| Coverage Policy Manual | |
| Policy #: | 2005010 |
| Category: | Radiology |
| Initiated: | February 2005 |
| Last Review: | December 2023 |
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| Cardiac and Coronary Artery Computed Tomography, CT Derived Fractional Flow Reserve and CT Coronary Calcium Scoring | |
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| Description: |
Computed tomographic angiography or CTA is a noninvasive imaging test that requires the use of intravenously administered contrast material and high-resolution, high-speed CT machinery to obtain detailed volumetric images of blood vessels. CTA can be applied to image blood vessels throughout the body; however, to apply CTA in the coronary arteries, several technical challenges must be overcome to obtain high-quality diagnostic images. First, very short image acquisition times are necessary to avoid blurring artifacts from the rapid motion of the beating heart. In some cases, premedication with beta-blocking agents is used to slow down the heart rate below about 60–65 beats per minute to facilitate adequate scanning, and electrocardiographic triggering or retrospective gating is used to obtain images during diastole when motion is reduced. Second, rapid scanning is also helpful so that the volume of cardiac images can be obtained during breath-holding. Third, very thin sections (<1 mm) are important to provide adequate spatial resolution and high-quality 3D reconstruction images.
Volumetric imaging permits multiplanar reconstruction (MPR) of cross-sectional images to display the coronary arteries. Curved MPR and thin-slab maximum intensity projections (MIPs) provide an overview of the coronary arteries, and volume-rendering techniques (VRT) provide a 3D anatomical display of the exterior of the heart. Quantification of coronary artery stenosis may be difficult given current techniques, though improvements in image reconstruction algorithms such as automatic vessel tracking are being developed.
Two different CT technologies can achieve high-speed CT imaging. Electron-beam CT (EBCT, also known as ultrafast CT) uses an electron gun rather than a standard x-ray tube to generate x-rays, thus permitting very rapid scanning, on the order of 50–100 milliseconds per image. Helical CT scanning (also referred to as spiral CT scanning) also creates images at greater speed than conventional CT by continuously rotating a standard x-ray tube around the patient so that data are gathered in a continuous spiral or helix rather than individual slices. Helical CT is able to achieve scan times of 500 milliseconds or less per image and use of partial ring scanning or post-processing algorithms may reduce the effective scan time even further.
Multidetector row helical CT scanning (MDCT) or multislice CT (MSCT) is a technological evolution of helical CT, which uses CT machines equipped with an array of multiple x-ray detectors that can simultaneously image multiple sections of the patient during a rapid volumetric image acquisition. Currently available MDCT machines may have 64 or more detectors. Diffusion of MDCT machines into the medical community has been occurring over the past several years.
Coronary CTA has been proposed as a noninvasive alternative to invasive coronary angiography. Applications of CTA include (but are not limited to) evaluation of:
Evaluation of obstructive CAD involves quantifying arterial stenoses to determine whether hemodynamically significant stenosis is present. Symptomatic lesions with greater than 50%–75% diameter stenosis are generally considered significant and often result in revascularization procedures when viable myocardium is present. It has been suggested that CTA may be helpful to rule out the presence of CAD and to avoid invasive coronary angiography in patients with a low clinical likelihood of significant CAD. Also of note is the increasing interest in exploring the role of nonsignificant plaques (i.e., those associated with less than 50% stenosis) because it is postulated that these plaques may undergo rupture or erosion and lead to acute myocardial infarction. Cross-sectional angiographic imaging may visualize the presence and composition of these plaques and quantify the plaque burden better than conventional angiography, which only visualizes the vascular lumen.
The information sought from angiography after coronary artery bypass graft surgery may depend on the length of time since surgery. Bypass graft occlusion may occur during the early postoperative period; whereas, over the long term, recurrence of obstructive CAD may occur in the bypass graft, which requires a similar evaluation as CAD in native vessels.
Congenital coronary arterial anomalies (i.e., abnormal origination or course of a coronary artery) that lead to clinically significant problems are relatively rare lesions. Symptomatic manifestations may include ischemia or syncope. Clinical presentation of anomalous coronary arteries is hard to distinguish from other more common causes of cardiac disease; however, anomalous coronary artery is an important diagnosis to exclude, particularly in young patients who present with unexplained symptoms (e.g., syncope). There is no specific clinical presentation to suggest a coronary artery aneurysm.
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. EBCT is able to achieve satisfactory images of the proximal and mid-segment coronary vessels without significant motion artifact in 92% of cases; whereas, MDCT was successful in only 73% of cases (p<0.001). Evaluation of the distal coronary arteries is generally more difficult than visualization of the proximal and mid-segment coronary arteries due to greater cardiac motion and the smaller caliber of coronary vessels in distal locations.
It is important to consider the radiation dose associated with CTA. In comparison, 4-row MDCT delivers approximately 8 – 12 mSv; EBCT delivers approximately 1.5 to 2.0 mSv, and conventional invasive coronary angiography delivers about 4 – 8 mSv. Higher row MDCT with modulation of the x-ray beam to avoid exposure during nonimaging phases of the cardiac cycle may reduce x-ray dosage.
Multidetector computed tomography of the heart (MDCT) and coronary computed tomographic angiography (CCTA) for coronary artery evaluation studies are reported with new Category III CPT Codes, CPT 0144T, 0145T, 0146T, 0147T, 0148T, 0149T, 0150T, and 0151T prior to 1/1/2010. Effective 1/1/2010, new CPT codes 75571-75574 should be reported. Prior to 2006, these procedures were reported with CPT 76497 (unlisted CT procedure), and HCPCS codes S8092 and S8093.
With the introduction of the 64 slice, sub-millimeter thin slice detectors CT scanners, imaging of the cardiac structure and morphology is possible, and the negative predictive value for coronary artery studies approaches 99%. (Hoffmann, Martin H, et. al.)
