Safety of statins when response is carefully monitored: a study of 336 heart recipients

[Abstract] Background. Statins are used as first-line drugs against hypercholesterolemia after heart transplantation. Randomized clinical trials have shown that they reduce cholesterol levels, and the incidence of rejection and coronary vasculopathy. Adverse effects have been related to the use of certain statins, high statin dosages, comorbidities, and coadministration with cyclosporine. However, estimation of the risk of adverse effects for a given patient is difficult. The aims of this study were to determine the incidence of various kinds of adverse effect of statins; to evaluate certain potential risk factors; and to assess the efficacy of early response to signs of adverse effects. Methods. Between April 1991 and December 2003, we retrospectively evaluated 336 heart transplant patients (including 55 women) with regard to the occurrence of possible adverse effects of statins (rhabdomyolysis, myalgia, hepatotoxicity, high CK without muscle symptoms, and others). Resolution on reduction of dosage or discontinuance and/or change of statin were deemed to constitute confirmation of cause. Relations were sought between adverse effects and age, sex, immunosuppressive therapy, kidney failure, body mass index (BMI), arterial hypertension, and diabetes mellitus. Results. Possible adverse events of statins were suffered by 60 patients, all of them men. The causal role of statins was confirmed in 41 (12.2% of all 336): hepatotoxicity was suffered by 13, high CK without muscle ache or weakness by 18, rhabdomyolysis by 5, myalgia by 3, and other effects by 2. The incidence of confirmed statin-related complications was higher among patients with BMI >29 kg/m2 than among those with lower BMI (P = .055). None of the patients with confirmed statin-related complications needed dialysis, none died, and permanent suspension of statin treatment was only necessary in 13 cases (3.9% of the 336). Conclusions. Some 10% to 20% of HT patients appear to suffer adverse side effects of initial statin therapy. However, early detection of such effects through diligent clinical and analytical monitoring allows the therapy to be modified in time to minimize the appearance of severe complications. In only a minority of cases permanent suspension of statin therapy is necessary

Impacto en la mortalidad tras la implantación de una red de atención al infarto agudo de miocardio con elevación del segmento ST: Estudio IPHENAMIC

[Abstract] Introduction and objectives: Little is known about the impact of networks for ST-segment elevation myocardial infarction (STEMI) care on the population. The objective of this study was to determine whether the PROGALIAM (Programa Gallego de Atención al Infarto Agudo de Miocardio) improved survival in northern Galicia. Methods: We collected all events coded as STEMI between 2001 and 2013. A total of 6783 patients were identified and divided into 2 groups: pre-PROGALIAM (2001-2005), with 2878 patients, and PROGALIAM (2006-2013), with 3905 patients. Results: In the pre-PROGALIAM period, 5-year adjusted mortality was higher both in the total population (HR, 1.22, 95%CI, 1.14-1.29; P <.001) and in each area (A Coruña: HR, 1.12; 95%CI, 1.02-1.23; P=.02; Lugo: HR, 1.34; 95%CI, 1.2-1.49; P <.001 and Ferrol: HR, 1.23; 95%CI, 1.1-1.4; P=.001). Before PROGALIAM, 5-year adjusted mortality was higher in the areas of Lugo (HR, 1.25; 95%CI, 1.05-1.49; P=.02) and Ferrol (HR, 1.32; 95%CI, 1.13-1.55; P=.001) than in A Coruña. These differences disappeared after the creation of the STEMI network (Lugo vs A Coruña: HR, 0.88; 95%CI, 0.72-1.06; P=.18, Ferrol vs A Coruña: HR, 1.04; 95%CI, 0.89-1.22; P=.58. Conclusions: For patients with STEMI, the creation of PROGALIAM in northern Galicia decreased mortality and increased equity in terms of survival both overall and in each of the areas where it was implemented. This study was registered at ClinicalTrials.gov (Identifier: NCT02501070).[Resumen] Introducción y objetivos. Se sabe muy poco del impacto que las redes de atención del infarto agudo de miocardio con elevación del segmento ST (IAMCEST) tienen en la población. El objetivo de este estudio es averiguar si el PROGALIAM (Programa Gallego de Atención al Infarto Agudo de Miocardio) mejoró la supervivencia en la zona norte de Galicia. Métodos. Se recogieron todos los eventos codificados como IAMCEST entre 2001 y 2013. Se identificó a 6.783 pacientes, divididos en 2 grupos: pre-PROGALIAM (2001-2005), 2.878 pacientes, y PROGALIAM (2006-2013), 3.905 pacientes. Resultados. En la etapa pre-PROGALIAM, la mortalidad ajustada a 5 años fue superior tanto en la población total (HR = 1,22; IC95%, 1,14-1,29; p < 0,001), como en cada una de las áreas (A Coruña, HR = 1,12; IC95%, 1,02-1,23; p = 0,02; Lugo, HR = 1,34; IC95%, 1,2-1,49; p < 0,001, y Ferrol, HR = 1,23; IC95%, 1,1-1,4; p = 0,001). Antes del PROGALIAM, la mortalidad a 5 años en las áreas de Lugo (HR = 0,8; IC95%, 0,67-0,95; p = 0,02) y Ferrol (HR = 0,75; IC95%, 0,64-0,88; p = 0,001) era superior que en A Coruña. Estas diferencias desaparecieron tras el desarrollo de la red (Lugo comparado con A Coruña, HR = 0,88; IC95%, 0,72-1,06; p = 0,18; Ferrol comparado con A Coruña, HR = 1,04; IC95%, 0,89-1,22; p = 0,58. Conclusiones. El desarrollo del PROGALIAM en el área norte de Galicia disminuyó la mortalidad e incrementó la equidad de los pacientes con IAMCEST tanto en general como en cada una de las áreas donde se implantó. Estudio registrado en ClinicalTrials.gov (Identificador: NCT02501070)

