A Fast Track Strategy for Managing Suspected Pulmonary Embolism (PE) in Outpatients.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1766-1766
Author(s):  
Waleed Ghanima ◽  
Vibeke Almaas ◽  
Saad Aballi ◽  
Dorje Christina ◽  
Per Morten Sandset

Abstract Background: Several strategies for managing patients with suspected PE have been validated. However, most of these strategies are complicated, involving multiple rounds of tests, and are thus, time consuming, costly and difficult to apply in clinical practice. Aiming to introduce a simple, fast and cost-effective strategy, we adopted a new diagnostic approach combining clinical probability assessment, D-Dimer and multi-slice spiral CT (MSSCT) scanning. Aims: The aim of this study was to assess the safety and efficacy of this management strategy by a prospective outcome study with 3-month follow-up. Methods: 495 consecutive patients referred to the Emergency Department at Østfold Hospital, Fredrikstad, Norway, for suspected PE, between Feb 2002 and Dec 2003, were considered for inclusion. 63 (12.7%) patients were excluded and the final cohort consisted of 432 patients. Patients were managed by serial non-invasive testing starting with D-Dimer test. Normal plasma D-Dimer (Liatest, latex agglutination assay, Stago-France, cut-off <0.4 mg/L) was deemed to rule out PE in patients with low-intermediate clinical probability (CP). CP for PE was assessed according to the categories proposed by Hyers. Patients with normal D-Dimer, but with high CP, and patients with elevated D-Dimer proceeded to MSSCT scan. A 4-row detector spiral CT scan was used in the study (scans were done with 2.5 mm collimation, pitch of 1.25). If MSSCT diagnosis was inconclusive, bilateral compression ultrasonography was recommended followed by a perfusion scan and eventually pulmonary angiography if further verification was necessary. Patients with verified PE received anticoagulation according to the hospitals guidelines. The entire cohort were followed-up for 3 months. Results: Normal D-Dimer and low-intermediate CP ruled out PE in 100 patients (23.1%). Twenty patients had normal D-Dimer but high CP and proceeded to MSSCT. All proved negative for PE. A total of 332 patients underwent MSSCT examination. PE was diagnosed in 95 patients (22%) and was ruled out by negative MSSCT in 221 patients. In 16 patients (4.8%), MSSCT was inconclusive due to suboptimal contrast filling (n=7), artefacts (n=2), or uncertain peripheral emboli (n=7). In ten, interpretation was inconclusive but decision to anticoagulate was made by the attending physician. Compression ultrasonography was performed in three of those; two had positive findings for DVT. In the remaining six, anticoagulation was withheld. Five had undergone further examination with ultrasound; none had DVT. Pulmonary angiography was carried out in one and perfusion lung scan in another patient; both examinations were negative. The diagnostic algorithm yielded a definite diagnosis in 96.3% of the patients. Follow-up was successfully completed in 321 (98.1%) of the patients in whom anticoagulation was withheld. Five of 321 patients (1.5%) in whom the diagnostic algorithm ruled out PE died during the follow-up period. The cause of death was adjudicated as not related to PE in three and possibly related to PE in two. No patient developed venous thromboembolism during the 3 month follow-up period, resulting in a 3-month thromboembolic rate of 0%, 95%CI (0–1.1%). Conclusions: Our results compare favorably to the results reported in previous outcome studies, and confirm the safety and efficacy of this management strategy combining D-Dimer as a first step test followed by MSSCT as a single imaging test in patients with elevated D-Dimer.

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. LBA-4-LBA-4
Author(s):  
Marc Righini ◽  
Paul den Exter ◽  
Josien van ES ◽  
Franck Verschuren ◽  
Alexandre Ghuisen ◽  
...  

