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Background: Although practice guidelines recommend outpatient care for selected, haemodynamically stable patients with pulmonary embolism, most treatment is presently inpatient based. We aimed to assess non-inferiority of outpatient care compared with inpatient care., Methods: We undertook an open-label, randomised non-inferiority trial at 19 emergency departments in Switzerland, France, Belgium, and the USA. We randomly assigned patients with acute, symptomatic pulmonary embolism and a low risk of death (pulmonary embolism severity index risk classes I or II) with a computer-generated randomisation sequence (blocks of 2-4) in a 1:1 ratio to initial outpatient (ie, discharged from hospital ≤24 h after randomisation) or inpatient treatment with subcutaneous enoxaparin (≥5 days) followed by oral anticoagulation (≥90 days). The primary outcome was symptomatic, recurrent venous thromboembolism within 90 days; safety outcomes included major bleeding within 14 or 90 days and mortality within 90 days. We used a non-inferiority margin of 4% for a difference between inpatient and outpatient groups. We included all enrolled patients in the primary analysis, excluding those lost to follow-up. This trial is registered with ClinicalTrials.gov, number NCT00425542., Findings: Between February, 2007, and June, 2010, we enrolled 344 eligible patients. In the primary analysis, one (0·6%) of 171 outpatients developed recurrent venous thromboembolism within 90 days compared with none of 168 inpatients (95% upper confidence limit [UCL] 2·7%; p=0·011). Only one (0·6%) patient in each treatment group died within 90 days (95% UCL 2·1%; p=0·005), and two (1·2%) of 171 outpatients and no inpatients had major bleeding within 14 days (95% UCL 3·6%; p=0·031). By 90 days, three (1·8%) outpatients but no inpatients had developed major bleeding (95% UCL 4·5%; p=0·086). Mean length of stay was 0·5 days (SD 1·0) for outpatients and 3·9 days (SD 3·1) for inpatients., Interpretation: In selected low-risk patients with pulmonary embolism, outpatient care can safely and effectively be used in place of inpatient care., Funding: Swiss National Science Foundation, Programme Hospitalier de Recherche Clinique, and the US National Heart, Lung, and Blood Institute. Sanofi-Aventis provided free drug supply in the participating European centres., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Rationale: Although associated with adverse outcomes in other cardiopulmonary conditions, the prognostic value of hyponatremia, a marker of neurohormonal activation, in patients with acute pulmonary embolism (PE) is unknown., Objectives: To examine the associations between hyponatremia and mortality and hospital readmission rates for patients hospitalized with PE., Methods: We evaluated 13,728 patient discharges with a primary diagnosis of PE from 185 hospitals in Pennsylvania (January 2000 to November 2002). We used random-intercept logistic regression to assess the independent association between serum sodium levels at the time of presentation and mortality and hospital readmission within 30 days, adjusting for patient (race, insurance, severity of illness, use of thrombolytic therapy) and hospital factors (region, size, teaching status)., Measurements and Main Results: Hyponatremia (sodium ≤135 mmol/L) was present in 2,907 patients (21.1%). Patients with a sodium level greater than 135, 130-135, and less than 130 mmol/L had a cumulative 30-day mortality of 8.0, 13.6, and 28.5% (P < 0.001), and a readmission rate of 11.8, 15.6, and 19.3% (P < 0.001), respectively. Compared with patients with a sodium greater than 135 mmol/L, the adjusted odds of dying were significantly greater for patients with a sodium 130-135 mmol/L (odds ratio [OR], 1.53; 95% confidence interval [CI], 1.33-1.76) and a sodium less than 130 mmol/L (OR, 3.26; 95% CI, 2.48-4.29). The adjusted odds of readmission were also increased for patients with a sodium of 130-135 mmol/L (OR, 1.28; 95% CI, 1.12-1.46) and a sodium less than 130 mmol/L (OR, 1.44; 95% CI, 1.02-2.02)., Conclusions: Hyponatremia is common in patients presenting with PE, and is an independent predictor of short-term mortality and hospital readmission.

