Medical Policy and and and and

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1 ARBenefits Approval: 10/12/2011 Effective Date: 01/01/2012 Revision Date: Code(s): 93799, Unlisted cardiovascular service or procedure Medical Policy Title: Percutaneous Transluminal Septal Myocardial Ablation Document: ARB0341 Administered by: Public Statement: 1) Percutaneous Transluminal Septal Myocardial Ablation (PTSMA), also known as Transcoronary Ablation of Septal Hypertrophy (TASH), is a minimally invasive treatment of an unusual form of cardiomyopathy. 2) PTSMA is done to improve the heart's ability to pump blood when the septum has become enlarged and thickened from Hypertrophic Obstructive Cardiomyopathy (HOCM). The septum is the heart muscle that separates the right and left ventricles of the heart. The septal enlargement and thickening blocks the heart from being able to pump blood out efficiently. HOCM may cause symptoms such as chest pain, shortness of breath, and dizziness, especially with exertion. HOCM may even cause sudden death. 3) PTSMA is subject to review for medical necessity. Medical Policy Statement: 1) Percutaneous Transluminal Septal myocardial ablation (PTSMA) by alcohol-induced septal branch occlusion is considered medically necessary for hypertrophic obstructive cardiomyopathy (HOCM) in adults when all of the following criteria are met: a) Member has severe symptoms (e.g., dyspnea, angina pectoris, [pre]syncope, palpitations or heart failure) despite optimal drug therapy (e.g., beta-blockers, calcium-antagonists), dual chamber pacing (DDD) therapy and/or ineffective previous surgical myotomy/myectomy; and b) Member is classified as New York Heart Association class III or IV ; and c) Member has a classical, asymmetric subaortic HOCM identified by echocardiography (ECHO), and not other forms of cardiomyopathy; and d) ECHO shows left ventricular wall thickness of greater than 13 mm in adults in the absence of another cause for left ventricular hypertrophy (LVH); and Page 1 of 5

2 e) Member has systolic anterior motion of the mitral valve on ECHO; and f) Member has a resting left ventricular outflow tract (LVOT) gradient of greater than 30 mm Hg or a stressed gradient of greater than 60 mm Hg, or member has less severe symptoms and LVOT of greater than 50 mm Hg at rest or greater than 100 mm Hg under stress; and g) Member does not have coronary artery disease (CAD) that would preclude performance of the procedure. HAYES B The Stages of Heart Failure NYHA Classification In order to determine the best course of therapy, physicians often assess the stage of heart failure according to the New York Heart Association (NYHA) functional classification system. This system relates symptoms to everyday activities and the patient's quality of life. Class Class I (Mild) Class II (Mild) Class III (Moderate) Class IV (Severe) Patient Symptoms No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Limits: Percutaneous transluminal septal myocardial ablation is considered experimental and investigational for all other indications. Background: 1) Hypertrophic obstructive cardiomyopathy (HOCM), also known as idiopathic hypertrophic subaortic stenosis (IHSS), is a primary, sometimes familial and Page 2 of 5

3 genetically determined myocardial hypertrophy with an incidence of about 0.2%. About 25% of the patients have dynamic left ventricular outflow tract (LVOT) obstruction, which usually develops during puberty and increases in severity until the age of 18 to 20 years. Not infrequently, HOCM is diagnosed for the first time in the elderly. 2) This condition is characterized by a super-normally contracting left ventricle, asymmetric septal hypertrophy, which affects mainly the interventricular septum, increased ventricular wall thickness (left ventricular wall thickness of > 13 mm in adults in the absence of another cause for left ventricular hypertrophy (LVH); 15 mm in an athlete), and systolic anterior motion of the mitral valve. 3) Asymptomatic adult patients probably do not require therapy or risk stratification studies, unless there is a malignant family history of sudden death or occupational need (airline pilot). Management decisions are dominated by the need to address sometimes disabling symptoms of dyspnea, angina pectoris, stress-induced syncope, palpitations or heart failure, and risk of sudden death. Treatment of symptomatic patients with HOCM aims at reduction of the left ventricular outflow tract gradient and improvement of diastolic filling either by pharmacological therapy with negative inotropic drugs (beta-blockers, calcium-antagonists), permanent DDD pacemaker therapy (i.e., dual chamber, dual pacing, dual sensing), or surgical myotomy/myectomy. 4) Left ventricular myotomy and myectomy (Morrow's procedure) has been the standard therapy for patients with severe symptoms (New York Heart Association functional class III-IV) that persist despite adequate pharmacotherapy and DDD pacing. 5) In 1994, as an alternative to surgery, non-surgical Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) by alcohol-induced septal branch occlusion was introduced to decrease left ventricular outflow tract (LVOT) gradient and improve symptoms in patients with HOCM. This method was substantially improved by the introduction of echocardiographic guidance in ) PTSMA involves transcatheter selection of one or two small septal branches of the left anterior descending artery, threading a small, short, low-pressure angioplasty balloon into position to occlude the artery, and the instillation of absolute alcohol into the myocardium. The resultant localized myocardial infarction reduces the amount of septal myocardium, opening up the left ventricular outflow tract. Compared with surgical myectomy, the literature shows that PTSMA has the advantage of being minimally invasive, easily repeated, and with relatively low major morbidity/mortality risk for patients with co-morbid conditions. References: 1. Hayes Inc, Medical Technology Directory; Alcohol ablation for obstructive cardiomyopathy, Jan Page 3 of 5