Abstract Introduction D-dimer testing allows to safely rule out pulmonary embolism (PE) without imaging test in approximately one third of outpatients. However, D-Dimer test is less useful as age increases because of a lower specificity. We recently derived an age-adjusted D-dimer cut-off value (age-adjusted cut-off = patient’s age x 10 in patients aged > 50 years, in μg/L), which allowed to significantly increase the proportion of patients in whom PE could be non-invasively excluded, without compromising safety. However, before being implemented in clinical practice, the safety of the age-adjusted cut-off should be verified in a management outcome study. Methods We designed a multicentre multinational prospective management outcome study. All consecutive outpatients seen in the emergency room of 22 centres in 4 countries with clinically suspected PE were assessed by a sequential diagnostic strategy based on the assessment of clinical probability, D-dimer measurement and computed tomography pulmonary angiography (CTPA). Patients with a D-dimer value between the usual threshold of 500 μg/L and their age-adjusted cut-off did not undergo CTPA and were left untreated and formally followed for a three-month period. Results Between January 1, 2010 and February 28, 2013, we included 3,377 patients. Mean age was 62 years, and 57% were females. Overall, the proportion of confirmed PE was 18%.  Among the 2,927 patients with a non-high clinical probability, 832 (28.4%) had a D-Dimer < 500 μg/L, and 345 additional patients (11.8%) had a D-Dimer comprised between 500 μg/L and their age-adjusted cut-off. During the 3-month follow-up period, out of the 345 patients with a D-Dimer between 500 μg/L and their age-adjusted cut-off, 18 patients received anticoagulation for another indication than PE. Of the remaining 327 patients, 7 died, and 7 underwent testing for suspected venous thromboembolism (VTE), of which one was confirmed. Therefore, the failure rate of the age-adjusted cut-off was 1/327: 0.3%, (95% CI 0.1 to 1.7%). Overall, 789 patients were aged 75 years or more, of them 697 had a non-high clinical probability. The proportion of patients with D-Dimer < 500 μg/L was 50/697 (7.2%). Another 161 patients had a D-Dimer above 500 μg/L and under their age-adjusted cut-off. Therefore, the proportion of patients > 75 with a negative D-Dimer using the age-adjusted cut-off was 211/697 (30.3%), of them none had a confirmed VTE during follow-up: 0.0%, (95%CI: 0.0 to 1.9%). Conclusions Our study demonstrates that the age-adjusted D-Dimer cut-off may now be used in clinical practice in emergency room patients with suspected PE. Combined with clinical probability, it increases the number of patients in whom PE can be excluded without imaging test, and this is particularly true among elderly patients, with a four-fold increased yield of D-dimer. A D-Dimer above 500 μg/L but under the age-adjusted cut-off safely excludes the diagnosis of PE, with a 3-month risk of VTE in line with that observed in patients with a D-Dimer under 500 μg/L or after a negative pulmonary angiography, the gold-standard test for PE. Disclosures: No relevant conflicts of interest to declare.


1999 ◽  
Vol 82 (12) ◽  
pp. 1588-1592 ◽  
Author(s):  
Marinus van Marwijk Kooy ◽  
Jos Pouwels ◽  
Anneke Engelage ◽  
Bart Kuipers ◽  
Harry Büller ◽  
...  

Summary Background. D-dimer assays have a potential to rule out pulmonary embolism in case of a normal test result. We studied the clinical utility of incorporating the SimpliRED D-dimer test result and clinical probability in the routine diagnostic work-up of patients with suspected acute pulmonary embolism. Methods. In a prospective management study 245 consecutive patients, hospitalised as well as outpatients, were included. A SimpliRED D-dimer test and perfusion/(ventilation) scintigraphy were obtained in all patients, whereas clinical probability was determined in the subgroup of patients with a non-diagnostic scan and normal D-dimer result. A diagnostic algorithm determined the necessity for further testing and decisions about treatment. All patients were followed up for 3 months. Results. In 54 patients (22%) with a normal lung scan and 50 patients (21%) with a high probability lung scan, antithrombotic therapy was withheld or started respectively, irrespective of the D-dimer result. A non-diagnostic lung scan was found in 137 (56%) patients, of whom 70 patients had an abnormal D-dimer test, in whom further testing was ordered. Of the remaining 67 patients with a non-diagnostic lung scan and normal D-dimer test 8 patients had a high clinical probability, and the subsequent ultrasonography and pulmonary angiography yielded pulmonary emboli in 1 patient. In the remaining 66 patients, pulmonary embolism was considered to be absent and antithrombotic treatment was stopped/withheld. During follow-up of these patients only one patient experienced a possible venous thromboembolic event (failure rate 1,5% ; 95% CI 0-8%). The SimpliRED D-dimer was normal in 6 of 61 patients with proven pulmonary embolism (sensitivity 90% ; 95% CI 80-96%). Conclusion. Our findings suggest that it is safe to withhold anticoagulant therapy in those patients with a non-diagnostic lung scan, a normal SimpliRED D-dimer test result, and without a high clinical probability. This results in a substantial decreased need for ultrasonography and pulmonary angiography. The SimpliRED should not be used in isolation to exclude pulmonary embolism.


