RESUMO
Importance: Uncontrolled studies suggest that pulmonary embolism (PE) can be safely ruled out using the YEARS rule, a diagnostic strategy that uses varying D-dimer thresholds. Objective: To prospectively validate the safety of a strategy that combines the YEARS rule with the pulmonary embolism rule-out criteria (PERC) rule and an age-adjusted D-dimer threshold. Design, Settings, and Participants: A cluster-randomized, crossover, noninferiority trial in 18 emergency departments (EDs) in France and Spain. Patients (N = 1414) who had a low clinical risk of PE not excluded by the PERC rule or a subjective clinical intermediate risk of PE were included from October 2019 to June 2020, and followed up until October 2020. Interventions: Each center was randomized for the sequence of intervention periods. In the intervention period (726 patients), PE was excluded without chest imaging in patients with no YEARS criteria and a D-dimer level less than 1000 ng/mL and in patients with 1 or more YEARS criteria and a D-dimer level less than the age-adjusted threshold (500 ng/mL if age <50 years or age in years × 10 in patients ≥50 years). In the control period (688 patients), PE was excluded without chest imaging if the D-dimer level was less than the age-adjusted threshold. Main Outcomes and Measures: The primary end point was venous thromboembolism (VTE) at 3 months. The noninferiority margin was set at 1.35%. There were 8 secondary end points, including chest imaging, ED length of stay, hospital admission, nonindicated anticoagulation treatment, all-cause death, and all-cause readmission at 3 months. Results: Of the 1414 included patients (mean age, 55 years; 58% female), 1217 (86%) were analyzed in the per-protocol analysis. PE was diagnosed in the ED in 100 patients (7.1%). At 3 months, VTE was diagnosed in 1 patient in the intervention group (0.15% [95% CI, 0.0% to 0.86%]) vs 5 patients in the control group (0.80% [95% CI, 0.26% to 1.86%]) (adjusted difference, -0.64% [1-sided 97.5% CI, -∞ to 0.21%], within the noninferiority margin). Of the 6 analyzed secondary end points, only 2 showed a statistically significant difference in the intervention group compared with the control group: chest imaging (30.4% vs 40.0%; adjusted difference, -8.7% [95% CI, -13.8% to -3.5%]) and ED median length of stay (6 hours [IQR, 4 to 8 hours] vs 6 hours [IQR, 5 to 9 hours]; adjusted difference, -1.6 hours [95% CI, -2.3 to -0.9]). Conclusions and Relevance: Among ED patients with suspected PE, the use of the YEARS rule combined with the age-adjusted D-dimer threshold in PERC-positive patients, compared with a conventional diagnostic strategy, did not result in an inferior rate of thromboembolic events. Trial Registration: ClinicalTrials.gov Identifier: NCT04032769.
Assuntos
Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Embolia Pulmonar/diagnóstico , Tromboembolia Venosa/diagnóstico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Causas de Morte , Intervalos de Confiança , Estudos Cross-Over , Serviço Hospitalar de Emergência , Feminino , França , Hospitalização/estatística & dados numéricos , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Estudos Prospectivos , Embolia Pulmonar/sangue , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/mortalidade , Reprodutibilidade dos Testes , Espanha , Tromboembolia Venosa/sangue , Adulto JovemRESUMO
OBJECTIVES: To describe the characteristics of patients with isolated lower-limb superficial vein thrombosis (SVT) treated in hospital emergency departments and to evaluate adherence to clinical practice guidelines on diagnosis (vein ultrasound imaging) and therapeutic management (start of anticoagulant therapy). MATERIAL AND METHODS: Retrospective cohort study in 18 Spanish emergency departments. We included all patients with a final emergency department diagnosis of lower-limb SVT aged 18 years or older between January 2016 and May 2017. Backward stepwise multiple logistic regression analysis was used to evaluate adherence to clinical practice guidelines on ordering vein ultrasound imaging and starting anticoagulant therapy. RESULTS: A total of 1166 patients were included. The mean patient age was 59.6 years, and 67.9% were women. About a quarter of the patients (24.4%) had a history of venous thromboembolic disease. Complications developed in 8.9% within 180 days: 4.6% experienced a recurrence and 3.6% progressed to SVT and 1.8% to deep vein thrombosis; pulmonary thromboembolism occurred in 0.9%. Hemorrhagic complications developed in 17 patients (1.5%). Sixteen patients (1.4%) died. Vein ultrasound imagine was ordered for 703 patients (60.3%). Anticoagulant agents were prescribed for 898 (77%) for a median period of 22 days. Variables associated with a decision to order anticoagulants were a history of venous thromboembolic disease (odds ratio [OR], 1.60; 95% CI, 1.12-2.30), varicose veins (OR, 1.40; 95% CI, 1.12-2.30); limb pain (OR, 1.44; 95% CI, 1.08-1.91); painful cord (OR, 1.30; 95% CI, 0.97-1.73); and availability of vein ultrasound images (OR, 1.60; 95% CI, 1.94-3.45). CONCLUSION: Adherence to clinical practice guidelines for the diagnosis and treatment of isolated lower-limb SVT is low in Spanish emergency departments. Ultrasound imaging is not ordered for 1 out of every 2 to 3 patients, and anticoagulant treatment is not started in 1 out of 4 patients. There is great room for improvement.
