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Protocol Implantable Cardioverter Defibrillator (70144) Medical Benefit Preauthorization Yes Effective Date: 01/01/16 Next Review Date: 11/16 Review Dates: 02/07, 02/08, 03/09, 01/10, 01/11, 09/11, 09/12, 01/13, 01/14, 05/14, 01/15, 11/15 Preauthorization is required. The following Protocol contains medical necessity criteria that apply for this service. The criteria are also applicable to services provided in the local Medicare Advantage operating area for those members, unless separate Medicare Advantage criteria are indicated. If the criteria are not met, reimbursement will be denied and the patient cannot be billed. Please note that payment for covered services is subject to eligibility and the limitations noted in the patient’s contract at the time the services are rendered. Populations Individuals: • With a high risk of sudden cardiac death due to ischemic cardiomyopathy in adulthood Interventions Interventions of interest are: • Transvenous implantable cardioverter defibrillator placement Comparators Comparators of interest are: • Medical management without implantable cardioverter-defibrillator placement Individuals: • With a high risk of sudden cardiac death due to nonischemic dilated cardiomyopathy in adulthood Interventions of interest are: • Transvenous implantable cardioverter defibrillator placement Comparators of interest are: • Medical management without implantable cardioverter-defibrillator placement Individuals: • With a high risk of sudden cardiac death due to hypertrophic cardiomyopathy in adulthood Interventions of interest are: • Transvenous implantable cardioverter defibrillator placement Comparators of interest are: • Medical management without implantable cardioverter-defibrillator placement Outcomes Relevant outcomes include: • Overall survival • Morbid events • Quality of life • Treatment-related morbidity • Treatment-related mortality Relevant outcomes include: • Overall survival • Morbid events • Quality of life • Treatment-related morbidity • Treatment-related mortality Relevant outcomes include: • Overall survival • Morbid events • Quality of life • Treatment-related morbidity • Treatment-related mortality Page 1 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 Populations Individuals: • With high risk of sudden cardiac death due to an inherited cardiac ion channelopathy Interventions Interventions of interest are: • Transvenous implantable cardioverter defibrillator placement Comparators Comparators of interest are: • Medical management without implantable cardioverter-defibrillator placement Individuals: • With indications for implantable cardioverter defibrillator without need for antibradycardia pacing and without arrhythmias responsive to antitachycardia pacing Interventions of interest are: • Subcutaneous implantable cardioverter defibrillator placement Comparators of interest are: • Transvenous implantable cardioverter-defibrillator placement Outcomes Relevant outcomes include: • Overall survival • Morbid events • Quality of life • Treatment-related morbidity • Treatment-related mortality Relevant outcomes include: • Overall survival • Morbid events • Quality of life • Treatment-related morbidity • Treatment-related mortality Description The automatic implantable cardioverter defibrillator (ICD) 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. A subcutaneous ICD (S-ICD) has been developed that does not employ transvenous leads, with the goal of reducing lead-related complications. Summary of Evidence The evidence for transvenous implantable cardioverter-defibrillator (TV-ICD) placement in individuals with high risk of sudden cardiac death (SCD) in adulthood due to ischemic or nonischemic cardiomyopathy includes multiple well-designed, well-conducted randomized controlled trials (RCTs) and systematic reviews of these trials. Relevant outcomes include overall survival, morbid events, quality of life, and treatment-related morbidity and mortality. There is an extensive literature base on the use of ICDs in patients with prior arrhythmogenic events and ischemic cardiomyopathy. Earlier trials first demonstrated a benefit in overall mortality for survivors of cardiac arrest and patients with potentially lethal cardiac arrhythmias. Multiple, well-done, RCTs have also demonstrated a benefit in overall mortality for patients with ischemic cardiomyopathy and reduced ejection fraction. RCTs of early ICD implantation following acute myocardial infarction (MI) do not support a benefit for immediate ICD implantation versus delayed implantation for at least 40 days. For nonischemic cardiomyopathy (NICM), there is less clinical trial evidence available, but the available evidence from a limited number of RCTs enrolling patients with NICM, and from subgroup analysis of RCTs with mixed populations, supports a survival benefit for this group. There is no high-quality evidence available to determine whether early versus delayed implantation improves outcomes for patients with NICM, and it is not possible to determine the optimal waiting period for ICD implantation following onset of NICM. At least one cohort study reports that most patients who meet criteria for an ICD at the time of initial NICM diagnosis will no longer meet the criteria for an ICD several months after initiation of treatment. The evidence is sufficient to determine qualtitatively that the technology results in a meaningful improvement in the net health outcome. The evidence for TV-ICD placement in individuals with high risk of SCD in adulthood due to hypertrophic cardiomyopathy (HCM) includes several large registry studies. Relevant outcomes include overall survival, morbid Page 2 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 events, quality of life, and treatment-related morbidity and mortality. In these studies, the annual rate of appropriate ICD discharge ranged from 3.6% to 5.3%. Given the long-term high risk of patients with HCM for SCD risk, with the assumption that appropriate shocks are life-saving, these rates are considered adequate evidence for the use of SCDs in patients with HCM. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome. The evidence for TV-ICD placement in individuals with high risk of SCD due to an inherited cardiac ion channelopathy includes small cohort studies of patients with these conditions treated with ICDs. Relevant outcomes include overall survival, morbid events, quality of life, and treatment-related morbidity and mortality. The limited available evidence for patients with long QT syndrome (LQTS), catecholaminergic polymorphic ventricular tachycardia (CPVT), and Brugada syndrome (BrS) reports high rates of appropriate shocks. No studies were identified on the use of ICDs for patients with short QT syndrome (SQTS). Studies comparing outcomes between patients treated and untreated with ICDs are not available. However, given the relatively small patient populations and the high risk of cardiac arrhythmias, clinical trials are unlikely. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for S-ICD placement in individuals with indications for a TV-ICD but without indications for antibradycardia pacing and without arrhythmias responsive to antitachycardia pacing includes nonrandomized controlled studies and case series. Relevant outcomes include overall survival, morbid events, quality of life, and treatment-related morbidity and mortality. Nonrandomized controlled studies report success rates in terminating laboratory-induced VFs that are similar to TV-ICD. However, there is scant evidence on comparative clinical outcomes of both types of ICD over longer periods of time. Case series report high rates of detection and successful conversion of VT, and inappropriate shock rates that are in the range reported for TV-ICD. This evidence is not sufficient to determine whether there are small differences in efficacy between the two types of devices, which may be clinically important due to the nature to the disorder being treated. Also, the adverse event (AE) rate is uncertain, with variable rates reported. At least one RCT is currently underway to compare SICD with TV-ICD. The evidence is insufficient to determine the effects of the technology on health outcomes. Policy Adults The use of the automatic implantable cardioverter defibrillator (ICD) may be considered medically necessary in adults who meet the following criteria: Primary Prevention • 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 one or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years; left ventricular hypertrophy greater than 30 mm; one 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 Page 3 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 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. • diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see Policy Guidelines): o congenital long QT syndrome; OR o Brugada syndrome; OR o short QT syndrome; OR o catecholaminergic polymorphic ventricular tachycardia. Secondary Prevention • Patients with a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes (e.g., acute ischemia) have been excluded. The use of the ICD is considered investigational in primary prevention patients who: • have had an acute myocardial infarction (i.e., less than 40 days before ICD treatment); • have NYHA Class IV congestive heart failure (unless patient is eligible to receive a combination cardiac resynchronization therapy ICD device); • have had cardiac revascularization procedure in past three months (coronary artery bypass graft [CABG] or percutaneous transluminal coronary angioplasty [PTCA]) or are candidates for a cardiac revascularization procedure; or • have noncardiac disease that would be associated with life expectancy less than one year. Pediatrics The use of the ICD may be considered 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. • hypertrophic cardiomyopathy (HCM) with one or more major risk factors for sudden cardiac death (history of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years; massive left ventricular hypertrophy based on age-specific norms; 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. • diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death (see Policy Guidelines): o congenital long QT syndrome; OR o Brugada syndrome; OR o short QT syndrome; OR o catecholaminergic polymorphic ventricular tachycardia. The use of the ICD is considered investigational for all other indications in pediatric patients. Page 4 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 Subcutaneous ICD The use of a subcutaneous ICD may be considered medically necessary for adults or children who have an indication for ICD implantation for primary or secondary prevention for any of the above reasons and meet all of the following criteria: • Have a contraindication to a transvenous ICD due to one or more of the following: (1) lack of adequate vascular access; (2) compelling