National Medical Policy

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1 National Medical Policy Subject: Policy Number: Three Dimensional (3D) Cardiac Echocardiography NMP289 Effective Date*: July 2006 Updated: April 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* X Other Medicare Fee Schedule, Payment and Reimbursement Benefit Guideline. CPT 76376, D Interpretation and Reporting of Imaging Studies - covered DX: t.com/2011/04/cpt dinterpretation-and.html None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Three D Echocardiography April 16 1

2 Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. may consider three-dimensional (3-D) echocardiography medically necessary, on an exceptional case by case basis, for surgical treatment planning of a complex surgical cardiac procedure, when the information produced from the 3D echocardiogram cannot be provided by a traditional 2D echocardiogram, or other testing (e.g. magnetic resonance imaging of the heart, Doppler study, ultrasound) Health Net, Inc considers three-dimensional (3-D) echocardiography investigational for all other indications as its use for clinical diagnosis and treatment has yet to be validated in well-designed studies comparing it with its competing technology. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures Have been replaced by ICD-10 code sets. ICD-9 Codes (List is not all inclusive) Ventricular septal defect Ostium secundum type atrial septal defect Unspecified anomaly of the heart ICD-10 Codes Q21.0 Ventricular septal defect Q21.1 Atrial septal defect Q20.9 Congenital malformation of cardiac chambers and connections, unspecified Q24.9 Congenital malformation of heart, unspecified CPT Codes D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image post processing under concurrent supervision; not requiring image post processing on an independent workstation Three D Echocardiography April 16 2

3 D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging, ultrasound, or other tomographic modality with image post processing under concurrent supervision; requiring image post processing on an independent workstation HCPCS Codes N/A Scientific Rationale Update April 2016 Park et al (2016) sought to investigate the feasibility of single-beat threedimensional echocardiography (sb3de) for RV volume and functional assessment in patients with dilated right ventricles. Fifty-two patients with severe tricuspid regurgitation or atrial septal defects were enrolled. Fifty patients underwent sb3de and cardiac magnetic resonance (CMR) within 24 hours under a euvolemic state, and the results of sb3de were compared with those of CMR, the reference method. Fifteen normal subjects were also recruited for a broader validation of sb3de. Of the 67 individuals, data from 59 study participants (44 patients and 15 normal subjects) with adequate image quality were analyzed (mean age, 46.9 ± 19.3 years; 58% women). The correlation was excellent between sb3de and CMR for measuring RV volumes and RV ejection fraction (RVEF) (r = 0.96, r = 0.93, and r = 0.93 [P <.001 for all] for RV end-diastolic volume, RV end-systolic volume, and RVEF, respectively). Bland-Altman analysis revealed that RV volumes, but not RVEF, tended to be slightly underestimated by sb3de (-5.8 ± 9.6%, -3.8 ± 14.1%, and -1.2 ± 9.4% for RV end-diastolic volume, RV end-systolic volume, and RVEF, respectively). Intra- and interobserver variability was acceptable for all indices (4.9% and 6.1% for RV end-diastolic volume, 4.2% and 7.9% for RV end-systolic volume, and 5.7% and 2.8% for RVEF, respectively). Among patients with RV dilation, the difference in RVEF between sb3de and CMR was more pronounced in patients with atrial fibrillation than those in sinus rhythm (-5.9% vs 0.9%, P =.041). The authors concluded in patients with dilated right ventricles and in normal subjects, assessment of RV volume and systolic function by sb3de is feasible in terms of accuracy and reproducibility. RV analysis using sb3de can be performed in patients with atrial fibrillation, with the possibility of RVEF underestimation. Scientific Rationale Update April 2014 Massaffanti et al. (2013) Right ventricular (RV) volumes and ejection fraction (EF) vary significantly with demographic and anthropometric factors and are associated with poor prognosis in several cardiovascular diseases. This multicenter study was designed to establish the reference values for RV volumes and EF using transthoracic three-dimensional (3D) echocardiography; investigate the influence of age, sex, and body size on RV anatomy; and to develop normative equations. RV volumes (enddiastolic volume and end-systolic volume), stroke volume, and EF were measured by 3D echocardiography in 540 healthy adult volunteers, prospectively enrolled, evenly distributed across age and sex. The relation of age, sex, and body size parameters was investigated using bivariate and multiple linear regression. Analysis was feasible in 507 (94%) subjects (260 women; age, 45±16 years; range, 18-90). Age, sex, height, and weight significantly influenced RV volumes and EF. Sex effect was significant (P<0.01), with RV volumes larger and EF smaller in men than in women. Older age was associated with lower volumes (end-diastolic volume, -5 mldecade; end-systolic volume, -3 ml/decade; EF, -2 ml/decade) and higher EF (+1% perdecade). Inclusion of body size parameters in the statistical models resulted in improved overall explained variance for volumes (end-diastolic volume, R(2)=0.43; end-systolic volume, R(2)=0.35; stroke volume, R(2)=0.30), while EF was Three D Echocardiography April 16 3

4 unaffected. Ratiometric and allometric indexing for age, sex, and body size resulted in no significant residual correlation between RV measures and height or weight. The presented normative ranges and equations could help standardize the 3D echocardiography assessment of RV volumes and function in clinical practice, considering the effects of age, sex, and body size. Scientific Rationale - Update March 2013 Echocardiography is the major non-invasive diagnostic tool for real-time imaging of cardiac structure and function. One of the significant advances in this field has been the development and refinement of three-dimensional (3D) imaging. Real-time three-dimensional (3D) echocardiography allows for rapid acquisition of images and datasets during a single breath-hold without the need for off-line reconstruction. Major advantages of 3D echocardiography compared to traditional two-dimensional (2D) echocardiography are the improved accuracy of evaluation of cardiac chamber volumes (by eliminating the need for geometric modeling as well as a reduction in errors caused by foreshortened views) and more realistic visualization of cardiac valves and congenital abnormalities Per the 2008 Guidelines on Adults with Congenital Heart Disease from the American College of Cardiology and American Heart Association, a transthoracic echocardiography (TTE) is the primary diagnostic imaging modality for a variety of indications, including but not limited to, atrial septal defect (ASD), ventricular septal defect, atrioventricular septal defect, and aortic valve disease. The guidelines do not address 3D echocardiography. Per the ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 Appropriate Use Criteria for Echocardiography, a TTE and a TEE examination and report will include the use and interpretation of 2-dimensional/M-mode imaging, color flow Doppler, and spectral Doppler as important elements of a comprehensive TTE/TEE evaluating relevant cardiac structures and hemodynamics. Stress echocardiography will include rest and stress 2-dimensional imaging at a minimum unless performed for hemodynamics, when Doppler must be included. The range of potential indications for echocardiography is quite large, particularly in comparison with other cardiovascular imaging tests. Thus, the indications are, at times, purposefully broad to cover an array of cardiovascular signs and symptoms as well as the ordering physician s best judgment as to the presence of cardiovascular abnormalities. In general, it is assumed that transesophageal echocardiography (TEE) is most appropriately used as an adjunct or subsequent test to TTE when indicated, such as when suboptimal TTE images preclude obtaining a diagnostic study. A review of 3D echocardiography in Up to Date (Dec 2012) concluded: Real-time three-dimensional (3D) echocardiography allows for rapid acquisition of images and datasets during a single breath-hold without the need for off-line reconstruction. Major advantages of 3D echocardiography compared to traditional two-dimensional (2D) echocardiography are the improved accuracy of evaluation of cardiac chamber volumes (by eliminating the need for geometric modeling as well as a reduction in errors caused by foreshortened views) and more realistic visualization of cardiac valves and congenital abnormalities. Principal reasons for requesting an echocardiogram in clinical practice include the assessment of left ventricular (LV) chamber size and systolic function. 3D technology permits frame-by-frame detection of the 3D endocardial surface from Three D Echocardiography April 16 4

