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Aim: To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years. Materials & methods: Postauthorization, observational, multicenter study, in which atrial fibrillation patients, treated with rivaroxaban ≥6 months were included. Results: A total of 1421 patients (74.2 ± 9.7 years, CHA 2 DS 2 -VASc 3.5 ± 1.6) were included. Overall, 22.9% received rivaroxaban 15 mg. The proper dose of rivaroxaban was taken by 83.3% (9.7% underdosed, 7.0% overdosed). Older age and renal insufficiency were associated with inadequate rivaroxaban dosage. There was a trend toward higher all-cause mortality among underdosed patients (adjusted hazard ratio 1.39; 95% CI 0.75–2.58), and more bleedings in overdosed patients (2.29 vs 0.80 events/100 patient-years; p = 0.14). Conclusion: In clinical practice, rivaroxaban is properly dosed in most patients.

Resumen Introduccion y objetivos La insuficiencia cardiaca (IC) avanzada conlleva altas tasas de hospitalizacion y mortalidad. El estudio LION-HEART fue un ensayo clinico aleatorizado y controlado con placebo que evaluo la eficacia y la seguridad de la administracion intravenosa de dosis intermitentes de levosimendan en pacientes ambulatorios con IC avanzada. El objetivo del presente estudio es realizar un analisis de costes para determinar si la menor tasa de hospitalizaciones por IC observada en pacientes tratados con levosimendan en el estudio LION-HEART puede generar ahorros para el Sistema Nacional de Salud, en comparacion con la opcion de no tratar a los pacientes con IC avanzada. Metodos Se realizo un modelo economico que incluyo las tasas de hospitalizacion por IC del estudio LION-HEART y los costes de hospitalizacion por IC y de adquisicion y administracion intravenosa de levosimendan. El horizonte temporal del analisis fue de 12 meses. Se realizaron 2 analisis, uno deterministico y otro probabilistico (simulacion de Monte Carlo de segundo orden). Resultados Segun el analisis deterministico, el ahorro total por cada paciente tratado con levosimendan ascenderia a –698,48 euros. En el analisis probabilistico, el ahorro por paciente tratado con levosimendan seria de –849,94 (IC95%, 133,12 a –2.255,31) euros. La probabilidad de que se produzcan ahorros con levosimendan en comparacion con la opcion de no tratar seria del 94,8%. Conclusiones El tratamiento ambulatorio intermitente con levosimendan puede generar ahorros para el Sistema Nacional de Salud, en comparacion con la opcion de no tratar a los pacientes con IC avanzada.

Introduction and objectives Advanced heart failure (HF) leads to high hospitalization and mortality rates. The LION-HEART study was a randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of intravenous administration of intermittent doses of levosimendan in outpatients with advanced HF. The aim of the present study was to perform a cost analysis to determine whether the lower rate of hospitalizations for HF, observed in patients treated with levosimendan in the LION-HEART study, can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF. Methods An economic model was used that included IC hospitalization rates from the LION-HEART study, the costs of hospitalization due to HF and those of the acquisition and intravenous administration of levosimendan. The time horizon of the analysis was 12 months. Two analyses were carried out, one deterministic and the other probabilistic (second-order Monte Carlo simulation). Results In the deterministic analysis, the total saving for each patient treated with levosimendan would amount to − €698.48. In the probabilistic analysis, the saving per patient treated with levosimendan would be − €849.94 (95%CI, €133.12 to − €2,255.31). The probability of savings with levosimendan compared with the no treatment option would be 94.8%. Conclusions Intermittent ambulatory treatment with levosimendan can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF.

INTRODUCTION AND OBJECTIVES The present report updates the characteristics and results of heart transplantation in Spain, mainly focused in the 2008-2017 period. METHODS We describe the recipient and donor characteristics, surgical procedures, and outcomes of heart transplants performed in 2017. The 2017 data were compared with those obtained from 2008 to 2016. RESULTS A total of 304 cardiac transplants were performed in 2017. Between 1984 and 2017, 8173 procedures were performed, 2689 of them after 2008. Significant temporal trends were observed in recipient characteristics (lower pulmonary vascular resistance, lower use of mechanical ventilation, and a higher percentage of diabetic patients and those with previous cardiac surgery), donor characteristics (older donor age and a higher percentage of female donors and those with a prior cardiac arrest) and procedures (lower ischemia time). In 2017, 27% of patients were transplanted after undergoing mechanical ventricular assistance (P

