Clinical Validity of a Normal Pulmonary Angiogram in Patients with Suspected Pulmonary Embolism—A Critical Review

doi:10.1053/crad.2001.0778

Clinical Radiology

Volume 56, Issue 10, October 2001, Pages 838-842

https://doi.org/10.1053/crad.2001.0778 Get rights and content

Abstract

AIM: To determine the validity of a normal pulmonary angiogram in the exclusion of pulmonary embolism (PE), based on the safety of withholding anticoagulant therapy in patients with a normal pulmonary angiogram. MATERIALS AND METHODS: A review of English reports published between 1965 and April 1999 was carried out. Eligible articles described prospective studies in patients with suspected PE and a normal pulmonary angiogram, who remained untreated and were followed-up for a minimum of 3 months. Articles were evaluated by two authors, using pre-defined criteria for strength of design. End points consisted of fatal and non-fatal recurrent thromboembolic events. A sensitivity analysis was performed, by removing one study at a time from the overall results and by comparing pre- and post-1990 publications. RESULTS: Among 1050 patients in eight articles included in the analysis, recurrent thromboembolic events were described in 18 patients (1.7% 95% CI: 1.0–2.7%). These were fatal in three patients (0.3% 95% CI: 0.02–0.7%). The recurrence rate of PE decreased from 2.9% (95% CI: 1.4–6.8%) before 1990 to 1.1% (95% CI: 0.5–2.2%) after 1990. CONCLUSION: It would appear that the ability to exclude PE by angiography has improved over the years, as indicated by recurrence rate of PE. The low recurrence rate of PE supports the validity of a normal pulmonary angiogram for the exclusion of PE. van Beek, E. J. R. et al. (2001). Clinical Radiology56, 838–842.

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Cited by (155)