5 real-time 3D datasets. Nearly all studies that have directly compared the accuracy of 3D measurements of LV volumes and LV ejection fraction have demonstrated the superiority of the 3D approach over the traditional 2D methodology. Due to the complex crescent shape of the right ventricle (RV), estimation of its volume based on geometric modeling from 2D images has been challenging. The intrinsic ability of 3D imaging to directly measure RV volumes without the need for geometrical modeling has resulted in significant improvements in accuracy and reproducibility in RV volume quantification. Assessment of regional wall motion abnormalities using 2D echocardiography is routinely performed by visually integrating regional endocardial motion and wall thickness. The reproducibility of this interpretation is limited due to its subjective nature, which is also dependent upon the experience of the interpreting clinician. Because the motion of any ventricular wall can be quantified by measuring a variety of wall motion parameters, 3D echocardiography permits evaluation of regional LV function and objective detection of wall motion abnormalities. A byproduct of 3D quantification of regional LV wall motion is the ability to quantify the timing of regional endocardial systolic contraction. Data from 3D echocardiography can provide objective evidence of LV systolic dyssynchrony which may serve as an additional criterion for referral for cardiac resynchronization therapy. Volume-rendered 3D displays of transthoracic or transesophageal images enable improved evaluation of the anatomy of the mitral valve and its supporting structures. 3D imaging of the mitral valve is particularly helpful to the cardiac surgeon or interventional cardiologist to provide the most detailed anatomic and functional information when planning an intervention on the mitral valve. Real-time 3D transesophageal echocardiography offers detailed anatomic views of many cardiac structures and is likely to become the preoperative and perioperative imaging modality of choice for patients undergoing mitral valve surgery. Thorstensen et al (2013) aimed to compare 3D and 2D echocardiography in the evaluation of patients with recent myocardial infarction (MI), using lateenhancement magnetic resonance imaging (LE-MRI) as a reference method. Echocardiography and LE-MRI were performed approximately 1 month after firsttime MI in 58 patients. Echocardiography was also performed on 35 healthy controls. Left ventricular (LV) ejection fraction by 3D echocardiography (3D-LVEF), 3D wallmotion score (WMS), 2D-WMS, 3D speckle tracking-based longitudinal, circumferential, transmural and area strain, and 2D speckle tracking-based longitudinal strain (LS) were measured. The global correlations to infarct size by LE- MRI were significantly higher (P < 0.03) for 3D-WMS and 2D-WMS compared with 3D-LVEF and the 4 different measurements of 3D strain, and 2D global longitudinal strain (GLS) was more closely correlated to LE-MRI than 3D GLS (P < 0.03). The segmental correlations to infarct size by LE-MRI were also significantly higher (P < 0.04) for 3D-WMS, 2D-WMS, and 2D LS compared with the other indices. Threedimensional WMS showed a sensitivity of 76% and a specificity of 72% for identification of LV infarct size >12%, and a sensitivity of 73% and a specificity of 95% for identification of segments with transmural infarct extension. Three- Three D Echocardiography April 16 5

6 dimensional WMS and 2D gray-scale echocardiography showed the strongest correlations to LE-MRI. The tested 3D strain method suffers from low temporal and spatial resolution in 3D acquisitions and added diagnostic value could not be proven. Kidawa et al (2013) reported that knowledge of right ventricular (RV) function may be crucial in diagnosis and proper management of patients with suspected acute MI. Standard echocardiography has several drawbacks, tissue Doppler echocardiography (TDE) and real-time three-dimensional echocardiography (RT3DE) could be used for evaluation of the RV performance. The purpose of this study was to assess RV function in patients with inferior wall acute MI with both TDE and RT3DE. The study included 85 patients in the acute phase of MI complicated with right ventricular myocardial infarction (RVMI) admitted for primary coronary intervention (PCI). Control group was formed from 85 patients with isolated inferior wall infarction matched to RVMI group. Before PCI all of the patients underwent echocardiografic examination with the assessment of RV function by TDE and RT3DE. TDE derived peak systolic velocity ', peak early diastolic velocity of RV free wall differed significantly between groups. Three-dimensional reconstruction and calculation of the right ventricular ejection fraction (RVEF) showed that in RVMI patients RVEF values were lower than in the controls (41.7 ± 6.03 vs ± 2.3%, respectively). RVEF < 51% allowed diagnosis of RVMI with sensitivity 91% and specificity 80%. Investigators concluded three-dimensional echocardiography is a useful method in the estimation of RVEF, however does not perform better than TDE in diagnosis of RVMI. Threshold of RVEF < 51% may be used for diagnosing of RVMI with adequate sensitivity and specificity. Ruddox et al (2013) performed a systematic review of 3D echocardiography (3DE) to evaluate whether it provides additional information to 2DE in general hospital clinical practice. Studies with a blinded comparison between 2DE and 3DE against a "gold standard" were included; these studies comprised patients with well defined inclusion and exclusion criteria. The number of patients, selection criteria, echo manufacturer, cardiac disorder, and types of comparisons, along with "gold standard" and principal results were compared. A total of 836 original articles were identified, of which 35 were screened for eligibility. 20 studies from 18 publications were included for analysis. The results for LV assessment and reproducibility were clearly in favor of 3DE. In valvular heart disease the superiority of 3DE was also apparent, but was less convincing due to patient selection, methodological problems and the application of questionable "gold standards". The reviewers concluded in patients with a regular heart rhythm and for whom it was possible to obtain good quality images the introduction of 3DE has improved the accuracy and reproducibility of LV volume and EF measurements. The results for valvular heart disease are still controversial. It does not seem justifiable to introduce 3DE into common cardiac practice. Further studies are needed in order to support such an implementation. Thavendiranathan et al (2012) sought to assess the feasibility, accuracy, and reproducibility of real-time full-volume 3-dimensional transthoracic echocardiography (3D RT-VTTE) to measure left ventricular (LV) volumes and ejection fraction (EF) using a fully automated endocardial contouring algorithm and to identify and automatically correct the contours to obtain accurate LV volumes in sinus rhythm and atrial fibrillation (AF). RT-VTTE was performed and 3D EF and volumes obtained using an automated trabecular endocardial contouring algorithm; an automated correction was applied to track the compacted myocardium. Cardiac magnetic resonance (CMR) and 2-dimensional biplane Simpson method were the reference standard. Ninety-one patients (67 in normal sinus rhythm [NSR], 24 in AF) were Three D Echocardiography April 16 6