Background: Optimal management of acute pulmonary embolism (PE) requires medical expertise, diagnostic testing, and therapies that may not be available consistently throughout the entire week. We sought to assess whether associations exist between weekday or weekend admission and mortality and length of hospital stay for patients hospitalized with PE., Methods and Results: We evaluated patients discharged with a primary diagnosis of PE from 186 acute care hospitals in Pennsylvania (January 2000 to November 2002). We used random-effect logistic models to study the association between weekend admission and 30-day mortality and used discrete survival models to study the association between weekend admission and time to hospital discharge, adjusting for hospital (region, size, and teaching status) and patient factors (race, insurance, severity of illness, and use of thrombolytic therapy). Among 15 531 patient discharges with PE, 3286 patients (21.2%) had been admitted on a weekend. Patients admitted on weekends had a higher unadjusted 30-day mortality rate (11.1% versus 8.8%) than patients admitted on weekdays, with no difference in length of stay. Patients admitted on weekends had significantly greater adjusted odds of dying (odds ratio 1.17, 95% confidence interval 1.03 to 1.34) than patients admitted on weekdays. The higher mortality among patients hospitalized on weekends was driven by the increased mortality rate among the most severely ill patients., Conclusions: Patients with PE who are admitted on weekends have a significantly higher short-term mortality than patients admitted on weekdays. Quality-improvement efforts should aim to ensure a consistent approach to the management of PE 7 days a week.

Background: Risk factors for early mortality after pulmonary embolism (PE) are widely known. However, it is uncertain which factors are associated with early readmission after PE. We sought to identify predictors of readmission after an admission for PE., Methods: We studied 14 426 patient discharges with a primary diagnosis of PE from 186 acute care hospitals in Pennsylvania from January 1, 2000, to November 30, 2002. The outcome was readmission within 30 days of presentation for PE. We used a discrete proportional odds model to study the association between time to readmission and patient factors (age, sex, race, insurance, discharge status, and severity of illness), thrombolysis, and hospital characteristics (region, teaching status, and number of beds)., Results: Overall, 2064 patient discharges (14.3%) resulted in a readmission within 30 days of presentation for PE. The most common reasons for readmission were venous thromboembolism (21.9%), cancer (10.8%), pneumonia (5.2%), and bleeding (5.0%). In multivariable analysis, African American race (odds ratio [OR], 1.19; 95% confidence interval [CI], 1.02-1.38), Medicaid insurance (OR, 1.54; 95% CI, 1.31-1.81), discharge home with supplemental care (OR, 1.40; 95% CI, 1.27-1.54), leaving the hospital against medical advice (OR, 2.84; 95% CI, 1.80-4.48), and severity of illness were independently associated with readmission; readmission also varied by hospital region., Conclusions: Early readmission after PE is common. African American race, Medicaid insurance, severity of illness, discharge status, and hospital region are significantly associated with readmission. The high readmission rates for venous thromboembolism and bleeding suggest that readmission may be linked to suboptimal quality of care in the management of PE.

Background: In the management of acute pulmonary embolism, the prevalence of thrombolytic therapy is uncertain, and its benefits compared with standard anticoagulation remain a subject of debate., Methods: This analysis included 15,116 patient discharges with a primary diagnosis of pulmonary embolism from 186 acute care hospitals in Pennsylvania (January 2000 to November 2002). We compared propensity score-adjusted mortality between patients who received thrombolysis and those who did not, using logistic regression to model mortality within 30 days of presentation and Poisson regression to model in-hospital mortality., Results: Of the 15,116 patient discharges, only 356 (2.4%) received thrombolytic therapy. The overall 30-day mortality rate for patients who received thrombolytic therapy was 17.4% compared with 8.6% for those who did not. The corresponding in-hospital mortality rates were 19.6 and 8.3, respectively, per 1000 person-days. However, mortality risk associated with thrombolysis varied with the propensity to receive thrombolysis: the odds ratios of 30-day mortality were 2.8 (P = .007), 3.9 (P < .001), 1.8 (P = .09), 1.0 (P = .98), and 0.7 (P = .30) for patients in the lowest to the highest quintiles of the propensity score distribution who received thrombolysis. A similar pattern was observed in the risk ratios for in-hospital death., Conclusions: In this large sample of patients hospitalized for acute pulmonary embolism, thrombolytic therapy was used infrequently. Risk of in-hospital and 30-day mortality appears to be elevated for patients who were unlikely candidates for this therapy based on characteristics at presentation, but not for patients with a relatively high predicted probability of receiving thrombolysis.

