Mortalidad en una cohorte de pacientes de Atención Primaria tratados con anticoagulantes antagonistas de la vitamina K / Mortality in a cohort of primary care patients treated with vitamin K antagonist anticoagulants

Introducción y objetivos: El uso de anticoagulantes para prevenir eventos embólicos en España es muy elevado, tendiendo a un aumento progresivo. Por ello pretendemos analizar la mortalidad de los pacientes tratados con anticoagulantes antagonistas de la vitamina K (AVK) de un área metropolitana de Granada, en 2 años no consecutivos.Pacientes y métodos: Estudio longitudinal, observacional, retrospectivo de 205 pacientes tratados con AVK. Se recogieron datos sociodemográficos, condiciones clínicas previas, patología causante del tratamiento AVK, grado de control y la mortalidad a 2 años del inicio del estudio.ResultadosEdad media, 76±11,8años (57,56% mujeres). La mortalidad a los 2 años fue del 22,4%, con un aumento significativo en función de la edad (p<0,001) y los años de tratamiento (p<0,001). Los pacientes con demencia (p<0,05), con enfermedad renal crónica (p<0,01) o con enfermedad pulmonar obstructiva crónica (p<0,01) presentaron también mayor mortalidad. El análisis multivariante demostró efecto significativo de la enfermedad renal crónica (odds ratio=4,075), la enfermedad pulmonar obstructiva crónica (odds ratio=3,694) y los años de tratamiento (odds ratio=1,236).ConclusionesA los 2 años de seguimiento, fallecieron uno de cada 5 pacientes tratados con AVK y se asociaron independientemente a este aumento la presencia de enfermedad renal crónica, enfermedad pulmonar obstructiva crónica y un mayor tiempo de tratamiento. La mayoría de los pacientes estaban anticoagulados por una fibrilación auricular, tenían una edad avanzada y una alta prevalencia de comorbilidades. (AU)

Introduction and objectives: The use of anticoagulants to prevent embolic events in Spain is very high, tending to a progressive increase. For this reason, we intend to analyse the mortality of patients from a metropolitan area of Granada treated with vitamin K antagonist anticoagulants (VKA), over 2 non-consecutive years.Patients and methods: Longitudinal, observational, retrospective study of 205 patients treated with VKA. Sociodemographic data, previous clinical conditions, pathology causing VKA treatment, degree of control and mortality were collected 2 years after the start of the study.ResultsAverage age, 76±11.8 years (57.56% women). Two-year mortality was 22.4%, with a significant increase depending on age (p<.001) and years of treatment (p<.001). Patients with dementia (p<.05), with chronic kidney disease (p<.01) or with chronic obstructive pulmonary disease (p<.01) also presented higher mortality. Multivariate analysis showed significant effect of chronic kidney disease (odds ratio=4.075), chronic obstructive pulmonary disease (odds ratio=3.694), and years of treatment (odds ratio=1.236).ConclusionsAt 2 years of follow-up, 1 in 5 patients treated with VKA died. The presence of chronic kidney disease, chronic obstructive pulmonary disease and a longer treatment time were independently associated with this increase of mortality. Most of the patients were anticoagulated by atrial fibrillation, they were elderly and had a high prevalence of comorbidities. (AU)

Mortality in a cohort of primary care patients treated with vitamin K antagonist anticoagulants. / Mortalidad en una cohorte de pacientes de Atención Primaria tratados con anticoagulantes antagonistas de la vitamina K.

INTRODUCTION AND OBJECTIVES: The use of anticoagulants to prevent embolic events in Spain is very high, tending to a progressive increase. For this reason, we intend to analyse the mortality of patients from a metropolitan area of Granada treated with vitamin K antagonist anticoagulants (VKA), over 2 non-consecutive years. PATIENTS AND METHODS: Longitudinal, observational, retrospective study of 205 patients treated with VKA. Sociodemographic data, previous clinical conditions, pathology causing VKA treatment, degree of control and mortality were collected 2 years after the start of the study. RESULTS: Average age, 76±11.8 years (57.56% women). Two-year mortality was 22.4%, with a significant increase depending on age (p<.001) and years of treatment (p<.001). Patients with dementia (p<.05), with chronic kidney disease (p<.01) or with chronic obstructive pulmonary disease (p<.01) also presented higher mortality. Multivariate analysis showed significant effect of chronic kidney disease (odds ratio=4.075), chronic obstructive pulmonary disease (odds ratio=3.694), and years of treatment (odds ratio=1.236). CONCLUSIONS: At 2 years of follow-up, 1 in 5 patients treated with VKA died. The presence of chronic kidney disease, chronic obstructive pulmonary disease and a longer treatment time were independently associated with this increase of mortality. Most of the patients were anticoagulated by atrial fibrillation, they were elderly and had a high prevalence of comorbidities.

The use and adherence of oral anticoagulants in Primary Health Care in Catalunya, Spain: A real-world data cohort study.

OBJECTIVE: We aimed to describe sociodemographic, comorbidities, co-medication and risk of thromboembolic events and bleeding in patients with NVAF initiating oral anticoagulants (OAC) for stroke prevention, and to estimate adherence and persistence to OAC. SETTING: Primary Health Care (PHC) in the Catalan Health Institute (ICS), Catalunya, Spain. PARTICIPANTS: All NVAF adult patients initiating OAC for stroke prevention in August 2013-December 2015. METHODS: Population-based cohort study. Persistence was measured in patients initiating OAC in August 2013-December 2014. DATA SOURCE: SIDIAP, which captures electronic health records from PHC in the (ICS), covering approximately 5.8 million people. RESULTS: 51,690 NVAF patients initiated OAC; 47,197 (91.3%) were naive to OAC and 32,404 (62.7%) initiated acenocoumarol. Mean age was 72.8 years (SD 12.3) and 49.4% were women. Platelet-aggregation inhibitors were taken by 9105 (17.6%) of the patients. Persistence and adherence were estimated up to the end of follow-up. For 22,075 patients, persistence was higher among the non-naive patients [n=258 (61.7%)] than among the naive [n=11,502 (53.1%)]. Adherence was estimated for patients initiating DOAC and it was similar in naive and non-naive patients. Among the naive to DOAC treatment, those starting rivaroxaban showed a highest proportion [(n=360 (80.1%)] of good adherence at implementation (MPR>80%) while patients starting dabigatran were less adherent [n=203 (47.8%)]. CONCLUSIONS: Acenocoumarol was the most frequently prescribed OAC as first therapy in NVAF patients. Non-naive to DOAC showed better persistence than naive. Rivaroxaban showed higher proportion of adherent patients during the implementation phase than apixaban and dabigatran the lowest.

