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Cardioverter Defibrillator: Implantable

Policy Number: MP-168

Latest Review Date:  June 2022

Category:  Surgery                                                                 

POLICY:

Effective for dates of service on and after July 16, 2022:

Implantable Cardioverter Defibrillator (ICD)

Adults- Primary Prevention

The use of an Implantable Cardioverter Defibrillator (ICD) may be considered medically necessary for coverage in adult patients for primary prevention who have at least one of the following:

  • Ischemic cardiomyopathy with LVEF less than or equal to 35% and in NYHA functional Class I, II or III who:
    • Are at least 40 days post-myocardial infarction, OR
    • Had a CABG or PCI with angioplasty and/or stenting within the past 3 months, OR
    • Have 1 or more clinical  symptoms or findings that would make the patient a candidate for coronary revascularization within 3 months (e.g. MI within past 60 days, decompensated CHF, multi-vessel CAD, unstable angina, cardiac stress testing indicating CABG is needed, abnormal heart rhythm, shortness of breath);
  • Nonischemic dilated cardiomyopathy with an LVEF less than or equal to 35% who have had at least 3 months of guideline directed medical therapy and who are in NYHA functional Class I, II or III; OR
  • Hypertrophic cardiomyopathy who have 1 or more major risk factors for SCD such as:
    • History of premature HCM related sudden death in 1 or more first degree relatives younger than 50 years
    • Left ventricular hypertrophy greater than 30mm
    • One or more runs of nonsustained ventricular tachycardia (120 bpm or greater) on 24 hour Holter monitor
    • Prior unexplained syncope inconsistent with neurocardiogenic origin; OR
  • Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:
    • Long QT syndrome with at least one of the following:
      • survivors of cardiac arrest; or
      • experience syncope and/or VT while on beta blocker therapy; or
      • family history of long QT syndrome with SCD; OR
    • Brugada syndrome with at least one of the following:
      • survivors of cardiac arrest; or
      • have documented ventricular tachycardia; or
      • history of syncope, seizure, or nocturnal agonal respiration caused by ventricular arrhythmias
      • Develop ventricular fibrillation during programmed electrical stimulation; OR
    • Short QT syndrome with at least one of the following:
      • Survivors of cardiac arrest
      • Symptomatic and have documented spontaneous VT with or without syncope
      • Asymptomatic or symptomatic and have a family history of SCD; OR
    • Catecholaminergic polymorphic ventricular tachycardia with at least one of the following:
      • Survivors of cardiac arrest; or
      • have syncope and/or documented sustained VT while receiving beta blockers;
      • Experience recurrent syncope or polymorphic/bidirectional VTG despite optimal medical management; or
      • Left cardiac sympathetic denervation; OR
  • Are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes; OR
  • Structural heart disease and spontaneous sustained VT whether hemodynamically stable or unstable; OR
  • Syncope of undetermined origin with clinically relevant, hemodynamically significant sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) induced at electrophysiological study; OR
  • Nonsustained VT due to prior myocardial infarction, LVEF less than or equal to 40%, and inducible ventricular fibrillation or sustained VT at electrophysiological study; OR
  • Syncope, significant LV dysfunction, and nonischemic dilated cardiomyopathy; OR
  • Sustained VT and normal or near-normal ventricular function, OR
  • Prevention of SCD in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy who have 1 or more risk factor for SCD; OR
  • Non-hospitalized patients awaiting transplantation; OR
  • Cardiac sarcoidosis; OR
  • Giant cell myocarditis; OR
  • Chagas disease; OR
  • Syncope and advanced structural heart disease in whom thorough invasive and noninvasive investigations have failed to define a cause; OR
  • A familial cardiomyopathy associated with sudden death; OR
  • LV noncompaction

 

The use of the ICD is considered investigational in primary prevention patients who:

  • Have had an acute myocardial infarction less than 40 days before ICD treatment;
  • With NYHA Class IV symptoms and drug-refractory congestive heart failure who are not candidates for cardiac transplantation or implantation of a CRT device that incorporates both pacing and defibrillation capabilities;
  • Have noncardiac disease that would be associated with life expectancy less than one year;
  • Do not have a reasonable expectation of survival with an acceptable functional status for at least 1 year, even if they meet ICD implantation criteria specified in the recommendations above;
  • With incessant VT or VF;
  • With significant psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up;
  • With syncope of undetermined cause without inducible ventricular tachyarrhythmias and without structural heart disease;
  • When VT or VF is amenable to surgical or catheter ablation (e.g., atrial arrhythmias associated with Wolff-Parkinson-White syndrome, right ventricular or LV outflow tract VT, idiopathic VT, or fascicular VT in the absence of structural heart disease);
  • With ventricular tachyarrhythmias due to a completely reversible disorder in the absence of structural heart disease (e.g., electrolyte imbalance, drugs, or trauma).

Adults- Secondary Prevention

The use of an Implantable Cardioverter Defibrillator (ICD) may be considered medically necessary in adult patients for secondary prevention when:

  • 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 for secondary prevention is considered investigational for patients who do not meet the criteria for secondary prevention.

 

Combination implantable cardiac defibrillators (ICD) and biventricular pacemakers may be considered medically necessary for patients who meet BOTH a biventricular pacemaker and an ICD. Please see policy No. 055 (Bi-Ventricular Pacemakers for the Treatment of Congestive Heart Failure) for criteria for the Bi-Ventricular Pacemaker.

Pediatrics

The use of an Implantable Cardioverter Defibrillator (ICD) may be considered medically necessary in pediatric patients who have or are at least one of the following:

  • A survivor of cardiac arrest after, after reversible causes have been excluded;
  • symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation;
  • Recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias;
  • Hypertrophic cardiomyopathy deemed to be at high risk for SCD by a physician and who have 1 or more major risk factors for SCD such as:
    • History of premature HCM related sudden death in 1 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; OR
  • Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:
    • Congenital long QT syndrome with at least one of the following: 
      • survivors of cardiac arrest; or
      • experience recurrent syncopal events while on beta blocker therapy; or
      • family history of long QT syndrome with SCD; or
      • infant with 2:1  atrioventricular block; or
      • a diagnosis of Jervell and Lange-Nielsen syndrome or Timothy syndrome;
      • a profound QT prolongation (>550msec); OR
    • Brugada syndrome :
      • survivors of cardiac arrest; or
      • have documented spontaneous sustained ventricular tachycardia; or
      • have spontaneous diagnostic type 1 ECG who have a history of syncope, seizure, or nocturnal agonal respiration caused by ventricular arrhythmias
      • Develop ventricular fibrillation during programmed electrical stimulation; OR
    • Short QT syndrome:
      • Survivors of cardiac arrest;
      • Symptomatic and have documented spontaneous VT with or without syncope;
      • Asymptomatic or symptomatic and have a family history of SCD; OR
    • Catecholaminergic polymorphic ventricular tachycardia:
      • Survivors of cardiac arrest; or
      • Experience recurrent syncope or polymorphic/bidirectional VTG despite optimal medical management; or
      • Left cardiac sympathetic denervation.

 

The use of the ICD is considered investigational for all other indications in pediatric patients.

Subcutaneous ICD (S-ICD)

The use of a Subcutaneous ICD may be considered medically necessary in adults and children when ALL of the following criteria are met:

  • The criteria for a transvenous ICD are met;

AND

  • Has the presence of ONE of the following:
    • Congenital heart disease that limits intracavitary lead placements; or
    • Is immunocompromised (e.g. previous organ transplant, on TNF alpha drugs or on chemotherapy, on chronic high-dose steroids); or
    • Has indwelling intravascular hardware at risk for endovascular infection; or
    • Inadequate vascular access; or
    • Young patient with likely need for long-term hemodialysis

AND

  • Has the absence of ALL of the following:
    • Symptomatic bradycardia; and
    • Incessant ventricular tachycardia (VT); and
    • Spontaneous frequent recurring VT reliably terminated with anti-tachycardia pacing; and
    • The need for anti-bradycardia pacing or Cardiac Resynchronization Therapy (CRT).

 

The use of a subcutaneous ICD is considered investigational for the adult and pediatric patient for all other situations.

 

Effective for dates of service April 16, 2019- July 15, 2022:

Implantable Cardioverter Defibrillator (ICD)

Adults- Primary Prevention

The use of an Implantable Cardioverter Defibrillator (ICD) may be considered medically necessary for coverage in adult patients for primary prevention who have at least one of the following:

  • Ischemic cardiomyopathy with LVEF less than or equal to 35% who are at least 40 days post-myocardial infarction, and who are in NYHA functional Class I, II or III; OR
  • Nonischemic dilated cardiomyopathy or heart disease with an LVEF less than or equal to 35% who have had at least 3 months of guideline directed medical therapy and who are in NYHA functional Class I, II or III; OR
  • Hypertrophic cardiomyopathy who have 1 or more major risk factors for SCD such as:
    • History of premature HCM related sudden death in 1 or more first degree relatives younger than 50 years
    • Left ventricular hypertrophy greater than 30mm
    • One or more runs of nonsustained ventricular tachycardia (120 bpm or greater) on 24 hour Holter monitor
    • Prior unexplained syncope inconsistent with neurocardiogenic origin; OR
  • Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:
    • Long QT syndrome with at least one of the following:
      • survivors of cardiac arrest; or
      • experience syncope and/or VT while on beta blocker therapy; or
      • family history of long QT syndrome with SCD; OR
    • Brugada syndrome with at least one of the following:
      • survivors of cardiac arrest; or
      • have documented ventricular tachycardia; or
      • history of syncope, seizure, or nocturnal agonal respiration caused by ventricular arrhythmias
      • Develop ventricular fibrillation during programmed electrical stimulation; OR
    • Short QT syndrome with at least one of the following:
      • Survivors of cardiac arrest
      • Symptomatic and have documented spontaneous VT with or without syncope
      • Asymptomatic or symptomatic and have a family history of SCD; OR
    • Catecholaminergic polymorphic ventricular tachycardia with at least one of the following:
      • Survivors of cardiac arrest; or
      • have syncope and/or documented sustained VT while receiving beta blockers;
      • Experience recurrent syncope or polymorphic/bidirectional VTG despite optimal medical management; or
      • Left cardiac sympathetic denervation; OR
  • Are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes; OR
  • Structural heart disease and spontaneous sustained VT whether hemodynamically stable or unstable; OR
  • Syncope of undetermined origin with clinically relevant, hemodynamically significant sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) induced at electrophysiological study; OR
  • Nonsustained VT due to prior myocardial infarction, LVEF less than or equal to 40%, and inducible ventricular fibrillation or sustained VT at electrophysiological study; OR
  • Syncope, significant LV dysfunction, and nonischemic dilated cardiomyopathy; OR
  • Sustained VT and normal or near-normal ventricular function, OR
  • Prevention of SCD in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy who have 1 or more risk factor for SCD; OR
  • Non-hospitalized patients awaiting transplantation; OR
  • Cardiac sarcoidosis; OR
  • Giant cell myocarditis; OR
  • Chagas disease; OR
  • Syncope and advanced structural heart disease in whom thorough invasive and noninvasive investigations have failed to define a cause; OR
  • A familial cardiomyopathy associated with sudden death; OR
  • LV noncompaction