The use of electron-beam CT or helical CT to detect coronary artery calcification is addressed in a separate policy No. 1997061, Coronary Artery Quantitative Calcium Scoring Using Electron Beam Computed Tomography or Multidetector Helical or Spiral Computed Tomography
CPT code 75571 (Computed tomography, heart, without contrast material, with quantitative evaluation of coronary calcium) is the appropriate code to bill when the study is done prior to CT coronary angiography to determine if there is too much calcium to do CT coronary angiography. The code is billed only when the CTA cannot be completed.
CAD Risk Assessment and Pre-test Probability
The following references (not an inclusive list) provide information on assessing CAD risk and pre-test probability.
Kane SP. ASCVD Risk Calculator: 10-Year Risk of First Cardiovascular Event Using Pooled Cohort Equations. ClinCalc: https://clincalc.com/Cardiology/ASCVD/PooledCohort.aspx. Updated August 6, 2020. Accessed at: https://clincalc.com/Cardiology/ASCVD/PooledCohort.aspx
Pretest Probability of Coronary Artery Disease by Age, Gender, and Symptoms (Table 2) in
Gibbons RJ, Balady GJ, Beasley JW, et al. ACC/AHA Guidelines for Exercise Testing: Executive Summary. Circulation. 1997;96:345-354. Accessed at: https://www.ahajournals.org/doi/full/10.1161/01.cir.96.1.345
CHART (eff April 09, 2023): Pretest Probability (%) of Coronary Artery Disease by Age, Gender, and Symptoms
Definitions:
Cardiac chest pain is centrally located, provoked by stress (exercise or emotional), and relieved by rest
Possible cardiac chest pain has two of the three characteristics associated with cardiac chest pain
Non-cardiac chest pain has one (or none) of the three characteristics associated with cardiac chest pain
Adapted from Knuuti J, Wijns W, Saraste A, et al. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020;41: 407–477.
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Policy/ Coverage: |
To Be Effective April 14, 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Coronary CT Angiography (CCTA)
(See Description section for information on assessment of pre-test probability and CAD risk)
The following indications meet primary coverage criteria for Coronary CT Angiography (CCTA).
A_Suspected CAD in symptomatic patients who have not had evaluation for CAD within the preceding 60 days
B_Established flow-limiting CAD in patients who have new or worsening symptoms
C_Established or suspected CAD
D_Miscellaneous indications for CCTA
Fractional Flow Reserve (FFR-CT) (now a separate section)
The following indications meet primary coverage criteria for FFR-CT when ALL of the following criteria are met:
CT Coronary Calcium Scoring
Quantitative coronary artery calcium scoring meets primary coverage criteria of effectiveness when performed:
CT for Cardiac Structure
The following indications meet primary coverage criteria for CT for Cardiac Structure:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
For Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed as covered above including screening, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed as covered above including screening, is considered investigational. Investigational services are Plan exclusions.
Effective April 09, 2023 - April 13, 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Coronary CT Angiography (CCTA)
(See Description section for information on assessment of pre-test probability and CAD risk)
The following indications meet primary coverage criteria for Coronary CT Angiography (CCTA).
A_Suspected CAD in symptomatic patients who have not had evaluation for CAD within the preceding 60 days
B_Established flow-limiting CAD in patients who have new or worsening symptoms
C_Established or suspected CAD
D_Miscellaneous indications for CCTA
Fractional Flow Reserve (FFR-CT) (now a separate section)
The following indications meet primary coverage criteria for FFR-CT when ALL of the following criteria are met:
CT Coronary Calcium Scoring
Quantitative coronary artery calcium scoring meets primary coverage criteria of effectiveness when performed
CT for Cardiac Structure
The following indications meet primary coverage criteria for CT for Cardiac Structure:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
For Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed as covered above including screening, does not meet primary coverage criteria.
For contracts without primary coverage criteria, for Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed as covered above including screening, is considered investigational. Investigational services are specific contract exclusions.
Effective March 13, 2022 to April 08, 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Coronary CT Angiography and FFR
(See Description section for information on CAD risk assessment of pre-test probability)
The following indications meet primary coverage criteria for Coronary CT Angiography (CCTA). For some of these indications, FFR-CT may also meet primary coverage criteria. For some indications, coronary CT meets coverage criteria only if the imaging facility has the capability to perform FFR.
1.Coronary CT Angiography only:
2.Coronary CT Angiography, with FFR when necessary.
3.Coronary CT Angiography, with FFR when necessary. For these indications, the imaging center MUST have the capability to perform FFR-CT if indicated.
Notes:
CT Coronary Calcium Scoring
Quantitative coronary artery calcium scoring meets primary coverage criteria of effectiveness when:
CT for Cardiac Structure
The following indications meet primary coverage criteria for CT for Cardiac Structure:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
For Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed above including screening, does not meet primary coverage criteria.
For contracts without primary coverage criteria, for Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed above including screening, is considered investigational. Investigational services are specific contract exclusions.
Effective Prior to March 13, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Coronary CT Angiography and FFR
The following indications meet primary coverage criteria for Coronary CT Angiography (CCTA). For some of these indications, FFR-CT may also meet primary coverage criteria. For some indications, coronary CT meets coverage criteria only if the imaging facility has the capability to perform FFR.
1.Coronary CT Angiography only:
2.Coronary CT Angiography, with FFR when necessary.
3.Coronary CT Angiography, with FFR when necessary. For these indications, the imaging center MUST have the capability to perform FFR-CT if indicated.
Notes:
CT Coronary Calcium Scoring
Quantitative coronary artery calcium scoring meets primary coverage criteria of effectiveness when:
CT for Cardiac Structure
The following indications meet primary coverage criteria for CT for Cardiac Structure:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
For Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed above including screening, does not meet primary coverage criteria.
