| Radiology Section - Contrast Enhanced Computed
Tomographic Angiography (CTA) for Coronary Artery Evaluation
| Topic: Contrast Enhanced Computed
Tomographic Angiography (CTA) for Coronary Artery
Evaluation |
Date of Origin: 06/07/2005 |
| Section: Radiology |
Policy No: 46 |
| Effective Date: 06/01/2011 |
|
| |
IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding
coverage in accordance with contract terms. Benefit determinations are based in all cases on
the applicable contract language. To the extent there may be any conflict between the Medical
Policy and contract language, the contract language takes precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that
are considered investigational or cosmetic. Providers may bill members for services or
procedures that are considered investigational or cosmetic. Providers are encouraged to inform
members before rendering such services that the members are likely to be financially responsible
for the cost of these services.
DESCRIPTION
Contrast-enhanced computed tomographic angiography
(CTA) is a noninvasive imaging study that requires
the use of intravenously administered contrast material
and high-resolution, high-speed CT machinery to obtain
detailed images of the coronary blood vessels. Very
short image acquisition times are necessary to avoid
blurring artifacts from the rapid motion of the beating
heart. Rapid scanning is also helpful so that the volume
of cardiac images can be obtained during breath-holding.
The various computed tomographic (CT) imaging devices
used to assess coronary arteries include but are not
limited to electron beam CT (also known as ultrafast
CT) and helical CTs including multi-detector row CT
(MDCT) and multi-slice CT (MSCT).
CTA has several important limitations. The presence
of dense arterial calcification or an intracoronary
stent can produce significant beam-hardening artifacts
and may preclude a satisfactory study. The presence
of an uncontrolled rapid heart rate or arrhythmia hinders
the ability to obtain diagnostically satisfactory images.
Evaluation of the distal coronary arteries is generally
more difficult than visualization of the proximal and
midsegment coronary arteries due to greater cardiac
motion and the smaller caliber of coronary vessels
in distal locations.
The effect of radiation exposure from CTA is not clearly
understood and estimates of excess cancer risk have
varied. The radiation delivered with 64-row MDCT is
typically 8 to 20 mSv. CCA delivers about 4 to 8 mSv.
Electrocardiographically (ECG)-controlled modulation
of the x-ray beam during the cardiac cycle can reduce
radiation exposure up to 50% by reducing exposure during
nonimaging phases of the cardiac cycle. The EBCT using
ECG triggering delivers the lowest dose (approximately
0.7 to 1.1 mSv with 3-mm sections).
POLICY/CRITERIA
Note: This policy only addresses the use of
CTA in the evaluation of coronary arteries and does
not address the use of CTA for evaluation of cardiac
structure and function (e.g. cardiac masses, emergent
evaluations of aortic dissection, suspected pulmonary
embolism, and structural morphology.)
The use of electron beam CT or helical CT to detect
coronary artery calcification is addressed in a separate
policy, Radiology 6, Computed Tomography to Detect
Coronary Artery Calcification.
- Anomalous Coronary Artery Mapping
Contrast-enhanced computed tomographic angiography
(CTA) for evaluation of congenital anomalous (native)
coronary arteries in symptomatic patients may be
considered medically necessary.
- Evaluation of Coronary Artery Disease and all other
indications
Contrast-enhanced computed tomographic angiography
(CTA) of the coronary arteries is considered investigational for
all other indications, including but not limited to
the diagnosis and screening of coronary artery disease
(CAD) including but not limited to:
- Evaluation of chest pain in any setting, including
but not limited to the emergency room or other
hospital setting
- Diagnosis of CAD in coronary artery bypass grafts
- Diagnosis of CAD after percutaneous stent placement
- Delineation of coronary artery anatomy prior
to a cardiovascular procedure
- Monitoring plaque density to evaluate treatment
effect
POSITION STATEMENT [1]
- Contrast-enhanced computed tomographic angiography
(CTA) appears to effectively determine the origin
and course of coronary arteries in cases when conventional
angiography is unsuccessful.