4 2. Spirito P. Alcohol septal ablation in the management of obstructive hypertrophic cardiomyopathy. Ital Heart J. 2000;1(11): Maron BJ. Role of alcohol septal ablation in treatment of obstructive hypertrophic cardiomyopathy. Lancet. 2000;355(9202): Seggewiss H. Current status of alcohol septal ablation for patients with hypertrophic cardiomyopathy. Curr Cardiol Rep. 2001;3(2): Kim JJ. Improvement in exercise capacity and exercise blood pressure response after transcoronary alcohol ablation therapy of septal hypertrophy in hypertrophic cardiomyopathy. Am J Cardiol. 1999;83(8): Kuhn H. Transcoronary ablation of septal hypertrophy (TASH): A new treatment option for hypertrophic obstructive cardiomyopathy. Z Kardiol. 2000;89(Suppl 4):IV41-IV Faber L. Percutaneous transluminal septal myocardial ablation for hypertrophic obstructive cardiomyopathy: Long term follow up of the first series of 25 patients. Heart. 2000;83(3): Seggewiss H. Current status of alcohol septal ablation for patients with hypertrophic cardiomyopathy. Curr Cardiol Rep. 2001;3(2): Qin JX, Shiota T, Lever HM, et al. Outcome of patients with hypertrophic obstructive cardiomyopathy after percutaneous transluminal septal myocardial ablation and septal myectomy surgery. J Am Coll Cardiol. 2001;38(7): Mutlak D, Gruberg L, Reisner S, et al. Non-surgical myocardial reduction in hypertrophic obstructive cardiomyopathy. Isr Med Assoc J. 2002;4(2): Jiang T, Wu X, Jia C, et al. Percutaneous transluminal septal myocardial ablation in patients with hypertrophic obstructive cardiomyopathy. Chin Med J (Engl). 2002;115(1): Kovacic JC, Muller D. Hypertrophic cardiomyopathy: State-of-the-art review, with focus on the management of outflow obstruction. Intern Med J. 2003;33(11): National Institute for Clinical Excellence (NICE). Interventional procedure overview of non-surgical reduction of myocardial septum. London, UK: NICE; November Available at: Accessed September 13, Li ZQ, Cheng TO, Zhang WW, et al. Percutaneous transluminal septal myocardial ablation for hypertrophic obstructive cardiomyopathy: The Chinese experience in 119 patients from a single center. Int J Cardiol. 2004;93(2-3): Veselka J, Prochazkova S, Duchonova R, et al. Alcohol septal ablation for hypertrophic obstructive cardiomyopathy: Lower alcohol dose reduces size of infarction and has comparable hemodynamic and clinical outcome. Catheter Cardiovasc Interv. 2004;63(2): National Institute for Clinical Excellence (NICE). Non-surgical reduction of myocardial septum. Interventional Procedure Guidance 40. London, UK: NICE; February Available at: Accessed September 13, Page 4 of 5

5 17. van der Lee C, ten Cate FJ, Geleijnse ML, et al. Percutaneous versus surgical treatment for patients with hypertrophic obstructive cardiomyopathy and enlarged anterior mitral valve leaflets. Circulation. 2005;112(4): Alam M, Dokainish H, Lakkis N. Alcohol septal ablation for hypertrophic obstructive cardiomyopathy: a systematic review of published studies. J Inter Cardiol Aug.; 19(4); Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 5 of 5