OBJETIVO: Describir las características de los pacientes diagnosticados de trombosis venosa superficial (TVS) aislada de miembros inferiores en servicios de urgencias hospitalarios (SUH), y evaluar la adherencia a las guías de práctica clínica en el manejo diagnóstico y terapéutico (realización de ecografía venosa e instauración de tratamiento anticoagulante). METODO: . Estudio de cohortes retrospectivo en 18 SUH españoles. Se incluyeron todos los pacientes atendidos en los SUH con diagnóstico final de TVS en miembros inferiores, con edad $ 18 años, de enero de 2016 a mayo de 2017. Para evaluar la no adherencia a las recomendaciones de las guías de práctica clínica (realización de ecografía venosa, e instauración de tratamiento anticoagulante) se ajustó un modelo de regresión logística múltiple por pasos hacia atrás. RESULTADOS: . Mil ciento sesenta y seis pacientes fueron incluidos. La edad media fue de 59,6 años, el 67,9% eran mujeres. El 24,4% tenían antecedentes de enfermedad tromboembólica venosa (ETV). El 8,9% tuvieron alguna complicación a 180 días [4,6% recurrencia y 3,6% progresión de TVS, 1,8% trombosis venosa profunda (TVP) y 0,9% tromboembolia pulmonar (TEP)]. Hubo 17 pacientes (1,5%) con hemorragia y 16 (1,4%) muertes. Se realizó ecografía venosa a 703 (60,3%) pacientes. Recibieron tratamiento anticoagulante 898 (77%), con una mediana de 22 días. Las variables asociadas con la decisión de anticoagular fueron: antecedentes ETV (OR 1,60; IC 95%: 1,12-2,30), varices (OR 1,40; IC 95%: 1,12-2,30), dolor de la extremidad (OR 1,44; IC 95%: 1,08-191), presencia de cordón doloroso (OR 1,30; IC 95%: 0,97-1,73) y realización de ecografía venosa (OR 1,60; IC 95%: 1,94-3,45). CONCLUSIONES: Existe una baja adherencia a las recomendaciones de las guías de práctica clínica en el manejo diagnóstico y terapéutico de los pacientes con diagnóstico de TVS aislada de miembros inferiores en los SUH españoles: no se realiza ecografía venosa en uno de cada 2-3 pacientes, y no se instaura tratamiento anticoagulante en 1 de cada 4. Esto constituye un margen de mejora muy relevante.
Assuntos
Trombose Venosa , Adolescente , Serviço Hospitalar de Emergência , Feminino , Hospitais , Humanos , Estudos Retrospectivos , Fatores de Risco , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/tratamento farmacológicoRESUMO
BACKGROUND: Metformin-associated lactic acidosis (MALA) is a widely documented adverse event of metformin. Despite being considered one of the main causes of metabolic acidosis, the association between an anion gap and MALA diagnosis is still uncertain. CASE PRESENTATION: Cases involving six Caucasian patients with suspected MALA who were admitted to the emergency department were analysed. All these patients presented with pH values < 7.35, lactate levels > 2 mmol/L, and estimated glomerular filtration < 30 mL/min. Metformin plasma concentrations were > 2.5 mg/L in all the patients. The highest metformin concentrations were not found in the patients with the highest lactate levels. The anion gap values ranged from 12.3 to 39.3, with only two patients exhibiting values > 14. CONCLUSIONS: In patients with MALA, there is a significant variability in the anion gap values, which is not related to the level of metformin accumulation, and therefore, it is doubtful whether measuring anion gaps is useful as an approach for MALA diagnosis.