Long-term results of heart transplant in recipients older and younger than 65 years: a comparative study of mortality, rejections, and neoplasia in a cohort of 445 patients

[Resumen] Background. Whether being older than 65 years should be considered an absolute counterindication to heart transplant (HT), as it is in some centers, is controversial. In our centre, patients older than 65 years are accepted for HT if they satisfy stringent conditions. The aim of this study was to examine whether heart recipients older than 65 years have a greater risk of rejection, neoplasia, or mortality than younger ones. Methods. We studied 445 patients who underwent HT between April 1991 and December 2003, 42 of whom were older than 65 years and 403 who were 65 years or younger. The parameters evaluated were the cumulative incidences of neoplasias and rejections (ISHLT grade ≥ 3A), and the survival rates 1 month, 1 year, and 5 years post-HT. Results. The two groups had similar percentages of patients with at least one rejection episode (≤65 years 56.9%, >65 years 51.3%; P > .05), and although there were proportionally almost twice as many tumors in the older group (14.2%) as in the younger (7.9%), this difference was not statistically significant either. Nor were there any significant differences in survival, the 1-month, 1-year, and 5-year rates being 87.8%, 82.1%, and 68.8%, respectively, in the younger group and 85.7%, 78.6%, and 73.4%, respectively, in the older. Conclusions. Among carefully selected patients aged more than 65 years, HT can be performed without incurring greater risk of rejection, malignancy, or death than is found among recipients younger than 65 years

Solar Thermal Collector Output Temperature Prediction by Hybrid Intelligent Model for Smartgrid and Smartbuildings Applications and Optimization

Currently, there is great interest in reducing the consumption of fossil fuels (and other non-renewable energy sources) in order to preserve the environment; smart buildings are commonly proposed for this purpose as they are capable of producing their own energy and using it optimally. However, at times, solar energy is not able to supply the energy demand fully; it is mandatory to know the quantity of energy needed to optimize the system. This research focuses on the prediction of output temperature from a solar thermal collector. The aim is to measure solar thermal energy and optimize the energy system of a house (or building). The dataset used in this research has been taken from a real installation in a bio-climate house located on the Sotavento Experimental Wind Farm, in north-west Spain. A hybrid intelligent model has been developed by combining clustering and regression methods such as neural networks, polynomial regression, and support vector machines. The main findings show that, by dividing the dataset into small clusters on the basis of similarity in behavior, it is possible to create more accurate models. Moreover, combining different regression methods for each cluster provides better results than when a global model of the whole dataset is used. In temperature prediction, mean absolute error was lower than 4 ∘ C.info:eu-repo/semantics/publishedVersio

