Medical Policy

 

Subject: Intravascular Optical Coherence Tomography (OCT)
Document #: RAD.00062 Publish Date:    12/27/2017
Status: Reviewed Last Review Date:    11/02/2017

Description/Scope

This document addresses the use of intravascular optical coherence tomography (OCT), a high resolution catheter-based imaging modality, intended to optimize visualization of coronary artery lesions. Intravascular OCT may also be referred to as OCT or intracoronary OCT.

Note: Please see the following document for additional information:

Position Statement

Investigational and Not Medically Necessary:

Intravascular optical coherence tomography (OCT) is considered investigational and not medically necessary for all indications including, but not limited to the assessment, treatment and follow-up of coronary disease.

Rationale

Potential applications of intravascular OCT identified in the published literature include:

Coronary Artery Lesion Assessment

There are multiple published studies assessing intravascular OCT for the evaluation of coronary artery vulnerable plaque, a number of which compare intravascular OCT to intravascular ultrasound (IVUS). In an early investigation, Jang and colleagues (2002) compared the findings of 42 coronary plaques in 10 individuals who underwent angiography, IVUS and intravascular OCT. Intravascular OCT had higher axial resolution compared to IVUS (13 microns vs. 98 microns). All of the fibrous plaques, microcalcifications and echolucent areas identified by IVUS were also imaged by intravascular OCT. There were additional cases of echolucent regions and intimal hyperplasia that were imaged with intravascular OCT but not seen with IVUS. The authors recommended additional clinical trials to support their findings.

Jang and colleagues (2005) studied intravascular OCT in individuals undergoing cardiac catheterization for acute and stable coronary syndromes for the evaluation of vulnerable plaques. Of 69 individuals enrolled, 57 had images that could be analyzed. Two observers independently examined the images using previously validated criteria for characterization of coronary plaque. Lipid-rich plaque (defined as lipid occupying two or more quadrants of the cross-sectional area) was observed in 90% of individuals with recent acute myocardial infarction (MI), 75% in those with non-ST-elevation MI or unstable angina, and in 59% with stable angina. Interference from blood and poor tissue penetration were reported as limitations of intravascular OCT.

Raffel and colleagues (2008) evaluated the in vivo association between coronary artery remodeling and underlying plaque characteristics identified by intravascular OCT. Coronary artery remodeling ranges from outward expansion (positive remodeling) to vessel shrinkage (negative remodeling). Intravascular OCT and IVUS were both performed in individuals undergoing cardiac catheterization. Originally, there were 69 lesions or areas of plaque with both IVUS and intravascular OCT data, but 15 were excluded from the analysis due to OCT signal attenuation which occurred as a result of poor blood clearing or a large burden of thrombus. A total of 54 lesions from 48 individuals were subject to final analysis in this study. Positive remodeling, compared with absent or negative remodeling, was more frequently associated with lipid-rich plaque (100% vs. 60% vs. 47.4%, respectively; p=0.01), a thin fibrous cap (median=40.2 vs. 51.6 vs. 87 microns, respectively; p=0.003) and the occurrence of thin-cap fibroatheroma (80% vs. 38.5% vs. 5.6%, respectively; p<0.001). Coronary plaques with positive remodeling appeared to exhibit the characteristic features of vulnerable plaque. Study limitations included potential selection bias, blood interference, limited penetration depth (2-3 millimeters [mm]), and the small size of the cohort. The authors noted that owing to the size and single time-point assessment of this study, prospective longitudinal studies with a larger cohort are needed to confirm these findings over time and to investigate their clinical significance.