For contracts without primary coverage criteria, for Coronary CT Angiography and FFR, coronary artery calcium, and CT for Cardiac Structure, any other indication not listed above including screening, is considered investigational. Investigational services are specific contract exclusions.
Effective Prior to February 14, 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Multidetector computed tomography (MDCT) provides advanced spatial and temporal resolution of the heart and allows imaging of the major vessels of the chest, including the coronary arteries. This new technology lacks evidence based indications, but indirect evidence, using diagnostic performance data, decision models, and an expert consensus approach validates the following current indications. Future revisions to these indications will occur as evidence based studies become available.
Multidetector computed tomography (MDCT) and coronary computed tomographic angiography (CCTA), using 32 or more detectors and sub millimeter slices can reliably evaluate cardiac structure and morphology, native and anomalous coronary arteries and bypass grafts, congenital heart disease, left and right ventricular function, ejections fractions, and segmental wall motion. The following indications meet primary coverage criteria of effectiveness:
Quantitative coronary artery calcium scoring meets primary coverage criteria of effectiveness when performed to determine if there is too much calcium present to proceed with CT coronary angiography.
*NOTE: Performance of multiple non-invasive coronary artery or myocardial perfusion imaging studies on the same patient should be rarely required, and will be subject to monitoring.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The following indications do not meet member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
Screening:
Low Risk Patients:
High Risk Patients who meet the ACC/AHA Guidelines for Coronary Angiography:
For contracts without primary coverage criteria, the indications above listed as not meeting primary
coverage criteria, are considered investigational. Investigational services are specific contract
exclusions.
Due to the detail of the policy statement, the document containing coverage statements for dates prior to August 2019 are not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
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| Rationale: |
This policy was developed based on a literature search conducted on MEDLINE via PubMed through January, 2006.
Evaluation of Obstructive Coronary Artery Disease (CAD):
For evaluation of CAD, the reference standard comparison for CTA is with conventional invasive coronary angiography, and CTA is proposed as a noninvasive alternative to invasive angiography. In patients with a relatively low clinical likelihood of coronary artery disease but adequate suspicion to warrant further evaluation, CT coronary artery angiography may provide a high enough negative predictive value to avoid invasive coronary angiography.
Summary:
MDCT studies performed on scanners with sub millimeter slice thickness and at least 16 detectors /rotation yield useful diagnostic information about cardiac structure and morphology, function, ejection fraction, and wall motion. CCTA studies performed on scanners with sub millimeter slice thickness and at least 32 detectors/rotation yield useful diagnostic information about native and anomalous coronary arteries and coronary bypass grafts. MDCT and CCTA are noninvasive tools which may be used to evaluate patients with suspected coronary artery disease, and may provide a negative predictive value which is sufficient to avoid invasive coronary angiography. These studies also yield valuable clinical information in patients with suspected congenital cardiac anomalies.
2012 Update
This policy is being updated with a search of the MEDLINE database. There was no new literature identified that would prompt a change in the coverage statement. There remains a lack of scientific evidence that computed tomographic angiography improves health outcomes when used for screening, for low-risk patients or for high-risk patients who meet ACC/AHA guidelines for angiography.
The use for screening a low-risk population was recently evaluated in 1,000 patients undergoing coronary CTA compared to a control group of 1,000 similar patients (McEvoy, 2011). Findings were abnormal in 215 screened patients. Over 18 months’ follow-up, screening was associated with more invasive testing, statin use, but without difference in cardiac event rates.
Appropriate use criteria (Taylor, 2010a) (Taylor, 2010b) (Taylor 2010c) and expert consensus documents (Mark, 2010a) (Mark, 2010b) Mark 2010c) have been published jointly by ACCF/ACR/AHA/NASCI/SAIP/SCAI/SCCT, but U.S. guidelines have not been developed. The authors of these publications state that the evidence base for CTA is not yet sufficiently robust to support clinical guideline development. The following are statements from the consensus document:
The “…overall sensitivity and specificity on a per-patient basis are both high, and the number of indeterminate studies due to inability to image important coronary segments in the select cohorts represented is less than 5%. In most circumstances, a negative coronary CT angiogram rules out significant obstructive coronary disease with a very high degree of confidence, based on the post-test probabilities obtained in cohorts with a wide range of pretest probabilities. However, post-test probabilities following a positive coronary CT angiogram are more variable, due in part to the tendency to overestimate disease severity, particularly in smaller and more distal coronary segments or in segments with artifacts caused by calcification in the arterial walls. At present, data on the prognostic value of coronary CTA using 64-channel or greater systems remain quite limited. Furthermore, no large-scale studies have yet made a direct comparison of long-term outcomes following conventional diagnostic imaging strategies versus strategies involving coronary CTA.”
“In the context of the emergency department evaluation of patients with acute chest discomfort, currently available data suggest that coronary CTA may be useful in the evaluation of patients presenting with an acute coronary syndrome (ACS) who do not have either acute electrocardiogram (ECG) changes or positive cardiac markers. However, existing data are limited, and large multicenter trials comparing CTA with conventional evaluation strategies are needed to help define the role of this technology in this category of patients.”
2013 Update
A literature search conducted through October 2013 using the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement. One prospective study and one guideline are summarized as follows:
The Study of Myocardial Perfusion and Coronary Anatomy Imaging Roles in Coronary Artery Disease (SPARC), is a prospective multicenter registry study of imaging modalities (Hachamovitch, 2012). From 1703 patients with no history of CAD, angiography was more frequent within 90 days following coronary CTA (13.2%) compared with SPECT (4.3%) or PET (11.1%). Although study results vary and all are observational with the attendant potential for selection bias (in effect confounding by test selection), angiography rates appear higher following coronary CTA.