Anestesia cardiovascular en cirugía no cardiaca / Cardiovascular anesthesia in noncardiac surgery

Clinical evaluation remains one of the main issues while considering anesthetic and surgical risk. Different scores for cardiac evaluation in non-cardiac surgery are traditionally based on the exclusion of active cardiac conditions, the risk of surgery, the functional capacity of the patient and the presence of specific cardiac risk factors. In recent decades, new guidelines incorporate an association between cardiac biomarkers and adverse cardiac events. For the management of coronary patients receiving double antiplatelet therapy, derived for non-cardiac surgery, the risk of stent thrombosis, the consequences of delaying the surgical procedure and the risk of bleeding must be considered. At this moment, there is no evidence regarding which is the best anesthetic management that decreased peri-operative cardiovascular complications in this group of patients. This article refers to the differences in preoperative assessment for non-cardiac surgery incorporated in the guidelines of the American College of Cardiology, the American Heart Association, the European Society of Cardiology and the Canadian Cardiovascular Society. Consideration are also given to the management of coronary patients on double antiplatelet therapy and its main complications as well as intraoperative management maneuvers that may decrease cardiovascular complications.

La valoración clínica sigue siendo uno de los pilares fundamentales en la evaluación del riesgo anestésico-quirúrgico. Los scores de riesgo para la evaluación cardiovascular y cirugía no cardíaca se basan tradicionalmente en la exclusión de condiciones cardíacas activas, la determinación del riesgo de cirugía, la capacidad funcional del paciente y la presencia de factores de riesgo cardíaco. En las últimas décadas, nuevas guías incorporan una asociación entre los biomarcadores cardiacos y los eventos cardiacos adversos. Para el manejo de pacientes coronarios en tratamiento antiagregante doble, derivados a cirugía no cardiaca, hay que considerar el riesgo de trombosis del stent, las consecuencias de retrasar el procedimiento quirúrgico y el aumento del riesgo de hemorragia. Hasta la fecha no existe evidencia acerca de cuál es el mejor manejo anestésico que disminuya las complicaciones cardiovasculares perioperatorias en este grupo de pacientes. Este artículo, hace referencia a las diferencias de la valoración preoperatoria para cirugía no cardiaca incorporados en las guías del American College of Cardiology, la American Heart Association, la European Society of Cardiology y la Canadian Cardiovascular Society. Algunas consideraciones acerca del manejo de pacientes coronarios, terapia antiplaquetaria dual y eventuales complicaciones. Se incluyen algunas estrategias farmacológicas, así como consideraciones específicas para el perioperatorio, con el fin de reducir morbilidad de origen cardiovascular.

Cirugía herniaria electiva en pacientes portadores de tratamiento anticoagulante / Elective hernia surgery in patients with anticoagulant treatment

Resumen Introducción: Diversas patologías requieren de tratamiento anticoagulante oral (TACO). Algunos de estos pacientes requieren resolución quirúrgica. El manejo perioperatorio de estos pacientes es variable dependiendo del centro. Objetivos: Evaluar la morbilidad y mortalidad del protocolo de manejo de patología herniaria en TACO, atendidos en nuestro hospital. Material y Métodos: Estudio descriptivo prospectivo de 37 pacientes sometidos a cirugía herniaria en TACO entre 2008-2016. Los datos fueron obtenidos de la base de datos computacional del Equipo de Hernias, con un seguimiento mínimo de 1 mes. Se evaluaron las características clínicas, quirúrgicas y la morbimortalidad postoperatoria. El traslape consistió en hospitalizar al paciente tres días previos a la cirugía, suspendiéndose el TACO e iniciando heparina de bajo peso molecular (HBPM) en dosis terapéuticas, que se suspende 24 h previas a la cirugía. Se reinicia la HPBM a las 12 a 24 h postoperatorias, y se inicia el traslape a TACO a las 24-48 h. Los datos fueron analizados con Stata v14. Resultados: De los 37 pacientes estudiados, veintiséis pacientes fueron hombres (70,2%), la media de edad fue de 67,3 años. El 48,7% tenían fibrilación auricular. El 100% consumía acenocumarol como TACO. La media en el inicio del traslape a la anticoagulación oral fue de 1,4 días. El promedio de INR al momento del alta fue de 2,04. Dos pacientes fueron dados de alta con dalteparina. Un paciente (2,7%), presentó dolor en el postoperatorio inmediato y uno (2,7%), equimosis del sitio quirúrgico. Conclusiones: El protocolo de trabajo utilizado, demostró ser seguro, con una mínima morbilidad postoperatoria.

Introduction: Various pathologies require oral anticoagulant treatment (TACO). Some of these patients present pathologies of surgical resolution. The perioperative management of these patients is variable depending on the center. Aim: To evaluate the morbidity and mortality of patients attended with hernia pathology and TACO, assisted in our hospital. Materials and Method: Prospective, descriptive study of 37 patients submmited to hernia surgery in TACO between 2008-2016. The data was obtained from the computer database of the Hernia Team, with a minimum follow-up of 1 month. Clinical, surgical characteristics and postoperative morbidity and mortality were evaluated. The treatment overlap from TACO to Low Molecular Weight Heparin (LMWH) in therapeutic doses, was initiated three days before surgery. LMWH was suspended 24 hours prior to surgery, and reinitiated 12 to 24 hours post operation. 48 to 72 hours TACO was resumed. The data was analyzed with Stata v14. Results: Twenty-six patients were men, the mean age was 67.3 years. 48.7% had atrial fibrillation. 100% consumed acenocoumarol as TACO. The mean time for resuming TACO after surgery was 1.4 days. The average INR at the time of discharge was 2.04. Two patients were discharged with dalteparin. One patient (2.7%) presented pain in the immediate postoperative period and one showed ecchymosis of the surgical site (2.7%). Conclusions: The work protocol used, proved to be safe, with minimal postoperative morbidity.