 

The use of the ICD is considered investigational in primary prevention patients who:

  • Have had an acute myocardial infarction less than 40 days before ICD treatment;
  • With NYHA Class IV symptoms and drug-refractory congestive heart failure who are not candidates for cardiac transplantation or implantation of a CRT device that incorporates both pacing and defibrillation capabilities;
  • Have had a cardiac revascularization procedure in past 3 months (CABG or PTCA) or are candidates for a cardiac revascularization procedure; or
  • Have noncardiac disease that would be associated with life expectancy less than one year;
  • Do not have a reasonable expectation of survival with an acceptable functional status for at least 1 year, even if they meet ICD implantation criteria specified in the recommendations above;
  • With incessant VT or VF;
  • With significant psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up;
  • With syncope of undetermined cause without inducible ventricular tachyarrhythmias and without structural heart disease;
  • When VT or VF is amenable to surgical or catheter ablation (e.g., atrial arrhythmias associated with Wolff-Parkinson-White syndrome, right ventricular or LV outflow tract VT, idiopathic VT, or fascicular VT in the absence of structural heart disease);
  • With ventricular tachyarrhythmias due to a completely reversible disorder in the absence of structural heart disease (e.g., electrolyte imbalance, drugs, or trauma).

 

Adults- Secondary Prevention

The use of an Implantable Cardioverter Defibrillator (ICD) may be considered medically necessary in adult patients for secondary prevention when:

  • 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 for secondary prevention is considered investigational for patients who do not meet the criteria for secondary prevention.

 

Combination implantable cardiac defibrillators (ICD) and biventricular pacemakers may be considered medically necessary for patients who meet BOTH a biventricular pacemaker and an ICD. Please see policy No. 055 (Bi-Ventricular Pacemakers for the Treatment of Congestive Heart Failure) for criteria for the Bi-Ventricular Pacemaker.

Pediatrics

The use of an Implantable Cardioverter Defibrillator (ICD) may be considered medically necessary in pediatric patients who have or are at least one of the following:

  • A survivor of cardiac arrest after, after reversible causes have been excluded;
  • symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation;
  • Recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias;
  • Hypertrophic cardiomyopathy deemed to be at high risk for SCD by a physician and who have 1 or more major risk factors for SCD such as:
    • History of premature HCM related sudden death in 1 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; OR
  • Diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for sudden cardiac death:
    • Congenital long QT syndrome with at least one of the following: 
      • survivors of cardiac arrest; or
      • experience recurrent syncopal events while on beta blocker therapy; or
      • family history of long QT syndrome with SCD; or
      • infant with 2:1  atrioventricular block; or
      • a diagnosis of Jervell and Lange-Nielsen syndrome or Timothy syndrome;
      • a profound QT prolongation (>550msec); OR
    • Brugada syndrome :
      • survivors of cardiac arrest; or
      • have documented spontaneous sustained ventricular tachycardia; or
      • have spontaneous diagnostic type 1 ECG who have a history of syncope, seizure, or nocturnal agonal respiration caused by ventricular arrhythmias
      • Develop ventricular fibrillation during programmed electrical stimulation; OR
    • Short QT syndrome:
      • Survivors of cardiac arrest;
      • Symptomatic and have documented spontaneous VT with or without syncope;
      • Asymptomatic or symptomatic and have a family history of SCD; OR
    • Catecholaminergic polymorphic ventricular tachycardia:
      • Survivors of cardiac arrest; or
      • Experience recurrent syncope or polymorphic/bidirectional VTG despite optimal medical management; or
      • Left cardiac sympathetic denervation.

 

The use of the ICD is considered investigational for all other indications in pediatric patients.

Subcutaneous ICD (S-ICD)

The use of a Subcutaneous ICD may be considered medically necessary when ALL of the following criteria are met:

  • The criteria for a transvenous ICD are met;

AND

  • Has the presence of ONE of the following:
    • Congenital heart disease that limits intracavitary lead placements; or
    • Is immunocompromised (e.g. previous organ transplant, on TNF alpha drugs or on chemotherapy, on chronic high-dose steroids); or
    • Has indwelling intravascular hardware at risk for endovascular infection; or
    • Has compromised venous access;

AND

  • Has the absence of ALL of the following:
    • Symptomatic bradycardia; and
    • Incessant ventricular tachycardia (VT); and
    • Spontaneous frequent recurring VT reliably terminated with anti-tachycardia pacing; and
    • The need for anti-bradycardia pacing or Cardiac Resynchronization Therapy (CRT).

 

The use of a subcutaneous ICD is considered investigational for the adult and pediatric patient for all other situations.

DESCRIPTION OF PROCEDURE OR SERVICE:

An implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient’s heart rate, recognize ventricular fibrillation or ventricular tachycardia, and deliver an electric shock to terminate these arrhythmias to reduce the risk of sudden death. A subcutaneous ICD (S-ICD), which lacks transvenous leads, is intended to reduce lead-related complications.

Ventricular Arrhythmia and Sudden Cardiac Death

The risk of ventricular arrhythmia and sudden cardiac death (SCD) may be significantly increased in various cardiac conditions such as ischemic cardiomyopathy, particularly when associated with reduced left ventricular ejection fraction and prior myocardial infarction; nonischemic dilated cardiomyopathy with reduced left ventricular ejection fraction; hypertrophic cardiomyopathy and additional risk factors; congenital heart disease, particularly with recurrent syncope; and cardiac ion channelopathies.

Treatment

Implantable cardioverter defibrillators (ICDs) monitor a patient’s heart rate, recognize ventricular fibrillation or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias to reduce the risk of SCD. Indications for ICD placement can be broadly subdivided into (1) secondary prevention, i.e., use in patients who have experienced a potentially life-threatening episode of VT (near SCD); and (2) primary prevention, i.e., use in patients who are considered at high risk for SCD but who have not yet experienced life-threatening VT or ventricular fibrillation.

The standard ICD placement surgery 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 ventricular fibrillation shock when a malignant arrhythmia is recognized.

A subcutaneous ICD (S-ICD) has also been developed. It does not use transvenous leads and thus avoids the need for venous access and complications associated with the insertion of venous leads. Rather, the S-ICD uses a subcutaneous electrode 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 have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval 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. Also, devices typically have approval in the secondary prevention setting for patients with previous myocardial infarction and reduced injection fraction.

KEY POINTS:

The most recent literature review was updated through April 4, 2022.

Summary of Evidence

Transvenous ICDs

For individuals who have a high risk of SCD due to ischemic or nonischemic cardiomyopathy in adulthood who receive TV-ICD placement for primary prevention, the evidence includes multiple well-designed and well-conducted RCTs as well as systematic reviews of these trials. Relevant outcomes are overall survival, morbid events, quality of life, and treatment-related mortality and morbidity. Multiple, well-done RCTs have shown a benefit in overall mortality for patients with ischemic cardiomyopathy and reduced ejection fraction. RCTs assessing early ICD use following recent myocardial infarction did not support a benefit for immediate vs delayed implantation for at least 40 days. For nonischemic cardiomyopathy, there is less clinical trial data, but pooled estimates of available evidence from RCTs enrolling patients with nonischemic cardiomyopathy and from subgroup analyses of RCTs with mixed populations have supported a survival benefit for this group. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a high risk of SCD due to HCM in adulthood who receive TV-ICD placement for primary prevention, the evidence includes several large registry studies. Relevant outcomes are overall survival, morbid events, quality of life, and treatment-related mortality and morbidity. In these studies, the annual rate of appropriate ICD discharge ranged from 3.6% to 5.3%. Given the long-term high risk of SCD in patients with HCM, with the assumption that appropriate shocks are life-saving, these rates are considered adequate evidence to support the use of ICDs in patients with HCM. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a high risk of SCD due to an inherited cardiac ion channelopathy who receive TV-ICD placement for primary prevention, the evidence includes small cohort studies of patients with these conditions treated with ICDs. Relevant outcomes are overall survival, morbid events, quality of life, and treatment-related mortality and morbidity. The limited evidence for patients with long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, and Brugada syndrome has reported high rates of appropriate shocks. No studies were identified on the use of ICDs for patients with short QT syndrome. Studies comparing outcomes between patients treated and untreated with ICDs are not available. However, given the relatively small patient populations with these channelopathies and the high risk of cardiac arrhythmias, clinical trials are unlikely. Given the long-term high risk of SCD in patients with inherited cardiac ion channelopathy, with the assumption that appropriate shocks are life-saving, these studies are considered adequate evidence to support the use of TV-ICDs in patients with inherited cardiac ion channelopathy. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a high-risk of SCD due to cardiac sarcoid who receive T-ICD placement for primary prevention, the evidence includes small cohort studies of patients with cardiac sarcoid treated with ICDs who received appropriate shocks. Studies comparing outcomes between patients treated and untreated with ICDs are not available. However, given the relatively small number of patients with cardiac sarcoid (5% of those with systemic sarcoidosis), clinical trials are unlikely. Given the long-term high-risk of SCD in patients with cardiac sarcoid, with the assumption that appropriate shocks are life-saving, these studies are considered adequate evidence to support the use of T-ICDs in patients with cardiac sarcoid who have not responded to optimal medical therapy. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have had symptomatic life-threatening sustained VT or VF or who have been resuscitated from sudden cardiac arrest (secondary prevention) who receive TV-ICD placement, the evidence includes multiple well-designed and well-conducted RCTs as well as systematic reviews of these trials. Relevant outcomes are overall survival, morbid events, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs have demonstrated a 25% reduction in mortality for ICD compared with medical therapy. Analysis of data from a large administrative database has confirmed that this mortality benefit is generalizable to the clinical setting. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Subcutaneous ICDs

