, HF patients had greater annual rates of MACE (3.0% vs. 0.5%; p < 0.01) and cardiovascular death (2.0% vs. 0.2%; p < 0.01), without significant differences regarding other outcomes, including thromboembolic or bleeding events. Previous HF was an independent predictor of MACE (odds ratio 3.4; 95% confidence interval 1.6-7.3; p = 0.002) but not for thromboembolic events or major bleeding. Conclusions: Among AF patients anticoagulated with rivaroxaban, HF patients had a worse clinical profile and a higher MACE risk and cardiovascular mortality. HF was independently associated with the development of MACE, but not with thromboembolic events or major bleeding

The effect of post-discharge educational intervention on patients in achieving objectives in modifiable risk factors six months after discharge following an episode of acute coronary syndrome, (CAM-2 Project): a randomized controlled trial

<p>Abstract</p> <p>Objectives</p> <p>We investigated whether an intervention mainly consisting of a signed agreement between patient and physician on the objectives to be reached, improves reaching these secondary prevention objectives in modifiable cardiovascular risk factors six-months after discharge following an acute coronary syndrome.</p> <p>Background</p> <p>There is room to improve mid-term adherence to clinical guidelines' recommendations in coronary heart disease secondary prevention, specially non-pharmacological ones, often neglected.</p> <p>Methods</p> <p>In CAM-2, patients discharged after an acute coronary syndrome were randomly assigned to the intervention or the usual care group. The primary outcome was reaching therapeutic objectives in various secondary prevention variables: smoking, obesity, blood lipids, blood pressure control, exercise and taking of medication.</p> <p>Results</p> <p>1757 patients were recruited in 64 hospitals and 1510 (762 in the intervention and 748 in the control group) attended the six-months follow-up visit. After adjustment for potentially important variables, there were, between the intervention and control group, differences in the mean reduction of body mass index (0.5 vs. 0.2; p < 0.001) and waist circumference (1.6 cm vs. 0.6 cm; p = 0.05), proportion of patients who exercise regularly and those with total cholesterol below 175 mg/dl (64.7% vs. 56.5%; p = 0.001). The reported intake of medications was high in both groups for all the drugs considered with no differences except for statins (98.1% vs. 95.9%; p = 0.029).</p> <p>Conclusions</p> <p>At least in the short term, lifestyle changes among coronary heart disease patients are achievable by intensifying the responsibility of the patient himself by means of a simple and feasible intervention.</p

One-Step Nucleic Acid Amplification (OSNA) of Sentinel Lymph Node in Early-Stage Endometrial Cancer: Spanish Multicenter Study (ENDO-OSNA)

The objective of this study was to evaluate the efficacy of one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis compared to standard pathological ultrastaging in patients with early-stage endometrial cancer (EC). A total of 526 SLNs from 191 patients with EC were included in the study, and 379 SLNs (147 patients) were evaluated by both methods, OSNA and standard pathological ultrastaging. The central 1 mm portion of each lymph node was subjected to semi-serial sectioning at 200 μm intervals and examined by hematoxylin–eosin and immunohistochemistry with CK19; the remaining tissue was analyzed by OSNA for CK19 mRNA. The OSNA assay detected metastases in 19.7% of patients (14.9% micrometastasis and 4.8% macrometastasis), whereas pathological ultrastaging detected metastasis in 8.8% of patients (3.4% micrometastasis and 5.4% macrometastasis). Using the established cut-off value for detecting SLN metastasis by OSNA in EC (250 copies/μL), the sensitivity of the OSNA assay was 92%, specificity was 82%, diagnostic accuracy was 83%, and the negative predictive value was 99%. Discordant results between both methods were recorded in 20 patients (13.6%). OSNA resulted in an upstaging in 12 patients (8.2%). OSNA could aid in the identification of patients requiring adjuvant treatment at the time of diagnosis.El objetivo de este estudio fue evaluar la eficacia de la amplificación de ácido nucleico en un solo paso (OSNA) para la detección de metástasis en el ganglio linfático centinela (GC) en comparación con la ultraestadificación patológica estándar en pacientes con cáncer de endometrio (CE) en estadio temprano. Se incluyeron en el estudio un total de 526 SLN de 191 pacientes con EC, y 379 SLN (147 pacientes) fueron evaluados por ambos métodos, OSNA y ultraestadificación patológica estándar. La porción central de 1 mm de cada ganglio linfático se sometió a un seccionamiento semiserie a intervalos de 200 μm y se examinó mediante hematoxilina-eosina e inmunohistoquímica con CK19; el tejido restante fue analizado por OSNA para ARNm de CK19. El ensayo OSNA detectó metástasis en el 19,7 % de los pacientes (14,9 % micrometástasis y 4,8 % macrometástasis), mientras que la ultraestadificación patológica detectó metástasis en el 8,8 % de los pacientes (3. 4% micrometástasis y 5,4% macrometástasis). Usando el valor de corte establecido para detectar metástasis SLN por OSNA en EC (250 copias/μL), la sensibilidad del ensayo OSNA fue del 92 %, la especificidad fue del 82 %, la precisión diagnóstica fue del 83 % y el valor predictivo negativo fue del 99 % Se registraron resultados discordantes entre ambos métodos en 20 pacientes (13,6%). OSNA resultó en una sobreestadificación en 12 pacientes (8,2%). OSNA podría ayudar en la identificación de pacientes que requieren tratamiento adyuvante en el momento del diagnóstico. Se registraron resultados discordantes entre ambos métodos en 20 pacientes (13,6%). OSNA resultó en una sobreestadificación en 12 pacientes (8,2%). OSNA podría ayudar en la identificación de pacientes que requieren tratamiento adyuvante en el momento del diagnóstico. Se registraron resultados discordantes entre ambos métodos en 20 pacientes (13,6%). OSNA resultó en una sobreestadificación en 12 pacientes (8,2%). OSNA podría ayudar en la identificación de pacientes que requieren tratamiento adyuvante en el momento del diagnóstico

Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care : the EFICAR study protocol

Background: Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors. Methods/Design: Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables. Discussion: A key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants

Hezkuntza proiektua lanketa prozesua ikastolen esparruan

Helburua: Ikerketa honen helburua Ikastolen eremuan Hezkuntza Proiektuaren lanketa prozesua analizatzea eta amaierako dokumentuak zer-nolako sinesgarritasuna eskaintzen duen aztertzea izan da. Ikertzailearen (doktoregaia) iritziz, proiektua lantzeko interesaz eta hura edukitzeko beharraz Eskola elkartean egiten den sentsibilizazio etengabeak zuzen eragiten dio prozesuan zehar lor daitekeen inplikazioari eta, ondorioz, prozesuaren bukaeran dokumentuari egingo zaion ezagutzari. @@ Zer: Ikertzailearen Hezkuntza Proiektuari buruzko hasierako kontzeptualizazioa honako hau zen: "Eskola elkarteak adostutako dokumentua da, guztion parte-hartzearekin osatua, eta ikastola ikastolen mugimenduko kide den hezkuntza erakunde gisa aurkezten du; hezkuntza jardueraren esparru eta erreferente nagusi gisa balio du eta baita beste dokumentu batzuk garatzeko ere, bai izaera curricularrekoak direnak bai gestioari eta funtzionamenduari dagozkionak". @@ Metodologia: Aukeratu eta erabili den metodologiari buruz, paradigma kualitatiboaren alde egitea erabaki nuen, zehatzago esanda, bi kasuren azterketa interpretatiboaren alde. Tokian tokiko lana bi kasu-ikastolatan egin zen, Egape (Urnieta) eta Jakintza (Ordizia), eta horixe izan zen informazioa biltzeko funtsezko tresna. @@ Zer egin horretako bi Ikastola horietan sortutako batzordeetan, ikertzailearen rola kanpoko laguntzailea izan zen, tokian tokiko lanak iraun zuen bitartean, bere eginbeharra aholkulari teknikoarena izanik, eta informazioa biltzeko teknika gisa behaketa parte-hartzailea erabiliz. @@ Informazio iturriak: Batzordeko kideek, bilera bakoitzaren bukaeran, taldearen jarrerari buruzko balorazioa egiteko galde zerrenda samur bat betetzen zuten. Ikertzaileak bere egunkarietan jasotako balorazioei eta batzordeetako kideek tokian tokiko bileretako galde zerrenden bidez azaldukoari Hardvard Graphics programa informatikoa aplikatu nien, eta horrela lortu nuen aurrez ezarritako bost kategoriei buruzko oszilazio-grafikoak: aurretiazko interesa, parte-hartzea, ekarpen kualitatiboak, jarraitzeko motibazioa eta aurreikusitako zailtasunak. @@ Tokian tokiko informazio hori osatzeko, behin lanketa prozesuak amaitu eta gero, batzorde bakoitzarekin talde elkarrizketak egin nituen. Horretaz gain, eta informazio iturri osagarriak gisa, ikerketako momentu desberdinetan biztanleria-ikastolek betetako hiru galde zerrenda erabili ziren: azterketaren hasieran, zuzendarien prestakuntzarako mintegian betetakoa eta lana burututakoan. @@ Datuen analisia: Lan hau garatzeko erabili nuen egiturak lau elementu biltzen ditu: faseak, tresnak, kasuak eta alderdiak. Tokian tokiko lanean oinarrituta bildutako informazio guztia zorrotz-zorrotz landu zen eta zehatz-mehatz aurkeztu zen. Datuen analisiarekin batera triangulazio ezberdin batzuk ere egin nituen. @@ Emaitzen integrazioa: Atal hau, aipatutako egitura berari jarraituta egin zen, lau puntuak -faseak, tresnak, kasuak eta alderdiak- batera hartuta eta, beraz, azken ondorioak izango zirenen hurbilketa nabarmena izan zen. Bestalde, erabilitako informazio iturrien emaitzei dagokionez, ikertzaileak horietako bakoitzaz egin zuen interpretazioa Tesi txostenean adierazten da. Informe honen amaieran berriro heltzen nien tesi proiektuan planteatu nituen galderei, bigarren mailakoak zein funtzezkoak direnak analizatuz eta interpretatuz. @@ Ondorioak: Bi kasu-ikastolen analisi interpretatibo paralelo eta independentea egin nuen -konparaziozko azterketetan sartu gabe-, bai estamentu organoen jarrerei dagokienez (lanketaz arduratu ziren batzordeak, zuzendariak, klaustroak, gestio batzordeak, familiak eta aholkularia), bai prozesuan garrantzitsuak izan diren beste alderdi batzuei dagokionez (ikastolen publifikazioa, prozesuko sentsibilizazioa, metodologia eta dokumentua emaitza gisa). @@ Sentsibilizazioaren sistematizazioa nabarmentzen nuen, harengan eragiten den unearen arabera, lau motatan desberdin behar dela adierazten nuen: aurresentsibilizazioa, hasierakoa, unean unekoa eta prozesukoa. @@ Prozesuko sentsibilizazio etengabea eta eskola elkartearen inplikazioa eta parte-hartzea dokumentuak eskaintzen duen sinesgarritasunarekin erlazionatzeko azken ahalegina egin nuen ondorengo ideia nagusi hau adieraziz: "Ikastola bateko Hezkuntza elkarteak Hezkuntza Proiektua bere egingo du eta ikastolaren dokumentu adierazgarria dela onartuko, baldin prozesuko sentsibilizazioa modu jarraituan eta etengabean garatu bada eta esparru-dokumentua lortzeko prozesuan egin den inplikazio eta parte-hartze planteamenduarekin batera burutu bada". @@ Iradokizunak: Aurrerantzean egin daitezkeen ikerketarako gomendio batzuk egin nituen eta, horietaz gain, indar-ideia gisa, izaera zehatzagoa duten beste batzuk ere agertzen nituen eta, zenbait kasutan, baita baldintza gisako beste batzuk ere, hezkuntza proiektuak lantzeko etorkizunean sor daitezkeen prozesuetan kontuan hartu beharrekoa

Diagnóstico de miocarditis aguda por cardiorresonancia magnética con contraste

La miocarditis es un proceso inflamatorio del músculo cardíaco. Los síntomas suelen ser inespecíficos y pueden simular un síndrome coronario agudo. Si bien la mayoría de los pacientes presentan una recuperación completa, en ocasiones puede desarrollarse una miocardiopatía dilatada e incluso la muerte. Las técnicas diagnósticas disponibles no son satisfactorias y es necesario desarrollar técnicas no invasivas que puedan garantizar un diagnóstico, pronóstico y seguimiento. La resonancia magnética con realce tardío de contraste es una herramienta útil para la valoración de un proceso inflamatorio cardíaco como la miocarditis. Presentamos el caso de un varón de 39 años con dolor torácico, elevación del segmento ST e incremento de marcadores de daño miocárdico tratado inicialmente con trombólisis. La coronariografía mostró unas arterias coronarias angiográficamente normales. El estudio con resonancia magnética mostró captación focal tardía de gadolinio con patrón parcheado típico de miocarditis