reason to preserve existing vascular access (i.e., need for chronic dialysis; younger patient with anticipated long-term need for ICD therapy); or (3) history of need for explantation of a transvenous ICD due to a complication, with ongoing need for ICD therapy. • Have no indication for antibradycardia pacing; AND • Do not have ventricular arrhythmias that are known or anticipated to respond to antitachycardia pacing. The use of a subcutaneous ICD is considered investigational for individuals who do not meet the criteria outlined above. Policy Guidelines This Protocol addresses the use of ICD devices as stand-alone interventions, not as combination devices to treat heart failure (i.e., cardiac resynchronization devices) or in combination with pacemakers. Unless specified, the policy statements are referring to transvenous ICDs. Indications for pediatric ICD use are based on American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) guidelines published in 2008, which acknowledged the lack of primary research in this field on pediatric patients. These are derived from nonrandomized studies, extrapolation from adult clinical trials, and expert consensus. Criteria for ICD Implantation in Patients with Cardiac Ion Channelopathies Individuals with cardiac ion channelopathies may have a history of a life-threatening clinical event associated with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes, in which case they should be considered for ICD implantation for secondary prevention, even if they do not meet criteria for primary prevention. Criteria for ICD implantation in patients with cardiac ion channelopathies are derived from results of clinical input, a 2013 consensus statement from the HRS, European Heart Rhythm Association (EHRA), and the AsiaPacific Heart Rhythm Society on the diagnosis and management of patients with inherited primary arrhythmia syndromes (Priori et al, 2013), 2013 guidelines from the ACC, AHA, HRS, the American Association of Thoracic Surgeons, and the Society of Thoracic Surgeons on device-based therapy of cardiac rhythm abnormalities (Tracy et al, 2013), and a report from the HRS/EHRA’s Second Consensus Conference on Brugada syndrome (Antzelevitch et al, 2005). Indications for consideration for ICD implantation for each cardiac ion channelopathy are as follows: • • Long QT syndrome: o Patients with a diagnosis of LQTS who are survivors of cardiac arrest. o Patients with a diagnosis of LQTS who experience recurrent syncopal events while on beta-blocker therapy. Brugada syndrome: o Patients with a diagnosis of BrS who are survivors of cardiac arrest. Page 5 of 16 Protocol • • Implantable Cardioverter Defibrillator Last Review Date: 11/15 o Patients with a diagnosis of BrS who have documented spontaneous sustained ventricular tachycardia (VT) with or without syncope. o Patients with a spontaneous diagnostic type 1 ECG who have a history of syncope, seizure, or nocturnal agonal respiration judged to be likely caused by ventricular arrhythmias (after noncardiac causes have been ruled out). o Patients with a diagnosis of BrS who develop ventricular fibrillation (VF) during programmed electrical stimulation. Catecholaminergic polymorphic ventricular tachycardia: o Patients with a diagnosis of CPVT who are survivors of cardiac arrest. o Patients with a diagnosis of CPVT who experience recurrent syncope or polymorphic/bidirectional VT despite optimal medical management, and/or left cardiac sympathetic denervation. Short QT syndrome: o Patients with a diagnosis of SQTS who are survivors of cardiac arrest. o Patients with a diagnosis of SQTS who are symptomatic and have documented spontaneous VT with or without syncope. o Patients with a diagnosis of SQTS or are asymptomatic or symptomatic and have a family history of sudden cardiac death. NOTE: For congenital LQTS, patients may have one or more clinical or historical findings other than those outlined above that may, alone or in combination, put them at higher risk for sudden cardiac death. These may include patients with a family history of sudden cardiac death due to LQTS, infants with a diagnosis of LQTS with functional 2:1 atrioventricular block, patients with a diagnosis of LQTS in conjunction with a diagnosis of Jervell and Lange-Nielsen syndrome or Timothy syndrome, and patients with a diagnosis of LQTS with profound QT prolongation (greater than 550 msec). These factors should be evaluated on an individualized basis by a clinician with expertise in LQTS in considering the need for an ICD implantation. Medicare Advantage For Medicare Advantage an implantable automatic defibrillator is medically necessary when the following indications are met: 1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause. 2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause. 3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy. 4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF) less than 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than four weeks after the qualifying MI.) 5. Documented prior MI and a measured LVEF less than 0.30; patients must not have: a. New York Heart Association (NYHC) classification IV; Page 6 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 b. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; c. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past three months; d. Had an enzyme positive MI within past month and must not have had an acute MI in the past 40 days; e. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or f. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than one year. 6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF less than 35%; 7. Patients with non-ischemic dilated cardiomyopathy (NIDCM) greater than nine months, NYHA Class II and III heart failure, and measured LVEF less than 35%; 8. Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure; All indications must meet the following criteria: a. Patients must not have irreversible brain damage from preexisting cerebral disease; b. MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction; Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria: a. Patients must be able to give informed consent; b. Patients must not have: 1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; 2. Had a CABG or PTCA within the past three months; 3. Had an acute MI within the past 40 days; 4. Clinical symptoms or findings that would make them a candidate for coronary revascularization; 5. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than one year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; d. The patient receiving the defibrillator implantation for primary prevention is enrolled in either a Food and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial, a trial under the CMS Clinical Trial Policy or a qualifying data collection system including approved clinical trials and registries. e. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient’s medical record. 9. Patients with NIDCM greater than three months, NYHA Class II or III heart failure, and measured LVEF less than 35%, only if the following additional criteria are also met: a. Patients must be able to give informed consent; b. Patients must not have: Page 7 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; 2. Had a CABG or PTCA within the past three months; 3. Had an acute MI within the past 40 days; 4. Clinical symptoms or findings that would make them a candidate for coronary revascularization; 5. Irreversible brain damage from preexisting cerebral disease; 6. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than one year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; d. MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction; e. The patient receiving the defibrillator implantation for this indication is enrolled in either an FDAapproved category B IDE clinical trial, a trial under the CMS Routine Services of a Clinical Trial Policy, or a prospective data collection system meeting the following basic criteria: 1. Written protocol on file; 2. Institutional Review Board review and approval; 3. Scientific review and approval by two or more qualified individuals who are not part of the research team; 4. Certification that investigators have not been disqualified. CMS will determine whether specific registries or clinical trials meet these criteria. f. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient’s medical record. Other Indications All other indications for implantable automatic defibrillators not currently covered in accordance with these criteria may fall under clinical trials. Background Automatic implantable cardioverter defibrillators (ICD) 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 ICD implantation can be broadly subdivided into (1) secondary prevention, i.e., their use in patients who have experienced a potentially life-threatening episode of VT (near sudden cardiac death); and (2) primary prevention, i.e., their use in patients who are considered at high risk for sudden cardiac death but who have not yet experienced life-threatening VT or VF. The standard 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. A totally subcutaneous ICD (S-ICD®) has also been developed. This device does not employ transvenous leads and thus avoids the need for venous access and complications associated with the venous leads. Rather, the SPage 8 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 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. Several automatic ICDs are approved by U.S. Food and Drug Administration (FDA) through the premarket approval application (PMA) process. FDA-labeled indications generally include patients who have experienced life-threatening VT associated with cardiac arrest or VT associated with hemodynamic compromise and resistance to pharmacologic treatment. Devices manufactured by Guidant are approved by 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 ventricular tachycardia (VT); or a prior myocardial infarction (MI), 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, FDA expanded the approved indications for the Guidant ICD devices to include the prophylactic use of Guidant ICDs for cardiac patients who have had a previous heart attack and have an ejection fraction that is 30% or less. This expanded indication is based on the results of the second Multicenter Automatic Defibrillator Implantation Trial (MADIT II trial), which is discussed here. 