Mikel Oribe

Home treatment in pulmonary embolism

BACKGROUND Limited data exist on the feasibility of providing outpatient care to patients with acute pulmonary embolism (PE). METHODS We conducted a multicenter randomized clinical trial in acute symptomatic PE to compare the efficacy and safety of early discharge versus standard hospitalization. A clinical prediction rule was used to identify low-risk patients. All patients were followed for three months. The primary outcomes were venous thromboembolic recurrences, major and minor bleeding, and overall mortality. RESULTS One hundred and thirty two low-risk patients with acute symptomatic PE were randomized to early discharge (n=72) or standard hospitalization (n=60). Overall mortality was 4.2% (95% CI, 0.5-8.9) in the early discharge group and 8.3% (95% CI, 1.1-15) in the standard hospitalization group (Relative Risk (RR) 0.5; 95% confidence interval [CI], 0.12-2.01). Non-fatal recurrences were 2.8% (95% CI, 1.1-6.6) in the early discharge group and 3.3% (95% CI, 1.3-8%) in the standard hospitalization group (RR 0.8; 95% CI, 0.12-5.74). The rates of clinically relevant bleeding were 5.5% in the early discharge group and 5% in the standard hospitalization group (P=0.60). Short-term mortality was 2.8% (95% CI, 0.8-9.6%) in the early discharge group as compared with 0% in the standard hospitalization group. Based on the rate of short-term death in a carefully selected population, the study was suspended. CONCLUSIONS In spite of the number of complications in patients with acute symptomatic PE randomized to standard hospitalization or early discharge did not differ significantly. The rate of short-term mortality was unexpectedly high in a (a priori) low-risk group of patients with acute PE. The accuracy of clinical prediction scores needs to be validated in well designed clinical trials. (ClinicalTrials.gov number, NCT00214929.).

Estándares asistenciales en hipertensión pulmonar* Documento de consenso elaborado por la Sociedad Española de Neumología y Cirugía Torácica (SEPAR) y la Sociedad Española de Cardiología (SEC)

En los ultimos anos se han producido importantes avances en el diagnostico y tratamiento de la hipertension pulmonar que han logrado una mejoria significativa en la supervivencia de esta enfermedad. Estas innovaciones se han recogido en guias de practica clinica basadas en la evidencia elaboradas por las sociedades cientificas. Sin embargo, no se incluyen en ellas, por falta de evidencia cientifica concluyente, algunos aspectos que inciden en la practica asistencial. Conscientes de ello, la Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) y la Sociedad Espanola de Cardiologia (SEC) han promovido la elaboracion de un documento de consenso para definir en nuestro medio los estandares de calidad adecuados para el diagnostico y tratamiento de la hipertension pulmonar en sus diversas formas de presentacion, asi como la via clinica y las directrices basicas de la organizacion asistencial del cuidado de estos pacientes, haciendo especial hincapie en los requisitos y funciones de las unidades de referencia. Para su redaccion la SEPAR y la SEC designaron a un grupo de trabajo formado por expertos en los distintos aspectos de la enfermedad. Para la elaboracion del documento se han utilizado las guias clinicas internacionales existentes, la revision de la evidencia cientifica disponible y el debate en panel entre los expertos. El documento final, aprobado por todos los participantes, ha sido evaluado por revisores externos.

