Predicting Cardiovascular Events in Familial Hypercholesterolemia: The SAFEHEART Registry (Spanish Familial Hypercholesterolemia Cohort Study).

BACKGROUND: Although risk factors for atherosclerotic cardiovascular disease (ASCVD) in familial hypercholesterolemia (FH) have been described, models for predicting incident ASCVD have not been reported. Our aim was to use the SAFEHEART registry (Spanish Familial Hypercholesterolemia Cohort Study) to define key risk factors for predicting incident ASCVD in patients with FH. METHODS: SAFEHEART is a multicenter, nationwide, long-term prospective cohort study of a molecularly defined population with FH with or without previous ASCVD. Analyses to define risk factors and to build a risk prediction equation were developed, and the risk prediction equation was tested for its ability to discriminate patients who experience incident ASCVD from those who did not over time. RESULTS: We recruited 2404 adult patients with FH who were followed up for a mean of 5.5 years (SD, 3.2 years), during which 12 (0.5%) and 122 (5.1%) suffered fatal and nonfatal incident ASCVD, respectively. Age, male sex, history of previous ASCVD, high blood pressure, increased body mass index, active smoking, and low-density lipoprotein cholesterol and lipoprotein(a) levels were independent predictors of incident ASCVD from which a risk equation with a Harrell C index of 0.85 was derived. The bootstrap resampling (100 randomized samples) of the original set for internal validation showed a degree of overoptimism of 0.003. Individual risk was estimated for each person without an established diagnosis of ASCVD before enrollment in the registry by use of the SAFEHEART risk equation, the modified Framingham risk equation, and the American College of Cardiology/American Heart Association ASCVD Pooled Cohort Risk Equations. The Harrell C index for these models was 0.81, 0.78, and 0.8, respectively, and differences between the SAFEHEART risk equation and the other 2 were significant (P=0.023 and P=0.045). CONCLUSIONS: The risk of incident ASCVD may be estimated in patients with FH with simple clinical predictors. This finding may improve risk stratification and could be used to guide therapy in patients with FH. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT02693548.

Coronary Heart Disease, Peripheral Arterial Disease, and Stroke in Familial Hypercholesterolaemia: Insights From the SAFEHEART Registry (Spanish Familial Hypercholesterolaemia Cohort Study).

OBJECTIVE: Heterozygous familial hypercholesterolemia (FH) is the most common premature atherosclerotic cardiovascular disease (ASCVD)-related monogenic disorder, and it is associated with ischemic heart disease. There is limited information whether FH increases the risk of peripheral arterial and cerebrovascular disease. Our aim was to analyze ASCVD prevalence and characteristics in different arterial territories in a large FH population, to compare them with an unaffected control population and to determine which factors are associated to ASCVD. APPROACH AND RESULTS: SAFEHEART (Spanish Familial Hypercholesterolaemia Cohort Study) is an ongoing registry of molecularly defined patients with heterozygous FH in Spain. ASCVD in the different arterial territories was analyzed, as well as individual characteristics, genetic variables, and lipid-lowering therapies. The study recruited 4132 subjects (3745 ≥18 years); 2,752 of those enrolled were molecularly diagnosed FH cases. Median age was 44.0 years (45.9% men) and 40 years (46.6% men) in FH patients and unaffected relatives (P<0.001). ASCVD was present in 358 (13.0%) and 47 (4.7%) FH patients and unaffected relatives, respectively (P<0.001). History of premature ASCVD was more prevalent in FH patients (9.4% and 2.4% in FH patients and unaffected relatives, respectively; P<0.001). Coronary artery-related manifestations and peripheral artery disease were more prevalent in FH patients than in controls, but no significant differences were found for cerebrovascular events. Age, body mass index, type 2 diabetes mellitus, high blood pressure, previous use of tobacco, and lipoprotein(a) >50 mg/dL were independently associated with ASCVD. CONCLUSIONS: The prevalence of ASCVD is higher, and the involvement of the arterial territories is different in FH patients when compared with their unaffected relatives. Age, male sex, increased body mass index, hypertension, type 2 diabetes mellitus, smoking habit, and lipoprotein(a) >50 mg/dL were independently associated to ASCVD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02693548.