Kubo and colleagues (2011) compared intravascular OCT and IVUS for identifying and classifying vulnerable plaques. A total of 96 target lesions were examined by both intravascular OCT and IVUS, and the presence of a vulnerable plaque was made using standard definitions for each procedure. Intravascular OCT identified 18 vulnerable plaques as evidenced by thin fibrous caps of less than 65 micrometers (μm). IVUS identified 16/18 vulnerable plaques, for a sensitivity of 89% compared to OCT. IVUS also identified an additional 11 lesions as vulnerable that did not meet the criteria by OCT. These were assumed to be false positive IVUS results, resulting in a specificity for IVUS of 86%. The positive and negative predictive values for IVUS were 59% and 97% respectively. A significant study limitation reported was that this was an in vivo validation study and a direct comparison between IVUS, intravascular OCT, and histopathology was required to confirm data. In addition, the authors noted selection bias and the exclusion of extremely tortuous vessels with heavy calcification. Prospective studies to investigate the prognostic values of these findings are needed.

Miyamoto and colleagues (2011) studied 81 coronary lesions with a plaque burden of greater than 40%. IVUS and intravascular OCT gave somewhat different profiles of plaque characteristics. Vulnerable plaques identified by intravascular OCT had a larger plaque burden, more positive remodeling, and less fibrous plaque compared with IVUS. Study limitations reported by the authors included a relatively small sample size and OCT image artifacts may have caused some misinterpretations. Furthermore, only limited vessel areas were observed due to system limitations for imaging certain complex lesions.

Uemura and colleagues (2011) published a prospective cohort study that evaluated the ability of intravascular OCT to predict the natural history of coronary plaques. A total of 53 participants, with 69 non-obstructing coronary plaques, who had undergone both PCI and intravascular OCT were enrolled. A second coronary angiogram was performed at a mean follow-up of 7 months to assess progression of plaques. There were 13/69 lesions (18.8%) that showed progression on angiography at follow-up. There were several plaque characteristics defined by intravascular OCT that were predictive of progression, while the luminal diameter of the stenoses was not predictive. The factors that were found more frequently in lesions that progressed were intimal laceration (61.5% vs. 8.9%, p<0.01), microchannel images (76.9% vs. 14.3%, p<0.01), lipid pools (100% vs. 60.7%, p=0.02), thin-cap fibroatheroma (76.9% vs. 14.3%, p<0.01), macrophage images (61.5% vs. 14.3%, p<0.01), and intraluminal thrombi (30.8% vs. 1.8%, p<0.01). On regression analysis, the presence of fine-cap atheroma and microchannel images were strong predictors of progression (odds ratio [OR]: 20.0, p<0.01; OR: 20.0, p<0.01, respectively). Limitations of this study included a small sample size, the limited penetration depth of intravascular OCT making it difficult to assess plaque features deep in coronary artery walls, and the technical complexity of procedures needed to get high-quality OCT images. Furthermore, the authors noted, it could not be completely ruled out that image wire and occlusion balloon may have injured the vessel contributing to subsequent plaque progression.

Jia and colleagues (2013) investigated morphological features of plaque erosion and calcified nodules by OCT examination in individuals with acute coronary syndrome (ACS). Study participants were selected from a multicenter registry of persons with ACS who had pre-intervention OCT lesion imaging. Of 206 individuals with ACS, 126 were included in the study. Cases were excluded with a history of pre-dilation, previous stent implantation in the culprit vessel, left main (LM) disease, massive thrombus and poor image quality. Lesions studied were classified as plaque rupture (PR), erosion (OCT-erosion), calcified nodule (OCT-CN), or with a new diagnostic OCT criteria set. The incidences of PR, OCT-erosion, and OCT-CN were: 43.7%, 31.0%, and 7.9%, respectively. Subjects with OCT-erosion were the youngest, as compared to those with PR and OCT-CN. Presentation with non–ST-segment elevation ACS was more common in subjects with OCT-erosion compared to those with PR. The OCT-erosion had a lower frequency of lipid plaque, thicker fibrous cap, and smaller lipid arc, than PR. The diameter stenosis was least severe in OCT-erosion, followed by OCT-CN and PR. The authors concluded that OCT is a promising modality for in vivo diagnosis of PR, OCT-erosion, and OCT-CN. Study limitations included a small cohort with ACS that was highly selective based on an ability to perform OCT imaging. Additionally, plaque erosion and calcified nodules detected by OCT were not validated by pathology.

