| 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 |
| Approved Date: 12/08/2009 |
Effective Date: 01/01/2010 |
| Next Review Date: 12/2010 |
|
| |
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.
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).
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 when conventional
angiography is unsuccessful or equivocal.
- Evaluation of Coronary Artery Disease
Contrast-enhanced computed tomographic angiography
(CTA) of the coronary arteries is considered investigational
for the diagnosis and screening of coronary artery
disease (CAD) including but not limited to:
- Evaluation of chest pain in an emergency
room 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
POSITION STATEMENT
- 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 CAD.
- 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.(6-33,45-47) 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.
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 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 studies may represent selection bias.
Diagnostic performance was analyzed and reported per
vessel or per segment rather than per patient. 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.
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.(34) 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: (35-42)
- 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 in the study.
- 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%. (43)
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.
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
- False positive or false negative results may lead
to unnecessary treatment (invasive angiography) 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 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.
Appropriateness criteria have recently been published
for both CTA and cardiac magnetic resonance imaging
(CMRI).(44) 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 Calcifications,
Regence Medical Policy Manual, Radiology, Policy No.
6
| Codes |
Number |
Description |
| CPT |
0146T
|
Computed tomography, heart,
with contrast material(s), including noncontrast
images, if performed, cardiac gating and 3D
image postprocessing; computed tomographic
angiography of coronary arteries (including
native and anomalous coronary arteries, coronary
bypass grafts), without quantitative evaluation
of coronary calcium (Deleted 1/1/2010)
|
| |
0147T
|
computed tomographic angiography
of coronary arteries (including native and anomalous
coronary arteries, coronary bypass grafts), with
quantitative evaluation of coronary calcium (Deleted
1/1/2010)
|
| |
0148T
|
cardiac structure and morphology
and computed tomographic angiography of coronary
arteries (including native and anomalous coronary
arteries, coronary bypass grafts), without quantitative
evaluation of coronary (Deleted 1/1/2010)
|
| |
0149T
|
cardiac structure and morphology
and computed tomographic angiography of coronary
arteries (including native and anomalous coronary
arteries, coronary bypass grafts), with quantitative
evaluation of coronary calcium (Deleted 1/1/2010)
|
| |
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) |
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