Statins do not increase the risk of developing type 2 diabetes in familial hypercholesterolemia: The SAFEHEART study.

BACKGROUND: Familial Hypercholesterolemia (FH) is the most common monogenic disorder that causes premature coronary artery disease (CAD). Our objective was to examine the risk of new onset type 2 diabetes mellitus (T2DM) among FH patients and unaffected relatives in relation to treatment with different statins in the SAFEHEART cohort study. METHODS: This is a cross-sectional and prospective cohort study in 2558 FH and 1265 unaffected relatives with a mean follow-up of 5.9 years. Several pertinent data, such as age, gender, metabolic syndrome, lipid profile, body mass index (BMI), waist circumference, HOMA-IR, dose, duration and type of statins, were obtained and examined as predictors of incident diabetes. RESULTS: The new onset diabetes was 1.7% in FH and 0.2% in non FH patients (p=0.001). In multivariate logistic regression, age (OR 1.02, CI 95%: 1.02-1.08), HOMA-IR (OR 1.17, CI 95%: 1.03-1.33), metabolic syndrome (OR 3.3, CI 95%: 1.32-8.28) and specifically plasma glucose, as a component of metabolic syndrome (OR 15.7, CI 95%: 4.70-52.53) were significant predictors of new onset T2DM in the FH group alone. In the adjusted Cox regression model in FH group, age (HR 1.03, CI 95% 1.00-1.06, p=0.031) and metabolic syndrome (HR 4.16, CI 95% 1.58-10.92, p=0.004) remained significant predictors of new onset T2DM. CONCLUSIONS: Our data do not support the postulated diabetogenic effect associated with high-dose statins use in our cohort of FH patients.

[Clinical profile of patients with very high hypertriglyceridemia from the Registry of Hypertriglyceridemia of the Spanish Atherosclerosis Society]. / Perfil clínico de los pacientes con hipertrigliceridemia muy severa del Registro de Hipertrigliceridemias de la Sociedad Española de Arteriosclerosis.

BACKGROUND AND OBJECTIVE: To describe clinical and epidemiological characteristics of patients with very high hypertriglyceridemia (HTG) who were attended in lipid units of the Spanish Society of Atherosclerosis (SEA). PATIENTS AND METHOD: Patients of the HTG Registry of SEA with at least one triglyceride concentration greater than 1,000mg/dL (n=298, HTG severe group) and those whose baseline triglycerides were between 200 and 246mg/dL (HTG control group, n=272) were included. RESULTS: Patients with very high triglyceride levels were younger (46.9±11.5 years vs 52.7±13 years; p<0.0001), with a larger waist circumference (100.5±10.6cm vs 98.5±11.1cm; p=0.0426), higher alcohol intake (170.7±179.1g/wk vs 118.8±106.4g/wk; p=0,0473), active smoking status (45.6% vs 26.8%; p<0.0001) and a higher frequency of pancreatitis (10.2% vs 3%; p=0.0006) than HTG control group. There was a higher percentage of patients with atherogenic dietary pattern in severe HTG group compared with the control group (138 [46.3%] vs. 94 [34.5%]; p=0,001). The multivariate analysis showed that factors associated with a triglyceride concentration greater than 1,000mg/dl were age, male sex, weight, waist circumference, alcohol, physical inactivity in non-business hours and the presence of diabetes mellitus. CONCLUSIONS: Patients with very high HTG were usually men in the fourth decade of life, with abdominal obesity, smoking and alcohol consumption. In 60% of cases the HTG was primary, and pancreatitis the most frequently complication.