7 included. Among all NSR patients, there was excellent correlation between RT-VTTE and CMR for end-diastolic volume (EDV), end-systolic volume (ESV), and EF (r = 0.90, 0.96, and 0.98, respectively; p<0.001). In patients with EF 50% (n = 36), EDV and ESV were underestimated by 10.7±17.5 ml (p = 0.001) and by 4.1±6.1 ml (p<0.001), respectively. In those with EF<50% (n = 31), EDV and ESV were underestimated by 25.7±32.7 ml (p<0.001) and by 16.2±24.0 ml (p = 0.001). Automated contour correction to track the compacted myocardium eliminated mean volume differences between RT-VTTE and CMR. In patients with AF, LV volumes and EF were accurate by RT-VTTE (r = 0.94, 0.94, and 0.91 for EDV, ESV, and EF, respectively; p<0.001). Automated 3D LV volumes and EF were highly reproducible. Investigators concluded rapid, accurate, and reproducible EF can be obtained by RT- VTTE in NSR and AF patients by using an automated trabecular edge contouring algorithm. Furthermore, automated contour correction to detect the compacted myocardium yields accurate and reproducible 3D LV volumes. Liu et al (2012) evaluated left ventricular systolic synchronization in patients implanted with dual-chamber DDD mode cardiac pacemakers by real-time threedimensional echocardiography (RT3DE). Twenty patients implanted with DDD mode cardiac pacemakers for 12 months and 20 healthy subjects underwent RT3DE. This method provided left ventricular end-diastolic volume (LEDV), left ventricular endsystolic volume (LESV), stroke volume (SV), left ventricular ejection fraction (LVEF), the mean value of the time to minimal systolic volume of the 16 left ventricular segments (Tmean), the standard deviation of Tmean (T-SD), the maximal difference of the time to minimal systolic volume of the 16 left ventricular segments (Tmax) and time-volume curves of the 16 left ventricular segments. Results showed that compared with the healthy group, LESV was significantly increased (P<0.05), SV and LVEF were significantly decreased (P<0.05) and T-SD and Tmax were significantly prolonged (P<0.05) in patients implanted with DDD mode cardiac pacemakers. The time to minimal systolic volume of the 16 left ventricular segments time-volume curves differed in patients implanted with DDD mode cardiac pacemakers. Asynchronization of the left ventricular systolic performance in patients implanted with DDD mode cardiac pacemakers was observed. Investigators concluded the results showed that RT3DE is a quantitative method used to evaluate left ventricular systolic synchronization. Black et al (2012) reviewed the use of 3DE with multiplanar reformatting (MPR) in children with congenital aortic stensosis undergoing percutaneous balloon aortic valvuloplastie to assess its accuracy in measuring the aortic valve annulus and any influence it may have on balloon sizing. All percutaneous aortic balloon valvuloplasties performed from 01/01/2009 to 01/09/2011 were included in the study. All imaging performed for the procedure to determine the size of the aortic valve annulus and aid in balloon sizing was reviewed. The maximum diameter of the aortic valve annulus using two-dimensional echocardiography (2DE), 3DE with MPR, and angiography was recorded. The balloon size used in the procedure was recorded and the balloon to annulus ratio was calculated. A total of 27 procedures were included in the study. Age varied from 1 day to 156 months (mean age, 53 months) and weight from kg (mean weight, 18.6 kg). Fourteen patients had 3DE with MPR available for analysis. The 3DE with MPR measurement (13.36 ± 5.4 mm) was not different from angiography (13.54 ± 6.4 mm; P=.803).The 2DE measurement was significantly different from angiography (11.72 ± 5 mm; P<.005). The balloon to annulus ratio based on angiographic measurements did not differ significantly between the patients with 3DE MPR and those without (0.94 ± vs 0.91 ± 0.1; P=.468). Reviewers concluded 3DE with MPR allows a more accurate assessment of Three D Echocardiography April 16 7

8 the aortic valve annulus compared to 2DE, which may reduce the tendency to undersize balloon choice. 3DE with MPR did not significantly affect our balloon choice, which was largely based on angiographic measurements. Mor-Avi et al (2012) studied in a multicenter setting, the accuracy and reproducibility of 3-dimensional echocardiography (3DE)-derived measurements of left atrial volume (LAV) using new, dedicated volumetric software, side by side with 2-dimensional echocardiography (2DE), using cardiac magnetic resonance (CMR) imaging as a reference. Increased LAV is associated with adverse cardiovascular outcomes. Although LAV measurements are routinely performed using 2DE, this methodology is limited because it is view dependent and relies on geometric assumptions regarding left atrial shape. Real-time 3DE is free of these limitations and accordingly is an attractive alternative for the evaluation of LAV. However, few studies have validated 3DE-derived LAV measurements against an accepted independent reference standard, such as CMR imaging. Investigators studied 92 patients with a wide range of LAV who underwent CMR (1.5-T) and echocardiographic imaging on the same day. Images were analyzed to obtain maximal and minimal LAV: CMR images using standard commercial tools, 2DE images using a biplane area-length technique, and 3DE images using Tomtec LA Function software. Intertechnique comparisons included linear regression and Bland-Altman analyses. Reproducibility of all 3 techniques was assessed by calculating the percentage of absolute differences in blinded repeated measurements. Kappa statistics were used to compare 2DE and 3DE classification of normal/enlarged against the CMR reference. 3DE-derived LAV values showed higher correlation with CMR than 2DE measurements (r = 0.93 vs. r = 0.74 for maximal LAV; r = 0.88 vs. r = 0.82 for minimal LAV). Although 2DE underestimated maximal LAV by 31 ± 25 ml and minimal LAV by 16 ± 32 ml, 3DE resulted in a minimal bias of -1 ± 14 ml for maximal LAV and 0 ± 21 ml for minimal LAV. Interobserver and intraobserver variability of 2DE and 3DE measurements of maximal LAV were similar (7% to 12%) and approximately 2 times higher than CMR (4% to 5%). 3DE classified enlarged atria more accurately than 2DE (kappa: 0.88 vs. 0.71). Investigators concluded that compared with CMR reference, 3DE-derived LAV measurements are more accurate than 2DE-based analysis, resulting in fewer patients with undetected atrial enlargement. Tong et al (2012) assessed left and right ventricular systolic function in patients with dilated cardiomyopathy (DCM) using RT-3DE. Fifty DCM patients and 50 normal subjects were enrolled. Left and right ventricular systolic function parameters including end-systolic volume (ESV) and end-diastolic volume (EDV), stroke volume (SV) and ejection fraction (EF) were measured with RT-3DE. The systolicdyssynchrony index (SDI) for left ventricular systolic function was also measured in the same time. The study compared the data of the left and right ventricular systolic function parameters between the DCM group and the control group. Cardiac magnetic resonance (CMRI) was performed in a subgroup of the 30 DCM patients to confirm RT-3DE measurements. The results of EDV, ESV and SDI measured by RT-3DE were significantly higher in patient group with DCM than those in the control group (P<0.001). The result of EF was significantly lower in patients with DCM than in normal subjects (P<0.001), but SV showed no significant difference between the two groups (P>0.05). In the DCM group, the results showed a significantly negative correlation between left ventricular ejection fraction (LVEF) and SDI (r=-0.697, P<0.001), and there was also a moderate correlation between LVEF and right ventricular ejection fraction (RVEF) (r=0.496, P<0.01). The results of ESV, EDV and EF showed no significant differences as measured by RT-3DE or CMRI in the patient group (P>0.05), and there was also good correlation between the two Three D Echocardiography April 16 8