ACCF/AHA/ACP/AATS/PCNA/SCAI/STS joint guidelines for management of patients with stable ischemic heart disease were published in 2012 (Fihn, 1012a; Fihn, 2012b; Fihn, 2012c). Guideline statements for use of coronary CTA were divided whether used in patients without diagnosed disease or those with known disease and a patient’s ability to exercise:
Diagnosis Unknown
Able To Exercise
Class IIb
“CCTA might be reasonable for patients with an intermediate pretest probability of IHD who have at least moderate physical functioning or no disabling comorbidity.” (Level of Evidence: B)
Unable to Exercise
Class IIa
“CCTA is reasonable for patients with a low to intermediate pretest probability of IHD who are incapable of at least moderate physical functioning or have disabling comorbidity.” (Level of Evidence: B)
“CCTA is reasonable for patients with an intermediate pretest probability of IHD who a) have continued symptoms with prior normal test findings, or b) have inconclusive results from prior exercise or pharmacological stress testing, or c) are unable to undergo stress with nuclear MPI or echocardiography.” (Level of Evidence: C)
For Patients With Known Coronary Disease:
Able To Exercise
Class IIb
“CCTA may be reasonable for risk assessment in patients with SIHD (stabile ischemic heart disease) who are able to exercise to an adequate workload but have an uninterpretable ECG.” (Level of Evidence: B)
Class III: No Benefit
“Pharmacological stress imaging (nuclear MPI, echocardiography, or CMR) or CCTA is not recommended for risk assessment in patients with SIHD who are able to exercise to an adequate workload and have an interpretable ECG.” (Level of Evidence: C)
Unable to Exercise
Class IIa
“Pharmacological stress CMR is reasonable for risk assessment in patients with SIHD who are unable to exercise to an adequate workload regardless of interpretability of ECG.” (Level of Evidence: B)
“CCTA can be useful as a first-line test for risk assessment in patients with SIHD who are unable to exercise to an adequate workload regardless of interpretability of ECG.” (Level of Evidence: C)
Regardless of Patients’ Ability to Exercise
Class IIb
“CCTA might be considered for risk assessment in patients with SIHD unable to undergo stress imaging or as an alternative to invasive coronary angiography when functional testing indicates a moderate- to high-risk result and knowledge of angiographic coronary anatomy is unknown.” (Level of Evidence: C)
Class III: No Benefit
“A request to perform either a) more than 1 stress imaging study or b) a stress imaging study and a CCTA at the same time is not recommended for risk assessment in patients with SIHD.” (Level of Evidence: C)
2017 Update
A literature search conducted through December 2016 using the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.
In 2016, the Agency for Healthcare Research and Quality (AHRQ) published a comparative effectiveness review on noninvasive testing for coronary artery disease (CAD) (Skelly et al, 2016). The review found that:
· After coronary computed tomography angiography (CCTA), clinical outcomes for patients with an intermediate pretest risk
o were similar when compared with usual care or functional testing (low-to-moderate strength of evidence).
o were similar when compared with single-photon emission computed tomography (SPECT) (low strength of evidence).
· After CCTA, referral for invasive coronary angiography (ICA) and revascularization
o was more common than after functional testing (high strength of evidence)
o was similar compared with SPECT and usual care (low strength of evidence).
· After CCTA, additional testing in the emergency department (ED) setting
o was less common compared with usual care (moderate strength of evidence).
o was more common than after SPECT (high strength of evidence)
· After CCTA, hospitalization
o was less common compared to usual care in the ED setting (moderate to low strength of evidence)
o was similar to functional testing in the outpatient setting (moderate strength of evidence).
Overall, the AHRQ review found no clear differences between strategies for clinical or management outcomes, although CCTA may lead to a higher frequency of referral for ICA and revascularization.
A 2014 RCT (CT-COMPARE) by Hamilton-Craig et al (2014) assessed length of stay and patient costs in 562 patients presenting to the ED with low-to-intermediate risk chest pain who received CCTA or exercise stress testing.17 Costs within 30 days of presentation were significantly lower in the CCTA group (mean, $2193) than in the exercise testing group (mean, $2704; p<0.001). Length of stay was significantly reduced in the CCTA patients compared with the exercise testing patients. Clinical outcomes at 30 days and at 12 months did not differ.
Linde et al (2013 & 2015) reported long-term follow-up from the CATCH trial. This trial randomized 600 patients to a CCTA-guided strategy or to standard of care (SOC). For the CCTA-guided strategy, referral for ICA required coronary stenosis greater than 70%. This trial differed in design from the other trials, because patients had been discharged from the ED, and if there was intermediate stenosis (50%-70%) on CCTA, a stress test was used. The referral rate for ICA was 17% for the CCTA strategy versus 12% with SOC (p=NS). At a median 18.7-month follow-up, a major cardiac event was observed in 5 patients in the CCTA-strategy arm compared to 14 in the SOC group (hazard ratio [HR], 0.36; 95% confidence interval [CI], 0.16 to 0.95; p=0.04). Three other follow-up studies reported no cardiac events after a negative CCTA in the ED after 12 (N=481), 24 (N=368), or 47 months (N=506) (Hollander et al, 2009; Schlett et al, 2011; Nasis et al, 2014).
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2018. No new literature was identified that would prompt a change in the coverage statement. Three RCTs for patients at risk of CAD comparing net health outcome after a CCTA strategy with outcomes from other noninvasive testing strategies were identified and are summarized below.
