Clinical Policy Title: Echocardiographic assessment of myocardial strain for cancer patients

Transcription

1 Clinical Policy Title: Echocardiographic assessment of myocardial strain for cancer patients Clinical Policy Number: Effective Date: April 1, 2016 Initial Review Date: November 18, 2015 Most Recent Review Date: January 18, 2017 Next Review Date: January 2018 Policy contains: Echocardiography. Chemotherapy side effects. Related policies: None. ABOUT THIS POLICY: AmeriHealth Caritas Louisiana has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Louisiana s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Louisiana when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Louisiana s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Louisiana s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Louisiana will update its clinical policies as necessary. AmeriHealth Caritas Louisiana s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Louisiana considers the use of echocardiographic assessment of myocardial strain to measure cardiac impairment in cancer patients treated with chemotherapy to be clinically proven and, therefore, medically necessary. Limitations: All other uses of echocardiographic assessment of myocardial strain may or may not be medically necessary depending on the purpose of the test. Alternative covered services: Various uses of echocardiography. 1

2 Background Echocardiographic assessment of myocardial strain, also known as echocardiographic strain imaging or deformation imaging, is a relatively new means of assessing myocardial function. This technology is one of the diagnostic methods considered potentially more advanced than conventional echocardiography, as it is able to evaluate components of cardiac function, including those functions not visually accessible. Strain and strain-rate imaging are often effective means of measuring prognosis of cardiac disease, along with effects of various therapies on the heart. Strain is another means of describing stretching of the myocardial system, while strain rate is the rate of this deformity. The high prevalence of cancer and the growing number of chemotherapy drugs used to treat cancer patients make precise measurements of various organ functions a vital part of treatment. In particular, chemotherapy can be cardiotoxic; treatment-related cardiac death is the most prevalent noncancer cause of death in adult survivors of child cancer (Armstrong, 2015). Historical studies of early changes in myocardial function have used conventional echocardiography to assess biological impact, but in recent years other technologies have offered the potential to improve this diagnostic function. Among these new methods are two-dimensional (2-D) and three-dimensional (3-D) echocardiography, tissue Doppler-derived strain imaging, and speckle tracking echocardiography (STE). The most commonly-measured cardiac functions in postchemotherapy patients are left ventricular systolic (LVS) function and left ventricular ejection fraction (LVEF). Searches AmeriHealth Caritas Louisiana searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on November 4, Search terms were: myocardial strain, chemotherapy AND echocardiography, OR Tissue Doppler. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. 2

3 Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Chemotherapy-related cardiac dysfunction was originally measured by periodic surveillance of LVEF through nuclear imaging, magnetic resource imaging, and other means. Echocardiography now has surpassed these modalities as the preferred method of measuring cardiac dysfunction, as it is more accurate, available, and portable, and less radioactive (Abdel-Qadir, 2015). Studies measuring cardiac dysfunction have typically focused on breast cancer survivors or adult survivors of childhood cancer. Various chemotherapy drugs known to cause cardiovascular side effects have been studied, including but not limited to: Anthracyclines, including doxorubicin (Adriamycin) and epirubicin (Ellence). Human epidermal growth factor receptor type 2 monoclonal antibody. Trastuzumab (Herceptin). Many reports are not controlled trials assessing which type of echocardiography best detects cardiovascular problems, but merely address the efficacy of a particular form of echocardiography. Some professional societies have produced guidelines on the topic. One is from the European Society for Medical Oncology (Bovelli, 2010). A more recent version is from the American Society of Echocardiography and European Association of Cardiovascular Imaging (Plana, 2014). Both extol the benefits of echocardiography due to its ability to assess more than ventricular function in a relatively low-cost, noninvasive, and radiation-free manner. As echocardiography technology evolved and newer models were used, several experts raised the question of whether more specialized echocardiographs could be more sensitive to any reductions in cardiac functions after chemotherapy than conventional testing. One relatively early study used 2-D echocardiography to document lower global myocardial strain, strain rates, and time to peak systolic strain in long-term child cancer survivors vs. healthy controls, and speculated that 2-D echocardiography might provide superior results to conventional echocardiography (Mavinkurve-Groothuis, 2010). Another stated that myocardial strain imaging had the potential to detect changes in cardiac function from chemotherapy earlier than conventional echocardiography (Stoodley, 2011a). Several more recent controlled trials that compared efficacy of different types of echocardiography updated earlier findings: One systematic review found that for 1,504 chemotherapy patients, tissue Doppler strain imaging most consistently detected early myocardial changes during therapy, while STE most consistently detected peak systolic global longitudinal strain (GLS) (Thavendiranathan, 2014). 3