Resumen La insuficiencia cardiaca tiene una elevada prevalencia y es el proceso asistencial con mayor carga de enfermedad en Espana. Las unidades de insuficiencia cardiaca se han desarrollado para sistematizar el diagnostico, el tratamiento y el seguimiento clinico de los pacientes con dicha enfermedad proporcionando una estructura que coordine las actuaciones de distintas entidades y personas implicadas en el cuidado de los pacientes, con el fin ultimo de mejorar su pronostico y la calidad de vida. Se dispone de amplia evidencia sobre las bondades de las unidades o los programas de insuficiencia cardiaca, y estas unidades han tenido un importante despliegue en nuestro pais. Uno de los retos a los que se enfrenta el analisis de las unidades de insuficiencia cardiaca es normalizar su clasificacion determinando que «programas» se puede identificar como «unidades» de insuficiencia cardiaca, asi como su nivel de complejidad, y cuales no. La finalidad de este documento es exponer los estandares elaborados por la Sociedad Espanola de Cardiologia para clasificar y establecer los requisitos para las unidades de insuficiencia cardiaca dentro del marco del proyecto SEC-Excelente.

Acute heart failure (AHF) requires considerable use of resources, is an economic burden, and is associated with high complication and mortality rates in emergency departments, on hospital wards, or outpatient care settings. Diagnosis, treatment, and continuity of care are variable at present, leading 3 medical associations (for cardiology, internal medicine, and emergency medicine) to undertake discussions and arrive at a consensus on clinical practice guidelines to support those who manage AHF and encourage standardized decision making. These guidelines, based on a review of the literature and clinical experience with AHF, focus on critical points in the care pathway. Regarding emergency care, the expert participants considered the initial evaluation of patients with signs and symptoms that suggest AHF, the initial diagnosis, first decisions about therapy, monitoring, assessment of prognosis, and referral criteria. For care of the hospitalized patient, the group developed a protocol for essential treatment. Objectives for the management and treatment of AHF on discharge were also covered through the creation or improvement of multidisciplinary care systems to provide continuity of care.La insuficiencia cardiaca aguda (ICA) supone un elevado uso de recursos, carga económica y morbimortalidad, tanto en los servicios de urgencias como durante la hospitalización o durante su control ambulatorio. La variabilidad actual existente en el diagnóstico, tratamiento y la continuidad asistencial ha inducido que diferentes sociedades científicas (cardiología, medicina interna y urgencias) redacten este documento de consenso sobre recomendaciones prácticas que den soporte a todos los profesionales intervinientes en el manejo de la ICA y permita homogeneizar la toma de decisiones. El enfoque de estas recomendaciones, basadas en la revisión de la literatura y la experiencia clínica, se ha realizado abarcando diferentes puntos críticos del proceso asistencial de los pacientes con ICA: en el servicio de urgencias, en cuanto a la evaluación inicial del paciente con clínica sugestiva de ICA, orientación diagnóstica, primeras decisiones terapéuticas, monitorización, evaluación del pronóstico y criterios de derivación; durante la hospitalización, con el desarrollo de un protocolo básico terapéutico; tras el alta, con la definición de objetivos de manejo y tratamiento de la ICA al alta del paciente; y de forma global, mediante la mejora o creación de una organización en la atención multidisciplinar y la continuidad asistencial en la ICA.

Cardiac allograft vasculopathy remains one of the major causes of death post-heart transplantation. Its etiology is multifactorial and prevention is challenging. The aim of this study was to prospectively determine factors related to cardiac allograft vasculopathy after heart transplantation. This research was planned on 179 patients submitted to heart transplant. Performance of an early coronary angiography with endothelial function evaluation was scheduled at three-month post-transplant. Patients underwent a second coronary angiography after five-yr follow-up. At the 5- ± 2-yr follow-up, 43% of the patients had developed cardiac allograft vasculopathy (severe in 26% of them). Three independent predictors of cardiac allograft vasculopathy were identified: cardiogenic shock at the time of the transplant operation (OR: 6.49; 95% CI: 1.86-22.7, p = 0.003); early coronary endothelial dysfunction (OR: 3.9; 95% CI: 1.49-10.2, p = 0.006), and older donor age (OR: 1.05; 95% CI: 1.00-1.10, p = 0.044). Besides early endothelial coronary dysfunction and older donor age, a new predictor for development of cardiac allograft vasculopathy was identified: cardiogenic shock at the time of transplantation. In these high-risk patient subgroups, preventive measures (treatment of cardiovascular risk factors, use of novel immunosuppressive agents such as mTOR inhibitors) should be earlier and much more aggressive.