The PROMISE trial randomized 10,003 patients to CCTA or exercise electrocardiography, nuclear stress testing, or stress echocardiography (as determined by physician preference) as the initial diagnostic evaluation (Douglas, 2015). For the composite end point of death, MI, hospitalization for unstable angina, or major procedural complication, the outcome rates between the 2 groups showed no statistically significant difference (HR=1.04; 95% CI, 0.83 to 1.29). CCTA also did not meet prespecified noninferiority criteria compared with alternative testing. Some clinical outcomes assessed at 12 months favored CCTA, but the differences were nonsignificant. Coronary catheterization rates and revascularization rates were higher in the CCTA group. In further prespecified analysis of PROMISE trial data, Hoffmann et al (2017) found that there was no difference in event rates (death, MI, or angina) between the groups at a median of 26 months follow-up (Hoffmann, 2017). However, CCTA had better discriminatory ability than functional testing to predict events (eg, in categories of normal, mildly abnormal, moderately abnormal, and severely abnormal) in patients who had nonobstructive CAD (p=0.04). When the Framingham Risk Score was added to functional testing results, there was no significant difference in prognostic capability between the approaches (p=0.29).
In the SCOT-HEART trial, 4146 patients were randomized to CCTA plus SOC or SOC alone. The primary end point was the change in the proportion of patients with a more certain diagnosis (presence or absence) of angina pectoris (Scot-Heart Investigators, 2015). Secondary outcomes included death, MI, revascularization procedures, and hospitalizations for chest pain. Analysis of the primary outcome showed that patients who underwent CCTA had an increase in the certainty of their diagnosis relative to those in usual care (relative risk, 1.79; 95% CI, 1.62 to 1.96). Regarding health outcomes, the rates of heart disease death and MI were lower with CCTA (1.3% vs 2.0%; HR=0.62; p=0.053), but results were of marginal statistical significance. In 2017, Williams et al reported on symptoms and quality of life for participants in the SCOT-HEART trial (Williams, 2017). Symptoms improved in both groups; however, improvements in symptoms and quality of life at 6 months were lower in patients in the CCTA arm than the functional testing arm. This outcome was due primarily to patients who were diagnosed with moderate CAD or had a new prescription of preventative therapy compared with patients diagnosed with normal coronary arteries or who had their preventative therapy discontinued.
The CAPP trial (2015) randomized 500 patients with stable chest pain to CCTA or exercise stress testing (McKavanagh, 2015). The primary outcome was the change difference in scores of Seattle Angina Questionnaire domains at 3 months. Patients were also followed for further diagnostic tests and management. In the CCTA arm, 15.2% of subjects underwent revascularization. In the exercise stress testing arm, 7.7% underwent revascularization. For the primary outcome, angina stability and quality of life showed significantly greater improvement in the CCTA arm than in the exercise stress testing arm.
A number of studies have evaluated the diagnostic accuracy of CCTA for diagnosing CAD in an outpatient population. In general, these studies have reported high sensitivity and specificity, although there is some variability in these parameters across studies. Meta-analyses of these studies have shown that, for detection of anatomic disease, CCTA has a sensitivity greater than 95%, which is superior to all other functional noninvasive tests. Specificity is at least as good as other noninvasive tests. However, the
link between improved diagnosis and health outcomes is not as clear, and thus outcome studies are necessary to demonstrate the clinical utility of CCTA.
Direct clinical trial evidence comparing CCTA and other strategies in the diagnostic management of stable patients with suspected CAD has not demonstrated the superiority of CCTA in any of the single clinical trials. Clinical trials have demonstrated greater utilization of ICA and subsequent revascularization procedures after CCTA. An important problem when interpreting the clinical trials is that the comparator strategies differ: in the PROMISE and the CAPP trials, CCTA was compared with an alternative non-invasive test; in other studies, CCTA supplemented usual care (which may or may not have included a noninvasive test). These trial design differences are likely to reflect how CCTA is used in clinical practice¾either as a substitute for another noninvasive test or as an adjunct to other noninvasive tests. The PROMISE trial explicitly compared CCTA with an alternative functional test as the initial diagnostic test. Although the trial did not show the superiority of CCTA and did not meet prespecified criteria for noninferiority, examination of some secondary clinical outcomes supports a conclusion of “at least” noninferiority. The results of the other randomized trials are consistent with the noninferiority of CCTA compared with other established noninvasive tests. Thus, the randomized studies indicate that outcomes of patients are likely to be similar with CCTA vs other noninvasive tests.
2019 Update
A literature search was conducted through December 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Systematic Reviews
Gongora et al published a meta-analysis of 10 RCTs (total N=6285 patients) comparing CCTA with the standard of care (SOC) in patients with acute chest pain in an ED setting or an inpatient setting (Gongora, 2018). Pooled results suggested that CCTA results in more frequent revascularization and ICA without reducing the risk of adverse cardiac events. Among the limitations of the review were the heterogeneity of SOC across assessed studies, the possibility of publication bias due to the small number of trials available, and the presence of only a few studies that prespecified downstream testing criteria following CCTA results.
Levsky et al published an RCT: in the CCTA arm, 39 (19%) patients were hospitalized, compared with 22 (11%) patients of the stress echocardiography arm, resulting in a difference of 8% (95% CI, 1% to 15%; p=0.026) (Levsky, 2018). Median length of stay in the hospital was longer for the CCTA arm (58 hours vs 34 hours; p=0.002, respectively). There was no significant difference between the CCTA and stress echocardiography arms in terms of major adverse cardiac events (MACE; including death): respectively, MACE occurred in 11 CCTA patients and 7 stress echocardiography patients (p=0.47) over a median follow-up of 24 months. The median complete initial work-up radiation exposure for the CCTA arm was 6.4 mSv (interquartile range, 5.3-7.8 mSv), significantly more than that of stress echocardiography (0 mSv; p<0.001). The trial had a number of limitations, including the single-center design and omission of high sensitivity troponin assays.
