Rapid blood test helps exclude pulmonary embolism for low risk patients

2016 ◽  
Author(s):  
BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040151
Author(s):  
Christine Baumgartner ◽  
Frederikus A Klok ◽  
Marc Carrier ◽  
Andreas Limacher ◽  
Jeanne Moor ◽  
...  

IntroductionThe clinical significance of subsegmental pulmonary embolism (SSPE) is currently unclear. Although growing evidence from observational studies suggests that withholding anticoagulant treatment may be a safe option in selected patients with isolated SSPE, most patients with this condition receive anticoagulant treatment, which is associated with a 90-day risk of recurrent venous thromboembolism (VTE) of 0.8% and major bleeding of up to 5%. Given the ongoing controversy concerning the risk-benefit ratio of anticoagulation for isolated SSPE and the lack of evidence from randomised-controlled studies, the aim of this clinical trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE.Methods and analysisSAFE-SSPE (Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism, a multicentre randomised placebo-controlled non-inferiority trial) is an international, multicentre, placebo-controlled, double-blind, parallel-group non-inferiority trial conducted in Switzerland, the Netherlands and Canada. Low-risk patients with isolated SSPE are randomised to receive clinical surveillance with either placebo (no anticoagulation) or anticoagulant treatment with rivaroxaban. All patients undergo bilateral whole-leg compression ultrasonography to exclude concomitant deep vein thrombosis before enrolment. Patients are followed for 90 days. The primary outcome is symptomatic recurrent VTE (efficacy). The secondary outcomes include clinically significant bleeding and all-cause mortality (safety). The ancillary outcomes are health-related quality of life, functional status and medical resource utilisation.Ethics and disseminationThe local ethics committees in Switzerland have approved this protocol. Submission to the Ethical Committees in the Netherlands and Canada is underway. The results of this trial will be published in a peer-reviewed journal.Trial registration numberNCT04263038.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 747-747
Author(s):  
Craig I Coleman ◽  
Christine G Kohn ◽  
Concetta Crivera ◽  
Jeff Schein ◽  
W Frank Peacock

Background: Current guidelines suggest that low risk pulmonary embolism (PE) patients may be managed as outpatients or with an abbreviated hospital stay. There is need for a claims-based prediction rule that payers and hospitals can use to efficiently risk stratify PE patients. The authors recently derived a rule found to have high sensitivity and moderate specificity for predicting in-hospital mortality. Objective: To validate the In-hospital Mortality for PulmonAry embolism using Claims daTa (IMPACT) prediction rule originally developed in a commercial claims database in an all-payer administrative database restricted to inpatient claims. Methods: This study utilized data from the 2012 Healthcare Cost and Utilization Project Nationwide Inpatient Sample (NIS). Adult PE admissions were identified by the presence of an appropriate International Classification of Diseases, ninth edition, Clinical Modification (ICD-9-CM) code either in the primary position or secondary position when accompanied by a primary code for a PE complication. The IMPACT rule, consists of age + 11 weighted comorbidities calculated based upon the maximum of 25 ICD-9-CM diagnosis codes and 25 procedural codes reported for each discharge in the NIS (myocardial infarction, chronic lung disease, stroke, prior major bleeding, atrial fibrillation, cognitive impairment, heart failure, renal failure, liver disease, coagulopathy, cancer), and was used to estimate patients' risk of in-hospital mortality. Low risk was defined as in-hospital mortality ≤1.5%. We present the validity of the rule by calculating prognostic test characteristics and 95% confidence intervals (CIs). In order to estimate the potential cost savings from an early discharge, we calculated the difference in total hospital costs between low-risk patients having and not having an abbreviated hospital stay (defined as ≤1, ≤2 or ≤3 days). Results: A total of 34,108 admissions for PE were included (46.7% male, mean ± standard deviation age of 61.9±17.2); and we observed a 3.4% in-hospital PE case-fatality rate. The IMPACT prediction rule classified 11,025 (32.3%) patient admissions as low-risk; and had a sensitivity of 92.4% (95%CI=90.7-93.8), specificity of 33.2% (95%CI=32.7-33.7), negative and positive predictive values of 99.2% (95%CI=99.0-99.4) and 4.6% (95%CI=4.4-4.9) and a C-statistic of 0.74 (95%CI=0.73-0.76) for in-hospital mortality. Low-risk patients had significantly lower in-hospital mortality (0.8% vs. 4.6%, odds reduction of 83%; 95%CI=79-87), shorter LOSs (-1.2 days, p<0.001) and lower total treatment costs (-$3,074, p<0.001) than patients classified as higher-risk. Of low-risk patients, 13.1%, 31.1% and 47.7% were discharged within 1, 2 and 3 days of admission. Low-risk patients discharged within 1 day accrued $5,465 (95%CI=$5,018-$5,911) less in treatment costs than those staying longer. Discharge within 2 or 3 days in low-risk patients was also associated with a reduced cost of hospital treatment [$5,820 (95%CI=$5,506-$6,133) and $6,314 (95%CI=$6,031-$6,597), respectively] when compared to those staying longer. Conclusion: The prior claims-based in-hospital mortality prediction rule was valid when used in this all-payer, inpatient only administrative claims database. The rule classified patients' mortality risk with high sensitivity and had a high negative predictive value; and consequently, may be valuable to those wishing to benchmark rates of PE treated at home or following an abbreviated hospital admission. Disclosures Coleman: Janssen Scientific Affairs, LLC: Consultancy, Research Funding. Crivera:Janssen Scientific Affairs, LLC: Employment, Equity Ownership. Schein:Janssen Scientific Affairs, LLC: Employment. Peacock:Singulex: Consultancy; Prevencio: Consultancy; The Medicines Company: Consultancy, Research Funding; Roche: Consultancy, Research Funding; Portola: Consultancy, Research Funding; Janssen Pharmaceuticals: Consultancy, Research Funding; Cardiorentis: Research Funding; Banyan: Research Funding; Alere: Research Funding; Abbott: Research Funding; Comprehensive Research Associates, LLC: Equity Ownership; Emergencies in Medicine, LLC: Equity Ownership.