Tension subcutaneous haematomas associated with anticoagulants in the elderly: Do they have earlier morbidity and mortality than hip fractures? / Hematomas subcutáneos a tensión por anticoagulantes en ancianos: ¿más morbimortalidad precoz que las fracturas de cadera?

INTRODUCTION: Complications related to anticoagulant therapy have been widely described, although tension haematomas in the extremities are frequently undervalued, and commonly considered banal pathologies. MATERIAL AND METHOD: Retrospective descriptive study between 2014 and 2017, including patients with limb haematomas after minimal trauma related with anticoagulant therapy, and surgically treated by Traumatology. RESULTS: 32 cases were eventually included, 81% were women, average age of 83.56 years, and a mean aCCI of 5.97. Anatomical location of haematomas was 65.6% in leg/foot, 15.6% in thigh/buttock, and 18.8% in the upper limb. Seventy-eight point thirteen percent received acenocoumarol, 15.63% LMWH, and 3.13% NOACs. Of the cases, 59.38% were due to AF, 15.63% to valvular heart disease/valve prosthesis, and 12.5% to PE/DVT. The mean time from diagnosis to surgical drainage was 2.66 days, mainly as a result of alterations in coagulation parameters. Forty-six point eighty-eight percent were reoperated for new drainage, cure or skin defect coverage, and 3 patients required embolisation. Of the patients, 78% needed consultation with other specialties. The average length of stay was 22.34 days, and the in-hospital mortality rate was 9.38%. CONCLUSION: Tension haematomas in the extremities associated with anticoagulants occur in patients with multiple comorbidities that make them vulnerable. Surgical drainage is usually delayed by numerous factors which lead to skin defects that require further surgical operations, and prolonged hospital stays that are associated with medical complications. In our study, the average length of stay and in-hospital mortality rate were higher than those for hip fractures, so we should not underestimate this pathology.

[Extended anticoagulant treatment of venous thromboembolic disease with direct oral anticoagulants]. / Tratamiento anticoagulante extendido de la enfermedad tromboembólica venosa con anticoagulantes orales directos.

Direct oral anticoagulants have demonstrated efficacy and safety in the treatment of venous thromboembolic disease. A review is presented of the results of direct oral anticoagulants in the published clinical trials of extended anticoagulant treatment (after the first 3-6 months of treatment) of venous thromboembolic disease.

Trombofilia hereditaria y trombo intracardíaco / Hereditary thrombophilia and intracardiac thrombus

Resumen La trombofilia es una condición hematológica que predispone a eventos tromboembólicos venosos y arteriales. Es un factor que predispone a trombos intracardíacos en la edad pediátrica y se debe sospechar si no hay otros factores que predispongan a trombosis. Se reporta el caso de una paciente con antecedente de trombosis venosa cerebral a quien se le diagnosticó trombofilia por mutación homocigota G202010A del gen de la protrombina. Desarrolló un trombo auricular derecho, el cual fue tratado con anticoagulación y vigilancia ecocardiográfica. Se resalta la importancia de realizar una evaluación ecocardiográfica en pacientes con trombofilia.

Abstract Thrombophilia is a haematological condition that predisposes to venous and arterial thromboembolic events. It is also a predisposing factor in intracardiac thrombi in paediatrics, and must be suspected if there are no other factors that predispose to thrombosis. The case is presented on a patient with a history cerebral venous thrombosis, who was diagnosed with thrombophilia due to a homozygote G202010A mutation of the prothrombin gene. She developed a right atrial thrombus, which was treated with anticoagulation and echocardiography monitoring. The importance of performing an echocardiography evaluation is highlighted in patients with thrombophilia.

Pacientes con fibrilación auricular atendidos en consulta de atención primaria de una institución de alta complejidad / Patients with atrial fibrillation treated in a Primary Care clinic of a high complexity health facility

Resumen Introducción: la fibrilación auricular es una enfermedad multifactorial, que alcanza una prevalencia del 1 al 2% en la población general. Objetivo: determinar las características clínicas de los pacientes con fibrilación auricular atendidos en atención primaria en una institución de alta complejidad del Nororiente colombiano. Métodos: estudio observacional descriptivo de corte transversal, en el que se recopilaron datos demográficos, clínicos, escala de riesgo tromboembólico y modalidades de tratamiento mediante las historias clínicas electrónicas de pacientes con fibrilación auricular. Resultados: entre 528 historias clínicas analizadas, se seleccionaron 199, con edad promedio de 76,47( 8,94 años; 121 fueron mujeres (60,80%). Respecto al tipo de fibrilación auricular, 35 (17,59%) pacientes eran de tipo valvular y 164 (82,41%) no valvular. 152 (76,38%) tenían anticoagulación oral, 67 (33,84%) manejo antiagregante (ácido acetilsalicílico) y 39 (19,60%) terapia combinada. Según la escala CHADS2, 9 (4,5%) pacientes se clasificaban en bajo riesgo, 30 (15,1%) en moderado y 160 (80,4%) en alto. En el grupo de bajo riesgo, 6 estaban en manejo anticoagulante mientras que en el grupo de alto riesgo, 11 no recibían tratamiento farmacológico. Conclusión: a partir de los hallazgos mencionados, es fundamental fortalecer los esquemas de tromboprofilaxis de los pacientes con fibrilación auricular mediante la actualización y el conocimiento de las guías de práctica clínica por parte del médico tratante. Así mismo, es recomendable usar las escalas CHADS2 y HAS-BLED con el fin de ofrecer tratamiento individualizado y oportuno de modo que se eviten complicaciones.