Practice guidelines recommend outpatient care for selected patients with non-massive pulmonary embolism (PE), but fail to specify how these low-risk patients should be identified. Using data from U.S. patients, we previously derived the Pulmonary Embolism Severity Index (PESI), a prediction rule that risk stratifies patients with PE. We sought to validate the PESI in a European patient cohort. We prospectively validated the PESI in patients with PE diagnosed at six emergency departments in three European countries. We used baseline data for the rule's 11 prognostic variables to stratify patients into five risk classes (I-V) of increasing probability of mortality. The outcome was overall mortality at 90 days after presentation. To assess the accuracy of the PESI to predict mortality, we estimated the sensitivity, specificity, and predictive values for low- (risk classes I/II) versus higher-risk patients (risk classes III-V), and the discriminatory power using the area under the receiver operating characteristic (ROC) curve. Among 357 patients with PE, overall mortality was 5.9%, ranging from 0% in class I to 17.9% in class V. The 186 (52%) low-risk patients had an overall mortality of 1.1% (95% confidence interval [CI]: 0.1-3.8%) compared to 11.1% (95% CI: 6.8-16.8%) in the 171 (48%) higher-risk patients. The PESI had a high sensitivity (91%, 95% CI: 71-97%) and a negative predictive value (99%, 95% CI: 96-100%) for predicting mortality. The area under the ROC curve was 0.78 (95% CI: 0.70-0.86). The PESI reliably identifies patients with PE who are at low risk of death and who are potential candidates for outpatient care. The PESI may help physicians make more rational decisions about hospitalization for patients with PE.

Background: The optimal length of stay (LOS) for patients with pulmonary embolism (PE) is unknown. Although reducing LOS is likely to save costs, the effects on patient safety are unclear. We sought to identify patient and hospital factors associated with LOS and assess whether LOS was associated with postdischarge mortality., Methods: We evaluated patients discharged with a primary diagnosis of PE from 186 acute care hospitals in Pennsylvania (January 2000 through November 2002). We used discrete survival models to examine the association between (1) patient and hospital factors and the time to discharge and (2) LOS and postdischarge mortality within 30 days of presentation, adjusting for patient and hospital factors., Results: Among 15 531 patient discharges with PE, the median LOS was 6 days, and postdischarge mortality rate was 3.3%. In multivariate analysis, patients from Philadelphia were less likely to be discharged on a given day (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.73-0.93), as were black patients (OR, 0.88; 95% CI, 0.82-0.94).The odds of discharge decreased notably with greater patient severity of illness and in patients without private health insurance. Adjusted postdischarge mortality was significantly higher for patients with an LOS of 4 days or less (OR, 1.55; 95% CI, 1.21-2.00) relative to those with an LOS of 5 to 6 days., Conclusions: Several hospital and patient factors were independently associated with LOS. Patients with a very short LOS had greater postdischarge mortality relative to patients with a typical LOS, suggesting that physicians may inappropriately select patients with PE for early discharge who are at increased risk of complications.

Background: In numerous high-risk medical and surgical conditions, a greater volume of patients undergoing treatment in a given setting or facility is associated with better survival. For patients with pulmonary embolism, the relation between the number of patients treated in a hospital (volume) and patient outcome is unknown., Methods: We studied discharge records from 186 acute care hospitals in Pennsylvania for a total of 15 531 patients for whom the primary diagnosis was pulmonary embolism. The study outcomes were all-cause mortality in hospital and within 30 days after presentation for pulmonary embolism and the length of hospital stay. We used logistic models to study the association between hospital volume and 30-day mortality and discrete survival models to study the association between in-hospital mortality and time to hospital discharge., Results: The median annual hospital volume for pulmonary embolism was 20 patients (interquartile range 10-42). Overall in-hospital mortality was 6.0%, whereas 30-day mortality was 9.3%. In multivariable analysis, very-high-volume hospitals (> or = 42 cases per year) had a significantly lower odds of in-hospital death (odds ratio [OR] 0.71, 95% confidence interval [CI] 0.51-0.99) and of 30-day death (OR 0.71, 95% CI 0.54-0.92) than very-low-volume hospitals (< 10 cases per year). Although patients in the very-high-volume hospitals had a slightly longer length of stay than those in the very-low-volume hospitals (mean difference 0.7 days), there was no association between volume and length of stay., Interpretation: In hospitals with a high volume of cases, pulmonary embolism was associated with lower short-term mortality. Further research is required to determine the causes of the relation between volume and outcome for patients with pulmonary embolism.