- It is uncertain if CTA can reliably diagnose the
presence or severity of coronary artery disease (CAD)
in patients with acute or chronic chest pain in any
setting (eg, emergency department, hospital, clinic).
- Evidence is insufficient to determine whether a
CTA diagnostic strategy provides greater benefits
and/or lesser harms than comparative approaches for
the evaluation of CAD.
- Currently, the “gold standard” for
evaluating the presence and severity of CAD is invasive
coronary angiography. Other tests used to diagnose
CAD in low to intermediate risk patients include
the exercise treadmill test (ETT), the nuclear stress
test, and stress echocardiography. How CTA should
be used in the context of these other diagnostic
protocols has not been well defined.
- In patients who are found to need invasive treatment,
an intervention can be done efficiently at the time
of angiography, thus avoiding the need for both CTA
and angiography. High risk patients are more
likely to require intervention, but which high risk
patient has not been well established.
Effectiveness
Mapping congenital anomalous coronary arteries
Several studies have shown that CTA may be able to
map the origin and direction of anomalous arteries
when conventional angiography cannot. [2-6] Anomalous
coronary arteries are an uncommon finding at angiography,
occurring in approximately 1% of coronary angiograms
completed for evaluation of chest pain. Given the incidence
and severity of this rare condition, the present level
of evidence is sufficient to support the use of CTA
for the presurgical mapping of anomalous coronary arteries
when conventional angiography is unsuccessful or equivocal.
Validity of CTA for the Diagnosis or Screening
of CAD
The majority of studies examining sensitivity, specificity,
and positive and negative predictive values of CTA
have significant limitations that do not allow conclusions
to be made about the effectiveness of this test for
evaluation of CAD in symptomatic or asymptomatic patients.
[6-42] Limitations include one or more of the following:
Studies were not adequately powered to prove equivalence
between CTA and conventional angiography. Sample
sizes were not determined in advance.
- Potential
Bias
CTA for diagnosis of CAD has largely been evaluated
in preselected, high risk patients who were scheduled
for angiography. The ability of CTA to
diagnose and prevent angiography in patients
with a low to intermediate risk, for which CTA
use is proposed, is still unknown. Safety and
efficacy for the low to intermediate risk population
may be different than for those patients already
scheduled for angiography.
Subjects of some studies were convenience samples,
limited to patients who agreed to be in the study,
subjects scheduled for elective surgery, or availability
of the research staff. These patient selection
methods do not address selection bias.
Diagnostic performance was analyzed and reported
per vessel or per segment rather than per patient
in some studies. While vessel or segment-based
analyses might be useful in determining treatment
decisions about single vessels, decisions about
whether to undergo invasive angiography are not
made on a vessel-by-vessel basis, but based on
all cardiac vessels in the patient as a whole.
Reporting was limited to evaluable coronary artery
segments only, with up to 12% of these segments
being excluded from analysis. In patients with
bypass grafts or stents, evaluation was unreliable
or impossible in 13-26% of the segments due to
vascular clips or calcification artifacts. Exclusion
of these segments from analysis could confound
sensitivity and specificity results. For example,
in a meta-analysis in which patients from 14
studies were pooled, sensitivity and specificity
fell from 90% and 91% to 79% and 81%, respectively
when nonassessable segments were included in
the analysis. [37]
Results for the technical validity of CTA, including
the sensitivity, specificity, and positive and negative
predictive values are inconsistent between studies
ranging from a sensitivity of 86% to 100% and a specificity
of 49% to 100%.
In patients with in-stent restenosis, measurements
of diameter were smaller on MDCT by 16% to 27% compared
with conventional angiography. It is not known how
this difference might influence clinical management
of the patient.
Clinical Utility Of CTA for the Diagnosis
and Treatment of CAD
The clinical utility of CTA depends on how the results
of the study can be used to benefit patient management. The
available evidence has not demonstrated that CTA can
improve patient outcomes to a greater extent than currently
available tests for the following reasons:
There is only one randomized controlled clinical trial
that addresses the use of CTA in a clinical setting.