Abstract Introduction: Atrial fibrillation is a disease caused by many factors, and has a prevalence of 1-2% in the general population. Objective: To determine the clinical characteristics of patients with atrial fibrillation treated in Primary care in a high complexity health centre in North-eastern Colombia. Material and methods: A cross-sectional, observational and descriptive study in which a record was made of the demographic and clinical data, with the scores on the thromboembolic risk scale, as well as any treatments, taken from the computerised medical records of patients with atrial fibrillation. Results: A total of 528 medical records analysed, from which 199 were selected. The mean age was 76.47( 8.94 years and 121 (60.8%) were women. As regards the type of atrial fibrillation, 35 (17.59%) patients had a valvular type, and 164 (82.41%) non-valvular. Oral anticoagulants were prescribed in 152 (76.38%) patients, 67 (33.84%) with antiplatelet (acetyl salicylic acid) treatment, and 39 (19.60%) were on combined therapy. According to the CHADS2 scale, 9 (4.5%) were classified as low risk, 30 (15.1%) as moderate, and 160 (80.4%) as high risk. In the low risk group, 6 were on anticoagulant therapy, while 11 patients in the high risk group did not receive any drug treatment. Conclusion: From the findings mentioned, it is essential that the thrombo-prophylaxis schemes of patients with atrial fibrillation are reinforced by updating, as well as knowledge of the clinical practice guidelines by the treating physician. Furthermore, it is recommended to use the CHADS2 and HAS-BLED scales, with the aim of offering individualised and appropriate treatment in order to avoid complications.

Direct oral anticoagulants: An update. / Anticoagulantes orales directos: puesta al día.

Vitamin K antagonists were the only choice for chronic oral anticoagulation for more than half a century. Over the past few years, direct oral anticoagulants have emerged, including one direct thrombin inhibitor (dabigatran etexilate) and three factor Xa inhibitors (apixaban, edoxaban and rivaroxaban). In randomised controlled trials comparing direct oral anticoagulants with traditional vitamin K antagonists, the direct oral anticoagulants all showed a favourable benefit-risk balance in their safety and efficacy profile, in prevention of thromboembolic events in patients with atrial fibrillation and in the prevention and treatment of venous thromboembolism and acute coronary syndrome. In 2008, dabigatran was the first direct oral anticoagulant approved by the European Medicine Agency. Subsequently, rivaroxaban, apixaban and edoxaban were also authorised. This article reviews the evidence related to the use of these drugs.

Evaluación de costo-efectividad de los nuevos anticoagulantes orales en pacientes con fibrilación auricular no valvular / Cost-effectiveness assessment of new oral anticoagulation drugs in patients with non-valvular atrial fibrillation

Resumen La fibrilación auricular es el trastorno más frecuente del ritmo cardíaco y una de las causas potencialmente tratables de cardioembolia y ataque cerebrovascular. La disponibilidad de nuevos anticoagulantes para pacientes con fibrilación auricular no valvular, plantea retos, derivados principalmente de los costos de su uso, perfiles de eficacia y seguridad, tolerancia y disponibilidad. Se llevó a cabo un análisis de costo-efectividad con base en un modelo de Markov, que permite comparar las estrategias de anticoagulación disponibles para fibrilación auricular no valvular en el país (apixabán, dabigatrán, rivaroxabán). La perspectiva empleada fue la del tercero pagador (sistema de salud colombiano), considerando solo costos médicos directos. Se siguieron las guías metodológicas para este tipo de estudios propuestas por ISPOR (International Society for Pharmacoeconomics and Outcomes Research) e INAHTA (International Network of Agencies for Health Technology Assessment). El horizonte temporal fue de 5 años, 10 años y toda la vida, en tanto que la tasa de descuento fue del 3%. Luego de la evaluación del modelo, con base en los análisis de sensibilidad realizados y el umbral de costo-efectividad para Colombia, se encontró que para el caso base, las diferentes moléculas evaluadas, si bien son costo-efectivas, exceden el umbral propuesto para este trabajo, siendo rivaroxabán y dabigatrán las únicas estrategias costo-efectivas con un horizonte temporal a 10 años con una tasa de descuento del 3% y para un horizonte temporal de toda la vida y tasa de descuento del 3%, las tres moléculas alcanzan el umbral de costo-efectividad establecido para Colombia. Dichas consideraciones son altamente sensibles al costo de los medicamentos.

Abstract Atrial fibrillation is the most common heart rate disorder and one of the potentially treatable causes of cardioembolisms and cerebrovascular events. Availability of new anticoagulation drugs in patients with non-valvular atrial fibrillation poses challenges that mostly derive from usage costs, efficacy and security profiles, tolerance and availability. A cost-effectiveness analysis was conducted based on the Markov model, which allows to compare the available anticoagulation strategies for non-valvular atrial fibrillation in the country (apixaban, dabigatran, rivaroxaban). The third payer perspective (according to Colombian health system) was used, taking into consideration only the direct medical costs. The methodological guides followed were suggested by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Network of Agencies for Health Technology Assessment (INAHTA). The time frame was 5 years, 10 years and a lifetime, whilst the discount rate was 3%. After assessing the model based on the conducted sensitivity analysis and the cost-effectiveness threshold for Colombia, it was revealed that for the baseline case the different molecules assessed, despite being cost effective, exceed the threshold proposed for this study. Rivaroxaban and dabigatran are the only cost-effective strategies in a 10-year time frame with a discount rate of 3% and for a lifetime time frame and discount rate of 3% all three molecules reach the costeffectiveness threshold established for Colombia. These considerations are highly sensitive to the cost of the medications.

Healthcare resources and needs in anticoagulant therapy for patients with nonvalvular atrial fibrillation. SAMOA Study. / Recursos y necesidades asistenciales en el tratamiento anticoagulante de los pacientes con fibrilación auricular no valvular. Estudio SAMOA.