Nonrandomized Studies
Durand et al compared the diagnostic performance of dobutamine-stress echocardiography (DSE) with CCTA in 217 adults (Durand, 2017). Patients had normal measurements of troponin I or T, and electrocardiograph results. All patients received DSE and CCTA, with only 75 (34.6%) patients receiving ICA, which served as the reference test. The primary end point was the diagnostic accuracy of the tests for detecting coronary stenosis greater than 50%. Forty-nine (22.6%) patients had a positive CCTA while 33 (15.2%) patients had a positive DSE. A negative CCTA result was reported in 144 (66.4%) patients, and 146 (67.3%) had a negative DSE result. Overall, CCTA was more sensitive than DSE in detecting CAD, while specificity was similar between tests. At 6 months, no patients had died or received a diagnosis of MI, but 1 patient presented with acute coronary syndrome whose diagnosed was initially missed. No limitations were identified.
Case Series
Sandstedt et al published a case series evaluating 1205 patients with suspected CAD who underwent CCTA at a single center (Sandstedt, 2018) Most patients had normal findings (n=668 [55.4%]). Of the 218 patients who underwent ICA, 149 patients had obstructive stenosis, 49 patients had nonobstructive stenosis, and 20 patients did not have evidence of stenosis. The study had several limitations, including a high number of exclusions because of poor image quality, a single-reader clinical evaluation, and limitations inherent of a single-center study.
Systematic Reviews
Foy et al conducted a systematic review comparing CCTA with functional stress testing for patients with suspected CAD and stable or acute chest pain (Foy, 2017). In the CCTA arm, there were 10,315 patients, and in the functional stress testing arm, there were 9777 patients; both CCTA and functional stress testing strategies varied among the 13 trials. Overall mortality and cardiac hospitalization did not differ between CCTA and functional stress testing groups. There were fewer cases of MI in the CCTA group than in the functional stress testing group; however, the incidence of ICA and revascularization were higher in the CCTA group. CCTA was associated with an increase in new diagnoses of CAD as well as increased prescription of aspirin and statin therapy. All trials reported a lack of blinding, both of patients and personnel, and overall quality of evidence was moderate, despite a high risk of bias in several studies included. Additional limitations included the lack of available patient-level data, the absence of assessment of time to hospital discharge, and differences in radiation exposure.
January 2020 Update
A literature search was conducted through December 2019. There was no new information identified that would prompt a change in the coverage statement.
November 2020 Update
A literature search was conducted through October 2019. Following is a summary of the new literature to date.
Coronary CT Angiography and FFR
Nørgaard et al (2017) reported on results from symptomatic patients referred for CCTA at a single-center in Denmark from May 2014 to April 2015. All data were obtained from medical records and registries; the study was described as a "review" of diagnostic evaluations and was apparently retrospectively conducted. Follow-up through 6 to 18 months was ascertained. From 1248 referred patients, 1173 underwent CCTA; 858 received medical therapy, 82 underwent ICA, 44 MPI, and 189 FFR-CT (185 [98%] obtained successfully). Of the 185 individuals who successfully obtained FFR-CT, FFR-CT demonstrated values of 0.80 or less in 1 or more vessels in 57 (31%) patients, and 49 (86%) went on to ICA; whereas of the 128 with higher FFR-CT values, only 5 (4%) went on to ICA. Assuming ICA was planned for all patients undergoing FFR-CT, these results are consistent with FFR-CT being able to decrease the rate of ICA. However, implications are limited by the retrospective design, performance at a singlecenter, and lack of a comparator arm including one for CCTA alone. Lu et al (2017) Retrospective Cohort
Lu et al (2017) retrospectively examined a subgroup referred to ICA48, from the completed PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial. PROMISE was a pragmatic trial comparing CCTA with functional testing for the initial evaluation of patients with suspected SIHD. Of 550 participants referred to ICA within 90 days, 279 were not considered for the analyses due to CCTA performed without nitroglycerin (n=139), CCTA not meeting slice thickness guidelines (n=90), or nondiagnostic studies (n=50). Of the remaining 271 patients, 90 scans were inadequate to obtain FFR-CT, leaving 181 (33%) of those referred to ICA for analysis. Compared with those excluded, patients in the analytic sample were less often obese, hypertensive, diabetic, minority, or reported a CAD equivalent symptom. The two 2 groups had similar pretest probabilities of disease, revascularization rates, and MACE, but the distribution of stenoses in the analytic sample tended to be milder (p=0.06). FFR-CT studies were performed in a blinded manner and not available during the conduct of PROMISE for decision making.
Severe stenosis (> or = 70%) or left main disease (> or = 50%) were present in 110 (66%) patients by CCTA result and in 54% by ICA. Over a 29-month median follow-up, MACE (death, nonfatal MI, hospitalization for unstable angina) or revascularization occurred in 51% of patients (9% MACE, 49% revascularization). A majority (72%) of the sample had at least 1 vessel with an FFR-CT of 0.80 or less, which was also associated with a higher risk of revascularization but with a wide CI (hazard ratio=5.1; 95% CI, 2.6 to 11.5). If reserved for patients with an FFR-CT of 0.80 or less, ICAs might have been avoided in 50 patients (ie, reduced by 28%) and the rate of ICA without 50% or more stenosis from 27% (calculated 95% CI, 21% to 34%) to 15% (calculated 95% CI, 10% to 23%). If the 90 patients whose images were sent for FFR-CT but were unsatisfactory proceeded to ICA—as would have occurred in practice—the rate of ICA might have decreased by 18% and ICA without significant stenosis from 31% to 25%.