Percutaneous coronary intervention (PCI) improves prognosis in patients with acute coronary syndromes (ACS) reducing ischaemic complications and the development of heart failure, thus potentially changing invasive mechanical ventilation (IMV) requirements. Little information exists about patients with ACS requiring IMV in the current era. We aimed to analyze IMV requirements and characteristics of ACS patients treated under current recommendations (including a high rate of PCI).Baseline characteristics, indications for IMV, management and in-hospital and mid-term clinical course were analyzed prospectively in a consecutive series of patients with ACS admitted to a tertiary care hospital.We included 1821 patients, of which 106 (5.8%) required IMV. Mean follow-up was 347 days. PCI was performed in 84% of cases. Patients with IMV had more comorbidities, worse left ventricular function and more unstable hemodynamic parameters on admission. In-hospital mortality in patients requiring IMV was 29%. These patients also had higher mid-term mortality (hazard ratio (HR) 6.58; 95% confidence interval (CI) 4.49-9.64; p 0.001). The most common indication for IMV was cardiopulmonary arrest (CA) (65; 61%), followed by pulmonary oedema (27; 26%) and shock (14; 13.2%). Patients with CA were younger, with better hemodynamic parameters at admission, more favourable coronary anatomy and higher rates of PCI. There were no significant differences in overall mortality between the three groups. The main cause of death in CA patients was persistent vegetative state.Mortality in patients with ACS requiring IMV remained high despite a high rate of PCI. Baseline characteristics, management and clinical course were different according to the reason for IMV. The most common cause for IMV requirement was CA.

La Seccion de Insuficiencia Cardiaca, Trasplante Cardiaco y otras Alternativas Terapeuticas de la Sociedad Espanola de Cardiologia desarrollo en Sevilla, en junio de 2005, una Conferencia de Consenso sobre trasplante cardiaco (TC) a la que fueron invitados a participar todos los grupos espanoles de TC. El objetivo fue determinar, discutir y consensuar los aspectos mas relevantes y/o controvertidos de diferentes areas del TC en la actualidad: organizacion, seleccion del receptor, donantes, rechazo, inmunosupresion, enfermedad vascular del injerto, complicaciones a largo plazo y TC pediatrico. Este documento reune las recomendaciones del grupo de trabajo incluyendo el grado de evidencia con que se respalda cada una.

Neoplasia is a common and serious complication that occurs after heart transplantation and is one of the most important causes of death over the long term. The Spanish Post-Heart-Transplant Tumor Registry, which began in 2004, is an on-line record of all patients who have undergone heart transplantation in Spain. It includes continually updated information on post-transplantation tumors. The most common neoplasias are skin tumors (54%), followed by noncutaneous, nonlymphoid tumors (39%) and lymphomas (7%). Their incidence increases with age and time from transplantation and is higher in males. After 15 years, only 62% of patients are tumor-free. Prognosis varies according to the type of tumor. The incidence of lymphomas has decreased by half in the last decade. The Registry provides useful information on the incidence, risk factors and prognosis of tumors that occur after transplantation and can help in devising better management strategies.

Barge-Caballero, E., Segovia-Cubero, J., Gonzalez-Vilchez, F., Delgado-Jimenez, J., Perez-Villa, F., Almenar-Bonet, L., Arizon-Del Prado, J.L., Lage-Galle, E., De La Fuente-Galan, L., Manito-Lorite, N., Sanz-Julve, M., Villa-Arranz, A., Lambert Rodriguez, J.L., Brossa-Loidi, V., Pascual-Figal, D., Muniz-Garcia, J., Crespo-Leiro, M.