For individuals who need an ICD and have a contraindication to a TV-ICD but no indications for antibradycardia pacing and no antitachycardia pacing-responsive arrhythmias who receive S-ICD placement, the evidence includes nonrandomized studies and case series. Relevant outcomes are overall survival, morbid events, quality of life, and treatment-related mortality and morbidity. Nonrandomized controlled studies have reported success rates in terminating laboratory-induced VF that are similar to TV-ICD. Case series have reported high rates of detection and successful conversion of VF, and inappropriate shock rates in the range reported for TV-ICD. Given the need for ICD placement in this population at risk for SCD, with the assumption that appropriate shocks are life-saving, these studies are considered adequate evidence to support the use of S-ICDs in patients with contraindication to TV-ICD. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who need an ICD and have no indications for antibradycardia pacing or antitachycardia pacing-responsive arrhythmias and have no contraindication to a T-ICD, who receive S-ICD placement, the evidence includes 1 RCT, nonrandomized studies and case series. Relevant outcomes are overall survival, morbid events, quality of life, and treatment-related mortality and morbidity. The PRAETORIAN (Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial is the only RCT on the effect of an S-ICD with health outcomes. PRAETORIAN found that S-ICD was noninferior to T-ICD on a composite outcome of complications and inappropriate shock at 48 months (Hazard Ratio 0.99; 95% confidence interval, 0.71 to 1.39; noninferiority margin, 1.45; P =.01 for noninferiority; P =.95 for superiority). There were more device related complications in the T-ICD group and more inappropriate shocks in the S-ICD group, but the trial was not powered for these endpoints. There is uncertainty over the applicability and interpretation of PRAETORIAN based on the choice of a composite outcome with discordant results, unclear rationale for choice of the noninferiority margin, inadequate length of follow up to determine rates of complications, and lack of reporting of quality of life data. Comparative observational studies are insufficient to draw conclusions on whether there are small differences in efficacy between the two types of devices, and reported variable adverse event rates. Ongoing studies could provide additional evidence on complications and device safety over the longer term. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Heart Association, American College of Cardiology, and Heart Failure Society of America (2022)

In 2022, the American Heart Association, American College of Cardiology, and the Heart Failure Society of America released a guideline for the management of heart failure. This guideline includes the following ICD recommendations:

Guideline for the Management of Heart Failure - Recommendations for ICDs

Recommendation

COR

LOE

"In patients with nonischemic DCM or ischemic heart disease at least 40 days post-MI with LVEF ≤35% and NYHA class I or II symptoms on chronic GDMT, who have reasonable expectation of meaningful survival for >1 year, ICD therapy is recommended for primary prevention of SCD to reduce total mortality."

1

A

"A transvenous ICD provides high economic value in the primary prevention of SCD particularly when the patient's risk of death caused by ventricular arrhythmia is deemed high and the risk of nonarrhythmic death (either cardiac or noncardiac) is deemed low based on the patient's burden of comorbidities and functional status."

 

A

"In patients at least 40 days post-MI with LVEF ≤30% and NYHA class I symptoms while receiving GDMT, who have reasonable expectation of meaningful survival for >1 year, ICD therapy is recommended for primary prevention of SCD to reduce total mortality."

1

B-R

"In patients with genetic arrhythmogenic cardiomyopathy with high-risk features of sudden death, with EF ≤45%, implantation of ICD is reasonable to decrease sudden death."

2a

B-NR

"For patients whose comorbidities or frailty limit survival with good functional capacity to <1 year, ICD and CRT-D are not indicated."

No benefit

C-LD

A: high; B-NR: moderate, non-randomized; B-R: moderate, randomized; C-LD: limited data; COR: class of recommendation; CRT-D: cardiac resynchronization therapy with defibrillation; DCM: dilated cardiomyopathy; EF: ejection fraction; GDMT: guideline-directed management and therapy; ICD: implantable cardioverter defibrillator: LOE: level of evidence; LVEF: left ventricular ejection fraction; MI: myocardial infarcation; NYHA: New York Heart Association; SCD: sudden cardiac death.

American Heart Association, American College of Cardiology, and Heart Rhythm Society Guidelines on Heart Failure (2017)

The American Heart Association (AHA,) American College of Cardiology (ACC), and Heart Rhythm Society (HRS) (2017) published joint guidelines on the management of heart failure, which updated their 2012 guidelines. These guidelines made the following recommendations on the use of implantable cardioverter defibrillator (ICD) devices:

Guidelines on Device-Based Therapy of Cardiac Rhythm Abnormalities

Recommendation

COR

LOE

“In patients with ischemic heart disease, who either survive SCA due to VT/VF or experience hemodynamically unstable VT (LOE: B-R) or stable VT (LOE: B-NR) not due to reversible causes, an ICD is recommended if meaningful survival of >1 year is expected”

I

B-R

B-NR

“A transvenous ICD provides intermediate value in the secondary prevention of SCD particularly when the patient’s risk of death due to a VA is deemed high and the risk of nonarrhythmic death (either cardiac or noncardiac) is deemed low based on the patient’s burden of comorbidities and functional status.”

 

B-R

“In patients with ischemic heart disease and unexplained syncope who have inducible sustained monomorphic VT on electrophysiological study, an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

“In patients resuscitated from SCA due to coronary artery spasm in whom medical therapy is ineffective or not tolerated, an ICD is recommended if meaningful survival of >1 year is expected”

IIa

B-NR

“In patients resuscitated from SCA due to coronary artery spasm, an ICD in addition to medical therapy may be reasonable if meaningful survival of >1 year is expected”

IIb

B-NR

“In patients with arrhythmogenic right ventricular cardiomyopathy and an additional marker of increased risk of SCD (resuscitated SCA, sustained VT, significant ventricular dysfunction with RVEF or LVEF ≤35%), an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

“In patients with arrhythmogenic right ventricular cardiomyopathy and syncope presumed due to VA, an ICD is recommended if meaningful survival of >1 year is expected”

IIa

B-NR

COR: class of recommendation; ICD: implantable cardioverter defibrillator; LOE: level of evidence; LVEF: left ventricular ejection fraction; RVEF: right ventricular ejection fraction; SCA: sudden cardiac arrest; SCD: sudden cardiac death; VA: ventricular arrhythmia; VF: ventricular fibrillation; VT: ventricular tachycardia.

Guidelines on Use of ICDs as a Primary Prevention of Ischemic Heart Disease

Recommendation

COR

LOE

“In patients with LVEF of 35% or less that is due to ischemic heart disease who are at least 40 days’ post-MI and at least 90 days postrevascularization, and with NYHA class II or III HF despite GDMT, an ICD is recommended if meaningful survival of >1 year is expected”

I

A

“ In patients with LVEF of 30% or less that is due to ischemic heart disease who are at least 40 days’ post-MI and at least 90 days postrevascularization, and with NYHA class I HF despite GDMT, an ICD is recommended if meaningful survival of >1 year is expected”

I

A

“A transvenous ICD provides high value in the primary prevention of SCD particularly when the patient’s risk of death due to a VA is deemed high and the risk of nonarrhythmic death (either cardiac or noncardiac) is deemed low based on the patient’s burden of comorbidities and functional status….”

 

B-R

“In patients with NSVT due to prior MI, LVEF of 40% or less and inducible sustained VT or VF at electrophysiological study, an ICD is recommended if meaningful survival of >1 year is expected”

I

B-R

“In nonhospitalized patients with NYHA class IV symptoms who are candidates for cardiac transplantation or an LVAD, an ICD is recommended if meaningful survival of >1 year is expected”

IIa

B-NR

“An ICD is not indicated for NYHA class IV patients with medication-refractory HF who are not also candidates for cardiac transplantation, an LVAD, or a CRT defibrillator that incorporates both pacing and defibrillation capabilities.”

IIIa

C-EO

CRT: cardiac resynchronization therapy; COR: class of recommendation; ICD: implantable cardioverter defibrillator; GDMT: guideline-directed management and therapy; HF: heart failure; LOE: level of evidence; LVAD: left ventricular assist device; LVEF: left ventricular ejection fraction; MI: myocardial infarction; NSVT: nonsustained ventricular tachycardia; NYHA: New York Heart Association; SCD: sudden cardiac death; VA: ventricular arrhythmia; VF: ventricular fibrillation; VT: ventricular tachycardia.

a No benefit.