9 measurements (LVEF: r=0.89, P<0.01; RVEF: r=0.85, P<0.01). Investigators concluded left and right ventricular systolic function in DCM could be evaluated by RT-3DE with left and right ventricular systolic function parameters. Gertz et al (2012) investigated fifty elderly patients (mean 86 years, 46% female) referred for cardiac catheterization to evaluate in aortic stenosis (AS) also underwent transthoracic echocardiography within 24 hours. To minimize assumptions all patients had 3-dimensional echocardiography (Echo-3D), and at catheterization using directly measured oxygen consumption (Cath-mVo(2)) and thermodilution cardiac output (Cath-TD). Correlation between Cath-mVo(2) and Echo-3D AVA was poor (r=0.41). Cath-TD AVA had a moderate correlation with Echo-3D AVA (r=0.59). Cath-mVo(2) (AVA=0.69 cm(2)) and Cath-TD (AVA=0.66 cm(2)) underestimated AVA compared with Echo-3D (AVA=0.76 cm(2;) P=0.08 for comparison with CathmVo(2); P=0.001 for Cath-TD). Compared with Echo-3D, the sensitivity and specificity for determining critical disease (AVA <0.8 cm(2)) were 81% and 42% for Cath-mVo(2), and 97% and 53% for Cath-TD. The only independent predictor of the difference between noninvasive and invasive AVA was stroke volume index (P<0.01). Resistance, a less flow-dependent measure, showed a stronger correlation between Echo-3D and Cath-mVo(2) (r=0.69), and Echo-3D and Cath-TD (r=0.77). Investigators concluded standard techniques of AVA assessment for AS show poor correlation in elderly patients, with frequent misclassification of critical AS. Less flowdependent measures, such as resistance, should be considered to ensure that only appropriate patients are treated with aortic valve replacement. Greupner et al (2012) compare the accuracy of 64-row contrast computed tomography (CT), invasive cineventriculography (CVG), 2-dimensional echocardiography (2D Echo), and 3-dimensional echocardiography (3D Echo) for left ventricular (LV) function assessment with magnetic resonance imaging (MRI). Cardiac function is an important determinant of therapy and is a major predictor for long-term survival in patients with coronary artery disease. A number of methods are available for assessment of function, but there are limited data on the comparison between these multiple methods in the same patients. A total of 36 patients prospectively underwent 64-row CT, CVG, 2D Echo, 3D Echo, and MRI (as the reference standard). Global and regional LV wall motion and ejection fraction (EF) were measured. In addition, assessment of interobserver agreement was performed. For the global EF, Bland-Altman analysis showed significantly higher agreement between CT and MRI (p < 0.005, 95% confidence interval: ±14.2%) than for CVG (±20.2%) and 3D Echo (±21.2%). Only CVG (59.5 ± 13.9%, p = 0.03) significantly overestimated EF in comparison with MRI (55.6 ± 16.0%). CT showed significantly better agreement for stroke volume than 2D Echo, 3D Echo, and CVG. In comparison with MRI, CVG-but not CT-significantly overestimated the enddiastolic volume (p < 0.001), whereas 2D Echo and 3D Echo significantly underestimated the EDV (p < 0.05). There was no significant difference in diagnostic accuracy (range: 76% to 88%) for regional LV function assessment between the 4 methods when compared with MRI. Interobserver agreement for EF showed high intraclass correlation for 64-row CT, MRI, 2D Echo, and 3D Echo (intraclass correlation coefficient >0.8), whereas agreement was lower for CVG (intraclass correlation coefficient = 0.58). Investigators concluded 64-row CT may be more accurate than CVG, 2D Echo, and 3D Echo in comparison with MRI as the reference standard for assessment of global LV function. Anwar et al (2012) evaluated the feasibility and possible additional value of transthoracic real-time three-dimensional echocardiography (RT3D-TTE) for the Three D Echocardiography April 16 9

10 assessment of cardiac structures as compared to 2D-TTE. 320 patients (mean age 45 ± 8.4 years, 75% males) underwent 2D-TTE and RT3D-TTE using 3DQ-Q lab software for offline analysis. Volume quantification and functional assessment was performed in 90 patients for left ventricle and in 20 patients for right ventricle. Assessment of native (112 patients) and prosthetic (30 patients) valves morphology and functions was performed. RT3D-TTE was performed for evaluation of septal defects in 30 patients and intracardiac masses in 52 patients. RT3D-TTE assessment of left ventricle was feasible and reproducible in 86% of patients while for right ventricle, it was (55%). RT3D-TTE could define the surface anatomy of mitral valve optimally (100%), while for aortic and tricuspid was (88% and 81% respectively). Valve area could be planimetered in 100% for the mitral and in 80% for the aortic. RT3D-TTE provided a comprehensive anatomical and functional evaluation of prosthetic valves. RT3D-TTE enface visualization of septal defects allowed optimal assessment of shape, size, area and number of defects and evaluated the outcome post device closure. RT3D-TTE allowed looking inside the intracardiac masses through multiple sectioning, valuable anatomical delineation and volume calculation. Investgators concluded initial experience showed that the use of RT3D-TTE in the assessment of cardiac patients is feasible and allowed detailed anatomical and functional assessment of many cardiac disorders. Scientific Rationale Update March 2012 Two-dimensional (2-D) echocardiography provides real-time imaging of heart structures throughout the cardiac cycle; more recently, 3-dimensional (3-D) echocardiography has been developed. As the technology continues to evolve, it will likely play an increasingly prominent role in echocardiographic diagnosis. The improvement in computational techniques allow the three-dimensional reconstruction of the heart (3D echocardiography), both by transthoracic or transesophageal. 3D echocardiography has emerged as a clinically relevant, although technically complex, modality, that usually requires post acquisition processing. Per the Journal of American College of Cardiology (JACC), 3D echocardiography is becoming increasingly prevalent and should be available in most modern training environments. The ability to complete adequate training in echocardiography will depend on the background and abilities of the trainee, as well as the effectiveness of the instructor and laboratory. The current trend to introduce the fundamental principles, indications, applications, and limitations of echocardiography into the education of medical students and residents is encouraged and will facilitate subsequent mastery of this discipline. Three-dimensional (3 D) echocardiography may be useful for the assessment of the severity of valvular stenosis or regurgitation where such information is critical for decisions regarding the need for valve repair. 3D echography is also useful in the evaluation of atrial and septal defects, intracardiac masses such as myxomas, and valve lesions such as abscesses and vegetations. 3D echocardiography is useful in assessment for the need of cardiac resynchronization therapy and is also useful for surgical treatment planning for complex congenital heart disease. Kurlinsky et al. (2012) Recent technologic advances in 3D echocardiography, using parallel processing to scan a pyramidal volume, have allowed for a superior ability to describe valvular anatomy using both transthoracic and transesophageal echocardiography. Three-dimensional echocardiography provides unique perspectives of valvular structures by presenting views of valvular structures, allowing for a better understanding of the topographical aspects of pathology, and a Three D Echocardiography April 16 10