Background: Prior studies with limited clinical information reported a higher short-term mortality for men than for women with pulmonary embolism (PE). We compared 30-day mortality for men and women hospitalized with PE using a large statewide database., Methods: The sample consisted of 9304 female and 6227 male patient discharges for PE treated at 186 Pennsylvania hospitals between January 2000 and November 2002. We compared 30-day mortality for women and men, using random-effect logistic regression to adjust for clinical characteristics shown to predict early mortality, as well as patient race, insurance status, and hospital volume. We assessed interactions among sex, race, and clinical variables., Results: The overall crude 30-day mortality rate was 8.9% for women and 9.8% for men. The unadjusted odds ratio (OR) of 30-day mortality for women was 0.90 (95% confidence interval [CI] 0.80, 1.00). After adjusting for baseline clinical and demographic characteristics, insurance status, and hospital volume, women had a lower risk of 30-day mortality (adjusted OR 0.8, 95% CI 0.7, 0.9)., Conclusions: Women hospitalized with PE had significantly lower odds of 30-day mortality compared with men.

Objective: To validate the Pulmonary Embolism Severity Index (PESI), a clinical prognostic model which identifies low-risk patients with pulmonary embolism (PE)., Design: Validation study using prospectively collected data., Setting: A total of 119 European hospitals., Subjects: A total of 899 patients diagnosed with PE., Intervention: The PESI uses 11 clinical factors to stratify patients with PE into five classes (I-V) of increasing risk of mortality. We calculated the PESI risk class for each patient and the proportion of patients classified as low-risk (classes I and II). The outcomes were overall and PE-specific mortality for low-risk patients at 3 months after presentation. We calculated the sensitivity, specificity and predictive values to predict overall and PE-specific mortality and the discriminatory power using the area under the receiver operating characteristic curve., Results: Overall and PE-specific mortality was 6.5% (58/899) and 2.3% (21/899) respectively. Forty-seven per cent of patients (426/899) were classified as low-risk. Low-risk patients had an overall mortality of only 1.2% (5/426) and a PE-specific mortality of 0.7% (3/426). The sensitivity was 91 [95% confidence interval (CI): 81-97%] and the negative predictive value was 99% (95% CI: 97-100%) for overall mortality. The sensitivity was 86% (95% CI: 64-97%) and the negative predictive value was 99% (95% CI: 98-100%) for PE-specific mortality. The areas under the receiver operating characteristic curve for overall and PE-specific mortality were 0.80 (95% CI: 0.75-0.86) and 0.77 (95% CI: 0.68-0.86) respectively., Conclusions: This validation study confirms that the PESI reliably identifies low-risk patients with PE who are potential candidates for less costly outpatient treatment.

Objectives: Previous studies reported a higher incidence of in-hospital mortality for Black patients who had pulmonary embolism than for White patients. We used a large statewide database to compare 30-day mortality (defined as death within 30 days from the date of latest hospital admission) for Black and White patients who were hospitalized because of pulmonary embolism., Methods: The study cohort consisted of 15531 discharged patients who had been treated for pulmonary embolism at 186 Pennsylvania hospitals between January 2000 and November 2002. We used random-effects logistic regression to model 30-day mortality for Black and White patients, and adjusted for patient demographic and clinical characteristics., Results: The unadjusted 30-day mortality rates were 9.0% for White patients, 10.3% for Blacks, and 10.9% for patients of other or unknown race. When adjusted for severity of disease using a validated clinical prognostic model for pulmonary embolism, Black patients had 30% higher odds of 30-day mortality compared with White patients at the same site (adjusted odds ratio = 1.3; 95% confidence interval, 1.1,1.6). Neither insurance status nor hospital volume was a significant predictor of 30-day mortality., Conclusion: Black patients who had pulmonary embolism had significantly higher odds of 30-day mortality compared with White patients.