Guidelines on Use of ICDs for Nonischemic Cardiomyopathy

Recommendation

COR

LOE

“In patients with NICM who either survive SCA due to VT/VF or experience hemodynamically unstable VT (LOE: B-R) (1-4) or stable VT (LOE: B-NR) (5) not due to reversible causes, an ICD is recommended if meaningful survival of >1 year is expected”

I

B-R
B-NR

“In patients with NICM who experience syncope presumed to be due to VA and who do not meet indications for a primary prevention ICD, an ICD or an electrophysiological study for risk stratification for SCD can be beneficial if meaningful survival of >1 year is expected”

IIa

B-NR

“In patients with NICM, HF with NYHA class II-III symptoms and an LVEF of 35% or less, despite GDMT, an ICD is recommended if meaningful survival of >1 year is expected”

IIa

B-R

“In patients with NICM, HF with NYHA class I symptoms and an LVEF of 35% or less, despite GDMT, an ICD is recommended if meaningful survival of >1 year is expected”

IIb

B-R

“In patients with medication-refractory NYHA class IV HF who are not also candidates for cardiac transplantation, an LVAD, or a CRT defibrillator that incorporates both pacing and defibrillation capabilities, an ICD should not be implanted.”

IIIa

C-EO

COR: class of recommendation; CRT: cardia resynchronization therapy; GDMT: guideline-directed management and therapy; HF: heart failure; ICD: implantable cardioverter defibrillator: LOE: level of evidence; LVAD: left ventricular assist device; LVEF: left ventricular ejection fraction; NICM: nonischemic cardiomyopathy; NYHA: New York Heart Association; SCA: sudden cardiac arrest; SCD: sudden cardiac death; VA: ventricular arrhythmia; VF: ventricular fibrillation; VT: ventricular tachycardia.

a No benefit.

Guidelines on Use of ICDs for HCM

Recommendation

COR

LOE

“In patients with HCM who have survived an SCA due to VT or VF, or have spontaneous sustained VT causing syncope or hemodynamic compromise, an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

“In patients with HCM and 1 or more of the following risk factors….

a. Maximum LV wall thickness ≥30 mm (LOE: B-NR).

b. SCD in 1 or more first-degree relatives presumably caused by HCM (LOE: C-LD).

c. 1 or more episodes of unexplained syncope within the preceding 6 months (LOE: C-LD)”

IIa


B-NR

C-LD

C-LD

“In patients with HCM who have spontaneous NSVT (LOE: C-LD) or an abnormal blood pressure response with exercise (LOE: B-NR), who also have additional SCD risk modifiers or high risk features an ICD is recommended if meaningful survival of >1 year is expected”

IIa

B-NR

C-LD

“In patients with HCM who have NSVT (LOE: B-NR) or an abnormal blood pressure response with exercise (LOE: B-NR) but do not have any other SCD risk modifiers, an ICD may be considered, but its benefit is uncertain.”

IIB

B-NR

B-NR

“In patients with an identified HCM genotype in the absence of SCD risk factors, an ICD should not be implanted“

IIIa

B-NR

COR: class of recommendation; HCM: hypertrophic cardiomyopathy; ICD: implantable cardioverter defibrillator; LOE: level of evidence; LV: left ventricular; NSVT: nonsustained ventricular tachycardia; SCA: sudden cardiac arrest; SCD: sudden cardiac death; VF: ventricular fibrillation; VT: ventricular tachycardia.

a No benefit.

Guidelines on Use of Subcutaneous ICDs for Cardiac Sarcoiditis

Recommendation

COR

LOE

"In patients with cardiac sarcoidosis who have sustained VT or are survivors of SCA or have an LVEF of 35% or less, an ICD is recommended, if meaningful survival of greater than 1 year is expected."

I

B-NR

"In patients with cardiac sarcoidosis and LVEF greater than 35% who have syncope and/or evidence of myocardial scar by cardiac MRI or positron emission tomographic (PET) scan, and/or have an indication for permanent pacing, implantation of an ICD is reasonable, provided that meaningful survival of greater than 1 year is expected."

 

IIa

 

B-NR

"In patients with cardiac sarcoidosis and LVEF greater than 35%, it is reasonable to perform an electrophysiological study and to implant an ICD, if sustained VA is inducible, provided that meaningful survival of greater than 1 year is expected." 

IIa

C-LD

"In patients with cardiac sarcoidosis who have an indication for permanent pacing, implantation of an ICD can be beneficial."

IIa

C-LD

ICD: implantable cardioverter defibrillator; COR: class of recommendation; LOE: level of evidence; VT: ventricular tachycardia; SCA: sudden cardiac arrest; LVEF: left

ventricular ejection fraction; MRI: magnetic resonance imaging; VA: ventricular arrhythmia

Guidelines on Use of ICDs for Other Conditions

Recommendation

COR

LOE

“In patients with HFrEF who are awaiting heart transplant and who otherwise would not qualify for an ICD (e.g., NYHA class IV and/or use of inotropes) with a plan to discharge home, an ICD is reasonable”

IIa

B-NR

“In patients with an LVAD and sustained VA, an ICD can be beneficial.”

IIa

C-LD

“In patients with a heart transplant and severe allograft vasculopathy with LV dysfunction, an ICD may be reasonable if meaningful survival of >1 year is expected”

IIb

B-NR

“In patients with neuromuscular disorders, primary and secondary prevention ICDs are recommended for the same indications as for patients with NICM if meaningful survival >1 year is expected

I

B-NR

In patients with a cardiac channelopathy and SCA, an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

In patients with catecholaminergic polymorphic ventricular tachycardia and recurrent sustained VT or syncope, while receiving adequate or maximally tolerated beta blocker, treatment intensification with either combination medication therapy, left cardiac sympathetic denervation, and/or an ICD is recommended.

I

B-NR

“In patients with Brugada syndrome with spontaneous type 1 Brugada electrocardiographic pattern and cardiac arrest, sustained VA or a recent history of syncope presumed due to VA an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

“In patients with early repolarization pattern on ECG and cardiac arrest or sustained VA, an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

“In patients resuscitated from SCA due to idiopathic polymorphic VT or VF an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

“For older patients and those with significant comorbidities, who meet indications for a primary prevention ICD, an ICD is reasonable if meaningful survival of >1 year is expected”

IIa

B-NR

“In patients with adult congenital heart disease with SCA due to VT or VF in the absence of reversible causes an ICD is recommended if meaningful survival of >1 year is expected”

I

B-NR

“In patients with repaired moderate or severe complexity adult congenital heart disease with unexplained syncope and at least moderate ventricular dysfunction or marked hypertrophy, either ICD implantation or an electrophysiological study with ICD implantation for inducible sustained VA is reasonable if meaningful survival of >1 year is expected”

IIa

B-NR

COR: class of recommendation; ECG: electrocardiogram; HFrEF; heart failure with reduced ejection fraction; ICD: implantable cardioverter defibrillator; LOE: level of evidence; LV: left ventricle; LVAD: left ventricular assist device; LVEF: left ventricular ejection fraction; NICM: nonischemic cardiomyopathy; NYHA: New York Heart Association; SCA: sudden cardiac arrest; VA: ventricular arrhythmia; VF: ventricular fibrillation; VT: ventricular tachycardia.

Guidelines on Use of Subcutaneous ICDs

Recommendation

COR

LOE

“In patients who meet criteria for an ICD who have inadequate vascular access or are at high risk for infection, and in whom pacing for bradycardia or VT termination or as part of CRT is neither needed nor anticipated, a subcutaneous implantable cardioverter-defibrillator is recommended.”

I

B-NR

“In patients who meet indication for an ICD, implantation of a subcutaneous implantable cardioverter-defibrillator is reasonable if pacing for bradycardia or VT termination or as part of CRT is neither needed nor anticipated.”

IIa

B-NR

“In patients with an indication for bradycardia pacing or CRT, or for whom antitachycardia pacing for VT termination is required, a subcutaneous implantable cardioverter-defibrillator should not be implanted.”

IIIa

B-NR

CRT: cardiac resynchronization therapy; COR: class of recommendation; ICD: implantable cardioverter defibrillator; LOE: level of evidence; VT: ventricular tachycardia.

a Harm.

 

The 2013 update made the following recommendations on ICD therapy for children:

Guidelines on ICD Therapy for Children

Recommendation

COR

LOE

ICD implantation is indicated in the survivor of cardiac arrest after evaluation to define the cause of the event and to exclude any reversible causes.

I

B

ICD implantation is indicated for patients with symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation. Catheter ablation or surgical repair may offer possible alternatives in carefully selected patients.

I

C

ICD implantation is reasonable for patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias at electrophysiological study.

IIa

B

ICD implantation may be considered for patients with recurrent syncope associated with complex congenital heart disease and advanced systemic ventricular dysfunction when thorough invasive and noninvasive investigations have failed to define a cause.

IIb

C

All class III recommendations found in Section 3, “Indications for Implantable Cardioverter-Defibrillator Therapy,” apply to pediatric patients and patients with congenital heart disease, and ICD implantation is not indicated in these patient populations.

IIIa

C

COR: class of recommendation; ICD: implantable cardioverter defibrillator; LOE: level of evidence; VT: ventricular tachycardia.

a Not recommended

American Heart Association/American College of Cardiology Guidelines on Hypertrophic Cardiomyopathy (2020)

In 2020, the American Heart Association and American College of Cardiology published a joint Guideline for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy. Recommendations relevant to this review are summarized below.

Patients Selection for ICD Placement in High-Risk Patients With Hypertrophic Cardiomyopathy

Recommendation

COR

LOE

For patients with HCM, and previous documented cardiac arrest or sustained ventricular tachycardia, ICD placement is recommended.

I

B-NR

For adult patients with HCM with 1 or more major risk factors for SCD, it is reasonable to offer an ICD

2a

B-NR

For children with HCM who have 1 or more conventional risk factors, ICD placement is reasonable after considering the relatively high complication rates of long-term ICD placement in younger patients

2a

B-NR

For patients 16 years and older with HCM and 1 or more major SCD risk factors, discussion of the estimated 5-year sudden death risk and mortality rates can be useful during the shared decision-making process for ICD placement

2a

B-NR

In patients with HCM without risk factors, ICD placement should not be performed

3:Harm

B-NR

In patients with HCM, ICD placement for the sole purpose of participation in competitive athletics should not be performed

3:Harm

B-NR

In patients with hypertrophic cardiomyopathy who are receiving an ICD, either a single chamber transvenous ICD or a subcutaneous ICD is recommended after a shared decision-making discussion that takes into consideration patient preferences, lifestyle, and expected potential need for pacing for bradycardia or ventricular tachycardia termination

I

B-NR

B-NR: moderate, non-randomized; COR: class of recommendation; HCM: hypertrophic cardiomyopathy; ICD: implantable cardioverter defibrillator; LOE: level of evidence; SCD: sudden cardiac death

ICD Therapy in Patients Not Well Represented in Clinical Trials

The HRS, ACC, and AHA (2014) published an expert consensus statement on the use of ICD therapy for patients not included or poorly represented in ICD clinical trials. The statement presented a number of consensus-based guidelines on the use of ICDs in select patient populations.