Background A number of changes in the management of heart transplantation (HT) patients have each tended to reduce the risk of post-HT hematologic cancer, but little information is available concerning the overall effect on incidence in the HT population. Methods Comparison of data from the Spanish Post-Heart-Transplantation Tumour Registry for the periods 1991–2000 and 2001–2010. Results The incidence among patients who underwent HT in the latter period was about half that observed in the former, with a particularly marked improvement in regard to incidence more than five yr post-HT. Conclusions Changes in HT patient management have jointly reduced the risk of hematologic cancer in the Spanish HT population. Long-term risk appears to have benefited more than short-term risk.

[Abstract] Objectives. We sought to investigate the potential impact of preoperative short-term mechanical circulatory support (MCS) with extracorporeal devices on postoperative outcomes after emergency heart transplantation (HT). Methods. We conducted an observational study of 669 patients who underwent emergency HT in 15 Spanish hospitals between 2000 and 2009. Postoperative outcomes of patients bridged to HT on short-term MCS (n = 101) were compared with those of the rest of the cohort (n = 568). Short-term MCS included veno-arterial extracorporeal membrane oxygenators (VA-ECMOs, n = 23), and both pulsatile-flow (n = 53) and continuous-flow (n = 25) extracorporeal ventricular assist devices (VADs). No patient underwent HT on intracorporeal VADs. Results. Preoperative short-term MCS was independently associated with increased in-hospital postoperative mortality (adjusted odds-ratio 1.75, 95% CI 1.05–2.91) and overall post-transplant mortality (adjusted hazard-ratio 1.60, 95% CI 1.15–2.23). Rates of major surgical bleeding, cardiac reoperation, postoperative infection and primary graft failure were also significantly higher among MCS patients. Causes of death and survival after hospital discharge were similar in MCS and non-MCS candidates. Increased risk of post-transplant mortality affected patients bridged on pulsatile-flow extracorporeal VADs (adjusted hazard-ratio 2.21, 95% CI 1.48–3.30) and continuous-flow extracorporeal VADs (adjusted hazard-ratio 2.24, 95% CI 1.20–4.19), but not those bridged on VA-ECMO (adjusted hazard-ratio 0.51, 95% CI 0.21–1.25). Conclusions. Patients bridged to emergency HT on short-term MCS are exposed to an increased risk of postoperative complications and mortality. In our series, preoperative bridging with VA-ECMO resulted in comparable post-transplant outcomes to those of patients transplanted on conventional support.

Background— Postoperative outcomes of patients with advanced heart failure undergoing ventricular assist device implantation are strongly influenced by their preoperative Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles. We sought to investigate whether a similar association exists in patients undergoing emergency heart transplantation. Methods and Results— By means of the Spanish National Heart Transplant Registry database, we identified 704 adult patients treated with emergency heart transplantation in 15 Spanish centers between 2000 and 2009. Post-transplant outcomes were analyzed pertaining to patient preoperative INTERMACS profiles, which were retrospectively assigned by 2 blinded cardiologists. Before transplantation, INTERMACS profile 1 (critical cardiogenic shock) was present in 207 patients, INTERMACS profile 2 (progressive decline) in 291, INTERMACS profile 3 (inotropic dependence) in 176, and INTERMACS profile 4 (resting symptoms) was present in 30 patients. In-hospital postoperative mortality rates were, respectively, 43%, 26.8%, and 18% in patients with profiles 1, 2, and 3 to 4 ( P P =0.03) and postoperative need for dialysis (1: 33.2%, 2: 18.9%, 3–4: 21.5%; P Conclusions— Preoperative INTERMACS profiles determine outcomes after emergency heart transplantation. Results call for a change in policies related to the management of heart transplant candidates presenting with INTERMACS profiles 1 and 2.

Heart failure is a very prevalent disease in the general population, but more so in the elderly. It has a very high morbidity and mortality and it is a growing public health problem. Half of the patients with heart failure have a reduced left ventricular ejection fraction and fewer have a left bundle branch block, which is our currently best selection criterion to identify electrical and mechanical dyssynchrony. When these patients are severely symptomatic despite adequate medical treatment of their heart failure, implantation of a biventricular pacemaker can resynchronize the ventricles and induce a reverse remodelling of the left ventricle and marked symptomatic improvement.