This trial evaluated the ability CTA compared to standard
nuclear stress testing to assess the severity and extent
of coronary stenosis in symptomatic patients treated
in the emergency room. [43] This study had significant
flaws and failed to demonstrate that CTA was superior
to nuclear stress testing for the following reasons:
- There was no clearly defined primary end point
stated in advance
- Although the study authors concluded the
interventions were equivalent, the study was not
sufficiently powered to support this conclusion.
- 94.7% of patients evaluated with nuclear stress
testing were able to be discharged to home compared
to only 67% of subjects who were discharged directly
home due to CTA findings alone.
- For intermediate stenosis or for non-diagnostic
CTA, a stress test was performed in addition to CTA,
resulting in a second radiation exposure in 24% of
the MSCT arm.
- 4% of the MSCT arm required a third radiation exposure.
Other studies evaluating the clinical utility of this
test include non-randomized case series with the following
limitations: [44-51]
- Within the emergency department, the accuracy of
the diagnosis was not dependent on CTA. Final
diagnosis and treatment planning were dependent on
the combination of clinical data, radionuclide testing,
coronary angiography, and stress echocardiography.
- No alternative strategy for making a diagnosis
was specifically defined.
- Within the setting of bypass graft assessment,
no information is provided about patient symptoms
or how the evidence of graft occlusion affected patient
management.
- One large case series reported CTA decreased the
rate of normal conventional cardiac angiography by
4.7% during a two-year period which was statistically
significant, but of modest magnitude. In the same
setting, accuracy achieved was less than desirable
with a false-negative rate of 10%. [52]
In summary, larger studies are needed to evaluate
low- to intermediate- risk patients and to compare
how clinical management of these patients is impacted
with the use of CTA.
Clinical Utility of CTA for Monitoring Response
to Treatment or Lifestyle Changes
Current evidence is insufficient to establish clinical
utility for the use of CTA in monitoring the effects
of treatment and lifestyle changes in patients with
or at risk of developing CAD. CTA has been used
in some studies as a tool to measure both plaque density
and lumen size. There are currently no studies comparing
health outcomes following treatment planning with versus
without plaque density monitoring.
Safety
There are significant safety considerations with use
of CTA for the evaluation of coronary arteries including
the following:
- CTA has as much as 2-3 times the level of radiation
exposure compared to conventional angiography; improved
technology is decreasing this radiation exposure.
Projected lifetime cancer risks from radiation exposure
with CTA vary, and appear to be higher for younger
patients and for women. Prospective outcomes data
is lacking.
- False positive or false negative results may lead
to unnecessary treatments or conversely, to inaction
when treatment is warranted
- The presence of dense arterial calcifications or
an intracoronary stent can interfere with imaging
quality and lead to the need for repeat testing
- The benefits and harms of evaluation of frequent
(up to 68%) incidental findings are not known. [53-61]
- The use of beta blockers, required for MSCT to
slow the heart rate, may present a risk under certain
clinical situations.
- The use of high contrast medium may impair renal
function under certain clinical situations.
Updated appropriateness criteria have recently been
published for both CTA and cardiac magnetic resonance
imaging (CMRI). [62] These criteria were developed
using a consensus process that compared the expected
benefit of the test with the expected negative consequences.
Although a number of scenarios were judged as appropriate
for use of CTA in evaluating coronary arteries, an
evidence-based review process was not required to make
decisions about expected benefits or harms.
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CROSS REFERENCES
Computed
Tomography to Detect Coronary Artery Calcification,
Regence Medical Policy Manual, Radiology, Policy No.
6
Ultrasonographic
Measurement of Carotid and Femoral Artery Intima-Media
Thickness as an Assessment of Atherosclerosis,
Regence Medical Policy Manual, Radiology, Policy No.
37
| Codes |
Number |
Description |
| CPT |
75574 |
Computed tomographic angiography,
heart, coronary arteries and bypass grafts (when
present), with contrast material, including 3D
image postprocessing (including evaluation of
cardiac structure and morphology, assessment
of cardiac function, and evaluation of venous
structures, if performed) |
| HCPCS |
None |
|
Radiology Section Table of Contents 

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