Evaluación de la seguridad de los anticoagulantes orales de acción directa / Safety assessment of new oral anticoagulants

Objetivo: Comparar la incidencia de hemorragias entre los anticoagulantes orales (ACO) y analizar los factores que influyen en la aparición de hemorragias. Material y métodos: Estudio observacional, retrospectivo unicéntrico. Tras estudiar la población total en tratamiento con ACO, se analizó a los pacientes en tratamiento con un ACO del sector II de Zaragoza que acudieron al Servicio de Urgencias de Hospital Universitario Miguel Servet de julio a diciembre de 2015 por presentar algún evento. Se registraron datos demográficos, variables clínicas y características del evento hemorrágico. Como factores independientes en la aparición de hemorragias se valoró la dosis, fármacos, el sexo y la edad. Resultados: Había 9.452 pacientes en tratamiento con ACO, de los cuales 371 presentaron un evento hemorrágico (3,9%). La frecuencia por ACO fue 4,1% (311) en pacientes tratados con antagonistas de la vitamina K (AVK), 3,8% (33) con rivaroxaban, 3,3% (19) con dabigatran y, por último, con apixaban 2,1% (8) (p<0,05). En el análisis multivariante solo obtuvieron una influencia estadísticamente significativa la selección del anticoagulante y el sexo, en concreto, la dosis de apixaban 2,5mg y ser mujer presentaban menor riesgo de hemorragia (OR=0,1; IC=0,014-0,71 y OR=0,688; IC=0,55-0,85, respectivamente). Conclusión: Según los datos obtenidos, las mujeres y los pacientes en tratamiento con apixaban presentaban menor riesgo hemorrágico, si bien existen dudas de si este mejor perfil de seguridad está relacionado con una infradosificación, que podría influir en su efectividad. Por lo tanto, estos resultados deben ser analizados con prudencia y se deben realizar más estudios para confirmar estos datos

Objective: To compare the occurrence of haemorrhages among the different oral anticoagulants (OAC) and to analyse factors that influence it. Material and methods: Single-centre, observational, retrospective study. After studying the total population treated with OAC, patients who were treated with an OAC from July 2015 to December 2015 in the II Sector of the Zaragoza Hospital, who consulted the Emergency Department of the Miguel Servet University Hospital and presented a haemorrhagic event, were analysed. Patients' demographic data, clinical variables and data on the haemorrhagic event characteristics were gathered. Results: There were 9,452 patients treated with an OAC, 371 (3.9%) of which presented a haemorrhagic event. The frequency per OAC was; 4.1% (311) in patients treated with vitamin K antagonists, 3.8% (33) with rivaroxaban, 3.3% (19) with dabigatran and 2.1% (8) with apixaban. In the multivariate analysis, only the choice of anticoagulant and sex had a statistically significant influence of a lower risk of haemorrhage, in particular the dose of apixaban at 2.5mg and being female. (OR=0.1, CI=0.014-0.71 and OR=0.688, CI=0.55-0.85, respectively). Conclusion: According to the results obtained, females and patients undergoing treatment with apixaban presented lower haemorrhagic risk, although there are doubts about whether this better safety profile is related to underdosing, which could influence its effectiveness. Therefore, these results should be analysed with caution and further studies are needed to confirm this data

Safety assessment of new oral anticoagulants. / Evaluación de la seguridad de los anticoagulantes orales de acción directa.