Amiloidosis cardiaca por cadenas ligeras y por transtirretina: características clínicas, historia natural y predictores pronósticos

[Abstract] Introduction and objectives. Light-chain amyloidosis (AL-CA) and transthyretin amyloidosis (ATTR-CA) are the most common types of cardiac amyloidosis (CA). We sought to study the clinical characteristics and prognosis of both diseases. Methods. We conducted a single-centre, retrospective review of all patients diagnosed with CA between 1998 and 2018. Clinical characteristics, complementary tests, survival and other adverse clinical events were studied. Results. We identified 105 patients with CA, 65 ATTR-CA and 40 AL-CA. Mean age was 74.4 years; 24.8% were women. In both groups, heart failure was the most frequent clinical presentation (55.2%). The most prevalent electrocardiographic findings were the pseudoinfarct pattern (68.5%) and a Sokolow-Lyon index <1.5 mV (67.7%), with no differences between the two subtypes of CA. One-year, 3-year, and 5-year survival was 43.3%, 40.4% and 35.4%, respectively, in AC-AL patients, and 85.1%, 57.3% and 31.4% in AC-ATTR patients (p = .004). AL-CA subtype (HR 3.41, CI95% 1.45−8.06, p = .005), previous admission for heart failure (HR 4.25, 95% CI 1.63−11.09, p = .003) and a NYHA class III-IV (HR 2.76, 95% CI 1.09−7.03, p = .033) were independent predictors of mortality, while beta-blocker therapy was associated with longer survival (HR .23, 95% CI .09–.59, p = .002). Conclusions. Differences exist between the clinical presentation of AL-CA and ATTR-CA patients. Both diseases, particularly AL-CA, are associated with poor life prognosis.[Resumen] Antecedentes y objetivos. La amiloidosis cardiaca (AC) por cadenas ligeras (AC-AL) y por transtirretina (AC-ATTR) son los dos subtipos más frecuentes de la enfermedad. Nos propusimos caracterizar clínicamente estas entidades y analizar su pronóstico. Material y métodos. Realizamos una revisión retrospectiva de todos los pacientes diagnosticados de AC entre 1998 y 2018 en un centro español. Además de recoger las características clínicas y los resultados de las pruebas complementarias al diagnóstico, analizamos la supervivencia y la incidencia de desenlaces clínicos adversos. Resultados. Identificamos 105 pacientes con AC, 65 AC-ATTR y 40 AC-AL. La edad media era de 74,4 años; el 24,8% eran mujeres. En ambos grupos la insuficiencia cardiaca (IC) fue la forma de presentación clínica más frecuente (55,2%). Los hallazgos electrocardiográficos más prevalentes fueron el patrón de pseudoinfarto (68,5%) y un índice de Sokolow-Lyon <1,5 mV (67,7%), sin diferencias entre los dos subtipos. La supervivencia a 1, 3 y 5 años fue del 43,3%, 40,4% y 35,4%, respectivamente, en pacientes con AC-AL y de 85,1%, 57,3% y 31,4% en pacientes con AC-ATTR (p = 0,004). El subtipo AC-AL (HR 3,41, IC95% 1,45-8,06, p = 0,005), el ingreso previo por IC (HR 4,25, IC95% 1,63-11,09, p = 0,003) y una clase NYHA III-IV (HR 2,76, IC95% 1,09-7,03, p = 0,033) fueron predictores independientes de mortalidad, mientras que el tratamiento betabloqueante se asoció con una mayor supervivencia (HR 0,23, IC95% 0,09-0,59, p = 0,002). Conclusiones. Existen ciertas diferencias en la presentación clínica de los pacientes con AC-AL y AC-ATTR. Ambas entidades, y muy especialmente la AC-AL, presentan un pobre pronóstico vital

Prevalence, etiology, and outcome of catheterization laboratory false alarms in patients with suspected ST-elevation myocardial infarction

