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Sensitivity and Specificity of Ultrasonography in the Diagnosis of Upper Extremity Deep Vein Thrombosis
A Systematic Review
Bisher O. Mustafa, MD;
Suman W. Rathbun, MD;
Thomas L. Whitsett, MD;
Gary E. Raskob, PhD
Arch Intern Med. 2002;162:401-404.
ABSTRACT
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Objectives To determine the sensitivity and specificity of ultrasonography in the
diagnosis of upper extremity deep vein thrombosis and to determine the safety
of withholding anticoagulant therapy in patients with negative ultrasonographic
results.
Data Sources The MEDLINE database was searched for literature published from January
1, 1980, to December 31, 2000, that evaluated ultrasonography for the diagnosis
of upper extremity deep vein thrombosis. Bibliographies of the retrieved articles
were cross-checked to identify additional studies.
Study Selection All prospective English-language studies were selected. Retrospective
studies, review articles, and case reports were excluded.
Data Extraction Two of us (B.O.M. and S.W.R.) used predefined criteria to independently
assess each study. Data on sensitivity and specificity and the associated
95% confidence intervals were recorded when available.
Data Synthesis Only one study met all of the predefined criteria for adequately evaluating
sensitivity and specificity. The sensitivity of duplex ultrasonography ranged
from 56% to 100%, and the specificity ranged from 94% to 100%. No study evaluated
the safety of withholding anticoagulant therapy without additional testing
in patients with negative ultrasonographic results.
Conclusion The safety of withholding anticoagulant treatment in a patient with
suspected upper extremity deep vein thrombosis and negative ultrasonographic
results is uncertain.
INTRODUCTION
UPPER EXTREMITY deep vein thrombosis is an increasingly common clinical
problem.1 It may cause pulmonary embolisms,
including fatal embolisms.2-6
Therefore, accurate diagnosis is essential.
The clinical diagnosis of upper extremity deep vein thrombosis is nonspecific.6 Its prevalence is less than 50% among symptomatic
patients,6 necessitating objective testing
to confirm or exclude the diagnosis. While venography remains the diagnostic
reference standard, it is invasive, has an associated risk of thrombophlebitis,
and may be unavailable or impractical. Ultrasonography is the most frequently
used objective test. However, in contrast to patients with suspected deep
vein thrombosis of the legs, the validity of ultrasonographic testing for
suspected upper extremity deep vein thrombosis is uncertain. Anatomical differences
between the upper and lower extremity deep venous system may influence the
performance characteristics of ultrasonography for the diagnosis of upper
extremity deep vein thrombosis. For example, the ability to image and compress
the middle of the subclavian vein is hindered by the overlying segment of
the clavicle. Moreover, which vessels are imaged and the diagnostic criteria
for the presence or absence of deep vein thrombosis vary. Most commonly, the
subclavian and axillary veins are imaged, but ultrasonographic testing for
upper extremity deep vein thrombosis may also include imaging of the internal
jugular, innominate, brachial, and basilic veins.7-8
Real-time ultrasonography is used to assess the presence or absence of vein
compressibility and the echogenicity within the vein lumen. Doppler ultrasonography
evaluates the characteristics of venous flow, including phasicity, pulsatility,
and variation with physiologic maneuvers. Duplex ultrasonography uses combined
real-time imaging and Doppler ultrasonographic assessment. Color flow Doppler
imaging enables the assessment of the presence and direction of venous flow.8
Because of the uncertain validity of ultrasonography for the diagnosis
of upper extremity deep vein thrombosis, we conducted a systematic review
of the literature. Our review had 2 objectives: (1) to determine the sensitivity
and specificity of ultrasonography in the diagnosis of upper extremity deep
vein thrombosis and (2) to determine the safety of withholding anticoagulant
therapy without further objective testing in patients with suspected upper
extremity deep vein thrombosis and negative results by ultrasonography.
MATERIALS AND METHODS
LITERATURE SEARCH AND DATA SOURCES
The MEDLINE database was searched for literature published from January
1, 1980, through December 31, 2000. Before 1980, no study that used noninvasive
vascular imaging for the diagnosis of upper extremity deep vein thrombosis
was identified. The Medical Subject Headings' terms upper
extremity and thrombosis were used in separate
searches, and studies found during each search were combined. Limits were
set for human only and English language only. We supplemented this reference
list by cross-checking bibliographies of retrieved articles to identify additional
studies.
STUDY SELECTION AND DATA EXTRACTION
Before performing the literature review, we defined criteria for the
inclusion of studies and for assessing the validity of these studies.9-10 We decided a priori to include all
prospective studies identified by the literature search, including abstracts,
that included ultrasonographic assessment of the upper extremity veins by
one or more of the following techniques: real-time ultrasonographic imaging,
standard Doppler evaluation, or color flow Doppler imaging. Retrospective
studies, review articles, and case reports were excluded. Two of us (B.O.M.
and S.W.R.) reviewed each article or abstract independently using the criteria
given in Table 1. These criteria
were established a priori before the articles were reviewed according to established
methodologic standards for the evaluation of diagnostic tests.11
A third independent reviewer (T.L.W.) adjudicated disagreements.