Author(s):  
Diana Paulina Chiluiza Reyes ◽  
Esther Barbero ◽  
Andrés Quezada ◽  
Edwin Mercedes ◽  
Francisco León ◽  
...  

CHEST Journal ◽  
2005 ◽  
Vol 128 (4) ◽  
pp. 2183-2189 ◽  
Author(s):  
Michael Hlavac ◽  
Julie Cook ◽  
Rob Ojala ◽  
Ian Town ◽  
Lutz Beckert

CHEST Journal ◽  
2013 ◽  
Vol 143 (1) ◽  
pp. 138-145 ◽  
Author(s):  
Paul L. den Exter ◽  
Vicente Gómez ◽  
David Jiménez ◽  
Javier Trujillo-Santos ◽  
Alfonso Muriel ◽  
...  

2019 ◽  
Vol 0 (0) ◽  
Author(s):  
Önsel Öner ◽  
Figen Deveci ◽  
Selda Telo ◽  
Mutlu Kuluöztürk ◽  
Mehmet Balin

Summary Background The aim of this study was to determine levels of Mid-regional Pro-adrenomedullin (MR-proADM) and Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) in patients with acute pulmonary embolism (PE), the relationship between these parameters and the risk classification in addition to determining the relationship between 1- and 3-month mortality. Methods 82 PE patients and 50 healthy control subjects were included in the study. Blood samples for MR-proANP and MR-proADM were obtained from the subjects prior to the treatment. Risk stratification was determined according to sPESI (Simplified Pulmonary Embolism Severity Index). Following these initial measurements, cases with PE were assessed in terms of all causative and PE related mortalities. Results The mean serum MR-proANP and MR-proADM levels in acute PE patients were found to be statistically higher compared to the control group (p < 0.001, p < 0.01; respectively) and statistically significantly higher in high-risk patients than low-risk patients (p < 0.01, p < 0.05; respectively). No statistical difference was determined in high-risk patients in case of sPESI compared to low-risk patients while hospital mortality rates were higher. It was determined that the hospital mortality rate in cases with MR-proANP ≥ 123.30 pmol/L and the total 3-month mortality rate in cases with MR-proADM ≥ 152.2 pg/mL showed a statistically significant increase. Conclusions This study showed that MR-proANP and MR-proADM may be an important biochemical marker for determining high-risk cases and predicting the mortality in PE patients and we believe that these results should be supported by further and extensive studies.


2008 ◽  
Vol 100 (05) ◽  
pp. 756-761 ◽  
Author(s):  
Muhammad Janjua ◽  
Aaref Badshah ◽  
Fadi Matta ◽  
Liviu G. Danescu ◽  
Abdo Y. Yaekoub ◽  
...  

SummaryThe purpose of this systematic review is to test the hypothesis that carefully selected low-risk patients with acute pulmonary embolism (PE) can safely be treated entirely as outpatients or after early hospital discharge.Included articles were required to describe inclusion or exclusion criteria and outcome of patients treated for PE.Early hospital discharge was defined as an average hospital stay ≤3 days.Six investigations included patients with PE who were treated entirely as outpatients; two investigations included patients with PE who were treated after early discharge. All investigations included only low-risk patients or patients with small or medium sized PE. Outcome after 3-46 months in patients treated entirely as outpatients showed recurrent PE in 0% to 6.2% of patients, major bleeding in 0% to 2.8% with one death from an intracerebral bleed. Definite death from PE did not occur, but there was one possible death from PE. Outcome in three months in patients treated after early discharge showed no instances of recurrent PE. Major bleeding occurred in 0% to 3.7% of patients.There were no deaths from PE, but there was one death from bleeding. In conclusion, outpatient therapy of acute PE is probably safe in low-risk,carefully selected compliant patients who have access to outpatient care if necessary. Such outpatient treatment would be cost-effective.


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