D’Ascenzo and colleagues (2015) performed a systematic review to evaluate the accuracy of OCT and intravascular ultrasound in identifying functionally significant coronary stenosis according to vessel diameter. A total of 15 studies were included based on the following criterion: evaluating accuracy of IVUS/OCT for lesion significance based on fractional flow reserve (FFR). Exclusion criteria included duplicate publication and absence of relationship between functional evaluation and imaging. Of the 15 studies, there were 2 with 110 subjects analyzing left main artery disease (LM), 5 with 224 subjects and 306 lesions using OCT, and 9 with 1532 subjects and 1681 lesions using IVUS. Primary findings were:

Based on their meta-analysis of OCT, the authors reported that neither MLA nor minimal luminal diameter (MLD) had adequate sensitivity or specificity to confidently guide decisions for revascularization. The authors stated “no recommendation should be given about OCT dimension and need for revascularization without a functional assessment.” There were multiple study limitations including significant interobserver variability even among experienced operators, the retrospective nature, lack of consistent cut-points predictive of FFR and the potential for underlying publication bias.

Treatment as an Adjunct to PCI

Multiple studies have compared IVUS to intravascular OCT as an adjunct to PCI. Yamaguchi and colleagues (2008) studied 76 individuals from eight medical centers who were undergoing angiography and possible PCI. Both IVUS and OCT were performed in a single target lesion selected for a native coronary artery with a visible plaque that is less than 99% of lumen diameter. Procedural success was 97.3% for OCT compared to 94.5% for IVUS. There were 5 cases in which the smaller OCT catheter could cross a tight stenosis where the IVUS catheter could not. There were no deaths or major complications of the procedures. MLD was highly correlated between the two modalities (r=0.91, p<0.0001). Visibility of the lumen border was superior with OCT, with poor visibility reported for 6.1% of OCT images compared to 17.3% by IVUS (p<0.0001). Significant study limitations included a small sample size, and the study was not designed to evaluate potential advantages of intravascular OCT over IVUS resulting from an increase in resolution. The authors recommended further analysis and noted that larger sample sizes are needed to establish and refine clinical application and safety of the intravascular OCT imaging system.

Kawamori and colleagues (2010) reported on 18 individuals who underwent stenting and had both intravascular OCT and IVUS performed. The lumen area of the culprit vessel was smaller on OCT images compared to IVUS. OCT was more sensitive in identifying instances of stent malapposition compared to IVUS (30% vs. 5%, p=0.04). OCT also picked up a greater number of cases with stent edge dissection (10% vs. 0%) and with stent thrombosis (15% vs. 5%). These results were interpreted as demonstrating the higher resolution and greater detail obtained with OCT compared with IVUS. Several study limitations reported included that this was a non-randomized retrospective study based on a limited sample size, potential selection bias and a limited ability to visualize certain lesions due to risks associated with producing a blood-free environment by occlusion balloon. Also, severely calcified tortuous vessels could not be imaged with OCT due to difficulty in passing the occlusion balloon through the lesion.

Prati and colleagues (2012) studied angiography alone versus angiography plus OCT in a matched comparison. A total of 335 individuals were treated with OCT as an adjunct to angiography and PCI, and were matched with 335 individuals undergoing PCI without adjunct OCT. The primary endpoint was the 1-year rate of cardiac death or MI. In 34.7% of cases in the OCT group, additional findings on OCT led to changes in management. Those in the OCT group had a lower rate of death or MI at 1 year, even following multivariate analysis with propensity matching (OR: 0.49, 95% confidence interval [CI], 0.25-0.96; p=0.037). Study limitations included lack of randomization.

