RESUMO
BACKGROUND: Right ventricular dysfunction (RVD) in pulmonary embolism (PE) has been associated with increased morbidity. Tools for RVD identification are not well defined. The prognostic value of RVD markers to predict serious adverse events (SAE) during hospitalization is unclear. OBJECTIVE: Prospectively compare the incidence of SAE in normotensive emergency department patients with PE based upon RVD by goal-directed echocardiography (GDE), cardiac biomarkers, and right-to-left ventricle ratio by computed tomography (CT). Simplified Pulmonary Embolism Severity Index (sPESI) was calculated. Deaths and readmissions within 30 days were recorded. METHODS: Consecutive normotensive PE patients underwent GDE focused on RVD (RV enlargement, hypokinesis, or septal bowing), serum troponin, and brain natriuretic peptide (BNP), and evaluation of the CT ventricle ratio. In-hospital SAE and complications within 30 days were recorded. RESULTS: We enrolled 123 normotensive PE patients (median age 59 years, 49% female). Twenty-six of 123 (26%) patients had one or more SAE. RVD was detected in 26% by GDE, in 39% by biomarkers, and in 38% with CT. In-hospital SAE included one death, six respiratory interventions, six dysrhythmias, three major bleeding episodes, and 21 hypotension episodes. Forty-one percent of patients RVD positive by GDE had SAE, compared to the 18% RVD negative by GDE. Odds ratios for GDE, CT, BNP, troponin, and sPESI for SAE were 3.2 (95% confidence interval [CI] 1.2-8.5), 2.0 (95% CI 0.8-5.1), 3.3 (95% CI 1.3-8.6), 4.2 (95% CI 1.4-13.5), and 2.9 (95% CI 1.1-8.3), respectively. Five patients had non-PE-related deaths within 30 days. CONCLUSION: The incidence of SAE within days of PE was significant in our cohort. Those with RVD had an increased risk of nonmortality SAE.
Assuntos
Pressão Sanguínea , Prognóstico , Embolia Pulmonar/complicações , Embolia Pulmonar/diagnóstico , Disfunção Ventricular Direita/etiologia , Adulto , Idoso , Biomarcadores/sangue , Estudos de Coortes , Ecocardiografia/métodos , Serviço Hospitalar de Emergência/organização & administração , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Medição de Risco/métodos , Sensibilidade e Especificidade , Estatísticas não Paramétricas , Disfunção Ventricular Direita/fisiopatologiaRESUMO
STUDY OBJECTIVE: We determine the diagnostic accuracy of goal-directed echocardiography, cardiac biomarkers, and computed tomography (CT) in early identification of severe right ventricular dysfunction in normotensive emergency department patients with pulmonary embolism compared with comprehensive echocardiography. METHODS: This was a prospective observational study of consecutive normotensive patients with confirmed pulmonary embolism. Investigators, blinded to clot burden and biomarkers, performed qualitative goal-directed echocardiography for right ventricular dysfunction: right ventricular enlargement (diameter greater than or equal to that of the left ventricle), severe right ventricular systolic dysfunction, and septal bowing. Brain natriuretic peptide and troponin cutoffs of greater than or equal to 90 pg/mL and greater than or equal to 0.07 ng/mL and CT right ventricular:left ventricular diameter ratio greater than or equal to 1.0 were also compared with comprehensive echocardiography. RESULTS: One hundred sixteen normotensive pulmonary embolism patients (111 confirmed by CT, 5 by ventilation-perfusion scan) were enrolled. Twenty-six of 116 patients (22%) had right ventricular dysfunction on comprehensive echocardiography. Goal-directed echocardiography had a sensitivity of 100% (95% confidence interval [CI] 87% to 100%), specificity of 99% (95% CI 94% to 100%), positive likelihood ratio (+LR) of 90.0 (95% CI 16.3 to 499.8), and negative likelihood ratio (-LR) of 0 (95% CI 0 to 0.13). Brain natriuretic peptide had a sensitivity of 88% (95% CI 70% to 98%), specificity of 68% (95% CI 57% to 78%), +LR of 2.8 (95% CI 2.0 to 3.9), and -LR of 0.17 (95% CI 0.06 to 0.43). Troponin had a sensitivity of 62% (95% CI 41% to 80%), specificity of 93% (95% CI 86% to 98%), +LR of 9.2 (95% CI 4.1 to 20.9), and -LR of 0.41 (95% CI 0.24 to 0.62). CT had a sensitivity of 91% (95% CI 72% to 99%), specificity of 79% (95% CI 69% to 87%), +LR of 4.3 (95% CI 2.8 to 6.7), and -LR of 0.11 (95% CI 0.03 to 0.34). CONCLUSION: Goal-directed echocardiography was highly accurate for early severe right ventricular dysfunction identification and pulmonary embolism risk-stratification. Brain natriuretic peptide was sensitive but less specific, whereas troponin had lower sensitivity but higher specificity. CT had good sensitivity and moderate specificity.