Comparison of international guideline recommendations for the diagnosis of pulmonary embolism
2023, The Lancet Haematology
Pulmonary embolism is one of the leading causes of death due to cardiovascular disease. Timely diagnosis is crucial, but challenging, as the clinical presentation of pulmonary embolism is unspecific and easily mistaken for other common medical emergencies. Clinical prediction rules and D-dimer measurement allow stratification of patients into groups of expected prevalence and are key elements in adequate selection of patients for diagnostic imaging; however, the strengths and weaknesses of the multiple proposed prediction rules, when to measure D-dimer, and which cutoff to apply might be elusive to a significant proportion of physicians. 13 international guidelines authored by medical societies or expert author groups provide recommendations on facets of the diagnostic investigations in suspected pulmonary embolism, some of which are hallmarked by pronounced heterogeneity. This Review summarises key recommendations of each guideline, considers the most recent evidence on the topic, compares guideline recommendations on each facet of the diagnosis of pulmonary embolism, and provides a synthesis on the most common recommendations.
Diagnosis of venous thromboembolism in pregnancy: a review of current guidelines
2022, Clinical Radiology
Venous thromboembolic disease (VTE) is the leading cause of maternal death throughout the developed world. International and national guidance for the diagnosis and management of VTE in pregnancy is varied and limited, which can result in problems in clinical practice. The imaging challenges of VTE in the general population are challenging but become more complex in pregnancy due to the physiological changes in the circulatory system, which alter clinical judgment and test performance. As an additional factor, the relative radiation risks to the mother and fetus arising from diagnostic tests need to be assessed and communicated to the patient in a clear and understandable way. The purpose of this review is fourfold. We propose to review and summarise the current imaging guidelines available for this condition; critically review the evidence base within the current literature; address the issues of test performance of imaging examinations used for VTE in pregnancy; and address the question of radiation risk and how to communicate this information to patients.
Toward a tailored diagnostic standard for future diagnostic studies in pulmonary embolism: Communication from the SSC of the ISTH
2021, Journal of Thrombosis and Haemostasis
The OPTICA study (Optimised Computed Tomography Pulmonary Angiography in Pregnancy Quality and Safety study): Rationale and design of a prospective trial assessing the quality and safety of an optimised CTPA protocol in pregnancy
2019, Thrombosis Research
CTPA is the gold standard investigation for evaluating suspected pulmonary embolism (PE) in the general population however is sometimes considered second line in pregnant and post-partum patients with a normal CXR due to its higher breast dose and the increased radio-sensitivity of breast tissue during this period. Guidelines advocating for scintigraphy over CTPA, however, quote significantly higher breast doses than those achievable with optimised low dose strategies. Defining the radiation dose achievable with a specific low-dose CTPA protocol is therefore imperative. As decreasing dose is associated with increased image noise, demonstrating the image quality and validity of a negative low-dose CTPA in out-ruling PE in this population is necessary.
The OPTICA study is a prospective multicentre observational study aiming to validate the clinical utility and safety of an optimised low-dose CTPA protocol in pregnancy. An optimised low-dose CTPA protocol has been agreed across all study sites with equivalent CT capabilities. Pregnant women undergoing CTPA for suspected PE will be included. Independent review of CTPAs by two radiology consultants, image data analysis and 3-month patient follow up will be performed. The primary outcome is the 3-month incidence of VTE in pregnant patients in whom PE was excluded at baseline CTPA. Secondary outcomes will confirm the associated radiation dose and image quality of this protocol. The radiation dose will be calculated using the Monte Carlo method and will include maternal effective, breast and foetal doses. Image quality will be assessed objectively by measuring opacification of the main pulmonary trunk, signal-to-noise and contrast-to-noise ratios and subjectively using a grading scale and inter-reader variability of CTPA results.
The OPTICA study is the first prospective trial of a low-dose CTPA protocol in the pregnant population. It will provide high-quality evidence defining the achievable dose, image quality and safety of an optimised CTPA for this population. It will assist other institutes with similar CT capabilities in achieving comparable low doses for its patients and provide an evidence base upon which modern CTPA protocols can be appropriately compared to scintigraphy in the pregnant population.
American Society of Hematology 2018 guidelines for management of venous thromboembolism: Diagnosis of venous thromboembolism
2018, Blood Advances
Citation Excerpt :
Part D describes new interests disclosed by individuals after appointment. ASH policy required that panel members with a current, direct financial interest in a commercial entity with any product that could be affected by the guidelines be recused from making judgments about relevant recommendations.4,12-14 However, no panel members met this criterion and hence no individuals were recused from making judgments about any recommendations.
Background: Modern diagnostic strategies for venous thromboembolism (VTE) incorporate pretest probability (PTP; prevalence) assessment. The ability of diagnostic tests to correctly identify or exclude VTE is influenced by VTE prevalence and test accuracy characteristics.
Objective: These evidence-based guidelines are intended to support patients, clinicians, and health care professionals in VTE diagnosis. Diagnostic strategies were evaluated for pulmonary embolism (PE), deep vein thrombosis (DVT) of the lower and upper extremity, and recurrent VTE.
Methods: The American Society of Hematology (ASH) formed a multidisciplinary panel including patient representatives. The McMaster University GRADE Centre completed systematic reviews up to 1 October 2017. The panel prioritized questions and outcomes and used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess evidence and make recommendations. Test accuracy estimates and VTE population prevalence were used to model expected outcomes in diagnostic pathways. Where modeling was not feasible, management and accuracy studies were used to formulate recommendations.
Results: Ten recommendations are presented, by PTP for patients with suspected PE and lower extremity DVT, and for recurrent VTE and upper extremity DVT.
Conclusions: For patients at low (unlikely) VTE risk, using D-dimer as the initial test reduces the need for diagnostic imaging. For patients at high (likely) VTE risk, imaging is warranted. For PE diagnosis, ventilation-perfusion scanning and computed tomography pulmonary angiography are the most validated tests, whereas lower or upper extremity DVT diagnosis uses ultrasonography. Research is needed on new diagnostic modalities and to validate clinical decision rules for patients with suspected recurrent VTE.
Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study
2017, The Lancet Haematology
The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmonary embolism who have a high prevalence of the condition. Our main objective was to prospectively assess the predictive value of negative PERC to rule out pulmonary embolism among European patients with low implicit clinical probability.
We did a multicentre, prospective, observational study in 12 emergency departments in France and Belgium. We included consecutive patients aged 18 years or older with suspected pulmonary embolism. Patients were excluded if they had already been hospitalised for more than 2 days, had curative anticoagulant therapy in progress for more than 48 h, or had a diagnosis of thromboembolic disease documented before admission to emergency department. Physicians completed a standardised case report form comprising implicit clinical probability assessment (low, moderate, or high) and a list of risk factors including criteria of the PERC rule. They were asked to follow international recommendations for diagnostic strategy, masked to PERC assessment. The primary endpoint was the proportion of patients with low implicit clinical probability and negative PERC who had venous thromboembolic events, diagnosed during initial diagnostic work-up or during 3-month follow-up, as externally adjudicated by an independent committee masked to the PERC and clinical probability assessment. The upper limit of the 95% CI around the 3-month thromboembolic risk was set at 3%. We did all analyses by intention to treat, including all patients with complete follow-up. This trial is registered with ClinicalTrials.gov, number NCT02360540.
Between May 1, 2015, and April 30, 2016, 1773 consecutive patients with suspected pulmonary embolism were prospectively assessed for inclusion, of whom 1757 were included. 1052 (60%) patients were classed as having low clinical probability, 49 (4·7%, 95% CI 3·5–6·1) of whom had a venous thromboembolic event. In patients with a low implicit clinical probability, 337 (32%) patients had negative PERC, of whom four (1·2%; 95% CI 0·4–2·9) went on to have a pulmonary embolism.
In European patients with low implicit clinical probability, PERC can exclude pulmonary embolism with a low percentage of false-negative results. The results of our prospective, observational study allow and justify an implementation study of the PERC rule in Europe.
French Ministry of Health.