The authors suggested that when CCTA is used as the initial evaluation for patients with suspected SIHD, adding FFR-CT could have decreased the referral rate to ICA in PROMISE from 12.2% to 9.5%, or close to the 8.1% rate observed in the PROMISE functional testing arm. They also noted the similarity of their findings to PLATFORM and concluded, "In this hypothesis-generating study of patients with stable chest pain referred to ICA after [C]CTA, we found that adding FFRCT may improve the efficiency of referral to ICA, addressing a major concern of an anatomic [C]CTA strategy. FFRCT has incremental value over anatomic [C]CTA in predicting revascularization or major adverse cardiovascular events."
This retrospective observational subgroup analysis from PROMISE would suggest that when CCTA is the initial noninvasive test for the evaluation of suspected SIHD, FFRCT before ICA has the potential to reduce unnecessary ICAs and increase the diagnostic yield. However, study limitations and potential generalizability are important to consider. First, analyses included only a third of CCTA patients referred to ICA, and some characteristics of the excluded group differed from the analytic sample. Second, conclusions assume that an FFR-CT greater than 0.80 will always dissuade a physician from recommending ICA and even in the presence of severe stenosis (eg, ≥70% in any vessel or ≥50% in the left main), or almost half (46%) of patients with an FFR-CT greater than 0.80. Finally, estimates including patients with either nondiagnostic CCTA studies (n=50) or studies inadequate for calculating FFR-CT (n=90) are more appropriate because in practice most likely those patients would most likely proceed in practice to ICA. Accordingly, the estimates are appropriately considered upper bounds for what might be seen in practice. It is also important to note that in strata of the PLATFORM trial enrolling patients for initial noninvasive testing (not planned ICA), ICA was more common following CCTA and contingent FFR-CT than following usual care (18.3% vs. 12.0%) and ICA, with no obstructive disease more frequent in the FFR-CT arm (12.5% vs. 6.0%).
Newby et al on behalf of the SCOT-HEART Investigators (2018) published the results of an open-label, multicenter, parallel-group trial (NCT01149590) that studied and reported 5-year clinical outcomes from patients with stable chest pain who used CTA in the diagnosis and assessment of their condition. In this trial, 4146 patients with stable chest pain who had been referred to a cardiology clinic for evaluation were randomly assigned to standard care plus CTA (2073 patients) or to standard care alone (2073 patients). Investigations, treatments, and clinical outcomes were assessed over 3 to 7 years of follow-up. The primary end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years. The 5-year rate of the primary end point was lower in the CTA group than in the standard-care group (2.3% [48 patients] vs. 3.9% [81 patients]; hazard ratio, 0.59; 95% confidence interval [CI], 0.41 to 0.84; P=0.004). Although the rates of invasive coronary angiography and coronary revascularization were higher in the CTA group than in the standard-care group in the first few months of follow-up, overall rates were similar at 5 years. more preventive therapies were initiated in patients in the CTA group. There were no significant differences in death rate between the two groups (cardiovascular, non-cardiovascular, or deaths from any cause). The researchers concluded that the use of CTA in addition to standard-care versus standard-care alone resulted in a significantly lower rate of death from coronary heart disease or nonfatal myocardial infarction at 5 years in patients with stable chest pain. Also, the addition of CTA did not increase invasive interventions (coronary angiography or coronary revascularization) over the 5-year follow up.
CT Coronary Calcium Scoring
In 2017, Ferencik et al evaluated whether the distribution of CAC in individual coronary arteries and segments, as well as CAC in the proximal dominant coronary artery, as detected by cardiac CT predicts incident major CHD events independent of traditional CAC score in 1268 asymptomatic subjects without prevalent major CHD from the offspring and third generation cohorts of the Framingham Heart Study (Ferencik, 2017). Results revealed a total of 42 major CHD events occurring during a median follow-up period of 7.4 years. Both the number of coronary arteries with CAC (hazard ratio [HR], 1.68 per artery, 95% CI, 1.10 to 2.57; p=0.02) and the presence of CAC in the proximal dominant coronary artery (HR, 2.59; 95% CI, 1.15 to 5.83; p=0.02) were associated with major CHD events after multivariable adjustment.
Erbel et al (2010) assessed NRI and risk prediction based on CAC scoring in comparison with traditional risk factors in 4129 subjects without overt CAD at baseline in the Heinz Nixdorf Recall study (Erbel, 2010). Results revealed that 93 coronary deaths and nonfatal MIs occurred after 5 years of follow-up (cumulative risk 2.3%; 95% CI, 1.8% to 2.8%). Reclassifying intermediate risk subjects with CAC <100 to the low risk category and with CAC ≥400 to the high-risk category yielded a NRI of 21.7% (p=0.0002) and 30.6% (p<0.0001) for the FRS, respectively. Adding CAC scores to the FRS and National Cholesterol Education Panel ATP III categories improved the AUC from 0.681 to 0.749 (p<0.003) and from 0.653 to 0.755 (p=0.001), respectively. The authors concluded that limiting CAC scoring to intermediate risk subjects assists in correctly identifying a high proportion of individuals at highest risk and may contribute to reducing the number of coronary events in the general population; however, clinicians need to be aware that this may not be applicable across the board, particularly for patients in a low risk category. In 2018, Lehmann et al published additional 10-year follow-up data from Heinz Nixdorf and concluded that CAC progression is associated with coronary and CV event rates, but only weakly adds to risk prediction (Lehmann, 2018). The authors stated that what counts is the most recent CAC value and risk factor assessment.
Gupta et al performed a systematic review and meta-analysis evaluating the odds of initiating or continuing pharmacological (ie, aspirin, lipid-lowering, and blood pressure lowering medications) and lifestyle preventive therapies in asymptomatic CAD patients with nonzero versus 0 CAC scores as detected on cardiac CT (Gupta, 2017). Results revealed that the odds of aspirin, lipid-lowering, and blood pressure lowering medication initiation, lipid-lowering medication continuation, an increase in exercise, and dietary changes were significantly higher in patients with nonzero CAC versus 0 CAC scores. However, the odds of aspirin or blood pressure-lowering medication continuation were not significantly increased in the nonzero CAC group. Statistical heterogeneity was present across studies for many of the outcomes; potential sources of heterogeneity included variations in sample size and the proportion of patients with 0 versus nonzero CAC, whether patients were shown their CAC scan, and differences in clinical characteristics of study populations.
