BlueCross BlueShield of Tennessee Medical Policy Manual

Cardioverter Defibrillators

DESCRIPTION

Cardioverter defibrillators are designed to monitor an individual’s heart rate, recognize ventricular fibrillation (VF) or ventricular tachycardia (VT) and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death.  Indications for cardioverter defibrillators include (1) secondary prevention in individuals who have experienced a potentially life-threatening episode of VT (near sudden death) and (2) primary prevention for use in individuals who are considered at high risk for sudden cardiac death (SCD) but who have not yet experienced life-threatening VT or VF.

There are three types of cardioverter defibrillators: implantable cardioverter defibrillator (ICD), subcutaneous ICD (S-ICD®) and wearable cardioverter defibrillator (WCD).

The ICD involves placement of a generator in the subcutaneous tissue of the chest wall.  Transvenous leads are attached to the generator and threaded intravenously into the endocardium.  The leads sense and transmit information on cardiac rhythm to the generator which analyzes the rhythm information and produces an electrical shock when a malignant arrhythmia is recognized.

The S-ICD uses a subcutaneous electrode that is implanted adjacent to the left sternum.  The electrodes sense the cardiac rhythm and deliver countershocks through the subcutaneous tissue of the chest wall.

A WCD is a temporary, external device intended for temporary conditions when an implantable device is contraindicated.  The WCD consists of a vest that is worn continuously underneath the individual’s clothing.  The vest includes an electrode belt that contains the cardiac-monitoring electrodes and the therapy electrodes that deliver a counter shock.  The vest is connected to a monitor with a battery pack and alarm module that is worn on the individual’s belt.  The monitor contains the electronics that interpret the cardiac rhythm and determines when a counter shock is necessary.  The alarm module alerts the individual to certain conditions by lights or voice messages.  The Lifecor WCD® 2000 system received FDA approval in December 2001.  The vest was renamed and is now called the Zoll® LifeVest.

POLICY

MEDICAL APPROPRIATENESS  

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

There is a lack of relevant published evidence to determine the net health outcome of the wearable cardioverter defibrillator for any other indications.

SOURCES

Adler, A., Halkin, A., & Viskin, S. (2013). Wearable cardioverter-defibrillators. Circulation, 127, 854-860. (Level 5 evidence)

American College of Cardiology Foundation, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computer Tomography and Society for Cardiovascular Magnetic Resonance. (2013). ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy. Retrieved February 14, 2014 from http://dx.doi.org/10.1016/.jhrthm.2013.01.008.

BlueCross BlueShield of Tennessee. Medical Policy Reference Manual. (5:2017). Wearable cardioverter defibrillators (2.02.15). Retrieved July 19, 2017 from BlueWeb. (30 articles and/or guidelines reviewed)

BlueCross BlueShield of Tennessee. Medical Policy Reference Manual. (5:2017). Implantable cardioverter defibrillators (7.01.44). Retrieved July 19, 2017 from BlueWeb. (102 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for implantable automatic defibrillators (20.4). Retrieved December 4, 2015 from www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?

CGS Administrators, LLC. (2017, January). LCD for automatic external defibrillators (L33690). Retrieved July 19, 2017 from www.cms.gov.

Duncker, D., König, T., Hohmann, S., Bauersachs, J., & Veltmann, C. (2017). Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: insights from the PROLONG study. Clinical Cardiology, 2017 Mar 23. Doi: 10.1002/clc.22706. [Epub ahead of print]. Abstract retrieved July 19, 2017 from PubMed database.

Duncker, D., König, T., Hohmann, S., Bauersachs, J., & Veltmann, C. (2017). Avoiding untimely implantable cardioverter/defibrillator implantation by intensified heart failure therapy optimization supported by the wearable cardioverter/defibrillator - The PROLONG study. Journal of the American Heart Association, 6 (1). Pii: e004512. Abstract retrieved July 19, 2017 from PubMed database.

ECRI Institute. Emerging Technology Evidence Report. (2015, September). Subcutaneous implantable cardioverter defibrillator for treating life-threatening ventricular tachyarrhythmia. Retrieved February 4, 2016 from ECRI Institute. (90 articles and/or guidelines reviewed)

Epstein, A.E., Abraham, W.T., Bianco, N.R., Kern, K.B., Mirro, M., et al. (2013). Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. Journal of the American College of Cardiology, 62 (21), 2000-2007. Abstract retrieved December 4, 2015 from PubMed database.

