of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at 3 months: multicenter double-blind, placebocontrolled randomized trial. J Thromb Haemost 2014; 12: 459-68.Summary. Background: Acute pulmonary embolism (PE) can worsen quality of life due to persistent dyspnea or exercise intolerance. Objective: Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE. Methods: Normotensive patients with PE and right ventricular (RV) strain (by echocardiography or biomarkers) were enrolled from eight hospitals. All patients received lowmolecular-weight heparin followed by random assignment to either a single weight-based bolus of tenecteplase or placebo, administered in a double-blinded fashion. The primary composite outcome included: (i) death, circulatory shock, intubation or major bleeding within 5 days or (ii) recurrent PE, poor functional capacity (RV dysfunction with either dyspnea at rest or exercise intolerance) or an SF36â Physical Component Summary (PCS) score < 30 at 90-day follow-up. Results: Eighty-three patients were randomized; 40 to tenecteplase and 43 to placebo. The trial was terminated prematurely. Within 5 days, adverse outcomes occurred in three placebo-treated patients (death in one and intubation in two) and one tenecteplase-treated patient (fatal intracranial hemorrhage). At 90 days, adverse outcomes occurred in 13 unique placebo-treated patients and five unique tenecteplase-treated patients Thus, 16 (37%) placebo-treated and six (15%) tenecteplase-treated patients had at least one adverse outcome (exact two-sided P = 0.017). Conclusions: Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome.

Background Clinical guidelines recommend risk stratification of patients with acute pulmonary embolism (PE). Active cancer increases risk of PE and worsens prognosis, but also causes incidental PE that may be discovered during cancer staging. No quantitative decision instrument has been derived specifically for patients with active cancer and PE. Methods Classification and regression technique was used to reduce 25 variables prospectively collected from 408 patients with AC and PE. Selected variables were transformed into a logistic regression model, termed POMPE-C, and compared with the pulmonary embolism severity index (PESI) score to predict the outcome variable of death within 30 days. Validation was performed in an independent sample of 182 patients with active cancer and PE. Results POMPE-C included eight predictors: body mass, heart rate >100, respiratory rate, SaO2%, respiratory distress, altered mental status, do not resuscitate status, and unilateral limb swelling. In the derivation set, the area under the ROC curve for POMPE-C was 0.84 (95% CI: 0.82-0.87), significantly greater than PESI (0.68, 0.60-0.76). In the validation sample, POMPE-C had an AUC of 0.86 (0.78-0.93). No patient with POMPE-C estimate ≤5% died within 30 days (0/50, 0-7%), whereas 10/13 (77%, 46-95%) with POMPE-C estimate >50% died within 30 days. Conclusion In patients with active cancer and PE, POMPE-C demonstrated good prognostic accuracy for 30 day mortality and better performance than PESI. If validated in a large sample, POMPE-C may provide a quantitative basis to decide treatment options for PE discovered during cancer staging and with advanced cancer.

Background-Use of pretest probability can reduce unnecessary testing. We hypothesize that quantitative pretest probability, linked to evidence-based management strategies, can reduce unnecessary radiation exposure and cost in low-risk patients with symptoms suggestive of acute coronary syndrome and pulmonary embolism. Methods and Results-This was a prospective, 4-center, randomized controlled trial of decision support effectiveness.Subjects were adults with chest pain and dyspnea, nondiagnostic ECGs, and no obvious diagnosis. The clinician provided data needed to compute pretest probabilities from a Web-based system. Clinicians randomized to the intervention group received the pretest probability estimates for both acute coronary syndrome and pulmonary embolism and suggested clinical actions designed to lower radiation exposure and cost. The control group received nothing. Patients were followed for 90 days. The primary outcome and sample size of 550 was predicated on a significant reduction in the proportion of healthy patients exposed to >5 mSv chest radiation. A total of 550 patients were randomized, and 541 had complete data. The proportion with >5 mSv to the chest and no significant cardiopulmonary diagnosis within 90 days was reduced from 33% to 25% (P=0.038). The intervention group had significantly lower median chest radiation exposure (0.06 versus 0.34 mSv; P=0.037, Mann-Whitney U test) and lower median costs ($934 versus $1275; P=0.018) for medical care. Adverse events occurred in 16% of controls and 11% in the intervention group (P=0.06). Conclusions-Provision of pretest probability and prescriptive advice reduced radiation exposure and cost of care in lowrisk ambulatory patients with symptoms of acute coronary syndrome and pulmonary embolism. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01059500.(Circ Cardiovasc Imaging. 2014;7:66-73.)

