The first reference equations for the 6-minute walk distance over a 10 m course.
RATIONALE: As primary care practice space is mostly limited to 10 m, the 6-minute walk test (6MWT) over a 10 m course is a frequently used alternative to evaluate patients' performance in COPD. Considering that course length significantly affects distance walked in 6 minutes (6MWD), this study aims to develop appropriate reference equations for the 10 m 6MWT.
METHODS: 181 healthy subjects, aged 40-90 years, performed two standardised 6MWTs over a straight 10 m course in a cross-sectional study.
RESULTS: Average distance achieved was 578±108 m and differed between males and females (p<0.001). Resulting sex-specific reference equations from multiple regression analysis included age, body mass index and change in heart rate, explaining 62% of the variance in 6MWD for males and 71% for females.
CONCLUSIONS: The presented reference equations are the first to evaluate 6MWD over a 10 m course and expand the usefulness of the 6MWT.
Bleeding Risk of Patients With Acute Venous Thromboembolism Taking Nonsteroidal Anti-Inflammatory Drugs or Aspirin.
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Combined anticoagulant and aspirin therapy is associated with increased bleeding risk in patients with atrial fibrillation, but the bleeding risk of combined use of anticoagulant and nonsteroidal anti-inflammatory drugs (NSAIDs) is poorly documented.
OBJECTIVE To estimate the bleeding risk of combined anticoagulant (rivaroxaban or enoxaparin-vitamin K antagonist [VKA]) and NSAID or aspirin therapy in patients with venous thromboembolism.
DESIGN, SETTING, AND PARTICIPANTS Prospective analysis of observational data from the EINSTEIN deep vein thrombosis and pulmonary embolism clinical trials comparing rivaroxaban with enoxaparin-VKA treatment, trials performed in hospitals and clinics in 8246 patients enrolled from 2007 to 2009.
EXPOSURE Bleeding event rates during exposure to NSAID and aspirin therapy were compared to time without exposure.
MAIN OUTCOMES AND MEASURES Days of NSAID or aspirin use and nonuse, clinically relevant bleeding event and major bleeding event rates by patient-years, and hazard ratios. RESULTS During NSAID-anticoagulant concomitant treatment, clinically relevant bleeding occurred with an event rate of 37.5 per 100 patient-years vs 16.6 per 100 patient-years during anticoagulant use only (hazard ratio [HR], 1.77 [95% CI, 1.46-2.14]). Major bleeding during NSAID-anticoagulant treatment occurred with an event rate of 6.5 per 100 patient-years, compared to 2.0 per 100 patient-years during nonuse (HR, 2.37 [95% CI, 1.51-3.75]). For aspirin-anticoagulant concomitant treatment, clinically relevant bleeding occurred with an event rate of 36.6 per 100 patient-years, compared to 16.9 per 100 patient-years during aspirin nonuse (HR, 1.70 [95% CI, 1.38-2.11]). Major bleeding in aspirin-anticoagulant-treated patients occurred with an event rate of 4.8 per 100 patient-years, compared to 2.2 per 100 patient-years during aspirin nonuse (HR, 1.50 [95% CI, 0.86-2.62]). Increases in risk for clinically relevant and major bleeding were similar for rivaroxaban and enoxaparin-VKA anticoagulation regimens.
CONCLUSIONS AND RELEVANCE Among patients with venous thromboembolism receiving anticoagulant therapy, concomitant use of an NSAID or aspirin is associated with an increased risk of clinically relevant and major bleeding.
Diagnostic outcome management study in patients with clinically suspected recurrent acute pulmonary embolism with a structured algorithm.
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The value of diagnostic strategies in patients with clinically suspected recurrent pulmonary embolism (PE) has not been established. The aim was to determine the safety of a simple diagnostic strategy using the Wells clinical decision rule (CDR), quantitative D-dimer testing and computed tomography pulmonary angiography (CTPA) in patients with clinically suspected acute recurrent PE.
MATERIALS AND METHODS: Multicenter clinical outcome study in 516 consecutive patients with clinically suspected acute recurrent PE without using anticoagulants.