2012 ◽  
Vol 107 (02) ◽  
pp. 369-378 ◽  
Author(s):  
Jan Schwonberg ◽  
Carola Hecking ◽  
Marc Schindewolf ◽  
Dimitrios Zgouras ◽  
Susanne Lehmeyer ◽  
...  

SummaryThe diagnostic value of D-dimer (DD) in the exclusion of proximal deep-vein thrombosis (DVT) is well-established but is less well-known in the exclusion of distal (infrapopliteal) DVT. Therefore, we evaluated the diagnostic abilities of five DD assays (Vidas-DD, Liatest-DD, HemosIL-DD, HemosIL-DDHS, Innovance-DD) for excluding symptomatic proximal and distal leg DVT. A total of 243 outpatients whose symptoms were suggestive of DVT received complete compression ultrasonography (cCUS) of the symptomatic leg(s). The clinical probability of DVT (PTP) was assessed by Wells score. Thirty-eight proximal and 31 distal DVTs (17 tibial/fibular DVTs, 14 muscle DVTs) were diagnosed by cCUS. Although all assays showed high sensitivity for proximal DVT (range 97–100%), the sensitivity was poor for distal DVT (range 78–93%). None of the assays were individually able to rule out all DVTs as a stand-alone test (negative predictive value [NPV] 91–96%). However, a negative DD test result combined with a low PTP exhibited a NPV of 100% for all DVTs (including proximal, tibial/fibular, and muscle DVTs) with the HemosIL-DDHS and Innovance-DD. All proximal and tibial/fibular DVTs, but not all muscle DVTs, could be ruled out with this strategy using the Liatest-DD and Vidas-DD. The HemosIL-DD could not exclude distal leg DVT, even in combination with a low PTP. The combination of a negative DD with a low PTP showed a specificity of 32–35% for all DVTs. In conclusion, our study shows that when used in conjunction with a low PTP some DD assays are useful tools for the exclusion of distal leg DVT.


2003 ◽  
Vol 127 (3) ◽  
pp. 310-315
Author(s):  
Julio Flores ◽  
Angel García-Avello ◽  
Victor M. Flores ◽  
JoséL. Navarro ◽  
Felipe Canseco ◽  
...  

Abstract Context.—Pulmonary embolism (PE) is a potentially fatal and frequent complication of deep venous thrombosis, and the most reliable techniques for the diagnosis of PE are not universally available and have other limitations. Objective.—To determine the efficacy of 4 different fibrinolysis system parameters, namely, tissue plasminogen activator (tPA), tissue plasminogen activator inhibitor type 1 (PAI-1), plasmin-antiplasmin complexes (PAP), and D-dimer, in the diagnosis of acute PE. Setting.—A 350-bed university hospital serving an area with 280 000 inhabitants. Patients.—Sixty-six consecutive outpatients with clinically suspected PE. The diagnosis of PE was based on ventilation-perfusion (V/Q) lung scan in combination with clinical assessment, lower limb study, and (when required) pulmonary angiography. Main Outcome Measures.—At the moment of clinical suspicion, a sample of venous blood was obtained to measure levels of tPA, PAI-1, PAP, and D-dimer using an enzyme-linked immunosorbent assay method. Results.—Twenty-seven patients (41%) were classified as PE positive (high clinical probability and V/Q lung scan [n = 12], nondiagnostic V/Q lung scan and high clinical probability [n = 1], inconclusive V/Q lung scan and positive lower limb examination for deep venous thrombosis [n = 11], and positive pulmonary angiography [n = 3]), and 39 patients (59%) were classified PE negative. The sensitivity/negative predictive value for tPA, using a cutoff of 8.5 ng/mL, and PAI-1, using a cutoff of 15 ng/mL, were 100%/100% and 100%/100%, respectively. A tPA level lower than 8.5 ng/mL occurred in 13 (19.7%; all PE negative) of 66 patients with suspected PE, and PAI-1 levels were lower than 15 ng/mL in 9 (13.6%; all PE negative) of 66 patients with suspected PE. The D-dimer, using a cutoff of 500 ng/mL, showed a sensitivity and negative predictive value of 92.6% and 87.5%, respectively. Conclusions.—Our data indicate that tPA and PAI-1 levels are potentially useful in ruling out PE, although tPA seems to be the better parameter. The sensitivity levels and negative predictive values for the rapid enzyme-linked immunosorbent assay for D-dimer used in this investigation were low compared with previous studies using the same test.