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 that of Medtronic. Regulatory Status Transvenous Implantable Cardioverter Defibrillators The Food and Drug Administration (FDA) has approved a large number of ICDs through the premarket approval (PMA) process (FDA product code: LWS). A 2014 review of FDA approvals of cardiac implantable devices reported that, between 1979 and 2012, FDA approved 19 ICDs (seven pulse generators, three leads, nine combined systems) through new PMA applications.1 Many originally-approved ICDs have undergone multiple supplemental applications. A summary of some currently-available ICDs is provided in Table 1 (not an exhaustive list). Table 1: Implantable Cardioverter Defibrillator with FDA Approval Device Ellipse/Fortify Assura Family (originally: Cadence Tiered Therapy Defibrillation System) Current Plus ICD (originally: Cadence Tiered Therapy Defibrillation System) Dynagen, Inogen, Origen, and Teligen Family (originally: Ventak, Vitality, Cofient family) Evera Family (originally: Virtuosos/ Entrust/Maximo/Intrisic/Marquis family) Subcutaneous Implantable Defibrillator System St. Jude Medical, Inc. (St. Paul, MN) Original PMA Approval Date July 1993 Transvenous St. Jude Medical, Inc. (St. Paul, MN) July 1993 Transvenous Boston Scientific, Inc. (Marlborough, MA) January 1998 Transvenous Medtronic, Inc. (Minneapolis, MN) December 1998 Transvenous Cameron Health, Inc. (San Clemente, CA); acquired by Boston Scientific, Inc. September 2012 Subcutaneous Manufacturer Type Subcutaneous ICDs In September 2012, the FDA approved the Subcutaneous Implantable Defibrillator (S-ICD®) System (Cameron Health, Inc, San Clemente, CA; acquired by Boston Scientific, Inc. Marlborough, MA), through the PMA process for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic Page 9 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing. In March 2015, the Emblem S-ICD™ (Boston Scientific, Inc.), which is smaller and longer-lasting than the original S-ICD, was cleared for marketing through a PMA supplement. NOTE: ICDs may be combined with other pacing devices, such as pacemakers for atrial fibrillation, or biventricular pacemakers designed to treat heart failure. This evidence review addresses ICDs alone, when used solely to treat patients at risk for ventricular arrhythmias. Related Protocol Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure Services that are the subject of a clinical trial do not meet our Technology Assessment Protocol criteria and are considered investigational. For explanation of experimental and investigational, please refer to the Technology Assessment Protocol. It is expected that only appropriate and medically necessary services will be rendered. We reserve the right to conduct prepayment and postpayment reviews to assess the medical appropriateness of the above-referenced procedures. Some of this Protocol may not pertain to the patients you provide care to, as it may relate to products that are not available in your geographic area. References We are not responsible for the continuing viability of web site addresses that may be listed in any references below. 1. Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. JAMA. Jan 22-29 2014; 311(4):385-391. PMID 24449317 2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of implantable cardioverter defibrillators for prevention of sudden death in patients at high risk for ventricular arrhythmia. TEC Assessments 2002; 17(Tab 10). 3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of implantable cardioverter defibrillators for prevention of sudden death in patients at high risk for ventricular arrhythmia. TEC Assessments 2004; 19(Tab 19). PMID 4. Desai AS, Fang JC, Maisel WH, et al. Implantable defibrillators for the prevention of mortality in patients with nonischemic cardiomyopathy—a meta-analysis of randomized controlled trials. JAMA. 2004; 292(23):28742879. 5. Uhlig K, Balk EM, Earley A, et al. Assessment on Implantable Defibrillators and the Evidence for Primary Prevention of Sudden Cardiac Death. Rockville (MD); 2013. 6. Raviele A, Bongiorni MG, Brignole M, et al. Early EPS/ICD strategy in survivors of acute myocardial infarction with severe left ventricular dysfunction on optimal beta-blocker treatment: The Beta-blocker Strategy plus ICD trial. Europace. 2005; 7(4):327-337. Page 10 of 16 Protocol Implantable Cardioverter Defibrillator Last Review Date: 11/15 7. Steinbeck G, Andresen D, Seidl K, et al. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009; 361(15):1427-1436. 8. Maron BJ, Spirito P, Shen WK, et al. Implantable cardioverter-defibrillators and prevention of sudden cardiac death in hypertrophic cardiomyopathy. JAMA. 2007; 298(4):405-412. 9. Ellenbogen KA, Levine JH, Berger RD, et al. Are implantable cardioverter defibrillator shocks a surrogate forsudden cardiac death in patients with nonischemic cardiomyopathy? Circulation. 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Sheppard R, Mather PJ, Alexis JD, et al. Implantable cardiac defibrillators and sudden death in recent onset nonischemic cardiomyopathy: results from IMAC2. J Card Fail. Sep 2012; 18(9):675-681. PMID 22939035 15. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008; 117(21):e350-408. 16. Jessup M, Abraham WT, Casey DE, et al. 2009 focused update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009; 119(14):1977-2016. Available online at: http://content.onlinejacc.org/cgi/reprintsidebar/1953/1915/1343. Last accessed November 2009. 17. Horner JM, Kinoshita M, Webster TL, et al. Implantable cardioverter defibrillator therapy for congenital long QT syndrome: a single-center experience. Heart Rhythm. Nov 2010; 7(11):1616-1622. PMID 20816872 18. Conte G, Sieira J, Ciconte G, et al. Implantable cardioverter-defibrillator therapy in Brugada syndrome: a 20year single-center experience. J Am Coll Cardiol. Mar 10 2015; 65(9):879-888. PMID 25744005 19. Dores H, Reis Santos K, Adragao P, et al. 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