Assuntos
Equilíbrio Ácido-Base , Acidose Láctica/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/efeitos adversos , Metformina/efeitos adversos , Acidose Láctica/sangue , Acidose Láctica/induzido quimicamente , Idoso , Idoso de 80 Anos ou mais , Ânions/sangue , Cátions/sangue , Feminino , Humanos , Ácido Láctico/sangue , Masculino , Metformina/sangue , Pessoa de Meia-IdadeRESUMO
OBJECTIVES: To analyze clinical, laboratory, and radiologic findings and final health outcomes in patients with pulmonary embolism and coronavirus disease 2019 (COVID-19). To compare them to findings and outcomes in patients with pulmonary embolism without COVID-19. MATERIAL AND METHODS: Multicenter, observational, retrospective study in 4 Spanish hospital emergency departments (EDs) from January 15 to April 15, 2020. Cases were located by reviewing all ED requests for pulmonary computed tomography angiography (CTA) procedures. Clinical, laboratory, and radiologic findings; medical histories and comorbidity; risk factors; and outcomes were compared between the 2 groups of patients (with or without COVID-19). RESULTS: A total of 399 CTAs were ordered; 88 pulmonary embolisms were diagnosed, 28 of them (32%) in patients with COVID-19. This group had more men, and a history of thromboembolic disease was more common. We found no between-group differences in clinical presentation, laboratory, or radiologic findings; nor were there differences in final outcomes. In-hospital mortality was 7% (2 cases) in patients with COVID-19 and 17% (10 cases) in patients without the virus (odds ratio for death in patients with pulmonary embolism and COVID-19, 0.38; 95% CI, 0.08-1.89). CONCLUSION: We found no clinically important differences in the clinical, laboratory, or radiologic findings between patients with or without COVID-19 who were treated for pulmonary embolism in our hospital EDs. Final outcomes also did not differ.
OBJETIVO: Analizar las características clínicas, analíticas, radiológicas y los resultados finales de salud en una cohorte de pacientes con embolia pulmonar (EP) y COVID-19, y compararlas con un grupo de pacientes con EP sin COVID-19. METODO: Estudio multicéntrico, observacional y retrospectivo realizado en cuatro servicios de urgencias hospitalarios (SUH) españoles del 15 de enero al 15 de abril de 2020. La detección de EP se hizo mediante la revisión de todas las angiografías por tomografía computarizada (angioTC) pulmonares solicitadas desde los SUH. Se han analizado dos grupos de pacientes con EP, con o sin enfermedad por COVID-19, y se comparan las características clínicas, analíticas, radiológicas, antecedentes y comorbilidad, factores de riesgo y resultados finales. RESULTADOS: Se realizaron 399 angioTC y se diagnosticaron 88 EP, 28 (32%) en pacientes con COVID-19. Estos pacientes fueron con más frecuencia hombres y tenían más antecedentes de enfermedad tromboembólica previa. No hubo diferencias en la presentación clínica, características analíticas o radiológicas ni en los resultados finales entre ambos grupos. La mortalidad intrahospitalaria fue del 7% (2 casos) en pacientes COVID y del 17% (10 casos) en pacientes sin COVID (OR de muerte en pacientes COVID con EP: 0,38, IC 95%: 0,08-1,89). CONCLUSIONES: No se han observado diferencias clínicamente relevantes en las características clínicas, analíticas, radiológicas y los resultados finales de salud en una cohorte de pacientes con EP y COVID-19 respecto a los pacientes con EP sin esta enfermedad atendidos en los SUH.