INTRODUCTION AND OBJECTIVES: To determine, in the various medical specialties, the healthcare process for anticoagulated patients with nonvalvular atrial fibrillation, to determine the available and necessary resources and to identify potential areas of improvement in the care of these patients. METHODS: We performed a cross-sectional survey of primary care and specialised physicians involved in the care of anticoagulated patients. The questionnaires referred to the healthcare process, the indication and prescription of anticoagulant therapy and the barriers and deficiencies present for these patients. RESULTS: A total of 893 physicians participated in the study, 437 of whom worked in primary care and 456 of whom were specialists (mostly cardiologists). Forty-two percent of the family doctors indicated that they assessed and prescribed anticoagulant therapy, and 66% performed the regular follow-up of these patients. In both healthcare settings, the physicians noted the lack of standardised protocols. There was also a lack of quality control in the treatment. CONCLUSIONS: The role of primary care in managing anticoagulated patients has grown compared with previous reports. The responses of the participating physicians suggest marked gaps in the standardisation of the healthcare process and several areas for improvement in these patients' follow-up. The promotion of training in direct-acting anticoagulant drugs remains pivotal.

Patrón tromboelastográfico en pacientes anticoagulados con rivaroxabán por fibrilaciónauricular / Thromboelastographic pattern in anticoagulated patients with rivaroxaban due to atrialfibrillation

Resumen Introducción: La fibrilación auricular es la arritmia más frecuente y se asocia con mayor riesgo de eventos tromboembólicos, que requieren tratamiento anticoagulante. En la actualidad no existe un examen que permita monitorizar el rango terapéutico cuando se usan nuevos anticoagulantes. Objetivo: Describir los patrones tromboelastográficos en los pacientes con fibrilación auricular que reciben terapia de anticoagulación con rivaroxabán del servicio de Cardiología del Hospital Universitario Fundación Santa Fe de Bogotá. Materiales y métodos: En este estudio de corte transversal se recolectaron los datos correspondientes a 30 pacientes con fibrilación auricular que recibieron tratamiento anticoagulante con rivaroxabán a partir del 10 de julio de 2013 hasta el 06 de enero de 2015. Se describieron las características generales de la muestra, así como de los parámetros obtenidos por medio del tromboelastograma, y se compararon los patrones de tromboelastografía de acuerdo con la dosis del anticoagulante. Resultados: La edad promedio fue 75,8 a˜nos y la principal indicación de anticoagulación fue la fibrilación auricular paroxística (56,67%). En más del 60% de los pacientes se obtuvo un tiempo de reacción prolongado y un índice de coagulación bajo. El resto de parámetros del tromboelastograma se encontraban dentro del rango normal en la mayoría de los casos. No hubo diferencias estadísticamente significativas en los parámetros del tromboelastograma al comparar la dosis de rivaroxabán de 15 mg versus 20 mg. Conclusión: El patrón tromboelastográfico obtenido en la mayoría de pacientes del estudio se caracterizó por un tiempo de reacción alto y un índice de coagulación bajo, posiblemente debido al efecto del inhibidor del factor Xa.

Abstract Introduction: Atrial fibrillation is the most common arrhythmia, and it is associated with a higher risk of thromboembolic events requiring anticoagulation therapy. Nowadays there is no test that allows monitoring the therapeutic range when using new anticoagulants. Motivation: To describe thromboelastographic patterns in patients with atrial fibrillation who are taking anticoagulants with rivaroxaban in the Cardiology Department at the University Hospital Fundación Santa Fe de Bogotá. Material and methods: The present cross-sectional study collected data relating to 30 patients with atrial fibrillation who received anticoagulation therapy with rivaroxaban between July 10th 2013 and January 6th 2015.General characteristics of the sample, as well as paramametres obtained from the thromboelastography, and they were compared to the thromboelastographic patterns according to the anticoagulant dose. Results: Average age was 75.8 years and the main indication for anticoagulation therapy was paroxysmal atrial fibrillation (56.67%). In more than 60% of patients a prolonged reaction time and low coagulation index was obtained. The remaining parametres from the thromboelastography were located within the normal range in most cases. No statistically significant differences were found in thromboelastographic patterns when comparing the 15 mg versus 20 mg rivaroxaban dose. Conclusion: Thromboelastographic patterns obtained in most study participants were characterized by a high reaction time and low coagulation index, possibly due to the effect of the factor Xa inhibitor.

Uso de tromboprofilaxis en pacientes con patología médica / Use of thromboprophylaxis in patients with a medical condition

Resumen Objetivo: Conocer las características de la población en riesgo de tromboembolia venosa y determinar si la profilaxis antitrombótica usada en patologías no quirúrgicas en un hospital universitario de tercer nivel, se adhiere a los protocolos de tromboprofilaxis establecidos. Métodos: Se llevó a cabo un estudio observacional de corte transversal, en el que se incluyeron pacientes mayores de 40 an˜os, hospitalizados por patologías de tratamiento médico no quirúr- gicas y con una permanencia de por lo menos 72 horas. Para evaluar el riesgo de trombembolia venosa y de sangrado se aplicaron las escalas PADUA e IMPROVE, respectivamente. Resultados: La muestra estuvo conformada por 233 pacientes, 56,6% del género masculino, con promedio de edad de 64,8 an˜os ± 13,1. La inmovilidad prolongada fue el principal factor de riesgo para trombembolia venosa durante la hospitalización; ésta fue cercana al 48,9% en la muestra total y a 69,4% en los pacientes evaluados mediante la escala de PADUA ≥4 (p < 0,01). Al determinar la frecuencia de tromboprofilaxis en los pacientes en riesgo, se determinó que 79,8% recibieron algún método de tromboprofilaxis. Entre los pacientes con puntaje en escala de PADUA < 4 se encontró que el 73,4% recibió tromboprofilaxis farmacológica. Conclusiones: En nuestro medio la tromboprofilaxis farmacológica se basa principalmente en el uso de heparinas de bajo peso molecular y se puede afirmar que dicho uso es adecuado y está por encima de otras series previamente referenciadas.