Características de la anemia en los pacientes oncológicos en tratamiento paliativo / Characteristics of anemia in cancer patients receiving palliative treatment

OBJETIVO: Estudio de la anemia en una unidad de cuidados paliativos (UCP) hospitalaria y del tratamiento empleado para su mejoría. Pacientes y MÉTODO: Estudio descriptivo, observacional y prospectivo de los pacientes ingresados en la UCP del Hospital General Universitario de Ciudad Real durante un año de seguimiento (junio de 2010 a junio de 2011) que presentaban síndrome anémico. El protocolo de estudio incluyó datos epidemiológicos, tipo de tumor y tratamiento recibido para la anemia. El control de los síntomas se midió con la escala ESAS y la supervivencia con la PaPScore. RESULTADOS: Durante el tiempo de estudio ingresaron en la unidad 208 pacientes. Se incluyeron en el estudio 65 (31,2%). De ellos 37 (57%) eran varones y 28 (43%) mujeres. La edad media fue de 70,5 años. El motivo de ingreso fue el síndrome anémico en 7 (10,8%) casos. El tipo de tumor más frecuente fue el gastrointestinal (25 [38,5%]), seguido del urológico (15 [23,1%]) y el pulmonar (14 [21,5%]). La causa más frecuente fue haber recibido quimioterapia (QT) previa, seguida de trastornos crónicos, déficit de ácido fólico y ferropenia. En 19 (29,2%) casos la etiología fue multifactorial y en 16 (24,6%) desconocida. Se administraron 42 tratamientos a 22 (33,8%) PACIENTES: 15 de ácido fólico, 13 de hierro, 12 transfusiones de hematíes y 2 de vitamina B12. Según la PaPScore se encontraban en el grupo A el 38,4% de los pacientes, en el B el 44,6% y en el C el 17%. CONCLUSIONES: La anemia en el paciente oncológico en tratamiento paliativo con frecuencia se debe a varias etiologías

OBJECTIVE: To study anaemia in cancer patients as well as the type of treatment used in a Palliative Care Unit (PCU). PATIENTS AND METHOD: Descriptive, prospective observational study of patients admitted to the General University Hospital PCU of Ciudad Real during a one year follow up (June 2010-2011) who had an anaemic syndrome. The study protocol included epidemiological data, type of tumour, and the treatment received for anaemia. Control of symptoms was measured with the ESAS scale, and patient survival with the PaP Score scale. RESULTS: The unit admitted 208 patients during the study period, of whom 65 (31.2%) were included. Of these, 37 (57%) were male and 28 (43%) were female. The mean age of the patients was 70.5 years. The reason for admission was anaemic syndrome in 7 (10.8%) of the cases. The most common type of tumour was gastrointestinal 25 (38.5%), followed by urological 15 (23.1%), and lung 14 (21.5%). The most common aetiology was receiving previous chemotherapy, followed by chronic disorders, folic acid and iron deficiency. In 19 (29.2%) cases the aetiology was multifactorial, and in 16 (24.6%) unknown. Forty-two treatments were administered to 22 (33.8%) PATIENTS: 15 with folic acid, 13 with iron, 12 transfusions of red blood cells, and 2 with vitamin B12. According to the PaP Score, 38.4% of patients were in group A, 44.6%, in group B, and 17% in group C. CONCLUSIONS: The anaemia in cancer patients receiving palliative treatment is of various aetiologies

Perfil clínico de los pacientes con hipertrigliceridemia muy severa del Registro de Hipertrigliceridemias de la Sociedad Española de Arteriosclerosis / Clinical profile of patients with very high hypertriglyceridemia from the Registry of Hypertriglyceridemia of the Spanish Atherosclerosis Society

