Automatic Implantable Cardioverter Defibrillator (AICD) and Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
© Blue Cross and Blue Shield of Montana
Current Effective Date:
April 18, 2013
Original Effective Date:
April 18, 2013
January 18, 2013
The automatic implantable cardioverter defibrillator (AICD) is a device designed to monitor a patient’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 AICD implantation can be broadly subdivided into the following:
- Primary prevention - for use in patients who are considered at high risk for sudden cardiac death but who have not yet experienced life-threatening VT or VF; and
- Secondary prevention - for use in patients who have experienced a potentially life-threatening episode of ventricular tachyarrhythmia (near sudden cardiac death).
Several automatic implantable cardioverter defibrillators are approved by the U.S. Food and Drug Administration (FDA) through the premarket application (PMA) approval process. The FDA-labeled indications generally include patients who have experienced life-threatening ventricular tachyarrhythmia associated with cardiac arrest, or ventricular tachyarrhythmia associated with hemodynamic compromise and resistance to pharmacologic treatment.
Devices manufactured by Guidant are approved by the FDA for use “in patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced at least one of the following: an episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained VT; or a prior myocardial infarction, left ventricular ejection fraction of less than or equal to 35%, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia.” On July 18, 2002, the FDA expanded the approved indications for the Guidant AICD devices to include the prophylactic use of Guidant AICDs for cardiac patients who have had a previous heart attack and have an ejection fraction that is less than or equal to 30%. This expanded indication is based on the results of the Multicenter Automatic Defibrillator Implantation Trial (MADIT II). Medtronic devices are approved “to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.” Other devices have approval language similar to Medtronic.
Subcutaneous Implantable Defibrillator System (S-ICD)
The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine implantable cardioverter debifrillator (ICD) placement procedure is not ideal such as patients with anatomy that makes it challenging to place one of the implantable defibrillators. The system uses a lead that is implanted just under the skin along the bottom of the rib cage and breast bone. Because the lead is placed under the skin rather than through a vein into the heart, a physician can implant the device without accessing a patient’s blood vessels or heart and without the need for fluoroscopy.
The S-ICD System is approved to provide an electric shock to the heart (defibrillation) when the patient’s heart is beating at a dangerous level or abnormally fast (ventricular tachyarrhythmias). It is approved only for patients who do not require a pacemaker or pacing therapy. (22)
- ischemic cardiomyopathy with New York Heart Association (NYHA) functional Class II or Class III symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 35% or less; or
- ischemic cardiomyopathy with NYHA functional Class I symptoms, a history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction of 30% or less; or
- nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible causes have been excluded, and the response to optimal medical therapy has been adequately determined; or
- hypertrophic cardiomyopathy (HCM) with 1 or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in 1 or more first-degree relatives younger than 50 years; left ventricular hypertrophy greater than 30 mm; 1 or more runs of nonsustained ventricular tachycardia at heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; prior unexplained syncope inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician experienced in the care of patients with HCM.
- Patients with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia.
- Patient’s with familial or inherited conditions with a high risk of life-threatening VT’s such as long QT syndrome or hypertrophic cardiomyopathy.
BCBSMT may consider the use of the ICD medically necessary in children who meet any of the following criteria:
- survivors of cardiac arrest, after reversible causes have been excluded;
- symptomatic, sustained ventricular tachycardia in association with congenital heart disease in patients who have undergone hemodynamic and electrophysiologic evaluation; or
- congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias.
37.94, 37.95, 37.96, 37.97, 37.98, 412, 414.8, 425.1, 425.4
Q20.0-Q20.9, Q21.0-Q21.9, Q22.0-Q22.9, Q23.0-Q23.9, Q24.0-Q24.9
33202, 33203, 33216, 33217, 33230, 33231, 33240, 33249, 93640, 93641, 93282, 93283, 93284, 93285, 93287, 93289, 93295, 93296, 93297, 0319T, 0320T, 0321T, 0326T, 0327T, 0328T, G0448
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