Assuntos
Embolia Pulmonar/diagnóstico , Disfunção Ventricular Direita/diagnóstico , Biomarcadores/sangue , Ecocardiografia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Ventrículos do Coração/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Peptídeo Natriurético Encefálico/sangue , Estudos Prospectivos , Embolia Pulmonar/sangue , Embolia Pulmonar/diagnóstico por imagem , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Troponina/sangue , Disfunção Ventricular Direita/sangue , Disfunção Ventricular Direita/diagnóstico por imagem , Disfunção Ventricular Direita/fisiopatologiaRESUMO
OBJECTIVES: To evaluate observer agreement using qualitative goal-directed echocardiographic criteria for right ventricular (RV) dysfunction prognostication in submassive pulmonary embolism (PE). METHODS: Two emergency physicians and 2 cardiologists independently reviewed 31 packets of goal-directed echocardiographic video clips consisting of at least 3 windows obtained by emergency physicians from normotensive patients with PE. Nine packets were repeated to assess for intraobserver agreement. Right ventricular dysfunction criteria on goal-directed echocardiography were as follows: RV enlargement was present, with a right-to-left ventricular basal diameter ratio of 1.0 or higher and blunting of the apex of the RV in 2 or more different windows; RV systolic dysfunction was present if the tricuspid annulus moved toward the apex 10 mm or less and there was RV free wall hypokinesis; and septal deviation was present with any flattening or deviation of the ventricular septum toward the left ventricle. RESULTS: Among the 4 participants, there was 83.9% agreement on the presence or absence of RV enlargement (κ = 0.84), 74.2% agreement on the presence or absence of RV systolic dysfunction (κ = 0.69), and 71.0% agreement on the presence or absence of septal deviation (κ = 0.59). Intraobserver agreement was 100% for each RV dysfunction variable for each observer (κ = 1.0). CONCLUSIONS: Agreement was substantial for both severe RV enlargement and RV systolic dysfunction and moderate for septal deviation. Right ventricular dysfunction assessment with qualitative goal-directed echocardiographic criteria is reproducible for PE risk stratification.
Assuntos
Ecocardiografia/métodos , Variações Dependentes do Observador , Embolia Pulmonar/complicações , Disfunção Ventricular Direita/complicações , Disfunção Ventricular Direita/diagnóstico por imagem , Estudos de Avaliação como Assunto , Ventrículos do Coração/diagnóstico por imagem , Humanos , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/fisiopatologia , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Disfunção Ventricular Direita/fisiopatologiaRESUMO
BACKGROUND: Despite the high incidence and the economic impact of the common cold, there are still no effective therapeutic options available. Although traditional Chinese medicine (TCM) is widely used in China to treat the common cold, there is still a lack of high-quality clinical trials. This article sets forth the protocol for a high-quality trial of a new TCM drug, Baoji Tablets, which is designed to treat the common cold with summer-heat and dampness syndrome (CCSDS). The trial is evaluating both the efficacy and safety of Baoji Tablets. METHODS/DESIGN: This study is designed as a multicenter, phase II, parallel-group, double-blind, double-dummy, randomized and placebo-controlled trial. A total of 288 patients will be recruited from four centers. The new tablets group are administered Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. The old pills group are administered dummy Baoji Tablets 0.9 g and Baoji Pills 3.7 g. The placebo control group are administered dummy Baoji Tablets 0.9 g and dummy Baoji Pills 3.7 g. All drugs are taken three times daily for 3 days. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary and secondary symptoms, changes in primary and secondary symptom scores and cumulative symptom score at day 4, as well as an evaluation of treatment efficacy. DISCUSSION: This is the first multicenter, double-blind, double-dummy, randomized and placebo-controlled trial designated to treat CCSDS in an adult population from China. It will establish the basis for a scientific and objective assessment of the efficacy and safety of Baoji Tablets for treating CCSDS, and provide evidence for a phase III clinical trial. TRIAL REGISTRATION: This study is registered with the Chinese Clinical Trial Registry. The registration number is ChiCTR-TRC-13003197.