OBJECTIVE: To compare the occurrence of haemorrhages among the different oral anticoagulants (OAC) and to analyse factors that influence it. MATERIAL AND METHODS: Single-centre, observational, retrospective study. After studying the total population treated with OAC, patients who were treated with an OAC from July 2015 to December 2015 in the II Sector of the Zaragoza Hospital, who consulted the Emergency Department of the Miguel Servet University Hospital and presented a haemorrhagic event, were analysed. Patients' demographic data, clinical variables and data on the haemorrhagic event characteristics were gathered. RESULTS: There were 9,452 patients treated with an OAC, 371 (3.9%) of which presented a haemorrhagic event. The frequency per OAC was; 4.1% (311) in patients treated with vitamin K antagonists, 3.8% (33) with rivaroxaban, 3.3% (19) with dabigatran and 2.1% (8) with apixaban. In the multivariate analysis, only the choice of anticoagulant and sex had a statistically significant influence of a lower risk of haemorrhage, in particular the dose of apixaban at 2.5mg and being female. (OR=0.1, CI=0.014-0.71 and OR=0.688, CI=0.55-0.85, respectively). CONCLUSION: According to the results obtained, females and patients undergoing treatment with apixaban presented lower haemorrhagic risk, although there are doubts about whether this better safety profile is related to underdosing, which could influence its effectiveness. Therefore, these results should be analysed with caution and further studies are needed to confirm this data.

[Reducing the number of orders for coagulation tests in the standard emergency department blood work-up]. / Reducción de la determinación de coagulación en las pruebas analíticas básicas en los servicios de urgencias.

OBJECTIVES: To evaluate the usefulness of a clinical protocol developed to reduce the number of orders for coagulation tests. MATERIAL AND METHODS: Quasi-experimental study with historical controls. We retrospectively included all patients whose records showed that a coagulation test had been ordered in the emergency department. We analyzed the number of tests ordered under the protocol and the number ordered during the period of standard practice. RESULTS: Orders for coagulation tests were given for 657 patients (77.2%) when physicians followed standard practices and for 448 (55.5%) when they followed the protocol (P <.001). Unnecessary tests numbered 431 (65.6%) and 227 (50.6%) in the standard-practice and protocol periods, respectively (P <.002). One patient (0.15% [95% CI, 0.004%-0.8%]) had significantly altered coagulation (international normalized ratio, 1.8), but none (0% [95% CI, 0%-0.6%]) required treatment and no treatment plans were changed based on a finding of unexpected coagulation disorder. CONCLUSION: The protocol to guide the ordering of coagulation tests has managed to reduce unnecessary tests and thus improve management of this health service resource.

OBJETIVO: Valorar el impacto de un protocolo de solicitud de coagulación para reducir determinaciones innecesarias. METODO: Estudio cuasiexperimental con control histórico. La selección de pacientes se realizó de forma retrospectiva. Se incluyeron de forma consecutiva todos los pacientes a los que se les realizó una analítica urgente. Se analizó la solicitud estándar frente a la aplicación del protocolo. RESULTADOS: En el grupo estándar se determinaron 657 coagulaciones (77,2%) y en el grupo protocolo 448 (55,5%) (p < 0,001), y fueron innecesarias 431 (65,6%) y 227 (50,6%) (p < 0,002), respectivamente. Un paciente [0,15% (IC 95%: 0,004-0,8)] mostró alteración de la coagulación significativa (INR 1,8), pero ninguno [0% (IC 95%,0-0,6)] requirió intervención terapéutica o cambio de plan clínico basado en la detección de una coagulopatía inesperada. CONCLUSIONES: La aplicación de un protocolo ha conseguido la reducción del número estudios de coagulación innecesarios con la consiguiente mejora en la gestión de este recurso.

Reducción de la determinación de coagulación en las pruebas analíticas básicas en los servicios de urgencias / Reducing the number of orders for coagulation tests in the standard emergency department blood work-up

Objetivo: Valorar el impacto de un protocolo de solicitud de coagulación para reducir determinaciones innecesarias. Método: Estudio cuasiexperimental con control histórico. La selección de pacientes se realizó de forma retrospectiva. Se incluyeron de forma consecutiva todos los pacientes a los que se les realizó una analítica urgente. Se analizó la solicitud estándar frente a la aplicación del protocolo. Resultados: En el grupo estándar se determinaron 657 coagulaciones (77,2%) y en el grupo protocolo 448 (55,5%) (p < 0,001), y fueron innecesarias 431 (65,6%) y 227 (50,6%) (p < 0,002), respectivamente. Un paciente [0,15% (IC 95%: 0,004-0,8)] mostró alteración de la coagulación significativa (INR 1,8), pero ninguno [0% (IC 95%,0-0,6)] requirió intervención terapéutica o cambio de plan clínico basado en la detección de una coagulopatía inesperada. Conclusiones: La aplicación de un protocolo ha conseguido la reducción del número estudios de coagulación innecesarios con la consiguiente mejora en la gestión de este recurso (AU)