4 A study of 1,820 adult survivors of pediatric cancer, most of whom were treated with anthracycline chemotherapy, found 32.1 percent with normal LVEFs after 3-D echocardiography had evidence of cardiac dysfunction when GLS was used (Armstrong, 2015). A study of 57 pediatric cancer survivors treated with chemotherapy found that the most sensitive parameters identifying subjects with subclinical myocardial dysfunction were 1) 3-D echocardiographic ejection fraction, 2) end-systolic volume index, 3) 3-D STE peak GLS magnitude, and 4) a decrease in early atrial myocardial velocity at the interventricular septum by Doppler tissue imaging (Toro-Salazar, 2016). STE was found to identify significantly more subjects with abnormal peak systolic strain and peak circumferential strain in pediatric cancer patients vs. controls (Pignatelli, 2015). A comparison of 2-D and 3-D echocardiograms, with and without contrast, in 56 female breast cancer patients undergoing chemotherapy found that noncontrast 3-D tests best reproduced LVEF and LV volume (Thavendiranathan, 2013). Echocardiography of myocardial strain might also be helpful in predicting adverse cardiac events prior to chemotherapy. A report on patients with hematologic cancers who were given echocardiography prior to chemotherapy found pretreatment LVEF was lower in patients with subsequent events, compared to those with no events (Ali, 2016). More comparisons of types of echocardiographic assessment of cardiac damage after chemotherapy are warranted to better understand relative efficacy of each method on various populations. Policy updates: Six new peer-reviewed references were added to this policy in November Summary of clinical evidence: Citation Ali (2016) Comparison of several diagnostic tests in patients with hematologic cancer Armstrong (2015) Content, Methods, Recommendations Key points: Patients with hematologic cancer, treated with anthracyclines, who also underwent prechemotherapy echocardiography , mean follow-up over four years. 450 patients (6%) experienced cardiac events. Prechemotherapy LVEF and GLS were lower in patients with cardiac events. Diabetes, hypertension, LVEF, and GLS were linked with cardiac events. Prechemotherapy GLS can stratify patients at high risk for cardiac events after anthracycline chemotherapy. Key points: Detecting treatment-related 1,820 adult survivors of pediatric cancer, St. Jude Children s Research Hospital. 4

5 Citation cardiac dysfunction in adult survivors of child cancer Thavendiranathan (2014) Review of various means of detecting cardiac dysfunction in chemotherapy patients Thavendiranathan (2013) Content, Methods, Recommendations All exposed to anthracycline (1,050), chest-directed radiotherapy (306), or both (464). Of survivors with normal 3-D LVEF, 32.1% were found to have cardiac dysfunction by GLS (28%), American Society of Echocardiography (ASE)-graded diastolic assessment (8.7%), or both. GLS and ASE-graded diastolic assessment can identify survivors who may benefit from early medical intervention. Key points: Systematic review, 35 articles, n=1504 (all with cancer and chemotherapy). Peak systolic longitudinal strain rate most consistently detected early myocardial changes during therapy, when tissue Doppler-based strain imaging was used. Peak systolic GLS most consistently detected early myocardial changes during therapy when STE was used. Echocardiographic myocardial deformation parameters for early detection of myocardial changes and prediction of cardiotoxicity for chemotherapy patients are effective. Key points: Reproducibility of methods to assess LVEF using echocardiography for chemotherapy patients 56 female breast cancer chemotherapy patients, stable for GLS up to 12 months posttreatment. Each given echocardiogram at 3, 6, 9, and 12 months after treatment, including 2-D and 3-D procedures with and without contrast administration. Noncontrast 3-D echocardiography was the most reproducible technique for LVEF and LV volume measurements. References Professional society guidelines/other: Bovelli D, Plataniotis G, Roila F, on behalf of the ESMO Guidelines Working Group. Cardiotoxicity of chemotherapeutic agents and radiotherapy-related heart disease: ESMO Clinical Practice Guidelines. Ann Oncol. 2010;21 Suppl 5:v Eschenhagen T, Force T, Ewer MS, et al. Cardiovascular side effects of cancer therapies: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2011; 13:1 10. Plana JC, Galderisi M, Barac A, et al. Expert consensus for multimodality imaging evaluation of adult patients during and after cancer therapy: a report from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. European Heart Journal Cardiovascular Imaging. 2014;15: Yancy CW, Jessup M, Bozkurt B, et al ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62:

6 Peer-reviewed references: Abdel-Qadir H, Amir E, Thavendiranathan P. The use of myocardial strain and newer echocardiography imaging techniques in cancer patients. Future Oncology. 2015;11(14): Ali MT, Yucel E, Bouras S, et al. Myocardial strain is associated with adverse clinical cardiac events in patients treated with anthracyclines. J Am Soc Echocardiogr. 2016;29(6): Al-Biltagi M, Abd Rab Elrasoul Tolba O, El-Shanshory MR, et al. Strain echocardiography in early detection of doxorubicin-induced left ventricular dysfunction in children with acute lymphoblastic leukemia. ISRN Pediatr. Epub January 24, Doi: /2012/ Armstrong GT, Joshi VM, Ness KK, et al. Comprehensive echocardiographic detection of treatment-related cardiac dysfunction in adult survivors of childhood cancer: results from the St. Jude Lifetime Cohort Study. J Am Coll Cardiol. 2015;65(23): Baratta S, Damiano M, Marchese M, et al. Serum markers, conventional Doppler echocardiography and two-dimensional systolic strain in the diagnosis of chemotherapy-induced myocardial toxicity. Rev Argent Cardiol. 2013;81: Dandel M, Lehmkuhl H, Knosalla C, Suarmelashvili N, Hetzer R. Strain and strain rate imaging by echocardiography basic concepts and clinical applicability. Curr Cardiol Rev. 2009;5(2): Fallah-Rad N, Walker JR, Wassef A, et al. The utility of cardiac biomarkers, tissue velocity and strain imaging, and cardiac magnetic resonance imaging in predicting early left ventricular dysfunction in patients with human epidermal growth factor receptor II-positive breast cancer treated with adjuvant trastuzumab therapy. J Am Coll Cardiol. 2011;57: Geyer H, Caracciolo G, Abe H, et al. Assessment of myocardial mechanics using speckle tracking echocardiography: fundamentals and clinical applications. J Am Soc Echocardiogr. 2010;23: Gorscan J, Tanaka H. Echocardiographic assessment of myocardial strain. Am Coll Cardiol. 2011;58(14): Hare JL, Brown JK, Leano R, Jenkins C, Woodward N, Marwick TH. Use of myocardial deformation imaging to detect preclinical myocardial dysfunction before conventional measures in patients undergoing breast cancer treatment with trastuzumab. Am Heart J. 2009;158: Ho E, Brown A, Barrett P, et al. Subclinical anthracycline- and trastuzumab-induced cardiotoxicity in the long-term follow-up of asymptomatic breast cancer survivors: a speckle tracking echocardiographic study. Heart. 2010;96:

7 Jurcut R, Wildiers H, Ganame J, et al. Strain rate imaging detects early cardiac effects of pegylated liposomal doxorubicin as adjuvant therapy in elderly patients with breast cancer. J Am Soc Echocardiogr. 2008;21: Mavinkurve-Groothuis AM, Groot-Loonen J, Marcus KA, et al. Myocardial strain and strain rate in monitoring subclinical heart failure in asymptomatic long-term survivors of childhood cancer. Ultrasound Med Biol. 2010;36: Mavinkurve-Groothuis AM, Marcus KA, Pourier M, et al. Myocardial 2D strain echocardiography and cardiac biomarkers in children during and shortly after anthracycline therapy for acute lymphoblastic leukaemia (ALL): a prospective study. Eur Heart J Cardiovasc Imaging. 2013;14: Mornos C, Petrescu L. Early detection of anthracycline-mediated cardiotoxicity: the value of considering both global longitudinal left ventricular strain and twist. Can J Physiol Pharmacol. 2013;91: Monsuez JJ. Detection and prevention of cardiac complications of cancer chemotherapy. Arch Cardiovasc Dis. 2012;105(11): Negishi K, Negishi T, Haluska BA, Hare JL, Plana JC, Marwick TH. Use of speckle strain to assess left ventricular responses to cardiotoxic chemotherapy and cardioprotection. Eur Heart J Cardiovasc Imaging. 2014;15: Park JH, Kim YH, Hyun MC, Kim HS. Cardiac functional evaluation using vector velocity imaging after chemotherapy including anthracyclines in children with cancer. Korean Circ J 2009;39: Pignatelli RH, Ghazi P, Reddy SC, et al. Abnormal myocardial strain indices in children receiving anthracycline chemotherapy. Pediatr Cardiol. 2015;36(8): Sawaya H, Sebag IA, Plana JC, et al. Early detection and prediction of cardiotoxicity in chemotherapytreated patients. Am J Cardiol 2011; 107: Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344: Smith LA, Cornelius VR, Plummer CJ, et al. Cardiotoxicity of anthracycline agents for the treatment of cancer: systematic review and meta-analysis of randomised controlled trials. BMC Cancer. 2010;10:337. doi: / Stoodley PW, Richards DA, Meikle SR, Clarke J, Hui R, Thomas L. The potential role of echocardiographic strain imaging for evaluating cardiotoxicity due to cancer therapy. Heart Lung Circ. 2011a;20(1):3 9. 7

8 Stoodley PW, Richards DA, Hui R, et al. Two-dimensional myocardial strain imaging detects changes in left ventricular systolic function immediately after anthracycline chemotherapy. Eur J Echocardiogr. 2011b;12: Stoodley PW, Richards DA, Boyd A, et al. Left ventricular systolic function in HER2/neu negative breast cancer patients treated with anthracycline chemotherapy: a comparative analysis of left ventricular ejection fraction and myocardial strain imaging over 12 months. Eur J Cancer. 2013;49(16): Thavendiranathan P, Grant AD, Negishi T, Plana JC, Popovic ZB, Marwick TH. Reproducibility of echocardiographic techniques for sequential assessment of left ventricular ejection fraction and volumes: application to patients undergoing cancer chemotherapy. J Am Coll Cardiol. 2013;61: Thavendiranathan P, Poulin F, Lim KD, Plana JC, Woo A, Marwick TH. Use of myocardial strain imaging by echocardiography for the early detection of cardiotoxicity in patients during and after chemotherapy: a systematic review. J Am Coll Cardiol. 2014;63(25 Pt A): Toro-Salazar OH, Ferranti J, Lorenzoni R, et al. Feasibility of echocardiographic techniques to detect subclinical cancer therapeutics-related cardiac dysfunction among high-dose patients when compared with cardiac magnetic resonance imaging. J Am Soc Echocardiogr. 2016;29(2): Yagci-Kupeli B, Varan A, Yorgun H, Kaya B, Buyukpamukcu M. Tissue Doppler and myocardial deformation imaging to detect myocardial dysfunction in pediatric cancer patients treated with high doses of anthracyclines. Asia Pac J Clin Oncol. 2012;8: Yu HK, Yu W, Cheuk DK, Wong SJ, Chan GC, Cheung YF. New three-dimensional speckle-tracking echocardiography identifies global impairment of left ventricular mechanics with a high sensitivity in childhood cancer survivors. J Am Soc Echocardiogr. 2013;26: Yu W, Li SN, Chan GC, Ha SY, Wong SJ, Cheung YF. Transmural strain and rotation gradient in survivors of childhood cancers. Eur Heart J Cardiovasc Imaging. 2013;14: CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes 8

9 Below are the most commonly submitted codes for the services and items subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code 0399T Description Myocardial strain imaging (quantitative assessment of myocardial mechanics using image-based analysis of local myocardial dynamics) (List separately in addition to code for primary procedure) Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, with spectral Doppler echocardiography, and with color flow Doppler echocardiography Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, without spectral or color Doppler echocardiography Comments ICD 10 Description Code I51.89 Chemotherapy-related cardiac dysfunction (CTRCD) Comments T45.1X5 Z08 HCPCS Code None Adverse effect of Doxorubicin, Mitoxantrone, 5-FU Encounter for follow-up examination after completed treatment for malignant neoplasm Description Comments 9