Abstract Objetive: To find out the characteristics of the population at risk of venous thromboembolism (VTE) and to determine whether antithrombotic prophylaxis used in nonsurgical conditions at a third level university hospital adheres to established protocols for thromboprophylaxis. Methods: A cross-sectional observational study was conducted. Selected patients were over 40 years of age, hospitalized due to nonsurgical, medical conditions and hospitalized for at least 72 hours. The PADUA score was used to assess the risk for VTE, and the IMPROVE score was used to assess bleeding. Results: The sample consisted of 233 patients, 56.6% of whom were men, with an average age of 64.8 ± 13.1 years. The main risk factor for VTE during hospitalization was prolonged immobility, at 48.9% of the total sample and 69.4% of patients with a Padua ≥4 (p=<0.01). When determining the frequency of thromboprophylaxis in patients at risk, results showed that 79.8% received some type of thromboprophylaxis. Among patients with a <4 Padua score it was found that 73.4% received pharmacologic thromboprophylaxis. Conclusions: In our field, pharmacologic thromboprophylaxis is mainly based on the use of low molecular weight heparins and it can be concluded that the use of thromboprophylaxis is appropriate and above that of other previously referenced series.

Relevancia clínica de la interacción de la warfarina y del acetaminofén: estudio de cohortes retrospective / Clinical relevance of the interaction of warfarin and acetaminophen: retrospective cohort study

Resumen Objetivo: Evaluar el uso concomitante de la warfarina y el acetaminofén en una población ambulatoria de pacientes anticoagulados, como posible factor de riesgo en el aumento de la Relación Normalizada Internacional (INR). Métodos: Estudio de cohortes retrospectivo. Se analizó la información de 1.458 pacientes anticoagulados con la warfarina. El factor de riesgo fue la utilización conjunta de warfarina- acetaminofén; el tiempo de seguimiento fue de 1 mes y como evento final se consideró un incremento del INR igual o mayor a 0,5 unidades. La asociación del factor de riesgo con el evento final se estableció con el riesgo relativo (RR) y el riesgo atribuible poblacional (RAP). Resultados: 63 pacientes cumplieron criterios de inclusión, 21 pacientes expuestos y 42 pacientes no expuestos. En los individuos expuestos se observó un aumento estadísticamente significativo en el INR al mes siguiente de haber iniciado el tratamiento con el acetaminofén comparado con el momento de ingreso al estudio (mes 1: mediana 3,06 vs. mes 0: mediana 2,63), (valor p = 0,003). En contraste, en los sujetos no expuestos no se observaron diferencias estadísticamente significativas en los valores del INR (mes 0: mediana 2,63 vs. mes 1: mediana 2,75), (valor p = 0,115). El uso de la warfarina y el acetaminofén representó un RR de 2,5 veces mayor de incrementar el INR mayor o igual de 0,5 unidades. Conclusión: El uso concomitante de la warfarina y el acetaminofén está asociado a un aumento del INR igual o mayor de 0,5 unidades, lo cual podría generar un mayor efecto anticoagulante y, por tanto, un mayor riesgo potencial de sangrado.

Abstract Motivation: To assess concomitant use of warfarin and acetaminophen in an outpatient population of patients receiving blood-thinning drugs as a possible risk factor for the increase of International Normalised Ratio (INR). Methods: Retrospective cohort study. The information pertaining 1,458 patients receiving blood-thinning drugs with warfarin was analysed. The risk factor was the joint intake of warfarin and acetaminophen; follow-up time was 1 month and the final event considered was a INR increase of or higher than 0.5 units. The association of the risk factor with the final event was establish with the Relative Risk (RR) and the Population Attributable Risk (PAR). Results: 63 patients met the inclusion criteria, of whom 21 were exposed patients and 42 were unexposed patients. In the exposed patients a statistically significant increase of INR on the month following the onset of treatment with acetaminophen was observed, compared to the baseline values (month 1: median 3.06 vs. month 0: median 2.63), (p = 0.003). In contrast, no statistically significant differences of INR values were observed in unexposed individuals (month 0: median 2.63 vs. month 1: median 2.75) (p = 0.115). The combination of warfarin and acetaminophen represented a RR 2.5 times higher to increase INR greater than or equal to 0.5 units. Conclusion: Concomitant use of warfarin and acetaminophen is associated to an increase of INR equal to or greater than 0.5 units, which could generate a higher blood-thinning effect and, thus, cause a potentially higher risk of bleeding.

Costo-efectividad de dabigatrán comparado con warfarina para el tratamiento de pacientes con fibrilación auricular no valvular / Cost-effectiveness of dabigatran compared with warfarin in the treatment of patients with non valvular atrial fibrillation in Colombia

Introducción: La fibrilación auricular, la arritmia cardiaca más frecuente, incrementa el riesgo de ataque cerebrovascular cinco veces. La prevalencia en Colombia se estimó en 3,6% en población mayor de 60 años (unos 180.000 pacientes). Objetivo: Estimar la costo-efectividad de dabigatrán 110 y 150 mg dos veces al día para el tratamiento de la fibrilación auricular no valvular en Colombia. Métodos: Con perspectiva de tercer pagador (sistema de salud), se usó un modelo de Markov con ciclos de tres meses, seis estados de salud (y muerte): ataque cerebrovascular no discapacitante, accidente cerebrovascular discapacitante, infarto de miocardio; y dos eventos de transición: sangrado menor y mayor. Las probabilidades de transición y proporciones de eventos se extrajeron del ensayo RE-LY, las utilidades se obtuvieron de la literatura, en tanto que los costos se tomaron de bases de datos oficiales, en pesos colombianos, con tasa de descuento del 5%, y un horizonte temporal de toda la vida (cerca de 20 años). El umbral fue tres veces el PIB per cápita (cerca de 45 millones de pesos). Resultados: En comparación con warfarina, los pacientes tratados con dabigatrán 150 y 110 mg ganaron, en promedio, 0,37 y 0,23 años de vida, respectivamente, o 0,55 y 0,43 años de vida ajustados por calidad (AVAC). La RCEI para dabigatrán 150 mg fue $ 23.078.506 por AVAC ganado, mientras que para dabigatrán de 110 mg fue de $ 34.186.731. Conclusiones: Dabigatrán (ambas dosis), comparado con warfarina, es una alternativa costo-efectiva para el tratamiento de la fibrilación auricular no valvular.