Aims: To validate a model for quantifying the prognosis of patients with pulmonary embolism (PE). The model was previously derived from 10 534 US patients., Methods and Results: We validated the model in 367 patients prospectively diagnosed with PE at 117 European emergency departments. We used baseline data for the model's 11 prognostic variables to stratify patients into five risk classes (I-V). We compared 90-day mortality within each risk class and the area under the receiver operating characteristic curve between the validation and the original derivation samples. We also assessed the rate of recurrent venous thrombo-embolism and major bleeding within each risk class. Mortality was 0% in Risk Class I, 1.0% in Class II, 3.1% in Class III, 10.4% in Class IV, and 24.4% in Class V and did not differ between the validation and the original derivation samples. The area under the curve was larger in the validation sample (0.87 vs. 0.78, P=0.01). No patients in Classes I and II developed recurrent thrombo-embolism or major bleeding., Conclusion: The model accurately stratifies patients with PE into categories of increasing risk of mortality and other relevant complications. Patients in Risk Classes I and II are at low risk of adverse outcomes and are potential candidates for outpatient treatment.

Background: A simple prognostic model could help identify patients with pulmonary embolism who are at low risk of death and are candidates for outpatient treatment., Methods: We randomly allocated 15,531 retrospectively identified inpatients who had a discharge diagnosis of pulmonary embolism from 186 Pennsylvania hospitals to derivation (67%) and internal validation (33%) samples. We derived our rule to predict 30-day mortality using classification tree analysis and patient data routinely available at initial examination as potential predictor variables. We used data from a European prospective study to externally validate the rule among 221 inpatients with pulmonary embolism. We determined mortality and nonfatal adverse medical outcomes across derivation and validation samples., Results: Our final model consisted of 10 patient factors (age > or = 70 years; history of cancer, heart failure, chronic lung disease, chronic renal disease, and cerebrovascular disease; and clinical variables of pulse rate > or = 110 beats/min, systolic blood pressure < 100 mm Hg, altered mental status, and arterial oxygen saturation < 90%). Patients with none of these factors were defined as low risk. The 30-day mortality rates for low-risk patients were 0.6%, 1.5%, and 0% in the derivation, internal validation, and external validation samples, respectively. The rates of nonfatal adverse medical outcomes were less than 1% among low-risk patients across all study samples., Conclusions: This simple prediction rule accurately identifies patients with pulmonary embolism who are at low risk of short-term mortality and other adverse medical outcomes. Prospective validation of this rule is important before its implementation as a decision aid for outpatient treatment.

Rationale: An objective and simple prognostic model for patients with pulmonary embolism could be helpful in guiding initial intensity of treatment., Objectives: To develop a clinical prediction rule that accurately classifies patients with pulmonary embolism into categories of increasing risk of mortality and other adverse medical outcomes., Methods: We randomly allocated 15,531 inpatient discharges with pulmonary embolism from 186 Pennsylvania hospitals to derivation (67%) and internal validation (33%) samples. We derived our prediction rule using logistic regression with 30-day mortality as the primary outcome, and patient demographic and clinical data routinely available at presentation as potential predictor variables. We externally validated the rule in 221 inpatients with pulmonary embolism from Switzerland and France., Measurements: We compared mortality and nonfatal adverse medical outcomes across the derivation and two validation samples., Main Results: The prediction rule is based on 11 simple patient characteristics that were independently associated with mortality and stratifies patients with pulmonary embolism into five severity classes, with 30-day mortality rates of 0-1.6% in class I, 1.7-3.5% in class II, 3.2-7.1% in class III, 4.0-11.4% in class IV, and 10.0-24.5% in class V across the derivation and validation samples. Inpatient death and nonfatal complications were