2020 ◽  
Vol 4 (20) ◽  
pp. 5002-5010
Author(s):  
Synne G. Fronas ◽  
Camilla T. Jørgensen ◽  
Anders E. A. Dahm ◽  
Hilde S. Wik ◽  
Jostein Gleditsch ◽  
...  

Abstract Guidelines for the diagnostic workup of deep vein thrombosis (DVT) recommend assessing the clinical pretest probability before proceeding to D-dimer testing and/or compression ultrasonography (CUS) if the patient has high pretest probability or positive D-dimer. Referring only patients with positive D-dimer for whole-leg CUS irrespective of pretest probability may simplify the workup of DVT. In this prospective management outcome study, we assessed the safety of such a strategy. We included consecutive outpatients referred to the Emergency Department at Østfold Hospital, Norway, with suspected DVT between February 2015 and November 2018. STA-Liatest D-Di Plus D-dimer was analyzed for all patients, and only patients with levels ≥0.5 µg/mL were referred for CUS. All patients with negative D-dimer or negative CUS were followed for 3 months to assess the venous thromboembolic rate. One thousand three hundred ninety-seven patients were included. Median age was 64 years (interquartile range, 52-73 years), and 770 patients (55%) were female. D-dimer was negative in 415 patients (29.7%) and positive in 982 patients (70.3%). DVT was diagnosed in 277 patients (19.8%). Six patients in whom DVT was ruled out at baseline were diagnosed with DVT within 3 months of follow-up for a thromboembolic rate of 0.5% (95% confidence interval, 0.2-1.2). A simple diagnostic approach with initial stand-alone D-dimer followed by a single whole-leg CUS in patients with positive D-dimer safely ruled out DVT. We consider this strategy to be a valuable alternative to the conventional workup of DVT in outpatients. This trial was registered at www.clinicaltrials.gov as #NCT02486445.


Diagnostics ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 365 ◽  
Author(s):  
Harish Patel ◽  
Haozhe Sun ◽  
Ali N. Hussain ◽  
Trupti Vakde

The incidence of venous thromboembolism (VTE), including lower extremity deep vein thrombosis (DVT) and pulmonary embolism (PE) is increasing. The increase in suspicion for VTE has lowered the threshold for performing imaging studies to confirm diagnosis of VTE. However, only 20% of suspected cases have a confirmed diagnosis of VTE. Development of pulmonary embolism rule-out criteria (PERC) and update in pre-test probability have changed the paradigm of ruling-out patient with low index of suspicion. The D-dimer test in conjunction to the pre-test probability has been utilized in VTE diagnosis. The age appropriate D-dimer cutoff and inclusion of YEARS algorithm (signs of the DVT, hemoptysis and whether PE is the likely diagnosis) for the D-dimer cutoff have been recent updates in the evaluation of suspected PE. Multi-detector computed tomography pulmonary angiography (CTPA) and compression ultrasound (CUS) are the preferred imaging modality to diagnose PE and DVT respectively. The VTE diagnostic algorithm do differ in pregnant individuals. The prerequisite of avoiding excessive radiation has recruited planar ventilation-perfusion (V/Q) scan as preferred in pregnant patients to evaluate for PE. The modification of CUS protocol with addition of the Valsalva maneuver should be performed while evaluating DVT in pregnant individual.


2005 ◽  
Vol 93 (03) ◽  
pp. 503-511 ◽  
Author(s):  
Abdelouahab Bellou ◽  
Francis Guillemin ◽  
Philippe Douek ◽  
Marie-Claude Laprévote-Heully ◽  
Denis Wahl ◽  
...  