Maehara and colleagues (2015) examined two studies, the ILUMIEN (Observational Study of OCT in Patients Undergoing FFR) (n=354) and the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) (n=586). The purpose of the study was to determine whether OCT guidance results in a degree of stent expansion comparable to IVUS guidance. Stent expansion was examined in all 940 subjects in a covariate-adjusted analysis as well as in 286 propensity-matched pairs (total n=572). Study analysis showed that in the matched-pair analysis, the degree of stent expansion was not significantly different between OCT and IVUS guidance (median [first, third quartiles] = 72.8% [63.3, 81.3] vs. 70.6% [62.3, 78.8], respectively, p=0.29). Similarly, after adjustment for baseline differences in the entire population, the degree of stent expansion was also not different between the two imaging modalities (p=0.84). Although a higher prevalence of post-PCI stent malapposition, tissue protrusion, and edge dissections was detected by OCT, the rates of major malapposition, tissue protrusion, and dissections were similar after both OCT and IVUS guided stenting. The authors concluded that OCT and IVUS guidance resulted in a comparable degree of stent expansion and that randomized trials are warranted to compare the outcomes of OCT- and IVUS-guided coronary stent implantation.

In the multicenter, randomized DOCTORS study, Meneveau and colleagues (2016) compared OCT with angiography for stent placement. A total of 240 participants, who had non-ST-segment elevation acute coronary syndromes, were randomized to an OCT-guided group (n=120) or an angiography-guided group (n=120). FFR, the primary endpoint, was statistically higher (p=0.005) for the OCT group (0.94 ± 0.04) than the angiography group (0.92 ± 0.05). In addition, FFR > 0.90 was significantly higher for the OCT group (p=0.0001). Due to stent expansion optimization, OCT enabled providers to improve overall strategy for 50% of the group compared to 22.5% of the angiography group (p<0.0001). There were no significant differences in adverse events between both groups (p=0.28); however, the OCT group received a significantly higher volume of contrast medium and radiation (p<0.0001). Also, for 32 participants in the OCT group, predilation was necessary to overcome subtotal occlusion of the artery. Limitations of the study included potential bias due to open-label design, differences in local practice methods, and the possibility that residual disease could have affected the FFR value.

Ali and colleagues (2016) conducted the ILUMIEN III: OPTIMIZE PCI, an industry-supported, multicenter, randomized controlled study that compared stent placement using OCT, IVUS, or angiography. A total of 450 subjects received a metallic drug-eluting stent during OCT-guided PCI (n=158), IVUS-guided PCI (n=146), or angiography-guided PCI (n=146). Participants included in the study had stable or unstable angina, silent ischemia, non-ST-segment elevation MI, or recent ST-segment elevation MI. For the OCT group, researchers devised a stent optimization algorithm to determine stent size, thus compensating for OCT’s low-depth penetration in lipid-rich lesions. The minimum stent area, which was the primary outcome, was 5.79 mm2 (interquartile range [IQR] 4.54-7.34) in the OCT group, 5.89 mm2 (IQR 4.67-7.80) in the IVUS group, and 5.49 mm2 (IQR 4.39-6.59) in the angiography group. The researchers concluded that OCT was noninferior (p=0.001) and not superior (p=0.42) to IVUS. In addition, OCT was not superior to angiography (p=0.12). Adverse events were low and not significantly different between the groups (OCT vs. IVUS, p=0.69; OCT vs. angiography, p=0.38). OCT showed promising advantages including better stent expansion and the ability to detect dissections, malapposition and tissue protrusion. Limitations of the study included a lack of standardization for IVUS, exclusion of bioresorbable scaffolds, and a non-inferiority margin of 1.0 mm2.

Follow-up Evaluation(s) Post-Stent Placement

Intravascular OCT has been used as a research tool in studies of coronary stenting to evaluate the degree of neoendothelial coverage of the stent within the first year of placement. Stent coverage has been shown to be predictive of clinical outcomes for those undergoing stenting.