[Abstract] Introduction and objectives. To investigate the prevalence, causes and outcome of catheterization laboratory false alarms (CLFAs) in a regional primary angioplasty network. Methods. A prospective registry of 1,662 patients referred for primary angioplasty between January 2003 and August 2008 was reviewed to identify CLFAs (i.e. when no culprit coronary lesion could be found). Results. No culprit coronary lesion could be identified in 120 patients (7.2%; 95% confidence interval [CI], 5.9- 8.5%). Of these, 104 (6.3%, 95% CI, 5.1-7.4%) had a discharge diagnosis other than ST-elevation myocardial infarction, 91 (5.5%; 95% CI, 4.3-6.6%) had no significant coronary disease, and 64 (3.8%; 95% CI, 2.9-4.8%) tested negative for cardiac biomarkers. The most frequent alternative diagnoses were: previous Q-wave myocardial infarction (18 cases), nonspecific ST-segment abnormalities (11), pericarditis (10) and transient apical dyskinesia (10). The 30-day mortality rate was similar in patients with and without culprit lesions (5.8% vs. 5.8%; P=.99). The prevalence of CLFAs was slightly higher in patients not previously evaluated by a cardiologist and referred from emergency departments in hospitals without catheterization laboratories than in those referred by cardiologists from emergency departments at hospitals with such facilities (9.5% vs. 6.1%; P=.02; odds ratio=1.64; 95% CI, 1.08-2.5). The prevalence of CLFAs was not significantly higher in patients referred by physicians with out-of-hospital emergency medical services (7.2%; P=.51; odds ratio=1.37; 95% CI, 0.79-2.37). Conclusions. The prevalence of CLFAs was 7.2%, with the criterion of no culprit coronary lesion. Our findings suggest that different patterns of referral to catheterization laboratories could account for small variations in the prevalence of CLFAs.[Resumen] Introducción y objetivos. Determinar prevalencia, causas y pronóstico de las «falsas alarmas» al laboratorio de hemodinámica (FALH) en una red regional de angioplastia primaria. Métodos. Registro prospectivo de 1.662 pacientes remitidos para angioplastia primaria entre enero de 2003 y agosto de 2008. Se definió FALH como ausencia de lesión coronaria causal. Resultados. En 120 pacientes (7,2%; intervalo de confianza [IC] del 95%, 5,9-8,5) no se identificó ninguna lesión coronaria causal. De ellos, 104 (6,3%; IC del 95%, 5,1-7,4) recibieron un diagnóstico alternativo a IAMCEST, 91 (5,5%; IC del 95%, 4,3-6,6) no presentaron enfermedad coronaria significativa y 64 (3,8%; IC del 95%, 2,9-4,8) presentaron marcadores de daño miocárdico negativos. Los diagnósticos alternativos más frecuentes fueron: infarto con onda Q previo (18 casos), alteraciones inespecíficas del segmento ST (11), pericarditis (10) y discinesia apical transitoria (10). La mortalidad a 30 días fue similar en los pacientes con y sin lesión causal (el 5,8 frente al 5,8%; p = 0,99). La prevalencia de FALH fue discretamente superior entre los pacientes remitidos desde los servicios de urgencias de hospitales no intervencionistas sin evaluación previa por un cardiólogo que entre los remitidos por cardiólogos desde el servicio de urgencias del hospital intervencionista (el 9,5 frente al 6,1%; p = 0,02; odds ratio [OR] = 1,64; IC del 95%, 1,08-2,5). No observamos un exceso de FALH entre los pacientes remitidos por médicos de UVI Móviles-061 (7,2%; p = 0,51; OR = 1,37; IC del 95%, 0,79-2,37). Conclusiones. Hemos observado una prevalencia de FALH del 7,2% de acuerdo con el criterio de ausencia de lesión coronaria causal. Nuestros resultados indican que diferentes modelos de activación del laboratorio de hemodinámica podrían justificar discretas variaciones en la prevalencia de FALH

Presence of Bacterial DNA in Thrombotic Material of Patients with Myocardial Infarction