Assuntos
Betacoronavirus , Infecções por Coronavirus/complicações , Pneumonia Viral/complicações , Embolia Pulmonar/diagnóstico por imagem , Idoso , COVID-19 , Comorbidade , Angiografia por Tomografia Computadorizada/estatística & dados numéricos , Infecções por Coronavirus/sangue , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva , Intubação Intratraqueal , Tempo de Internação , Masculino , Razão de Chances , Pandemias , Pneumonia Viral/sangue , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , Embolia Pulmonar/sangue , Embolia Pulmonar/etiologia , Embolia Pulmonar/mortalidade , Estudos Retrospectivos , Fatores de Risco , SARS-CoV-2 , Espanha/epidemiologiaRESUMO
OBJECTIVES: . The main purpose was to assess our emergency department's level of adherence to clinical practice guidelines (CPGs) for the diagnosis of pulmonary embolism in different age groups. The secondary aims were to study the utility and estimated the number of avoidable CT angiography with this approach of age-adjusted D-dimer concentrations in combination with the Wells score in the diagnosis of pulmonary embolism. MATERIAL AND METHODS: Retrospective observational study of a series of hemodynamically stable patients suspected of having pulmonary embolism in the emergency department of a tertiary care university hospital in 2012. Cases were identified in hospital discharge records on the basis of orders for D-dimer assays and computed tomography (CT) angiography of pulmonary arteries justified by suspicion of pulmonary embolism. We analyzed the degree of adherence to CPGs according to age groups, calculated the specificity and sensitivity of combining age-adjusted D-dimer test results and the Wells score, and estimated the number of potentially avoidable CT angiography procedures. RESULTS: We found a total of 785 patients (mean age, 69 years; range, 18-97 years) suspected of having pulmonary embolism; 403 (51.3%) were women. Significant differences were detected in adherence to CPGs, depending on which clinical prediction models were used and patient age (50 years or younger, 69.7%-76.5% adherence; 65-74 years, 32.3%-53.2%; 75-84 years, 29.1%-46.8%; 85-89 years, 32.7%-41.8%; and 90 years or older, 24.4%-46.7%). Adherence was increased when D-dimer test result and the simplified Wells score were combined (increments of 10.4%, 8.0%, 13.6%, 11.1%, respectively in the following age groups: 65-74 years, 75-84 years, 85-89 years, and 90 years or older). Using an ageadjusted D-dimer cut-point increased diagnostic specificity (34.2% without such a cut-point vs 45.8% with one). The positive predictive value of the test also increased when an age-adjusted D-dimer cut-point was used (to 11.4%, from 9.6% without age adjustement). Seventy CT angiograph procedures (12.5%) could have been avoided by using age-adjusted cut-points. CONCLUSION: We observed different degrees of age-related adherence to CPGs in cases in which pulmonary embolism was suspected. Using the simplified Wells score combined with an age-adjusted cut-point for D-dimer assay positivity improved the specificity and positive predictive value of the D-dimer assessment in comparison with standard practice. Using age-adjusted D-dimer cut-points could decrease the number of pulmonary artery CT angiograms required.
OBJETIVO: El objetivo principal fue estudiar la adherencia a las guías de práctica clínica (GPC) para el diagnóstico de embolismo pulmonar (EP) según la edad del paciente. Los objetivos secundarios fueron investigar las características del dímero-D corregido por edad (DDc) en combinación con la Escala de Wells para el diagnóstico de EP y el número de angio-TC pulmonares potencialmente evitables con dicha estrategia. METODO: Estudio observacional retrospectivo de una serie de casos de pacientes con sospecha de EP con estabilidad hemodinámica en un servicio de urgencias de un hospital universitario de tercer nivel durante el año 2012. Los casos se obtuvieron a partir de las solicitudes de dímero-D, las angio-TC pulmonares realizadas por sospecha de EP y el registro de altas hospitalarias. Se realizó un análisis del grado de adherencia a las GPC según grupos de edad y se calculó las características del DDc en combinación con la Escala de Wells y el número de angio-TC potencialmente evitables con dicha estrategia. RESULTADOS: Se incluyeron 785 pacientes con sospecha de EP con una edad mediana de 69 años (rango 18-97), de los cuales 403 (51,3%) fueron mujeres. Se observaron diferencias significativas del grado de adherencia a las GPC en función del grupo de edad de los pacientes para las diferentes escalas de probabilidad clínica (EPC) ( 50 años: 69,7%-76,5%; 65-74 años: 32,3%-53,2%; 75-84 años: 29,1%-46,8%; 85-89 años: 32,7%-41,8%; 90 años: 24,4%-46,7%). La combinación del DDc y la Escala de Wells simplificada aumentó la adherencia (incrementos del 10,4%, 8,0%, 13,6%, 11,1%, en cada grupo de edad, respectivamente). El punto de corte del DDc aumentó la especificidad (34,2% vs 45,8%) y el valor predictivo positivo (9,6% vs 11,4%), y hubiera evitado 70 (12,5%) angio-TC pulmonares. CONCLUSIONES: Se hallaron diferencias de adherencia a las GPC en las sospechas de EP en función de la edad. La Escala de Wells simplificada combinada con el punto de corte del DDc obtuvo una mayor especificidad y valor predictivo positivo que con el DD estándar, lo que podría disminuir el número de angio-TC pulmonares.