11 refined definition of the spatial relationships of intracardiac structures. Threedimensional echocardiography makes available indices not described by 2D echocardiography and has been demonstrated to be superior to 2D echocardiography in a variety of valvular disease scenarios. The information gained from 3D echocardiography has especially made an impact in guiding clinical decisions in the evaluation of mitral valve (MV) disease. The decision of early surgery in degenerative MV disease is based on the suitability of repair, and the suitability of repair is generally based on echocardiography. The superior understanding of MV anatomy afforded by 3D echocardiography has been shown to be quite valuable in this setting. Although 3D cardiac echocardiography has emerged as an important clinical tool in the assessment of valvular heart disease, it is still in evolution and at an early phase of adaptation with respect to its clinical application. This treatment needs to be validated in well-designed studies comparing it with its competing technology, such as magnetic resonance imaging of the heart. Scientific Rationale Update March 2010 Echocardiography is the major diagnostic tool for real-time imaging of cardiac structure and function. One of the significant advances in this field has been the development and refinement of three-dimensional (3D) imaging. Since the potential of 3D echocardiographic imaging to overcome many of the limitations of 2D echocardiography is being seen for the future, ultrasound imaging has gone through multiple phases of development, each bringing this imaging technology a step closer to real-time imaging. Real-time three-dimensional echocardiographic reconstruction is valuable for the assessment of cardiac morphology. Details of valve structure, the size and location of septal defects, abnormalities of the ventricular myocardium, and details of the great vessels can often be appreciated on 3-D echo, which may not be as readily apparent using 2-D imaging. Reconstruction of the view that the surgeon will encounter in the operating room, promised to make this technique a valuable adjunct for preoperative imaging. Early 3D echo imaging was based on computer reconstruction of contiguous 2D cross-sectional images, and was hampered by difficulties in accurately registering the ultrasound image data in time and space and by long image processing time. Development of gating techniques, improved computer technology and software, and refinement of the user interface have resulted in shorter acquisition and reconstruction times and improved image quality. The introduction of real-time 3D echocardiography (RT-3DE) allows the technology to complement, and enhances its potential to eventually replace 2D echocardiography, in clinical practice. RT-3DE sends and receives a pyramidal set of ultrasound energy data from several thousand piezoelectric transducer elements, producing a 3D image using parallel image processing techniques. Although spatial and temporal resolution of current RT-3DE technology are still somewhat limited, given the rapid evolution of the technology, image quality is certain to approach that of 2D echo in the near future. van der Zwanze et al. (2010) completed a study to test the feasibility, accuracy, and reproducibility of the assessment of right ventricular (RV) volumes and ejection fraction (EF) using real-time three-dimensional echocardiographic (RT3DE) imaging in patients with congenital heart disease (CHD), using cardiac magnetic resonance (CMR) as a reference. RT3DE data sets and short-axis cine CMR images were obtained in 62 consecutive patients (mean age, 26.9 ± 10.4 years; 65% men) with Three D Echocardiography April 16 11

12 various CHDs. RV volumetric quantification was done using semiautomated 3- dimensional border detection for RT3DE images and manual tracing of contours in multiple slices for CMR images. Adequate RV RT3DE data sets could be analyzed in 50 of 62 patients (81%). The time needed for RV acquisition and analysis was less for RT3DE imaging than for CMR (P <.001). Compared with CMR, RT3DE imaging underestimated RV end-diastolic and end-systolic volumes and EF by 34 ± 65 ml, 11 ± 55 ml, and 4 ± 13% (P <.05) with 95% limits of agreement of ±131 ml, ±109 ml, and ±27%, as shown by Bland-Altman analyses, with highly significant correlations (r = 0.93, r = 0.91, and r = 0.74, respectively, P <.001). Interobserver variability was 1 ± 15%, 6 ± 17%, and 8 ± 13% for end-diastolic and end-systolic volumes and EF, respectively. In the majority of unselected patients with complex CHD, RT3DE imaging provides a fast and reproducible assessment of RV volumes and EF with fair to good accuracy compared with CMR reference data when using current commercially available hardware and software. Further studies are warranted to confirm our data in similar and other patient populations to establish its use in clinical practice. In summary, there is a lack of peer-reviewed, randomized controlled trials using three dimensional cardiac echocardiography. The majority of the studies that were found were various author s reviews or case reports of specific individuas who underwent surgical procedures in which 3D cardiac echocardiography was used (i.e. Nishimura et al. 2010, Eitel et al. 2010, Horton et al. 2010, and Novero 2010). Data from well-designed RCTs or comparison trials are needed to validate the use of three diminensional cardiac echocardiaography for clinical diagnosis and treatment and compare it with procedures that are currently used (i.e. Magnetic resonance imaging of the heart). Outcome studies are needed to support the safety and efficacy of this procedure in the long-term. Scientific Rationale Initial M-mode and two dimensional (2-D) echocardiography (echo) have made significant contributions to the non-invasive evaluation of cardiac disease for many years and have evolved into the most predominant non-invasive diagnostic imaging technique in cardiology. However, current echo technology is limited by viewing and evaluating intracardiac anatomy in only two dimensions. The interpretation of echocardiographic images, therefore, requires a mental integration of multiple image planes for a true understanding of anatomic and pathologic structures. Recent advances in ultrasound instrumentation, computer and transducer technology, and image processing has enabled computer-based 3-D reconstruction procedures to be performed even faster and more precisely. Consequently, this has lead to the development of two techniques: (1) 3-D reconstruction which allows the physician to reconstruct the heart and view the structural defects at any angle; and (2) real-time 3-D (RT3-D) volumetric imaging. The former requires extrapolation of a series of two-dimensional (2-D) images of known orientation and location that then is compiled into a three-dimensional data set. This process is very time-consuming and this method still suffers from the fact that the derived data are collected at different times, not in real time. Because the 3-dimensional data were still collected in different cardiac cycles, unpredictable inaccuracies for quantification are probably caused by patient motion, respiration, and the complex linear and rotational movements of the heart between diastole and systole. Accordingly, it is difficult to evaluate complex beat-to-beat changes of the heart. The latter, RT3-D echocardiography, uses a 2-D matrix phased array transducer with multiple parallel processing to produce real-time volumetric images of the heart free of geometric Three D Echocardiography April 16 12

13 assumptions. The main advantage of live RT3-D imaging is its ability to capture 3-D data in real time. This technique offers hope in improving patient care by providing more precise and rapid identification of cardiac abnormalities because it avoids the motion artifact inherent with any reconstructive technique and permits analysis of events during a single cardiac cycle. It is thought that the representation of images in a 3-dimensional format more closely resembles reality and it is the real-time aspect of live 3-D echo that enables clinicians to quickly and accurately assess and quantify global and regional left ventricular (LV) function, LV mass, and view the different heart chambers, all of which are critical in assessing specific conditions and cardiac performance for obtaining a precise diagnosis. In addition, 3-dimensional imaging allows direct calculation of volumes and is, thus, more accurate than current models relying on geometric assumptions. However, at present, RT3-D imaging has poorer image quality and lacks the Doppler capability. The concept of live 3-D echo is particularly important as patients present with multiple, complex problems. As live 3-D echo evolves as a tool for the complete management of the cardiac patient, it is also benefiting the clinical side by verifying much of the data obtained by 2-D echo, thereby enhancing diagnostic confidence for more rapid diagnosis, improving patient care and peace of mind, and driving clinical efficiencies. The continuous acquisition of volumetric data also permits structures to be scanned rapidly, eliminating the previous lengthy steps required for data coordination. This mechanism has the potential to provide 3-dimensional images from which quantitative data can be derived and tissue structure recognized with examination requirements no greater than those of 2-dimensional scanning. The motion of all the imaged structures during the cardiac cycle can be evaluated in a dynamic mode. In addition, one has the ability to view the heart in 2 dimensions in any desired plane. Numerous applications of three-dimensional echocardiography (3D-echo) have been proposed. For example, improvements in image interpretation with 3D-echo could be of value in the decision making and planning of cardiac surgery, and in the diagnosis of complex congenital cardiac lesions. In addition, 3-dimensional imaging allows quantitative parameters such as valve areas, the size of defects (atrial septal defect, ventricular septal defect) or volumes to be obtained. With new developments that allow system integration of 3D scanning, rapid or even near real time 3D-reconstruction and measurements, 3D-echo is now on the verge of becoming an integral part of an echo examination. It remains a technique in evolution for which increases in image processing technology and speed have allowed substantial advancement in the last several years. Even though 3D echocardiography provides unique orientations of cardiac anatomy not obtainable by routine 2D echocardiography, this modality has not been adopted in routine clinical practice because of its cumbersome and time-consuming process. In the future, with further developments that allow system integration of 3D scanning, rapid or even near real time 3D-reconstruction and measurements, most cardiologists feel that there are four clinical situations where live 3D echo may impact directly on the quality of patient care. The first is the diagnosis of congenital heart disease. Many of these disorders are caused by complex geometrical distortions of cardiac anatomy. Currently, a combination of 2-D echocardiography and cardiac catheterization is used to diagnose these diseases. It is reasonable to think that real-time 3-D echocardiography will provide more detailed information with one noninvasive test. Second, is in the planning and assessment of mitral valve Three D Echocardiography April 16 13