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Inhaled NO reduced dyspnoea without adverse events in eight patients with severe submassive PE. This protocol can serve as the basis for a phase II trial or for a compassionate use protocol.

Background-High body mass index (BMI) increases the probability of indeterminate findings on diagnostic studies, length of stay, and cost of care for hospitalized patients. No study has examined the economic and operational impact of BMI in patients with chest complaints presenting to the emergency department (ED). The objective was to measure the association of BMI with the main outcomes of cost of care, length of stay (including time in the ED and time in the wards if admitted), and radiation exposure in patients presenting to the ED with chest pain and dyspnea. Methods and Results-This was a prospective, 4-center, outcomes study. Patients were adults with dyspnea and chest pain, nondiagnostic electrocardiograms, and no obvious diagnosis. Patients were followed for the main outcomes for 90 days. Outcomes that were stratified by BMI in 5 categories, underweight, normal weight, overweight, obese, and morbidly obese, were compared using the Kruskall-Wallis rank test, and the independent predictive value of BMI was tested with multivariate regressions. Compared with medical costs for normal weight patients, costs were 22% higher for overweight patients (P=0.077), 28% higher for obese patients (P=0.020), and 41% higher for morbidly obese patients (P=0.015). Morbidly obese patients without computerized tomographic scanning stayed in the hospital 34% longer than normal weight patients (P=0.073), and morbidly obese patients with computerized tomographic scanning stayed in the hospital 44% longer than normal weight patients (P=0.083). BMI was not a significant predictor of radiation exposure. Morbidly obese patients had the highest proportion (87%) of no significant cardiopulmonary diagnosis for 90 days after computerized tomographic pulmonary angiography. Conclusions-BMI was associated with increases in cost of care and length of hospital stay for patients with chest pain and dyspnea. These results emphasize a need for specific protocols to manage morbidly obese patients presenting to the ED with chest pain and dyspnea. Clinical Trial Registration-http://www.clinicaltrials.gov. Unique identifier: NCT01059500.(Circ Cardiovasc Qual Outcomes. 2014;7:292-298.)

Objectives: In a patient with symptoms of pulmonary embolism (PE), the presence of an elevated pulse, respiratory rate, shock index, or decreased pulse oximetry increases pretest probability of PE. The objective of this study was to evaluate if normalization of an initially abnormal vital sign can be used as evidence to lower the suspicion for PE.Methods: This was a prospective, noninterventional, single-center study of diagnostic accuracy conducted on adults presenting to an academic emergency department (ED), with at least one predefined symptom or sign of PE and one risk factor for PE. Clinical data, including the first four sets of vital signs, were recorded while the patient was in the ED. All patients underwent computed tomography pulmonary angiography (CTPA) and had 45-day follow-up as criterion standards. Diagnostic accuracy of each vital sign (pulse rate, respiratory rate, shock index, pulse oximetry) at each time was examined by the area under the receiver operating characteristic curve (AUC).Results: A total of 192 were enrolled, including 35 (18%) with PE. All patients had vital signs at triage, and 174 (91%), 135 (70%), and 106 (55%) had second to fourth sets of vital signs obtained, respectively. The initial pulse oximetry reading had the highest AUC (0.63, 95% confidence interval [CI] = 0.50 to 0.76) for predicting PE, and no other vital sign at any point had an AUC over 0.60. Among patients with an abnormal pulse rate, respiratory rate, shock index, or pulse oximetry at triage that subsequently normalized, the prevalences of PE were 18, 14, 19, and 33%, respectively.Conclusions: Clinicians should not use the observation of normalized vital signs as a reason to forego objective testing for symptomatic patients with a risk factor for PE.ACADEMIC EMERGENCY MEDICINE 2012; 19:11-17 ª 2012 by the Society for Academic Emergency Medicine A ssessment of patients with suspected pulmonary embolism (PE) in the emergency department (ED) usually occurs over several hours.During this time, clinicians receive new information and update existing data that they use to formulate their gestalt impression as to whether the patient has PE or not. In contrast, objective decision rules operate in a static point in time. The heart rate, respiratory rate, pulse oximetry, blood pressure, and the derived variable, the shock index (pulse rate ⁄ systolic blood pressure), are variably incorporated into published objective decision rules.

An investigator-initiated, FDA-regulated, multicentre trial of fibrinolysis for submassive PE was conducted, but was limited by screening costs and a low mortality rate. Quality of life measurements might represent a more important patient-centred end-point.