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Table 1. Criteria Used to Review the Studies
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RESULTS
LITERATURE SEARCH AND DATA SOURCES
The literature search identified 18 articles, 6 case reports, and 1
abstract. Of the 18 articles, 12 were excluded: 9 were retrospective studies
(a list is available from the authors), 1 included only patients with neck
swelling or palpable masses and jugular vein thrombosis,12
1 examined only asymptomatic patients,13 and
1 did not use ultrasonography in the initial diagnosis.14
The 6 case reports were excluded (a list is available from the authors). The
one abstract was excluded because of insufficient information to assess study
validity. Thus, 6 original prospective studies6, 15-19
were assessed using the criteria given in Table 1 and were included in the systematic review.
STUDY APPRAISAL
Table 2 summarizes the results
of our appraisal of the 6 prospective studies. Only 1 study6
stated that a consecutive series of all patients with suspected upper extremity
deep vein thrombosis was examined. All 6 studies6, 15-19
included information on the vessels that were imaged and the ultrasonographic
methods used. In 4 studies,6, 16, 18-19
the results of ultrasonography and venography were interpreted independently.
Only 1 study6 included enough information to
assess the spectrum of patients examined. All studies reported the number
of patients in whom thrombosis was associated with a venous catheter. The
sample sizes of these studies ranged from 2 to 58 patients (Table 2).
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Table 2. Prospective Studies Evaluating the Use of Ultrasonography
in the Diagnosis of Suspected Upper Extremity Deep Vein Thrombosis*
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SENSITIVITY AND SPECIFICITY
Five studies reported the sensitivity and 3 studies reported the specificity
or provided enough information to calculate these values. The sensitivity
of ultrasonography ranged from 56% to 100%, and the specificity ranged from
77% to 100%. The sensitivity and specificity varied with the ultrasonographic
method used (Table 2). Only 1
study6 reported the 95% confidence intervals
for the sensitivity and specificity. The 95% confidence intervals for sensitivity
and specificity were calculated for the remaining studies where possible.
SAFETY OF WITHHOLDING ANTICOAGULANT THERAPY
No prospective study was identified in which anticoagulant therapy was
withheld without additional testing in patients with suspected upper extremity
deep vein thrombosis and negative results on ultrasonographic testing. One
study6 followed up patients who had undergone
ultrasonography and venography; in this study, the decision to give or withhold
anticoagulant therapy was based on the venographic results.
COMMENT
We sought to determine the sensitivity and specificity of ultrasonography
for the diagnosis of upper extremity deep vein thrombosis and to determine
the safety of withholding anticoagulant therapy in patients with negative
ultrasonographic results. Our results support 3 inferences.
First, only 1 study6 met all of the predefined
methodologic criteria11 for adequately evaluating
the sensitivity and specificity of a diagnostic test. However, even in this
study, the 95% confidence intervals for sensitivity and specificity were broad,
indicating that the true sensitivity of duplex ultrasonography could be as
low as 82% and that the true specificity could be as low as 69% (Table 2). The remaining studies15-19
lacked details regarding the characteristics of the patients and an independent
interpretation of ultrasonography and venography.
Second, there was a clinically important variation (56%-100%) in the
sensitivity of ultrasonography for upper extremity deep vein thrombosis (Table 2). This variation is likely due
to differences in patient selection and the ultrasonographic technique used
and the relatively few patients examined in all studies. The main limitation
of real-time imaging of the upper extremity is imaging the portion of the
subclavian vein that passes beneath the clavicle. Haire et al18
found that this was the major cause of poor sensitivity and that it occurred
most often on the left side. The specificity of duplex ultrasonography was
high (94%-100%) (Table 2).
The sensitivity and specificity of ultrasonography varied with the technique
used. The results indicate that Doppler evaluation alone is less sensitive
and less specific than real-time imaging or duplex ultrasonography for upper
extremity deep vein thrombosis.6 The available
data do not support an important improvement in sensitivity and specificity
by the addition of color flow Doppler imaging over real-time imaging alone.
Third, no study has evaluated the safety of withholding anticoagulant
therapy without additional testing in patients with suspected upper extremity
deep vein thrombosis and negative ultrasonographic results.
We conclude that ultrasonography for clinically suspected upper extremity
deep vein thrombosis has not been adequately evaluated. The safety of withholding
anticoagulant treatment in a patient with suspected upper extremity deep vein
thrombosis and negative ultrasonographic results is uncertain. There is a
need for prospective studies in more patients using the design features outlined
in Table 1 to definitively evaluate
the sensitivity, specificity, and safety of duplex ultrasonography for the
diagnosis of upper extremity deep vein thrombosis.
AUTHOR INFORMATION
Accepted for publication July 31, 2001.
This study was supported by a research grant from the Presbyterian Health
Foundation, Oklahoma City, Okla. Dr Raskob is a Samuel Roberts Noble Foundation
Presidential Professor.
Corresponding author and reprints: Suman W. Rathbun, MD, Department
of Medicine, Room WP 3120, The University of Oklahoma Health Sciences Center,
920 Stanton L. Young Blvd, Oklahoma City, OK 73104 (e-mail: suman-rathbun{at}ouhsc.edu).
From the Departments of Medicine (Drs Mustafa, Rathbun, Whitsett, and
Raskob) and Biostatistics and Epidemiology (Dr Raskob), The University of
Oklahoma Health Sciences Center, and Veterans Administration Medical Center,
Oklahoma City.
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