14 repair. Current 2-D echo provides good information regarding valve deformations, but it is not uncommon for the surgeon to find different or additional abnormalities in surgery that were not identified pre-operatively by current echo techniques. Since these observations of surgery are made in an arrested and flaccid heart, it is sometimes difficult for the surgeon to determine their importance to valve competence. Real-time 3- D echo will allow a more complete dynamic assessment of valve dysfunction. Thirdly, real-time 3-D technology will find an important application in the future in the guidance of percutaneous catheter-based techniques to treat cardiovascular disease particularly valvular heart disease. There is a huge effort going on right now to develop catheter systems to repair and replace both the aortic and mitral valve. Currently, many, if not all, of these techniques are hampered by positioning problems. That is, with current 2-D technology, it is difficult to visualize the appropriate anatomical landmarks to use these new devices optimally. As these technologies expand, so will the need for 3-D echocardiography. Finally, 3- D echocardiography may be extremely helpful in guiding the treatment of heart failure patients. Post-infarction heart failure affects millions of people and costs billions of dollars to treat every year. Despite intense study, the five-year survival for this disease is less than 50% worse than most cancers. Real-time 3-D echocardiography may be used to determine subtle geometrical changes in the left ventricle that will identify patients who are at high risk for ventricular remodeling leading to heart failure after a heart attack. Such information will allow these patients to receive therapy earlier before symptoms occur and before this horribly progressive disease has reached its irreversible stage. In addition, real-time 3-D ventricular imaging may allow a better assessment of the on-going effectiveness of heart failure therapy and allow the clinician to make more informed decisions regarding adjustments in pharmacological and surgical therapy. However, despite the potential of 3D-echo to visualize cardiac structures and perform volume computations this technique has not gained wide spread acceptance to date. This might be related to several factors: (1) 3-D echo can only visualize what is also seen on the two dimensional image, thus, an experienced echocardiographer will obtain similar information from a conventional examination without the need for costly instrumentation and long post-processing times; (2) operator experience with the reconstruction and interpretation of 3-Dimages is a must; (3) 3D-image quality greatly depends on the quality of the twodimensional image and the ability to obtain a motion and artifact free 3D-data set; and (4) three-dimensional imaging only creates a virtual sense of depth on a flat (2-dimensional) screen. And finally, manual endocardial contour tracing is still required to obtain 3D-volumes. Three-dimensional echocardiographic imaging has been introduced as a tool to improve the assessment of both morphologic and functional parameters of the heart. With the rapid advances in digital image processing, 3-D imaging is probably just at the beginning of its evolution with a number of innovations already approaching that will allow improved visualization of cardiac structures. The integration of 3D-systems into conventional scanners and operator friendly applications will reduce the time and effort required to obtain 3-D images. Improvements in 2-dimensional imaging and 3- dimensional reconstruction software will lead to enhanced image quality. Novel ways of image representation such as stereoscopy, holography or the generation of physical 3D-models could enhance our perception of cardiac structures. The techniques of three-dimensional echocardiography are still in the developmental stages. Currently, the full 3-D potential of these imaging modalities cannot be Three D Echocardiography April 16 14

15 appreciated, since the 3-D data are presented on a flat 2D screen. Virtual dynamic systems, known as virtual reality, can assist with the interpretation of 3-D data of the heart in space and makes it possible to dive into the 3-D model of the heart. Every imaging technique in cardiology aims at a complete visualization and comprehensive assessment of cardiac morphology and pathology, as the heart is a complex geometric structure. Analysis of the heart in motion in all three or four (including time) dimensions can therefore further facilitate and enhance the diagnostic capabilities of echocardiography. Three-dimensional echocardiography is still in its evolution and at the phase of early adaptation with respect to its clinical application. It should complement current echocardiographic techniques by providing better understanding of the topographical aspects of pathology and refined definition of the spatial relationships of intracardiac structures. Review History July 2006 March 2007 March 2008 March 2010 April 2011 March 2012 March 2013 April 2014 April 2015 April 2016 Medical Advisory Council initial approval Coding Updates Updated with no changes Update. No revisions. Codes reviewed. Updated with Medicare table Update. No revisions Update. Revised policy to consider 3-D echocardiography medically necessary for surgical treatment planning of a complex surgical cardiac procedure, on an exceptional case by case basis. Code updates Update no revisions. Code updates. Update no revisions Update no revisions This policy is based on the following evidence-based guidelines: 1. American Society of Echocardiography Indications and Guidelines for Performance of Transesophageal Echocardiography in the Patient with Pediatric Acquired or Congenital Heart Disease - January American Society of Echocardiography Guidelines and Standards for Performance the Fetal Echocardiogram - July ACC/AHA/ASE 2003 Guideline Update for the Clinical Application of Echocardiography: Summary Article A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 4. Picard MH, Adams D, Bierig M, et al. American Society of Echocardiography. Recommendations for Quality Echocardiography. Laboratory Operations. Guidelines and Standards. January ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 Appropriate Use Criteria for Echocardiography. 5. Warnes CA, Williams RG, American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines on the Management of Adults With Congenital Heart Disease); American Society of Echocardiography; Heart Rhythm Society; International Society for Adult Congenital Heart Disease; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines on the Management of Adults With Congenital Heart Disease). Developed in Collaboration With the American Society of Echocardiography, Heart Rhythm Three D Echocardiography April 16 15

