Prognostic significance of multidetector CT in normotensive patients with pulmonary embolism: results of the protect study.

BACKGROUND: In patients with acute pulmonary embolism (PE), rapid and accurate risk assessment is paramount in selecting the appropriate treatment strategy. The prognostic value of right ventricular dysfunction (RVD) assessed by multidetector CT (MDCT) in normotensive patients with PE has lacked adequate validation. METHODS: The study defined MDCT-assessed RVD as a ratio of the RV to the left ventricle short axis diameter greater than 0.9. Outcomes assessed through 30 days after the diagnosis of PE included all-cause mortality and 'complicated course', which consisted of death from any cause, haemodynamic collapse or recurrent PE. RESULTS: MDCT detected RVD in 533 (63%) of the 848 enrolled patients. Those with RVD on MDCT more frequently had echocardiographic RVD (31%) than those without RVD on MDCT (9.2%) (p<0.001). Patients with RVD on MDCT had significantly higher brain natriuretic peptide (269±447 vs 180±457 pg/ml, p<0.001) and troponin (0.10±0.43 vs 0.03±0.24 ng/ml, p=0.001) levels in comparison with those without RVD on MDCT. During follow-up, death occurred in 25 patients with and in 13 patients without RVD on MDCT (4.7% vs 4.3%; p=0.93). Those with and those without RVD on MDCT had a similar frequency of complicated course (3.9% vs 2.3%; p=0.30). CONCLUSIONS: The PROgnosTic valuE of CT study showed a relationship between RVD assessed by MDCT and other markers of cardiac dysfunction around the time of PE diagnosis, but did not demonstrate an association between MDCT-RVD and prognosis.

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.

Endovascular treatment of a haemodynamically unstable massive pulmonary embolism using fibrinolysis and fragmentation. Experience with 111 patients in a single centre. Why don't we follow ACCP recommendations?

INTRODUCTION: Fibrinolysis is recommended in several consensus documents for the treatment of a haemodynamically unstable massive pulmonary embolism (HUMPE). MATERIAL AND METHODS: A total of 111 patients were treated in a single centre from January 2001 to December 2009. They were 55 males and 56 females diagnosed with HUMPE (systolic arterial pressure>90 mmHg) with at least two of the following criteria: Miller index>0, ventricular dysfunction, and need of vasoactive drugs. Local fibrinolysis with urokinase was performed in all cases, and fragmentation with a pig-tail catheter in the majority of them. An inferior vena cava (IVC) filter was implanted in 94 patients as a prophylactic measure. RESULTS: Technical success was 100%. The Miller index improved from 0.7 ± 0.12, pre-treatment, to 0.09 ± 0.16. The mean pulmonary arterial pressure fell from 39.93 ± 7.0 mmHg to 20.47 ± 3.3 mmHg in the 30-90 days review. Of the 94 patients with IVC filters implanted, 79% were withdrawn satisfactorily. Seven patients died: 3 due to their neoplasia, 3 due to right cardiac failure at 1, 7 and 30 days, and another died of a brain haemorrhage in the first 24 hours. There were complications in 12.6% of the cases, of which 4.5% were major. CONCLUSION: Local fibrinolysis with fragmentation achieves a rapid return to normal of the pulmonary pressure and is a safe and effective method for the treatment of HUMPE.

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.).

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.

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.

[Standards of care in pulmonary hypertension. Consensus Statement of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Spanish Society of Cardiology (SEC)]. / 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).

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.

[Standards of care in pulmonary hypertension. Consensus statement of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Spanish Society of Cardiology (SEC)]. / 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).

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.

Standards of care in pulmonary hypertension.

Consensus Statement of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Spanish Society of Cardiology (SEC). 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.

Prognostic models for selecting patients with acute pulmonary embolism for initial outpatient therapy.