There are several small studies which evaluate the clinical utility of intravascular OCT for follow-up evaluation post-stenting. Capodanno and colleagues (2009) compared OCT with IVUS for stent evaluation in 20 individuals who had stent implantation 6 months prior. Parameters that were compared include stent length, vessel luminal area, stent area, and the percent of stent coverage with neoendothelial cells. The measurement of stent length was similar between IVUS and OCT (16.3 ± 3.0 mm vs. 16.2 ± 3.8 mm, p=0.82). However, the other measured parameters differed between groups. Vessel luminal area was significantly lower by OCT compared to IVUS (3.83 ± 1.60 mm2 vs. 4.05 ± 1.44 mm2, p=0.82), while stent area was significantly higher with OCT (6.61 mm2 ± 1.39 vs. 6.17 ± 1.07 mm2, p<0.001). The percentage of tissue coverage was also higher with OCT (43.4 ± 16.1% vs. 35.5 ± 16.4%), suggesting that IVUS underestimates stent coverage compared with OCT.

Inoue and colleagues (2011) used OCT to evaluate 25 individuals who had previously undergone PCI with drug-eluting stents. Intravascular OCT was performed at a mean of 236 ± 39 days post PCI. OCT identified neointimal coverage of the stent in 98.4% of cases. In 0.52% of cases there was evidence of stent malapposition and a lack of neointimal coverage. Full neointimal coverage was evident in 37% of stents. In 7.2% of those studied, there was evidence of a low-intensity area surrounding the struts, which is thought to be indicative of abnormal neointimal maturation. There were no intra-stent thrombi identified and no major complications of the procedure.

Both studies noted above, which assessed intravascular OCT for follow-up evaluation post-stenting, were limited by small sample size.

Other Considerations

In 2011, the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions (ACCF/AHA/SCAI) issued a guideline for percutaneous coronary intervention. The guideline indicates that OCT may be of value in clinical research; however, its role in clinical decision making has yet to be established. The ACCF/AHA/SCAI document includes the following statement:

Compared with IVUS, optical coherence tomography has greater resolution (10 to 20 micronmeter axially) but more limited depth of imaging (1 to 1.5 mm). Unlike IVUS, optical coherence tomography requires that the artery be perfused with saline solution or crystalloid during image acquisition and therefore does not permit imaging of ostial lesions. Clinical studies have shown low optical coherence tomography complication rates, similar to those of IVUS. The excellent resolution of optical coherence tomography permits detailed in vivo 2-dimensional imaging of plaque morphological characteristics (e.g., calcification, lipid, thrombus, fibrous cap thickness, and plaque ulceration or rupture) and evaluation of the arterial response to stent implantation (e.g., stent strut neointimal thickness and apposition) and may be of value in clinical research. The appropriate role for optical coherence tomography in routine clinical decision making has not been established.

A consensus report on standardization and validation of techniques and reporting for OCT was published in 2012 by the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. This document provided guidance on the following areas that are important to the use of OCT in both research and clinical care:

The Society of Cardiovascular Angiography and Interventions (Lofti, 2014) published an expert consensus statement on the use of FFR, IVUS, and OCT, and made the following statements regarding the benefit of OCT:

Conclusion

Currently, there is a lack of sufficient data supporting a predictive role for intravascular OCT for the assessment of cardiovascular risk, catheter-based interventions, or follow-up evaluations. Although preliminary findings may appear promising, intravascular OCT has not been sufficiently validated and lacks an established role in clinical decision making.

Background/Overview

There have been numerous comparisons made between intravascular OCT and IVUS with important similarities and differences noted between the two. Intravascular OCT utilizes infrared light waves that reflect off the internal microstructure within the biological tissues, while IVUS utilizes acoustic waves for imaging. Compared to the conventional IVUS, intravascular OCT is reported to have a ten-fold higher image resolution. OCT generates cross-sectional images by using the time delay and intensity of light reflected from internal tissue structures (Prati, 2010). Near-infrared light at approximately 1300 nanometers (nm) wavelength is emitted by OCT and images are formed by the detection of backscattered light (Johnson, 2014). The main obstacle to OCT is the difficulty of imaging through blood, necessitating saline flushes or occlusion techniques to obtain images. Frequency-domain OCT is a newer generation device that partially alleviates this problem by allowing faster scanning and less need for blood clearing.