Introduction:Atrial fibrillation (AF), the most common cardiac rhythm disorder, increases the risk of stroke risk by 5 fold. AF prevalence in Colombia has been estimated in 3.6% in population age 60 or over (some 180 000 patients). Objective: The aim of this study was to estimate cost-effectiveness of dabigatran 110 and 150 mg BID compared with warfarin as a therapy for non valvular AF in Colombian population. Methods: From a third-party payer perspective (Colombian health system) we used a three-month cycle Markov model with 6 health states (and death): non-disabling stroke, disabling stroke, myocardial infarction and pulmonary embolism; two additional events were minor and mayor bleeding. Transition probabilities and proportion of events were extracted from the RELY trial; utilities were derived from the literature. Costs for medications and procedures were obtained from official government databases, all costs were in 2014 Colombian pesos (1 USD = 2.000 COP). Annual discount rate was 5% and we used a life time horizon (close to 20 years, on average). Cost-effectiveness threshold was 3 times per capita GDP (around USD 22,500). Results: Compared with warfarin, patients treated with dabigatran 150 and 110 mg gained, on average 0.37 and 0.23 life-years respectively, or 0.55 and 0.43 QALYs. The ICER for dabigatran 150 mg was USD 11,537 per QALY, and for dabigatran 110 mg was 17,090 per QALY gained. Conclusions: Dabigatran 150 and 110 mg, compared with warfarin -the standard therapy- are cost-effective therapies for ambulatory treatment of patients with non valvular AF.

Impacto de Ia telemedicina en Ia calidad del control de tratamiento anticoagulante oral / Impact of tele-medicine for control of oral anticoagulant treatment

Antecedentes: En el año 2014 se inició Telemedicina desde el Policlinico de Tratamiento Anticoagulante oral del Hospital San Juan de Dios y el Hospital de Curacaví, evitando así el traslado de pacientes a Santiago para el control con el médico especialista. Métodos: Se utilizó licencia de video conferencia en el Hospital San Juan de Dios, dispositivo móvil, equipo de INR capilar y stock de Acenocumarol en el Hospital de Curacaví. Resultados: En total se han realizado 2.174 consultas vía Telemedicina (junio 2014 a diciembre 2015). Esta estrategia ha sido bien evaluada por los pacientes. La mejora en la calidad del tratamiento ha sido evidente: 58,3% de los pacientes del Hospital de Curacaví se encuentran en rango terapéutico, superior al 50,8% de los pacientes del Hospital San Juan de Dios (p < 0,05). En cuanto al Tiempo en Rango Terapéutico (TTR) 50,6% de los pacientes del Hospital de Curacaví se encuentran en rango versus 46,2% de los pacientes del Hospital San Juan de Dios (p< 0,05). Conclusiones: La Telemedicina utilizada por equipos comprometidos es capaz de mantener indicadores de calidad de la atención que la validan como herramienta de atención clínica a distancia. La Telemedicina, en cuanto es una herramienta que acerca el especialista a comunidades alejadas de centros hospitalarios complejos, es valorada y muy bien calificada por los usuarios.

Background: Starting in 2014 telemedicine has been used to control oral anticoagulant treatment (OAT) in patients attending a peripheral hospital (Curacaví), in connection with Hospital San Juan de Dios, based in Santiago. Methods: A license for video conference was available to communicate both hospitals. Capillary INR and medications were available at Curacaví Hospital. Results: Between June 2014 and December 2015, 2174 indications for OAT have been made through tele-medicine. Different estimates of quality of care and user satisfaction have been rated > 6.7 (1-7 scale). Percent of INR measurements in therapeutic range was 58.3% in Curacavi and 50.8% at Hospital San Juan de Dios (p<0.05) and time in therapeutic range was 50.6% vs 42.6%, respectively (p<0.05) Conclusion: Tele-medicine allowed a close relationship between remote medical facilities and a complex medical center and was fully validated as a means of controlling OAT with a high degree of acceptance by patients.

Experiencia de una clínica de anticoagulación / Experience of an anticoagulation clinic

Introducción: La Clínica de Anticoagulación de la Fundación Santa Fe surgió como una estrategia para reducir las complicaciones asociadas a la anticoagulación. En ella se evalúan las indicaciones, contraindicaciones e interacciones farmacológicas que potencialmente pueden desencadenar desenlaces incapacitantes en los pacientes que reciben esta terapia. Objetivo: Describir la demografía, las indicaciones y el comportamiento de la terapia anticoagulante de los pacientes de la Clínica de Anticoagulación del Hospital Universitario Fundación Santa Fe de Bogotá. Metodología: Se realizó un estudio descriptivo retrospectivo que incluyó a 257 pacientes tratados en la Clínica de Anticoagulación entre abril de 2008 y diciembre de 2013, que recibieron terapia anticoagulante con warfarina, enoxaparina, rivaroxabán, apixabán o dabigatrán. Resultados: El 62,6% correspondía a mujeres con un promedio de edad de 65,3 años (DE 17,38); 71,20% recibió warfarina, 5,05% enoxaparina, 14,78% rivaroxabán, 8,17% dabigatrán y 0,77% apixabán. Las principales indicaciones de anticoagulación fueron trombosis venosa (47,08%) y fibrilación auricular (36,96%). Las complicaciones asociadas fueron sangrado mayor en el 1,16%, sangrado no mayor en el 8,17% y eventos trombóticos en el 3,5%. El tiempo en el rango terapéutico con INR 2-3 fue del 53,5% en los pacientes tratados con warfarina. Conclusión: Este estudio concuerda con la literatura internacional al proponer que la selección de la terapia anticoagulante y su vigilancia pueden disminuir la frecuencia de efectos adversos (sangrado y trombosis). La clínica de anticoagulación también permite optimizar el tiempo en rango terapéutico de los pacientes tratados con warfarina.