Objective: To evaluate the usefulness of a clinical protocol developed to reduce the number of orders for coagulation tests. Methods: Quasi-experimental study with historical controls. We retrospectively included all patients whose records showed that a coagulation test had been ordered in the emergency department. We analyzed the number of tests ordered under the protocol and the number ordered during the period of standard practice. Results: Orders for coagulation tests were given for 657 patients (77.2%) when physicians followed standard practices and for 448 (55.5%) when they followed the protocol (P<.001). Unnecessary tests numbered 431 (65.6%) and 227 (50.6%) in the standard-practice and protocol periods, respectively (P<.002). One patient (0.15% [95% CI, 0.004%-0.8%]) had significantly altered coagulation (international normalized ratio, 1.8), but none (0% [95% CI, 0%-0.6%]) required treatment and no treatment plans were changed based on a finding of unexpected coagulation disorder. Conclusions: The protocol to guide the ordering of coagulation tests has managed to reduce unnecessary tests and thus improve management of this health service resource (AU)

El síndrome platipnea-ortodeoxia: claves clínicas para su sospecha en urgencias / Platypnea-orthodeoxia syndrome in Spain

El síndrome de platipnea-ortodeoxia (SPO) se caracteriza por disnea e hipoxemia en ortostatismo. Su diagnóstico diferencial muestra causas cardiacas y extracardiacas responsables de distintos mecanismos fisiopatológicos. Se ha realizado una revisión desde enero de 2002 hasta junio de 2014 de los casos confirmados de SPO en el Hospital Universitario Miguel Servet de Zaragoza. Se encontraron un total de 4 casos: 3 de ellos secundarios a un shunt derecha-izquierda intracardiaco a través de un foramen oval permeable (FOP) y uno secundario a un shunt vascular pulmonar en el contexto de un síndrome hepatopulmonar. Se presentan dos de estos casos y se discuten las claves clínicas para su sospecha en urgencias (AU)

Platypnea orthodeoxia (PO) syndrome is characterized by dyspnea and orthostatic hypoxemia. Various cardiac and noncardiac conditions responsible for the pathophysiological mechanisms involved in the syndrome are found during differential diagnosis. We searched the records of Hospital Universitario Miguel Servet in Saragossa for confirmed cases of PO syndrome diagnosed between January 2002 and June 2014 and found 4 cases. Three were secondary to rightto-left shunt by way of a patent foramen ovale. The fourth was secondary to an intrapulmonary vascular shunt in the context of hepatopulmonary syndrome. A total of 129 titles on PO syndrome were indexed in MEDLINE between 1979 and April 2013; 77% were published in the last 10 years. PO syndrome is under diagnosed. The evident increase in incidence in recent years is probably attributable to better diagnostic techniques (AU)

[Platypnea-orthodeoxia syndrome in Spain]. / El síndrome platipnea-ortodeoxia: claves clínicas para su sospecha en urgencias.

EN: Platypnea orthodeoxia (PO) syndrome is characterized by dyspnea and orthostatic hypoxemia. Various cardiac and noncardiac conditions responsible for the pathophysiological mechanisms involved in the syndrome are found during differential diagnosis. We searched the records of Hospital Universitario Miguel Servet in Saragossa for confirmed cases of PO syndrome diagnosed between January 2002 and June 2014 and found 4 cases. Three were secondary to rightto- left shunt by way of a patent foramen ovale. The fourth was secondary to an intrapulmonary vascular shunt in the context of hepatopulmonary syndrome. A total of 129 titles on PO syndrome were indexed in MEDLINE between 1979 and April 2013; 77% were published in the last 10 years. PO syndrome is under diagnosed. The evident increase in incidence in recent years is probably attributable to better diagnostic techniques.