Short-term clinical outcome after acute symptomatic pulmonary embolism

Though studies have identified clinical variables that predict adverse events in patients with acute pulmonary embolism (PE), they have typically not differentiated short-term from long-term predictors. This multicenter prospective cohort study included consecutive outpatients with objectively confirmed symptomatic acute PE. We analyzed the incidence and time course of death, venous thromboembolism (VTE) recurrence, and major bleeding, and we compared event rates during short-term (first week) and long-term (3 months) follow-up after the diagnosis of PE. We also assessed risk factors for short-term mortality. During the first three months after diagnosis of PE, 142 of 1,338 (10.6%) patients died. Thirty-six deaths (2.7%) occurred during the first week after diagnosis of PE, and 61.1% of these were due to PE. Thirty-eight patients (2.8%) had recurrent VTE during the three-month follow-up, though none of the recurrences occurred during the first week after diagnosis of PE. During the three-month follow-up, major bleeding occurred in 48 patients (3.6%). Twenty-one (1.6%) major bleeds occurred during the first week of follow-up, and nine of these were fatal. Short-term mortality was significantly increased in patients who initially presented with systolic arterial hypotension (odds ratio [OR] 3.35; 95% CI, 1.51-5.41) or immobilization due to a medical illness (OR 2.89; 95% confidence interval [CI], 1.31-6.39). In conclusion, during the first week after the diagnosis of PE, death and major bleeding occur more frequently than recurrent VTE. Patients with systolic arterial hypotension and immobilization at the time of PE diagnosis had an increased risk of short-term mortality.

Standards of care in pulmonary hypertension.

Substantial progress in the diagnosis and treatment of patients with pulmonary hypertension in recent years has led to significant improvement in survival. Evidence-based clinical practice guidelines issued by scientific societies reflect these new developments. However, certain clinically relevant issues have not been covered in consensus guidelines because of the lack of conclusive scientific evidence. Therefore, the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Spanish Society of Cardiology (SEC) have promoted the present consensus statement in order to define national standards of care in the evaluation and management of pulmonary hypertension in its various forms, as well as to outline a clinical pathway and the basic principles for organizing health care in this clinical setting, with special emphasis on the requirements for and functions of specialized referral units. To prepare the statement, SEPAR and SEC formed a task force composed of national experts in various aspects of pulmonary hypertension. The resulting consensus is based on international clinical guidelines, a review of available scientific evidence, and panel discussion among the task force members. The final statement, approved by all participants, underwent external review.

Echocardiographic assessment of pulmonary arterial pressure in the follow-up of patients with pulmonary embolism

BACKGROUND Echocardiography remains a clinically useful screening test for chronic thromboembolic pulmonary hypertension (CTEPH) in patients with a history of pulmonary embolism (PE). To devise an effective screening strategy, the definition of a high-risk group is necessary. METHODS We examined a total of 744 patients with acute symptomatic pulmonary embolism (PE) who were enrolled in a Spanish multicenter study. Patients were monitored every 6months during the first two years, and then once a year thereafter. Transthoracic echocardiography was used to screen patients with a clinical suspicion of CTEPH during follow-up. Pulmonary arterial hypertension was defined as an estimated pulmonary artery systolic pressure (PAP)>50mm Hg. The index thromboembolic episode was considered severe if: (a) the patient was immobilized for medical reasons; or (b) systolic blood pressure was less than 90mm Hg; or (c) troponin T values were above the reference range. RESULTS The incidence of PAP>50mm Hg at 36months was 8.3% (95% confidence interval=4.6%-14.5%). Statistical analysis showed a highly significant association between a severe index thromboembolic episode and the subsequent detection of PAP>50mm Hg on echocardiography, with high positive likelihood ratio (2.40) and negative predictive value (>0.97). CONCLUSIONS Patients with a severe index thromboembolic episode would constitute a high-risk group for the development of CTEPH. This group of patients should be subjected to a strict follow-up protocol.