Introduction: The anticoagulation clinic emerged as a strategy to reduce the complications associated with anticoagulation therapy. There, the indications, contraindications and drug interactions that could cause potential functional disabilities of individual patients receiving this treatment are evaluated. Objective:To describe the demographic profile and pharmacologic indications and to determine the behavior of anticoagulant therapy of patients consulting at the Anticoagulation Clinic of the University Hospital Fundación Santa Fe de Bogotá. Methods: A descriptive retrospective study was carried out that included 257 patients of the anticoagulation clinic between April 2008 and December 2013, who received anticoagulation therapy with warfarin, enoxaparin, rivaroxaban, apixaban or dabigatran. Results: 62.6% were female; the average age was 65.3 years old; 71.20% received warfarin, 5.05% enoxaparin, rivaroxaban 14.78%, 8.17% dabigatran and 0.77% apixaban. The chief indications for anticoagulation were venous thrombosis (47.08%) and atrial fibrillation (36.96%.) Leading complications associated with total anticoagulant strategy were: major bleeding (1.16%), mild bleeding (8.17%) and re-thrombotic events (3.5%). The time spent in therapeutic range (INR 2-3) was 53.5% in the warfarin group. Conclusion: This study is consistent with international literature in suggesting that the selection and monitoring of anticoagulation therapy could reduce the frequency of adverse effects (bleeding and thrombosis). The anticoagulation clinic also allows to optimise the time in the therapeutic range of the patients treated with warfarin.

Diagnostic evaluation and treatment of patients with rectus abdominis hematoma.

PURPOSE: To identify clinical characteristics, treatment modalities, and course of spontaneous rectus sheath hematoma (SRSH). In the literature, there is no prospective clinical trial that is intended for treatment in clinical research. METHODS: Seventeen SRSH patients diagnosed and treated between March 2012 and March 2014 at the general Surgery Department of Erzincan University Training and Research Hospital were included. Age, sex, weight, height, predisposing factors, comorbid diseases, Charlson index, current medical treatment, physical examination signs, imaging methods, lowest hemoglobin value, blood type, SRSH type, INR/Factor V Leiden mutation/Factor VII/Factor VIII/Factor X/Protein S/Protein C values, treatment method, transfusions hospitalization duration, and outcome were studied. RESULTS: Thirteen patients were female. The mean age was 63.3 ± 18.7 years (range, 22-87 years), and the mean BMI was 27.8 ± 3.5 (range, 20.9-33.7). Six patients had Grade I SRSH, 5 had Grade II SRSH, and 6 had Grade III SRSH. Thirteen were hospitalized for a mean duration of 9.3 ± 8.1 days (range, 1-30 days). The death rate attributable to SRSH was 5.8%. CONCLUSION: Early diagnosis of SRSH by ultrasonography and/or computerized tomography is important for a low mortality rate. Even though medical treatments are important, arterial embolization by interventional radiology, or more radical interventions such as surgery, may be required.

Guía basada en la evidencia para el manejo perioperatorio de la anticoagulación oral con warfarina en pacientes con alto riesgo embólico que serán llevados a implante de dispositivos de estimulación cardiaca / Evidence-based guidelines for the perioperative management of oral anticoagulation with warfarin in patients scheduled for implantation of a cardiac electronic device

Introducción: El manejo perioperatorio de la anticoagulación crónica representa dificultad para los médicos que realizan implantes de dispositivos de estimulación cardíaca, quienes utilizan la terapia puente con heparinas con la intención de disminuir el riesgo de sangrado. Sin embargo, este tratamiento es controversial. Objetivo: Generar recomendaciones basadas en evidencia sobre el tratamiento perioperatorio de la anticoagulación de los pacientes con riesgo embólico moderado y alto, que requieren anticoagulación oral con warfarina y serán llevados a implante de dispositivos de estimulación cardíaca. Métodos: Se realizó una búsqueda de la literatura para identificar guías de práctica clínica basadas en evidencia, las cuales se calificaron con la herramienta AGREE II. Se actualizó la evidencia desde el 1 de enero de 2009 hasta el 30 de noviembre de 2013, incluidas revisiones sistemáticas y experimentos clínicos. Los estudios se calificaron con los instrumentos GRADE y SIGN. Se generaron recomendaciones con metodología GRADE, llevadas a consenso formal de expertos. Resultados: Las guías SIGN y CHEST tuvieron la mejor calificación con AGREE II. Con la nueva evidencia disponible proveniente de tres revisiones sistemáticas y dos experimentos clínicos, se generó recomendación fuerte a favor de continuar la anticoagulación oral con warfarina durante el perioperatorio de implante de dispositivos de estimulación cardíaca en pacientes con riesgo embólico moderado y alto. Conclusiones: A partir de la nueva evidencia cambia la recomendación propuesta por las guías SIGN y CHEST. La alternativa de continuar la terapia con warfarina a cambio de realizar terapia puente, debe considerarse en la práctica clínica.

Introduction: The perioperative management of chronic anticoagulation concerns all physicians involved in the implantation of cardiac electronic devices (either pacemakers and cardioverter-defibrillators). Switching from warfarin to low molecular weight heparins (LMWH) has been performed to reduce the risk of bleeding. However, this approach has been shown to be controversial. Objective: To generate evidence-based recommendations on the perioperative management of oral anticoagulation with warfarin in patients who will undergo the implantation of a cardiac electronic device. Methods: A literature search was performed to identify evidence-based clinical practice guidelines, which were assessed using the AGREE II instrument. The guidelines were updated with systematic reviews and randomized clinical trials published from February 2009 to November 2013 comparing the continuation of warfarin versus switching to a LMWH or withholding warfarin. These studies were analyzed using the SIGN and GRADE scales to assess methodological quality. Recommendations were put forward through an expert panel. Results: The guidelines with highest methodological quality were the SIGN (Scottish Intercollegiate Guidelines Network) guideline published in June 2013 and the CHEST guideline published in February 2012. The update included three systematic reviews and two randomized clinical trials. The continuation of warfarin for the perioperative management of implantable cardiac electronic devices in patients with moderate and high risk is recommended. Conclusion: Based on the new evidence changes the recommendation given by the CHEST SIGN and guides. The alternative of continued therapy with warfarin in exchange for performing therapy bridge, should be considered in clinical practice.