Análisis de 3 métodos para determinar el dímero D en pacientes con sospecha de trombosis venosa profunda / Clinical usefulness of three quantitative D-dimers tests in outpatients with suspected deep vein thrombosis

Antecedentes y objetivo. En los algoritmos diagnósticos de pacientes ambulatorios con sospecha de trombosis venosa profunda (TVP), se incluye la determinación del dímero D (DD). Un valor elevado del DD no es diagnóstico de TVP, pero una cifra normal contribuye a excluir una TVP. Desconocemos el mejor método para determinar el DD. Hemos analizado la utilidad clínica de 3 métodos cuantitativos para determinar el DD en pacientes ambulatorios con sospecha de TVP. Pacientes y métodos. Incluimos a pacientes consecutivos, ambulatorios, con sospecha de TVP que fueron remitidos a la consulta de enfermedad tromboembólica venosa. Aplicamos un algoritmo diagnóstico que incluía la determinación de la probabilidad clínica de padecer una TVP (escala de Wells) y la determinación del DD mediante 3 métodos cuantitativos (ELISA mini-VIDAS®, Acute-care DDMR y DD-Plus). El diagnóstico de TVP se confirmó mediante ecografía compresiva seriada de miembros inferiores. Analizamos la concordancia entre los 3 métodos analíticos para cuantificar el DD, así como sus características. Resultados. Incluimos 306 pacientes (edad media: 60 años; mujeres: 62%) con sospecha de TVP. La ecografía compresiva confirmó el diagnóstico de TVP en el 23,8% de los casos. Los pacientes en los que se descartó TVP no fueron anticoagulados y no se produjo ningún evento tromboembólico en 3 meses de seguimiento. Los métodos de determinación de DD que mejor se correlacionaron fueron el ELISA mini-VIDAS® y el Acute-care DDMR. Ambos métodos mostraron una elevada sensibilidad y un valor predictivo negativo. El mejor método analítico para el subgrupo de pacientes con probabilidad clínica baja de TVP fue el ELISA mini-VIDAS®. Conclusiones. El método ELISA mini-VIDAS® para la determinación del DD descarta con seguridad una TVP en pacientes con baja probabilidad clínica(AU)

Background and objective. The diagnostic approach in outpatients with suspected deep vein thrombosis (DVT) of the lower limbs includes D-dimer measurement (DD). Elevated DD is not a diagnostic value for DVT. However, a normal value contributes to ruling out DVT. We do not know the best method to determine DD. Therefore, we have analyzed the clinical utility of three quantitative assays to determine DD in outpatients with suspected DVT. Patients and methods. Consecutive outpatients with suspected DVT of the lower limbs who were referred to the DVT medical consultation were enrolled in the study. We used a diagnostic algorithm that included determining the pretest clinical probability (PCP) (Wells scale), DD level using three different quantitative methods (ELISA mini-VIDAS®, Acure-care DDMR and DD-Plus). The DVT diagnosis was confirmed by seriated compression ultrasonography of the lower limbs. We analyzed the concordance between the three analytic methods to quantify DD and the characteristics. Results. A total of 306 patients (mean age 60 years, 62% women) with suspected DVT of the lower limbs were included. The compression ultrasonography confirmed the diagnosis of DVT in 23.8% of the patients. Anticoagulation treatment was not performed in patients in whom DVT was ruled out, and no thromboembolic event occurred during the 3 months of follow-up. The best concordance test results were between ELISA mini-VIDAS® and Acure-care DDMR assays. Both assays demonstrated elevated sensibility and a negative predictive value. ELISA mini-VIDAS® was the best analytic method for the subgroup of patients with low clinical probability. Conclusions. The ELISA mini-VIDAS® method to determine DD rules out DVT in patients with low clinical probability(AU)

[Clinical usefulness of three quantitative D-dimers tests in outpatients with suspected deep vein thrombosis]. / Análisis de 3 métodos para determinar el dímero D en pacientes con sospecha de trombosis venosa profunda.

BACKGROUND AND OBJECTIVE: The diagnostic approach in outpatients with suspected deep vein thrombosis (DVT) of the lower limbs includes D-dimer measurement (DD). Elevated DD is not a diagnostic value for DVT. However, a normal value contributes to ruling out DVT. We do not know the best method to determine DD. Therefore, we have analyzed the clinical utility of three quantitative assays to determine DD in outpatients with suspected DVT. PATIENTS AND METHODS: Consecutive outpatients with suspected DVT of the lower limbs who were referred to the DVT medical consultation were enrolled in the study. We used a diagnostic algorithm that included determining the pretest clinical probability (PCP) (Wells scale), DD level using three different quantitative methods (ELISA mini-VIDAS(®), Acure-care DDMR and DD-Plus). The DVT diagnosis was confirmed by seriated compression ultrasonography of the lower limbs. We analyzed the concordance between the three analytic methods to quantify DD and the characteristics. RESULTS: A total of 306 patients (mean age 60 years, 62% women) with suspected DVT of the lower limbs were included. The compression ultrasonography confirmed the diagnosis of DVT in 23.8% of the patients. Anticoagulation treatment was not performed in patients in whom DVT was ruled out, and no thromboembolic event occurred during the 3 months of follow-up. The best concordance test results were between ELISA mini-VIDAS(®) and Acure-care DDMR assays. Both assays demonstrated elevated sensibility and a negative predictive value. ELISA mini-VIDAS(®) was the best analytic method for the subgroup of patients with low clinical probability. CONCLUSIONS: The ELISA mini-VIDAS(®) method to determine DD rules out DVT in patients with low clinical probability.