ES: El síndrome de platipnea-ortodeoxia (SPO) se caracteriza por disnea e hipoxemia en ortostatismo. Su diagnóstico diferencial muestra causas cardiacas y extracardiacas responsables de distintos mecanismos fisiopatológicos. Se ha realizado una revisión desde enero de 2002 hasta junio de 2014 de los casos confirmados de SPO en el Hospital Universitario Miguel Servet de Zaragoza. Se encontraron un total de 4 casos: 3 de ellos secundarios a un shunt derecha-izquierda intracardiaco a través de un foramen oval permeable (FOP) y uno secundario a un shunt vascular pulmonar en el contexto de un síndrome hepatopulmonar. Se presentan dos de estos casos y se discuten las claves clínicas para su sospecha en urgencias.

Meningoencefalitis por Loa loa secundaria a tratamiento con mebendazol / Loa loa meningoencephalitis secondary to treatment with mebendazol

No disponible

[Efficiency and cost-effectiveness for a safety device]. / Efectividad y coste-efectividad de un dispositivo de seguridad.

When dealing with preventive measures, it is necessary to evaluate their effectiveness and to analyze the costs involved in implementing those measures. Therefore, the authors carried out a before-after intervention study on the use of a safe intravenous peripheral catheter in emergency ward services; this study included the participation by workers in selecting material by means of a Likert questionnaire. The effectiveness of a safe intravenous peripheral catheter was calculated comparing skin accidents caused by this device 40 months before and after its implantation. An economic analysis was calculated by means of a cost-effectiveness index fined as a "Euros spent for accident prevented" index. Workers who participated chose a passive safe intravenous peripheral catheter (p < 0.05). During the pre-intervention period, 17 intravenous peripheral catheter expositions were declared, during the post-intervention period, none were declared. The total net cost per intervention came to 36.606 Euro. The cost effectiveness index was 2.579,3 Euro for accident prevented.

Efectividad y coste-efectividad de un dispositivo de seguridad / Efficiency and Cost-Effectiveness for a safety device

En actividades de prevención es necesario evaluar la efectividad y analizar el coste de su implantación. Por ello, se efectúa un estudio de intervención antes-después del uso de un catéter endovenoso periférico (CEVP) seguro, en un Servicio de Urgencias, con participación de trabajadores en la selección del material con una encuesta tipo Likert. La efectividad del CEVP seguro se midió comparando accidentes percutáneos por el dispositivo 40 meses antes y después de la introducción del mismo. El análisis económico se calculó mediante un índice coste-efectividad definido como «euros gastados por accidente evitado». Los trabajadores eligieron un CEVP de seguridad pasiva (p < 0,05). En periodo preintervención se declararon 17 exposiciones por CEVP, en periodo postintervención no se declaró ninguna. El coste total neto de la intervención supuso 36.606 €. El índice coste-efectividad fue de 2.579,3 € por accidente evitado(AU)

When dealing with preventive measures, it is necessary to evaluate their effectiveness and to analyze the costs involved in implementing those measures. Therefore, the authors carried out a before-after intervention study on the use of a safe intravenous peripheral catheter in emergency ward services; this study included the participation by workers in selecting material by means of a Likert questionnaire. The effectiveness of a safe intravenous peripheral catheter was calculated comparing skin accidents caused by this device 40 months before and after its implantation. An economic analysis was calculated by means of a cots-effectiveness index fined as a «Euros spent for accident prevented» index. Workers who participated chose a passive safe intravenous peripheral catheter (p < 0,05). During the pre-intervention period, 17 intravenous peripheral catheter expositions were declared; during the post-intervention period, none were declared. The total net cost per intervention came to € 36.606. The cost effectiveness index was € 2.579,3 for accident prevented(AU)