Fundamento y objetivo Describir las características clínico-epidemiológicas de los pacientes con hipertrigliceridemia (HTG) muy severa atendidos en las Unidades de Lípidos de la Sociedad Española de Arteriosclerosis (SEA).Pacientes y método Se incluyeron los pacientes del Registro de HTG de la SEA con al menos una trigliceridemia superior a 1.000mg/dl (n=298, grupo HTG muy severa) y aquellos cuya trigliceridemia basal fuese entre 200 y 246mg/dl (grupo HTG control, n=272). Resultados Los pacientes con HTG muy severa eran más jóvenes (46,9±11,5 vs 52,7±13 años; p<0,0001), con un perímetro de cintura abdominal mayor (100,5±10,6 vs 98,5±11,1cm; p=0,0426), mayor ingesta de alcohol (170,7±179,1 vs 118,8±106,4g/semana; p=0,0473), tabaquismo activo (45,6 vs 26,8%; p<0,0001) y una mayor frecuencia de pancreatitis (10,2 vs 3%; p=0,0006) que el grupo control. Hubo un mayor porcentaje de pacientes con un patrón de consumo aterógeno en el grupo de HTG muy severa comparado con el grupo control (138 [46,3%] vs. 94 [34,5%]; p=0,001). El modelo multivariante mostró que los factores asociados a alguna determinación de triglicéridos mayor de 1.000mg/dl fueron la edad, el sexo masculino, el peso, el perímetro de cintura abdominal, el alcohol, la inactividad física fuera de la jornada laboral y la presencia de diabetes mellitus. Conclusiones Los pacientes con HTG muy severa suelen ser varones en la cuarta década de la vida, con obesidad abdominal, fumadores y consumidores de alcohol. En el 60% de los casos la HTG fue primaria, y la pancreatitis fue la complicación más frecuente (AU)

Background and objective To describe clinical and epidemiological characteristics of patients with very high hypertriglyceridemia (HTG) who were attended in lipid units of the Spanish Society of Atherosclerosis (SEA).Patients and method Patients of the HTG Registry of SEA with at least one triglyceride concentration greater than 1,000mg/dL (n=298, HTG severe group) and those whose baseline triglycerides were between 200 and 246mg/dL (HTG control group, n=272) were included.ResultsPatients with very high triglyceride levels were younger (46.9±11.5 years vs 52.7±13 years; p<0.0001), with a larger waist circumference (100.5±10.6cm vs 98.5±11.1cm; p=0.0426), higher alcohol intake (170.7±179.1g/wk vs 118.8±106.4g/wk; p=0,0473), active smoking status (45.6% vs 26.8%; p<0.0001) and a higher frequency of pancreatitis (10.2% vs 3%; p=0.0006) than HTG control group. There was a higher percentage of patients with atherogenic dietary pattern in severe HTG group compared with the control group (138 [46.3%] vs. 94 [34.5%]; p=0,001). The multivariate analysis showed that factors associated with a triglyceride concentration greater than 1,000mg/dl were age, male sex, weight, waist circumference, alcohol, physical inactivity in non-business hours and the presence of diabetes mellitus. Conclusions Patients with very high HTG were usually men in the fourth decade of life, with abdominal obesity, smoking and alcohol consumption. In 60% of cases the HTG was primary, and pancreatitis the most frequently complication (AU)

Planificación y rehabilitación inmediata en la cirugía mínimamente invasiva / Treatment planning and immediate rehabilitation in minimally invasive surgery

Fundamento: En los comienzos de los tratamientos con implantes dentales, la planificación de los casos se basaba en la interpretación de imágenes radiográficas bidimensionales. Hoy en día, podemos conseguir una planificación minuciosa mediante el procesado informático de la información que nos ofrece la tomografía computada (TC) y llevarla al acto quirúrgico mediante guías quirúrgicas confeccionadas mediante estereolitografía; ello nos habilitará para realizar una cirugía mínimamente invasiva así como para colocar prótesis provisionales en el mismo acto quirúrgico. Material y método: Realizamos una revisión bibliográfica de los estudios que avalan el uso de las distintas pruebas diagnósticas radiográficas, así como del uso de sistemas informáticos para la planificación en los tratamientos con implantes. Se presenta un caso clínico donde se desarrollan los distintos pasos a seguir para un buen diagnóstico, planificación, cirugía mínimamente invasiva y rehabilitación inmediata. Resultados: La información obtenida en la planificación, fue llevada al acto quirúrgico, obteniendo los resultados estéticos deseados. Conclusiones: Con una exhaustiva planificación y el uso de guías quirúrgicas estereolitográficas se ve simplificada la cirugía de implantes; asimismo, se puede diseñar la prótesis provisional previa a la intervención y ser colocada en el mismo acto quirúrgico (AU)