16 Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol Dec 2;52(23):e References Update April Jone PN, Patel SS, Cassidy C, Ivy DD. Three-dimensional Echocardiography of Right Ventricular Function Correlates with Severity of Pediatric Pulmonary Hypertension. Congenit Heart Dis Feb Park JB, Lee SP, Lee JH, et al. Quantification of Right Ventricular Volume and Function Using Single-Beat Three-Dimensional Echocardiography: A Validation Study with Cardiac Magnetic Resonance. J Am Soc Echocardiogr Mar Toida R, Watanabe N, Obase K, et al. Prognostic Implication of Three- Dimensional Mitral Valve Tenting Geometry in Dilated Cardiomyopathy. J Heart Valve Dis Sep;24(5): References Update April de Agustin JA, Viliani D, Vieira C, et al. Proximal isovelocity surface area by single-beat three-dimensional color Doppler echocardiography applied for tricuspid regurgitation quantification. J Am Soc Echocardiogr 2013; 26: Maffessanti F, Muraru D, Esposito R, et al. Age-, body size-, and sex-specific reference values for right ventricular volumes and ejection fraction by threedimensional echocardiography: a multicenter echocardiographic study in 507 healthy volunteers. Circ Cardiovasc Imaging 2013; 6: Thavendiranathan P, Liu S, Datta S, et al. Quantification of chronic functional mitral regurgitation by automated 3-dimensional peak and integrated proximal isovelocity surface area and stroke volume techniques using real-time 3- dimensional volume color Doppler echocardiography: in vitro and clinical validation. Circ Cardiovasc Imaging 2013; 6:125. References Update March Aktürk E, Kurtoğlu E, Ermiş N, et al. Assessment of left ventricular volume and functions by real-time three-dimensional echocardiography in patients with compensated and decompensated heart failure. Turk Kardiyol Dern Ars Sep;40(5): Amzulescu MS, Slavich M, Florian A, et al. Does two-dimensional image reconstruction from three-dimensional full volume echocardiography improve the assessment of left ventricular morphology and function? Echocardiography Jan;30(1): Anwar AM, Nosir YF, Zainal-Abidin SK, et al. Real-time three-dimensional transthoracic echocardiography in daily practice: initial experience. Cardiovasc Ultrasound Mar 26;10: Benenstein R, Saric M. Mitral valve prolapse: role of 3D echocardiography in diagnosis. Curr Opin Cardiol Sep;27(5): Buechel RR, Sommer G, Leibundgut G, et al. Assessment of left atrial functional parameters using a novel dedicated analysis tool for real-time three-dimensional echocardiography: validation in comparison to magnetic resonance imaging. Int J Cardiovasc Imaging Sep Biswas S, Ananthasubraminam K. Clinical Utility of Three-Dimensional Echocardiography For the Evaluation of Ventricular Function. Cardiol Rev Feb Black D, Ahmad Z, Lim Z, et al. The accuracy of three-dimensional echocardiography with multiplanar reformatting in the assessment of the aortic Three D Echocardiography April 16 16

17 valve annulus prior to percutaneous balloon aortic valvuloplasty in congenital heart disease. J Invasive Cardiol Nov;24(11): Chang SA, Kim HK, Lee SC, et al. Assessment of Left Ventricular Mass in Hypertrophic Cardiomyopathy by Real-Time Three-Dimensional Echocardiography Using Single-Beat Capture Image. J Am Soc Echocardiogr Jan Cai Q, Ahmad M. Three-dimensional echocardiography in valvular heart disease. Echocardiography Jan;29(1): Dorosz JL, Lezotte DC, Weitzenkamp DA, et al. Performance of 3-dimensional echocardiography in measuring left ventricular volumes and ejection fraction: a systematic review and meta-analysis. J Am Coll Cardiol May 15;59(20): Gertz ZM, Raina A, O'Donnell W, et al. Comparison of invasive and noninvasive assessment of aortic stenosis severity in the elderly. Circ Cardiovasc Interv Jun;5(3): Greupner J, Zimmermann E, Grohmann A, et al. Head-to-head comparison of left ventricular function assessment with 64-row computed tomography, biplane left cineventriculography, and both 2- and 3-dimensional transthoracic echocardiography: comparison with magnetic resonance imaging as the reference standard. J Am Coll Cardiol May 22;59(21): Kang Y, Sun MM, Cui J, et al. Three-dimensional speckle tracking echocardiography for the assessment of left ventricular function and mechanical dyssynchrony. Acta Cardiol Aug;67(4): Kidawa M, Chizynski K, Zielinska M, et al. Real-time 3D echocardiography and tissue Doppler echocardiography in the assessment of right ventricle systolic function in patients with right ventricular myocardial infarction. Eur Heart J Cardiovasc Imaging Jan Kleijn SA, Aly MF, Knol DL, et al. A meta-analysis of left ventricular dyssynchrony assessment and prediction of response to cardiac resynchronization therapy by three-dimensional echocardiography. Eur Heart J Cardiovasc Imaging Sep;13(9): Kurklinsky A, Mankad S. Three-dimensional Echocardiography in Valvular Heart Disease. Cardiol Rev Mar-Apr;20(2): Lancellotti P, Badano LP, Lang RM, et al. Normal Reference Ranges for Echocardiography: rationale, study design, and methodology (NORRE Study). Eur Heart J Cardiovasc Imaging Jan Liu L, Zhang L, Duan S. Use of real-time three-dimensional echocardiography to assess left ventricular systolic synchronization after dual-chamber pacing therapy. Exp Ther Med Nov;4(5): Mor-Avi V, Yodwut C, Jenkins C, et al. Real-time 3D echocardiographic quantification of left atrial volume: multicenter study for validation with CMR. JACC Cardiovasc Imaging Aug;5(8): Ruddox V, Mathisen M, Bækkevar M, et al. Is 3D echocardiography superior to 2D echocardiography in general practice?: A systematic review of studies published between 2007 and Int J Cardiol Jan Sadron Blaye-Felice MA, Séguéla PE, et al. Usefulness of three-dimensional transthoracic echocardiography for the classification of congenital bicuspid aortic valve in children. Eur Heart J Cardiovasc Imaging Dec;13(12): Scali MC, Basso M, Gandolfo A, et al. Real time 3D echocardiography (RT3D) for assessment of ventricular and vascular function in hypertensive and heart failure patients. Cardiovasc Ultrasound Jun 28;10:27. Three D Echocardiography April 16 17

18 23. Sudhakar S, Nanda NC. Role of live/real time three-dimensional transthoracic echocardiography in pericardial disease. Echocardiography Jan;29(1): Thavendiranathan P, Liu S, Verhaert D, et al. Feasibility, accuracy, and reproducibility of real-time full-volume 3D transthoracic echocardiography to measure LV volumes and systolic function: a fully automated endocardial contouring algorithm in sinus rhythm and atrial fibrillation. JACC Cardiovasc Imaging 2012; 5: Thorstensen A, Dalen H, Hala P, et al. Three-Dimensional Echocardiography in the Evaluation of Global and Regional Function in Patients with Recent Myocardial Infarction: A Comparison with Magnetic Resonance Imaging. Echocardiography Jan Tong K, Zhang J, Wang J, et al. Quantification of left and right ventricular systolic function in patients with dilated cardiomyopathy using real-time threedimensional echocardiography. Zhong Nan Da Xue Xue Bao Yi Xue Ban Jun;37(6): Zhao B, Li J, Zhu WH, et al. Real-time three-dimensional echocardiographic assessment of left ventricular diastolic dyssynchrony and dysfunction in hypertrophic cardiomyopathy. Nan Fang Yi Ke Da Xue Xue Bao Jan;33(1): Zhao B, Li J, Xu Y, Zhu HW, Zhi G. An initial study on left ventricular diastolic function in patients with hypertrophy cardiomyopathy using single-beat, realtime, three-dimensional echocardiography. J Geriatr Cardiol Sep;9(3): Zhu WH, Zhang J, Tong K, et al. Assessment of the right ventricular function in healthy volunteers with one beat full-volume real-time three-dimensional echocardiography. Zhonghua Xin Xue Guan Bing Za Zhi Aug;40(8): References Update March Chandra S, Vijay SK, Dwivedi SK, et al. Delineation of Anatomy of the Ruptured Sinus of Valsalva with Three-Dimensional Echocardiography: The Advantage of the Added Dimension. Echocardiography Feb 13. doi: /j x. [Epub ahead of print]. 2. Kurklinsky A, Mankad S. Three-dimensional Echocardiography in Valvular Heart Disease. Cardiol Rev Mar;20(2): Mor-Avi V, Lang RV, Sugeng L, et al. Three-dimensional echocardiography. UpToDate. May 25, Sonne C, Bott-Flügel L, Hauck S, et al. PLoS One. 2012;7(2):e Epub 2012 Feb 3. Acute Beneficial Hemodynamic Effects of a Novel 3D-Echocardiographic Optimization Protocol in Cardiac Resynchronization Therapy. References Update - March van der Zwaan HB, Helbing WA, MD, McGhiea JS, et al. Clinical Value of Real- Time Three-Dimensional Echocardiography for Right Ventricular Quantification in Congenital Heart Disease: Validation With Cardiac Magnetic Resonance Imaging. Journal of the American Society of Echocardiography - Volume 23, Issue 2 (February 2010). 2. Nishimura K, Okayama H, Inoue K, et al. Visualization of traumatic tricuspid insufficiency by three-dimensional echocardiography. J Cardiol Jan;55(1): Epub 2009 May Mor-Avi V, Lang RM, Sugeng L, et al. Three-dimensional echocardiography. UpToDate. June 15, Updated December 30, Three D Echocardiography April 16 18