RESULTS: An unlikely clinical probability (Wells rule 4 points or less) was found in 182 of 516 patients (35%), and the combination of an unlikely CDR-score and normal D-dimer result excluded PE in 88 of 516 patients (17%), without recurrent venous thromboembolism (VTE) during 3month follow-up (0%; 95% CI 0.0-3.4%). CTPA was performed in all other patients and confirmed recurrent PE in 172 patients (overall prevalence of PE 33%) and excluded PE in the remaining 253 patients (49%). During follow-up, seven of these 253 patients returned with recurrent VTE (2.8%; 95% CI 1.2-5.5%), of which in one was fatal (0.4 %; 95 % CI 0.02-1.9%). The diagnostic algorithm was feasible in 98% of patients.
CONCLUSIONS: A diagnostic algorithm consisting of a clinical decision rule, D-dimer test and CTPA is effective in the management of patients with clinically suspected acute recurrent PE. CTPA provides reasonable safety in excluding acute recurrent PE in patients with a likely clinical probability or an elevated D-dimer test for recurrent PE, with a low risk for fatal PE at follow-up.
Pulmonary Embolism Rule-out Criteria vs D-dimer testing in low-risk patients for the diagnosis of pulmonary embolism: a retrospective study in Paris, France.
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STUDY OBJECTIVES: The Pulmonary Embolism Rule-out Criteria (PERC) score has shown excellent negative predictive value; however, its use in the European population with high prevalence of PE is controversial. In Europe, PERC is not part of routine practice. For low-risk patients, guidelines recommend D-dimer testing, followed if positive by imaging study. We aimed to study the rate of diagnosis of PE after D-dimer testing in PERC-negative patients that could have been discharged if PERC was applied.
METHOD: This was a multicenter retrospective study in Paris, France. We included all patients with a suspicion of PE who had D-dimer testing in the emergency department, low pre-test probability, and a negative PERC score (that was retrospectively calculated). Patients with insufficient record to calculate PERC score were excluded. The primary end point was the rate of PE diagnosis before discharge in this population. Secondary end points included rate of invasive imaging studies and subsequent adverse events.
RESULTS: We screened 4301 patients who had D-dimer testing, 1070 of whom were PERC negative and could be analyzed. The mean age was 35 years and 46% were men. D-dimer was positive (>500 ng/L) in 167 (16%) of them; CTPA or V/Q scan was performed in 153 (14%) cases. PE was confirmed in 5 cases (total rate 0.5%, 95% confidence interval 0.1%-1.1%). Fifteen patients (1%) experienced non-severe adverse events.
CONCLUSION: D-dimer testing in PERC-negative patients led to a diagnosis of PE in 0.5% of them, with 15% of patients undergoing unnecessary irradiative imaging studies.
Detection of pulmonary embolism during pregnancy: comparing radiation doses of CTPA and pulmonary scintigraphy.
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OBJECTIVE: In pregnant patients pulmonary embolism is a common occurrence with potentially devastating outcomes, necessitating timely imaging diagnosis. In every patient, especially in pregnant patients, radiation exposure is an important consideration while selecting the best imaging modality.
MATERIALS AND METHODS: We performed a retrospective analysis comparing radiation doses of computed tomography pulmonary angiography (CTPA), perfusion scintigraphy, and perfusion/ventilation scintigraphy for suspected pulmonary embolism in 53 pregnant patients at our hospital between 2006 and 2012. Effective dose and breast-absorbed and uterus-absorbed doses for CTPA as well as effective dose and breast and fetus-absorbed doses for pulmonary scintigraphy were estimated using International Commission on Radiological Protection 103 weighting factors.
RESULTS: For CTPA and perfusion scintigraphy, average doses were estimated as effective doses of 21 and 1.04 mSv, breast-absorbed doses of 44 and 0.28 mGy, and uterus-absorbed dose of 0.46 mGy and fetal-absorbed dose of 0.25 mGy, respectively. With inclusion of the ventilation component of pulmonary scintigraphy, doses increased to an effective dose of 1.29 mSv, a breast-absorbed dose of 0.37 mGy, and a fetal-absorbed dose of 0.40 mGy.
CONCLUSION: Perfusion nuclear medicine study has a statistically significantly lower effective and breast-absorbed dose (P<0.0001) when compared with CTPA. Similarly, the fetal-absorbed dose for pulmonary scintigraphy has a statistically lower dose (P=0.0010) when compared with CTPA, even if the ventilation component of pulmonary scintigraphy is performed, although these values are so small that they are unlikely to be clinically significant.