Basis: In the early years of treatment with dental implants, treatment planning was based on the interpretation of two-dimensional radiographic images. Today we can carry out a more precise preparation with the computerized information obtained from CT scans. The planning can be directly taken to the surgical phase thanks to the surgical guide generated by stereolithography; this gives the surgeon the possibility to perform less invasive surgeries, as well as to place a provisional prosthesis during the same intervention. Material and Method: We reviewed the literature published in support of the use of different radiographic diagnostic tools and the use of IT systems in the preparation for treatments involving dental implants. Also, a clinical case is presented which shows the various steps to follow in order to achieve a good diagnosis and preparation, a less invasive surgical intervention and an immediate rehabilitation. Results: The information gained from the treatment planning was used in surgery, providing the desired aesthetic results. Conclusions: With an exhaustive preparation and the use of stereolithographic surgical guides, implant surgery is simplified. The provisional prosthesis can be designed prior to the surgical intervention and placed during surgery (AU)

Planificación y rehabilitación inmediata en la cirugía mínimamente invasiva / Treatment planning and immediate rehabilitation in minimally invasive surgery

Fundamento: En los comienzos de los tratamientos con implantes dentales, la planificación de los casos se basaba en la interpretación de imágenes radiográficas bidimensionales. Hoy en día, podemos conseguir una planificación minuciosa mediante el procesado informático de la información que nos ofrece la tomografía computada (TC) y llevarla al acto quirúrgico mediante guías quirúrgicas confeccionadas mediante estereolitografía; ello nos habilitará para realizar una cirugía mínimamente invasiva así como para colocar prótesis provisionales en el mismo acto quirúrgico. Material y método: Realizamos una revisión bibliográfica de los estudios que avalan el uso de las distintas pruebas diagnósticas radiográficas, así como del uso de sistemas informáticos para la planificación en los tratamientos con implantes. Se presenta un caso clínico donde se desarrollan los distintos pasos a seguir para un buen diagnóstico, planificación, cirugía mínimamente invasiva y rehabilitación inmediata. Resultados: La información obtenida en la planificación, fue llevada al acto quirúrgico, obteniendo los resultados estéticos deseados. Conclusiones: Con una exhaustiva planificación y el uso de guías quirúrgicas estereolitográficas se ve simplificada la cirugía de implantes; asimismo, se puede diseñar la prótesis provisional previa a la intervención y ser colocada en el mismo acto quirúrgico

Basis: In the early years of treatment with dental implants, treatment planning was based on the interpretation of two-dimensional radiographic images. Today we can carry out a more precise preparation with the computerized information obtained from CT scans. The planning can be directly taken to the surgical phase thanks to the surgical guide generated by stereolithography; this gives the surgeon the possibility to perform less invasive surgeries, as well as to place a provisional prosthesis during the same intervention. Material and Method: We reviewed the literature published in support of the use of different radiographic diagnostic tools and the use of IT systems in the preparation for treatments involving dental implants. Also, a clinical case is presented which shows the various steps to follow in order to achieve a good diagnosis and preparation, a less invasive surgical intervention and an immediate rehabilitation. Results: The information gained from the treatment planning was used in surgery, providing the desired aesthetic results. Conclusions: With an exhaustive preparation and the use of stereolithographic surgical guides, implant surgery is simplified. The provisional prosthesis can be designed prior to the surgical intervention and placed during surgery