[Abstract] In this study we analyzed Spanish Post-Heart-Transplant Tumour Registry data for adult heart transplantation (HT) patients since 1984. Median post-HT follow-up of 4357 patients was 6.7 years. Lung cancer (mainly squamous cell or adenocarcinoma) was diagnosed in 102 (14.0% of patients developing cancers) a mean 6.4 years post-HT. Incidence increased with age at HT from 149 per 100 000 person-years among under-45s to 542 among over-64s; was 4.6 times greater among men than women; and was four times greater among pre-HT smokers (2169 patients) than nonsmokers (2188). The incidence rates in age-at-diagnosis groups with more than one case were significantly greater than GLOBOCAN 2002 estimates for the general Spanish population, and comparison with published data on smoking and lung cancer in the general population suggests that this increase was not due to a greater prevalence of smokers or former smokers among HT patients. Curative surgery, performed in 21 of the 28 operable cases, increased Kaplan–Meier 2−year survival to 70% versus 16% among inoperable patients.

[Abstract] Introduction. Malignancy is a major complication in the management of solid organ transplant patients. Skin cancers show a better prognosis than other neoplasms, but not all others are equal: Ideally, patient management must take into account the natural history of each type of cancer in relation to the transplanted organs. We sought to determine the prognosis of various groups of noncutaneous nonlymphomatous (NCNL) cancers after heart transplantation (HT). Methods. We retrospectively analyzed the records of the Spanish Post-Heart-Transplant Tumour Registry, which collects data on posttransplant tumors in all patients who have undergone HT in Spain since 1984. Data were included in the study up to December 2008. We considered only the first NCNL post-HT tumors. Results. Of 4359 patients, 375 developed an NCNL cancer. The most frequent were cancers of the lung (n = 97; 25.9%); gastrointestinal tract (n = 52; 13.9%); prostate gland (n = 47; 12.5%; 14.0% of men), bladder (n = 32; 8.5%), liver (n = 14; 3.7%), and pharynx (n = 14; 3.7%), as well as Kaposi's sarcoma (n = 11; 2.9%). The corresponding Kaplan-Meier survival curves differed significantly (P < .0001; log-rank test), with respective survival rates of 47%, 72%, 91%, 73%, 36%, 64%, and 73% at 1 year versus 26%, 62%, 89%, 56%, 21%, 64%, and 73% at 2 years; and 15%, 51%, 77%, 42%, 21%, 64%, and 52% at 5 years post-diagnosis, respectively. Conclusion. Mortality among HT patients with post-HT NCNL solid organ cancers was highest for cancers of the liver or lung (79%–85% at 5 years), and lowest for prostate cancer (23%).

Introduccion y objetivos Se han elaborado unas recomendaciones de tratamiento de la insuficiencia cardiaca a partir de la revision sistematica de la evidencia disponible sobre los distintos tratamientos farmacologicos. Material y metodos La revision se ha centrado en el tratamiento de la insuficiencia cardiaca cronica y sistolica. Se identificaron todos los estudios publicados en ingles sobre los tratamientos farmacologicos de la insuficiencia cardiaca. Para cada tratamiento se clasificaron las evidencias en funcion de: a) variables de eficacia (reduccion de la mortalidad y de los ingresos hospitalarios, mejoria de la clase funcional, fraccion de eyeccion y de la tolerancia al ejercicio), y b) nivel de calidad de la evidencia segun una escala de evaluacion. Tambien se revisaron las evidencias sobre las comparaciones y las combinaciones de los tratamientos, y sobre su toxicidad y costes. Resultados Las pautas de tratamiento han sido definidas en funcion de la clase funcional de la NYHA y se han clasificado en las categorias A, B o C segun el nivel de calidad de la evidencia disponible. Las evidencias de mortalidad se han considerado las mas importantes. Se han tenido en cuenta los farmacos de primera eleccion, las alternativas y otros posibles tratamientos. Conclusiones Se dispone de suficiente informacion para elaborar recomendaciones terapeuticas en todas las fases de la insuficiencia cardiaca basadas en evidencias sobre variables, como la reduccion de la mortalidad o de los ingresos hospitalarios. Esto pone de manifiesto el interes y la prioridad de utilizarlas en el proceso de evaluacion y mejora de resultados en este proceso patologico.