American Heart Association

AHA (2010) issued a scientific statement, endorsed by HRS, on cardiovascular implantable electronic device infections and their management. This statement made the following recommendations on the removal of device-related infections.

Guidelines on the Management of CIED Infections

Recommendation

COR

LOE

Complete device and lead removal is recommended for all patients with definite CIED infection, as evidenced by valvular and/or lead endocarditis or sepsis.

I

A

Complete device and lead removal is recommended for all patients with CIED pocket infection as evidenced by abscess formation, device erosion, skin adherence, or chronic draining sinus without clinically evident involvement of the transvenous portion of the lead system.

I

B

Complete device and lead removal is recommended for all patients with valvular endocarditis without definite involvement of the lead(s) and/or device.

I

B

Complete device and lead removal is recommended for patients with occult staphylococcal bacteremia.

I

B

CIED: cardiovascular implantable electronic device; COR: class of recommendation; LOE: level of evidence.

Heart Rhythm Society- Arrhythmogenic Cardiomyopathy

In 2019, the HRS published a consensus statement on evaluation, risk stratification, and management of arrhythmogenic cardiomyopathy. Recommendations related to ICD risk stratification and placement decisions are shown below.

Guidelines on Risk Stratification and ICD Decisions

Recommendation

COR

LOE

In individuals with ARVC with hemodynamically tolerated sustained VT, an ICD is reasonable.

IIa

B-NR

ICD implantation is reasonable for individuals with ARVC and three major, two major and two minor, or one major and four minor risk factors for ventricular arrhythmia.

IIa

B-NR

ICD implantation may be reasonable for individuals with ARVC and two major, one major and two minor, or four minor risk factors for ventricular arrhythmia.

IIb

B-NR

In individuals with ACM with LVEF 35% or lower and NYHA class II-III symptoms and an expected meaningful survival of greater than 1 year, an ICD is recommended.

I

B-R

In individuals with ACM with LVEF 35% or lower and NYHA class I symptoms and an expected meaningful survival of greater than 1 year, an ICD is reasonable.

IIa

B-R

In individuals with ACM (other than ARVC) and hemodynamically tolerated VT, an ICD is recommended.

I

B-NR

In individuals with phospholamban cardiomyopathy and LVEF <45% or NSVT, an ICD is reasonable.

IIa

B-NR

In individuals with lamin A/C ACM and two or more of the following: LVEF <45%, NSVT, male sex, an ICD is reasonable.

IIa

B-NR

In individuals with FLNC ACM and an LVEF <45%, an ICD is reasonable.

IIa

C-LD

In individuals with lamin A/C ACM and an indication for pacing, an ICD with pacing capabilities is reasonable.

IIa

C-LD

ICD: Implantable cardioverter defibrillator; ACM: arrhythmogenic cardiomyopathy; ARVC: arrhythmogenic right ventricular cardiomyopathy; LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; NSVT: nonsustained ventricular tachycardia; VT: ventricular tachycardia; FLNC: filamin-C COR: Class of Recommendation; LOE: Level of Evidence 1Class I: Strong; Class IIa: Moderate; Class IIb: Weak. 2B-R: Randomized; B-NR: nonrandomized; C-LD: limited data

Heart Rhythm Society et al – Inherited Primary Arrhythmia Syndromes

HRS, the European Heart Rhythm Association, and the Asia-Pacific Heart Rhythm Society (2013) issued a consensus statement on the diagnosis and management of patients with inherited primary arrhythmia syndromes, which included recommendations on ICD use in patients with long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, and short QT syndrome.

Guidelines on the Diagnosis and Management of Inherited Primary Arrhythmia Syndromes

Recommendation

COR

Long QT syndrome

 

ICD implantation is recommended for patients with a diagnosis of LQTS who are survivors of a cardiac arrest

I

ICD implantation can be useful in patients with a diagnosis of LQTS who experience recurrent syncopal events while on beta-blocker therapy

IIa

Except under special circumstances, ICD implantation is not indicated in asymptomatic LQTS patients who have not been tried on beta-blocker therapy

IIIa

Brugada syndrome

 

ICD implantation is recommended in patients with a diagnosis of BrS who:

  • Are survivors of a cardiac arrest and/or
  • Have documented spontaneous sustained VT with or without syncope.

I

ICD implantation can be useful in patients with a spontaneous diagnostic type I ECG who have a history of syncope judged to be likely caused by ventricular arrhythmias.

IIa

ICD implantation may be considered in patients with a diagnosis of BrS who develop VF during programmed electrical stimulation (inducible patients).

IIb

ICD implantation is not indicated in asymptomatic BrS patients with a drug-induced type I ECG and on the basis of a family history of SCD alone.

IIIa

Catecholaminergic polymorphic ventricular tachycardia

 

ICD implantation is recommended for patients with a diagnosis of CPVT who experience cardiac arrest, recurrent syncope or polymorphic/bidirectional VT despite optimal medical management, and/or left cardiac sympathetic denervation.

I

ICD as a standalone therapy is not indicated in an asymptomatic patient with a diagnosis of CPVT

IIIa

Short QT syndrome

 

ICD implantation is recommended in symptomatic patients with a diagnosis of SQTS who:

  • Are survivors of cardiac arrest and/or
  • Have documented spontaneous VT with or without syncope.

I

ICD implantation may be considered in asymptomatic patients with a diagnosis of SQTS and a family history of sudden cardiac death.

IIb

BrS: Brugada syndrome; COR: class of recommendation; CPVT: catecholaminergic polymorphic ventricular tachycardia; ECG: electrocardiogram; ICD: implantable cardioverter defibrillator; LQTS: long QT syndrome; SCD: sudden cardiac death; SQTS: short QT syndrome; VF: ventricular fibrillation; VT: ventricular tachycardia.

a Not recommended.

ICD implantation may be considered in patients with LVEF in the range of 36%–49% and/or RV ejection fraction <40%, despite optimal medical therapy and a period of immunosuppression (if indicated).

Heart Rhythm Society - Cardiac Sarcoid

In 2014, the HRS published a consensus statement on the diagnosis and management of arrhythmias associated with cardiac sarcoiditis, including recommendations for ICD implantation in patients with cardiac sarcoid The writing group concluded that although there are few data specific to ICD use in patients with cardiac sarcoid, data from the major primary and secondary prevention ICD trials were relevant to this population and recommendations from the general device guideline documents apply to this population.

Recommendations for ICD Implantation in Patients with Cardiac Sarcoid

Recommendation

COR

ICD implantation is recommended in patients with cardiac sarcoid and one or more of the following:

  • Spontaneous sustained ventricular arrhythmias, including prior cardiac arrest
  • LVEF <35%, despite optimal medical therapy and a period of immunosuppression (if there is active inflammation).

I

ICD implantation can be useful in patients with cardiac sarcoid, independent of ventricular function, and one or more of the following:

  • An indication for permanent pacemaker implantation;
  • Unexplained syncope or near-syncope, felt to be arrhythmic in etiology;
  • Inducible sustained ventricular arrhythmias (>30 seconds of monomorphic VT orpolymorphic VT) orclinically relevant VF.*

IIa

ICD implantation may be considered in patients with LVEF in the range of 36%–49% and/or an RV ejection fraction <40%, despite optimal medical therapy for heart failure and a period of immunosuppression (if there is active inflammation).

IIb

ICD implantation is not recommended in patients with no history of syncope, normal LVEF/RV ejection fraction, no LGE on CMR,a negative EP study, and no indication for permanent pacing. However, these patients should be closely followed for deterioration in ventricular function. ICD implantation is not recommended in patients with one or more of the following:

  • Incessant ventricular arrhythmias;
  • Severe New York Heart Association class IV heart failure.

III

ICD: Implantable cardioverter defibrillator; COR: Class of Recommendation; LVEF: left ventricular ejection fraction; RV: right ventricular;LGE-CMR: late gadolinium-enhanced cardiovascular magnetic resonance; LOE: Level of Evidence 1Class I: Strong; Class IIa: Moderate; Class IIb: Weak.

Pediatric and Congenital Electrophysiology Society and Heart Rhythm Society

The Pediatric and Congenital Electrophysiology Society and HRS (2014) issued an expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease. The statement made the following recommendations on the use of ICD therapy in adults with congenital heart disease.

Guidelines on the Management of CHD

Recommendation

COR

LOE

ICD therapy is indicated in adults with CHD who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable ventricular tachycardia after evaluation to define the cause of the event and exclude any completely reversible etiology.

I

B

ICD therapy is indicated in adults with CHD and spontaneous sustained ventricular tachycardia who have undergone hemodynamic and electrophysiologic evaluation.

I

B

ICD therapy is indicated in adults with CHD and a systemic left ventricular ejection fraction <35%, biventricular physiology, and NYHA class II or III symptoms.

I

B

ICD therapy is reasonable in selected adults with tetralogy of Fallot and multiple risk factors for sudden cardiac death, such as left ventricular systolic or diastolic dysfunction, nonsustained ventricular tachycardia, QRS duration >180 ms, extensive right ventricular scarring, or inducible sustained ventricular tachycardia at electrophysiologic study.