[Abstract] Infectious agents have been suggested to be involved in etiopathogenesis of Acute Coronary Syndrome (ACS). However, the relationship between bacterial infection and acute myocardial infarction (AMI) has not yet been completely clarified. The objective of this study is to detect bacterial DNA in thrombotic material of patients with ACS with ST-segment elevation (STEMI) treated with Primary Percutaneous Coronary Intervention (PPCI). We studied 109 consecutive patients with STEMI, who underwent thrombus aspiration and arterial peripheral blood sampling. Testing for bacterial DNA was performed by probe-based real-time Polymerase Chain Reaction (PCR). 12 probes and primers were used for the detection of Aggregatibacter actinomycetemcomitans, Chlamydia pneumoniae, viridans group streptococci, Porphyromonas gingivalis, Fusobacterium nucleatum, Tannarella forsythia, Treponema denticola, Helycobacter pylori, Mycoplasma pneumoniae, Staphylococus aureus, Prevotella intermedia and Streptococcus mutans. Thus, DNA of four species of bacteria was detected in 10 of the 109 patients studied. The most frequent species was viridans group streptococci (6 patients, 5.5%), followed by Staphylococus aureus (2 patients, 1.8%). Moreover, a patient had DNA of Porphyromonas gingivalis (0.9%); and another patient had DNA of Prevotella intermedia (0.9%). Bacterial DNA was not detected in peripheral blood of any of our patients. In conclusion, DNA of four species of endodontic and periodontal bacteria was detected in thrombotic material of 10 STEMI patients. Bacterial DNA was not detected in the peripheral blood of patients with bacterial DNA in their thrombotic material. Bacteria could be latently present in plaques and might play a role in plaque instability and thrombus formation leading to ACS

Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease

[Resumen] Introducción y objetivos. Los estudios económicos pueden ayudar a tomar decisiones en el tratamiento de la enfermedad multivaso en el infarto. Se planteó realizar una evaluación económica del ensayo clínico CROSS-AMI (Complete Revascularization or Stress Echocardiography in Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction). Métodos. Se realizó un análisis de comparación de costes económicos de las estrategias (revascularización angiográfica completa [RCom] y revascularización selectiva guiada por isquemia en ecocardiograma de estrés [RSel]) comparadas en el ensayo clínico CROSS-AMI (N = 306), derivados de la hospitalización inicial y del primer año de seguimiento, según las tarifas oficiales vigentes en nuestro sistema de salud. Resultados. El coste de la hospitalización inicial resultó superior en el grupo de RCom que en la rama de RSel (19.657,9 ± 6.236,8 frente a 14.038,7 ± 4.958,5 euros; p < 0,001). No hubo diferencias entre ambos grupos en el coste del primer año de seguimiento (RCom, 2.423,5 ± 4.568,0 euros; Rsel, 2.653,9 ± 5.709,1 euros; p = 0,697). El coste total fue 22.081,3 ± 7.505,6 euros en la rama de RCom y 16.692,6 ± 7.669,9 euros en la rama de RSel (p < 0,001). Conclusiones. En el ensayo clínico CROSS-AMI, el sobrecoste inicial de la RCom frente a la RSel no se vio compensado por un ahorro significativo en el seguimiento. La RSel parece ser una estrategia más eficiente que la RCom para los pacientes con síndrome coronario agudo con elevación del segmento ST y enfermedad multivaso tratados mediante angioplastia emergente.[Abstract] Introduction and objectives. Economic studies may help decision making in the management of multivessel disease in the setting of myocardial infarction. We sought to perform an economic evaluation of CROSS-AMI (Complete Revascularization or Stress Echocardiography in Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction) randomized clinical trial. Methods. We performed a cost minimization analysis for the strategies (complete angiographic revascularization [ComR] and selective stress echocardiography–guided revascularization [SelR]) compared in the CROSS-AMI clinical trial (N = 306), attributable the initial hospitalization and readmissions during the first year of follow-up, using current rates for health services provided by our health system. Results. The index hospitalization costs were higher in the ComR group than in SelR arm (19 657.9 ± 6236.8 € vs 14 038.7 ± 4958.5 €; P < .001). There were no differences in the costs of the first year of follow-up rehospitalizations between both groups for (ComR 2423.5 ± 4568.0 vs SelR 2653.9 ± 5709.1; P = .697). Total cost was 22 081.3 ± 7505.6 for the ComR arm and 16 692.6 ± 7669.9 for the SelR group (P < .001). Conclusions. In the CROSS-AMI trial, the initial extra economic costs of the ComR versus SelR were not offset by significant savings during follow-up. SelR seems to be more efficient than ComR in patients with ST-segment elevation acute coronary syndrome and multivessel disease treated by emergent angioplasty