SummaryPulmonary embolism (PE) is a common and potentially fatal disorder. Non-specific findings make the clinical diagnosis of PE difficult. To assess the diagnostic value and inter-observer agreement of magnetic resonance angiography (MRA) in a cohort of patients with suspected PE, we conducted a prospective clinical study. MRA was compared for sensitivity and specificity to a diagnostic strategy including clinical probability, D-dimer testing, spiral CT, ultrasound leg compression and pulmonary angiography. A total of 89 patients with clinically suspected PE were included: the clinical probability of PE was intermediate or high in 78, and low in the remaining 11. All patients underwent mono-or multi-slice spiral CT and MRA with gadolinium injection (both within 24 hours of entry to the study). Anticoagulation was withheld in patients concerned about the strategy. All subjects were followed up for 3 months. MRA was read independently by two experienced teams of radiologists: one local and one from another university centre. Spiral CT was positive in 62 of 63 cases of confirmed PE. No patient with negative CT findings was positive ultrasonographically. Only one patient with a negative CT (and negative ultrasound) had a recurrent thromboembolic event. The first team diagnosed PE with MRA in 47 cases, with a sensitivity of 71% and a specificity of 92%; the second team obtained the diagnosis in 23 cases, with a sensitivity of 31% and a specificity of 85%. Inter-observer agreement between MRA reading was low: Kappa = 0.16 (-0.01 to 0.33); p = 0.07. In conclusion, compared with a non-invasive strategy based on spiral CT, the diagnostic value of MRA is limited by poor inter-observer agreement.


VASA ◽  
2002 ◽  
Vol 31 (1) ◽  
pp. 15-21 ◽  
Author(s):  
Bounameaux

Diagnosing deep vein thrombosis and pulmonary embolism has become definitely easier and more reliable over the past fifteen years, especially thanks the development of lower limbs venous compression ultrasonography and fibrin D-Dimer measurement. These tests allowed reducing the requirement for venography and pulmonary angiography to a small minority of patients. Simultaneously, ventilation/perfusion lung scan criteria have been standardized, and the performance of spiral computed tomography has been analyzed in an appropriate way. New sequential, mainly noninvasive strategies could be developed that proved to be safe in large-scale prospective cohort studies with prolonged follow-up. They should now be implemented in daily practice according to cost-effectiveness analyses as well as local facilities and expertise.


2003 ◽  
Vol 90 (12) ◽  
pp. 1198-1203 ◽  
Author(s):  
Daniel Hayoz ◽  
Bertrand Yersin ◽  
Arnaud Perrier ◽  
Ghassan Barghouth ◽  
Pierre Schnyder ◽  
...  

SummaryOur goal was to evaluate the diagnostic utility of C-reactive protein (CRP) alone or combined with clinical probability assessment in patients with suspected pulmonary embolism (PE), and to compare its performance to a D-dimer assay. We conducted a prospective study in which we performed a common immuno-turbidimetric CRP test and a rapid enzyme-linked immunosorbent assay (ELISA) D-dimer test in 259 consecutive outpatients with suspected PE at the emergency department of a teaching hospital. We assessed clinical probability of PE by a validated prediction rule overridden by clinical judgment. Patients with D-dimer levels ≥ 500 µg/l underwent a work-up consisting of lower-limb venous ultrasound, spiral computer-ized tomography, ventilation-perfusion scan, or pulmonary angiography. Patients were followed up for three months. Seventy-seven (30%) of the patients had PE.The CRP alone had a sensitivity of 84% (95% confidence interval [CI).: 74 to 92%) and a negative predictive value (NPV) of 87% (95% CI: 78 to 93%) at a cutpoint of 5 mg/l. Overall, 61 (24%) patients with a low clinical probability of PE had a CRP < 5 mg/l. Due to the low prevalence of PE (9%) in this subgroup, the NPV increased to 97% (95% CI: 89 to 100%). The D-dimer (cutpoint 500 µg/l) showed a sensitivity of 100% (95% CI: 95 to 100%) and a NPV of 100% (95% CI: 94 to 100%) irrespective of clinical probability and accurately rule out PE in 56 (22%) patients. Standard CRP tests alone or combined with clinical probability assessment cannot safely exclude PE.


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