OBJECTIVE: To assess the performance of two prognostic models in predicting short-term mortality in patients with pulmonary embolism (PE). SUBJECTS AND METHODS: We compared the test characteristics of two prognostic models for predicting 30-day outcomes (mortality, thromboembolic recurrences, and major bleeding) in a cohort of 599 patients with objectively confirmed PE. Patients were stratified into the PE severity index (PESI) risk classes I-V and the Geneva low-risk and high-risk strata. We compared the discriminatory power of both prognostic models. RESULTS: The PESI classified fewer patients as low risk (strata I and II) [36%; 216 of 599 patients; 95% confidence interval (CI), 32 to 40%] compared to the Geneva prediction rule (84%; 502 of 599 patients; 95% CI, 81 to 87%) [p < 0.0001]. Using either prediction rule, the low-risk groups showed statistically relevant 30-day mortality difference (PESI, 0.9%; 95% CI, 0.3 to 2.2; vs Geneva, 5.6%; 95% CI, 3.6 to 7.6) [p < 0.0001], although nonfatal recurrent venous thromboembolism or major bleeding rates were statistically similar (PESI, 2.8%; 95% CI, 0.6 to 5.0%; vs Geneva, 4.2%; 95% CI, 2.4 to 5.9%). The area under the receiver operating characteristic curve was higher for the PESI (0.76; 95% CI, 0.69 to 0.83) than for the Geneva score (0.61; 95% CI, 0.51 to 0.71) [p = 0.002]. CONCLUSIONS: The PESI quantified the prognosis of patients with PE better than the Geneva score. This study demonstrated that PESI can select patients with very low adverse event rates during the initial days of acute PE therapy and assist in selecting patients for treatment in the outpatient setting.

[Longitudinal incidence of tuberculosis in a cohort of contacts: factors associated with the disease]. / Incidencia longitudinal de la tuberculosis en una cohorte de contactos: factores asociados a la enfermedad.

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.

Development and validation of a clinical prediction rule for severe community-acquired pneumonia.

RATIONALE: Objective strategies are needed to improve the diagnosis of severe community-acquired pneumonia in the emergency department setting. OBJECTIVES: To develop and validate a clinical prediction rule for identifying patients with severe community-acquired pneumonia, comparing it with other prognostic rules. METHODS: Data collected from clinical information and physical examination of 1,057 patients visiting the emergency department of a hospital were used to derive a clinical prediction rule, which was then validated in two different populations: 719 patients from the same center and 1,121 patients from four other hospitals. MEASUREMENTS AND MAIN RESULTS: In the multivariate analyses, eight independent predictive factors were correlated with severe community-acquired pneumonia: arterial pH < 7.30, systolic blood pressure < 90 mm Hg, respiratory rate > 30 breaths/min, altered mental status, blood urea nitrogen > 30 mg/dl, oxygen arterial pressure < 54 mm Hg or ratio of arterial oxygen tension to fraction of inspired oxygen < 250 mm Hg, age > or = 80 yr, and multilobar/bilateral lung affectation. From the beta parameter obtained in the multivariate model, a score was assigned to each predictive variable. The model shows an area under the curve of 0.92. This rule proved better at identifying patients evolving toward severe community-acquired pneumonia than either the modified American Thoracic Society rule, the British Thoracic Society's CURB-65, or the Pneumonia Severity Index. CONCLUSIONS: A simple score using clinical data available at the time of the emergency department visit provides a practical diagnostic decision aid, and predicts the development of severe community-acquired pneumonia.

[Early complications in patients with pulmonary embolism]. / Complicaciones precoces en pacientes con embolia de pulmón.

BACKGROUND AND OBJECTIVE: Mortality, recurrences and hemorrhages are the most serious early complications of pulmonary embolism (PE). We intended to ascertain the frequency and mechanisms of complications within the first 10 days after PE was diagnosed. PATIENTS AND METHOD: We included patients suspected of suffering PE between December 2003 and August 2004 from 8 hospitals. We performed a multicenter observational prospective study of 8 Spanish hospitals with consecutive outpatients diagnosed with PE. Database of clinical variables: computerized Registry of Patients with Venous Thromboembolism (RIETE). Statistic analysis included chi2 and Student's t test to compare the 2 groups of patients (with and without complications). RESULTS: Six hundred eighty one patients were included, 336 men and 345 women (mean age 66 and 70, respectively). During the first 10 days, 33 (4.8%) of them died, and 22 (3.2%) had an hemorrhage yet no recurrences appeared. Previous immobilization and the presence of respiratory failure, cancer or renal failure were significantly associated with early complications while previous surgery and thoracic pain were not associated with those. CONCLUSIONS: Early complications and some of the associated factors were in agreement with published data. Other situations such as previous surgery or thoracic pain appeared to be protective factors.