IIa

B

ICD therapy may be reasonable in adults with a single or systemic right ventricular ejection fraction <35%, particularly in the presence of additional risk factors such as complex ventricular arrhythmias, unexplained syncope, NYHA functional class II or III symptoms, QRS duration >140 ms, or severe systemic AV valve regurgitation.

IIb

C

ICD therapy may be considered in adults with CHD and a systemic ventricular ejection fraction <35% in the absence of overt symptoms (NYHA class I) or other known risk factors.

Ib

C

ICD therapy may be considered in adults with CHD and syncope of unknown origin with hemodynamically significant sustained ventricular tachycardia or fibrillation inducible at electrophysiologic study.

Ib

B

ICD therapy may be considered for nonhospitalized adults with CHD awaiting heart transplantation.

Ib

C

ICD therapy may be considered for adults with syncope and moderate or complex CHD in whom there is a high clinical suspicion of ventricular arrhythmia and in whom thorough invasive and noninvasive investigations have failed to define a cause.

Ib

C

Adults with CHD and advanced pulmonary vascular disease (Eisenmenger syndrome) are generally not considered candidates for ICD therapy.

IIIa

 

Endocardial leads are generally avoided in adults with CHD and intracardiac shunts. Risk assessment regarding hemodynamic circumstances, concomitant anticoagulation, shunt closure prior to endocardial lead placement, or alternative approaches for lead access should be individualized.

IIIa

 

AV: arteriovenous; CHD: coronary heart disease; COR: class of recommendation; ICD: implantable cardioverter defibrillator; LOE: level of evidence; NYHA: New York Heart Association.

a Not recommended.

In 2021, the Pediatric and Congenital Electrophysiology Society and Heart Rhythm Society also issued an expert consensus statement on the indications and management of cardiovascular implantable electronic devices in pediatric patients. The table below summarizes recommendations for ICD therapy from this statement.

Recommendations for ICD Therapy in Pediatric Patients

Recommendation

COR

LOE

ICD implantation is indicated for survivors of SCA due to VT/VF if completely reversible causes have been excluded and an ICD is considered to be more beneficial than alternative treatments that may significantly reduce the risk of SCA.

I

B-NR

ICD implantation may be considered for patients with sustained VT that cannot be adequately controlled with medication and/or catheter ablation.

2b

C-EO

ICD therapy may be considered for primary prevention of SCD in patients with genetic cardiovascular diseases and risk factors for SCA or pathogenic mutations and family history of recurrent SCA.

2b

C-EO

ICD therapy is not indicated for patients with incessant ventricular tachyarrhythmias due to risk of ICD storm.

3:Harm

C-EO

ICD therapy is not indicated for patients with ventricular arrhythmias that are adequately treated with medication and/or catheter ablation.

3:Harm

C-LD

ICD therapy is not indicated for patients who have an expected survival <1 year, even if they meet ICD implantation criteria specified in the above recommendations.

3:Harm

C-EO

ICD implantation along with the use of beta-blockade is indicated for patients with a diagnosis of LQTS who are survivors of SCA.

I

B-NR

ICD implantation is indicated in LQTS patients with symptoms in whom beta-blockade is either ineffective or not  tolerated and cardiac sympathetic denervation or other medications are not considered effective alternatives.

I

B-NR

ICD therapy may be considered for primary prevention in LQTS patients with established clinical risk factors and/or pathogenic mutations.

2b

C-LD

ICD implantation is not indicated in asymptomatic LQTS patients who are deemed to be at low risk of SCA and have not been tried on beta-blocker therapy.

3:Harm

C-LD

ICD implantation is indicated in patients with a diagnosis of CPVT who experience cardiac arrest of arrhythmic syncope despite maximally tolerated beta-blocker plus flecainide and/or cardiac sympathetic denervation.

I

C-LD

ICD implantation is reasonable in combination with pharmacologic therapy with or without cardiac sympathetic  denervation when aborted SCA is the initial presentation of CPVT. Pharmacologic therapy and/or cardiac sympathetic denervation without ICD may be considered as an alternative.

2a

C-LD

ICD therapy may be considered in CPVT patients with polymorphic/bidirectional VT despite optimal pharmacologic therapy with or without cardiac sympathetic denervation.

2b

C-LD

ICD implantation is not indicated in asymptomatic patients with a diagnosis of CPVT.

3:Harm

C-EO

ICD implantation is indicated in patients with a diagnosis of BrS who are survivors of SCA or have documented spontaneous sustained VT.

I

B-NR

ICD implantation is reasonable for patients with BrS with a spontaneous type I Brugada ECG pattern and recent syncope presumed due to ventricular arrhythmias.

2a

B-NR

ICD implantation may be considered in patients with syncope presumed due to ventricular arrhythmias with a type IBrugada ECG pattern only with provocative medications.

2b

C-EO

ICD implantation is not indicated in asymptomatic BrS patients in the absence of risk factors.

3: No benefit

C-EO

ICD implantation is indicated in patients with HCM who are survivors of SCA or have spontaneous sustained VT.

I

B-NR

For children with HCM who have ≥1 primary risk factors, including unexplained syncope, massive left ventricular hypertrophy, nonsustained VT, or family history of early HCM-related SCD, ICD placement is reasonable after considering the potential complications of long-term ICD placement.

2a

B-NR

ICD implantation may be considered in patients with HCM without the above risk factors but with secondary risk factors for SCA such as extensive LGE cardiac MRI or systolic dysfunction.

2b

B-NR

ICD implantation is not indicated in patients with an identified HCM genotype in the absence of known pediatric SCA risk factors.

3:Harm

C-LD

ICD implantation is indicated in patients with ACM who have been resuscitated from SCA or sustained VT that is not hemodynamically tolerated.

I

B-NR

ICD implantation is reasonable in patients with ACM with hemodynamically tolerated sustained VT, syncope presumed due to ventricular arrhythmia, or an LVEF ≤35%.

2a

B-NR

ICD implantation may be considered in patients with inherited ACM associated with increased risk of SCD based on an assessment of additional risk factors.

2b

C-LD

ICD implantation is indicated in patients with NIDCM who either survive SCA or experience sustained VT not due to completely reversible causes.

I

B-NR

ICD implantation may be considered in patients with NIDCM and syncope or an LVEF ≤35%, despite optimal medical therapy.

2b

C-LD

ICD implantation is not recommended in patients with medication-refractory advanced heart failure who are not  cardiac transplantation or left ventricular assist device candidates.

3:Harm

C-EO

ICD therapy is not indicated for patients with advanced heart failure who are urgently listed for cardiac transplantation and will remain in the hospital until transplantation, even if they meet ICD implantation criteria specified in the above recommendations.

3: No benefit

C-EO

ICD implantation is indicated for CHD patients who are survivors of SCA after evaluation to define the cause of the event and exclude any completely reversible causes.

I

B-NR

ICD implantation is indicated for CHD patients with hemodynamically unstable sustained VT who have undergone hemodynamics and EP evaluation.

I

C-LD

ICD implantation is reasonable for CHD patients with systemic LVEF <35% and sustained VT or presumed arrhythmogenic syncope.

2a

C-LD

ICD implantation may be considered for CHD patients with spontaneous hemodynamically stable sustained VT who have undergone hemodynamic and EP evaluation.

2b

C-EO

ICD implantation may be considered for CHD patients with unexplained syncope in the presence of ventricular dysfunction, nonsustained VT, or inducible ventricular arrhythmias at EP study.

2b

C-LD

ICD implantation may be considered for CHD patients with a single or systemic right ventricular ejection fraction≤35%, particularly in the presence of additional risk factors such as VT, arrhythmic syncope, or severe systemic AV valve insufficiency.

2b

C-EO

ACM: arrhythmogenic cardiomyopathy; AV: atrioventricular; B-NR: moderate, non-randomized; BrS: Brugada syndrome; C-EO: consensus of expert opinion; CHD: coronary heart disease; C-LD: limited data; COR: class of recommendation; CPVT: catecholaminergic polymorphic ventricular tachycardia; ECG: electrocardiogram; EP: electrophysiology; HCM: hypertrophic cardiomyopathy; ICD: implantable cardioverter defibrillator; LGE: late gadolinium-enhanced; LOE: level of evidence; LQTS: long QT syndrome; LVEF: left ventricular ejection fraction; MRI: magnetic resonance imaging; NIDCM: non-ischemic dilated cardiomyopathy; SCA: sudden cardiac arrest; SCD: sudden cardiac death; VF: ventricular fibrillation; VT: ventricular tachycardia.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Ventricular fibrillation (VF), ventricular tachycardia (VT), defibrillator, automatic implantable cardioverter defibrillator (AICD), Subcutaneous ICD, S-ICD® system, SICD, transvenous ICD, TVICD, TV-ICD

APPROVED BY GOVERNING BODIES:

Transvenous Implantable Cardioverter Defibrillators

A large number of ICDs have been approved by FDA 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 (7 pulse generators, 3 leads, 9 combined systems) through new PMA applications. Many originally approved ICDs have received multiple supplemental applications. A selective summary of some currently available ICDs is provided below.

Subcutaneous ICDs

In 2012, the Subcutaneous Implantable Defibrillator (S-ICD™) System was approved by FDA through the PMA process for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant VT, or spontaneous, frequently recurring VT that is reliably terminated with antitachycardia pacing (see table below).

In 2015, the Emblem™ S-ICD (Boston Scientific), which is smaller and longer-lasting than the original S-ICD, was approved by FDA through the PMA supplement process.

In February 2021, Boston Scientific issued a recall of the Emblem S-ICD because of increased risk of device fractures. FDA designated the recall a Class I event, the most serious type of recall, indicating a situation in which there is a reasonable probability that the use of the device may cause serious injuries or death.