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^f1: Author for correspondence and guarantor of study: Dr Edwin J. R. van Beek, Section of Academic Radiology, Royal Hallamshire Hospital, Floor C, Glossop Road, Sheffield S10 2JF, U.K. Fax: +44 114 2724760; E-mail: [email protected]

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Regular ArticlesClinical Validity of a Normal Pulmonary Angiogram in Patients with Suspected Pulmonary Embolism—A Critical Review

Abstract

Chest

Chest

Am J Med

Chest

JVIR

Neth J Med

Chest

Anatomic distribution of pulmonary emboli at pulmonary angiography: implications for cross-sectional imaging

Radiology

Effect of anatomic distribution of pulmonary emboli on interobserver agreement in the interpretation of pulmonary angiography

AJR

Interobserver variability of pulmonary angiography in patients with non-diagnostic lung scan results: conventional versus digital subtraction arteriography

Radiology

Possible pulmonary embolus: evaluation with digital subtraction versus cut-film angiography—prospective study in 80 patients

Radiology

Pulmonary embolism: comparison of cut-film and digital pulmonary angiography

Radiology

Diagnosis of pulmonary embolism with spiral CT: comparison with pulmonary angiography and scintigraphy

Radiology

Pulmonary embolism: validation of spiral CT angiography in 149 patients

Radiology

The clinical course of patients with suspected pulmonary embolism

Arch Intern Med

Risk of fatal pulmonary embolism

JAMA

Reassessment of pulmonary angiography for the diagnosis of pulmonary embolism: relation of interpreter agreement to the order of the involved pulmonary arterial branch

Radiology

Anticoagulant drugs in the treatment of pulmonary embolism. A controlled study

Lancet

Pulmonary embolism in outpatients with pleuritic chest pain

Arch Intern Med

The clinical course of patients with suspected pulmonary embolism and a negative pulmonary arteriogram

Radiology

Regular Articles
Clinical Validity of a Normal Pulmonary Angiogram in Patients with Suspected Pulmonary Embolism—A Critical Review