One goal of intravascular OCT has been risk stratification of vulnerable plaque regarding their risk of rupture. Coronary artery plaque is a deposit consisting of cholesterol-rich fat, calcium, and other substances found in the blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots which can lead to a heart attack. Vulnerable plaque is coronary artery plaque that is unstable and at high risk of rupturing, thereby causing a clinical cardiovascular event.

Other goals of intravascular imaging are as an adjunct to PCI with stent placement and for follow-up evaluations post stent placement. Stent features that are often evaluated immediately post-procedure include the position of the stent, apposition of the struts to the vessel wall, and presence of thrombus or intimal flaps. Subsequent follow-up intravascular imaging at several months to 1 year post-stenting has been used to evaluate neoendothelialization on the endoluminal surface of the stent.

There are several U.S. Food and Drug Administration (FDA) approved intravascular OCT systems available. LightLab Imaging, Inc. (Westford, MA) received 510(k) clearance in April 2010 for the C7 XrTM Imaging System and in August 2011 for its next generation frequency domain C7 XrTM Imaging System. Additional systems include the ILUMIENTM OPTISTM PCI Optimization System, the OPTISTM Integrated System Mobile Workstation, and the OPTISTM Mobile System (St. Jude Medical, Inc., St. Paul, MN).

Definitions

Fibroatheroma: Lipid rich plaque suspected to be a type of vulnerable plaque.

Intimal: Pertains to the inner layer of a blood vessel.

Lipid: A fatty substance in the blood.

Vulnerable plaque: Coronary artery plaque that is unstable and at high risk of rupturing, thereby causing a clinical cardiovascular event.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

92978

Endoluminal imaging of coronary vessel or graft using intravascular ultrasound (IVUS) or optical coherence tomography during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report; initial vessel [when specified as OCT; add-on]