19 4. Iriart X, Montaudon M, Lafitte S, et al. Right ventricle three-dimensional echography in corrected tetralogy of Fallot: accuracy and variability. Eur J Echocardiogr Eitel C, Döring M, Gaspar T, et al. Cardiac resynchronization therapy with individualized placement of two left ventricular leads at the sites of latest mechanical left ventricular contraction: guided by 3D-echocardiography and coronary sinus rotation angiography. Eur J Heart Fail Feb 11. [Epub ahead of print] 6. Horton KD, Whisenant B, Horton S, et al. Percutaneous Closure of a Mitral Perivalvular Leak Using Three Dimensional Real Time and Color Flow Imaging. J Am Soc Echocardiogr Feb 10. [Epub ahead of print]. 7. Novero LJ, Rosenkranz ER, Kardon RE, et al. Supravalvar Mitral Ring With Complete Atrioventricular Septal Defect: A Case Report and Three-Dimensional Echocardiography Evaluation. J Am Soc Echocardiogr Jan 29. [Epub ahead of print] References Initial 1. Mark J Monaghan. Role of real time 3D echocardiography in evaluating the left ventricle. Heart 2006;92: Sugeng L, Coon P, Weinert L, et al. Use of real-time 3-dimensional transthoracic echocardiography in the evaluation of mitral valve disease. J Am Soc Echocardiogr Apr;19(4): Perich Duran RM, Subirana Domenech MT, Malo Concepcion P. Progress in Pediatric Cardiology and Congenital Heart Defects. Rev Esp Cardiol Feb;59(Supl.1): Acar P. Three-dimensional echocardiography in congenital heart disease. Arch Pediatr Jan;13(1):51-6. Epub 2005 Nov Valocik G, Kamp O, Visser CA. Three-dimensional echocardiography in mitral valve disease. Eur J Echocardiogr Dec;6(6): Xie MX, Wang XF, Cheng TO, et al. Real-time 3-dimensional echocardiography: a of the development of the technology and its clinical application. Prog Cardiovasc Dis Nov-Dec;48(3): Chan KL, Liu X, Ascah KJ, et al. Comparison of real-time 3-dimensional echocardiography with conventional 2-dimensional echocardiography in the assessment of structural heart disease. J Am Soc Echocardiogr. 2004; 17(9): van den Bosch AE, Koning AHJ, Meijboom FJ, et al. Dynamic 3D echocardiography in virtual reality. Cardiovasc Ultrasound. 2005; 3: Devore GR. Three-dimensional and four-dimensional fetal echocardiography: a new frontier. Curr Opin Pediatr Oct;17(5): Frommelt PC. Update on pediatric echocardiography. Curr Opin Pediatr Oct;17(5): van den Bosch AE, Krenning BJ, Roelandt JR. Three-dimensional echocardiography. Minerva Cardioangiol Jun;53(3): Forster T. Present and future of non-invasive cardiologic diagnostics. Orv Hetil May 15;146(20 Suppl 2): Salehian O, Chan KL. Impact of three-dimensional echocardiography in valvular heart disease. Curr Opin Cardiol Mar;20(2): Gill EA Jr, Quaife RA. The echocardiographer and the diagnosis of patent foramen ovale. Cardiol Clin Feb;23(1): Roldan FJ, Vargas Barron J. Indications for and information of tridimensional echocardiography. Arch Cardiol Mex Jan-Mar;74 Suppl 1:S Three D Echocardiography April 16 19

20 16. von Bardeleben RS, Kuhl HP, Mohr-Kahaly S, Franke A. Second-generation realtime three-dimensional echocardiography. Finally on its way into clinical cardiology? Z Kardiol. 2004;93 Suppl 4:IV Naqvi TZ. Recent advances in echocardiography. Expert Rev Cardiovasc Ther Jan;2(1): Wang XF, Deng YB, Nanda NC, et al. Live three-dimensional echocardiography: imaging principles and clinical application. Echocardiography Oct;20(7): Bruining N, Roelandt JR, Grunst G, et al. Three-Dimensional Echocardiography: The Gateway to Virtual Reality! Echocardiography 1999, 16: Bruining N, Lancee C, Roelandt JR, Bom N: Three-dimensional echocardiography paves the way toward virtual reality. Ultrasound Med Biol 2000, 26: Agati L: Three-dimensional echocardiography: the virtual reality in cardiology luxury or useful technique? Eur Heart J 1996, 17: Salustri A, Roelandt JR. Three-dimensional echocardiography: where we are, where we are going? Ital Heart J 2000, 1: Sugeng L, Weinert L, Lang R.M. Left ventricular assessment using real time three dimensional echocardiography. Heart :iii29-iii Siu SC, Rivera JM, Guerrero JL, et al. Three-dimensional echocardiography in vivo validation for left ventricular volume and function. Circulation : Abstract 25. Sutariaa N, Northridgea D, Masanib N, Pandianc N. Three dimensional echocardiography for the assessment of mitral valve disease. Heart 2000;84(Suppl 2):ii7-ii Shiota T, McCarthy PM, White RD, et al. Initial clinical experience of real-time three-dimensional echocardiography in patients with ischaemic and idiopathic dilated cardiomyopathy. Am J Cardiol : Mondelli JA, Di Luzio S, Nagaraj A, Kane BJ, et al. The validation of volumetric real-time 3-dimensional echocardiography for the determination of left ventricular function. J Am Soc Echocardiogr : Lange A, Palka P, Burstow D, Godman M. Three-Dimensional Echocardiography: Historical Development and Current Applications. J Am Soc Echocardiogr 2001;14: Zabalgoitia M, Klas B. Three-dimensional echocardiography, Part 1: Understanding principles and techniques. J Crit Illness 1999;14: Wang X, Deng Y, Nanda N, Deng J, Miller A, Xie M, Live Three-Dimensional 31. Echocardiography: Imaging Principles and Clinical Application Echocardiography 2003;20: Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and Three D Echocardiography April 16 20

21 otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Three D Echocardiography April 16 21

22 Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Three D Echocardiography April 16 22