Implantable Cardioverter Defibrillators With FDA Approval

Device

Manufacturer

Original PMA Approval Date

Transvenous

 

 

Ellipse™/Fortify Assura™ Family (originally: Cadence Tiered Therapy Defibrillation System)

St. Jude Medical

Jul 1993

Current® Plus ICD (originally: Cadence Tiered Therapy Defibrillation System)

St. Jude Medical

Jul 1993

Dynagen™, Inogen™, Origen™, and Teligen® Family (originally: Ventak, Vitality, Cofient family)

Boston Scientific

Jan 1998

Evera™ Family (originally: Virtuosos/Entrust/Maximo/ Intrisic/Marquis family)

Medtronic

Dec 1998

Subcutaneous

 

 

Subcutaneous Implantable Defibrillator System (S-ICD™)

Cameron Health; acquired by Boston Scientific

Sep 2012

FDA: Food and Drug Administration; PMA: premarket application

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will review for medical necessity.

CURRENT CODING: 

CPT Codes:

33215

Repositioning of previously implanted transvenous pacemaker or implantable defibrillator (right atrial or right ventricular) electrode

33216

Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator

33217

Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator

33218

Repair of single transvenous electrode, permanent pacemaker or pacing implantable defibrillator

33220

 

Repair of two transvenous electrodes for permanent pacemaker or pacing implantable defibrillator

33223

Revision of skin pocket for implantable defibrillator

33230

Insertion of implantable defibrillator pulse generator only; with existing dual leads

33231

Insertion of implantable defibrillator pulse generator only; with existing multiple leads

33240

Insertion of - implantable defibrillator pulse generator only; with existing single lead

33241

Removal of pacing cardioverter-defibrillator pulse generator only

 

33243

Removal of single or dual chamber implantable defibrillator electrode(s); by thoracotomy

33244

;by transvenous extraction

33249

Insertion or replacement of permanent implantable defibrillator system with transvenous lead(s), single or dual chamber

33262

 

Removal of implantable defibrillator pulse generator with replacement of implantable defibrillator pulse generator; single lead system

 

33263

;dual lead system

33264

; multiple lead system

33270

Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed

 

33271

Insertion of subcutaneous implantable defibrillator electrode

33272

Removal of subcutaneous implantable defibrillator electrode

33273

Repositioning of previously implanted subcutaneous implantable defibrillator electrode

93260

Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system

93261

Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system

93282 –

93284

Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional, codes specific to the type of device

93287

Peri-procedural device evaluation(in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or other qualified health care professional; single, dual, or multiple lead implantable defibrillator system

93289

Interrogation device evaluation (in person) with analysis, review and report, by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; single, dual, or multiple lead transvenous implantable defibrillator system, including analysis of heart rhythm derived data elements

 

93295 –

93297

Interrogation device evaluation(s) (remote), up to 90 days

93640 -93644

Electrophysiologic evaluation

0571T

Insertion or replacement of implantable cardioverter-defibrillator system with substernal electrode(s), including all imaging guidance and electrophysiological evaluation (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters), when performed (Effective 01/01/2020)

0572T

Insertion of substernal implantable defibrillator electrode (Effective 01/01/20)

0573T

Removal of substernal implantable defibrillator electrode (Effective 01/01/20)

0574T

Repositioning of previously implanted substernal implantable defibrillator-pacing electrode (Effective 01/01/20)

0575T

Programming device evaluation (in person) of implantable cardioverter-defibrillator system with substernal electrode, with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional (Effective 01/01/20)

0576T

Interrogation device evaluation (in person) of implantable cardioverter-defibrillator system with substernal electrode, with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter (Effective 01/01/20)

0577T

Electrophysiologic evaluation of implantable cardioverter-defibrillator system with substernal electrode (includes defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters) (Effective 01/01/20)

0578T

Interrogation device evaluation(s) (remote), up to 90 days, substernal lead implantable cardioverter-defibrillator system with interim analysis, review(s) and report(s) by a physician or other qualified health care professional (Effective 01/01/20)

0579T

Interrogation device evaluation(s) (remote), up to 90 days, substernal lead implantable cardioverter-defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results (Effective 01/01/20)

0580T

Removal of substernal implantable defibrillator pulse generator only (Effective 01/01/20)

0614T

Removal and replacement of substernal implantable defibrillator pulse generator (Effective 07/01/2020)

 

HCPCS:

G0448

Insertion or replacement of a permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber with insertion of pacing electrode, cardiac venous system, for left ventricular pacing

 

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  98. Olde Nordkamp LR, Brouwer TF, Barr C, et al. Inappropriate shocks in the subcutaneous ICD: Incidence, predictors and management. Int J Cardiol. Sep 15 2015; 195:126-133.
  99. Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol 2012; 60(19):1933-9.
  100. Olde Nordkamp LR, Postema PG, Knops RE, et al. Implantable cardioverter-defibrillator harm in young patients with inherited arrhythmia syndromes: A systematic review and meta-analysis of inappropriate shocks and complications. Heart Rhythm. Feb 2016; 13(2):443-454.
  101. Ommen SR, Mital S, Burke MA, et al. 2020 AHA/ACC Guideline for the Diagnosis and Treatment of Patients With HypertrophicCardiomyopathy: Executive Summary: A Report of the American College of Cardiology/American Heart Association JointCommittee on Clinical Practice Guidelines. Circulation. Dec 22 2020; 142(25): e533-e557.
  102. Pedersen SS, Mastenbroek MH, Carter N, et al. A comparison of the quality of life of patients with an entirely subcutaneous implantable defibrillator system versus a transvenous system (from the EFFORTLESS S-ICD Quality of Life Substudy). Am J Cardiol. Aug 15 2016; 118(4):520-526.
  103. Persson R, Earley A, Garlitski AC, et al. Adverse events following implantable cardioverter defibrillator implantation: a systematic review. J Interv Card Electrophysiol. Aug 2014; 40(2):191-205.
  104. Pettit SJ, McLean A, Colquhoun I, et al. Clinical experience of subcutaneous and transvenous implantable cardioverter defibrillators in children and teenagers. Pacing Clin Electrophysiol. Dec 2013; 36(12):1532-1538.
  105. Phang RS, Kang D, et al. High risk of ventricular arrhythmias in patients with nonischemic dilated cardiomyopathy presenting with syncope. American Journal of Cardiology, February 2006, Vol. 97, No. 3.
  106. Plitt A, Dorbala S, Albert MA, et al. Cardiac sarcoidosis: case report, workup, and review of the literature. Cardiol Ther. Dec 2013; 2(2): 181-97.
  107. Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation. Oct 19 2010; 122(16):1553-1561.
  108. Poole JE, Gold MR.  Who should receive the subcutaneous implanted defibrillator?:  The subcutaneous implantable cardioverter defibrillator (ICD) should be considered in all ICD patients who do not require pacing.  Available at: www.circep.ahajournals.org/content/6/6/1236.
  109. Priori SG, Blomstrom-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. Nov 1 2015; 36(41):2793-2867.
  110. Priori SG, Wilde AA, Horie M, et al. HRS/EHRA/APHRS expert consensus statement on the diagnosis and management of patients with inherited primary arrhythmia syndromes: document endorsed by HRS, EHRA, and APHRS in May 2013 and by ACCF, AHA, PACES, and AEPC in June 2013. Heart Rhythm. Dec 2013; 10(12):1932-1963.
  111. Providencia R, Kramer DB, Pimenta D, et al. Transvenous implantable cardioverter-defibrillator (ICD) lead performance: a meta-analysis of observational studies. J Am Heart Assoc. Nov 2015; 4(11).
  112. Raviele A BM, 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):327-37.
  113. Ricci RP, Pignalberi C, Magris B et al. Can we predict and prevent adverse events related to high-voltage implantable cardioverter defibrillator lead failure? J Interv Card Electrophysiol 2012; 33(1):113-21.
  114. 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.
  115. Roses-Noguer F, Jarman JW, Clague JR, et al. Outcomes of defibrillator therapy in catecholaminergic polymorphic ventricular tachycardia. Heart Rhythm. Jan 2014; 11(1):58-66.
  116. Schinkel AF, Vriesendorp PA, Sijbrands EJ, et al. Outcome and complications after implantable cardioverter defibrillator therapy in hypertrophic cardiomyopathy: systematic review and meta-analysis. Circ Heart Fail. Sep 01 2012; 5(5):552-559.
  117. Shah MJ, Silka MJ, Silva JNA, et al. 2021 PACES Expert Consensus Statement on the Indications andManagement of Cardiovascular Implantable Electronic Devices in Pediatric Patients: Developed in collaborationwith and endorsed by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the AmericanHeart Association (AHA), and the Association for European Paediatric and Congenital Cardiology (AEPC)Endorsed by the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and theLatin American Heart Rhythm Society (LAHRS). JACC Clin Electrophysiol. Nov 2021; 7(11): 1437-1472.
  118. 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 2012; 18(9):675-81.
  119. Silka M KJ, Dunnigan A et al. Sudden cardiac death and the use of implantable cardioverter-defibrillators in pediatric patients. Circulation 1993; 87(3):800-7.
  120. Smit J KE, Schonheyder HC. Infections associated with permanent pacemakers and implanted cardioverter-defibrillator devices. A 10-year regional study in Denmark. Scand J Infect Dis 2010; 42(9):658-64.
  121. Sohail MR, Hussain S, Le KY et al. Risk factors associated with early- versus late-onset implantable cardioverter-defibrillator infections. J Interv Card Electrophysiol 2011; 31(2):171-83.
  122. Stavrakis S, Asad Z, Reynolds D. Implantable cardioverter defibrillators for primary prevention of mortality in patients with non-ischemic cardiomyopathy: a meta-analysis of randomized controlled trials. J Cardiovasc Electrophysiol. Mar 18 2017.
  123. Steinbeck G, Andersen D, et al. Defibrillator implantation early after myocardial infarction. NEJM, October 2009, Vol. 361, No. 15, pp. 1427-1436.
  124. Sterns LD, Meine M, Kurita T, et al. Extended detection time to reduce shocks is safe in secondary prevention patients: the secondary prevention sub-study of PainFree SST. Heart Rhythm. Mar 14 2016.
  125. Steven D, Roberts-Thomson KC, Inada K, et al. Long-term follow-up in patients with presumptive Brugada syndrome treated with implanted defibrillators. J Cardiovasc Electrophysiol. Oct 2011; 22(10):1115-1119.
  126. Strickberger SA, Hummel JD, Bartlett TG, et al. Amiodarone versus implantable cardioverter-defibrillator:randomized trial in patients with nonischemic dilated cardiomyopathy and asymptomatic nonsustained ventricular tachycardia--AMIOVIRT. J Am Coll Cardiol. May 21 2003; 41(10):1707-1712.
  127. Tan VH, Wilton SB, Kuriachan V, et al. Impact of programming strategies aimed at reducing nonessential implantable cardioverter defibrillator therapies on mortality: a systematic review and meta-analysis. Circ Arrhythm Electrophysiol. Feb 2014; 7(1):164-170.
  128. Theuns DA, Crozier IG, Barr CS, et al. Longevity of the subcutaneous implantable defibrillator: long-term follow-up of the European Regulatory Trial cohort. Circ Arrhythm Electrophysiol. Oct 2015; 8(5):1159-1163.
  129. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm AbnormalitiesA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2013; 61(3):e6-e75.
  130. Towbin JA, McKenna WJ, Abrams DJ, et al. 2019 HRS expert consensus statement on evaluation, risk stratification, and management of arrhythmogenic cardiomyopathy. Heart Rhythm. Nov 2019; 16(11): e301-e372.
  131. U. S.  Food and Drug Administration.  Summary of Safety and Effectiveness Data, P010031b, InSync® ICD.  www.fda.gov/cdrh/pdf/P010031b.doc.
  132. U.S. Food and Drug Administration.  Summary of Safety and Effectiveness Data, P01012b, Contak CD CRT-D.  www.fda.gov/cdrh/pdf/P010012b.pdf.
  133. U.S. Food and Drug Administration. Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.: FDA Safety Communication. 2014; www.fda.gov/medicaldevices/safety/alertsandnotices/ucm314930.htm. Accessed September, 2014.
  134. 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.
  135. van Rees JB, de Bie MK, Thijssen J, et al. Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices: a systematic review of randomized clinical trials. J Am Coll Cardiol. Aug 30 2011; 58(10):995-1000.
  136. van Rees JB, et al.  Inappropriate implantable cardioverter-defibrillator shocks.  Journal of the American College of Cardiology 2011; 57:556-562.
  137. Wasiak M, Tajstra M, Kosior D, et al. An implantable cardioverter-defibrillator for primary prevention in non-ischemiccardiomyopathy: A systematic review and meta-analysis. Cardiol J. Apr 12 2021.
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POLICY HISTORY:

Medical Policy Group, June 2004 (4)

Medical Policy Administration Committee, July 2004

Available for comment July 12-August 25, 2004

Medical Policy Group, February 2006 (1)

Medical Policy Administration Committee, February 2006

Available for comment March 4-April 17, 2006

Medical Policy Group, May 2006 (4)

Medical Policy Administration Committee, June 2006

Available for comment June 3-July 17, 2006

Medical Policy Group, September 2006 (2)

Medical Policy Administration Committee, September 2006

Available for comment September 22-November 5, 2006

Medical Policy Group, August 2008 (1)

Medical Policy Administration Committee, August 2008

Available for comment August 13-September 26, 2008

Medical Policy Group, October 2008 (1)

Medical Policy Administration Committee, October 2008

Available for comment October 22-December 6, 2008

Medical Policy Group, October 2009 (1)

Medical Policy Group, October 2010 (1): No literature updates available, no change in policy statement for wearable cardioverter-defibrillator

Medical Policy Group, April 2011; Updated Key Points (2011) and References

Medical Policy Group October 2011 (1): Update to Key Points and References; no change in policy statement

Medical Policy Group, December 2011 (1): 2012 Code revisions (3) and additions (1)

Medical Policy Group, April 2012: (3): Policy change for wearable defibrillators, Reference

Medical Policy Administration Committee April 2012

Available for comment April 12 through May 28, 2012

Medical Policy Group, December 2012 (3): 2013Coding updates: Added range of codes 0319T through 0328T; Verbiage update to Codes 93287, 93289, 93292, and 93745.

Medical Policy Group, December 2012 (4): Added sub q defibrillator to Policy, updated Description, Key Points, Approved Governing Bodies, Key Words and References.

Medical Policy Administration Committee February 2013

Available for comment February 21 through April 7, 2013

Medical Policy Group, July 2014 (4): Removed portions of policy #168 relating to wearable/external cardioverter defibrillators which are now located on policy #557.  Added an indication to policy statement excluding reversible causes, such as acute ischemia, prior to implanting the defibrillator. Also updated Description, Key Points and References.

Medical Policy Administration Committee, August 2014

Available for comment July 24 through September 6, 2014

Medical Policy Panel, October 2014

Medical Policy Group, October 2014 (3): 2014 Updates to Description, Key Points, Governing Bodies & References; no change in policy statement

Medical Policy Group, November 2014: 2015 Annual Coding update. Added CPT codes 33270-33273, 93260, 93261, 93644 and moved to Previous Coding 0319T-0328T: Updated CPT 33240 to change from pacing cardioverter to implantable defibrillator. Also, removed ‘physician’ and ‘cardioverter’ in CPT 93287 and 93289. Added ‘transvenous’ to code 93289. (mc)

Medical Policy Group, April 2015 (4):  Update to References.

Medical Policy Group, June 2015 (4):  Update to Policy Statement.  Added coverage criteria for S-ICD.  Update to Key Points, Key Words and References.

Medical Policy Administration Committee, June 2015

Available for comment June 10 through July 25, 2015

Medical Policy Panel, October and November 2015

Medical Policy Group, January 2016 (4): Updates to Description, Key Points, Key Words, Approved Governing Bodies and References. Policy section updated for TV-ICD. Added primary and secondary prevention; added coverage indications for TV-ICD in adult and pediatrics; added investigational indications for primary and secondary prevention statements.

Medical Policy Administration Committee, January 2016

Available for comment January 14 through February 28, 2016

Medical Policy Panel, May 2016

Medical Policy Group, June 2016 (4):  Updates to Description, Key Points, Coding and References. Moved HCPCS code G0300 to previous coding.

Medical Policy Panel, May 2017

Medical Policy Group, June 2017 (4): Updates to Description, Key Points, and References.  No change to policy statement.

Medical Policy Panel, May 2018

Medical Policy, June 2018 (4): Updates to Description, Key Points, Policy, and References. Policy statements removed effective for dates of service prior to June 15, 2015 and Previous Coding removed for dates of service prior to January 1, 2015. No change to policy statements.

Medical Policy Group, February 2019 (4): Updated medical policy statement regarding guideline directed medical therapy. Removed policy statements for effective dates of service June 15, 2015 through February 28, 2016.

Medical Policy Administrative Committee: March 2019

Available for comment February 27, 2019 – April 15, 2019

Medical Policy Panel, May 2019

Medical Policy Group, May 2019 (4): Updates to Key Points.  No change to policy statements.

Medical Policy Group, December 2019 (4): 2020 Annual Coding Update.  Added new CPT codes 0571T – 0580T to Current Coding.

Medical Policy Group, June 2020: Quarterly Coding Update.  Added new CPT code 0614T to Current Coding.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4): Updates to Key Points and References. No change to policy statements. Added CPT codes 93282 -93284, 93295 – 93297, and 93640 – 93643 to Current Coding.  Removed CPT codes 33224 and 33225 from Current Coding.

Medical Policy Group, November 2020: 2021 Annual Coding Update.  Revised CPT code 0577T but updating “electrophysiological” to “electrophysiologic”.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021 (4): Updates to Key Points, Approved by Governing Bodies, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent. The following references were removed:  Gregoratos G, Abrams J, Epstein AE, et al. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Gruberg Luis. DEFINITE: Defibrillators in non-ischemic cardiomyopathy treatment evaluation; Heidenreich PA, Keeffee B, McDonald KM and Hlatky MA. Overview of randomized trials of antiarrhythmic drugs and devices for the prevention of sudden cardiac death; Multicenter Automatic Defibrillator Implantation Trial (MADIT): Design and clinical protocol; Wilber DJ, Zareba W, Hall WJ, et al.  Time dependence of mortality risk and defibrillator benefit after myocardial infarction; Antzelevitch C, Brugada P, Borggrefe M, et al. Brugada Syndrome: Report of the Second Consensus Conference; Theuns D, Klootwijk A, Peter J, et al.  Clinical variables predicting inappropriate use of implantable cardioverter-defibrillator in patients with coronary heart disease or nonischemic dilated cardiomyopathy.

Medical Policy Panel, May 2022

Medical Policy Group, June 2022 (4): Updates to Policy statements, Key Points and References. 

Removed policy statements effective for dates of service on and after February 29, 2016 through April 15, 2019.  Added coverage criteria for ICD for “CABG or PCI with angioplasty and/or stenting within the past 3 months, or Have 1 or more clinical  symptoms or findings that would make the patient a candidate for coronary revascularization within 3 months (e.g. MI within past 60 days, decompensated CHF, multi-vessel CAD, unstable angina, cardiac stress testing indicating CABG is needed, abnormal heart rhythm, shortness of breath)” and removed “or heart disease from Nonischemic dilated cardiomyopathy criteria statement.  Also specified criteria coverage for SICD for adults and children and clarified “inadequate vascular access or young patient with likely need for long-term hemodialysis. Removed the following references: Adams KF, et al. Heart Failure Society of America. Electrophysiologic testing and the use of devices in heart failure. J Card Fail 2006; Al-Khatib SM, et al. Non-Evidence-Based ICO implantations in the United States. JAMA Jan 2011; 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 and 2004.

Medical Policy Administration Committee: May 2022

Available for Comment: June 1, 2022 – July 16, 2022

 

 

 

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract.

Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.