Epstein, A.E., DiMarco, J.P., Ellenbogen, K.A., Estes, N.A.M III, Freedman, R.A., Gettes, L.S. et al. (2013). 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Journal of the American College of Cardiology, 61, e6-e75.

European Society of Cardiology. (2015). 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Retrieved March 16, 2016 from http://eurheartj.oxfordjournals.org.

Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. (2011). 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy. Journal of Thoracic and Cardiovascular Surgery, 142, e153-e203.

Goldberger, J.J., Subacius, H., Patel, T., Cunnane, R., & Kadish, A.H. (2014). Sudden cardiac death risk stratification in patients with nonischemic dilated cardiomyopathy. Journal of the American College of Cardiology, 63(18), 1879-1889. (Level 1 evidence)

Gronda, E., Bourge, R.C., Costanzo, M.R., Deng, M., Mancini, D., Martinelli, L., & Torre-Amione, G. (2006). Heart rhythm considerations in heart transplant candidates and considerations for ventricular assist devices: International Society for heart and lung transplantation guidelines for the care of cardiac transplant guidelines - 2006. Journal Heart Lung Transplant, 25, 1043-1056.

Hohnloser, S.H., & Israel, C.W. (2013). Current evidence base for use of the implantable cardioverter-defibrillator. Circulation, 128, 172-183. (Level 1 evidence)

Jessup, M., Abraham, W.T., Casey, D.E., Feldman, A.M., Francis, G.S., Ganiats, T.G., et al. (2009). 2009 focused update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology, 53, 1343-1382.

Kao, A., Krause, S., Handa, R., Karia, D., Reyes, G., Bianco, N., et al. (2012). Wearable defibrillator use in heart failure (WIF): results of a prospective registry. BMC Cardiovascular Disorders, 12 (123), 1-7. (Level 3 evidence)

Kutyifa, V., Moss, A., Klein, H., Biton, Y., McNitt, S., Mackecknie, B., Zareba, W., & Goldenberg, I. (2015). Use of the wearable cardioverter defibrillator in high-risk cardiac patients. Circulation, 132, 1613-1619. (Level 1 evidence)

Moss, A., Zareba, W., Hall, J., Klein, H., Wilber, D., Cannom, D., et al. (2002). Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. The New England Journal of Medicine, 346 (12), 877-883. (Level 2 evidence)

National Institute for Health and Care Excellence. (2013, April). Insertion of a subcutaneous implantable cardioverter defibrillator for prevention of sudden cardiac death. Retrieved February 10, 2014 from http://guid>>Piccini, J.P. Sr., Allen, L.A., Kudenchuk, P.J., Page, R.L., Patel, M.R., Turakhia, M.P.; on behalf of the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing. Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death: a science advisory from the American Heart Association. Circulation, 2016, 133: 1715-1727. DOI 10.1161/CIR.0000000000000394.

Salehi, N., Nasiri, M., Bianco, N., Opreanu, M., Singh, V., Satija, V., et al. (2016). The wearable cardioverter defibrillator in nonischemic cardiomyopathy: a US national database analysis. Canadian Journal of Cardiology, 32 (10), 1247. Abstract retrieved July 19, 2017 from PubMed database.

U. S., Food and Drug Administration. (2012, September). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database, P110042. Retrieved November 16, 2012 from http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042a.pdf.

U.S. Food and Drug Administration. (2001, December). Center for Devices and Radiological Health. Pre-market approval decisions for December 2001. P010030 Wearable cardioverter defibrillator (WCD) 2000 Lifevest. Retrieved November 30, 2015 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p010030.

Weiss, R., Knight, B., Gold, M., Leon, A., Herre, J., Hood, M., et al. (2013). Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation, 2013; 128:944-953.

Yancy, C.W., Jessup, M., Bozkurt, B., Butler, J., Casey D.E., Drazner, M.H., et al. (2013). 2013 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. Journal of the American College of Cardiology, 62, e147-e239.  

Zipes, D.P., Camm, A.J., Borggrefe, M., Buxton, A.E., Chaitman, B., Fromer, M., et al.  (2006). ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). Circulation,114,e385-e484.

ORIGINAL EFFECTIVE DATE:  6/13/2015

MOST RECENT REVIEW DATE:  12/20/2017

ID_BT

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