The American College of Cardiology and American Heart Association (2019) Guideline on the Primary Prevention of Cardiovascular Disease is in line with the blood cholesterol guideline stating that adults (40 to 75 years of age) who are being evaluated for cardiovascular disease prevention should initially undergo 10-year atherosclerotic cardiovascular disease (ASCVD) risk estimation with a clinician-patient risk discussion before starting pharmacological therapy (Arnett, 2019). The guideline also notes that assessing for other risk-enhancing factors can help guide decision making "about preventive interventions in select individuals, as can CAC scanning." The guideline specifically states the following recommendation regarding assessment of cardiovascular risk and CAC:
In adults at intermediate risk (≥7.5% to < 20% 10-year ASCVD risk) or selected adults at borderline risk (5% to <7.5% 10-year ASCVD risk), if risk-based decisions for preventive interventions remain uncertain, it is reasonable to measure a CAC score to guide clinician-patient risk discussion [Class (Strength) of Recommendation: IIa; Level (Quality) of Evidence: B-NR]. A IIa class of recommendation is of moderate strength based on moderate quality nonrandomized studies.
Kong et al (2015) published a study that evaluated the utility of preoperative coronary calcium
scores for predicting early postoperative cardiovascular complications in liver transplant recipients. This was an observational study that retrospectively analyzed the outcomes of 443 liver transplant recipients between 2010 and 2012. Preoperative CV assessments, including coronary CT, were performed. A positive finding was defined as a coronary calcium score of > 400. Other predictive factors of early postoperative cardiovascular complications were also evaluated. Major cardiovascular complications occurring during a period of 1 month after transplant were noted. Of the 443 patients, 38 (8.6%) experienced one or more cardiovascular complications. Positive coronary CT findings were seen in 11 (2.5%) patients. The authors concluded that A preoperative coronary calcium score of >400 predicted cardiovascular complications occurring 1 month after LT, suggesting that preoperative evaluation of coronary calcium scores could help predict early postoperative cardiovascular complications in liver transplant recipients. Kong et al (2015b) also published a retrospective observational study that evaluated the incidence and cardiovascular risk factors of a coronary calcium score >400 in 548 liver transplant recipients between 2013-2014 that found similar conclusions.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Cainzos-Achirica et al assessed whether use of CAC improved appropriate aspirin use for primary prevention compared with other risk calculators (Cainzos-Achirica, 2020). In multivariable regression analysis, a CAC score ≥100 was independently associated with an increased risk of CVD events compared with those with a CAC score of 0 (hazard ratio [HR], 3.9; 95% CI, 2.5 to 6.1]. The pooled cohort equations and an estimated cardiovascular risk threshold of >20% failed to identify optimal candidates for aspirin; however, a CAC score of at least 100 was able to identify subgroups of patients where aspirin would yield benefit.
2021 Update
A literature search was conducted through September 2021. Following is a summary of the new literature to date.
In 2020, the ACC/AHA published a Guideline for the Management of Patients With Valvular Heart Disease with recommendations for the diagnosis and management of valvular heart disease (Otto et al, 2021). ACC/AHA made the following recommendations related to evaluation of a patient with valvular heart disease:
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.
CCTA for CAD
In 2022, SCCT published an expert consensus document on use of CCTA for patients presenting to the emergency department with acute chest pain (Maroules et al, 2022). Relevant recommendations from the consensus document are listed below.
CCTA with Selective Noninvasive FFR
An et al (2023) conducted a meta-analysis of machine learning-based methods of determining fractional flow reserve compared to invasive methods. A total of 13 studies in patients with suspected or confirmed CAD were combined for the analysis. Characteristics of the studies were not provided, including the potential for bias, but the authors stated that none of the studies were "large sample size diagnostic performance studies". Machine learning fractional flow reserve had a lower sensitivity and higher specificity than invasive fractional flow determination (0.80 vs. 0.87; p<.01 and 0.86 vs. 0.35; p<.01, respectively). Heterogeneity for all assessments was high (I2, 57.12% to94.52%) and the authors noted that machine learning methods differed among studies.
Wang et al (2019) conducted a single-center prospective cohort study of the diagnostic accuracy of the Deep Vessel FFR platform. In 63patients who underwent CCTA, the deep learning software was compared to wire-based (invasive) FFR. Deep Vessel FFR had a higher diagnostic performance as assessed by area under the receiver-operation characteristics curve (0.928) compared to wire-based FFR (0.664).Deep Vessel FFR had a sensitivity, specificity, positive predictive value, and negative predictive value of 97.14%, 75%, 82.93%, and 95.45%,respectively.
Qiao et al (2022) conducted a prospective, single-center, nonrandomized cohort study in patients with suspected CAD. Patients received either CCTA alone (n=567) or fractional flow reserve measurement using CCTA (n=566). The primary outcome of interest, ICA that showed nonobstructive disease at 90 days, occurred in 33.3% of the CCTA alone group and 19.8% of the fractional flow reserve group (risk difference, 13.5%; 95% CI, 8.4% to 18.6%; p=.03). ICA was utilized more frequently in the CCTA alone group than the fractional flow reserve group (27.5% vs. 20.3%; p=.003). At 1 year, MACE was more common in the CCTA alone group compared to the fractional flow reserve group (6.7% vs. 3.9%; hazard ratio [HR], 1.73; 95% CI, 1.01 to 2.95; p=.04).
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