Pneumonia: Criteria for Patient Instability on Hospital Discharge

BACKGROUND A study was undertaken to identify and weigh at the time of hospital discharge simple clinical variables that could predict short-term outcomes in patients with pneumonia. METHODS In a prospective observational cohort study of 870 patients discharged alive after hospitalization for pneumonia, we collected oxygenation and vital signs on discharge and assessed mortality and readmission within 30 days. From the beta-parameter obtained in a multivariate Cox proportional hazard regression model, a score was assigned to each predictive variable. The effects of instability at discharge on outcomes within 30 days thereafter were examined by adjusted models with use of the pneumonia severity index at hospital admission, the length of stay, the Charlson comorbidity index, or the preillness functional status. RESULTS Four variables related to a 30-day mortality rate from all causes were identified in the multivariate model; these included one major criterion (temperature >37.5 degrees C) and three minor criteria (systolic BP < 90 mm Hg or diastolic BP < 60 mm Hg, respiratory rate > 24 breaths/min, and oxygen saturation < 90%). The developed score remained significantly associated with a higher risk-adjusted rate of death. Patients with a score > or = 2 (one major criterion or two minor criteria) had a sixfold-greater risk-adjusted hazard ratio (HR) of death (HR, 5.8; 95% confidence interval, 2.5 to 13.1). CONCLUSIONS Four criteria of instability on discharge seem to be related to the mortality rate after discharge, but each of the factors must be weighed differently. The resulting score is a simple alternative that can be used by clinicians in the discharge process.

Longitudinal Incidence of Tuberculosis in a Cohort of Contacts: Factors Associated With the Disease

OBJECTIVE To investigate the incidence of tuberculosis (TB) in a cohort of contacts and to analyze the variables associated with the disease. METHODS A prospective analysis was undertaken of all the contact investigations carried out in a health district in the Basque Country in northern Spain between January 1, 1995 and December 31, 2004. The dependent variable was the number of cases of TB detected among the contacts. Independent variables were age, sex, tuberculin skin test result, and the degree of contact. In index cases, additional variables were the site of the disease and smear test result. RESULTS Analysis of 5444 contacts of 596 patients with TB yielded 66 secondary cases of TB (40 at the time of the contact investigation and 26 at a later stage); the majority (73%) developed the disease within 12 months. Multivariate analysis revealed a significant relationship between the detection of secondary cases and the following variables: close contact (odds ratio [OR], 3.05; 95% confidence interval [CI], 1.75-5.31), positive smear test (OR, 8.54; 95% CI, 2.06-35.43), induration of 10 mm or larger (OR, 10.18; 95% CI, 4.27-24.26), and age under 30 years (OR, 3.35; 95% CI, 1.88-5.98). The final predictive model constructed on the basis of these 3 variables had a sensitivity of 77.4%, a specificity of 80.3%, and an area under the curve of 0.83 (95% CI, 0.78-0.88). CONCLUSIONS The contact investigation is a valid strategy for the detection of new cases of TB. Prophylactic treatment should be implemented at an early stage and priority should be given to young contacts of smear positive patients using an induration size of 10 mm or more as a reference.

Assessment of coexisting deep vein thrombosis for risk stratification of acute pulmonary embolism

BACKGROUND In patients with acute pulmonary embolism (PE), studies have shown an association between coexisting deep vein thrombosis (DVT) and short-term prognosis. It is not known whether complete compression ultrasound testing (CCUS) improves the risk stratification of their disease beyond the recommended prognostic models. METHODS We included patients with normotensive acute symptomatic PE and prognosticated them with the European Society of Cardiology (ESC) risk model for PE. Subsequently, we determined the prognostic significance of coexisting DVT in patients with various ESC risk categories. The primary endpoint was a complicated course after the diagnosis of PE, defined as death from any cause, haemodynamic collapse, or adjudicated recurrent PE. RESULTS According to the ESC model, 37% of patients were low-risk, 56% were intermediate-low risk, and 6.7% were intermediate-high risk. CCUS demonstrated coexisting DVT in 375 (44%) patients. Among the 313 patients with low-risk PE, coexisting DVT (46%) did not show a significant increased risk of complicated course (2.8%; 95% confidence interval [CI], 0.8%-7.0%), compared with those without DVT (0.6%; 95% CI, 0%-3.2%), (P = 0.18). Of the 478 patients with intermediate-low risk PE, a complicated course was 14% and 6.8% for those with and without DVT, respectively (P = 0.01). Of the 57 patients that had intermediate-high risk PE, a complicated course occurred in 17% and 18% for those with and without DVT, respectively (P = 1.0). CONCLUSIONS In normotensive patients with PE, testing for coexisting DVT might improve risk stratification of patients at intermediate-low risk for short-term complications.