92979

Endoluminal imaging of coronary vessel or graft using intravascular ultrasound (IVUS) or optical coherence tomography during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report; each additional vessel [when specified as OCT; add-on]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Ali ZA, Maehara A, Généreux P, et al. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016; 388(10060):2618-2628.
  2. Ben-Dor I, Mahmoudi M, Pichard AD, et al. Optical coherence tomography: a new imaging modality for plaque characterization and stent implantation. J Interv Cardiol. 2011; 24(2):184-192.
  3. Capodanno D, Prati F, Pawlowsky T, et al. Comparison of optical coherence tomography and intravascular ultrasound for the assessment of in-stent tissue coverage after stent implantation. EuroIntervention. 2009; 5(5):538-543.
  4. D'Ascenzo F, Barbero U, Cerrato E, et al. Accuracy of intravascular ultrasound and optical coherence tomography in identifying functionally significant coronary stenosis according to vessel diameter: a meta-analysis of 2,581 patients and 2,807 lesions. Am Heart J. 2015; 169(5):663-673.
  5. Inoue T, Shite J, Yoon J, et al. Optical coherence evaluation  of everolimus-eluting stents 8 months after implantation. Heart. 2011; 97(17):1379-1384.
  6. Jang IK, Bouma BE, Kang DH et al. Visualization of coronary atherosclerotic plaques in patients using optical coherence tomography: comparison with intravascular ultrasound. J Am Coll Cardiol. 2002; 39(4):604-609.
  7. Jang IK, Tearney GJ, MacNeill B, et al. In vivo characterization of coronary atherosclerotic plaque by use of optical coherence tomography. Circulation. 2005; 111(12):1551-1555.
  8. Jia H, Abtahian F, Aguirre AD, et al. In vivo diagnosis of plaque erosion and calcified nodule in patients with acute coronary syndrome by intravascular optical coherence tomography. J Am Coll Cardiol. 2013; 62(19):1748-1758.
  9. Johnson PM, Patel J, Yeung M, Kaul P. Intra-coronary imaging modalities. Curr Treat Options Cardiovasc Med. 2014; 16(5):304.
  10. Kubo T, Nakamura N, Matsuo Y, et al. Virtual histology intravascular ultrasound compared with optical coherence tomography for identification of thin-cap fibroatheroma. Int Heart J. 2011; 52(3):175-179.
  11. Maehara A, Ben-Yehuda O, Ali Z, et al. Comparison of stent expansion guided by optical coherence tomography versus intravascular ultrasound: the ILUMIEN II Study (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Intervention.  JACC Cardiovasc Interv. 2015; 8(13):1704-1714.
  12. Meneveau N, Souteyrand G, Motreff P, et al. Optical coherence tomography to optimize results of percutaneous coronary intervention in patients with non-ST-elevation acute coronary syndrome: results of the multicenter, randomized DOCTORS study (does optical coherence tomography optimize results of stenting). Circulation. 2016; 134(13):906-917.
  13. Miyamoto Y, Okura H, Kume T, et al. Plaque characteristics of thin-cap fibroatheroma evaluated by OCT and IVUS. JACC Cardiovasc Imaging. 2011; 4(6):638-646.
  14. Prati F, Di Vito L, Biondi-Zoccai G, et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention. 2012; 8(7):823-829.
  15. Prati F, Jenkins MW, Di Giorgio A, Rollins AM. Intracoronary optical coherence tomography, basic theory and image acquisition techniques. Int J Cardiovasc Imaging. 2011; 27(2):251-258.
  16. Prati F, Regar E, Mintz GS, et al. Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J. 2010; 31(4):401-415.
  17. Raffel OC, Merchant FM, Tearney GJ, et al. In vivo association between positive coronary artery remodeling and coronary plaque characteristics assessed by intravascular optical coherence tomography. Eur Heart J. 2008; 29(14):1721-1728.
  18. Regar E, Ligthart J, Bruining N, van Soest G. The diagnostic value of intracoronary optical coherence tomography. Herz. 2011; 36(5):417-429.
  19. Suh WM, Seto AH, Margey RJ, et al. Intravascular detection of the vulnerable plaque. Circ Cardiovasc Imaging. 2011; 4(2):169-178.
  20. Tarkin JM, Dweck MR, Evans NR, et al. Imaging atherosclerosis. Circ Res. 2016; 118(4):750-769.
  21. Uemura S, Ishigami KI, Soeda T, et al. Thin-cap fibroatheroma and microchannel findings in optical coherence tomography correlate with subsequent progression of coronary atheromatous plaques. Eur Heart J. 2012; 33(1):78-85.
  22. Yamaguchi T, Terashima M, Akasaka T, et al. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol 2008; 101(5):562-567.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Levine GN, Bates ER, Blankenship JC, et al. American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011; 58(24):e44-122.
  2. Lotfi A, Jeremias A, Fearon WF, et al. Society of Cardiovascular Angiography and Interventions. Expert consensus statement on the use of fractional flow reserve, intravascular ultrasound, and optical coherence tomography: a consensus statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2014; 83(4):509-418.
  3. Tearney GJ, Regar E, Akasaka, T et al. Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012; 59(12):1058-1072.
  4. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Rockville, MD: FDA. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed on August 24, 2017.
Index

Intracoronary OCT
Intravascular optical coherence tomography (OCT)

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. Rationale, Background/Overview and References sections updated. The document header wording updated from “Current Effective Date” to “Publish Date.”

Reviewed

11/03/2016

MPTAC review. Rationale and References sections updated. Updated Coding section with 01/01/2017 CPT changes.

Reviewed

11/05/2015

MPTAC review. Rationale and Reference sections updated. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Description, Rationale and Reference sections updated.

Reviewed

11/14/2013

MPTAC review. Rationale, Background and Reference sections updated.

Reviewed

11/08/2012

MPTAC review. Rationale, Background and Reference sections updated.

New

11/17/2011

MPTAC initial document development.