Percutaneous Transluminal Septal Myocardial Ablation
DESCRIPTION
Percutaneous transluminal septal myocardial ablation (PTSMA), also known as alcohol septal ablation, is used to treat hypertrophic obstructive cardiomyopathy (HOCM). The current "gold standard" treatment for this disease is ventricular septal myotomy-myomectomy of Morrow (open-heart surgery), which consists of surgical resection of a small amount of muscle from the subaortic portion of the septum. This approach has demonstrated that relief of outflow tract obstruction occurs in 70-90% of individuals and improves symptoms and outcomes. It is, however, a major operation with significant morbidity and mortality.
HOCM (also known as left ventricular outflow tract obstruction) occurs in a small subset of individuals who have the autosomal-dominantly inherited genetic disease familial hypertrophic cardiomyopathy. Individuals with this disease are at risk for sudden death, angina, syncope, and heart failure. HOCM can occur at rest, be induced with the Valsalva maneuver or with dobutamine, isoproterenol infusion, or amyl nitrite inhalation. These individuals can have multiple cardiac irregularities with ventricular dysfunction, and the disease is usually disabling and progressive.
PTSMA is a catheter-based treatment used for severely symptomatic medically refractory HOCM. A balloon catheter is used to cannulate and isolate the first or second septal perforator coronary artery. After the balloon inflation and intracoronary myocardial contrast echocardiography is completed, ethyl alcohol is injected through the catheter lumen to cause proximal intraventricular septum infarction. This causes relief of outflow tract obstruction with improvement of symptoms. Septal scarring and thinning with reductions in the outflow tract gradients ensues over the following six to twelve weeks. PTSMA has been proposed as a procedure that can be performed easily in the catheterization laboratory and seems to be effective, at least in the short-term follow-up period.
POLICY
Percutaneous transluminal septal myocardial ablation for the treatment of hypertrophic obstructive cardiomyopathy is considered medically necessary as an alternative to myomectomy if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Percutaneous transluminal septal myocardial ablation for the treatment of all other conditions is considered investigational.
MEDICAL APPROPRIATENESS
Percutaneous transluminal septal myocardial ablation is considered medically appropriate as an alternative to myomectomy if ANY ONE of the following criteria are met:
Class II symptomatic heart failure as defined by the New York Heart Association (NYHA) Classification when concomitant risk factors for sudden cardiac death also exist
Class III or IV symptomatic heart failure as defined by the New York Heart Association (NYHA) Classification if ALL of the following criteria are met:
Basal outflow gradient greater than or equal to 50 mm Hg
Hypertrophic obstructive cardiomyopathy refractory to medical therapy.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
Studies have not sought to evaluate the clinical importance of percutaneous transluminal septal myocardial ablation for uses other than as an alternative to myomectomy for the treatment of hypertrophic obstructive cardiomyopathy.
SOURCES
Alam, M., Dokainish, H., & Lakkis, N. (2006). Alcohol septal ablation for hypertrophic obstructive cardiomyopathy: A systematic review of published studies. Journal of Interventional Cardiology, 19 (4), 319-327. Abstract retrieved June 18, 2007 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2003). Transcoronary ablation of septal hypertrophy [TASH] (2.02.14). Retrieved February 1, 2010 from BlueWeb.
Fernanes, V. L., Nielsen, C., Nagueh, S. F., Herrin, A. E., Slifka, C., Franklin, J., et al. (2008, October). Follow-up of alcohol septal ablation for symptomatic hypertrophic obstructive cardiomyopathy the Baylor and Medical University of South Carolina experience 1996 to 2007. Journal of the American College of Cardiology, 1 (5), 561-570. Abstract retrieved February 1, 2010 from PubMed database.
Journal of the American College of Cardiology. (2007, June). Predictors of complete heart block after transcoronary ablation of septal hypertrophy. Results of a prospective electrophysiological investigation in 172 patients with hypertrophic obstructive cardiomyopathy. Retrieved June 18, 2007 from http://content.onlinejacc.org/cgi/content/abstract/49/24/2356.
U. S. National Institutes of Health. (2006, July). Clinical Trials. A comparison of two treatments: Pacemaker and percutaneous transluminal septal ablation for hypertrophic cardiomyopathy. Retrieved June 19, 2007 from http://clinicaltrials.gov/ct/show/NCT00001894?order=1.
U. S. National Institutes of Health. (2006, July). Clinical Trials. Alcohol septal ablation in obstructive hypertrophic cardiomyopathy: A pilot study. Retrieved June 19, 2007 from http://clinicaltrials.gov/ct/show/NCT00035386?order=2.
Veselka, J., Duchonova, R., Palenickova, J., Zemanek, D., Tiserova, M., Linhartova, K., et al. (2006). Impact of ethanol dosing on the long-term outcome of alcohol septal ablation for obstructive hypertrophic cardiomyopathy: A single-center prospective, and randomized study. Circulation Journal, 70 (12), 1550-1552. Abstract retrieved June 18, 2007 from PubMed database.
ORIGINAL EFFECTIVE DATE: 9/1/2001
MOST RECENT REVIEW DATE: 4/8/2010
ID_BT
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